New funding from Dr. Song augments $3.0 million in funding advances from AlpineBrook Capital in 2025 above and beyond the $5.5 million proceeds and additional $4 million commitments in previously-disclosed AlpineBrook convertible notes. SANTA ANA, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- 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 therapeu ...

SANTA ANA, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- 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 an upcoming presentation on Phase 1 clinical data from the Company's Phase 1/2a trial evaluating troculeucel, cryopreserved expanded autologous NK cell therapy, in patients with moderate Alzheimer's disease (AD), at ...

SANTA ANA, Calif., April 14, 2025 (GLOBE NEWSWIRE) -- 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 that Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen, will be speaking at the 7th China International Biotechnology Conference & Exhibition (BIOTEC-CHINA 2025), to be held in Beijing, China, April ...

Moderate Alzheimer’s disease (AD) patients in the trial received the highest dose of troculeucel to date at 6 billion cells per treatment. After 12 months of treatment, both patients who completed 17 doses improved from moderate to mild AD within just 3 months. One patient stabilized at their improved score, while the other patient continued to show ongoing improvement. Clinical development of troculeucel is ongoing and will be evaluated for safety and efficacy in the randomized, placebo-controlled Phase 2a ...

SANTA ANA, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- 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 that Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen, will present at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (“AD/PD™ 2025”) takin ...

SANTA ANA, Calif., March 13, 2025 (GLOBE NEWSWIRE) -- 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 that Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen, will present at the 13th Annual Alzheimer’s & Parkinson’s Drug Development Summit (the “Summit”) to be held in Boston, MA, from March 18–20, ...

Trading commencing on the OTC Markets on March 5, 2025.Trading expected to continue under ticker symbol “NKGN” for common stock and “NKGNW” for warrants.NKGen Biotech, Inc. (“NKGen” or the “Company”) has regained compliance on its public reporting obligations with the filing of its most recent quarterly report on Form 10-Q on March 4, 2025; and intends to continue complying with all Securities and Exchange (“SEC”) reporting requirements.The Company has cancelled its previously announced 1-for-6 reverse stoc ...

Financial Performance - The company reported a net loss of $6.6 million for the three months ended September 30, 2024, compared to a loss of $33.2 million for the same period in 2023, with an accumulated deficit of $177.0 million as of September 30, 2024[240]. - Total net income (loss) for the nine months ended September 30, 2024 was a loss of $14,872,000, an improvement of $34,476,000 compared to a loss of $49,348,000 in the same period of 2023[268]. - The company experienced a $34.5 million increase in net loss during the nine months ended September 30, 2024, compared to the previous year[327]. Revenue and Product Development - No revenue was recognized during the three and nine months ended September 30, 2024 and 2023, as the company does not currently have any products approved for sale[244]. - The company received IND clearance from the FDA for SNK01 in Alzheimer's disease on October 20, 2023, and began dosing participants in the clinical trial on December 28, 2023[236]. - In a Phase I clinical trial for SNK01, 30% of patients showed clinical improvement on the ADCOMS score compared to baseline, and 60% showed stable scores one week after the last dose[237]. - The Phase 2 trial for SNK01 in moderate Alzheimer's disease will involve 30 patients, with 20 receiving SNK01 and 10 receiving a placebo[238]. - The company presented Phase I clinical interim trial data for SNK02, showing 100% of patients demonstrated stable disease after eight cycles of treatment[239]. Expenses - Research and development expenses are expected to increase as the company continues to develop its platform and product candidates[246]. - General and administrative expenses are anticipated to rise due to ongoing costs of operating as a public company and establishing sales and marketing functions[253]. - Research and development expenses for Q3 2024 were $2,778,000, a decrease of $1,151,000 or 29% compared to Q3 2023[267]. - General and administrative expenses increased by $1,036,000 or 35% to $4,010,000 in Q3 2024 compared to Q3 2023[267]. - Total expenses for Q3 2024 were $6,788,000, a slight decrease of $115,000 or 2% from $6,903,000 in Q3 2023[267]. - General and administrative expenses increased by $4.0 million, or 46%, for the nine months ended September 30, 2024, mainly due to a $3.8 million increase in professional fees[281]. Cash Flow and Financing - As of September 30, 2024, the company had cash and cash equivalents of $8 thousand and a working capital deficit of approximately $36.2 million[295]. - The company raised total proceeds of $2.6 million from Private Placement Agreements during the nine months ended September 30, 2024[313]. - The company drew down $4.9 million from a $5.0 million revolving line of credit agreement, which is secured by all of its assets[307]. - For the nine months ended September 30, 2024, net cash used in operating activities was $13.9 million, a decrease of $1.1 million compared to $15.0 million for the same period in 2023[326][328][329]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $13.9 million, a decrease of $10.1 million from $24.0 million in the same period in 2023[333][334][335]. Debt and Liabilities - The company incurred significant transaction costs related to the Business Combination and issued various financial instruments, including Senior Convertible Notes and warrants[235]. - The company had outstanding debts of $19.9 million as of September 30, 2024, which included a revolving line of credit with East West Bank[296]. - Interest expense for the nine months ended September 30, 2024 was $2,188,000, an increase of $1,881,000 or 613% compared to $307,000 in the same period of 2023[268]. - Loss on issuance of financial instruments totaled $17.9 million for the nine months ended September 30, 2024, primarily due to additional issuances made during 2024[287]. Going Concern and Future Outlook - The company expressed substantial doubt about its ability to continue as a going concern without securing additional funding[242]. - The company has expressed substantial doubt regarding its ability to continue as a going concern due to ongoing net losses and the need for potential debt or equity financing[302]. - The company prioritized AD trials in 2024, leading to a significant reduction in overall research and development costs[269]. Fair Value and Financial Instruments - The fair value of the company's common shares was based on publicly listed share prices beginning October 2, 2023[349]. - The Public Warrants, SPA Warrants, and Deferred Founder Shares were classified as equity instruments, while the Senior Convertible Notes and various warrants were classified as liabilities[356]. - The fair value of liability-classified instruments includes Private Warrants, Working Capital Warrants, and 2024 Convertible Notes, which are measured at fair value on a recurring basis[362]. - The estimated fair value of liability-classified warrants was determined using a Black-Scholes model, incorporating assumptions related to stock-price volatility and risk-free interest rates[364]. - The fair value of the 2024 Convertible Notes will be measured using a probability weighted scenario model starting April 1, 2024, reflecting changes in entity-specific assumptions[367]. Company Classification - The company qualifies as an emerging growth company and may rely on certain exemptions from public company reporting requirements for up to five years following its IPO[374]. - The company is classified as an emerging growth company until certain conditions are met, including achieving total annual gross revenue of at least $1.235 billion[375]. - The company qualifies as a "smaller reporting company" with a market value of common stock held by non-affiliates plus gross proceeds from the Business Combination being less than $700 million[376]. - Annual revenue for the most recently completed fiscal year is less than $100 million, allowing the company to maintain its smaller reporting company status[376].

Core Viewpoint - NKGen Biotech has initiated the administration of troculeucel, an autologous NK cell therapy, to a stroke patient under a compassionate use IND approved by the FDA, marking a significant step in exploring its therapeutic potential in post-stroke treatment [1][3]. Company Overview - NKGen Biotech is a clinical-stage biotechnology company focused on developing and commercializing innovative autologous and allogeneic NK cell therapeutics, headquartered in Santa Ana, California [7]. Product Development - Troculeucel is a novel, patient-specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate, being developed for neurodegenerative disorders and various cancers. The WHO has assigned the International Nonproprietary Name (INN) "troculeucel" for SNK01, which is a significant milestone for the company [6]. Clinical Collaboration - NKGen is collaborating with Dr. Dimitri Sigounas and Dr. Amarendra K. Neppalli from George Washington University Medical Center to explore the potential of troculeucel in reducing chronic neuroinflammation and damage in stroke patients [3][5]. Clinical Assessment - The stroke patient receiving troculeucel will undergo regular independent assessments by Dr. Sigounas at GWU Medical Center to evaluate the treatment's effectiveness [4]. Research Insights - Neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) are identified as markers of brain injury, and previous trials have shown that troculeucel can cross the blood-brain barrier to reduce cerebrospinal fluid levels of these markers, indicating its potential to improve outcomes in stroke patients [5].

Core Viewpoint - NKGen Biotech has initiated the administration of troculeucel, an autologous NK cell therapy, to a frontotemporal dementia (FTD) patient under a compassionate use IND approved by the FDA, marking a significant step towards potential treatment options for FTD patients with limited alternatives [1][3]. Company Overview - NKGen Biotech, Inc. is a clinical-stage biotechnology company focused on developing and commercializing innovative autologous and allogeneic NK cell therapeutics, headquartered in Santa Ana, California [6]. Treatment Context - Approximately 60,000 individuals in the U.S. are currently living with FTD, with up to 40% of cases having a genetic component, such as the C9orf72 gene mutation present in the patient receiving troculeucel [2]. - There are currently no available treatments that can slow or halt the progression of FTD [2]. Research Collaboration - NKGen is collaborating with Dr. Mario Mendez and Dr. Jessica Rexach from UCLA to explore the therapeutic potential of troculeucel for FTD, with this initial administration being part of a broader effort to investigate NK cell therapy for neurodegenerative diseases [3]. Scientific Insights - Previous studies have shown that troculeucel can cross the blood-brain barrier and improve levels of amyloid, α-synuclein, and tau proteins in cerebrospinal fluid (CSF) of Alzheimer's patients, while also reducing neuroinflammation indicated by decreased levels of glial fibrillary acidic protein (GFAP) [4]. - GFAP and tau proteins are consistently elevated in FTD patients, supporting the rationale for testing troculeucel in this population [4]. Future Directions - The administration of troculeucel is seen as a pivotal step towards developing effective strategies for immune cell modulation in FTD, with the potential to address currently incurable neurodegenerative disorders [4][5].