The clinical-stage biotech Cybin Inc. reported a loss of $10,5 million in the third fiscal quarter that ended Dec. 31. However, it highlighted its progress on its drug development programs aimed at major depression disorder and anxiety.
The quarter’s loss was down from $30.3m in the previous year. As the company progressed multiple clinical studies, research costs rose from $7.4 to $18.8 millions.
Cybin reported that the company ended its quarter with $136.3 Million in cash. This will allow it to continue funding clinical studies until 2025.
Biotech firm CYB003 develops CYB003, a proprietary psilocin deuterated compound, that has recently been granted Breakthrough Therapy Designation (BTD) by FDA in the treatment of major depressive disorders. PARADIGM will be a Phase 3, a program which evaluates CYB003 on approximately 550 patients in over 40 clinical locations across North America and Europe.
In a press release, Doug Drysdale CEO of Cybin said: “With the initiation PARADIGM our multinational pivotal phase 3 program evaluating CYB003 as an adjunctive treatment for MDD, We look forward to a thorough investigation and confirm the data of our Phase 2 trial in a large patient population.”
According to the company, earlier clinical results showed encouraging results. 100% of those who received two doses responded to treatment, and 71% achieved remission after six months.
The company has also advanced CYB004, a DMT deuterated compound, through a Phase 2-study for the treatment of generalized anxiety disorder. The topline data on safety and efficacy from this trial are expected to be available in the first quarter of 2025.
Operating expenses for the third quarter totaled 31.3 million dollars, compared to $27 million during the same period last year. The increase reflected higher research costs partially offset by lower G&A expenses.
Cybin will begin Phase 3 studies on CYB003 in mid-2025. This includes EMBRACE which is a pivotal second trial and EXTEND which is a long term extension study.
Cantor-Fitzgerald announced a $100-million equity program to fund clinical research.