UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): September 4, 2025
NKGen Biotech, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-40427 | 86-2191918 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
3001 Daimler Street
Santa Ana, CA, 92705
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (949) 396-6830
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| OTC Expert Market | ||||
| OTC Expert Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.01 Completion of Acquisition or Disposition of Assets
On September 4, 2025, NKGen Biotech, Inc. (the “Company”) completed the acquisition of a majority equity stake in NKMax Co., Ltd. (“NKMax”), a Korean biotechnology company, out of bankruptcy, previously disclosed in the Current Reports on Form 8-K filed on June 20, 2025 and December 2, 2024. The Company purchased 46,400,000 common shares of NKMax at a price per share of approximately $0.36. This transaction grants the Company full control over NKMax’s global manufacturing infrastructure, intellectual property (“IP”), and exclusive commercialization rights.
The acquisition was supported by funding of approximately $17 million, with the majority of the funding provided by AlpineBrook Capital GP I Limited and the remainder supplied by Paul Y. Song, M.D., the Company’s Chairman and Chief Executive Officer. The terms of such funding are currently under discussion and will be disclosed upon finalization.
As a result of the transaction, the Company now owns a 65%% interest in NKMax and has assumed control of NKMax’s manufacturing infrastructure and IP. This acquisition is expected to accelerate the clinical development of the Company’s lead therapeutic candidate, troculeucel, and expand the Company’s pipeline of natural killer cell therapies.
As determined in accordance with Rule 13d-3 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), NKMax beneficially owns a greater than 10% equity interest in the Company. Founded in 2002 and headquartered in Seoul, South Korea, NKMax is a clinical-stage biotechnology company focused on advancing immune cell therapies. In addition to its therapeutic innovations, NKMax develops and commercializes bioreagents and immunodiagnostic kits, with revenues derived from these products as well as health supplements. In 2016, NKMax completed its GMP-certified manufacturing facility, strengthening its capabilities in high-quality cell therapy production. Listed on the KOSDAQ, a South Korean stock exchange, NKMax’s trading has since been suspended during the course of ongoing rehabilitation efforts.
Item 7.01 Regulation FD Disclosure
The Company issued a press release on September 9, 2025, announcing the completion of the acquisition. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information presented in Item 7.01 of this Current Report on Form 8-K and the accompanying press release shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or specifically incorporates it by reference into a filing under the Securities Act or the Exchange Act.
1
Forward-Looking Statements
Statements contained in this press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are patient to risks and uncertainties, many of which are outside of the Company’s 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’s 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’s 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’s 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 the Company’s ability to raise additional funding to complete the development of its product candidates. Additional risks include uncertainties related to the Company’s acquisition of a majority interest in NKMax, including risks regarding the future performance of NKMax’s business, the Company’s ability to successfully integrate NKMax’s operations, personnel, and technologies, potential challenges in realizing expected synergies and cost savings, and risks that the Company may not achieve the anticipated strategic, financial, or operational benefits of the acquisition on the expected timeline or at all. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in the Company’s filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website at www.sec.gov and on the Company’s website under the subheading “Investors—Financial and Filings”. 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.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press release, dated September 9, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
2
SIGNATURES
Pursuant to the requirements of Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| NKGEN BIOTECH, INC. | ||
| Date: September 9, 2025 | /s/ Paul Y. Song | |
| Name: | Paul Y. Song | |
| Title: | Chief Executive Officer | |
| (Principal Executive Officer) | ||
3
Exhibit 99.1
NKGen Biotech, Inc. Announces Completion of NKMax Co., Ltd. Acquisition; Gains Full Control of Global Manufacturing and Intellectual Property Assets
| ● | NKGen acquires controlling stake in NKMax, marking a pivotal moment in its transformation into a fully integrated, self-sustaining, cell therapy company with global manufacturing and IP control. |
| ● | Approximately $16.9 million paid to acquire 65% equity stake in recapitalized debt-free NKMax, with NKMax operations now expected to be funded through 2026. |
| ● | Funding provided by AlpineBrook Capital GP 1 Limited and NKGen CEO Dr. Paul Y. Song. |
SANTA ANA, Calif., September 9, 2025 -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced the successful completion of its acquisition of a majority equity stake in NKMax Co., Ltd. (“NKMax”), a Korean biotechnology company, out of bankruptcy. This acquisition marks a transformative step for NKGen, granting full control over key global manufacturing infrastructure, intellectual property (“IP”), and exclusive commercialization rights, while solidifying the Company’s position as an independent and vertically integrated leader in NK cell therapeutics.
This transaction is a culmination of a multi-year journey that has seen NKGen overcome significant challenges, emerge stronger, and continue its unwavering commitment to advancing groundbreaking cell therapies. Originally founded as a subsidiary of NKMax in 2017, NKGen has long benefited from its parent’s financial backing to drive the development of its innovative NK cell therapy platform. In October 2023, NKGen made the pivotal decision to go public in the U.S., securing a $25 million backstop commitment from NKMax to fund clinical development of NKGen’s flagship Alzheimer’s treatment. However, NKMax ultimately provided only $10 million of the $25 million backstop initially committed, marking the start of financial challenges for NKGen.
There were several unforeseen and unfortunate circumstances which led to the suspension of trading of NKMax shares on the KOSDAQ Korean Stock Exchange, and NKMax’s subsequent collapse into bankruptcy in 2024. This created significant financial challenges and uncertainty for NKGen which negatively impacted its own stock, ability to raise funds and eventual delisting from Nasdaq. In response to these challenges, NKGen’s leadership acted swiftly, with the support of AlpineBrook Capital GP 1 Limited (“AlpineBrook”), which recognized the potential of the combined companies. AlpineBrook provided the majority of the $17 million funding to NKGen for the purchase of NKMax shares. The entirety of the funding for the NKMax shares was provided by AlpineBrook and NKGen CEO Dr. Paul Y. Song, with terms to be finalized and disclosed in due course. This strategic partnership and infusion of capital are a testament to AlpineBrook’s confidence in the long-term growth and success of NKGen, now poised to leverage its newly acquired assets to drive future commercialization.
“This is more than an acquisition, it’s a turning point in our company’s history,” said Paul Y. Song, M.D., Chairman and CEO of NKGen. “The past couple of years have been incredibly challenging, but we had an unwavering belief in the science behind our therapy and its true potential to change lives. This belief drove each of us, at every level of the company, to make sacrifices, stay committed, and keep building even though our future was very uncertain. With the support of AlpineBrook, who recognized our dedication and scientific promise, we have been blessed with the chance to now fully integrate NKMax’s capabilities and expertise into NKGen while taking full control of all IP and global distribution rights. We believe removing the uncertainty of the parent company overhang has also begun to generate renewed interest from U.S. and international investors alike and will allow us to enter a new era of opportunity and long-term growth. We believe the acquisition of NKMax will also allow us to rapidly expand and forge partnerships throughout Asia and the Middle East.”
Dr. Song continued, “I am incredibly optimistic about the future of our lead therapeutic candidate, troculeucel, which has already been granted fast track designation by the U.S. Federal Drug Administration. We are consistently demonstrating cessation of disease progression and/or demonstrable cognitive improvements in over 90% of all Alzheimer’s patients treated to date and we are eagerly awaiting the completion of enrollment and generation of clinical and biomarker data from our double blinded randomized Phase 2 trial for moderate stage Alzheimer’s disease. With past challenges behind us, we are more focused and energized than ever, now turning our attention to advancing our clinical trials both in the U.S. and globally, with the goal of delivering this groundbreaking therapy to the patients who need it the most.”
Looking ahead, we believe NKGen is well-positioned to accelerate the clinical development of its lead Alzheimer’s therapy, troculeucel, and expand its pipeline of NK cell therapies. With full ownership of NKMax’s manufacturing infrastructure and IP, the company expects to be primed for global commercial success and further strategic partnerships. The Company anticipates significant investor interest, as it enters a new chapter focused on long-term value creation for shareholders and patients worldwide.
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 (“INN”) for SNK01 assigned by the World Health Organization (“WHO”). The WHO INN approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on NKGen’s journey toward bringing this therapy to market.
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 https://nkgenbiotech.com/.
Forward-Looking Statements
Statements contained in this press release may contain “forward-looking statements” 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 “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are patient to risks and uncertainties, many of which are outside of the Company’s 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’s 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’s 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’s 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’s ability to raise additional funding to complete the development of its product candidates. Additional risks include uncertainties related to the Company’s acquisition of a majority interest in NKMax, including risks regarding the future performance of NKMax’s business, the Company’s ability to successfully integrate NKMax’s operations, personnel, and technologies, potential challenges in realizing expected synergies and cost savings, and risks that the Company may not achieve the anticipated strategic, financial, or operational benefits of the acquisition on the expected timeline or at all. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in the Company’s filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website at www.sec.gov and on the Company’s website under the subheading “Investors—Financial and Filings”. 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
dchua@nkgenbiotech.com
External Contact:
Kevin Gardner
Managing Director
LifeSci Advisors, LLC
kgardner@lifesciadvisors.com