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Pasithea Therapeutics Corp. Warrants - KTTAW STOCK NEWS

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Pasithea Therapeutics Corp is a biotechnology company focused on the discovery, research, and development of treatments for central nervous system (CNS) disorders and other diseases, including RASopathies. Leveraging expertise in neuroscience, translational medicine, and drug development, the company's pipeline includes Neurofibromatosis Type 1, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Schizophrenia.

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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.

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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.

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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.

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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.

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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.

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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/
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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.

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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.

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Pasithea Therapeutics Corp. (NASDAQ: KTTA) announced the acceptance of an abstract for poster presentation at the 2024 ASCO Annual Meeting for their drug PAS-004, a macrocyclic MEK inhibitor targeting neurofibromatosis type 1 (NF1) and other indications. The drug is the first of its kind in human clinical trials, offering extended half-life for improved efficacy.

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Pasithea Therapeutics Corp. announces the completion of initial dosing for the first cohort in a Phase 1 trial evaluating PAS-004 in RAS, NF1, and RAF mutated cancers. Safety, tolerability, and biomarker data expected in 2H 2024. PAS-004 is a next-generation MEK inhibitor for neurofibromatosis type 1 (NF1) and other indications, showing potential as a best-in-class inhibitor.
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FAQ

What is the current stock price of Pasithea Therapeutics Warrants (KTTAW)?

The current stock price of Pasithea Therapeutics Warrants (KTTAW) is $0.023 as of December 11, 2024.

What is Pasithea Therapeutics Corp focused on?

Pasithea Therapeutics Corp is focused on the discovery, research, and development of treatments for central nervous system (CNS) disorders and other diseases, including RASopathies.

What is included in Pasithea Therapeutics Corp's pipeline?

The company's pipeline includes treatments for Neurofibromatosis Type 1, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Schizophrenia.

What areas of expertise does Pasithea Therapeutics Corp leverage?

Pasithea Therapeutics Corp leverages expertise in neuroscience, translational medicine, and drug development.

Who can be contacted for corporate communications at Pasithea Therapeutics Corp?

For corporate communications, you can reach out to Patrick Gaynes at pgaynes@pasithea.com.

When is the initial safety, tolerability, and biomarker data expected to be reported?

The initial safety, tolerability, and biomarker data are expected to be reported in the second half of 2024.

When is the initial interim safety and PK data release on track for?

The initial interim safety and PK data release is on track for the third quarter of 2024.

What diseases does Pasithea Therapeutics Corp focus on?

Pasithea Therapeutics Corp focuses on treating central nervous system (CNS) disorders, RASopathies, and other diseases.

What is Pasithea Therapeutics Corp's primary area of research?

The company's primary area of research is in developing treatments for central nervous system (CNS) disorders.

What is the core mission of Pasithea Therapeutics Corp?

The core mission of Pasithea Therapeutics Corp is to advance the treatment options for patients with CNS disorders and other related conditions.

How does Pasithea Therapeutics Corp contribute to the field of medicine?

Pasithea Therapeutics Corp contributes by developing innovative therapies for challenging conditions like Neurofibromatosis Type 1, ALS, MS, and Schizophrenia.

Pasithea Therapeutics Corp. Warrants

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