March Company Update

March 7, 2022

Posted By: Morgan Kervitsky

Dear friends, Colleagues and Shareholders,

Mydecine has made strides towards our goals over the last few months! We continue to gain momentum as we reach significant milestones in our clinical trial programs and advance our drug development pipeline.

Positive Pre-IND Meeting With FDA For MYCO-001 Smoking Cessation Study

We’re pleased to share our meeting with the FDA, regarding our Investigational New Drug (IND) application, was incredibly positive. The team is preparing our IND application to administer MYCO-001, in combination with therapy, for those seeking smoking cessation treatment. Johns Hopkins University will serve as the lead investigator for this multi-site study.

Along with our IND application, we plan to submit a request for Breakthrough Therapy designation. A drug that receives breakthrough therapy designation can lead to accelerated approval, which helps companies get new, improved medicines to practitioners and patients sooner.

We plan to submit both applications within the next 60 days. Patient recruitment will begin promptly after the study has been cleared.

Full Release Here

New Drug Development Video

Last month, we published a new video on our YouTube channel explaining the strategy and latest enhancements behind our drug development program. We believe our second-generation products will offer a more refined, more scalable line of psychedelic-based medicine that better meets the needs of patients and physicians.

Watch Video Here

MYCO-005: A Family of Novel Molecules With Improved Safety

Our recent provisional patent application covers our family of MYCO-005 molecules. These molecules include enhancements we believe are critical for psychedelic medicine to become accepted and adopted into traditional medical settings. These improvements include safety, delivery, stability and reduced side effects.

MYCO-005 includes a novel psilocin analog that could potentially be considered a heart-safe microdose drug by eliminating a possible known risk factor. Although microdosing has been gaining popularity in mainstream media as a possible treatment for indications such as ADHD, depression and anxiety, more research is needed to confirm the safety and efficacy of this method. We believe our MYCO-005 family of molecules are safer than what’s currently available.

Full Release Here

New Partnership with Combat Stress to Treat PTSD in Veterans

We are excited to partner with Combat Stress to use psilocybin as part of a psychedelic-assisted psychotherapy treatment for post-traumatic stress disorder (PTSD) in veterans.

Combat Stress, a leading U.K. charity for veterans, will be one of several sites for Mydecine’s upcoming clinical trials. Our lead psilocybin drug candidate, MYCO-001, will be evaluated as an adjunct to psychotherapy to treat severe PTSD in veterans who have failed to respond to traditional therapies.

Full Release Here

Dr. Victoria Hale Is Our Newest Independent Board Member

Our Board of Directors further strengthens with the addition of Dr. Victoria Hale. Dr. Hale is a pharmaceutical scientist and executive, as well as a global health social entrepreneur.

She brings valuable experience in drug development and psychedelic medicine, and currently is chair of the board of the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit research and educational organization that raises awareness of psychedelics.

Full Release Here

This month’s recap highlights so many keys to our overall success - an experienced team, a robust drug development process and a solid clinical trial strategy. With momentum on many fronts, we look forward to sharing more exciting milestones soon.

Sincerely,

Mydecine Management