SANTA ANA, Calif. – NKGen Biotech Inc. (NASDAQ:NKGN), a clinical-stage biotech company, announced findings from a Phase I trial suggesting its SNK01 therapy could reduce α-synuclein protein levels in the cerebral spinal fluid (CSF) of Alzheimer's patients. The trial data was presented at the Alzheimer’s Association International Conference on July 30, 2024, in Philadelphia, PA.
α-synuclein is associated with worse cognitive performance in Alzheimer's disease (AD) and is not currently targeted by approved treatments. SNK01, an autologous non-genetically modified NK cell product, is designed to enhance cytotoxicity and activating receptor expression.
In the trial, despite 70% of patients receiving low doses of SNK01, 60% saw a reduction in CSF α-synuclein levels. Moreover, 90% of patients demonstrated stable or improved cognitive function at 11 weeks, measured by the ADCOMS score. No treatment-related adverse events were observed, and the therapy was well-tolerated with no dose-limiting toxicities noted.
Dr. Paul Y. Song, MD, Chairman and CEO of NKGen Biotech, highlighted the absence of current Alzheimer’s treatments targeting α-synuclein and expressed enthusiasm for SNK01's potential based on these findings. The company plans to pursue a larger Phase II trial with higher doses and extended treatment duration, and to explore SNK01's application in other synucleinopathy-related neurodegenerative diseases.
The company's in vitro studies have shown SNK01’s ability to internalize and degrade α-synuclein aggregates, supporting its use for α-synucleinopathies. While the data is preliminary, it suggests that SNK01 could cross the blood-brain barrier and impact both cognition and protein aggregates in AD patients.
NKGen Biotech specializes in developing autologous, allogeneic, and CAR-NK NK cell therapeutics for neurodegenerative disorders and a range of cancers. The company is headquartered in Santa Ana, California.
NKGen Biotech has made several key changes to its financial agreements and board membership. The firm amended its forward purchase agreements with Sandia Investment Management LP, Polar Multi-Strategy Master Fund, and Meteora Capital Partners, which resulted in an increase in the Prepayment Shortfall and additional shares under the Confirmation.
Moreover, Dr. Marco Gottardis has joined NKGen Biotech's board, filling a vacancy left by Ms. Alana McNulty's resignation. The company also received clearance from the U.S. Food and Drug Administration to proceed with its Investigational New Drug application for SNK01, a therapy aimed at treating Parkinson’s disease. The approval paves the way for the company to initiate its Phase 1/2a clinical trial.
InvestingPro Insights
As NKGen Biotech Inc. (NASDAQ:NKGN) forges ahead with its SNK01 therapy for Alzheimer's disease, the financial health and market performance of the company provide a context for understanding its potential future. According to recent data from InvestingPro, NKGen Biotech has an adjusted market capitalization of approximately $32.21 million USD. The company's P/E ratio stands at -0.32, reflecting the challenges it faces as a clinical-stage biotech company investing heavily in research and development before reaching profitability. The adjusted P/E ratio for the last twelve months as of Q1 2024 further underscores this point at -0.42.
InvestingPro Tips indicate that NKGen Biotech suffers from weak gross profit margins and has short-term obligations that exceed its liquid assets. These factors are crucial for investors to consider as they evaluate the company's financial stability and its ability to fund ongoing trials and research initiatives. Moreover, the company has not been profitable over the last twelve months and does not pay dividends to shareholders, which may influence investment decisions for those seeking immediate returns or income from their investments.
Despite the challenges, the company's focus on innovative treatments such as SNK01 could be a game-changer in the fight against neurodegenerative diseases. For investors interested in the biotech sector and NKGen Biotech's pioneering approach to Alzheimer's treatment, additional InvestingPro Tips can provide deeper insights. There are 5 more tips available on InvestingPro, which can be accessed by visiting https://www.investing.com/pro/NKGN. Remember to use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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