Cybin Reports Q2 Financial Results And Latest News, Including FDA & DEA Research Approvals

Toronto-based, Cybin Inc. CYBN CYBN, a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics,” reported its unaudited financial results on Monday for the second quarter ended September 30, 2021.

Second-Quarter Financial Highlights

  • Cash and cash equivalents totaled C$75.2 million as of September 30, 2021.
  • Net loss was $17.6 million for the quarter, of which non-cash expenses totaled $6 million and cash-based operating expenses totaled $11.6 million.

Recent Business Highlights:

  • The company announced preclinical data for its novel deuterated psilocybin analog, CYB003, for the potential treatment of major depressive disorder and alcohol use disorder.
  • Cybin expects to complete the ongoing preclinical studies of CYB003 in the first quarter of 2022 and submit an investigational new drug application to the U.S. Food and Drug Administration (FDA) and a clinical trial application with the U.K. Medicines and Healthcare Products Regulatory Agency in the second quarter of 2022. The data demonstrated that CYB003 may provide significant treatment benefits to address the challenges and limitations of oral psilocybin, including:

  • Improved safety through less patient variability;

  • Reduced clinic times through faster onset of action and shorter duration of effect; and,

  • Lower dosing through improved brain penetration, which may result in fewer side effects, ultimately offering an improved patient experience.

  • The firm was granted a Schedule I manufacturing license from the U.S. Drug Enforcement Agency (DEA) that is expected to allow the Company to expand its internal research and development capabilities.

  • The company received approval from the FDA for its application to proceed with a company-sponsored feasibility study using the Kernel Flow quantitative neuroimaging technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.

  • Also, Cybin launched the EMBARK Psychedelic Facilitator Training Program in collaboration with the University of Washington in preparation for the first clinical trial of psilocybin-assisted psychotherapy to address COVID-19 related distress in frontline healthcare professionals.

“The first half of the year has been a transformative period for Cybin that included significant and swift advancements in our research and development pipeline and overall business. Through CYB003, we believe that we have identified a potentially safer treatment option for patients with depression and addiction disorders that we expect to have strong intellectual property protection and a positive pharmacokinetic profile for patients, providers, and payers,” said Doug Drysdale, CEO of Cybin.

“In addition, we continue to evolve our value-driving, patient-centered approach to potential treatments for mental health and addiction through our commitment to advancing programs such as EMBARK, as well as targeted research using the Kernel Flow neuroimaging technology that we expect will allow us to quantitively understand the psychedelic experience in the brain as it is happening."

Drysdale continued, “We believe these programs combined with our proprietary psychedelic new chemical entities have the potential to transform the treatment landscape for various psychiatric and neurological conditions.” 

Business Update

Cybin has decided not to proceed with its nutraceutical product line in order to focus its efforts on the research and development of its psychedelic molecules.

Further, Cybin no longer anticipates conducting business activities in Jamaica, as it focuses on the new Deuterated Psilocybin Analog Program.

Photo Courtesy of Cybin 


Market News and Data brought to you by Benzinga APIs
Actual EPS
EPS Surprise
Actual Rev
Rev Surprise
Posted In: EarningsNewsPenny StocksCybinDoug Drysdale
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!