Core Viewpoint - Pasithea Therapeutics is presenting its lead program, Basel IV, which is the first macrocyclic MEK inhibitor to enter clinical trials, highlighting its differentiated profile in terms of safety, pharmacokinetics, and early signs of efficacy [3]. Company Overview - Pasithea Therapeutics is participating in Oppenheimer's 36th Annual Life Sciences Conference, showcasing its innovative approach in the biotech sector [1]. - The CEO of Pasithea, Tiago Reis Marques, emphasizes the company's commitment to advancing its clinical programs despite personal health challenges [2]. Product Focus - The lead program, Basel IV, targets neurofibromas associated with neurofibromatosis type 1, specifically focusing on plexiform neurofibromas and cutaneous neurofibromas [3]. - The presentation will include data supporting the safety and pharmacokinetic profile of Basel IV, as well as early efficacy results in monotherapy [3].

Core Viewpoint - Pasithea Therapeutics Corp. is advancing its lead drug candidate, PAS-004, a next-generation macrocyclic oral MEK inhibitor, aimed at treating NF1-associated plexiform neurofibromas and is actively participating in the Oppenheimer 36th Annual Healthcare Life Sciences Conference [1][2]. Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company focused on the research and development of PAS-004, which targets RASopathies, MAPK pathway-driven tumors, and other diseases [4]. - The company is currently conducting a Phase 1 clinical trial for PAS-004 in advanced cancer patients (NCT06299839) and a Phase 1/1b clinical trial for adult patients with NF1-associated plexiform neurofibromas (NCT06961565) [4]. Event Details - The presentation by CEO Tiago Reis Marques is scheduled for February 26, 2026, from 4:00 to 4:30 PM ET, and will be available for viewing via a live webcast [2][3]. - Management will also be available for one-on-one meetings with qualified investors registered for the conference [2].

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]