PAS-004

January 13, 2026 — Pasithea Therapeutics Corp. (NASDAQ: KTTA) announced updated timelines for clinical readouts for PAS-004, an oral macrocyclic MEK inhibitor being developed for neurofibromatosis type 1–associated plexiform neurofibromas (NF1-PN) and advanced cancers.

For its ongoing Phase 1/1b trial in adults with NF1-PN (NCT06961565), Pasithea reported completing enrollment of 12 patients across four Part A dose cohorts (4, 8, 12, and 18 mg tablets). The company plans to present second-half 2026 data including safety, tolerability, pharmacokinetics, and available efficacy through a six-month timepoint for plexiform and cutaneous neurofibromas.

For its Phase 1 advanced cancer trial (NCT06299839), Pasithea expects to present longer-term follow-up from Cohort 4 (15 mg capsule) through Cohort 8 (45 mg capsule) in Q2 2026. The company also referenced prior November 2025 results, including a partial response and a 71.4% disease control rate among efficacy-evaluable patients with BRAF-mutated tumors, and noted a $60 million public offering (December 2025) funding operations into at least H1 2028.