Tag: $MYCOF

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Mydecine Reports Successful Synthesis of Novel Tryptamine Improving the Pharmaceutical Properties of Psilocin

Mydecine Reports Successful Synthesis of Novel Tryptamine Improving the Pharmaceutical Properties of Psilocin

Further strengthens the Company’s drug development pipeline of tryptamines by introducing novel psilocin analogues containing enhancements in safety and efficacy tailored for medical use

DENVER, Oct. 27, 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 that it has successfully synthesized a novel psilocin analogue with improved pharmaceutical properties to further expand its library of patent-pending tryptamines.

The synthesis of this novel psilocin analogue, a tryptamine, is the newest compound to be added to Mydecine’s growing library of patent-pending compounds. The inclusion of this compound supports and builds upon Mydecine’s strategy to improve the safety and efficacy of its drug development candidates for use in therapy and medical practice. With the addition of this compound, the Company has further demonstrated its ability to achieve proven principles of drug chemistry, improved delivery, time course of action and compound stability.

Rob Roscow, Chief Scientific Officer of Mydecine, stated, “Our ability to rapidly uncover safer and more efficacious novel compounds, such as this psilocin analogue, is a true testament to the value and success of our AI-driven drug discovery program, bringing us closer to introducing the next-generation of psychedelic-based therapeutics to the market. Utilizing this advanced technology, we have effectively produced an extensive base of preclinical, in vitro data that supports and expands our named drug pipeline. As we progress forward, we see great value from this development as we can now leverage the achieved receptor binding data for serotonin receptor (5-HT2A) and expand our drug pipeline focusing on the agonistic activity of psilocin and other tryptamines at different ratios on serotonin receptors.”

Mydecine’s AI-driven drug discovery program is part of a joint research venture between the Company and Applied Pharmaceutical Innovation (API) at the University of Alberta. Since partnering with API in February 2021 and integrating its advanced AI technology, Mydecine has accelerated its natural product research and novel drug design, allowing them to scale faster than would be achievable with traditional research methods.

Further commenting on the strengthened drug development pipeline, Dr. Khaled Barakat, Principal Investigator at API and University of Alberta Associate Professor, added, “Our AI technologies construct billions of new drug candidates and filter them for their ability to modulate the activity of the psychedelic-related targets. These AI models also predict the interactions and affinity of each drug candidate to the level of a single atom. By considering the unique structural and dynamical fingerprint of each target, our AI-drug discovery program paves the road towards designing selective modulators, hence, reducing any potential side effects that may emerge in the future.”

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) 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 therapeutic 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 with a focus on psychedelic 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 view mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Twitter and LinkedIn.

For more information, please contact:

Media Contacts
Anne Donohoe / Nick Opich
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1265 / 1-212-896-1206

Investor Contacts
Charles Lee, Investor Relations
corp@mydecineinc.com
1-720-277-9879

Allison Soss / Erika Kay
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1267

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

Source: Mydecine Innovations Group Inc.

Released October 27, 2021

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Mydecine To Supply Lead Drug Candidate, MYCO-001, for Multi-Site NIDA Grant-Funded Smoking Cessation Study Lead by Dr. Matthew Johnson

Mydecine To Supply Lead Drug Candidate, MYCO-001, for Multi-Site NIDA Grant-Funded Smoking Cessation Study Lead by Dr. Matthew Johnson

Research to take place at Johns Hopkins, New York University and University of Alabama Birmingham

DENVER, Oct. 05, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), a biopharmaceutical company focused on the treatment of mental health disorders and addiction, today announced that it plans to supply its lead drug candidate, MYCO-001, for a multi-site smoking cessation study being conducted at Johns Hopkins University (“JHU”), New York University and the University of Alabama Birmingham by leading drug and substance use researcher, Dr. Matthew Johnson. 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.

Mydecine, which exercises a five-year research agreement with JHU to study the impact of psychedelics on smoking cessation amongst other initiatives, announced earlier this September that it had partnered with Dr. Johnson to complete a seamless Phase 2/3 smoking cessation clinical trial for MYCO-001. Projected to launch in Q1 2022, the Phase 2/3 clinical trial will run concurrently with the newly announced multi-state study. The company believes both studies will serve to provide further supportive efficacy and safety data for MYCO-001.

Josh Bartch, CEO of Mydecine stated, “The NIDA’s decision to fund the continuation of Dr. Johnson’s smoking cessation study is a strong validator of medicines, such as our MYCO-001 formulation, for the treatment of smoking cessation. Previous clinical results by Dr. Johnson and his team at Hopkins have shown six-month abstinence rates as high as 80%, which is unheard of in the addiction space. NIDA ranked this study incredibly high, which further solidifies our approach to treat this deadly addiction.”

Bartch continued, “We are excited to support Dr. Johnson and his team in this concurrently running study which we believe will add a significant benefit to support our 2/3 seamless design. We have made significant progress advancing our MYCO-001 clinical trials for smoking cessation to date with JHU. The opportunity to play an integral role in this landmark study by supplying our lead drug candidate, not only offers a significant opportunity to further advance our drug development through safer and more viable results, but demonstrates Mydecine’s leadership position in the emerging psychedelic-assisted psychotherapy industry.”

“The incredibly promising clinical data that has been accumulated by the evolving psychedelic therapeutics industry to date makes these types of collaborations potentially a game-changer in smoking cessation,” said Mydecine CMO, Dr. Rakesh Jetly. “The U.S. government’s recognition of this valuable data and their support in advancing the development of psychedelic-based therapy to help create a more effective treatment option supports our mission to bring these needed drugs to the forefront of the market.”

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and addiction. Mydecine Innovations Group was founded in 2019 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and therapeutic 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 with a focus on psychedelic 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 view mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Twitter, and LinkedIn.

For more information, please contact:

Media Contacts
Anne Donohoe / Nick Opich
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1265 / 1-212-896-1206

Investor Contacts
Charles Lee, Investor Relations
corp@mydecineinc.com
1-720-277-9879

Allison Soss / Erika Kay
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1267

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

Source: Mydecine Innovations Group Inc.

Released October 5, 2021

Posted on

Mydecine Completes Spin-Out of U.S. Cannabis Assets

Mydecine Completes Spin-Out of U.S. Cannabis Assets

DENVER, Oct. 01, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biopharmaceutical company focused on the treatment of mental health and addiction, today announced that it has completed its previously announced spin-out transaction (the “Transaction”) of ALT House Cannabis Inc. (“SpinCo”), a wholly-owned subsidiary of Mydecine which held the Company’s U.S. cannabis assets.

SpinCo was incorporated on August 9, 2021 for the purposes of the Transaction, enabling Mydecine to transfer to SpinCo all of the Company’s interests in: (i) 1176392 BC Ltd; (ii) Alternative Distribution Company, LLC; (iii) Drink Fresh Water, LLC; (iv) Tealief Brands, LLC; (v) Relyfe Brands, LLC; (vi) We are Kured, LLC; and (vii) Trellis Holdings Oregon OP, LLC (collectively, the “U.S. Cannabis Subsidiaries”) in exchange for 2,500,000 common shares of SpinCo (the “SpinCo Shares”). Mydecine’s current shareholders received for each common share of Mydecine held: (a) one new Mydecine common share; and (b) 0.010300 SpinCo Shares. The new Mydecine common shares are expected to continue trading on the NEO Exchange on October 1, 2021. Holders of Mydecine warrants (NEO: MYCO.WT) who validly exercise such warrants following the Transaction shall receive, for each warrant held, one whole Mydecine common share and, for no additional consideration, 0.010300 SpinCo Shares. The CUSIP numbers for the new Mydecine Shares and the SpinCo Shares will be 62849F101 and 021242102, respectively.

The purpose of the Transaction was to permit the Company to comply with NASDAQ Listing Qualification requirements and comparable London Stock Exchange requirements regarding U.S. cannabis assets as the Company continues its listing review process with NASDAQ. Management believes that transferring the U.S. cannabis assets and cannabis projects to a separate public company removes an unintended obstacle to its planned NASDAQ and London Stock Exchange listings and the expected benefits that such listings will provide the Company and its shareholders. Additionally, SpinCo plans to leverage and monetize the Company’s U.S. cannabis assets and cannabis projects and commercial relationships in the sector.

Going forward Mydecine’s principal business will focus on the development and commercialization of end-to-end mental health treatments through its robust and technologically innovative discovery platform. Mydecine will leverage its world-class R&D facilities to focus on advancing novel compounds and increased efficacy through proprietary technology. Mydecine will continue to accelerate its pipeline with preclinical and clinical development to bring patients safe and FDA-approved solutions and it will no longer be involved in the manufacturing or sale of cannabis and CBD products.

SpinCo intends to make an application to list the SpinCo common shares on either the Canadian Securities Exchange or the NEO Exchange, but no assurance can be provided that such a listing will be obtained in a timely manner or at all. Any such listing will be subject to SpinCo fulfilling all the requirements of the applicable stock exchange.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and addiction. Mydecine Innovations Group was founded in 2019 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and therapeutic 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 with a focus on psychedelic 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 view mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Twitter.

For more information, please contact:

Media Contacts
Anne Donohoe / Nick Opich
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1265 / 1-212-896-1206

Investor Contacts
Charles Lee, Investor Relations
corp@mydecineinc.com
1-720-277-9879

Allison Soss / Erika Kay
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1267

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Forward-looking statements herein include, without limitation, statements relating to the listing of securities of the Company on NASDAQ or the London Stock Exchange and the benefits of such listings, benefits of the Transaction for shareholders of the Company, the structure of the Transaction, SpinCo being able to leverage and monetize the Company’s U.S. cannabis assets and cannabis projects, the listing of the common shares of SpinCo on a stock exchange and the Company’s ability to build out a robust R&D pipeline. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

Source: Mydecine Innovations Group Inc.

Released October 1, 2021

Posted on

Say goodbye to extreme anxiety

Mydecine Files MYCO-003 Final Patent Application and Reports Positive Preclinical Data

Mydecine Innovations Group (MYCO) filed a patent for a new anxiety and PTSD drug that provides more immediate relief than pure psilocybin.

The compound, MYCO-003, combines a serotonin agonist with a serotonin releasing agent – two drug classes that increase one’s sense of well-being, safety, and happiness. The formulation has shown positive preclinical data and has potential to relieve extreme anxiety before needing to provide extensive supportive care, according to the Chief Science Officer.

The patent was filed with both the United States Patent and Trademark Office (USPTO) and the World Intellectual Property Organization (WIPO).

PDF of article

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Mydecine Files MYCO-003 Final Patent Application and Reports Positive Preclinical Data

Mydecine Files MYCO-003 Final Patent Application and Reports Positive Preclinical Data

DENVER, Sept. 22, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) (“Mydecine” or the “Company”), a biopharmaceutical company focused on the treatment of mental health and addiction, today announced that it has filed its final patent application with the United States Patent and Trademark Office (USPTO) and the World Intellectual Property Organization (WIPO) for one of its lead drug candidates, MYCO-003, which is being developed to offer enhanced treatment of anxiety and post-traumatic stress disorder (PTSD).

In addition, the Company is pleased to report positive preclinical data supporting the continued development of MYCO-003. This patent pending formulation has the potential to further reduce patient anxiety as compared to pure psilocybin, when used in therapy or medical practice. MYCO-003 combines a serotonin agonist with a serotonin releasing agent; these drug classes are being demonstrated in research to increase the efficacy of therapy, and produce increased sense of wellbeing, safety, and happiness during stressful therapy. Mydecine believes these properties will be synergistic and particularly important for the effective treatment of patients with severe PTSD and extreme anxiety disorders.

“Current psilocybin-based treatments can overcome the risk of extreme anxiety reactions with supportive care. With our enhanced MYCO-003, this promising candidate has the potential to reduce anxiety during therapy before needing to provide extensive supportive care. Therefore, we believe that MYCO-003 would have a greater appeal to patients suffering from extreme anxiety and PTSD driving a more effective and immediate treatment result for patients in need,” said Rob Roscow, Chief Science Officer.

“This is another exciting progression in the execution of our drug development pipeline which is consistently demonstrating the value and efficacy of our psychedelic-assisted therapeutics and the wide array of therapeutic applications we can target,” said Josh Bartch, CEO of Mydecine. “As we advance our product portfolio, Mydecine continues to add layers of efficacy and safety to the already established medical value of our proprietary drug candidates currently in the pipeline. We believe the continued development of MYCO-003 can play a significant role in delivering a more effective treatment for PTSD and anxiety.”

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and addiction. Mydecine Innovations Group was founded in 2019 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and therapeutic 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 with a focus on psychedelic 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 view mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Twitter.

For more information, please contact:

Media Contact
Courtney Ryan
LS2group
cryan@ls2group.com
515-770-4823

Anne Donohoe / Nick Opich
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1265 / 1-212-896-1206

Investor Contacts
Charles Lee, Investor Relations
corp@mydecineinc.com
1-720-277-9879

Allison Soss / Erika Kay
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1267

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

Source: Mydecine Innovations Group Inc.

Released September 22, 2021

Posted on

Mydecine Innovations Group Announces MYCO-001 Seamless Phase 2/3 Smoking Cessation Clinical Trial

Mydecine Innovations Group Announces MYCO-001 Seamless Phase 2/3 Smoking Cessation Clinical Trial

Dr. Matthew Johnson will lead research to look at the science and efficacy of MYCO-001 for the treatment of smoking cessation and nicotine dependence

DENVER, Sept. 07, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA), a biopharmaceutical company focused on the treatment of mental health and addiction, announced it has partnered with Principal Investigator Dr. Matthew Johnson of Johns Hopkins University on a study evaluating the administration of MYCO-001 with a structured smoking cessation treatment program in nicotine dependent individuals.

The planned placebo-controlled study, based with the Johns Hopkins psychedelic research group, will study the science and efficacy of MYCO-001 to treat nicotine dependence. Dr. Matthew Johnson, a globally recognized leader in this field who has published extensively on the science of psychedelics, has been contracted by Mydecine to complete this phase 2/3 clinical trial of his ongoing research and develop methodologies to better advance future-controlled studies and clinical trials of psychedelics. The proposed study is projected to launch in Q1 2022 and will be looking at primary endpoints of three and six months. This study could be completed as early as Q4 2022.

Combining two or more phases into one study is known as an operationally seamless clinical trial. Operationally, seamless clinical trial designs utilize results acquired throughout the trial to adjust the course of the study as data is collected. Analyses of the accumulating study data are performed at pre-planned time points within the study; therefore it could be possible to change the study dose, treatment duration, or study endpoints. This adaptive approach allows resources to be used more efficiently and can often be more informative and ethical than a traditional fixed design.

A 2014 Johns Hopkins University study published in the Journal of Psychopharmacology, showed an 80% abstinence rate at six months. Currently, the center is conducting a continuation on smoking cessation with a randomized comparative efficacy study involving 80 patients in which a transdermal nicotine patch and cognitive therapy treatment or psilocybin and cognitive therapy treatment are administered. Over half of the patients in the ongoing study have completed their 13-week program with compelling success rates that far exceed the 10% to 35% success rates for traditional smoking cessation therapies.

Mydecine CEO Josh Bartch stated, “Current clinical data coming out of Johns Hopkins on the ongoing smoking cessation study is showing 12-month efficacy rates significantly higher than today’s gold standard with drastically increased safety profiles. We have been diligently working with the teams at Hopkins, Applied Pharmaceutical Innovation, The Weinberg Group, and ethica CRO to design the planned study.” Bartch continues on to say, “We firmly believe in the high likelihood of receiving breakthrough therapy status on our MYCO-001 product for smoking cessation and look forward to updating the market soon on future developments.”

Tobacco, and its active ingredient nicotine, is one of the most highly addictive substances in the world, and one of the deadliest. According to the Centers for Disease Control (CDC) and Prevention, cigarette smoking is responsible for one out of every five deaths in the United States, roughly 480,000 people every year. Smoking is also directly associated in $1.4 trillion in health expenditures and productivity losses combined.

Approximately 14% of the U.S. population, 34.1 million Americans, currently smoke cigarettes.

  • 68% have stated they would like to quit smoking
  • 55% have made an attempt to quit
  • Approximately 7.5% are successful

In 2019, the global market for tobacco addiction was valued at $6 billion. By 2026, the market is expected to reach $64 billion, growing at a CAGR of 16.9%. Currently, the most popular form of tobacco addiction treatment is Nicotine Replacement Therapy (NRT), with various formulations available in transdermal patches, spray, gum, lozenges, and so on.

“As a physician who has worked with many patients struggling to quit highly addictive substances, I have seen firsthand the tremendous harm nicotine has on the body,” said Mydecine CMO Dr. Rakesh Jetly. “We are excited to be working alongside Johns Hopkins University toward safer and more effective treatments.”

Until it was recalled in July 2021, one of the most successful smoking cessations treatments was varenicline, or Chantix. Sales for Chantix reached $1.1B in 2020 despite the potential harmful side effects. Although a wide variety of treatments exist, tobacco addiction continues to remain largely untreated.

“We wholeheartedly believe the future success of psychedelic medicine is dependent on collaborative efforts between top-tier research institutions and private organizations to better understand the effectiveness of these drugs compared to current treatment options. The research of Dr. Johnson and his team at Johns Hopkins University has played a significant role in the renaissance of psychedelics and its growing acceptance within the scientific and medical communities. We are honored to begin working with them to advance this important study,” said Chief Science Officer of Mydecine, Rob Roscow. “Additionally, as Mydecine advances its own commercialized efforts to develop novel molecules and drug candidates like MYCO-001, the work of Dr. Johnson will inform as to how we can best build upon the academic success seen in this field and advance real world treatment options for the patients who desperately need them.”

Dr. Matthew W. Johnson, Ph.D., is a professor of psychiatry and behavioral sciences at Johns Hopkins University. 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. As principal Investigator, he developed and published the first research on psychedelic treatment of tobacco addiction in 2014. Dr. Johnson was the 2019 president of the Psychopharmacology and Substance Abuse Division of the American Psychological Association and is current president of the International Society for Research on Psychedelics, an organization he founded with colleagues.

About Mydecine Innovations Group

Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and addiction. Mydecine Innovations Group was founded in 2019 on the guiding principle that there is a significant unmet need and lack of innovations in the mental health and therapeutic 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 with a focus on psychedelic 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 view mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA with international offices in Leiden, Netherlands. For more information, please visit www.Mydecineinc.com.

For more information, please contact:

Media Contacts
Courtney Ryan
CRyan@LS2group.com
1- 515-770-4823

Investor Contacts
Charles Lee, Investor Relations
corp@mydecineinc.com
1-720-277-9879

Allison Soss / Erika Kay
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1267

On behalf of the Board of Directors:

Joshua Bartch, Chief Executive Officer contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the company’s profile on SEDAR at www.sedar.com or visit the company’s website at www.mydecine.com. This news release contains forward-looking information within the meaning of Canadian securities laws regarding the company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes”, or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, or “will” be taken, occur, or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the company to adequately protect and enforce its intellectual property, the company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale, and use of the company’s products. Although the company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated, or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the company does not assume any obligation to update or revise them to reflect new events or circumstances as required under applicable securities legislation.

Source: Mydecine Innovations Group Inc.

Released September 7, 2021

Posted on

Mydecine to Participate in Upcoming Conferences in September 2021

Mydecine to Participate in Upcoming Conferences in September 2021

DENVER, Sept. 02, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and addiction, today announced that Josh Bartch, CEO of Mydecine, will participate in three upcoming conferences:

  • H.C. Wainwright 23rd Annual Global Investment Conference to be held virtually on September 13-15, 2021. Mr. Bartch’s corporate presentation will be available on-demand starting Monday, September 13th at 7:00 a.m. ET.
  • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit to be held virtually on September 20-23, 2021. Mr. Bartch will present on Tuesday, September 21st at 1:15 p.m. ET.
  • Maxim’s Advances in Mental Health Conference to be held virtually on Wednesday, September 22, 2021.  Mr. Bartch will participate in the Addiction, Delivery/Manufacturing/Technology and Next-Gen NCEs panels as part of the “Disruptors in the Mental Health Space” virtual panel series.

For more information about the conferences, or to schedule a one-on-one meeting with Mydecine management, please contact your appropriate representative directly, or send an email to H.C. Wainwright at lk@hcwco.com, Oppenheimer at opcoconferences@opco.com, Maxim at jthompson@maximgrp.com, or KCSA Strategic Communications at MYCO@kcsa.com.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA)  is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders and addiction. Mydecine Innovations Group was founded in 2019 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and therapeutic 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 with a focus on psychedelic 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 view mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Facebook, Twitter, and Instagram.

For more information, please contact:

Media Contacts
Anne Donohoe / Nick Opich
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1265 / 1-212-896-1206

Investor Contacts
Charles Lee, Investor Relations
corp@mydecineinc.com
1-720-277-9879

Allison Soss / Erika Kay
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1267

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

Source: Mydecine Innovations Group Inc.

Released September 2, 2021

Posted on

Mydecine Innovations Group Announces Mailing of Management Information Circular and Provides Update on Spin-Out of U.S. Cannabis Assets

Mydecine Innovations Group Announces Mailing of Management Information Circular and Provides Update on Spin-Out of U.S. Cannabis Assets

DENVER, Aug. 24, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) (“Mydecine” or the “Company”), is pleased to announce that it has filed and mailed its management information circular (the “Information Circular”) and related meeting and proxy materials for the annual general and special meeting of the shareholders of the Company to be held virtually on Monday, September 20, 2021 at 11:00 a.m. (Pacific time) (the “Meeting”).

The purpose of the Meeting is, among other things, to consider and, if thought advisable, to pass a special resolution approving the Company’s previously announced spin-out transaction (the “Transaction”) by way of a court-approved plan of arrangement under the Business Corporations Act (British Columbia) pursuant to an amended and restated arrangement agreement dated August 9, 2021 (the “Arrangement Agreement”) between Mydecine and Alt House Cannabis Inc. (“Spinco”). Spinco is a wholly-owned subsidiary of Mydecine, recently incorporated for the purposes of the Transaction. As part of the Transaction, Mydecine will transfer to Spinco all of the Company’s interests in: (i) 1176392 BC Ltd; (ii) Alternative Distribution Company, LLC; (iii) Drink Fresh Water, LLC; (iv) Tealief Brands, LLC; (v) Relyfe Brands, LLC; (vi) We are Kured, LLC; and (vii) Trellis Holdings Oregon OP, LLC (collectively, the “U.S. Cannabis Subsidiaries”) in exchange for 2,500,000 common shares of Spinco (the “Spinco Shares”). Mydecine’s current shareholders will receive such 2,500,000 Spinco Shares in proportion to their shareholdings in Mydecine, being 0.010416 Spinco Shares for each common share of Mydecine held. Holders of Mydecine warrants (NEO: MYCO.WT) who validly exercise such warrants following the Transaction shall receive, for each warrant held, one whole Mydecine common share and, for no additional consideration, 0.010416 Spinco Shares.

Upon completion of the Transaction, Mydecine’s principal business will focus on the development and commercialization of solutions for treating mental health problems through its psilocybin research and development and it will no longer be involved in the manufacturing or sale of cannabis and CBD products.

The purpose of the Transaction will be, among other things, to allow the Company to pursue business and financing opportunities unavailable to it while it continues to hold an interest in the U.S. Cannabis Subsidiaries, including its proposed listing on NASDAQ Capital Markets and the London Stock Exchange. The Information Circular contains, among other things, a detailed description of the Transaction, including additional reasons therefor, and other information relating to Mydecine and Spinco following the Transaction.

On August 20, 2021, the Company obtained an interim order (the “Interim Order”) of the Supreme Court of British Columbia, which, among other things, authorizes the calling and holding of the Meeting, stipulates the dissent rights granted to the Company’s shareholders, and specifies certain other matters relating to the conduct of the Meeting. The Transaction remains conditional on the approval of the shareholders of Mydecine at the Meeting in accordance with the Interim Order. The Transaction also remains conditional on the approval of the Aequitas Neo Exchange and final approval of the Supreme Court of British Columbia.

The Transaction is expected to close on or about September 27, 2021.

Following the Transaction, Spinco is expected to be an unlisted public company. Spinco intends to apply to list its common shares on the Canadian Securities Exchange or the Aequitas Neo Exchange following completion of the Arrangement, although there can be no assurances that such listing will be achieved.

ON BEHALF OF THE BOARD OF MYDECINE INNOVATIONS GROUP

“David Joshua Bartch”

David Joshua Bartch, Chief Executive Officer

For more information:

Media Contact
Courtney Ryan
LS2group
cryan@ls2group.com
515-770-4823

Investor Contacts
Charles Lee, Investor Relations
corp@mydecineinc.com
1-720-277-9879

Allison Soss / Erika Kay
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1267

About Mydecine Innovations Group

Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms.

Learn more at: https://www.mydecine.com/ and follow us on Facebook, Twitter, and Instagram.

Forward-Looking Statements

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Forward looking-information in this news release includes, but is not limited to: statements with respect to completion of the Arrangement; benefits of the Arrangement; obtaining Shareholder and final court approval of the Arrangement; the listing of Spinco Shares on a stock exchange and timing thereof; the listing of Mydecine shares on NASDAQ Capital Markets and the London Stock Exchange; and timing of closing of the Arrangement. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

Source: Mydecine Innovations Group Inc.

Released August 24, 2021

Posted on

If you missed the cannaBUS, jump on the psilocybin train

Maxim Group Gives Buy Rating To 10 Psychedelic Stocks: Compass, MindMed, Cybin, Field Trip And More

Now is the time to buy these 10 psychedelic stocks.

When the cannabis company GW Pharmaceuticals sold for billions earlier this year, those who didn’t invest were left with major regret. If you missed out on cannabis, now is your chance to be an early investor in the shroom boom as psychedelic companies begin to follow a similar pathway. These 10 companies are worth the buy according to Maxim Group’s latest analysis.

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