Posted on

PharmaTher Announces Successful Completion of Pre-IND Meeting with FDA for the Clinical Development of Ketamine in the Treatment of Parkinson’s Disease

TORONTO, Feb. 04, 2021 (GLOBE NEWSWIRE) — Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), who through its wholly-owned subsidiary, PharmaTher Inc. (“PharmaTher”), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, announced today the successful completion of a Type B pre-Investigational New Drug (“pre-IND”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding PharmaTher’s clinical development plan and its proposed Phase 2 clinical study for ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease (“LID-PD”). Based on the FDA’s feedback from the written response meeting, the FDA confirmed that a 505(b)(2) regulatory pathway is acceptable, which allows for the potential to accelerate the clinical development for drug approval.

In addition to responses of several aspects of the nonclinical and clinical development plan, the FDA was supportive of the proposed Phase 2 clinical study and the use of the Unified Dyskinesia Rating Scale score at three weeks as the primary efficacy endpoint. The FDA also recommended to include various efficacy and safety parameters and endpoints in the proposed Phase 2 clinical study to support future pivotal clinical trials, also known as ‘registration studies’ used by regulatory authorities to evaluate a drug’s safety and efficacy for commercial approval.

PharmaTher will proceed to file an IND application in Q1-2021 with the aim to initiate the Phase 2 clinical study in Q2-2021.

“We were very pleased with the outcome of our pre-IND meeting with the FDA as it provided positive guidance to support our clinical development program for ketamine to treat Parkinson’s disease patients while also outlining the various safety and efficacy endpoints to be used in the Phase 2 study to support a potential Phase 3 clinical study in the future,” said Fabio Chianelli, CEO of PharmaTher. “We have an exemplary clinical and regulatory team that will focus on completing our IND application with the goal to initiate the Phase 2 clinical study in Q2-2021.”

The Company has assembled a prolific scientific and clinical team experienced in Parkinson’s disease, including Dr. Scott Sherman and Dr. Torsten Falk from the University of Arizona, Dr. Alberto Espay from the University of Cincinnati and Dr. Robert Hauser from the University of South Florida.

Ketamine is an FDA-approved drug with a known safety profile. PharmaTher entered into an exclusive license agreement with the University of Arizona to develop and commercialize ketamine to treat Parkinson’s disease and movement disorders.
​
​Study results from preclinical studies and case studies in Parkinson’s disease patients from the University of Arizona have shown that low-dose sub-anesthetic ketamine infusion indicates tolerability, safety and the potential of long-term therapeutic benefit to reduce levodopa-induced dyskinesia, improve on time, and reduce depression.1-5

​Parkinson’s disease is a debilitating disorder that affects over 1 million people in the U.S. and more than 7 million people worldwide. There is currently no cure for Parkinson’s disease, although some drug combinations are used to treat the disease symptoms. The global Parkinson’s disease market is expected to grow from USD $5 billion in 2019 to USD $7.5 billion by the end of 2025 6 and it is estimated that the potential market opportunity for LID-PD to be over USD $3 billion in the U.S. alone.

​About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, such as ketamine, for FDA approval to treat mental health, neurological and pain disorders.

​Learn more at:  PharmaTher.com and follow us on Twitter, LinkedIn and Facebook.

​For more information, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Inc.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement
​
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Newscope Capital Corporation’s (the “Company) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of November 30, 2020 (“MD&A”), dated January 27, 2021, which is available on the Company’s profile at www.sedar.com.

​​This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

References:

  1. UA Clinical Trial to Repurpose Ketamine for Parkinson’s Patients.
  2. US20190060254A1— Compositions and methods for treating motor disorders.
  3. Bartlett, et al, 2020. Preclinical evidence in support of repurposing sub-anesthetic ketamine as a treatment for L-DOPA-induced dyskinesia. Experimental Neurology. Volume 333.
  4. Bartlett, M.J., Joseph, R.M., LePoidevin, L.M., Parent, K.L., Laude, N.D., Lazarus, L.B., Heien, M.L., Estevez, M., Sherman, S.J., Falk, T., 2016. Long-term effect of sub-anesthetic ketamine in reducing L-DOPA-induced dyskinesias in a preclinical model.
  5. Sherman, S.J., Estevez, M., Magill, A.B., Falk, T., 2016. Case reports showing a long-term effect of subanesthetic ketamine infusion in reducing L-DOPA-induced dyskinesias. Case Rep. Neurol. 8, 53–58.
  6. 360iResearch 2020.
Posted on

Core One Labs Announces Its Entrance into the Ketamine Space With Proposed Acquisition of Ketamine Infusion Centers of Texas

Vancouver, British Columbia, Canada – February 4, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company”) a biotechnology research and development company focused in life sciences and on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy is pleased to announce it has entered into a letter of intent (the “Letter of Intent”) dated January 20, 2021 with Ketamine Infusion Centers of Texas, LLC (“KICT”), an arms-length-party, to review a potential acquisition of KICT.

KICT is a Health and Wellness Clinic located in Woodlands, Texas that was established to address treatment-resistant depression and other mental health disorders, through the delivery of Ketamine infusion treatments.  KICT aims to be known as a centre of excellence in the management of treatment-resistant depression and strives to achieve this by providing unparalleled and individualized care based on the uniqueness of eachclient. Using research-based data, KICT has created proven, effective treatment protocols that have helped patients suffering from treatment-resistant depression, as well as other mental health disorders.  These include major depressive disorder, bipolar disorder, post-partum depression, post-traumatic stress disorder and obsessive compulsive disorder.

“The acquisition of KICT poses an exciting growth opportunity for Core One as we endeavour to broaden our footprint in the ‘psychedelics as alternative medicines’ market and expand our presence in medical clinics across North America. It is our first step into the leading psychedelic treatment methodology in the US which opens up a whole new market for us” stated Joel Shaker, CEO of the Company.

“KICT’s history as established practitioners in this burgeoning field, and Core One’s ongoing research and development in alternative psychedelic medicines and delivery methods, create a unique and international platform to address mental health. This acquisition is the first step in building our foundation and infrastructure in the US, where regulations surrounding psychedelics are shifting rapidly. Given KICT’s cutting edge treatment approach and client base, Core One is positioned to take advantage of a variety of new treatment options that are going through the FDA process. Furthermore, this provides us with an impressive avenue to conduct research and clinical trials to create additional novel IP.”

ABOUT KETAMINE

Ketamine is a legal drug and at a sub-anesthetic dose produces a non-ordinary state of consciousness that produces psychedelic and euphoric effects. Ketamine is showing much success in providing symptom relief for depression, anxiety, and other mental health conditions when administered in conjunction with psychotherapy.

In 2000 Yale University published the first study on Ketamine’s use for the treatment of depression. Since this first study many subsequent studies have been published, providing evidence of the safety and efficacy of Ketamine, as an alternative treatment method. The use of Ketamine has been so effective that Dr. Thomas Insel, Director of the National Institutes of Health stated, “Recent data suggest that Ketamine, given intravenously, may be the most important breakthrough in antidepressant treatment in decades”.

According to the World Health Organization, 300 million people worldwide have depression. 16.2 million Americans or roughly 7% have experienced depression in the past year. 10.3 million Americans have experienced an episode that has caused severe impairment including loss of jobs and relationships. Depression is the leading cause of disability worldwide. The total economic burden is estimated to be $210 billion annually.

“There are many facets of depression including bipolar disorders, anxiety disorders, and post-traumatic stress disorder (PTSD). We all have been affected by depression in one way or another. Many of  us witnessing firsthand what depression can do to a loved one, a close friend, or work colleague. Depression can create an incredible void in these individuals, yet unfortunately, depression and the field of mental health has taken a back seat in our present day culture. Unlike diagnoses such as hypertension, coronary artery disease, or diabetes, depression is not a condition that is well accepted by society and causes people with this disorder to withdraw even further away, shutting out the world around them,” stated Michael Nguyen, M.D., Psy.D., Medical Director of KICT.

LETTER OF INTENT TERMS

Pursuant to the terms of the Letter of Intent, it is contemplated that the Company would acquire all of the outstanding membership interests in KICT in consideration for US$200,000, which would be satisfied through the issuance of common shares of the Company upon closing.

Completion of the acquisition of KICT is subject to a number of conditions, including, but not limited to, completion of due diligence, negotiation of definitive documentation and the receipt of any required regulatory approvals.  The proposed acquisition is not expected to constitute a fundamental change for the Company, nor is it expected to result in a change of control of the Company, within the meaning of applicable securities laws and the policies of the Canadian Securities Exchange.

ABOUT CORE ONE LABS INC.

Core One Labs Inc. is a biotechnology research and technology company focused in life sciences and on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy.  The Company has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. With this technology, the Company intends to further develop its IP technology to focus on delivering psychedelic molecules with an initial focus on psilocybin. Core One also holds an interest in walk-in medical clinics which maintain a database of over 200,000 patients combined. Through research and development in these clinics, including the integration of its intellectual property related to psychedelic treatments and novel drug therapies, the Company intends to work towards regulatory approval for research that advances psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. The Company cautions that all forward looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with environmental and governmental regulations. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information. In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription. Health Canada has not approved psilocybin as a drug for any indication. Core One Labs Inc. does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One Labs Inc. believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One Labs Inc. does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

Posted on

Mydecine Innovations Group Receives Conditional Approval to List on NEO Exchange

Published at PychedelicFinance.com

‍

DENVER, Feb.  01, 2021 — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine”), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, announced today that it has received Conditional Approval to migrate and uplist its common shares with the NEO Exchange (“NEO”). Final approval is subject to the Company fulfilling all of NEO’s listing requirements.

With the impending migration from the CSE to the NEO, the Company is positioning its common shares to be traded on a senior exchange in Canada, providing exposure to an increased number of retail and institutional investors.

“The NEO is a senior stock exchange which offers a highly personalized approach to service while providing enhanced liquidity, and increased access to retail and institutional investors. Becoming a NEO-listed company represents a significant milestone for Mydecine to expand our appeal to a larger shareholder base and raise the company’s profile among the investment community. As a senior exchange, NEO provides added liquidity and exposure to institutional investors to allow our growth to continue, which simply is not available on the junior exchanges,” said Josh Bartch, CEO and Co-Founder of Mydecine.

The anticipated uplisting is not expected to impact the ability of current investors to trade shares of Mydecine and the symbol will remain ‘MYCO.’

About Mydecine Innovations Group
Mydecine Innovations Group™ (CSE: 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.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

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

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.

The NEO Exchange has neither approved nor disapproved the contents of this news release and is not responsible for the adequacy and accuracy of the contents herein.

The CSE has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

Certain information contained herein may constitute “forward-looking information” under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “will be”, “looking forward” or variations of such words and phrases or statements that certain actions, events or results “will” occur. Forward-looking statements regarding the Company increasing investors awareness are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Mydecine to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Mydecine will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.

‍

Posted on

PharmaTher Signs Exclusive Worldwide License Agreement for Patented Microneedle Delivery Technology to Deliver Ketamine

TORONTO, Feb. 01, 2021 (GLOBE NEWSWIRE) — Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), who through its wholly-owned subsidiary, PharmaTher Inc. (“PharmaTher”), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce that PharmaTher has entered into an Exclusive Worldwide Patent and Know-how License Agreement (the “Agreement”) with The Queen’s University of Belfast (“QUB”) for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to support PharmaTher’s product and clinical development initiatives with ketamine.

PharmaTher will incorporate KETABET™, its licensed patented formulation that combines FDA-approved ketamine and betaine, with Professor Donnelly’s patented hydrogel-forming microneedle (“MN”) patch technology.

The proposed KETABET™ MN patch offers a potential game-changing therapeutic solution to treat mental health disorders, neurological and pain disorders.

Most recently, Professor Donnelly’s lab successfully completed research and published a paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery” validating the delivery of esketamine, the S(+) enantiomer of ketamine, in a novel microneedle patch which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format.1

The FDA granted Fast Track and Breakthrough Therapy designations for SPRAVATO® (esketamine) nasal spray and in March 2019 approved SPRAVATO®, in conjunction with an oral antidepressant, for treatment-resistant depression to Janssen Pharmaceuticals, Inc. SPRAVATO® requires numerous administration sessions in a certified medical office under medical supervision by a health care provider.3 An equity analyst predicted that SPRAVATO® could generate $3 billion in peak sales.4

PharmaTher’s KETABET™ MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than being under supervision by a healthcare provider at a certified medical office. KETABET™ MN patch has the potential for enabling continuous delivery of KETABET™ (without pain) with minimal formulation manipulation into systemic circulation while maintaining constant plasma levels for more than 24 hours that will improve efficacy and compliance for patients.1-2

Also, PharmaTher’s KETABET™ MN patch will incorporate anti-tampering and anti-abuse features because of the combined presence of ketamine and betaine and the delivery format of the product that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

PharmaTher has the exclusive worldwide license for KETABET™ which has shown in clinical research to enhance the antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine.5 Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.

The patented MN technology licensed by PharmaTher consists of hydrogel-forming microneedle arrays and accompanying reservoir which will overcome any limitations by the quantity of drug that can be loaded into the needles or onto the needle surfaces. As such, the MN technology can greatly increase the amount of drug that can permeate through the microneedle array and into the skin.2

“With this exclusive license we have created a solid intellectual property foundation and a development and commercialization path for KETABET™ MN patch that could potentially change the way how mental health, neurological and pain disorders are treated,” said Fabio Chianelli, CEO of PharmaTher. “We are pursuing the clinical development of KETABET™ MN patch to overcome the current limitations of ketamine and to unlock the known potential therapeutic value of ketamine as a prescription for regulatory approval worldwide. We look forward to working with Professor Donnelly in delivering the next generation ketamine solution.”

Professor Ryan Donnelly commented: “Our recent research with esketamine in our patented microneedle technology shows the potential of an alternative delivery method that can overcome the limitations of current ketamine delivery options without comprising the safety and compliance of patients. I am excited to work with PharmaTher in their quest to develop a next generation ketamine solution that could help the millions of people who suffer from mental health worldwide.”

Professor Ryan Donnelly is the Chair of Pharmaceutical Technology at QUB. He is a leading expert and researcher in the field of transdermal delivery with primary focus on microneedle drug delivery and its applications on improving therapeutic outcomes for patients. He has authored over 600 peer-reviewed publications, including several granted patents, 5 textbooks and approximately 250 full papers. His work has attracted numerous awards, including the Academy of Pharmaceutical Sciences Innovative Science Award in 2020, the Controlled Release Society Young Investigator Award in 2016, BBSRC Innovator of the Year in 2013, the GSK Emerging Scientist Award in 2012 and the Royal Pharmaceutical Society Science Award in 2011. He graduated with a B.Sc. degree in pharmacy (1999) and a Ph.D. in pharmaceutics (2003) from QUB.

Under the terms of the Agreement, PharmaTher gained exclusive worldwide development and commercial rights to an intellectual property portfolio consisting of granted patents in the U.S., Europe, Japan, India and China and know-how pursuant to the hydrogel-forming microneedle technology for use in the field of ketamine, esketamine, betaine and combinations thereof.

PharmaTher and QUB agreed to terms consistent with industry standards, including future payments based on clinical trial and revenue milestones.
​

About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, such as ketamine and psilocybin, for FDA approval to treat mental health, neurological and pain disorders.
​Learn more at:  PharmaTher.com and follow us on  Twitter, LinkedIn and Facebook.
For more information, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Inc.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Newscope Capital Corporation’s (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of November 30, 2020 (“MD&A”), dated January 27, 2021, which is available on the Company’s profile at www.sedar.com.
​
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

References:

  1. Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.
  2. Donnelly R.F. Hydrogel-forming microneedles prepared from “super swelling” polymers combined with lyophilised wafers for transdermal drug delivery. PLoSONE. 2014 doi: 10.1371/journal.pone.0111547.
  3. https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified
  4. https://www.fiercepharma.com/pharma/j-j-s-depression-nasal-spray-spravato-carrying-big-expectations-and-restrictions-scores-fda
  5. J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice, Psychopharmacology (Berl). 233 (2016) 3223–32
Posted on

Mydecine Innovations Group Sponsors Study on Neuron Level Response to Psilocybin at University of Maryland

Published at GlobeNewswire.com

‍

DENVER, Jan. 28, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced therapeutic medicine for mainstream use, announced that it is sponsoring a study titled: “Facilitating extinction of fear with psilocybin: Model development of biomarkers and mechanisms,” at the University of Maryland School of Medicine in Baltimore, Maryland.

The research, led by Principal Investigator Dr. Jaylyn Waddell, Assistant Professor of Neuroscience, will be testing a novel hypothesis on the mechanism of psilocybin action in a lab setting. The goal of the research is to get a pointed understanding of the heightened plasticity that permits the therapeutic response to psilocybin in order to obtain a better understanding of when, where and how psilocybin is most appropriate for use in human therapeutics.

“Our laboratory, with Dr. Aditi Banerjee, will examine inhibition of fear, and the effect of psilocybin on markers of brain maturity and plasticity,” said Dr. Waddell. “Inhibition of fear, facilitated by psychedelic drugs in many therapeutic contexts, is paradoxically more stable in the immature brain. This is an intriguing potential insight into the mechanism of psilocybin and provides a roadmap for biomarker discovery. Patterns in peripheral biomarkers can inform treatment, enhancing our understanding of mental health states that are amenable to psychedelic medicine. Though we tend to use general terms like depression and anxiety, the etiology of such states is diverse. We will use the sensitive acoustic startle reflex to model fear learning and its inhibition. The startle reflex is highly translational, capturing the hypervigilance and anxiety experienced in humans suffering from PTSD. Behavioral studies will be coupled with functional resting state neuroimaging, genetic sequencing of peripheral blood markers of pathology and plasticity as well as mechanistic molecular assays with a focus on translation to humans.”

“The University of Maryland has a well-earned reputation as one of the leading research institutions advancing the promise of psychedelic medicines to solve some of humanity’s greatest mental health issues,” said Josh Bartch, CEO and Co-Founder of Mydecine. “Dr. Waddell in particular has done tremendous work in the field of behavioral neuroscience and we are excited to be a part of her scientific research. Applying a strict scientific understanding as to how our brain’s respond to psychedelic molecules like psilocybin will be tremendously important as we move forward to establish the protocols for our Phase 2A clinical trials and future research.”

Dr. Waddell is an Assistant Professor of Neuroscience at the University of Maryland. Her research focuses on developmental brain injury and recovery with a focus on sex differences. Dr. Waddell’s training focused heavily on Pavlovian conditioning, learning and contextual modulation of acquired associations and she now applies this background to understand how to improve long-term functional outcomes post-brain injury.

About Mydecine Innovations Group
Mydecine Innovations Group™ (CSE: 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.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

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

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.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. 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, 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. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.

Posted on

Mydecine Innovations Group Files Application to list to the NASDAQ

Published at GlobeNewswire.com

‍

DENVER, Jan. 27, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, announced that it has submitted a formal application to list its common shares (“Shares”) on the NASDAQ Stock Exchange (“NASDAQ”). NASDAQ is the second largest exchange by market capitalization worldwide and is home to many of the world’s best technology companies.

In connection with its application to list on NASDAQ, Mydecine expects to, in due course, file a Form 20-F Registration Statement with the United States Securities and Exchange Commission (SEC). Acceptance for listing the Company’s shares is subject to approval based on several factors including satisfaction of minimum listing requirements for the NASDAQ Capital Market. The Company intends to satisfy all of the applicable listing requirements; however, there is no assurance that its application will be approved. During the NASDAQ review process, the Company’s common stock will continue to trade in Canada on the CSE under its current symbol, MYCO and on the OTC under the symbol, MYCOF.

“We believe the Company is entering an accelerated growth phase and the timing could not be better for listing our Shares to NASDAQ,” said Josh Bartch, CEO & Chair of Mydecine. “This listing is intended to open the investment opportunity to a larger and more diverse pool of investors and help create greater shareholder value. A listing on the NASDAQ Capital Market is a natural progression for the Company and our shareholders.”

The Company has engaged Ellenoff Grossman & Schole LLP (EGS) as its US legal counsel to oversee the process of the NASDAQ listing.

About Mydecine Innovations Group
Mydecine Innovations Group™ (CSE: 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.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

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

‍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.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. 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, the ultimate approval of the Company’s listing application on the NASDAQ, 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. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.

‍

Posted on

Nova Launches Preclinical Autism Spectrum Disorder Therapeutic Study Develops Microbiome Diagnostic Index

January 26, 2021 6:00 am Published by 

Develops Microbiome Diagnostic Index
Novamentis

Vancouver, British Columbia – January 26, 2021 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCPK: LIBFF) (“NOVA” or the “Company”) is pleased to announce that it has commenced the diagnostic and treatment phase of its ongoing preclinical model study of autism spectrum disorder (ASD).   In this model, which is well accepted by neuroscientists, pregnant rats are exposed to valproic acid (VPA) and the resultant offspring have ASD behavioral symptoms.

NOVA had previously identified statistically significant changes in levels of inflammatory molecules, called cytokines, and in certain bacterial species within the intestinal microbiome of the ASD animals. In the current study, the Company will continue its measurement of the microbiome and cytokines in the animals with severe ASD behavioral symptoms and comparisons will be made to control animals. A treatment phase with its proprietary psilocybin compound is scheduled to begin in February 2021.

NOVA is also pleased to inform the medical community that the Company is actively designing human clinical observational study protocols to further confirm its Microbiome Diagnostic Index in ASD. Clinical protocols will be submitted for Institutional Review Board (IRB) approval in the U.S. and Europe as well as appropriate regulatory authorities.

“I am excited with the recent progress made by NOVA scientists, especially the announcement of our ASD psychedelic treatment study and the associated clinical application of our newly developed Microbiome Diagnostic Index,” stated Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “We’re studying the microbiome-related correlates of VPA-induced Autism Spectrum Disorder (ASD) associated behaviors in a rodent model. In particular, we will be looking at temporal changes in the biome in newborn rodents prior to weaning, which has direct application to the human disorder.”

The utilization of the VPA ASD behavioral rat model was based on several facts. ASD is a developmental disorder whose main features are impairments in social interaction and verbal/non-verbal communication, together with stereotyped patterns of behavior. Despite scientific and clinical studies to date, the causes of ASD are still unknown. What is known is that human prenatal exposure to the drug valproate (VPA) is associated with increased risk of neurodevelopmental problems, cognitive deficits, and autism in children.

Dr. Trezza has shown that “a single prenatal injection of VPA in rodents results in behavioral impairments resembling the core signs of ASD, supporting the high face validity for prenatal VPA as an animal model of autism.” – Tartaglione, 2019(1). Several other research groups confirm these findings.

NOVA’s scientific premise is that the autism pathway induced by VPA may involve similar factors causing other chronic human diseases, including genetic, environmental chemicals, infections, neuroinflammation (oxidative stress), immune system dysfunction and alterations in the microbiome.

The Microbiome Diagnostic Index is being developed with the assistance of Dr. Kyle H. Ambert, a member of the NOVA Scientific Advisory Board.   Dr. Ambert is currently Director of Data Science at Nike, Inc., and has extensive experience in data analytics, machine learning, artificial intelligence, and applied analytics.  It is the goal of the Company to utilize machine learning to create a statistically objective biomarker program to measure psychedelic treatment response.  As drug design and discovery becomes more personalized, machine learning methods are poised to become a central component of the pharmaceutical development workflow.

(1) Tartaglione, A.T., Schiavi, S., Calamandrei, G. and Trezza, V. 2019. Prenatal valproate in rodents as a tool to understand the neural underpinnings of social dysfunctions in autism spectrum disorder. Neuropharmacology 159,107477.

About Nova Mentis Life Science Corp.

Nova Mentis Life Science Corp. is a Canadian based biotechnology company that is focused on the emerging field of psychedelic medicine. The Company aims to become a global leader in this field by integrating the latest state-of-the-art medical and scientific technology into its drug development program. The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as Autism Spectrum Disorder (ASD).

For further information on the Company, please visit https://www.novamentis.ca or email info@novamentis.ca.

On Behalf of the Board
Will Rascan, President & CEO
Nova Mentis Life Science Corp.

Phone: 778-819-0244
Toll Free: 1-833-542-5323
Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential” and similar expressions, or that events or conditions “will,” “would,” “may,” “could” or “should” occur.

Posted on

Core One Labs Announces Vocan Assembles Equipment to produce biosynthesized Psilocybin

Vancouver, British Columbia, Canada – January 23, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company”) is pleased to announce its wholly-owned subsidiary Vocan Biotechnologies Inc. (“Vocan”) has assembled the necessary equipment, which will allow the laboratory to commence the process of recombinant production of psilocybin.  The process that engineers bacteria incorporating optimized biosynthetic genes from the Psilocybe cubensis mushroom, will enable the bacteria to act as a biological factory and synthesize psilocybin that is cost effective using simple building blocks.

Vocan’s platform can make the active compounds that occur naturally, by using a gene mimicry process and simple chemical modifications to enable the creation of bioidentical compounds as well as known and novel analogs.  The analog compounds could prove to be more effective, targeted and safer.

Vocan has now received and assembled equipment required to move forward on its plan to produce biosynthesized psilocybin. Due to the cost and long lead times, this is a critical milestone in the company’s plan. The equipment enables Vocan to improve on the current work being conducted in the lab and puts Vocan ahead of schedule on its plan to begin the recombinant production of psilocybin.

“Vocan’s recombinant production of psilocybin is a significant improvement over the current methods of psilocybin production. Reducing both the cost and time needed to produce and purify psilocybin to only a few days, compared to much longer and more expensive methods for whole mushroom extraction. Having the equipment purchased and assembled positions Vocan to execute on its objectives in the short term.” Stated Joel Shacker CEO of the Company.

Further to the Company’s press release dated January 15, 2021 announcing the closing of its sale of non-core assets, the Company wishes to correct that it has issued a total of 500,000 common shares as an administrative fee to three arms-length third-parties who assisted with facilitating such sale, not 350,000 shares to two parties, as previously announced.

About Core One Labs Inc.

Core One Labs Inc. is a biotechnology research and development company focused in life sciences and on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy.  The Company has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. With this technology, the Company intends to further develop its IP technology to focus on delivering psychedelic molecules with an initial focus on biosynthesized psilocybin. Core One also holds an interest in walk-in medical clinics which maintain a database of over 200,000 patients combined. Through research and development in these clinics, including the integration of its intellectual property related to psychedelic treatments and novel drug therapies, the Company intends to work towards regulatory approval for research that advances psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

 

Cautionary Disclaimer Statement:

 

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

 

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. The Company cautions that all forward looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with environmental and governmental regulations. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information. In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription. Health Canada has not approved psilocybin as a drug for any indication. Core One Labs Inc. does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One Labs Inc. believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One Labs Inc. does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

Posted on

Mydecine Innovations Group Included in First-Ever Psychedelics ETF

Published at globenewswire.com

‍

DENVER, Jan. 22, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, has been included in the first-ever Psychedelics Exchanged Traded Fund (ETF).

The Horizons Psychedelic Stock Index ETF index, which was announced in December 2020 and includes 17 companies in the U.S. and Canada, is expected to start trading on Tuesday, January 26 under the ticker PSYK on the NEO exchange.

“While medicinal psychedelics are certainly not new, the legal market and the ability to invest in these cutting-edge companies certainly is new,” said Joshua Bartch, Co-Founder & CEO, Mydecine. “Together, with these 17 companies, Mydecine is helping to build an industry that is investing in and researching innovative solutions for treating previously untreatable mental illness. We are honored that we are included, and we are also mindful that this now gives more people, who may be new to the space, the ability to access and diversify their investments. By having exposure to many different companies with solid fundamentals, but different approaches, philosophies, indications, and technologies, is healthy for investors in the industry.”

The ETF will will track an underlying index – the North American Psychedelic Stock Index – provided by the German-based Solactive. Additional details on the ETF, including how it is weighted and conditioned, can be found here.

Additionally, the Company will be participating in the KCSA Virtual Psychedelics Investor Conference, at 10:20 AM ET on Wednesday January 27, 2021.

About Mydecine Innovations Group
Mydecine Innovations Group™ (CSE: 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.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

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

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.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. 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, 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. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.

‍

Posted on

Mydecine Innovations Group Files Preliminary Prospectus

Published at Yahoo!Finance

‍

Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, is pleased to announce that, in connection with its bought deal offering (the “Offering”) previously announced on January 14, 2021, it has filed a preliminary short form prospectus (the “Preliminary Prospectus”) with the securities commissions or similar authorities in each province of Canada, other than Quebéc, and entered into an underwriting agreement with Canaccord Genuity Corp. (the “Underwriter”) dated January 20, 2021 (the “Underwriting Agreement”).

Pursuant to the Underwriting Agreement, the Underwriter has agreed to purchase, on a bought deal basis, an aggregate of 30,000,000 units of the Company (the “Units”) at a price of C$0.50 per Unit (the “Issue Price”) for aggregate gross proceeds to the Company of C$15,000,000 (the “Offering”). Each Unit will be comprised of one common share in the capital of the Company (a “Common Share”) and one Common Share purchase warrant (a “Warrant”). Each Warrant will be exercisable to acquire one Common Share (a “Warrant Share”) for a period of 36 months following the Closing Date at an exercise price of $0.70 per Warrant Share. The Company also granted the Underwriter an over-allotment option to purchase up to an additional 4,500,000 Units at the Issue Price for a period of 30 days following the Closing. If the Over-Allotment Option is exercised in its entirety, the aggregate gross proceeds of the Offering will be C$17,250,000.

Pursuant to the Underwriting Agreement, the Underwriter shall be paid (i) a cash commission equal to 7.0% of the aggregate gross proceeds of the Offering and (ii) such number of warrants equal to 7.0% of the aggregate number of Units issued pursuant to the Offering, with each warrant exercisable at any time prior to the date that is 36 months from the Closing Date to acquire one Unit at the Issue Price. Additionally, the Company shall pay the Underwriter a corporate finance fee equal to that number of Units which is equal to 2.5% of the aggregate number of Units issued pursuant to the Offering.

The Company plans to use the net proceeds of the Offering to invest in additional clinical trials, for expansion of its intellectual property portfolio, continued development of its drug pipeline, expanded research and development partnerships and initiatives and for general working capital purposes.

The Offering is scheduled to close on or about February 3, 2021, or such other date as agreed to by the Company and the Underwriter, and is subject to certain conditions including, but not limited to, the receipt of all necessary approvals, including the approval of the Canadian Securities Exchange and the applicable securities regulatory authorities.

This news release does not constitute an offer to sell or a solicitation of an offer to sell any of the securities in the United States. The securities have not been and will not be registered under the U.S. Securities Act of 1933 (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons (as defined in Regulation S under the U.S. Securities Act) unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

The Preliminary Prospectus containing important information relating to these securities has been filed with securities commissions or similar authorities in each province of Canada, other than Quebéc. The Preliminary Prospectus is still subject to completion or amendment. A copy of the Preliminary Prospectus can be obtained under the Company’s corporate profile on SEDAR at www.sedar.com. There will not be any sale or any acceptance of an offer to buy the securities until a receipt for the final short form prospectus has been issued.

About Mydecine Innovations Group

Mydecine Innovations Group™ (CSE: 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.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

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

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.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. 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, and which may include, but are not limited to, statements with respect to the expected Closing date of the Offering, the listing of the Common Shares and Warrant Shares on the Canadian Securities Exchange, the use of proceeds of the Offering, and the timing of such events. 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. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210121005925/en/

‍