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MIAMI - Pasithea Therapeutics Corp. (NASDAQ: KTTA), a biotech firm specializing in treatments for central nervous system disorders and certain cancers, has announced interim data from a Phase 1 trial of its drug PAS-004. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 6.58, though it faces challenges with cash burn rates in its development programs. The drug is being tested for its efficacy in treating advanced cancers driven by the MAPK pathway.
The trial, which includes patients with advanced solid tumors with specific mutations or who have not responded to BRAF/MEK inhibition, has shown that PAS-004 can inhibit ERK phosphorylation (pERK) by up to 91%. This level of inhibition was observed at an 8mg dose, indicating strong target engagement and aligning with prior pharmacokinetic/pharmacodynamic models.
One patient with stage 4 KRAS G12R-mutated pancreatic cancer and progressive disease after three prior lines of therapy experienced a tumor volume reduction of 9.8% over five months of treatment with PAS-004. This patient remains on study, and several others have also achieved stable disease and tumor shrinkage.
Dr. Tiago Reis Marques, CEO of Pasithea, commented on the results, emphasizing the drug’s potential to modulate MAPK pathway activity due to its long half-life and favorable pharmacokinetic profile. He noted the absence of rash, a common side effect with other MEK inhibitors, and expressed optimism about the drug’s clinical signals across multiple cancer types.
The ongoing Phase 1 trial is an open-label, dose escalation study that aims to evaluate the safety, tolerability, and preliminary efficacy of PAS-004. Further safety, pharmacokinetic, and pharmacodynamic data are expected to be released in the coming months. With the next earnings report due on May 14, InvestingPro subscribers can access additional insights about the company’s R&D investments and financial health metrics.
Pasithea’s focus extends beyond cancer treatments to include research and development for central nervous system disorders and RASopathies. The company has cautioned that while the interim data is encouraging, future clinical trial results may vary and are subject to numerous conditions.
Investors are advised that this information is based on a press release statement from Pasithea Therapeutics Corp. and should be considered alongside broader market data and additional scientific research. InvestingPro analysis indicates the stock is currently undervalued, with the company’s market cap at $3.84 million and share price showing significant volatility, having declined over 80% in the past year. Subscribers can access 8 additional ProTips and comprehensive financial metrics to make more informed investment decisions.
In other recent news, Pasithea Therapeutics Corp. has received approval from its external Safety Review Committee to advance its Phase 1 clinical trial of PAS-004 to a higher dosage level. The trial will now proceed to a 30mg capsule dosage following a review of safety data from three patients, which showed no dose-limiting toxicities or instances of rash, a common side effect of similar medications. Notably, no rashes have occurred in the first 19 patients involved in the trial, which includes both capsule and tablet formulations of PAS-004. Pasithea’s CEO, Dr. Tiago Reis Marques, emphasized the strong enrollment demand and expressed anticipation for additional safety, pharmacokinetic, and pharmacodynamic data in the upcoming weeks. The ongoing trial is a multi-center, open-label study aimed at assessing the safety, tolerability, and preliminary efficacy of PAS-004 in patients with advanced solid tumors driven by MAPK pathway mutations or those unresponsive to BRAF/MEK inhibition. Pasithea Therapeutics is also working on treatments for neurological disorders such as neurofibromatosis type 1 and Amyotrophic Lateral Sclerosis. The company has made forward-looking statements regarding the trial’s outcomes, cautioning that these are based on current estimates and assumptions, and actual results may vary.
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