Tillkännagivande • May 05
Pasithea Therapeutics Corp. Appoints Kartik Krishnan as Chief Medical Officer, Effective May 1, 2026 Pasithea Therapeutics Corp. announced the appointment of Kartik Krishnan, M.D., Ph.D. as Chief Medical Officer (CMO) of the Company, effective May 1, 2026. Dr. Krishnan will oversee all clinical development and medical strategy as the Company advances PAS-004 through the clinic for the treatment of neurofibromatosis type 1 (NF1) associated plexiform and cutaneous neurofibromas. Dr. Krishnan has over 20 years of experience in clinical development, pharmacovigilance, clinical operations, regulatory affairs, and R&D strategy. Prior to joining Pasithea, Dr. Krishnan was Chief Executive Officer at OncoNano Medicines, a privately held company developing anti-cancer assets. Prior to that, Dr. Krishnan was Chief Medical Officer at Arcus Biosciences, a discovery and clinical development company focusing on combination therapies in immuno-oncology. Earlier in his career, he held various clinical development and medical director roles of increasing responsibility at companies including, Astex Pharmaceuticals, Genentech, Five Prime Therapeutics, BioMarin, and Amgen. Prior to joining industry, Dr. Krishnan held a faculty position in the Department of Pediatrics at the University of Arizona, with both clinical and primary research responsibilities. While at Genentech, Dr. Krishnan was an integral part of the clinical team for cobimetanib (Cotellic), contributing to the approval in the United States and Europe in 2015, for treatment of BRAF V600E or BRAF V600K melanoma in combination with vemurafenib (Zelboraf). In addition, Dr. Krishnan worked to establish development opportunities for this MEK inhibitor beyond melanoma, including monotherapy work in diseases such as Langerhans cell histiocytosis (for which cobimetinib was approved in 2022) and novel combinations in breast and colon cancer. Dr. Krishnan received his B.A. in History (with Distinction) from the University of Virginia. He completed his M.D. and Ph.D. in Molecular, Biochemical and Biophysical Studies at Columbia University. His Ph.D. studies were completed in the lab of Dr. John Krolewski, focusing on JAK/STAT signaling in the interferon pathway. Dr. Krishnan trained in pediatrics at UCLA and in pediatric hematology and oncology at the Johns Hopkins University and the National Cancer Institute. Tillkännagivande • Apr 21
Pasithea Therapeutics Corp Announces Grant of Rare Pediatric Disease Designation by FDA to Pas-004 for Treatment of Neurofibromatosis Type 1 Pasithea Therapeutics Corp. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to PAS-004 for treatment of Neurofibromatosis type-1 (NF1). The FDA grants RPDD for serious or life-threatening diseases in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years and affect fewer than 200,000 people in the U.S. There are approximately 115,000 individuals in the U.S living with NF1. Under the FDA's Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval of a new drug application (NDA) or biologics license application (BLA) for a rare pediatric disease may be eligible for a Priority Review Voucher (PRV) which can be redeemed to obtain priority review for a subsequent marketing application for a different product. The PRV may be sold or transferred to another sponsor. In the last 12 months, disclosed PRV sales have ranged from $150–$205 million. PAS-004 has so far been granted the following FDA regulatory designations: Orphan Drug Designation, Fast Track Designation and Rare Pediatric Disease Designation. The Company is currently conducting a Phase 1/1b multicenter, open-label, dose escalation trial of PAS-004 in adult participants with symptomatic, inoperable, incompletely resected, or recurrent NF1-PN (NCT06961565). Plexiform neurofibromas (PN) are tumors originating from the nerve sheath that grow through and around nerves and may involve multiple nerve branches. Thirty to fifty(30-50%) of patients with NF1 will harbor PNs, which can undergo malignant transformation. PN-related morbidities are primarily caused by the direct impact of the tumor on surrounding structures and can be life-threatening when they compress vital organs or when they become malignant. Pasithea is currently testing PAS-004 in a Phase 1 clinical trial in patients with advanced cancer (NCT06299839), and a Phase 1/1b clinical trial in patients with neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas with symptomatic and inoperable, incompletely resected, or recurrent PN (NCT06961565). Tillkännagivande • Apr 01
Pasithea Therapeutics Corp Announces Grant of Fast Track Designation by Fda to Pas-004 for Treatment of Neurofibromatosis Type 1 Associated Plexiform Neurofibromas Causing Significant Morbidity Pasithea Therapeutics Corp. a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PAS-004 for the treatment of NF1-associated PN causing significant morbidity. Fast Track designation includes the following opportunities to facilitate Fast Track product development: Frequent communications with the FDA review team throughout the product development process. Rolling Review, which allows portions of a marketing application to be reviewed and assessed by the FDA before the company submits the complete application. In addition, a Fast Track designation product may potentially be eligible for accelerated approval and/or priority review if relevant criteria are met. The Company is currently conducting a Phase 1/1b multicenter, open-label, dose escalation trial of PAS-004 in adult participants with symptomatic, inoperable, incompletely resected, or recurrent NF1-PN (NCT06961565). Plexiform neurofibromas (PN) are tumors originating from the nerve sheath that grow through and around nerves and may involve multiple nerve branches. Thirty to fifty percent (30-50%) of patients with NF1 will harbor PNs, which can undergo malignant transformation. PN-related morbidities are primarily caused by the direct impact of the tumor on surrounding structures and can be life-threatening when they compress vital organs or when they become malignant. Pasithea is a clinical-stage biotechnology company primarily focused on the research and development of its lead drug candidate, PAS-004, a next-generation macrocyclic MEK inhibitor intended for the treatment of RASopathies, MAPK pathway-driven tumors, and other diseases. The Company is currently testing PAS-004 in a Phase 1 clinical trial in patients with advanced cancer (NCT06299839), and a Phase 1/1b clinical trial in patients with neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas with symptomatic and inoperable, incompletely resected, or recurrent PN (NCT06961565). Tillkännagivande • Feb 21
Pasithea Therapeutics Corp. Receives Notice of Non-Compliance with Nasdaq Minimum Bid Price Listing Rule On February 20, 2026, Pasithea Therapeutics Corp. (the “Company”) received a written notice (the “Notice”) from the Listing Qualifications Department of The Nasdaq Stock Market (“Nasdaq”) indicating that the Company is not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the “Bid Price Requirement”). The Notice does not result in the immediate delisting of the Company’s common stock from The Nasdaq Capital Market. The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price of the Company’s common stock for 30 consecutive business days prior to the delivery of the Notice, the Company no longer meets this requirement. The Notice indicated that the Company will be provided 180 calendar days in which to regain compliance, or until August 19, 2026. If at any time during this period, the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, the Nasdaq staff will provide the Company with a written confirmation of compliance and the matter will be closed. Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, the Company may be eligible for an additional 180 calendar day compliance period, provided (i) it meets the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the Bid Price Requirement) and (ii) it provides written notice to Nasdaq of its intention to cure this deficiency during the second compliance period, by effecting a reverse stock split, if necessary. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, and if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is not otherwise eligible, the Staff will provide the Company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. At that time, the Company may appeal the delisting determination to a hearings panel. The Company intends to monitor the closing bid price of its common stock and is considering its options to regain compliance with the Bid Price Requirement. The Company’s receipt of the Notice does not affect the Company’s business, operations or reporting requirements with the Securities and Exchange Commission. Tillkännagivande • Jan 13
Pasithea Therapeutics Provides Outlook on Pas-004 Clinical Programs and Data Release Timelines Pasithea Therapeutics Corp. provided updated timelines on its ongoing clinical trials in advanced cancer and adult NF1-PN patients. Ongoing Phase 1/1b clinical trial in adult patients with NF1-PN (NCT06961565): Pasithea has completed enrollment of 12 patients through the first 4 dose cohorts (4, 8, 12 and 18 mg tablets) in Part A of the study. The Company plans to present data in the second half of 2026, including available efficacy data through the six-month timepoint for both plexiform and cutaneous neurofibromas. The planned data release is also expected to include safety, tolerability and pharmacokinetic (PK) data. Ongoing Phase 1 clinical trial in advanced cancer patients (NCT06299839): Pasithea expects to present longer-term follow-up data from patients in Cohort 4 (15mg capsule) through Cohort 8 (45mg capsule) in the second quarter of 2026. Tillkännagivande • Dec 02
Pasithea Therapeutics Corp. has completed a Follow-on Equity Offering in the amount of $59.934847 million. Pasithea Therapeutics Corp. has completed a Follow-on Equity Offering in the amount of $59.934847 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 14,846,665
Price\Range: $0.75
Discount Per Security: $0.053
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 65,153,335
Price\Range: $0.749
Discount Per Security: $0.053 Tillkännagivande • Nov 27
Pasithea Therapeutics Corp. has filed a Follow-on Equity Offering. Pasithea Therapeutics Corp. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 75,000,000
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 75,000,000 Tillkännagivande • Nov 25
Pasithea Therapeutics Announces Completion of Cohort 7 in Ongoing Phase 1 Trial of PAS-004 in Advanced Cancer Patients, with Positive Safety, Pharmacokinetic (PK), and Pharmacodynamic (PD) Data Pasithea Therapeutics Corp. announced positive safety, PK and PD data from Cohort 7 (37mg capsules) in its ongoing first-in-human trial evaluating PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation, or in patients who have failed prior BRAF/MEK inhibition (NCT06299839). PAS-004 has demonstrated in Cohort 7 (37mg capsules): Safety and Tolerability Results: PAS-004 was safe and well tolerated with no dose limiting toxicities (DLTs), and no treatment-related adverse events observed during the DLT period. After reviewing cohort 7 data, the Safety Review Committee recommended to proceed to Cohort 8, 45mg capsules, without modification. Pharmacodynamics (PD) Results: At steady-state, individual patient plasma data showed PAS-004 inhibiting phosphorylated extracellular signal-regulated kinase (pERK) at a level of 80% near Cmax. At steady-state, individual patient plasma data showed PAS-004 inhibiting pERK at a level above 60% at Cmin (24-hour postdose). Pharmacokinetics (PK) Results: Linear PK and dose-proportionality. PK curve with Cmax/Cmin ratio <2. AUC: 6,690 ng*h/mL; Cmax: 313 ng/mL; Cmin: 260 ng/mL. New Risk • Nov 20
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 32% per year over the past 5 years. Shareholders have been substantially diluted in the past year (488% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$4.91m market cap). Minor Risk Share price has been volatile over the past 3 months (12% average weekly change). Tillkännagivande • Nov 19
Pasithea Therapeutics Corp. has filed a Follow-on Equity Offering in the amount of $10 million. Pasithea Therapeutics Corp. has filed a Follow-on Equity Offering in the amount of $10 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 13,929,516
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 13,929,516
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 13,929,516 Tillkännagivande • Nov 06
Pasithea Therapeutics Corp. Announces Activation of Clinical Trial Site At University of Alabama At Birmingham for Ongoing Phase 1/1B Trial of Pas-004 in Adult Nf1 Patients Pasithea Therapeutics Corp. announced activation of a new U.S. clinical trial site at the University of Alabama at Birmingham ("UAB") for its ongoing Phase 1/1b open-label study evaluating PAS-004 in adult patients with neurofibromatosis type 1 (NF1) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas. The UAB site joins the list of clinical centers participating in the Company's global Phase 1/1b trial, which is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 in adult NF1 patients. Enrollment at the UAB site is expected to begin immediately. Tillkännagivande • Sep 16
Pasithea Therapeutics Corp. Announces Activation of Clinical Trial Sites in South Korea for Phase 1/1b Trial of PAS-004 in Adult NF1 Patients Pasithea Therapeutics Corp. announced activation of two South Korea clinical trial sites participating in its Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PAS-004, in adult participants with neurofibromatosis type 1 (NF1) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas. The South Korea clinical trial sites, ASAN Medical Centre and Severance Hospital Yonsei University Health System, are now actively recruiting NF1 trial participants. The primary objective of the Phase 1/1b study (NCT06961565) is to evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle in adult NF1 participants with at least one and up to two additional target plexiform neurofibroas (PNs) that are symptomatic and inoperable. Secondary objectives are (i) to identify the recommended Part B dose ("RPBD") or Maximum Tolerated Dose (MTD) of PAS-004. (ii) to characterize the PK and PD profile of PAS-004, (iii) to evaluate the preliminary efficacy of PAS-004 on target PN volume, (iv) to evaluate the preliminary efficacy the preliminary efficacy of PAS -004 on the size, appearance, and associated symptoms of cutaneous neurofibromas (CNs), and (v) to evaluate the impact of PAS-004 on quality of life ("QOL") and any physical symptoms attributed to the target PN. In Part A (dose escalation phase), following a screening period of up to 28 days, up to 24 eligible participants will be enrolled sequentially to receive one of four planned dose levels of PAS-004 tablets (4mg, 8mg, 12mg, 18mg) in a modified 3+3 design. The study is planned to be conducted at five clinical trial sites in Australia, South Korea and the U.S. Tillkännagivande • Sep 08
Pasithea Therapeutics Corp. Announces Enrollment of Cohort 2 Following Positive Safety Review Committee (SRC) Recommendation for its Ongoing Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients Pasithea Therapeutics Corp. announced that the external Safety Review Committee recommended that the Company's Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PAS-004, in adult participants with neurofibromatosis type 1 (NF1) should proceed to Cohort 2, 8mg tablet, without modification. This recommendation was based on the review of the safety data from three patients from Cohort 1 and the absence of any dose limiting toxicities (DLT's). The primary objective of the Phase 1/1b study (NCT06961565) is to evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle in adult NF1 participants with at least one and up to two additional target plexiform neurofibromas (PNs) that are symptomatic and inoperable, incompletely resected, or recurrent. Secondary objectives are (i) to identify the recommended Part B dose ("RPBD") or Maximum Tolerated Dose (MTD) of PAS-004; (ii) to characterize the PK and PD profile of PAS-004, (iii) to evaluate the preliminary efficacy of PAS-004 on target PN volume, (iv) to evaluate the preliminary efficacy the preliminary efficacy of PAS -004 on the size, appearance, and associated symptoms of cutaneous neurofibromas (CNs), and (v) to evaluate the impact of PAS-004 on quality of life ("QOL") and any physical symptoms attributed to the target PN. In Part A, following a screening period of up to 28 days, up to 24 eligible participants will be enrolled sequentially to receive one of four planned dose levels of PAS-004 tablets (4mg, 8mg, 12 mg, 18mg) in a modified 3+3 design. The study is planned to be conducted at five clinical trial sites in Australia, South Korea, and the U.S. New Risk • Aug 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$12m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$12m free cash flow). Earnings have declined by 36% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 6x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$5.23m market cap). Tillkännagivande • Jul 31
Pasithea Therapeutics Completes Enrollment and Initial Dosing of First Cohort from its Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients Pasithea Therapeutics Corp. announced the Company has completed enrollment and initial dosing of three subjects in Cohort 1 (4mg tablet) from its ongoing Phase 1/1b multicenter, open-label clinical trial evaluating PAS-004 in adult NF1 patients with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas. The primary objective of the Phase 1/1b study (NCT06961565) is to evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle in adult NF1 participants with at least one and up to two additional target plexiform neurofibroas (PNs) that are symptomatic and inoperable. Secondary objectives are (i) to identify the recommended Part B dose (RPBD) or Maximum Tolerated Dose (MTD) of PAS-004, (ii) to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) profile of PAS-004, ("iii) to evaluate the preliminary efficacy of PAS-004 on target PN volume, (iv) to evaluate theiminary efficacy of PAS-003 on the size, appearance, and associated symptoms of cutaneous neurofibromas (CNs), and (v) to evaluate the impact of PAS-004 on quality of life ("QOL") and any physical symptoms attributed to the target PN. In Part A, following a screening period of up to 28 days, up to 24 eligible participants will be enrolled sequentially to receive one of four planned dose levels of PAS-004 tablets (4mg, 8mg, 12 mg, and 18mg) in a modified 3+3 design. The study is planned to be conducted at five clinical trial sites in Australia, South Korea and the U.S. Tillkännagivande • Jul 16
Pasithea Therapeutics Corp., Annual General Meeting, Sep 03, 2025 Pasithea Therapeutics Corp., Annual General Meeting, Sep 03, 2025. Tillkännagivande • Jun 29
Pasithea Therapeutics Receives Nasdaq Non-Compliance Notice Regarding Minimum Bid Price Requirement On June 23, 2025, Pasithea Therapeutics Corp. received a written notice from the Listing Qualifications Department of The Nasdaq Stock Market indicating that the Company is not in compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. The Notice does not result in the immediate delisting of the Company’s common stock from The Nasdaq Capital Market. The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price of the Company’s common stock for 30 consecutive business days prior to the delivery of the Notice, the Company no longer meets this requirement. The Notice indicated that the Company will be provided 180 calendar days in which to regain compliance, or until December 22, 2025. If at any time during this period, the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, the Nasdaq staff (the “Staff”) will provide the Company with a written confirmation of compliance and the matter will be closed. Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, the Company may be eligible for an additional 180 calendar day compliance period, provided (i) it meets the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the Bid Price Requirement) and (ii) it provides written notice to Nasdaq of its intention to cure this deficiency during the second compliance period, by effecting a reverse stock split, if necessary. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, and if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is not otherwise eligible, the Staff will provide the Company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. At that time, the Company may appeal the delisting determination to a hearings panel. The Company intends to monitor the closing bid price of its common stock and is considering its options to regain compliance with the Bid Price Requirement. The Company’s receipt of the Notice does not affect the Company’s business, operations or reporting requirements with the Securities and Exchange Commission. Tillkännagivande • Jun 11
Pasithea Therapeutics Appoints James Lee to Scientific Advisory Board Pasithea Therapeutics Corp. announced the appointment of Dr. James Lee to its scientific advisory board to help guide the development of PAS-004 for the treatment of ETS2 pathway inflammatory diseases including inflammatory bowel disease (IBD), ulcerative colitis, Crohn’s disease, primary sclerosing cholangitis, and ankylosing spondylitis. Dr. Lee is the lead author on a 2024 Nature publication that identified ETS2 as a central regulator of macrophage-driven inflammation in IBD and other indications, and also identified that MEK inhibitors are the drug class that most effectively suppress ETS2-driven inflammation. Dr. James Lee is a Clinician Scientist Group Leader at the Francis Crick Institute (London, UK) and an Honorary Consultant Gastroenterologist at the Royal Free Hospital. He has clinical expertise in inflammatory bowel disease (IBD) and is also an active member of the UK and International IBD Genetics Consortia. Dr. Lee trained at Oxford, Cambridge, and Harvard and leads a research group that seeks to translate genetic associations into a better understanding of autoimmune and inflammatory disease biology. His research is internationally renowned with publications in such scientific journals as Nature and Cell. Tillkännagivande • Jun 02
Pasithea Therapeutics Presents Updated Interim Data from Ongoing Phase 1 Study of PAS-004 At the ASCO Annual Meeting 2025 Pasithea Therapeutics Corp. announced updated interim results from its ongoing dose escalation Phase 1 study evaluating PAS-004 in advanced cancer patients in a poster presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting. The Phase 1 clinical trial is a multi-center, open-label, dose escalation, modified 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation, or patients who have failed BRAF/MEK inhibition (NCT06299839). As of the cut-off date of April 2, 2025, a total of 21 patients had been enrolled and received at least one dose of PAS-004 in six cohorts (Capsules: 2mg, 4mg, 8mg, 15mg, 22mg /Tablets: 4mg). The second patient with Stage 4 BRAF-mutated melanoma, having progressed on two prior lines of therapy, including a prior MEK inhibitor + BRAF inhibitor combination treatment, achieved tumor diameter reduction of -14.9% and remains on study for over 5 months. Tillkännagivande • May 20
Pasithea Therapeutics Announces Preclinical Data That Shows PAS-004 Inhibits ETS2 Signaling, a Key Driver of Inflammation in IBD and Other Large Addressable Market Diseases Pasithea Therapeutics Corp. announced new preclinical data demonstrating that PAS-004 provides superior inhibition of ETS2-driven inflammatory responses compared to selumetinib in a human macrophage model of chronic inflammation that mimics the inflammatory milieu seen in inflammatory bowel disease (IBD). This study was conducted at the Francis Crick Institute in London, U.K. by Dr. James Lee, a gastroenterologist and Clinician Scientist Group Leader at the Genetic Mechanisms of Disease Laboratory. Dr. Lee was the lead author of a landmark 2024 Nature paper that identified ETS2 as a master regulator of inflammatory responses in IBD, and uncovered a novel genetic mechanism behind the disease, which pointed to a new, potentially effective treatment strategy through MEK inhibition. In this new study RNA sequencing was used to measure gene expression, with PAS-004 consistently outperforming the FDA-approved MEK inhibitor selumetinib across all tested doses (0.01 mM, 0.1 mM, and 1 mM), showing greater downregulation of ETS2 target genes, as well as experimentally validated MEK1/2 pathway genes. These data suggest more robust and durable MEK inhibition by PAS-004 under inflammatory conditions. Tillkännagivande • May 15
Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site Pasithea Therapeutics Corp. announced initiation of its Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PAS-004, in adult participants with neurofibromatosis type 1 (NF1) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas. The first active clinical trial site is the Royal North Shore Hospital in Sydney, Australia, which is expected to begin patient enrollment in second quarter 2025. Additional clinical trial sites in Australia, South Korea, and the United States are expected to be opened in the coming months. PAS-004 is also given as a once daily dose that offers a more convenient regimen than current FDA-approved therapies that are dosed twice a day and which could improve patient compliance. The initiation of this clinical trial in NF1, the initial indication seek FDA marketing approval for, marks an important milestone for Pasithea and for patients living with NF1-related plexiform neurofibroas. Activating first clinical trial site underscores commitment to advancing PAS-004 as a potential best-in-class next-generation MEK inhibitor. In addition, The company anticipates meaningful cash rebates of eligible trial costs through the Australian R&D Tax Incentive, further enhancing the efficiency of this program. The primary objective of the Phase 1/1b study (NCT06961565) is to evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle in adult NF1 participants with at least one and up to two additional target plexiform neurofibromaas (PNs) that are symptomatic and inoperable and inoperable, incompletefully resected, or recurrent. In Part A, following a screening period of up to 28 days, up to 24 eligible participants will be enrolled sequentially to receive one of four planned dose levels of PAS-004 tablets (4mg, 8mg, 12 mg, 18mg) in a modified 3+3 design. The study is planned to be conducted at five clinical trial sites in Australia,South Korea and the U.S. Tillkännagivande • May 09
Pasithea Therapeutics Corp. has completed a Follow-on Equity Offering in the amount of $4.999522 million. Pasithea Therapeutics Corp. has completed a Follow-on Equity Offering in the amount of $4.999522 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,094,284
Price\Range: $1.4
Discount Per Security: $0.098
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 477,144
Price\Range: $1.399
Discount Per Security: $0.098
Security Name: Series C Common Warrants
Security Type: Equity Warrant
Securities Offered: 3,571,428
Security Name: Series D Common Warrants
Security Type: Equity Warrant
Securities Offered: 3,571,428 Tillkännagivande • May 08
Pasithea Therapeutics Reports Positive Pharmacodynamic Results Demonstrating Robust Target Engagement from its Ongoing Phase 1 Clinical Trial of PAS-004 Pasithea Therapeutics Corp. announced positive interim pharmacodynamic (PD) data from its ongoing Phase 1 trial of PAS-004 in advanced cancer patients. The data includes results from cohorts 3 and 4A, evaluating 8mg and 15mg capsules, as well as cohort 4B evaluating 4mg tablets, and demonstrates strong target engagement consistent with PAS-004's favorable pharmacological profile. To evaluate target engagement, pERK levels were measured in peripheral blood mononuclear cells (PBMCs) collected from patients at baseline and steady-state at day 22. Preliminary results demonstrate robust pERK inhibition, with reductions in pERK levels of up to 91% even at the 8mg dose level, in line with a previous developed PK/PD model, confirming substantial target engagement in patients receiving PAS-004. Pharmacodynamic activity is supported by encouraging preliminary clinical observations, with several patients achieving stable disease and tumor shrinkage while on PAS-004 treament. Notably, one patient in cohort 4A (15mg capsule) with stage 4 KRAS G12R-mutated pancreatic cancer, having progressive disease while on three prior lines of therapy, achieved a tumor volume reduction of -9.8% over 5 months of PAS-004 treatment and currently remains on study. The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839). Tillkännagivande • May 01
Pasithea Therapeutics Corp. has filed a Follow-on Equity Offering. Pasithea Therapeutics Corp. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,246,753
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 3,246,753
Security Name: Series C Common Warrants
Security Type: Equity Warrant
Securities Offered: 3,246,753
Security Name: Series D Common Warrants
Security Type: Equity Warrant
Securities Offered: 3,246,753 Tillkännagivande • Apr 30
Pasithea Therapeutics Announces Completion of Enrollment and Initial Dosing of Patients in Cohort 6 from its Phase 1 Trial of PAS-004 in Advanced Cancer Patients Pasithea Therapeutics Corp. announced the Company has completed enrollment and initial dosing of three subjects in Cohort 6 with 30 mg capsules of PAS-004. The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839). Tillkännagivande • Apr 24
Pasithea Therapeutics to Present Updated Data from Ongoing Phase 1 Trial of PAS-004 in Advanced Cancer Patients at the 2025 ASCO Annual Meeting Pasithea Therapeutics Corp. announced the acceptance of an abstract for a poster prenstation at the Annual Meeting of the American Society for Clinical Oncology (ASCO) taking place May 30 - June 3, 2025, in Chicago, Illinois. The Company will present updated interim clinical data from its onging Phase 1 clinical trial of PAS-004 in patients with MAPK pathway driven advanced solid tumors. The company will present updated interim clinical data of PAS-004 through cohort 4A and 4B, that to date has demonstrated clinical activity, target engagement, and a favorable safety profile. Tillkännagivande • Apr 13
Pasithea Therapeutics Corp. Announces Positive Safety Review Committee (SRC) Recommendation from its Ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer Pasithea Therapeutics Corp. announced that the external Safety Review Committee recommended that the Company's Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to Cohort 6, 30mg capsule, without modification. This recommendation was based on the review of the safety data from three patients from Cohort 5 and the absence of any dose limiting toxicities (DLT's). In addition, no rash has been observed to date during the DLT period in any of the first 19 patients in either capsule (15 patients) or tablet (four patients) formulation of PAS-004.ash is a common adverse event (AE) that is observed at low doses with competitor MEK inhibitors and may lead to the discontinuation rate in real world practice. The on label rash rate for both approved MEKi for NF1 exceeds 80% which leads to patients discontinuing who otherwise should remain on treatment for longer periods of time". The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839). New Risk • Mar 26
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 160% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$14m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 47% per year over the past 5 years. Shareholders have been substantially diluted in the past year (160% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.38m market cap). New Risk • Mar 25
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$14m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$14m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 47% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (US$1.58m market cap). Minor Risk Shareholders have been diluted in the past year (22% increase in shares outstanding). New Risk • Feb 05
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 54% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (US$2.63m market cap). Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (22% increase in shares outstanding). Tillkännagivande • Feb 05
Pasithea Therapeutics Announces Positive Safety Review Committee (Src) Recommendation from Its Ongoing Phase 1 Clinical Trial of Pas-004 in Advanced Cancer Pasithea Therapeutics Corp. announced that the external Safety Review Committee recommended that the Company's Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to cohort 5, 22mg capsule, without modification. This recommendation was based on the review of the safety data from three patients in cohort 4A (15mg capsule) and the absence of any dose limiting toxicities (DLT's). In addition, no rash has been observed to date in any of the first 14 patients who have been dosed with PAS-004 in either capsule (12 patients) or tablet (2 patients) formulation.ash is a common adverse event (AE) that is observed at low doses with competitor MEK inhibitors and may lead to the high discontinuation rate in real world practice. The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839). Tillkännagivande • Nov 27
Pasithea Therapeutics Corp. has filed a Follow-on Equity Offering in the amount of $2.076 million. Pasithea Therapeutics Corp. has filed a Follow-on Equity Offering in the amount of $2.076 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Tillkännagivande • Nov 20
Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer Pasithea Therapeutics Corp. announced that the external Safety Review Committee recommended proceeding to cohort 4, 15mg capsule, without modifications. This recommendation was based on the absence of any dose limiting toxicities (DLT’s). In addition, no rash was observed in any of the first 9 patients who received PAS-004. The Company has decided to add a cohort 4b to the trial, which will consist of 3 additional patients and introduce an alternate formulation which is intended for commercial use. The Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation, or patients who have failed BRAF/MEK inhibition (NCT06299839). PAS-004 Demonstrates a Differentiated MEK Inhibitor Profile: Unlike first-generation MEK inhibitors for the treatment of NF1 that require twice-daily dosing (BID) and exhibit short half-lives (<8 hours), PAS-004 has the potential to achieve prolonged target inhibition and once-daily dosing (QD) due to its long half-life of approximately 70 hours. As disclosed previously, the PK profile shows consistent plasma levels at steady-state, as reflected by a low Cmax to Cmin ratio, potentially reducing the risks for Cmax-related toxicity. These findings provide a compelling rationale for the advancement of PAS-004 into clinical trials for both the treatment of cutaneous and plexiform neurofibromas in NF1, cancer and other MAPK-driven opportunities. The company expects to provide additional trial updates on a periodic basis as the trial progresses. New Risk • Nov 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$15m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$15m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Earnings have declined by 54% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (US$4.18m market cap). Minor Risk Shareholders have been diluted in the past year (22% increase in shares outstanding). Tillkännagivande • Oct 01
Pasithea Therapeutics Corp. announced that it has received $5.000003 million in funding On September 30, 2024, Pasithea Therapeutics Corp closed the transaction Tillkännagivande • Sep 27
Pasithea Therapeutics Corp. announced that it expects to receive $5.000003 million in funding Pasithea Therapeutics Corp. announced that it has entered into definitive agreements for the issuance and sale of an aggregate of 1,219,513 shares of its common stock at a purchase price of $4.10 per share for gross proceeds of $5.000003 million on September 26, 2024. The Series A and the short-term Series B warrants will have an exercise price of $3.85 per share and will be exercisable immediately upon issuance. The Series A warrants will expire five years from the issuance date and the short-term Series B warrants will expire 18 months from the issuance date. The closing of the offering is expected to occur on or about September 30, 2024, subject to the satisfaction of customary closing conditions. Tillkännagivande • Sep 03
Pasithea Therapeutics Announces Appointment of Dr. Rebecca Brown to its Scientific Advisory Board Pasithea Therapeutics Corp. announced that Rebecca Brown, M.D., Ph.D. has been appointed as a member of the Company’s Scientific Advisory Board. Dr. Brown is currently Director of the Neurofibromatosis Clinic at The Mount Sinai Hospital and Assistant Professor in the Department of Neurology (Division of Neuro-Oncology), Internal Medicine, and Neurosurgery at the institution. Dr. Brown will contribute scientific insights and valuable clinical perspectives to Pasithea's development of PAS-004. Dr. Brown has been an investigator in dozens of NF1 research studies including basic, translational, and clinical trials, with a focus on cutaneous and plexiform neurofibromas in NF1. Her research has been published extensively in major scientific journals and regularly serves as faculty at national and international meetings. Dr. Rebecca Brown (M.D., Ph.D.) is a board-certified adult neuro-oncologist who specializes in Neurofibromatosis (NF) and Schwannomatosis (SWN) genetic nerve tumor predisposition syndromes. She earned her Ph.D. from The University of Texas at Austin (UT Austin) in Neuroscience studying the molecular genomics and behavioral outcomes of endocrine-disrupting pollutants on females across multiple generations. Dr. Brown completed a post-doctoral fellowship at the Center for Strategic and Innovative Technologies at UT Austin in human performance research and then earned her M.D. from UT Southwestern in 2013. She completed her intern year at East Tennessee State University in 2014 and her neurology residency at Mount Sinai Hospital in NYC in 2017. She specialized in neuro-oncology during a fellowship at Memorial Sloan Kettering Cancer Center (MSKCC) completed in 2019. She worked as an instructor at MSKCC for 18 months prior to accepting a position as Assistant Professor and Director of the all-ages NF and SWN Clinic at The Mount Sinai Health System in January 2021. Dr. Brown has experience on both sides of the bench in NF laboratory research involving the RAS-RAF-MEK-ERK (MAPK) pathway, including genome editing, cell culture, xenografts, and clinical trials. Her particular interest is in developing treatments for NF1-associated dermal tumors called cutaneous neurofibromas. New Risk • Jul 30
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10.0% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$14m free cash flow). Earnings have declined by 69% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (US$5.42m market cap). Minor Risk Share price has been volatile over the past 3 months (10.0% average weekly change). Tillkännagivande • Jun 15
Pasithea Therapeutics Corp. Announces Completion of Enrollment and Initial Dosing of Cohort 2 Following Positive Safety Review Committee Recommendation for PAS-004 in Ongoing Phase 1 Clinical Trial Pasithea Therapeutics Corp. announced that an independent Safety Review Committee (SRC) has completed its safety review of data from the first dose cohort (2mg) treated in the ongoing Phase 1 clinical trial (NCT06299839) of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition. Based on these findings, the SRC recommended that the trial escalate to the next dose level (4mg) without modifications. This recommendation was based on the absence of any dose limiting toxicities (DLT's) or clinically relevant treatment-emergent adverse events in the initial cohort of 3 patients. The Company has now completed enrollment and initial dosing of 3 patients in the second cohort. The Phase 1 trial is a multicenter, open-label, dose escalation study evaluating the safety, tolerability, and pharmacokinetics (PK) and pharmacodynamics (PD) of PAS-003 in patients with MAPK pathwaydriven advanced solid tumors with a documentedRAS, NF1 orRA mutation or patients who have failed BraF/MEK inhibition. The primary objective of the study is to assess the safety and tolerability of PAS-004, with secondary objectives including PK and PD parameters, an evaluation of the preliminary anticancer activity (efficacy) of PAS-004 and defining the preliminary recommended Phase 2 dose(s). Tillkännagivande • May 17
Pasithea Therapeutics Corp., Annual General Meeting, Jun 26, 2024 Pasithea Therapeutics Corp., Annual General Meeting, Jun 26, 2024. Location: via the internet, United States Tillkännagivande • Apr 25
Pasithea Therapeutics Corp. Announces the First Cohort Has Completed the Initial Dosing in Its Phase 1 Trial Evaluating Pas-004 in Ras, Nf1 and Raf Mutated Cancers Pasithea Therapeutics Corp. announced the first cohort of 3 patients have commenced dosing. PAS-004 is being evaluated in a Phase 1 multicenter open label clinical trial (NCT06299839) in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition. PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials, with an expected extended half-life which may provide better compliance rates, as well as improved efficacy in NF1. Macrocycles are known to exhibit stronger binding, better solubility and longer half-life with more selectivity and less off target effect as compared to acyclic small molecules. Tillkännagivande • Feb 14
Pasithea Therapeutics Announces Opening of Enrollment in the U.S. for Its Phase 1 Trial of Pas-004 Pasithea Therapeutics Corp. announced the activation of four clinical trial sites in the United States. These U.S. clinical trial sites in Texas and Virginia are now open and actively enrolling patients. This announcement follows the approval from the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for PAS-004, and FDA review of the protocol for the Company’s Phase 1 multicenter, open-label trial of PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition. The objective of the Phase 1 study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 as well as to evaluate the preliminary anticancer activity (efficacy) of PAS-004 and to define the preliminary recommended Phase 2 dose. The Company's clinical development plan for PAS-004 following the Phase 1 study is to begin a Phase 2 clinical trial in NF1 pediatric and adult patients as soon as safety and PK are established. Pasithea has selected Novotech as the clinical research organization (CRO) for the Phase 1 trial and will be collaborating in the U.S. with NEXT Oncology, led by Dr. Anthony Tolcher M.D., along with Dr. Ildefonso Rodriguez M.D., acting as principal investigator for the San Antonio, TX site. There are also three other clinical trial sites in Eastern Europe that are expected to open in the coming months. PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials, with an expected extended half-life in humans which may provide better compliance rates as well as improved efficacy in NF1. Macrocycles are known to exhibit stronger binding, better solubility and longer half-life with more selectivity and less off target effect as compared to acyclic small molecules. PAS-004 is a small molecule allosteric inhibitor of MEK 1/2, which are dual-specificity protein kinases, in the MAPK signaling pathway. The MAPK pathway has been implicated in a variety of diseases, as it functions to drive cell proliferation, differentiation, survival and a variety of other cellular functions that, when abnormally activated, are critical for the formation and progression of tumors, fibrosis and other diseases. MEK inhibitors block phosphorylation (activation) of extracellular signal-regulated kinases (ERK), which can lead to cell death and inhibition of tumor growth. Existing FDA approved MEK inhibitors are marketed for a range of diseases, including certain cancers and neurofibromatosis type 1 (NF1). They believe these MEK inhibitors suffer from certain limitations, including known toxicities. Unlike current FDA approved MEK inhibitors, PAS-004 is macrocyclic, which believe may lead to improved pharmacokinetic and safety (tolerability) profiles. Cyclization offers rigidity for stronger binding with drug target receptors. PAS-004 was designed to provide a longer half-life with what believe is a better therapeutic window. Further, believe the potency and safety profile that PAS-004 has demonstrated in preclinical studies may also lead to stronger and more durable response rates and efficacy, as well as better dosing schedules. PAS-004 has been tested in a range of mouse models of various diseases and has completed preclinical testing and animal toxicology studies. Additionally, PAS-004 has received orphan-drug designation from the FDA for the treatment of NF1, which may provide seven years of marketing exclusivity upon approval of an NDA. Tillkännagivande • Jan 10
Pasithea Therapeutics Announces Invention of Crystalline Form of PAS-004; Establishes Strengthened Intellectual Property (IP) Position Pasithea Therapeutics Corp. announced the invention of a crystalline form of PAS-004 which is captured in polymorph and stereoisomer patent filings that when issued company believes will extend patent protection to at least 2045. About PAS-004: PAS-004 is a small molecule allosteric inhibitor of MEK 1/2, which are dual-specificity protein kinases, in the MAPK signaling pathway. The MAPK pathway has been implicated in a variety of diseases, as it functions to drive cell proliferation, differentiation, survival and a variety of other cellular functions that, when abnormally activated, are critical for the formation and progression of tumors, fibrosis and other diseases. MEK inhibitors block phosphorylation (activation) of extracellular signal-regulated kinases (ERK). Blocking the phosphorylation of ERK can lead to cell death and inhibition of tumor growth. Existing FDA approved MEK inhibitors are marketed for a range of diseases, including certain cancers and neurofibromatosis type 1 (NF1). Company believes these MEK inhibitors suffer from certain limitations, including known toxicities. Unlike current FDA approved MEK inhibitors, PAS-004 is macrocyclic, which company believes may lead to improved pharmacokinetic and safety (tolerability) profiles. Cyclization offers rigidity for stronger binding with drug target receptors. PAS-004 was designed to provide a longer half-life with what company believes is a better therapeutic window. Further, company believes the potency and safety profile that PAS-004 has demonstrated in preclinical studies may also lead to stronger and more durable response rates and efficacy, as well as better dosing schedules. PAS-004 has been tested in a range of mouse models of various diseases and has completed preclinical testing and animal toxicology studies. Additionally, PAS-004 has received orphan-drug designation from the FDA for the treatment of NF1. Tillkännagivande • Jan 02
Pasithea Therapeutics Corp. Announces FDA Acceptance of Ind Application to Evaluate Pas-004 in Advanced Cancer Patients Pasithea Therapeutics Corp. announced the Investigational New Drug Application (IND) clearance to proceed by the U.S. Federal Drug Administration (FDA) to evaluate PAS-004, a macrocyclic MEK (1/2) inhibitor, in patients with MAPK pathway driven advanced solid tumors with a documented RAS, RAF or NF1 mutation or patients who have failed BRAF/MEK inhibition. Pasithea expects to dose the first patient in the first quarter of 2024. The objectives of the dose escalation study are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics as well as anti-tumor responses of PAS-004 as monotherapy in up to 36 advanced cancer patients with preliminary early data expected as early as Third Quarter 2024. Administered orally, PAS-004 is expected to be an once day or less frequent dose which may provide better compliance rates as well as superior efficacy. PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials. Macrocycles exhibit unique drug-like profiles because of their cyclic structure, potentially improving bioavailability, binding affinity, and overall pharmacokinetics in comparison to acyclic counterparts. New Risk • Nov 20
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$18m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$18m free cash flow). Revenue is less than US$1m (US$487k revenue). Market cap is less than US$10m (US$6.46m market cap). Minor Risk Share price has been volatile over the past 3 months (12% average weekly change). Tillkännagivande • Nov 10
Pasithea Therapeutics Corp. Selects PAS-003 Lead Development Candidate Pasithea Therapeutics Corp. announced that it has selected a lead therapeutic candidate for its PAS-003 program, a proprietary humanized monoclonal antibody (mAb) that targets a5b1 integrin, a protein found to be overexpressed in both human and mouse subjects with amyotrophic lateral sclerosis (ALS). Scientists at Pasithea have performed extensive mAb screening and characterization to enable selection of a lead therapeutic candidate with optimal properties for the treatment of ALS. This work included further validation of a5b1 integrin as a target in both familial (SOD1) and sporadic (TDP-43) ALS mouse models with reproducible improvements on behavior and survival. In July 2023, in conjunction with scientists at the Mayo Clinic and Oregon Health Sciences University, published a study in the renowned scientific peer-reviewed journal Proceedings of the National Academy of Sciences (PNAS) describing an increase of a5b1 integrins expression with disease progression in both mouse models of ALS and in human postmortem tissue samples of ALS patients. Additionally, this publication highlights the role of a5b1 integin on different cell types involved in neuroinflammation in ALS and has shown that blocking a5b1 integrin is a therapeutic target for the treatment of ALS. Tillkännagivande • Oct 27
Pasithea Therapeutics Corp., Annual General Meeting, Nov 29, 2023 Pasithea Therapeutics Corp., Annual General Meeting, Nov 29, 2023, at 09:00 US Eastern Standard Time. Agenda: To consider .Election of the director; to consider Adoption and approval of an amendment to Amended and Restated Certificate of Incorporation; to consider Approval of the Pasithea Therapeutics Corp. 2023 Stock Incentive Plan; to consider Adoption and approval of an Amended and Restated Certificate of Incorporation; to consider Ratification of the appointment of Marcum LLP as independent registered public accounting firm; to consider Transacting such other business as may properly come before the Annual Meeting or any adjournment thereof. Board Change • Oct 20
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 3 experienced directors. No highly experienced directors. CEO & Director Tiago Marques is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Tillkännagivande • Aug 02
Pasithea Therapeutics Corp. Publishes Study in Proceedings of the National Academy of Sciences Related to its PAS-003 Drug Discovery Program Pasithea Therapeutics Corp. announced a publication in the internationally renowned scientific peer-reviewed journal Proceedings of the National Academy of Sciences (PNAS), related to its PAS-003 drug discovery program, that describes an increased expression of a5/ß1 (a5) integrin on motor neurons in ALS human and mouse tissue, as well as the blockade of this integrin as a potential new approach to treat ALS patients. The paper presents new findings from an interdisciplinary collaboration of scientific teams at Pasithea, the Mayo Clinic, and Oregon Health & Science University, combining results from human post-mortem tissues from ALS patients and from tissue samples from the superoxide dismutase-1 G93A mouse model of ALS (SOD1G93A). Key findings from the publication show: an increased expression of a5 integrin in motor pathways of the central and peripheral nervous system in post-mortem tissues from ALS patients with various clinical ALS phenotypes and disease duration; specificity of a5 integrin in ALS compared to other integrins; presence of a5 integrin-positive microglia, particularly in the zone of active and prior neuronophagia; an increased expression of a5 integrin in microglia and macrophages in the SOD1G93A mouse model of ALS linked to disease progression; the administration of a monoclonal antibody against a5 integrin increased survival in the SOD1G93A mouse model of ALS compared to an isotype control; and the administration of a monoclonal antibody against a5 integrin improved motor function on behavioral testing in the SOD1G93A mouse model of ALS compared to an isotype control. PAS-003 is a monoclonal antibody targeting a5/ß1 integrin for the treatment of Amyotrophic Lateral Sclerosis (ALS) and other neurological diseases. New Risk • Jul 21
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Revenue is less than US$1m (US$487k revenue). Minor Risk Market cap is less than US$100m (US$15.5m market cap). Tillkännagivande • Jun 07
Lucy Scientific Discovery Inc. (NasdaqCM:LSDI) made a proposal to acquire Pasithea Therapeutics Corp. (NasdaqCM:KTTA) for $22.2 million. Lucy Scientific Discovery Inc. (NasdaqCM:LSDI) made a proposal to acquire Pasithea Therapeutics Corp. (NasdaqCM:KTTA) for $22.2 million on June 5, 2023. Under the terms of the offer, Lucy proposes to pay $0.60 in cash, and $0.25 cents in Lucy stock (NASDAQ: LSDI) for every share of Pasithea common stock. Given that Pasithea’s stock closed at $0.35 per share on June 1, 2023, the Proposal of $0.85 per share equates to 142% premium to Pasithea’s share price. In fact, the cash component alone represents a 71% premium. In the event that the proposal is not endorsed by Pasithea's Board of Directors, Lucy is prepared to present it directly to the Pasithea shareholders. Tillkännagivande • Jan 26
Pasithea Therapeutics Receives A Written Notice from Nasdaq Regarding Minimum Bid Price Requirement On January 19, 2023, Pasithea Therapeutics Corp. (the Company") received a written notice (the Notice") from the Listing Qualifications Department of The Nasdaq Stock Market (Nasdaq") indicating that the Company is notin compliance with the $1.00 minimum bid price requirement set in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the Bid Price Requirement"). The Notice does not result in the immediate delisting of the Company's common stock from The Nasdaq Capital Market. The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price of the Company's common stock for 30 consecutive business days prior to the delivery of the Notice, the Company no longer meets this requirement. The Notice indicated that the Company will be provided 180 calendar days in which to regain compliance, or until July 18, 2023. If at any time during this period the bid price of the Company's common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, the Nasdaq staff (the Staff") will provide the Company with a written confirmation of compliance and the matter will be closed. Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, the Company may be eligible for an additional 180 calendar day compliance period, provided (i) it meets the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the Bid Price Requirement) and (ii) it provides written notice to Nasdaq of its intention to cure this deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, and if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is not otherwise eligible, the Staff will provide the Company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. At that time, the Company may appeal the delisting determination to a hearings panel. The Company intends to monitor the closing bid price of its common stock and is considering its options to regain compliance with the Bid Price Requirement. The Company's receipt of the Notice does not affect the Company's business, operations or reporting requirements with the Securities and Exchange Commission. Tillkännagivande • Dec 08
Concord IP2 Recommends Stockholders to Vote for Boardroom Change at Pasithea Therapeutics On December 7, 2022, Camac Partners, LLC, affiliates of Concord Investment Partners Ltd., and Leonite Capital LLC issued a statement recommending stockholders vote on Camac Partners’ proxy card to remove Pasithea Therapeutics Corp.’s Board of Directors at the upcoming special meeting of stockholders scheduled for December 9th, 2022. Price Target Changed • Nov 16
Price target decreased to US$2.30 Down from US$2.50, the current price target is provided by 1 analyst. New target price is 123% above last closing price of US$1.03. Stock is down 59% over the past year. The company posted a net loss per share of US$0.21 last year. Board Change • Nov 16
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Emer Leahy was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Tillkännagivande • Nov 02
Concord IP2 Ltd Files a Lawsuit Against the Directors of Pasithea Therapeutics Corp On October 31, 2022, Concord IP2 Ltd., Leonite Capital LLC, and Camac Fund, LP (Reporting Person) filed a lawsuit in the Delaware Court of Chancery asserting a claim for breach of fiduciary duties against Pasithea Therapeutics Corp’s directors. The Lawsuit alleges that the Directors breached their fiduciary duties by approving the Company’s recent acquisitions of Alpha-5 Integrin, LLC and Allomek Therapeutics, LLC (the Acquisitions) for the primary purpose of diluting the shares held by the Reporting Persons and other stockholders supporting the special meeting request, while increasing the voting power of the Directors’ allies. The Lawsuit seeks, among other things, (i) a preliminary and permanent injunction to enjoin the Issuer from counting the shares issued in the Acquisitions at the upcoming special meeting and the Company’s next annual meeting with respect to the election of directors, (ii) a temporary restraining order that restrains the Directors from holding the special meeting until the preliminary injunction motion is resolved, (iii) a declaration that the Directors breached their fiduciary duties, and (iv) an order rescinding the Acquisitions. Tillkännagivande • Oct 14
Camac Partners Comments on Pasithea Therapeutics’ Acquisition of AlloMek Therapeutics On October 13, 2022, Camac Partners, LLC, affiliates of Concord Investment Partners Ltd., and Leonite Capital LLC issued a statement regarding Pasithea Therapeutics Corp.'s recently announced dilutive acquisition of AlloMek Therapeutics, LLC. As a reminder, Camac Partners stated that it has successfully requisitioned Pasithea Therapeutics’ Board of Directors to call a special meeting of stockholders. Camac Partners added that its calls on the Board to schedule the special meeting, as required by the Company’s corporate documents. Camac Partners stated that the Board should not use any improper or questionable tactics to delay the special meeting further. Camac Partners also stated that it remains firm in its position that removing all sitting directors will best position Pasithea Therapeutics to enhance its corporate governance and Board composition, ultimately leading to improved capital allocation and enhanced value for all stockholders. Tillkännagivande • Sep 30
Camac Partners LLC Sends a Letter to Pasithea Therapeutics Corp On September 29, 2022, Camac Partners LLC announced that it has sent a letter to Pasithea Therapeutics Corp, highlighting its opinion over Company’s decision to appoint a director without consulting stockholders and urged the Company to convene special meeting to remove the current directors without delay. Board Change • Sep 23
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Emer Leahy was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Tillkännagivande • Sep 21
Pasithea Therapeutics Corp. Appoints Alfred J. Novak to Its Board of Directors Pasithea Therapeutics Corp. announced that Alfred J. Novak was appointed to its Board of Directors (the “Board”). Mr. Novak replaces Dr. Yassine Bendiabdallah, who stepped down from the Board on September 14, 2022. Mr. Novak has broad operating experience as a Chief Executive Officer and Chief Financial Officer and has served on the boards of several pharmaceutical and medical device companies. Mr. Novak brings financial acumen and extensive expertise in product development, regulatory approval, commercial activities, and a track record of delivering substantial value for stockholders. Mr. Novak served as a director of Dova Pharmaceuticals, which was sold to Swedish Orphan Biovitrum AB or Sobi™, a company focused on rare diseases, for over $900 million; a director and CEO of Biosense, which was sold to Johnson & Johnson for $400 million; and CFO of Cordis Corporation, which was acquired by Johnson & Johnson for $1.8 billion. He received his MBA from the Wharton School of the University of Pennsylvania with a concentration in Healthcare Administration and a BS from the United States Merchant Marine Academy. Tillkännagivande • Sep 16
Pasithea Therapeutics Corp. Appoints Dr. Merit Cudkowicz to its Scientific Advisory Board Pasithea Therapeutics Corp. announced the appointment of Dr. Merit Cudkowicz to its Scientific Advisory Board (SAB). Dr. Cudkowicz is the Chief of Neurology at Massachusetts General Hospital, Director of the Sean M. Healey & AMG Center for ALS, and the Julieanne Dorn Professor of Neurology at Harvard Medical School. A member of the National Academy of Medicine, Dr. Cudkowicz has been a pioneer in promoting and devising more efficient methods for the development of new therapies for people with neurological disorders such as ALS and is one of the founders and co-directors of the Northeast ALS (NEALS) Consortium, a group of over 130 clinical sites in the United States and Canada dedicated to performing collaborative academic-led clinical trials in ALS. Dr. Cudkowicz is also the Study Chair and Principal Investigator of the HEALEY ALS Platform Trial, a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Dr. Cudkowicz received the American Academy of Neurology 2009 Sheila Essay ALS award, the 2017 Forbes Norris Award from the International MND Alliance, the 2017 Pinnacle Award from the Boston Chamber of Commerce, and the 2019 Ray Adams American Neurological Association Award. She received a B.S. in Chemical Engineering from Massachusetts Institute of Technology, an M.D. from Harvard Medical School, and a MSc. in Clinical Epidemiology from Harvard School of Public Health. Tillkännagivande • Aug 26
Camac Partners Urges Stockholders of Pasithea Therapeutics to Vote to Call Special Meeting On August 24, 2022, Camac Partners, LLC issued a letter to fellow stockholders of Pasithea Therapeutics Corp. In the letter, Camac Partners stated that it is seeking to call a special meeting of stockholders at the Company for a reason: it has lost all confidence in the incumbent Board of Directors to be effective and prudent stewards of its capital. Camac Partners stated that it has been pleased with the high degree of investor engagement and support it has received thus far, such that it is close to the threshold needed to call the special meeting. Tillkännagivande • Aug 12
Pasithea Therapeutics Corp. Announces Results of Preclinical Study Demonstrating Tolerizing Vaccine Efficacy in Relapsing-Remitting Model of Multiple Sclerosis Pasithea Therapeutics Corp. announced positive results from a preclinical proof of concept study of PAS002, its tolerizing vaccine program in multiple sclerosis (“MS”). Earlier this year, a study in Nature, the world's leading science journal, showed that a molecule called GlialCAM found in the brain’s white matter is attacked in MS. GlialCAM shares a component of its protein structure that mimics an identical component of the Epstein Barr Virus (“EBV”) Nuclear Antigen-1, which plays a critical role in triggering MS. In this proof of concept study, relapsing paralysis was established in a mouse model of relapsing-remitting experimental autoimmune encephalomyelitis (“EAE”), the standard animal model of MS. In three groups, a proprietary DNA cassette was engineered to encode GlialCAM and injected to potentially block acute disease and its relapse. These DNA molecules were designed to protect against paralytic disease by tolerizing the immune system so it would not attack myelin in the brain and spinal cord. The engineered DNA molecule creates tolerance, working like an ‘inverse vaccine’, and was administered intra-muscularly at days 0, 3, 7, 10, and 14. The study had a standard duration of 32 days. The data showed that the engineered DNA plasmids provide a high level of efficacy in reducing disease severity and incidence of relapse when administered prophylactically in the EAE model, a widely used relapsing-remitting model of MS. Key findings from the study include: treatment with a DNA tolerizing ‘inverse vaccine’ delayed the onset of paralysis when compared to vehicle (p<0.001); a statistically significant reduction in disease severity, when compared to vehicle (p=0.002); a statistically significant reduction in relapse severity, when compared to vehicle (p<0.001); treatment with a DNA vaccine prevented disease in approximately 50% of the mice, when compared to vehicle (p=0.004). The study was conducted at Hooke Laboratories, an independent full-service Contract Research Organization with deep experience in the EAE animal model of MS. Tillkännagivande • Aug 06
Concord Investment Partners Ltd Urges Stockholders of Pasithea Therapeutics Corp to Call Special Meeting On August 5, 2022, Concord Investment Partners Ltd announced that it urged the stockholders of Pasithea Therapeutics Corp to call special meeting by returning the white card for removal of the incumbent Board of Directors, a board that has overseen a massive destruction in the value of the investment. Tillkännagivande • Jul 29
Concord IP2 Ltd Nominates Candidates to the Board of Pasithea Therapeutics Corp On July 28, 2022, Concord IP2 Ltd requested the Pasithea Therapeutics Corp to call a special meeting of the shareholders and made 2 books and records demands to receive additional information regarding the Company and investigate potential actions by the board. In addition, Concord IP2 Ltd submitted a nomination notice to the Company nominating David Delaney, Avi Geller and Eric Shahinian to the Company board. Tillkännagivande • Jul 02
Concord IP2 Ltd Files Solicitation Statement to Call a Special Meeting of Stockholders of Pasithea Therapeutics Corp On July 1, 2022, Pasithea Therapeutics Corp announced that it has filed a preliminary proxy statement and request to call a special meeting of stockholders for the following purposes: 1) to remove, without cause, Tiago Reis Marques, Yassine Bendiabdallah, Lawrence Steinman, Simon Dumesnil and Emer Leahy as directors of the Company, 2) to vote on a proposal related to the filling of vacancies on the Board that arise as the result of the removal of one or more directors by stockholders, 3) to repeal each provision or amendment of the Bylaws adopted by the Board without the approval of the Company’s stockholders after April 13, 2021 (the last date that the Bylaws were publicly disclosed by Pasithea), and prior to the approval of this proposal, and 4) transact such other business as may properly come before the special meeting. In addition, Concord IP2 stated that at this time, it is only soliciting shareholders written request to call a special meeting and not currently seeking shareholder proxy, consent, authorization or agent designation for approval of the proposals or any other actions. Further Concord IP2 stated that if a special meeting is called, it will send shareholder proxy materials relating to the proposals. Tillkännagivande • Jun 28
Concord IP2 Ltd Provides Information to Shareholders of Pasithea Therapeutics Corp On June 27, 2022, Concord IP2 Ltd communicated with shareholders of Pasithea Therapeutics Corp and highlighting the Company’s response on its concerns regarding acquisition of Alpha-5 and stated that it intends to file a definitive proxy statement and inform the shareholders to it intends to withhold vote on the election of all the current directors of the Company at the upcoming annual meeting of stockholders. In addition, Concord IP2 Ltd stated that it intends to convene a special meeting of stockholders at the earliest possible opportunity to remove and replace all the sitting directors. Tillkännagivande • Jun 17
Concord IP2 Ltd Sends a Letter to Pasithea Therapeutics Corp On June 16, 2022, Concord IP2 Ltd announced that it has submitted a demand pursuant to Section 220 of the Delaware General Corporation Law for certain books and records of the Company. Tillkännagivande • Jun 11
Stanley Gloss, the Chief Financial Officer of Pasithea Therapeutics Corp., Passes Away On June 7, 2022, Stanley Gloss, the Chief Financial Officer of Pasithea Therapeutics Corp., passed away. The Company is in the process of looking for a new Chief Financial Officer. Tillkännagivande • Jun 02
Concord IP2 Ltd Sends a Letter to Pasithea Therapeutics Corp On June 1, 2022, Concord IP2 Ltd sent a letter to Pasithea Therapeutics Corp and mentioned its concerns regarding declining in Company’s stock price since its IPO, substantial discount to the Company’s cash value per share implied by the Company’s current valuation, and compensation paid to the members of the Company board. Tillkännagivande • May 14
Pasithea Therapeutics Corp., Annual General Meeting, Jun 23, 2022 Pasithea Therapeutics Corp., Annual General Meeting, Jun 23, 2022, at 09:00 US Eastern Standard Time. Agenda: To consider election of the director nominees named in this Proxy Statement to serve for a term of one year; to consider ratification of the appointment of Marcum LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2022; to consider transacting such other business as may properly come before the meeting or any adjournment thereof. Board Change • Apr 27
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Emer Leahy was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Tillkännagivande • Feb 10
Pasithea Therapeutics Appoints Daniel Weinberger to Its Scientific Advisory Board Pasithea Therapeutics Corp. announced the appointment of Dr. Daniel Weinberger to its Scientific Advisory Board. Dr. Weinberger is the Director and CEO of the Lieber Institute for Brain Development at the Johns Hopkins Medical Center and Professor of Psychiatry, Neurology, Neuroscience and Human Genetics at the Johns Hopkins School of Medicine. He was formerly Director of the Genes, Cognition, and Psychosis Program of the Intramural Research Program, National Institute of Mental Health, National Institutes of Health in Bethesda, Maryland. Dr. Weinberger attended college at the Johns Hopkins University and medical school at the University of Pennsylvania and did residencies in psychiatry at Harvard Medical School and in neurology at George Washington University. He is board certified in both psychiatry and neurology. Tillkännagivande • Feb 04
Pasithea Therapeutics Initiates New Chemical Entity Drug Development Program in Multiple Sclerosis Pasithea Therapeutics Corp. announced a new chemical entity development program and named Massachusetts-based Hooke Laboratories as its research partner. Tillkännagivande • Nov 30
Pasithea Therapeutics Corp. announced that it has received $30.38 million in funding On November 29, 2021, Pasithea Therapeutics Corp. closed the transaction. Tillkännagivande • Nov 26
Pasithea Therapeutics Corp. announced that it expects to receive $30.38 million in funding Pasithea Therapeutics Corp. announced that it has entered into securities purchase agreements with certain institutional investors to purchase 8,680,000 shares of its common stock and warrants to purchase 8,680,000 shares of its common stock, at a purchase price of $3.50 per share for gross proceeds of $30,380,000 on November 24, 2021. The warrants will be immediately exercisable from the date of issuance and have an exercise price of $3.50 per share. The warrants will expire five years from the date of issuance. The securities were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, and Regulation D promulgated thereunder and have not been registered under the Act, or applicable state securities laws. The company is required to file an initial registration statement with the Securities and Exchange Commission covering the resale of the securities to be issued to the investors in the private placement no later than 15 days from the date of the securities purchase agreements and to use best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days after the date of the securities purchase agreements. The offering is expected to close on or about November 29, 2021, subject to the satisfaction of customary closing conditions. Tillkännagivande • Nov 24
Pasithea Therapeutics Adds Esketamine Nasal Spray to Its Clinic Offerings in the U.K Pasithea Therapeutics Corp. announced that its wholly owned subsidiary, Pasithea Clinics, has been approved to provide esketamine nasal spray for treatment-resistant depression in adults, and has begun offering the treatment in its Knightsbridge, London location. Only three clinics in the U.K. have been accredited to offer this treatment. SPRAVATOCIII nasal spray is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate receptor – an ionotropic glutamate receptor. It has a novel mechanism of action, meaning it works differently than currently available therapies for major depressive disorder. SPRAVATO is approved in the United States, in conjunction with an oral antidepressant, to treat adults with treatment- resistant depression and depressive symptoms in adults with MDD with acute suicidal ideation or behavior. SPRAVATO has been submitted for health authorities’ review for TRD and adults with MDD who have current suicidal ideation with intent in other markets around the world, including Europe.