Groundbreaking Progress in Clinical Trial and Drug Discovery Programs
Enhanced Technology Offering with Mindleap 2.0, its Digital Health Platform to Support the Adoption of Psychedelics into Mental Health and Inner Wellness
DENVER, Aug. 16, 2021 (GLOBE NEWSWIRE) -- Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, today reported its financial results for the second quarter ended June 30, 2021 and provided a business update.
“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.
“We have also significantly leveraged our partnerships with research institutions to drive the evolution of the drug discovery process and partnered with the University of Alberta to initiate a next-generation AI-assisted drug discovery program. We are focused on expanding into more technological end-to-end treatments and launched Mindleap 2.0 in July to support the widespread adoption and normalization of psychedelic-based integration with mental health. Our recent milestones exhibit revolutionary potential with layering applications of first and second-generation therapeutics,” concluded Mr. Bartch.
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.
About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms.
At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.
For more information, please contact:
Anne Donohoe / Nick Opich
KCSA Strategic Communications
1-212-896-1265 / 1-212-896-1206
Charles Lee, Investor Relations
Allison Soss / Erika Kay
KCSA Strategic Communications
On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.
This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company's ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company's products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.