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Breaking News Provides New Biotech Idea (MYCOF) With Early Breakout Fuel As Profile Trends Green First Thing

(US: MYCOF) - (Canada: MYCO)

January 13th

SCF Readers,

MYCOF needs to be the center of your universe right now.

Dropping some game-changing news this AM, MYCOF is trending green and could be picking up some breakout steam.

Check out the news now:

Mydecine to Launch Special Access Support and Supply Program in Canada Expanding Access to Psych-e-delic-Assisted Psychotherapy For Patients

With the addition of psi-lo-cybin and MD-MA to Health Canada’s Special Access Program, Mydecine looks to offer a package of cGMP products and support services promoting responsible administration to patients and creating near-term revenue potential

VANCOUVER, British Columbia, Jan. 13, 2022 (GLOBE NEWSWIRE) -- Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, announced today they would be launching The Special Access Support and Supply Program (SASSP) to provide products and services to physicians, clinics, and hospitals in Canada who are looking to treat patients through psych-e-delic-assisted psychotherapy. With the new addition of psi-lo-cybin and MD-MA to the approved list of substances under Health Canada's Special Access Program (SAP), the company aims to fill a critical gap in the market by allowing thousands of healthcare professionals and clinics the resources needed to bring these treatments to patients in need.

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Read the full article here.

On top of this awesome news, MYCOF is also trading above multiple lines of potential support.

Those lines include MYCOF's:

  • 5-Day Exponential Moving Average (EMA)
  • 13-Day EMA
  • 20-Day Simple Moving Average (SMA)
  • 50-Day SMA

Could this signal that MYCOF is building up a ton of potential support that could be used as building blocks towards a continued vertical surge near term?

Take a second now to pour through my initial report and get MYCOF on your radar quickly.

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Humanity is in a very dark place right now.

In recent years we've been dealing with all types of anxiety-inducing issues, from war to famines to diseases and climate change.

But it feels like the pace was picked up in the pandemic.

Separation has come in all forms from our neighbors, our family, our churches, our schools, our friends, etc.

It has led to an increase in Anxiety, Stress, Addiction, Depression, and Suicides. (Source 1)

In the U.S., the CDC has reported that more than 50% of people will be diagnosed with a mental illness or disorder at some point in their lifetime. (Source 2)

Most people just don’t have the resources available or are unresponsive to current treatments on the market.

What the street’s been searching for is a company that has the types of material advantages that will make it a winner in the mental health industry.

I've discovered a company that has a world-class management and research team behind it, and an undeniably incredible market advantage at the research and API level.

*Mydecine Innovations Group Inc. (MYCOF)*

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Mydecine Innovations Group is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure.

Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders.

Mydecine Innovations Group's business model combines clinical trials and data outcome, technology, scientific and regulatory expertise, focusing on psych-e-delic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we treat mental health disorders.

And right now the company has a handful of potential breakout catalysts to know which include:

No. 1 - Major Supercomputing Breakthrough

No. 2 - Signed LOI To Develop New Platform

No. 3 - Filing Of Patent Application + New Board Appointment

No. 4 - Huge 3rd Quarter Business Update

But more on those in a second...

Tackling the Addiction and PTSD Crisis

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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 drug 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

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Artificial Intelligence Drug Discovery Program

  • AI/ML program ranked top 3 in the world globally
  • Launched in-silico drug discovery program in conjunction with researchers at the University of Alberta
  • Developing artificial intelligence/machine learning (AI/ML) supported drug screenings, including the ability to build drugs from the receptor up and assess drugs 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 drug development expert, Dr. Khaled Barakat
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Milestones: 2021 and Beyond

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More from the company presentation.

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And right now, the company has several potential catalysts that could spark vertical chart growth near term. Here's what you need to know...

No. 1 MYCOF Potential Breakout Catalyst - Major Supercomputing Breakthrough

Mydecine Achieves Innovative Supercomputing Artificial Intelligence Modeling in Psych-e-delic Drug Development Enabling Quick Screening of Billions of Compounds

The new serotonin receptor model (5-HT2A) will allow the Company to rapidly increase drug analysis promoting near-term patent filings for novel psych-e-delic molecules.

DENVER, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, announced today they have completed a target-based model of the classic psych-e-delic serotonin receptor 5-HT2A for use in their AI-driven drug discovery program. The new model will allow them to expeditiously screen billions of structures to determine which novel compounds are most likely to increase binding affinity, enabling them to continue creating improved second and third generation psych-e-delic molecules for medical use.

By centering their drug discovery efforts around artificial intelligence (AI) and machine learning (ML), Mydecine is positioned to discover drug enhancements more cost effectively and more efficiently than their competitors. Using AI technology is relatively new in the drug development space and its applications are continuously expanding. The goal of this technology is to eliminate, or drastically reduce, the manual efforts companies typically undergo to identify possible drug improvements. By filtering the drug candidates with AI, the Company is inherently making their investments in later stage drug development more valuable by eliminating potential candidates that are likely to fail early on in the process.

Without AI and ML, based on their hypotheses, companies have to manually synthesize each molecule and individually test the likelihood of a successful binding agent. This process can consume enormous amounts of time and money; therefore, efficiently eliminating candidates likely to fail in preference for candidates that are more promising is extremely valuable.

AI gives us an incredibly robust tool for screening potential novel psych-e-delic compounds. This screening gives us increased confidence in investing in the later stages of our drug development and enables rapid development in our pipeline,” said Chief Science Officer Rob Roscow.

[...]

Read the full article here.

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No. 2 MYCOF Potential Breakout Catalyst - Signed LOI To Develop New Platform

Mydecine Signs LOI with Maya to Co-Develop a Novel Prescription Digital Therapeutic Platform Aiming to Further Increase Safety, Efficacy, and Accessibility of Psych-e-delic-Assisted Treatments

DENVER, Dec. 22, 2021 (GLOBE NEWSWIRE) -- Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NF.F) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, announced today that the Company has signed an LOI (letter of intent) with Maya. Together, the two companies plan to co-develop a novel digital therapeutics (DTx) platform. This platform would allow Mydecine to enhance treatment effectiveness by pairing the DTx with the Company’s existing digital health platform, Mindleap Health (“Mindleap”), alongside the Company’s medication-based treatments to create a trifecta approach.

This collaborative partnership aims to enhance Mindleap’s digital platform by collecting and computing unique data to create more personalized treatments for patients. Once the new DTx platform is complete, physicians could prescribe the new digital therapeutic in addition to Mydecine’s drug and therapy protocols or as a standalone option. The Company believes this will improve the efficacy of current treatment options by personalizing them to the patient and making them more accessible.

Maya is a purpose-built platform enabling real-world data and research to optimize outcomes and industry standards by enhancing safety, reducing the cost of care, increasing IP equity, and informing regulation of psych-e-delic-based therapy. Maya’s clinically validated surveys, biometric tracking, and protocol customization combined with Mindleap’s telemedicine, exclusive digital content, and community features will allow both companies to accelerate the development and commercialization of a novel DTx platform.

Both companies will pursue rigorous studies to achieve FDA Section 510(k) clearance upon software integration and a comprehensive regulatory assessment. This clearance will allow the DTx platform to be registered and used as a medical device to allow patients to receive insurance reimbursement coverage for treatments on the platform. This developing partnership with Maya will enable both companies to create standalone evidence-based software as a medical device DTx platform. In addition, the current smoking cessation clinical trial Mydecine is conducting in partnership with Johns Hopkins University, and Mindleap’s current consumer-facing offerings, will not be altered or affected.

The technology integration of the two software platforms is aimed at enhancing Mindleap’s medical capabilities to more quickly and efficiently develop a personalized prescription-based digital therapeutic that will not only complement Mydecine’s smoking cessation treatment but eventually for all primary and ancillary indications the Company is targeting. We believe Digital Therapeutics is the next big wave in healthcare. We feel confident that once our DTx platform is complete, Mydecine will be on the cutting-edge and well-ahead of the competition. Creating and integrating a DTx will be equally as valuable as the drug discovery and therapeutic protocols that the Company currently has under development. The new platform will provide improved adherence to treatment protocols, patient experience, biometric insights, and post-approval insurance reimbursements,” commented Damon Michaels, Mydecine Co-Founder, Director, and COO.

[...]

Read the full article here.

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No. 3 MYCOF Potential Breakout Catalyst - Filing Of Patent Application + New Board Appointment

Mydecine Files Full Patent Application Covering Multiple Families of Psi-lo-cin Analogs

Dr. Saeid Babaei Appointed Independent Board Member as Mydecine Moves Closer to NASDAQ Listing in Q1 2022

DENVER, Dec. 06, 2021 (GLOBE NEWSWIRE) -- Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, today announced it has filed a full patent application covering multiple families of psi-lo-cin analogs. The application includes solutions to directly address further precision in delivery control and shelf stabilization of psi-lo-cin, psi-lo-cybin’s active metabolite, both of which are critical for use in the medical setting.

When psi-lo-cybin is administered orally, there is wide variability in onset time for each patient, making it more difficult to standardize protocols and scale treatments. The purpose of Mydecine’s dermal route for the administration of psi-lo-cin is to directly address such controllability concerns. The Company’s patent pending permeation enhanced prodrug provides more control over the drug while also possibly eliminating undesirable properties like nausea by bypassing the digestive system.

Another concern of naturally produced psi-lo-cybin is its poor shelf stability. Mydecine’s recent filing includes a family of stabilized psi-lo-cin analogs, moving the Company closer to a drug that will meet regulatory requirements and address concerns for medical use; specifically providing access to a reliable potency psi-lo-cin source for physicians.

The goal of creating these improved second-generation compounds is to enable safer, more effective treatments for patients along with improved management of dosage and drug behavior for clinicians. We believe these improvements are necessary for psych-e-delic medicines to become an accepted and adopted form of treatment,” said Chief Science Officer, Rob Roscow.

Mydecine also announced today that it has appointed Dr. Saeid Babaei, PhD, to its Board of Directors. Dr. Babaei is an experienced leader in bringing drug products from early development to commercialization. Dr. Babaei’s track record includes over 20 years of academic and corporate experience, during which he has led a number of novel and first-in-class product opportunities to either commercialization or to late-stage development. He brings tremendous business foresight having closed over 25 licensing and strategic alliance transactions, as well as raising over $50Mn in equity and debt fin-an-cing.

We are pleased to welcome Dr. Babaei to the team as he brings decades of experience in biotechnology development, award-winning discoveries in gene therapy, and licensing and strategic advancements for the companies he has founded and accelerated. As Mydecine continues to move our lead candidates down the pipeline, Dr. Babaei will play an integral role in advancing our novel psych-e-delic-based therapeutic candidates as well as meeting NASDAQ listing requirements,” said Josh Bartch, Chairman & CEO of Mydecine.

Read the full article here.

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No. 4 MYCOF Potential Breakout Catalyst - Huge 3rd Quarter Business Update

Mydecine Reports Third Quarter 2021 Fin-an-cial Results and Provides Business Update

To Launch Phase 2/3 Smoking Cessation Clinical Trial with Johns Hopkins University (JHU)

Signed 5-Year Research Agreement with JHU to Further Mydecine’s Research of Multiple Molecules for a Variety of Indications

--DENVER, Nov. 16, 2021 (GLOBE NEWSWIRE) -- Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, today reported its fin-an-cial results for the third quarter ended September 30, 2021 and provided a business update.

During the third quarter of 2021, we entered into a 5-year research agreement with Johns Hopkins University School of Medicine, one of the most experienced university departments in conducting clinical research related to the therapeutic use of psych-e-delics. In collaboration with JHU, we are rapidly progressing one of our lead candidates, MYCO-001, through clinical trials with the upcoming seamless Phase 2/3 smoking cessation clinical trial, and their NIDA grant-funded smoking cessation study which will use MYCO-001. This marks the first time in over 50 years that the U.S government has funded a study of a psych-e-delic compound for therapeutics,” stated Joshua Bartch, CEO of Mydecine. “As we prepare for the launch of these trials, we expect to meet with the FDA for Pre-Investigational New Drug Application (Pre-IND) meetings in early 2022, another step closer to bringing to market more effective treatments for today’s unmet needs in mental health and addiction.

Business Highlights During and Subsequent to the Third Quarter 2021

Clinical Trials

Prepared to supply its lead drug candidate, MYCO-001, for a JHU multi-site NIDA grant-funded smoking cessation study led by Dr. Matthew Johnson.

Announced upcoming launch of seamless Phase 2/3 smoking cessation clinical trial studying the science and efficacy of MYCO-001.

Signed a five-year research agreement with JHU School of Medicine to advance clinical trials and explore multiple molecules and medicines for a variety of indications.

IP Portfolio

Filed final patent application for MYCO-003 with the United States Patent and Trademark Office and the World Intellectual Property Organization, which is being developed to offer enhanced treatment of anxiety and PTSD.

Filed new patent for MD-MA-like compounds further expanding its robust portfolio of novel compounds after MDMA-assisted psychotherapy received Breakthrough Therapy Designation from the Food and Drug Administration (FDA).

Filed a technology patent that allows for the creation of formulations that utilize nanoemulsion technology to enhance, stabilize and make repeatable properties of ingredients from traditional medicine. The patent will cover formulations that are generally recognized as safe by FDA (GRAS-certified).

Successfully synthesized a novel psi-lo-cin analogue with improved pharmaceutical properties to further expand its library of patent-pending tryptamines.

Technology

Launched Mindleap 2.0, an updated version of its virtual health platform, providing improved infrastructure, better user experience, and expanded content. The 2.0 version also adds focus on the conscious and trustworthy adoption of psych-e-delics into the broader categories of mental health.

Continued development of AI-driven drug discovery program, screening billions of new drug candidates and filtering them for their ability to modulate the activity of the psych-e-delic-related targets.

Corporate

Completed its spin-out transaction of ALT House Cann-a-bis Inc., which now holds the Company’s U.S. cann-a-bis assets in order for the Mydecine Innovations Group's team to focus on the company's core drug development business.

[...]

Read the full article here.

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MYCOF Potential Catalysts Recap - Key Details To Know Now

No. 1 - Major Supercomputing Breakthrough

No. 2 - Signed LOI To Develop New Platform

No. 3 - Filing Of Patent Application + New Board Appointment

No. 4 - Huge 3rd Quarter Business Update

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Coverage is officially initiated on MYCOF. When you have time, do this:

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Get MYCOF on your radar now.

Sincerely,

Axel Adams

Editor, SCF


Source 1
Source 2


(Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.)​

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