Cybin Inc. Reports Financial Results and Prepares for Phase 3 Study of Lead Drug CYB003

LOS ANGELES- Cybin Inc. announced its audited financial results for the fiscal year ending March 31, 2024. The company, which currently has no revenue, reported cash holdings of C$209 million at the end of the fourth quarter.

Financial Performance

Cybin reported a net loss of C$21 million for the fourth quarter, with operating expenses totaling C$24 million, up from C$13 million in the same period last year. For the full fiscal year, the company recorded a net loss of C$78 million and operating expenses of C$65 million, compared to C$47 million the previous year. The company completed a private placement in 2023, which, along with its current cash position and at-the-market equity program, provides access to over C$285 million.

Advancements and Upcoming Milestones

Cybin’s CEO, Doug Drysdale, highlighted the company’s progress in advancing its lead programs CYB003 for major depressive disorder (MDD) and CYB004 for generalized anxiety disorder (GAD). “As we stand poised to commence our Phase 3 study of CYB003, Cybin has evolved into a mature, late-stage company with critical milestones on the near-term horizon,” Drysdale stated. Supported by the FDA’s Breakthrough Therapy Designation and positive four-month durability data for CYB003, the company is progressing quickly toward potentially changing the treatment paradigm for MDD and GAD.

Key Projects and Programs

1. Deuterated Psilocybin Analog Program (CYB003)
2. Deuterated Dimethyltryptamine Program (CYB004, SPL028, and SPL026)
3. Phenethylamine Derivatives Program (CYB005)
4. Technology Programs

Phase 3 Study and Patent

Cybin plans to initiate a multinational, multisite Phase 3 program for CYB003 in the summer of 2024. The study aims to further evaluate the safety and efficacy of CYB003 capsules as an adjunctive treatment in a larger MDD patient population. Cybin received U.S. patent 11,958,807 for its CYB003 program, providing exclusivity until at least 2041. The Phase 3 study will include 30 sites across the United States and Europe, with an estimated cost of C$13 million.

Phase 2 Study of CYB004

Updates for CYB004’s Phase 2 results are expected by the end of 2024. In January 2024, the FDA cleared Cybin’s Investigational New Drug application for CYB004. The drug is being developed as a scalable intermittent treatment with a relatively short psychedelic experience, with a single intramuscular dose expected to result in acute effects lasting approximately 90 minutes.

As Cybin continues to advance its clinical programs and prepare for significant milestones, the company aims to bring innovative treatment options to market for patients with MDD and GAD, leveraging its strong financial position and strategic initiatives.