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MIAMI - Pasithea Therapeutics Corp. (NASDAQ: KTTA), a clinical-stage biotechnology company with a market capitalization of approximately $6 million, has announced interim results from a Phase 1 trial of its drug PAS-004, showing preliminary clinical activity in treating refractory solid tumors. While the stock has seen significant pressure, declining over 80% in the past year, InvestingPro analysis suggests the company maintains strong liquidity with more cash than debt on its balance sheet. The study, presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, is evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of the drug in patients with advanced solid tumors driven by the MAPK pathway. According to InvestingPro data, the company maintains a healthy current ratio of 3.84, indicating strong ability to fund ongoing clinical development. Unlock 5+ additional ProTips and comprehensive financial metrics with an InvestingPro subscription.
As of April 2, 2025, 21 patients had been dosed across six cohorts, with the most common diagnoses being pancreatic cancer, colorectal cancer, and melanoma. Treatment-related adverse events were mild, with no grade 3 or higher adverse events reported. Notably, no dose-limiting toxicities (DLTs) were observed, allowing ongoing dose escalation in the trial.
PAS-004, a next-generation macrocyclic MEK inhibitor, has shown a dose-dependent pharmacokinetic profile with a half-life exceeding 60 hours, suggesting prolonged target engagement at tolerable doses. Early response evaluations in 16 efficacy-evaluable patients indicated stable disease in 10 patients, with progression-free survival up to 159 days and overall survival up to 253 days.
In cohort 4A, two patients achieved stable disease, with one patient with stage 4 KRAS-mutated pancreatic cancer showing a tumor reduction of 9.8% and another with stage 4 BRAF-mutated melanoma showing a reduction of 14.9%; both remain on treatment for over five months.
Dr. Tiago Reis Marques, CEO of Pasithea, expressed optimism about PAS-004’s potential as a best-in-class MEK inhibitor for a broad range of MAPK pathway-driven tumors. He highlighted the drug’s high selectivity and sustained pathway suppression, which could make it optimal for monotherapy and combination therapy, including in patients who have failed prior MEK inhibitors. Based on InvestingPro’s Fair Value analysis, the stock appears undervalued despite current financial metrics indicating weak overall health scores.
Pasithea is also conducting a Phase 1/1b trial of PAS-004 in adult patients with neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas. The company’s forward-looking statements, including the potential success of PAS-004, are subject to risks and uncertainties that could cause actual results to differ materially. This article is based on a press release statement from Pasithea Therapeutics Corp.
In other recent news, Pasithea Therapeutics Corp. has reported promising interim data from a Phase 1 trial of its drug PAS-004, which is being tested for its efficacy in treating advanced cancers driven by the MAPK pathway. The trial has shown that PAS-004 can inhibit ERK phosphorylation by up to 91%, indicating strong target engagement. One patient with stage 4 pancreatic cancer experienced a tumor volume reduction of 9.8% over five months of treatment. Additionally, the external Safety Review Committee has approved advancing the trial to a 30mg capsule dosage, with no dose-limiting toxicities observed in the initial cohort.
Pasithea’s ongoing study aims to evaluate the safety, tolerability, and preliminary efficacy of PAS-004 in patients with advanced solid tumors. The company has highlighted the absence of rash, a common side effect with similar medications, in its trial participants. Furthermore, Pasithea has shared new preclinical findings suggesting that PAS-004 could be more effective in inhibiting certain inflammatory responses than the current FDA-approved MEK inhibitor selumetinib. These developments are part of Pasithea’s broader focus on central nervous system disorders and cancer treatments. The company continues to caution that while results are encouraging, future outcomes may vary.
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