PAS-004

Jan. 13, 2026: Pasithea Therapeutics Corp. (NASDAQ: KTTA) provided updated clinical timelines for PAS-004, an oral macrocyclic MEK inhibitor, in neurofibromatosis type 1–associated plexiform neurofibromas (NF1-PN) and advanced cancer.

PAS-004 in adult NF1-PN (Phase 1/1b; NCT06961565): Enrollment is complete for 12 patients across the first four dose cohorts (4, 8, 12, 18 mg tablets) in Part A. The company plans to present data in 2H 2026, including available efficacy through the six-month timepoint for plexiform and cutaneous neurofibromas, plus safety, tolerability, and pharmacokinetic data.

PAS-004 in advanced cancer (Phase 1; NCT06299839): The company expects to present longer-term follow-up data in 2Q 2026 from Cohort 4 (15 mg capsule) through Cohort 8 (45 mg capsule).

The release also referenced previously disclosed November 2025 findings in advanced cancer patients previously treated with a MEK inhibitor (including a partial response and a 71.4% initial disease control rate among efficacy-evaluable patients with BRAF-mutated tumors) and a December 2025 $60 million gross public offering financing.