Cybin Inches Closer to FDA Submission, Increases Losses in Q1

Toronto-based Cybin Inc. (NYSE: CYBN) (NEO: CYBN) increased its losses for its first fiscal quarter of 2023 to C$14.5 million, up from C$13.1 million a year prior, but company leadership remained bullish that it’s on the right path to gain federal approval in the U.S. for its psychedelic mental health treatments.

Cybin continued investing in research, development, and clinical studies of synthetic psychedelics designed to combat depression and anxiety, including variations of psilocybin and dimethyltryptamine (DMT). Cybin anticipates delivering data on its synthetic version of psilocybin, CYB003, to the U.S. Food and Drug Administration for consideration in the fourth quarter of 2023.

The company also closed an $8.25 million marketed public offering in Q1 to help fund further R&D.

While Cybin’s operating expenses for the quarter hit C$12.7 million, its cash flows were just C$3.5 million, an imbalance that’s unlikely to be resolved until the company can bring at least one new drug to market.

On that front, Cybin this past quarter:

• Launched clinical dosing for CYB003, its synthetic psilocybin, in its sixth batch of patient testing of up to 12 milligrams, which thus far has “shown to have a favorable safety and tolerability profile” with “no serious adverse events.”
• Continued with phase 1 of clinical trials for Cybin’s DMT substitute, CYB004, which is aimed at treating general anxiety disorder. So far, the drug has been found to deliver a psychedelic high within 2 minutes that peaks after 12 minutes, which Cybin is trying to extend to 45-60 minutes. Initial results are expected later this year.
• Announced a new partnership with Worldwide Clinical Trials to further support its psychedelic trials and studies.
• Launched a new psychedelic training program called Embark for health care professionals interested in conducting larger-scale psychedelic studies. So far about 1,500 individuals have registered.

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