MYCOF Profile

OUR NEW PROFILE IS:   MYCOF

(NEO:MYCO)🇨🇦                  (FSE:0NFA)🇬🇧

Psychedelic Drugs Are Moving From The Fringes Of Medicine To The Mainstream

The company signed a five-year research agreement with Johns Hopkins University (JHU) School of Medicine

33,000+ telehealth platform downloads

Multiple patents

Conducting a US Gov. backed study

CHECK OUT THE INVESTOR PRESENTATION HERE

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Hello Everyone,

We have an exciting profile for today’s session that we wanted to get in front of you so you can start your research.

Pull up MYCOF immediately.  

Mydecine Innovations GroupTM is a biotech 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. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Their global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

The CEO just put out an update on the company’s website:

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

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

Company rapidly prepares to submit IND and Breakthrough Therapy Status Applications

DENVER, March 01, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced a positive meeting with the Food and Drug Administration (FDA) regarding their Investigational New Drug (IND) and breakthrough therapy status applications.

The Company reported a meeting with the FDA on February 28th to review their IND application to administer MYCO-001, in combination with therapy, to humans as part of smoking cessation treatment. Leading drug and substance abuse researcher, Dr. Matthew Johnson of Johns Hopkins University, will serve as the lead investigator for this multi-site study.

“The data from John Hopkins University’s ongoing studies assessing psychedelic-assisted therapy to treat nicotine addiction is showing efficacy rates 2-3 times higher than the current gold standard of treatment. Our team is eager to start collecting the data needed to bring an approved drug product to market that could potentially save millions of lives,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly.

“Mydecine plans to submit a request forBreakthrough Therapy designation with our IND submission. Psilocybin-assisted therapy has shown meaningful advantages over available medications for tobacco addiction including significant increases in safety and efficacy. We are looking forward to closely working with the FDA to bring safer and more effective therapy to the millions of people who are trying to quit smoking across the globe,” said Mydecine’s Senior Director of Clinical and Regulatory Affairs, Jessica Riggleman.

“We had an extremely positive meeting with the FDA in regards to our proposed smoking cessation study. The FDA provided helpful feedback on our study design that we will implement. We are now working rapidly in preparing our IND submission for the 2B portion of the study which we believe will be next month. Once cleared, we will move swiftly into patient recruitment. This is a study we have been diligently working on over the last two years and we’re excited to continue moving it forward,” said Mydecine CEO Josh Bartch.

Drug Development Highlights

  • Four lead drug candidates with improved controllability delivery mechanisms, safety, stability, shelf-life
  • Ability to cultivate, extract, conduct R&D, import and export full cGMP certified pharmaceutical grade natural and synthetic psi-lo-cybin and other tryptamines
  • Enhancing first generation molecules as well as novel molecular design
  • Global clinical trials focused on safe, approved standards and solutions at 7 clinical sites
  • Team of small molecule dr-ug design experts from Novartis, Pfizer, University of Alberta, Yale, etc.
  • Exclusive with world’s first accredited CRO
  • Partnership with internationally recognized FDA consulting firm, The Weinberg Group
  • 6 pending patents covering thousands of inventions that can be layered and standardized to FDA guidelines to achieve the desired or controlled outcome
  • Strong network of partners, including John Hopkins University, Applied Pharmaceutical Innovation (API), University of Alberta, Institute of Mental Health Research.
  • Health Canada Scheduled 1 Drugs and Substances Dealer’s License
Lead Drug Candidates
Artificial Intelligence Dr-ug Discovery Program
  • AI/ML program ranked top 3 in the world globally
  • Launched in-silico dr-ug discovery program in conjunction with researchers at the University of Alberta
  • Developing artificial intelligence/machine learning (AI/ML) supported dr-ug screenings, including the ability to build dr-ugs from the receptor up and assess dr-ugs around the receptors
  • Combining AI with in-silico structural modeling to design novel Serotonin Receptors modulators
  • More rapidly screen hundreds of thousands of new molecules without the need to produce them as well as its proprietary library of novel compounds
  • Led by top computer-aided dr-ug development expert, Dr. Khaled Barakat
Milestones: 2021 and Beyond

CLINICAL TRIALS

Healing Through Psychedelic-Assisted Psychotherapies

Search for Safer More Effective Treatments

Psychedelics offer the potential to revolutionize the mental healthcare industry as we know it. Mydecine was founded to discover, analyze, and bring psychedelic and functional compounds to global markets to support mental health and addiction solutions. Our clinical trials focus on psychedelic-assisted psychotherapy for post-traumatic stress disorder (PTSD) and nicotine dependency.

Clinical Trials & Sponsored Research

Seamless Phase 2/3 Clinical Trial

Utilizing Psilocybin for Smoking Cessation

We will be launching a seamless phase 2/3 clinical trial in early 2022 in partnership with Johns Hopkins University led by Dr. Matthew Johnson. Dr. Johnson is professor of Psychiatry and Behavioral Sciences at Johns Hopkins. He is one of the world’s most published scientists on the human effects of psychedelics and has conducted seminal research in the behavioral economics of drug use, addiction, and risk behavior. The planned study evaluates the administration of MYCO-001 with a structured smoking cessation treatment program in nicotine dependent individuals.

Learn more about our study design in our blog post, “Can psilocybin help you quit smoking?

NIDA Grant-Funded Smoking Cessation Study Led by Dr. Matthew Johnson

Utilizing Psilocybin for Smoking Cessation

Mydecine plans to supply our lead drug candidate, MYCO-001, for Dr. Matthew Johnson’s upcoming multi-site smoking cessation trial with research to take place at Johns Hopkins University, New York University, and the University of Alabama Birmingham. Dr. Johnson received a U01 grant from National Institute on Drug Abuse (NIDA) to fund this study, making it the first time in over 50 years that the U.S. government has funded a study of a psychedelic compound for therapeutics. Supplying our lead drug candidate for this study offers a significant opportunity to collect additional safety and efficacy data as well as demonstrating Mydecine’s leadership position in the emerging psychedelic-assisted psychotherapy industry. Read more here.

Study to Help Treat PTSD in Veterans

Even the Strong Need Mental Health Support

We are planning a Phase 2A clinical trial focusing on PTSD in veterans, first responders, and front-line workers. We have approved global test sites at Leiden University, University of Alberta, Royal Ottawa Hospital, and Western Ontario University. In addition, we are finalizing several U.S. sites including Boston, Los Angeles, and San Francisco.

Large-scale Microdose Study

Big Solutions Through Low Doses

We are currently supporting a large-scale microdose study co-sponsored by the National Institute for Health Research at Imperial College of London with Dr. David Erritzoe, a member of our Medical, Scientific, and Technology Advisory Board.

First-of-its-kind Microdose Study

Innovating the Way Psychedelics Are Used

We are conducting a first-of-its-kind microdose study at Macquarie University in Australia. Our Medical, Scientific and Technology Advisory Board member Dr. Vince Polito is leading this ongoing study.

Mydecine’s Exclusive Dealer Identified as Licensed Psilocybin and MDMA Supplier in Canada

Mydecine now able to supply cGMP products to healthcare providers for patients with serious and life-threatening conditions through the Special Access Program

VANCOUVER, British Columbia, Feb. 08, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced that Health Canada has included the dealer’s license Mydecine operates under as a supplier for the Special Access Program, which allows healthcare providers to request specific drugs for approved patients who have not responded to other available treatment options.

The licensed dealer facility, available to Mydecine through its exclusive agreement with Applied Pharmaceutical Innovation (API), contains a unique research and development infrastructure as well as a manufacturing facility in Edmonton, Canada. With the license, Mydecine is able to provide psilocybin and MDMA that meet Current Good Manufacturing Practices (cGMP) through Health Canada’s Special Access Program (SAP). This program allows practitioners to request psilocybin and MDMA for a patient with a serious or life-threatening condition where conventional treatments have failed, are unsuitable, or are generally not available in Canada.

“While we will continue to advance the research of psychedelic-assisted psychotherapy through our clinical trials and drug development process, we understand there are patients in need of treatments today. Through our dealer’s license, we can offer psilocybin and MDMA to practitioners and clinics in Canada who want to offer these treatment options for patients in need,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly.

Following the addition of psilocybin and MDMA to Health Canada’s SAP in January, Mydecine launched its Special Access Support and Supply Program for physicians, clinics and hospitals throughout Canada, providing access to cGMP products, protocol training, therapy manuals, and technology to ensure safe and effective therapy outcomes for patients.

Approach to Drug Discovery

Our research strategy hinges on identifying and developing novel psychedelic and non-psychedelic molecules for medical use. We use molecules found in nature as building blocks to produce improved second-generation drugs, leveraging artificial intelligence and machine learning (AI/ML) to discover drug enhancements cost effectively and efficiently. This portfolio of new drugs represents major improvements to existing natural and synthetics products, such as enhanced safety, efficacy, stability, dosing and reduced side effects.

Using Research to Understand the Power of Psychedelics

The goal of creating these improved, second-generation compounds is to enable safer, more effective treatments for patients, along with improved dosage management and drug behavior for clinicians. To create these enhanced molecules, we study the large number of psychedelics reported in the literature, as well as anecdotal reports, to gain an understanding of how these drugs have been used therapeutically, and more importantly, what their shortcomings are.

Breaking Down Psychedelics for Their Best Use

A thorough analysis of each drug on a molecular level allows us to determine which features are responsible for undesirable effects and shortcomings. This information is then used to design new second-generation molecules with improved performance, which allows better management in the clinicians’ hands.

Evolving Nature to Its Most Powerful Being

The current generation of psychedelic natural products evolved in nature, making them most equipped to deal with the organism’s natural environment. Although these molecules have been found remarkably useful for therapeutic use, they are not naturally made for a clinical setting. Therefore, there is an immense demand for these next-generation drugs that will be more responsive to the needs of patients and physicians.

ACQUISITIONS

NEUROPHARM INC.

Out with the Old, In with the New

Changing the way mental health treatment works, NeuroPharm Inc. (NPI) focuses on developing a proprietary set of pharmaceutical and natural health products addressing mental wellness in vulnerable populations including veterans, EMS personnel, and other high-risk groups. Using evidence-based medicine, NPI, in collaboration with its partners, is developing a psilocybin dosing technology and establishing a therapeutic psilocybin-based treatment to address the unmet needs of high-risk populations. NPI is implementing an intellectual property strategy via patent filings, copyrights, trademarks, and other protective actions.

MINDLEAP HEALTH

A Next-Generation Inner Wellness Platform

Mindleap Health’s Mindleap platform offers a unique user experience that combines therapeutic and educational content, 1-on-1 professional support for psychedelic integration and inner wellness, and a private health journal for mental health and lifestyle monitoring. The platform is designed to be highly scalable and offers a unique clinical practice management system that will continue to be built out in order to support psychedelic practitioners and organizations in unique ways. With this strategic technology acquisition, we are positioned to support psychedelic wellness as a part of the broader categories of mental health and inner wellness, in a distributed and global fashion.

CHART

NEWS

MANAGEMENT

Joshua Bartch

DIRECTOR, CHIEF EXECUTIVE OFFICER

Mr. Bartch is an experienced entrepreneur. He co-founded AudioTranscriptionist.com and founded the Denver-based dispensary, Doctor’s Orders, in 2009. He later founded a boutique investment firm that operated throughout the U.S. and Canadian markets. In 2014, Mr. Bartch co-founded Cannabase.io, the most significant and sophisticated legal cannabis wholesale platform in the United States. He took successful exits from AudioTranscriptionist.com, Doctor’s Orders and Cannabase.io.

Damon Michaels

DIRECTOR, CHIEF OPERATIONS OFFICER

Mr. Michaels previously consulted for various hemp businesses through his company, Emerald Baron. Before that, he served as general manager for ebbu, a top multi-platform cannabinoid research and technology firm. By 2018, ebbu was the cutting-edge leader in cannabinoid science and was acquired for CAD$429 million by Canopy Growth Corporation, the largest cannabis company in the world. Mr. Michaels has held executive roles with multiple large brands throughout the cannabis vertical. He also served on the business development team for a Google Ventures company, developed a national snowboard brand and was one of four entrepreneurs who created Colorado’s first-ever glass recycling company.

Robert Roscow, M.A.

DIRECTOR, CHIEF SCIENTIFIC OFFICER

As an experienced geneticist, Mr. Roscow has spent his academic and professional career identifying valuable and unique medicinal molecules found in nature. He holds both master’s and bachelor’s degrees in biology. Prior to joining Mydecine, Mr. Roscow was director of genetics at Victory Hemp Foods and also at ebbu, which was acquired as a subsidiary of Canopy Growth Corporation, the largest cannabis company in the world. At ebbu, Mr. Roscow ran the world’s first cannabis genetic editing laboratory. He has leveraged an expertise in genomics, evolution and molecular biology to identify novel molecules and advance their use in a pharmacological context. His work has resulted in multiple patent filings and accolades in a variety of scientific and popular publications.

Dean Ditto

CHIEF FINANCIAL OFFICER

Mr. Ditto is a seasoned executive with experience helping small and mid-market companies develop and execute strategic plans, while ensuring the accounting, finance and administrative capabilities scale appropriately to support growth objectives. He has served in leadership roles for 20+ years in multiple industries, including health sciences, heading initiatives to build finance function capabilities, improve profits and secure capital. He brings experience in SEC reporting, business analytics and systems, cash management, internal controls, risk management and building compliance functions for regulated companies. Mr. Ditto recently led a financial services business turnaround, improving profits by $15 million annually, as well as collaborating with operations to restructure a medical device business unit, increasing profits by $10 million annually.

Dr. Rakesh Jetly, OMM, CD, M.D., FRCPC

CHIEF MEDICAL OFFICER

Dr. Jetly is the former chief of psychiatry for the Canadian Armed Forces and retired in 2021 as a colonel after 31 years of service. He began his career as a general duty medical officer and flight surgeon deploying on missions in Rwanda and the Middle East. He spent his final 20 years as a psychiatrist deploying twice and leading mental health programs in Afghanistan. Dr. Jetly maintains academic appointments at Dalhousie University and the University of Ottawa. He is the inaugural chair of the CF Brigadier Jonathan C. Meakins CBE, RCMAC, and chair in Military Mental Health at the Royal Ottawa Hospital. During his career, Dr. Jetly has led initiatives within Canada and NATO to better understand and innovate solutions in the mental health field. He has published extensively on topics such as PTSD, suicide, leveraging technology in mental health and occupational psychiatry.

Sincerely,

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