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MIAMI - Pasithea Therapeutics Corp. (NASDAQ: KTTA), a clinical-stage biotech company, has announced promising safety and preliminary efficacy data from the initial cohorts of its Phase 1 trial for the drug PAS-004. The trial is focused on treating advanced solid tumors with mutations in the MAPK pathway.
The patient data released from the trial, which includes individuals who have failed to respond to prior BRAF/MEK inhibition, indicated that PAS-004 has a favorable safety profile. Notably, a patient with stage 3 colon cancer, who had undergone four prior lines of therapy, achieved prolonged stable disease and is currently in the 6th dosing cycle without experiencing any treatment-related adverse events (TRAEs) or dose-limiting toxicities (DLTs), including the absence of rash or gastrointestinal side effects commonly associated with MEK inhibitors.
PAS-004 has demonstrated a distinctive pharmacokinetic (PK) profile with a half-life of approximately 70 hours, supporting the potential for once-daily or less frequent oral dosing. This long half-life is a significant divergence from first-generation MEK inhibitors, which often have half-lives of less than 8 hours. The drug's steady-state systemic exposure and minimal fluctuation in plasma concentration suggest it can maintain constant target inhibition, potentially reducing peak plasma toxicities.
Dr. Tiago Reis Marques, CEO of Pasithea, expressed optimism about the drug's differentiated profile and its potential to improve on safety, dosing frequency, and efficacy over current MEK inhibitors. The data may position PAS-004 as a promising candidate for not only NF1 but also other cancers and conditions driven by the MAPK pathway.
The company has started dosing in the third cohort at an increased dose and has filed a protocol amendment for an increased dosing schedule. Pasithea expects to provide further updates on the trial as it progresses.
The information reported is based on a press release statement by Pasithea Therapeutics Corp. and reflects the company's current views regarding the ongoing Phase 1 clinical trial and the characteristics of PAS-004.
In other recent news, Pasithea Therapeutics Corp. has made significant strides in its research and development efforts. The biotech firm announced the successful completion of chronic toxicity studies for its drug candidate PAS-004, which is currently being tested in a Phase 1 clinical trial with advanced cancer patients. The studies showed a consistent safety profile in long-term dosing, supporting chronic patient dosing for the drug.
The company also reported promising preclinical data for PAS-004, demonstrating potent inhibition of NRAS mutant cancer cell lines and surpassing existing MEK inhibitors. Furthermore, PAS-004 received an orphan-drug designation from the FDA for the treatment of neurofibromatosis type 1 (NF1).
In addition to these research and development milestones, Pasithea held its annual stockholder meeting where Dr. Emer Leahy was elected as a Class I director for a three-year term. The stockholders also ratified Marcum LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2024.
These are some of the recent developments at Pasithea Therapeutics Corp., reflecting the company's ongoing commitment to bringing innovative treatments to the market.
InvestingPro Insights
Pasithea Therapeutics Corp. (NASDAQ: KTTA) has recently highlighted promising data from its Phase 1 trial, which may be of interest to investors monitoring the company's clinical advancements. According to real-time data from InvestingPro, Pasithea has a market capitalization of $4.28 million, underscoring its status as a small-cap biotech company with potential for growth given successful trial outcomes.
InvestingPro Tips reveal that while Pasithea holds more cash than debt on its balance sheet, indicating some financial stability, the company is quickly burning through cash, which is a critical factor for investors to consider as it progresses through expensive clinical trials. Additionally, the company's stock has taken a considerable hit over the last week, reflecting investor reactions to recent company performance or market conditions.
The InvestingPro Data further indicates that the stock is trading near its 52-week low with a price of $3.85 at the previous close, which may present a potential entry point for investors believing in the long-term prospects of PAS-004. It's important to note that the stock has not fared well over the last month and six months, with price total returns reflecting a significant decline.
Despite these challenges, Pasithea does not pay a dividend to shareholders, which is common for clinical-stage biotech companies that typically reinvest all earnings into research and development. Moreover, the company's valuation implies a poor free cash flow yield, a metric that investors often scrutinize when assessing the sustainability of a company's financial health.
For those interested in a deeper dive into Pasithea's financials and stock performance, InvestingPro offers additional tips and insights. Currently, there are 11 more InvestingPro Tips available at https://www.investing.com/pro/KTTA, which could provide further guidance to investors considering this biotech company for their portfolios.
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