Mydecine Innovations Group Inc (OTC:MYCOF, NEO:MYCO) has concluded what it said was an “extremely productive” first quarter as it worked diligently to decrease expenses, increase efficiencies and set the company up for future success.
Releasing results for the three months to March 31, 2022, the Denver-based biotech company said total expenses reduced to $4.74 million compared to $5 million a year earlier. It ended the quarter with cash and cash equivalents of $264,679, before raising an additional $1.65 million in financing post-quarter-end.
“On the heels of Mydecine's positive pre-Investigational New Drug Application (IND) meeting with the FDA and a conditional Institutional Review Board (IRB) approval, we are excited, and working towards submitting our full IND and breakthrough therapy applications for our previously announced Phase 2b MYCO-001 Smoking Cessation Study in the near term,” CEO Josh Bartch said in a statement. “Lastly, Mydecine's science team has been making headway on our second-generation New Chemical Entities (NCEs) which we hope will lead to increased accessibility by better meeting the needs of our existing healthcare infrastructure."
READ: Mydecine ends FY2021 with C$1.5M in cash to help propel mental health treatment initiatives in 2022
Business highlights during and subsequent to 1Q 2022:
- Clinical Research
- Submitted pre-IND briefing package for the previously announced multi-site MYCO-001 Phase 2b Smoking Cessation Study and had a positive pre-IND meeting with FDA; and
- Received conditional IRB approval for multi-site MYCO-001 Phase 2b Smoking Cessation Study.
- Drug Development
- Announced MYCO-005 family of improved safety microdose novel molecules which the company hopes will lead to improved safety;
- Collected positive nonclinical data for multiple NCEs which indicate potential enhanced safety, efficacy, stability, dosing and reduced side effects; and
- Completed multiple serotonin receptor models for the company's artificial intelligence drug development program enabling quick screening of billions of compounds.
- Corporate
- Welcomed pharmaceutical scientist and executive and global health social entrepreneur Dr Victoria Hale to Mydecine's board of directors;
- Announced plan to launch Special Access Support and Supply Program in Canada in order to work toward expanding access to psychedelic-assisted psychotherapy for patients;
- Identified as licensed psilocybin supplier in Canada through Mydecine's exclusive partnership with Applied Pharmaceutical Innovation to provide drug substance for patients in need; and
- Signed LOI with The Newly Institute to provide psychedelic-assisted psychotherapy to patients under Health Canada's Special Access Program.
Mydecine reminded investors that it completed a 1:50 reverse stock split whereby shareholders received one post-consolidation common share for every fifty pre-consolidation common shares held. The post-consolidation shares began trading on April 21, 2022.
Earnings per share in its 1Q financial statements, and other disclosures, include the effects of the consolidation, it added.
For the three months to 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 1Q 2021.
Mydecine is a biotechnology company developing innovative first- and second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure.
Contact the author at stephen.gunnion@proactiveinvestors.com