Financial Results for the Nine Months ended December 31, 2023
[Japanese GAAP] (non-consolidated)
February 9, 2024
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:: February 9, 2024
Scheduled date of dividend payment commencement:－
Supplementary materials for financial statements: NoneBriefing of financial results: None(Millions of yen, rounded down to the nearest million)
1. Financial results for fiscal for the nine months ended December 31, 2023 (April 1, 2023 – December 31, 2023)(1) Results of Operation(Percentages represent changes from the same period of previous year)
Net sales
Nine months ended
December 31, 2023
December 31, 2022

Millionyen
05Operating income
%

-98.7
－

Millionyen-947-1,218

Ordinary income%－－

Millionyen-947-1,223

Net income%－－

Millionyen-953-1,225%－－

Fully diluted net
income per
share
Nine months ended
Yen
Yen
December 31, 2023
-15.14－
December 31, 2022
-20.91－(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 ofDecember 31, 2023
March 31, 2023
(Reference) Shareholders’ equity

Net assets

Million yen
1,428
1,701
As of December 31, 2023
As of March 31, 2023

Equity ratio

Million yen
772
1,567
747 million yen
1,547 million yen

%
52.4
90.9

2. Dividends
Annual dividends per share
1Q
Yen
－
－

2Q
Yen
0.00
0.00

3Q
Yen
－
－

4Q
Yen
0.00

Total
Yen
0.00

Fiscal year ended March 31, 2023
Fiscal year ending March 31, 2024
Fiscal year ending March 31, 2024
0.00
0.00
(Forecast)(Note)
Revisions to the forecast of cash dividends most recently announced: None
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 previous year)
Net income
Operating income Ordinary income
Net income
Net sales
per share
MillionMillionMillionMillion
%
%
%
%
Yen
yen
yen
yen
yen
Full year0-98.7 -1,588-24.04－ -1,589－ -1,592－(Note)
Revisions to the projected financial results most recently announced: Yes

[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 ofDecember31, 2023
As ofDecember31, 2023
9 months
ended
December31, 2023

64,841,300 shares

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

9 months
ended
63,008,301 shares
December31, 2022

1 share58,603,295 shares* 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 Nine Months Ended December 31, 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 Nine Months Ended December 31, 2023 .................... 2(1) Overview of Operating Results ................................................................................................................. 2(2) Overview of Financial Position .................................................................................................................. 4(3) Outlook for the Fiscal Year Ending March 31, 2024 ................................................................................. 4
2. Financial Statements and Primary Notes ....................................................................................................... 5(1) Balance Sheets ......................................................................................................................................... 5(2) Statements of Operations ......................................................................................................................... 6(3) Notes to Financial Statements .................................................................................................................. 7(Notes on going concern assumption) ....................................................................................................... 7(Notes on significant changes in shareholders’ equity) ............................................................................. 7(Significant subsequent events) ................................................................................................................ 7―1―

1. Qualitative Information of Business Results for the Nine Months Ended December 31, 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 nine months ended December 31, 2023.
Cell therapy agents<iPSC derived natural killer T-cell (NKT cell) therapy: BP2201>
BP2201(iPS-NKT) is a novel allogeneic cell therapy candidate for cancer treatment that uses naturalkiller T-cells (NKT cells)1 with manifold anti-tumor effects including killing cancer cells, manufactured athigh yield by iPS cell technologies. Cancer treatment has entered a new age with the appearance of
CAR-T cell2 drug that is a combination of T-cells collected either from patients themselves or fromhealthy individuals and chimeric antigen receptors (CAR) that can recognize cancer antigens toenhance its ability killing cancer cells. For hematologic cancer treatments, several CAR-T cell productsthat are genetically modified based on T-cells collected from patients themselves have already been
approved and followed by development of next-generation CAR-T cells with high function. The
Company is developing a differentiated CAR-T cell product (CAR-iPSNKT) by adopting NKT cells
generated from healthy donor-derived iPS cells as its T-cell.
The Company, so far, obtained exclusive license to use a patent in Japan, the US, and the EU toprotect the Company’s extensive and exclusive use of iPS-derived NKT cells for allogeneic cell therapy
from Institute of Physical and Chemical Research (a.k.a. RIKEN), developed a manufacturing process
to differentiate iPS cells in the master iPS cell bank into high-purity and high-yield NKT cells andimplemented a gene-editing technology. As for clinical application of iPS-NKT, an investigator-initiatedPhase 1 trial of iPS-NKT in patients with head and neck cancers (started in June 2020) is underway at
Chiba University. This Phase 1 trial stays on trach and, un until now, no safety issues have beenreported.
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.
<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
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 molecules3 or immunomodulatory molecules suppress the immune―2―

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 for specific cancer types and tumor tissues, the Company has altered
BP1202 to add the function to selectively eliminate tumor cells and Tregs. In addition, the target
combination of BP1212 is a potential candidate for the first-in-class drug, that is, the first breakthroughdrug approved in the same drug class.
Proof of concept has been achieved 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 vaccines4 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 HLA5A2 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 ninemonths ended December 31, 2023 as follows: operating loss of 947,173 thousand yen (1,218,371
thousand yen in the corresponding period of the prior year), ordinary loss of 947,580 thousand yen(1,223,957 thousand yen in the corresponding period of the prior year), and net loss of 953,765
thousand yen (1,225,382 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.
<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.
―3―2. CAR-T cell
Chimeric antigen receptor gene-modified T-cell. Chimeric antigen receptors are gene-transfected into
T-cells (a type of lymphocyte with anti-tumor immunity) to recognize antigens expressed by cancer cells.
3. 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.
4. 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.
5. 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 December 31, 2023, total assets were 1,428,572 thousand yen, a decrease of 272,872
thousand yen from the end of the prior fiscal year. The main factors for this include a decrease of
234,026 thousand yen due to expenditures related to research and development, etc. in cash anddeposits.
(ii) Liabilities
As of December 31, 2023, total liabilities were 655,819 thousand yen, an increase of 521,915
thousand yen from the end of the prior fiscal year. The main factors for this include a record of 500,000
thousand yen in current portion of bonds payable by issuing the series 2 unsecured bonds.
(iii) Net assets
As of December 31, 2023, net assets were 772,753 thousand yen, a decrease of 794,787 thousand
yen from the end of the prior fiscal year. The factor for this is a net loss of 953,765 thousand yen.
As a result of the above, equity ratio was 52.4% compared to 90.9% at the end of the prior fiscal
year.
(3) Outlook for the Fiscal Year Ending March 31, 2024
We revised our projected financial results for the fiscal year ending March 31, 2024 from thoseannounced on May 12, 2023. In accordance with “Announcement of Issuance of Series 16 Moving
Strike Warrants and Unsecured Bonds (Private Placement Bonds:PPB) dated November 14, 2023, wepropelled our development and research activities including development of CAR-iNKT prototype
product.

―4―

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

As of December 31, 2023

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

1,530,969
55

1,296,943
24

120,184

82,307

1,651,210

1,379,275

Non-current assets
Property, plant and equipment

00Intangible assets
Investments and other assets

050,234049,296

Total non-current assets

50,23449,296

1,701,444

1,428,572

77

18
500,000

Total assets
Liabilities
Current liabilities
Accounts payable - trade
Current portion of bonds payable
Income taxes payable
Other－
10,40966,072

Total current liabilities

5,976
91,90776,558597,902

Non-current liabilities
Provision for retirement benefits

34,78935,291

Asset retirement obligations
Other

22,556
0

22,6250Total non-current liabilities
Total liabilities

57,34557,916

133,903655,819

Net assets
Shareholders' equity
Capital stock

362,185

439,412

Capital surplus
Retained earnings

2,670,720-1,485,633

2,747,947-2,439,399

Treasury stock
Total shareholders’ equity
Share acquisition rights
Total net assets
Total liabilities and net assets

―5―

-0

-0

1,547,272

747,960

20,26824,792

1,567,541

772,753

1,701,444

1,428,572

(2) Statements of Operations(Thousands of yen)
Nine months ended
December 31, 2022
Net sales
Cost of sales
Gross profit

Nine months ended
December 31, 2023

5,229
1,282
3,946

67
16
50

Selling, general and administrative expenses

1,222,318

947,223

Operating income-1,218,371-947,173Interest income
Other

11
546

6
186

Total non-operating income

557

193

4,018
2,064

510

Non-operating income

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

61

－
90

6,144

601

-1,223,957-947,580－

4,760

Total extraordinary losses

－

4,760

Income before income taxes-1,223,957-952,340

1,425

1,425

Income taxes - current
Total income taxes
Net income

―6―

1,425

1,425

-1,225,382-953,765

(3) Notes to Financial Statements(Notes on going concern assumption)
Not applicable.
(Notes on significant changes in shareholders’ equity)
Capital stock and capital surplus increased by 77,226 thousand yen each by execution of the series 16
warrants during the nine months ended December 31, 2023. As of December 31, 2023, capital stock was
439,412 thousand yen and capital surplus was 2,747,947 thousand yen.
(Significant subsequent events)(Exercise of Series 16 warrants)
The series 16 warrants with exercise price amendment clause (third-party allotment) held by Macquarie
Bank Limited has been partially exercised during the period from January 1, 2024 to February 8, 2024. Summaryof the exercise of the warrants is as follows:
1. Class and number of shares issued

Common stock 2,050,000 shares

2. Total amount of issue price160,350 thousand yen

As a result, capital stock and capital surplus increased by 80,513 thousand yen each, including 676 thousand
yen transferred from share acquisition rights.

―7―