Cybin Announces Q1 FY2025 Financial Results and Business Highlights

Cybin Inc., a clinical-stage neuropsychiatry company focused on mental health treatments, has shared its unaudited financial results for the first quarter ending June 30, 2024, along with recent business achievements. The company is advancing its development of innovative therapeutics to address mental health disorders, primarily through its two main programs: CYB003 and CYB004.

CYB003 is a proprietary deuterated psilocybin analog designed for the adjunctive treatment of Major Depressive Disorder (MDD). The program has shown promising results, with 75% of participants in a Phase 2 study in remission from depression four months post-treatment. This program has been granted Breakthrough Therapy Designation by the U.S. FDA, and Cybin anticipates releasing 12-month efficacy data from this study in the fall. A Phase 3 pivotal trial for CYB003 is also expected to begin shortly, involving 30 clinical sites across the U.S. and Europe.

CYB004, another key program, focuses on a proprietary deuterated dimethyltryptamine (dDMT) for treating Generalized Anxiety Disorder (GAD). The Phase 2 study for CYB004 is currently in the dosing phase, with topline data on safety and efficacy expected by the end of the year or early in the first quarter of 2025. The program aims to provide a novel intramuscular formulation that would deliver a therapeutic experience lasting approximately 90 minutes.

To expedite these programs, Cybin has enhanced its research and development team with the appointments of Dr. Atul R. Mahableshwarkar and Dr. Tom Macek as Senior Vice Presidents of Clinical Development. Dr. Mahableshwarkar, who leads the CYB003 program, brings extensive experience as a board-certified psychiatrist and drug development executive. Dr. Macek, leading the CYB004 program, possesses decades of pharmaceutical industry experience in drug development across various phases of research.

In addition to these advancements, Cybin has strengthened its intellectual property portfolio. On July 23, 2024, the company was granted a U.S. patent (No. 12,042,564), providing additional protection for the CYB004 program.

Financially, as of June 30, 2024, Cybin reported cash reserves of CAD 183 million, with access to over CAD 247 million when considering previously announced public offerings and the potential exercise of warrants. The company reported a net loss of CAD 15 million for the quarter, consistent with the same period last year. Operating expenses, including research and administrative costs, amounted to CAD 16 million, up from CAD 11 million in the previous year. Cash flows used in operating activities were CAD 27 million for the quarter, compared to CAD 11 million in the same period last year, while financing activities contributed CAD 0.2 million, down from CAD 3.5 million last year.

Cybin, founded in 2019 and headquartered in Canada, is committed to advancing mental healthcare through innovative treatment options. Its operations extend across Canada, the United States, the United Kingdom, the Netherlands, and Ireland. The company's mission is supported by a network of world-class partners and scientists dedicated to advancing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches, and treatment regimens.