Core Insights - Pasithea Therapeutics Corp. is set to present its next-generation macrocyclic MEK inhibitor, PAS-004, at the 2025 CAGLA NeauxCancer Conference, highlighting its potential in treating neurofibromatosis type 1 (NF1) and other cancer indications [1][2] - The presentation will include interim safety, tolerability, and pharmacokinetic data from an ongoing Phase 1 study involving advanced cancer patients with MAPK pathway-driven tumors [2] - The CAGLA NeauxCancer Conference is a significant event for oncology researchers and industry professionals, focusing on advancements in cancer treatment [3] Company Overview - Pasithea Therapeutics is a biotechnology firm dedicated to developing innovative treatments for central nervous system disorders and RASopathies, with a focus on conditions like NF1, solid tumors, and ALS [4] - The company boasts a team of experts in neuroscience, translational medicine, and drug development, aiming to create new molecular entities for various neurological disorders [4]

Clinical Trial Progress - Pasithea Therapeutics has opened three new clinical trial sites in Eastern Europe, specifically in Romania and Bulgaria, in addition to the four existing sites in the United States for the PAS-004 Phase 1 trial [1] - The company has completed initial dosing of three patients in Cohort 4A (15mg capsule) and is actively recruiting patients for Cohort 4B (4mg tablet) [3] - Interim safety and pharmacokinetic (PK) data from Cohorts 4A and 4B are expected to be presented in Q1 2025 [3] Partnerships and Collaborations - Pasithea is collaborating with Arensia Exploratory Medicine and several oncology institutes in Eastern Europe, including the Institute of Oncology Bucharest, Institute of Oncology Cluj-Napoca, and Multiprofile Hospital for Active Treatment Sveta Sofia- EOOD [2] Trial Design and Objectives - The ongoing Phase 1 clinical trial is a multi-center, open-label, dose-escalation 3+3 study designed to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 [4] - The trial focuses on patients with MAPK pathway-driven advanced solid tumors with documented RAS, NF1, or RAF mutations, or those who have failed BRAF/MEK inhibition [4] Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications [1] - The company is focused on the discovery, research, and development of innovative treatments for central nervous system (CNS) disorders and RASopathies, including NF1, solid tumors, and Amyotrophic Lateral Sclerosis (ALS) [5]

Financial Performance - The company reported a net loss of $2,999,834 for the three months ended September 30, 2024, a decrease of 17.0% compared to a net loss of $3,612,590 for the same period in 2023[119]. - Net loss from continuing operations was $(10,726,923) for the nine months ended September 30, 2024, compared to $(10,476,484) for the same period in 2023[136]. - Other income, net decreased by approximately $172,000, or 97%, for the three months ended September 30, 2024, compared to the same period in 2023[132]. - Cash and cash equivalents decreased by approximately $7.0 million for the nine months ended September 30, 2024, compared to a decrease of approximately $13.5 million for the same period in 2023[136]. - Working capital decreased by approximately $5.0 million between December 31, 2023, and September 30, 2024, primarily due to cash used to fund operations[135]. Expenses - Research and development expenses were $1,581,376 for the three months ended September 30, 2024, a slight decrease of 2.7% from $1,624,766 in the prior year[119]. - General and administrative expenses decreased by 34.3% to $1,423,228 for the three months ended September 30, 2024, compared to $2,164,560 in the same period of 2023[119]. - General and administrative expenses decreased by approximately $779,000, or 13%, for the nine months ended September 30, 2024, compared to the same period in 2023[125]. - Research and development expenses increased by approximately $939,000, or 20%, for the nine months ended September 30, 2024, compared to the same period in 2023[129]. - The company expects general and administrative expenses to continue at lower levels in fiscal year 2024 compared to fiscal year 2023[126]. - The company anticipates an increase in research and development expenses in fiscal year 2024 primarily due to clinical development activities[130]. Clinical Development - The company is currently conducting a Phase 1 clinical trial for its lead candidate PAS-004 at four clinical sites in the U.S. and plans to open three additional sites in Eastern Europe by Q4 2024[110]. - The FDA cleared the IND for PAS-004 in December 2023, allowing the company to proceed with its Phase 1 multicenter trial[109]. - The company ceased development of the PAS-002 program for multiple sclerosis due to high costs and the availability of effective treatments[111]. - The company expects to incur significant operating losses and expenses as it advances its product candidates through development and clinical trials[113]. Funding and Capital - The company raised approximately $4.5 million from a securities purchase agreement in September 2024, selling pre-funded warrants and PIPE warrants[115]. - As of September 30, 2024, the company had approximately $9.4 million in operating bank accounts and money market funds[137]. - The company requires significant cash resources to execute its business plans and is dependent on obtaining additional working capital funding[137]. Market Conditions - Inflation has negatively impacted the company's costs, particularly in employee compensation and outside services, with expectations of continued pressure throughout 2024[120]. - 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[116].

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]

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 ...