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MIAMI - Pasithea Therapeutics Corp. (NASDAQ: KTTA), a micro-cap biotechnology firm with a market capitalization of $5.7 million, has reported new preclinical findings that suggest its drug candidate, PAS-004, could be more effective in inhibiting certain inflammatory responses than the current FDA-approved MEK inhibitor selumetinib. According to InvestingPro analysis, while the company maintains a strong liquidity position with a current ratio of 3.84 and more cash than debt, its stock has experienced significant volatility, declining over 85% in the past year. The study, conducted at the Francis Crick Institute in London, focused on the drug’s impact on ETS2-driven inflammation, a pathway associated with inflammatory bowel disease (IBD).
The research, led by Dr. James Lee, indicated that PAS-004 more effectively downregulated ETS2-regulated genes and reduced macrophage functions vital to chronic inflammation, such as cytokine production, phagocytosis, and reactive oxygen species generation. These functions are crucial in the development and maintenance of chronic inflammatory diseases. The study employed RNA sequencing to compare the gene expression profiles of PAS-004 with selumetinib, revealing that PAS-004 consistently outperformed selumetinib at all tested doses.
Gene Set Enrichment Analysis further demonstrated that PAS-004’s effects closely resembled those of ETS2 knockout profiles, suggesting a more robust and durable MEK inhibition under inflammatory conditions. Dr. Lee commented on the potential of PAS-004 to provide superior inhibition of macrophage inflammatory pathways, emphasizing the importance of targeting multiple cytokines in the treatment of chronic inflammatory diseases.
Dr. Tiago Reis Marques, CEO of Pasithea, expressed optimism about PAS-004’s potential as a new oral treatment for inflammatory diseases, supported by the drug’s safety data from a Phase 1 clinical trial in advanced cancer patients. With the company reporting an EBITDA of -$13.24 million in the last twelve months, InvestingPro subscribers can access additional insights about the company’s financial health and growth prospects, including 8 more exclusive ProTips that could help inform investment decisions. Dr. Larry Steinman, Executive Chairman of Pasithea, echoed these sentiments, highlighting the preclinical results as a promising development in the search for better drugs targeting inflammatory conditions.
Pasithea is currently focused on the discovery and development of novel treatments for CNS disorders, RASopathies, and MAPK pathway-driven tumors. The company’s forward-looking statements, as per the press release, indicate ongoing clinical trials and future plans for PAS-004, including its potential growth opportunities in large market inflammatory indications.
This news is based on a press release statement from Pasithea Therapeutics Corp. and has not been independently verified. Pasithea’s stock is publicly traded on the NASDAQ under the ticker symbol KTTA. Investors should note that the company’s next earnings report is scheduled for May 21, 2025. InvestingPro subscribers gain access to comprehensive financial analysis tools, real-time Fair Value calculations, and expert insights to better evaluate biotech investment opportunities.
In other recent news, Pasithea Therapeutics Corp. has announced interim results from its Phase 1 trial of the cancer drug PAS-004, showing promising data in treating advanced cancers. The trial demonstrated that PAS-004 can inhibit ERK phosphorylation by up to 91% at an 8mg dose, indicating significant target engagement. A notable outcome was observed in a patient with stage 4 KRAS G12R-mutated pancreatic cancer, who experienced a tumor volume reduction of 9.8% over five months of treatment. Additionally, the company’s external Safety Review Committee has approved advancing the trial to a 30mg dosage level after confirming no dose-limiting toxicities. Pasithea’s CEO, Dr. Tiago Reis Marques, emphasized the absence of rash, a common side effect with similar medications, across both capsule and tablet formulations. The ongoing trial aims to evaluate the safety, tolerability, and preliminary efficacy of PAS-004 in patients with specific mutations or those unresponsive to BRAF/MEK inhibition. The company anticipates releasing further safety and pharmacokinetic data in the coming weeks. Investors are reminded that while the interim data is encouraging, future clinical results may vary.
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