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NKGen Biotech and HekaBio Enter Strategic Partnership to Bring Novel NK Cell Therapy to Japan

In connection with HekaBio鈥檚 recently announced strategic investment in NKGen, the partnership will expedite the regulatory, manufacturing, and commercial development of NKGen鈥檚 autologous NK cell therapy, troculeucel, in Japan.

Under Japan鈥檚 Regenerative Medicine guidelines, cell therapies enjoy a regulatory environment with multiple paths for expedited commercialization.

Troculeucel is well positioned to be the first-in-class forerunner for the treatment of several intractable neurodegenerative diseases.

SANTA ANA, Calif., July 17, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (鈥淣KGen鈥� or the 鈥淐ompany鈥�), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (鈥淣K鈥�) cell therapeutics, and HekaBio K.K., headquartered in Chuo-ku, Tokyo (鈥淗ekaBio鈥�), announced聽a strategic partnership to accelerate the regulatory, manufacturing and commercial development of NKGen鈥檚 autologous NK cell therapy, troculeucel, in Japan following HekaBio鈥檚 recently announced investment in common equity of NKGen.

HekaBio will lead all clinical trials in Japan and oversee all regulatory activities with Japan's Pharmaceuticals and Medical Devices Agency for pre-market approval of troculeucel in several neurodegenerative disease indications, including Alzheimer鈥檚 and Parkinson鈥檚 Diseases.

As troculeucel is an autologous, non-genetically modified cell therapy, there is allowance under regenerative medicine regulations in Japan to offer this therapy to patients on an accelerated path, much faster than in other major markets. HekaBio will fully leverage the regulation and its domestic strategic partner network, aiming for first dosing in Japanese patients over the next 12 months. Beyond intractable disease, troculeucel has the potential to also support Japan鈥檚 aging population in the longevity/wellness space.

鈥淛apan has always had an advanced progressive health care system where great attention has been placed on the use of novel autologous cell therapies for prevention, longevity, and wellness as well as for the treatment of more chronic illnesses,鈥� said Paul Y. Song, MD, Chairman and Chief Executive Officer (鈥淐EO鈥�) of NKGen. 鈥淚 am convinced that HekaBio鈥檚 clinical, regulatory, and commercial expertise will guide us to satisfy all regulatory requirements, find the best local manufacturing partner to make our therapy readily available, and ultimately develop the best commercial strategy for Japan. We are very excited to partner with HekaBio.鈥�

鈥淒ementia, particularly Alzheimer鈥檚 Disease, and other neurodegenerative diseases together present significant health and social challenges in Japan due to the country鈥檚 aging population. We are very excited about our partnership with NKGen and look forward to advancing troculeucel for the benefit of patients and society,鈥� said Rob Claar, CEO of HekaBio.

About NKGen Biotech

NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. NKGen is headquartered in Santa Ana, California, USA. For more information, please visit聽.

About Troculeucel

Troculeucel is a novel cell-based, patient specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate. NKGen is developing troculeucel for the treatment of neurodegenerative disorders and a broad range of cancers. Troculeucel is the International Nonproprietary Name (鈥淚NN鈥�) for SNK01 assigned by the World Health Organization (鈥淲HO鈥�). The WHO INN approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on NKGen鈥檚 journey toward bringing this therapy to market.

About HekaBio

HekaBio is a Japan-based healthcare platform that accelerates patient access to global medicines and MedTech across Asia-Pacific. HekaBio reviews over 200 assets annually to in-license a select few, focusing on early-stage yet de-risked opportunities in CNS, oncology and healthy longevity. HekaBio synchronizes U.S. and Japan development timelines and leverages strategic partnerships to optimize commercial success. Japan, the world鈥檚 third-largest healthcare market, serves as its launchpad for regional expansion. To learn more about HekaBio鈥檚 mission and portfolio, please visit聽.

Forward-Looking Statements

Statements contained in this press release may contain 鈥渇orward-looking statements鈥� within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as 鈥渁nticipate鈥�, 鈥渂elieve鈥�, 鈥渃ould鈥�, 鈥渃ontinue鈥�, 鈥渆xpect鈥�, 鈥渆stimate鈥�, 鈥渕ay鈥�, 鈥減lan鈥�, 鈥渙utlook鈥�, 鈥渇uture鈥� and 鈥減roject鈥� and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are outside of the Company鈥檚 control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company鈥檚 plans and expected timing for developing troculeucel and SNK02, including the expected timing of completing and announcing further results from its ongoing clinical studies; and the Company鈥檚 expected timing for developing its product candidates and potential benefits of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: the Company鈥檚 ability to execute its plans and strategies; risks related to performing clinical studies; the risk that initial and interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will not be completed as planned; the risk that the abstract will not be published as planned including delays in timing, format, or accessibility; and NKGen鈥檚 ability to raise additional funding to complete the development of its product candidates. These and other risks and uncertainties are described more fully under the caption 鈥淩isk Factors鈥� and elsewhere in the Company鈥檚 filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission鈥檚 website at www.sec.gov and on the Company鈥檚 website under the subheading 鈥淚nvestors鈥擣inancial and Filings鈥�. Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Internal Contact:

Denise Chua, MBA, CLS, MLS (ASCP)
SVP, Corporate Affairs
949-396-6830

External Contact:

Kevin Gardner
Managing Director
LifeSci Advisors, LLC