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Mydecine's Q3 Financials & Update, Sustained Target On Smoking Cessation For Next 12 Months

Benzinga · 11/15/2022 12:25

Mydecine Innovations Group (OTC:MYCOF), the psychedelics biotech company headquartered in Denver, Colorado with international offices in the Netherlands, reported its financial results and business highlights for the three and nine months ended September 30, 2022.

Mydecine held cash and cash equivalents for a total of $88,933, compared to a total of $1,495,311 on December 31, 2021.

R&D expenses for the three and nine months ended September 30, 2022, were $467,169 and $2,169,180, respectively, as compared to $560,231 and $1,882,361 in the same time periods ended September 30, 2021.

Net loss attributable to common stockholders was $11.47 million from operations (or a basic and diluted loss per share of $1.57), compared to $18.02 million (or a basic and diluted loss per share of $3.94) for the same period in 2021.

Pipeline Advances

Mydecine’s main focus is novel drug development, and its primary target indication is smoking cessation. 

This said, during the next 12 months the company intends to advance these projects through the use of AI and machine learning to design and screen potential drugs, animal studies and human trials on its under-development molecule families MYCO-004, MYCO-005 and MYCO-006, and new strategic partnerships to leverage ongoing efforts.

MYCO-004 is a family of novel psilocybin analogs; MYCO-005 is a family of novel psilocin analogs including one molecule that potentially holds heart-safe microdose enabling properties, and MYCO-006 is a family of novel, short-acting MDMA analogs specifically designed to have a shorter half-life than traditional MDMA.

Efforts towards MYCO-001 were redirected to MYCO-004. As the company disclosed, shortly after a positive pre-IND meeting with the FDA, it chose a lead psilocybin drug candidate, which received FDA approval for a National Institute on Drug Abuse (NIDA)-funded trial at Johns Hopkins University on smoking-cessation led by Drs. Matthew Johnson and Albert Garcia-Romeu

Mydecine is donating the drug product for the ongoing NIDA trial, and further plans to have the MYCO-004 (instead of the originally planned MYCO-001 trial) Phase 2 clinical study at that same institution, as part of a 5-year research collaboration agreement. 

Additionally, the company is planning to supply MYCO-001 for several studies worldwide in 2023, most noticeably at Leiden University, Macquarie University and Imperial College London.

Specifically, the location for the Phase 1 clinical trial of a psilocybin analog will be announced in late 2022 with plans to dose the first patient in the second quarter of 2023.

Photo courtesy of pdsci on Shutterstock and Wikimedia Commons.