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 (KTTA) will present initial Part A clinical data from its ongoing Phase 1/1b trial of PAS-004 in adults with neurofibromatosis type 1 (NF1) at the 2026 European Neurofibromatosis Conference in Vienna, Austria, from November 12–14, 2026.

Rhea-AI Summary

Pasithea Therapeutics (KTTA) will present initial Part A clinical data from its ongoing Phase 1/1b trial of PAS-004 in adults with neurofibromatosis type 1 (NF1) at the 2026 European Neurofibromatosis Conference in Vienna, Austria, from November 12–14, 2026.

PAS-004 is described as a next-generation macrocyclic oral MEK inhibitor being developed for long-term treatment of chronic diseases including NF1-associated neurofibromas. The conference presentations will mark the first public disclosure of clinical data from Part A of the PAS-004 trial. Cutaneous neurofibromas (CN) data will be delivered in an oral presentation, and plexiform neurofibromas (PN) data will be shared in a poster session.

The oral presentation, by Rebecca Brown, MD of the University of Alabama at Birmingham, is scheduled in “Clinical Session 3: Visible Manifestations in Neurofibromatosis” on Friday, November 13, 2026, from 08:00–09:30 (CET) in Lecture Hall 1 at the Hyatt Regency Vienna. The PN-focused poster will be presented by Pasithea’s Chief Executive Officer, Tiago Reis Marques, during the Thursday, November 12 poster session. The company plans a follow-up press release with detailed clinical results at the time of presentation.

Key Figures

Trial phase: Phase 1/1b Data presentation date: November 12–14, 2026

Trial phase

Phase 1/1b

Ongoing PAS-004 trial in adults with NF1

Data presentation date

November 12–14, 2026

2026 European Neurofibromatosis Conference

Key Terms

cutaneous neurofibromas, plexiform neurofibromas, phase 1/1b, mek inhibitor

4 terms

cutaneous neurofibromas medical

"present cutaneous neurofibromas (CN) clinical data"

Benign tumors that grow on or under the skin from nerve sheaths, often seen in people with the genetic condition neurofibromatosis type 1; they appear as soft bumps that can vary in size, number and symptoms (pain, itching, or cosmetic impact). They matter to investors because they create a defined patient population and clinical unmet need that drives markets for drugs, devices, and surgical or diagnostic services, and they influence trial design and regulatory assessment.

plexiform neurofibromas medical

"present plexiform neurofibromas (PN) clinical data"

Plexiform neurofibromas are large, often tangled growths that form along nerves, caused by a genetic condition; they are non‑cancerous but can cause pain, disfigurement and loss of function like a knotted rope pressing on nearby tissues. They matter to investors because they represent a clear medical need and a defined patient group for drug and device developers—successful treatments can drive clinical progress, regulatory approvals and commercial opportunities in a specialized but meaningful market.

phase 1/1b medical

"ongoing Phase 1/1b trial of PAS-004"

Phase 1/1b describes early-stage clinical testing in humans where researchers first assess a drug’s safety, tolerable dose range and how the body processes it; phase 1b often means small expansion groups to explore the best dose and look for initial signs the treatment might work. For investors, these studies are like the first road tests of a new product—positive results reduce risk and increase value potential, while negative or unclear results raise uncertainty about future development.

mek inhibitor medical

"a next-generation macrocyclic oral MEK inhibitor"

A MEK inhibitor is a drug that blocks MEK enzymes, which act like a relay in a cell’s growth-signaling pathway; by cutting that relay these drugs can slow or stop uncontrolled cell growth seen in some cancers and other proliferative conditions. Investors care because clinical trial outcomes, safety data, and regulatory approvals determine whether a MEK inhibitor becomes a marketable therapy, directly affecting a developer’s revenue prospects and valuation — like a product passing a crucial safety and sales test.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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- 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
pgaynes@pasithea.com