Mydecine Innovations Group ended its third quarter of 2021 with $1.6 million in cash as it continues to progress its lead drug candidate, MYCO-001, with the upcoming seamless Phase2/3 smoking cessation clinical trial.
The Denver-based biotech company said it is preparing to supply its drug MYCO-001 for a Johns Hopkins University multi-side National Institute of Drug Abuse (NIDA)-funded smoking cessation study led by Matthews Johnson.
It’s the first time that a federal drug research agency has funded a psilocybin smoking cessation study since the War on Drugs was declared in the 1970s.
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“During the third quarter of 2021, we entered into a five-year research agreement with Johns Hopkins University School of Medicine, one of the most experienced university departments in conducting clinical research related to the therapeutic use of psychedelics. In collaboration with JHU, we are rapidly progressing one of our lead candidates, MYCO-001, through clinical trials with the upcoming seamless Phase 2/3 smoking cessation clinical trial, and their NIDA grant-funded smoking cessation study which will use MYCO-001,” said Joshua Bartch, CEO of Mydecine.
He added: “This marks the first time in over 50 years that the U.S government has funded a study of a psychedelic compound for therapeutics.”
The NIDA allotted $4 million for the three-year project, 5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder.
Bartch said that as the biotech firm prepares for the launch of these trials, “we expect to meet with the FDA for Pre-Investigational New Drug Application (Pre-IND) meetings in early 2022, another step closer to bringing to market more effective treatments for today’s unmet needs in mental health and addiction.”
The company also filed a patent application for MYCO-003 with the United States Patent and Trademark Office (USPTO) and the World Intellectual Property Organization, which is being developed to offer enhanced treatment of anxiety and PTSD.
Another new patent for MDMA-like compounds was filed to further expand the company’s robust portfolio of novel compounds after MDMA-assisted psychotherapy received Breakthrough Therapy Designation from the Food and Drug Administration (FDA).
For the period ended September 30, 2021, Mydecine significantly narrowed its net loss to $4.5 million, or a basic and diluted loss per share of $0.02, compared to a net loss of $17.4 million, or a basic and diluted loss per share of $0.11 for 3Q 2020.
Mydecine is developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and therapeutic treatment environments.
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