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MIAMI - Pasithea Therapeutics Corp. (NASDAQ:KTTA), a micro-cap biotech company with a market capitalization of $5.44 million, has completed enrollment and initial dosing of three subjects in the first cohort of its Phase 1/1b clinical trial evaluating PAS-004 in adult patients with neurofibromatosis type 1 (NF1), the company announced Thursday. According to InvestingPro analysis, the company maintains strong liquidity with a current ratio of 3.84, despite its stock declining 76.78% year-to-date.
The trial is testing PAS-004, a next-generation macrocyclic MEK inhibitor, in adult NF1 patients with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas. InvestingPro data shows the company holds more cash than debt on its balance sheet, providing important financial flexibility for its clinical development programs.
The study is designed in two parts, with Part A enrolling up to 24 participants across four planned dose levels (4mg, 8mg, 12mg, and 18mg) to identify the recommended dose for Part B. The completed first cohort received the 4mg tablet dose.
PAS-004 is being developed as a once-daily treatment, which differs from current FDA-approved therapies that require twice-daily dosing for NF1 patients with plexiform neurofibromas.
"Completion of enrollment and initial dosing of Cohort 1 marks a key milestone in our mission to develop PAS-004," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea.
The company plans to present initial proof-of-concept data from the NF1 trial in the first quarter of 2026. The study is being conducted at five clinical trial sites across Australia, South Korea and the United States.
Pasithea is also currently testing PAS-004 in a separate Phase 1 clinical trial in advanced cancer patients.
This article is based on a press release statement from Pasithea Therapeutics. Investors should note that the company’s next earnings report is scheduled for August 14, 2025, which could provide additional insights into the trial’s progress. InvestingPro analysis suggests the stock is currently undervalued, with additional financial metrics and insights available to subscribers.
In other recent news, Pasithea Therapeutics Corp. has reported promising interim results from a Phase 1 trial of its drug PAS-004, which is being tested for its efficacy in treating refractory solid tumors. The study, presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, showed preliminary clinical activity in patients with advanced solid tumors, with no dose-limiting toxicities observed. Additionally, Pasithea has announced new preclinical findings suggesting that PAS-004 could be more effective than the current FDA-approved MEK inhibitor selumetinib in inhibiting certain inflammatory responses associated with inflammatory bowel disease. The study indicated that PAS-004 effectively downregulated ETS2-regulated genes and reduced macrophage functions crucial to chronic inflammation. Furthermore, Pasithea has scheduled its 2025 annual meeting of stockholders for September 3, 2025, with proxy materials expected to be available by July 24. These developments highlight the company’s ongoing progress in its drug development efforts.
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