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]

Financial Performance - For the three months ended June 30, 2024, general and administrative expenses were $1,587,060, a decrease of 11.9% from $1,800,536 in the same period of 2023[88]. - The net loss from continuing operations for the three months ended June 30, 2024, was $3,866,249, representing a 7.5% increase from $3,598,084 in the prior year[88]. - The net loss for the six months ended June 30, 2024, was $7,727,089, an increase of 5.8% from $7,300,909 in the same period of 2023[89]. - Net loss from continuing operations was $7,727,089 for the six months ended June 30, 2024, compared to $6,863,894 for the same period in 2023[104]. - Other income (expense), net decreased by approximately $152,000, or 66%, for the three months ended June 30, 2024, compared to the same period in 2023[100]. Research and Development - Research and development expenses increased by 16.3% to $2,357,974 for the three months ended June 30, 2024, compared to $2,028,165 in 2023[88]. - Research and development expenses increased by approximately $307,000, or 15%, for the three months ended June 30, 2024, primarily due to clinical trial costs related to PAS-004[96]. - Research and development expenses increased by approximately $982,000, or 31%, for the six months ended June 30, 2024, driven by clinical trial costs for PAS-004[97]. - The company expects research and development expenses to increase in fiscal year 2024 due to clinical development activities for PAS-004[98]. - The company has ceased further development of the PAS-002 program for multiple sclerosis due to high costs and the availability of effective treatments[82]. Operational Outlook - The company expects to incur significant operating losses for the foreseeable future as it advances its product candidates through development and clinical trials[84]. - The company anticipates ongoing inflationary pressures impacting costs throughout 2024, particularly in employee compensation and outside services[87]. - The company requires significant additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures[106]. Clinical Trials and Developments - The FDA cleared the IND for PAS-004 in December 2023, allowing the company to proceed with a Phase 1 trial for patients with MAPK pathway-driven advanced tumors[81]. - The company plans to open three additional clinical trial sites in Eastern Europe in the third quarter of 2024[81]. Capital and Cash Flow - Working capital decreased by approximately $6.8 million from December 31, 2023, to June 30, 2024, primarily due to cash used to fund operations[103]. - Cash and cash equivalents decreased by approximately $8.4 million for the six months ended June 30, 2024, compared to a decrease of approximately $6.4 million for the same period in 2023[104]. - 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[85].

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]

Financial Performance - For the three months ended March 31, 2024, general and administrative expenses increased by approximately $175,380, or 8.3%, compared to the same period in 2023[109]. - The net loss from continuing operations for the three months ended March 31, 2024 was $3,860,840, an increase of 18.2% compared to a net loss of $3,265,810 in the same period in 2023[109]. - Net loss for the three months ended March 31, 2024, was $3,860,840, compared to a net loss of $3,537,679 for the same period in 2023[119]. - Working capital decreased by approximately $3.3 million from December 31, 2023, to March 31, 2024, primarily due to cash used to fund operations[118]. - Cash and cash equivalents decreased by approximately $4.3 million for the three months ended March 31, 2024, compared to a decrease of approximately $3.2 million for the same period in 2023[119]. - The accumulated deficit as of March 31, 2024, was approximately $39.1 million, indicating significant operating losses and negative cash flows from operations[120]. Research and Development - Research and development expenses for the three months ended March 31, 2024 were $1,749,128, representing a significant increase of 59.6% from $1,096,286 in the same period in 2023[109]. - Research and development expenses increased by approximately $652,000, or 60%, for the three months ended March 31, 2024, compared to the same period in 2023[114]. - The company expects research and development expenses to increase in fiscal year 2024 compared to fiscal year 2023, primarily due to clinical development activities[115]. - The company has ceased further development of the PAS-002 program for multiple sclerosis due to high costs and the availability of effective treatment options[101]. - The FDA cleared the IND for PAS-004 in December 2023, allowing the company to proceed with a Phase 1 clinical trial for patients with MAPK pathway-driven advanced tumors[100]. - The company plans to open three additional clinical trial sites in Eastern Europe in the third quarter of 2024[100]. Operational Challenges - The company expects to incur significant operating losses for the foreseeable future as it advances its product candidates through development and clinical trials[102]. - The company anticipates that inflation will negatively impact its operations throughout 2024, particularly in employee compensation and outside services[106]. - The company requires significant additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures[122]. Strategic Focus - The company aims to establish a sales, marketing, and distribution infrastructure to commercialize any approved product candidates[107]. - The company has discontinued support services to anti-depression clinics in the U.K. and related at-home services in New York, resulting in a focus on the Therapeutics segment[117]. Stock and Capital Structure - 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[104]. - Other income (expense), net increased by approximately $233,000 for the three months ended March 31, 2024, primarily due to dividend income of $153,000[116].

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 ...

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, 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: 005-92867 PASITHEA THERAPEUTICS CORP. (Exact name of Registrant as specified in its charter) | Delaware | 85-1591963 | | ...