Core Viewpoint - Pasithea Therapeutics Corp. is advancing its clinical trials for PAS-004, a macrocyclic MEK inhibitor aimed at treating neurofibromatosis type 1 associated plexiform neurofibromas and advanced cancer, with significant milestones achieved in 2025 [1][3]. Clinical Trials - The ongoing Phase 1/1b clinical trial for adult patients with NF1-PN (NCT06961565) is part of the company's strategy to develop PAS-004 [2]. - The Phase 1 clinical trial in advanced cancer patients (NCT06299839) is expected to present longer-term follow-up data in Q2 2026, with initial promising results reported in 2025 [3][4]. - Enrollment of 12 patients has been completed through the first four dose cohorts in the NF1-PN study, with data presentation planned for the second half of 2026 [6]. Financial Developments - In December 2025, the company raised $60 million in gross proceeds through a public offering, which will support the advancement of PAS-004 and operations through at least the first half of 2028 [3]. Drug Development Insights - Initial results from the advanced cancer study indicated a partial response and a disease control rate of 71.4% among patients with BRAF-mutated tumors, supporting the potential of PAS-004 for NF1-PN treatment [3]. - The company aims to deliver safe and effective therapies for patients with significant unmet medical needs, particularly in chronic dosing scenarios [3].

Core Viewpoint - Pasithea Therapeutics Corp. has successfully closed a public offering of 80 million shares at $0.75 per share, raising approximately $60 million in gross proceeds, which will be used for general corporate purposes and to extend its cash runway through at least the first half of 2028 [1][3][8]. Group 1: Offering Details - The public offering consisted of 80,000,000 shares of common stock or pre-funded warrants at an offering price of $0.75 per share [1]. - The offering was led by healthcare-focused investors, including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners, and Squadron Capital Management [1][8]. - H.C. Wainwright & Co. acted as the exclusive placement agent for the offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated for general corporate purposes, including ongoing research, pre-clinical studies, clinical trials, and the development of new technologies [3]. - The company plans to invest in or acquire synergistic companies and engage in licensing activities related to its current and future product candidates [3]. Group 3: Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company focused on developing PAS-004, a next-generation macrocyclic MEK inhibitor for treating neurofibromatosis type 1-associated plexiform neurofibromas [6]. - The company is currently conducting a Phase 1 clinical trial for PAS-004 in advanced cancer patients and a Phase 1/1b clinical trial in adult patients with NF1-associated plexiform neurofibromas [6].

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]

Core Viewpoint - Pasithea Therapeutics Corp. has announced a public offering of 80 million shares at $0.75 per share, aiming to raise approximately $60 million to support its ongoing research and development efforts [1][3]. Group 1: Offering Details - The public offering consists of 80,000,000 shares of common stock or pre-funded warrants at an offering price of $0.75 per share [1]. - The offering is led by healthcare-focused investors, including Vivo Capital, Janus Henderson Investors, and others [1][8]. - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2]. Group 2: Financial Implications - The gross proceeds from the offering are expected to be around $60 million before deducting fees and expenses [3]. - The net proceeds will be used for general corporate purposes, including ongoing research, clinical trials, and potential acquisitions [3]. - Following the offering, the company's cash runway is projected to extend through at least the first half of 2028 [3][8]. Group 3: Company Overview - Pasithea is a clinical-stage biotechnology company focused on developing PAS-004, a macrocyclic MEK inhibitor for treating neurofibromatosis type 1-associated plexiform neurofibromas [6]. - The company is currently conducting a Phase 1 clinical trial for PAS-004 in advanced cancer patients and a Phase 1/1b trial in adult patients with NF1-associated plexiform neurofibromas [6].

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]

As filed with the Securities and Exchange Commission on November 26, 2025 Registration No. 333-291611 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 PASITHEA THERAPEUTICS CORP. (Exact name of registrant as specified in its charter) | Delaware | 001-40804 | 85-1591963 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organiza ...

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]

Core Insights - Pasithea Therapeutics Corp. announced positive pharmacokinetic (PK) data for its oral MEK inhibitor PAS-004, indicating improved properties in tablet form compared to capsules [1][2] Pharmacokinetics (PK) - The tablet formulation of PAS-004 (4mg and 8mg cohorts) showed a Cmin of 37.6 ng/mL, with dose-normalized exposures approximately three times higher than the capsule formulation [2] - The 8mg tablet demonstrated an area under the curve (AUC) and Cmax slightly greater than the 22mg capsule, with less patient variability and a similar Tmax range [2] - Cohort 1 (4mg tablet) results: AUC of 1,120 ng·h/mL and Cmax of 58.1 ng/mL; Cohort 2 (8mg tablet) results: AUC of 2,290 ng·h/mL, Cmax of 118 ng/mL, and Cmin of 75.4 ng/mL [3] Company Overview - Pasithea Therapeutics is focused on developing PAS-004 for treating neurofibromatosis type 1-associated plexiform neurofibromas and other diseases, currently in Phase 1 clinical trials [6]

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].