Financial Performance - The company reported net losses of $16.1 million for the three months ended June 30, 2024, and an accumulated deficit of $183.6 million as of the same date[176]. - The company has no products approved for sale and recognized no revenue during the three and six months ended June 30, 2024, and 2023[179]. - Net loss for the three months ended June 30, 2024, was $16.1 million, representing an increase of $8.2 million, or 105%, compared to a net loss of $7.8 million in the same period in 2023[191]. - Net loss for the six months ended June 30, 2024, was $21.5 million, an increase of $5.3 million, or 33%, compared to a net loss of $16.2 million in the same period in 2023[192]. - The company reported net cash used in operating activities of $10.0 million for the six months ended June 30, 2024, compared to $10.4 million for the same period in 2023, indicating a decrease of approximately 3.8%[238][239]. Research and Development - 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[172]. - 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[173]. - The company plans to conduct a Phase 2 trial for SNK01 involving 30 patients with moderate Alzheimer's disease, following clearance from an Independent Review Board[174]. - Research and development expenses are expected to increase as the company continues to develop its product candidates and platform[181]. - Research and development expenses decreased by $1.0 million, or 24%, for the three months ended June 30, 2024, compared to the same period in 2023[193]. - Total research and development expenses for the six months ended June 30, 2024, were $15.1 million, an increase of $1.7 million, or 12%, compared to $13.4 million in the same period in 2023[192]. Expenses and Costs - General and administrative expenses increased by $1.8 million, or 71%, for the three months ended June 30, 2024, compared to the same period in 2023[190]. - Total expenses for the three months ended June 30, 2024, were $7.5 million, an increase of $0.8 million, or 13%, compared to $6.6 million in the same period in 2023[190]. - Interest expense for the three months ended June 30, 2024, was $0.6 million, an increase of $0.9 million, or 944%, compared to $0.06 million in the same period in 2023[191]. - General and administrative expenses increased by $3.0 million, or 52%, for the six months ended June 30, 2024, primarily due to a $2.6 million increase in professional fees[202]. - The company incurred significant transaction costs related to the Business Combination and issued several financial instruments, including Senior Convertible Notes[171]. Funding and Capital - The company expressed substantial doubt about its ability to continue as a going concern without securing additional funding[178]. - The company expects to finance its cash needs through a combination of equity and debt financings, which may dilute existing stockholders' ownership[213]. - The company raised total proceeds of $10.2 million from the issuance of 10,209,994 PIPE warrants at a purchase price of $1.00 per warrant[231]. - The company raised $1.5 million from private placement agreements during the six months ended June 30, 2024[228]. - The company issued additional debts of $3.2 million in July and August 2024, including $3.0 million in 2024 Convertible Notes[215]. Debt and Liabilities - As of June 30, 2024, the company had cash and cash equivalents of $0.1 million and a working capital deficit of approximately $50.2 million[214]. - The company had outstanding debts of $35.8 million as of June 30, 2024, which included a revolving line of credit with East West Bank[215]. - The company incurred approximately $15.1 million in accounts payable and accrued expenses related to transaction expenses from the Business Combination as of June 30, 2024[215]. - The company experienced an increase in accounts payable and accrued expenses, contributing to the net cash used in operating activities[238]. Fair Value Measurements - The company determined that the Public Warrants and Deferred Founder Shares are classified as equity instruments, while various convertible notes and warrants, including Senior Convertible Notes and PIPE Warrants, are classified as liabilities[257]. - The fair value of liability-classified instruments, such as Private Warrants and Working Capital Warrants, is measured using Level 3 inputs and accounting estimates, which can significantly affect reported financial positions[262]. - The estimated fair value of the liability classified warrants was determined using a Black-Scholes model, incorporating assumptions related to expected stock-price volatility and risk-free interest rates[263]. - 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 and the diversity of expected behaviors[266]. Company Classification - The company qualifies as an emerging growth company and may remain so for up to five years, allowing it to rely on certain exemptions from public company reporting requirements[271]. - The company qualifies as a "smaller reporting company" with a market value of common stock held by non-affiliates plus proposed gross proceeds from the Business Combination being less than $700.0 million[273]. - The company's annual revenue is less than $100.0 million during the most recently completed fiscal year[273]. - Smaller reporting companies have reduced disclosure obligations regarding executive compensation[273].

Two of the first three patients in the Phase 1 cohort of the Phase 1/2a clinical trial, treated at the highest dose of 6 billion cells per treatment, were found to have improved CDR-SB cognitive scores, resulting in a clinical upgrade from moderate AD to mild AD after only three months on therapy. First patient dosed in the Phase 2 cohort of the trial, continuing at the highest dose of 6 billion cells per treatment. With the advancement to Phase 2 of the trial, SNK01 will now be referred to by its INN name, ...

SNK01, a cryopreserved autologous non-genetically modified NK cell product, is able to effectively reduce αsynuclein (α-syn) protein levels in the cerebral spinal fluid (CSF) of Alzheimer's patients; an important finding since increased α-syn has been correlated with worse cognitive performance and is not a target for any currently approved Alzheimer's treatments SANTA ANA, Calif., July 30, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (NASDAQ:NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology ...

SNK01, a cryopreserved autologous non-genetically modified NK cell product, is able to effectively reduce αsynuclein (α-syn) protein levels in the cerebral spinal fluid (CSF) of Alzheimer's patients; an important finding since increased α-syn has been correlated with worse cognitive performance and is not a target for any currently approved Alzheimer's treatments SNK01 treatment appears to stabilize or improve cognitive function and reduce α-synuclein levels in CSF in addition to improving previously report ...

NKGen will present data on SNK01's ability to reduce α-synuclein in Alzheimer's patients, which is significant given that α-synuclein has been shown to correlate with worse cognitive function in Alzheimer's disease. Presentation details are as follows: More information about AAIC 2024 can be found at: https://aaic.alz.org/. About NKGen Biotech 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 Sec ...

More information about AAIC 2024 can be found at: https://aaic.alz.org/. A copy of the poster will be available on the Scientific Publications page of the Company's website at https://nkgenbiotech.com/ once the poster presentation has concluded. Previously disclosed Phase 1 data on the positive effects of SNK01 on amyloid, tau, and neuroinflammation biomarkers in Alzheimer's patients, which may not be included in this poster presentation, can also be found on the Scientific Publications webpage. About NKGen ...

Dr. Gottardis holds a Bachelor of Science degree in Biology from Columbia University and a PhD in Human Oncology from the University of Wisconsin-Madison. About NKGen 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", "estimat ...

Dr. Song's presentation explored the potential benefits of eliminating pre-treatment lymphodepletion in patients undergoing SNK02 therapy, aiming to safeguard immune function and aid in recovery. Avoiding lymphodepletion before administering cancer treatment can provide many benefits including reduced toxicity, preservation of immune function and potentially enhancing treatment efficacy. The presentation also included a discussion on the results from the Company's Phase 1 SNK02 clinical study in solid tumor ...

Core Insights - The presentation by Dr. Song highlighted the potential benefits of eliminating pre-treatment lymphodepletion in patients undergoing SNK02 therapy, which may help preserve immune function and enhance recovery [1][5] - The Phase 1 clinical trial results indicated that SNK02 was well-tolerated as a monotherapy and showed clinical activity against heavily pretreated solid tumors without the need for lymphodepletion [2][6] Company Overview - NKGen Biotech, Inc. is a clinical-stage biotechnology company focused on developing and commercializing innovative autologous, allogeneic, and CAR-NK natural killer cell therapeutics [5][9] - The company is headquartered in Santa Ana, California, and is dedicated to advancing NK cell therapies for a broad range of cancers [9] Clinical Trial Details - The Phase 1 clinical trial involved administering SNK02 intravenously on a weekly basis for a total of 8 weeks, starting with a dose of 6 x 10^9 SNK02 cells [6] - The trial enrolled 6 patients with advanced refractory solid tumors, with a median age of 64 years and an average of 4 prior lines of therapy [2] - Among the patients who completed 8 cycles of SNK02, 100% demonstrated stable disease, indicating that the tumor growth was halted [2] Safety and Efficacy - Adverse events related to the investigational product were reported, with 17 Grade 1, 3 Grade 2, and 1 Grade 3 adverse events observed, indicating a generally favorable safety profile [2][6] - The development of auto-antibodies was noted around Cycle 5, but there was no correlation with adverse events or tumor response [2] Future Directions - The company plans to further explore the efficacy of SNK02 in combination with immune checkpoint inhibitors and monoclonal antibodies for treating solid tumors [2][5]

SANTA ANA, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer ("NK") cell therapeutics, today announced that Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech, will present details on their cryopreserved allogeneic NK cell therapy platform as well as updated Phase 1 data on its use in ...