Pasithea Therapeutics Corp.

What they do

Pasithea Therapeutics is a clinical-stage biotech focused on treatments for RASopathies, MAPK pathway-driven tumors, and CNS disorders. Its lead candidate, PAS-004, is a next-generation macrocyclic MEK 1/2 inhibitor with potential indications including NF1, BRAF-mutated tumors, and ALS. The company also has PAS-001 in discovery for schizophrenia; PAS-003 for ALS was discontinued in 2025. Operations are primarily in the Therapeutics segment, with non-core subsidiaries dissolved or discontinued.

Revenue drivers

• Product revenue — No approved products; revenue has been negligible (e.g., $486,559 in 2022, $15,062 in 2021) and comes from minimal sources, not core operations.
• Grants and collaborations — Not reported as a separate revenue line; the company expects to finance operations through equity, debt, or collaborations, but no collaboration revenue is currently reported.

Recent performance

For fiscal year 2025, net loss was $-20.4M, compared to $-13.9M in 2024; diluted EPS was $-2.91. Operating cash flow was $-15.2M in 2025. As of 2026-03-31, cash and equivalents were $50.4M, with total assets of $56.4M and total liabilities of $1.5M. The company has not generated meaningful revenue; annual revenue was $15,062 in 2021 and $486,559 in 2022, with no recent quarterly revenue reported.

Strategy

Management prioritizes advancing PAS-004 through clinical development, with Phase 1 trials in advanced tumors and NF1-PN ongoing. Plans include filing a protocol amendment to continue dose escalation using a tablet formulation and a food effect assessment. The company aims to seek regulatory approval for PAS-004 in symptomatic NF1-PN in adults and pediatrics. PAS-003 development was halted to focus resources on PAS-004. PAS-001 remains in discovery for schizophrenia.

Risks

• Clinical-stage dependency — Company is dependent on PAS-004, which is not approved and requires successful clinical trials and regulatory approval.
• Capital needs — Will need additional capital to fund development; failure to raise capital could force delays or termination of programs.
• Operating losses — History of operating losses and expects to continue incurring substantial costs for the foreseeable future.
• Delisting risk — Received a delisting notice or listing-rule failure on 2026-02-20, which could affect stock liquidity.

Outlook

Management expects to complete the FIH Phase 1 Advanced Cancer Study in 2028. The NF1-PN Phase 1/1b trial initiated in May 2025 is ongoing. Future steps include dose escalation with tablet formulation and potential registrational trials in NF1-PN populations.