“Mydecine has continued to make groundbreaking progress and novel discoveries in its psilocybin compound research and psychedelic-assisted drug development in the second quarter of 2021. We identified our four novel lead drug candidates in preparation for Pre-Investigational New Drug Application (Pre-IND) meetings with the U.S. Food and Drug Administration (FDA) and Health Canada. As well as discovering over 40 potential pharmacologically active novel compounds in mushrooms, demonstrating the continued success of our integrated research and cultivation facilities as we build today’s most advanced and extensive portfolio of psychedelic-assisted therapeutics,” stated Joshua Bartch, CEO of Mydecine.
Business Highlights During and Subsequent to the Second Quarter 2021
Groundbreaking Progress in Clinical Trials and Research
Identified its four lead novel drug candidates that are unique and patentable in advance of upcoming pre-IND meetings with the FDA and Health Canada to prepare for human clinical trials.
Discovered over 40 compounds with pharmacological potential in mushrooms, increasing the ability to discover new compounds and test for efficacy and manufacturing for clinical research.
Selected substance use disorder and smoking cessation as the initial target indications for its psychedelic molecule MYCO-004.
Unique Partner Relationships
Established partnership with LeadGen Labs to support its novel psychedelic drug development efforts and target novel molecular entities and enhanced formulations, including effective dosages and safety.
Launched its in-silico drug discovery program in conjunction with researchers at the University of Alberta to develop artificial intelligence/machine learning (AI/ML) supported drug screenings, including both the ability to build drugs from the receptor up and assess drugs around the receptors.
Strengthened Licensing Rights and IP Portfolio
Received Health Canada approval to expand its cultivation capabilities for psilocybin producing mushrooms at its current good manufacturing practice (cGMP) facility, the Applied Pharmaceutical Innovation in Canada.
Filed a new patent for MDMA-like compounds further expanding its drug development program to include the improvement of entactogenic compounds.
Enhanced Technology Platform
Launched Mindleap 2.0 version of Mindleap Health’s virtual health platform to provide the infrastructure to support the conscious and trustworthy adoption of psychedelics into the broader categories of mental health and inner wellness.
Financial Results for the Second Quarter 2021
Net Loss: Net loss attributable to common stockholders was $3.8 million for the second quarter 2021, or a basic and diluted loss per share attributable to common stockholders of $0.02, as compared to a net loss attributable to common stockholders of $4.6 million for the second quarter 2020, or a basic and diluted loss per share attributable to common stockholders of $0.05.
Cash Position: As of June 30, 2021, the Company had cash and cash equivalents of $7.0 million.