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— FDA clearance allows Pasithea to advance PAS-004 for NF1-associated cNF, a condition affecting over 95% of people with NF1 and for which there are currently no FDA-approved systemic therapies. —

MIAMI, Nov. 03, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation oral macrocyclic MEK inhibitor for the treatment of chronic diseases, including neurofibromatosis type 1 (NF1)-associated neurofibromas, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a randomized, placebo-controlled Phase 2 clinical trial for PAS-004 in patients with NF1 associated cutaneous neurofibromas (cNF). The Phase 2 study will be conducted under an active IND overseen by the FDA Division of Dermatology and Dentistry (DDD).

“FDA clearance of our IND for PAS-004 in cutaneous neurofibromas is an important milestone for Pasithea and a significant step forward for people living with NF1 who have cNFs,” said Kartik Krishnan, MD, PhD, Chief Medical Officer of Pasithea. “Cutaneous neurofibromas are among the most visible and burdensome manifestations of NF1, and there are currently no approved systemic therapies for them. PAS-004 is designed to address this unmet need as a once-daily oral MEK inhibitor whose long half-life and flat pharmacokinetic profile may support chronic dosing.”

“We are pleased to expand the clinical development of PAS-004 into NF1-associated cNF, the second indication for which we intend to seek regulatory approval. PAS-004 has the potential to become the first FDA-approved systemic treatment for NF1-associated cNF, addressing a significant unmet medical need and what we believe represents a multibillion-dollar market opportunity,” said Dr. Tiago Reis Marques, MD, PhD, CEO of Pasithea. “PAS-004 is intended for the more than 80,000 NF1 patients in the United States estimated to have moderate to severe cNF disease burden.”

Pasithea supported its IND with nonclinical safety, clinical safety, tolerability and pharmacokinetic data and early signals of treatment response emerging from its ongoing Phase 1/1b study in adults with NF1-associated plexiform neurofibromas and its ongoing Phase 1 study in adults with advanced cancer.

With the IND now in effect, Pasithea may proceed with clinical development of PAS-004 in patients with NF1-cNFs in the United States.

About Cutaneous Neurofibromas

NF1-associated cutaneous neurofibromas (cNF) are benign tumors that grow in or just beneath the skin at virtually any location in the body and are a hallmark of NF1 It is a serious condition and associated with significant morbidity that can have substantial impact on day-to-day functioning, leading patients to rate this as the most significant burden of NF1 despite other potentially life-threatening complications. cNF typically begin to appear in adolescence, generally increase in number and volume with age. The number of cNF on an individual patient can range from a few to tens of thousands. Although malignant transformation does not occur with NF1-associated cNF, cNF are present in over 95% of individuals with NF1 and have a significant negative impact both physically, with disfigurement, and on health-related quality of life (QoL). A greater cNF burden, particularly volume and number of cNF and facial involvement, are associated with poorer health-related QoL. Patients have rated cutaneous manifestations of NF1 as the most significant burden of NF1 largely owing to cNF-associated disfigurement despite other potentially life-threatening complications. In a Patient Listening Session organized by the Children’s Tumor Foundation (CTF), four of the six representatives who were selected to collectively represent the NF1 community described how the appearance of the cNF and associated stigma consistently interferes with their activities of daily living, including being denied employment opportunities, harassed and in fear of being out in public. Current management relies largely on procedural approaches such as surgical excision, electrodesiccation, or laser therapy. There are no FDA approved therapies approved for the treatment of NF1-associated cNF.

About Pasithea Therapeutics Corp.

Pasithea is a clinical-stage biotechnology company primarily focused on the research and development of its lead drug candidate, PAS-004, a next-generation macrocyclic MEK inhibitor intended for the treatment of RASopathies, MAPK pathway-driven tumors, and other diseases. The Company is currently testing PAS-004 in a Phase 1 clinical trial in advanced cancer patients (NCT06299839), and a Phase 1/1b clinical trial in adult patients with neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas (NCT06961565).

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the Company’s Investigational New Drug (IND) application for PAS-004 in cutaneous neurofibroma (cNF), the Company’s plans for and the design, timing, size, enrollment, and conduct of a Phase 2 clinical trial of PAS-004 in patients with NF1-associated cNF, the potential of PAS-004 as a treatment for cNF, the unmet medical need in cNF, the Company’s clinical data from its Phase 1 dose-escalation study of PAS-004 in advanced solid tumors, the Company’s Phase 1/1b clinical trial of PAS-004 in adult NF1 patients, and the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and preliminary efficacy of PAS-004, as well as all other statements, other than statements of historical fact, regarding the Company’s current views and assumptions with respect to future events regarding its business, as well as other statements with respect to the Company’s plans, assumptions, expectations, beliefs and objectives, the success of the Company’s current and future business strategies, product development, pre-clinical studies, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth and financing opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including risks related to the initiation, design, timing, enrollment, and conduct of clinical trials and interactions with regulatory authorities, and risks that future clinical trial results may not match results observed to date, may be negative or ambiguous, or may not reach the level of statistical significance required for regulatory approval, as well as other factors set forth in the Company’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings made with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.

Contact

Company Contact:
Patrick Gaynes
Corporate Communications
pgaynes@pasithea.com

For Investor Inquiries:
Mike Moyer
Managing Director, LifeSci Advisors, LLC
mmoyer@lifesciadvisors.com