KTTA News & Events

Pasithea Therapeutics announced that the U.S. Food and Drug Administration, FDA, has granted Rare Pediatric Disease Designation, RPDD, to PAS-004 for treatment of Neurofibromatosis type-1. The FDA grants RPDD for serious or life-threatening diseases in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years and affect fewer than 200,000 people in the U.S. There are approximately 115,000 individuals in the U.S living with NF1. Under the FDA's Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval of a new drug application (NDA) or biologics license application for a rare pediatric disease may be eligible for a Priority Review Voucher which can be redeemed to obtain priority review for a subsequent marketing application for a different product. The PRV may be sold or transferred to another sponsor. In the last 12 months, disclosed PRV sales have ranged from $150-$205 million

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.