Core Viewpoint - Pasithea Therapeutics Corp. has successfully completed long-term chronic toxicity studies for its lead candidate PAS-004, a macrocyclic MEK inhibitor, which is currently in a Phase 1 clinical trial for advanced cancer patients [1][2]. Group 1: Study Results - The long-term studies showed that daily treatment with PAS-004 for 6 months in rats and 9 months in dogs confirmed previous 28-day toxicity study results, indicating a similar safety profile across both species [2]. - The 9-month study in dogs established 0.5 mg/kg as the no adverse effect level (NOAEL), which is significant for determining safe dosing in future studies [2]. - PAS-004 demonstrated a consistent safety profile at doses that correlate with significant pathway engagement, suggesting potential for significant pERK reduction when dosed below the NOAEL [2]. Group 2: Formulation and Administration - PAS-004 was administered in crystalline form during chronic toxicity studies, showing a similar adverse event profile and equivalent NOAEL in dogs compared to the original amorphous formulation [3]. - The company is utilizing the crystalline form of PAS-004 in its human clinical trials, which may enhance the drug's efficacy and safety [3]. Group 3: Future Outlook - The company believes that sustained MAPK pathway suppression over a prolonged period will lead to enhanced efficacy with a more manageable side effect profile compared to other MEK inhibitors [4]. - Additional data on PAS-004, including initial interim pharmacokinetic and pharmacodynamic data from the Phase 1 clinical study, is expected to be shared later this quarter [4]. Group 4: Company Overview - Pasithea Therapeutics is focused on developing innovative treatments for central nervous system disorders and RASopathies, with a team experienced in neuroscience, translational medicine, and drug development [5].

Core Insights - Pasithea Therapeutics Corp. has appointed Dr. Rebecca Brown to its Scientific Advisory Board to aid in the development of PAS-004, a next-generation macrocyclic MEK inhibitor targeting neurofibromatosis type 1 (NF1) and other indications [1][4] Company Overview - Pasithea is a clinical-stage biotechnology company focused on innovative treatments for central nervous system disorders and RASopathies, including NF1, solid tumors, and amyotrophic lateral sclerosis (ALS) [8] Dr. Rebecca Brown's Role - Dr. Brown is the Director of the Neurofibromatosis Clinic at The Mount Sinai Hospital and brings extensive experience in NF1 research, having participated in numerous studies related to cutaneous and plexiform neurofibromas [2][3] - Her expertise will provide valuable clinical insights as the company prepares to initiate its Phase 1/2a clinical trial for PAS-004 [4] PAS-004 Development - PAS-004 is designed as a small molecule allosteric inhibitor of MEK 1/2, targeting the MAPK signaling pathway, which is crucial for tumor growth and other cellular functions [6] - The drug aims to overcome limitations of existing MEK inhibitors by offering improved pharmacokinetic and safety profiles, a longer half-life, and potentially better therapeutic index [6][7] - PAS-004 has received orphan-drug designation from the FDA for NF1, which may grant seven years of marketing exclusivity upon NDA approval [7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______to ________. Commission file number: 001-40804 PASITHEA THERAPEUTICS CORP. (Exact name of Registrant as specified in its charter) | --- | --- | |------------------- ...

Core Viewpoint - Pasithea Therapeutics Corp. is advancing its Phase 1 clinical trial of PAS-004, a macrocyclic MEK inhibitor, for treating neurofibromatosis type 1 (NF1) and other advanced solid tumors, following a positive safety review by an independent committee [1][2][3] Group 1: Clinical Trial Progress - The independent Safety Review Committee (SRC) has completed its safety review of the first dose cohort (2mg) and recommended escalating to the next dose level (4mg) due to the absence of dose limiting toxicities (DLTs) [2] - Enrollment and initial dosing of 3 patients in the second cohort at 4mg has been completed following the SRC's recommendation [2][3] - The Phase 1 trial is a multicenter, open-label, dose escalation study focusing on the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 in patients with specific mutations or those who have failed previous treatments [3] Group 2: Company Overview - Pasithea Therapeutics is a biotechnology company dedicated to developing innovative treatments for central nervous system (CNS) disorders and RASopathies, with a focus on conditions like NF1, solid tumors, and amyotrophic lateral sclerosis (ALS) [9]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______to ________. Commission file number: 001-40804 PASITHEA THERAPEUTICS CORP. (Exact name of Registrant as specified in its charter) | Delaware | 85-1591963 | | --- | ...

Corporate Structure and Control - As of March 23, 2024, officers, directors, and principal stockholders own approximately 30.4% of the outstanding Common Stock, potentially impacting corporate control [312]. - The company is classified as an emerging growth company until it exceeds $1.235 billion in annual revenue or meets other specific criteria [302]. Compliance and Regulatory Issues - The company received a Nasdaq compliance notice on January 19, 2023, for not maintaining a minimum bid price of $1.00 per share, with a compliance period extended to January 15, 2024 [316]. - On January 17, 2024, the company regained compliance with the Nasdaq minimum bid price requirement [318]. - The company may face increased legal and financial compliance costs due to changing laws and regulations affecting public companies [305]. - The company may be subject to securities litigation, which could divert management's attention and incur substantial costs [308]. Financial Performance and Strategy - The company does not currently intend to pay dividends on its Common Stock, focusing instead on retaining earnings for business development [309]. - Exchange rate fluctuations, particularly between the U.S. dollar, British pound, and Euro, may materially affect the company's financial results [315]. - The company has opted to delay adopting new accounting standards under the JOBS Act, which may impact financial reporting [303]. Operational Changes - As of December 31, 2023, the company has discontinued all operations of its Clinics segment [325].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Securities registered pursuant to Section 12(b) of the Act: | | | Name of each exchange on | | --- | --- | --- | | Title of each class | Trading Symbol(s) | which registered | | Common Stock, par v ...

For the Quarterly Period Ended June 30, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to ________. Commission file number: 001-40804 PASITHEA THERAPEUTICS CORP. (Exact name of Registrant as specified in its charter) | Delaware | 85-1591963 | | --- | ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to ________. Commission file number: 001-40804 PASITHEA THERAPEUTICS CORP. (Exact name of Registrant as specified in its charter) | Delaware | 85-1591963 | | --- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________________ to __________________________ Commission file number 001-40804 PASITHEA THERAPEUTICS CORP. (Exact name of registrant as specified in its ...