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SANTA ANA, Calif. - NKGen Biotech, Inc. (OTC:NKGN), a $22.46 million market cap biotechnology company whose stock has declined 74% over the past year, has administered the first dose of troculeucel, an expanded autologous natural killer (NK) cell therapy, to a patient with mild-stage Alzheimer’s disease under a compassionate use authorization from the FDA, the company announced Thursday. According to InvestingPro analysis, the company’s stock currently trades at $0.30.
The patient had exhibited continued cognitive decline despite ongoing treatment with lecanemab, an amyloid-targeting therapy. This exploratory work is being conducted in collaboration with Dr. Anita Fletcher, Director of Neuroscience Clinical Research at AdventHealth Neuroscience Institute in Orlando.
While NKGen’s current Phase 2a trial focuses on moderate-stage Alzheimer’s disease, this single-IND case represents the company’s first potential expansion into treating mild Alzheimer’s, particularly for patients who don’t respond to existing therapies.
"Currently, there are two FDA-approved amyloid-targeting therapies available for Alzheimer’s patients with mild cognitive impairment. While both have been shown to slow the rate of cognitive decline, they do not halt disease progression or improve cognitive function," said Paul Y. Song, Chairman and CEO of NKGen.
According to the company, troculeucel crosses the blood-brain barrier and has shown improvement in levels of amyloid, α-synuclein, and tau proteins in cerebrospinal fluid, while also reducing neuroinflammation in previous clinical experience.
Dr. Fletcher noted, "The inflammatory changes that lead to neurodegeneration remain critical and underexplored and have potential to provide a new mechanism for meaningful clinical benefit."
The information in this article is based on a press release statement from NKGen Biotech.
In other recent news, NKGen Biotech has amended its loan agreement with East West Bank, as reported in a recent SEC filing. The Santa Ana-based company has extended the maturity date of its existing $5 million loan to January 15, 2027, retroactive to April 14, 2025. The revised terms include an increased interest rate of 10% per annum, payable monthly. NKGen Biotech is required to place $250,000 in a restricted account for interest payments and has set a new amortization schedule for principal repayments. The initial payment of $1 million is due on June 1, 2025, with subsequent payments outlined in the amendment. Additionally, if the company defaults or reaches the loan’s maturity, the interest rate will increase by 5 percentage points, without exceeding the maximum legal rate. This financial restructuring is detailed in the 8-K form filed with the SEC on April 22, 2025. NKGen Biotech’s recent actions aim to manage its financial obligations and secure operational funding for the future.
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