SANTA ANA, Calif. - NKGen Biotech, Inc. (Nasdaq: NKGN), a clinical-stage biotechnology company, has reported encouraging preliminary results from its Phase 1/2a clinical trial of troculeucel, an innovative cell therapy for Alzheimer's disease (AD). The early data suggests that two out of three patients treated with the highest dose experienced cognitive improvements, advancing from moderate to mild AD.
The trial, which involves a cryopreserved autologous enhanced natural killer (NK) cell therapy, has shown no drug-related adverse reactions among the patients in the Phase 1 cohort. These individuals received a dose of 6 billion cells per treatment. Following the successful interim results, the first patient in the Phase 2 cohort has been dosed, marking a significant step in the development of troculeucel.
Phase 2 will continue to investigate the efficacy and safety of troculeucel in a larger group of 30 patients with moderate AD. This phase of the trial is randomized, double-blind, and placebo-controlled, with 20 patients receiving the treatment and 10 receiving a placebo.
The company is optimistic about the potential of troculeucel as a treatment for AD, especially given the favorable outcomes from the Phase 1 study. These findings align with the results from the MX04 Phase 1 AD study, where a patient also showed improvement in cognitive scores after receiving a high dose of the therapy.
NKGen Biotech has activated four clinical sites across North America for the trial and plans to increase enrollment in the coming months. Further interim cognitive data from the Phase 1 cohort is expected to be presented at a national Alzheimer's conference in Q4 2024.
The company's Chairman and CEO, Paul Y. Song, MD, expressed enthusiasm for the progress made in the clinical program and the potential benefits of the higher dosing regimen being tested in Phase 2.
Troculeucel, formerly known as SNK01, has been assigned its International Nonproprietary Name (INN) by the World Health Organization (WHO), signifying a key step towards market approval.
This report is based on a press release statement from NKGen Biotech. The company's forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those projected. Investors are cautioned not to place undue reliance on these forward-looking statements.
In other recent news, NKGen Biotech has made significant strides in its financial and operational management. The firm amended its forward purchase agreement, increasing both financial commitment and share consideration to Meteora Capital Partners, and secured $2.75 million in financing through a promissory note with CFIC-2015 NV Family Investments, LLC. This note allows conversion of outstanding principal and interest into common stock at $2.00 per share.
In a different development, the company's COO, Pierre Gagnon, has left his role but will serve as an advisor until November 2024. Additionally, the company's shareholders approved a potential issuance of shares, which could significantly influence its capital structure.
On the clinical front, NKGen Biotech reported progress in its Phase I trial for SNK01, a potential Alzheimer's treatment. Despite these advancements, NKGen Biotech received a notice from the Nasdaq Stock Market for failing to file its quarterly financial report on time. The company is working with its auditors and advisors to file the required Form 10-Q promptly. These are the recent developments for NKGen Biotech.
InvestingPro Insights
As NKGen Biotech (Nasdaq: NKGN) continues to advance its clinical trials for troculeucel, the company's financial health and stock performance provide critical context for investors. The latest InvestingPro Data reveals a market capitalization of $20.1 million, indicating the scale of the company within the biotech industry. However, the financial metrics highlight some challenges, with a negative P/E ratio for the last twelve months as of Q1 2024, standing at -0.26. This suggests that the company has not been profitable during this period, which is corroborated by an operating loss of $30.57 million.
InvestingPro Tips suggest caution, noting that NKGen Biotech's stock has experienced significant declines, including a 92.54% drop in the one-year price total return as of the latest available data. Additionally, the stock is trading near its 52-week low, with the price at only 6.06% of the 52-week high. These figures may raise concerns about the company's current financial stability and market confidence, despite the promising developments in its clinical trials.
Investors interested in the biotech sector and NKGen Biotech's journey through clinical trials for Alzheimer's treatments may find additional insights among the 9 InvestingPro Tips available, which provide a more nuanced view of the company's performance and potential. These tips, accessible on the InvestingPro platform, can offer valuable guidance in assessing the risks and opportunities associated with NKGen Biotech.
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