Exhibit 4.4


 


 


 


Mind Medicine (MindMed) Inc.


 


Annual Information Form


 


For the year ended December 31, 2020


 


Dated March 29, 2021


 






    			 



     


    







 


TABLE OF CONTENTS


 


	GLOSSARY	 	 	1	 
	MEANING OF CERTAIN REFERENCES AND CURRENCY INFORMATION	 	 	8	 
	MARKET AND INDUSTRY DATA	 	 	8	 
	CAUTIONARY STATEMENT REGARDING FORWARD LOOKING INFORMATION	 	 	9	 
	CORPORATE STRUCTURE	 	 	10	 
	GENERAL DEVELOPMENT OF THE BUSINESS	 	 	11	 
	DESCRIPTION OF THE BUSINESS	 	 	14	 
	RISK FACTORS	 	 	46	 
	DIVIDENDS AND DISTRIBUTIONS	 	 	72	 
	DESCRIPTION OF CAPITAL STRUCTURE	 	 	72	 
	MARKET FOR SECURITIES	 	 	75	 
	ESCROWED SECURITIES AND SECURITIES SUBJECT TO CONTRACTUAL RESTRICTION ON TRANSFER	 	 	77	 
	DIRECTORS AND OFFICERS	 	 	78	 
	PROMOTERS	 	 	83	 
	LEGAL PROCEEDINGS AND REGULATORY ACTIONS	 	 	84	 
	INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS	 	 	84	 
	TRANSFER AGENT AND REGISTRAR	 	 	84	 
	MATERIAL CONTRACTS	 	 	84	 
	INTERESTS OF EXPERTS	 	 	84	 
	ADDITIONAL INFORMATION	 	 	85	 
	Appendix “A” – AUDIT COMMITTEE CHARTER OF MIND MEDICINE (MINDMED) inc.	 	 	A-1	 




 






    			 



     


    







 


GLOSSARY


 


“18-MC”
means 18-methoxycoronaridine;


 


“18-MC Program” means the drug
development project for 18-MC;


 


“1934
Act” has the meaning ascribed thereto under the section entitled “Description of Capital Structure”;


 


“ACA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“ACMS” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“ADHD”
means attention deficit/hyperactivity disorder;


 


“Addiction
Treatment Program” mean the Corporation’s program investigating the use of hallucinogenic and non-hallucinogenic treatments
for addiction;


 


“Additional
Escrowed Securities” has the meaning ascribed thereto under the section entitled “Escrowed Securities and Securities
Subject To Contractual Restriction On Transfer”;


 


“Agent”
has the meaning ascribed thereto under the section entitled “Escrowed Securities and Securities Subject to Contractual
Restriction on Transfer”;


 


“AIF”
or “Annual Information Form” means this annual information form of the Corporation for the year ended December 31,
2020;


 


“Albert”
has the meaning ascribed thereto under the section entitled “Description of the Business”;


 


“Arrangement”
has the meaning ascribed thereto under the section entitled “General Development of the Business”;


 


“Arrangement
Agreement” means the arrangement agreement dated as of October 15, 2019 between Broadway, Madison Metals, Delaware
Subco and MindMed US, including the schedules thereto, providing for, among other things, the Transaction;


 


“ARTG” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“AWV” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“Banned Substances” has the
meaning ascribed thereto under the section entitled “Description of the Business – Government Regulation”;


 


“BCBCA” means the Business
Corporations Act (British Columbia) and the regulations thereunder, as amended from time to time;


 


“Beneficial
Ownership Limitation” has the meaning ascribed thereto under the section entitled “Description of Capital Structure”;


 


“BID” means twice a day, from
the Latin phrase bis in die;


 


“Board” means the board of
directors of the Corporation;


 


“Broadway” means Broadway Gold
Mining Ltd., the name of the Corporation prior to completion of the Transaction;


 


“Canaccord” means Canaccord
Genuity Corp.;


 






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“CAT” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“CC” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“CCPA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“CDC”
means the U.S. Centers for Disease Control and Prevention;


 


“cGMP” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“CHMP” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“Clarocity” has the meaning
ascribed there under the section entitled “Directors and Officers”;


 


“Class A Shares” means
the Class A common shares in the capital of MindMed US;


 


“Class B Shares” means
the Class B common shares in the capital of MindMed US;


 


“Class C Shares” means
the Class C common shares in the capital of MindMed US;


 


“Class D Shares” means
the Class D common shares in the capital of MindMed US;


 


“ClinO” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“CMOs” means contract manufacturing
organizations;


 


“Code” means U.S. Internal
Revenue Code of 1986, as amended;


 


“Compensation Warrants” has
the meaning ascribed thereto under the section entitled “General Development of the Business”;


 


“Consolidation” means the consolidation
of all of the issued and outstanding common shares of Broadway on an eight-for-one basis;


 


“Conversion
Ratio” has the meaning ascribed thereto under the section entitled “Description of Capital Structure”;


 


“CROs” means prospective contract
research organizations;


 


“CSA” means the Controlled
Substances Act of 1970 of the United States;


 


“CTN” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“DEA” means the U.S. Drug Enforcement
Administration;


 


“December Offering” means
the “bought deal” short form prospectus offering by the Corporation of December Offering Units completed on December 11,
2020;


 


“December Offering
Compensation Options” means the compensation options issued in connection with the December Offering exercisable
into December Offering Units at a price of $1.90 per December Offering Unit until December 11, 2023;


 






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“December Offering
Unit” means the units issued in connection with the December Offering at a price per unit of $1.90 consisting of
one Subordinate Voting Share and one-half of one December Offering Warrant;


 


“December Offering
Warrant” means the warrants partially comprising the December Offering Units which entitle the holder thereof to
purchase one Subordinate Voting Share at an exercise price of $2.45 until December 11, 2023;


 


“December Underwriting Agreement”
means the underwriting agreement dated November 27, 2020 among the Corporation, Canaccord and Eight Capital and entered into in connection
with the December Offering;


 


“Delaware Subco” means Broadway
Delaware Subco Inc.;


 


“DMT”
means N,N-Dimethyltryptamine;


 


“DPA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“DSCA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“EEA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“EFPIA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“Eight Capital” means Eight
Capital;


 


“EMA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“Escrowed
Securities” has the meaning ascribed thereto under the section entitled “Escrowed Securities and Securities
Subject to Contractual Restriction on Transfer”;


 


“EU” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“Exchange Ratio” has the meaning
ascribed thereto under the section entitled “General Development of the Business”;


 


“FC” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“FCA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“FDA” means the U.S. Food and
Drug Administration;


 


“FDC” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“FDCA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“FFC
Act” means the U.S. Federal Food, Drug, and Cosmetic Act;


 


“FOPH” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 






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“Foreign Private Issuer” has
the meaning ascribed thereto under the section entitled “Risk Factors”;


 


“forward-looking information”
has the meaning ascribed thereto under the section entitled “Cautionary Statement Regarding Forward-Looking Information”;


 


“Foundational
Agreement” means the foundational agreement entered into by Savant, Liquidity Holdings LLC, LDL Corp., and MindMed US on July 23,
2019;


 


“FPI
Condition” has the meaning ascribed thereto under the section entitled “Description of Capital Structure”;


 


“FWB”
means the Börse Frankfurt - Frankfurt Stock Exchange in Germany;


 


“GCP” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“GDPR” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“GLP” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“GMP” means the FDA’s
current Good Manufacturing Practices;


 


“HealthMode” means HealthMode, Inc.,
the wholly-owned subsidiary of the Corporation following the Merger;


 


“HealthMode
Escrowed Securities” has the meaning ascribed thereto under the section entitled “Escrowed Securities and Securities
Subject to Contractual Restriction on Transfer”;


 


“HCP” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“HCO” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“HHS”
means the Department of Health and Human Services of the United States;


 


“HIPAA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“HITECH” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“HRA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“HREC” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“ICH” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“IFRS” means International
Financial Reporting Standards as issued by the International Accounting Standards Board, as incorporated in the CPA Canada Handbook at
the relevant time applied on a consistent basis;


 


“IND” means an investigational
new drug application;


 


“IRS” means the Internal Revenue
Service;


 


“IRB” means institutional review
board;


 






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“ITO” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“January Offering” means
the “bought deal” short form prospectus offering by the Corporation of January Offering Units completed on January 7,
2021;


 


“January Offering
Compensation Options” means the compensation options issued in connection with the January Offering exercisable
into January Offering Units at a price of $5.75 per January Offering Unit until January 7, 2024;


 


“January Offering
Units” means the units issued in connection with the January Offering at a price per unit of $4.40 consisting of
one Subordinate Voting Share and one-half of one January Offering Warrant;


 


“January Offering
Warrants” means the warrants partially comprising the January Offering Units which entitle the holder thereof to
purchase one Subordinate Voting Shares at an exercise price of $5.75 per share until January 7, 2024;


 


“January Underwriting Agreement”
means the underwriting agreement dated December 18, 2020, as amended and restated on December 31, 2020, among the Corporation,
Canaccord, Eight Capital and CIBC World Markets Inc. and entered into in connection with the January Offering;


 


“Leahy-Smith Act” means the
Leahy-Smith America Invents Act;


 


“Lock-Up
Terms” has the meaning ascribed thereto under the section entitled “Escrowed Securities and Securities Subject
to Contractual Restriction on Transfer”;


 


“LSD” means lysergic acid diethylamide;


 


“MA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“MAA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“MAD” means multiple ascending
dose;


 


“Madison
Metals” means Madison Metals Inc., a corporation existing under the BCBCA;


 


“Madison Project” means the
Broadway and Madison mine project in the Butte-Anaconda region of Montana, a porphyry-based mining district, comprised of 450 acres of
land, a 192 acre ranch, buildings, mine equipment and fixtures, 6 patented, 35 unpatented mineral claims, and mineral rights to a four-square-mile
property;


 


“March Offering” means
the “bought deal” private placement offering by the Corporation of March Offering Units completed on March 9, 2021;


 


“March Offering
Compensation Options” means the compensation options issued in connection with the March Offering exercisable into
March Offering Units at a price of $3.25 per March Offering Unit until March 9, 2024;


 






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“March Offering Units”
means the units issued in connection with the March Offering at a price of $3.25 consisting of one Subordinate Voting Share and one-half
of one Subordinate Voting Share purchase warrant;


 


“March Offering
Warrant” means the warrants partially comprising the March Offering Units which entitle the holder thereof to purchase
one Subordinate Voting Share at an exercise price of $4.40 until March 9, 2024;


 


“May Offering” means the
 “bought deal” short form prospectus offering by the Corporation of May Offering Units completed on May 26, 2020;


 


“May Offering
Compensation Warrants” means the compensation warrants issued in connection with the May Offering exercisable into
Subordinate Voting Shares at a price of $0.53 per share until May 26, 2022;


 


“May Offering Units” means
the units issued in connection with the May Offering at a price per unit of $0.53 consisting of one Subordinate Voting Share and
one-half of one Subordinate Voting Share purchase warrant;


 


“May Offering
Warrants” means the warrants partially comprising the May Offering Units which entitle the holder thereof to purchase
one Subordinate Voting Share at an exercise price of $0.79 until May 26, 2022;


 


“May Underwriting Agreement”
means the underwriting agreement dated May 8, 2020 between the Corporation and Eight Capital and entered into in connection with
the May Offering;


 


“MD&A” means the Management
Discussion and Analysis of the Corporation;


 


“Merger” has the meaning ascribed
thereto under the section entitled “General Development of the Business”;


 


“Merger Agreement” has the
meaning ascribed thereto under the section entitled “General Development of the Business”;


 


“MindMed” or the “Corporation”
means Mind Medicine (MindMed) Inc., a corporation existing under the BCBCA;


 


“MindMed Australia” means MindMed
Pty Ltd., a corporation existing under the laws of Australia;


 


“MindMed Switzerland” means
MindMed Discover GmbH, a corporation existing under the laws of Switzerland;


 


“MindMed US” means Mind Medicine, Inc.,
a corporation existing under the laws of the State of Delaware;


 


“MindMed
US Offering” means the private placement by MindMed US, completed in tranches by way of (i) a commercially reasonable
efforts brokered private placement, and (ii) a non-brokered private placement, of MindMed US Class D Shares;


 


“MJDS” means the multijurisdictional
disclosure system established by National Instrument 71-101 – The Multijurisdictional Disclosure System;


 


“Multiple Voting Shares” means
the new class of multiple voting shares of the Corporation created by Broadway, immediately prior to the closing of the Transaction and
in connection with the Arrangement;


 


“MVS Offer” means an offer
to purchase Multiple Voting Shares;


 


“NarcA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“NDA” means a new drug application;


 


“NEO” means the Neo Exchange
Inc.;


 


“NIDA” means the U.S. National
Institute on Drug Abuse;


 


“NYU Langone Health” means
NYU Langone Health and the NYU Grossman School of Medicine;


 


“NYU Langone Training Program”
means the NYU Langone Health Psychedelic Medicine Clinical Training Program;


 


“Odyssey
Escrowed Securities” has the meaning ascribed thereto under the section entitled “Escrowed Securities and Securities
Subject To Contractual Restriction On Transfer”;


 


“October Offering” means
the “bought deal” short form prospectus offering by the Corporation of October Offering Units completed on October 30,
2020;


 






    6


     


    

 


“October Offering
Compensation Options” means the compensation options issued in connection with the October Offering exercisable
into October Offering Units at a price of $1.05 per October Offering Compensation Unit until October 30, 2023;


 


“October Offering Units”
means the units issued in connection with the October Offering at a price per unit of $1.05 consisting of one Subordinate Voting
Share and one-half of one October Offering Warrant;


 


“October Offering
Warrants” means the warrants partially comprising the October Offering Units which entitle the holder thereof to
purchase one Subordinate Voting Share at an exercise price of $1.40 until October 30, 2023;


 


“October Underwriting Agreement”
means the underwriting agreement dated December 18, 2020 between the Corporation and Canaccord and entered into in connection with
the October Offering;


 


“OTCQB”
means the OTCQB Venture Market in the United States;


 


“PDUFA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“PRIME” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“Prohibited
Imports Regulation” means the Customs (Prohibited Imports) Regulations of Australia;


 


“Project Flow” means the Corporation’s
clinical trial of LSD microdosing for adult ADHD;


 


“Project
Layla” means the Corporation’s initiative to develop a non-hallucinogenic version of the psychedelic ibogaine to
address the opioid crisis and other substance use disorders;


 


“Project
Lucy” means the Corporation’s drug development program for its LSD product candidate for anxiety
disorders;


 


“PSURs” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“R&D” means research and
development;


 


“REMS” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“RMP” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“RSM” means RSM Canada LLP;


 


“RSU Plan” means the restricted
share unit plan of the Corporation;


 


“RSUs” means restricted plan
units;


 


“Savant”
means Savant Addiction Medicine, LLC, a Delaware limited liability company;


 


“SEDAR” means the System for
Electronic Document Analysis and Retrieval;


 


“Shares” means the Multiple
Voting Shares and the Subordinate Voting Shares of the Corporation, collectively;


 


“SL” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 






    7


     


    

 


“Stock Options” has the meaning
ascribed thereto under the section entitled “Description of Capital Structure”;


 


“Stock Option Plan” means the
stock option plan established by the Corporation;


 


“Subordinate Voting Shares”
has the meaning ascribed thereto under the section entitled “General Description of the Business”;


 


“Swissmedic” has the meaning
ascribed thereto under the section entitled “Description of the Business – Government Regulation”;


 


“Tax
Act” means the Income Tax Act (Canada) and the regulations thereunder;


 


“Tax Cuts and Jobs Act” has
the meaning ascribed thereto under the section entitled “Risk Factors”;


 


“TGA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“Times Three” has the meaning
ascribed there under the section entitled “Directors and Officers”;


 


“TPA” has the meaning ascribed
thereto under the section entitled “Description of the Business – Government Regulation”;


 


“Transaction” has the meaning
ascribed thereto under the section entitled “Corporate Structure”;


 


“UHB
Liechti Lab” means the University Hospital Basel’s Liechti Lab;


 


“USPTO” means the United States
Patent and Trademark Office;


 


“USRPHC” means a United States
real property holding corporation within the meaning of Section 897(c)(2) of the Code;


 


“United
States” or “U.S.” means the United States of America, its territories and possessions, any State of
the United States and the District of Columbia; and


 


“Warrants” has the meaning
ascribed thereto under the heading “Description of Capital Structure”.


 


MEANING OF CERTAIN REFERENCES AND CURRENCY INFORMATION


 


In this Annual Information Form, unless the context
otherwise requires, the “Corporation” or “MindMed” refers to Mind Medicine (MindMed) Inc. together with its wholly-owned
subsidiaries.


 


This AIF applies to the business activities and
operations of the Corporation for the year ended December 31, 2020. Unless otherwise indicated, the information in this AIF is given
as of the date hereof.


 


Unless otherwise indicated, all references to
 “$” in this AIF refer to Canadian dollars and all references to “US$” in this AIF refer to United States dollars.


 


MARKET AND INDUSTRY DATA


 


Unless otherwise indicated, market data and certain
industry data and forecasts included in this AIF concerning the industry of the Corporation and the markets in which it operates or seeks
to operate were obtained from internal surveys, market research, publicly available information, reports of governmental agencies and
industry publications and surveys. MindMed has relied upon industry publications as its primary sources for third-party industry data
and forecasts. Industry surveys, publications and forecasts generally state that the information contained therein has been obtained from
sources believed to be reliable, but that the accuracy and completeness of such information is not guaranteed. MindMed has not independently
verified any of the data from third-party sources, nor has MindMed ascertained the underlying economic assumptions relied upon therein.
Similarly, industry forecasts and market research, which MindMed believes to be reliable based upon management’s knowledge of the
industry, have not been independently verified. By their nature, forecasts are particularly subject to change or inaccuracies, especially
over long periods of time. In addition, MindMed does not know what assumptions regarding general economic growth were used in preparing
the forecasts cited in this AIF or in the documents incorporated by reference herein. While MindMed is not aware of any misstatements
regarding the industry data presented herein, MindMed’s estimates involve risks and uncertainties and are subject to change based
on various factors, including those discussed under “Forward-Looking Statements” and “Risk Factors” in this AIF.
While MindMed believes its internal business research is reliable and market definitions are appropriate, neither such research nor definitions
have been verified by any independent source.


 






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CAUTIONARY STATEMENT REGARDING FORWARD LOOKING
INFORMATION


 


This AIF includes “forward-looking
information” and “forward-looking statements” within the meaning of applicable Canadian securities laws and United
States securities laws. All information, other than statements of historical facts, included in this AIF that addresses activities, events
or developments that the Corporation expects or anticipates will or may occur in the future is forward-looking information. Forward-looking
information is often identified by the words “may”, “would”, “could”, “should”, “will”,
 “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect”
or similar expressions and includes, among others, information regarding: the duration and effects of COVID-19 and any other pandemics
on the Corporation’s workforce, business, operations and financial condition; expectations of future loss and accumulated deficit
levels; projected financial position and estimated cash burn rate; requirements for, and the ability to obtain, future funding on favorable
terms or at all; projections for development plans and progress of each of MindMed’s product candidates, particularly with respect
to the timely and successful completion of studies and trials and availability of results from such studies and trials; expectations
about MindMed’s products’ safety and efficacy; expectations regarding MindMed’s ability to arrange for and scale up
the manufacturing of MindMed’s product candidates; expectations regarding the progress, and the successful and timely completion,
of the various stages of the regulatory approval process; expectations about the timing of achieving milestones and the cost of MindMed’s
development programs; plans to market, sell and distribute product candidates; expectations regarding the acceptance of the Corporation’s
product candidates by the market; MindMed’s ability to retain and access appropriate staff, management and expert advisers; expectations
about whether various clinical and regulatory milestones will be achieved; the Corporation’s ability to strictly comply with federal,
state, local and regulatory agencies in the United States and other jurisdictions in which the Corporation operates, including Australia,
Switzerland and the Netherlands; the Corporation’s expectation that jurisdictions in which the Corporation operates, including
Australia, Switzerland and the Netherlands, have similar regulatory frameworks as the United States; the Corporation’s expectations
of the costs and timing to reach commercial production of drug products; the Corporation’s ability to secure strategic partnerships
with academic research institutions and larger pharmaceutical and biotechnology companies; the Corporation’s continuation of strategic
collaborations; MindMed’s strategy to acquire and develop new product candidates and to enhance the safety and efficacy of existing
product candidates; expectations with respect to existing and future corporate alliances and licensing transactions with third parties,
and the receipt and timing of any payments to be made by the Corporation or to the Corporation in respect of such arrangements; the Corporation’s
strategy with respect to the expansion and protection of its intellectual property; and the Corporation’s evaluation of a potential
listing of the Subordinate Voting Shares on the NASDAQ and any regulatory approvals related thereto.




 





Readers are cautioned that forward-looking
information and statements are not based on historical facts but instead are based on reasonable assumptions and estimates of management
of the Corporation at the time they were provided or made and involve known and unknown risks, uncertainties and other factors which may
cause the actual results, performance or achievements of the Corporation, as applicable, to be materially different from any future results,
performance or achievements expressed or implied by such forward-looking information and statements. Such factors include, among others,
substantial fluctuation of losses from quarter to quarter and year to year due to numerous external risk factors, and anticipation that
the Corporation will continue to incur significant losses in the future; uncertainty as to the Corporation’s ability to raise additional
funding to support operations; the Corporation’s ability to generate product revenue to maintain its operations without additional
funding; fluctuation of foreign exchange rates; the duration of COVID-19 and the extent of its economic and social impact; psychedelic
inspired medicines may never be approved by regulator and the risks associated with violating any laws and regulations; the risks associated
with the development of the Corporation’s product candidates which are at early stages of development; the difficulty of researching
and developing drugs that target the central nervous system; consequences of the Corporation’s failure to comply with health and
data protection laws and regulations; difficulty in establishing the Corporation’s reputation and its brand recognition; compliance
with environmental, health and safety laws and regulations; unfavourable publicity or consumer perception; unfavourable future clinical
research results; heightened scrutiny by the United States and Canadian authorities; inaccurate information posted on social media platforms;
the Corporation’s reliance on the success of its product candidates; reliance on third parties to plan, conduct and monitor MindMed’s
preclinical studies and clinical trials; unforeseen disruption in the process of drug development activities; reliance on third party
contract manufacturers to deliver quality clinical and preclinical materials; requirements regarding commercial scale and quality manufactured
products; the Corporation’s product candidates may fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities
or may not otherwise produce positive results; delays in clinical testing; risks related to filing INDs to commence clinical trials and
to continue clinical trials if approved; the risks of delays and inability to complete clinical trials due to difficulties enrolling patients;
Corporation’s inability to obtain regulatory approval; risks associated with not achieving the Corporation’s milestones; competition
from other biotechnology and pharmaceutical companies; the Corporation’s reliance on the capabilities and experience of MindMed’s
key executives and scientists and the resulting loss of any of these individuals; misconduct or improper activities of the Corporation’s
employees, contractors, consultants and agents; the Corporation’s ability to fully realize the benefits of its acquisitions; the
inability to meet revenue targets of the Corporation’s investments; negative results from clinical trials; the novelty of psychedelics
and the potential resulting lack of information; product liability claims; the Corporation’s ability to maintain product liability
insurance; risks related to the Corporation’s information technology systems; the outbreak of infectious disease; difficulty of
enforcing judgements; the Corporation’s limited operating history; the Corporation’s ability to adequately protect its intellectual
property and trade secrets; the Corporation’s ability to source and maintain licenses from third-party owners; changes in patent
law; the risk of patent-related litigation; risks related to sharing trade secrets; volatility of biopharmaceutical companies’ securities;
the Corporation’s lack of dividends; risks related to various tax matters; the uncertainty of positive returns on the Corporation’s
securities; risks related to the sales or conversion of the Corporation’s Subordinate Voting Shares; failure of the Corporation
to maintain its internal controls; liquidity of the Corporation’s securities; risks related to the public markets; risks related
to additional issuances and dilution of the Corporation’s securities; risks related to the Corporation’s Foreign Private Issuer
status; risks related to the Corporation’s limited number of shareholders; risks related to the Corporation’s capital structure;
potential declines in trading prices; risks related to published research and reports; the costs associated with maintain public listings;
and other factors beyond the Corporation’s control, as more particularly described under the heading "Risk Factors"
in this AIF.

 






    9


     


    

 


Readers are cautioned that the foregoing list
is not exhaustive of all factors and assumptions which may have been used. Although the Corporation has attempted to identify important
factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated,
estimated or intended. There can be no assurance that such forward-looking information and statements will prove to be accurate as actual
results and future events could differ materially from those anticipated in such information and statements. Accordingly, readers should
not place undue reliance on forward-looking information and statements. The forward-looking information and statements contained herein
are presented for the purposes of assisting readers in understanding the Corporation’s expected financial and operating performance
and the Corporation’s plans and objectives and may not be appropriate for other purposes.


 


The forward-looking information and statements
contained in this AIF represent the Corporation’s views and expectations as of the date of this AIF and forward-looking information
and statements contained herein represent the Corporation’s views as of the date of hereof. The Corporation anticipates that subsequent
events and developments may cause its views to change. However, while the Corporation may elect to update such forward-looking information
and statements at a future time, it has no current intention of doing so except to the extent required by applicable law.


 


CORPORATE STRUCTURE


 


Name, Address and Incorporation


 


On February 27, 2020, the Corporation (formerly
existing as Broadway) completed a reverse takeover transaction (the “Transaction”) by way of plan of arrangement under
the BCBCA pursuant to the terms of the Arrangement Agreement between Broadway, Madison Metals, Delaware Subco, and MindMed US. The Corporation
is governed by the provisions of the BCBCA.


 


In connection with the Transaction, immediately
prior to the closing of the Transaction, the Corporation, among other things, changed its name to “Mind Medicine (MindMed) Inc.”


 


The
registered office and records office of the Corporation is located at 1166 Alberni Street, Suite 1604, Vancouver, British Columbia
V6E 3Z3, and the head office of the Corporation is located at One World Trade Center, Suite 8500, New York, New York 10007.
The principal address of MindMed US is 1325 Airmotive Way, Suite 175A, Reno, Nevada 89502 and the registered head office is 1209
Orange Street, Wilmington, Delaware 19801.


 






    10


     


    

 


Inter-Corporate Relationships


 


The
following diagram presents the inter-corporate relationships among the Corporation and its subsidiaries as of the date hereof.


 


 


 





 


On
May 30, 2019, MindMed US was incorporated under the laws of the State of Delaware. On February 27, 2020, pursuant to the Arrangement
Agreement, MindMed US merged with Delaware Subco under the corporate laws of Delaware. MindMed US is a wholly-owned subsidiary
of the Corporation.


 


On December 5, 2019, MindMed Australia was
incorporated under the laws of Australia. MindMed Australia is a wholly-owned indirect subsidiary of MindMed US.


 


On August 26, 2020, MindMed Switzerland was
incorporated under the laws of Switzerland. MindMed Switzerland is a wholly-owned subsidiary of the Corporation.


 


On February 16, 2021, MindMed Mergerco Inc.
was incorporated under the laws of the State of Delaware for the sole purpose of facilitating the merger with HealthMode, Inc. On
February 26, 2021, MindMed Mergerco Inc. merged with and into HealthMode, Inc. with the surviving corporation becoming a wholly-owned
subsidiary of the Corporation and changing its name to “HealthMode, Inc.”


 


GENERAL DEVELOPMENT OF THE BUSINESS


 


Prior
to the completion of the Transaction, Broadway was focused on the exploration and development of the Broadway and Madison mine
and the delineation of the porphyry source of their mineralization. The Corporation’s right, title and interest to the Madison Project
was spun-out to Madison Metals as part of the Transaction. Pursuant to the Transaction, Broadway disposed of the Madison Project and acquired
the business of MindMed US. As further described herein, MindMed is now a clinical stage psychedelic medicine biotech company developing
product candidates based on psychedelic substances through rigorous science and clinical trials.


 


The Transaction


 


Immediately prior to the closing of the Transaction
and in connection with the Arrangement, Broadway: (a) completed the Consolidation, (b) changed its name to “Mind Medicine
(MindMed) Inc.”, (c) reclassified its post-Consolidation common shares as subordinate voting shares (the “Subordinate
Voting Shares”), and (d) created the Multiple Voting Shares.


 






    11


     


    

 


Pursuant to the Arrangement, Delaware Subco merged
with MindMed US under the corporate laws of Delaware. All outstanding Class B Shares, Class C Shares and Class D Shares
were exchanged for Class A Shares, immediately following which the Class B Shares, Class C Shares and Class D Shares
exchanged for Class A Shares were exchanged, on a one-for-one basis (the “Exchange Ratio”) for Subordinate Voting
Shares of the Corporation, and all originally outstanding Class A Shares were exchanged on a one-for-one-hundredth basis for Multiple
Voting Shares, in accordance with the Arrangement Agreement. All Class A Shares were then cancelled pursuant to the Arrangement,
and MindMed US issued 1,000 shares of common shares to the Corporation as consideration for issuing the Shares to the (former) MindMed
US shareholders.


 


Pursuant
to the Arrangement Agreement, Broadway’s right, title and interest, and all associated liabilities in the Madison Project
were transferred to Madison Metals. Madison Metals is not related to the Corporation in any manner.


 


The Subordinate Voting Shares of the Corporation
were listed for trading on the NEO on March 3, 2020. The Corporation’s shares also trade on the OTCQB market and on the FWB.


 


History


 


On May 30, 2019, MindMed US was incorporated
under the laws of the State of Delaware. MindMed US’s program in addiction medicine received its initial funding in late 2012 in
the form of a non-dilutive, multi-million-dollar grant from the NIDA to the previous owner of a drug development project for 18-MC and
subsequently, the 18-MC Program, to support the filing of an IND application.


 


Pursuant to the Foundational Agreement, Savant
and Savant HWP, Inc., the previous owners of 18-MC, transferred their right, title and interest in 18-MC to MindMed US effective
July 23, 2019.


 


On September 24, 2019, MindMed US completed
a non-brokered offering of 45,972,630 Class C Shares and 15,000,0000 Class D Shares at a price of US$0.10 per share.


 


On
October 15, 2019, in connection with the Transaction, Broadway entered into the Arrangement Agreement among Broadway, MindMed US,
Delaware Subco and Madison Metals to complete a reverse-takeover of Broadway by way of plan of arrangement under the BCBCA (the
 “Arrangement”).


 


On
November 4, 2019, MindMed US entered into an engagement letter with Canaccord to complete the MindMed US Offering. On February 26,
2020, MindMed US completed the MindMed US Offering, in three tranches, issuing a total of 97,105,055 Class D Shares at a price of
$0.33 per share for aggregate gross proceeds of $32,044,668.05. In connection with the MindMed US Offering, MindMed US issued a total
of 6,797,354 Compensation Warrants exercisable into Class D Shares at a price of $0.33 per Compensation Warrant until March 3,
2021. Pursuant to the Transaction, the Compensation Warrants are exercisable into Subordinate Voting Shares.


 


On April 1, 2020, the Corporation announced
that it entered into a multi-year, branch exclusive collaboration with the laboratory of Professor Dr. Matthias Liechti, the world-leading
psychedelics pharmacology and clinical research group at University Hospital Basel in Switzerland. Pursuant to the agreement, MindMed
acquired exclusive worldwide rights to data, compounds, and patent rights associated with the Liechti Laboratory's research with LSD and
other psychedelic compounds, including data from preclinical studies and eight completed or ongoing LSD clinical trials.


 


On April 20, 2020, the Corporation announced
the appointment of Jeanne Bonelle as Executive Vice President of Technical Operations of the Corporation.


 


On
April 21, 2020, the Corporation announced that the UHB Liechti Lab discovered and filed a patent application falling under
the Corporation’s collaboration with the UHB Liechti Lab in the United States (preserving all worldwide rights) for a neutralizer
technology intended to shorten and stop the effects of an LSD trip during a therapy session.


 


On May 8, 2020, the Corporation entered into
a clinical trial agreement with Maastricht University to undertake a Phase 2a clinical trial for LSD in adult patients with ADHD.


 






    12


     


    

 


On May 26, 2020, MindMed completed the May Offering,
issuing a total of May Offering Units for aggregate gross proceeds of $13,255,540.50. Each May Offering Unit consisted of one
Subordinate Voting Share and one-half of one May Offering Warrant. Each May Offering Warrant entitles the holder thereof to
purchase one Subordinate Voting Share at an exercise price of $0.79 until May 26, 2022, subject to acceleration in certain circumstances.
In connection with the May Offering, MindMed issued a total of 994,034 May Offering Compensation Warrants exercisable into one
Subordinate Voting Share at a price of $0.53 per May Offering Compensation Warrant until May 26, 2022.


 


On June 2, 2020, the Corporation announced
the expansion of its Phase 2a clinic trial of LSD microdosing for adult patients with ADHD, with an additional clinical trial site and
principal investigator at the UHB Liechti Lab.


 


On June 4, 2020, the Corporation announced
the launch of Project Lucy, the Corporation’s drug development program for the treatment of anxiety disorders.


 


On June 8, 2020, the Corporation announced
the collaboration on a Phase 2 clinical trial evaluating LSD for the treatment of cluster headaches at the UHB Liechti Lab.


 


On July 28, 2020, the Corporation announced
the completion of dosing in a Phase 1 SAD study of 18-MC.


 


On August 6, 2020, the Corporation announced
the engagement of Dr. Peter Gasser as an advisor to Project Lucy.


 


On August 13, 2020, the Corporation announced
the appointment of Dr. Miriam Halperin Wernli as President of the Corporation.


 


On September 24, 2020, the Corporation announced
a research and development collaboration with the UHB Liechti Lab in a study to better understand and compare the altered states of consciousness
induced by psilocybin and LSD.


 


On October 30, 2020, MindMed completed the
October Offering, issuing a total of 27,381,500 October Offering Units for aggregate gross proceeds of $28,750,575. Each October Offering
Unit consisted of one Subordinate Voting Share and one-half of one October Offering Warrant. Each October Offering Warrant entitles
the holder thereof to purchase one Subordinate Voting Share at an exercise price of $1.40 until October 30, 2023. In connection with
the October Offering, MindMed issued a total of 1,642,890 October Offering Compensation Options exercisable into one October Offering
Unit at a price of $1.05 per October Offering Compensation Option until October 30, 2023.


 


On November 2, 2020, the Corporation in partnership
with the UHB Liechti Lab announced the completion and publication of a Phase 1 study on the acute dose dependent effects of LSD.


 


On November 24, 2020, the Corporation announced
the launch of its digital medicine division, Albert.


 


On December 11, 2020, MindMed completed the
December Offering, issuing a total of 18,170,000 December Offering Units for aggregate gross proceeds of $34,523,000. Each December Offering
Unit consists of one Subordinate Voting Share of the Corporation and one-half of one December Offering Warrant. Each December Offering
Warrant entitles the holder thereof to purchase one Subordinate Voting Share at an exercise price of $2.45 until December 11, 2023,
subject to acceleration in certain circumstances. In connection with the December Offering, MindMed issued a total of 1,090,200 December Offering
Compensation Options exercisable into one December Offering Unit at a price of $1.90 per December Offering Unit until December 11,
2023.


 


On December 14, 2020, the Corporation announced
the completion of a pre-IND meeting with the FDA regarding the development of LSD to assist therapy for an anxiety disorder as part of
Project Lucy.


 


Subsequent to December 31, 2020


 


On
January 7, 2021 MindMed completed the January Offering, issuing a total of 20,930,000 January Offering Units for gross
proceeds of approximately $92,092,000. Each January Offering Unit consists of one Subordinate Voting Share of the Corporation and
one-half of one January Offering Warrant. Each January Offering Warrant entitles the holder thereof to purchase one Subordinate
Voting Share at an exercise price of $5.75 until January 7, 2024, subject to acceleration in certain circumstances. In connection
with the January Offering, MindMed issued a total of 1,255,800 January Offering Compensation Options exercisable into
January Offering Units at a price of $5.75 per January Offering Unit until January 7, 2024.


 






    13


     


    

 


On January 14, 2021, the Corporation announced
the appointment of Robert Barrow as Chief Development Officer of the Corporation.


 


On February 2, 2021, the Corporation announced
the resignation of Stephen Hurst as Co-Chief Executive Officer and Executive Chair of the Corporation and the resignation of Dr. Stanley
Glick as director of the Corporation. The Corporation also announced that J.R. Rahn became the sole Chief Executive Officer of the Corporation
and Perry Dellelce was appointed as Chair of the Board.


 


On February 11, 2021, MindMed announced a
new partnership between the Corporation and Swiss startup MindShift Compounds AG to develop and patent next-generation psychedelic compounds
with psychedelic or empathogenic properties.


 


On February 18, 2021, the Corporation announced
that it had entered into a definitive agreement (the “Merger Agreement”) to acquire HealthMode, Inc., a digital
medicine and therapeutics start-up that uses artificial intelligence (AI)-enabled digital measurement to increase the precision and speed
of clinical research and patient.


 


On
February 26, 2021, the Corporation completed the acquisition of HealthMode, Inc. (the “Merger”) pursuant
to the Merger Agreement, whereby MindMed Mergerco Inc., a wholly-owned subsidiary of the Corporation, merged with and into Healthmode, Inc.,
with the surviving corporation becoming a wholly-owned subsidiary of the Corporation and changing its name to HealthMode, Inc. In
consideration for the acquisition of HealthMode, MindMed issued 81,497 Multiple Voting Shares (convertible into 8,149,700 Subordinate
Voting Shares) and the payment of approximately $286,000 in cash to certain former securityholders of HealthMode, Inc. In connection
with the Merger, MindMed assumed 7,891 outstanding HealthMode options at an exchange ratio of one HealthMode option for 4.260451 options
of MindMed issuable pursuant to MindMed’s stock option plan. Each such MindMed option is fully vested and exercisable into one Subordinate
Voting Share at an exercise price of $0.02 per share (taking into account the exchange ratio). In connection with the Merger, Dr. Daniel
R. Karlin, co-founder of HealthMode, was appointed as Chief Medical Officer of the Corporation, and Bradford Cross, co-founder of HealthMode,
was appointed as Chief Technology Officer of the Corporation.


 


On
March 9, 2021, the Corporation completed the March Offering issuing a total of 6,000,000 March Offering Units for gross
proceeds of approximately $19,500,000. Each March Offering Unit consists of one Subordinate Voting Shares of the Corporation and
one-half of one March Offering Warrant. Each March Offering Warrant entitles the holder thereof to purchase one Subordinate
Voting Share at an exercise price of $4.40 until March 9, 2024, subject to acceleration in certain circumstances. In connection with
the March Offering, MindMed issued a total of 360,000 March Offering Compensation Options exercisable into March Offering
Units at a price of $3.25 per March Offering Unit until March 9, 2024.


 


DESCRIPTION OF THE BUSINESS


 


General


 


MindMed is a clinical stage neuro-pharmaceutical
drug development company developing product candidates based on psychedelic substances through rigorous science and clinical trials. MindMed’s
mission is to discover, develop and deploy psychedelic inspired medicines and therapies intended to treat diseases in the areas
of psychiatry, neurology, addiction, pain and, potentially, others such as anxiety disorders, substance use disorders and withdrawal,
and Adult Attention Deficit Disorder. The Corporation defines its “psychedelic inspired medicines” program to include medicines
which have the therapeutic benefits of psychedelics without the hallucinogenic effects. The Corporation defines its therapies program
to include other substances with hallucinogenic properties administered in combination with therapy that may be performed in-clinic under
the supervision of medical professionals or in a similar therapeutic setting. Through MindMed’s drug development platform, the Corporation
seeks to demonstrate the safety and efficacy of psychedelic-based medicines for a continuum of mental illnesses and unmet medical needs.
MindMed has operations in Switzerland, Australia, the United States and Canada.


 






    14


     


    

 


MindMed
US is the Corporation’s main operating subsidiary, through which its three drug development programs are overseen: the Addiction
Treatment Program (as described below), the microdose LSD program (as described below) and its LSD therapy program for anxiety disorders,
known as Project Lucy. The UHB Liechti Lab collaboration with the Corporation and the Corporation’s other research and development
efforts related to psychedelics are now supported through the Corporation’s Swiss subsidiary, MindMed Switzerland. Additionally,
MindMed Australia is conducting a Phase 1 study on normal healthy volunteers to determine the safety and tolerability of single ascending
doses (SAD) and multiple ascending doses (MAD) of 18-MC for its Addiction Treatment Program.


 


In furtherance of the Corporation’s mission
to address mental health and addiction, MindMed is conducting preclinical trials to develop a portfolio of product candidates and assemble
a compelling drug development pipeline of psychedelic inspired medicines and therapies for human clinical trials in accordance with the
regulations of the FDA and regulatory authorities in other jurisdictions where MindMed or its affiliates operate.


 


MindMed utilizes a Discover, Develop and Deploy
process in order to advance psychedelic inspired medicines and therapies. MindMed defines Discover as being the non-clinical, pre-clinical,
and human clinical trials of psychedelic substances led by academic clinical investigators, discovery of new chemical entities and formulations
based on psychedelics, and the advancement of research and development on technologies that seek to demonstrate the safety and efficacy
of psychedelic inspired medicines and therapies. MindMed defines Develop as being drug development programs that are being advanced
from the Discover mandates and transitioned to be company-sponsored drug development programs through clinical registration trials. MindMed
defines Deploy as being MindMed’s commercialization mandates that will aim to partner with insurers, technology companies
and care providers to scale access to the Corporation’s medicines, if approved for marketing by regulatory authorities, to patients
in need. Each term is used throughout this AIF.


 


MindMed’s
business is premised on a growing body of research supporting the use of psychedelics to treat a myriad of mental health problems. For
all product candidates, the Corporation will continue to proceed through research and development, and with marketing, if any, of the
product candidates are ultimately approved, pursuant to the regulations of US FDA and ex-US regulatory authorities. This entails, among
other things, conducting clinical trials utilizing research scientists with extensive psychedelics backgrounds, using experienced clinical
drug development teams, producing and supplying drugs according to current Good Manufacturing Practices (“GMP”), and conducting
all trials and development in accordance with the regulations of the US FDA and ex-US regulatory authorities.


 


This approach places MindMed in an industry in
which there are high barriers to entry, due to the need to conduct trials pursuant to applicable regulations, the time and costs required
to do so, and the related need to develop and protect intellectual property associated with drug development. Therefore, MindMed’s
ability to build a compelling drug portfolio and pipeline and to raise the financing necessary for its operations are key to its success.


 


Discover


 


In the Discover projects, the Corporation conducts
R&D in collaboration with the UHB Liechti Lab on various psychedelics and new potential therapeutic programs based on a multi-year,
exclusive collaboration agreement with the UHB Liechti Lab signed on April 1, 2020. The agreement first covered LSD, but has since
been expanded to incorporate other compounds and psychedelic substances such as methylenedioxy-methylamphetamine (MDMA), dimethyltryptamine
(DMT), MDMA-LSD and psilocybin. These R&D clinical trials, intellectual property and technologies may ultimately be translated to
commercial development programs. The Corporation is continually evaluating the acquisition of agreements and studies focusing on the medical
benefits of other psychedelic substances and new chemical entities similar to known psychedelic substances to advance its R&D efforts.


 


On November 24, 2020, the Corporation announced
that as part of its Discover projects, it is establishing a digital medicine division known as “Albert” (“Albert”).
Albert is in the process of assembling and recruiting a team of technologists, therapists, and clinical drug development experts to help
the Corporation research, develop and build an integrated technical platform and comprehensive toolset aimed at delivering psychedelic
inspired medicines and therapies combined with digital therapeutics. Digital therapeutics are defined as evidence-based therapeutic interventions
for patients to prevent, manage, or treat a mental disorder or disease. The Corporation will be evaluating the potential to pair digital
tools, which may include wearables and the latest in machine learning, with psychedelic assisted therapies in order to give healthcare
providers the ability to optimize and better understand the patient journey and therapeutic outcomes from pre-care through after-care.
Recent advancements in digital therapeutics have the potential to enable a real time assessment of efficacy in both clinical trials and
real world settings which can lead to a more robust understanding of the value of a treatment and long-term impact on patient outcomes.


 






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Develop


 


Currently,
the Corporation’s commercial development pipeline consists of agreements and studies relating to 18-MC and LSD. The
Corporation’s immediate commercial development priorities are to address the opioid crisis and other substance use disorders
by developing a non-hallucinogenic version of the psychedelic ibogaine, conduct clinical trials of LSD microdosing for adult ADHD,
and to conduct clinical trials of LSD therapy for anxiety disorders.


 


Deploy


 


The
Corporation’s strategy is currently focused on the discovery and development of product candidates based on psychedelic substances,
but the Corporation will ultimately seek to commercialize and deploy its psychedelic inspired medicines and therapies to patients in need.
As a result, the Corporation has recently entered into a funding arrangement with NYU Langone Health to establish the NYU Langone Training
Program to help the Corporation understand and prepare for the future Deploy phase of its business plan.


 


Projects That Have Not Yet Generated Revenue


 


The Corporation currently has six significant
projects, none of which have yet generated revenue, as well as a Deploy program that is not intended to generate revenue:


 


		a.	developing a non-hallucinogenic version of the psychedelic ibogaine to address the opioid crisis and other substance use disorders,
                                                              known as “Project Layla”;



 


		b.	developing clinical trials of LSD therapy for anxiety disorders (Project Lucy);



 


		c.	running a clinical trial of LSD microdosing for adult ADHD, known as “Project Flow”;



 


		d.	the ongoing collaboration with the UHB Liechti Lab;



 


		e.	project Albert to combine digital therapeutics with psychedelic inspired medicines and therapies; and



 


		f.	the NYU Langone Training Program.



 


Develop Projects


 


Addiction Treatment Program


 


The Corporation is investigating
the use of hallucinogenic and non-hallucinogenic treatments for addiction, which it calls its Addiction Treatment Program and which involved
the consideration of various initiatives. Included in these initiatives is the development of Project Layla, which is focused on opioid
withdrawal treatment, the treatment of opioid use disorder, and the treatment of other substance use disorders, in respect of which the
Corporation is currently conducting a Phase 1 trial evaluating 18-MC, a non-hallucinogenic synthetic derivative of the psychedelic substance
ibogaine. The preliminary data from this trial suggests that 18-MC is safe and well tolerated at the doses tested to date, and no serious
adverse events have been reported. In Study MMED003, a Phase 1 clinical trial being conducted at a single clinical research site in Perth,
Australia, a total of 55 subjects have been administered 18-MC at doses ranging from 4 to 150 mg BID (for one day; n=5 per arm) and 2
to10 mg BID (for up to 7 days, n=5 per arm). Based on the safety profile observed in this study to date, the study’s Safety Review
Committee has determined to continue dose escalation in the study to gather data from subjects administered higher doses of 18-MC for
one or seven days. Once that additional data has been reviewed, MindMed plans to initiate a Phase 2a proof of concept study to evaluate
18-MC’s effectiveness in mitigating the symptoms of opioid withdrawal in patients undergoing opioid detoxification and assess the
safety and tolerability of 18-MC in this patient population. The Corporation previously anticipated that the Phase 2a proof of concept
study would be initiated in 2020 or early 2021. The favorable safety profile has been observed even though early findings from this study
indicated that plasma levels of 18-MC were greater than expected. As a result, the Corporation has determined to take additional time
to evaluate the data from the Phase 1 trial, and the Corporation now anticipates that the Phase 2a study will be initiated in the second
half of 2021 or later. A meeting with the FDA has been confirmed for Q2 2021 to continue discussions regarding the 18-MC clinical development
plan. As part of Project Layla, MindMed is also contemplating initiating a Phase 2 study of 18-MC for opioid use disorder and other substance
use disorders after the Phase 2a for opioid withdrawal commences.


 






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A Phase 3 clinical trial for opioid withdrawal, opioid use disorder
and other substance use disorders is projected to commence, at the very earliest, in 2023, subject to statistically significant results
and findings from the Phase 2 clinical trials and input from the FDA. Findings from the Phase 2 trials could greatly impact timelines
and future capital requirements for the Addiction Treatment Program. In addition, the Corporation may need to conduct additional Phase
2 trials or additional Phase 1 studies to progress Project Layla, which may impact timelines and required capital. The above also assumes
that the Corporation intends to apply for “Breakthrough Therapy Designation” from the FDA for Project Layla, which may or
may not positively impact the projected timelines referred to above if granted by the FDA. MindMed may elect to add additional drug development
projects that complement the Addiction Treatment Program, including hallucinogenic treatments for addiction, but none have been selected
for development at this time.


 


Project Lucy


 


As part of MindMed’s decision to add a therapy for anxiety disorders
to its clinical development pipeline, MindMed has established Project Lucy. In December 2020, the Corporation successfully completed a
pre-IND meeting with the FDA for the treatment of an anxiety disorder with LSD. The Corporation intends to submit an IND with the FDA
in the second half of 2021, with a Phase 2b clinical trial evaluating experiential doses of LSD in an anxiety disorder. MindMed is assembling
and using data from its data acquisition from the UHB Liechti Lab to help support its IND filing to the FDA.


 


As a result of the Corporation’s data acquisition
from the UHB Liechti Lab, MindMed received the data and worldwide rights to an ongoing Phase 2 academic trial in respect of LSD for anxiety
administered by Professor Dr. Matthias Liechti and a psychedelic therapy expert, Dr. Peter Gasser. Dr. Gasser was appointed
as the Clinical Advisor for Project Lucy in August 2020. The data and knowhow will help build MindMed’s understanding of LSD’s
uses for anxiety disorders and its potential as a medication for serious mental health conditions.


 


On November 2, 2020, the Corporation announced
that, in collaboration with the UHB Liechti Lab, it has completed an academic Phase 1 study measuring LSD dose-dependent induced subjective
responses at microdoses (25 μg) up to experiential doses (200 μg) of LSD. The academic study provided relevant data to support
Project Lucy as the Corporation identifies optimal dose levels of LSD to test in the intended Phase 2 LSD anxiety trial referenced above.


 


Project Flow


 


The
Corporation is preparing a clinical trial of LSD microdosing for adult ADHD (Project Flow). A Phase 2a proof of concept trial for the
microdose LSD program has received regulatory approvals from the Netherlands and Switzerland. The Corporation has appointed two principal
investigators and signed clinical trial agreements with the UHB Liechti Lab and Maastricht University. After MindMed’s clinical
team assesses the results from the Phase 2a proof of concept clinical trial, the Corporation will determine the best future strategy for
additional clinical trials based on these findings and future milestones for the project. To the knowledge of the Corporation and management,
this is the first ever Phase 2a clinical trial of microdosing LSD for commercial drug development. It is extremely complex to estimate
what future trials and studies will be required until a proof of concept of the technology has been established in the current trial being
prepared by the Corporation. At such time, the Corporation will be in a better position to anticipate the needed capital to advance the
microdose LSD program. The Corporation’s budgeted Phase 2a costs for the proof of concept trial are currently anticipated to be
between US$3 million and US$4 million, the results of which will inform future budgets of Phase 2 trials. The Corporation previously anticipated
that the trial would begin as early as Q4 2020 or Q1 2021. However, the Corporation will be required to use GMP-compliant LSD, and as
a result of the additional time required to formulate GMP-compliant LSD, the Corporation now anticipates that the trial will run over
two years from Q3 2021 to Q3 2023.


 






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Microdose LSD Program


 


On January 12, 2021, the Corporation announced
an LSD microdosing study evaluating the potential benefits of LSD microdosing. Specifically, the study will be a randomized placebo-controlled
study evaluating the effects of daytime and evening administration of low doses of LSD on cognitive performance, sleep quality, mood,
neuroplasticity markers, emotion regulation, quality of life, and immune system response. The study will provide an additional research
pathway for MindMed’s psychedelic microdosing division and will immediately integrate with MindMed’s plans in digital therapeutics
through its newly formed Albert unit for digital medicine. The new study will be conducted in collaboration with Dr. Kim Kuypers
of Maastricht University in the Netherlands, a global, leading authority on the microdosing of psychedelics. In order to advance the scientific
understanding of microdosing for clinical purposes, the randomized placebo-controlled study will specifically measure the effects of microdoses
of LSD on neuroplasticity markers such as brain-derived neurotrophic factor (BDNF) plasma levels, as well as on various sleep measures,
mood, cognitive performance, emotion regulation, quality of life, and immune system response. MindMed is integrating innovative digital
tracking devices and software into the study to better assess LSD’s effects on various digital clinical markers on the human body.



 


Discover Projects


 


UHB Liechti Lab Initiatives


 


Exclusive License to Clinical
Trials of LSD, MDMA, DMT, and Psilocybin and UHB Liechti Lab R&D Collaboration


 


On April 1, 2020, the Corporation announced
that it had signed a multi-year, exclusive collaboration with the UHB Liechti Lab, the world-leading psychedelics pharmacology and clinical
research group at the UHB Liechti Lab in Basel, Switzerland. Under the agreement, MindMed gained exclusive worldwide rights to data, compounds,
and patent rights associated with the UHB Liechti Lab’s research with LSD and other psychedelic compounds, including data from preclinical
studies and completed or ongoing LSD and MDMA clinical trials. MindMed has begun working with the UHB Liechti Lab to file patents for
the data and clinical trials it has generated over a 10-year period and from current ongoing trials.


 


MindMed will support ongoing and planned R&D
clinical trials and commercial development trials under the direction of Professor Dr. Liechti. Professor Dr. Liechti will have
primary responsibility for the development of the selected compounds, and MindMed will provide research funding and milestone payments
in return for the exclusive license to existing and future data and intellectual property generated from clinical trials. UHB will receive
royalties and development revenue on any products marketed through the collaboration.


 


MDMA and DMT Research and
Development


 


MindMed recently added the psychedelic compound
MDMA to its R&D pipeline, with research being led by Professor Dr. Liechti. After starting the UHB Liechti Lab, over the past
ten years Professor Dr. Liechti has led multiple clinical trials of the safety profile of MDMA and how it interacts with the human
body. The cumulative data from the work done in the UHB Liechti Lab will enable MindMed to design clinical trials and form a strategy
for MDMA as part of its portfolio.


 


MindMed has committed to fund future R&D of
new psychedelic therapies being pursued by the UHB Liechti Lab with the intention to create next-generation psychedelic inspired medicines
that incorporate MDMA as a component of these therapies. The UHB Liechti Lab and MindMed plan to explore combination treatments of LSD
and MDMA to optimize the subjective effect profiles and potentially join the benefits of both psychedelics in various treatment paradigms.
A combined MDMA LSD randomized placebo controlled Phase 1 trial was initiated in Q1 2021.


 


Concurrently, MindMed will pursue N,N-Dimethyltryptamine
(DMT), the principally active ingredient in ayahuasca. MindMed is providing startup funding for a Phase 1 clinical trial testing various
intravenous dosing regimens of DMT, expected to begin in Q2 2021. DMT is a naturally occurring psychedelic substance that causes a rapid
onset and offset of action compared to similar psychedelic substances such as psilocybin or LSD. When administered as an ayahuasca brew,
natural substances are mixed with DMT to prolong its experiential effects and slow the metabolism in the human body. Through this Phase
1 clinical trial, MindMed and the UHB Liechti Lab are exploring how DMT can achieve experiential effects similar to ayahuasca by testing
a more controlled intravenous dosing method. The Phase 1 study is a randomized, double blind, placebo-controlled, 5-period crossover trial
in 30 healthy volunteers who will undergo five sessions with different DMT doses.


 






    18


     


    

 


DMT is rapidly metabolized as it enters the body
if taken orally and therefore it has a very short duration of action. In contrast, through a continuous intravenous perfusion application
the effect of DMT is longer and can be stopped rapidly. In order to potentially induce a stable DMT experience lasting 1-2 hours, various
intravenous dosing regimens including a starting dose and then a maintenance dose will be evaluated in the Phase 1 clinical trial. This
intravenous administration may also allow therapists to induce and to end an experiential state safely and more quickly, as required.


 


The human safety data and associated knowhow gathered
in this Phase 1 clinical trial will better enable MindMed’s clinical team to design future potential drug development programs based
on DMT sessions. Currently, no study has validly determined the elimination half-life of DMT and other pharmacokinetic parameters and
there is limited known data on dosing regimens of pure DMT. This Phase 1 double blind placebo controlled 5-period crossover design study
will provide a well-controlled study setting to illuminate these shortcomings in the current clinical understanding of DMT and pave the
way for future Phase 2a proof of concept efficacy studies in various indications.


 


Neutralizer Technology


 


In collaboration with the UHB Liechti Lab,
MindMed filed a patent application in the United States (preserving all worldwide rights) for neutralizer technology intended to
shorten and stop the hallucinogenic effects of using LSD during a therapy session. This discovery, when further developed, may act as the
 ‘off-switch’ to certain hallucinogenic effects. The invention may help reduce the acute effects of a psychedelic drug
and help shorten the hallucinogenic effects when required by a patient or medical professional. One of the many fears and stigmas
associated with psychedelics are rare occurrences of negative hallucinogenic effects, colloquially referred to as ‘bad
trips’. MindMed is seeking to equip therapists and other medical professionals with the resources and technology to better
control the effects of dosing LSD in a clinical setting to improve the patient experience and outcomes. This would pave the way for
greater therapeutic applications of LSD and shorter-acting psychedelic therapy treatments. MindMed believes this technology, when
further developed, may one day be marketed as an added feature to shorten or stop a therapy session if the patient is not
comfortable.


 


MindMed is working in collaboration with the UHB
Liechti Lab on a Phase 1 double-blind, placebo-controlled, random-order 2-period crossover design clinical trial evaluating the effect
of ketanserin on the acute response to LSD in healthy subjects after LSD administration. The study is being conducted at the UHB Liechti
Lab and is expected to be completed during the 2021 calendar year. This study will support the patent application that was filed in 2020
(preserving all worldwide rights) for a neutralizer technology intended to shorten and stop the effects of an LSD trip during a therapy
session.


 


Personalized Medicine Technology


 


MindMed, in collaboration with UHB Liechti Lab,
is also in the process of researching and developing technologies and analytics that will seek to personalize psychedelic therapy experiences
for a specific patient. The technology aims to optimize the dosing of MDMA, LSD and other psychedelics based on individual characteristics
including age, sex, pharmacogenetics, personality traits, states of mood, metabolic markers and therapeutic drug monitoring. A considerable
problem for doctors, clinical researchers, and therapists is to understand and predict optimal doses of medicines based on psychedelic
substances for patients. Through its clinical research, the UHB Liechti Lab is identifying ways to predict and optimize the amount of
a psychedelic dose and dosing regimen for therapy, which may be utilized with MindMed’s product candidates. To assemble a patient’s
personalized dosing regimen and therapy session, MindMed and the UHB Liechti Lab’s analytics method is being developed to aggregate
multiple data and criteria of patients in a pre-dose screening and analysis process. MindMed intends to apply this personalized medicine
approach to its development of psychedelic-assisted therapies for patients suffering from mental health and addiction issues. Three patent
applications have been filed covering MDMA dose optimization and LSD dose response. MindMed has received the exclusive rights from the
UHB Liechti Lab to commercialize the outcome of these patent applications on a global basis. Further, biomarkers such as BDNF are assessed
and evaluated to potentially be used as predictors of markers of positive effects on neuroplasticity and therapeutic response.


 






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Cluster Headache Treatment


 


MindMed is supporting and collaborating on a Phase
2 clinical trial evaluating LSD for the treatment of cluster headaches at the UHB Liechti Lab. Cluster headaches are a relatively uncommon
primary headache disorder that is one of the trigeminal autonomic cephalgias; they are considered to be among the most severe forms of
pain. The Phase 2 trial began recruiting patients in early Q1 2019 and has commenced treating patients with LSD. Professor Dr. Liechti
is serving as principal investigator of the clinical trial. The UHB Liechti Lab and MindMed intend to learn how they can make the administration
of LSD more targeted for cluster headache patients through this Phase 2 trial and future clinical trials. As part of the collaboration
with the UHB Liechti Lab, MindMed gained exclusive, global use to all data and intellectual property generated in this Phase 2 trial of
LSD for cluster headaches.


 


Partnership with Swiss
Psychedelic Drug Discovery Startup MindShift Compounds AG


 


MindMed has entered into a partnership with Swiss
start-up, MindShift Compounds AG, to develop and patent next-generation psychedelic compounds with psychedelic or empathogenic properties.
As part of this partnership, MindMed and MindShift Compounds AG have agreed to develop next-generation psychedelic and empathogenic substances
together. The first initial compounds have already been synthesized by MindShift Compounds AG and related patent applications were filed
by MindMed. MindMed plans to begin first-in-human Phase 1 clinical trials as early as the first quarter of 2022 through its existing clinical
trial platform for psychedelic and empathogenic compounds in Switzerland. The partnership on these initial targets will expand MindMed’s
current, well-established clinical pipeline with additional backup and expansion compounds with similar and potentially improved therapeutic
properties. The related synthesis intellectual property and pharmaceutical technology will be owned outright by MindMed, and MindShift
Compounds AG will exclusively provide to MindMed all intellectual property related to the new psychedelic compounds. MindMed plans to
work with the experienced drug discovery team at MindShift Compounds AG to further broadly cover preclinical psychedelics research into
novel compounds and expects to continue to file patent applications on novel substance matters, production innovations, and later clinical
applications.


 


Deploy Projects


 


Albert and HealthMode


 


On
November 24, 2020, the Corporation announced that it was establishing a digital medicine division known as “Albert”.
Albert aims to have a team of technologists, therapists, and clinical drug development experts to help the Corporation research, develop
and build an integrated technical platform and comprehensive toolset aimed at delivering psychedelic inspired medicines and therapies
combined with digital therapeutics. Digital therapeutics are defined as evidence-based therapeutic interventions for patients to prevent,
manage, or treat a mental disorder or disease. The potential to pair digital tools, which may include wearables and the latest in machine
learning, with psychedelic assisted therapies, can give healthcare providers the ability to optimize and better understand the patient
journey and therapeutic outcomes from pre-care through after-care. Recent advancements in digital therapeutics have the potential to enable
a real time assessment of efficacy in both clinical trials and real-world settings, which can lead to a more robust understanding of the
value of a treatment and long-term impact on patient outcomes.


 


In February 2021, MindMed completed the acquisition
of HealthMode to build out the Albert division. HealthMode is a digital medicine and therapeutics startup that uses Artificial Intelligence
(AI)-enabled digital measurement to increase the precision and speed of clinical research and patient monitoring. With the acquisition,
MindMed has gained access to HealthMode’s intellectual property, platforms for clinical drug trials, and its entire twenty-four-person
digital medicine team. MindMed will incorporate HealthMode’s machine learning engineering, product development, and operations employees
based in Silicon Valley, New York City, Bratislava and Prague into Albert.


 


NYU Langone Health Psychedelic
Medicine Clinical Training Program


 


The Corporation has recently entered into a funding
arrangement with NYU Langone Health to establish the NYU Langone Training Program to help the Corporation understand and prepare for the
future Deploy phase of its business plan.


 


On October 6, 2020, the Corporation announced a commitment of US$5
million over a five-year period to found and launch a clinical training program focused on psychedelic assisted therapies and psychedelic
inspired medicines at NYU Langone Health, one of the United States’ premier academic medical centers. The NYU Langone Training Program
is the first step in a larger initiative to establish a Center for Psychedelic Medicine at NYU Langone Health. The NYU Langone training
program is intended to train additional clinical researchers in psychedelic medicines. In addition, the Corporation hopes to work with
NYU Langone and other academic institutions as it prepares for the future Deploy phase of its business plan that will inevitably require
training large numbers of medical personnel including psychiatrists to administer psychedelic assisted therapies at scale in the United
States. NYU Langone Health will have full and free discretion in using the funds for the development and conduct of the training program
and operations of the Center for Psychedelic Medicine. The launch of the Center for Psychedelic Medicine at NYU Langone Health is still
subject to additional funding from other partners and parties. It is not anticipated that the Corporation will generate future revenue
from this project.


 






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Specialized Skill and Knowledge Requirements


 


The nature of the Corporation’s business
requires specialized knowledge and skills relating to psychedelic-based substances, clinical trials, drug development and the regulatory
regime governing the Corporation’s operations. The required knowledge and skills to succeed in this industry are available to the
Corporation through certain members of the Corporation’s management, directors, officers, employees, consultants and advisors.


 


Competitive Conditions


 


The
biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. The Corporation’s
competitors include large, well-established pharmaceutical companies, biotechnology companies, academic and research institutions developing
therapeutics for the same indications the Corporation is targeting and competitors with existing marketed therapies. Many other companies
are developing or commercializing therapies to treat the same diseases or indications for which regulatory approval may be sought for
MindMed’s product candidates. The competitive conditions and the Corporation’s
assessment of its competitive position are more particularly described in the “Risk Factors” section herein, under
the heading “Risks Related to the Corporation’s Business and Industry”.


 


Intellectual Property


 


Prior to the acquisition of the 18-MC Program
by MindMed US, Savant maintained intellectual property as trade secrets. Following the acquisition, MindMed US filed a United States Provisional
Patent Application entitled “18-MC FOR TREATMENT OF SUBSTANCE USE DISORDERS” (No. 62/908,754, filed October 1, 2019),
encompassing the intellectual property previously held as trade secrets. This application covers extensive data on 18-MC in humans, including
surprising results related to absorption and metabolism in humans and human pharmacokinetic activity. UHB Liechti Lab has filed a patent
application in the U.S. (preserving all worldwide rights) for a neutralizer technology intended to shorten and stop the effects of an
LSD trip during a therapy session and the Corporation has entered into an exclusive license agreement with UHB Liechti Lab, as set forth
above, gaining exclusive worldwide rights to such patent rights. Additionally, MindMed US is the assignee of a patent family filed in
the U.S., Australia, Canada, Europe, Japan and New Zealand directed to methods of combining psychotherapy with the administration of the
psychostimulant 3-MMC in treating distress, particularly in treating PTSD, relationship distress, and generalized anxiety disorder.


 


As MindMed generates new data it intends to continue
to expand patent coverage throughout the development program.


 


Product Information and Distribution


 


MindMed does not currently market or distribute
any products and will formulate product information and distribution plans as products are developed.


 


Distribution Methods & Principal Markets


 


MindMed does not currently have nor does it plan
to acquire the infrastructure or capability internally to manufacture its clinical drug supplies for use in MindMed’s clinical trials,
and it lacks the resources and the capability to manufacture any of its drug candidates on a clinical or commercial scale. Instead, MindMed
will rely on contract manufacturers for the production of 18-MC and its other drug candidates. The facilities used by MindMed’s
contract manufacturers must be approved by the applicable regulatory authorities, including the FDA, pursuant to inspections that will
be conducted after an NDA is submitted to the FDA or the non-US equivalent thereof. Other than through “Quality Agreements”
to be entered into with its suppliers, MindMed will not control the manufacturing process of 18-MC or other drug candidates and will be
dependent on its contract manufacturing partners for compliance with the FDA’s requirements for manufacture of both the active drug
substances and finished drug products.


 






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Future Research and Development


 


MindMed’s mission to discover, develop and
deploy medicines based on psychedelic substances to treat a continuum of mental illnesses and unmet medical needs encompasses the research
and development of new and improved psychedelic inspired medicines ranging from proprietary psychedelic compounds to non-psychedelic analogs
with medicinal properties. While MindMed’s clinical development programs are MindMed’s first priority, proprietary research
and development programs are essential to advancing MindMed’s product portfolio position as the leader in psychedelic inspired medicines.
For the time being, in addition to the patent applications mentioned above under “Intellectual Property”, MindMed maintains
intellectual property generated by its R&D programs as trade secrets. MindMed anticipates that as these programs mature, additional
patent applications will be filed and more details about these programs will be disclosed at such time.


 


Government Regulation


 


MindMed
is focused on developing and commercializing psychedelic inspired medicines and therapies as regulated medicines. In order to develop
regulated medicines, MindMed’s process must be conducted in strict compliance with the regulations of the regulatory agencies in
the jurisdictions in which MindMed operates, including the United States, the Netherlands, Switzerland and Australia. These regulatory
authorities regulate, among other things, the research, manufacture, promotion and distribution of drugs in specific jurisdictions under
applicable law and regulations.


 


The FDA and other regulatory authorities at federal,
state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing,
manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, recordkeeping, approval,
advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs. MindMed, along with its vendors, contract
research organizations and contract manufacturers, will be required to navigate the various preclinical, clinical, manufacturing and commercial
approval requirements of the governing regulatory agencies of the countries in which MindMed wishes to conduct studies or seek approval
of MindMed’s product candidates. The process of obtaining regulatory approvals of drugs and ensuring subsequent compliance with
appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources
and may not be successful.


 


United States


 


In the United States, the FDA regulates drug products
under the Federal Food, Drug, and Cosmetic Act (“FDCA”), as amended, its implementing regulations and other laws. Failure
to comply with applicable FDA or other requirements at any time with respect to product development, clinical testing, approval or any
other legal requirements relating to product manufacture, processing, handling, storage, quality control, safety, marketing, advertising,
promotion, packaging, labeling, export, import, distribution, or sale may lead to administrative or judicial sanctions or other legal
consequences. These sanctions or consequences could include, among other things, the FDA’s refusal to approve pending applications,
issuance of clinical holds for ongoing studies, suspension or revocation of approved applications, warning or untitled letters, product
withdrawals or recalls, product seizures, relabeling or repackaging, total or partial suspensions of manufacturing or distribution, injunctions,
fines, civil penalties or criminal prosecution. Pharmaceutical products are also subject to other federal, state and local statutes and
regulations. In particular, controlled substances, like LSD, DMT, MDMA, and psilocybin are regulated as Schedule I controlled substances
by the DEA. A failure to comply with any requirements during the product development, approval, or post-approval periods, may lead to
administrative or judicial sanctions, which could include the imposition of a hold on clinical trials, refusal to approve pending marketing
applications or supplements, withdrawal of approval, warning letters, product recalls, product seizures, total or partial suspension of
production or distribution, injunctions, fines, civil penalties or criminal prosecution.


 






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The process required by the FDA before MindMed’s
product candidates are approved as drugs for therapeutic indications and may be marketed in the United States generally involves the following:


 


		·	Completion of extensive preclinical studies in accordance with applicable regulations, including studies
conducted in accordance with good laboratory practice (“GLP”) requirements;



 


		·	Completion of the manufacture, under current Good Manufacturing Practices (“cGMP”),
conditions, of the drug substance and drug product that the sponsor intends to use in human clinical trials along with required analytical
and stability testing;



 


		·	Submission to the FDA of an IND, which must become effective before clinical trials may begin;



 


		·	Approval by an IRB or IRBs, or independent ethics committee(s) before each trial may be initiated;



 


		·	Performance of adequate and well-controlled clinical trials in accordance with applicable IND regulations,
good clinical practice (“GCP”), requirements and other clinical trial-related regulations to establish the safety and
efficacy of the investigational product for each proposed indication;



 


		·	Submission to the FDA of an NDA;



 


		·	Payment of user fees for FDA review of the NDA;



 


		·	A determination by the FDA within 60 days of its receipt of an NDA, to accept the filing for review;



 


		·	Satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities
where the drug will be produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate
to preserve the drug’s identity, strength, quality and purity;



 


		·	Potentially, satisfactory completion of FDA audit of the clinical trial sites that generated the data
in support of the NDA; and



 


		·	FDA review and approval of the NDA, including consideration of the views of any FDA advisory committee,
prior to any commercial marketing or sale of the drug in the United States.



 


In certain cases, a drug may require scheduling
by DEA prior to commercialization. This step is required if the drug has a potential for abuse and is not currently controlled (scheduled)
by DEA or is controlled in Schedule I.


 


Preclinical Studies and Clinical Trials for
Drugs


 


Before testing any drug in humans, the product
candidate must undergo rigorous preclinical testing. Preclinical studies include laboratory evaluations of drug chemistry, formulation
and stability, as well as in vitro and animal studies to assess safety and in some cases to establish the rationale for therapeutic
use. The conduct of preclinical studies is subject to federal and state regulation, including GLP requirements for safety/toxicology studies
and the Animal Welfare Act, which is enforced by the Department of Agriculture. The results of the preclinical studies, together with
manufacturing information and analytical data, must be submitted to the FDA as part of an IND. An IND is a request for authorization from
the FDA to administer an investigational product to humans and must become effective before clinical trials may begin. Some long-term
preclinical testing may continue after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA,
unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the clinical trial, including concerns
that human research subjects will be exposed to unreasonable health risks, and imposes a full or partial clinical hold. FDA must notify
the sponsor of the grounds for the hold and any identified deficiencies must be resolved before the clinical trial can begin. Submission
of an IND may result in the FDA not allowing clinical trials to commence or not allowing clinical trials to commence on the terms originally
specified in the IND. A clinical hold can also be imposed once a trial has already begun, thereby halting the trial until the deficiencies
articulated by FDA are corrected.


 






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The clinical stage of development involves the
administration of the product candidate to healthy volunteers or patients under the supervision of qualified investigators, who generally
are physicians not employed by or under the trial sponsor’s control, in accordance with GCP requirements, which include the requirements
that all research subjects provide their informed consent for their participation in any clinical trial. Clinical trials are conducted
under protocols detailing, among other things, the objectives of the clinical trial, administration procedures, subject selection and
exclusion criteria and the parameters and criteria to be used in monitoring safety and evaluating effectiveness. Each protocol, and any
subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical trial must be reviewed
and approved by an IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals participating
in the clinical trials are minimized and are reasonable compared to the anticipated benefits. The IRB also approves the informed consent
form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until
completed. The FDA, the IRB, or the sponsor may suspend or discontinue a clinical trial at any time on various grounds, including a finding
that the subjects are being exposed to an unacceptable health risk. There also are requirements governing the reporting of ongoing clinical
trials and completed clinical trials to public registries. Information about clinical trials, including results for clinical trials other
than Phase I investigations, must be submitted within specific timeframes for publication on www.ClinicalTrials.gov, a clinical trials
database maintained by the National Institutes of Health.


 


A sponsor who wishes to conduct a clinical trial
outside of the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. If a foreign clinical
trial is not conducted under an IND, FDA will nevertheless accept the results of the study in support of an NDA if the study was conducted
in accordance with GCP requirements, and the FDA is able to validate the data through an onsite inspection if deemed necessary.


 


Clinical trials to evaluate therapeutic indications
to support NDAs for marketing approval are typically conducted in three sequential phases, which may overlap.


 


		·	Phase I—Phase I clinical trials involve initial introduction of the investigational product
into healthy human volunteers or patients with the target disease or condition. These studies are typically designed to test the safety,
dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, excretion, the side effects associated
with increasing doses, and, if possible, to gain early evidence of effectiveness.



 


		·	Phase II—Phase II clinical trials typically involve administration of the investigational
product to a limited patient population with a specified disease or condition to evaluate the drug’s potential efficacy, to determine
the optimal dosages and administration schedule and to identify possible adverse side effects and safety risks. Phase 2 clinical
trials are typically controlled and conducted in a limited patient population.



 


		·	Phase III—Phase III clinical trials typically involve administration of the investigational
product to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy
and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended
to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval and physician
labeling. In most (though not all) cases, the FDA requires two adequate and well controlled Phase 3 clinical trials to support approval
of a drug.



 


Post-approval trials, sometimes referred to as
Phase IV clinical trials or post-marketing studies, may be conducted after initial marketing approval. These trials are used to gain additional
experience from the treatment of patients in the intended therapeutic indication and are commonly intended to generate additional safety
data regarding use of the product in a clinical setting. In certain instances, the FDA may mandate the performance of Phase IV clinical
trials as a condition of NDA approval.


 


Progress reports detailing the results of the
clinical trials, among other information, must be submitted at least annually to the FDA. Written IND safety reports must be submitted
to the FDA and the investigators fifteen days after the trial sponsor determines the information qualifies for reporting for serious and
unexpected suspected adverse events, findings from other studies or animal or in vitro testing that suggest a significant risk
for human volunteers and any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the
protocol or investigator brochure. The sponsor must also notify the FDA of any unexpected fatal or life-threatening suspected adverse
reaction as soon as possible but in no case later than seven calendar days after the sponsor’s initial receipt of the information.


 






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Concurrent with clinical trials, companies usually
complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the
product candidate and finalize a process for manufacturing the drug product in commercial quantities in accordance with cGMP requirements.
The manufacturing process must be capable of consistently producing quality batches of the product candidate and manufacturers must develop,
among other things, methods for testing the identity, strength, quality and purity of the final drug product. In addition, appropriate
packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo
unacceptable deterioration over its shelf life.


 


US Marketing Approval for Drugs


 


Assuming successful completion of the required
clinical testing, the results of the preclinical studies and clinical trials, together with detailed information relating to the product’s
chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of an NDA package requesting
approval to market the product for one or more indications. An NDA is a request for approval to market a new drug for one or more specified
indications and must contain proof of the drug’s safety and efficacy for the requested indications. The marketing application is
required to include both negative and ambiguous results of preclinical studies and clinical trials, as well as positive findings. Data
may come from company-sponsored clinical trials intended to test the safety and efficacy of a product’s use or from a number of
alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient
in quality and quantity to establish the safety and efficacy of the investigational product to the satisfaction of the FDA. FDA must approve
an NDA before a drug may be marketed in the United States.


 


Data from clinical trials conducted outside the
United States may be accepted by the FDA subject to certain conditions. For example, the clinical trial must be conducted in accordance
with GCP requirements or the FDA must be able to validate the data from the clinical trial through an onsite inspection if it deems such
inspection necessary. Where data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the United
States, the FDA will not approve the application on the basis of foreign data alone unless those data are considered applicable to the
U.S. patient population and U.S. medical practice, the clinical trials were performed by clinical investigators of recognized competence,
and the data is considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to
be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. If the drug has a potential
for abuse, the NDA must include a description and analysis of studies or information related to abuse of the drug, including a proposal
for scheduling under the federal CSA. A description of any studies related to overdosage is also required, including information on dialysis,
antidotes, or other treatments, if known.


 


The FDA reviews all submitted NDAs before it accepts
them for filing and may request additional information rather than accepting the NDA for filing. The FDA must make a decision on accepting
an NDA for filing within 60 days of receipt, and such decision could include a refusal to file by the FDA. If the application is not sufficiently
complete, the FDA may refuse to accept the NDA for filing and request additional information. A refusal to file, which requires resubmission
of the NDA with the requested additional information, delays review of the application. Further, under the Prescription Drug User Fee
Act (“PDUFA”), as amended, each NDA must be accompanied by a substantial user fee. The applicant under an approved
NDA is also subject to an annual program fee. The FDA adjusts the PDUFA user fees on an annual basis. Fee waivers or reductions are available
in certain circumstances, including a waiver of the application fee for the first application filed by a small business and in the case
of orphan drug designation.


 


Once the submission is accepted for filing, the
FDA begins an in-depth substantive review of the NDA. The FDA reviews an NDA to determine, among other things, whether the drug is safe
and effective for the indications sought and whether the facility in which it is manufactured, processed, packaged or held meets standards
designed to assure the product’s continued safety, quality and purity. Under the goals and policies agreed to by the FDA under the
PDUFA, the FDA targets 10 months, from the filing date, in which to complete its initial review of a new molecular entity NDA and respond
to the applicant, and six months from the filing date of a new molecular entity NDA for priority review. The FDA does not always meet
its PDUFA goal dates for standard or priority NDAs, and the review process is often extended by FDA requests for additional information
or clarification.


 






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The FDA also may require submission of a Risk
Evaluation and Mitigation Strategy (“REMS”), if it believes that a REMs is necessary to ensure that the benefits of
the drug outweigh its risks. A REMS can include use of risk evaluation and mitigation strategies like medication guides, physician communication
plans, assessment plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries, or other risk-minimization
tools.


 


The FDA may refer an application for a novel drug
to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts,
which reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The
FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.


 


Before approving an NDA, the FDA typically will
inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that
the manufacturing processes and facilities are in compliance with cGMP requirements and are adequate to assure consistent production of
the product within required specifications. In addition, before approving an NDA, the FDA may inspect one or more clinical trial sites
to assure compliance with GCP and other requirements and the integrity of the clinical data submitted to the FDA.


 


After evaluating the NDA and all related information,
including the advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial
sites, the FDA may issue an approval letter, or, in some cases, a complete response letter. A complete response letter generally contains
a statement of specific conditions that must be met in order to secure final approval of the NDA and may require additional clinical or
preclinical testing in order for the FDA to reconsider the application. Even with submission of this additional information, the FDA ultimately
may decide that the application does not satisfy the regulatory criteria for approval. Data from clinical trials are not always conclusive,
and the FDA’s interpretation of data may differ from the sponsor’s. Obtaining approval can take years, requires substantial
resources and depends on a number of factors, including the severity of the targeted disease or condition, the availability of alternative
treatments, and the risks and benefits demonstrated in clinical trials.


 


If and when those conditions have been met to
the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the
drug with specific prescribing information for specific indications.


 


Even if the FDA approves a product, depending
on the specific risks to be addressed it may limit the approved indications for use of the product, require that contraindications, warnings
or precautions be included in the product labeling, require that post-approval studies, including Phase IV clinical trials, be conducted
to further assess a drug’s safety and efficacy after approval, require testing and surveillance programs to monitor the product
after commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms under
a REMS, which can materially affect the potential market and profitability of the product. Once granted, product approvals may be withdrawn
if compliance with regulatory standards is not maintained or problems are identified following initial marketing. For example, the FDA
may prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After approval,
some types of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling claims,
are subject to further testing requirements and FDA review and approval of a new NDA or an NDA supplement before the change can be implemented.
An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA generally
applies the same procedures and standards in reviewing NDA supplements as it does in reviewing NDAs.


 


From time to time, legislation is drafted, introduced
and passed in the U.S. Congress that could significantly change the statutory provisions governing the approval, manufacturing and marketing
of products regulated by the FDA. In addition to new legislation, the FDA regulations and policies are often revised or reinterpreted
by the agency in ways that may significantly affect MindMed’s business and its product candidates.


 






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Expedited Development and Review Programs for
Drugs


 


The FDA maintains several programs intended to
facilitate and expedite development and review of new drugs to address unmet medical needs in the treatment of serious or life-threatening
diseases or conditions. These programs include Fast Track designation, Breakthrough Therapy designation, Priority Review and Accelerated
Approval, and the purpose of these programs is to either expedite the development or review of important new drugs to get them to patients
more quickly than standard FDA review timelines typically permit.


 


A drug is eligible for Fast Track designation
if it is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address unmet medical
needs for such disease or condition. Fast Track designation provides increased opportunities for sponsor interactions with the FDA during
preclinical and clinical development, in addition to the potential for rolling review once a marketing application is filed. Rolling review
means that the agency may review portions of the marketing application before the sponsor submits the complete application. In addition,
a drug may be eligible for Breakthrough Therapy designation if it is intended to treat a serious or life-threatening disease or condition
and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more
clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Breakthrough Therapy designation
provides all the features of Fast Track designation in addition to intensive guidance on an efficient drug development program, and FDA
organizational commitment to expedited development, including involvement of senior managers and experienced review staff in a cross-disciplinary
review, where appropriate.


 


Any product submitted to the FDA for approval,
including a product with Fast Track or Breakthrough Therapy designation, may also be eligible for additional FDA programs intended to
expedite the review and approval process, including Priority Review designation and Accelerated Approval. A product is eligible for Priority
Review designation, once an NDA or BLA is submitted, if the drug that is the subject of the marketing application has the potential to
provide a significant improvement in safety or effectiveness in the treatment, diagnosis or prevention of a serious disease or condition.
Under priority review, the FDA’s goal date to take action on the marketing application is six months compared to ten months for
a standard review. Products are eligible for Accelerated Approval if they can be shown be for a serious or life-threatening condition
and to have an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or an effect on an intermediate clinical
endpoint that can be measured earlier than an effect on irreversible morbidity or mortality, which is reasonably likely to predict an
effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the
condition and the availability or lack of alternative treatments.


 


Accelerated Approval is usually contingent on
a sponsor’s agreement to conduct additional post-approval studies to verify and describe the product’s clinical benefit. The
FDA may withdraw approval of a drug or an indication approved under Accelerated Approval if, for example, the confirmatory trial fails
to verify the predicted clinical benefit of the product, other evidence demonstrates that the product is not shown to be safe and effective
under conditions of use, or required post-approval studies are not conducted with due diligence. In addition, the FDA generally requires,
as a condition for Accelerated Approval, that all advertising and promotional materials intended for dissemination or publication within
120 days of marketing approval be submitted to the agency for review during the pre-approval review period. After the 120-day period has
passed, all advertising and promotional materials must be submitted at least 30 days prior to the intended time of initial dissemination
or publication.


 


Even if a product qualifies for one or more of
these programs, the FDA may later decide that the product no longer meets the conditions for qualification or the time period for FDA
review or approval may not be shortened. Furthermore, Fast Track designation, Breakthrough Therapy designation, Priority Review and Accelerated
Approval do not change the scientific or medical standards for approval or the quality of evidence necessary to support approval, though
they may expedite the development or review process.


 


US Post-Approval Requirements for Drugs


 


Drugs manufactured or distributed pursuant to
FDA approvals are subject to continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping,
periodic reporting, product sampling and distribution, reporting of adverse experiences with the product, complying with promotion and
advertising requirements, which include restrictions on promoting products for unapproved uses or patient populations (known as “off-label
use”) and limitations on industry-sponsored scientific and educational activities. Although physicians may prescribe legally available
products for off-label uses, manufacturers may not market or promote such uses. The FDA and other agencies actively enforce the laws and
regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be
subject to significant liability, including investigation by federal and state authorities. Prescription drug promotional materials must
be submitted to the FDA in conjunction with their first use or first publication. Further, if there are any modifications to the drug,
including changes in indications, labeling or manufacturing processes or facilities, the applicant may be required to submit and obtain
FDA approval of a new NDA or NDA supplement, which may require the development of additional data or preclinical studies and clinical
trials.


 






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The FDA may impose a number of post-approval requirements
as a condition of approval of an NDA. For example, the FDA may require post-market testing, including Phase IV clinical trials, and surveillance
to further assess and monitor the product’s safety and effectiveness after commercialization. In addition, drug manufacturers and
their subcontractors involved in the manufacture and distribution of approved drugs are required to register their establishments with
the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance
with ongoing regulatory requirements, including cGMPs, which impose certain procedural and documentation requirements. Failure to comply
with statutory and regulatory requirements may subject a manufacturer to legal or regulatory action, such as warning letters, suspension
of manufacturing, product seizures, injunctions, civil penalties or criminal prosecution. There is also a continuing, annual prescription
drug product program user fee.


 


Later discovery of previously unknown problems
with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply
with regulatory requirements, may result in revisions to the approved labeling to add new safety information, requirements for post-market
studies or clinical trials to assess new safety risks, or imposition of distribution or other restrictions under a REMS. Other potential
consequences include, among other things:


 


		·	Restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from
the market or product recalls;



 


		·	The issuance of safety alerts, Dear Healthcare Provider letters, press releases or other communications
containing warnings or other safety information about the product;



 


		·	Fines, warning letters or holds on post-approval clinical trials;



 


		·	Refusal of the FDA to approve applications or supplements to approved applications, or suspension or revocation
of product approvals;



 


		·	Product seizure or detention, or refusal to permit the import or export of products;



 


		·	Injunctions or the imposition of civil or criminal penalties; and



 


		·	Consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;
or mandated modification of promotional materials and labeling and issuance of corrective information.



 


Controlled Substances


 


The federal CSA and its implementing regulations
establish a “closed system” of regulations for controlled substances. The CSA imposes registration, security, recordkeeping
and reporting, storage, manufacturing, distribution, importation, exportation, disposal and other requirements under the oversight of
the DEA. The DEA is the federal agency responsible for regulating controlled substances, and requires those individuals or entities that
manufacture, import, export, distribute, research, or dispense controlled substances to comply with the regulatory requirements in order
to prevent the diversion of controlled substances to illicit channels of commerce.


 






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The DEA categorizes controlled substances into
one of five schedules — Schedule I, II, III, IV or V — with varying qualifications
for listing in each schedule. Schedule I controlled substances by definition have a high potential for abuse, have no currently accepted
medical use in treatment in the United States and lack accepted safety for use under medical supervision. Pharmaceutical products having
a currently accepted medical use that are otherwise approved for marketing may be listed as Schedule II, III, IV or V controlled
substances, with Schedule II controlled substances presenting the highest potential for abuse and physical or psychological dependence,
and Schedule V controlled substances presenting the lowest relative potential for abuse and dependence. The regulatory requirements are
more restrictive for Schedule II controlled substances than Schedule III-V controlled substances. For example, all Schedule II
drug prescriptions must be signed by a physician, physically presented to a pharmacist in most situations, and cannot be refilled. LSD,
DMT, MDMA, and psilocybin are regulated as Schedule I controlled substances. MindMed’s products, if approved in the United States,
will require scheduling by the DEA before they can be marketed.


 


Facilities that manufacture, distribute, import
or export any controlled substance must register annually with the DEA. The DEA registration is specific to the particular location, activity(ies)
and controlled substance schedule(s). For example, separate registrations are required for importation and manufacturing activities, and
each registration authorizes which schedules of controlled substances the registrant may handle. Certain coincident activities are permitted
without obtaining a separate DEA registration, however, such as distribution of controlled substances by the manufacturer that produces
them.


 


The DEA inspects all manufacturing facilities
to review security, recordkeeping, reporting and handling prior to issuing a controlled substance registration. The specific security
requirements vary by the type of business activity and the schedule and quantity of controlled substances handled. The most stringent
requirements apply to manufacturers of Schedule I and Schedule II controlled substances. Required security measures commonly include background
checks on employees and physical control of controlled substances through storage in approved vaults, safes and cages, and through use
of alarm systems and surveillance cameras. An application for a manufacturing registration as a bulk manufacturer (not a dosage form manufacturer
or a repacker/relabeler) for a Schedule I or II controlled substance must be published in the Federal Register, and is open for 60 days
to permit interested persons to submit comments or objections. A copy of the notice of the Federal Register publication is forwarded by
the DEA to all those registered, or applicants for registration, as bulk manufacturers of that substance. Once registered, manufacturing
facilities must maintain records documenting the manufacture, receipt and distribution of all controlled substances. Manufacturers must
submit periodic reports to the DEA of the distribution of Schedule I and II controlled substances, Schedule III narcotic substances, and
other designated substances. Registrants must also report any controlled substance thefts or significant losses, and must obtain authorization
to destroy or dispose of controlled substances. As with applications for registration as a bulk manufacturer, an application for an importer
registration for a Schedule I or II controlled substance must also be published in the Federal Register, which remains open for 30 days
for comments. Imports of Schedule I and II controlled substances for commercial purposes are generally restricted to substances not already
available from a domestic supplier or where there is not adequate competition among domestic suppliers. Importers and exporters must have
a separate registration for each principal place of business where controlled substances are imported or exported. Registration applications
for importers and exporters are limited to the controlled substances specified in the registration.


 


For drugs manufactured in the United States, the
DEA establishes annually an aggregate quota for the amount of substances within Schedules I and II that may be manufactured or produced
in the United States based on the DEA’s estimate of the quantity needed to meet legitimate medical, scientific, research and industrial
needs. The quotas apply equally to the manufacturing of the active pharmaceutical ingredient and production of dosage forms. The DEA may
adjust aggregate production quotas a few times per year, and individual manufacturing or procurement quotas from time to time during the
year, although the DEA has substantial discretion in whether or not to make such adjustments for individual companies.


 


The DEA has established an application process
for researchers who wish to study Schedule I controlled substances not currently approved for medical use in clinical trials, which includes
registering with the DEA, providing information about their qualifications, research protocol and the institution where the research is
being conducted, and receiving approval of such research protocol. A researcher may manufacture or import the basic class of the controlled
substance or substances for which registration was issued, provided that such manufacture or import is set forth in the protocol required
in 21 CFR §1301.18 and to distribute such class to persons registered or authorized to conduct research with such class
of controlled substance or registered or authorized to conduct chemical analysis with controlled substances. In the case of a clinical
investigation with controlled substances listed in Schedule I, and in lieu of submitting the protocol, the applicant must submit three
copies of the IND with a statement of security provisions to, and have such submission approved by, the FDA. The applicant shall also
submit a certificate certifying the submission of the IND to FDA. If an applicant wishes to increase the quantity of the controlled substance
used for an approved research project, a request must be submitted to the Registration Unit of the DEA, which will forward it to the FDA
for approval. If approval is granted, the applicant shall be authorized to use additional quantities of the controlled substance in the
research project. If the applicant desires to conduct research outside the approved protocol, the applicant will need to submit three
copies of the supplemental protocol, which shall be reviewed and processed in the same way as the original protocol.


 






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The states also maintain separate controlled substance
laws and regulations, including licensing, recordkeeping, security, distribution, and dispensing requirements. State authorities, including
Boards of Pharmacy, regulate use of controlled substances in each state. Failure to maintain compliance with applicable requirements,
particularly as manifested in the loss or diversion of controlled substances, can result in enforcement action that could have a material
adverse effect on business, operations and financial conditions. The DEA may seek civil penalties, refuse to renew necessary registrations,
or initiate proceedings to revoke those registrations. In certain circumstances, violations could lead to criminal prosecution.


 


U.S. Foreign Corrupt Practices Act


 


The U.S. Foreign Corrupt Practices Act, to which
MindMed is subject, prohibits corporations and individuals from engaging in certain activities to obtain or retain business or to influence
a person working in an official capacity. It is illegal to pay, offer to pay or authorize the payment of anything of value to any foreign
government official, government staff member, political party or political candidate in an attempt to obtain or retain business or to
otherwise influence a person working in an official capacity.


 


Coverage, Pricing and Reimbursement


 


Significant uncertainty exists as to the coverage
and reimbursement status of any product candidates for which MindMed obtains regulatory approval. In the United States and markets in
other countries, sales of any therapy for which MindMed receives regulatory approval for commercial sale will depend, in part, on the
availability of coverage and reimbursement for MindMed’s products from third-party payors, such as government health care programs
(e.g., Medicare, Medicaid), managed care providers, private health insurers, health maintenance organizations, and other organizations.
These third-party payors decide which medications they will pay for and will establish reimbursement levels. The availability of coverage
and extent of reimbursement by governmental and other third-party payors is essential for most patients to be able to afford treatments
such as novel therapies.


 


In the United States, the principal decisions
about reimbursement for new medicines are typically made by CMS. CMS decides whether and to what extent MindMed’s products will
be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree. Factors payors consider in determining
reimbursement are based on whether the product is:


 


		·	a covered benefit under its health plan;



 


		·	safe, effective and medically necessary;



 


		·	appropriate for the specific patient;



 


		·	cost-effective; and



 


		·	neither experimental nor investigational.



 






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MindMed’s ability to successfully commercialize
its product candidates will depend in part on the extent to which coverage and adequate reimbursement for its products and related treatments
will be available from third-party payors. Moreover, a payor’s decision to provide coverage for a product does not imply that an
adequate reimbursement rate will be approved. Even if coverage is provided, the approved reimbursement amount may not be high enough to
allow the Corporation to establish or maintain price levels sufficient to realize an appropriate return on its investment in product development.


 


No uniform policy for coverage and reimbursement
for products exist among third-party payors in the United States. Therefore, coverage and reimbursement for MindMed’s products can
differ significantly from payor to payor. The process for determining whether a payor will provide coverage for a product may be separate
from the process for setting the reimbursement rate that the payor will pay for the product. One payor’s determination to provide
coverage for a medical product or service does not ensure that other payors will also provide coverage for the medical product or service,
or will provide coverage at an adequate reimbursement rate. Third-party payors may also limit coverage to specific products on an approved
list, or formulary, which might not include all of the FDA-approved products for a particular indication.


 


A decision by a third-party payor not to cover
or not to separately reimburse for MindMed’s medical products or therapies using its products could reduce physician utilization
of the Corporation’s products if approved and have a material adverse effect on MindMed’s sales, results of operations and
financial condition. If there is coverage for MindMed’s product candidates, or therapies using its product candidates by a third-party
payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high.
MindMed cannot be sure that coverage and reimbursement in the United States, will be available for its current or future product candidates,
or for any procedures using such product candidates, and any reimbursement that may become available may not be adequate or may be decreased
or eliminated in the future. Further, if MindMed or its collaborators develop therapies for use with its product candidates, MindMed,
or its collaborators, will be required to obtain coverage and reimbursement for these therapies separate and apart from the coverage and
reimbursement MindMed seeks for its product candidates, if approved.


 


Further, third-party payors are increasingly challenging
the price and examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and
efficacy. In order to secure coverage and reimbursement for any product candidate that might be approved for sale, MindMed may need to
conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of such product, in addition
to the costs required to obtain FDA or comparable regulatory approvals. Additionally, MindMed may also need to provide discounts to purchasers,
private health plans or government healthcare programs. MindMed’s product candidates may nonetheless not be considered medically
necessary or cost-effective. If third-party payors do not consider a product to be cost-effective compared to other available therapies,
they may not cover the product, after approval, as a benefit under their plans or, if they do, the level of payment may not be sufficient
to allow a company to sell its products at a profit. A decision by a third-party payor not to cover a product could reduce physician utilization
once the product is approved and have a material adverse effect on sales, MindMed’s operations and financial condition. MindMed
expects to experience pricing pressures from third-party payors in connection with the potential sale of any of its product candidates.


 


Other Healthcare Laws and
Compliance Requirements


 


Healthcare providers, physicians, and third-party
payors will play a primary role in the recommendation and prescription of any products for which MindMed obtains marketing approval. MindMed’s
business operations and any current or future arrangements with third-party payors, healthcare providers and physicians may expose MindMed
to broadly applicable federal and state fraud and abuse laws, as well as other healthcare laws and regulations. These laws may impact,
among other things, MindMed’s business or financial arrangements and relationships through which the Corporation researches, as
well as market, sell and distribute the therapies for which it obtains approval. In addition, MindMed may be subject to health information
privacy regulation by both the federal government and the states in which it conducts its business.


 






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In the United States the laws that may affect
MindMed’s ability to operate include, among others:


 


		·	The federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly
and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly,
overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order,
arrangement or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal
healthcare program, such as Medicare and Medicaid. The term remuneration has been interpreted broadly to include anything of value. Further,
courts have found that if “one purpose” of remuneration is to induce referrals, the federal Anti-Kickback Statute is violated.
The federal Anti-Kickback Statute has been interpreted to apply to arrangements between manufacturers on one hand and prescribers, purchasers,
and formulary managers on the other. A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or
specific intent to violate it to have committed a violation. Violations are subject to significant administrative civil and criminal fines
and penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from government healthcare
programs. In addition, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback
Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act (“FCA”), or federal civil
money penalties statute. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from
prosecution; but the exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection;



 


		·	The federal civil and criminal false claims laws, such as the FCA, which prohibit, among other things,
individuals or entities from knowingly presenting, or causing to be presented claims for payment or approval from Medicare, Medicaid,
or other third-party payors, that are false, fictitious, or fraudulent; from knowingly making, using or causing to be made or used, a
false statement or record material to a false or fraudulent claim or obligation to pay or transmit property to the federal government;
or from knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government.
Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to
 “cause” the submission of false or fraudulent claims. The FCA also permits a private individual acting as a “whistleblower”
to bring qui tam actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. When
an entity is determined to have violated the FCA, the government may impose civil fines and penalties for each false claim, plus treble
damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;



 


		·	The federal civil monetary penalties laws, which impose civil fines for, among other things, the offering
or transferring of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair
market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence
the beneficiary’s selection of a particular provider, practitioner, or supplier of items or services reimbursable by a federal or
state healthcare program;



 


		·	The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”),
which created additional federal criminal liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud
any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or
property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (i.e., public or private)
and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false,
fictitious, or fraudulent statements or representations in connection with the delivery of, or payment for, healthcare benefits, items
or services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual
knowledge of the statute or specific intent to violate it in order to have committed a violation;



 


		·	HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”),
and its respective implementing regulations, which imposes, among other things, certain requirements on certain covered healthcare providers,
health plans, and healthcare clearinghouses as well as their respective business associates relating to the privacy, security and transmission
of individually identifiable health information. Among other things, HITECH makes HIPAA’s privacy and security standards directly
applicable to business associates, those independent contractors or agents of covered entities that create, receive, maintain, transmit
or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also increased the
civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state
attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and
seek attorney’s fees and costs associated with pursuing federal civil actions;



 






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		·	Numerous federal and state laws and regulations, including state data breach notification laws, state
health information privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the FTC Act), govern the collection,
use, disclosure and protection of health-related and other personal information. Failure to comply with data protection laws and regulations
could result in government enforcement actions and create liability, private litigation and/or adverse publicity;



 


		·	The California Consumer Privacy Act (“CCPA”), which became effective on January 1,
2020, creates individual privacy rights for California consumers and increases the privacy and security obligations of entities handling
certain personal data. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that
is expected to increase data breach litigation. Similar laws have been proposed at the federal level and in other states.



 


		·	The federal Physician Payment Sunshine Act, created under the Patient Protection and Affordable Care Act,
as amended by the Health Care and Education Reconciliation Act, collectively, the Affordable Care Act (“ACA”), which
requires applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid
or the Children’s Health Insurance Program to report annually to the HHS, information related to payments or other transfers of
value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as
well as ownership and investment interests held by the physicians described above and their immediate family members. Effective January 1,
2022, these reporting obligations will extend to include transfers of value made during the previous year to certain non-physician providers,
such as physician assistants and nurse practitioners;



 


		·	Federal government price reporting laws, which require the Corporation to calculate and report complex
pricing metrics in an accurate and timely manner to government programs;



 


		·	Federal consumer protection and unfair competition laws, which broadly regulate marketplace activities
and activities that potentially harm consumers; and



 


		·	Analogous state and foreign equivalents of each of the healthcare laws and regulations described above,
such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial
insurers or patients; state and local marketing and/or transparency laws applicable to manufacturers that may be broader in scope than
the federal requirements; state laws that require pharmaceutical companies to comply with the pharmaceutical industry voluntary compliance
guidelines and other relevant compliance guidance promulgated by the federal government,; state laws that require the reporting of information
related to drug pricing; state laws that require drug manufacturers to report information related to payments and other transfers of value
to physicians and other healthcare providers or marketing expenditures and pricing information; state and local laws that require the
licensure and/or registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of
health information that may be more stringent than those in the United States (such as the European Union (“EU”), which
adopted the General Data Protection Regulation (“GDPR”)), many of which differ from each other in significant ways
and often are not preempted by HIPAA, thus complicating compliance efforts.



 


The distribution of pharmaceutical products is
subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended
to prevent the unauthorized sale of pharmaceutical products. At the federal level, the Drug Supply Chain Security Act (“DSCA”),
regulates the distribution and tracing of prescription drugs. The DSCA imposes requirements to ensure accountability in prescription drug
distribution, for example, it requires manufacturers to affix a product identifier to each package and case of a prescription drug product
intended for sale. A product identifier is an electronically-readable graphic that contains information including the product’s
unique numerical identifier, lot number, and expiration date. The DSCA also requires relevant parties and to identify and remove illegitimate
products from the market, including products that are counterfeit, stolen, intentionally contaminated, or otherwise harmful.


 






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In order to distribute products commercially,
MindMed must also comply with state law requirements for registration of manufacturers and wholesale distributors of pharmaceutical products,
including, in some states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors
have no place of business within the state. Several states, and more recently some large cities, have enacted legislation requiring pharmaceutical
companies to, among other things, establish marketing compliance programs, file periodic reports with the state, register their sales
representatives, and/or limit other specified sales and marketing practices. All of MindMed’s activities are potentially subject
to federal and state consumer protection and unfair competition laws.


 


The full scope and enforcement of each of these
laws is uncertain and subject to rapid change in the current environment of healthcare reform. Federal and state enforcement bodies have
continued to increase their scrutiny on interactions between healthcare companies and healthcare providers, which has led to a number
of significant investigations, prosecutions, convictions and settlements in the healthcare industry. If business practices do not comply
with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations
or if there is a violation, there may be significant penalties, including, without limitation, administrative, civil and criminal penalties,
damages, fines, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, the curtailment or restructuring
of MindMed’s operations, exclusion from participation in federal and state healthcare programs (such as Medicare and Medicaid),
imprisonment, additional oversight and reporting obligations under a corporate integrity agreement or similar settlement to resolve allegations
of non-compliance, and curtailment or restructuring of operations.


 


Healthcare Reform


 


In the United States and in some foreign jurisdictions,
there have been, and likely will continue to be, a number of legislative and regulatory changes and proposed changes regarding the healthcare
system directed at broadening the availability of healthcare, improving the quality of healthcare, and containing or lowering the cost
of healthcare. For example, in March 2010, the ACA was enacted, which, among other things, increased rebates for drugs sold to Medicaid
programs owed by most manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid
managed organizations; introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are
calculated for drugs that are inhaled, infused, instilled, implanted or injected; imposes mandatory discounts for certain Medicare Part D
beneficiaries in which manufacturers must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible
beneficiaries during their coverage gap period as a condition for manufacturers’ outpatient drugs coverage under Medicare Part D;
subjects drug manufacturers of certain branded prescription drugs to annual, nondeductible fees and taxes; expanded healthcare fraud and
abuse laws (including the FCA and the Anti-Kickback Statute), government investigative powers and enhances penalties for non-compliance;
expands eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals
with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;
expands the entities eligible for discounts under the 340B Drug Pricing Program; created new requirements to report financial arrangements
with physicians, as defined by such law, and teaching hospitals, commonly referred to as the Physician Payments Sunshine Act; created
a new requirement to annually report the identity and quantity of drug samples that manufacturers and authorized distributors of record
provide to physicians; created a new Patient Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative
clinical effectiveness research, along with funding for such research; and established the Center for Medicare and Medicaid Innovation
at the Centers for Medicare & Medicaid Services, or CMS, an agency within HHS, to test innovative payment and service delivery
models to lower Medicare and Medicaid spending.


 


Since its enactment, there have been numerous
judicial, administrative, executive, and legislative challenges to certain aspects of the ACA, and MindMed expects there will be additional
challenges and amendments to the ACA in the future.


 


It is unclear whether the ACA will be overturned,
repealed, replaced, or further amended. Further legislative changes to and regulatory changes under the Affordable Care Act remain possible.


 






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MindMed expects that changes to the Affordable
Care Act, the Medicare and Medicaid programs, changes allowing the federal government to directly negotiate drug prices and changes stemming
from other healthcare reform measures, especially with regard to healthcare access, financing or other legislation in individual states,
could have a material adverse effect on the healthcare industry


 


Moreover, payment methodologies may be subject
to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop new payment and delivery models, such as
bundled payment models. Recently, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for
their marketed products. Such scrutiny has resulted in several recent U.S. Congressional inquiries and proposed and enacted federal and
state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and
manufacturer patient programs, reduce the cost of drugs under Medicare, and reform government program reimbursement methodologies for
pharmaceutical products.


 


At the state level, legislatures have increasingly
passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement
constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases,
designed to encourage importation from other countries and bulk purchasing.


 


MindMed expects that additional foreign, federal
and state healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments
will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for MindMed’s
products, if approved, or additional pricing pressures.


 


European Union


 


Regulation and Procedures Governing Approval
of Medicinal Products in the European Union


 


In order to market any product outside of the
United States, a company must also comply with numerous and varying regulatory requirements of other countries and jurisdictions regarding
quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and distribution
of products. Whether or not it obtains FDA approval for a product, an applicant will need to obtain the necessary approvals by the comparable
foreign regulatory authorities before it can initiate clinical trials or marketing of the product in those countries or jurisdictions.
Specifically, the process governing approval of medicinal products in the European Union generally follows the same lines as in the United
States, although the approval of a medicinal product in the United States is no guarantee of approval of the same product in the European
Union, either at all or within the same timescale as approval may be granted in the United States. It entails satisfactory completion
of pharmaceutical development, non-clinical studies and adequate and well-controlled clinical trials to establish the safety and efficacy
of the medicinal product for each proposed indication. It also requires the submission to relevant competent authorities for clinical
trials authorization for a marketing authorization application (“MAA”), and granting of a marketing authorization by
these authorities before the product can be marketed and sold in the European Union or its member states (as well as Iceland, Norway and
Liechtenstein). If MindMed fails to comply with applicable requirements, it may be subject to, among other things, fines, suspension of
clinical trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal
prosecution.


 


Clinical Trial Approval


 


Pursuant to the currently applicable
Clinical Trials Directive 2001/20/EC and the Directive 2005/28/EC on GCP, a system for the approval of clinical trials in the
European Union has been implemented through national legislation of the member states. Under this system, an applicant must obtain
approval from the competent national authority of a European Union member state in which the clinical trial is to be conducted or in
multiple member states if the clinical trial is to be conducted in a number of member states. Furthermore, the applicant may only
start a clinical trial at a specific study site after the independent ethics committee has issued a favorable opinion in relation to
the clinical trial. In April 2014, the European Union adopted a new Clinical Trials Regulation (EU) No 536/2014, to replace the
Clinical Trials Directive 2001/20/EC. The regulation will overhaul the current system of approvals for clinical trials in the
European Union. Specifically, the new legislation, which will be directly applicable in all EU member states (meaning that no
national implementing legislation in each European Union member state is required), aims to simplify and streamline the approval of
clinical trials in the European Union. For instance, the new Clinical Trials Regulation provides for a streamlined application
procedure via a single-entry point and strictly defined deadlines for the assessment of clinical trial applications. It is expected
that the new Clinical Trials Regulation (EU) No. 536/2014 will come into effect following confirmation of full functionality of
the Clinical Trials Information System, the centralized EU portal and database for clinical trials foreseen by the new Clinical
Trials Regulation, through an independent audit.


 






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Marketing Authorization


 


To obtain a marketing authorization for a product
under the European Union regulatory system, an applicant must submit an MAA, either under a centralized procedure administered by the
EMA or one of the procedures administered by competent authorities in European Union member states (decentralized procedure, national
procedure, or mutual recognition procedure). A marketing authorization may be granted only to an applicant established in the European
Union.


 


The centralized procedure provides for the grant
of a single marketing authorization by the European Commission that is valid for all European Union member states (as well as Iceland,
Norway and Liechtenstein). Pursuant to Regulation (EC) No 726/2004, the centralized procedure is compulsory for specific products. For
instance, it is required for medicinal products that are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000,
medicinal products developed by certain specific biotechnological processes, advanced therapy medicinal products (as defined in section
2 of Regulation (EC) No 1394/2007) and medicinal products for human use containing a new active substance for which the therapeutic indication
is the treatment of any of the following diseases: acquired immune deficiency syndrome, cancer, neurodegenerative disorder, diabetes,
auto-immune diseases and other immune dysfunctions, and viral diseases. For those products for which the use of the centralized procedure
is not mandatory, applicants may elect to use the centralized procedure where either the product contains a new active substance indicated
for the treatment of other diseases, or where the applicant can show that the product constitutes a significant therapeutic, scientific
or technical innovation, or for which a centralized process is in the interest of patients at a European Union level.


 


Under the centralized procedure, the Committee
for Medicinal Products for Human use (“CHMP”), which is the EMA’s committee that is responsible for human medicines,
established at the EMA is responsible for conducting the assessment of whether a medicine meets the required quality, safety and efficacy
requirements, and whether the product has a positive risk/benefit/risk profile. Under the centralized procedure, the maximum timeframe
for the evaluation of an MAA is 210 days from the receipt of a valid MAA, excluding clock stops when additional information or written
or oral explanation is to be provided by the applicant in response to questions of the CHMP. Clock stops may extend the timeframe of evaluation
of an MAA considerably beyond 210 days. Where the CHMP gives a positive opinion, it provides the opinion together with supporting documentation
to the European Commission, who make the final decision to grant a marketing authorization. Accelerated evaluation may be granted by the
CHMP in exceptional cases, when a medicinal product is of major interest from the point of view of public health and, in particular, from
the viewpoint of therapeutic innovation. If the CHMP accepts such a request, the timeframe of 210 days for assessment will be reduced
to 150 days (excluding clock stops), but it is possible that the CHMP may revert to the standard time limit for the centralized procedure
if it determines that the application is no longer appropriate to conduct an accelerated assessment.


 


PRIME Scheme


 


EMA now offers a scheme that is intended to reinforce
early dialogue with, and regulatory support from, EMA in order to stimulate innovation, optimize development and enable accelerated assessment
of PRIority Medicines (“PRIME”). It is intended to build upon the scientific advice scheme and accelerated assessment
procedure offered by EMA. The scheme is voluntary and eligibility criteria must be met for a medicine to qualify for PRIME.


 


The PRIME scheme is open to medicines under development
and for which the applicant intends to apply for an initial marketing authorization application through the centralized procedure. Eligible
products must target conditions for which where is an unmet medical need (there is no satisfactory method of diagnosis, prevention or
treatment in the European Union or, if there is, the new medicine will bring a major therapeutic advantage) and they must demonstrate
the potential to address the unmet medical need by introducing new methods or therapy or improving existing ones. Applicants will typically
be at the exploratory clinical trial phase of development, and will have preliminary clinical evidence in patients to demonstrate the
promising activity of the medicine and its potential to address to a significant extent an unmet medical need. In exceptional cases, applicants
from the academic sector or SMEs (small and medium sized enterprises) may submit an eligibility request at an earlier stage of development
if compelling non-clinical data in a relevant model provide early evidence of promising activity, and first in man studies indicate adequate
exposure for the desired pharmacotherapeutic effects and tolerability.


 






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If a medicine is selected for the PRIME scheme,
EMA:


 


		·	Appoints a rapporteur from the Committee for CHMP or from the Committee for Advanced Therapies (“CAT”)
to provide continuous support and to build up knowledge of the medicine in advance of the filing of a marketing authorization application;



 


		·	Issues guidance on the applicant’s overall development plan and regulatory strategy;



 


		·	Organizes a kick-off meeting with the rapporteur and experts from relevant EMA committees and working
groups;



 


		·	Provides a dedicated EMA contact person; and



 


		·	Provides scientific advice at key development milestones, involving additional stakeholders, such as health
technology assessment bodies and patients, as needed.



 


Medicines that are selected for the PRIME scheme
are also expected to benefit from EMA’s accelerated assessment procedure at the time of application for marketing authorization.
Where, during the course of development, a medicine no longer meets the eligibility criteria, support under the PRIME scheme may be withdrawn.


 


Regulatory Data Protection in the European Union


 


In the European Union, new chemical entities approved
on the basis of a complete independent data package qualify for eight years of data exclusivity upon grant of a marketing authorization
and an additional two years of market exclusivity pursuant to Regulation (EC) No. 726/2004, as amended, and Directive 2001/83/EC,
as amended. Data exclusivity prevents regulatory authorities in the European Union from referencing the innovator’s data to assess
a generic (abbreviated) application for a period of eight years. During the additional two-year period of market exclusivity, a generic
marketing authorization application can be submitted, and the innovator’s data may be referenced, but no generic medicinal product
can be marketed until the expiration of the market exclusivity period. The overall 10-year period will be extended to a maximum of 11
years if, during the first eight years of those 10 years, the marketing authorization holder obtains an authorization for one or more
new therapeutic indications which, during the scientific evaluation prior to authorization, is held to bring a significant clinical benefit
in comparison with existing therapies. Even if a compound is considered to be a new chemical entity so that the innovator gains the prescribed
period of data exclusivity, another company may market another version of the product if such company obtained marketing authorization
based on an MAA with a complete independent data package of pharmaceutical tests, preclinical tests and clinical trials.


 


Periods of Authorization and Renewals


 


A marketing authorization is valid for five years,
in principle, and it may be renewed after five years on the basis of a re-evaluation of the risk benefit balance by the EMA or by the
competent authority of the authorizing member state. To that end, the marketing authorization holder must provide the EMA or the competent
authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since
the marketing authorization was granted, at least nine months before the marketing authorization ceases to be valid. Once renewed, the
marketing authorization is valid for an unlimited period, unless the European Commission or the competent authority decides, on justified
grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period. Any authorization that is not followed
by the placement of the product on the European Union market (in the case of the centralized procedure) or on the market of the authorizing
member state within three years after authorization ceases to be valid.


 






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Controlled Drugs Classification


 


In the UK, Class A drugs under the
Misuse of Drugs Act 1971, as amended, and as Schedule 1 drugs under the Misuse of Drugs Regulations 2001, as amended, are considered
to be the most potentially harmful, and have the highest level of control exerted over them under the Misuse of Drugs Act 1971.
Similarly, Schedule 1 of the Misuse of Drugs Regulations 2001 lists those drugs to which the most restrictive controls apply: they
are considered to have no legitimate or medicinal use, and can only be imported, exported, produced, supplied and the like under a
license issued by the UK Government’s Home Office. If and when granted a marketing authorization by the MHRA in respect of the
UK, psilocybin would still remain a Schedule 1 drug until rescheduled by the UK. Government’s Home Office. Unless and until
psilocybin is rescheduled under the Misuse of Drugs Regulations 2001, and unless a statutory exemption was to be passed for COMP360
following the grant of a UK marketing authorization and before rescheduling, any prescribing doctors in the UK would require a Home
Office license to prescribe COMP360, and similarly any patients to whom COMP360 was prescribed would require a Home Office license
to possess COMP360. There can be no guarantee that such Home Office licenses would be granted or that rescheduling would be
successful. The position in the member states of the European Union is not harmonized: member states have implemented the relevant
UN Conventions (the Single Convention of Narcotic Drugs 1961 and the Convention on Psychotropic Substances 1971) into their national
legislation, which has led to differences in how controlled substances are regulated in different countries of the European Union.
It is therefore important to determine at a national level whether a substance is controlled and to comply with the applicable legal
requirements. If MindMed is successful in obtaining a marketing authorization in key EU member states, it is likely that
rescheduling of psilocybin will also be required to enable prescribing.


 


Regulatory Requirements After Marketing Authorization


 


Following approval, the holder of the marketing
authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of the
medicinal product.


 


These include compliance with the European Union’s
stringent pharmacovigilance or safety reporting rules, pursuant to which post-authorization studies and additional monitoring obligations
can be imposed. The holder of a marketing authorization must establish and maintain a pharmacovigilance system and appoint an individual
qualified person for pharmacovigilance, who is responsible for oversight of that system. Key obligations include expedited reporting of
suspected serious adverse reactions and submission of periodic safety update reports (“PSURs”).


 


In addition, all new MAAs must include a
risk management plan (“RMP”), describing the risk management system that the Corporation will put in place and
documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose
specific obligations as a condition of the marketing authorization. Such risk-minimization measures or post-authorization
obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical
trials or post-authorization safety studies. RMPs and PSURs are routinely available to third parties requesting access, subject to
limited redactions.


 


Furthermore, the manufacturing of authorized products,
for which a separate manufacturer’s license is mandatory, must also be conducted in strict compliance with the EMA’s cGMP
requirements and comparable requirements of other regulatory bodies in the European Union, which mandate the methods, facilities and controls
used in manufacturing, processing and packing of products to assure their safety and identity.


 


Finally, the marketing and promotion of authorized
products, including industry-sponsored continuing medical education and advertising directed toward the prescribers of products, are strictly
regulated in the European Union under Directive 2001/83/EC, as amended. The advertising of prescription-only medicines to the general
public is not permitted in the European Union. Although general requirements for advertising and promotion of medicinal products are established
under EU Directive 2001/83/EC as amended, the details are governed by regulations in each European Union member state (as well as Iceland,
Norway and Liechtenstein) and can differ from one country to another.


 






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Coverage, Pricing and Reimbursement


 


In some foreign countries, the proposed pricing
for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country.
For example, in the European Union. pricing and reimbursement schemes vary widely from country to country. Some EU member states provide
that products may be marketed only after a reimbursement price has been agreed. Some EU member states may require the completion of additional
studies that compare the cost effectiveness of a particular product candidate to currently available therapies (so called health technology
assessments) in order to obtain reimbursement or pricing approval. There can be no assurance that any country that has price controls
or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of MindMed’s
product candidates. Increasingly high barriers are being erected to the entry of new products. Political, economic and regulatory developments
may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing
used by various European Union member states and parallel trade (arbitrage between low-priced and high-priced member states) can further
reduce prices. Acceptance of any medicinal product for reimbursement may come with cost, use and often volume restrictions, which again
can vary by country. Historically, products launched in the European Union do not follow price structures of the United States and generally
prices tend to be significantly lower.


 


European Data Collection is Governed by Restrictive Regulations
Governing the Use, Processing and Cross-border Transfer of Personal Information.


 


The conduct of future clinical trials in the European
Union or commercialization of products outside the United States may be subject to additional privacy and data protection requirements
and restrictions. The collection, use, storage, disclosure, transfer, or other processing of personal data, including personal health
data, is subject to European Union and national level data protection and privacy laws including, most notably GDPR, which became effective
on May 25, 2018. The GDPR is wide-ranging in scope and applies to both entities established in the EU and, under certain conditions,
to entities established outside the EU that process personal data of individuals in the EU, and imposes numerous requirements on entities
that process personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individuals
to whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguards
to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when
engaging third-party processors that will have access to personal data. The GDPR also imposes strict rules on the transfer of personal
data to countries outside the European Economic Area (“EEA”), including the United States. Entities that fail to comply
with the requirements of the GDPR may be subject to very significant penalties, including potential fines of up to the greater or €20
million or 4%. The GDPR may increase responsibility and liability in relation to personal data where such processing is subject to the
GDPR, and may require additional mechanisms to ensure compliance with the GDPR, including as implemented by individual countries. Further,
the UK’s decision to leave the EU, often referred to as Brexit, has created uncertainty with regard to data protection regulation
in the UK and how transfers from the EU to the UK will be regulated once the UK’s departure from the European Union is finalized.
The European Commission is however, expected to take an adequacy decision with respect to the UK which would mean that no additional requirements
would apply to a transfer of personal data from the EU to the UK.


 


Switzerland


 


General Principles on Swiss Regulations of Medicinal
Products


 


Swiss laws and regulations extensively regulate,
among other things, the research, development, pre-clinical and clinical testing, trial, safety, effectiveness, approval, manufacture,
quality control, release, labeling, packaging, storage, distribution, wholesale, dispensing, import, export, recordkeeping, advertising,
promotion, marketing, post-approval monitoring and post-approval reporting of drugs.


 


As Switzerland is neither a member of the EU nor
part of the EEA, regulations and directives adopted for the EU member states are not directly applicable. However, the Swiss regulatory
regime on medicinal products generally follows internationally accepted standards (such as guidelines issued by the International Council
for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”)) and certain procedures and concepts
under EU law.






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In principle, medicinal products are subject to
the Swiss Federal Therapeutics Products Act (“TPA”), as amended, its implementing ordinances and other laws. The Swiss
Agency for Therapeutic Products (“Swissmedic”), and other authorities at federal and cantonal level, are responsible
for the enforcement of the applicable laws. Failure to comply with the applicable regime may entail administrative, judicial or criminal
sanctions or other legal consequences.


 


Sanctions or legal consequences could include,
among other things, the authorities’ refusal to approve pending applications, orders for a suspension or cessation of ongoing activities,
suspension or revocation of approvals, product seizures, product withdrawals, returns or recalls, relabeling or repackaging, total or
partial suspensions of manufacturing or distribution, injunctions, fines, civil damages or criminal prosecution.


 


Where active ingredients of medicinal products
are derived from certain chemical substances, including, among others, hallucinogens such as lysergide (LSD 25), diethyltryptamine (DMT),
methylenedioxy-methylamphetamine (MDMA), psilocybin, and ibogaine, additional regulatory requirements apply under the Swiss Narcotics
Act (“NarcA”) and implementing ordinances.


 


Placing on the Market of Medicinal Product


 


To place a medicinal product on the market in
Switzerland, a company must prove that its product complies with all regulatory requirements regarding quality, safety and efficacy and
obtain all trial, manufacture, and marketing approvals from the applicable Swiss regulatory authority. The process requires the investment
of substantial resources for a considerable period of time and may not be successful.


 


As a rule, the process governing the marketing
approval of medicinal products in Switzerland generally follows the same lines as in the United States, although the approval of a medicinal
product in the United States is no guarantee of approval of the same product in Switzerland, either at all or within the same timescale
as approval may be granted in the United States. It entails satisfactory completion of pharmaceutical development, non-clinical studies
and adequate and well-controlled clinical trials to establish the safety and efficacy of the medicinal product for each proposed indication.
It also requires the submission to competent authorities and ethics committees for a clinical trials authorization, for a marketing authorization
(“MA”), and granting of an MA by these authorities before the product can be marketed and sold in Switzerland. If MindMed
fails to comply with applicable requirements, MindMed may be subject to, among other things, fines, suspension of clinical trials, suspension
or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.


 


Clinical Trial Approval


 


Under the Swiss Human Research Act (“HRA”)
and the implementing Clinical Trial Ordinance (“ClinO”), human clinical trials at trial sites in Switzerland may only
be conducted with prior approval of the competent ethics committee and, subject to certain exceptions, Swissmedic. Prior to commencing
clinical trials, the sponsor must in principle register certain data in a federal trial registry (the Swiss National Clinical Trials Portal)
and in a primary registry recognized by the World Health Organization (“WHO”), or in the registry of the US National
Library of Medicine, and must continuously update the data in yearly intervals. The registry data is accessible to the public via a portal
specified in the ClinO. The data to be registered with a primary registry recognized by the WHO or the US National Library of Medicine
consists in the minimum data set (version 1.2.1) as specified by the WHO. The trial regulations are subject to an ongoing revision and
may be amended in view of the impending entry into force of the European Regulation (EU) No. 536/2014 and increased international
transparency requirements in the publication of trial results.


 


Marketing Authorization


 


To obtain a marketing authorization for a product
under the TPA, an applicant must submit an MAA to Swissmedic. Swissmedic will assess whether a medicine meets the required quality, safety
and efficacy requirements, and whether the product has a positive risk/benefit profile. Where a marketing authorization was granted by
a regulator under a regulation equivalent to that of Switzerland (including, inter alia, the US and the EU), the applicant may
base its application on the assessment provided by the regulator in such jurisdiction and the foreign assessment will be considered by
Swissmedic. A marketing authorization may be granted only to an applicant established in Switzerland with a registered seat or branch
who is a holder of an authorization to manufacture, import or conduct wholesale trade issued by the competent authority.


 






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The processes and the duration of the procedure
adopted by Swissmedic are based on those of the European Medicines Agency (“EMA”) for the centralized approval procedure.


 


An accelerated marketing authorization procedure
for a medicinal product for human use is available if (i) it is a promising prevention or therapy against a serious, disabling or
life-threatening disease, (ii) there are no or unsatisfactory treatment options available with approved drugs, and (iii) the
use of the medicinal product is expected to provide a high therapeutic benefit. To prove the latter condition, the applicant must demonstrate
that based on a preliminary assessment of the submitted data, the therapeutic benefit exceeds the benefit of the previously approved therapy/standard
therapy (basis of comparison) by a clinically relevant margin compared to all therapies with approved drugs (as monotherapy or in combination)
available in Switzerland for the contemplated indication at the time of submission of the application for an accelerated procedure.


 


Regulatory Data Protection


 


New active substances approved on the basis of
a complete independent data package qualify for ten years of data exclusivity upon the granting of a marketing authorization. An additional
data exclusivity period of three years applies to new indications, new modes of administration, new preparation forms or new dosages.
New indications of known active substances are eligible for a data exclusivity period of ten years if a significant clinical benefit over
existing therapies can be expected and the indication is supported by extensive clinical trials. Drugs considered important for rare diseases
may qualify for a data exclusivity period of fifteen years.


 


Data exclusivity prevents Swissmedic from referencing
the innovator’s data to assess a generic application for the duration of the data exclusivity period.


 


Periods of Authorization and Renewal


 


A marketing authorization is valid for five years,
in principle, and it may be renewed after five years on the basis of a re-evaluation of the risk benefit balance by Swissmedic. To that
end, the marketing authorization holder must provide Swissmedic with a consolidated version of the file in respect of quality, safety
and efficacy, including all variations introduced since the marketing authorization was granted. Once renewed, the marketing authorization
is valid for an unlimited period, unless Swissmedic or the competent authority decides, on justified grounds, to limit the renewal period.
Any authorization that is not followed by the placement of the product on the Swiss market within three years after authorization may
be revoked by Swissmedic.


 


Post-Marketing Authorization Scheme


 


Following approval, the holder of the marketing
authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of the
medicinal product.


 


These include compliance with the TPA’s
and implementing ordinances stringent pharmacovigilance or safety reporting rules, pursuant to which post-authorization studies and additional
monitoring obligations can be imposed. The holder of a marketing authorization must establish and maintain a pharmacovigilance system
and appoint an individual qualified person for pharmacovigilance, who is responsible for oversight of that system. Key obligations include
expedited reporting of suspected serious adverse reactions in accordance with the recognised rules of good vigilance practice and
the submission of PSURs for medicinal products with new active substances for a period of four years following the marketing authorization.


 


In addition, all MAAs for medicinal products
with new active substances or orphan drugs must include an RMP describing the risk management system that the Corporation will put
in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also
impose specific obligations as a condition of the marketing authorization. Such risk-minimization measures or post-authorization
obligations may include additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical
trials or post-authorization safety studies.


 


Furthermore, the manufacturing of authorized products,
for which a separate manufacturer’s license is mandatory, must also be conducted in strict compliance with the GMP specified by
the Swiss Federal Council (“FC”) in accordance with international standards, which mandate the methods, facilities
and controls used in manufacturing, processing and packing of products to assure their safety and identity.


 






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Advertising for medicinal products is stringently
regulated under the TPA and the implementing Ordinance on the Advertising of Medicinal Products (“AWV”). The AWV generally
prohibits advertising of certain drugs to the general public, and sets out restrictions on, inter alia, the supply of samples.
Advertisements for unapproved medicinal products are forbidden. The advertising of prescription-only medicines to the general public is
not permitted.


 


Controlled Substances


 


The Swiss regime on narcotic substances set out
in the NarcA extensively regulates the cultivation, import and export, production, processing, storing, trade and placing on the market
of certain narcotic substances, as well as the prescription, dispensing and administering of narcotic substances. The NarcA provides for
certain permit requirements, including:


 


		·	The cultivation, import, production and placing on the market of certain substances (the “Banned
Substances”) requires exceptional administrative licenses granted for a specific legally permitted purpose. Amongst the Banned
Substances classified as belonging to category “d” are hallucinogens such as lysergide (LSD 25), diethyltryptamine (DMT),
methylenedioxy-methylamphetamine (MDMA), psilocybin, and ibogaine.



 


		·	An exceptional license may be obtained from the Swiss Federal Office of Public Health (“FOPH”)
if the Banned Substance is needed for scientific research or the development of medicinal products, or from Swissmedic if the Banned Substance
is an active ingredient in an authorized medicinal product.



 


Any person who cultivates, manufactures, dispenses,
or trades with controlled substances must ensure that the recipient is authorized to receive them whenever they are transferred.


 


Advertising of controlled substances, including
Banned Substances, to the general public is prohibited. A medicinal product containing controlled substances that is advertised to healthcare
professionals must be expressly and visibly designated as a medicinal product subject to control in accordance with the NarcA. Sample
packs for medicinal products with Banned Substances must not be distributed.


 


Additionally, trade with medicinal products containing
Banned Substances is subject to extensive notification obligations. Specifically, any shipment and receipt of Banned Substances by the
holder of an operating license issued by federal authorities must be notified to Swissmedic and shipments must be accompanied by a certain
waybill. Records of such shipments must be kept for ten years.


 


Further, stringent record-keeping and reporting
obligations apply to holders of operating licenses issued for the handling of Banned Substances.


 


Violations of the NarcA may entail, among other
things, fines and administrative sanctions, suspension or withdrawal of regulatory approvals, seizure of products, operating restrictions
and criminal prosecution.


 


Coverage, Pricing and Reimbursement


 


In Switzerland, the coverage and reimbursement
status of any product candidates for which MindMed may obtain regulatory approval is uncertain. Under the Swiss statutory health insurance
scheme, holders of a marketing authorization may apply for a listing in the positive specialty list (“SL”) for medicinal
products prescribed by a physician in outpatient treatment. Coverage or reimbursement will apply based on the maximum price set forth
in the SL. The FOPH decides on the listing following a health technology assessment in accordance with internationally accepted methodology.
The Federal Drug Commission (“FDC”) advises the FOPH on the evaluation of medicinal products. The listing procedure
takes at least 18 weeks.


 






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In addition to reimbursement of listed medicinal
products, public health insurance will in exceptional cases reimburse the costs of unlisted medicinal products that are either authorised
by Swissmedic or imported from a country featuring an equivalent market authorisation scheme.


 


Other Healthcare Laws and Compliance Requirements


 


In Switzerland, healthcare providers, physicians,
and third-party payors will play a primary role in the recommendation and prescription of any products for which MindMed obtains marketing
approval. MindMed’s business operations and any current or future arrangements with third-party payors, healthcare providers and
physicians may expose MindMed to broadly applicable federal and cantonal fraud and abuse laws, as well as other healthcare laws and regulations.
These laws may impact, among other things, MindMed’s business or financial arrangements and relationships through which MindMed
conducts research, as well as markets, sells and distributes the therapies for which it obtains approval. In addition, MindMed may be
subject to health information privacy regulation by both the federal government and the cantons in which MindMed conducts its business.


 


In Switzerland the laws that may affect MindMed’s
ability to operate include, among others:


 


		·	Any cooperation between MindMed and health care practitioners (“HCP”) and health care
organizations (“HCO”) is subject to criminal provisions on bribery and unlawful inducements under the general Swiss
Criminal Code (“CC”) and under the regime on medicinal products, as set out in the TPA and the Ordinance on Integrity
and Transparency in the Therapeutic Products Sector (“ITO”), and professional and industry code of conducts.



 


		·	Additionally, the 2021 Pharma Cooperation Code and 2021 Pharma Code signed by the major pharmaceutical
companies operating in Switzerland, reflecting the TPA and ITO and modelled after the European Federation of Pharmaceutical Industries
and Associations (“EFPIA”) EFPIA 2019 Code of Practice, provide for industry guidelines with regard to marketing directed
at and transfers of value to HCP, HCO, and patient organisations.



 


		·	Further, all price discounts and rebates granted in the purchase of therapeutic products to persons or
organizations that prescribe, dispense, use or purchase therapeutic products for the prescription, use or dispensing must be disclosed
to the FOPH upon request (subject only to certain exceptions for low-risk medicinal products).



 


		·	The Swiss Data Protection Act (“DPA”) governs the collection, use, disclosure and protection
of health-related and other personal information. Failure to comply with data protection laws and regulations could result in government
enforcement actions and create liability, private litigation and/or adverse publicity. Data collected in human studies (including clinical
trials) is subject to stringent regulation under the HRA and implementing ordinances.



 


		·	Further, federal consumer protection and unfair competition laws apply, which broadly regulate marketplace
activities and activities that potentially harm consumers.



 


		·	The distribution of pharmaceutical products is subject to additional requirements and regulations, including
extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.
The wholesale of medicinal products requires a wholesale license.



 


Australia


 


Regulation and Procedures
Governing Approval of Medicinal Products in Australia


 


In Australia, the approval process for commencing
Phase 1 and 2 clinical trials resides with the Human Research Ethics Committee (“HREC”). Prior to commencing a clinical
trial, a sponsor must submit to the HREC a study protocol, an investigator brochure and a template informed consent for such clinical
trial. The HREC approval process generally takes four to eight weeks.


 






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Once a study is approved by the HREC, a Clinical
Trial Notification (“CTN”), is submitted online (together with the relevant fee) to the Australian Government Department
of Health, Therapeutic Goods Administration (“TGA”). The CTN is a notification that the HREC has approved the safety,
efficacy and ethical acceptability of the trial, approved the trial protocol and evaluated the scientific merit of the trial. The TGA
does not send an acknowledgment letter by email, as this information can be viewed and printed via the online portal, providing evidence
that the clinical trial has been notified to the TGA. The target time to process online CTNs is 5-7 working days, and will therefore usually
be completed within two weeks of lodgment.


 


In Australia and New Zealand, sponsors register
clinical trial information on a website maintained by the Australian New Zealand Clinical Trials Registry at www.anzctr.org.au. When a
clinical trial is registered on these websites, certain information regarding the product, patient population, phase of investigation,
study sites and investigator, and other aspects of the clinical trial must be posted. Sponsors are also obligated to disclose the results
of many of these trials after completion, although under certain circumstances disclosure of the results of these trials can be delayed
until the product or new indication being studied has been approved. Competitors may use this publicly-available information to gain knowledge
regarding the design and progress of MindMed’s development programs.


 


Marketing Authorization
in Australia


 


In Australia, unless a relevant exclusion or exemption
applies, a therapeutic good must be registered, listed or included on the Australian Register of Therapeutic Goods (“ARTG”)
before it may be imported into, exported from, supplied or manufactured in Australia. It is also an offence to advertise unapproved therapeutic
goods. The process for obtaining registration depends on the type of product in question (e.g. prescription medicine, complementary or
over-the-counter medicine, medical devices, etc.), but the regulatory regime is designed to address quality, safety and efficacy
of the therapeutic good.


 


A new chemical entity will also be scheduled at
about the time it is registered on the ARTG. Scheduling decisions are recorded in the Poisons Standard in force from time to time.
The scheduling decision will impact how a therapeutic good may be manufactured, stored, supplied, possessed and used, as well as advertised.
For example, Schedule 4 – prescription-only medicines may not be advertised to patients. Licensing matters, and rules about
storage, possession, prescription and use of poisons and therapeutic goods are covered by State and Territory legislation.


 


Controlled Drugs Classification
in Australia


 


Schedule 8 – Controlled Drugs are those
substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce
abuse, misuse and physical or psychological dependence. The TGA’s Scheduling Handbook notes that substances evaluated by the TGA
as part of the registration process for a new chemical entity will not routinely be referred to a scheduling advisory committee; however,
for any drugs proposed to be included in Schedule 8, the TGA will refer this to the Advisory Committee on Medicines Scheduling (“ACMS”)
for advice (because of the impact on State/Territory regulation, monitoring and compliance) (see https://www.tga.gov.au/sites/default/files/scheduling-handbook-guidance-amending-poisons-standard.pdf).


 


Coverage, Pricing and Reimbursement


 


In Switzerland, healthcare providers, physicians,
and third-party payors will play a primary role in the recommendation and prescription of any products for which MindMed obtains marketing
approval. MindMed’s business operations and any current or future arrangements with third-party payors, healthcare providers and
physicians may expose MindMed to broadly applicable federal and cantonal fraud and abuse laws, as well as other healthcare laws and regulations.
These laws may impact, among other things, MindMed’s business or financial arrangements and relationships through which MindMed
conducts research, as well as markets, sells and distributes the therapies for which it obtains approval. In addition, MindMed may be
subject to health information privacy regulation by both the federal government and the cantons in which MindMed conducts its business.


 






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In Switzerland the laws that may affect MindMed’s
ability to operate include, among others:


 


		·	Any cooperation between MindMed and HCPs and HCOs is subject to criminal provisions on bribery and unlawful
inducements under the general Swiss CC and under the regime on medicinal products, as set out in the TPA and ITO, and professional and
industry code of conducts.



 


		·	Additionally, the 2021 Pharma Cooperation Code and 2021 Pharma Code signed by the major pharmaceutical
companies operating in Switzerland, reflecting the TPA and ITO and modelled after the EFPIA, EFPIA 2019 Code of Practice, provide for
industry guidelines with regard to marketing directed at and transfers of value to HCP, HCO, and patient organizations.



 


		·	Further, all price discounts and rebates granted in the purchase of therapeutic products to persons or
organizations that prescribe, dispense, use or purchase therapeutic products for the prescription, use or dispensing must be disclosed
to the FOPH upon request (subject only to certain exceptions for low-risk medicinal products).



 


		·	The Swiss DPA governs the collection, use, disclosure and protection of health-related and other personal
information. Failure to comply with data protection laws and regulations could result in government enforcement actions and create liability,
private litigation and/or adverse publicity. Data collected in human studies (including clinical trials) is subject to stringent regulation
under the Swiss HRA and implementing ordinances.



 


		·	Further, federal consumer protection and unfair competition laws apply, which broadly regulate marketplace
activities and activities that potentially harm consumers.



 


		·	The distribution of pharmaceutical products is subject to additional requirements and regulations, including
extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.
The wholesale of medicinal products requires a wholesale license.



 


Restrictions and Data Protection Obligations


 


Clinical trials conducted in Australia, to the
extent that such sites include certain university, company or government agencies, may be subject to restrictions and data protection
obligations under the Privacy Act 1988 (Cth). Additional data protection laws in Australia in the states and territories in which trials
are conducted similarly restrict the ability to collect, analyze and transfer medical records and other patient data.


 


Regulatory Strategy


 


Research on 18-MC in animal models suggests the
potential for efficacy in relation to substance abuse and certain compulsive behaviours, including compulsive eating. The regulatory path
to NDA approval for substance abuse disorders in the U.S. is through the FDA. The U.S. IND for 18-MC (IND 118783) became effective July 9,
2014.


 


Once the safety profile of 18-MC is better understood
through MindMed’s studies, which are intended to take place outside of the United States and are currently occurring in Australia,
then U.S. clinical studies under the U.S. IND, in accordance with FDA regulations, will be initiated with a significant human safety database
already in place.


 


In December 2020, the Corporation successfully
completed a pre-IND meeting with the FDA for the treatment of an anxiety disorder with LSD. The Corporation intends to submit an IND with
the FDA in August 2021, with a Phase 2b clinical trial evaluating experiential doses of LSD in an anxiety disorder. MindMed is assembling
and using data from its data acquisition from the UHB Liechti Lab to help support its IND filing to the FDA.


 


The Corporation has received legal advice with
respect to its United States regulatory obligations to comply with the FDA’s drug development and approval processes as a precondition
of marketing the Addiction Treatment Program, Project Flow and Project Lucy within the United States.


 






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While
MindMed is focused on programs using psychedelic inspired compounds and classic psychedelics, MindMed does not have any direct or indirect
involvement with the illegal selling, production or distribution of any substances in the jurisdictions in which it operates. The
Corporation is a neuro-pharmaceutical drug development company and does not advocate for the legalization of any psychedelic substances
and does not deal with psychedelic substances except in laboratory and clinical trial settings in compliance with applicable regulations.
MindMed’s products will not be commercialized prior to applicable regulatory approval, which will only be granted if clinical evidence
of safety and efficacy for the intended uses is successfully developed. Furthermore,
because the Corporation only deals with psychedelic substances in laboratory and clinical trial settings in compliance with applicable
regulations, in the Corporation’s view, there are minimal risks associated with third-party service providers that relate to the
treatment of psychedelic substances under applicable laws. The Corporation also feels that it has minimized other risks associated with
third-party service providers through standard contractual obligations.


 


Employees


 


The Corporation relies on a combination of employees
and consultants (either full-time or part-time) and, as of the date of this AIF, has a total of 22 full-time employees, 28 full-time consultants,
and no part-time consultants. Full time employees are distributed among several departments, including operations, science, and sales.


 


Foreign Operations


 


The
Corporation has four wholly-owned subsidiaries that were incorporated and operate in foreign jurisdictions, being MindMed US, MindMed
Australia, MindMed Switzerland and HealthMode. MindMed US is the Corporation’s main operating subsidiary, through which its three
drug development programs are overseen: the Addiction Treatment Program, Project Flow and Project Lucy. The UHB Liechti Lab collaboration
with the Corporation and the Corporation’s other research and development efforts related to psychedelics are supported through
the Corporation’s Swiss subsidiary, MindMed Switzerland. The Corporation’s Phase 1 study on normal healthy volunteers to determine
the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of 18-MC for the Corporation’s Addiction
Treatment Program is currently being conducted by MindMed Australia. HealthMode is the Corporation’s digital medicine and
therapeutics subsidiary based in the United States, which uses Artificial Intelligence (AI)-enabled digital measurement to increase the
precision and speed of clinical research and patient monitoring.


 


RISK FACTORS


 


The following discussion summarizes the principal
risk factors that apply to the Corporation’s business and that may have a material adverse effect on the Corporation’s business,
financial condition and results of operations, or the trading price of the Subordinate Voting Shares. Some of the following factors are
interrelated and, consequently, readers should treat such risk factors as a whole. These risks and uncertainties are not the only ones
that could affect the Corporation or the shares of the Corporation and additional risks and uncertainties not currently known to the Corporation,
or that it currently deems to be immaterial, may also impair the business, financial condition and results of operations of the Corporation
and the value of the Corporation’s shares. If any of the following risks or other risks occur, they could have a material adverse
effect on the Corporation’s business, financial condition and results of operations and the value of the Corporation’s shares.
There is no assurance that any risk management steps taken by the Corporation will avoid future loss due to the occurrence of the risks
described below or other unforeseen risks.


 


Risks Related to the Corporation’s Financial Position and
Need for Additional Capital


 


The Corporation expects to incur future losses and may never become
profitable


 


The Corporation has historically incurred losses
and incurred an operating loss for the year ending December 31, 2020. The Corporation believes that operating losses will continue
as the Corporation is planning to incur significant costs associated with its research and development initiatives. The Corporation’s
net losses have had and will continue to have an adverse effect on, among other things, shareholders’ equity, total assets and working
capital. The Corporation expects that losses will fluctuate from quarter to quarter and year to year, and that such fluctuations may be
substantial. The Corporation cannot predict when it will become profitable, if at all.


 






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Negative operating cash flow


 


The Corporation has negative cash flow from operating
activities and has historically incurred net losses. There is no assurance that sufficient revenues will be generated in the near future.
To the extent that the Corporation has negative operating cash flows in future periods, it may need to deploy a portion of its existing
working capital to fund such negative cash flows. The Corporation will be required to raise additional funds through the issuance of additional
equity securities or through loan financing. There is no assurance that additional capital or other types of financing will be available
if needed or that these financings will be on terms at least as favourable to the Corporation as those previously obtained, or at all.


 


The Corporation will require additional capital
to finance its operations, which may not be available to the Corporation on acceptable terms, or at all.


 


As a research and development company, MindMed
expects to spend a substantial amount of money to continue the research, development and testing of its product candidates and to prepare
to commercialize products subject to approvals from the FDA in the United States and similar regulatory authorities in the other jurisdictions
in which the Corporation operates, including Australia, Switzerland and the Netherlands. The Corporation will also require significant
additional funds if it expands the scope of its current clinical plans or if it were to acquire any new assets and advance their development.
As a result, for the foreseeable future, the Corporation will have to fund all of its operations and development expenditures from cash
on hand, equity financings, through collaborations with other biotechnology or pharmaceutical companies or through financings from other
sources. If it does not succeed in raising additional funds on acceptable terms, the Corporation might not be able to complete planned
preclinical studies and clinical trials or pursue and obtain approval of any product candidates from the FDA and other regulatory authorities.
It is possible that future financing will not be available or, if available, may not be on favorable terms. The availability of financing
will be affected by the achievement of the Corporation’s corporate goals, the results of scientific and clinical research, the ability
to obtain regulatory approvals, the state of the capital markets generally and with particular reference to drug development companies,
the status of strategic alliance agreements and other relevant commercial considerations. If adequate funding is not available, the Corporation
may be required to delay, reduce or eliminate one or more of its product development programs, or obtain funds through corporate partners
or others who may require the Corporation to relinquish significant rights to product candidates or obtain funds on less favourable terms
than the Corporation would otherwise accept. To the extent that external sources of capital become limited or unavailable or available
on onerous terms, the Corporation’s intangible assets and its ability to continue its clinical development plans may become impaired,
and the Corporation’s assets, liabilities, business, financial condition and results of operations may be materially or adversely
affected.


 


The Corporation currently has no product revenue
and will not be able to maintain its operations and research and development without additional funding


 


To date, the Corporation has generated no product
revenue and cannot predict when or if it will generate product revenue. The Corporation’s ability to generate product revenue and
ultimately become profitable depends upon its ability, alone or with partners, to successfully develop its product candidates, obtain
regulatory approval, and commercialize products, including any of its current product candidates, or other product candidates that it
may develop, in-license or acquire in the future. The Corporation does not anticipate generating revenue from the sale of products for
the foreseeable future. The Corporation expects its research and development expenses to increase in connection with its ongoing activities,
particularly as it advances its product candidates through clinical trials.


 


The Corporation is exposed to the financial
risk related to the fluctuation of foreign exchange rates and the degrees of volatility of those rates


 


The Corporation may be adversely affected by foreign
currency fluctuations. To date, the Corporation has been primarily funded through equity issuances and from interest income on funds available
for investment, which are primarily denominated in Canadian dollars. A significant portion of the Corporation’s expenditures are
also in currencies other than Canadian dollars, and the Corporation is therefore subject to foreign currency fluctuations which may, from
time to time, impact its financial position and results of operations.


 






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Risks Related to the Corporation’s Business and Industry


 


Violations of laws and regulations could result
in repercussions, and psychedelic inspired drugs may never be approved as medicines and psychedelic assisted therapy may face similar challenges


 


In the United States, certain psychedelic
drugs, including lysergic acid diethylamide (LSD), ibogaine, methylenedioxy-methylamphetamine (MDMA), dimethyltryptamine (DMT) and
psilocybin, are classified as Schedule I drugs under the CSA (21 U.S.C. § 801 et seq.) and the Controlled Substances
Import and Export Act (21 U.S.C. § 951 et seq.) and as such, medical and recreational use is illegal under U.S. federal
law. Certain other jurisdictions in which the Corporation currently operates, including Australia, Switzerland and the Netherlands,
have similarly regulated certain psychedelic drugs. There is no guarantee that psychedelic drugs or psychedelic inspired drugs will
ever be approved as medicines in any jurisdiction in which the Corporation operates. Similarly, no psychedelic assisted therapies
have been approved to date and there is no guarantee that any psychedelic assisted therapies that the Corporation is exploring will
ever be approved in any jurisdiction in which the Corporation operates. MindMed’s programs involving Schedule I drugs are
conducted in strict compliance with the laws and regulations regarding the production, storage and use of Schedule I drugs. As such,
all facilities engaged with such substances by or on behalf of MindMed do so under current licenses and permits issued by
appropriate federal, state and local governmental agencies. While MindMed is focused on programs using psychedelic inspired
compounds, MindMed does not have any direct or indirect involvement with the illegal selling, production or distribution of any
substances in the jurisdictions in which it operates and does not intend to have any such involvement. However, the laws and
regulations generally applicable to the industries in which the Corporation is involved in may change in ways currently unforeseen.
Any amendment to or replacement of existing laws or regulations, including the classification or re-classification of the substances
the Corporation is developing or working with, which are matters beyond the Corporation's control, may cause the Corporation’s
business, financial condition, results of operations and prospects to be adversely affected or may cause the Corporation to incur
significant costs in complying with such changes, or it may not be able to comply with such changes at all. A violation of any U.S.
federal laws and regulations, such as the CSA and Controlled Substances Import and Export Act, or of similar legislation in the
jurisdictions in which it operates, including Australia, Switzerland and the Netherlands, could result in significant fines,
penalties, administrative sanctions, convictions or settlements arising from civil proceedings initiated by either government
entities in the jurisdictions in which the Corporation operates, or by private citizens, or through criminal charges. The loss of
the necessary licenses and permits for Schedule I drugs could have an adverse effect on MindMed’s operations.


 


Research and development of drugs targeting
the central nervous system is particularly difficult, which makes it difficult to predict and understand why such drugs have a positive
effect on some patients but not others


 


Discovery and development of new drugs targeting
central nervous system disorders are particularly difficult and time-consuming, as evidenced by the higher failure rate for new drugs
for central nervous system disorders compared with most other areas of drug discovery. Any setbacks in the Corporation’s clinical
development could have a material adverse effect on its business and operating results. In addition, any later stage clinical trials may
present challenges related to conducting adequate and well-controlled clinical trials, including designing an appropriate comparator arm
in trials given the potential difficulties related to maintaining the blinding during the trial or placebo or nocebo effects.


 


Due to the complexity of the human brain and the
central nervous system, it can be difficult to predict and understand why a drug may have a positive effect on some patients but not others
and why some individuals may react to the drug differently from others. Moreover, if patients being treated in clinical trials have previously
been treated with other drugs or therapies, the prior use of such drugs or therapies concurrently or up to two weeks prior to administration
may interfere with the mechanism of action of, or response to, the Corporation’s therapies. Further, the size and heterogenous nature
of certain populations that the Corporation studies may further result in different reactions and impact the effectiveness of the Corporation’s
investigational therapies. All of these factors may make it difficult to assess the prior use or the overall efficacy of the Corporation’s
therapies.


 






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Failure to comply with health and data protection
laws and regulations could lead to federal, state or provincial government enforcement actions, including civil or criminal penalties,
private litigation, and adverse publicity and could negatively affect MindMed’s operating results and business


 


The Corporation and any potential collaborators
may be subject to federal, state and provincial data protection laws and regulations in the jurisdictions in which it operates, such as
laws and regulations that address privacy and data security. In addition, the Corporation may obtain health information from third parties,
including research institutions from which the Corporation obtains clinical trial data, which are subject to privacy and security requirements
under applicable laws. Depending on the facts and circumstances, the Corporation could be subject to significant civil, criminal, and
administrative penalties if the Corporation obtains, uses, or discloses individually identifiable health information maintained by entities
covered by applicable health and data protection laws in a manner that is not authorized or permitted by such laws.


 


Compliance with privacy and data protection laws
and regulations could require the Corporation to take on more onerous obligations in the Corporation’s contracts, restrict the Corporation’s
ability to collect, use and disclose data, or in some cases, impact the Corporation’s ability to operate in certain jurisdictions.
Failure to comply with these laws and regulations could result in government enforcement actions (which could include civil, criminal
and administrative penalties), private litigation, or adverse publicity and could negatively affect the Corporation’s operating
results and business. Moreover, clinical trial subjects, employees and other individuals about whom the Corporation or its potential collaborators
obtain personal information, as well as the providers who share this information with the Corporation, may limit the Corporation’s
ability to collect, use and disclose the information. Claims that the Corporation has violated individuals’ privacy rights, failed
to comply with data protection laws, or breached contractual obligations, even if the Corporation is not found liable, could be expensive
and time-consuming to defend and could result in adverse publicity that could harm the Corporation’s business.


 


If the Corporation is not able to establish,
maintain and enhance the Corporation’s reputation and brand recognition, the Corporation’s business, financial condition and
results of operations will be harmed


 


MindMed believes that establishing, maintaining
and enhancing the Corporation’s reputation and brand recognition is critical to the Corporation’s relationships with existing
and future therapists, patients and collaborators. The promotion of the Corporation’s brand may require it to make substantial investments
and MindMed anticipates that, as its market becomes increasingly competitive, these marketing initiatives may become increasingly difficult
and expensive. Brand promotion and marketing activities may not be successful or yield increased revenue, and to the extent that these
activities yield increased revenue, the increased revenue may not offset the expenses the Corporation incurs and the Corporation’s
business, financial condition and results of operations could be harmed. In addition, any factor that diminishes the Corporation’s
reputation or that of its management, including failing to meet the expectations of its network of therapists, patients and collaborators,
could harm its reputation and brand and make it substantially more difficult for the Corporation to attract new therapists, patients and
collaborators. If the Corporation does not successfully establish, maintain and enhance the Corporation’s reputation and brand recognition,
its business may not grow and the Corporation could lose its relationships with therapists, patients and collaborators, which would harm
the Corporation’s business, financial condition and results of operations.


 


Because MindMed is subject to environmental,
health and safety laws and regulations, the Corporation may become exposed to liability and substantial expenses in connection with environmental
compliance or remediation activities which may adversely affect the Corporation’s business and financial condition


 


The Corporation’s operations, including
its research, development and testing, although primarily conducted by third parties, are nonetheless subject to numerous foreign, federal,
state, provincial and local environmental, health and safety laws and regulations. These laws and regulations govern, among other things,
the controlled use, handling, release and disposal of and the maintenance of a registry for, hazardous materials, such as chemical solvents,
human cells, carcinogenic compounds, mutagenic compounds and compounds that have a toxic effect on reproduction, laboratory procedures
and exposure to blood-borne pathogens.


 






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Although the Corporation contracts all manufacturing
to third parties, it may nonetheless incur significant costs to comply with current or future environmental and health and safety laws
and regulations. Furthermore, if the Corporation fails to comply with such laws and regulations, the Corporation could be subject to fines
or other sanctions. As with other companies engaged in similar activities, the Corporation faces a risk of environmental liability inherent
in its current and historical activities, including liability relating to releases of, or exposure to, hazardous materials and, as a result,
may incur material liability as a result of any such releases or exposures. Environmental, health and safety laws and regulations are
becoming more stringent. The Corporation may incur substantial expenses in connection with any current or future environmental compliance
or remediation activities, in which case, research and development efforts may be interrupted or delayed and the Corporation’s financial
condition and results of operations may be materially adversely affected. In the event of an accident involving hazardous materials, an
injured party may seek to hold the Corporation liable for any damages that result.


 


Unfavourable publicity or consumer perception
of psychedelic inspired medicine may have an adverse impact on the Corporation’s operational results, consumer base and financial
results


 


The psychedelic drug industry is highly dependent
upon consumer perception regarding the safety, efficacy and quality of the psychedelic inspired medicinal applications. The success of
the industry in which the Corporation operates may be significantly influenced by the public’s perception of psychedelic inspired
medicinal applications. Consumer perception can be significantly influenced by scientific research or findings regarding the consumption
of psychedelic inspired products. There is no guarantee that future scientific research, publicity, regulations, medical opinion, and
public opinion relating to psychedelic inspired medicine will be favorable to the market or any particular product, or consistent with
earlier research or findings. The industry in which the Corporation operates is in its early stages and is constantly evolving, with no
guarantee of viability. The market for psychedelic inspired medicines is uncertain, and any adverse or negative publicity, scientific
research, limiting regulations, medical opinion and public opinion relating to the consumption of psychedelic inspired medicines may have
a material adverse effect on the Corporation’s operational results, consumer base and financial results. While the Corporation is
focused on programs using psychedelic inspired compounds, and does not advocate for the legalization of any psychedelic substances or
deal with psychedelic substances except within laboratory and clinical trial settings conducted within approved regulatory frameworks,
any unfavourable publicity or consumer perception regarding psychedelic substances (in addition to psychedelic inspired medicines) could
also have a material adverse effect on the Corporation’s operational results, consumer base and financial results.


 


In addition, research in Canada, the U.S. and
internationally regarding the medical benefits, viability, safety, efficacy and dosing of psychedelic drugs remains in early stages. There
have been relatively few clinical trials on the benefits. Although the Corporation believes that various articles, reports and studies
support its beliefs regarding the medical benefits, viability, safety, efficacy and dosing of psychedelic inspired medicines, future research
and clinical trials may prove such statements to be incorrect or could raise concerns. Future research studies and clinical trials may
draw opposing conclusions to those stated in this AIF or reach negative conclusions regarding the medical benefits, viability, safety,
efficacy, dosing, or other facts related to psychedelic inspired medicinal applications, which could have a material adverse effect on
the demand for the Corporation’s products, and therefore on its business, prospects, revenue, results of operation and financial
condition.


 


The
results of future clinical research may be unfavorable to psychedelic inspired medicines, which may have a material adverse
effect on the demand for the Corporation’s products


 


The
psychedelic drug industry is highly dependent upon consumer perception regarding the safety, efficacy and quality of the psychedelic
inspired medicinal applications. Consumer perception can be significantly influenced by scientific research or findings regarding the
consumption of psychedelic inspired products. There can be no assurance that future scientific research or findings will be favorable
to the market or any particular product, or consistent with earlier research or findings. Research in Canada, the U.S. and internationally
regarding the medical benefits, viability, safety, efficacy and dosing of psychedelic drugs remains in early stages. There have been relatively
few clinical trials on the benefits. Although the Corporation believes that various articles, reports and studies support the Corporation’s
beliefs regarding the medical benefits, viability, safety, efficacy and dosing of psychedelic inspired medicines, future research and
clinical trials may prove such statements to be incorrect or could raise concerns. Future research studies and clinical trials may draw
opposing conclusions to those stated in this AIF or reach negative conclusions regarding the medical benefits, viability, safety, efficacy,
dosing, or other facts related to psychedelic inspired medicinal applications, which could have a material adverse effect on the demand
for the Corporation’s products, and therefore on its business, prospects, revenue, results of operation and financial condition.


 






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The Corporation may be subject to heightened
scrutiny by United States and Canadian authorities, which could ultimately lead to the market for Subordinate Voting Shares becoming highly
illiquid and the Corporation’s shareholders having no ability to effect trades in Subordinate Voting Shares


 


The
Corporation’s Subordinate Voting Shares are traded on the NEO and on the OTCQB in the United States. The Corporation’s
business, operations and investments in the United States, and any future business, operations or investments, may become the subject
of heightened scrutiny by regulators, stock exchanges and other authorities in Canada and the United States. As a result, the Corporation
may be subject to significant direct and indirect interaction with public officials. There can be no assurance that this heightened scrutiny
will not in turn lead to the imposition of certain restrictions on the Corporation’s ability to operate or invest in the United
States or any other jurisdiction.


 


Information about the Corporation posted to
social media platforms may be inaccurate or adverse to the Corporation’s interests, each of which may harm the Corporation’s
business, financial condition and results of operations


 


There has been a recent marked increase in the
use of social media platforms and similar channels that provide individuals with access to a broad audience of consumers and other interested
persons. The availability and impact of information on social media platforms is virtually immediate and many social media platforms publish
user-generated content without filters or independent verification as to the accuracy of the content posted. Information posted about
the Corporation may be adverse to the Corporation’s interests or may be inaccurate, each of which may harm the Corporation’s
business, financial condition and results of operations.


 


The Corporation’s prospects depend on
the success of its product candidates which are at early stages of development, and it may not generate revenue for several years, if
at all, from these products


 


Given the early stage of the Corporation’s
product development, the Corporation can make no assurance that its research and development programs will result in regulatory approval
or commercially viable products. To achieve profitable operations, the Corporation, alone or with others, must successfully develop, gain
regulatory approval for, and market its future products. The Corporation currently has no products that have been approved by the FDA
or any similar regulatory authority in other countries. To obtain regulatory approvals for its product candidates that are in development
and to achieve commercial success, clinical trials must demonstrate that the product candidates are safe for human use and that they demonstrate
efficacy. While the Corporation has commenced clinical trials for 18-MC, the Corporation has not yet completed later stage clinical trials
for any of its product candidates.


 


Many product candidates never reach the stage
of clinical testing and even those that do have only a small chance of successfully completing clinical development and gaining regulatory
approval. Product candidates may fail for a number of reasons, including, but not limited to, being unsafe for human use or due to the
failure to provide therapeutic benefits equal to or better than the standard of treatment at the time of testing. Unsatisfactory results
obtained from a particular study relating to a research and development program may cause the Corporation or its collaborators to abandon
commitments to that program. Positive results of early preclinical research may not be indicative of the results that will be obtained
in later stages of preclinical or clinical research. Similarly, positive results from early-stage clinical trials may not be indicative
of favourable outcomes in later-stage clinical trials, and the Corporation can make no assurance that any future studies, if undertaken,
will yield favourable results.


 


The early stage of MindMed’s product development
makes it particularly uncertain whether any of its product development efforts will prove to be successful and meet applicable regulatory
requirements, and whether any of its product candidates will receive the requisite regulatory approvals, be capable of being manufactured
at a reasonable cost or be successfully marketed. If the Corporation is successful in developing its current and future product candidates
into approved products, the Corporation will still experience many potential obstacles, which would affect the Corporation’s ability
to successfully market and commercialize such approved products, such as the need to develop or obtain manufacturing, marketing and distribution
capabilities, price pressures from third-party payors, or proposed changes in health care systems. If the Corporation is unable to successfully
market and commercialize any of its products, its financial condition and results of operations may be materially and adversely affected.


 






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The Corporation can make no assurance that any
future studies, if undertaken, will yield favorable results. Many companies in the pharmaceutical and biotechnology industries have suffered
significant setbacks in later-stage clinical trials after achieving positive results in early-stage development, and MindMed cannot be
certain that it will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings made while
clinical trials were underway or safety or efficacy observations made in clinical trials, including previously unreported adverse events.
Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed
their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or any similar
regulatory authority approval. If the Corporation fails to produce positive results in its future clinical trials of 18-MC, LSD and other
programs, the development timeline and regulatory approval and commercialization prospects for MindMed’s product candidates, and,
correspondingly, its business and financial prospects, would be materially adversely affected.


 


The Corporation relies and will continue to
rely on third parties to plan, conduct and monitor its preclinical studies and clinical trials, and its failure to perform as required
could cause substantial harm to its business


 


The Corporation relies and will continue to rely
on third parties to conduct a significant portion of its preclinical and clinical development activities. Preclinical activities include
in vivo studies providing access to specific disease models, pharmacology and toxicology studies, and assay development. Clinical development
activities include trial design, regulatory submissions, clinical patient recruitment, clinical trial monitoring, clinical data management
and analysis, safety monitoring and project management. If there is any dispute or disruption in the Corporation’s relationship
with third parties, or if it is unable to provide quality services in a timely manner and at a feasible cost, MindMed’s active development
programs will face delays. Further, if any of these third parties fail to perform as the Corporation expects or if their work fails to
meet regulatory requirements, MindMed’s testing could be delayed, cancelled or rendered ineffective.


 


The Corporation is likely to be reliant on
third parties to implement and staff the Albert digital medicine division plan, and its failure to attract third parties to build out
the division could cause substantial harm to its business


 


The Albert digital medicine division aims to have
a team of technologists, therapists, and clinical drug development experts to help the Corporation research, develop and build an integrated
technical platform and comprehensive toolset aimed at delivering psychedelic inspired medicines and therapies combined with digital therapeutics.
Many of these experts will be external third parties to the Corporation, and the Corporation will aggregate these various parties and
potential therapies for a significant portion of these therapies. If there is any dispute or disruption in the Corporation’s relationship
with third parties, or if they are unable to provide quality services in a timely manner and at a feasible cost, the development of the
Albert division could face delays. Further, if any of these third parties fail to perform as the Corporation expects, or if their work
fails to meet regulatory requirements, or if MindMed is unable to attract third parties to participate in Albert, or if they are unable
to meet the Corporation’s timetable and requirements, the Corporation may be delayed in the development of its Albert division or
may not be able to develop it at all.


 


Additionally, arrangements with third parties,
collaborations and in-licenses could involve numerous risks, including, but not limited to:


 


		(1)	substantial cash expenditures;



 


		(2)	technology development risks;



 


		(3)	difficulties in assimilating the products, therapies and offerings of the third parties; and



 


		(4)	diverting the Corporation’s management’s attention away from other business concerns.



 


The Corporation has experience in entering collaborations and in-licensing
product candidates; however, the Corporation cannot provide assurance that any collaboration or in-license will result in short-term or
long-term benefits to it. The Corporation may incorrectly judge the value or worth of any collaborator, third party or in-licensed candidate.


 


The process of drug development activities
is dependent on a number of factors, and any unforeseen disruption could negatively impact the Corporation’s ability to make regulatory
submissions, initiate nonclinical or clinical studies, or meet other development milestones


 


The progress of drug development activities, including
the supply of investigational material, is dependent on a number of factors, including but not limited to: availability of starting materials,
solvents, reagents, excipients, manufacturing components, container closure systems, labels, fillers and other supplies; identification
of qualified vendors to perform manufacturing and analytical activities under cGMPs; qualification of such vendors under MindMed’s
quality management systems; availability of manufacturing and analytical facilities, personnel and documentation to facilitate completion
of manufacturing and analytical activities under cGMPs; analysis of investigational materials under cGMPs; and the stability of investigational
material, which is subject to change over time.  Lack of availability of required components, or disruption or changes in schedules,
or any other unforeseen disruption, including those that are outside of MindMed’s control, of one or more of these dependencies
could result in delays or failures in manufacturing campaigns. As a result, any such disruptions could negatively impact the Corporation’s
ability to make regulatory submissions, initiate nonclinical or clinical studies, or meet other development milestones, all of which could
negatively affect MindMed’s operating results and business.


 


The Corporation relies on contract manufacturers
over whom it has limited control. If the Corporation is subject to quality, cost or delivery issues with the preclinical and clinical
grade materials supplied by contract manufacturers, its business operations could suffer significant harm


 


The
Corporation has limited manufacturing experience and relies on CMOs to manufacture its product candidates for preclinical studies and
clinical trials. MindMed relies on CMOs for manufacturing, filling, packaging, storing and shipping of drug product in compliance with
current GMP regulations applicable to its products. The FDA and
similar regulatory authorities in other countries ensure the quality of drug products by carefully monitoring drug manufacturers’
compliance with GMP regulations. The GMP regulations for drugs contain minimum requirements for the methods, facilities and controls used
in manufacturing, processing and packing of a drug product.


 


There can be no assurances that CMOs will be able
to meet the Corporation’s timetable and requirements. The Corporation has not contracted with alternate suppliers for 18-MC and
LSD drug substance production in the event that the current provider is unable to scale up production, or if it otherwise experiences
any other significant problems. If the Corporation is unable to arrange for alternative third-party manufacturing sources on commercially
reasonable terms or in a timely manner, the Corporation may be delayed in the development of its product candidates. Further, CMOs must
operate in compliance with GMP and failure to do so could result in, among other things, the disruption of product supplies. The Corporation’s
dependence upon third parties for the manufacture of its products may adversely affect its profit margins and its ability to develop and
deliver products on a timely and competitive basis.


 






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The Corporation requires commercial scale and
quality manufactured product to be available for pivotal or registration clinical trials. If the Corporation does not have commercial
grade drug supply when needed, it may face delays in initiating or completing pivotal trials and its business operations could suffer
significant harm


 


To date, the Corporation’s product has been
manufactured in small quantities for preclinical studies and clinical trials by third party manufacturers. In order to commercialize its
product, the Corporation needs to manufacture commercial quality drug supply for use in registration clinical trials. Most, if not all,
of the clinical material used in phase 3/pivotal/registration studies must be derived from the defined commercial process including scale,
manufacturing site, process controls and batch size. If MindMed has not scaled up and validated the commercial production of its product
prior to the commencement of pivotal clinical trials, it may have to employ a bridging strategy during the trial to demonstrate equivalency
of early stage material to commercial drug product, or potentially delay the initiation or completion of the trial until drug supply is
available. The manufacturing of commercial quality drug product has long lead times, is very expensive and requires significant efforts
including, but not limited to, scale-up of production to anticipated commercial scale, process characterization and validation, analytical
method validation, identification of critical process parameters and product quality attributes, and multiple process performance and
validation runs. If the Corporation does not have commercial drug supply available when needed for pivotal clinical trials, MindMed’s
regulatory and commercial progress may be delayed, and it may incur increased product development costs. This may have a material adverse
effect on the Corporation’s business, financial condition and prospects, and may delay marketing of the product.


 


If clinical trials of the Corporation’s
product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive
results, the Corporation would incur additional costs or experience delays in completing, or ultimately be unable to complete, the development
and commercialization of its product candidates


 


Before obtaining marketing approval from regulatory
authorities for the sale of the Corporation’s product candidates, MindMed must conduct preclinical studies in animals and extensive
clinical trials in humans to demonstrate the safety and efficacy of the product candidates. Clinical testing is expensive and difficult
to design and implement, can take many years to complete and has uncertain outcomes. The outcome of preclinical studies and early clinical
trials may not predict the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final
results. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical
trials due to lack of efficacy or unacceptable safety profiles, notwithstanding promising results in earlier trials. The Corporation does
not know whether the clinical trials it may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to
market any of its product candidates in any jurisdiction. A product candidate may fail for safety or efficacy reasons at any stage of
the testing process. A major risk the Corporation faces is the possibility that none of its product candidates under development will
successfully gain market approval from the FDA or other regulatory authorities, resulting in the Corporation being unable to derive any
commercial revenue from them after investing significant amounts of capital in their development.


 


If the Corporation experiences delays in clinical
testing, it will be delayed in commercializing its product candidates, and its business may be substantially harmed


 


The Corporation cannot predict whether any clinical
trials will begin as planned, will need to be restructured, or will be completed on schedule, or at all. The Corporation’s product
development costs will increase if it experiences delays in clinical testing. Significant clinical trial delays could shorten any periods
during which the Corporation may have the exclusive right to commercialize its product candidates or allow its competitors to bring products
to market before MindMed, which would impair the Corporation’s ability to successfully commercialize its product candidates and
may harm its financial condition, results of operations and prospects. The commencement and completion of clinical trials for MindMed’s
products may be delayed for a number of reasons, including delays related, but not limited, to:


 


		(1)	failure by regulatory authorities to grant permission to proceed or placing the clinical trial on hold;
		(2)	patients failing to enroll or remain in the Corporation’s trials at the rate the Corporation expects;



 






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		(3)	suspension or termination of clinical trials by regulators for many reasons, including concerns about
patient safety or failure of the Corporation’s CMOs to comply with GMP requirements;
		(4)	any changes to the Corporation’s manufacturing process that may be necessary or desired;
		(5)	delays or failure to obtain clinical supply from CMOs of the Corporation’s products necessary to
conduct clinical trials;
		(6)	product candidates demonstrating a lack of safety or efficacy during clinical trials;
		(7)	patients choosing an alternative treatment for the indications for which the Corporation is developing
any of its product candidates or participating in competing clinical trials;
		(8)	patients failing to complete clinical trials due to dissatisfaction with the treatment, side effects or
other reasons;
		(9)	reports of clinical testing on similar technologies and products raising safety or efficacy concerns;
		(10)	competing clinical trials and scheduling conflicts with participating clinicians;
		(11)	clinical investigators not performing the Corporation’s clinical trials on their anticipated schedule,
dropping out of a trial, or employing methods not consistent with the clinical trial protocol, regulatory requirements or other third
parties not performing data collection and analysis in a timely or accurate manner;
		(12)	failure of the Corporation’s CROs to satisfy their contractual duties or meet expected deadlines;
		(13)	inspections of clinical trial
sites by regulatory authorities, IRBs or ethics committees finding regulatory violations that require the Corporation to undertake
corrective action, resulting in suspension or termination of one or more sites or the imposition of a clinical hold on the entire study;
		(14)	one or more IRBs or ethics committees
rejecting, suspending or terminating the study at an investigational site, precluding enrollment of additional subjects, or withdrawing
the Corporation’s approval of the trial; or
		(15)	failure to reach agreement on acceptable terms with prospective clinical trial sites.



 


MindMed’s product development costs will
increase if it experiences delays in testing or approval or if the Corporation needs to perform more or larger clinical trials than planned.
Additionally, changes in regulatory requirements and policies may occur, and the Corporation may need to amend study protocols to reflect
these changes. Amendments may require the Corporation to resubmit its study protocols to regulatory authorities or IRBs or ethics committees
for re-examination, which may impact the cost, timing or successful completion of that trial. Delays or increased product development
costs may have a material adverse effect on the Corporation’s business, financial condition and prospects.


 


The Corporation may not be able to file investigational
new drug applications to commence additional clinical trials on the timelines it expects, and even if the Corporation is able to, the
FDA or similar regulatory authorities may not permit the Corporation to proceed in a timely manner, or at all


 


Prior to commencing clinical trials in the United
States or other jurisdictions, including Australia, Switzerland and the Netherlands, for any of the Corporation’s product candidates,
MindMed may be required to have an allowed IND (or equivalent) for each product candidate and to file additional INDs prior to initiating
any additional clinical trials for 18-MC, LSD or other psychedelic substances. The Corporation believes that the data from previous studies
will support the filing of additional INDs to enable MindMed to undertake additional clinical studies as it has planned. However, submission
of an IND (or equivalent) may not result in the FDA (or equivalent authorities) allowing further clinical trials to begin and, once begun,
issues may arise that will require MindMed to suspend or terminate such clinical trials. Additionally, even if relevant regulatory authorities
agree with the design and implementation of the clinical trials set forth in an IND, these regulatory authorities may change their requirements
in the future. Failure to submit or have effective INDs (or equivalent) and commence or continue clinical programs will significantly
limit the Corporation’s opportunity to generate revenue.


 






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If the Corporation has difficulty enrolling
patients in clinical trials, the completion of the trials may be delayed or cancelled


 


As the Corporation’s product candidates
advance from preclinical testing to clinical testing, and then through progressively larger and more complex clinical trials, the Corporation
will need to enroll an increasing number of patients that meet its eligibility criteria. There is significant competition for recruiting
patients in clinical trials, and MindMed may be unable to enroll the patients it needs to complete clinical trials on a timely basis or
at all. The factors that affect the Corporation’s ability to enroll patients are largely uncontrollable and include, but are not
limited to, the following:


 


		(1)	size and nature of the patient population;
		(2)	eligibility and exclusion criteria for the trial;
		(3)	design of the study protocol;
		(4)	competition with other companies for clinical sites or patients;
		(5)	the perceived risks and benefits of the product candidate under study;
		(6)	the patient referral practices of physicians; and
		(7)	the number, availability, location and accessibility of clinical trial sites.



 


Regulatory approval processes are lengthy,
expensive and inherently unpredictable. The Corporation’s inability to obtain regulatory approval for its product candidates would
substantially harm its business


 


The Corporation’s development and commercialization
activities and product candidates are significantly regulated by a number of governmental entities, including the FDA and comparable authorities
in other countries, including Australia, Switzerland and the Netherlands. Regulatory approvals are required prior to each clinical trial
and the Corporation may fail to obtain the necessary approvals to commence or continue clinical testing. MindMed must comply with regulations
concerning the manufacture, testing, safety, effectiveness, labeling, documentation, advertising, and sale of products and product candidates
and ultimately must obtain regulatory approval before it can commercialize a product candidate. The time required to obtain approval by
such regulatory authorities is unpredictable but typically takes many years following the commencement of preclinical studies and clinical
trials. Any analysis of data from clinical activities the Corporation performs is subject to confirmation and interpretation by regulatory
authorities, which could delay, limit or prevent regulatory approval. Even if the Corporation believes results from its clinical trials
are favorable to support the marketing of its product candidates, the FDA or other regulatory authorities may disagree. In addition, approval
policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s
clinical development and may vary among jurisdictions. The Corporation has not obtained regulatory approval for any product candidate
and it is possible that none of its existing product candidates or any future product candidates will ever obtain regulatory approval.


 


MindMed could fail to receive regulatory approval
for its product candidates for many reasons, including, but not limited to:


 


		(1)	disagreement with the design or implementation of its clinical trials;
		(2)	failure to demonstrate that
a product candidate is safe and effective for the Corporation’s proposed indication;
		(3)	failure of clinical trials to meet the level of statistical significance required for approval;
		(4)	failure to demonstrate that
a product candidate’s clinical and other benefits outweigh the Corporation’s safety risks;
		(5)	disagreement with the Corporation’s interpretation of data from preclinical studies or clinical
trials;
		(6)	the insufficiency of data collected from clinical trials of the Corporation’s product candidates
to support the submission and filing of an IND or other submission to obtain regulatory approval;
		(7)	deficiencies in the manufacturing processes or the failure of facilities of CMOs with whom the Corporation
contracts for clinical and commercial supplies to pass a pre-approval inspection; or
		(8)	changes in the approval policies or regulations that render the Corporation’s preclinical and clinical
data insufficient for approval.



 


A regulatory authority may require more information,
including additional preclinical or clinical data to support approval, which may delay or prevent approval and the Corporation’s
commercialization plans, or the Corporation may decide to abandon the development program. If the Corporation were to obtain approval,
regulatory authorities may approve any of its product candidates for fewer or more limited indications than the Corporation requested,
may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label
that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Moreover,
depending on any safety issues associated with the Corporation’s product candidates that garner approval, the FDA or similar regulatory
authorities in other countries may impose a risk evaluation and mitigation strategy, thereby imposing certain restrictions on the sale
and marketability of such products.


 






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The Corporation may not achieve its publicly
announced milestones according to schedule, or at all


 


From time to time, the Corporation may announce
the timing of certain events it expects to occur, such as the anticipated timing of results from its clinical trials. These statements
are forward-looking and are based on the best estimates of management at the time relating to the occurrence of such events. However,
the actual timing of such events may differ from what has been publicly disclosed. The timing of events such as initiation or completion
of a clinical trial, filing of an application to obtain regulatory approval, or announcement of additional clinical trials for a product
candidate may ultimately vary from what is publicly disclosed. These variations in timing may occur as a result of different events, including
the nature of the results obtained during a clinical trial or during a research phase, timing of the completion of clinical trials, problems
with a CMO or a CRO or any other event having the effect of delaying the publicly announced timeline. The Corporation undertakes no obligation
to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise,
except as otherwise required by law. Any variation in the timing of previously announced milestones could have a material adverse effect
on the Corporation’s business plan, financial condition or operating results and the trading price of the Subordinate Voting Shares.


 


The Corporation faces competition from other
biotechnology and pharmaceutical companies and its financial condition and operations will suffer if it fails to effectively compete


 


The biotechnology and pharmaceutical industries
are intensely competitive and subject to rapid and significant technological change. The Corporation’s competitors include large,
well-established pharmaceutical companies, biotechnology companies, academic and research institutions developing therapeutics for the
same indications the Corporation is targeting and competitors with existing marketed therapies. Many other companies are developing or
commercializing therapies to treat the same diseases or indications for which MindMed’s product candidates may be useful. 


 


Many of the Corporation’s competitors have
substantially greater financial, technical and human resources than MindMed does and have significantly greater experience than MindMed
in conducting preclinical testing and human clinical trials of product candidates, scaling up manufacturing operations and obtaining regulatory
approvals of products. Accordingly, the Corporation’s competitors may succeed in obtaining regulatory approval for products more
rapidly than MindMed does. The Corporation’s ability to compete successfully will largely depend on:


 


		(1)	the efficacy and safety profile of its product candidates relative to marketed products and other product
candidates in development;
		(2)	MindMed’s ability to develop and maintain a competitive position in the product categories and technologies
on which it focuses;
		(3)	the time it takes for MindMed’s product candidates to complete clinical development and receive
marketing approval;
		(4)	MindMed’s ability to obtain required regulatory approvals;
		(5)	MindMed’s ability to commercialize any of its product candidates that receive regulatory approval;
		(6)	MindMed’s ability to establish, maintain and protect intellectual property rights related to its
product candidates; and
		(7)	acceptance of any of MindMed’s product candidates that receive regulatory approval by physicians
and other healthcare providers and payers.



 


Competitors have developed and may develop
technologies that could be the basis for products that challenge the discovery research capabilities of 18-MC, LSD or other products
MindMed is developing. Some of those products may have an entirely different approach or means of accomplishing the desired
therapeutic effect than MindMed’s product candidates and may be more effective or less costly than its product candidates. The
success of the Corporation’s competitors and their product candidates relative to MindMed’s technological capabilities
and competitiveness could have a material adverse effect on the future preclinical studies and clinical trials of MindMed’s
product candidates, including its ability to obtain the necessary regulatory approvals for the conduct of such clinical trials. This
may further negatively impact MindMed’s ability to generate future product development programs using 18-MC, LSD or other
psychedelic inspired compounds.


 






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If the Corporation is not able to compete effectively
against its current and future competitors, MindMed’s business will not grow, and its financial condition and operations will substantially
suffer.


 


The Corporation heavily relies on the capabilities
and experience of its key executives and scientists and the loss of any of them could affect the Corporation’s ability to develop
its products


 


The loss of any of the Corporation’s key
executives or other key members of the Corporation’s staff could harm MindMed. The Corporation also depends on its scientific and
clinical collaborators and advisors, all of whom have outside commitments that may limit their availability to the Corporation. In addition,
MindMed believes that its future success will depend in large part upon its ability to attract and retain highly skilled scientific, managerial,
medical, manufacturing, clinical and regulatory personnel, particularly as MindMed expands its activities and seeks regulatory approvals
for clinical trials. The Corporation enters into agreements with its scientific and clinical collaborators and advisors, key opinion leaders
and academic partners in the ordinary course of its business. The Corporation also enters into agreements with physicians and institutions
who will recruit patients into MindMed’s clinical trials on its behalf in the ordinary course of its business. Notwithstanding these
arrangements, the Corporation faces significant competition for these types of personnel from other companies, research and academic institutions,
government entities and other organizations. The Corporation cannot predict its success in hiring or retaining the personnel it requires
for continued growth. The loss of the services of any of the Corporation’s executive officers or other key personnel could potentially
harm its business, operating results or financial condition.


 


The Corporation’s employees, contractors,
consultants and agents may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements,
which could have a material adverse effect on its business


 


The Corporation is exposed to the risk that employees,
independent contractors and consultants may engage in fraud, illegal activity, fraud, or other misconduct. Misconduct by employees, contractors
and consultants could include failures to comply with FDA and similar regulations, provide accurate information to the FDA or similar
regulatory authorities in other countries, comply with manufacturing standards the Corporation has established, comply with federal and
state healthcare fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities
to the Corporation. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws
and regulations intended to prevent fraud, kickbacks, self-dealing, and other abusive practices. These laws and regulations may restrict
or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business
arrangements. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which
could result in regulatory sanctions and serious harm to the Corporation’s reputation. It may not always be possible for the Corporation
to identify and prevent misconduct by the Corporation’s employees and other third parties, and the precautions taken by the Corporation
to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting the Corporation
from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
The Corporation cannot provide assurance that the Corporation’s internal controls and compliance systems will protect the Corporation
from acts committed by the Corporation’s employees, agents or business partners in violation of U.S. federal or state or local laws
or the laws of other jurisdictions in which the Corporation operates. If any such actions are instituted against the Corporation, and
MindMed is not successful in defending itself or asserting the Corporation’s rights, those actions could have a substantial impact
on the Corporation’s business and results of operations, including the imposition of substantial fines or other sanctions.


 






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The Corporation may expand its business through
the acquisition of companies or businesses or by entering into collaborations or by in-licensing product candidates, each of which could
disrupt the Corporation’s business and harm its financial condition


 


The Corporation has in the past and may in the
future seek to expand its pipeline and capabilities by acquiring one or more companies or businesses, entering into collaborations, or
in-licensing one or more product candidates. Acquisitions, collaborations and in-licenses involve numerous risks, including, but not limited
to:


 


		(1)	substantial cash expenditures;
		(2)	technology development risks;
		(3)	potentially dilutive issuances of equity securities;
		(4)	incurrence of debt and contingent liabilities, some of which may be difficult or impossible to identify
at the time of acquisition;
		(5)	difficulties in assimilating the operations of the acquired companies;
		(6)	potential disputes regarding contingent consideration;
		(7)	diverting the Corporation’s management’s attention away from other business concerns;
		(8)	entering markets in which the Corporation has limited or no direct experience; and
		(9)	potential loss of the Corporation’s key employees or key employees of the acquired companies or
businesses.



 


The Corporation has experience in making acquisitions,
entering collaborations and in-licensing product candidates; however, the Corporation cannot provide assurance that any acquisition, collaboration
or in-license will result in short-term or long-term benefits to it. The Corporation may incorrectly judge the value or worth of an acquired
company or business or in-licensed product candidate. In addition, MindMed’s future success would depend in part on its ability
to manage the rapid growth associated with some of these acquisitions, collaborations and in-licenses. The Corporation cannot provide
assurance that it would be able to successfully combine its business with that of acquired businesses, manage a collaboration or integrate
in-licensed product candidates. Furthermore, the development or expansion of the Corporation’s business may require a substantial
capital investment by the Corporation.


 


Acquisitions involve risks that the acquired business
will not perform as expected and that business judgments concerning the value, strengths and weaknesses of the acquired business will
prove incorrect. In addition, potential acquisition targets may be in states in which the Corporation does not currently operate, which
could result in unforeseen operating difficulties and difficulties coordinating geographically dispersed operations, personnel and facilities.
In addition, if the Corporation enters into new geographic markets, it may be subject to additional and unfamiliar legal and regulatory
requirements. Acquired businesses may have unaudited financial statements that have been prepared by management and have not been independently
reviewed or audited. The Corporation cannot guarantee that such financial statements would not be materially different if such statements
were independently reviewed or audited. The Corporation cannot guarantee that the Corporation will, or will continue to, acquire businesses
at valuations consistent with prior acquisitions or that it will complete future acquisitions at all. The Corporation cannot guarantee
that there will be attractive acquisition opportunities at reasonable prices, that financing will be available or that it can successfully
integrate acquired businesses into existing operations. In addition, the results of operations from these acquisitions could, in the future,
result in impairment charges for any of the Corporation’s intangible assets, including goodwill or other long-lived assets, particularly
if economic conditions worsen unexpectedly. The Corporation’s inability to effectively manage the integration of its completed and
future acquisitions could prevent it from realizing expected rates of return on an acquired business and could have a material and adverse
effect on the Corporation’s financial condition, results of operations or liquidity.


 


The Corporation may invest in pre-revenue companies
which may not be able to meet anticipated revenue targets in the future


 


The
Corporation has made and may in the future make investments in companies with no significant sources of operating cash flow and
no revenue from operations. The Corporation’s investments in such companies will be subject to risks and uncertainties that new
companies with no operating history may face. In particular, there is a risk that the Corporation’s investment in these pre-revenue
companies will not be able to meet anticipated revenue targets or will generate no revenue at all, or such underperforming pre-revenue
companies may fail, which could have a material adverse effect on the Corporation’s business, prospects, revenue, results of operation
and financial condition.


 






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Negative results from clinical trials or studies
of others and adverse safety events involving the targets of the Corporation’s products may have an adverse impact on the Corporation’s
future commercialization efforts


 


From time to time, studies or clinical trials
on various aspects of biopharmaceutical products are conducted by academic researchers, competitors or others. The results of these studies
or trials, when published, may have a significant effect on the market for the biopharmaceutical product that is the subject of the study.
The publication of negative results of studies or clinical trials or adverse safety events related to the Corporation’s product
candidates, or the therapeutic areas in which the Corporation’s product candidates compete, could adversely affect its share price
and MindMed’s ability to finance future development of its product candidates, and its business and financial results could be materially
and adversely affected.


 


The Corporation faces risks related to the
novelty of the psychedelic inspired medicines industry, and the resulting lack of information regarding comparable companies, unanticipated
expenses, difficulties and delays, and the offering of new products and services in an untested market


 


As
a relatively new industry, there are not many established players in the psychedelic inspired medicines industry whose business model
the Corporation can emulate. Similarly, there is little information about comparable companies available for potential investors
to review in making a decision about whether to invest in the Corporation.


 


Shareholders
and investors should consider, among other factors, the Corporation’s prospects for success in light of the risks and uncertainties
encountered by companies, like the Corporation, that are in their early stages. For example, unanticipated expenses and problems or technical
difficulties may occur, which may result in material delays in the operation of the Corporation’s business. MindMed may fail to
successfully address these risks and uncertainties or successfully implement the Corporation’s operating strategies. If the Corporation
fails to do so, it could materially harm the Corporation’s business to the point of having to cease operations and could impair
the value of the Subordinate Voting Shares to the point where investors may lose their entire investments.


 


The Corporation has committed and expects to continue
committing significant resources and capital to develop and market new products and services. These products and services are relatively
untested in the marketplace, and the Corporation cannot provide assurance that it will achieve market acceptance for these products and
services. Moreover, these products and services may be subject to significant competition from offerings by new and existing competitors
in the business. In addition, new products and services may pose a variety of challenges and require the Corporation to attract additional
qualified employees. The failure to successfully develop and market these new products and services could materially harm the Corporation’s
business, prospects, revenue, results of operation and financial condition.


 


The Corporation faces the risk of product liability
claims, which could exceed its insurance coverage, and product recalls, each of which could deplete the Corporation’s cash resources


 


The Corporation is exposed to the risk of product
liability claims alleging that use of its product candidates caused an injury or harm. These claims can arise at any point in the development,
testing, manufacture, marketing or sale of MindMed’s product candidates and may be made directly by patients involved in clinical
trials of its product candidates, by consumers or healthcare providers or by individuals, organizations or companies selling its products.
Product liability claims can be expensive to defend, even if the product or product candidate did not actually cause the alleged injury
or harm.


 


Insurance covering product liability claims becomes
increasingly expensive as a product candidate moves through the development pipeline to commercialization. MindMed currently maintains
clinical trial liability insurance coverage; however, there can be no assurance that such insurance coverage is or will continue to be
adequate or available to the Corporation at a cost acceptable to it or at all. The Corporation may choose or find it necessary under its
collaborative agreements to increase its insurance coverage in the future. The Corporation may not be able to secure greater or broader
product liability insurance coverage on acceptable terms or at reasonable costs when needed. Any liability for damages resulting from
a product liability claim could exceed the amount of its coverage, require the Corporation to pay a substantial monetary award from MindMed’s
own cash resources and have a material adverse effect on its business, financial condition and results of operations. Moreover, a product
recall, if required, could generate substantial negative publicity about its products and business, inhibit or prevent commercialization
of other products and product candidates or negatively impact existing or future collaborations.


 






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If the Corporation is unable to maintain product
liability insurance required by its third parties, the corresponding agreements would be subject to termination, which could have a material
adverse impact on its operations


 


Some of the Corporation’s licensing and
other agreements with third parties require or might require it to maintain product liability insurance. If the Corporation cannot maintain
acceptable amounts of coverage on commercially reasonable terms in accordance with the terms set forth in these agreements, the corresponding
agreements would be subject to termination, which could have a material adverse impact on its operations.


 


The Corporation faces risks related to its
information technology systems, including potential cyber-attacks and security and privacy breaches


 


The
Corporation’s technology is critical in its continued operations. The Corporation is susceptible to operational, financial
and information security risks resulting from cyber-attacks or technological malfunctions. Successful cyber-attacks or technological malfunctions
affecting the Corporation, or its service providers, can result in, among other things, financial losses, the inability to process transactions,
the unauthorized release of customer information or other confidential information and reputational risk. The Corporation has not experienced
any material losses to date relating to cyber-attacks, other information breaches or technological malfunctions. However, there can be
no assurance that the Corporation will not incur such losses in the future. As cybersecurity threats continue to evolve, the Corporation
may be required to use additional resources to continue to modify or enhance protective measures or to investigate and redress security
vulnerabilities.


 


The
Corporation is also subject to laws, rules and regulations in the United States and other jurisdictions relating to the collection,
production, storage, transfer and use of personal data. The Corporation may store and collect personal information. It is the Corporation’s
responsibility to protect that information from privacy breaches that may occur through procedural or process failure, information technology
malfunction or deliberate, unauthorized intrusions. Any such theft or privacy breach could have a material adverse effect on the Corporation’s
business, prospects, revenue, results of operation and financial condition. Additionally, the Corporation’s ability to execute transactions
and to possess and use personal information and data in conducting the Corporation’s business subjects it to legislative and regulatory
burdens that may require it to notify regulators or other individuals of a data security breach. Evolving compliance and operational requirements
under the privacy laws, rules and regulations of jurisdictions in which the Corporation operates impose significant costs that are
likely to increase over time. In addition, non-compliance could result in proceedings against the Corporation by governmental entities
or the imposition of significant fines, could negatively impact the Corporation’s reputation and may otherwise materially, adversely
impact the Corporation’s business, financial condition and operating results.


 


The effects of the outbreak of infectious disease
could materially negatively impact the Corporation’s operations


 


Emerging
infectious diseases or the threat of outbreaks of viruses or other contagions or epidemic diseases could have a material adverse effect
on the Corporation. The outbreak of the novel strain of coronavirus, specifically identified as “COVID-19”, has resulted
in governments worldwide enacting emergency measures to combat the spread of the virus. These measures, which include the implementation
of travel bans, self-imposed quarantine periods and social distancing, have caused material disruption to businesses globally resulting
in an economic slowdown. Global equity markets have experienced significant volatility and weakness. Governments and central banks
have reacted with significant monetary and fiscal interventions designed to stabilize economic conditions. The duration and impact of
the COVID-19 outbreak is unknown at this time, as is the efficacy of the government and central bank interventions. It is not possible
to reliably estimate the length and severity of these developments and the impact on the financial results and condition of the Corporation
and its operating subsidiaries in future periods. However, depending on the length and severity of the pandemic, COVID-19 could impact
the Corporation’s operations, could cause delays relating to approval from the FDA and equivalent organizations in other countries,
could postpone research activities, could impair the Corporation’s ability to raise funds depending on COVID-19’s effect on
capital markets, and could affect logistics and the Corporation’s ability to move materials in a timely manner to clinical trial
sites or production of GMP materials (which availability of GMP materials may also impact clinical trial timelines).


 






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The Corporation relies on third parties to conduct
and monitor the Corporation’s pre-clinical studies and clinical trials. However, to the knowledge of Corporation’s management,
the ability of these third parties to conduct and monitor pre-clinical studies and clinical trials has not been and is not anticipated
to be impacted by COVID-19. The Corporation is not currently aware of any changes in laws, regulations or guidelines, including tax and
accounting requirements, arising from COVID-19 which would be reasonably anticipated to materially affect the Corporation’s business.


 


Investors in certain jurisdictions
may have difficulty in enforcing judgments and effecting service of process on the Corporation and its directors and officers


 


The enforcement by investors of civil liabilities
under the United States federal or state securities laws may be affected adversely by the fact that the Corporation is organized under
the laws of British Columbia, that some of the Corporation’s officers and directors are residents of countries other than the United
States, and that certain of their assets and of the Corporation’s assets are located outside the United States. It may not be possible
for investors to effect service of process within the United States on certain of its directors and officers or enforce judgments obtained
in the United States courts against the Corporation or certain of the Corporation’s directors and officers based upon the civil
liability provisions of United States federal securities laws or the securities laws of any state of the United States.


 


There is some doubt as to whether a judgment of
a United States court based solely upon the civil liability provisions of United States federal or state securities laws would be enforceable
in Canada against the Corporation or certain of its directors and officers. There is also doubt as to whether an original action could
be brought in Canada against the Corporation or certain of its directors and officers to enforce liabilities based solely upon United
States federal or state securities laws.


 


In addition, certain directors and officers of
the Corporation reside outside of Canada. Some or all of the assets of such persons may be located outside of Canada. Therefore, it may
not be possible for investors to collect or to enforce judgments obtained in Canadian courts predicated upon the civil liability provisions
of applicable Canadian securities laws against such persons. Moreover, it may not be possible for investors to effect service of process
within Canada upon such persons.


 


The Corporation has a limited operating history


 


The Corporation has a limited history of operations
and will be in an early stage of development as it attempts to create an infrastructure to capitalize on the opportunity for value creation
in the psychedelics medicines industry. Accordingly, the Corporation is subject to many of the risks common to early-stage enterprises,
including under-capitalization, cash shortages, limitations with respect to personnel, financial and other resources and lack of revenue.
The limited operating history may also make it difficult for investors to evaluate the Corporation’s prospects for success. There
is no assurance that the Corporation will be successful, and its likelihood of success must be considered in light of its early stage
of operations.


 


The Corporation may not be able to achieve or
maintain profitability and may incur losses in the future. In addition, the Corporation is expected to increase its capital investments
as it implements initiatives to grow its business. If the Corporation’s revenues do not increase to offset these expected increases,
the Corporation may not generate positive cash flow. There is no assurance that future revenues will be sufficient to generate the funds
required to continue operations without external funding.


 


Forward-looking statements may prove to be
inaccurate


 


Investors should not place undue reliance on forward-looking
statements. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, of both
general and specific nature, that could cause actual results to differ materially from those suggested by the forward-looking statements
or contribute to the possibility that predictions, forecasts or projections will prove to be materially inaccurate. Additional information
on these risks, assumptions and uncertainties can be found in this AIF under the heading “Cautionary Statement Regarding Forward
Looking Information”.


 






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Risks Related to Intellectual Property


 


If the Corporation is unable to adequately
protect and enforce its intellectual property, the Corporation’s competitors may take advantage of its development efforts or acquired
technology and compromise its prospects of marketing and selling its key products


 


MindMed’s success will depend in part upon
its ability to protect its intellectual property and proprietary technologies and upon the nature and scope of the intellectual property
protection the Corporation receives. The ability to compete effectively and to achieve partnerships will depend on its ability to develop
and maintain proprietary aspects of MindMed’s technology and to operate without infringing on the proprietary rights of others.
The presence of such proprietary rights of others could severely limit its ability to develop and commercialize its products, to conduct
its existing research and could require financial resources to defend litigation, which may be in excess of MindMed’s ability to
raise such funds. There is no assurance that the Corporation’s pending patent applications or those that it intends to acquire will
be approved in a form that will be sufficient to protect its proprietary technology and gain or keep any competitive advantage that the
Corporation may have or, if approved, will be upheld in any post-grant proceedings brought by any third parties.


 


The patent positions of pharmaceutical companies
can be highly uncertain and involve complex legal, scientific and factual questions for which important legal principles remain unresolved.
Patents issued to the Corporation or its respective licensors may be challenged, invalidated or circumvented. To the extent MindMed’s
intellectual property, including licensed intellectual property, offers inadequate protection, or is found to be invalid or unenforceable,
MindMed is exposed to a greater risk of direct competition. If the Corporation’s intellectual property does not provide adequate
protection against the Corporation’s competitors’ products, its competitive position could be adversely affected, as could
MindMed’s business, financial condition and results of operations. Both the patent application process and the process of managing
patent disputes can be time-consuming and expensive, and the laws of some foreign countries may not protect the Corporation’s intellectual
property rights to the same extent as do the laws of Canada and the United States.


 


The Corporation will be able to protect its intellectual
property from unauthorized use by third parties only to the extent that its proprietary technologies, key products, and any future products
are covered by valid and enforceable intellectual property rights including patents or are effectively maintained as trade secrets, and
provided the Corporation has the funds to enforce its rights, if necessary.


 


If the Corporation loses its licenses from
third-party owners, the Corporation may be unable to continue a substantial part of its business


 


The Corporation is a party to licenses that gives
its rights to intellectual property that are necessary or useful for a substantial part of its business. The Corporation may also enter
into licenses in the future to access additional third-party intellectual property. If the Corporation fails to pay annual maintenance
fees, development and sales milestones, or it is determined that MindMed does not use commercially reasonable efforts to commercialize
licensed products, MindMed could lose its licenses which could have a material adverse effect on its business and financial condition.


 


The Corporation may require additional third-party
licenses to effectively develop and manufacture its key products and is currently unable to predict the availability or cost of such licenses


 


A substantial number of patents have already been
issued to other biotechnology and pharmaceutical companies. To the extent that valid third-party patent rights cover MindMed’s products
or services, the Corporation, or its strategic collaborators, would be required to seek licenses from the holders of these patents in
order to manufacture, use or sell these products and services, and payments under them would reduce the Corporation’s profits from
these products and services. MindMed is currently unable to predict the extent to which the Corporation may wish or be required to acquire
rights under such patents, the availability and cost of acquiring such rights, and whether a license to such patents will be available
on acceptable terms or at all. There may be patents in the United States or in foreign countries or patents issued in the future that
are unavailable to license on acceptable terms. MindMed’s inability to obtain such licenses may hinder or eliminate its ability
to manufacture and market its products.


 






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Changes in patent law and its interpretation
could diminish the value of patents in general, thereby impairing MindMed’s ability to protect its product candidates


 


As is the case with other biotechnology and pharmaceutical
companies, the Corporation’s success is heavily dependent on intellectual property rights, particularly patents. Obtaining and enforcing
patents in the biopharmaceutical industry involves technological and legal complexity, and obtaining and enforcing biopharmaceutical patents
is costly, time consuming and inherently uncertain. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing
the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition
to increasing uncertainty with regard to MindMed and its licensors’ or collaborators’ ability to obtain patents in the future,
this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the
U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would
weaken MindMed and its licensors’ or collaborators’ ability to obtain new patents or to enforce existing patents and patents
MindMed and its licensors or collaborators may obtain in the future.


 


Recent patent reform legislation could increase
the uncertainties and costs surrounding the prosecution of MindMed and its licensors’ or collaborators’ patent applications
and the enforcement or defense of MindMed or its licensors’ or collaborators’ issued patents. On September 16, 2011,
the Leahy-Smith Act was signed into law. The Leahy-Smith Act includes a number of significant changes to United States patent law. These
include provisions that affect the way patent applications are prosecuted and may also affect patent litigation. The USPTO recently developed
new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated
with the Leahy-Smith Act, and in particular, the first to file provisions, only became effective on March 16, 2013. Accordingly,
it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of the Corporation’s business. However, the
Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of the Corporation or its
licensors’ or collaborators’ patent applications and the enforcement or defense of MindMed or its licensors’ or collaborators’
issued patents, all of which could have a material adverse effect on MindMed’s business and financial condition.


 


Litigation regarding patents, patent applications,
and other proprietary rights may be expensive, time consuming and cause delays in the development and manufacturing of the Corporation’s
key products


 


The Corporation’s success will depend in
part on its ability to operate without infringing the proprietary rights of third parties. The pharmaceutical industry is characterized
by extensive patent litigation. Other parties may have, or obtain in the future, patents and allege that the use of the Corporation’s
technologies infringes these patent claims or that the Corporation is employing these parties’ proprietary technology without authorization.
The Corporation cannot assure that third parties will not assert intellectual property claims against the Corporation. In addition, third
parties may challenge or infringe upon MindMed’s existing or future patents. Proceedings involving the Corporation’s patents
or patent applications or those of others could result in adverse decisions regarding:


 


		(1)	the patentability of MindMed’s inventions relating to its key products; and






		(2)	the enforceability, validity, or scope of protection offered by MindMed’s patents relating to its
key products.



 


If the Corporation is unable to avoid infringing
the patent rights of others, the Corporation may be required to seek a license, defend an infringement action, or challenge the validity
of the patents in court. Regardless of the outcome, patent litigation is costly and time-consuming. In some cases, the Corporation may
not have sufficient resources to bring these actions to a successful conclusion. In addition, if MindMed does not obtain a license, develop
or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared invalid, the
Corporation may:


 


		(1)	incur substantial monetary damages;






		(2)	encounter significant delays in bringing its key products to market; and






		(3)	be precluded from participating in the manufacture, use or sale of its key products or methods of treatment
requiring licenses.



 






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Even if the Corporation is successful in these
proceedings, the Corporation may incur substantial costs and divert management time and attention in pursuing these proceedings, which
could have a material adverse effect on the Corporation.


 


The Corporation’s reliance on third parties
requires MindMed to share its trade secrets, which increases the possibility that a competitor will discover them


 


Because the Corporation relies on third parties
to develop its products, the Corporation must share trade secrets with them. The Corporation seeks to protect its proprietary technology
in part by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements,
consulting agreements or other similar agreements with its collaborators, advisors, employees and consultants prior to beginning research
or disclosing proprietary information. These agreements typically restrict the ability of its collaborators, advisors, employees and consultants
to publish data potentially relating to its trade secrets. The Corporation’s academic and clinical collaborators typically have
rights to publish data, provided that the Corporation is notified in advance and the Corporation may delay publication for a specified
time in order to secure any intellectual property rights arising from the collaboration. In other cases, publication rights are controlled
exclusively by the Corporation, although in some cases the Corporation may share these rights with other parties. MindMed may also conduct
joint research and development programs which may require the Corporation to share trade secrets under the terms of research and development
collaborations or similar agreements. Despite MindMed’s efforts to protect its trade secrets, MindMed’s competitors may discover
its trade secrets, either through breach of these agreements, independent development or publication of information including its trade
secrets in cases where MindMed does not have proprietary or otherwise protected rights at the time of publication. A competitor’s
discovery of MindMed’s trade secrets may impair its competitive position and could have a material adverse effect on its business
and financial condition.


 


Risks Related to the Corporation’s Securities


 


Limited operating history as a public company


 


The Subordinate Voting Shares commenced trading
in Canada on the NEO in March 2020 and therefore the Corporation has a limited operating history as a public company. To operate
effectively, the Corporation will be required to continue to implement changes in certain aspects of the Corporation’s business,
improve information systems and develop, manage and train management-level and other employees to comply with ongoing public company requirements.
Failure to take such actions, or delay in implementation thereof, could adversely affect the business, financial condition, liquidity
and results of operations of the Corporation and, more specifically, could result in regulatory penalties, market criticism or the imposition
of cease trade orders in respect of the Subordinate Voting Shares.


 


The market prices for securities of biopharmaceutical companies
have historically been volatile


 


A number of factors could influence the volatility
in the trading price of the Corporation’s Subordinate Voting Shares, including changes in the economy or in the financial markets,
industry-related developments, the results of product development and commercialization, changes in government regulations, and developments
concerning proprietary rights, litigation and cash flow. The Corporation’s quarterly losses may vary because of the timing of costs
for manufacturing, preclinical studies and clinical trials. Also, the reporting of adverse safety events involving the Corporation’s
products and public rumors about such events could cause the Corporation’s share price to decline or experience periods of volatility.
Each of these factors could lead to increased volatility in the market price of the Subordinate Voting Shares. In addition, changes in
the market prices of the securities of the Corporation’s competitors may also lead to fluctuations in the trading price of the Subordinate
Voting Shares.


 


Financial
markets have historically experienced periodic, significant price and volume fluctuations that: (i) have especially affected the
market prices of equity securities of companies and (ii) have often been unrelated to the operating performance, underlying asset
values or prospects of such companies. Accordingly, the market price of the Subordinate Voting Shares from time to time may decline even
if the Corporation’s operating results, underlying asset values and prospects have not changed. Additionally, these factors,
as well as other related factors, may cause decreases in asset values that may result in impairment losses to us. There can be no assurance
that further fluctuations in price and volume of Subordinate Voting Shares traded will not occur. If increased levels of volatility and
market turmoil continue, the Corporation’s operations could be adversely impacted, and the trading price of the Subordinate Voting
Shares may be materially adversely affected.


 






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The Corporation has never paid dividends and does not expect to
do so in the foreseeable future


 


The Corporation has not declared or paid any cash
dividends on its Subordinate Voting Shares to date and it is not anticipated that the Corporation will pay any dividends in the foreseeable
future. The payment of dividends in the future will be dependent on its earnings and financial condition in addition to such other factors
as MindMed’s Board considers appropriate. Unless and until the Corporation pays dividends, shareholders may not receive a return
on their shares. There is no present intention by MindMed’s Board to pay dividends on its shares.


 


The Corporation will be subject to Canadian and United States tax
on its worldwide income


 


The Corporation will be deemed to be a resident
of Canada for Canadian federal income tax purposes by virtue of being organized under the laws of a province of Canada. Accordingly, the
Corporation will be subject to Canadian taxation on its worldwide income, in accordance with the rules in the Tax Act generally applicable
to corporations resident in Canada.


 


Notwithstanding that the Corporation will be deemed
to be a resident of Canada for Canadian federal income tax purposes, the Corporation is treated as a United States corporation for United
States federal income tax purposes, pursuant to Section 7874(b) of the Code, and will be subject to United States federal income
tax on its worldwide income. As a result, the Corporation will be subject to taxation both in Canada and the United States, which could
have a material adverse effect on the business, financial condition or results of operations of the Corporation.


 


Dispositions of Subordinate Voting Shares will be subject to Canadian
and United States tax


 


Dispositions of Subordinate Voting Shares will
be subject to Canadian tax. In addition, dispositions of Subordinate Voting Shares by U.S. Holders (as defined below) will be subject
to U.S. tax, and certain dispositions of Subordinate Voting Shares by non-U.S. Holders (including if the Corporation is treated as a USRPHC)
will be subject to U.S. tax. Dividends on the Subordinate Voting Shares may be subject to Canadian or United States withholding tax. It
is currently not anticipated that the Corporation will pay any dividends on the Subordinate Voting Shares in the foreseeable future.


 


To the extent dividends are paid on the Subordinate
Voting Shares, dividends received by shareholders who are residents of Canada for purposes of the Tax Act (and non-U.S. Holders for purposes
of the Code) will be subject to U.S. withholding tax. Any such dividends may not qualify for a reduced rate of withholding tax under the
Canada- United States tax treaty. In addition, a Canadian foreign tax credit or a deduction in respect of such U.S. withholding taxes
paid may not be available.


 


Dividends received by U.S. Holders will not be
subject to U.S. withholding tax but will be subject to Canadian withholding tax. Dividends paid by the Corporation will be characterized
as U.S. source income for purposes of the foreign tax credit rules under the Code. Accordingly, U.S. Holders may not be able to claim
a credit for any Canadian tax withheld unless, depending on the circumstances, they have other foreign source income that is subject to
a low or zero rate of foreign tax.


 


Dividends received by shareholders that are neither
Canadian nor U.S. shareholders will be subject to U.S. withholding tax and will also be subject to Canadian withholding tax. These dividends
may not qualify for a reduced rate of U.S. withholding tax under any income tax treaty otherwise applicable to a shareholder of the Corporation,
subject to examination of the relevant treaty. These dividends may, however, qualify for a reduced rate of Canadian withholding tax under
any income tax treaty otherwise applicable to a shareholder of the Corporation, subject to examination of the relevant tax treaty.


 






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For purposes hereof, a “U.S. Holder”
is a beneficial holder of Subordinate Voting Shares who or that, for U.S. federal income tax purposes, is:


 


		·	an individual who is a United States citizen or resident of the United States;



 


		·	a corporation or other entity treated as a corporation for United States federal income tax purposes created
in, or organized under the laws of, the United States, any state thereof or the District of Columbia;



 


		·	an estate the income of which is includible in gross income for United States federal income tax purposes
regardless of its source; or



 


		·	a trust (A) the administration of which is subject to the primary supervision of a United States
court and which has one or more United States persons (within the meaning of the Code) who have the authority to control all substantial
decisions of the trust or (B) that has in effect a valid election under applicable U.S. Treasury Regulations to be treated as a United
States person.



 


U.S. Tax Classification – United States Real Property Holding
Company


 


The Corporation is treated as a U.S. domestic
corporation for U.S. federal income tax purposes under Section 7874 of the Code. As a U.S. domestic corporation for U.S. federal
income tax purposes, the taxation of the Corporation’s non-U.S. Holders upon a disposition of Subordinate Voting Shares generally
depends on whether the Corporation is classified as a USRPHC for U.S. federal income tax purposes. The Corporation believes that it presently
is not a USRPHC and it does not presently anticipate that it will become a USRPHC. However, because this determination is made from time
to time and is dependent upon a number of factors, some of which are beyond the Corporation’s control, including the value of its
assets, there can be no assurance that the Corporation will not become a USRPHC. If the Corporation ultimately is determined by the IRS
to constitute a USRPHC, its non-U.S. Holders may be subject to U.S. federal income tax on any gain associated with the disposition of
the Subordinate Voting Shares.


 


Changes in tax laws may affect the Corporation and holders of Subordinate
Voting Shares


 


There can be no assurance that the Canadian and
U.S. federal income tax treatment of the Corporation or an investment in the Corporation will not be modified, prospectively or retroactively,
by legislative, judicial or administrative action, in a manner adverse to the Corporation or holders of Subordinate Voting Shares.


 


A return on the Corporation’s securities is not guaranteed


 


There
is no guarantee that the Corporation’s securities will earn any positive return in the short term or long term. A holding
of the Corporation’s securities is speculative and involves a high degree of risk and should be undertaken only by holders whose
financial resources are sufficient to enable them to assume such risks and who have no need for immediate liquidity in their investment.
A holding of the Corporation’s securities is appropriate only for holders who have the capacity to absorb a loss of some or all
of their investment.


 


Future sales or issuances of equity securities
and the conversion of outstanding securities to Subordinate Voting Shares could decrease the value of the Subordinate Voting Shares, dilute
investors’ voting power, and reduce the Corporation’s earnings per share


 


The Corporation may sell additional equity securities
in future offerings, including through the sale of securities convertible into equity securities, to finance operations, acquisitions
or projects, and issue additional Subordinate Voting Shares, which may result in dilution.


 






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The Board has the authority to authorize certain
offers and sales of additional securities without the vote of, or prior notice to, shareholders. Based on the need for additional capital
to fund expected expenditures and growth, it is likely that the Corporation will issue additional securities to provide such capital.
Such additional issuances may involve the issuance of a significant number of Subordinate Voting Shares at prices less than the current
market price for the Subordinate Voting Shares.


 


Sales of substantial amounts of the Corporation’s
securities, or the availability of such securities for sale, as well as the issuance of substantial amounts of the Subordinate Voting
Shares upon conversion of outstanding convertible equity securities, could adversely affect the prevailing market prices for the Corporation’s
securities and dilute investors’ earnings per share. A decline in the market prices of the Corporation’s securities could
impair the Corporation’s ability to raise additional capital through the sale of securities should the Corporation desire to do
so.


 


Any failure to maintain an effective system
of internal controls may result in material misstatements of the Corporation’s financial statements or cause MindMed to fail to
meet its reporting obligations or fail to prevent fraud


 


The Corporation is subject to various Canadian
reporting and other regulatory requirements. The Corporation will incur expenses and, to a lesser extent, diversion of its management’s
time in its efforts to comply with applicable Canadian securities laws regarding internal controls over financial reporting. Effective
internal controls are necessary for MindMed to provide reliable financial reports and prevent fraud. If the Corporation fails to maintain
an effective system of internal controls, the Corporation might not be able to report its financial results accurately or prevent fraud;
and in that case, the Corporation’s shareholders could lose confidence in its financial reporting, which would harm its business
and could negatively impact the price of the Corporation’s Subordinate Voting Shares. While the Corporation believes that the Corporation
has sufficient personnel and review procedures to allow it to maintain an effective system of internal controls, MindMed cannot provide
assurance that the Corporation will not experience potential material weaknesses in its internal controls. Even if MindMed concludes that
its internal control over financial reporting provides reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with IFRS as issued by the International Accounting Standards Board, because
of its inherent limitations, internal control over financial reporting may not prevent or detect fraud or misstatements. Failure to implement
required new or improved controls, or difficulties encountered in their implementation, could harm the Corporation’s results of
operations or cause it to fail to meet its future reporting obligations. If the Corporation fails to timely achieve and maintain the adequacy
of its internal control over financial reporting, the Corporation may not be able to produce reliable financial reports or help prevent
fraud. In addition, any testing by the Corporation conducted in connection with applicable Canadian securities laws, or the subsequent
testing by an independent registered public accounting firm when required, may reveal deficiencies in its internal controls over financial
reporting that are deemed to be material weaknesses or that may require prospective or retrospective changes to its consolidated financial
statements or identify other areas for further attention or improvement. MindMed’s failure to achieve and maintain effective internal
control over financial reporting could prevent the Corporation from complying with its reporting obligations on a timely basis, which
could result in the loss of investor confidence in the reliability of its consolidated financial statements, harm the Corporation’s
business and negatively impact the trading price of its Subordinate Voting Shares.


 


There is no assurance an active or liquid market
for the Subordinate Voting Shares will be developed or sustained


 


No assurance can be given that an active or liquid
trading market for the Subordinate Voting Shares will be sustained. If an active or liquid market for the Subordinate Voting Shares fails
to be sustained, the prices at which such securities trade may be adversely affected. Whether or not the common shares will trade at lower
prices depends on many factors, including the liquidity of the Subordinate Voting Shares, prevailing interest rates, the markets for similar
securities, general economic conditions and the Corporation’s financial condition, historic financial performance and future prospects.


 


The
Corporation cannot predict at what prices the Subordinate Voting Shares will continue to trade, and there is no assurance that
an active trading market will be sustained. The Subordinate Voting Shares trade on the NEO but do not currently trade on any U.S. national
securities exchange. In the event Subordinate Voting Shares begin trading on any U.S. national securities exchange, the Corporation cannot
predict at what prices the Subordinate Voting Shares will trade and there is no assurance that an active trading market will develop or
be sustained. There is a significant liquidity risk associated with an investment in the Subordinate Voting Shares of the Corporation.


 






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Trading in securities quoted on the OTCQB is often
thin and characterized by wide fluctuations in trading prices, due to many factors, some of which may have little to do with the Corporation’s
operations or business prospects. This volatility could depress the market price of Subordinate Voting Shares for reasons unrelated to
operating performance. Moreover, the OTCQB is not a U.S. national securities exchange, and trading of securities on the OTCQB is often
more sporadic than the trading of securities listed on a U.S. national securities exchange like the NASDAQ or the NYSE. These factors
may result in investors having difficulty reselling Subordinate Voting Shares on the OTCQB.


 


Public markets and share prices


 


The market price of the Subordinate Voting Shares
on the NEO, OTCQB and Frankfurt Exchange could be subject to significant fluctuations in response to variations in the Corporation’s
operating results or other factors. In addition, fluctuations in the stock market may adversely affect the market price of additional
Subordinate Voting Shares that may become listed and posted for trading on the NEO, OTCQB and Frankfurt Exchange or any other stock exchange
regardless of the operating performance of the Corporation. Securities markets have also experienced significant price and volume fluctuations
from time to time. In some instances, these fluctuations have been unrelated or disproportionate to the operating performance of issuers.
Market fluctuations may adversely impact the market price of the Subordinate Voting Shares.


 


Additional issuances and dilution


 


The Corporation may issue and sell additional
equity or convertible debt securities to finance its operations, which may dilute existing shareholder’s holdings in the Corporation.
The Corporation’s articles permit the issuance of an unlimited number of Multiple Voting Shares and Subordinate Voting Shares, and
existing shareholders will have no pre-emptive rights in connection with such further issuances. Moreover, additional Subordinate Voting
Shares will be issued by the Corporation on the conversion of the Multiple Voting Shares in accordance with their terms. To the extent
holders of the Corporation’s options or other convertible securities convert or exercise their securities and sell Subordinate Voting
Shares they receive, the trading price of the Subordinate Voting Shares may decrease due to the additional amount of Subordinate Voting
Shares available in the market. Further, the Corporation may issue additional securities in connection with strategic acquisitions. The
Corporation cannot predict the size or type of future issuances of its securities or the effect, if any, that future issuances and sales
of securities will have on the market price of any of its securities issued and outstanding from time to time. Sales or issuances of substantial
amounts of MindMed’s securities, or the perception that such sales could occur, may adversely affect prevailing market prices for
the Corporation’s securities issued and outstanding from time to time. With any additional sale or issuance of MindMed’s securities,
holders will suffer dilution with respect to voting power and may experience dilution in the Corporation’s earnings per share.


 


Future sales of Subordinate Voting Shares by
existing shareholders may decrease the trading price of the Subordinate Voting Shares


 


Sales
of a large number of Subordinate Voting Shares in the public markets, or the potential for such sales, could occur at any time either
by existing holders of Subordinate Voting Shares or by holders of the Multiple Voting Shares, which are convertible into Subordinate Voting
Shares on the satisfaction of certain conditions. These sales, or the market perception that the holders of a large number of Subordinate
Voting Shares or Multiple Voting Shares intend to sell Subordinate Voting Shares, could reduce the market price of the Subordinate Voting
Shares. If this occurs and continues, it could impair the Corporation’s ability to raise additional capital through the sale
of securities.


 






    68


     


    

 


The Corporation is considered a Foreign Private
Issuer under current SEC guidance but may lose such status if the SEC guidance were to change


 


The Corporation is a “foreign private issuer”
as defined in Rule 405 under the U.S. Securities Act and Rule 3b-4 under the U.S. Exchange Act (a “Foreign Private
Issuer”). The term Foreign Private Issuer is defined as a corporation or other organization incorporated or organized under
the laws of a country other than the United States, except any issuer meeting the following conditions:


 


		(1)	more than 50 percent of the outstanding voting securities of such issuer are, directly or indirectly, held of record by residents
of the United States; and






		(2)	any one of the following:






		(a)	the majority of the executive officers or directors are United States citizens or residents, or






		(b)	more than 50 percent of the assets of the issuer are located in the United States, or






		(c)	the business of the issuer is administered principally in the United States.



 


For purposes of determining whether more than
50% of the Corporation’s outstanding voting securities are held “of record” by U.S. residents, MindMed must “look
through” the record ownership of brokers, dealers, banks, or nominees holding securities for the accounts of their customers, and
also consider any beneficial ownership reports or other information available to MindMed. The Corporation must conduct this “look
through” in three jurisdictions: the United States, Canada (the Corporation’s home jurisdiction), and the primary trading
market for its voting securities, if different from MindMed’s home jurisdiction. Additionally, if the Corporation is not able to
obtain information about the record holders’ accounts after reasonable inquiry, MindMed may rely on the presumption that such accounts
are held in the broker’s, dealer’s, bank’s, or nominee’s principal place of business.


 


In December 2016, the SEC issued a Compliance
and Disclosure Interpretation to clarify that issuers with multiple classes of voting stock carrying different voting rights may choose
one of two methods in determining whether more than 50% of its outstanding voting securities are directly or indirectly owned of record
by residents in the United States; (a) the issuer may look to whether more than 50% of the voting power of those classes on a combined
basis, is directly or indirectly owned of record by residents of the United States; or (b) the issuer may make the determination
based on the number of voting securities. Issuers must apply a determination methodology on a consistent basis. Based on this interpretation,
each issued and outstanding Multiple Voting Share is counted as one voting security, and each issued and outstanding Subordinate Voting
Share is counted as one voting security for the purposes of determining the 50% U.S. resident threshold. Accordingly, MindMed is currently
treated as a Foreign Private Issuer. However, should the SEC’s guidance and interpretation change on this matter, the Corporation
may lose its Foreign Private Issuer status.


 


A loss of the Corporation’s Foreign Private
Issuer status may have adverse consequences on the Corporation’s cost of, and ability to raise, capital


 


The
Corporation may lose its status as a Foreign Private Issuer if, as of the last business day of its second fiscal quarter for any year,
more than 50% of the Corporation’s outstanding voting securities (as determined under Rule 405 of the U.S. Securities Act)
are directly or indirectly held of record by residents of the United States. Loss of Foreign Private Issuer status may have adverse consequences
on the Corporation’s ability to raise capital in private placements or Canadian prospectus offerings. In addition, loss of MindMed’s
Foreign Private Issuer status would likely result in increased reporting requirements and increased audit, legal and administration costs.
The regulatory and compliance costs to the Corporation under U.S. federal securities laws as a U.S. domestic issuer may be significantly
more than the costs the Corporation incurs as a Canadian Foreign Private Issuer eligible to use MJDS. If the Corporation is not a Foreign
Private Issuer, it would not be eligible to use the MJDS or other foreign issuer forms and would be required to file periodic and current
reports and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive than the forms available
to a Foreign Private Issuer and are generally subject to more in-depth review by the SEC. Further, should the Corporation seek to list
on a national securities exchange in the United States, loss of Foreign Private Issuer status may increase the cost and time required
for such a listing. These increased costs may have a material adverse effect on the business, financial condition or results of operations
of the Corporation.


 


The Corporation could lose its status as a Foreign
Private Issuer if all or a portion of the Multiple Voting Shares directly or indirectly held of record by U.S. residents are converted
into Subordinate Voting Shares. The conversion rights attached to the Multiple Voting Shares contain restrictions on conversion that are
intended to avoid such a result; however there can be no guarantee that such restrictions on conversion will be effective to prevent the
Corporation from potentially losing Foreign Private Issuer status if a sufficient number of Multiple Voting Shares are converted into
Subordinate Voting Shares and such Subordinate Voting Shares are acquired, either upon conversion or pursuant to a subsequent transaction,
by U.S. residents. In addition, the Corporation could potentially lose its Foreign Private Issuer status as a result of future issuances
of Subordinate Voting Shares from treasury to the extent such shares are acquired by U.S. residents.


 






    69


     


    

 


A significant number of securities of the Corporation
are owned by a limited number of existing shareholders


 


The Corporation’s management, directors
and employees own a substantial number of the outstanding Subordinate Voting Shares and Multiple Voting Shares (on a non-diluted and partially-diluted
basis). As such, the Corporation’s management, directors and employees, as a group, are in a position to exercise influence over
matters requiring shareholder approval, including the election of directors and the determination of corporate actions, including, but
not limited to, any arrangement or sale of all or substantially all of its assets. Even if such management, directors and employees do
not retain their position with the Corporation, they will continue to have the ability to exercise the same significant voting power.
These shareholders are also in a position to delay, defer or prevent a change in control of the Corporation, an arrangement involving
the Corporation or a sale of all or substantially all of its assets that could otherwise be beneficial to the Corporation’s shareholders.
Conversely, this concentrated control could allow such holders to consummate such a transaction that its other shareholders do not support.
In addition, such holders may make long-term strategic investment decisions and take risks that may not be successful and may seriously
harm the Corporation’s business.


 


The Corporation’s capital structure and voting control may
cause unpredictability


 


Although
other Canadian companies have dual class or multiple voting share structures, given the concentration of voting control that is held by
the Corporation’s management, directors and employees, this capital structure and concentration of control could result in a lower
trading price for, or greater fluctuations in, the trading price of the Subordinate Voting Shares, adverse publicity to the Corporation
or other adverse consequences for the Corporation.


 


A decline in the price or trading volume of
the Subordinate Voting Shares could affect the Corporation’s ability to raise further capital and adversely impact its ability to
continue operations


 


A
prolonged decline in the price or trading volume of the Subordinate Voting Shares could result in a reduction in the liquidity of the
Subordinate Voting Shares and a reduction in the Corporation’s ability to raise capital. Because a significant portion of
the Corporation’s operations have been and will be financed through the sale of equity securities, a decline in the price or trading
volume of the Subordinate Voting Shares could be especially detrimental to the Corporation’s liquidity and operations. Such reductions
may force the Corporation to reallocate funds from other planned uses and may have a material adverse effect on the Corporation’s
business plan and operations, including the ability to operationalize existing licenses and complete planned capital expenditures. If
the price or trading volume of the Subordinate Voting Shares declines, there can be no assurance that the Corporation will be able to
raise additional capital or generate funds from operations sufficient to meet the Corporation’s obligations. If the Corporation
is unable to raise sufficient capital in the future, it may not have the necessary resources to continue normal operations.


 


If securities or industry analysts do not publish
or cease publishing research or reports or publish misleading, inaccurate or unfavorable research about us, the Corporation’s business
or market, stock price and trading volume could decline


 


The
trading market for Subordinate Voting Shares may be influenced by the research and reports that securities or industry analysts publish
about us, the Corporation’s business, market or competitors. If no or few securities or industry analysts cover the Corporation,
the trading price and volume of the Subordinate Voting Shares would likely be negatively impacted. If one or more of the analysts who
cover the Corporation downgrades the Subordinate Voting Shares or publishes inaccurate or unfavorable research about the Corporation’s
business, or provides more favorable relative recommendations about the Corporation’s competitors, the price of the Subordinate
Voting Shares would likely decline. If one or more of these analysts ceases coverage of MindMed or fails to publish reports on MindMed
regularly, demand for the Subordinate Voting Shares could decrease, which could cause the Corporation’s stock price or trading volume
to decline.


 


As a public company, there are costs associated
with maintaining a public listing


 


As
a public company in Canada, the Corporation is subject to the reporting requirements, rules and regulations under the applicable
Canadian securities laws and rules of stock exchange(s) on which the Corporation’s securities may be listed. There
are increased costs associated with legal, accounting and other expenses related to such regulatory compliance. Securities legislation
and the rules and policies of the NEO require listed companies to, among other things, adopt corporate governance and related practices,
and to continuously prepare and disclose material information, all of which add to a company’s legal and financial compliance costs.
The Corporation may also elect to devote greater resources than it otherwise would have on communication and other activities typically
considered important by publicly traded companies.


 






    70


     


    

 


DIVIDENDS AND DISTRIBUTIONS


 


The Corporation has not declared or paid any cash
dividends on its Subordinate Voting Shares or Multiple Voting Shares since the date of its incorporation. The Corporation intends to retain
its earnings, if any, to finance the growth and development of its business and does not expect to pay dividends or to make any other
distributions in the near future. The Board will review this policy from time to time having regard to the Corporation’s financing
requirements, financial condition and other factors considered to be relevant.


 


DESCRIPTION OF CAPITAL STRUCTURE


 


On February 27, 2020, in connection with the
Transaction, the Corporation filed articles of amendment providing for the consolidation of its common shares on an eight-for-one basis,
the re-designation of its common shares as the Subordinate Voting Shares and the creation of the Multiple Voting Shares. The Corporation
is authorized to issue an unlimited number of Subordinate Voting Shares and an unlimited number of Multiple Voting Shares. As at the
date of this AIF, the Corporation also has issued and outstanding (i) 340,056,002 Subordinate Voting Shares; (ii) 666,497 Multiple Voting
Shares; (iii) Stock Options (as hereinafter defined) to acquire an aggregate of up to 19,862,991 Subordinate Voting Shares; (iv) 26,449,220
Warrants (as hereinafter defined); and (v) 500,000 RSUs (as hereinafter defined).


 


Subordinate Voting Shares and Multiple Voting
Shares


 


All holders of Subordinate Voting Shares and Multiple
Voting Shares are entitled to receive notice of any meeting of shareholders of the Corporation, and to attend, vote and speak at such
meetings, except those meetings at which only holders of a specific class of shares are entitled to vote separately as a class under the
BCBCA. A quorum for the transaction of business at any meeting of shareholders is two persons present at the meeting, each of whom is
entitled to vote at the meeting, and who hold or represent by proxy in the aggregate not less than 5% of the outstanding shares of the
Corporation entitled to vote at the meeting.


 


On all matters upon which shareholders the Corporation
are entitled to vote:


 


		·	each Subordinate Voting Share is entitled to one vote per Subordinate Voting Share; and



 


		·	each Multiple Voting Share is entitled to 100 votes per Multiple Voting Share.



 


Unless
a different majority is required by law or the articles of the Corporation, resolutions to be approved by shareholders require
approval by a simple majority of the total number of votes of all Shares cast at a meeting of shareholders at which a quorum is present
based on the voting entitlements of each class of Shares described above.


 


As of the date of this AIF, the Subordinate Voting Shares represent
approximately 83.61% of the voting rights attached to outstanding securities of the Corporation and the Multiple Voting Shares represent
approximately 16.39% of the voting rights attached to outstanding securities of the Corporation. If the Multiple Voting Shares were converted
as of the date of this AIF, an equivalent of 66,649,700 Subordinate Voting Shares would be issued and outstanding and no Multiple Voting
Shares would be issued and outstanding.


 


The Subordinate Voting Shares and the Multiple
Voting Shares are substantially identical with the exception of the multiple voting and conversion rights attached to the Multiple Voting
Shares, and the related take-over bid protections attached to the Subordinate Voting Shares, all as described herein.


 


The
Multiple Voting Shares carry a greater number of votes per share relative to the Subordinate Voting Shares and accordingly the Subordinate
Voting Shares are “restricted securities” within the meaning of such term under applicable Canadian securities laws.


 






    71


     


    

 


Conversion Rights


 


Issued and outstanding Multiple Voting Shares,
including fractions thereof, may at any time, subject to the FPI Condition and Beneficial Ownership Limitation (as such terms are defined
below), at the option of the holder, be converted into Subordinate Voting Shares at an initial conversion ratio (the “Conversion
Ratio”) of 100 Subordinate Voting Shares per Multiple Voting Share. The Conversion Ratio is subject to adjustment from time
to time in certain events including distributions to holders of, or recapitalizations (including stock dividends, subdivisions and consolidations)
involving, the Subordinate Voting Shares. Further, the Board may require holders of Multiple Voting Shares to convert all, but not less
than all, of their Multiple Voting Shares at the applicable Conversion Ratio if (a) the Subordinate Voting Shares are registered
for resale and may be sold pursuant to an effective registration statement or prospectus covering the Subordinate Voting Shares under
the United States Securities Act of 1933, as amended and (b) the Corporation is subject to the reporting requirements of Section 13
or 15(d) of the United States Securities and Exchange Act of 1934, as amended (the “1934 Act”).


 


Conversion Conditions


 


The right of the Multiple Voting Shares to convert
into Subordinate Voting Shares is subject to certain conditions in order to maintain the status of the Corporation as a “foreign
private issuer” under United States securities laws. The right to convert the Multiple Voting Shares is subject to the condition
that the aggregate number of Subordinate Voting Shares and Multiple Voting Shares (calculated as a single class) held of record, directly
or indirectly, by residents of the United States (as determined in accordance with Rules 3b-4 and 12g3-2(a) under the 1934 Act),
may not exceed forty-five percent (45%) of the aggregate number of Subordinate Voting Shares and Multiple Voting Shares issued and outstanding
after giving effect to such conversions (calculated as a single class) (the “FPI Condition”).


 


In addition, the Corporation shall not affect
any conversion of Multiple Voting Shares, and a holder shall not have the right to convert any portion of Multiple Voting Shares, to the
extent that after giving effect to such issuance after conversion, the holder (together with its affiliates and any other persons acting
as a group with the holder or its affiliates) would beneficially own in excess of 9.99% of the number of Subordinate Voting Shares outstanding
immediately after giving effect to such conversion (the “Beneficial Ownership Limitation”). Notwithstanding the foregoing,
a holder of Multiple Voting Shares, upon notice to the Corporation, may increase or decrease the Beneficial Ownership Limitation, provided
that the Beneficial Ownership Limitation shall not exceed 19.9% of the number of Subordinate Voting Shares outstanding immediately after
giving effect to the conversion and any increase in the Beneficial Ownership Limitation will not be effective until the 61st day after
such notice of increase is delivered to the Corporation.


 


No fractional Subordinate Voting Shares will be
issued on any conversion of any Multiple Voting Shares and any fractional Subordinate Voting Shares will be rounded up to the nearest
whole number.


 


Dividend Rights


 


Holders of Shares are entitled to receive dividends
out of any cash or the assets legally available for the payment or distribution of dividends at such times and in such amount and form
as the Board may from time to time determine, on the following basis, and otherwise without preference or distinction among or between
the Shares: each Multiple Voting Share will be entitled to an amount equal to the amount paid or distributed per Subordinate Voting Share
multiplied by the Conversion Ratio. No dividend will be declared or paid on the Multiple Voting Shares unless the Corporation simultaneously
declares or pays, as applicable, equivalent dividends (on an as-converted to Subordinate Voting Share basis) on the Subordinate Voting
Shares.


 


Liquidation Rights


 


In the event of the liquidation, dissolution or
winding-up of the Corporation or any other distribution of its assets among its shareholders for the purpose of winding-up its affairs,
whether voluntarily or involuntarily, the holders of Shares will, subject to the prior rights of the holders of any shares of the Corporation
ranking in priority to the Shares, be entitled to receive all of the Corporation’s assets remaining after payment of all debts and
other liabilities, rateably amongst all holders of Multiple Voting Shares (on an as-converted to Subordinate Voting Share basis at the
then current Conversion Ratio) and Subordinate Voting Shares, and otherwise without preference or distinction among or between the Shares.


 






    72


     


    

 


Pre-Emptive and Redemption Rights


 


Holders of Shares do not have any rights of first
refusal, or pre-emptive or redemption rights.


 


Subdivision or Consolidation


 


No subdivision or consolidation of any class of
Shares may be carried out unless, at the same time, the Subordinate Voting Shares and Multiple Voting Shares, as the case may be, are
subdivided or consolidated in the same manner and on the same basis, so as to preserve the relative rights of the holders of each class
of Shares.


 


Issuance of Additional Multiple Voting Shares


 


The Corporation may issue additional Multiple
Voting Shares upon the approval of the Board. Approval is not required in connection with a subdivision or consolidation on a pro rata
basis as between the Subordinate Voting Shares and the Multiple Voting Shares.


 


Take-Over Bid Protection


 


If an MVS Offer is made where: (i) by reason
of applicable securities legislation or stock exchange requirements, the offer must be made to all or substantially all holders of the
class of Multiple Voting Shares; and (ii) no equivalent offer is made for the Subordinate Voting Shares, the holders of Subordinate
Voting Shares have the right, pursuant to the Articles, at their option, to convert their Subordinate Voting Shares into Multiple Voting
Shares at the inverse of the then current Conversion Ratio for the purpose of allowing the holders of the Subordinate Voting Shares to
tender to such MVS Offer, provided that such conversion into Multiple Voting Shares will be solely for the purpose of tendering the Multiple
Voting Shares to the MVS Offer in question and that any Multiple Voting Shares that are tendered to the MVS Offer but that are not, for
any reason, taken up and paid for by the offeror will automatically be reconverted at the then current Conversion Ratio into the Subordinate
Voting Shares that existed prior to such conversion.


 


Warrants


 


As at the date of this AIF, 26,449,220 warrants
to acquire an aggregate of up to 26,449,220 Subordinate Voting Shares are issued and outstanding (the “Warrants”).
The Warrants include (i) 2,347,214 May Offering Warrants; (ii) 4,020,050 October Offering Warrants; (iii) 4,728,606 December Offering
Warrants; (iv) 272,550 December Offering Compensation Options; (v) 10,465,000 January Offering Warrants;
(vi) 1,255,800 January Offering Compensation Options; (vii) 3,000,000 March Offering Warrants; and(viii) 360,000 March Offering Compensation
Options.


 


Stock Options


 


The Corporation has established the Stock Option
Plan, which provides that the Board may from time to time, in its discretion, grant to directors, officers, employees and consultants
of the Corporation, or any subsidiary of the Corporation, options to purchase Subordinate Voting Shares (the “Stock Options”).
The Stock Option Plan permits the Board to grant Stock Options to purchase up to ten percent (10%) of the number of Shares issued and
outstanding provided that for the purpose of such calculation, the number of Shares outstanding shall include the number of Shares issuable
upon conversion of the then issued and outstanding Multiple Voting Shares as at the date of such Stock Option grant, as permitted by the
policies of the NEO. As of the date of this AIF, Stock Options to purchase an aggregate of up to 19,862,991 Subordinate Voting Shares
were issued to directors, officers, employees and consultants of the Corporation.


 






    73


     


    


 


Restricted Share Units


 


The
Corporation has established the RSU Plan, which permits the Board to grant RSUs to its senior officers, directors, employees and consultants
as a discretionary payment in consideration for significant contributions to the long-term success of the Corporation. The RSU Plan permits
the Board to grant RSUs to purchase up to ten percent (10%) of the number of Shares issued and outstanding provided that for the purpose
of such calculation, the total number of Stock Options and RSUs awarded shall not exceed ten (10%) of the number of Shares issued and
outstanding and the number of Shares outstanding shall include the number of Shares issuable upon conversion of the then issued and outstanding
Multiple Voting Shares as at the date of such RSU grant, as permitted by the policies of the NEO. As of the date of this AIF, 500,000
RSUs have been issued.


 


MARKET FOR SECURITIES


 


Trading Price and Volume


 


Subordinate Voting Shares


 


The
Subordinate Voting Shares are currently listed for trading on the NEO under the symbol “MMED”, on the FWB under the symbol
 “MMQ” and is quoted on the OTCQB under the symbol “MMEDF”. The Subordinate Voting Shares commenced trading on
the NEO effective March 3, 2020. The following table indicates the monthly ranges of high and low prices per Subordinate Voting
Share as well as total monthly volumes traded on the NEO since the commencement of trading to December 31, 2020 (Source: https://www.aequitasneo.com).


 


	 	 	Price Range

 ($)	 	 	 	 
	Period	 	High	 	 	Low	 	 	Volume	 
	December, 2020	 	 	6.47	 	 	 	1.93	 	 	 	215,353,132	 
	November, 2020	 	 	2.58	 	 	 	1.01	 	 	 	105,400,514	 
	October, 2020	 	 	1.42	 	 	 	0.77	 	 	 	107,391,881	 
	September, 2020	 	 	1.11	 	 	 	0.43	 	 	 	57,842,855	 
	August, 2020	 	 	0.52	 	 	 	0.42	 	 	 	11,638,419	 
	July, 2020	 	 	0.54	 	 	 	0.40	 	 	 	15,954,091	 
	June, 2020	 	 	0.56	 	 	 	0.395	 	 	 	38,733,761	 
	May, 2020	 	 	0.67	 	 	 	0.53	 	 	 	38,600,366	 
	April, 2020	 	 	0.8	 	 	 	0.49	 	 	 	35,583,150	 
	March, 2020	 	 	0.99	 	 	 	0.24	 	 	 	93,701,309	 



 


The price of the Subordinate Voting Shares as
quoted by the NEO at the close of business on March 26, 2021 was $3.06.


 






    74


     


    

 


May Offering Warrants


 


The May Offering Warrants are currently listed
for trading on the NEO under the symbol “MMED.WT” and are quoted on the OTCQB under the symbol “MMDWF”. The May Offering
Warrants commenced trading on the NEO effective May 28, 2020. The following table indicates the monthly ranges of high and low prices
per May Offering Warrant as well as total monthly volumes traded on the NEO since the commencement of trading to December 31,
2020 (Source: Bloomberg).


 


	 	 	Price Range 

($)	 	 	 	 
	Period	 	High	 	 	Low	 	 	Volume	 
	December, 2020	 	 	4.70	 	 	 	1.23	 	 	 	2,902,717	 
	November, 2020	 	 	1.38	 	 	 	0.38	 	 	 	8,981,731	 
	October, 2020	 	 	0.55	 	 	 	0.21	 	 	 	3,391,254	 
	September, 2020	 	 	0.27	 	 	 	0.035	 	 	 	2,679,533	 
	August, 2020	 	 	0.055	 	 	 	0.03	 	 	 	2,002,280	 
	July, 2020	 	 	0.07	 	 	 	0.04	 	 	 	1,452,467	 
	June, 2020	 	 	0.085	 	 	 	0.06	 	 	 	1,160,762	 
	May, 2020	 	 	0.10	 	 	 	0.08	 	 	 	549,950	 



 


The price of the May Offering Warrants as
quoted by the NEO at the close of business on March 26, 2021 was $2.27.


 


October Offering Warrants


 


The October Offering Warrants are currently
listed for trading on the NEO under the symbol “MMED.WS” and are quoted on the OTCQB under the symbol “MMDCF”.
The October Offering Warrants commenced trading on the NEO effective November 2, 2020. The following table indicates the monthly
ranges of high and low prices per October Offering Warrant as well as total monthly volumes traded on the NEO since the commencement
of trading to December 31, 2020 (Source: Bloomberg).


 


	 	 	Price Range

 ($)	 	 	 	 
	Period	 	High	 	 	Low	 	 	Volume	 
	December, 2020	 	 	4.09	 	 	 	0.69	 	 	 	3,239,946	 
	November, 2020	 	 	0.79	 	 	 	0.24	 	 	 	4,569,227	 



 


The price of the October Offering Warrants
as quoted by the NEO at the close of business on March 26, 2021 was $1.65.


 


December Offering Warrants


 


The December Offering Warrants are currently
listed for trading on the NEO under the symbol “MMED.WA and are quoted on the OTCQB under the symbol “MMCWF”. The December Offering
Warrants commenced trading on the NEO effective December 15, 2020. The following table indicates the monthly ranges of high and low
prices per December Offering Warrant as well as total monthly volumes traded on the NEO since the commencement of trading to December 31,
2020 (Source: Bloomberg).


 


The price of the December Offering Warrants
as quoted by the NEO at the close of business on March 26, 2021 was $1.35.


 


	 	 	Price Range 
 ($)	 	 	 	 
	Period	 	High	 	 	Low	 	 	Volume	 
	December, 2020	 	 	2.15	 	 	 	1.32	 	 	 	1,896,919	 



 






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Prior Sales


 


The following table details the issuances of securities
by the Corporation during the year ended December 31, 2020 as part of each class of securities of the Corporation that is not listed
or quoted on a marketplace.


 


	Date of Issuance	 	Number of Securities Issued	 	Price per

 Security /

 Exercise Price	 
	February 27, 2020	 	18,902,500 Stock Options(1)	 	$	0.33	 
	March 24, 2020	 	300,000 Stock Options	 	$	0.33	 
	April 13, 2020	 	1,770,000 Stock Options	 	$	0.54	 
	May 6, 2020	 	1,450,000 Stock Options(2)	 	$	0.55	 
	May 26, 2020	 	994,034 Compensation Warrants	 	$	0.53	 
	July 21, 2020	 	2,250,000 Stock Options	 	$	0.50	 
	September 9, 2020	 	2,078,000 Stock Options	 	$	0.445	 
	October 30, 2020	 	1,642,890 October Offering Compensation Options	 	$	1.05	 
	December 11, 2020	 	1,090,200 December Offering Compensation Options	 	$	1.90	 



 


		Notes:	



 


		(1)	320,000 of such Stock Options were subsequently cancelled in accordance with their terms.



 


		(2)	300,000 of such Stock Options were subsequently cancelled in accordance with their terms.



 


ESCROWED SECURITIES AND SECURITIES SUBJECT TO
CONTRACTUAL RESTRICTION ON TRANSFER


 


The following table summarizes details of the
Corporation’s securities of each class held, to the Corporation’s knowledge, in escrow or that are subject to a contractual
restriction on transfer as of the date of this AIF:


 


	Designation
    of Class	 	Number
    of Securities Held in 

    Escrow	 	 	Percentage
    of Class	 
	Subordinate
    Voting Shares	 	 	9,105,000	(1)(2)	 	 	2.68	%
	Multiple
    Voting Shares	 	 	521,497	(1)(2)(3)(4)	 	 	78.24	%



 


Notes


 


		(1)	In connection with the Transaction and as required
by the NEO, the Corporation, Odyssey Trust Company and certain former security holders of MindMed US, entered into an escrow agreement
dated February 27, 2020, pursuant to which such security holders were required to submit 33,220,000 Subordinate Voting Shares and
585,000 Multiple Voting Shares into escrow (collectively, the “Odyssey Escrowed Securities”). Of the Odyssey Escrowed
Securities, 25% of such securities were released from escrow on each of March 3, 2020, September 3, 2020, and March 3,
2021, and an additional 25% will be released on September 3, 2021. An additional 4,200,000 Subordinate Voting Shares were subject
to an escrow (the “Additional Escrowed Securities”, and together with the Odyssey Escrowed Securities, the “Escrowed
Securities”), evidenced by legended stock, with the same release provisions as the Odyssey Escrowed Securities described above.
As of the date of this AIF, 9,105,000 Subordinate Voting Shares and 146,250 Multiple Voting Shares (convertible into 14,265,000
Subordinate Voting Shares) are currently in deposit in escrow.



 


		(2)	In connection with the Private Placement, shareholders of MindMed US entered into voluntary lock-up agreements
in favour of the registered dealer that acted as agent in connection with the Private Placement (the “Agent”) pursuant
to which 550,000 Multiple Voting Shares (convertible into 55,000,000 Subordinate Voting Shares) were locked up for a period of twenty-four
(24) months until March 3, 2022, of which 10% of the locked-up Multiple Voting Shares were released on each of September 3,
2020 and March 3, 2021, and of which an additional 10% will be released on September 3, 2021, and the remaining 70% of the locked-up
Multiple Voting Shares will be released on March 3, 2022 (collectively, the “Lock-Up Terms”). As of the date hereof,
440,000 Multiple Voting Shares (convertible into 44,000,000 Subordinate Voting Shares) are subject to the Lock-Up Terms.



 


		(3)	146,250 of such Multiple Voting Shares (convertible into 14,625,000 Subordinate Voting Shares) represent
Shares that are both Escrowed Securities and are also subject to the Lock-Up Terms, and 293,750 of such Multiple Voting Shares (convertible
into 29,375,000 Subordinate Voting Shares) represent Shares that are only subject to the Lock-Up Terms.



 






    76


     


    

 


		(4)	In connection with the Merger, the Corporation
issued 81,497 Multiple Voting Shares (convertible into 8,149,700 Subordinate Voting Shares) to certain former securityholders of HealthMode, Inc.
(the “HealthMode Escrowed Securities”), which are subject to the provisions of an escrow agreement among the Corporation,
Odyssey Trust Company and certain former securityholders of HealthMode, Inc. Of the HealthMode Escrowed Securities, (i) 32,703
Multiple Voting Shares (convertible into 3,270,300 Subordinate Voting Shares) were issued to former convertible noteholders of HealthMode, Inc.,
50% of which will be released from escrow on each of July 1, 2021 and January 1, 2022; and (ii) 48,794 of such Multiple
Voting Shares (convertible into 4,879,400 Subordinate Voting Shares) were issued to certain other equity holders of HealthMode, Inc.,
one-third of which will be released from escrow on each of July 1, 2021, January 1, 2022 and September 1, 2022. As of the
date hereof, 81,497 Multiple Voting Shares (convertible into 8,149,700 Subordinate Voting Shares) are HealthMode Escrowed Securities.



 


DIRECTORS AND OFFICERS


 


The following table sets forth the name, municipality
of residence, position held with the Corporation, principal occupation for the five preceding years and number of Shares and percentage
of securities of each class of voting securities represented by such Shares beneficially owned by each person who is a director or an
executive officer of the Corporation. The statement as to the Shares beneficially owned, controlled or directed, directly or indirectly,
by the directors and executive officers hereinafter named is in each instance based upon information furnished by the person concerned
and is as at the date hereof.


 


	Name,

    Position with the Corporation and Municipality of Residence 	Director/Officer

    Since	Principal
    Occupation(s)	Number
    of Shares 

Beneficially Owned,

    Directly or Indirectly or

    Over Which Control or

    Direction is Exercised
	
    Jamon Alexander (J.R.) Rahn(1)

    Chief Executive Officer and a Director

    Miami, Florida, USA
	February, 2020	
    Chief
Executive Officer of the Corporation (2021 – Present); Co-Chief Executive Officer of the Corporation (2020 – 2021);
Chief Executive Officer of Upgraded Technologies Inc. (2016 – 2017); Operations Manager at Uber Technologies Inc. (2015 –
2016)

     
	
    4,506,100

    Subordinate Voting Shares


35,000 Multiple

Voting Shares

(1.97%)



	
    Miriam Halperin Wernli(1)

    President and a Director

    Baar, Switzerland
	February, 2020	Executive President of the Corporation (2020 – Present); Co-founder and Group Chief Executive Officer of Creso Pharma Ltd. (2016 - 2020); Vice President, Deputy Head Global Clinical Development, Global Head Business & Science Affairs of Actelion Pharmaceuticals (2007 - 2016)

                                                                                 
	
    450,000 Subordinate Voting Shares

        (0.11%)

	
    David Guebert

    Chief Financial Officer

    Calgary, Alberta, Canada
	April, 2020	
    Chief Financial Officer of the Corporation (2020
    – Present); Chief Financial Officer of Mount Logan Capital Inc. (2008 - 2019); Chief Financial Officer of Clarocity Corporation
    (2016 –

    2019)

     
	Nil
	
    Carol Nast

    Chief Operating Officer

    Santa Rosa, California, USA
	February, 2020	Chief Operating Officer of the Corporation (2020 – Present); President of Enterprise Catalyst Group, Inc (2009 - 2020)

                                                                                 
	
    358,073 Subordinate Voting Shares

        (0.09%)

	
    Donald Gehlert

    Chief Scientific Officer

    Boulder, Colorado, USA
	February, 2020	Chief Scientific Officer of the Corporation (2020 – Present); Consultant for Matrix Pharma Consulting, LLC (2015 - Present)

                                                                                 
	Nil



 






    77


     


    

 


	Name,

    Position with the Corporation and Municipality of Residence 	Director/Officer

    Since	Principal
    Occupation(s)	Number
    of Shares 

Beneficially Owned,

    Directly or Indirectly or

    Over Which Control or

    Direction is Exercised
	
    Stephen Hurst(1)

    Director

    Reno, Nevada, USA 
	February, 2020	
    Co-Chief Executive Officer of MindMed (2020-2021),
    Co-founder & CEO of Savant HWP, Inc. (2009-2019)

     
	
    520,643 Multiple

    Voting Shares(2)

    (12.80%)



	
    Bruce Linton(3)(4)

    Director

    Ottawa, Ontario, Canada
	February, 2020	
    Director, Co-Chairman and former Chief Executive
    Officer of Martello Technologies Group Inc. (2007 – Present); Chief Executive Officer of Canopy Growth Corporation (2014 –
    2019); Executive Chairman of Vireo Health International (November 2019 – Present); Executive Chairman of Gage Cannabis (November 2019
    – Present); CEO and Chairman of the Board of Collective Growth Corporation (May 2020 to Present)

     
	


10,200,000 Subordinate Voting Shares(5)

(2.51%)



	
    Perry Dellelce(3)(4)

    Chair of the Board and Director

    Toronto, Ontario, Canada

     
	February, 2020	Managing Partner of Wildeboer Dellelce LLP (1993 – Present)	
    6,895,744 Subordinate Voting Shares

    (1.70%)(6)



	
    Brigid Makes(3)(4)

    Director

    Foster City, California, USA
	February, 2020	Consultant (2017 - Present); Senior Vice President and Chief Financial Officer of Miramar Labs (2011 - 2017) Director and Auditor of Aziyo Biologics (2020 - Present)

                                                                                 
	
    172 Multiple Voting

    Shares

    (0.00%)



	
    Robert Barrow

    Chief Development Officer

    Madison, Wisconsin, USA
	February, 2021	
    Chief Development Officer of the Corporation (2021
    – Present); Director of Drug Development of Promega Corporation (2019 – 2020)

    Founder and Owner of Jasper Biopharmaceutical Advisors
    LLC (2018 - Present)

    Chief Financial Officer of Olatec Therapeutics
    LLC (2009 – 2018)

     
	
    Nil

     

     

	
    Daniel R. Karlin

    Chief Medical Officer

    New York, New York, USA
	February, 2021	Chief Medical Officer of the Corporation (2021 – Present); Chief Executive Officer and co-Founder of HealthMode, Inc. (2018-2021)

                                                                                 
	21,569 Multiple Voting Shares

                                                                                (0.53%) 

	
    Bradford Cross

    Chief Technology Officer

    Walnut Creek, California, USA
	February, 2021	Chief Technology Officer of the Corporation (2021 – Present); Director and co-Founder of HealthMode, Inc. (2017-2021)	21,569 Multiple Voting Shares

                                                                                (0.53%)



 


Notes:


		(1)	Member of the Technology, Evaluation,
Acquisition and Scientific Integrity Committee. Ms. Wernli is the Chair.






		(2)	Mr. Hurst controls 488,425 Multiple Voting Shares through Savant and
32,218 Multiple Voting Shares through Sunray Asset Management.






		(3)	Member of the Audit Committee.
Ms. Makes is the Chair.






		(4)	Member of the Compensation, Nomination
and Governance Committee. Mr. Linton is the Chair.






		(5)	Mr. Linton  controls 5,000,000 Subordinate Voting Shares through The Linton Family Trust.






	(6)	Mr. Dellelce controls 6,621,041 Subordinate Voting Shares through Perry
N. Dellelce Professional Corporation.



 






    78


     


    

 


The directors of the Corporation are elected by
the shareholders at each annual general meeting and typically hold office until the next annual general meeting at which time they may
be re-elected or replaced.


 


The by-laws of the Corporation permit the Board
to appoint directors to fill any casual vacancies that may occur. Individuals appointed as directors to fill casual vacancies on the Board
hold office for the remainder of the term of the director that he or she is replacing, which is until the next annual general meeting
at which time they may be re-elected or replaced.


 


As of the date of this AIF, the directors and
executive officers, as a group, beneficially own, directly or indirectly, or exercise control or direction over, a total of 22,409,917
Subordinate Voting Shares and 598,952 Multiple Voting Shares, representing approximately 20.24% of the voting rights attached to outstanding
Shares on a non-diluted basis.


 


Corporate Cease
Trade Orders


 


To the Corporation’s knowledge, except as
disclosed herein, no director or executive officer of the Corporation is, as of the date hereof, or was within ten years before the date
hereof, a director, chief executive officer or chief financial officer of any company (including the Corporation), that:


 


		(a)	was subject to a cease trade order, an order similar to a cease trade order, or an order that denied the
relevant company access to any exemption under securities legislation, that was in effect for a period of more than 30 consecutive days
that was issued while the director or executive officer was acting in the capacity as director, chief executive officer or chief financial
officer; or



 


		(b)	was subject to a cease trade order, an order similar to a cease trade order, or an order that denied the
relevant company access to any exemption under securities legislation, that was in effect for a period of more than 30 consecutive days,
that was issued after the director or executive officer ceased to be a director, chief executive officer or chief financial officer and
which resulted from an event that occurred while that person was acting in the capacity as director, chief executive officer or chief
financial officer.



 


Mr. Guebert was the Chief Financial Officer
and Vice-President Finance of Times Three Wireless Inc. (“Times Three”) from May 2004 to June 2015. On May 6,
2014, the Alberta Securities Commission issued a cease trade order against Times Three for failing to file required annual financial statements
and related management’s discussion and analysis and officer certifications. Similar orders were issued by the British Columbia
Securities Commission on May 8, 2014, the Manitoba Securities Commission on May 14, 2014, the Ontario Securities Commission
on May 26, 2014, and the Quebec Autorité des Marchés Financiers on May 26, 2014. None of the orders have been
rescinded. On June 23, 2015, the Court of Queen’s Bench of Alberta issued a bankruptcy order adjudging Times Three to be bankrupt.


 


Mr. Guebert was the Chief Financial Officer of Clarocity Inc. (“Clarocity”) from September 2016 to April 2019.
On May 6, 2019, the Alberta Securities Commission issued a cease trade order against Clarocity for failing to file required annual
financial statements and related MD&A. Similar orders were issued by other commissions. None of the orders have been rescinded. On
June 11, 2019, the Court of Queen’s Bench of Alberta appointed a receiver and on July 19, 2019 the Court of Queen’s
Bench approved the sale of substantially all assets of Clarocity in settlement of claims from secured creditors.


 


On July 9, 2020, Lendified Holdings Inc.,
in respect of which Perry Dellelce was and remains a director, was issued a cease trade order from the Ontario Securities Commission for
failing to file audited annual financial statements of Lendified PrivCo Holding Corporation for the year ended December 31, 2019.
The audited annual financial statements were subsequently filed, and the cease trade order is no longer in effect.


 


Bankruptcies and Other Proceedings


 


Except as disclosed immediately above, to the
Corporation’s knowledge, no director or executive officer of the Corporation, or a shareholder holding a sufficient number of securities
of the Corporation to affect materially the control of the Corporation:


 






    79


     


    

 


 


		(a)	is, as of the date hereof, or has been within the ten years before the date hereof, a director or executive
officer of any company (including the Corporation) that, while that person was acting in that capacity, or within a year of that person
ceasing to act in that capacity, became bankrupt, made a proposal under any legislation relating to bankruptcy or insolvency or was subject
to or instituted any proceedings, arrangement or compromise with creditors or had a receiver, receiver manager or trustee appointed to
hold its assets; or



 


		(b)	has, within the ten years before the date hereof, become bankrupt, made a proposal under any legislation
relating to bankruptcy or insolvency, or become subject to or instituted any proceedings, arrangement or compromise with creditors, or
had a receiver, receiver manager or trustee appointed to hold the assets of the director, executive officer or shareholder.



 


Penalties or Sanctions


 


To the Corporation’s knowledge, no director
or executive officer of the Corporation, or a shareholder holding a sufficient number of securities of the Corporation to affect materially
the control of the Corporation, has been subject to:


 


		(a)	any penalties or sanctions imposed by a court relating to securities legislation or by a securities regulatory
authority or has entered into a settlement agreement with a securities regulatory authority; or



 


		(b)	any other penalties or sanctions imposed by a court or regulatory body that would likely be considered
important to a reasonable investor in making an investment decision.



 


Conflicts of Interest


 


The
directors of the Corporation are required by law to act honestly and in good faith with a view to the best interests of the Corporation
and to disclose any interests, which they may have in any project or opportunity of the Corporation. If a conflict of interest arises
at a meeting of the Board, any director in a conflict is required to disclose his or her interest and abstain from voting on such matter.
Conflicts, if any, will be subject to the procedures and remedies provided under the BCBCA.


 


Other
than disclosed herein, there are no known existing or potential conflicts of interest among the Corporation, its directors and officers
or other members of management of the Corporation or of any proposed director, officer or other member of management as a result of their
outside business interests except that certain of the directors and officers serve as directors or officers of other companies, and therefore
it is possible that a conflict may arise between their duties to the Corporation and their duties as a director or officer of such other
companies. See "Risk Factors".


 


AUDIT
COMMITTEE DISCLOSURE


 


Audit Committee Charter


 


The
Audit Committee has adopted a written charter setting out its mandate and responsibilities. The Audit Committee is responsible for assisting
the Board in fulfilling its oversight responsibilities relating to financial accounting and reporting processes and internal controls.
The Audit Committee’s primary duties and responsibilities are to: (i) recommend to the Board the appointment and compensation
of the Corporation’s external auditor; (ii) oversee the work of the external auditor, including the resolution of disagreements
between the external auditor and management; (iii) pre-approve all non-audit services (or delegating such pre-approval if and to
the extent permitted by law) to be provided to the Corporation by the Corporation’s external auditor; (iv) satisfy themselves
that adequate procedures are in place for the review of the Corporation’s public disclosure of financial information, other than
those described in (vii) below, extracted or derived from its financial statements, including periodically assessing the adequacy
of such procedures; (v) establish procedures for the receipt, retention and treatment of complaints received by the Corporation regarding
accounting, internal controls or auditing matters, and for the confidential, anonymous submission by employees of the Corporation of concerns
regarding questionable accounting or auditing matters; (vi) review and approve any proposed hiring of current or former partners
or employees of the current and former auditor of the Corporation; and (vii) review and approve the annual and interim financial
statements, related MD&A and other financial information provided by the Corporation to any governmental body or the public. The Audit
Committee is responsible for inquiring of management and the external auditors about significant risks or exposures, both internal and
external to which the Corporation may be subject and assessing the steps management has taken to minimize such risks. The Audit Committee
is also responsible for establishing and implementing procedures in respect of complaints and submissions relating to accounting matters
and the approval of non-audit services by the external auditors.


 






    80


     


    

 


The Charter of the Corporation’s Audit Committee
is set forth in Appendix “A” attached hereto.


 


Composition of the Audit Committee


 


The
Audit Committee has been constituted to oversee the financial reporting processes of the Corporation and is comprised of three independent
directors; namely Brigid Makes (Chair), Bruce Linton, and Perry Dellelce. Each member of the Audit Committee is financially literate and
possesses extensive financial knowledge, experience and comprehension of financial statements. All of the Audit Committee members
have experience in financial matters; each has an understanding of accounting principles used to prepare financial statements and varied
experience as to the general application of such accounting principles, as well as the internal controls and procedures necessary for
financial reporting, garnered from working in their individual fields.


 


Relevant Education and Experience


 


Each member of the Audit Committee has experience
relevant to his or her responsibilities as an Audit Committee member.


 


Brigid
Makes (Chair) Ms. Makes has served as an independent consultant for medical device and healthcare companies since
July 2017, specifically advising on finance, accounting strategy and funding responsibilities. From September 2011 to July 2017,
Ms. Makes served as Senior Vice President and Chief Financial Officer of Miramar Labs, Inc., a biotechnology company focused
on aesthetics and dermatology. From 2006 to 2011, Ms. Makes served as Senior Vice President and Chief Financial Officer of AGA Medical
Corp, a leader in developing interventional devices for the minimally invasive treatment of structural heart defects and peripheral vascular
disorders. Prior to AGA, Ms. Makes held various positions at Nektar Therapeutics Inc. from 1999 to 2006, including serving as Chief
Financial Officer. Since September 2020, Ms. Makes has also been a member of the board of directors of Aziyo Biologics Inc.,
a publicly traded commercial-stage regenerative medicine company, where Ms. Makes serves as chair on the Audit Committee and the
Nominating/Governance Committee. Ms. Makes holds an M.B.A. from Bentley University and a Bachelor of Commerce degree in Finance &
International Business from McGill University.


 


Bruce
Linton (Member) Bruce has extensive experience with the reporting requirements of Canadian public companies through his
various positions with Canadian public companies. Bruce currently holds the positions of Chairman and CEO of Collective Growth Corporation;
a special acquisition purpose company which went public on the NASDAQ exchange on May 1, 2020. Bruce is Executive Chairman for Gage
Cannabis Co., Chairman of the Advisory Board for Red Light Holland Corp., is Non-Executive Chairman of Óskare Capital, and on the
board of directors of the Canadian Olympic Foundation, and is an active investor with Slang Worldwide Inc and with OG DNA Genetics Inc.
He is the Founder and former Chairman and CEO of Canopy Growth Corporation (CGC/WEED), Co-Chairman and past CEO of Martello Technologies,
and Co-founder of Ruckify. Bruce chairs the board’s Compensation, Governance and Nomination Committee.


 


Perry
Dellelce (Member) Perry is a founder and the managing partner of Wildeboer Dellelce LLP, one of Canada’s leading
corporate finance and transactional law firms. Perry practices in the areas of securities, corporate finance and mergers and acquisitions.
Perry serves on the boards of many of Canada’s leading businesses. Perry is chair of the NEO, Canada’s newest stock exchange.
He is also a member of the board of Mount Logan Capital Inc. and Lendified Inc. Perry is the past chair and a current member of the board
of directors of the Sunnybrook Foundation and the current chair of the Canadian Olympic Foundation. Perry holds an MBA degree from the
University of Notre Dame.


 


Reliance on Certain Exemptions


 


Since the commencement of the Corporation’s
most recently completed financial year, the Corporation has not relied on the exemptions contained in Sections 2.4 (De Minimis Non-Audit
Services), Subsection 3.2 (Initial Public Offerings), Subsection 3.4 (Events Outside Control of Member), Subsection 3.5 (Death, Incapacity
or Resignation) or Part 8 (Exemptions) of NI 52-110.


 






    81


     


    

 


Audit Committee Oversight


 


At no time since the commencement of the Corporation’s
most recently completed financial year was a recommendation of the Audit Committee to nominate or compensate an external auditor not adopted
by the Board.


 


Pre-Approval Policies and Procedures


 


The Audit Committee has not adopted specific policies and procedures
for the engagement of non-audit services.


 


External Auditor Service Fees


 


The aggregate fees billed and estimated to be
billed by the Corporation’s external auditors from the date of incorporation of MindMed US (May 30, 2019) to December 31,
2020 are set out in the table below.


 


	Financial Year Ending	 	 	 	Audit Fees(1)	 	 	Audit Related Fees(2)	 	 	Tax Fees(3)	 	 	All Other Fees(4)
	December 31, 2020(5)	 	 	$	US111,035	 	 	Nil	 	$	US4,826	 	 	Nil
	December 31, 2019(6)	 	 	$	US312,105	 	 	Nil	 	 	Nil	 	 	Nil



 


Notes


 


	(1)	“Audit Fees” include fees necessary to perform the annual audit and quarterly reviews of Broadway’s
financial statements. Audit Fees include fees for review of tax provisions and for accounting consultations on matters reflected in the
financial statements. Audit Fees also include audit or other attest services required by legislation or regulation, such as comfort letters,
consents, reviews of securities filings and statutory audits.
	(2)	“Audit-Related Fees” include fees for services that are traditionally performed by the auditor.
These audit-related services include employee benefit audits, due diligence assistance, accounting consultations on proposed transactions,
internal control reviews and audit or attest services not required by legislation or regulation.
	(3)	“Tax Fees” include fees for all tax services other than those included in “Audit Fees”
and “Audit-Related Fees”. This category includes fees for tax compliance, tax planning and tax advice. Tax planning and tax
advice includes assistance with tax audits and appeals, tax advice related to mergers and acquisitions, and requests for rulings or technical
advice from tax authorities.
	(4)	“All Other Fees” include all other non-audit services.
	(5)	Prior to completion of the Transaction, the external auditor for Broadway was MNP LLP. RSM was appointed
as the Corporation’s external auditors following the completion of the Transaction on February 27, 2020.
	(6)	For the financial year ending August 31, 2019, Broadway’s external auditor service fees were
as follows: (i) Audit Fees: $29,960; (ii) Audit Related Fees: $5,530; (iii) Tax Fees: $5,136; and (iv) All Other Fees:
Nil.



 


PROMOTERS


 


Each of Stephen Hurst and Jamon Alexander Rahn could be considered
persons who are “promoters” (as that term is defined in the Securities Act (Ontario)) of MindMed US, having taken initiative
in founding and organizing MindMed US. Mr. Hurst directly or indirectly has control over 520,643 Multiple Voting Shares, which represent
12.80% of the voting rights attached to outstanding securities of the Corporation as of the date hereof. Mr. Hurst is also entitled to
certain salary, bonus and consulting fees in consideration for his services to the Corporation, which fees totalled $536,670 in 2020.
Mr. Rahn beneficially owns 4,506,100 Subordinate Voting Shares and 35,000 Multiple Voting Shares, which together represent 1.97% of the
voting rights attached to outstanding securities of the Corporation as of the date hereof. Mr. Rahn also holds 47,500 May Offering Warrants
and 3,750,000 Stock Options, exercisable to purchase 3,750,000 Subordinate Voting Shares at an exercise price of $0.33 per Subordinate
Voting Share. In April, 2020, Mr. Rahn received a payment of US$175,000 for advisory services rendered to the Corporation prior to the
completion of the Transaction. Mr. Rahn is also entitled to certain salary, bonus and consulting fees in consideration for his services
to the Corporation, which fees totalled $396,858 in 2020.


 






    82


     


    

 


Each of Leonard Latchman and Scott Freeman could be considered persons
who have acted as “promoters” (as that term is defined in the Securities Act (Ontario)) of MindMed US within the two
years immediately preceding the date hereof (though each of them has since ceased acting in such capacity), having taken initiative in
the organization of MindMed US. In late 2019 and early 2020, Mr. Latchman’s involvement in the day-to-day operations of MindMed
US decreased, and his involvement ceased completely on February 27, 2020 upon completion of the Transaction. Dr. Freeman resigned in his
capacity as Chief Medical Officer on August 31, 2020. Following his resignation, Dr. Freeman has been involved with the Corporation only
on an as-needed basis as an advisor for clinical strategy. Neither Mr. Latchman nor Dr. Freeman is currently involved in the Corporation’s
business in a significant capacity, and neither is involved in any respect in the governance or management of the Corporation. To the
knowledge of the Corporation, Mr. Latchman beneficially owns 13,220,000 Subordinate Voting Shares, which represents 3.25% of the voting
rights attached to outstanding securities of the Corporation as of the date hereof. Between January and April, 2020, Mr. Latchman received
payments totalling US$275,000 for advisory services rendered to the Corporation prior to the completion of the Transaction. To the knowledge
of the Corporation, Dr. Freeman indirectly has control over 29,083.99 Multiple Voting Shares, which represent 0.72% of the voting rights
attached to outstanding securities of the Corporation as of the date hereof.


 


LEGAL PROCEEDINGS AND REGULATORY ACTIONS


 


There are no legal proceedings or regulatory actions
to which the Corporation or its subsidiaries or properties are or were subject to, during the most recently completed financial year ended
December 31, 2020.


 


INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL
TRANSACTIONS


 


Other than as disclosed elsewhere in this AIF
and in the Corporation’s financial statements, no director, executive officer or principal shareholder of the Corporation, or any
associate or affiliate of the foregoing, has had any material interest, direct or indirect, in any transaction within the three most recently
completed financial years or during the current financial year prior to the date of this AIF that has materially affected or will materially
affect the Corporation.


 


TRANSFER AGENT AND REGISTRAR


 


The transfer agent and registrar for the Shares
is Odyssey Trust Company at its principal office in Vancouver, British Columbia.


 


MATERIAL CONTRACTS


 


The only material contracts entered into by MindMed,
other than in the ordinary course of business, since the date of incorporation are as follows:


 


		(a)	Foundational Agreement;



 


		(b)	Arrangement Agreement;



 


		(c)	May Underwriting Agreement;



 


		(d)	October Underwriting Agreement;



 


		(e)	December Underwriting Agreement; and



 


		(f)	January Underwriting Agreement.



 


INTERESTS OF EXPERTS


 


The Corporation’s independent auditor is
RSM at its office located at 700-11 King Street West, Toronto, Ontario M5H 4C7. RSM is independent with respect to the Corporation within
the meaning of the relevant rules and related interpretations prescribed by the relevant professional bodies in Canada and any applicable
legislation or regulation.


 


The former independent auditor of the Corporation
(previously existing as Broadway) was MNP LLP at its office located at 2200-1021 Hastings Street West, Vancouver, British Columbia V6E
0C3. MNP LLP was independent to the Corporation (previously existing as Broadway) within the meaning of the relevant rules and related
interpretations prescribed by the relevant professional bodies in Canada and any applicable legislation or regulation.


 






    83


     


    

 


None of the aforementioned firms or persons, nor
any directors, officers or employees of such firms, are currently expected to be elected, appointed or employed as a director, officer
or employee of the Corporation or of any associate or affiliate of the Corporation.


 


ADDITIONAL INFORMATION


 


Additional
information relating to the Corporation is available on SEDAR at www.sedar.com and on the Corporation’s website at www.mindmed.co.
Additional information, including information concerning directors’ and officers’ remuneration and indebtedness, principal
holders of the Corporation’s securities and securities authorized for issuance under equity compensation plans, where applicable,
will be contained in the management proxy circular of the Corporation for its annual shareholders’ meeting to be held in 2021.


 


Additional financial information is contained
in the Corporation’s audited financial statements and MD&A for the most recently completed financial year, copies of which have
been filed with the securities regulatory authorities in the provinces of Alberta, British Columbia, Ontario, Saskatchewan, Manitoba,
New Brunswick, Nova Scotia, Prince Edward Island and Newfoundland. Such documents, as well as additional information about the Corporation,
may be found under the Corporation’s issuer profile on SEDAR at www.sedar.com.


 






    84


     


    

 


Appendix “A”–
AUDIT COMMITTEE CHARTER OF MIND MEDICINE (MINDMED) inc.


 


		A.	PURPOSE



 


The audit committee (the “Audit
Committee”) is a committee of the board of directors (the “Board”) of Mind Medicine (MindMed) Inc. (the “Corporation”).
The primary function of the Audit Committee is to assist the directors of the Corporation in fulfilling their applicable roles by:


 


(a)            recommending
to the Board the appointment and compensation of the Corporation’s external auditor;


 


(b)           overseeing
the work of the external auditor, including the resolution of disagreements between the external auditor and management;


 


(c)            pre-approving
all non-audit services (or delegating such pre-approval if and to the extent permitted by law) to be provided to the Corporation by the
Corporation’s external auditor;


 


(d)           satisfying
themselves that adequate procedures are in place for the review of the Corporation’s public disclosure of financial information,
other than those described in (g) below, extracted or derived from its financial statements, including periodically assessing the
adequacy of such procedures;


 


(e)           establishing
procedures for the receipt, retention and treatment of complaints received by the Corporation regarding accounting, internal controls
or auditing matters, and for the confidential, anonymous submission by employees of the Corporation of concerns regarding questionable
accounting or auditing matters;


 


(f)            reviewing
and approving any proposed hiring of current or former partners or employees of the current and former auditor of the Corporation; and


 


(g)           reviewing
and approving the annual and interim financial statements, related Management Discussion and Analysis (“MD&A”)
and other financial information provided by the Corporation to any governmental body or the public.


 


The Audit Committee should
primarily fulfill these roles by carrying out the activities enumerated in this Charter. However, it is not the duty of the Audit Committee
to prepare financial statements, to plan or conduct internal or external audits, to determine that the financial statements are complete
and accurate and are in accordance with Canadian generally accepted accounting principles, to conduct investigations, or to assure compliance
with laws and regulations or the Corporation’s internal policies, procedures and controls, as these are the responsibility of management,
and in certain cases, the external auditor.


 


		B.	LIMITATIONS ON AUDIT COMMITTEE’S DUTIES



 


In contributing to the Audit
Committee’s discharge of its duties under this Charter, each member of the Audit Committee shall be obliged only to exercise the
care, diligence and skill that a reasonably prudent person would exercise in comparable circumstances. Nothing in this Charter is intended
to be, or may be construed as, imposing on any members of the Audit Committee a standard of care or diligence that is in any way more
onerous or extensive than the standard to which the directors are subject.


 


Members of the Audit Committee
are entitled to rely, absent actual knowledge to the contrary, on: (i) the integrity of the persons and organizations from whom they
receive information, (ii) the accuracy and completeness of the information provided, (iii) representations made by management
as to the non-audit services provided to the Corporation by the external auditor, (iv) financial statements of the Corporation represented
to them by a member of management or in a written report of the external auditors to present fairly the financial position of the Corporation
in accordance with generally accepted accounting principles, and (v) any report of a lawyer, accountant, engineer, appraiser or other
person whose profession lends credibility to a statement made by any such person.


 






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		C.	COMPOSITION AND MEETINGS



 


The Audit Committee should
be comprised of not less than three directors as determined by the Board, all of whom shall be independent within the meaning of National
Instrument 52-110 – Audit Committees (“52-110”) of the Canadian Securities Administrators, and free of
any relationship that, in the opinion of the Board, would interfere with the exercise of his or her independent judgment as a member of
the Audit Committee, unless an exemption from such independence requirement is available to the Corporation under 52-110. All members
of the Audit Committee should have (or should gain within a reasonable period of time after appointment) a working familiarity with basic
finance and accounting practices. At least one member of the Audit Committee should have accounting or related financial management expertise
and be considered a financial expert. Each member should be “financially literate” within the meaning of 52-110. The Audit
Committee members may enhance their familiarity with finance and accounting by participating in educational programs conducted by the
Corporation or an outside consultant.


 


The members of the Audit Committee
shall be elected by the Board on an annual basis or until their successors shall be duly appointed. Unless a Chair of the Audit Committee
(the “Chair”) is elected by the full Board, the members of the Audit Committee may designate a Chair by majority vote
of the full Audit Committee membership.


 


In addition, the Audit Committee
members should meet all of the requirements for members of audit committees as defined from time to time under applicable legislation
and the rules of any stock exchange on which the Corporation’s securities are listed or traded.


 


The Audit Committee should
meet at least four times annually, or more frequently as circumstances require. The Audit Committee should meet within forty-five (45)
days following the end of the first three financial quarters to review and discuss the unaudited financial results for the preceding quarter
and the related MD&A, and should meet within 90 days following the end of the fiscal year end to review and discuss the audited financial
results for the preceding quarter and year and the related MD&A.


 


The Audit Committee may ask
members of management or others to attend meetings and provide pertinent information as necessary. For purposes of performing their duties,
members of the Audit Committee shall have full access to all corporate information and any other information deemed appropriate by them,
and shall be permitted to discuss such information and any other matters relating to the financial position of the Corporation with senior
employees, officers and the external auditor of the Corporation, and others as they consider appropriate.


 


For greater certainty, management
is indirectly accountable to the Audit Committee and is responsible for the timeliness and integrity of the financial reporting and information
presented to the Board.


 


In order to foster open communication,
the Audit Committee or its Chair should meet at least annually with management and the external auditor in separate sessions to discuss
any matters that the Audit Committee or each of these groups believes should be discussed privately. In addition, the Audit Committee
or its Chair should meet with management quarterly in connection with the Corporation’s interim financial statements.


 


A quorum for the transaction
of business at any meeting of the Audit Committee shall be a majority of the number of members of the Audit Committee or such greater
number as the Audit Committee shall by resolution determine.


 


Meetings of the Audit Committee
shall be held from time to time and at such place as any member of the Audit Committee shall determine upon 48 hours’ notice to
each of its members. The notice period may be waived by all members of the Audit Committee. Each of the Chair of the Board, the external
auditor, the Chief Executive Officer, the Chief Financial Officer or the Secretary shall be entitled to request that any member of the
Audit Committee call a meeting. This Charter is subject in all respects to the Corporation’s articles of incorporation and by-laws
from time to time.


 






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		D.	ROLE



 


As part of its function in
assisting the Board in fulfilling its oversight role (and without limiting the generality of the Audit Committee’s role), the Audit
Committee should:


 


		(1)	Determine any desired agenda items.



 


		(2)	Review and recommend to the Board changes to this Charter, as
considered appropriate from time to time.



 


		(3)	Review the public disclosure regarding the Audit Committee required
by 52-110



 


		(4)	Review and seek to ensure that disclosure controls and procedures
and internal controls over financial reporting frameworks are operational and functional.



 


		(5)	Summarize in the Corporation’s annual information form
the Audit Committee’s composition and activities, as required.



 


		(6)	Submit the minutes of all meetings of the Audit Committee to
the Board upon request.



 


Documents / Reports Review


 


		(7)	Review and recommend to the Board for approval the Corporation’s
annual and interim financial statements, including any certification, report, opinion, undertaking or review rendered by the external
auditor and the related MD&A, as well as such other financial information of the Corporation provided to the public or any governmental
body as the Audit Committee or the Board require.



 


		(8)	Review other financial information provided to any governmental
body or the public as they see fit.



 


		(9)	Review, recommend and approve any of the Corporation’s
press releases that contain financial information.



 


		(10)	Seek to satisfy itself and ensure that adequate procedures are
in place for the review of the Corporation’s public disclosure of financial information extracted or derived from the Corporation’s
financial statements and related MD&A and periodically assess the adequacy of those procedures.



 


External Auditor


 


		(11)	Recommend to the Board the selection of the external auditor,
considering independence and effectiveness, and review the fees and other compensation to be paid to the external auditor.



 


		(12)	Review and seek to ensure that all financial information provided
to the public or any governmental body, as required, provides for the fair presentation of the Corporation’s financial condition,
financial performance and cash flow.



 


		(13)	Instruct the external auditor that its ultimate client is not
management and that it is required to report directly to the Audit Committee, and not management.



 


		(14)	Monitor the relationship between management and the external
auditor including reviewing any management letters or other reports of the external auditor and discussing any material differences of
opinion between management and the external auditor.



 


		(15)	Review and discuss, on an annual basis, with the external auditor
all significant relationships it has with the Corporation to determine the external auditor’s independence.



 


		(16)	Pre-approve all non-audit services (or delegate such pre-approval,
as the Audit Committee may determine and as permitted by applicable Canadian securities laws) to be provided by the external auditor.



 






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		(17)	Review the performance of the external auditor and any proposed
discharge of the external auditor when circumstances warrant.



 


		(18)	Periodically consult with the external auditor without management
present about significant risks or exposures, internal controls and other steps that management has taken to control such risks, and
the fullness and accuracy of the financial statements, including the adequacy of internal controls to expose any payments, transactions
or procedures that might be deemed illegal or otherwise improper.



 


		(19)	Communicate directly with the external auditor and arrange for
the external auditor to be available to the Audit Committee and the full Board as needed.



 


		(20)	Review and approve any proposed hiring by the Corporation of
current or former partners or employees of the current (and any former) external auditor of the Corporation.



 


Audit Process


 


		(21)	Review the scope, plan and results of the external auditor’s
audit and reviews, including the auditor’s engagement letter, the post-audit management letter, if any, and the form of the audit
report. The Audit Committee may authorize the external auditor to perform supplemental reviews, audits or other work as deemed desirable.



 


		(22)	Following completion of the annual audit and quarterly reviews,
review separately with each of management and the external auditor any significant changes to planned procedures, any difficulties encountered
during the course of the audit and, if applicable, reviews, including any restrictions on the scope of work or access to required information
and the cooperation that the external auditor received during the course of the audit and, if applicable, reviews.



 


		(23)	Review any significant disagreements between management and
the external auditor in connection with the preparation of the financial statements.



 


		(24)	Where there are significant unsettled issues between management
and the external auditor that do not affect the audited financial statements, the Audit Committee shall seek to ensure that there is
an agreed course of action leading to the resolution of such matters.



 


Financial Reporting Processes


 


		(25)	Review the integrity of the financial reporting processes, both
internal and external, in consultation with the external auditor as they see fit.



 


		(26)	Consider the external auditor’s judgments about the quality,
transparency and appropriateness, not just the acceptability, of the Corporation’s accounting principles and financial disclosure
practices, as applied in its financial reporting, including the degree of aggressiveness or conservatism of its accounting principles
and underlying estimates, and whether those principles are common practices or are minority practices.



 


		(27)	Review all material balance sheet issues, material contingent
obligations (including those associated with material acquisitions or dispositions) and material related party transactions.



 


		(28)	Review with management and the external auditor the Corporation’s
accounting policies and any changes that are proposed to be made thereto, including all critical accounting policies and practices used,
any alternative treatments of financial information that have been discussed with management, the ramification of their use and the external
auditor’s preferred treatment and any other material communications with management with respect thereto.



 


		(29)	Review the disclosure and impact of contingencies and the reasonableness of the provisions, reserves and
estimates that may have a material impact on financial reporting.



 






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		(30)	If considered appropriate, establish separate systems of reporting to the Audit Committee by each of management
and the external auditor.



 


		(31)	Periodically consider the need for an internal audit function,
if not present. Risk Management



 


		(32)	Review program of risk assessment and steps taken to address significant risks or exposures of all types,
including insurance coverage and tax compliance.



 


General


 


		(33)	With prior Board approval, the Audit Committee may at its discretion retain independent counsel, accountants
and other professionals to assist it in the conduct of its activities and to set and pay (as an expense of the Corporation) the compensation
for any such advisors.



 


		(34)	Respond to requests by the Board with respect to the functions and activities that the Board requests
the Audit Committee to perform.



 


		(35)	Periodically review this Charter and, if the Audit Committee deems appropriate, recommend to the Board
changes to this Charter.



 


		(36)	Review the public disclosure regarding the Audit Committee required from time to time by applicable Canadian
securities laws, including:



 


		(i)	the Charter of the Audit Committee;



 


		(ii)	the composition of the Audit Committee;



 


		(iii)	the relevant education and experience of each member of the
Audit Committee;



 


		(iv)	the external auditor services and fees; and



 


		(v)	such other matters as the Corporation is required to disclose
concerning the Audit Committee.



 


		(37)	Review in advance, and approve, the hiring and appointment of the Corporation’s senior financial
executives by the Corporation, if any.



 


		(38)	Perform any other activities as the Audit Committee deems necessary or appropriate including ensuring
all regulatory documents are compiled to meet Committee reporting obligations under 52-110.



 


		E.	AUDIT COMMITTEE COMPLAINT PROCEDURES



 


Submitting a Complaint


 


		(39)	Anyone may submit a complaint regarding conduct by the Corporation or its employees or agents (including
its independent auditors) reasonably believed to involve questionable accounting, internal accounting controls or auditing matters. The
Chair should oversee treatment of such complaints.



 


Procedures


 


		(40)	The Chair will be responsible for the receipt and administration
of employee complaints.



 


		(41)	In order to preserve anonymity when submitting a complaint regarding
questionable accounting or auditing matters, the employee may submit a complaint confidentially.



 


Investigation


 


		(42)	The Chair should review and investigate the complaint. Corrective
action will be taken when and as warranted in the Chair’s discretion.



 






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Confidentiality


 


		(43)	The identity of the complainant and the details of the investigation
should be kept confidential throughout the investigatory process.



 


Records and Report


 


		(44)	The Chair should maintain a log of complaints, tracking their
receipt, investigation, findings and resolution, and should prepare a summary report for the Audit Committee.



 


The Audit Committee
is a committee of the Board and is not and shall not be deemed to be an agent of the Corporation’s securityholders for any purpose
whatsoever. The Board may, from time to time, permit departures from the terms hereof, either prospectively or retrospectively, and no
provision contained herein is intended to give rise to civil liability to securityholders of the Corporation or other liability whatsoever.


 






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