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Mydecine Files Full Patent Application Covering Multiple Families of Psilocin Analogs

Mydecine Files Full Patent Application Covering Multiple Families of Psilocin 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 psilocin analogs. The application includes solutions to directly address further precision in delivery control and shelf stabilization of psilocin, psilocybin’s active metabolite, both of which are critical for use in the medical setting.

When psilocybin 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 psilocin 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 psilocybin is its poor shelf stability. Mydecine’s recent filing includes a family of stabilized psilocin 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 psilocin 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 psychedelic 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 $50 million in equity and debt financing.

“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 psychedelic-based therapeutic candidates as well as meeting NASDAQ listing requirements,” said Josh Bartch, Chairman & CEO of Mydecine.

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 treat 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, Instagram and LinkedIn.

For more information, please contact:

Media Contact
Morgan Kervitsky, Director of Marketing
(720) 689-4638
pr@mydecineinc.com

Investor Relations
Morgan Kervitsky, Director of Marketing
(720) 689-4638
contact@mydecineinc.com

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.

Primary Logo

Source: Mydecine Innovations Group Inc.

Released December 6, 2021

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Mydecine Reports Third Quarter 2021 Financial Results and Provides Business Update

Mydecine Reports Third Quarter 2021 Financial 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 financial 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 psychedelics. 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 psychedelic 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 MDMA-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 psilocin 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 psychedelics 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 psychedelic-related targets.

Corporate

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

Financial Results for the Third Quarter 2021

Net Loss: Net loss attributable to common stockholders was $4.5 million for the third quarter 2021, or a basic and diluted loss per share attributable to common stockholders of $0.02, as compared to a net loss attributable to common stockholders of $17.4 million for the third quarter 2020, or a basic and diluted loss per share attributable to common stockholders of $0.11.

Cash Position: As of September 30, 2021, the Company had cash and cash equivalents of $1.6 million.

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.

MYDECINE INNOVATIONS GROUP INC.
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
UNAUDITED
(EXPRESSED IN CANADIAN DOLLARS)

As at, September 30,
2021
$		 December 31,
2020 (audited)
$
Current assets
Cash 1,593,516 2,190,702
Rent and other receivable 135,674 27,746
Inventory 41,268 47,262
Sales tax receivable 73,632 13,734
Prepaids and deposits 3,782,180 216,003
Total current assets 5,626,270 2,495,447
Non-current assets
Prepaids and deposits 1,922,559 –
Investment in joint venture 158,432 303,982
Note receivable 327,536 316,110
Investment in associate 233,579 4,481,988
Right-of-use asset 154,347 223,645
Investment properties 1,419,347 1,418,345
Property and equipment 521,867 291,614
Total assets 10,363,937 9,531,131
Current liabilities
Accounts payable and accrued liabilities 1,315,927 1,187,486
Convertible debentures 272,740 2,959,755
Derivative liabilities 837,207 1,586,744
Lease liability – current portion 76,969 69,329
Total current liabilities 2,502,843 5,803,314
Non-current liabilities
Long-term portion of lease liability 94,515 167,118
Total liabilities 2,597,358 5,970,432
Shareholders’ equity
Share capital 105,648,795 85,298,435
Contributed surplus 14,848,383 12,734,636
Equity portion of convertible debentures 17,190 254,690
Accumulated other comprehensive loss (449,317 ) (444,803 )
Deficit (112,298,472 ) (94,282,259 )
Total shareholders’ equity 7,766,579 3,560,699
Total liabilities and shareholders’ equity 10,363,937 9,531,131

 

MYDECINE INNOVATIONS GROUP INC.
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
UNAUDITED
(EXPRESSED IN CANADIAN DOLLARS)

For the three-month
period ended,		 For the nine-month
period ended,
September
30, 2021		 September
30, 2020		 September
30, 2021		 September
30, 2020
Sales 73 17,158 21,278 43,391
Cost of goods sold (35 ) (21,153 ) (10,032 ) (31,829 )
Gross margin 38 (3,995 ) 11,246 11,562
Expenses
Finance cost 22,995 19,151 146,692 19,151
Corporate development 410,424 325,038 2,838,317 1,099,728
Amortization 47,572 61,886 126,767 128,926
Consulting fees 1,617,184 461,623 3,835,207 1,744,009
Director and management fees 454,215 186,520 1,286,723 367,622
Foreign exchange loss (gain) (65,862 ) (21,233 ) 249,746 (158,014 )
Insurance 171,704 – 324,927 –
Office and miscellaneous 427,486 113,441 648,961 170,235
Share of losses (income) from investment in Joint Venture 28,503 – 136,604 –
Share of (income) from investment in Associate 45,056 (7,470 ) 86,808 (15,411 )
Professional fees 179,130 43,255 1,529,599 143,088
Regulatory and filing fees 7,879 12,644 185,791 27,091
Research and development 1,265,610 433,408 2,587,740 434,791
Salaries 311,355 – 545,686 –
Share-based payments – 3,715,421 – 4,725,174
Total expenses (4,923,251 ) (5,343,684 ) (14,529,568 ) (8,686,360 )
Other income (expenses)
Change in fair value of derivative liabilities 353,612 (740,434 ) 575,505 (740,434 )
Impairment of investment in associate – – (4,169,616 ) –
Consideration paid in excess of net assets acquired from acquisition – (10,645,239 ) – (10,645,239 )
Write-off of inventory – (458,921 ) – (458,921 )
Other income – 35 – 35
Rental income 33,073 45,293 98,539 141,715
Gain (loss) on settlement of debt – 21,879 (2,319 ) 33,304
Total other income (expenses) 386,685 (11,777,387 ) (3,497,891 ) (11,669,540 )
Net loss for the period (4,536,528 ) (17,125,066 ) (18,016,213 ) (20,344,338 )
Foreign currency translation adjustment 44,114 (279,811 ) (4,514 ) (152,659 )
Net loss and comprehensive loss for the period (4,492,414 ) (17,404,877 ) (18,020,727 ) (20,496,997 )
Net loss per share – Basic and diluted (0.02 ) (0.11 ) (0.08 ) (0.22 )
Weighted average number of shares outstanding – Basic and diluted 240,222,065 152,596,239 228,662,632 95,039,381
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Mydecine’s Chief Medical Officer, Dr. Rakesh Jetly, to Participate at Horizons’ Veterans & Families Forum on November 10, 2021

Mydecine’s Chief Medical Officer, Dr. Rakesh Jetly, to Participate at Horizons’ Veterans & Families Forum on November 10, 2021

DENVER, Nov. 10, 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 Dr. Rakesh Jetly, Chief Medical Officer of Mydecine, will be participating in a panel entitled, “The State of Care and the Case for Psychedelic Therapy” on Wednesday, November 10, 2021 at 7:30 p.m. on the eve of Veterans Day also known as Remembrance Day in Canada.

Hosted by Reconsider and Horizons PBC, the first of their events specifically for the veterans community, will take place live in NYC at Judson Memorial Church and will be available virtually worldwide. The Veterans + Families Forum explores the potential of therapies that use MDMA, psilocybin, ibogaine, and ayahuasca to transform the lives of the veterans and their families that struggle with mental health challenges following their service.

Dr. Jetly, Chief Medical Officer at Mydecine, stated, “It is an honor to participate in this Horizons event that is especially dedicated to raising awareness and advocating for our efforts to bring today’s most transformative therapies to veterans suffering from mental health issues. In “The State of Care and the Case for Psychedelic Therapy” panel, I will speak about our responsibilities to veterans and families, as it truly is our duty to provide them with the most advanced and effective therapies. Today, that treatment lies within the power of psychedelics.” It’s extremely encouraging to see these treatments gain acceptance in the marketplace and support from people such as Mike Ellis.”

Mike Ellis, Associate Minister of Mental Health and Addictions Alberta, recently spoke out about psychedelic-assisted psychotherapies highlighting the benefits they will bring to veterans calling them, “legitimate therapies”.

You can register for the event here.

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 November 10, 2021

Posted on

Creating billions of drugs with AI

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

Using an AI drug discovery program, Mydecine (MYCO) successfully added a novel psilocin analogue with improved delivery and stability to its pipeline.

The AI technology synthesizes billions of drug candidates and filters them based on psychedelic-related targets such as how they bind to receptors.

Mydecine also filed a patent for nanoemulsion technology that can:

  • help the company develop compounds inspired by traditional plant medicines such as reishi and cordyceps mushrooms
  • improve control in delivery, which is critical in microdosing and customizing dosages
  • advance development of over-the-counter consumer products

PDF of article 1

PDF of article 2

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Mydecine to Participate in Wonderland: Miami on November 8-9, 2021

Mydecine to Participate in Wonderland: Miami on November 8-9, 2021

DENVER, Oct. 29, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), a biotechnology and digital technology company focused on the treatment of mental health disorders and addiction, today announced that it will participate in Microdose’s Wonderland: Miami to be held at the Adrienne Arsht Center for the Performing Arts in Miami, FL on November 8-9, 2021.

For more information about the event, or to schedule a one-on-one meeting with Mydecine management, please request a meeting here or contact KCSA Strategic Communications at MYCO@kcsa.com.

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 treat 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 29, 2021

Posted on

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

Posted on

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

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