Quarterly report [Sections 13 or 15(d)]

Nature of the Organization and Business

v3.26.1
Nature of the Organization and Business
6 Months Ended
Jun. 30, 2026
Nature of the Organization and Business [Abstract]  
NATURE OF THE ORGANIZATION AND BUSINESS

NOTE 1 – NATURE OF THE ORGANIZATION AND BUSINESS

 

Pasithea Therapeutics Corp. (“Pasithea” or the “Company”) was incorporated in the State of Delaware on May 12, 2020 and completed an initial public offering (the “Initial Public Offering”) on September 17, 2021. The Company is a clinical-stage biotechnology company focused on the discovery, research and development of innovative treatments for RASopathies, MAPK pathway-driven tumors and other diseases, including central nervous system (CNS) disorders.

 

The Company’s lead product candidate, PAS-004, is a next-generation oral once-daily macrocyclic mitogen-activated protein kinase, or MEK inhibitor being developed for the long-term treatment of chronic diseases, including the neurocutaneous manifestations of neurofibromatosis type 1 (“NF1 “). Following the U.S. Food and Drug Administration (the “FDA”) clearance of its Investigational New Drug application (the “IND”) in December 2023, the Company is conducting a Phase 1 open-label, dose escalation trial of PAS-004 in patients with MAPK pathway-driven advanced tumors at sites in the United States and in Eastern Europe.

 

In May 2025, the Company initiated a Phase 1/1b open-label, dose escalation trial of PAS-004 in adult patients with NF1 with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas (“PN”) that is being conducting at sites in the United States, Australia, and South Korea. 

 

The Company’s initial planned indication for FDA and other regulatory approval is symptomatic and inoperable NF1-PN in adult and pediatric patients, and it aims to conduct a pediatric Phase 1 trial and registrational trials in both populations.

 

Additionally, the Company has one program, PAS-001, in the discovery stage, for the treatment of schizophrenia.

 

Throughout this report, the terms “our,” “we,” “us,” and the “Company” refer to Pasithea Therapeutics Corp. and its subsidiaries, Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, Pasithea Clinics Inc., Alpha-5 Integrin, LLC (“Alpha-5”), AlloMek Therapeutics, LLC (“AlloMek”) and Pasithea MacroMEK Pty Ltd. Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda is a private limited company registered in Portugal. Pasithea Clinics Inc., legally dissolved as of September 3, 2025, was incorporated in Delaware. Alpha-5 and AlloMek are both Delaware limited liability companies. Pasithea MacroMEK Pty Ltd is registered in Australia. The operations of Pasithea Therapeutics Portugal, Sociedade Unipessoal Lda, and Pasithea Clinics Inc. have been discontinued.

 

Emerging Growth Company

 

The Company is an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933, as amended, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and it may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and approval of any golden parachute payments not previously approved. Further, Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period.

 

Liquidity and Capital Resources

 

As of June 30, 2026, the Company had approximately $45.8 million in operating bank accounts and money market funds, and working capital of approximately $46.4 million. The Company’s major sources of cash have been comprised of proceeds from various private and public offerings, the Initial Public Offering, ATM sales and the exercise of warrants. The Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plans and continue operations.

 

The accompanying condensed consolidated financial statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses and negative cash flows from operations since inception. On June 30, 2026, the Company had cash and cash equivalents of approximately $45.7 million and an accumulated deficit of approximately $78.2 million. The Company has incurred recurring losses, has experienced recurring negative operating cash flows, and requires significant cash resources to execute its business plans. Historically, the Company’s major sources of cash have been comprised of proceeds from various public and private offerings of its capital stock. The Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plans and continue operations. Management considered whether or not there are conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern, and concluded that there are none as it estimates that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of these condensed consolidated financial statements.