• Pasithea outlined clinical development plans for PAS-004, a macrocyclic MEK1/2 inhibitor targeting NF1 and MAPK pathway-driven solid tumors.
• Interim Phase 1 monotherapy data in advanced cancers showed no dose-limiting toxicities; treatment-related adverse events were Grade 1-2.
• Pharmacokinetics showed an approximately 60-hour half-life; cohort 7 peak and trough concentrations exceeded the cellular IC50.
• One partial response was reported in a MEK-rechallenged patient with a BRAF V600E-mutated tumor; the patient remained on treatment at 11 months.
• Initial focus is adult NF1 plexiform neurofibromas, followed by NF1 cutaneous neurofibromas; interim adult NF1-PN results are expected in 2H 2026.

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