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Mydecine Innovations Group (MYCOF) reported its financial results for the fiscal year ended December 31, 2021, showing a net loss of $28.9 million, a slight increase from $26.9 million the previous year. The company made significant progress in clinical trials, particularly for its MYCO-001 smoking cessation study, having received conditional IRB approval and preparing for full FDA IND application in Q2 2022. Mydecine also advanced its intellectual property portfolio with multiple new patents. As of December 31, 2021, the company had $1.5 million in cash.
Mydecine Innovations Group has received conditional approval from the Institutional Review Board (IRB) for its Phase 2b smoking cessation trial, with Johns Hopkins University as the lead site. The trial aims to evaluate MYCO-001 with hopes of submitting an Investigational New Drug (IND) application to the FDA in Q2 2022. Mydecine aims to be the first commercial IND approved for psilocybin in this indication. The total cost of smoking in the U.S. is over $300 billion annually. The trial’s primary endpoint is six months, with data expected by Q4 2023.
Mydecine Innovations Group (NEO: MYCO, OTC: MYCOF) is a biotechnology firm focused on mental health and addiction treatment. On March 3, 2022, the company announced its participation in three upcoming investor conferences: the 34th Annual Roth Conference (March 13-15), the Oppenheimer Annual Healthcare Conference (March 15-16), and the Maxim Group Virtual Growth Conference (March 28-30). Meetings will discuss the company's clinical trials, patent strategies, and research pipeline. Mydecine is leading a sponsored trial assessing psilocybin for nicotine addiction.
Mydecine Innovations Group (NEO: MYCO) announced a successful meeting with the FDA on February 28, 2022, regarding its Investigational New Drug (IND) and Breakthrough Therapy applications for MYCO-001, aimed at smoking cessation. The drug has shown efficacy rates 2-3 times higher than existing treatments, according to ongoing studies at Johns Hopkins University. The company is preparing its IND submission for the 2B study, expected to launch in March 2022, while Dr. Matthew Johnson will lead the multi-site study.
Mydecine Innovations Group announced positive clinical data for its patent-pending microdose compound, MYCO-005, aimed at addressing cardiovascular risks associated with psilocin analogs. The novel molecule exhibits heart-safe microdosing properties, with research suggesting it binds effectively to the 5-HT2A receptor while avoiding binding to the 5-HT2B receptor, thus reducing cardiac risks. The patent-pending formulation seeks to improve delivery and stability, potentially offering a safer alternative for treating mental health disorders. Mydecine aims to advance its innovative drug discovery pipeline.
Mydecine Innovations Group has received approval from Health Canada to supply cGMP psilocybin and MDMA to healthcare providers under the Special Access Program. This license allows practitioners to request these substances for patients with serious conditions who have not responded to conventional treatments. The company partnered with Applied Pharmaceutical Innovation to establish a manufacturing facility in Edmonton, enhancing its R&D capabilities. Mydecine also launched a Special Access Support and Supply Program to ensure safe therapy outcomes for patients in Canada.
Mydecine Innovations Group has appointed Dr. Victoria Hale to its Board of Directors, enhancing its leadership in the mental health and psychedelic therapy sectors. Dr. Hale brings extensive experience from her role as Chair of MAPS and a solid background in drug development, having raised $230 million for health initiatives. She aims to address the global mental health crisis through innovative therapeutic solutions. The appointment is seen as a strategic move for the company's future growth and underscores its commitment to improving public health outcomes.
Mydecine Innovations Group (NEO: MYCO) has submitted a pre-Investigational New Drug (IND) briefing package to the FDA for MYCO-001, aimed at smoking cessation therapy. This clinical study, led by Dr. Matthew Johnson of Johns Hopkins University, will evaluate the safety and efficacy of psilocybin-assisted psychotherapy in treating tobacco addiction. The Phase 2/3 trial is set to launch in Q2 2022, with a planned operationally seamless design to optimize resource use. Tobacco addiction remains largely untreated, highlighting the need for innovative therapy options amid safety concerns over existing treatments.
Mydecine Innovations Group has announced a partnership with Combat Stress and King's College London to further clinical trials involving MYCO-001, aimed at treating PTSD in veterans. This collaboration will explore the use of psilocybin in psychoactive-assisted psychotherapy for veterans suffering from severe PTSD resistant to conventional treatments. Professor Dominic Murphy will lead the study, which addresses a significant unmet need in mental health treatment. The partnership highlights Mydecine's commitment to developing novel therapies for mental health disorders, particularly among veterans.
Mydecine Innovations Group has established a partnership with The Newly Institute to advance psychedelic-assisted psychotherapy in Canada. Under the Special Access Support and Supply Program, Mydecine will supply cGMP psilocybin and MDMA to The Newly, which is opening mental health clinics across Canada. They aim to develop therapy protocols and manuals to enhance patient care. Both companies will collaborate on evidence-based treatments targeting mental health issues, with a revenue sharing model in place to support their efforts.