Mydecine Innovations Group Inc (OTC: MYCOF, NEO: MYCO) concluded what it called an “extremely productive” first quarter as it worked diligently to reduce expenses, increase efficiency and prepare the business for the future success.
Reporting its results for the three months to March 31, 2022, the Denver-based biotech company said its total expenses had been reduced to $4.74 million from $5 million a year earlier. It ended the quarter with cash and cash equivalents of $264,679, before raising additional funding of $1.65 million after the end of the quarter.
“On the heels of Mydecine’s positive pre-Investigational New Drug Application (IND) meeting with the FDA and a conditional approval from the Institutional Review Board (IRB), we are excited and are working towards submitting our full applications. of IND and breakthrough therapy for our previously announced short-term Phase 2b MYCO-001 Smoking Cessation Study,” CEO Josh Bartch said in a statement. “Finally, the Mydecine science team has made progress on our new second-generation chemical entities (NCEs) that we hope will lead to increased accessibility by better meeting the needs of our existing healthcare infrastructure.”
READ: Mydecine ends fiscal 2021 with C$1.5 million in cash to help propel mental health treatment initiatives into 2022
Highlights of activity during and after Q1 2022:
- Clinical research
- Submission of a pre-IND information package for the previously announced multi-site Phase 2b smoking cessation study MYCO-001 and successful meeting with the FDA prior to the IND; and
- Received conditional approval from the IRB for the multi-site MYCO-001 Phase 2b smoking cessation study.
- Drug development
- Announcement of the MYCO-005 family of new microdosed molecules with improved safety which it hopes will lead to better safety;
- Collection of positive non-clinical data for several NCEs that indicate potential improvement in safety, efficacy, stability, dosage and reduced side effects; and
- Completed several serotonin receptor models for the company’s artificial intelligence drug development program enabling rapid screening of billions of compounds.
- Welcomed Dr. Victoria Hale, pharmaceutical scientist and global health executive and social entrepreneur, to the Mydecine Board;
- Announcing a plan to launch a Special Access Supply and Support Program in Canada to work to expand access to psychedelic-assisted psychotherapy for patients;
- Identified as an authorized provider of psilocybin in Canada through Mydecine’s exclusive partnership with Applied Pharmaceutical Innovation to provide drug substance to patients in need; and
- Signed a letter of intent with The Newly Institute to provide psychedelic-assisted psychotherapy to patients under Health Canada’s Special Access Program.
Mydecine reminded investors that it had completed a 1:50 reverse stock split whereby shareholders received one post-consolidation ordinary share for every fifty ordinary shares held before the consolidation. The post-consolidation shares began trading on April 21, 2022.
Earnings per share in its first-quarter financial statements and other information include the effects of consolidation, he added.
For the three months through March 31, 2022, the company reported a net loss of $5.6 million, or $1.20 per share, compared to a net loss of $5.2 million, or $1.26 $ per share, for Q1 2021.
Mydecine is a biotechnology company that develops new, innovative first- and second-generation therapies for the treatment of mental health and addiction using world-class technology and drug development infrastructure.
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