FDA grants expanded access for NKGen’s cell therapy in neurodegenerative diseases

SANTA ANA, Calif. - The U.S. Food and Drug Administration (FDA) has authorized an Expanded Access Program for NKGen Biotech’s troculeucel, allowing treatment of up to 20 patients with various neurodegenerative diseases, the company announced Monday. The micro-cap biotech firm, currently valued at approximately $18 million, has seen its stock price decline by over 79% in the past year, though InvestingPro analysis suggests the company is currently undervalued.

Troculeucel, a cryopreserved autologous enhanced natural killer cell therapy, will be available through this program for patients with conditions including early-stage Alzheimer’s, Parkinson’s, ALS, Multiple System Atrophy, Progressive Supranuclear Palsy, Frontotemporal Dementia, Corticobasal Degeneration, Multiple Sclerosis, and Lewy Body Dementia.

The company, which trades on the OTC market (OTC:NKGN), is currently conducting a double-blind randomized Phase 2a trial focused on moderate-stage Alzheimer’s disease. This expanded access authorization broadens the potential application of the therapy to other neurodegenerative conditions. InvestingPro data reveals the company faces financial challenges with a weak overall health score and a current ratio of 0.02, indicating potential liquidity concerns. Subscribers can access 8 additional ProTips and comprehensive financial metrics to better evaluate the company’s prospects.

According to NKGen, troculeucel has shown preliminary clinical benefit without drug-related adverse events in two Phase I clinical trials for Alzheimer’s disease. The therapy is administered intravenously.

"There is a common element of autoimmune neuroinflammation in all of these neurodegenerative diseases due to autoreactive T cells," said Paul Y. Song, Chairman and CEO of NKGen Biotech, in the press release. "Troculeucel appears to cross the blood brain barrier to reduce neuroinflammatory and protein biomarkers in CSF."

The company expects to begin patient enrollment in the third quarter of 2025, though it noted that enrollment speed will depend on funding availability. With a debt-to-capital ratio of 0.63 and short-term obligations exceeding liquid assets, the funding concerns appear justified based on InvestingPro’s financial analysis.

Troculeucel, previously known as SNK01, recently received its International Nonproprietary Name from the World Health Organization, establishing a universally recognized name for the therapy as it progresses toward potential market approval.

In other recent news, NKGen Biotech, Inc. has formed a strategic partnership with Tokyo-based HekaBio K.K. to advance the development of troculeucel, NKGen’s autologous natural killer cell therapy, in Japan. The collaboration aims to expedite clinical trials and regulatory activities for treating neurodegenerative diseases, including Alzheimer’s and Parkinson’s. In a separate development, NKGen has administered the first dose of troculeucel to an Alzheimer’s patient under a compassionate use authorization from the FDA, marking a potential expansion into treating mild-stage Alzheimer’s disease. This treatment is being conducted in collaboration with AdventHealth Neuroscience Institute.

Additionally, NKGen Biotech has revised its loan agreement with East West Bank, extending the maturity date of a $5 million loan to January 15, 2027, and agreeing to an increased interest rate of 10% per annum. The company will also place $250,000 in a restricted account for interest payments. This financial restructuring is detailed in an SEC filing and reflects NKGen’s efforts to secure operational funding. The partnership with HekaBio and the financial maneuvers indicate NKGen’s strategic initiatives to advance its therapeutic offerings and maintain financial stability.

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