Debra BorchardtFollowing a reverse share split, Cybin Inc. (NYSE American: CYBN) updated investors on the company’s pipeline.
Share consolidation
On Thursday, Cybin completed its share consolidation to reduce the number of outstanding shares and drive the value per share higher. Shareholders had approved a consolidation as high as one share for every 50 shares, but ultimately it became a one to 38 ratio. As a result of the consolidation, the 759,692,495 shares issued and outstanding before the move have been reduced to approximately 19,991,907 shares.
Missed start date
Cybin also teased investors that its CBY003 Phase 3 study would begin imminently, but did not give a date. Cybin has said previously that the study for the drug would start in late summer 2024, but seeing that the end of September is in sight, that goal was missed. In August, when Green Market Report covered the company’s second-quarter earnings, Cybin said that the clinical site selection had been completed for the Phase 3 study, and the company said it was on track to begin enrolling patients soon.
Cybin told investors in August that it expected to spend approximately $13 million to initiate the Phase 3 study of CYB003 in MDD in the summer of 2024, of which approximately $2.3 million was spent during that quarter. Roughly $2.9 million was spent during the twelve months ending March 31, 2024, resulting in an approximate remaining spend of $7.9 million.
The company said it held a productive Type B Initial Breakthrough Therapy Meeting in August with the U.S. Food and Drug Administration (FDA) in preparation for the start of its CYB003 pivotal program in MDD. The company statement said, “For the upcoming Phase 3 study, Cybin has selected 30 high-quality clinical sites across the United States and Europe. The Phase 3 pivotal trial design incorporates several elements to address critical methodological issues such as functional unblinding that are considered important for drugs in this class.”
However, beyond the site selection, no patients have been enrolled yet.
Cybin also noted that results from a completed Phase 2 MDD study of CYB003 had shown rapid, improvements in symptoms of depression with a single dose, and durable effects four months after two doses with a 75% remission rate in the 16mg dose group. “The Company expects to report 12-month Phase 2 efficacy data in early Q4 2024, providing further insights into CYB003’s potential to provide long-lasting relief for MDD patients,” read the statement.
