Press Releases September 14, 2026 07:00 AM

Pasithea Therapeutics Announces Presentation of Initial PAS-004 Clinical Data from Ongoing Phase 1/1b Clinical Trial in Adult NF1 Patients at the 2026 European Neurofibromatosis Conference

Pasithea Therapeutics to present initial Phase 1/1b PAS-004 clinical data for NF1 patients at 2026 European Neurofibromatosis Conference

By Sofia Navarro
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KTTA

Pasithea Therapeutics announced it will present initial clinical data from Part A of its ongoing Phase 1/1b trial of PAS-004, a novel oral MEK inhibitor for neurofibromatosis type 1 (NF1)-associated neurofibromas, at the 2026 European Neurofibromatosis Conference in Vienna. This marks the company's first public disclosure of clinical data for the drug candidate in adult NF1 patients, highlighting its progress in developing treatments for RASopathies and MAPK pathway-driven diseases.

Pasithea Therapeutics Announces Presentation of Initial PAS-004 Clinical Data from Ongoing Phase 1/1b Clinical Trial in Adult NF1 Patients at the 2026 European Neurofibromatosis Conference
KTTA
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Key Points

  • Pasithea Therapeutics will present initial clinical data from its Phase 1/1b PAS-004 trial targeting NF1-associated neurofibromas at a major European conference, signaling advancement in clinical development.
  • PAS-004 is a next-generation macrocyclic oral MEK inhibitor aimed at treating chronic diseases including NF1 and MAPK pathway-driven tumors, addressing an unmet medical need.
  • The presentations include both oral and poster formats, emphasizing the company's active engagement with the neurofibromatosis research community and transparency with clinical progress.

- Pasithea has been selected to present cutaneous neurofibromas (CN) clinical data in an oral presentation

- Pasithea has been selected to present plexiform neurofibromas (PN) clinical data in a poster presentation

- The European Neurofibromatosis Conference 2026 will take place in Vienna, Austria, from November 12–14, 2026

MIAMI, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, for the long-term treatment of chronic diseases including neurofibromatosis type 1 (NF1)-associated neurofibromas, today announced it will present initial Part A clinical data from its ongoing Phase 1/1b trial of PAS-004 in adults with NF1.

The data will be presented at the 2026 European Neurofibromatosis Conference, taking place November 12–14, 2026, at the Hyatt Regency Vienna in Vienna, Austria, and will represent the Company’s first public disclosure of clinical data from Part A of the trial.

Details of the Oral Presentation:
Presenter: Rebecca Brown, MD, University of Alabama at Birmingham
Presentation Type: Oral Presentation
Session title: Clinical Session 3: Visible Manifestations in Neurofibromatosis
Session day and time: Friday, 13 November 2026, 08:00-09:30 (CET)
Room: Lecture Hall 1

Details of the Poster Presentation:
Presenter: Tiago Reis Marques, Pasithea Therapeutics Chief Executive Officer
Presentation Type: Poster
Poster Session: Thursday, November 12

The full presentations will be made available in accordance with the conference’s program schedule. The Company plans to issue a follow-up press release with detailed results at the time of presentation.

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 planned presentation of first-in-human data at the 2026 European Neurofibromatosis Conference, the Company’s sponsorship of the conference, the Company’s ongoing Phase 1 clinical trial of PAS-004 in advanced cancer patients, 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 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

Patrick Gaynes
Investor Relations
[email protected]


Risks

  • Clinical trial data is preliminary and may not predict future success or regulatory approval, potentially impacting product development timelines and investor sentiment.
  • The forward-looking statements highlight uncertainties such as variability in clinical trial outcomes and market acceptance, exposing the company to regulatory and commercial risk.
  • Competition in the biotechnology sector and the challenges of developing treatments for rare genetic disorders like NF1 pose ongoing risks to Pasithea's growth and financial performance.

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