March 15, 2023
(Commencement of electronic provision measures: March 9, 2023)
To Our Shareholders:
2-12-10 Shiba-Daimon, Minato-ku, Tokyo
Noile-Immune Biotech, Inc.
Koji Tamada, President & CEO

Notice of the 8th Ordinary General Meeting of Shareholders
Dear Shareholders:
We would like to express our sincere gratitude for your continued support and patronage.
This is to notify you that the 8th Ordinary General Meeting of Shareholders of Noile-Immune Biotech, Inc.
(the “Company”) will be held for the purposes outlined below.
To facilitate the electronic provision of this General Meeting of Shareholders, all the relevant reference
documents are now available on the Company website under the heading "NOTICE OF THE 8th
ORDINARY
GENERALMEETINGOF
SHAREHOLDERS"
at
https://www.noileimmune.com/ir/stock/meeting.html.
In light of the ongoing COVID-19 pandemic, shareholders are requested to refrain from attending thephysical venue for the General Meeting of Shareholders. You are encouraged to exercise your voting rights
by completing the enclosed Voting Instruction Form. Kindly review the accompanying Reference Documents
for the General Meeting of Shareholders, indicate your approval or disapproval of the proposals in theenclosed Voting Instruction Form, sign or affix your name and seal, and return it by post. Please ensure the
Voting Instruction Form will be received by us no later than 5:00 pm on Wednesday, March 29, 2023.
Yours Sincerely,【Notice】
1. Date2. Location

3. Agenda of the Meeting
Matters to be reported:
Matters to be resolved:

March 30, 2023 (Thursday) 3:00 p.m.
2-12-10 Shiba-Daimon, Minato-ku, Tokyo
T&G Hamamatsucho Building 5th Floor
Noile-Immune Biotech, Inc. Meeting Room at Headquarters
The 8th Fiscal Year Business and Financial Statements(January 1, 2022 to December 31, 2022)
Election of Four (4) Directors

Details of the agenda can be found in the “Reference Documents for the General Meeting of
Shareholders”.
4. Treatment of Voting Rights
If neither approval nor disapproval of each proposal is indicated on the Voting Instruction Form, the1Company will deem that you indicated your approval of the proposal.
(End of document)～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～～
If amendments to the Electronic Provision Measures Matters are to be taken arise, a notice of theamendments and the details of the matters before and after the amendments will be posted on the Company's
aforementioned website.

2March 15, 2023
(Commencement of electronic provision measures: March 9, 2023)
To Our Shareholders:Information on Live Streaming of the General Shareholders' Meeting
In light of the current COVID-19 situation, we kindly request that you exercise your voting rights bysubmitting a Voting Instruction Form instead of attending the physical venue for the General Meetingof Shareholders, regardless of your state of health.
The General Meeting of Shareholders will be live-streamed on the internet to ensure yourparticipation in the meeting. Prior application is required to view the Shareholders’ Meeting via theinternet, so kindly complete the application in accordance with the following procedure:【How to Apply for Live Streaming】
Please send your application via email to admin@noile-immune.com by the following deadline.
Application deadline: Monday, March 27, 2023, 5:00 p.m.
Email title: Live Streaming of the General Shareholders' Meeting
Email message (Please be assured to provide the following two items):
1. Your address
2. Your name (corporate name and representative name for the corporation)(end of document)Voting Instruction Form
To: Noile-Immune Biotech, Inc.

I hereby exercise my voting rights for the 8th Ordinary General Meeting of Shareholders of NoileImmune Biotech, Inc. scheduled for March 30, 2023, including any continued or adjourned meetings.
I indicate my vote by circling either "Approve" or "Disapprove" for each matter submitted for
resolution, as shown below:
Number of voting rights exercisedVote(s)Matters to be resolved

Approval or Disapproval

ProposalApproval ／ Disapproval(Excluding

)

Date:
Your Address:

Your Name:

Note: Please indicate your vote for or against each proposal on the Voting Instruction Form and return it to us by 5:00
pm on Wednesday, March 29, 2023.

If neither approval nor disapproval of a proposal is indicated, it shall be deemed a vote of approval for
Company proposals.

Reference Documents for the General Meeting of Shareholders[Proposal and Reference Information]
Proposal: Election of Four (4) Directors
The Company seeks approval for the election of four directors whose terms of office expire inaccordance with Article 21 (Term of Office of Directors) of the Articles of Association.
The following candidates have already given their consent to this proposal.
Name(Date of birth)

Koji Tamada(March 28, 1968)

Tsutomu Tokashiki(December 14, 1981)

Philippe Fauchet(November 2, 1957)

Career summary, positions and areas of responsibility
Jun 1992: Joined Kyushu University Hospital
Apr 1998: Postdoctoral Researcher of Mayo Clinic, Minnesota,USA
Oct 2002: Assistant Professor of Mayo Clinic, Minnesota, USA
Aug 2005: Assistant Professor of Johns Hopkins University,
Maryland, USA
Sep 2009: Associate Professor of Cancer Center, University of
Maryland, USA
May 2011: Professor of Yamaguchi University Graduate Schoolof Medicine, Department of Immunology (to present)
Mar 2016: Director of Noile-Immune biotech, Inc.
Sep 2020: President & CEO of Noile-Immune Biotech, Inc. (topresent)(Significant concurrent position)
Professor of Yamaguchi University Graduate School of Medicine,
Department of Immunology
June 2006: Joined Onco Therapy Science, Inc.
Dec 2014: President of Reading Valley Co.
Jul 2015: Joined Noile-Immune Biotech, Inc.
Jan 2018: General Manager of Corporate Planning Dept.,
Business Administration Headquarters of Noile-Immune Biotech,Inc.
May 2019: Director of Noile-Immune Biotech, Inc. (to present)
Jun 2019: General Manager of Business Division and Manager ofBusiness Planning Dept. of Noile-Immune Biotech, Inc.
Jan 2020: Manager of Business Planning Research Dept. of NoileImmune Biotech, Inc. (to present)
Jun 2001: President & CEO of Sanofi Santelabo K.K. (current
Sanofi K.K.)
May 2005: President & CEO of Sanofi-Aventis K.K. (current
Sanofi K.K.)
1 / 2

Number of theCompany’s
shares owned

3,750,000
shares

25,000 shares―

Jan 2010: President & CEO of GlaxoSmithKline K.K.
Apr 2017: Chairman of GlaxoSmithKline K.K.
May 2019: External Director of BONAC Corporation
Mar 2020: Director of Noile-Immune Biotech, Inc. (to present)
Sep 2020: External Director of Rezolute Inc. (to present)
Jun 2022: External Director of LUCA Science Inc. (to present)
Jun 2022: External Director of JCR Pharmaceuticals Co., Ltd. (topresent)(Significant concurrent position)
External Directors of Rezolute Inc.
External Director of LUCA Science Inc.
External Director of JCR Pharmaceuticals Co., Ltd.
Apr 1999: Joined Nagano & Morita CPA
Feb 2004: Joined Ernst and Young Global Financial Service
Hiroko Nagai
Oct 2010: Launched Hiroko Nagai CPA Office(October 5, 1976)―
Mar 2020: Joined Noile-Immune Biotech, Inc. and became
Manager of Administrative Dept. (to present)
Jun 2020: Director of Noile-Immune Biotech, Inc. (to present)(Notes) 1. Each candidate has no special conflicts of interest with the Company.
2. Mr. Philippe Fauchet is a candidate for external director.
3. The Company nominates Mr. Philippe Fauchet as a candidate for external director becauseof his abundant knowledge and insights into the pharmaceutical industry and corporate
management. We expect him to provide helpful advice for the management of theCompany.
4．Mr. Philippe Fauchet was appointed as an outside director of the Company in March 2020,
which will have been for three years after the General Meeting of Shareholders.
5. The Company has concluded a Directors' and Officers' liability insurance policy with aninsurance company, pursuant to Article 430-3, Paragraph 1 of the Companies Act. This
insurance policy covers damages that may arise when a claim for damages is made against
the insured director or auditor, etc. during the term of the policy due to duties performedby the insured person as a director or an auditor, etc. (However, this shall not apply incases where damage is caused intentionally knowing that the act may result in damage.) If
each candidate is elected as a Director of the Company pursuant to this proposal, they will
be insured under the relevant insurance. The Company plans to renew the contract withthe same contents at the next renewal.
6． The Company has designated Mr. Philippe Fauchet as an independent director as stipulatedby the Tokyo Stock Exchange and plans to extend the designation subject to his reelection.

2 / 2

The 8th Fiscal YearBusiness Report
From January 1, 2022
To December 31, 2022

Noile-Immune Biotech, Inc.
2-12-10 Shiba-Daimon, Minato-ku, Tokyo

1

Business Report
From January 1, 2022
To December 31, 2022

1. Current Status of the Company(1)

Business summary for the fiscal year ended December 31, 2022(a) Outline and results of business operations【The Company’s core technology】
Proliferation-Inducing and Migration-Enhancing (“PRIME”) technology, our core technology, is ahighly promising platform technology that may overcome limitations of Chimeric Antigen ReceptorT (“CAR-T”) cell therapy which has yet to be proven to be efficacious in treating solid tumors. The
PRIME Technology is expected to suppress solid tumor growth effectively and sustainably as it canaccumulate CAR-T cells and the host’s immunocompetent cells, including T cells and dendritic cells,in solid tumor, improve the functions of the accumulated cells, and build immune memory against
cancer cells in part of those cells. We concluded an exclusive license agreement concerning the patent
for the PRIME technology with Yamaguchi University on October 1, 2015, and Koji Tamada,President and CEO of the Company, and his research team published details of the technology in
Nature Biotechnology*.
*IL-7 and CCL19 expression in CAR-T cells improves immune cell infiltration and CAR-T cell survival in the tumor.
Adachi K, Kano Y, Nagai T, Okuyama N, Sakoda Y, Tamada K. Nat Biotechnol. 2018 Apr;36(4):346-351. doi:
10.1038/nbt.4086. Epub 2018 Mar 5.

【Research and development】
The Company is currently conducting Phase I clinical trial of NIB101, one of our original drug
development pipelines using the PRIME technology, (ClinicalTrials.gov Identifier: NCT05192174),
and working on identification of target cases. We are also working on the research of another new
pipelines and the next-generation technologies. In the joint research with Yamaguchi University since2017, we have continued to work on next-generation gene-modified cell therapies mainly using CART and TCR-T, cancer immunotherapy using allogeneic cells, and the next-generation PRIME
technology.
【Business alliance】
We entered into an agreement with Takeda Pharmaceutical Company Limited (“Takeda”) in
December 2018 to license our pipelines NIB102 (development pipeline code in Takeda: TAK-102)
and NIB103 (development pipeline code in Takeda: TAK-103) using the PRIME technology, andthese pipelines are currently under Phase I clinical trial. In November 2022, Takeda gave a poster
presentation for the interim results of NIB102 at the 37th Annual Meeting of the Society for2

Immunotherapy of Cancer, demonstrating encouraging results in the preliminary data in terms ofsafety, cellular kinetics and pharmacodynamic considerations, and the dose-escalation study is
ongoing.
We have also continued to work on the research and development of next-generation SPEAR Tcell using the PRIME technology with Adaptimmune Therapeutics plc and of next-generation CART cell therapies using the PRIME technology with Autolus Therapeutics plc, both started in 2019. In
August 2022, we entered into an agreement to grant a license of the PRIME technology to Chugai
Pharmaceutical Co., Ltd. based on the research on the technology assessment with the company since2020. In October 2021, we entered into an alliance agreement regarding technology assessment with
DAIICHI SANKYO COMPANY, LIMITED, and the assessment of the PRIME technology is stillongoing. We have also continued to work on the joint development with Shibuya Corporation whichstarted in 2019 to establish the automated cell manufacturing system aiming at mass production andstable supply of CAR-T cells at a reduced cost.
【Patent】
The patent applications for which we have obtained an exclusive license from Yamaguchi
University (PCT/JP2015/05080) are in the process of securing patent rights in various countries
including Japan, the U.S. and Europe. We are also filing patent applications and securing patents
based on findings of applied research based on that technology.
As a result, for the fiscal year ended December 31, 2022, the Company recorded operating revenueof ¥625,783 thousand (up 521.2% year-on-year), operating loss of ¥106,345 thousand (¥767,511
thousand of operating loss for FY2021), ordinary loss of ¥384,202 thousand (¥792,615 thousand of
ordinary loss for FY2021) due to recognition of listing expenses of ¥268,210 thousand, and net lossof ¥386,622 thousand (¥795,035 thousand of net loss for FY2021).
(b) Funding status
The Company issued 621,200 shares through a third-party allotment to MEDIPAL Innovation
Investment Limited Partnership with the payment date of August 31, 2022 and raised ¥500,066
thousand.
(c) Capital expenditure
Not applicable.
(d) Business transfers, absorption-type splits, or incorporation-type splits
Not applicable.
(e) Businesses transferred from other companies
3Not applicable.
(f) Rights and obligations related to other companies’ businesses assumed as a result of absorptiontype mergers or splits
Not applicable.
(g) Acquisition or disposition of shares, other equity interests, or subscription rights to shares of othercompanies
Not applicable.
(2) Assets and Profit or Loss
PeriodItems
Operating revenue(thousands of yen)
Ordinary income (loss)(thousands of yen)
Net income (loss)(thousands of yen)
Net income (loss) per
share (yen)Total assets(thousands of yen)
Net assets(thousands of yen)
Net assets per share (yen)

5th Fiscal Year

6th Fiscal Year

7th Fiscal Year

8th Fiscal Year(Ended December
31, 2019)(Ended December
31, 2020)(Ended December
31, 2021)(Ended December
31, 2022)

521,004

97,277100,732

625,783

56,906(604,610)(792,615)(384,202)

55,086(636,649)(795,035)(386,622)

1.60(17.93)(20.75)(9.87)

2,338,973

2,674,261

4,271,049

4,641,032

2,235,032

2,598,379

4,185,334

4,300,617

64.67

72.24

107.30108.48(Notes) 1. The Company effected a ten-for-one stock split of its common stock on June 30, 2019 and afive-for-one stock split of its common stock on November 11, 2021. Net income (loss) per shareand net assets per share are calculated assuming that stock split had been implemented on
January 1, 2019.
2. Figures for the 6th fiscal year were restated due to corrections of errors, etc.
(3)

Current status of major parent company and subsidiaries(a) Parent company
Not applicable.
(b) Major subsidiaries
Not applicable.

4

(4)

Issues to be addressed
The Company recognizes the following matters as issues to be addressed.
(a) Expansion of basic research system for the PRIME technology and promotion of joint researchand development with academic and private institutions in Japan and overseas
We have built up multiple pipelines through joint research with Yamaguchi University. We are also
conducting basic research on the improvement and application of our core PRIME technology. We
will enhance our research system so as to further increase pipelines and create intellectual property
related to the PRIME technology in close cooperation with Yamaguchi University and through joint
research and development with academic and private institutions in Japan and overseas.
(b) Promotion of clinical trials
We have built up several pipelines. We believe our effort to promote clinical trials of these pipelines
on our own initiative and assess the data obtained from such trials can also accelerate the developmentat our licensees. We will steadily proceed with the clinical trials of NIB101, which is at the mostadvanced stage among our original pipelines.
(c) Support for our licensees
We plan to continuously cooperate with the pharmaceutical companies to whom we have granted
a license for the PRIME technology by providing technical advice or sharing work under someagreements, to facilitate clinical development.
(d) Enhancement of our systems to increase licensing agreements
We aim to secure talented personnel in order to build stable business portfolio and obtain further
revenue opportunity as well as to find more pharmaceutical companies in Japan and overseas to enter
into licensing agreements with for our “Co-pipeline” business.
(e) New cooperation with external institutions to obtain new business opportunities
We aim to expand pipelines as well as build new forms of pipelines and improve efficiency ofcellular medicine manufacturing. To that end, we are trying to expand cooperation with external
institutions having technologies such as new genome editing technologies, gene transfer methods andautomated cell cultivation equipment.
(f) Enhancement of financial baseWe have raised funds through multiple equity financing and licensing fees from several partnercompanies, and we will enhance financial base by raising funds at an appropriate time as needed to further
promote research and development in the future.

5

(g) Recruitment, development and promotion of the Company’s full-time employees
Our basic policy is to operate our principal business with our full-time employees. It is because
we believe the fact that our team members who truly empathize with the Company’s corporate
philosophy proactively work on research and development or work with our licensees will enhance
the quality and speed of the business promotion and significantly differentiate ourselves from ourcompetitors, giving us the biggest competitive advantage in the industry.
In recruiting new employees, we evaluate and screen candidates based on their background, ability,and potential, and, at the final interview, explain our corporate philosophy and see whether they canempathize with it. In terms of the development after they join the Company, we provide them withon-the-job training from supervisors and other trainings based on the personalized education andtraining schedule prepared by the head of the department.
Employees’ assignment, promotion, pay raise, demotion, and pay reduction are determined basedon the assessment of each employee’s performance using the individual goal management sheet
prepared in advance and also on the assessment by the Human Resources Evaluation Committee of
whether their daily behaviors have been in line with the Company’s corporate philosophy.
Based on the above method, we will strive to secure appropriate and sufficient human resources asneeded according to the acceleration in research and development and the progress of pipelines.
(5)

Principal business (as of December 31, 2022)
We have been conducting research and development of the next-generation cancer immunotherapy,
called Chimeric Antigen Receptor (“CAR”) -T therapy, which is expected to demonstrate antitumor
efficacy as CAR-T cells that carry genes encoding antibody fragments binding to tumor-specificantigens and the sequence necessary to activate T cells administered to cancer patients will identify
and attack cancer antigen on the surface of cancer cells inside the patients’ body. In recent years, thenumber of clinical trials for CAR-T cell therapies has been growing rapidly worldwide, and several
products were also approved in Japan since 2019.
While progress has been made in application of the CAR-T cell therapy to hematologic cancers,
the effective CAR-T cell therapy for solid tumors, which account for over 90 % of all cancer cases,
has yet to be established. In order to address this issue, we have been conducting research on the
PRIME technology, which can be the core technology for CAR-T cell products that are effective forsolid tumors and promoting clinical development of CAR-T cell therapies using such technology. In
terms of clinical development, we promote the original drug development business in which wedevelop CAR-T cell products using the PRIME technology in-house and license them topharmaceutical companies, and the co-pipeline business in which we license the PRIME technology
and develop CAR-T/TCR-T cell products using the PRIME technology jointly with partners.

6

(6)

Major offices (as of December 31, 2022)
Name

Location

Headquarters

Minato-ku, Tokyo

Shonan Research Center

Fujisawa, Kanagawa

Yamaguchi University Laboratory

Ube, Yamaguchi(7) Employees (as of December 31, 2022)
Number of employees

Changes from theprevious year-end

Average age

Average service years

19

Increase by 5

49.0 years old

2 years 1 month(Notes)1. Number of employees represents full-time employees.
2. The increase in the number of employees is mainly associated with the establishment of amanagement system to prepare for the stock listing.
(8)

Major lenders and the amount of borrowings (as of December 31, 2022)
Not applicable.

(9) Other material matters regarding the current status of the Company
Not applicable.

72. Status of Shares (as of December 31, 2022)(1) Total number of authorized shares:

155,800,000 shares(2) Total number of shares issued and outstanding:(3) Number of shareholders:(4)

39,579,865 shares

34

Major shareholders (Top 10)
Name of shareholders

Number of shares owned(shares)

Stock ownership ratio(%)

Tsurukame Co., Ltd.

9,871,350

24.94

Takeda Pharmaceutical
Company Limited

8,119,800

20.51

Koji Tamada

3,750,000

9.47

Binex Co., Ltd.

2,277,825

5.75

Hidenobu Ishizaki

2,000,000

5.05

Satoshi Wada

2,000,000

5.05

Kyoko Seto

2,000,000

5.05

Daiwa Taiwan-Japan Biotech
Fund

1,349,200

3.40

Apricot Co., Ltd.

1,203,850

3.04

Yukimi Sakota

1,000,000

2.52(Notes)1. The Company does not own treasury stock.
2. Stock ownership ratio is rounded down to two decimal places.

(5) Other material matters regarding shares
Not applicable.

83. Subscription Rights to Shares(1)

Subscription rights to shares held by the Company’s officers, etc. as of December 31, 2022

Name of subscription rights tosharesSubscription rights to shares(2nd round)

Subscription rights to shares(3rd round)

Date of resolution to issue

March 29, 2017

August 10, 2018

Number of subscription rights toshares (units)

154 (Note) 1

69 (Note) 1

Common stock

Common stock

770,000 (Note) 1

345,000 (Note) 1

Cash payment for subscription
rights to shares(yen per unit)

10,8000

Exercise price(yen per share)

100

240

From April 7, 2019

From August 11, 2020

To March 31, 2027

To August 9, 2028

(Note) 2(Note) 2

Class and number of underlying
shares (shares)

Exercise period
Conditions on exercise

Directors(excluding external

Statusdirectors)ofholding

Number ofsubscription
rights tosharesNumber ofunderlying
sharesNumber ofholders

External directors

byofficers
Corporate auditors

Number ofsubscription
rights to
40 units
shares57 units
Number ofunderlying
200,000 shares shares
285,000 shares
Number of
1 person holders
1 person――

Number ofsubscription
rights tosharesNumber ofunderlying
sharesNumber ofholders

5 units
25,000 shares
1 person9―Name of subscription rights tosharesSubscription rights to shares(4th round)

Subscription rights to shares(5th round)

Date of resolution to issue

August 10, 2018

May 17, 2019

Number of subscription rights toshares (units)

80 (Note) 1

28 (Note) 1

Common stock

Common stock

400,000 (Note) 1

140,000 (Note) 1

Cash payment for subscription
rights to shares(yen per unit)

27,3000

Exercise price(yen per share)

228

255

From August 10, 2020

From May 18, 2021

To August 9, 2028

To May 16, 2029

Class and number of underlying
shares (shares)

Exercise period
Conditions on exercise

StatusDirectorsof(excluding external

holding

directors)

byofficers

External directors
Corporate auditors(Note) 2(Note) 2
Number of
Number ofsubscription
subscription
rights torights toshares40 units
shares20 units
Number of
Number ofunderlying
underlying
200,000 shares shares
100,000 sharessharesNumber of
Number ofholders
1 person holders
1 person
―
―
―

10

―

Name of subscription rights tosharesSubscription rights to shares(6th round)

Subscription rights to shares(9th round)

Date of resolution to issue

May 17, 2019

April 13, 2020

Number of subscription rights toshares (units)

33 (Note) 1

390 (Note) 3

Common stock

Common stock

165,000 (Note) 1

195,000 (Note) 3

Cash payment for subscription
rights to shares(yen per unit)

36,8000

Exercise price(yen per share)

248

705

From May 17, 2021

From April 14, 2022

To May 16, 2029

To April 13, 2030

Class and number of underlying
shares (shares)

Exercise period
Conditions on exercise

Directors(excluding external

Statusdirectors)ofholdingbyofficers

External directors

Corporate auditors(Note) 2(Note) 2
Number of
Number ofsubscription
subscription
rights torights toshares
6 units
shares200 units
Number of
Number ofunderlying
underlying
30,000 shares shares
100,000 sharessharesNumber of
Number ofholders
1 person holders
1 person
Number ofsubscription
rights toshares50 units―
Number ofunderlying
25,000 sharessharesNumber ofholders
1 person――11

Name of subscription rights tosharesSubscription rights to shares(11th round)

Subscription rights to shares(12th round)

Date of resolution to issue

March 23, 2021

May 12, 2022

Number of subscription rights toshares (units)

638 (Note) 3

1,080 (Note) 4

Common stock

Common stock

319,000 (Note) 3

108,000 (Note) 4

Cash payment for subscription
rights to shares(yen per unit)

00Exercise price(yen per share)

779

804

From March 24, 2023

From May 13, 2024

To March 23, 2031

To May 12, 2032

(Note) 2(Note) 2

Class and number of underlying
shares (shares)

Exercise period
Conditions on exercise

StatusDirectorsof(excluding external

holding

directors)

byofficers

Number ofsubscription
rights tosharesNumber ofunderlying
sharesNumber ofholders

Number ofsubscription
rights to
100 units
sharesNumber ofunderlying
50,000 shares shares
Number of
2 persons holders

280 units
28,000 shares
2 personsExternal directors――

Corporate auditors

―

―

12

Name of subscription rights tosharesSubscription rights to shares(13th round)

Date of resolution to issue

May 12, 2022

Number of subscription rights toshares (units)

200 (Note) 4

Class and number of underlying
sharesCommon stock
20,000 (Note) 4

Cash payment for subscription
rights to shares(yen per unit)

9,200

Exercise price(yen per share)

780

Exercise period
Conditions on exercise

StatusDirectorsof(excluding external

holding

directors)

byofficers

From May 13, 2024
To May 12, 2032
(Note) 2
Number ofsubscription
rights tosharesNumber ofunderlying
sharesNumber ofholders

120 units
12,000 shares
1 personExternal directors―

Corporate auditors―(Notes) 1. The number of underlying shares per unit of subscription rights to shares is 5,000 shares.
2. Conditions on exercise of subscription rights to shares(a) Those to whom subscription rights to shares are allotted (“Holders of Subscription Rights
to Shares”) must continue to be directors or employees of the Company or its subsidiaries
up to the date of exercise to be eligible, except when directors retire upon expiration of theirterm of office, employees retire at full retirement age, or there is any other due reason
specifically provided by the Board of Directors.
(b) Subscription rights to shares may be inherited when Holders of Subscription Rights toShares die.
(c) Subscription rights to shares less than one unit may not be exercised.
3. The number of underlying shares per unit of subscription rights to shares is 500 shares.
4. The number of underlying shares per unit of subscription rights to shares is 100 shares.

13

(2)

Subscription rights to shares granted to the Company’s employees, etc. as consideration for executionof duties during the fiscal year ended December 31, 2022
Name of subscription rights tosharesSubscription rights to shares(12th round)

Date of resolution to issue

May 12, 2022

Number of subscription rights toshares (units)

1,080 (Note) 1
Common stock

Class and number of underlying
shares (shares)

108,000 (Note) 1

Cash payment for subscription
rights to shares(yen per unit)0

Exercise price(yen per share)

804
From May 13, 2024

Exercise period

To May 12, 2032

Conditions on exercise(Note) 2
Number ofsubscription
rights tosharesNumber ofunderlying
sharesNumber ofholders

Status of
grant toEmployees of

employees,

the Company

etc.

800 units
80,000 shares
15 persons(Notes) 1. The number of underlying shares per unit of subscription rights to shares is 100 shares.
2. Conditions on exercise of subscription rights to shares(a) Those to whom subscription rights to shares are allotted (“Holders of Subscription Rights
to Shares”) must continue to be directors or employees of the Company or its subsidiaries
up to the date of exercise to be eligible, except when directors retire upon expiration of theirterm of office, employees retire at full retirement age, or there is any other due reason
specifically provided by the Board of Directors.
(b) Subscription rights to shares may be inherited when Holders of Subscription Rights toShares die.
(c) Subscription rights to shares less than one unit may not be exercised.

14

(3) Other material matters regarding subscription rights to shares (as of December 31, 2022)
Name of subscription rights tosharesSubscription rights to shares(8th round)Category and number of eligible
person (person)

Joint researcher: 1

Date of resolution to issue

August 7, 2019

Number of subscription rights toshares (units)

730 (Note) 1
Common stock

Class and number of underlying
shares (shares)

365,000 (Note) 1

Cash payment for subscription
rights to shares(yen per unit)0

Exercise price(yen per share)

255
From August 7, 2020 or date of

Exercise period

listing, whichever comes laterto August 6, 2029

Conditions on exercise(Note) 2(Notes) 1. The number of underlying shares per unit of subscription rights to shares is 500 shares.
2. Conditions on exercise of subscription rights to shares(a) Those to whom subscription rights to shares are allotted (“Holders of Subscription Rights
to Shares”) must continue to be related parties of the Company or its subsidiaries up to thedate of exercise to be eligible, except when directors retire upon expiration of their term ofoffice, employees retire at full retirement age, or there is any other due reason specificallyprovided by the Board of Directors.
(b) Subscription rights to shares may be inherited when Holders of Subscription Rights toShares die.
(c) Subscription rights to shares less than one unit may not be exercised.

15

4. Officers(1) Directors and corporate auditors (as of December 31, 2022)
Name

Post and responsibility

Material posts concurrently held

Koji Tamada

President & CEO,
Representative Director
Director,
Manager of Business PlanningResearch Dept.
Director,
Manager of Administrative Dept.
Director

Professor of Immunology, Yamaguchi University,
Graduate School of Medicine

TsutomuTokashiki
Hiroko Nagai
Philippe
FauchetKazuyuki
Fujiwara
Hironari
Hashioka

Full-time Corporate Auditor

Yukiyasu
NakataCorporate Auditor

Corporate Auditor――
External Director of Rezolute Inc.
External Director of LUCA Science Inc.
External Director of JCR Pharmaceuticals Co., Ltd―
Partner of Vasco da Gama Law Offices (Attorney at
Law)
External Corporate Auditor of Trenders, Inc.
External Director of Kufu Company Inc.
Representative of Nakata Yukiyasu Accounting &Tax Office
Corporate Auditor of Promat Japan Corporation(Notes) 1. Mr. Philippe Fauchet, Director, is external director.
2. Mr. Kazuyuki Fujiwara, Mr. Hironari Hashioka, and Mr. Yukiyasu Nakata, Corporate Auditors,
are external corporate auditors.
3. Mr. Hironari Hashioka, Corporate Auditor, is an attorney at law, and Mr. Yukiyasu Nakata,Corporate Auditor, is a certified public accountant and tax accountant.
4. Upon conclusion of the 7th Annual General Meeting of Shareholders held on March 29, 2022, Mr.
Hidenobu Ishizaki and Mr. Yoshinori Ito, Directors, retired due to expiration of their terms ofoffice.
5. Mr. Shigeo Furusawa retired from office due to resignation on June 15, 2022.
6. Pursuant to provisions of Article 427, Paragraph 1 of the Companies Act, Mr. Hironari Hashioka
and Mr. Yukiyasu Nakata, Corporate Auditors, and the Company entered into an agreement tolimit the liability for damages provided for in Article 423, Paragraph 1 of the Companies Act ofJapan. The maximum liability for damages under such contracts is limited to the amountstipulated by law.
7.

As stipulated in Article 430-3, Paragraph 1 of the Companies Act, the Company has
obtained a directors' and corporate auditors' liability insurance policy with aninsurance company that covers all directors and corporate auditors of the Company.
The insurance policy covers compensation for damages and litigation expenses that
may arise from the performance of their duties, and the Company bears all insurance
16

premiums.
(2) Directors and corporate auditors who retired during the fiscal year
As noted above, Mr. Hidenobu Ishizaki and Mr. Yoshinori Ito, Directors, and Mr. Shigeo Furusawa,
Corporate Auditor, retired.

17

(3)

Remuneration, etc. of directors and corporate auditors①Policy on Determining Directors' and Auditors' Remuneration Amount or Calculation Method
The Company's policy for determining the amount of remuneration and method of calculation for
directors and auditors is described in the Company's Regulation of Executive Compensation.
The remuneration for directors is determined by the Board of Directors (or by the Representative
Director if the Board of Directors entrusts the decision to the Representative Director) within
the total amount of remuneration approved at the General Meeting of Shareholders in accordancewith the Regulation of Executive Compensation. The determination takes into consideration
various factors including the balance between remuneration, management details, and employee
salaries, and is aligned with the standards of the industry.
The remuneration for corporate auditors is determined through discussions among the corporate
auditors, based on the Regulation of Executive Compensation, within the total amount of
remuneration approved at the General Meeting of Shareholders. The discussions take into
consideration various factors including the balance among the remuneration, the content of audits,and employee salaries.
The Remuneration Committee reviewed and determined the remuneration amount for directors
and corporate auditors for the most recent fiscal year. The General Meeting of Shareholders
passed a resolution to approve the amount of remuneration, which was 150,000 thousand yen for
directors (resolved at the Ordinary General Meeting of Shareholders held on March 24, 2020)
and 50,000 thousand yen for corporate auditors (resolved at the Extraordinary General Meetingof Shareholders held on May 17, 2019). The amount of remuneration for each individual director
is determined within the limit of the approved amount. The determination of each director's
remuneration was entrusted to Koji Tamada, Representative Director, by the Board of Directors,
based on the proposal of the Remuneration Committee. This is because it is appropriate toevaluate the level of contribution by those most familiar with the Company's business.
In principle, the Board of Directors is primarily responsible for deciding on the granting of stock
options. However, the Compensation Committee may consider the matter in advance as necessary
and appropriate.
②Total amount of remuneration by director classification and number of directors subject toremuneration
Post

NumberTotal amount of remuneration, etc.

Directors

6¥64 million(of which, external directors)(1)(¥8 million)

Corporate auditors(of which, external corporate

4¥12 million(4)(¥12 million)

18

auditors)
Total

10

¥77 million(of which, external officers)(5)(¥20 million)(4) Other material matters regarding officers
Not applicable.
(5) External officers(a) Relationship between the Company and other companies where our officers hold material concurrent
positionsNot applicable.
(b) Family relationship with business executing persons of the Company or entities that have a special
relationship with the Company
Not applicable.

19(c) Major activities during the fiscal year ended December 31, 2022
Attendance and participation
Philippe Fauchet
Director
Kazuyuki Fujiwara
Corporate Auditor

Hironari Hashioka
Corporate Auditor

Shigeo Furusawa
Corporate Auditor

Yukiyasu Nakata
Corporate Auditor

Mr. Fauchet attended all 17 meetings of the Board of Directors held
during the fiscal year ended December 31, 2022, and participated in
discussions, as necessary.
Mr. Fujiwara attended all 17 meetings of the Board of Directors held
during the fiscal year ended December 31, 2022, and participated in
discussions, as necessary.
He also attended all 35 meetings of the Board of Corporate Auditors held
during the fiscal year ended December 31, 2022, and participated in
discussions, as necessary.
Mr. Hashioka attended all 17 meetings of the Board of Directors held
during the fiscal year ended December 31, 2022, and participated in
discussions, as necessary from the viewpoint of legal counsel.
He also attended all 35 meetings of the Board of Corporate Auditors held
during the fiscal year ended December 31, 2022, and participated in
discussions, as necessary.
Mr. Furusawa attended all 9 meetings of the Board of Directors held
during the fiscal year ended December 31, 2022 (during his term ofoffice), and participated in discussions, as necessary.
He also attended all 19 meetings of the Board of Corporate Auditors held
during the fiscal year ended December 31, 2022 (during his term ofoffice), and participated in discussions, as necessary.
Mr. Nakata attended all 17 meetings of the Board of Directors held
during the fiscal year ended December 31, 2022, and participated in
discussions, as necessary from the viewpoint of CPA and tax accountant.
He also attended all 35 meetings of the Board of Corporate Auditors held
during the fiscal year ended December 31, 2022, and participated in
discussions, as necessary.

20

5. Independent Auditors(1) Name: Deloitte Touche Tohmatsu LLC(2) Remuneration of independent auditors
Amount of remuneration
Amount of remuneration paid to the independent auditors for the
fiscal year ended December 31, 2022
a. Remuneration based on attestation service
b. Remuneration based on non-audit service
Total amount of cash and other remuneration to be paid by theCompany to the independent auditors¥37,620 thousand¥12,810 thousand¥50,430 thousand(3) Description of non-audit services
During the fiscal year ended December 31, 2022, the Company engaged Deloitte Touche Tohmatsu
LLC to obtain advice on the consideration of accounting policies in connection with the application of“Accounting Standard for Revenue Recognition” and to prepare a comfort letter in English for theoverseas share issuance scheduled in Mach 2023.
(4) Reason why the Board of Corporate Auditors agreed on the independent auditors’ remuneration
In light of “Practical Guideline on Cooperation with Independent Auditors” issued by Japan Audit& Supervisory Board Members Association, the Board of Corporate Auditors agreed on the amount of
remuneration paid to the independent auditors as provided for in Article 399, Paragraph 1 of theCompanies Act, based on the verification and examination of the independent auditors’ audit plan, theperformance status of their duties in previous years, and the calculation basis for estimatedremuneration by obtaining necessary documents from and conducting interviews with directors,
relevant departments, and independent auditors.
(5) Policies to determine dismissal or non-reappointment of the independent auditors
When it is acknowledged that the independent auditors fall under any of the items in Article 340,
Paragraph 1 of the Companies Act, the Board of Corporate Auditors will dismiss the independent
auditors with the unanimous consent of all members of the Board of Corporate Auditors.
When it is determined that the independent auditors are incapable of adequately performing the audit
service, or when determined necessary, the Board of Corporate Auditors will decide on the content of
the agenda regarding dismissal or non-reappointment of the independent auditors to be submitted to a
general meeting of shareholders.

21

6. The Company’s System and Policies(1)

Summary of the systems to ensure that the execution of duties by directors and employees is incompliance with laws and regulations and the Articles of Incorporation and other systems to ensure
proper business operation
a. System to ensure that the execution of duties by directors is in compliance with laws and regulations
and the Articles of Incorporation(a) The Board of Directors shall make decisions on important management affairs in accordancewith laws and regulations, the Articles of Incorporation, resolutions of general meeting ofshareholders and “Regulations of the Board of Directors.”(b) President & CEO shall make decisions on the Company’s business execution delegated bydirectors in accordance with “Regulations of the Board of Directors” and execute duties inaccordance with such decisions, resolutions of the Board of Directors meetings and“Regulations of the Board of Directors.”(c) The Board of Directors shall determine the basic policy of internal control and monitor
whether directors appropriately design and operate internal control system and execute theirduties in compliance with such system.
(d) Directors shall promote information sharing with other directors to mutually monitor businessexecution.
(e) Directors shall be audited based on the audit policy and plan developed by corporate auditors.
(f) The Administrative Department shall promote the use of the whistleblowing system according
to “Whistleblowing Regulations” in an effort to detect violations of laws or issues that might
inhibit “Core Value.”b. System to store and manage information on the directors’ execution of the duties
Minutes of general meeting of shareholders and Board of Directors meetings and important
information on management and business execution shall be appropriately recorded and maintained
for a specified period in accordance with laws and regulations and relevant rules including“Approval Rules” and “Approval Procedural Regulations.” Other relevant rules shall be reviewed
and updated, as necessary.
c. System to ensure efficient execution of duties by directors(a) To ensure efficient execution of duties by directors, provisions regarding operation of theBoard of Directors meetings shall be established in “Regulations of the Board of Directors”
and the Board of Directors meetings shall be held on a monthly basis and as necessary.
(b) Directors shall endeavor to promptly obtain accurate management informationd. System to ensure that the execution of duties by employees is in compliance with laws andregulations and the Articles of Incorporation
President & CEO shall establish a system whereby any compliance-related incident will be reported
to President & CEO, the Board of Directors, corporate auditors, and corporate lawyers.
22

e. Regulations and other systems to manage potential risks of losses(a) President & CEO shall establish a system to minimize risks by identifying and assessing
company-wide risks and prepare countermeasures in coordination with directors in charge
and department managers.
(b) To facilitate risk management, the Company shall establish risk management rules and otherinternal rules to raise awareness of risks, enable early detection and prevention, and determine
emergency procedures.
f. Matters concerning employees assigned to assist duties of corporate auditors when such assignmentis requested by corporate auditors
Although the Company does not assign any employees to assist duties of corporate auditors, theBoard of Directors may appoint and assign such employees based on discussions with corporate
auditors when necessary.
g. Matters concerning independence of employees assigned to assist duties of corporate auditors fromdirectors when such assignment is requested by corporate auditors
During the assignment, the right of command over the assigned employees shall be considered to betransferred to corporate auditors, and therefore the assigned employees shall not be subjected to
instruction from directors.
h. System for directors and employees to report to corporate auditors and other systems concerning
reports to corporate auditors(a) Corporate auditors shall attend the Board of Directors meetings as well as management
meetings and other important meetings concerning business execution such as budget meetings
to receive reports on material issues of the Company, facts that may cause damages to theCompany, etc.
(b) Directors and employees shall report to corporate auditors about important matters to be
discussed and important decisions made by the Board of Directors, decisions made at otherimportant meetings, significant accounting policies and standards and changes thereof, andother important matters that need to be reported.
(c) Directors and employees shall immediately report to corporate auditors when they becomeaware of any facts that may cause substantial damages to the Company, fraudulent acts, orserious violation of laws and regulations or the Articles of Incorporation.
i. Other systems to ensure effective performance of audit by corporate auditors(a) Corporate auditors shall hold meetings with President & CEO on a regular basis tocommunicate and exchange opinions.
(b) Corporate auditors shall also exchange opinions and information with independent auditors tomaintain coordination and request investigation and report, as necessary.
j. Basic policy and system to eliminate anti-social forces
The basic policy of the Company shall be not to have any relationship with any anti-social forces,23

organizations, or individuals and not to respond to any unreasonable or illegal demands. Directors
and employees shall be thoroughly informed about such policy, and the Company shall establish asystem enabling the entire company to promptly take actions by collecting information from relevant
administrative agencies on a regular basis and maintaining close contact with relevant administrative
agencies and legal experts in the event of an incident.
(2)

Summary of the operating status of the systems to ensure proper business operation
In accordance with the aforementioned basic policy to ensure proper business operation, the Company
has established systems to ensure proper business operation as a company and implemented thefollowing measures to ensure proper operation of such systems.
(a) The Board of Directors consists of four directors (including one external director) and makes
decisions about important matters concerning the Company’s business operation and mattersprovided for by laws and regulations. In principle, the Board of Directors meetings are held on amonthly basis and also when needed. During the fiscal year ended December 31, 2022, the Boardof Directors meetings were held 17 times, where, in accordance with “Regulations of the Boardof Directors,” directors deliberated and decided on items on agenda, monitored the status ofexecution of duties, and actively exchanged opinions, enabling prompt decision making andensuring effective monitoring.
(b) Compliance trainings are held annually to thoroughly inform employees of “Compliance Rules,”etc.
(c) Internal auditors perform internal audit on a regular basis to verify that the Company’s business
operation is in compliance with laws and regulations, the Articles of Incorporation, internal rules,
etc. The results of the internal audit along with areas for improvement are reported to President& CEO and corporate auditors. Corporate auditors meet with independent auditors and internal
auditors, as needed, to exchange opinions about compliance, the status of the internal control
system in place, etc.
(d) The Company has a system in place to eliminate anti-social forces in accordance with “Anti-social
Forces Elimination Rules,” with Representative Director as the responsible person and theAdministrative Department as the responsible division. The Company also coordinates withexternal agencies in an effort to eliminate anti-social forces, and receives instructions and collects
information.

24

The 8th Fiscal Year

Supplementary Schedules
Related to Business Report

Noile-Immune Biotech, Inc.
2-12-10 Shiba-Daimon, Minato-ku, Tokyo

25

Supplementary Schedules(From January 1, 2022 to December 31, 2022)
1. Other significant matter to supplement the contents of the Business Report
Not applicable.

26

The 8th Fiscal Year

Financial Statements

Noile-Immune Biotech, Inc.
2-12-10 Shiba-Daimon, Minato-ku, Tokyo1

Balance Sheet(As of December 31, 2022)(In thousands of yen)Account

AmountAccount(Assets)
Current assets
Cash and deposits

Amount(Liabilities)
4,584,184

Current liabilities

335,1814,520,997

Other payables

217,815

Inventory

3,926

Accrued expenses

45,939Advance payments

26,943

Income taxes payable

18,309Prepaid expenses

27,015Contract liabilities

4,846

Other

5,301

Deposits received

44,728Fixed assets

56,848

Other

3,542

Investments and other assets

56,848 Non-current liabilities

5,233

Long-term prepaid expenses

3,007

Long-term deposits

35,034

Total liabilities

Guarantee deposits

18,806(Net assets)

Asset retirement obligations

Shareholders’ equity

4,641,032

340,4144,293,716

Capital2,787,552

Capital surplus

2,765,396

Capital reserve

2,765,396

Retained earnings(1,259,232)

Other retained earnings(1,259,232)

Retained earnings brought forward(1,259,232)

Subscription rights to shares
Total assets

5,233

6,901

Total net assets

4,300,617

Total liabilities and net assets

4,641,032(Note) Amounts less than one thousand yen is rounded down.

2

Statement of Income(From January 1, 2022 to December 31, 2022)(In thousands of yen)Account

AmountOperating revenue

625,783

Operating expenses
Operating cost

7,077

Research and development expenses

334,804

Other selling, general and administrative expenses

390,247

Operating loss

732,129(106,345)

Non-operating income
Interest income

41Interest on refund

14

Subsidy income

330

Foreign exchange gain

5,477

5,863

Non-operating expenses
Listing expenses

268,210

Outsourcing expense

13,758

Share issuance cost

1,750

Other

2

Ordinary loss

283,720(384,202)

Net loss before income taxes(384,202)

Income taxes - current

2,420

Net loss

2,420(386,622)(Note) Amounts less than one thousand yen is rounded down.

3

Statement of Changes in Net Assets(From January 1, 2022 to December 31, 2022)(In thousands of yen)
Shareholders’ equity
CapitalRetained
surplusearnings
Retained
CapitalCapitalearnings
reservebrought
forward
Beginning balance

2,537,519

2,515,363

250,033

250,033(872,610)

Total
Subscription
shareholders’ rights tosharesequity4,180,272

5,061

Total
net assets

4,185,334

Changes during the year
Issuance of newsharesNet loss
Issuance ofsubscription rights tosharesNet changes in items
other thanshareholders’ equity
during the year
Total changes during
the yearEnding balance(386,622)

500,066

500,066(386,622)(386,622)
1,840

1,840

250,033

250,033(386,622)

113,443

1,840

115,283

2,787,552

2,765,396(1,259,232)

4,293,716

6,901

4,300,617(Note) Amounts less than one thousand yen is rounded down.

4

【Notes to financial statements】(Significant accounting policies)

1. Valuation basis and method of inventory(1) Work in process: Stated at cost using the specific identification method (Net book value is written
down to reflect a decline in profitability)(2) Supplies: Stated at cost using the last purchase cost method.

2. Translation of assets and liabilities denominated in foreign currencies to Japanese yen
Monetary receivables and payables denominated in foreign currencies are translated into Japanese yen
using the spot exchange rates at the end of the reporting period, with the difference arising from thetranslation recognized in profit or loss.

3. Recognition criteria for allowance
To provide for credit loss on trade receivables, loans receivable, etc., allowance for doubtful accounts
is recorded at the estimated uncollectible amount based on the past bad debt ratio for performing
receivables and based on individual assessment of collectability for non-performing receivables.
No allowance for doubtful accounts is recorded for the fiscal year ended December 31, 2022 asthere was no credit loss recognized or non-performing receivables.

4. Recognition criteria for major revenue and expenses
The description of major performance obligations related to revenue from contracts with customers in
our principal business and the point at which these performance obligations are generally satisfied are
as follows.
 Licensing revenue
The Company recognizes income generated from granting licenses for intellectual property acquired
through research and development (upfront fee, milestone income, etc.) as revenue.
In general, income generated from granting a license is recognized as revenue over the licensing
term if the nature of the arrangement is determined as provision of a right to access the Company’s
intellectual property which is a performance obligation satisfied over time, and recognized as revenue
at the point when the license is granted if the nature is determined as provision of a right to use theCompany’s intellectual property which is a performance obligation satisfied at a point in time.
Milestone income is recognized as revenue from the point when all conditions are satisfied as
uncertainties regarding revenue recognition are not resolved and the amount of recognized revenue
may be reduced until conditions set forth in the agreement, such as progress of the research and5development, are satisfied.
Transaction price to be recognized as revenue is based on the amount specified in the agreement
in consideration of the amount allocated to other performance obligations included in the agreement.
Consideration for transactions are payable from customers within one year after the conclusion of
the agreement, achievement of certain milestones, etc. No significant financing component is includedin the agreements.
(Accounting estimates)
Recoverability of deferred tax assets(1) Amounts recognized in the financial statements for the fiscal year ended December 31, 2022
Deferred tax assets: ¥－ thousand(2) Information on significant accounting estimates related to identified items
Deferred tax assets are calculated based on the company classification specified in the “Implementation
Guidance on Recoverability of Deferred Tax Assets” (Accounting Standards Board of Japan (ASBJ)
Guidance No. 26) for deductible temporary differences and unused tax losses by reasonably estimating
taxable profits in future years and assessing the recoverability. The amount of taxable profits is estimatedbased on the budgets, etc. for the following fiscal year approved by the Board of Directors.
The estimate of taxable profits and the assessment of recoverability of deferred tax assets have been
made under the assumption that the impact of COVID-19 on the Company’s business results is limited.
However, because there is high uncertainty about the impact of the infection, the estimate of taxable
profits and the calculated amount of deferred tax assets for the fiscal year ended December 31, 2022
may change depending on the situation of COVID-19 infections in the future.
(Changes in accounting policy)
For the fiscal year ended December 31, 2022
(Application of accounting standard for revenue recognition, etc.)
The Company applied the “Accounting Standard for Revenue Recognition” (ASBJ Statement No. 29,
March 31, 2020, “Accounting Standard for Revenue Recognition”), etc. from January 1, 2022, andrecognizes revenue at an amount that it expects to receive in exchange for the promised goods or services
when the control of the goods or services is transferred to a customer.
We applied the Accounting Standard for Revenue Recognition, etc. from January 1, 2022 pursuant
to the transitional treatment provided for in the proviso of Paragraph 84 of the Accounting Standard for
Revenue Recognition, with the cumulative effect of the retrospective application, assuming the new
accounting policy had been applied to periods prior to January 1, 2022, adjusted to the beginning balance6

of retained earnings as of January 1, 2022.
There was no impact of the application of the Accounting Standard for Revenue Recognition, etc.
on profit or loss for the fiscal year ended December 31, 2022 and retained earnings as of January 1,
2022.
(Application of accounting standard for fair value measurement, etc.)
The Company applied the “Accounting Standard for Fair Value Measurement” (ASBJ Statement No.
30, July 4, 2019, “Accounting Standard for Fair Value Measurement”), etc. from January 1, 2022, andthe new accounting policies stipulated in the Accounting Standard for Fair Value Measurement, etc. areapplied prospectively pursuant to the transitional treatment provided for in Paragraph 19 of the
Accounting Standard for Fair Value Measurement and Paragraph 44-2 of the “Accounting Standard for
Financial Instruments” (ASBJ Statement No. 10, July 4, 2019). The application has no impact on thefinancial statements.
(Statement of changes in net assets)
1. Class and total number of shares issued and outstanding as of December 31, 2022
Common stock
Balance as of January 1, 2022

38,958,665 shares

Increase during the year

621,200 shares

Decrease during the year

－ shares

Balance as of December 31, 2022

39,579,865 shares(Reason of change)
Increase due to issuance of new shares through a third-party allotment: 621,200 shares

7

2. Subscription rights to shares
The class and number of shares to be issued upon exercise of subscription rights to shares as ofDecember 31, 2022 (excluding those whose exercise period has yet to start)
Subscription rights to
Number of underlying
Class of underlying shares
Outstanding balancesharesshares
2nd round

Common stock

615,000 shares

123 units

3rd round

Common stock

205,000 shares

41 units

4th round

Common stock

240,000 shares

48 units

5th round

Common stock

45,000 shares

9 units

6th round

Common stock

60,000 shares

12 units

9th round

Common stock

39,000 shares

78 units

10th round

Common stock

3,000 shares

6 units(Deferred tax accounting)Major components of deferred tax assets and liabilities(In thousands of yen)
Deferred tax assets
Excess depreciation

5,424

One-time depreciation asset

17

Contract liabilities
Asset retirement obligations

473
1,602

Tax loss carryforward

590,248

Deferred tax assets subtotal

597,766

Valuation allowance for tax loss carryforward
Valuation allowance for total deductible temporary differences
Valuation allowance subtotal(590,248)(7,518)(597,766)

Total deferred tax assets

0Deferred tax liabilities
Tangible fixed assets

0

Total deferred tax liabilities

0

Net deferred tax assets－8

(Financial instruments)
1 Overview of financial instruments(1) Policy on financial instruments
The Company limits its investment options to short-term deposits only and raises funds through equity
financing.
(2) Description and risk of financial instruments
Accounts receivable is trade receivable and exposed to credit risk of customers. Trade receivable
denominated in foreign currencies is exposed to foreign exchange rate risk.
Other payables are trade payable and generally due within one year. Trade payable denominated inforeign currencies is exposed to foreign exchange rate risk.
(3) Risk management system for financial instruments(a) Management of credit risk (risk of default by customers, etc.)
For trade receivable, the Administrative Department manages due dates and outstanding balance foreach customer in accordance with the sales management regulation and strives to detect possible
uncollectible accounts due to deterioration of customers’ financial condition at an early stage andmitigate loss.
(b) Management of market risk (risk of changes in exchange rates, interest rates, etc.)
For trade receivable and payable denominated in foreign currencies, the Administrative Department
monitors foreign exchange rates on a monthly basis.
(c) Management of liquidity risk associated with funding (risk of being unable to make payments whendue)
The Administrative Department manages liquidity risk by preparing and updating the cash flow plan
in a timely manner based on the reports from relevant departments and maintaining liquidity on hand.
(4) Supplemental information on fair value of financial instruments, etc.
The fair value of financial instruments includes values based on the market price or reasonably
calculated values when there are no market prices. As such values are calculated using variable factors,
using different assumptions may result in different values.
(5) Concentration of credit risk
The Company’s trade receivable is highly likely to concentrate on certain large customers.

9

2 Fair value of financial instruments
The disclosure on cash and deposits, other payables, income taxes payable and deposits received are omitted
as they are settled within a short period of time and their carrying amounts approximates their fair values.
(Note) 1. The redemption schedule of monetary receivables after the reporting date
For the fiscal year ended December 31, 2022
(In thousands of yen)
Within one year

After one year

After five years

through five years

through 10 years

After 10 years

Cash and deposits

4,520,997

－

－

－

Total

4,520,997－－－(Related party transactions)Not applicable

10(Revenue recognition)(1) Disaggregation of revenue from contracts with customers(By type of goods or services)(In thousands of yen)
Item

Fiscal year ended December 31, 2022

Revenue recognized at a point in time

597,147

Revenue recognized over time

28,635

Royalty―

Revenue from contracts with customers

625,783

Other revenue―

Revenue from external customers

625,783(2) Information that serves as the basis for understanding revenue from contracts with customers
Please see “(Significant accounting policies) 4. Recognition criteria for major revenue and expenses.”(3) Information on when and how much revenue is expected to be recognized in the future periods fromthe contracts with customers existing as of December 31, 2022(a) Balance of contract liabilities, etc.
(In thousands of yen)
Year ended December 31, 2022
Contract liabilities (Beginning balance)

6,020

Contract liabilities (Ending balance)

4,846(b) Transaction price allocated to remaining performance obligations
The disclosure on transaction price allocated to remaining performance obligations is omitted as wehave no significant transactions with an original expected duration exceeding one year.
(Per share information)
Net assets per share:¥108.48

Net loss per share:¥9.87(Material subsequent events)
Not applicable
11

The 8th Fiscal Year

Supplementary Schedules
Related to Financial Statements

Noile-Immune Biotech, Inc.
2-12-10 Shiba-Daimon, Minato-ku, Tokyo

12

Supplementary Schedules(From January 1, 2022 to December 31, 2022)

1. Details of tangible and intangible fixed assets

Carrying
amountAccumulated
as ofdepreciation
December
31

Carrying
amountas ofJanuary 1

Increaseduring theyear

Decreaseduring theyear

Depreciation

－

－

－

－

－

14,430

－

－

－

－

－

39,316

Other

－

－

－

－

－

585

Total

－

－

－

－

－

54,332

Software

－

－

－

－

－

2,711

Total

－

－

－

－

－

2,711

Category

Asset type

Tangible
fixed assets

improvements

LeaseholdTool, furnitureand fixtures

Intangible
fixed assets(In thousands of yen)

(Note) Accumulated depreciation includes accumulated impairment losses.

2. Details of research and development expenses(In thousands of yen)Account

AmountRemarks

Salaries

51,252

Bonus

1,395

Legal welfare expense

7,781

Recruitment and education expenses

3,529

Travel and transportation expenses

6,268

Repair expense

1,692

Compensation

8,613

Outsourcing expense

533

Staffing expense

19,998Rent expense

9,827

Research materials expense

3,867

Research outsourcing expense

217,433

Other

2,611
Total

334,80413

3. Details of other selling, general and administrative expenses

Account(In thousands of yen)AmountRemarks

Directors’ remuneration

75,014

Salaries

80,483

Bonus

1,937

Legal welfare expense

16,492

Recruitment and education expenses

9,136

Travel and transportation expenses

8,155

Communication expense

2,286

Office supplies expense

2,934

Repair expense

640

Membership fee

700

Fees and commissions

7,229

Compensation

43,968Outsourcing expense

26,578Staffing expense

4,983

Rent expense

17,047

Lease expense

2,171

Insurance premium

1,905

Taxes and dues

29,648

Patent-related expense

55,266

Other

3,666
Total

390,247

14

(TRANSLATION)
INDEPENDENT AUDITOR’S REPORT
February 10, 2023
To the Board of Directors of
Noile-Immune Biotech, Inc.:
Deloitte Touche Tohmatsu LLC
Tokyo office
Designated Partner
Engagement Partner

Certified Public Accountant Hideki Ono

Designated Partner
Engagement Partner

Certified Public Accountant Akihiro Sano

OpinionPursuant to Article 436, Paragraph 2, Item 1 of the Companies Act, we have audited the financial statements ofNoile-Immune Biotech, Inc. (the “Company”), namely, the balance sheet as of December 31, 2022, and thestatements of income and changes in net assets for the 8th fiscal year from January 1, 2022 to December 31,
2022, and the related notes and the accompanying supplementary schedules (the “Financial Statements, etc.”).
In our opinion, the Financial Statements, etc. referred to above present fairly, in all material respects, thefinancial position of the Company as of December 31, 2022, and its financial performance for the year thenended in accordance with accounting principles generally accepted in Japan.
Basis for Opinion
We conducted our audit in accordance with auditing standards generally accepted in Japan. Our responsibilities
under those standards are further described in the “Auditor’s Responsibilities for the Audit of the Financial
Statements, etc.” section of our report. We are independent of the Company in accordance with the provisionsof the Code of Professional Ethics in Japan, and we have fulfilled our other ethical responsibilities as auditors.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our
opinion.
Other information
Other information comprises the business report and the accompanying supplementary schedules.
Management is responsible for preparation and disclosure of the other information. Corporate Auditors andthe Board of Corporate Auditors are responsible for supervising the execution of duties by directors withregard to design and operation of reporting process of the other information.
Our audit opinion on the financial statements does not cover the other information, and we do not express an
opinion thereon.
In connection with our audit of the financial statements, our responsibility is to read the other information
and, in doing so, consider whether the other information is materially inconsistent with the financial statementsor our knowledge obtained in the audit or otherwise appears to be materially misstated.
If, based on the work we have performed, we conclude that there is a material misstatement of this otherinformation, we are required to report that fact.
We have nothing to report in this regard.

1

Responsibilities of Management and Corporate Auditors and the Board of Corporate Auditors for the
Financial Statements, etc.
Management is responsible for the preparation and fair presentation of the Financial Statements, etc. inaccordance with accounting principles generally accepted in Japan, and for such internal control as
management determines is necessary to enable the preparation and fair presentation of the Financial
Statements, etc. that are free from material misstatement, whether due to fraud or error.
In preparing the Financial Statements, etc., management is responsible for assessing whether it isappropriate to prepare the Financial Statements, etc. based on the premise of a going concern and fordisclosing matters related to going concern when it is required to do so in accordance with accounting
principles generally accepted in Japan.
Corporate Auditors and the Board of Corporate Auditors are responsible for overseeing the Directors’
execution of duties relating to the design and operation of the Company’s financial reporting process.
Auditor’s Responsibilities for the Audit of the Financial Statements, etc.
Our responsibility is to obtain reasonable assurance about whether the Financial Statements, etc. as a whole
are free from material misstatement, whether due to fraud or error, and to express an opinion on the Financial
Statements, etc. from an independent standpoint in an auditor’s report. Misstatements can arise from fraud or
error and are considered material if they could reasonably be expected to, individually or collectively,
influence the decisions of users taken on the basis of the Financial Statements, etc.
As part of an audit in accordance with auditing standards generally accepted in Japan, we exercise
professional judgment and maintain professional skepticism throughout the audit. We also:• Identify and assess the risks of material misstatement, whether due to fraud or error, and design and perform
audit procedures to address those risks. We select and apply audit procedures based on our judgement. In
addition, we obtain sufficient and appropriate audit evidence to provide a basis for our opinion.
• Consider internal control relevant to the audit when performing risk assessment procedures in order todesign audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company’s internal control.
• Evaluate the appropriateness of accounting policies adopted by management and the method of theirapplication as well as the reasonableness of accounting estimates made by management and the adequacy ofrelated disclosures.
• Determine whether it is appropriate for management to prepare the Financial Statements, etc. on the premiseof a going concern and, based on the audit evidence obtained, determine whether there exists a material
uncertainty related to events or conditions that may cast significant doubt on the Company’s ability tocontinue as a going concern. If we conclude that a material uncertainty exists, we are required to draw
attention in our auditor’s report to the related disclosures in the Financial Statements, etc., or, if thedisclosures in the Financial Statements, etc. pertaining to the material uncertainty are inadequate, we are
required to issue a modified opinion. While our conclusions are based on the audit evidence obtained up to
the date of our auditor’s report, future events or conditions may cause the Company to cease to continue as agoing concern.
• Evaluate whether the presentation and disclosures of the Financial Statements, etc. are in accordance withaccounting principles generally accepted in Japan, and whether the overall presentation, structure andcontent of the Financial Statements, etc. including related disclosures as well as the Financial Statements,
etc. fairly represent the underlying transactions and accounting events.
We communicate with Corporate Auditors and the Board of Corporate Auditors regarding the planned scope
and timing of the audit and material audit findings, including any significant deficiencies in internal control
identified during the course of our audit, and other matters required under the auditing standards.
We also provide Corporate Auditors and the Board of Corporate Auditors with a statement that we havecomplied with professional ethical provision regarding independence in Japan, and communicate with themregarding matters that are reasonably considered to have an impact on our independence and any safeguards inplace to reduce or eliminate obstacles, where applicable.
Interest
Our firm or its designated engagement partners do not have any interest in the Company which is required tobe disclosed pursuant to the provisions of the Certified Public Accountants Act of Japan.

2

(Translation)

AUDIT REPORT
We, the Board of Corporate Auditors, have prepared this audit report upon deliberation based on the audit reports
prepared by each Corporate Auditor concerning the performance of duties by Directors during the 8th fiscal year
from January 1, 2022 to December 31, 2022, and hereby report as follows.
1. Methods and Details of the Audit by Corporate Auditors and the Board of Corporate Auditors(1) The Board of Corporate Auditors established the audit policies, the division of duties and other matters, andreceived reports from each Corporate Auditor on the status and results of its audits. In addition, the Board of
Corporate Auditors received reports from Directors, etc., and the Independent Auditor regarding theperformance of their duties, and requested explanations, as necessary.
(2) In accordance with the standards for the audit by Corporate Auditors as established by the Board of
Corporate Auditors, and based on the audit policies and division of duties, each Corporate Auditor
communicated with Directors, the Internal Audit Department, employees, etc., using means such as
telephone lines or the Internet, strived to gather information and enhance the audit environment, and also
performed audit by the method described below.
(a)Each Corporate Auditor attended the meetings of the Board of Directors and other important meetings,
received reports from Directors, employees and others regarding the performance of their duties,
requested explanations as necessary, inspected important documents supporting decisions and otherrecords and examined the status of operations and assets at the head office and major operating
locations.
(b) In terms of the contents of the Board of Directors’ resolutions concerning the establishment of systems,
which are described in the Business Report, to ensure that Directors’ performance of their duties is incompliance with the laws and regulations and the Company’s Articles of Incorporation as stipulated in
Article 100, Paragraphs 1 and 3 of the Ordinance for Enforcement of the Companies Act and the statusof the systems established based on such resolution (internal control system), each Corporate Auditor
periodically received reports from Directors, employees and others on the status of development andoperation, requested explanations as necessary and expressed their opinion.
(c) Each Corporate Auditor monitored and verified whether the Independent Auditor maintained
independence and performed proper audit, received reports from the Independent Auditor regarding thestatus of the performance of its duties, and requested explanations as necessary. Corporate Auditors
also received the notification from the Independent Auditor that it had established a “system to ensure
appropriate performance of its duties” (matters prescribed in each item of Article 131 of the Regulation
on Corporate Accounting) in accordance with the “Quality Control Standards for Auditing” (BusinessAccounting Council, October 28, 2005), and requested explanation as necessary.
Based on the aforementioned methods, the Board of Corporate Auditors examined the business report andsupplementary schedules thereto and the financial statements (balance sheet, statements of income and changes in
net assets, and notes to the financial statements) and supplementary schedules thereto for the fiscal year ended
December 31, 2022.

1

2. Results of Audit(1) Results of Audit of the Business Reports, etc.
(a) In our opinion, the business report and the supplementary schedules present fairly the condition of theCompany in accordance with laws and regulations and the Articles of Incorporation of the Company.
(b) There are no fraudulent acts or serious violation of any applicable laws and regulations or the Articles ofIncorporation of the Company concerning Directors’ performance of their duties.
(c) In our opinion, the details of the Board of Directors’ resolutions concerning the internal control system areappropriate. Furthermore, there were no findings to be reported regarding the description in the business report
and Directors’ performance of their duties concerning the internal control system.
(2) Results of Audit of the Financial Statements and the Supplementary Schedules
In our opinion, the auditing method and results of the Independent Auditor, Deloitte Touche Tohmatsu LLC, areappropriate.

March 2, 2023
Board of Corporate Auditors of Noile-Immune Biotech, Inc.
Kazuyuki Fujiwara
Full-time Corporate Auditor (External Corporate Auditor)
Hironari Hashioka
External Corporate Auditor
Yasuyuki Nakata
External Corporate Auditor2