Financial Results for the Six Months ended September 30, 2023
[Japanese GAAP] (non-consolidated)
November 10, 2023
BrightPath Biotherapeutics Co., Ltd.
Listed Market Growth, TSE
TSE Code 4594
URL
https://www.brightpathbio.com/english/index.html
Representative(Title)President & CEO(Name) Kenichi Nagai
Contact(Title)CFO(Name) Yoichi Takeshita(TEL) +81-3-5840-7697
Scheduled date to file quarterly securities report:: November 10, 2023
Scheduled date of dividend payment commencement:－
Supplementary materials for financial statements: NoneBriefing of financial results: Yes (for analysts/institutional investors)(Millions of yen, rounded down to the nearest million)
1. Financial results for the six months ended September 30, 2023 (April 1, 2023 – September 30, 2023)(1) Results of Operation(Percentages represent changes from the same period of prior year)
Net sales
Six months ended
September 30, 2023
September 30, 2022

Millionyen
00Operating income
%

-75.0
-31.9

Million
yen
-550
-805

Ordinary income
Million
yen
-551
-809

%
－
－

Net income%－－

Million
yen
-553
-810

%
－
－

Fully diluted net
income pershare
Six months ended
Yen
Yen
September 30, 2023
-8.81－
September 30, 2022
-14.20－(Note) 1.
Fully diluted net income per share is not stated as net loss was recorded for this period although there areresidual shares.
Net income pershare(2) Financial Position
Total assets
As of
September 30, 2023
March 31, 2023
(Reference) Shareholders’ equity

Net assets

Equity ratio

Million yen
Million yen
1,163
1,013
1,701
1,567
As of September 30, 2023 993 million yen
As of March 31, 2023
1,547 million yen

%
85.4
90.9

2. Dividends
Annual dividends per share

Fiscal year ended March 31, 2023
Fiscal year ending March 31, 2024
Fiscal year ending March 31, 2024
(Forecast)

1Q
Yen
－
－

2Q
Yen
0.00
0.00

3Q
Yen
－

4Q
Yen
0.00

Total
Yen
0.00

－

0.00

0.00

3. Projected financial results for the fiscal year ending March 31, 2024 (April 1, 2023 – March 31, 2024)(Percentages represent changes from the same period of prior year)
Net income
Net sales
Operating income Ordinary income
Net income
per share
MillionMillionMillionMillion
%
%
%
%
Yen
yen
yen
yen
yen
Full year
0 -100.0 -1,353-21.58－ -1,353－ -1,357－(Note) 1. The Company manages business results on an annual basis, and therefore only the full-year financial forecasts
are disclosed.
2. There is no change in projected financial results from the latest official forecast.

[Notes](1) Adoption of accounting treatment specific to the preparation of quarterly non-consolidated financial statements: None
(2) Changes in significant accounting policies, changes in accounting estimates and restatements
1) Changes in accounting policies due to revisions of accounting standards, etc.

: None2) Changes in accounting policies due to other reasons than above 1): None3) Changes in accounting estimates: None4) Restatements: None(3) Number of shares outstanding (common stock)1) Number of shares outstanding at theend of the period (including treasury
stock)
2) Number of shares of treasury stock at
the end of the period
3) Average number of shares during theperiodAs of
September
30, 2023
As of
September
30, 2023
6 months
ended
September
30, 2023

62,891,200 shares

As of March
62,891,200 shares
31, 2023
As of March
31, 2023

1 share6 months
ended
62,891,199 shares
September
30, 2022

57,094,711 shares

1 share* These financial results are outside the scope of audits by a certified public accountant or an audit corporation.
* Explanations regarding appropriate use of forecasts and projections of financial results, and other specific notes- All forecasts and projections contained in this document are based on the information available and certain
assumptions deemed reasonable by the Company at this time. They are not intended to represent our promise toattain them as a goal. Actual results may differ substantially due to various reasons. For details on the assumptions
and conditions for forecasts and projections as well as notes on their use, please refer to “1. Qualitative Informationof Business Results for the Six Months Ended September 30, 2023, (3) Outlook for the Fiscal Year Ending March
31, 2024” on page 5 of the attachment.

Contents of the Attachment
1. Qualitative Information of Business Results for the Six Months Ended September 30, 2023 ...................... 2(1) Overview of Operating Results ................................................................................................................. 2(2) Overview of Financial Position .................................................................................................................. 4(3) Outlook for the Fiscal Year Ending March 31, 2024 ................................................................................. 5
2. Financial Statements and Primary Notes ....................................................................................................... 6(1) Balance Sheets ......................................................................................................................................... 6(2) Statements of Operations ......................................................................................................................... 7(3) Statements of Cash Flows ........................................................................................................................ 8(4) Notes to Financial Statements .................................................................................................................. 9(Notes on going concern assumption) ....................................................................................................... 9(Notes on significant changes in shareholders’ equity) ............................................................................. 9―1―

1. Qualitative Information of Business Results for the Six Months Ended September 30, 2023
(1) Overview of Operating Results
BrightPath Biotherapeutics Co., Ltd. (the “Company”) has built an environment for exploring anddeveloping cancer immunotherapeutics (drugs that treat cancer by utilizing the immune system) during
the six months ended September 30, 2023.
Cell therapy agents<iPSC derived natural killer T-cell (NKT cell) therapy: BP2201>
BP2201 (iPS-NKT) is a novel allogeneic cell therapy agent for cancer treatment that uses naturalkiller T-cells (NKT cells)1 induced from iPS cells. This cell therapy agent is a kind of T-cell engineered
with chimeric antigen receptors (CAR) that can recognize cancer antigens, and such CAR-T celltherapy2 is currently under development globally. Compared with T-cells, NK cells or γδT cells typicallyused in other companies’ development projects, NKT cells have a differentiated function and are
expected to show a greater presence as immune cells which will underpin the future CAR-T cell therapy.
The Company has been promoting the research and development of the cellular therapy using NKT
cells, jointly with Institute of Physical and Chemical Research (a.k.a. RIKEN). In November 2022, theCompany exercised the option right to obtain a worldwide exclusive license to develop, manufacture
and market BP2201 from RIKEN.
This license has allowed the Company to build an iPS-NKT platform that consists of: (1) the patentin Japan, the US, and the EU to protect the Company’s extensive and exclusive use of iPSC-derived
NKT cells for allogeneic cell therapy, (2) the master iPS cell bank (MCB), and (3) the manufacturing
process capable of differentiating iPS cells in the MCB into high-purity and high-yield NKT cells. The
clinical safety and efficacy of the MCB is expected to be demonstrated in the ongoing clinical trial.
This platform serves as a cornerstone for developing novel iPS-NKT cells by transducing CAR Tcells targeting various tumor antigens and ensures the application of iPS-NKT cells to treatment ofvarious types of cancer in many regions of the world.
At the Annual Meeting of Society for Immunotherapy of Cancer held in the US in November 2022
(SITC 2022), the Company reported the non-clinical data of the world’s first prototype CAR iPS-NKT
created on the iPS-NKT platform, demonstrating anti-tumor effects in vitro3.
The company entered into research and licensing agreement in May 2023 to receive non-exclusive
rights to Artisan’s STAR-CRISPRTM editing platform to accelerate development of iPS-NKT cells.
As for clinical application of iPS-NKT, an investigator-initiated Phase 1 trial of iPS-NKT in patientswith head and neck cancers (started in June 2020) is underway at Chiba University. This Phase 1 trial
stays on track and, up until now, no safety issues have been reported.
<HER2 CAR-T cell therapy: BP2301>
BP2301 is a chimeric antigen receptor gene-transfected T-cell (CAR-T cell) therapy that targets
HER2 that is highly expressed in various solid tumors. In the Phase I investigator-initiated clinical trial
started in May 2022 at Shinshu University, the treatment of HER2-positive relapsed or advanced
sarcomas and gynecological malignancies is being tested.
Until today, CAR-T cell therapies targeting hematologic cancers have been approved globally withexcellent clinical benefits demonstrated in clinical trials. However, the deployment of CAR-T celltherapies to treat solid tumors, from which a larger number of people suffer, faces a challenge due tothe lack of sufficient clinical efficacy of CAR-T cells resulting from their exhaustion and dysfunction in
the immune-suppressive tumor microenvironment. To overcome this challenge, BP2301 contains alarge number of stem cell-like immune memory phenotype cells that are characterized by excellent―2―replication and long-term viability in the body and are expected to provide exhaustion resistance andsustained anti-tumor effects in the tumor microenvironment. It has been allowed through the joint
development of a novel cell culture method with Professor Yozo Nakazawa and Professor Shigeki
Yagyu of Shinshu University, based on Professor Nakazawa's non-viral gene transfer method.
Antibody drugs
Since immune checkpoint molecules4 or immunomodulatory molecules suppress the immune
system to eliminate tumor cells, the Company is developing antibody drugs capable of binding to suchmolecules and inhibiting their function. The Company’s antibody drug development pipelines cover
BP1200, BP1202, BP1210 and BP1212. BP1200 and BP1202 target CD73 and CD39 respectively,
both of which help prevent the production of immunosuppressive adenosine. BP1210 targets TIM-3,
which is expressed in immune cells and restraints anti-tumor immunity. Furthermore, BP1212 is aCD39/TIM-3 bispecific antibody targeting immune cells which co-express CD39 and TIM-3 andsimultaneously blocking multiple immunosuppressive mechanisms.
Since the Company had ascertained high CD39 expression in regulatory T-cells (Tregs), whichstrongly suppress tumor immunity, the Company has altered BP1202 to add the function of selectively
eliminate Tregs. Due to the combination of CD39 and TIM-3 as targets, BP1212 is a potential candidate
for the first-in-class drug, that is, the first breakthrough drug approved in the same drug class. The preclinical data for BP1212 were reported in SITC 2022 in November 2022. Proof of concept has beenachieved in the pre-clinical phase for these novel antibody drugs.
Cancer vaccines<Fully personalized neoantigen vaccine with immune checkpoint antibodies: BP1209>
BP1209 is a new platform of fully personalized neoantigen vaccines5 optimized to induce eachindividual patient’s anti-tumor immunity targeting immunogenic neoantigens derived from mutations incancer cell derived genes. BP1209 uses checkpoint inhibitor antibodies to deliver neoantigen peptides
to dendritic cells acting as messengers to T-cells. To facilitate the binding of BP1209 to such antibodies,
the Company’s original linker technology is utilized. The Company has demonstrated in a tumor-bearing
mouse model that efficient delivery of vaccine antigens to dendritic cells which direct anti-tumor
immunity can induce many more cancer-killing T-cells which identify and attack neoantigens than
peptides alone do.
<Cancer peptide vaccine: GRN-1201>
GRN-1201 is a cancer peptide vaccine consisting of four tumor associated antigen-derived HLA6A2 restricted peptides. HLA-A2 types are common among Europeans and Americans, and GRN-1201
is intended for global deployment including the US and Europe. In May 2022, the Company decided on
the early termination of the Phase II clinical trial of the cancer peptide vaccine GRN-1201 in combination
with the immune checkpoint inhibitory antibody targeting PD-1 for non-small cell lung cancer conductedin the US. At present, the Company is seeking a development partner to initiate a new clinical trial.
As a consequence of all of the foregoing, the Company recorded the financial results for the six
months ended September 30, 2023 as follows: operating loss of 550,569 thousand yen (805,068
thousand yen in the corresponding period of the prior year), ordinary loss of 551,566 thousand yen(809,792 thousand yen in the corresponding period of the prior year), and net loss of 553,922 thousandyen (810,742 thousand yen in the corresponding period of the prior year).
Segment information is omitted as the Company operates in the single business segment of thepharmaceutical development business and there is no other significant segment information.

―3―

<Glossary>
1. NKT cell
An immune cell combining the properties of natural killer (NK) cells and T-cells and serving as afunctional bridge between innate and acquired immunity. NKT cells have the ability to directly kill cancer
cells through T-cell receptors or NK cell receptors and at the same time have an adjuvant action that
activates other immune cells such as T-cells and dendritic cells. When activated, they produce a variety
of cytokines and promote the activation of NK cells belonging to the innate immune system and thematuration of dendritic cells. Mature dendritic cells further proliferate and activate killer T-cells belonging
to the acquired immune system, thereby synergistically enhancing anti-tumor effects.
2. CAR-T cell therapy
Chimeric antigen receptor T-cell therapy. Chimeric antigen receptors that recognize antigens expressedby cancer cells are gene-transfected into T-cells (a type of lymphocyte with anti-tumor immunity), which
are then grown in culture and administered.
3. in vitro
Experiments in a model environment, often in a laboratory tube.
4. Immune checkpoint molecule
A group of molecules that suppress the immune response to self as well as suppress excessive immune
responses in order to maintain immune homeostasis. In cancer immunity, they are present to preventthe attack on self by over-activation, but in the carcinogenic process, they are used by cancer cells toevade attack from the immune system and to proliferate.
5. Fully personalize neoantigen vaccine
A tailor-made cancer vaccine that searches for neoantigens in cancer cells of individual patients. Clinical
trials currently conducted overseas by academia and leading development companies include those formRNA vaccines, that is, lipid nanoparticles (LNP) loaded with mRNAs coding for neoantigens.
6. HLA
Human leukocyte antigens are proteins which are expressed on the surface of almost all cells in thehuman body and regulate the immune system. The HLA system, which is also known as the major
histocompatibility complex (MHC), is involved in the elimination of pathogens such as bacteria andviruses, cancer cell rejection and organ transplant rejection. HLA expression occurs on the surface ofcancer cells as well. In the mechanism of action of cancer vaccines, HLAs bind to peptides formed fromantigenic peptides in cancer cells, migrate to the cancer cell surface, and enable cytotoxic T-cells (CTL)
to recognize cancer cells. HLA are markers to distinguish self and non-self, and there are diverse typesof HLAs to differentiate many varieties of non-self from self. Peptides bind to a specific type of HLA
alone and do not bind to any other different types.
(2) Overview of Financial Position(i) Assets
As of September 30, 2023, total assets were 1,163,667 thousand yen, a decrease of 537,777
thousand yen from the end of the prior fiscal year. The main factors for this include a decrease of
467,781 thousand yen due to expenditures related to research and development, etc. in cash anddeposits.
(ii) Liabilities
As of September 30, 2023, total liabilities were 150,048 thousand yen, an increase of 16,145
thousand yen from the end of the prior fiscal year. The main factors for this include an increase of
13,960 thousand yen in accounts payable included in other current liabilities.
(iii) Net assets
As of September 30, 2023, net assets were 1,013,618 thousand yen, a decrease of 553,922
thousand yen from the end of the prior fiscal year. The factor for this is a decrease of a net loss of―4―

553,922 thousand yen. As a result of the above, equity ratio was 85.4% compared to 90.9% at the endof the prior fiscal year.
(iv) Overview of Cash Flows
As of September 30, 2023, cash and cash equivalents (hereinafter “net cash”) amounted to
1,063,188 thousand yen, a decrease of 467,781 thousand yen from the end of the prior fiscal year.
The situation of each cash flow for the six months ended September 30, 2023 and the underlying factors
are as follows:(Cash flows from operating activities)
Net cash used in operating activities amounted to 466,327 thousand yen (588,604 thousand yen
used in the corresponding period of the prior year). This was mainly due to recording loss before income
taxes of 552,972 thousand yen.
(Cash flows from investing activities)
Net cash used in investing activities amounted to 1,454 thousand yen (none used in thecorresponding period of the prior year). This was due to purchase of intangible assets.
(Cash flows from financing activities)
No cash flows were recorded in financing activities (197,491 thousand yen provided in thecorresponding period of the prior year).
(3) Outlook for the Fiscal Year Ending March 31, 2024
Our recent business outlook is the same as the projected financial results announced on May 12,
2023.

―5―

2. Financial Statements and Primary Notes(1) Balance Sheets(Thousands of yen)
As of March 31, 2023

As of September 30, 2023

AssetsCurrent assets
Cash and deposits
Accounts receivable - trade
Other
Total current assets

1,530,969
55

1,063,18830

120,184

50,214

1,651,210

1,113,432

Non-current assets
Property, plant and equipment

00Intangible assets
Investments and other assets

050,234050,234

Total non-current assets

50,23450,234

1,701,444

1,163,667

Accounts payable - trade
Income taxes payable77
10,409

12
8,836

Other

66,072

83,148

Total current liabilities

76,55891,99734,78922,55635,44922,602

Total assets
Liabilities
Current liabilities

Non-current liabilities
Provision for retirement benefits
Asset retirement obligations
Other

0

0

57,34558,051

133,903150,048

Capital stock
Capital surplus

362,185
2,670,720

362,185
2,670,720

Retained earnings
Treasury stock-1,485,633-0-2,039,555-0

Total shareholders’ equity

1,547,272

993,350

20,26820,2681,567,541

1,013,618

1,701,444

1,163,667

Total non-current liabilities
Total liabilities
Net assets
Shareholders' equity

Share acquisition rights
Total net assets
Total liabilities and net assets―6―

(2) Statements of Operations(Thousands of yen)Six months ended
September 30, 2022
Net sales
Cost of sales
Gross profit

Six months ended
September 30, 2023
179
44
134

44
11
33

Selling, general and administrative expenses

805,202550,603

Operating income-805,068-550,569

Interest income
Other

11
546

6
186

Total non-operating income

557

193

4,146
1,073

1,190

Non-operating income

Non-operating expenses
Foreign exchange losses
Share issuance cost
Other
Total non-operating expenses
Ordinary income
Extraordinary losses
Impairment loss

－

61

－

5,281

1,190

-809,792-551,566－

1,406

Total extraordinary losses

－

1,406

Income before income taxes-809,792-552,972

950

950

Income taxes - current
Total income taxes
Net income

―7―

950

950

-810,742-553,922

(4) Statements of Cash Flows(Thousands of yen)

Cash flows from operating activities
Loss before income taxes
Depreciation
Impairment loss

Six months ended
September 30, 2022

Six months ended
September 30, 2023

-809,792-552,972

8,359

48
1,406

Interest and dividend income
Decrease (increase) in notes and accounts receivable - trade－-11
16,506

Increase (decrease) in notes and accounts payable - trade
Increase (decrease) in retirement benefit liability

-63
805

-64
660

Other, net

198,200

86,468Subtotal-585,604-464,436

13
-202

9

Interest and dividend income received
Interest paid

-624-2,420－-1,900-588,604-466,327

Purchase of intangible assets－-1,454

Net cash provided by (used in) investing activities－-1,454-87,500-0－－284,991－

Income taxes paid
Net cash provided by (used in) operating activities
Cash flows from investing activities

Cash flows from financing activities
Redemption of bonds
Purchase of treasury stock
Proceeds from issuance of shares resulting from exercise of shareacquisition rights
Net cash provided by (used in) financing activities

197,491－

Net increase (decrease) in cash and cash equivalents-391,113-467,781

Cash and cash equivalents at beginning of period

2,305,026

1,530,969

Cash and cash equivalents at end of period

1,913,913

1,063,188―8―

(3) Notes to Financial Statements(Notes on going concern assumption)
Not applicable.
(Notes on significant changes in shareholders’ equity)
Not applicable.

―9―