Latest news with #NKGenBiotech
Yahoo
3 days ago
- Business
- Yahoo
NKGen Receives FDA Expanded Access Protocol Authorization for Landmark Treatment of Several Neurodegenerative Diseases
Troculeucel, a cryopreserved, autologous enhanced natural killer cell therapy, has demonstrated preliminary clinical benefit without any drug-related adverse events in two Phase I clinical trials in Alzheimer's Disease. Company receives expanded access protocol authorization from the U.S. Food and Drug Administration (FDA) for troculeucel granted to treat patients with known diagnoses of multiple neurodegenerative diseases. IND approval allows for up to 20 patients to be enrolled; first patient enrollment is anticipated in Q3 2025. SANTA ANA, Calif., July 21, 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 the U.S. Food and Drug Administration (FDA) has granted Expanded Access Program (EAP) authorization for its IND for an open-label, non-randomized, multi-center intermediate size expanded access protocol for use of troculeucel for neurodegenerative diseases. This includes its use for the treatment of several neurodegenerative diseases, many of which currently have no effective therapy. While NKGen's ongoing double-blind randomized Phase 2a trial is focused on moderate-stage Alzheimer's disease (NCT06189963), this EAP IND marks the company's exploration into the treatment of other less common neurodegenerative diseases. In addition to earlier stage Alzheimer's Disease (AD), this IND includes the treatment of Parkinson's Disease (PD), Amyotrophic Lateral Sclerosis (ALS), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP), Frontotemporal Dementia (FTD), Corticobasal degeneration (CBD), Multiple Sclerosis (MS) and Lewy Body Dementia (LBD). This IND approval will allow NKGen to expand and explore the use of troculeucel in up to 20 patients. 'There is a common element of autoimmune neuroinflammation in all of these neurodegenerative diseases due to autoreactive T cells, many in response to either an amyloid, alpha-synuclein, or tau protein deposition,' said Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech. 'As we have demonstrated in two Phase I trials in Alzheimer's Disease, troculeucel, given via a simple IV, appears to cross the blood brain barrier to reduce neuroinflammatory and protein biomarkers in CSF. We believe there is ample scientific and clinical rationale to offer this to patients with other neurodegenerative diseases for which there is no effective therapy and little hope. We will begin enrolling patients as soon as possible, but the speed of enrollment will depend on funding.' 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 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. 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@
Yahoo
16-07-2025
- Business
- Yahoo
NKGen Biotech Announces New Funding to Regain Compliance with Reporting Obligations and Listing Standards
Funding in the amount of $2.0M from Japanese strategic investor, in the form of common equity PIPE with warrants. New funding provides for necessary resources to regain compliance with reporting obligations and listing standards. Share trading will move to the OTC Expert Market temporarily, with potential to uplist to OTCQB as soon as SEC filings are current, with plan to return to Nasdaq or to NYSE American. SANTA ANA, Calif., July 16, 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 it has raised $2 million in new capital from a Japanese strategic investor, who will help NKGen bring its novel NK cell therapy, troculeucel, autologous expanded NK cell therapy, to the Japanese market. The new investment was made in the form of shares of the Company's common stock priced at $0.25 per share and warrants, as described in the Company's Form 8-K filed with the Securities and Exchange Commission on July 16, 2025. This new injection of capital, the Company's ramping up of its Phase 2 clinical trial, the expected near-term satisfaction of public company reporting requirements and satisfaction of the previously disclosed payment obligation on the Company's senior secured debt are all critical to position the Company for long-term success. 'This past year presented significant external challenges, particularly stemming from the unexpected bankruptcy of our former parent company, NKMax Co., Ltd. in June 2024,' said Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen. 'This event initially disrupted our ability to raise capital in the U.S. despite the encouraging progress we continued to make in our clinical trials and compassionate use cases. However, our team remained focused and committed to our mission. Through disciplined execution of our science and clinical programs, we not only sustained our momentum but also succeeded in securing the capital necessary to acquire a majority stake in NKMax out of bankruptcy, as previously disclosed. This transaction, expected to officially close in the coming month, removes a major overhang and allows us to consolidate key intellectual property rights across Asia. This strategic acquisition has already sparked renewed interest from both U.S. and international investors. We look forward to sharing further details in the near future about NKMax and strategic relationships and plans in Asia.' 'This marks our first strategic investor in an important market for our therapy for Alzheimer's and other neurodegenerative diseases,' said James Graf, NKGen's Interim Chief Financial Officer. 'As in our other recently announcing funding, this new funding comes at a pivotal time for the Company, which has faced operational challenges due to limited financial resources and the need to make hard decisions on our use of cash, including the unfortunate but unavoidable delay in our financial filings. With all the necessary service providers fully engaged on the effort now, we're on track to regain compliance in the near term.' Mr. Graf continued, 'The Company has been informed by the OTC Markets Group that its trading will move from OTC Pink to the Expert Market until it regains compliance in its financial filings. The Expert Market allows for limited trading but does not allow public access to bid and ask prices or other information, including trading volume. Instead, pricing information will only be accessible to brokers and market makers. The move will make it more difficult for investors to freely trade the shares of NKGen during this short period until we regain filing compliance. We take our filing obligations seriously and greatly regret the short-term impact resulting from our prior limited access to capital. We ask our investors for patience during this time, after which we expect to emerge on OTCQB and later back on Nasdaq well-positioned for the future.' The Company also announced that it is committed to uplisting back to Nasdaq or to NYSE American as soon as it meets the requirements for newly listed companies, including among other things SEC filing compliance, minimum market capitalization and public float and minimum share price. On February 25, 2025, the Company's shareholders approved a reverse split that is intended to aid in compliance with the share price requirement before uplisting, if so exercised. 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 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@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
11-07-2025
- Business
- Globe and Mail
Delisting of Securities from The Nasdaq Stock Market
NEW YORK, July 11, 2025 (GLOBE NEWSWIRE) -- The Nasdaq Stock Market announced today that it will delist the common stock and warrants of NKGen Biotech, Inc. NKGen Biotech, Inc.'s securities were suspended on March 5, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock, rights, and units of Aquaron Acquisition Corp. Aquaron Acquisition Corp.'s securities were suspended on March 7, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock, warrants, and rights of Bannix Acquisition Corp. Bannix Acquisition Corp.'s securities were suspended on March 17, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock of Avenue Therapeutics, Inc. Avenue Therapeutics, Inc.'s stock was suspended on March 19, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock, warrants, units, and rights of WinVest Acquisition Corp. WinVest Acquisition Corp.'s securities were suspended on March 21, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock, warrants, units, and rights of WinVest Acquisition Corp. WinVest Acquisition Corp.'s securities were suspended on March 21, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock of IMAC Holdings, Inc. IMAC Holdings, Inc.'s stock was suspended on March 26, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common shares of Lytus Technologies Holdings PTV Ltd. Lytus Technologies Holdings PTV. Ltd.'s commons shares were suspended on March 31, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the ordinary shares of Luokung Technology Corp. Luokung Technology Corp's security was suspended on March 31, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common shares of Aptose Biosciences, Inc. Aptose Biosciences, Inc.'s common shares were suspended on April 2, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock of Virpax Pharmaceuticals, Inc. Virpax Pharmaceuticals, Inc.'s stock was suspended on April 4, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the Class A ordinary shares, warrants, units, and rights of ClimateRock. ClimateRock's securities were suspended on April 10, 2025 and have not traded on Nasdaq since that time. The Nasdaq Stock Market announced today that it will delist the common stock of Phoenix Motor Inc. Phoenix Motor Inc.'s stock was suspended on April 15, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the ordinary shares, units, and rights of AI TRANSPORTATION ACQUISITION CORP. AI TRANSPORTATION ACQUISITION CORP's securities were suspended on April 16, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the Class A ordinary shares, warrants, and units of Denali Capital Acquisition Corp. Denali Capital Acquisition Corp.'s securities were suspended on April 16, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock of Thunder Power Holdings, Inc. Thunder Power Holdings, Inc.'s stock was suspended on April 22, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock of Charles & Colvard Ltd. Charles & Colvard Ltd.'s stock was suspended on April 25, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock, rights, units, and warrants of Yotta Acquisition Corporation. Yotta Acquisition Corporation's securities were suspended on April 28, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the ordinary shares and warrants of Heramba Electric plc. Heramba Electric plc's securities were suspended on April 29, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the Class A Common Stock of Cumulus Media Inc. Cumulus Media Inc.'s stock was suspended on May 2, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the warrants, units, and subunits of Aimfinity Investment Corp I. Aimfinity Investment Corp. I's securities were suspended on May 5, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the Class A ordinary shares of Starbox Group Holdings Ltd. Starbox Group Holdings Ltd.'s Class A ordinary shares were suspended on May 5, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock and warrants of Zoomcar Holdings, Inc. Zoomcar Holdings, Inc.'s securities were suspended on May 8, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock of ConnectM Technology Solutions, Inc. ConnectM Technology Solutions, Inc.'s stock was suspended on May 8, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the Class A ordinary shares, warrants, and units of Investcorp AI Acquisition Corp. Investcorp AI Acquisition Corp.'s securities were suspended on May 8, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the Class A ordinary shares, warrants, and units of Cartesian Growth Corporation II. Cartesian Growth Corporation II's securities were suspended on May 13, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock of Hepion Pharmaceuticals, Inc. Hepion Pharmaceuticals, Inc.'s stock was suspended on May 13, 2025 and has not traded on Nasdaq since that time Nasdaq also announced today that it will delist the common stock of Accelerate Diagnostics, Inc. Accelerate Diagnostics, Inc.'s stock was suspended on May 15, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock of Affimed NV. Affimed N.V.'s stock was suspended on May 20, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock and warrants of AppTech Payments Corp. AppTech Payments Corp.'s securities were suspended on May 20, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock of Damon Inc. Damon Inc.'s stock was suspended on May 20, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the ordinary shares and warrants of Zapp Electric Vehicles Group Limited. Zapp Electric Vehicles Group Limited's securities were suspended on May 20, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common shares and warrants of LeddarTech Holdings Inc. LeddarTech Holdings Inc.'s securities were suspended on June 20, 2025 and have not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock of Marin Software Incorporated. Marin Software Incorporated's stock was suspended on June 26, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock of Marin Software Incorporated. Marin Software Incorporated's stock was suspended on June 26, 2025 and has not traded on Nasdaq since that time. Nasdaq also announced today that it will delist the common stock and warrants of Hall of Fame Resort & Entertainment Company. Hall of Fame Resort & Entertainment Company's securities were suspended on June 27, 2025 and have not traded on Nasdaq since that time. For more information about The Nasdaq Stock Market, visit the Nasdaq Web site at Nasdaq's rules governing the delisting of securities can be found in the Nasdaq Rule 5800 Series, available on the Nasdaq Web site: .
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
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
