Pasithea Therapeutics Corp - KTTAW STOCK NEWS

Pasithea Therapeutics (NASDAQ: KTTA) has expanded its Phase 1 clinical trial for PAS-004, a next-generation macrocyclic MEK inhibitor, by opening three new sites in Eastern Europe. The trial now includes locations in Romania and Bulgaria, operating alongside four existing U.S. sites. The company has completed initial dosing of three patients in Cohort 4A (15mg capsule) and is currently recruiting for Cohort 4B (4mg tablet).

The ongoing trial is a multi-center, open-label, dose-escalation study evaluating PAS-004's safety, tolerability, and preliminary efficacy in patients with MAPK pathway-driven advanced solid tumors. The company expects to present interim safety and pharmacokinetic data from Cohorts 4A and 4B in Q1 2025.

Pasithea Therapeutics (NASDAQ: KTTA) announced positive safety results from its Phase 1 clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor. The Safety Review Committee recommended advancing to cohort 4 with a 15mg capsule dose, following no dose-limiting toxicities in the first 9 patients. Notably, no rash was observed, which is a common adverse event with competitor MEK inhibitors. The company will add cohort 4b to test a commercial formulation. PAS-004 demonstrates advantages over first-generation MEK inhibitors, including a longer half-life of 70 hours enabling once-daily dosing, and consistent plasma levels at steady-state.

Pasithea Therapeutics Corp. (NASDAQ: KTTA) has announced a $5 million private placement priced at-the-market under Nasdaq rules. The offering includes the sale of 1,219,513 shares of common stock (or pre-funded warrants) with accompanying Series A and short-term Series B warrants at $4.10 per share. Both warrant series have an exercise price of $3.85 per share, with Series A expiring in 5 years and Series B in 18 months.

The closing is expected around September 30, 2024, subject to customary conditions. H.C. Wainwright & Co. is the exclusive placement agent. Pasithea plans to use the net proceeds for working capital and general corporate purposes. The securities are offered under Section 4(a)(2) of the Securities Act and/or Regulation D and have not been registered, limiting their sale in the United States.

Pasithea Therapeutics (NASDAQ: KTTA) announced positive initial data from its Phase 1 clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor, for advanced cancer treatment. The trial, conducted at four U.S. sites, showed promising results in safety, tolerability, pharmacokinetics (PK), and preliminary efficacy.

Key findings include:

• No treatment-related adverse events or dose-limiting toxicities observed
• Long half-life of ~70 hours, supporting once-daily or less frequent oral dosing
• Constant target inhibition while avoiding peak plasma toxicities
• A patient with stage 3 colon cancer achieved prolonged stable disease

The company believes PAS-004 demonstrates a differentiated MEK inhibitor profile, potentially outperforming current inhibitors in safety, dosing frequency, and efficacy for treating neurofibromatosis type 1 (NF1) and other cancer indications.

Pasithea Therapeutics Corp. (NASDAQ: KTTA) has successfully completed long-term chronic toxicity studies for its lead candidate PAS-004, a next-generation macrocyclic MEK inhibitor. The studies, conducted in rats (6 months) and dogs (9 months), confirm the safety profile observed in prior 28-day toxicity studies. Key findings include:

1. Establishment of 0.5 mg/kg as the no adverse effect level (NOAEL) in dogs, the most sensitive species.
2. Consistent safety profile at doses correlating with significant pathway engagement.
3. Similar adverse event profile and equivalent NOAEL for crystalline PAS-004 compared to the original amorphous formulation.

These results support chronic patient dosing and highlight PAS-004's potential as a best-in-class MEK inhibitor for treating neurofibromatosis type 1 (NF1) and other cancer indications. Pasithea plans to share initial interim pharmacokinetic and pharmacodynamic data from its Phase 1 clinical study later this quarter.

Pasithea Therapeutics Corp. (NASDAQ: KTTA) has appointed Dr. Rebecca Brown to its Scientific Advisory Board. Dr. Brown, the Director of the Neurofibromatosis Clinic at The Mount Sinai Hospital, brings extensive expertise in Neurofibromatosis type 1 (NF1) research and treatment. This appointment aligns with Pasithea's development of PAS-004, a next-generation macrocyclic MEK inhibitor for NF1 treatment.

Dr. Brown's experience, particularly in cutaneous and plexiform neurofibromas, will contribute to Pasithea's upcoming Phase 1/2a clinical trial for NF1. She highlighted PAS-004's potential advantages, including a long half-life, superior therapeutic index, cleaner safety profile, and once-daily dosing, which could represent a significant advancement in NF1 treatment.

Pasithea Therapeutics Corp. (NASDAQ: KTTA), a clinical-stage biotech company, will present at the H.C. Wainwright 26th Annual Global Investment Conference in New York City. The company is developing PAS-004, a next-generation macrocyclic MEK inhibitor for treating neurofibromatosis type 1 (NF1) and other cancer indications.

Key points:

• Presentation available online from 7:00 a.m. ET on September 9th, 2024
• Management to conduct 1x1 meetings from September 9-11, 2024
• Conference held at the Lotte New York Palace Hotel
• Registration available at https://hcwevents.com/annualconference/

Pasithea Therapeutics has completed enrollment and initial dosing for the second cohort in its Phase 1 clinical trial of PAS-004, a macrocyclic MEK inhibitor aimed to treat neurofibromatosis type 1 (NF1) and other conditions. The Safety Review Committee (SRC) recommended escalating to the next dose level (4mg) after a positive safety review of the first dose cohort (2mg), which showed no dose-limiting toxicities or clinically relevant adverse events. The trial, involving patients with advanced solid tumors driven by MAPK pathway mutations, aims to assess the safety, tolerability, and pharmacokinetics (PK) of PAS-004. Initial safety and PK data are expected by Q3 2024.

Pasithea Therapeutics announced new preclinical data for PAS-004, revealing its strong inhibition of NRAS mutant cancer cell lines and superior activity in xenograft studies. PAS-004 demonstrated greater efficacy than selumetinib and binimetinib, comparable efficacy to trametinib without plateauing, and achieved over 50% maximal growth inhibition in more cell lines. The data will be presented at the ASCO Annual Meeting on June 1, 2024. PAS-004, a macrocyclic MEK inhibitor, is in clinical trials for neurofibromatosis type 1 (NF1) and other cancers, offering potential advantages in pharmacokinetics, pharmacodynamics, and tolerability.