MIAMI, May 07, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics, Corp. (“Pasithea,” or the “Company”) (Nasdaq: KTTA; KTTAW), 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 closing of its previously announced public offering of 3,571,428 shares of its common stock (or pre-funded warrants in lieu thereof) and accompanying Series C warrants to purchase up ...

MIAMI, May 06, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics, Corp. (“Pasithea,” or the “Company”) (Nasdaq: KTTA; KTTAW), 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 pricing of a public offering of 3,571,428 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) and accompanying Series C warrants to purchase up to 3,571,428 ...

Core Insights - Pasithea Therapeutics Corp. announced positive interim pharmacodynamic data from its Phase 1 trial of PAS-004, a macrocyclic MEK inhibitor targeting neurofibromatosis type 1 and other MAPK pathway-driven cancers [1][5] - The trial demonstrated up to 91% inhibition of pERK, confirming substantial target engagement and a favorable pharmacological profile [1][3] - One patient with stage 4 KRAS G12R mutated pancreatic cancer showed a tumor volume reduction of -9.8% over 5 months of treatment with PAS-004 [1][4] Pharmacodynamic Data - Inhibition of ERK phosphorylation (pERK) is a recognized biomarker for assessing MEK inhibitor activity, with measurements taken from patients at baseline and day 22 [2] - The results indicated robust pERK inhibition, with reductions of up to 91% at the 8mg dose level, aligning with previous PK/PD models [3] Clinical Observations - Preliminary clinical observations showed several patients achieving stable disease and tumor shrinkage while on PAS-004 treatment [4] - The ongoing Phase 1 trial is a multi-center, open-label, dose escalation study evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with MAPK pathway-driven advanced solid tumors [5] Company Overview - Pasithea Therapeutics is focused on developing innovative treatments for central nervous system disorders, RASopathies, and MAPK pathway-driven tumors [6]

MIAMI, April 29, 2025 (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 MAPK pathway driven cancer indications, today announced the Company has completed enrollment and initial dosing of three subjects in Cohort 6 with 30 mg capsules of PAS-004. “We are pleased to have recruited, enrolled and commenc ...

Core Viewpoint - Pasithea Therapeutics Corp. announced the acceptance of an abstract for a poster presentation at the ASCO Annual Meeting, highlighting the ongoing Phase 1 clinical trial of PAS-004, a macrocyclic MEK inhibitor for treating neurofibromatosis type 1 and other MAPK pathway-driven conditions [1][2]. Group 1: Clinical Trial Details - The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway-driven advanced solid tumors [5]. - Updated interim clinical data from cohorts 4A and 4B of the trial has shown clinical activity, target engagement, and a favorable safety profile [3]. Group 2: Presentation Information - The poster presentation will take place on June 2, 2025, from 1:30 PM to 4:30 PM CDT, under the title "Phase 1 dose-escalation study of the safety and pharmacokinetics of PAS-004" [4]. - The full abstract will be available on the ASCO website on May 22, 2025, at 5:00 PM ET [4]. Group 3: Company Overview - Pasithea Therapeutics is focused on the discovery, research, and development of innovative treatments for central nervous system disorders, RASopathies, and MAPK pathway-driven diseases [6].

– SRC recommended that the trial escalate to the next dose level of 30mg capsule – – No dose-limiting toxicities (DLT’s) or rash observed to date – MIAMI, April 10, 2025 (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 reco ...

Financial Performance - The company incurred net losses of approximately $13.9 million and $16.0 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of approximately $49.6 million as of December 31, 2024 [211]. - For the year ended December 31, 2024, the net loss was $13,904,584, a decrease of $2,057,074 or 12.9% compared to a net loss of $15,961,658 in 2023 [359]. - Working capital decreased by $7.8 million from December 31, 2023, to December 31, 2024, primarily due to cash used to fund operations [367]. - Cash and cash equivalents decreased by approximately $9.4 million for the year ended December 31, 2024, compared to a decrease of approximately $16.8 million for the year ended December 31, 2023 [369]. - Other income, net decreased by approximately $126,000, or 26.8%, for the year ended December 31, 2024, primarily due to an increase in the fair value of warrant liabilities [365]. Capital Requirements - As of December 31, 2024, the company had cash and cash equivalents of approximately $6.9 million, indicating a need for additional capital to fund operations [215]. - The company may need to raise additional funds sooner to pursue a more accelerated development of its product candidates [214]. - The company is dependent on obtaining additional working capital funding to continue executing its development plans and operations [370]. - The company entered into an At The Market Offering Agreement allowing it to issue and sell up to $2,076,000 of its Common Stock [217]. Product Development and Regulatory Challenges - The company is dependent on the successful development and commercialization of its lead product candidate, PAS-004, which is not yet approved [204]. - The regulatory approval processes for product candidates are lengthy and unpredictable, with no assurance of obtaining necessary approvals [243]. - The FDA or foreign regulatory bodies may delay or deny approval of product candidates, significantly harming the company's business prospects [247]. - The company may need to abandon or change the prioritization of product candidates based on various factors, including regulatory requirements and market conditions [238]. - Clinical trial delays may arise from various factors, including inability to generate sufficient preclinical data and delays in reaching agreements with contract research organizations [255]. Market and Economic Risks - The company faces risks from unfavorable global economic conditions, including extreme volatility in credit and financial markets, rising interest rates, and geopolitical events [228]. - Future adverse developments in the financial services industry may lead to market-wide liquidity shortages, impairing the company's ability to access working capital [230]. - Disruptions in the global economy and supply chains since 2020 have resulted in longer lead times and increased costs, impacting the company's financial condition and operations [281]. - Inflation may increase costs related to clinical trials and research and development, potentially leading to faster depletion of cash reserves [282]. Operational and Staffing Challenges - Increased labor costs and staffing challenges are expected, which could disrupt business operations and increase operating expenses [233]. - The company has incurred increased labor costs and may face challenges in attracting and retaining key leadership talent, impacting operational efficiency [232]. - The company has a limited operating history, making it difficult for investors to evaluate its current business and predict future success [205]. Internal Controls and Compliance - The company identified a material weakness in financial reporting related to certain tax disclosures, which has since been remediated [315]. - Management evaluated the effectiveness of internal control over financial reporting as of December 31, 2024, using the criteria from the Internal Control - Integrated Framework (2013) [392]. - Management concluded that internal control over financial reporting was effective at a reasonable assurance level as of December 31, 2024 [393]. - There were no changes in internal control over financial reporting during the fiscal quarter ended December 31, 2024, that materially affected internal control [398]. Stock and Market Conditions - The market price of the company's Common Stock ranged from $2.54 to $8.75 per share for the year ended December 31, 2024, indicating high volatility [305]. - The company has never declared or paid any cash dividends on its equity securities and does not anticipate doing so in the foreseeable future [326]. - The company’s stockholders may face significant fluctuations in the market price of its Common Stock and Warrants due to various market conditions [306]. Strategic Partnerships and Collaborations - The company may face significant competition in securing strategic partnerships, which could delay the development and commercialization of product candidates [275]. - Future collaborations may restrict the company's ability to independently pursue new product candidates, impacting strategic initiatives [304]. - The company faces risks related to potential conflicts with collaborators that could delay or terminate product development [300]. Research and Development Focus - The company is focused on developing PAS-004, a next-generation MEK inhibitor, with a Phase 1 multicenter trial currently underway at four U.S. sites and three in Eastern Europe [351]. - The FDA cleared the Investigational New Drug application for PAS-004 in December 2023, allowing the company to proceed with clinical trials [351]. - The company anticipates an increase in research and development expenses in fiscal year 2025 due to ongoing clinical research for PAS-004 [364].

Core Insights - Pasithea Therapeutics Corp. is set to present its next-generation macrocyclic MEK inhibitor, PAS-004, at the 2025 CAGLA NeauxCancer Conference, highlighting its potential in treating neurofibromatosis type 1 (NF1) and other cancer indications [1][2] - The presentation will include interim safety, tolerability, and pharmacokinetic data from an ongoing Phase 1 study involving advanced cancer patients with MAPK pathway-driven tumors [2] - The CAGLA NeauxCancer Conference is a significant event for oncology researchers and industry professionals, focusing on advancements in cancer treatment [3] Company Overview - Pasithea Therapeutics is a biotechnology firm dedicated to developing innovative treatments for central nervous system disorders and RASopathies, with a focus on conditions like NF1, solid tumors, and ALS [4] - The company boasts a team of experts in neuroscience, translational medicine, and drug development, aiming to create new molecular entities for various neurological disorders [4]

Clinical Trial Progress - Pasithea Therapeutics has opened three new clinical trial sites in Eastern Europe, specifically in Romania and Bulgaria, in addition to the four existing sites in the United States for the PAS-004 Phase 1 trial [1] - The company has completed initial dosing of three patients in Cohort 4A (15mg capsule) and is actively recruiting patients for Cohort 4B (4mg tablet) [3] - Interim safety and pharmacokinetic (PK) data from Cohorts 4A and 4B are expected to be presented in Q1 2025 [3] Partnerships and Collaborations - Pasithea is collaborating with Arensia Exploratory Medicine and several oncology institutes in Eastern Europe, including the Institute of Oncology Bucharest, Institute of Oncology Cluj-Napoca, and Multiprofile Hospital for Active Treatment Sveta Sofia- EOOD [2] Trial Design and Objectives - The ongoing Phase 1 clinical trial is a multi-center, open-label, dose-escalation 3+3 study designed to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 [4] - The trial focuses on patients with MAPK pathway-driven advanced solid tumors with documented RAS, NF1, or RAF mutations, or those who have failed BRAF/MEK inhibition [4] Company Overview - Pasithea Therapeutics is 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 [1] - The company is focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders and RASopathies, including NF1, solid tumors, and Amyotrophic Lateral Sclerosis (ALS) [5]

Financial Performance - The company reported a net loss of $2,999,834 for the three months ended September 30, 2024, a decrease of 17.0% compared to a net loss of $3,612,590 for the same period in 2023[119]. - Net loss from continuing operations was $(10,726,923) for the nine months ended September 30, 2024, compared to $(10,476,484) for the same period in 2023[136]. - Other income, net decreased by approximately $172,000, or 97%, for the three months ended September 30, 2024, compared to the same period in 2023[132]. - Cash and cash equivalents decreased by approximately $7.0 million for the nine months ended September 30, 2024, compared to a decrease of approximately $13.5 million for the same period in 2023[136]. - Working capital decreased by approximately $5.0 million between December 31, 2023, and September 30, 2024, primarily due to cash used to fund operations[135]. Expenses - Research and development expenses were $1,581,376 for the three months ended September 30, 2024, a slight decrease of 2.7% from $1,624,766 in the prior year[119]. - General and administrative expenses decreased by 34.3% to $1,423,228 for the three months ended September 30, 2024, compared to $2,164,560 in the same period of 2023[119]. - General and administrative expenses decreased by approximately $779,000, or 13%, for the nine months ended September 30, 2024, compared to the same period in 2023[125]. - Research and development expenses increased by approximately $939,000, or 20%, for the nine months ended September 30, 2024, compared to the same period in 2023[129]. - The company expects general and administrative expenses to continue at lower levels in fiscal year 2024 compared to fiscal year 2023[126]. - The company anticipates an increase in research and development expenses in fiscal year 2024 primarily due to clinical development activities[130]. Clinical Development - The company is currently conducting a Phase 1 clinical trial for its lead candidate PAS-004 at four clinical sites in the U.S. and plans to open three additional sites in Eastern Europe by Q4 2024[110]. - The FDA cleared the IND for PAS-004 in December 2023, allowing the company to proceed with its Phase 1 multicenter trial[109]. - The company ceased development of the PAS-002 program for multiple sclerosis due to high costs and the availability of effective treatments[111]. - The company expects to incur significant operating losses and expenses as it advances its product candidates through development and clinical trials[113]. Funding and Capital - The company raised approximately $4.5 million from a securities purchase agreement in September 2024, selling pre-funded warrants and PIPE warrants[115]. - As of September 30, 2024, the company had approximately $9.4 million in operating bank accounts and money market funds[137]. - The company requires significant cash resources to execute its business plans and is dependent on obtaining additional working capital funding[137]. Market Conditions - Inflation has negatively impacted the company's costs, particularly in employee compensation and outside services, with expectations of continued pressure throughout 2024[120]. - A one-for-20 reverse stock split was executed on January 2, 2024, reducing the number of authorized shares from 495 million to 100 million[116].