Pasithea Therapeutics Corp Stock Price, News & Analysis

Pasithea Therapeutics (NASDAQ: KTTA), a clinical-stage biotech company, will participate in the upcoming H.C. Wainwright 27th Annual Global Investment Conference. The company's CEO, Dr. Tiago Reis Marques, will deliver a presentation on September 10, 2025, at 2:30 PM ET at the Lotte New York Palace Hotel.

Pasithea is currently developing PAS-004, a next-generation macrocyclic MEK inhibitor. Management will be available for one-on-one meetings throughout the conference, which runs from September 8-10, 2025.

Pasithea Therapeutics (NASDAQ: KTTA) has achieved a significant milestone in its clinical development program by completing enrollment and initial dosing of three subjects in Cohort 1 of its Phase 1/1b trial for PAS-004. The trial evaluates a novel once-daily macrocyclic MEK inhibitor in adult patients with neurofibromatosis type 1 (NF1) who have symptomatic and inoperable plexiform neurofibromas.

The company expects to present initial interim safety, tolerability, biomarker, and preliminary efficacy data in Q1 2026. PAS-004 aims to differentiate itself from current FDA-approved therapies that require twice-daily dosing, potentially offering better patient compliance and tolerability advantages.

Pasithea Therapeutics (NASDAQ: KTTA) has appointed Dr. James Lee, a renowned expert from the Francis Crick Institute, to its Scientific Advisory Board. Dr. Lee, who authored a significant 2024 Nature publication identifying ETS2 as a key regulator of inflammation in IBD, will guide the development of PAS-004, the company's next-generation macrocyclic MEK inhibitor. The appointment aims to expand PAS-004's applications beyond NF1 to treat various ETS2-driven inflammatory diseases, including IBD, ulcerative colitis, Crohn's disease, primary sclerosing cholangitis, and ankylosing spondylitis. The company plans to fund this expansion through non-dilutive financing, including grants and strategic collaborations. Dr. Lee, who trained at Oxford, Cambridge, and Harvard, currently serves as a Clinician Scientist Group Leader and Honorary Consultant Gastroenterologist, bringing extensive expertise in IBD research and treatment.

Pasithea Therapeutics has presented updated interim data from its Phase 1 study of PAS-004, a next-generation macrocyclic MEK inhibitor, at ASCO 2025. The study enrolled 21 patients with MAPK pathway-driven advanced solid tumors across six dosing cohorts. Key findings show PAS-004 demonstrating preliminary clinical activity in heavily pre-treated patients, with notable results in cohort 4A (15mg capsule). A stage 4 BRAF-mutated melanoma patient achieved stable disease with -14.9% tumor reduction after 5+ months. The drug showed favorable pharmacokinetics with a half-life exceeding 60 hours and maintained good tolerability with only grade 1 or 2 adverse events. Of 16 evaluable patients, 10 achieved stable disease, with progression-free survival up to 159 days and overall survival up to 253 days. The results suggest PAS-004's potential as a best-in-class MEK inhibitor for various MAPK pathway-driven tumors.

Pasithea Therapeutics (NASDAQ: KTTA) has announced promising preclinical data for its drug candidate PAS-004, a next-generation macrocyclic MEK inhibitor. The study, conducted at the Francis Crick Institute, demonstrated that PAS-004 outperforms FDA-approved MEK inhibitor selumetinib in inhibiting ETS2-driven inflammatory responses in IBD models. Key findings show PAS-004 achieved: - Superior suppression of ETS2 signaling across all tested doses - Significant reduction in ETS2-dependent functions - Higher normalized enrichment score (-3.96 vs -3.56) compared to selumetinib - Greater statistical significance (1.2 x 10⁻²⁵⁰ vs 3.7 x 10⁻⁷⁴) The results suggest PAS-004's potential as a treatment for inflammatory diseases like IBD and ankylosing spondylitis, with the ability to affect multiple cytokines including TNFα, IL-23, and IL-1β. The company reports favorable safety data from its Phase 1 clinical trial in advanced cancer patients.

Pasithea Therapeutics (NASDAQ: KTTA) has initiated a Phase 1/1b open-label study for PAS-004, their next-generation macrocyclic MEK inhibitor, in adult patients with neurofibromatosis type 1 (NF1). The trial will begin at Royal North Shore Hospital in Sydney, Australia, with patient dosing expected in Q2 2025. The study will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy of PAS-004 in treating both plexiform and cutaneous neurofibromas, starting with a 4mg daily tablet dosage. The company plans to expand to additional sites in Australia, South Korea, and the U.S. Notably, Pasithea expects to receive up to 48.5% cash refund on eligible R&D activities through Australian tax incentives. The company is now funded to produce initial interim patient data, with PAS-004 showing promising safety profiles in previous cancer trials.

Pasithea Therapeutics (NASDAQ: KTTA) has closed its previously announced public offering, raising total gross proceeds of approximately $6.3 million. The offering consisted of 3,571,428 shares of common stock (or pre-funded warrants) and accompanying Series C and D warrants at $1.40 per share. The company received $5.0 million from the initial offering and an additional $1.3 million from the immediate exercise of Series D warrants by certain investors.

The Series C warrants have a 5-year term while Series D warrants expire in 18 months, both with an exercise price of $1.40 per share. H.C. Wainwright & Co. served as the exclusive placement agent. The funds will support general corporate purposes, including research, clinical trials, technology development, potential acquisitions, and working capital.

Pasithea Therapeutics (NASDAQ: KTTA) has announced the pricing of a $5 million public offering consisting of 3,571,428 shares of common stock (or pre-funded warrants) at $1.40 per share. The offering includes accompanying Series C warrants (5-year expiration) and Series D warrants (18-month expiration), both with an exercise price of $1.40 per share.

H.C. Wainwright & Co. is serving as the exclusive placement agent, with the offering expected to close around May 7, 2025. The company plans to use the proceeds for general corporate purposes, including research, clinical trials, technology development, potential acquisitions, and working capital. Pasithea is developing PAS-004, a next-generation macrocyclic MEK inhibitor for neurofibromatosis type 1 and other cancer indications.

Pasithea Therapeutics (NASDAQ: KTTA) reported positive interim pharmacodynamic data from its Phase 1 trial of PAS-004, a next-generation macrocyclic MEK inhibitor. The trial evaluated doses of 8mg, 15mg capsules, and 4mg tablets in advanced cancer patients. Key findings include up to 91% inhibition of pERK, demonstrating robust target engagement. Notably, a stage 4 pancreatic cancer patient with KRAS G12R mutation achieved tumor volume reduction of -9.8% over 5 months of treatment. The drug shows a favorable safety profile with no rash observed. PAS-004 aims to treat neurofibromatosis type 1 (NF1) and other MAPK pathway driven cancers. The ongoing Phase 1 trial (NCT06299839) is designed to evaluate safety, tolerability, and preliminary efficacy in patients with MAPK pathway driven advanced solid tumors.