(CYBN) – Cybin releases second quarter financial results and latest news, including FDA and DEA research approvals

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Based in Toronto, Cybin Inc. (NEO: CYBN) (NYSE: CYBN), a biopharmaceutical company focused on advancing “psychedelics into therapeutics,” on Monday announced its unaudited financial results for the second quarter ended September 30, 2021.

Second Quarter Financial Highlights

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

Recent business highlights:

  • The company announced preclinical data for its new deuterated psilocybin analogue, CYB003, for the potential treatment of major depressive disorder and alcohol use disorder.
  • Cybin plans to complete ongoing preclinical studies of CYB003 in the first quarter of 2022 and submit an investigational new drug application to the United States Food and Drug Administration (FDA) and a clinical trial application with the UK Agency. regulation of drugs and health products during the second. quarter 2022. Data demonstrated that CYB003 may provide significant therapeutic benefits to address the challenges and limitations of oral psilocybin, comprising:

  • Improved safety thanks to less patient variability;

  • Reduced intervention times thanks to a faster onset of action and a shorter duration of effect; and,

  • Lower dosage due to better penetration into the brain, which can lead to fewer side effects, ultimately providing a better patient experience.

  • The company has obtained a Schedule I manufacturing license from the US Drug Enforcement Agency (DEA) which is expected to allow the company to expand its in-house research and development capabilities.

  • The company received approval from the FDA for its request to conduct a feasibility study sponsored by the company using the Core flow quantitative neuroimaging technology to measure the psychedelic effect of ketamine on hemodynamics of the cerebral cortex.

  • Additionally, Cybin launched the EMBARK Psychedelic Facilitator Training Program in collaboration with the Washington University in preparation for the first clinical trial of psilocybin-assisted psychotherapy to treat COVID-19 Distress Among Frontline Health Care Professionals.

“The first half of the year has been a time of transformation for Cybin which has included significant and rapid advancements in our research and development pipeline and across all of our businesses. With CYB003, we believe we have identified a potentially safer treatment option for patients with depression and substance abuse 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 patient-centered, value-focused approach to potential mental health and addiction treatments through our commitment to advancing programs such as EMBARK, as well as targeted research. using Kernel Flow neuroimaging technology which we believe allow us to quantitatively understand the psychedelic experience in the brain as it occurs. “

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

Commercial update

Cybin decided not to pursue his range of nutraceuticals in order to concentrate its efforts on the research and development of its psychedelic molecules.

Additionally, Cybin no longer plans to conduct business in Jamaica as she focuses on the new deuterated psilocybin analog program.

Photo courtesy of Cybin

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