November 1, 2022

BrightPath Exercised the Option to Obtain Exclusive Development,
Manufacturing and Marketing License for iPS-NKT from RIKENTokyo, Japan - November 1, 2022/ -- BrightPath Biotherapeutics (TSE Growth 4954), a
clinical-stage biopharmaceutical company focused on developing novel cancer
immunotherapeutics, today announced its decision to exercise the option right to obtain aworldwide exclusive license to develop, manufacture and market induced pluripotent stem cell(iPSC)-derived NKT cell (iPS-NKT) from Institute of Physical and Chemical Research (RIKEN).
iPS-NKT is novel allogeneic cell that uses natural killer T (NKT) cells1 differentiated from iPSC
for cancer treatment. At present, an investigator-initiated Phase 1 trial of iPS-NKT in patientswith head and neck cancers is underway at Chiba University as the world’s first clinicalapplication of iPSC-derived NKT cells for cellular therapy.
Since the acquisition of the option to license iPS-NKT from RIKEN in March 2018, BrightPath
has been supporting the Phase 1 study started in June 2020 and working toward theimprovement of the manufacturing process for the subsequent clinical development andcommercialization.
The Phase 1 trial stays on track in general while the patient enrollment is slightly behind theoriginal schedule. The clinical safety assessment is primary focus as the first-in-humanadministration of iPS cell-derived NKT cells and up until now, no safety issues have beenreported.
Over these years autologous CAR-T cell therapy has demonstrated remarkable clinicaloutcomes in patients suffering from blood cancers and subsequently, allogeneic CAR-T has
been developed to overcome the hurdles of autologous CAR-T’s manufacturing instability, theturnaround time from blood sampling to administration, and manufacturing costs. iPS cellderived immune cells are expected to be a key next-generation platform of allogeneic celltherapy that allows for the manufacturing of unprecedentedly homogeneous and large-quantity
cells. Global big pharma have recently inked partnering2 with cellular immunotherapy venturesthat have an iPS cell-derived NK cell platform to develop CAR-iPS-NK.
BrightPath's option exercise is intended to facilitate its effort to build an iPS-NKT platform thatconsists of: (i) the basic patent, (ii) the master iPS cell bank (MCB) and (iii) the manufacturing
process from iPS cell to accurately differentiated NKT cell. The (i) patent in Japan, the US, andthe EU allows BrightPath to stand as the only player licensed to use iPSC-derived NKT cells
for allogeneic cell therapy. The (ii) MCB enables BrightPath alone to access the iPSC-derived
reproducibility of which clinical safety is being evaluated in the ongoing Phase 1 trial. The (iii)manufacturing process ensures that BrightPath is the sole company having a process capableof differentiating iPS cells into properly functioning NKT cells at high yield and high purity incompliance with the industry regulations.
The (i) and (ii) can be achieved through exercising the option right and (iii) has been achieved
as a development milestone through BrightPath’s continuous improvement efforts since its
participation in the iPS-NKT project in 2018 and will be completed by putting it into the format

for clinical settings.
BrightPath is exploring franchising the iPS-NKT platform to CAR iPS-NKT. BrightPath will bereporting the prototype CAR iPS-NKT‘s first non-clinical data at the 37th Annual Meeting ofSociety for Immunotherapy of Cancer (SITC 2022) held in Boston, United States onNovember 8 to 12, 2022.
BrightPath’s option exercise signifies its achievement of one of the development milestones in
the manufacturing process and BrightPath will accelerate the iPS-NKT project as thecompany’s key clinical trial pipeline.
The information disclosed in the announcement has no impact on the earnings forecast for
the fiscal year ending March 2023 announced on May 12, 2022.

1. NKT cells
NKT cells have both properties of a part of NK cells and T cells and bridge innate immunity
and adaptive immunity. NKT cells exhibit a wide variety of antitumor effects that can killcancer cells directly or indirectly. Since NKT cells make up less than 1% of thelymphocytes, the conventional manufacturing process has room for improvement inproliferating properly functioning NKT cells, necessary for the administration to the patient.
One of the effective solutions to overcome the hurdle of clinical-scale manufacturing fromsuch a rare subset of T cells is iPS technology to reprogram NKT cells into iPS cells andproliferate the iPS cells and then re-differentiate iPS cells into NKT cells.
2. Partnering
Fate, Century and Shoreline have CAR-iPSNK platforms and they entered intodevelopment collaborations with Johnson & Johnson, Bristol Myers Squibb, and Gilead,respectively. Fate commenced a Phase 1 trial of CAR-untransduced iPS-NK cells in 2018
and entered an alliance with Johnson & Johnson in 2020.

About BrightPath:
BrightPath is a clinical stage biopharmaceutical company focused on the development ofnovel cancer immuno-therapies to transform cancer treatment for refractory or progressive
cancers that cannot be treated with conventional standard therapies. BrightPath is actively
involved in developing cell therapies currently in clinical trials, immunomodulatory antibodies
and new drug targeted at cancer specific neoantigens.
For more information, visit www.brightpathbio.com/english/index.html.
Forward-Looking Statements:
This news release contains forward-looking statements that are based on the current
expectations and beliefs of BrightPath. All statements, other than statements of historical fact,
are statements that could be deemed forward-looking statements. BrightPath cautions thatthese forward-looking statements do not guarantee our future financial results but involverisks and uncertainties that could cause actual results to differ materially from those
discussed in the forward-looking statements. These forward-looking statements speak only asof the date of this press release and BrightPath assumes no duty to update forward-looking
statements, except as may be required by law.

Investor and Media Contact:+81-3-5840-7697
irpr@brightpathbio.com
www.brightpathbio.com/english/index.html