Extends cash runway through at least the first half of 2028Led by healthcare-dedicated investors, including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners and Squadron Capital Management MIAMI, Dec. 02, 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 oral MEK inhibitor for the treatment of ne ...

Market Overview - U.S. stocks experienced an upward trend, with the Dow Jones increasing by over 250 points, closing up 0.60% at 47,709.91, while the NASDAQ rose 0.36% to 23,297.13 and the S&P 500 gained 0.38% to 6,838.77 [1] - Energy shares saw a notable increase of 1.6%, while health care stocks declined by 0.6% on the same day [1] Company Earnings - Chagee Holdings Limited (NASDAQ:CHA) reported a 7% increase in shares after releasing its third-quarter earnings, with non-GAAP net income decreasing to RMB502.8 million ($70.6 million) from RMB646.6 million year-over-year, and net revenues falling to RMB3,208.3 million ($450.7 million) from RMB3,541.2 million [2] Commodity Prices - In commodity markets, oil prices rose by 1% to $59.26, gold increased by 0.8% to $4,237.60, silver surged by 4.9% to $56.210, and copper climbed 1.8% to $5.2870 [5] European Markets - European shares showed positive movement, with the eurozone's STOXX 600 rising by 0.26%, Spain's IBEX 35 Index up 0.12%, London's FTSE 100 increasing by 0.31%, Germany's DAX 40 gaining 0.31%, and France's CAC 40 rising by 0.29% [6] Asian Markets - Asian markets closed mixed, with Japan's Nikkei gaining 0.17%, Hong Kong's Hang Seng falling 0.34%, China's Shanghai Composite rising 0.34%, and India's BSE Sensex decreasing by 0.02% [7] Notable Stock Movements - DeFi Technologies Inc. (NASDAQ:DEFT) shares surged 11% to $1.5300 following the approval of QCAD as Canada's first compliant CAD stablecoin [8] - Pasithea Therapeutics Corp. (NASDAQ:KTTA) saw a significant increase of 61% to $1.7017 after announcing a $60 million public offering of common stock [8] - HeartBeam, Inc. (NASDAQ:BEAT) shares rose by 23% to $0.7452 after outlining its regulatory strategy post-FDA's NSE decision [8] - Rubico Inc. (NASDAQ:RUBI) shares dropped 25% to $0.1623 due to a reported reverse stock split [8] - Tilray Brands, Inc. (NASDAQ:TLRY) shares fell 19% to $0.8310 following its announcement of a reverse stock split [8] - Rich Sparkle Holdings Limited (NASDAQ:ANPA) shares decreased by 34% to $17.53 after announcing plans to purchase up to $50 million in EDU tokens [8]

Extends cash runway through at least the first half of 2028Led by Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners, and Squadron Capital Management MIAMI, Nov. 28, 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 oral MEK inhibitor for the treatment of neurofibromatosis type 1-associated plexifo ...

Company Highlights - Zynex, Inc. (NASDAQ:ZYXI) experienced a 98% increase in stock price, reaching $1.46 from a low of $0.695, with a trading volume exceeding 66 million shares, driven by strong Q3 results [1][6] - Pasithea Therapeutics Corp. (KTTA) saw a 69.4% rise in stock price to $0.826, peaking at $1.34 during the day, with a trading volume of approximately 124 million shares, following a $1 million grant from the ALS Association for ALS research [2][6] - Amber International Holding Ltd (Nasdaq: AMBR) reported a 59.49% jump in stock price to $2.52, with over 85 million shares traded, and announced a $50 million share repurchase program, reflecting strong business momentum [3][6] - SMX (NASDAQ:SMX) saw its stock price climb by 58.21% to $9.35, with over 12 million shares traded, showcasing strong momentum at the 2025 DMCC Precious Metals Conference [4][6] Market Trends - The market is characterized by significant investor interest and stock price volatility across various sectors, including healthcare, biotechnology, real estate, and technology, driven by company-specific developments and broader market trends [5]

Core Insights - The ALS Association has awarded Pasithea Therapeutics a grant of approximately $1 million to study PAS-004 in ALS patients, focusing on its efficacy, safety, and tolerability [1][2] - This grant marks the initiation of the first clinical trial of PAS-004 in individuals with ALS, which is a significant milestone for the company [2] - PAS-004 is a next-generation macrocyclic MEK inhibitor that has shown promising results in preclinical models and is currently being tested in other clinical trials for different conditions [2][3] Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company focused on developing PAS-004 for various diseases, including ALS, RASopathies, and MAPK pathway-driven tumors [3] - The company is conducting a Phase 1 clinical trial of PAS-004 in advanced cancer patients and a Phase 1/1b trial in patients with neurofibromatosis type 1 [3] ALS Association Overview - The ALS Association is the largest organization dedicated to ALS, funding research, providing support to patients and families, and advocating for better public policies [4] - The association's mission is to make ALS livable and ultimately find a cure for the disease [4] Disease Context - Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that leads to loss of motor function and is typically fatal within five years of diagnosis [5] - There is a significant unmet need for new therapies to address the functional deficits and progression of ALS [5]

Core Insights - Pasithea Therapeutics Corp. announced positive safety, pharmacokinetic (PK), and pharmacodynamic (PD) data from Cohort 7 (37mg capsules) in its ongoing first-in-human trial for PAS-004, a macrocyclic oral MEK inhibitor targeting MAPK pathway-driven advanced solid tumors [1][2][8] Safety and Tolerability Results - Zero treatment-related adverse events were observed during the dose-limiting toxicity (DLT) period in Cohort 7 [1][6] - The Safety Review Committee recommended proceeding to the next dose level, Cohort 8 (45mg capsules), without modifications [1][6] Pharmacodynamics (PD) Results - PD data supports continuous suppression of the MAPK pathway throughout the 24-hour dosing cycle [1][2] - PAS-004 demonstrated an ability to inhibit phosphorylated extracellular signal-regulated kinase (pERK) at levels of 80% near Cmax and above 60% at Cmin [6] Pharmacokinetics (PK) Results - The PK profile showed linearity and dose-proportionality with a Cmax/Cmin ratio of less than 2 [1][6] - Achieved AUC of 6,690 ng·h/mL, Cmax of 313 ng/mL, and Cmin of 260 ng/mL [1][6] Company Overview - Pasithea is focused on developing PAS-004 for treating RASopathies, MAPK pathway-driven tumors, and other diseases, currently in Phase 1 clinical trials for advanced cancer and neurofibromatosis type 1 [8]

-- Tablet PK exposure increases proportionally with an increase in dose -- -- More favorable PK properties in tablets enable a lower dose to achieve the same exposure as the capsule formulation, with improved predictability and reduced variability -- -- Tablet steady state showing Cmax/Cmin ratio <2 -- MIAMI, Nov. 21, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral ...

Core Insights - Pasithea Therapeutics Corp. announced positive interim Phase 1 data for PAS-004, a macrocyclic oral MEK inhibitor, targeting neurofibromatosis type 1-associated plexiform neurofibromas and advanced solid tumors with specific mutations [1][2]. Interim Phase 1 Results - Initial signals of clinical activity were observed, with a partial response in a melanoma patient previously treated with a MEK + BRAF inhibitor, remaining on trial for over 11 months [3][4]. - Among 21 efficacy evaluable patients, the disease control rate was 71.4%, with 5 out of 7 patients with BRAF-mutated tumors achieving stable disease [3][7]. - PAS-004 demonstrated a favorable safety profile, with all treatment-related adverse events classified as Grade 1 or 2, and no ocular or cardiovascular toxicities reported [3][7]. Pharmacokinetics and Drug Exposure - At the highest reported dose of 30mg, PAS-004 showed significant drug exposure with an Area Under the Curve (AUC) greater than 5,400 ng·h/mL, indicating sustained pathway inhibition [2][3]. - The pharmacokinetic profile was characterized by a Cmax/Cmin ratio of less than 2, with a long half-life of approximately 60 hours [7]. Safety and Tolerability - The drug was well-tolerated across all dose levels, with no dose-limiting toxicities or treatment discontinuations reported [7]. - Limited adverse effects included rash (7.4%), nausea (18.5%), vomiting (14.8%), and diarrhea (7.4%) [7]. Company Overview - Pasithea Therapeutics is focused on developing PAS-004 for RASopathies, MAPK pathway-driven tumors, and other diseases, currently conducting Phase 1 clinical trials in advanced cancer patients and NF1-associated plexiform neurofibromas [5].

Financial Performance - The net loss for the three months ended September 30, 2025, was $3,037,420, representing a slight increase of 1.3% from the net loss of $2,999,834 in the same period in 2024 [135]. - Net loss for the nine months ended September 30, 2025, was $(10,316,815), a decrease of 3.8% compared to $(10,726,923) for the same period in 2024 [148]. - The loss from operations for the nine months ended September 30, 2025, was $10,601,133, a decrease of 3.5% from the loss of $10,990,412 in the same period in 2024 [135]. Expenses - For the three months ended September 30, 2025, general and administrative expenses increased by approximately $329,000, or 23.1%, compared to the same period in 2024, primarily due to higher legal and corporate expenses [136]. - For the nine months ended September 30, 2025, general and administrative expenses increased by approximately $62,879, or 1.2%, compared to the same period in 2024 [137]. - Research and development expenses for the three months ended September 30, 2025, decreased by approximately $223,583, or 14.1%, compared to the same period in 2024 [135]. - Research and development expenses decreased by approximately $224,000, or 14%, for the three months ended September 30, 2025, compared to the same period in 2024 [142]. - Research and development expenses decreased by approximately $452,000, or 8%, for the nine months ended September 30, 2025, compared to the same period in 2024 [143]. - The company expects research and development expenses to increase throughout fiscal year 2025 compared to fiscal year 2024 due to ongoing clinical trials for PAS-004 [144]. Cash and Working Capital - Working capital decreased by approximately $2.1 million from $6,248,444 as of December 31, 2024, to $4,152,115 as of September 30, 2025 [147]. - Cash, cash equivalents, and restricted cash decreased by approximately $2.7 million for the nine months ended September 30, 2025, compared to a decrease of approximately $7.0 million for the same period in 2024 [148]. - As of September 30, 2025, the company had approximately $4.1 million in operating bank accounts and money market funds, with working capital of approximately $4.2 million [149]. - The company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities to continue operations [149]. Regulatory and Development Updates - The FDA cleared the Investigational New Drug application for PAS-004 in December 2023, with a Phase 1 multicenter trial expected to complete in 2026 [125]. - The company initiated a Phase 1/1b trial for PAS-004 in adult patients with neurofibromatosis type 1 in May 2025, with a total of five sites involved [126]. - The company plans to seek FDA marketing approval for PAS-004 for the treatment of symptomatic plexiform neurofibromas in both adult and pediatric patients [127]. Economic Impact - The company anticipates inflation will continue to negatively impact its operations throughout 2025, affecting costs related to employee compensation and outside services [134]. - As of September 30, 2025, the calculated public float is below $75.0 million, restricting the company from selling more than one-third of its public float through primary public offerings in any twelve-month period [150]. Other Income - Other income, net increased by approximately $68,000, or 1,423%, for the three months ended September 30, 2025, compared to the same period in 2024 [145].

Core Insights - Pasithea Therapeutics Corp. has activated a new clinical trial site at the University of Alabama at Birmingham (UAB) for its Phase 1/1b study of PAS-004 in adult patients with neurofibromatosis type 1 (NF1) [1][2] - The company is also serving as a Platinum Sponsor for the 2025 NF Caregivers Symposium, emphasizing its commitment to the NF1 community [3] Clinical Trial Details - The Phase 1/1b study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 in adult NF1 patients with symptomatic and inoperable plexiform neurofibromas [2][4] - The trial will be conducted in two parts: Part A will involve dose escalation with up to 24 participants receiving one of four planned dose levels (4mg, 8mg, 12mg, 18mg) [5] - Part B will enroll approximately 24 participants to receive doses at the recommended phase 2 dose (RP2D) for up to six continuous 28-day treatment cycles [5][6] Objectives of the Study - Primary objectives include evaluating the safety and tolerability of PAS-004, identifying the recommended Part B dose, and assessing preliminary efficacy on target neurofibromas and quality of life [4][5] - Secondary objectives focus on the impact of PAS-004 on cutaneous neurofibromas and associated symptoms, as well as pain and function related to plexiform neurofibromas [4][5] Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company focused on developing PAS-004, a next-generation macrocyclic MEK inhibitor for treating RASopathies and MAPK pathway-driven tumors [7] - The company is currently conducting multiple clinical trials, including a Phase 1 trial in advanced cancer patients [7]