Pasithea Therapeutics Corp

Pasithea Therapeutics Corp. is a biotechnology company focuses on the research and discovery of new and treatments for psychiatric and neurological disorders. The company was founded by Yassine Bendiabdallah and Steinman Lawrence J in May, 2020 and is headquartered in Miami Beach, FL.

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-- SRC recommended that the trial escalate to the next dose level of 15mg capsule -- -- No dose-limiting toxicities (DLTs) observed to date -- -- No rash observed to date -- MIAMI, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced that the external Safety Review Committee recommended proceeding to cohort 4, 15mg capsule, without modifications. This recommendation was based on the absence of any dose limiting toxicities (DLT's).

Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer

MIAMI, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced that it has entered into definitive agreements for the issuance and sale of an aggregate of 1,219,513 shares of its common stock (or pre-funded warrants in lieu thereof), accompanying Series A warrants to purchase up to 1,219,513 shares of common stock and accompanying short-term Series B warrants to purchase up to 1,219,513 shares of common stock at a purchase price of $4.10 per share (or per pre-funded warrant in lieu thereof) and accompanying warrants in a private placement priced at-the-market under the rules of the Nasdaq Stock Market. The Series A and the short-term Series B warrants will have an exercise price of $3.85 per share and will be exercisable immediately upon issuance. The Series A warrants will expire five years from the issuance date and the short-term Series B warrants will expire 18 months from the issuance date. The closing of the offering is expected to occur on or about September 30, 2024, subject to the satisfaction of customary closing conditions.

Pasithea Therapeutics Announces $5 Million Private Placement Priced At-The-Market Under Nasdaq Rules

On Thursday, Pasithea Therapeutics Corp.  KTTA announced safety, tolerability, pharmacokinetic (PK), and preliminary efficacy data from the first 2 cohorts of patients (n=6) in its Phase 1 trial of PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition.

Why Is Pasithea Therapeutics Stock Surging On Thursday?

-- Single patient in 2mg cohort with stage 3 colon cancer who received 4 prior lines of therapy achieves prolonged stable disease and remains on drug into 6th dosing cycle -- -- No treatment-related adverse events (TRAEs) or dose-limiting toxicities (DLTs) observed to date, including no rash or gastrointestinal (GI) AEs -- -- Systemic exposure at steady-state enables constant target inhibition while avoiding peak plasma toxicities -- -- Half-life of approximately 70 hours supports once-daily or less frequent oral dosing -- -- Distinctive MEK inhibitor profile for the treatment of both NF1-related plexiform and cutaneous neurofibromas, cancer, and other opportunities -- MIAMI, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced safety, tolerability, pharmacokinetic (PK) and preliminary efficacy data from the first 2 cohorts of patients (n=6) in its Phase 1 clinical trial of PAS-004, being conducted at four clinical sites in the United States.

Pasithea Therapeutics Announces Positive Initial Safety, Tolerability, Pharmacokinetic (PK), and Preliminary Efficacy Data from its Phase 1 Clinical Trial of PAS-004 in Advanced Cancer

Pasithea completes chronic toxicity studies for PAS-004, showing safety and potential for long-term use in NF1 and cancer treatment; Phase 1 trial ongoing

Pasithea Therapeutics Announces Successful Completion of PAS-004 Chronic Toxicity Studies

Pasithea Tx appoints Dr. Rebecca Brown, an expert in Neurofibromatosis and Director at Mount Sinai, to its Scientific Advisory Board to aid in PAS-004.

Pasithea Therapeutics Announces Appointment of Dr. Rebecca Brown to its Scientific Advisory Board

SOUTH SAN FRANCISCO, Calif. and MIAMI, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”) a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced that members of its management team will deliver a company presentation at the H.C.

Pasithea Therapeutics to Present at the H.C. Wainwright 26th Annual Global Investment Conference

Pasithea to present preclinical data at ASCO 2024 showing PAS-004 superior inhibition of NRAS cancer cells and xenograft tumors compared to current MEKi's

Pasithea Therapeutics to Present New Preclinical Data Showing PAS-004 Strongly Inhibits NRAS Cancer Cell Lines and Demonstrates Superior Activity in Xenograft Studies at 2024 ASCO Annual Meeting

SOUTH SAN FRANCISCO, Calif. and MIAMI, April 29, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 (NF1) and other indications, today announced the acceptance of an abstract for poster presentation at the American Society of Cancer Oncology (“ASCO”), which will be held in Chicago from May 31 – June 4, 2024.

Pasithea Therapeutics Announces PAS-004 Abstract Accepted for Poster Presentation at 2024 ASCO Annual Meeting

Pasithea Tx (Nasdaq: KTTA) Phase 1 trial on PAS-004 for RAS, NF1, and RAF mutated cancers completes initial dosing, with safety data expected in 2H 2024.

Pasithea Therapeutics Announces the First Cohort has Completed the Initial Dosing in its Phase 1 Trial Evaluating PAS-004 in RAS, NF1 and RAF Mutated Cancers

-- Activation of four U.S. sites for Phase 1 clinical trial of PAS-004 to evaluate safety, dose, key biomarker data and preliminary efficacy -- -- Plans to open three additional sites in Eastern Europe in the coming months -- -- Preliminary interim data expected in 2H 2024 -- SOUTH SAN FRANCISCO, Calif. and MIAMI, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced the activation of four clinical trial sites in the United States.

Pasithea Therapeutics Announces Opening of Enrollment in the U.S. for its Phase 1 Trial of PAS-004

-- Polymorph and Stereoisomer Patents when Issued Extend Portfolio to at least 2045 -- -- Polymorph and Stereoisomer Patent Filings Continue to Expand Patent Portfolio -- SOUTH SAN FRANCISCO, Calif. and MIAMI, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical stage biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, today announced the invention of a crystalline form of PAS-004 which is captured in polymorph and stereoisomer patent filings that when issued we believe will extend patent protection to at least 2045.

Pasithea Therapeutics Announces Invention of Crystalline Form of PAS-004; Establishes Strengthened Intellectual Property (IP) Position

-- PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials -- -- Phase 1 dose escalation study in patients with MAPK pathway driven advanced solid tumors to begin in Q1 2024 – -- Initial readout expected as early as Q3 2024 – SOUTH SAN FRANCISCO, Calif. and MIAMI, Jan. 02, 2024 (GLOBE NEWSWIRE) --   Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, today announced the Investigational New Drug Application (IND) clearance to proceed by the U.S. Federal Drug Administration (FDA) to evaluate PAS-004, a macrocyclic MEK (1/2) inhibitor, in patients with MAPK pathway driven advanced solid tumors with a documented RAS, RAF or NF1 mutation or patients who have failed BRAF/MEK inhibition.

Pasithea Therapeutics Announces FDA Acceptance of IND Application to Evaluate PAS-004 in Advanced Cancer Patients

Pasithea Therapeutics (Nasdaq: KTTA) adjourns stockholder meeting again to Dec 29 for voting on charter amendments, after partial adjournment on Dec 19.

Pasithea Therapeutics Announces Adjournment of Reconvened Meeting of Stockholders to December 29, 2023

SOUTH SAN FRANCISCO, Calif. and MIAMI, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (“Pasithea” or the “Company”) (NASDAQ: KTTA), today announced that it held its annual meeting of stockholders (the “Annual Meeting”) on December 19, 2023.

Pasithea Therapeutics Announces Results from 2023 Annual Meeting

Pasithea Therapeutics (NASDAQ: KTTA ) stock is falling on Wednesday after the company's shares experienced major volatility on Tuesday. Investors watching KTTA stock will note that it closed out Tuesday up less than 1%.

Why Is Pasithea Therapeutics (KTTA) Stock Down 12% Today?

Pasithea Therapeutics (NASDAQ: KTTA ) stock is rocketing higher on Monday after the biotechnology company announced results from two preclinical trials of PAS-004. The first study saw positive results from PAS-004 as a treatment for lung cancer.

Why Is Pasithea Therapeutics (KTTA) Stock Up 105% Today?

Pasithea Therapeutics (Nasdaq: KTTA) announced positive preclinical efficacy in models conducted ahead of its planned Phase I, in-human trials in 1Q24.

Pasithea Therapeutics Announces Positive In Vivo Preclinical Efficacy Data for PAS-004 from NRAS Mutation Cancer Xenograft Models

SOUTH SAN FRANCISCO, Calif. and MIAMI, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (“Pasithea” or the “Company”) (NASDAQ: KTTA), today announced that its annual meeting of stockholders held on November 29, 2023 (the “Annual Meeting”) was convened and then adjourned, without conducting any business, in order to provide stockholders additional time within which to vote on the proposals described in the Company's definitive proxy statement filed with the Securities and Exchange Commission (“SEC”) on October 26, 2023 (the “Proxy Statement”).

Pasithea Therapeutics Announces Adjournment of 2023 Annual Meeting of Stockholders

-- Company on track to submit PAS-004 IND application in current quarter -- -- Pasithea plans to begin PAS-004 Phase 1 dose escalation trial in advanced solid tumor patients harboring RAS, RAF and NF1 mutations -- SOUTH SAN FRANCISCO, Calif. and MIAMI, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for Central Nervous System (CNS) disorders, announced receipt of written responses to questions submitted for a Type 2 pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) regarding clinical development plan for PAS-004.

Pasithea Therapeutics Announces Outcome of Pre-IND Meeting with FDA for PAS-004 Clinical Development

Pasithea Tx (Nasdaq: KTTA) Selects Lead Development Candidate, Humanized mAb that Targets α5β1 Integrin for Treatment of both Sporadic and Familial ALS

Pasithea Therapeutics Selects PAS-003 Lead Development Candidate, a Humanized Monoclonal Antibody that Targets α5β1 Integrin for the Treatment of both Sporadic and Familial ALS

Pasithea Therapeutics Corp. Announces Final Results of Tender Offer

-- Attendees may request 1 x 1 meeting with management at meetings@hcwco.com --  PALO ALTO, Calif. and MIAMI, Fla., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders, announced today that Pasithea's management team will participate in the H.C. Wainwright 25th Annual Global Investment Conference, to be held in New York City, September 11-13.

Pasithea Therapeutics to Participate in H.C. Wainwright 25th Annual Global Investment Conference

-- PAS-003 is a monoclonal antibody targeting α 5/ β1 integrin for the treatment of amyotrophic lateral sclerosis (“ALS”) --   -- Lead α 5/ β1 integrin drug candidate to be selected in H2 2023 --

Pasithea Therapeutics publishes study in Proceedings of the National Academy of Sciences (PNAS) that shows an increase in α5 integrin expression in ALS human and mouse brain tissue, and further demonstrates targeting α5 integrin results in improved surviv

PALO ALTO, Calif. and MIAMI, July 20, 2023 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a biotechnology company focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders, today announced that its Board of Directors (the "Board") has authorized the repurchase, through a $4.0 million tender offer ("Tender Offer"), of up to approximately 5.7 million shares of the Company's outstanding common stock, at an anticipated cash purchase price of $0.70 per share.

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