Cybin reports Q2 net loss C$15M vs. C$15M last year

Reports cash totaled C$183M as of June 30, 2024. .”During the recent quarter we continued to move quickly, having achieved meaningful progress on the development of our two lead product candidates: CYB003, our proprietary deuterated psilocybin analog program in development for the adjunctive treatment of Major Depressive Disorder, and CYB004, our proprietary deuterated dimethyltryptamine program in development for the treatment of Generalized Anxiety Disorder. The path towards approval and commercialization for our novel therapeutics is coming into focus as we work efficiently to provide improved outcomes for patients and their families,” said Doug Drysdale, Chief Executive Officer of Cybin. “To spearhead these programs through the next phases of development, we have hired two talented and experienced drug development experts: Dr. Atul R. Mahableshwarkar, and Dr. Tom Macek, to lead the CYB003 and CYB004 programs, respectively. Both bring in-depth expertise, and we welcome their guidance as we advance toward regulatory approval.” “Importantly, CYB003, which is in development for the possible adjunctive treatment of MDD, has received U.S. Food and Drug Administration Breakthrough Therapy Designation. To date, CYB003 has demonstrated a robust, sustained benefit, with 75% of patients in the Phase 2 study in remission from depression four months after two doses (16mg). We expect to report 12-month efficacy data from our Phase 2 study this fall, providing further insights into the long-term efficacy of CYB003 in MDD. We also look forward to commencing our Phase 3 pivotal trial for CYB003 shortly. Concurrently, we are progressing our Phase 2 study of CYB004, in development for the treatment of GAD, where dosing is underway, and expect to share topline safety and efficacy data around year-end, or early Q1 2025. With our two lead programs, we are excited by the prospect of unlocking innovative mental health treatment options that are effective and patient-friendly as we continue our evolution into a late-stage clinical development company,” concluded Drysdale.