MIAMI - Pasithea Therapeutics Corp. (NASDAQ: KTTA), a biotech firm specializing in central nervous system disorders and cancer treatments, today announced the successful completion of chronic toxicity studies for its drug candidate PAS-004. The studies, which are part of the development process for treating neurofibromatosis type 1 (NF1) and other cancers, showed a consistent safety profile in long-term dosing.
The research involved once daily treatment with PAS-004 for six months in rats and nine months in dogs at various dose levels. Findings confirmed earlier 28-day toxicity study observations, with the 9-month dog study establishing a no adverse effect level (NOAEL) of 0.5 mg/kg. These results are expected to support chronic patient dosing for the drug.
PAS-004 is currently being tested in a Phase 1 clinical trial with advanced cancer patients. The drug's crystalline form, used in the toxicity studies and human trials, demonstrated an adverse event profile and NOAEL in dogs comparable to the original amorphous formulation.
The company's CEO, Dr. Tiago Reis Marques, expressed optimism about PAS-004's potential as a leading MEK inhibitor, citing the drug's sustained MAPK pathway suppression and anticipated enhanced efficacy with manageable side effects. Additional data from the Phase 1 clinical study, including interim pharmacokinetic (PK) and pharmacodynamic (PD) results, is expected later this quarter.
Pasithea Therapeutics is focused on developing treatments for various neurological disorders, including NF1, solid tumors, and amyotrophic lateral sclerosis (ALS). The company's forward-looking statements are based on current estimates and assumptions but are subject to risks, uncertainties, and changes in circumstances.
This report is based on a press release statement and does not include any speculative or promotional content. Pasithea's stock is publicly traded under the ticker KTTA on the NASDAQ exchange.
In other recent news, Pasithea Therapeutics Corp. reported significant developments from their annual stockholder meeting. Elections saw Dr. Emer Leahy securing a Class I director seat with a three-year term. The meeting also ratified Marcum LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2024.
In addition to these corporate governance updates, Pasithea Therapeutics has made strides in its research and development efforts. The company shared positive preclinical data for its novel drug candidate, PAS-004, which has demonstrated potent inhibition of NRAS mutant cancer cell lines, surpassing existing MEK inhibitors. The data is set to be presented at the American Society of Clinical Oncology Annual Meeting.
Furthermore, PAS-004 has completed preclinical testing and animal toxicology studies, and received an orphan-drug designation from the FDA for the treatment of neurofibromatosis type 1 (NF1). These recent developments reflect Pasithea's ongoing commitment to bringing innovative treatments to the market.
InvestingPro Insights
As Pasithea Therapeutics Corp. (NASDAQ: KTTA) announces promising results from chronic toxicity studies for its PAS-004 drug candidate, it's important to consider the company's financial health and market performance. According to InvestingPro, Pasithea holds more cash than debt on its balance sheet, which is a positive sign for the company's financial stability. Additionally, liquid assets exceed short-term obligations, providing the company with a cushion to support ongoing research and development activities.
However, it's worth noting that the company is not profitable over the last twelve months, and the valuation implies a poor free cash flow yield. This could be a concern for investors looking for short-term profitability, but it's not uncommon for biotech firms in the development stage to focus on long-term potential rather than immediate earnings.
InvestingPro Data metrics reveal that Pasithea has a market capitalization of approximately $4.37 million, with a price-to-book ratio in the last twelve months as of Q2 2024 standing at 0.27. The stock has also experienced significant volatility, with a 1-week price total return showing a decrease of 7.94%, reflecting the inherent risks and high stakes of biotech investing.
InvestingPro offers additional tips on Pasithea Therapeutics, which can provide further insights into the company's performance and outlook. For those interested in a deeper analysis, visiting the InvestingPro platform could offer valuable information to complement the updates on the PAS-004 drug candidate's development.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.