Document:

EX-10.1

 

 Exhibit 10.1 Peak Bio Corporate Presentation Ladenburg Thalmann Investor
Conference-September 2022 Confidential 1

 

 Disclaimer This confidential presentation (the
“presentation”) is being delivered to you by Peak Bio (the “Company”) for use in connection with a proposed business combination with Ignyte Acquisition Corp. (“Ignyte”) and the related transactions contemplated
thereby (collectively, the “Business Combination”). This presentation is for informational purposes only and is being provided to you solely in your capacity as a potential investor in considering an investment in the Company. Any
reproduction or distribution of this presentation, in whole or in part, or the disclosure of its contents, without the prior consent of the Company is prohibited. By accepting this presentation, each recipient and its directors, partners, officers,
employees, attorney(s), agents and representatives (“recipient”) agrees: (i) to maintain the confidentiality of all information that is contained in this presentation and not already in the public domain; and(ii) to return or destroy all
copies of this presentation or portions thereof in its possession following the request for the return or destruction of such copies. This presentation and any oral statements made in connection with this presentation shall neither constitute an
offer to sell nor the solicitation of an offer to buy any securities, or the solicitation of any proxy, vote, consent or approval in any jurisdiction in connection with the proposed business combination, nor shall there be any sale of securities in
any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdictions. This communication is restricted by law; it is not intended for distribution
to, or use by any person in, any jurisdiction where such distribution or use would be contrary to local law or regulation. No Representations and Warranties This presentation is for informational purposes only and does not purport to contain all of
the information that may be required to evaluate a possible investment decision with respect to the Company. The recipient agrees and acknowledges that this presentation is not intended to form the basis of any investment decision by the recipient
and does not constitute investment, tax or legal advice. No representation or warranty, express or implied, is or will be given by the Company or any of their respective affiliates, directors, officers, employees or advisers or any other person as
to the accuracy or completeness of the information in this presentation or any other written, oral or other communications transmitted or otherwise made available to any party in the course of its evaluation of a possible Transaction and no
responsibility or liability whatsoever is accepted for the accuracy or sufficiency thereof or for any errors, omissions or misstatements, negligent or otherwise, relating thereto. The recipient also acknowledges and agrees that the information
contained in this presentation is preliminary in nature and is subject to change, and any such changes may be material. The Company disclaims any duty to update the information contained in this presentation. Forward-Looking Statements This
presentation includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1996. Actual results may differ from their expectations, estimates and
projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect”, “estimate”, “project”, “budget”, “forecast”,
“anticipate”, “intend”, “plan”, “may”, “will”, “could”, “should”, “believes”, “predicts”, “potential”, “continue”,
and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to future performance and anticipated financial impacts of
the Transaction, the satisfaction of closing conditions to the Transaction and the timing of the completion of the Transaction. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to
differ materially from the expected results. There will be risks and uncertainties described in certain filings made with the Securities and Exchange Commission (the “SEC”) regarding the Transaction. These filings will identify and
address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward looking statements. Most of these factors are outside the Company’s control and are difficult
to predict. Factors that may cause such differences include, but are not limited to: (1) the outcome of any legal proceedings that may be instituted against the Company following the announcement of the Business Combination; (2) the inability to
complete the Business Combination, including due to the inability to concurrently close any private placement of common stock or due to failure to obtain required approval for the Business Combination; (3) delays in obtaining, adverse conditions
contained in, or the inability to obtain any necessary regulatory approvals or complete regular reviews required to complete the Business Combination; (4) the risk that the Business Combination disrupts current plans and operations as a result of
the announcement and consummation of the Business Combination; (5) the inability to recognize the anticipated benefits of the Business Combination, which may be affected by, among other things, competition, the ability of the combined company to
grow and manage growth profitably, maintain relationships with customers and suppliers and retain its key employees; (6) costs related to the Business Combination; (7) changes in the applicable laws or regulations; (8) the possibility that the
combined company may be adversely affected by other economic, business, and/or competitive factors; (9) the impact of the global COVID-19 pandemic; and (10) other risks and uncertainties indicated from time to time described in filings with the SEC.
The Company cautions that the foregoing list of factors is not exclusive and not to place undue reliance upon any forward-looking statements, including projections, which speak only as of the date made. The Company neither undertakes nor accepts any
obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. 2

 

 Disclaimer Industry and Market Data In this presentation, the Company
relies on and refers to publicly available information and statistics regarding market participants in the sectors in which the Company competes and other industry data. Any comparison of the Company to the industry or to any of its competitors is
based on this publicly available information and statistics and such comparisons assume the reliability of the information available to the Company. The Company obtained such information and statistics from third-party sources, including reports by
market research firms and company filings. While the Company believes such third-party information is reliable, there can be no assurance as to the accuracy or completeness of the indicated information. The Company has not independently verified the
information provided by the third-party sources. Trademarks This presentation may contain trademarks, service marks, trade names and copyrights of other companies, which are the property of their respective owners. Solely for convenience, some of
the trademarks, service marks, trade names and copyrights referred to in this presentation may be listed without the TM, SM © or ® symbols, but the Company will assert, to the fullest extent under applicable law, the rights of the
applicable owners, if any, to these trademarks, service marks, trade names and copyrights. Private Placement Any securities to which this presentation relates have not been registered with the SEC under the Securities Act of 1933, as amended (the
“Securities Act”), or the securities laws of any other jurisdiction. This presentation relates to securities that may be offered in reliance on exemptions from the registration requirements of the Securities Act and other applicable
laws. These exemptions apply to offers and sales of securities that do not involve a public offering. Resales of the securities will be prohibited except pursuant to an exemption from the registration requirements under the Securities Act or until
the securities are registered with the SEC. The securities have not been approved or recommended by any federal, state or foreign securities authorities, nor have any of these authorities passed upon the merits of this offering or determined that
this presentation is accurate or complete. Any representation to the contrary is a criminal offense. Financial and Other Information The financial information contained in this presentation has been taken from or prepared based on the historical
financial statements of the Company or its predecessors for the periods presented. An audit of these financial statements is in process. Accordingly, such financial information and data may not be included in, may be adjusted in or may be presented
differently in any registration statement to be filed with the SEC in connection with the Transaction. This information is preliminary and subject to change. As such, the Company’s actual results may differ from the estimated preliminary
results presented here and will not be finalized until the Company completes its year- end accounting procedures. Use of Projections This presentation also contains certain financial forecasts. The Company’s independent auditors have not
studied, reviewed, compiled or performed any procedures with respect to the projections for the purpose of their inclusion in this presentation, and accordingly, neither of them expressed an opinion or provided any other form of assurance with
respect thereto for the purpose of this presentation. These projections are for illustrative purposes only and should not be relied upon as being necessarily indicative of future results. The assumptions and estimates underlying the prospective
financial information are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the prospective
financial information. Projections are inherently uncertain due to a number of factors outside of the Company’s control. While all financial projections, estimates and targets are necessarily speculative, the Company believes that the
preparation of prospective financial information involves increasingly higher levels of uncertainty the further out the projection, estimate or target extends from the date of preparation. Accordingly, there can be no assurance that the prospective
results are indicative of future performance of the combined company after the Transaction or that actual results will not differ materially from those presented in the prospective financial information. Inclusion of the prospective financial
information in this presentation should not be regarded as a representation by any person that the results contained in the prospective financial information will be achieved. 3

 

 Risk Factors The risks presented below are certain of the general risks
related to the Company, Ignyte and the proposed Business Combination and such list is not exhaustive. The list below has been prepared solely for the purposes of the Business Combination and not for any other purposes. You should carefully consider
these risks and uncertainties and should carry out your own diligence and consult with your own financial and legal advisors concerning the risks and suitability of an investment in the Transaction before making an investment decision. Risks
relating to the business of the Company will be disclosed in future documents filed or furnished by the Company and Ignyte with the SEC, including the documents filed or furnished in connection with the Business Combination. The risks presented in
such filings will be consistent with those that would be required for a public company in its SEC filings, including with respect to the business and securities of the Company and Ignyte and the Business Combination, and may differ significantly
from, and be more exhaustive than, those presented below. All references to “we,” “us” or “our” refer to the business of the Company. Competitive and Business Risks ▪ We have incurred and expect to continue
to incur operating losses and may not establish and maintain profitability. ▪ We are a global company and are subject to the risks and uncertainties of conducting business outside the United States. While international expansion is one of our
growth objectives, we may not be able to materialize available growth opportunities or guarantee that we will successfully integrate those opportunities into our existing business. ▪ The success of our business is highly dependent on the
existence and maintenance of intellectual property rights in the products and services we create. ▪ If we fail to maintain, protect or enforce our intellectual property rights, the value of our brand and other intangible assets may be
diminished, and our business, results of operations, financial condition and prospectus could be negatively impacted. ▪ In order to support the growth of our business, we may need to seek capital through new equity or debt financings, and such
sources of additional capital may not be available to us or on acceptable terms or at all. ▪ We may enter into collaborations, joint ventures, strategic alliances or partnerships with third parties that may not result in the development of
commercially viable solutions or the generation of significant future revenues. ▪ We operate in highly competitive markets and face competition from large, well-established healthcare and pharmaceutical providers with significant resources,
and, as a result, we may not be able to compete effectively. If we are unable to compete effectively, we will not be able to establish our products and services in the marketplace, and as a result, our business may not be profitable. ▪ We are
dependent on our ability to recruit, retain and develop a large, highly skilled and diverse workforce. We must evolve our culture in order to successfully grow our business. ▪ We are substantially dependent on the success of our product
candidates and cannot guarantee that any of our product candidates will successfully complete any planned or ongoing clinical trials, receive regulatory approval, or be successfully commercialized. ▪ We may expend our limited resources to
pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success. ▪ Our future growth may depend on our ability to
identify and develop product candidates and if we do not successfully identify and develop product candidates or integrate them into our operations, we may have limited growth opportunities. ▪ If we cannot demonstrate an acceptable safety and
toxicity profile for our product candidates, we will not be able to continue our clinical trials of or obtain approval for those product candidates. ▪ Changes in product candidate manufacturing or formulation may result in additional costs or
delay. ▪ We may be sued for infringing the intellectual property rights of others. ▪ We face significant competition from other pharmaceutical and biotechnology companies, academic institutions, government agencies, and other research
organizations. Our operating results will suffer if we fail to compete effectively. ▪ If any of our current or future product candidates do not achieve broad market acceptance, the revenues that we generate from their sales will be limited.
▪ It is difficult and costly to protect our proprietary rights and as a result we may not be able to ensure their protection. In addition, patents have a limited lifespan and will eventually expire. ▪ We may be unable to adequately
prevent disclosure of trade secrets and other proprietary information. Global Market Risks • Our business may be adversely affected by geopolitical and other risks associated with operations outside of the U.S. and, as we continue to expand
internationally, we may incur higher than anticipated costs and may become more susceptible to these risks. • Our business may be adversely impacted by U.S. and global market and economic conditions. • Potential tariffs or trade wars
could increase the cost of our products, which could adversely impact the competitiveness of our products and our financial results. • We face certain challenges and risks to our international business that may adversely affect our strategy.
• We incur risks related to our international business due to currency exchange rate fluctuations that could impact our financial results and financial position. 4

 

 Risk Factors Regulatory and Compliance Risks • If safety and
efficacy data for our product candidates, a reference drug, or published literature does not satisfactorily demonstrate safety and efficacy to the FDA or EMEA, or if the FDA, EMEA and other regulators do not permit us to rely on the data of a
reference drug or published literature, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates. • The regulatory approval processes
of the FDA and comparable foreign authorities are lengthy, time consuming, and inherently unpredictable. If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our
product candidates as expected, and our ability to generate revenue will be materially impaired. • Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad. • The
FDA or EMEA may determine that any of our current or future product candidates have undesirable side effects that could delay or prevent their regulatory approval or commercialization. • If we experience delays or difficulties in the
enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented. • Regulatory approval is limited by the FDA or comparable foreign regulatory authorities to those specific indications and
conditions for which clinical safety and efficacy have been demonstrated, and we may be subject to fines, penalties, injunctions, or other enforcement actions if we are determined to be promoting the use of our products for unapproved or
“off-label” uses, resulting in damage to our reputation and business. • We are, and if any of our product candidates receive regulatory approval, will continue to be subject to ongoing obligations and continued regulatory review,
which may result in significant additional expense. Additionally, any of our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with
regulatory requirements or experience unanticipated problems with our products. • If we or third parties with whom we partner or contract fail to comply with applicable laws and regulations, we could be subject to liability and our business
could be harmed. • Changes in laws or regulations, or a failure to comply with any laws and regulations, may adversely affect our business and results of operations. • We could be subject to challenges by U.S. and foreign tax authorities
that could result in additional taxes and penalties. • Tax changes, including tax reform in the United States, could affect the Company’s effective tax rate and future profitability. Post-Business Combination Risks ▪ If the
benefits of the Business Combination do not meet the expectations of investors or securities analysts, the market price of the Company’s common stock may decline. ▪ An active trading market for the Company’s shares of commons stock
may not be available on a consistent basis to provide stockholders with adequate liquidity. The stock price may be volatile, and the stockholders could lose a significant part of their investment. ▪ There can be no assurance that the common
stock issued in connection with the Business Combination will be approved for listing on Nasdaq following the closing, or that we will be able to comply with the continued listing standards of Nasdaq. ▪ The Company has broad discretion in how
it uses the net proceeds from the Business Combination and the Company may not use them effectively. ▪ The Company may be subject to securities litigation, which is expensive and could divert management attention. ▪ Because the Company
has no current plans to pay cash dividends for the foreseeable future, you may not receive any return on investment unless you sell your shares for a price greater that which you paid for them. ▪ If, following the Business Combination,
securities or industry analysts do not publish or cease publishing research or reports about the Company, its business, or its market, of if they change their recommendations regarding the Company’s securities adversely, the price and trading
volume of the Company’s securities could decline. ▪ Future sales and issuances of the Company’s common stock or rights to purchase the Company’s common stock, including pursuant to the Company’s equity incentive plans,
or other equity securities or securities convertible into the Company’s common stock, could result in additional dilution of the percentage ownership of the Company’s stockholders and could cause the stock price of the Company’s
common stock to decline. ▪ Warrants will become exercisable for the combined company’s common stock, which could increase the number of shares eligible for future resale in the public market and result in dilution to the Company’s
stockholders. ▪ Investors in the Transaction will experience immediate and substantial dilution. ▪ We may issue shares of preferred stock in the future, which could make it difficult for another company to acquire us or could otherwise
adversely affect holders of our common stock. COVID-19 Pandemic Risks ▪ Our business operations, financial condition, results of operations and cash flows may be adversely affected by the effects of health epidemics, pandemics, or outbreaks of
infectious diseases, including the recent COVID-19 pandemic 5

 

 Transaction Structure and Illustrative Pro Forma Ownership Peak Bio PIPE
Ignyte Shareholders SPAC Investors ~65 % OS ~26 % OS ~9% OS ▪ Peak Bio will be acquired by Ignyte Acquisition Corp. (“IGNY”) $57.5M Cash in Trust* ▪ Expected closing: Q4 2022 $25M PIPE Proceeds ▪ Approximate
post-transaction enterprise value: ~ $205M (at $10.00 per share) ▪ PIPE size: $25M ▪ Approximate cash at closing: $72.5M*+ $70M+ in Capital *Assumes no redemptions of trust account ($57.5M) post merger, actual redemptions may vary, and
does not reflect any fees or expenses incurred in connection with the transaction. 6

 

 Why We are Excited About The Ignyte / Peak Bio Merger Peak Bio is a
vision of key pH Pharma Executives who aggressively acquired key assets and raised capital* to develop them which now will be the “backbone” of Peak Bio’s Value Proposition Rationale Peak Bio Experienced Management Team ✓
Visibility on Concurrent Financing ✓ Compelling Therapeutic Pipeline with Potentially Differentiated ADC Cancer Platform ✓ (Target(s), Payloads & Linker stability)** Substantiated Target Valuation ✓ Near-Term News Flow /
Catalysts ✓ Access To Capital From Asia / USA ✓ * 100M+ USD raised to acquire and develop pH Pharma’s assets including those that will merge with Ignyte/Peak Bio Includes: Clinical stage PHP-303 (Bayer) and Preclinical ADC/Toxin
platform **Criscitiello et al. J Hematol Oncol (2021) 14:20 https://doi.org/10.1186/s13045-021-01035-z; potentially meets all the criteria for an ”ideal ADC” (1) Antibody/Target, (TROP2) (2); Linker Stability; (3) Payload (Novel payload
that is potent, potentially Immunomodulatory, and has demonstrated in preclinical work lack of MDR transport (resistance) in Peak Bio’s early preclinical work described in later slides. 7

 

 Presenters HOYOUNG HUH STEPHEN LAMOND SATYAJIT MITRA MD, PhD PharmD, MBA
PhD Chief Executive Officer Chief Operating Officer Head of Oncology 8

 

 Investment Highlights Experienced Leadership with Led by serial
entrepreneur and investor, Hoyoung Huh, M.D., Ph.D., who has had multiple successful exits Proven Track Record for biotech companies through both acquisitions and public markets th Potent and Selective 5 Underserved market opportunity potentially
addressing previous therapeutic shortfalls with a highly selective and most potent reversible NE inhibitor with a favorable on target inhibition, PK /safety profile in Generation NE Inhibitor* multiple clinical studies (acquired from Bayer)
Differentiated Inflammation and Oncology pipeline include a Phase II ready program targeting AATD Multiple Shots-on-Goal with (Orphan) and ARDS, a differentiated toxin and ADC platform, creating numerous novel clinical Near-Term Catalysts
opportunities Differentiated Antibody Drug Conjugate development platform providing an ability to birth multiple Unique Platform Technology therapeutic candidates in large markets with high unmet needs Backed by high quality investors including SBI
(SoftBank Investment), Palo Alto Investors and others with Financed by Quality over $100M raised to-date Institutional Investors Differentiated Access to Asian Deep connections with Korea and Southeast Asia will enable future funding, partnerships
and collaborations given entire pipeline is available (Pan-Pacific) Markets and Large Pharma * Neutrophil elastase inhibitors for the treatment of (cardio) pulmonary diseases: Into clinical testing with pre-adaptive Pharmacophores F. von Nussbaum,
V. M.-J. Li / Bioorg. Med. Chem. Lett. 25 (2015) 4370–4381 9

 

 Multiple Product Candidates and Milestones to Drive Future Value
Program Opportunity Discovery Preclinical Phase I Phase II Upcoming Milestones • Phase II (EU) Initiation (Q1 2023) • Phase II (EU) Data (2H 2024) AATD AATD* • Phase IIb/III (EU/US) Initiation Alpha-1 Antitrypsin PHP-303 (2H 2024)*
Deficiency Bayer P2a 5th Generation Neutrophil Elastase Inhibitor• IND submission (1H 2023) ARDS • Phase 2 initiation (1H 2023) Acute Respiratory Distress (Preclin & DoD Dependent) Syndrome ADC Targeting • IND submission (2H
2023) • Phase Ia initiation (1H 2024) Trop2 ADC Target PH-1 • Additional research Candidate collaborations Novel ADC Platform Selection Discovery work • Toxin PH5 and PH6 Go/No Go decisions on Novel Toxins *Adaptive trial design
still under consideration *Note: Bayer has tested PHP-303 in a P2a in a non-cystic fibrosis bronchiectasis trial; Safety and efficacy of the human neutrophil elastase inhibitor BAY 85-8501 10 for the treatment of non-cystic fibrosis bronchiectasis:
A randomized controlled trial. N=82 pts completed study. (https://pubmed.ncbi.nlm.nih.gov/30917927/)

 

 PHP-303 Targeting AATD & Other Diseases 11

 

 Neutrophil Elastase Inhibitor Overview and Role of PHP-303 Overview of
Neutrophil Elastase (NE) • Neutrophil Elastase (NE) is a proteolytic enzyme that is required in the inflammatory response to tissue injury • In healthy lungs, there is a balance between NE (and other proteases) vs its opposing
antiproteases • Excess neutrophil elastase initiates an inflammatory cascade response leading to fibrosis and impaired lung function Neutrophil Elastase Inhibitors (NEIs) • NEIs reduce the inflammatory process associated with a NE
imbalance • The reduction in the acute and chronic inflammatory process leads to a reduction in tissue destruction and limits exacerbation of associated diseases History and Challenges of NEIs • Earlier generations of NEIs have had
limited success e.g., Augmentation, Infusion therapies are costly and difficult to manage • Improved potency and selectivity is key to future NEIs with early generations historically demonstrating equivocal result Our 5th Generation NE
Inhibitor – Lead Clinical Asset • Our lead asset PHP-303 is an Oral QD, reversible and highly selective small molecule addressing previous shortfalls • PHP-303 is potentially an ideal solution for disease conditions where NE
imbalance is an important contributor to disease 12

 

 th 1 PHP-303: 5 Generation Potent, Highly Specific NE Inhibitor Earlier
Bayer Molecule BAY-678 Human Alpha-1 Sivelestat Mereo Pharma 5 2 3 supplanted by PHP-303 Protease Inhibitors Sodium Asset (AZ) PHP-303 th nd rd th st 4 Gen 2 Gen 3 Gen 5 Gen 1 Gen 1987 Present • Oral • Extensive Preclinical and CMC
• Requires Infusions Work • BID dosing regimen • Weekly Infusions • Equivocal Clinical • High Cost• Novel approach • Improved potency and 4 Benefit • Specialty Pharma selectivity • All Cause
Mortality • Adverse Side Effects • Phase 2 clinical data with • Daily IV Only × Potency could still be an issue • Infusion Site Reactions biological effect on 3 • Hospital Administered × Selectivity ≤
Mereo (AZ asset) biomarkers th PHP-303 – 5 Generation Phase II Ready NE Inhibitor Targeting AATD and ARDS rd th • Most potent NEI in development: Chemistry improvement over 3 and 4 Gen with significant increase in potency •
Structural confirmation ‘freezes’ structure in an ideal bioactive conformation (e.g., “Lock and Key”) rd th • Even more selective than 3 and 4 Gen • Improved DMPK properties resulting in an oral small molecule
compound requiring only once-daily dosing • Inhibits bioactive form of NE with a sustained, dose-dependent suppression of NE activity up 90% or more • Favorable safety achieved and dose established for upcoming clinical trials 1 2 3 4 F.
von Nussbaum, V. M.-J. Li /Bioorg. Med. Chem. Lett. 25 (2015) 4370–4381; Prolastin®-Grifols, Zemaira®-CSL Behring, Aralast®-Baxter); Elaspol® Ono Pharma (Lilly) Japan, Korea only; Sivelestat only approved in 5 Japan and
Republic of Korea; PHP-303 (BAY 85-8501) 13

 

 Alpha-1 Antitrypsin Deficiency (AATD) Overview What is Alpha-1
Antitrypsin Deficiency? • AATD is a chronic, genetic orphan disease caused by mutations in gene encoding Alpha-1 Antitrypsin (AAT) • AAT is an endogenous protein that protects bodily tissues from being attacked by their own enzymes
• AAT is produced in the liver and released into the bloodstream with a key role of inhibiting NE in the lung • In AATD, abnormal AAT can become trapped in the liver and is unable to reach the lungs to inhibit NE leading to damage in
both organs (Differential diagnosis suggests that Emphysema patients should be screened for AATD) Current Treatment Options & Limitations • Currently no cure for AATD • Existing therapies attempt to reduce the inflammatory process,
reduce exacerbations and the eventual tissue/organ destruction. (E.g., Augmentation/infusions and traditional Bronchodilators, steroids, etc.) • Limitations of current therapies include: 1) low lung penetration, 2) cost 3) inconvenient weekly
IV infusions, 4) procurement & 5) pathogen risk Epidemiology & Market Opportunity Disease Prevalence Undiagnosed Patients Adults Developing Lung Disease Growing Market ~120K US / ~75K EU ~90% of patients with genetic ~60- 70% Estimated $1.8
Billion COPD due to Alpha-1 (greatest risk based on genotype) market by 2025 Epidemiology & Market Opportunity Sources: Alpha- Antitrypsin Deficiency (AATD) - Market Insight, Epidemiology and Market Forecast – 2030; DelveInsight Market
Insights 2020. 14 Torres-Durá n et al. Orphanet Journal of Rare Diseases (2018) 13:114 https://doi.org/10.1186/s13023-018-0856-9 

 

 PHP-303 Potentially Addresses the Unmet Medical Need in AATD •
Clinical efforts by Bayer and now pH Pharma have both demonstrated a well-behaved molecule Demonstrated • PHP-303 is well-tolerated with no severe or dose limiting toxicities or adverse events Safety and PK • Steady state (PK) between 11
and 18 days make for ideal oral, QD use in chronic condition Relevance in • NE likely important determinant in AATD disease progression (Chronic inflammatory imbalance) • PHP-303 inhibits bioactive form of enzyme AATD •
Dose-dependent NE inhibition demonstrated in clinical studies Proof of Concept • Doses of 10-20 mg required for greatest inhibition Data • Phase II EU CTA protocol approved • Supported by grant from Alpha 1 Project Advocacy group
Other Key • Orphan disease with potential for additional exclusivity • Likely single pivotal Phase II / Phase III adaptive trial design Considerations • Growth: Major medical societies recommend screening ALL COPD patients for
alpha-1* 15 *Include: 

 

 PHP-303 Attributes PHP-303 is a highly targeted and selective NE
inhibitor Originator Clinical Stage Phase II ready Potency Ki (nM) 0.08 (150X) Mechanism of Inhibits bioactive form of enzyme Action 1 Selectivity 375,000+ Max NE Inhibition ~90% or more at 5mg, 10mg, and 20mg QD (at 24hr dose) Oral, QD Dosing
Regimen 10mg, 20mg 1 16 F. von Nussbaum, V. M.-J. Li /Bioorg. Med. Chem. Lett. 25 (2015) 4370–4381 

 

 Peak Bio ADC Platform 17

 

 Antibody Drug Conjugate Overview What Are ADCs? Why Use ADCs? •
ADCs are a class of anti-cancer agents that combine selectivity • Chemotherapies and targeted small molecules delivered of monoclonal antibodies with the cytotoxic potential of small- systemically must be dosed until the target at the tumor
site molecule chemotherapeutics is saturated • ADCs work by targeting-• Inability to focus treatment to the cancer target results in: a) exposure to higher doses and b) off-target toxicity to other o An Antigen: protein targets are
present on cancer cell organs surface • ADCs reduce systemic exposure of payload by combining: o With an Antibody: a large protein made by the immune system to seek out and destroy non-self antigens o cancer-specific antigens o Using a Linker:
a chemical moiety that serves as a bridge o high target specificity, affinity, and favorable and can be designed to immolate in the tumor cell / pharmacokinetics of mAbs environment o linkers responsive to tumor environment • This combination
results in delivering a Payload / Toxin: a small • Therefore, ADCs focus therapeutic delivery to cancer over molecule with sub-nanomolar potency against target cells normal cells improving the therapeutic index ▪ There continues to be
concerns of off-target effects and toxicities with current ADCs and their respective Payloads ▪ Peak Bio has a platform of Differentiated Approaches to expand the utility of ADCs (Neutropenia) ▪ Approximately 70% of ADCs use payloads
targeting tubulin or DNA, emergence of resistance to these pay-loads is growing ▪ A Third-Generation approach to Toxins for ADCs 18

 

 Growing ADC Market: >$22B by 2030 with Large Deal Flow Approved
Therapies Projected Revenue: $22B+ by Strong Deal Flow Even in Early Stages of Development 1 2030 • ADC market projected to grow > 20% over the next few years 2 • Global Trop2 market expected to surpass $4 billion by 2026 • Key
Trop2 antibody market competitors include Daiichi Sankyo/ AstraZeneca and Immunomedics/ Gilead 1 Sources: Evercore ISI Market Research Report: Health Care | Biotechnology / Drug Discovery, DEEP DIVE on ADCs - The Time Is Right, Now; June 2021 2
Global TROP2 Antibody Market & Clinical Trials Insight 2026; (Global TROP2 Antibody Market & Clinical Trials Report 2021-2026 - Ongoing Clinical Trials Assessment by Status, Phase & Region December 21, 2021 | Other Source(s):
https://njbio.com/antibody-drug-conjugates/ and corporate websites (see deal table) 19

 

 What Makes Peak Bio’s Unique Approach to ADCs Potentially Better?
Antibody + Linker + Chemotherapeutic / Toxin (Targeted CytoToxicity) Traditional o Over 90% of current ADC payloads target tubulin or DNA (Processes essential to dividing cancer cells or their DNA*) ADC o There is emerging resistance to these
payloads Approach o Industry standard payloads are STILL associated with significant toxicities E.g., Ocular, bone marrow, peripheral neuropathy o Substrates of MDR (ABC) Transporters (Emerging drug resistance mechanisms) Peak Bio approach engages
the immune system: What o Enhances tumoricidal activity beyond cytotoxicity creating a potential Best-in-Class approach to treating Cancer Makes our o Engaging the Host Response (T and B cells) can co-evolve and can counter resistance mutations
Solution o Payloads that act as poor substrate for MDR Transporters Better? o Immune memory and can re-engage when treated cancers reoccur Antibody + Linker + Peak Bio Toxin w/ Immune Modulation = Better ‘Mouse Trap’ Spliceosome
Modulation (PH1) Our Novel, o Targeting proper splicing of introns results in mRNA decay depriving cancer cells of essential proteins and mis-spliced proteins Potentially o Creates neoepitopes for immune cells to target well after the initial
“chemotherapy” is delivered Differentiated Immuno- DNA Mismatch Repair (MMR) Interference (PH5) stimulatory o Prevent cancer cells from repairing mistakes during active DNA replication, thereby fixing the errors in translated proteins
(neoepitopes) Payload Immune Suppression (PH6) Approach o Killing tumor cells and pro-tumor immune cells that have been coopted *Topoisomerase and microtubule inhibitor payloads inhibit DNA replication and cancer cell division and PBD payloads
cross-link DNA 20

 

 PH1: Novel and Potentially Differentiated Payload Reduced Drug
Resistance via MDR* Changed & Increased Neoepitopes* • Average expression of spliced RNA transcripts treated by As PH1 is not recognized by Multi-Drug Resistance (MDR) transporters, the PH1 vs tubulin payload DM1 (Kadcyla) same
concentration of PH1 is required to kill MES cells in conditions below ThA13d2 Cytotox (5 Day) MMAE Cytotox (5 Day) MES 100 100 high MES-SA MES MDR MES-SA MES-SA/MX2 MES-SA/MX2 ← 198X → high MES-SA/MX2 + MES MDR MES-SA/MX2 + 50 50
Elacridar (Seagen) Elacridar + MDR inhibitor PH1 MMAE 0 0 0.0001 0.01 1 100 10000 0.0001 0.01 1 100 10000 Concentration [nM] Concentration [nM] Other ADC payloads such as MMAE (Seagen) can be ‘pumped out’ by MDR transporters resulting in
200X higher concentrations required to kill MES overexpressing MDRs • Each mark / dot represents an alternatively spliced gene transcript Red – MES cells • Blue marks in PH1 reflects 3-fold greater impact on global splicing Blue
– Resistant MES cells expressing high levels of MDRs • Resistance gained by increasing the number of cell surface transporters • Red marks in PH1 reflect 9-fold increased numbers of mis-spliced RNAs pumping payload out of the cell.
potentially contributing to neoepitopes Purple – MES with high MDR expression plus MDR inhibitor Elacridar • Inhibits MDR transporter activity so cannot pump payload out even though highly expressed. Returns activity back to baseline.
*Source(s): Data on file, Internal Peak Bio Research Program reports 21 % Live % Live

 

 Peak Bio's Differentiated ADC Candidate Targeting Trop2 Clinically
Validated Target (Trop2) Trop2 PH1 ADC-Potent In-vitro Activity* ▪ Superior linker stability compared to an FDA approved competitor ▪ Superior specificity to cancer cells and ability to generate neoepitopes and synergizes with I/O
therapies ▪ Tumor recruitment of T-helper cells No cytotoxicity against normal human In gastric cancer, superior cytotoxicity fibroblasts as observed in FIC at lower DAR than first-in-class (FIC) (Attributed to superior linker stability)
▪ Anti-tumor immune memory upon experiments ▪ Wide safety margin in non-human primate tox study ▪ IND-lead candidate chosen & 18-24 months to FIH In pancreatic cancer cells, comparable In bladder cancer, comparable *Source(s):
Data on file, Internal Peak Bio Research Program reports cytotoxicity at lower DAR than FIC cytotoxicity at lower DAR than FIC 22

 

 Corporate Summary 23

 

 Multiple Product Candidates and Milestones to Drive Future Value
Program Opportunity Discovery Preclinical Phase I Phase II Upcoming Milestones • Phase II (EU) Initiation (Q1 2023) • Phase II (EU) Data (2H 2024) AATD AATD* • Phase IIb/III (EU/US) Initiation Alpha-1 Antitrypsin PHP-303 (2H 2024)*
Deficiency Bayer P2a 5th Generation Neutrophil Elastase Inhibitor• IND submission (1H 2023) ARDS • Phase 2 initiation (1H 2023) Acute Respiratory Distress (Preclin & DoD Dependent) Syndrome ADC Targeting • IND submission (2H
2023) • Phase Ia initiation (1H 2024) Trop2 ADC Target PH-1 • Additional research Candidate collaborations Novel ADC Platform Selection Discovery work • Toxin PH5 and PH6 Go/No Go decisions on Novel Toxins *Adaptive trial design
still under consideration *Note: Bayer has tested PHP-303 in a P2a in a non-cystic fibrosis bronchiectasis trial; Safety and efficacy of the human neutrophil elastase inhibitor BAY 85-8501 24 for the treatment of non-cystic fibrosis bronchiectasis:
A randomized controlled trial. N=82 pts completed study. (https://pubmed.ncbi.nlm.nih.gov/30917927/)

 

 Investment Highlights Experienced Leadership with Led by serial
entrepreneur and investor, Hoyoung Huh, M.D., Ph.D., who has had multiple successful exits Proven Track Record for biotech companies through both acquisitions and public markets th Potent and Selective 5 Underserved market opportunity potentially
addressing previous therapeutic shortfalls with a highly selective and most potent reversible NE inhibitor with a favorable on target inhibition, PK /safety profile in Generation NE Inhibitor* multiple clinical studies (acquired from Bayer)
Differentiated Inflammation and Oncology pipeline include a Phase II ready program targeting AATD Multiple Shots-on-Goal with (Orphan) and ARDS, a differentiated toxin and ADC platform, creating numerous novel clinical Near-Term Catalysts
opportunities Differentiated Antibody Drug Conjugate development platform providing an ability to birth multiple Unique Platform Technology therapeutic candidates in large markets with high unmet needs Backed by high quality investors including SBI
(SoftBank Investment), Palo Alto Investors and others with Financed by Quality over $100M raised to-date Institutional Investors Differentiated Access to Asian Deep connections with Korea and Southeast Asia will enable future funding, partnerships
and collaborations given entire pipeline is available (Pan-Pacific) Markets and Large Pharma * Neutrophil elastase inhibitors for the treatment of (cardio) pulmonary diseases: Into clinical testing with pre-adaptive Pharmacophores F. von Nussbaum,
V. M.-J. Li / Bioorg. Med. Chem. Lett. 25 (2015) 4370–4381 25

 

 Appendices 26form8-k_hirmanretirement

5      Exhibit 10.1      HERITAGE FINANCIAL CORPORATION    TRANSITIONAL RETIREMENT AGREEMENT    This TRANSITIONAL RETIREMENT AGREEMENT (the “Agreement”) is made and entered into  on September 26, 2022, effective as of January 1, 2023 (the “Effective Date”), by and between  HERITAGE FINANCIAL CORPORATION and CINDY M. HIRMAN (f/k/a Cindy Huntley) (“Executive”).   Unless specifically defined herein, capitalized terms have the meanings set forth in the Prior Agreement.  RECITALS    A. Executive is currently employed by the Company pursuant to that certain Employment  Agreement, effective as of July 1, 2019 (the “Prior Agreement”).  B. Executive is currently employed as an Executive Vice President of the Company and as an  Executive Vice President and Chief Banking Officer of Heritage Bank.  C. The Company desires, with Executive’s assistance, to implement a succession plan with  respect to Executive’s employment, and Executive desires to provide such assistance.  D. The Company desires to continue to employ Executive pursuant to the terms of this  Agreement and Executive desires to continue to be employed by the Company pursuant to such terms.  E. The Parties have made commitments to each other on a variety of important issues  concerning Executive’s employment with the Company, including the performance that will be expected  of Executive, the compensation Executive will be paid, how long and under what circumstances Executive  will remain employed, and the financial details relating to any decision that either the Company or  Executive may make to terminate this Agreement and Executive’s employment with the Company.  AGREEMENT  In consideration of the foregoing and the mutual promises and covenants of the Parties set forth in  this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are  hereby acknowledged, the Parties, intending to be legally bound, hereby expressly covenant and agree as  follows:    Prior Agreement.  Subject to the terms of Section 0 and Section 0, as of the Effective Date, this  Agreement shall supersede and replace any and all prior agreements respecting Executive’s employment  by, or service to, the Company as may from time to time have been made by and between the Parties,  whether or not in writing, including but not limited to the Prior Agreement; provided, however, that any  vested benefits due to Executive pursuant to any pension plan, welfare benefit plan or any other employee  benefit plan, including without limitation the Endorsement Method Split Dollar Agreement by and between  Heritage Bank and Executive, as amended, shall continue to be subject to the terms and conditions of the  applicable plan, program, or agreement, as may be in effect from time to time.  Employment Period.  The Company shall continue to employ Executive during the Employment  Period and Executive shall continue to remain in the employ of the Company and provide services to the  Company during the Employment Period in accordance with the terms of this Agreement.  The  “Employment Period” shall be the period beginning on the Effective Date and ending on April 3, 2023 (the  “Retirement Date”), unless sooner terminated as provided herein.  The use of the term “Retirement Date”  herein is not intended to have any determinative impact on the definition of the terms “retirement,”  “retirement date,” or similar terms in any other plan, program or agreement that Executive may be subject  to, and such terms shall solely be as defined in such plan, program, or agreement, as may be applicable.  

 

6    Duties.  During the Employment Period, Executive shall serve in her existing roles on a full-time  basis through and including December 31, 2022, and as Executive Vice President of the Company, a part- time, exempt position thereafter.  It is the expectation of the Parties that Executive’s role hereunder will not  entail more than twenty-four (24) hours of service per week, on average, following January 1, 2023.   Executive shall be subject to the direction of the President and Chief Operating Officer of the Company.   Executive shall perform the duties required by this Agreement at the Company’s Principal Business  Location and/or virtually, unless the nature of such duties requires otherwise.   Compensation and Benefits.  During the Employment Period, while Executive is employed by  the Company, the Company shall compensate Executive as follows:  From the Effective Date through and including December 31, 2022, Executive shall be paid  a base salary at an annual rate of Two Hundred Ninety-Two Thousand Seven Hundred and sixty-three  dollars and fifty-two cents ($292,763.52) which shall be payable in accordance with the normal payroll  practices of the Company then in effect.  From January 1, 2023 through and including April 3, 2023, Executive shall be paid a base  salary at an annual rate of One Hundred Seventy-Five Thousand Six Hundred and fifty-eight dollars and  eleven cents ($175,658.11), which shall be payable in accordance with the normal payroll practices of the  Company then in effect  Executive shall continue to be eligible to receive an Incentive Bonus for 2022 pursuant to  the terms of the Prior Agreement and the Company’s incentive plan.  Executive will not be required to be  employed on the Incentive Bonus payment date, provided she remains continuously employed through the  earlier of such payment date or the Retirement Date.  Executive shall be ineligible to receive any Incentive  Bonus for 2023.  Executive shall continue to be eligible to receive a Company Contribution for the 2022  Plan Year under the Heritage Financial Corporation Deferred Compensation Plan and Executive’s  participation agreements and addendums thereunder.  Executive shall be ineligible to receive Company  Contributions for 2023 or any subsequent Plan Years.  Executive shall continue to vest in any outstanding equity awards through the Retirement  Date pursuant to the terms of the Company’s equity incentive plan and Executive’s award agreements  thereunder.  As of the Effective Date, Executive shall be ineligible for any future equity awards.  Executive and Executive’s dependents, as the case may be, shall be eligible to participate,  subject to the terms thereof, in all retirement, health and welfare plans of the Company as may be in effect  from time to time with respect to part-time employees employed by the Company, on as favorable a basis  as other similarly situated employees.  Rights upon Termination.    From the Effective Date through and including December 31, 2022, the termination  provisions of Section 4 of the Prior Agreement shall continue to apply by reference in their entirety, as if  fully restated herein, provided that Executive executes a Release as provided in Section 5 of the Prior  Agreement.  From January 1, 2023, through and including April 3, 2023, in the event Executive’s  employment is terminated by the Company for any reason other than Cause, this Agreement and the  obligations and benefits hereunder shall remain in full force and effect as if Executive was employed  through the Retirement Date, provided that Executive executes a Release as provided in Section 5 of the  Prior Agreement.  From January 1, 2023, through and including April 3, 2023, in the event Executive’s  employment is terminated (i) by the Company for Cause; (ii) by Executive for any reason; or (iii) due to  

 

7    Executive’s death or Disability, the Company shall have no further obligations to Executive (except for  payment of the Minimum Benefits) and the Company shall continue to have all other rights available  hereunder.  Executive’s rights following a termination of employment with the Company and its  Affiliates for any reason with respect to any benefits, incentives, or awards provided to Executive pursuant  to the terms of any plan, program, or arrangement sponsored or maintained by the Company or its Affiliates,  whether tax-qualified or not, which are not specifically addressed herein, shall be subject to the terms of  such plan, program, or arrangement and this Agreement shall have no effect upon such terms except as  specifically provided herein.  Restrictive Covenants.  Section 6 of the Prior Agreement is incorporated herein by reference as if  fully restated herein and shall remain in full force and effect.  General Provisions.  Section 7, Section 8, Section 10, and Sections 12–20 of the Prior Agreement  are incorporated herein by reference as if fully restated herein and shall remain in full force and effect.   Applicable Law.  All questions concerning the construction, validity, and interpretation of this  Agreement and the performance of the obligations imposed by this Agreement shall be governed by the  internal laws of the State of Washington applicable to agreements made and wholly to be performed in such  state without regard to conflicts of law provisions of any jurisdiction.  Entire Agreement.  This Agreement constitutes the entire agreement between the Parties  concerning the subject matter hereof, and supersedes all prior negotiations, undertakings, agreements, and  arrangements with respect thereto, whether written or oral (specifically including the Prior Agreement).  By  way of clarification and not limitation, except as specifically provided in this Agreement, the applicable  plan documents with respect to any particular Company benefit plan shall control with respect to the  benefits provided thereunder.  If a court of competent jurisdiction determines that any provision of this  Agreement is invalid or unenforceable, then the invalidity or unenforceability of that provision shall not  affect the validity or enforceability of any other provision of this Agreement and all other provisions shall  remain in full force and effect.  The various covenants and provisions of this Agreement are intended to be  severable and to constitute independent and distinct binding obligations.  Without limiting the generality of  the foregoing, if the scope of any covenant contained in this Agreement is too broad to permit enforcement  to its full extent, such covenant shall be enforced to the maximum extent permitted by law, and the Parties  hereby agree that such scope may be judicially modified accordingly.  IN WITNESS WHEREOF, the Company has caused this Agreement to be executed in its name  and on its behalf, and Executive acknowledges understanding and acceptance of, and agrees to, the terms  of this Agreement, all as of the Effective Date.   HERITAGE FINANCIAL CORPORATION   By:  /s/ Jeffrey J. Deuel   Jeffrey J. Deuel   President and Chief Executive Officer   EXECUTIVE   By: /s/ Cindy M. Hirman   Cindy M. Hirman

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