Clinical-stage biotech Cybin Inc. (NYSE: CYBN) reported a net loss of $10.5 million for its fiscal third quarter ending Dec. 31, but highlighted progress in its lead drug development programs targeting major depressive disorder and anxiety.
The quarterly loss narrowed significantly from $30.3 million in the same period last year. Research expenses rose to $18.8 million from $7.4 million a year ago as the company advanced multiple clinical trials.
Cybin ended the quarter with $136.3 million in cash, positioning it to fund planned clinical studies through key milestones in 2025, the company said.
The biotech firm is developing CYB003, a proprietary deuterated psilocin compound that recently received Breakthrough Therapy Designation from the FDA for treating major depressive disorder. The company has initiated PARADIGM, a Phase 3 program that will evaluate CYB003 across approximately 550 patients at over 40 clinical sites in the U.S. and Europe.
“With the initiation of PARADIGM, our multinational pivotal Phase 3 program evaluating CYB003 for the adjunctive treatment of MDD, we look forward to a rigorous investigation and to confirming the data from our Phase 2 study in a larger patient population,” said Doug Drysdale, CEO of Cybin, in a statement.
Earlier clinical data showed promising results, with 100% of participants receiving two doses responding to treatment and 71% achieving remission at six months, according to the firm.
The company is also advancing CYB004, a deuterated DMT compound, in a Phase 2 study for generalized anxiety disorder. Topline safety and efficacy data from that trial is expected in the first half of 2025.
During the quarter, operating expenses totaled $31.3 million versus $27 million in the prior year period. The increase reflected higher research costs partially offset by lower G&A expenses.
Cybin plans to initiate additional Phase 3 studies of CYB003 around mid-2025, including EMBRACE, a second pivotal trial, and EXTEND, a long-term extension study.
The company also announced the launch of a new $100 million at-the-market equity program through Cantor Fitzgerald to help fund ongoing clinical development.
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