Latest news with #PaulY.Song
Yahoo
14-04-2025
- Health
- Yahoo
NKGen Biotech Presents Data from Phase 1/2a Clinical Trial of Troculeucel in Moderate Alzheimer's Disease at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD™ 2025)
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 part of the study. SANTA ANA, Calif., April 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 the oral presentation of updated Phase 1 clinical data from the Phase 1/2a trial evaluating troculeucel, cryopreserved expanded autologous NK cell therapy, in patients with moderate AD at the International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2025) in Vienna, Austria. Dr. Paul Y. Song, Chairman and Chief Executive Officer of NKGen Biotech, delivered an oral presentation to conference attendees which was focused on the six and twelve-month cognitive and biomarker results from the Phase 1 cohort of the Phase 1/2a clinical trial for troculeucel NK cell therapy in moderate Alzheimer's disease (NCT06189963). Highlights from the presentation: Troculeucel was administered intravenously at a dose of 6 x 109 cells to three patients with moderate AD [median Clinical Dementia Rating – Sum of Boxes (CDR-SB) score of 11]. Primary endpoint was safety, monitored for 21 days after the first dose for each patient. Patients were treated every three weeks. Two patients completed 17 doses while one patient completed 10 doses. Preliminary efficacy was measured using cognitive scales CDR-SB, Mini Mental State Examination (MMSE), Activities of Daily Living Scale (ADCS-ADL-Severe) and Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog-11), with the calculated Alzheimer's Disease Composite Score (ADCOMS) score as an additional measure. Secondary endpoints included changes in protein aggregate and neuroinflammation biomarker levels in the CSF and blood at 6 and 12 months. After up to 12 months of treatment, with a dose of 6 x 109 cells every three weeks, the three patients had no drug-related adverse reactions. At 3 months, preliminary efficacy analyses for the three patients showed stable or improved cognitive scores on CDR-SB and ADCOMS; two of the three patients improved on all cognitive scales and ADCOMS score and downgraded their AD stage from moderate to mild (based on CDR-SB score). At 6 months, all three patients were stable/improved on CDR-SB, ADAS-Cog-11 and ADCOMS with two of the three patients stable/improved on all cognitive scales and ADCOMS score. At 12 months, the two patients completing the 17 doses continued to show stable or improved CDR-SB, ADAS-Cog-11, ADCS-ADL-Severe and ADCOMS scores, with one patient reaching a CDR-SB of 4.5 (considered the cutoff between mild cognitive impairment [MCI] and mild AD). While the initial cohort consisted of three patients, the third patient withdrew from the trial prior to reaching 12 months. This withdrawal was not related to any adverse effects or drug related issues. At 6 months, all three patients showed decreased levels in both CSF and plasma for Glial Fibrillary Acidic Protein (GFAP) while at 12 months, the remaining two patients in the study continue to show decreased levels in plasma. At 12 months, the CSF and plasma Amyloid Beta (Aβ) 42/40 ratio improved in both patients, while the CSF p-Tau 181 and p-Tau 217 levels remained relatively stable. Troculeucel at the highest dose given to moderate AD patients was well tolerated and in 2/3 patients showed clinical improvements after only 3 months on therapy; cognitive scores continued to show stability or improvement through the end of study period at 12 months. Troculeucel will be evaluated for safety and efficacy in the randomized, placebo-controlled Phase 2a part of the study. 'In our prior proof-of-concept Phase 1 dose escalation trial (NCT04678453) we were able to demonstrate that troculeucel was well tolerated and appears to cross the blood brain barrier to improve CSF levels of amyloid, p-tau, and alpha-synuclein proteins,' said Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen. 'Despite the fact that 2/3 of the patients were sub-optimally dosed, 90% of patients had stable or improved cognitive functions (ADCOMS) after 11 weeks of treatment (4 doses).' Dr. Song continued, 'In this new Phase 1/2a trial, we are only treating moderate stage patients and at our highest dose of 6 x 109 cells given every three weeks for one full year. We are pleased again to see no drug related adverse events, and more importantly 100% stable or improved cognitive function using CDR-SB and ADCOMS scores. In fact, two of the first three patients treated at our highest dose have improved from moderate to mild disease including one patient who improved from a CDR-SB baseline score of 11 to 4.5. As GFAP has been shown by others to be a very strong independent biomarker, which correlates well with dementia severity and progression, we observed reductions in GFAP in CSF and plasma which appeared to correlate with cognitive improvement in our patients. We also found improvements in levels of Aβ 42/40. As we begin to rapidly enroll patients in our double-blind randomized Phase 2a trial, we expect to see significant cognitive and biomarker differences between the treatment arm and placebo group within as little as 6 months. We are very excited that troculeucel continues to be well tolerated and shows promising disease modifying activity.' A copy of the presentation will be added to the Scientific Publications page of the Company's website after the conference has concluded. About TroculeucelTroculeucel 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 BiotechNKGen 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 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. 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 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 Affairs949-396-6830dchua@ External Contacts:Kevin GardnerManaging DirectorLifeSci Advisors, LLCkgardner@ in to access your portfolio
Yahoo
14-04-2025
- Business
- Yahoo
NKGen Biotech To Present on the Use of Troculeucel for Alzheimer's and Parkinson's Disease at the 7th China International Biotechnology Conference & Exhibition
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 16-18, 2025. BIOTEC-CHINA 2025 is a premier gathering of biotechnology and pharmaceutical professionals from across the globe. With close to 1,500 attendees, the event offers a unique opportunity for intensive networking, collaboration, and the exploration of promising new partnerships. Covering a broad range of life science research and applications, BIOTEC-CHINA 2025 will spotlight key innovation areas such as drug discovery, biomanufacturing, genomics, nanotechnology, and cell therapy. NKGen Presentation Details: Title: Use of Autologous Enhanced Natural Killer Cells for Alzheimer's and Parkinson's Disease Location: Shuijing Hall, Beijing Huanghe Jingdu Conference Center, The Third Building Date and Time: April 17, 2025, at 10:20 am – 10:40 am CST (China Standard Time) UTC/GMT +8 Dr. Song will present on the use of troculeucel in the treatment of patients with Alzheimer's and Parkinson's disease, highlighting the promising results previously observed in our Phase 1 clinical trials and compassionate use cases. Additionally, Dr. Song will provide an update on NKGen's ongoing Phase 1/2a clinical trial for moderate Alzheimer's disease, with recent data presented at the AD/PD™ 2025 conference. The favorable clinical outcomes and biomarker data disclosed to date offer strong indications that troculeucel may emerge as a viable treatment option for patients with Alzheimer's and Parkinson's disease. Previously disclosed data for troculeucel in Alzheimer's disease can be found on the Scientific Publications page of the Company's website at News releases containing troculeucel clinical trial updates and regulatory approvals can be found on the News page of the Company's website at About TroculeucelTroculeucel 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 BiotechNKGen 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 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 subject 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. 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 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 Affairs949-396-6830dchua@ External Contact:Kevin GardnerManaging DirectorLifeSci Advisors, LLCkgardner@ in to access your portfolio
Yahoo
25-03-2025
- Business
- Yahoo
NKGen Biotech To Present Updated Troculeucel Data at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD™ 2025)
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') taking place online and in Vienna, Austria from April 1 – 5, 2025. AD/PD™ 2025 is a premier event bringing together top international experts to discuss the latest advancements in Alzheimer's and Parkinson's research, clinical trials, and treatments. With over 4,700 participants from 70+ countries and 2,250 abstracts in 2024, it offers a platform for groundbreaking discoveries from the leading experts in the field. Presentation Details: Title: Preliminary Cognitive Improvement in Phase 1 Cohort of Moderate Alzheimer's Disease Subjects Treated with Autologous Natural Killer Cells (Troculeucel; SNK01) Session Name: 7540 – Advances in AD Drug Development 02 Session Type: Symposium Presentation Date: Saturday, April 5, 2025, at 5:10 pm – 5:25 pm CEST Room: Hall E Dr. Song's presentation will focus on the three-month cognitive and biomarker results from the Phase 1 cohort of the Phase 1/2a clinical trial for troculeucel NK cell therapy in moderate Alzheimer's disease, as well as new data from the six-month analysis of this cohort. Previously disclosed data for troculeucel in Alzheimer's disease and solid tumors can be found on the Scientific Publications page of the Company's website at News releases containing troculeucel clinical trial updates and regulatory approvals can be found on the News page of the Company's website at About TroculeucelTroculeucel 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 BiotechNKGen 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 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 subject 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. 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 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 Affairs949-396-6830dchua@ External Contacts:Kevin GardnerManaging DirectorLifeSci Advisors, LLCkgardner@
Yahoo
13-03-2025
- Business
- Yahoo
NKGen Biotech To Present on Potential of Troculeucel for the Treatment of Neurodegenerative Diseases at the 13th Annual Alzheimer's & Parkinson's Drug Development Summit
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, 2025. Dr. Song's presentation will highlight troculeucel, the Company's autologous, non-genetically modified NK cell therapy, as a potential treatment for neurodegenerative diseases. The Summit is the only industry-focused event covering the entire drug development process from discovery to commercialization. This year's Summit will spotlight advancements in neurodegenerative therapeutics, presymptomatic diagnosis, and new targets, modalities, and technologies. Over 150 experts will collaborate to address key challenges and drive the next wave of transformative treatments. Presentation Details: Title: Showcasing the Potential of Enhanced NK Cell Therapies for the Treatment of Neurodegenerative Disease: Introducing Troculeucel Conference Track: In Vivo Translation & Early Clinical Date and Time: March 20, 2025, at 12:00 PM ET Dr. Song's presentation will showcase the potential of enhanced NK cell therapy for the treatment of neurodegenerative disease, introducing troculeucel. Dr. Song will outline the mechanism of troculeucel, the Company's novel, autologous NK cell therapy, for treating neurodegeneration. He will also present promising data from the Company's Phase 1 clinical trial, demonstrating early signs of clinical benefit, leading to the U.S. Food and Drug Administration Fast Track designation for moderate Alzheimer's Disease and a new Investigational New Drug for Parkinson's Disease. Moreover, Dr. Song will highlight the future directions for troculeucel in Frontotemporal Dementia and post-stroke/traumatic brain injury. Previously disclosed data for troculeucel in Alzheimer's disease and solid tumors can be found on the Scientific Publications page of the Company's website at News releases containing troculeucel clinical trial updates and regulatory approvals can be found on the News page of the Company's website at About TroculeucelTroculeucel 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 BiotechNKGen 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 Forward-Looking StatementsStatements 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 subject 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. 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 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 Affairs949-396-6830dchua@ External Contacts:Chris CalabreseManaging DirectorLifeSci Advisors, LLCccalabrese@ Kevin GardnerManaging DirectorLifeSci Advisors, LLCkgardner@ in to access your portfolio
Yahoo
04-03-2025
- Business
- Yahoo
NKGen Biotech, Inc. to Transition from the Nasdaq Global Market to OTC Markets; Reverse Stock Split will not be Implemented
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 stock split. Enrollment in randomized Phase 2a Alzheimer's trial is expected to be completed by the end of Q2 with an initial readout planned for later in 2025. SANTA ANA, Calif., March 04, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer ('NK') cell therapeutics, today announced that on March 3, 2025 it received notice that the Nasdaq Hearings Panel determined to delist the Company's common stock from the Nasdaq Global Market after the close of trading on March 4, 2025, solely due to the Company's continued failure to comply with Rule 5450(b)(2)(A) of Nasdaq's Listing Requirements, related to the market value of its common stock. After delisting from Nasdaq, the Company expects that the common stock will be traded on a market operated by the OTC Markets Group, Inc. commencing on March 5, 2025. The Company intends to apply to trade on the OTCQX platform, the highest OTC tier, which requires ongoing compliance with SEC public reporting requirements. After initial trading on OTC Pink in a short transition period, NKGen's common stock and warrants are expected to begin trading on the OTCQX platform under the same ticker symbols, 'NKGN' for shares of common stock and 'NKGNW' for warrants. With the move away from Nasdaq and its minimum bid price requirement, the Company will not implement the previously announced 1-for-6 reverse stock split. 'Our Company has navigated significant challenges this past year, mostly related to the financial restructuring of our former parent company in South Korea, NKMAX, Co. Ltd.,' said Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen. 'Despite these obstacles, our science and clinical data have remained a consistent source of strength. While initially met with skepticism, our innovative approach using one's own enhanced NK cells to improve proteins and reduce neuroinflammation in Alzheimer's patients and other neurodegenerative diseases has gained significant traction. We've presented promising data at major Alzheimer's focused medical conferences, Alzheimer's Association International Conference (AAIC) and Clinical Trials on Alzheimer's Disease (CTAD) in 2024, received U.S. FDA Fast Track designation, published our Phase 1 results in Alzheimer's Research & Therapy, and attracted growing interest and support. We continue to work on funding the business to support our Phase 2 clinical trial, with the goal of achieving the necessary data and milestones towards obtaining accelerated approval. We remain intently focused on completing enrollment in our randomized Phase 2a Alzheimer's clinical trial with an expected preliminary readout by year-end, and we look forward to resuming trading on Nasdaq once we are able to meet the necessary listing requirements and apply again.' NKGen Interim Chief Financial Officer James Graf added, 'We look forward to continued support from our stockholders and active liquidity in our shares trading on the OTC Markets until we can re-list on Nasdaq. We do not expect this transition to materially affect our ongoing financing discussions, especially as we intend to maintain SEC reporting obligations and do not have to proceed with the previously announced reverse stock split.' About NKGen BiotechNKGen 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 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 subject 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. 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 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 Affairs949-396-6830dchua@ in to access your portfolio
