Pasithea Therapeutics Corp. received a $1 million Hoffman ALS Clinical Trial Award from the ALS Association, a non‑dilutive grant that will fund the company’s first Phase 1 study of its macrocyclic MEK inhibitor PAS‑004 in amyotrophic lateral sclerosis (ALS). The award, announced on November 25, 2025, will support enrollment of twelve patients across three sequential dose cohorts and a 28‑week follow‑up period, with safety, tolerability, ALS Functional Rating Scale–Revised scores and neurofilament light chain levels as primary readouts.
The grant expands PAS‑004’s clinical portfolio beyond its existing neurofibromatosis and advanced‑cancer programs, positioning the drug as a potential treatment for a disease with a high unmet need. Pasithea’s CEO, Tiago Reis Marques, emphasized that the award validates the company’s scientific strategy: “Inflammation and TDP‑43 aggregation are key drivers of ALS, and targeting MEK offers a novel therapeutic approach.” The funding also provides a critical cash cushion for a company that reported a $3.03 million net loss for Q3 2025, a slight increase from the $2.99 million loss in the same quarter a year earlier, and faces “substantial doubt” about its ability to continue as a going concern without additional capital.
The ALS Association’s Hoffman program specifically supports early‑stage, biomarker‑driven trials, and the grant’s focus on neurofilament light chain levels aligns with the association’s emphasis on measurable disease progression. Pasithea’s management highlighted that the Phase 1 trial will generate early signals of clinical activity, potentially accelerating the drug’s development timeline across indications. The company’s recent positive data in advanced cancer and neurofibromatosis—showing favorable pharmacokinetics, tolerability, and early efficacy signals—has already bolstered investor confidence and set the stage for the ALS study.
While the grant is a significant milestone, Pasithea remains a high‑risk, high‑potential biotech. The company’s current market capitalization is approximately $3 million, and its cash position, though sufficient for the short‑term, is limited relative to the long‑term funding required to bring a drug to market. The grant, however, reduces the immediate capital burden and demonstrates external validation of PAS‑004’s therapeutic potential, which could improve the company’s ability to secure future financing or partnerships.
Pasithea’s management reiterated its commitment to advancing PAS‑004 across multiple indications, noting that the ALS trial will complement ongoing studies in neurofibromatosis and advanced cancer. The company’s strategy to pursue a broad MEK‑inhibitor platform is designed to leverage shared disease mechanisms and accelerate development timelines, potentially creating multiple revenue streams if PAS‑004 proves effective in ALS.
The announcement underscores the ALS Association’s role in supporting early‑stage research and highlights Pasithea’s progress toward addressing a disease with limited treatment options. The grant not only provides financial support but also signals confidence from a leading ALS advocacy organization, strengthening the company’s position in a competitive therapeutic landscape.
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