The article 2022 End of Year Review: Cybin was originally published on Microdose.

The end of the year is a convenient time to look back and take stock on the progress of both the industry and individual companies.

We’ll start with Cybin, who’ve moved their lead candidate CYB003 from preclinical to the clinical trials in just over a year, a quick move forward from their announcement just over a year ago at Wonderland.

Below you’ll find Cybin’s 2022 review. For more on Cybin’s work this past year, see Cybin’s most recent financial results, Cybin Doses First Patients in Phase 1/2a Depression trial, and Cybin Buys License to Mindset Pharma’s Psychedelic Compounds.

• Transitioned CYB003 from preclinical stage to a first-in-human trial, marking the first novel deuterated psilocybin analog to ever enter clinical development.
• Accelerated the development of CYB004 with the strategic acquisition of a Phase I DMT study (CYB004-E).
• Strengthened the Company’s IP through the strategic acquisition of an exclusive license to a targeted catalog of psychedelic-based compounds from Mindset Pharma Inc.
• Continued to grow its IP portfolio to support current and planned preclinical studies and future development programs.
• Initiated and expanded a psychological support training program for psychedelic-based treatments
• Awarded Psilocybin Company of the Year
• Launched a US$35 million At-The-Market equity program

Cybin Highlights 2022 Accomplishments and Milestones

– Strategic initiatives and pipeline advancements support clinical development of CYB003 and CYB004 exploring potential therapeutic benefits using psychedelic-based molecules –

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American: CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics®, is pleased to provide a year-end summary of its key milestone accomplishments in 2022.

“2022 was a momentous year marked by steady progress across our pipeline of differentiated psychedelic-based therapeutics and partnerships targeting mental health. Most notable were the advancements of our two lead programs, CYB003 and CYB004, into clinical stage – within less than 18 months since discovery – which is a remarkable accomplishment, and a true testament to the strength of our team,” said Doug Drysdale, Cybin’s Chief Executive Officer. “Along with our clinical programs, we have continued to execute on strategic opportunities to strengthen our intellectual property and generate value creation through the expansion of our preclinical drug discovery platform. Heading into 2023, we remain committed to leading the development of our innovative investigational therapies to address significant unmet needs for people with mental health conditions and delivering on key 2023 data catalysts, including top-line data from our ongoing CYB003 and CYB004 trials.”

2022 Highlights:

Transitioned CYB003 from preclinical stage to a first-in-human trial, marking the first novel deuterated psilocybin analog to ever enter clinical development. CYB003, the Company’s proprietary deuterated psilocybin analog, has demonstrated several key advantages over oral psilocybin in preclinical studies, including faster onset of action, shorter duration of effect, and less variability in plasma levels. CYB003’s therapeutic profile as a differentiated treatment for major depressive disorder was highlighted in poster presentations at multiple scientific conferences in 2022. The Company expects to provide an interim safety and pharmacokinetic readout from the Phase 1/2a trial in early 2023.

Accelerated the development of CYB004 with the strategic acquisition of a Phase I DMT study (CYB004-E). The CYB004-E studyevaluating IV N,N-dimethyltryptamine (“DMT”)is expected to yield essential safety and dosing optimization data that will inform further clinical advancement of CYB004 (deuterated DMT) for the treatment of anxiety disorders. To date, the trial has completed dosing of four out of five cohorts with no clinically significant safety or tolerability issues. During the year, Cybin secured intellectual property (“IP”) protection for CYB004, including a U.S. patent covering CYB004 composition of matter and filed patent applications for inhalation delivery of multiple psychedelic molecules, including CYB004. In April 2022, the Company announced positive preclinical data demonstrating the significant advantages of CYB004 over intravenous and inhaled DMT, including rapid onset and longer duration of action. Cybin expects to provide an update on the Phase 1 CYB004-E study in the first quarter of 2023.

Strengthened the Company’s IP through the strategic acquisition of an exclusive license to a targeted catalog of psychedelic-based compounds from Mindset Pharma Inc. The exclusive license provides Cybin with access to an expansive number of preclinical molecules that complement the Company’s R&D strategy and current preclinical library and also serves to expand the Company’s discovery and development platform.

Continued to grow its IP portfolio to support current and planned preclinical studies and future development programs. Over the course of 2022, Cybin continued to strengthen its intellectual property portfolio that now includes access to over 35 patents and applications across 6 patent families through internal filings and licensing arrangements.

Initiated and expanded a psychological support training program for psychedelic-based treatments utilizing EMBARK, a leading-edge model of psychedelic-assisted psychotherapy co-developed by Dr. Alex Belser, Cybin’s Chief Clinical Officer. The EMBARK model is currently being implemented in two clinical-stage trials, including Cybin’s Phase 1/2a trial evaluating the Company’s investigational deuterated psilocybin analog, CYB003.

Awarded Psilocybin Company of the Year at the Second Annual Microdose Awards,recognizing Cybin’s leadership in innovating psilocybin-based therapeutics and commitment to improving the lives of patients.The award marks the second year in a row Cybin was awarded a Microdose Award as voted on by the psychedelic industry.

Launched a US$35 million At-The-Market equity program to support the Company’s ongoing operations and future pipeline growth and strategic opportunities.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

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