Pasithea Therapeutics Corp. (KTTA)

The company is a biotechnology business focused on discovering, researching and developing treatments for Central Nervous System (CNS) disorders and RASopathies, drawing on expertise in neuroscience, translational medicine and drug development to advance new molecular entities aimed at the underlying pathophysiology of disease. It reports two segments, Therapeutics and Clinics. Therapeutics covers discovery, research and development of innovative treatments for CNS and other diseases.

Clinics previously provided business support services, though not medical services, to anti-depression clinics in the U.K. and the U.S. that administered intravenous ketamine, including through partnerships with Nadelson Medical PLLC and Zen Healthcare, with operations in New York, Los Angeles and the U.K. The company has since discontinued the Clinics segment, including its U.K. and New York services and its Los Angeles clinical operations, and is exploring disposal of the related property. The therapeutic pipeline has four programs. The lead candidate, PAS-004, was acquired through the October 2022 acquisition of AlloMek Therapeutics.

It is a next-generation, macrocyclic, small molecule allosteric MEK 1/2 inhibitor in the MAPK pathway, designed to improve on the pharmacokinetics, tolerability, potency and dosing burden of approved MEK inhibitors. It is intended for RASopathies such as neurofibromatosis type 1 (NF1) and Noonan syndrome, as well as LMNA cardiomyopathy and certain cancers. PAS-004 has completed preclinical testing and animal toxicology work to support an IND, has FDA orphan-drug designation for NF1, and is planned for IND submission in the third quarter of 2023, followed by a Phase 1 trial in healthy volunteers and potentially a Phase 2 proof-of-concept trial in NF1 patients.

NF1 is the initial target indication, with Noonan syndrome and other RASopathies to follow. Three discovery-stage programs target novel mechanisms. PAS-003, acquired with Alpha-5 integrin, LLC in June 2022, is a humanized monoclonal antibody against a5b1 integrin for ALS and other neuroinflammatory disorders such as MS.

PAS-002 is a DNA plasmid tolerizing vaccine targeting GlialCAM for multiple sclerosis. PAS-001 is a brain-penetrant small molecule targeting complement component 4A for schizophrenia. The strategy is to initiate clinical development of PAS-004 in NF1, expand it to Noonan syndrome and other indications, and advance the discovery programs to lead candidate selection.

The company also plans selective business development, non-dilutive funding and collaborations, including potential out-licensing to larger pharmaceutical companies, and may commercialize products alone or with partners.