Pasithea Shares Surge 66% as PAS-004 Trial Reaches 8 mg Cohort

Introduction

Pasithea Therapeutics Corp (Nasdaq: KTTA) is a Miami Beach, Florida-based biotechnology company focused on the discovery, research, and development of therapies for central nervous system (CNS) disorders and RASopathies. As of November 26, 2025, KTTA shares closed at $0.81 on the NASDAQ, marking an increase of 66.12% for the day, with a trading volume of 1,977,614 shares.

Corporate Structure

Founded in 2020, Pasithea operates as a public company with a staff size of 11–50 employees. Its headquarters at 1111 Lincoln Road, Suite 500, Miami Beach, functions as the center for medicinal chemistry, neuroscience, and translational medicine efforts. The leadership team, including CEO Tiago Reis Marques, oversees research programs focused on a proprietary macrocyclic MEK inhibitor, PAS-004, and manages investor relations through regular SEC filings and capital-raising activities.

Biotechnology by Louis Reed

Recent Developments and News

On November 25, 2025, Pasithea filed a Form 8-K (CIK: 0001841330) reporting material events under Items 7.01, 8.01, and 9.01. Earlier, on November 18, 2025, the company submitted a Form S-1 to register up to 13,929,516 shares of common stock and warrants, each exercisable at $0.7179, to support its R&D funding. A Form 10-Q filed on November 13, 2025, provided financial details, including cash and equivalents totaling $4.12 million and a trailing twelve-month net loss of $13.49 million.

In November, Pasithea announced on LinkedIn the enrollment of Cohort 2 in its ongoing Phase 1/1b study of PAS-004 in adult NF1 patients with plexiform neurofibromas. Following a recommendation from the independent Safety Review Committee, dosing advanced to 8 mg without any observed dose-limiting toxicities. Interim data from the first two cohorts are anticipated in Q1 2026. At the 2025 ASCO Annual Meeting, investigators reported that the six cohorts (2–22 mg) of PAS-004 in advanced solid tumors exhibited no grade 3+ or class-related adverse events, linear pharmacokinetics (half-life >60 hours), and stable disease in 10 of 16 evaluable patients.

Financial and Strategic Analysis

With a market capitalization near $3.09 million and an intraday enterprise value of –$8.89 million, Pasithea has not reported any revenue to date, consistent with its pre-commercial stage. The trailing P/E and forward P/E ratios are not applicable; diluted EPS stands at –4.43. Its balance sheet, as of November 13, 2025, indicates $4.12 million in cash with no long-term debt; however, levered free cash flow was –$7.94 million over the preceding twelve months.

The S-1 registration indicates Pasithea’s reliance on equity financing to progress PAS-004 through clinical development. Warrants exercisable at $0.7179 may provide additional funding upon exercise, contingent on shareholder approval. Ongoing R&D expenditures are primarily focused on CNS indications such as neurofibromatosis type 1, ALS, multiple sclerosis, and schizophrenia, with PAS-004 as the lead candidate.

Market Position and Industry Context

Pasithea operates in the MEK inhibition space for CNS and oncology indications. Its primary competitor in NF1 is AstraZeneca’s selumetinib (Koselugo™), which is the only FDA-approved therapy for pediatric plexiform neurofibromas. In the context of ALS and multiple sclerosis, existing therapeutic options are known to modestly slow disease progression without offering reversal. Schizophrenia treatment remains dominated by antipsychotic medications with limited efficacy on cognitive and negative symptoms. Early clinical data on PAS-004—indicating tolerability and a prolonged half-life along with evidence of disease stabilization—suggest its potential as a differentiated MEK inhibitor. However, the company faces common biotech challenges, including regulatory requirements, funding necessities, and competition from other drug developments. Liquidity may be impacted by its modest market capitalization, which could contribute to share price volatility.

tl;dr

Pasithea advanced its Phase 1/1b PAS-004 trial to the 8 mg cohort on November 2025, with no reported dose-limiting toxicities, and aims for interim data in Q1 2026. At ASCO 2025, the drug showed linear pharmacokinetics (half-life >60 h) and stable disease in 10 of 16 patients. The company filed a Form S-1 on November 18 to register approximately 14 million shares and warrants at $0.7179, and on November 25 filed an 8-K detailing material corporate events. Future developments include Cohort 2 readouts and potential warrant exercises to fund ongoing clinical development.