Debra BorchardtCybin Inc. (NYSE American: CYBN) (Cboe CA: CYBN) reported unaudited financial results for its first quarter ended June 30, 2024, with no revenue to report at this time as the company develops its drug portfolio.
The company reported a net loss of C$15 million for the quarter, the same as last year. Operating expenses rose to C$16 million versus last year’s expense of C$11 million.
Cybin looks to be in a good position with cash of C$183 million at the end of the quarter. Cash flows used in operating activities were C$27 million versus last year’s C$11 million. The company noted that with the previously announced public offerings of units and a combination of its current cash position, and assuming the exercise in full of the warrants issued as part of the units, the company has access to over C$247 million.
“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.
More to come in 2024
Cybin reported that it is close to initiating its Phase 3 multinational study for the CYB003 program in the late summer of 2024. The Phase 3 MDD study will include thirty sites in the United States and Europe. Clinical site selection has been completed for the Phase 3 study, and the company said it is on track to begin enrolling patients soon. The 12-month efficacy data from the Phase 2 MDD study is expected in the fourth quarter of 2024.
Drysdale added, “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.”
Cybin told investors it expects to spend approximately $13 million to initiate a Phase 3 study of CYB003 in MDD in summer 2024, of which approximately $2.3 million was spent during the quarter and roughly $2.9 million was spent during the twelve months ending March 31, 2024, resulting in an approximate remaining spend of $7.9 million.
Concerning CYB004, dosing is underway and topline safety and efficacy readout from the Phase 2 GAD study is expected around the end of 2024, or early 2025. CYB004 is being developed as a novel intramuscular formulation that is expected to deliver an experience lasting approximately 90 minutes.
On July 23, 2024, the company was granted US patent no. 12,042,564, providing additional patent protection for the CYB004 program.
“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.
