Cybin Inc. (NYSE-A:CYBN, NEO:CYBN) reported that it has narrowed its net loss year-over-year as it has advanced its two lead clinical programs CYB003 and CYB004 during the 2023 fiscal year.
For the fiscal year ended on March 31, 2023, the psychedelics-focused clinical-stage biopharmaceutical company posted a net loss of C$47.5 million, down from C$67.6 million in the previous fiscal year.
For the fourth quarter ended in March, its net loss was C$13.7 million compared to a net loss of C$18.1 in the year-ago quarter.
The company exited fiscal 2023 with C$16.6 million in cash.
It noted that under its US$35 million ATM equity program, the company could issue and sell up to US$22 million in shares to gain access to additional cash for growth opportunities and working capital purposes.
Along with its 4Q and full-year fiscal 2023 results, Cybin provided an update on its two lead clinical programs, CYB003, a deuterated psilocybin analog targeting major depressive disorder, and CYB004, a deuterated DMT analog for generalized anxiety disorder.
“We expect to share topline results later this year, with the potential to submit CYB003 Phase 1/2a data to the Food and Drug Administration (FDA) in the fourth calendar quarter of 2023 for an end of Phase 2 meeting,” Cybin CEO Doug Drysdale said.
He also noted that the company was encouraged by the recently announced draft FDA guidelines for psychedelic clinical trials which he said signalled the agency's commitment to a clear regulatory pathway for psychedelic drug development.
“Importantly, these guidelines also help remove regulatory uncertainty for investors and clinical trial sponsors,” Drysdale said in a statement.
“With these catalysts in our sights, we believe that we are moving ever closer to our goal of developing treatment options, as demonstrated in our Phase 1 and Phase 2 studies to date.”
Cybin’s US-listed shares were trading up 1.3% at US$0.33 shortly after the market opened on Thursday morning.
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