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The Window of Opportunity is Here

Published at smallcapexclusive.com

 

Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FRA:0NFA) Continues to Advance Research & Development Initiatives in the Field of Natural Medicines

 

Prior  to his monumental comeback at the age of 54, former World Heavyweight Boxing Champion Mike Tyson was delivered a message from a frog.

More precisely, he received the message from a psychedelic sourced from the venomous Colorado River Toad, also known as the Sonoran Desert Toad, known as 5-MeO-DMT (aka “5-MeO” or “frog venom”).

“I took the [5-MeO-DMT] and the medicine told me to get into shape,” Tyson said to USA Today.[1] “It really blew my mind. It told me to come back and start getting in shape.”

With the help of the psychedelic, Tyson lost more than 100 pounds for a major exhibition bout against Roy Jones Jr.—his first fight in 15 years.

Said to be more transcendent and less visual than its plant-based cousin DMT, 5-MeO-DMT can be a stronger experience for some.

Most 5-MeO trips are kept to under an hour, and require far smaller dose sizes than other psychedelics.

But even more impressive is the fast-acting psychedelic’s potential, which researchers at Johns Hopkins have discovered can bring about improvements in depression and anxiety.[2]

The potential for psychedelics to treat mental health issues is truly on the precipice of a major breakout—especially as acceptance of this once taboo form of treatment begins to make its way into mainstream medicine conversations.

Tyson is not alone, being among elite athletes who have looked to psychedelics to turn their life around.

Former Los Angeles Lakers star Lamar Odom successfully used the psychedelic drugs ketamine and ibogaine to combat his drug addiction[3]—crediting the drugs with saving his life.

There are other success stories, including those of NHL Enforcers Riley Cote[4] and Daniel Carcillo,[5] former NFL player Kerry Rhodes,[6] and former UFC MMA Fighters Ian McCall[7] and Dean Lister,[8] utilizing previously taboo treatments such as ayahuasca, ketamine, ibogaine, psilocybin, MDMA, and now 5-MeO-DMT.

Now these treatments are shifting from anecdotal to potential alternative medicinal reality, with the advent of clinical trials being advanced by some of the world’s top psychedelic and mental health professionals, including doctors, scientists, and molecular researchers.

Some analysts are projecting the psychedelics medicine industry to reach $6.85 billion by 2027.[9] As psychedelic companies gain acceptance within the investment community, there is an opportunity to review these companies in a new light.

Recently, a new psychedelics ETF began trading in January, and others are emerging to meet the demand, with two surpassing the US$1 billion market cap threshold.

Highlighted within this group of psychedelic companies is one company underpinned by thought leaders in medicine and science, warranting further due diligence and review: Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA).

The company recently announced and closed a bought deal financing of C$17.25 million, announced uplisting to the NASDAQ, and was just included in the inaugural psychedelics-inspired ETF.

With several clinical trials announced in 2020 and early 2021, including involvement with the first lab-based study co-sponsored by the National Institute for Health Research at Imperial College of London, and a Phase 2A clinical study on PTSD in veterans, EMS, and front-line workers, Mydecine continues to approach research and development with cautious optimism as their programs develop.

7 Reasons Why We’re Watching Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA)

  1. World-Renowned Medical and Scientific Advisory is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems.
  2. 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.
  3. 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
  4. Seven Patent Pending Applications That Represent Thousands of Inventions with multiple layers of protection on the company’s proprietary medical development pipeline.
  5. Proprietary Digital Health Platform, Mindleap, allows Mydecine to generate revenue in the fast-growing US$41.4 billion telemedicine market
  6. Numerous Clinical Trials are currently underway, including a Phase 2A clinical trial on PTSD in Veterans, EMS, and Front Line Workers, a First-of-its-Kind Microdose Study, and Preclinical Animal Work for a Late-State Addiction Study aiming at a Mechanistic Understanding of Psilocybin.
  7. Numerous Novel Next Generation Drugs Under Development: Mydecine is currently developing numerous novel next generation drugs for the treatment of various indications to improve upon the first generation of psychedelic medicines

 

Combatting the Mental Health Crisis with Psychedelics

COVID-19 is taking its toll on all of us, including rising deaths of despair[10] and an urgent mental health crisis among health workers.[11]

A recent study that screened 402 survivors of COVID-19 found that 55% presented a clinical score for at least one mental disorder, including anxiety (42%), insomnia (40%), depression (31%), PTSD (28%), and OCD (20%).[12]

Anxiety disorders are the most common mental illness in the US, affecting 40 million adults—or 18.1% of the population every year.[13]

Sadly, only 36.9% of those suffering receive treatment, and MORE THAN HALF of people who take antidepressants never get relief.[14]

In cases of Veterans with PTSD, several patients are put on SSRIs, however, only 20-30% of patients achieve complete remission.[15]

SOMETHING needs to change.

Thankfully, we’re witnessing what’s being deemed a “Paradigm Shift in Psychiatric Research and Development.”[16]

That paradigm shift is coming from PSYCHEDELICS.

Now, we’re seeing mainstream coverage being given to the novel mental health approach on 60 Minutes,[17] Forbes,[18] Fox Business,[19] NPR,[20] and Today.[21]

A new wave of mental health sufferers are turning towards small doses of psychedelics, known as “micro-dosing”, to cope with depression and anxiety,[22] or even to achieve higher levels of concentration and creativity,[23] as experts are saying that “legalization is inevitable” for treatments involving psilocybin and other psychedelic treatments.

Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) is establishing psychedelic-based therapies, and addressing the unmet needs of high-risk constituents.[24]

The concept is to assist those who have been failed by the current regime of SSRIs and other established antidepressants.

Mydecine’s (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) ongoing research to date includes clinicals using psilocybin therapy for PTSD[25] (which has been featured in FORBES[26]), a clinical trial initiative with leading European Research Institute Leiden University Medical Center of the Netherlands,[27] and the first lab-based study of established microdosers at Macquarie University in Australia.[28]

An Evolving Industry Gaining Traction

While therapists are looking at innovative therapies to treat patients, the investment communities within Wall Street and Silicon Valley are also investigating new ways to approach the psychedelic sector. [29]

Naysayers of whether this type of “new medicine” could ever get mainstream acceptance were silenced, when Compass Pathways (backed by ATAI Life Sciences AG), received FDA breakthrough therapy designation on a psilocybin treatment, perhaps better known as the active medical ingredient in magic mushrooms.[30]

ATAI has raised more than US$100 million from major investors such as PayPal co-founder Peter Thiel—and later this year, they are expected to go public at a valuation of US$1-2 billion.[31]

Mydecine continues to expand its technical platforms and outreach with its available and downloadable app: MindLeap.

Through its proprietary Mindleap platform, Mydecine is also giving practitioners the ability to aid their patients better through telehealth abilities and an AI-powered progress monitoring program.

Mindleap is an after-care smart app platform that not only connects patients with their therapists, but also can significantly improve upon monitoring progress, provide follow-up treatment, and give patients other beneficial activities such as meditation, breathing work, and yoga instruction.

Mindleap currently has over 60 specialists with thousands of downloads to date, and is available on both iOS and Android devices.

Comparing Mental Health Psychedelic Stocks

At the end of 2020, the first-ever Psychedelics ETF was announced, which includes 17 companies in the US and Canada, and began trading on January 26, 2021, under the ticker PSYK on the NEO exchange. Announced among and included in that group of 17 was Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA).

Let’s take a look at some of the other Big Pharma/Mental Health Medicine Stocks.

*Market cap and share price taken from Yahoo Finance on March 9, 2021

 

As you can see, Mydecine (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) is already far along in the licensing process when compared to its peers.

 

Economic Advantages from Mushroom Research

Out of all of Mydecine’s advantages in the field of developing new medicines, perhaps its largest is its relationship with the University of Alberta, which holds an 11-year-old aged Schedule I license to research, develop, and produce a number of unique APIs (Active Pharmaceutical Ingredients) from their naturally-sourced cGMP psychedelic extracts.

Through this partnership, Mydecine (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) has established the World’s First Natural-Sourced cGMP Psilocybin supply for Global Research, Sales, and Distribution.[35]

Currently, scientists are paying $7,000 to $10,000 per gram[36] for synthetic mushroom ingredients—whereas MYCO can legally derive and produce the real organic version of the same ingredients for significantly lower than what is currently available.

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Mydecine’s Upcoming Timeline

Mydecine’s Thought Leadership

Mydecine (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) has assembled a talented team of thought leaders, whose accomplishments include:

  • 100+ published peer-reviewed studies/papers
  • World-class team coming from Pfizer, Novartis, Yale, Imperial College, and Canadian, US, and EU Militaries
  • Proven medical development and approval experience
  • 30+ years of combined psychedelic industry experience
  • Accomplished entrepreneurs, multiple successful exits
  • 7-Nobel Peace Prize Nominee

Joshua Bartch, Director, CEO & Co-Founder Bartch’s entrepreneurial career took off in 2009 when he co-founded AudioTranscriptionist.com and founded the Denver-based dispensary, Doctors Orders. Following these ventures, Mr. Bartch founded a boutique investment firm that operated throughout the US and Canadian markets. In 2014, Bartch co-founded Cannabase.io, the USA’s most significant legal and sophisticated pot wholesale platform. In 2015, Cannabase.io was acquired by Helix TCS.

Damon Michaels, Director, COO & Co-Founder Prior to joining MIG, Michaels was consulting for various hemp businesses through his company, Emerald Baron. Before that, he served as GM for the leading multi-platform cannabinoid research and technology firm based in Colorado called ebbu, which was acquired by Canopy Growth for CA$429 million in November 2018. Michaels developed a national snowboard brand with his team, was one of four entrepreneurs who created Colorado’s first-ever glass recycling company, and was on the business development team for a Google Ventures Company.

Robert Roscow, MA – CSO & Co-Founder With expertise in genomics, evolution, and molecular biology, Roscow has previously worked at both Canopy Growth and ebbu, where he ran the genetics divisions. He has filed multiple patents and holds numerous publications under his belt, including Nature and Rolling Stone.

Professor Eric Vermetten MD, Ph.D. Colonel, an internationally recognized leader in the treatment of PTSD and other mental disorders and an active Colonel of the Dutch military. He is also professor of Medical-Biological and Psychiatric Aspects of Psychotrauma, LUMC/University of Leiden. The chair was established by Arq Psychotrauma Research and the Dutch Ministry of Defense. Eric Vermetten is an active clinical psychiatrist at the MGGZ in Utrecht (Military Mental Health care). From 1991 he has been linked to several universities as a researcher, including Stanford University, Yale University, and Emory University.

Dr. Vermetten has published over 300 articles and book chapters on topics ranging from large longitudinal studies following soldiers’ deployments to innovative approaches to treatment. He continues to be a leader within the international psych traumatology community within NATO and beyond.

Dr. Rakesh Jetly, OMM, CD, MD, FRCPC is currently the Head of the Centre of Excellence on Mental Health in Ottawa, Ontario, and an associate professor of psychiatry at Dalhousie University, and the University of Ottawa. He has published numerous articles in professional journals and presents nationally and internationally on such topics as post-traumatic stress disorder and operational psychiatry.

Carl Castro is the research director for the USC Center for Innovation and Research on Veterans and Military Families. Castro has authored more than 150 scientific articles and reports in numerous areas and currently serves as chair of a NATO research group on military mental health training. He serves as an advisor for several Department of Defense research panels focused on psychological health.

7 Investment Highlights of Mydecine Innovations Group Inc. (CSE:MYCO) (OTCQB:MYCOF) (FRA: 0NFA)

  1. Management, research teams, partners (military, scientists, researchers) and one of the original senior marketing executives that launched Red Bull in the US
  2. Substances Dealer’s Licenses from Health Canada that allow Mydecine (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) the ability to cultivate, import, export, extract, and commercialize psilocybin and other functional mushroom products.
  3. Technology and Analytics from the Mindleap platform that’s connected to clinics across the globe, providing TONS of data that’s privacy protected, and can improve upon the AI capabilities of this state-of-the-art telemedicine service.
  4. Equipped for industry leading research through 7,500 sq ft Colorado Lab
  5. Access to Top 15 Global Research through the University of Alberta.
  6. Low-cost cultivation that’s capable of deriving APIs from mushrooms at a cost of pennies per gram when scientists are currently paying $7,000-$10,000 per gram for synthetically derived ingredients, giving HUGE leverage to complete clinical studies.

First-of-its-Kind clinical trials (featured in Forbes), with a current pipeline of 8 studies lined up through 2021, through 7 different respected research institutions.

[1] https://www.usatoday.com/story/sports/boxing/2020/11/27/mike-tyson-roy-jones-jr-fight-psychedelic-drugs/6442985002/

[2] https://www.hopkinsmedicine.org/news/newsroom/news-releases/fast-acting-psychedelic-associated-with-improvements-in-depressionanxiety

[3] https://psychedelicspotlight.com/how-psychedelics-saved-former-nba-star-lamar-odom-from-drug-addiction/

[4] https://psychedelicspotlight.com/how-psychedelics-helped-riley-cote/

[5] https://www.forbes.com/sites/amandasiebert/2020/11/26/these-four-former-pro-athletes-are-using-psychedelics-to-heal-their-brain-injuries/?sh=33302f5c70d7

[6] https://www.forbes.com/sites/amandasiebert/2020/11/26/these-four-former-pro-athletes-are-using-psychedelics-to-heal-their-brain-injuries/?sh=33302f5c70d7

[7] https://www.msn.com/en-us/sports/mma-ufc/ufc-eyes-psychedelics-as-therapy-for-fighters-brain-injuries/ar-BB1cLl7N

[8] https://www.forbes.com/sites/amandasiebert/2020/11/26/these-four-former-pro-athletes-are-using-psychedelics-to-heal-their-brain-injuries/?sh=33302f5c70d7

[9] https://www.prnewswire.com/news-releases/psychedelic-drugs-market-projected-to-reach-6-85-billion-by-2027–301082594.html

[10] https://www.sciencenews.org/article/deaths-of-despair-depression-mental-health-covid-19-pandemic

[11] https://abcnews.go.com/US/urgent-mental-health-crisis-health-workers-facing-immense/story?id=75925696

[12] https://www.ctvnews.ca/health/coronavirus/mental-disorders-affect-more-than-half-of-covid-19-survivors-study-1.5050969

[13] https://adaa.org/understanding-anxiety/facts-statistics

[14] https://www.sciencedaily.com/releases/2009/10/091023163346.htm

[15] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5047000/

[16] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6041963/

[17] https://www.cbsnews.com/news/psilocybin-active-agent-in-magic-mushrooms-could-treat-addiction-depression-and-anxiety-60-minutes-2019-10-10/

[18] https://www.forbes.com/sites/robinseatonjefferson/2019/09/12/magic-mushrooms-as-medicine-johns-hopkins-scientists-launch-center-for-psychedelic-research-say-psychedelics-could-treat-alzheimers-depression-and-addiction/#3ec549efc171

[19] https://video.foxbusiness.com/v/6085830149001/#sp=show-clips

[20] https://www.npr.org/2019/10/01/766057380/how-magic-mushrooms-can-help-smokers-kick-the-habit?fbclid=IwAR0HsI05xIPrh8cl3CiJj1SD-lVKZ8wXXEDQfs2TEwfqKit9hUyYSPfeOfM&utm_campaign=storyshare&utm_medium=social&utm_source=facebook.com

[21] https://www.today.com/video/could-psychedelic-drugs-be-a-cure-for-depression-71467589539

[22] https://globalnews.ca/news/7610610/pandemic-mushrooms-anxiety-micro-dosing/

[23] https://futurism.com/neoscope/nose-spray-microdosing-psilocybin

[24] https://www.prnewswire.com/news-releases/psychedelic-compounds-could-be-used-in-mental-healthcare-301093625.html

[25] https://www.globenewswire.com/news-release/2020/08/13/2077822/0/en/Mydecine-Innovations-Group-Featured-in-Forbes-for-the-First-Of-Its-Kind-Clinicals-Using-Psilocybin-Therapy-For-PTSD.html

[26] https://www.forbes.com/sites/javierhasse/2020/08/12/psilocybin-trial-ptsd-veterans/#33e5b34b4601

[27] https://www.newswire.ca/news-releases/mydecine-innovations-group-inc-announces-neuropharm-inc-commences-ptsd-clinical-trial-initiative-with-leading-european-research-institute-852788451.html

[28] https://www.mydecine.com/news/mydecine-innovations-group-sponsors-first-lab-based-study-of-established-microdosers-at-macquarie-university-in-australia

[29] https://www.wsj.com/articles/silicon-valley-and-wall-street-elites-pour-money-into-psychedelic-research-11597941470

[30] https://compasspathways.com/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression/

[31] https://www.cnbc.com/2020/11/23/peter-thiel-backs-psychedelics-startup-atai.html

[32]https://www.globenewswire.com/news-release/2020/08/18/2079824/0/en/Mydecine-Launches-World-s-First-Natural-Sourced-cGMP-Psilocybin-for-Global-Research-Sales-and-Distribution-Enterprise.html

[33]https://mindmed.co/news/press-release/mindmed-announces-successful-completion-of-pre-ind-meeting-with-the-fda-for-project-lucy

[34]https://compasspathways.com/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression/

[35] https://finance.yahoo.com/news/mydecine-launches-worlds-first-natural-113000629.html

[36] https://qz.com/1235963/scientists-who-want-to-study-psychedelic-mushrooms-have-to-pay-7000-per-gram/

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Perception Neuroscience And Otsuka Pharmaceutical Announce Collaboration On Development Of PCN-101 (R-ketamine) In Japan For Treatment-of Depressive Disorders

NEW YORK and TOKYO, March 16, 2021 /PRNewswire/ — Perception Neuroscience (Perception), an atai Life Sciences (atai) company focused on developing innovative therapies in neuropsychiatric disorders, and Otsuka Pharmaceutical Co., Ltd. (Otsuka), announce a collaboration and licensing agreement for the development and commercialization of Perception’s lead molecule, PCN-101 (R-ketamine) in Japan as a potential treatment for mood disorders such as major depressive disorder (MDD) and treatment-resistant depression (TRD). Outside of Japan, Perception is developing PCN-101 for the treatment of treatment-resistant depression.

PCN-101 is a formulation of R-ketamine, a single isomer of ketamine that belongs to a new generation of glutamate receptor modulators, being developed as a rapid acting antidepressant (RAAD). Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. In nonclinical depression models it possessed more durable and potent effects than S-ketamine, a lower affinity to the NDMA receptor, and potentially a more favorable safety and tolerability profile. A Phase 1, single ascending dose study has been completed for PCN-101 and a Phase 2 proof-of-concept study in TRD is planned to be initiated by Perception in the first half of 2021.

Under the terms of the license, Otsuka will have exclusive rights to develop and commercialize products containing PCN-101 in Japan. Otsuka will undertake development, regulatory, and commercialization activities in Japan, with input and guidance from both companies. Perception will receive an upfront payment of $20 million, which will help fund the company’s overall development of treatments. In addition, Perception will be eligible to receive development, regulatory and commercial milestones, as well as tiered, double-digit royalties on future sales.

“Otsuka is one of the world’s premier pharmaceutical companies in the neuropsychiatric space.” said Terence Kelly, PhD, CEO of Perception. “To have such a strong collaborator at this early stage of development is a significant vote of confidence in the potential of PCN-101 for patients suffering from depression.”

Florian Brand, CEO and co-founder of atai, said, “Otsuka is dedicated to finding unconventional solutions to treat mental health disorders with a deepening focus on digital medicine. Its innovative approach to mental health paired with their experience in commercializing neuropsychiatric drugs as demonstrated by the successful roll-out of products such as Rexulti and Abilify Maintena, makes Otsuka a great company for us to work with. We look forward to working together with them on Perception’s lead compound”.

Makoto Inoue, president of Otsuka Pharmaceutical, remarked, “We have a long and deep engagement in the CNS  field, including our in-line products Rexulti, Abilify Maintena, and specific to the U.S, the first-in-the-world digital medicine, Abilify Mycite. Looking to the future, Perception Neuroscience’s PCN-101, a candidate with rapid onset for use in treatment-resistant depression, could provide an urgently needed treatment option. Perception Neuroscience is uniquely positioned to work with us in Japan on this urgent task.”

About Perception Neuroscience, Inc

Perception Neuroscience is a New York City- based biopharmaceutical company committed to developing therapies for neuropsychiatric diseases. Perception’s mission is to provide substantially more effective treatment solutions to serious psychiatric disorders. The company is a majority-owned subsidiary of atai Life Sciences.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York, San Diego and London. For more information, please visit www.atai.life.

About Otsuka

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy:
“Otsuka–people creating new products for better health worldwide.” Otsuka researches,
develops, manufactures, and markets innovative products, with a focus on pharmaceutical
products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal and
cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13.3 billion in 2020.

All Otsuka stories start by taking the road less traveled. Learn more about Otsuka at www.otsuka.co.jp/en/.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

Otsuka contact in Japan:
Jeffrey Gilbert
Leader, Pharmaceutical PR
Email: Gilbert.jeffrey@otsuka.jp

Forward Looking Statements:

This press release contains statements that are or may be forward-looking statements, including statements that relate to the company’s future prospects, developments, and strategies. The forward looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, our expectations regarding the potential therapeutic benefits of PCN-101, our plans to initiate and conduct a Phase 2a proof-of-concept study evaluating PCN-101 as a potential treatment for treatment-resistant depression (TRD), our plans to advance PCN-101 for the treatment of TRD and those risks and uncertainties described in the risk factors included in the regulatory filings for Perception Neuroscience, Inc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE atai Life Sciences

Related Links

http://www.atai.life/

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IntelGenx Announces Strategic Partnership with atai Life Sciences and Proposed TSX Graduation

SAINT LAURENT, Quebec, and NEW YORK, March 15, 2021 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQB:IGXT) (the “Corporation”) today announced that its wholly owned subsidiary, IntelGenx Corp. (“IntelGenx”), a leader in pharmaceutical films, has agreed to the terms of a strategic partnership with atai Life Sciences (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, including an equity investment by atai, pursuant to which atai will initially acquire an approximate 25% interest in the Corporation. The Corporation also announced that atai has granted to IntelGenx a secured loan in the amount of US$2,000,000.

As part of the strategic partnership, IntelGenx will exclusively partner with atai to develop compounds for the prevention or treatment of mental health diseases or disorders, including compounds that have psychedelic, entactogenic and/or oneirophrenic properties.

“This transaction with atai is truly transformational for IntelGenx, catapulting us into a leadership position within the novel therapeutics field of psychedelics while, at the same time, providing the requisite financial resources to continue to advance our robust portfolio of other innovative pharmaceutical film product candidates towards commercialization,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “We look forward to building a strong partnership.”

“We continue to believe that the combination of our development candidates with IntelGenx’s film technology holds strong clinical promise in the treatment of mental health disorders. The film technology avoids first-pass metabolism and may allow for the delivery of compounds that are non-orally bioavailable. Further, eliminating first-pass metabolism may reduce the serum concentrations of metabolites, potentially improving safety and tolerability,” said Florian Brand, CEO of atai. “We are delighted to progress from collaborators to partners, making IntelGenx’s film technology an integral part of our platform.”

The partnership and investment are subject to the approval of the TSX Venture Exchange (the “Exchange”) and approval of the shareholders of the Corporation (the “Shareholders”) and will be subject to certain customary closing conditions. Shareholders will be asked to consider and vote on the proposed transaction with atai at the Corporation’s Annual Meeting of Shareholders (the “Meeting”) on May 11, 2021.

Strategic Development Agreement

Under a strategic development agreement, atai and IntelGenx will cooperate to conduct research and development projects in areas relating to the parties’ respective technologies. A portion of the funds (20%) that the Corporation receives through atai’s equity investment under the securities purchase agreement described below will be available to be credited against the costs to IntelGenx of the research and development projects. So long as atai maintains certain levels of its initial equity ownership in the Corporation, IntelGenx will work exclusively with atai in the field of compounds for the prevention or treatment of mental health diseases or disorders or compounds that have psychedelic, entactogenic and/or oneirophrenic properties, but excluding certain specific compounds and veterinary applications.

The commercialization of any technologies that result from the research and development projects under the strategic development agreement will be subject to agreements to be negotiated, as well as to specified pricing and royalty terms for manufacturing conducted by IntelGenx or third parties.

Securities Purchase Agreement

Under a securities purchase agreement, atai has agreed to purchase 37,300,000 shares of common stock of the Corporation (the “Shares”) and 22,380,000 warrants (the “Warrants”) for aggregate gross proceeds of US$12,346,300 (the “Investment”) following receipt of Shareholders’ approval at the Meeting. Each Warrant will entitle atai to purchase one Share at a price of US$0.35 for a period of three years from closing of the initial investment.

The securities purchase agreement also provides atai with the right to subscribe (in cash, or in certain circumstances, atai equity) for up to 130,000,000 additional units (“Additional Units”) for a period of three years from the closing of the initial investment. Each Additional Unit will be comprised of (i) one share of common stock (an “Additional Share”) and (ii) one half of one warrant (each whole warrant, an “Additional Warrant”). The price for the Additional Units will be (i) until the date which is 12 months following the closing, US$0.331 (subject to certain exceptions), and (ii) following the date which is 12 months following the closing, the lower of (A) a 20% premium to the market price on the date of purchase, and (B) US$0.50 if purchased in the second year following closing and US$0.75 if purchased in third year following closing. Each Additional Warrant will entitle atai, for a period of three years from the date of issuance, to purchase one Share at the lesser of either (i) a 20% premium to the price of the corresponding Additional Share, or (ii) the price per share under which shares of the Corporation are issued under convertible instruments that were outstanding on February 16, 2021, the date on which the parties entered into a non-binding letter of intent to enter into a definitive securities purchase agreement (“Outstanding Convertibles”), provided that atai may not exercise Additional Warrants to purchase more than the lesser of (x) 44,000,000 common shares of the Corporation, and (y) the number of common shares issued by the Corporation under Outstanding Convertibles.

Under the securities purchase agreement, the Corporation also granted atai a pro-rata equity participation right for any issuances of new securities, subject to certain exceptions.

Following the initial closing, atai will hold approximately 25% (approximately 35% on a partially diluted basis) of the issued and outstanding Shares and therefore become a new “Control Person” of the Corporation as such term is defined under the policies of the Exchange. Based on the number of issued and outstanding Shares and outstanding convertible instruments on the date hereof, assuming the full exercise of its option to acquire the Additional Units and exercise of the Initial Warrants and Additional Warrants, atai would hold approximately 60% (approximately 60% on a partially diluted basis) of the issued and outstanding Shares.

Proposed Graduation to the Toronto Stock Exchange

Under the securities purchase agreement, the Corporation has agreed to use reasonable efforts to list its Shares on the Toronto Stock Exchange with a target to achieve such listing shortly after the initial closing contemplated by the securities purchase agreement and the Corporation intends to promptly submit a listing application to the Toronto Stock Exchange. Any listing of the Corporation’s common shares on the Toronto Stock Exchange is subject to the Corporation meeting all of the listing requirements of and obtaining the approval of the Toronto Stock Exchange.

Purchaser Rights Agreement

Under the purchaser rights agreement, atai will have the right to appoint nominees in the same proportion to the number of Board members of the Corporation as the Shares then held by atai, registration rights, and financial and other information rights.

The Corporation will have the right to terminate the purchaser rights agreement if atai ceases to own a certain amount of the Corporation’s equity.

Term Loan

atai has granted to IntelGenx a secured loan in the amount of US$2,000,000. The loan is repayable on the date that is 120 days following the date of the Meeting, but in any event not later than September 30, 2021. The securities purchase agreement provides that an amendment is to be entered into at the initial closing of the atai investment under which the maturity date will be following the first closing of a subscription for Additional Units if the proceeds from such subscription amount to at least $3,000,000. The loan provides for the possibility of an additional advance to IntelGenx of up to US$500,000, subject to certain conditions. The loan is guaranteed by the Corporation and secured by all of present and future fixed assets of IntelGenx, excluding any intellectual property or technology controlled or owned by IntelGenx.

IntelGenx has applied approximately US$800,000 from the loan to fully repay the outstanding amount on the Corporation’s credit facilities with the Bank of Montreal. IntelGenx intends to use the balance of the loan for general working capital purposes.

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.

About atai

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York, San Diego and London. For more information, please visit www.atai.life.

Disclaimer

The Shares, Warrants, Additional Units, Additional Warrants, Additional Shares and shares of common stock of the Corporation issuable on exercise of the Warrants and the Additional Warrants have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws, and may not be offered or sold in the United States, or to or for the account or benefit of, persons in the United States or U.S. Persons (as defined in Regulation S under the U.S. Securities Act) absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of securities of the Corporation in any jurisdiction in which such offer, solicitation or sale would be unlawful.

Forward-Looking Information

This document may contain forward-looking information which involves substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the U.S. Securities Act. Forward-looking information or forward-looking statements by their nature are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation at the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Words such as “expects”, “continue”, “will”, “anticipates” and “intends” or similar expressions are intended to identify forward-looking statements. More particularly and without limitation, this document contains forward-looking statements and information regarding a planned strategic cooperation with and an investment by atai and an intended graduation to the TSX. Because these forward-looking statements are subject to a number of risks and uncertainties, the Corporation’s actual results, objectives and plans could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include failure to obtain Shareholder approval; failure to obtain required approvals from regulators or security exchanges; failure to satisfy other conditions to closing under the Securities Purchase Agreement; the cooperation with atai under the strategic development agreement may not result in projects that are successful or that can be monetized by the Corporation; and the cooperation with atai may prevent the Corporation from pursuing cooperation with other partners or other opportunities. The foregoing list is not exhaustive of the factors that may affect the forward-looking statements. Some of the important risks and uncertainties that could affect forward-looking statements are discussed under the heading “Risk Factors” in the Corporation’s annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. Forward-looking statements are made based on management’s beliefs, estimates and opinions on the date the statements are made, and the Corporation assumes no obligation to update any such forward-looking statements except as required by law. Moreover, all forward-looking information contained herein is subject to certain assumptions. Investors are cautioned against attributing undue certainty to forward-looking statements.

All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

Each of the TSX Venture Exchange and OTCQB has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, any securities.

Contact Information

For IntelGenx:

Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
stephen@intelgenx.com

Or

Andre Godin, CPA, CA
President and CFO
IntelGenx Technologies Corp.
(514) 331-7440 ext 203
andre@intelgenx.com

For atai Life Sciences:

Investor Contact:
Greg Weaver
ATAI – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

Posted on

DemeRx Receives MHRA Approval for DMX-1002 (Ibogaine) to Commence Phase 1/2a Study as First Clinical Trial in Opioid Use Disorder in the UK

NEW YORK, March 10, 2021 /PRNewswire/ — DemeRx IB, Inc. (DemeRx), an atai Life Sciences (atai) platform company focused on developing ibogaine for the treatment of opioid use disorder (OUD), today announced the company has approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to commence subject enrollment in a Phase 1/2a clinical trial of ibogaine HCl (DMX-1002).

Ibogaine is a naturally-occurring psychedelic product isolated from a West African shrub that has demonstrated rapid and sustained efficacy in treating OUD. This regulatory approval comes as a break-through for patients seeking to end their intractable cycle of drug dependence.

The Phase 1 portion of the MHRA approved trial will be conducted at the Manchester clinical unit of MAC Clinical Research (MAC), one of Europe’s largest clinical development organizations. MAC’s extensive good clinical practice experience, expertise and infrastructure will provide a platform for what is hoped to be a successful and significant trial.

“Our clinical trial authorization is a critical milestone,” said Dr. Deborah Mash, CEO and President of DemeRx. “Stage 1 of the study will provide assessment of safety through the evaluation of ibogaine’s potential adverse effects before we move to the proof-of-concept efficacy portion of our study in patients who seek to detoxify from opioids”.

“This approval allows DemeRx to progress clinical research beyond the previously published uncontrolled studies with ibogaine into well-designed, controlled studies in support of regulatory processes,” said Srinivas Rao, Chief Scientific Officer and Co-founder of atai Life Sciences. “With the initiation of this trial, we start a journey towards understanding the potential of DMX-1002, in-line with regulatory bodies. We are optimistic for the future of DMX-1002 in treating OUD – this is a great step forward for DemeRx.”

“Timing could not be more important as the world faces an ever-growing opioid epidemic. Current treatment options are not highly effective; approximately 75% of patients undergoing OUD therapy experience relapse within one year of treatment,” said Florian Brand, Chief Executive Officer and Co-founder of atai Life Sciences. “This approval allows DemeRx to initiate this well-designed protocol to advance our understanding of how DMX-1002 may provide patients with a potentially transformative therapy, where currently the industry has developed few treatment solutions.”

About the Phase 1/2a clinical trial approval

The approval for a Phase 1/2a clinical trial will enable DemeRx to study DMX-1002 in recreational drug users before the start of Stage 2 in opioid-dependent patients. Before the start of Stage 2, the trial will pause to allow MHRA to review human safety data together with nonclinical study results.

About DemeRx, Inc. & DMX-1002

DemeRx, Inc. is a Miami-based clinical stage pharmaceutical company focused on developing ibogaine and noribogaine for the treatment of OUD. DemeRx’s mission is to advance the development of potential treatments for OUD in order to prevent patient suffering, provide better treatment retention, and decrease illegal opioid use.

DemeRx is developing DMX-1002 for the treatment of OUD. DMX-1002 is a GMP drug product manufactured for human use.

Company Contacts:
Deborah C Mash PhD
CEO & Founder, DemeRx Inc.
Phone: +1(305)753-2175
Email: dmash@demerx.com

Matthias Luz MD
Executive Vice President & Chief Medical Officer
Email: mluz@demerx.com

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York. For more information, please visit www.atai.life.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

SOURCE atai Life Sciences

Related Links

http://www.atai.life

Posted on

atai Life Sciences Announces the Closing of its $157 Million Series D Financing Round

NEW YORK, March 3, 2021 /PRNewswire/ — atai Life Sciences (“atai” or the “Company”), a clinical-stage biopharmaceutical company developing psychedelic and non-psychedelic compounds for various mental health indications, today announced the successful closing of its $157 million Series D financing round. The round was led by our existing investors Apeiron Investment Group, the family office of atai’s founder Christian Angermayer, Thiel Capital, and joined by Woodline Partners LP.

atai is excited to welcome Woodline Partners onboard as a new investor; an investment firm that implements a fundamental equity strategy focused primarily on the global Healthcare and Technology sectors.

The Series D fundraising saw participation from existing and new investors including Fearless Ventures, Falcon Edge Capital, Pura Vida Pro LLC, Catalio Capital Management, Michael Auerbach’s Subversive Capital and Highline Capital.

The proceeds from this financing will support the expansion and development of the Company’s diverse drug candidate pipeline and enabling technologies. In addition, the financing will provide the necessary runway to continue advancing its current clinical developments, as well as scale its experienced team in order to continue delivering key milestones.

“This marks a monumental moment for atai; we continue on our mission challenging the current way mental health conditions are treated. We have become better equipped than ever to accelerate the development of more efficacious treatments,” said Florian Brand, CEO & co-founder of atai. “With support from our investors, we are determined to improve care and innovate.”

“To achieve our goal of developing alternative treatments for mental health disorders, we must empower the world with our vision for the future of care,” said Christian Angermayer. “Moments such as this show the importance of our work. It is a step forward, and we thank those continuing to drive this vision so that patients may eventually live more fulfilled lives.”

“We are excited to continue supporting atai, the only company in neuropsychiatry today that is thoughtfully pursuing platform diversity alongside scientific depth. The company is well-positioned to deliver on the vision of its founders by creating a new wave of therapies for patients in need” said Jason Camm, Managing Director and Chief Medical Officer of Thiel Capital.

“There is a need for more efficacious treatments to address mental health disorders,” said Matthew Katten, Portfolio Manager at Woodline Partners. “We believe atai has built a leading position in this space and we are excited to partner with them to drive innovation for improved mental health patient outcomes.”

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York. For more information, please visit www.atai.life.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

SOURCE atai Life Sciences

Related Links

http://www.atai.life

Posted on

Psychedelic Therapeutics Reviewed by NeuroPerspective

SAN DIEGO, March 2, 2021 /PRNewswire/ — NeuroPerspective has released its March/April 2021 issue, featuring its first-ever, comprehensive review of the rapidly-expanding Psychedelic Therapeutics space, where substances formerly relegated to sacramental and/or illegal status are being formally tested as treatments for CNS disorders. Psilocybin, LSD, DMT, 5-MeO-DMT are some of the ‘classic’ psychedelic substances being explored, along with ’empathogens’ like MDMA, dissociative drugs like ketamine, esketamine, arketamine, and a few substances less easily categorized, like ibogaine and its derivatives.

NI Research
NI Research

As NeuroPerspective publisher Harry Tracy PhD notes: “This is not a fallacy or fad, there is already substantial clinical support for the use of psychedelic drugs based on thousands of case-reports and small-scale studies. Now, much more rigorous studies are underway. Already, there is a compelling body of work supporting clinical value in PTSD (where MAPS has had a successful PhIII trial), Treatment-Resistant Depression (Compass Pathways currently is running a PhIIb study), Cancer-related Pain/Anxiety, and Addictions. Other areas, like Eating Disorders, Phantom-Limb Pain, Cancer Pain  and intractable migraines, and even cognitive disorders like ADHD and Alzheimer’s, are being assessed for the potential usefulness of psychedelics.”

 

The Review assesses close to fifty companies involved in psychedelics research: Including MAPS, Compass Pathways, ATAI Life Sciences and its panoply of partnered programs (Viridia, Perception Neuroscience, DeMeRx, Entheogenix, EmpathBio); MindMed,  Beckley Psytech, Field Trip Health, MindCure, Diamond Therapeutics, MYND, Gilgamesh Pharma, Cybin, PsyBio, Small Pharma, Mindset,  Tactogen, Usona Institute, Entheon Biomedical, Eleusis, and many more. These companies cover the gamut of skillsets and viability, from well-founded to ephemeral pipedreams. The rationale for psychedelic mechanisms (e.g. classic 5HT-2a binding, impact on default mode networks) are reviewed, factors governing the path forward for the class are examined in detail.

Despite the numerous books, papers, and conferences that have sprung up in the past two to three years, no publication combines insights into the science, medical, and business underpinnings of the new wave of Psychedelics Therapeutics, and frank assessments of their prospects, like NeuroPerspective provides with this release.

The issue also includes a Company Spotlight appraisal of MindMed; a brief discussion regarding the aducanumab PDUFA extension, and coverage of six Alzheimer’s programs and their clinical news, including Cassava Sciences, Cortexyme, Lilly, and Biohaven.

The report contains 43 pages.

About NI Research

NI Research is the leading publisher of independent research on the neurotherapeutics industry, and has developed an unmatched information base regarding both publicly and privately held CNS companies.

A one-year (1-5 user) subscription to NeuroPerspective is $2900. A 6-10 user subscription is $4950. Other customized userbase and startup pricing options are available.

The March/April issue covering Psychedelic Therapeutics is being made available as a single-issue purchase, for $750.

NI Research has just released the 2021 edition of NeuroLicensing, which comprehensively reviews current licensing trends in the CNS area, and assesses large and midsize pharma companies in terms of their licensing agendas and performance.

NI Research’s Second Opinion provides consulting services to the pharma industry on strategic direction and licensing.

Further information and online purchasing with immediate downloads are available at http://www.niresearch.com/onlinestore.html.

Harry M. Tracy PhD
760.753.6376
304196@email4pr.com

SOURCE NI Research

Posted on

Perception Neuroscience’s PCN-101 (R-Ketamine) Demonstrates Tolerability in Phase 1 Single Ascending Dose Study

NEW YORK, Feb. 19, 2021 /PRNewswire/ — Perception Neuroscience (Perception), an atai Life Sciences (atai) biopharmaceutical company focused on developing innovative therapies in neuropsychiatric diseases, today announced positive data from its first Phase 1 clinical study demonstrating the safety and tolerability of PCN-101 (R-ketamine). R-ketamine is a stereoisomer of ketamine that is being developed for therapeutic treatment of psychiatric illnesses such as Treatment Resistant Depression (TRD).

The two-stage study first evaluated the safety, tolerability and pharmacokinetics of single ascending doses of PCN-101 in 58 healthy adult volunteers, administered via intravenous infusion and compared to placebo. In this study, PCN-101 was safe and well-tolerated at all doses up to 150 mg, the highest dose tested. There were no serious adverse events reported. The pharmacokinetics of PCN-101 in plasma were approximately dose-proportional.

The second stage of the study compared the relative safety and tolerability of PCN-101 to that of S-ketamine. The results demonstrated that PCN-101 required substantially higher doses to induce similar perceptual changes than S-ketamine.

“We are excited by the Phase 1 results that support the hypothesis that PCN-101 can be developed as a rapidly acting antidepressant with the potential for at-home use,” said Terence Kelly, PhD, CEO of Perception Neuroscience. “The upcoming Phase 2 proof-of-concept trial in patients with Treatment Resistant Depression is the next important step in demonstrating the full potential of PCN-101.”

Dr. Kelly also announced that Perception has secured additional funding to enable the Phase 2a proof-of-concept study of PCN-101. This study is expected to initiate in the second quarter of 2021. The financing round was led by atai Life Sciences.

“The success of Perception’s Phase 1 clinical study leads us to believe that PCN-101 has the potential to offer a highly differentiated profile from current treatment options,” said Florian Brand, CEO & Co-founder of atai Life Sciences. “We are thrilled by this success, with these results paving the way for our upcoming Phase 2 clinical study. The incredible work of the teams at Perception and atai, combined with the support of our investors, provides progress in our mission of delivering optionality to patients who suffer from Treatment Resistant Depression.”

About the Phase 1 study

This was a Phase 1 single-center, randomized, placebo-controlled, double-blind single ascending dose study of the safety, tolerability and pharmacokinetics of PCN-101 that included a subsequent relative safety comparison of PCN-101 and S-ketamine. Healthy subjects were administered a single 40-minute intravenous infusion of PCN-101 or placebo.

The safety and tolerability assessments included reported adverse events, changes in hematology, serum chemistry, vital signs, ECG, sedation, and the development of dissociative or perceptual changes.

About PCN-101

Perception Neuroscience is developing PCN-101 (R-ketamine) for the treatment of treatment-resistant depression. PCN-101 is a single isomer of ketamine and belongs to a new generation of glutamate receptor modulators with the potential for rapid acting antidepressant (RAAD) activity and anti-suicidal effects. Pharmacologically, PCN-101 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. Nonclinical depression model studies in rodents suggest that R-ketamine could possess more durable and potent effects than S-ketamine despite a lower affinity to the NDMA receptor and potentially a more favorable safety and tolerability profile.

About Perception Neuroscience, Inc

Perception Neuroscience is a New York City- based biopharmaceutical company committed to developing therapies for neuropsychiatric diseases. Perception’s mission is to provide substantially more effective treatment solutions to serious psychiatric disorders. The company is a majority-owned subsidiary of atai Life Sciences.

About atai Life Sciences

atai is a biotechnology company that was founded in 2018 as a direct response to the significant and growing unmet needs of mental health patients worldwide. atai is pioneering the development of more effective and potentially-disease modifying mental health treatments for patients suffering from significant unmet medical needs. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its business entities, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York and San Diego. For more information, please visit www.atai.life.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: greg.weaver@atai.life

Media Contact:
Anne Donohoe
KCSA Strategic Communications
Phone: +1 (212) 896-1265
Email: atai@KCSA.com

Forward Looking Statements:

This press release contains statements that are or may be forward-looking statements, including statements that relate to the company’s future prospects, developments, and strategies. The forward looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, our expectations regarding the potential therapeutic benefits of PCN-101, our plans to initiate a Phase 2 trial evaluating PCN-101 as a potential treatment for Treatment Resistant Depression (TRD) and a Phase 2a proof-of-concept study evaluating PCN-101 in patients with TRD, our plans to advance PCN-101 for the treatment of TRD and those risks and uncertainties described in the risk factors included in the regulatory filings for Perception Neuroscience, Inc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE atai Life Sciences

Posted on

Joint feasibility assessment of Bionomics’ BNC210 and EmpathBio’s MDMA derivative EMP-01 treatment regimen for PTSD

ADELAIDE, Australia, Feb. 17, 2021 /PRNewswire/ — Bionomics Limited (ASX: BNO,OTCQB: BNOEF, Germany: AU000000BNO5) (Bionomics) today announced that it has entered into a Memorandum of Understanding with EmpathBio Inc (EmpathBio), a wholly owned subsidiary of Germany-based CNS clinical development company, atai Life Sciences (atai). Under the Memorandum of Understanding, Bionomics and EmpathBio propose to collectively explore a combination drug treatment regimen with Bionomics’ BNC210 and EmpathBio’s 3,4-Methylenedioxymethamphetamine (MDMA) derivative EMP-01. The parties will explore whether the different mechanisms of action of EMP-01 and BNC210 may offer the potential for developing an improved treatment regimen for the treatment of Post-Traumatic Stress Disorder (PTSD).

BNC210 is Bionomics’ lead drug candidate, which has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of PTSD and other trauma-related and stress-related disorders. A new solid dose formulation of BNC210 has recently been developed and will be used in a Phase 2 study in PTSD, projected to commence in the middle of 2021.

MDMA-assisted psychotherapy (two to three treatment sessions) has demonstrated significant symptom improvement in PTSD patients which continued at least 12 months post-treatment (Jerome et al., Psychopharmacology 237: 2485-2497, 2020).  The FDA has granted a Breakthrough Therapy designation to MDMA-assisted psychotherapy, which is currently in Phase 3 trials being conducted by US not-for-profit organization, the Multidisciplinary Association for Psychedelic Studies (MAPS).

EmpathBio’s EMP-01 is one of 11 programs in atai’s pipeline. EmpathBio specifically focuses on developing MDMA derivatives that EmpathBio believes may permit the entactogenic effects of MDMA to be separated from some of the known adverse effects. If successful, such an approach could help minimize some of the transient physiological changes caused by MDMA, potentially expanding the pool of PTSD patients who will be medically eligible for the therapy.

Bionomics’ Executive Chairman, Dr Errol De Souza, said “We are delighted to have entered into this exploratory collaboration with EmpathBio, which is looking at novel approaches to the treatment of PTSD. We consider that EMP-01, a derivative of MDMA, being developed by EmpathBio could be a very interesting treatment regimen when combined with BNC210 for the treatment of PTSD. Our entry into a Memorandum of Understanding with EmpathBio has drawn together an initial collaborative framework of preclinical studies, in which we can develop some deeply informed views about the possibility of a combination treatment regimen warranting clinical evaluation at a later date.”

EmpathBio CEO, Glenn Short, said “We look forward to collaborating with Bionomics and the possibility of expanding the development potential of EMP-01 in combination with BNC210. Current clinical trials for MDMA carry a significant psychotherapy protocol which we could possibly re-evaluate with Bionomics’ BNC210 to reduce some of the unwanted side effects and improve patient outcomes. We are fortunate to be working with a Bionomics team that brings a wealth of scientific and clinical experience to the collaboration. Should the results of our exploratory studies support progressing to clinical trials, we will look to negotiate a legally binding definitive Agreement with Bionomics to conduct combination treatment regimen trials.”

atai CEO, Florian Brand, said “We are extremely excited for Bionomics and EmpathBio to have entered into this collaboration, bringing incredible expertise together to explore how we might increase the efficacy of treatments for PTSD. This shared goal will allow us to advance our understanding of treatments as we evaluate this specific treatment regimen and the ways in which it may reduce unwanted side effects, with the ultimate mission of delivering increased optionality for patients.”

About Bionomics Limited 

Bionomics (ASX: BNO) is a global, clinical stage biopharmaceutical company leveraging its proprietary platform technologies to discover and develop a deep pipeline of best in class, novel drug candidates. Bionomics’ lead drug candidate BNC210 is a novel, proprietary negative allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor. Beyond BNC210, Bionomics has a strategic partnership with MSD (known as Merck & Co in the US and Canada) and a pipeline of clinical-stage ion channel programs targeting pain, depression, cognition and epilepsy.

www.bionomics.com.au

About EmpathBio

EmpathBio, a wholly-owned subsidiary of atai Life Sciences, is a clinical-stage biopharmaceutical company developing derivatives of 3,4-methylenedioxy-methamphetamine (MDMA) for the treatment of post-traumatic stress disorder (PTSD) and other indications.

https://www.empath.bio/

FOR FURTHER INFORMATION PLEASE CONTACT: 

Bionomics Limited:

Mr Jack Moschakis
Legal Counsel & Company Secretary
Bionomics Limited
31 Dalgleish St,
Thebarton, South Australia
+61 8 8354 6100
jmoschakis@bionomics.com.au

EmpathBio & atai Life Sciences:

Investor Contact: 

Greg Weaver
Chief Financial Officer
atai Life Sciences
greg.weaver@atai.life

Media Contact:

Anne Donohoe
KCSA Strategic Communications
+1 (212) 896-1265
atai@KCSA.com

Factors Affecting Future Performance

This announcement contains “forward-looking” statements within the meaning of the United States’ Private Securities Litigation Reform Act of 1995. Any statements contained in this announcement that relate to prospective events or developments, including, without limitation, statements made regarding Bionomics’ drug candidates (including BNC210), its licensing agreements with MSD and any milestone or royalty payments thereunder, drug discovery programs, ongoing and future clinical trials, and timing of the receipt of clinical data for our drug candidates are deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “projects,” “forecasts,” “will” and similar expressions are intended to identify forward-looking statements.

There are a number of important factors that could cause actual results or events to differ materially from those indicated by these forward-looking statements, including unexpected safety or efficacy data, unexpected side effects observed in clinical trials, risks related to our available funds or existing funding arrangements, our failure to introduce new drug candidates or platform technologies or obtain regulatory approvals in a timely manner or at all, regulatory changes, inability to protect our intellectual property, risks related to our international operations, our inability to integrate acquired businesses and technologies into our existing business and to our competitive advantage, as well as other factors. Results of studies performed on our drug candidates and competitors’ drugs and drug candidates may vary from those reported when tested in different settings.

SOURCE Bionomics Limited

Related Links

http://www.bionomics.com.au

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Novamind Announces Strategic Investment in Bionomics to Support PTSD Clinical Trial

Cedar Clinical Research to be Evaluated to Support Phase IIb Trial of Novel PTSD Treatment

TORONTO, ON / ACCESSWIRE / February 11, 2021 / Novamind Inc. (CSE:NM) (“Novamind”), a leading mental health company specialized in psychedelic medicine, is pleased to announce that it has made a strategic investment of AU$827,486 (approximately CAN$810,000, the “Strategic Investment”), in Bionomics Limited (“Bionomics”) (ASX:BNO, OTCQB:BNOEF, Germany:AU000000BNO5), a biopharmaceutical company dedicated to developing better treatments for central nervous system disorders.

In addition, Cedar Clinical Research (“CCR”), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics’ Phase IIb trial examining BNC210. BNC210 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of post-traumatic stress disorder (PTSD).

With its investment in Bionomics, Novamind joins a group of well-known investors that specialize in psychedelics and biotech: Apeiron Investments, Biotech Value Fund, Merck & Co., Mike Novogratz, and Peter Thiel, an early investor in ATAI Life Sciences.

Novamind’s Strategic Investment is included in Bionomics’ latest round of financing, which was underwritten by Apeiron Investments and received commitments for AU$16,000,000 (approximately CAN$15,680,000, the “Bionomics Financing”). Novamind will purchase a total of 5,706,800 common shares in the Bionomics Financing, at AU$0.145 per share, a 20% discount to the 30-day volume weighted average price as of February 5th, 2021. Proceeds from the Bionomics Financing will support the initiation of a Phase IIb trial for BNC210, planned for mid-2021.

Bionomics intends to evaluate Cedar Clinical Research’s deep expertise in facilitating Phase I to Phase IV clinical trials for leading pharmaceutical companies, and how it may potentially serve as a research site for Bionomics’ Phase IIb clinical trial examining BNC210 in PTSD patients.

Cedar Clinical Research, led by Novamind’s Chief Medical Officer, Dr. Reid Robison, is currently contracted for seven clinical trials with various sponsors, including leading pharmaceutical companies. Dr. Robison has led over 100 clinical trials in neuropsychiatry, researching a spectrum of psychiatric conditions, including PTSD.

“I’m happy to welcome Novamind as a strategic investor in Bionomics,” said Dr. Errol De Souza, Executive Chairman of Bionomics. “Dr. Robison and the team at Cedar Clinical Research have unique experience related to clinical trials for mental health therapeutics.”

Yaron Conforti, CEO and Director of Novamind, added, “We are pleased to participate in Bionomics’ financing to support the development of its novel drug candidate for the treatment of PTSD. Cedar Clinical Research has unique expertise in PTSD research, and we look forward to the opportunity to contribute to the development of BNC210.”

To learn more about Cedar Clinical Research, please visit cedarclinicalresearch.com.

About Bionomics
Bionomics is a global, clinical stage biopharmaceutical company leveraging its proprietary platform technologies to discover and develop a deep pipeline of best in class, novel drug candidates. Bionomics’ lead drug candidate BNC210, currently in development for initiation of a second Phase II trial for the treatment of PTSD, is a novel, proprietary negative allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor. Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc (known as MSD outside the United States and Canada). To learn more, please visit bionomics.com.au.

About Novamind
Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics, retreats, and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of Cedar Psychiatry clinics and operates Cedar Clinical Research, a contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. Both Cedar Psychiatry and Cedar Clinical Research are wholly owned subsidiaries of Novamind. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visitnovamind.ca.

Contact Information
Novamind
Yaron Conforti, CEO and Director
Telephone: +1 (647) 953 9512

Bill Mitoulas, Investor Relations
Email: bill@novamind.ca

Forward-Looking Statements
This news release contains forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations including the risks detailed from time to time in the Company’s public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.

Posted on

Core One Labs Engages Donohoe Advisory for Nasdaq Listing and Schedules Special Investor Call with Dr. Robert E.W. Hancock to Demonstrate Recent Research Outcome

Vancouver, British Columbia, Canada – February 6, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company”) announces that it has engaged Donohoe Advisory Associates LLC (“Donohoe Advisory”) in connection with its efforts to seek a listing for its common shares on a NASDAQ Stock Market.  The Company expects that listing its common shares on NASDAQ will provide increased investor awareness and market liquidity for shareholders.

Donohoe Advisory was founded by Dave Donohoe in 2004, and since that time the firm has successfully represented hundreds of companies in a wide range of listing matters for both the NASDAQ Stock Market and the New York Stock Exchange.  Donohoe’s senior advisory team have previously worked for either NASDAQ or the New York Stock Exchange (NYSE). Prior to forming Donohoe Advisory, Dave Donohoe spent over nine years with NASDAQ, where he ultimately served as Chief Counsel in the Listing Qualifications Department. Other senior advisors include Katherine Roberson Petty, former Senior Counsel for NASDAQ’s Office of General Counsel, Bruce Poignant, former NYSE Executive in their Capital Markets Group, Tamara Kondic, former Director in the Listing Qualifications Department at the Nasdaq Stock Market LLC, and David Compton, former Director of Corporate Governance Interpretations at NASDAQ.

NASDAQ is ranked the second largest exchange by market capitalization worldwide, behind the New York Stock Exchange.  To qualify for listing on the exchange, a company must be registered with the United Sates Securities and Exchange Commission, must have at least three market makers and must meet minimum requirements for assets, capital, public shares, and shareholders.

With investor interest in the psychedelics space on the rise the Company believes that a near term listing on NASDAQ is most opportune. Investor interest is acquiring some very high profile executives and celebrities, as well, and providing exposure for investing in the psychedelic sectors future.  Hedge fund billionaire Steven Cohen, Joby Pritzker, cofounder of Tao Capital and an heir to the Hyatt hotel fortune, along with Bob Parsons billionaire founder of GoDaddy and golf equipment manufacturer PXG, have all donated to Multidisciplinary Association for Psychedelic Sturdies (MAPS) – a non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.

Compass Pathways was the first Psychedelic company to complete an Initial Public Offering (IPO) on the NASDAQ last year, with Billionaire Peter Thiel holding an approximate ownership of 7.54%. ATAI Life Sciences is another company in the psychedelics space that is expected to go public this year with an expected valuation between $1-2 billion.  In addition to these new and soon to be players, the psychedelics space has witnessed the launch of a new ETF – the Horizons Psychedelic Stock Index – which further indicates the appetite for psychedelics is growing at a rapid pace.  According to Data Bridge Market Research, the psychedelic drug market is projected to grow at a CAGR of 16.3% over the next eight years to reach 6.85 billion by 2027.

“Donohoe Advisory is the premier advisory firm for managing the legal requirements, regulatory issues, and application processes necessary for a successful uplisting. Listing the company on the NASDAQ will open access to larger institutional and Wall Street Investors seeking investments in the psychedelic space.  I anticipate Core One Labs will garner strong interest from investors as its operations are comparable to other NASDAQ listed companies in the space. In addition, this greater exposure would lead to a more reasonable valuation as management believes that the company is significantly undervalued compared to its peers.” stated Joel Shacker CEO of the Company.

Readers are cautioned that while the Company has engaged Donohoe Advisory in connection with its efforts to seek a listing on NASDAQ, the Company has not yet applied for a listing or made a final decision to proceed with a listing.  Completion of a listing is subject to regulatory approvals and the satisfaction of applicable listing requirements and will require the consolidation of the outstanding share capital of the Company in order to meet minimum market value requirements.  In the event the Company does elect to proceed with a listing, it is contemplated that its common shares would continue to trade in Canada on the Canadian Securities Exchange.

The Company will be hosting an investor conference call on Wednesday February 10, 2021 at 1:30 p.m. PST, 4:30 p.m. EST, 10:30 p.m. CET, with Dr. Robert E.W. Hancock, Chairman and Joel Shacker, CEO to discuss development and strategy.

Dr. Robert E.W. Hancock will be discussing progress that has been made at Core One’s Lab in British Columbia. He will provide updates on major milestones that have been reached. He will also provide an in depth look at the psychedelic space, and what Core One Labs is doing that separates itself from other companies in this space.

PARTICIPANT TELEPHONE NUMBERS

Canada/USA TF: 1-800-319-4610
International Toll: +1-604-638-5340
Germany TF: 0800-180-1954
Callers should dial in 5 – 10 min prior to the scheduled start time and simply ask to join the call

CONFERENCE REPLAY (For Distribution)
Canada/USA TF: 1-800-319-6413
International Toll: +1-604-638-9010
Replay Access Code: 6172

 

About Core One Labs Inc.

Core One Labs Inc. is a 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.