KTTA News & Events

Pasithea Therapeutics provided updated timelines on its ongoing clinical trials in advanced cancer and adult NF1-PN patients. Ongoing Phase 1/1b clinical trial in adult patients with NF1-PN: Pasithea has completed enrollment of 12 patients through the first 4 dose cohorts in Part A of the study. The Company plans to present data in the second half of 2026, including available efficacy data through the six-month timepoint for both plexiform and cutaneous neurofibromas. The planned data release is also expected to include safety, tolerability and pharmacokinetic data. Ongoing Phase 1 clinical trial in advanced cancer patients: Pasithea expects to present longer-term follow-up data from patients in Cohort 4 through Cohort 8 in the second quarter of 2026.

Pasithea Therapeutics announced the pricing of a public offering of 80,000,000 shares of the Company's common stock at an offering price of $0.75 per share of common stock. The public offering was led by healthcare-dedicated investors, including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners, and Squadron Capital Management. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The closing of the offering is expected to occur on or about December 1, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to the Company from the offering are expected to be approximately $60M, before deducting the placement agent's fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for general corporate purposes. The Company's cash position following the closing will extend its cash runway through at least the first half of 2028.

Pasithea Therapeutics announced that the ALS Association has awarded a Hoffman ALS Clinical Trial Award grant worth ~$1 million to study PAS-004 in ALS patients. The award was given to study the "Efficacy, safety and tolerability of PAS-004 for the treatment of ALS". "We are honored that the ALS Association recognizes the promise of PAS-004," said Dr. Lawrence Steinman, Chairman of Pasithea. "Its support enables the initiation of the first clinical trial of PAS-004 in individuals living with ALS, which is a significant milestone for Pasithea as we look to provide proof-of-concept that PAS-004 may be the best-in-class MEK inhibitor for the treatment of many indications. I am delighted to continue working on the development of potentially effective treatments for ALS. PAS-004 targets a critical molecule in the pathophysiology of motor neuron disease and has delivered significant and promising results in the ALS gold standard SOD mouse model. PAS-004, already in the clinic for neurofibromatosis and advanced cancers, is showing a promising safety profile and initial monotherapy efficacy signal. We are excited for PAS-004 to enter the clinic for ALS, a disease in great need of advances in therapy."