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atai Life Sciences Launches Invyxis to Accelerate Discovery of Next-Generation Mental Health Treatments

Invyxis will add proven medicinal chemistry and comprehensive biological evaluation capabilities to grow atai’s portfolio of new chemical entities (NCEs)

Early focus will be on designing unique, novel compounds aimed at the serotonin 5-HT2A receptor with other central nervous system (CNS) targets to follow

This new platform company is a further step-up in atai’s commitment to next-generation treatments, complementing its machine learning-powered computational chemistry with EntheogeniX and biosynthesis-based drug discovery approaches with TryptageniX

NEW YORK and BERLIN, Jan. 27, 2022 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today launched Invyxis, a new, wholly owned platform company committed to developing new chemical entities (NCEs) and to further pioneering next-generation mental health treatments. Invyxis will bring proven medicinal chemistry tools and comprehensive biological screening approaches to atai’s growing enterprise of drug discovery and design.

The launch of Invyxis is a further step-up in atai’s growth and commitment to innovation in the treatment of mental health disorders. The new atai platform company has entered into a strategic collaboration with Dalriada Drug Discovery, specialists in the discovery of small molecule therapeutics. Invyxis will harness a broad array of methods including structure-based design, synthetic chemistry, high-throughput screening, and in vivo characterization.

Invyxis’ goal will be to discover new agents with potential in treating mental health disorders, generating NCEs to progress into atai’s research & development pipeline of psychedelic and non-psychedelic compounds. The platform company will initially focus on agonists at the 5-HT2A receptor, recognizing the importance of this key serotonin receptor system in treating a range of mental health disorders.

Expanding intellectual property (IP) has been essential to atai’s strategy since inception, with key investments made to unlock NCEs. In 2019, atai launched EntheogeniX to pursue novel compounds using machine learning-based drug discovery, and the recent launch of TryptageniX added biosynthetic capabilities to atai’s discovery efforts.1,2 atai has already made substantial progress in its drug discovery efforts to date, synthesizing and screening approximately 300 compounds and identifying novel scaffolds that display potential in targeting mental health disorders.

“The global mental health crisis continues to escalate at an alarming rate and many patients do not find sufficient relief from currently available treatments. We urgently need newer, better options and innovative drug discovery is integral to this,” said Florian Brand, Chief Executive Officer and Co-Founder of atai Life Sciences. “With the addition of Invyxis, atai is now even more equipped to bring forward revolutionary new treatments and optimize next-generation therapies to better meet patient needs.”

“Expanding IP and growing our library of NCEs has been essential to our strategy since our inception,” said Srinivas Rao, Chief Scientific Officer and Co-Founder of atai Life Sciences. “By establishing differentiated potential treatments, with near, middle, and long-term developmental timelines, we add value and sustainability to our extensive pipeline of novel compounds with potential in targeting mental health indications. We are uniquely positioned, as a leading developer of psychedelic therapeutics, with the resources necessary to commit to and deliver this forward-looking strategy.”

“The use of psychedelic compounds to create improved next-generation mental health therapies is a highly promising and emerging field,” said Diana Kraskouskaya, Dalriada Chief Executive and Co-Founder. “We’re delighted to be partnering with atai to make an impact in this area. This creation of Invyxis brings together Dalriada’s ability to provide a rapid set-up and advancement of NCE discovery pipelines and atai’s expertise in the preclinical and clinical development of psychedelic therapeutics.”

Mental health disorders impact over 1 billion people around the world, representing a growing global crisis, but medical innovation has failed to offer recent novel solutions.3 Only 7 treatments have been approved by the FDA for psychiatry disorders since 2015; a time in which approximately 100 have been advanced in oncology.4 atai Life Sciences is proud to be a driving force in mental health innovation and to make Invyxis the latest addition to its diversified platform, to develop new therapeutic options in key areas of patient unmet need.

References:

  1. ATAI Life Sciences and Cyclica Launch Joint Venture to Revolutionize Drug Development for Mental Health Disorders. [Press Release] https://www.businesswire.com/news/home/20191111005299/en/ATAI-Life-Sciences-and-Cyclica-Launch-Joint-Venture-to-Revolutionize-Drug-Development-for-Mental-Health-Disorders. Published November 11, 2019. Accessed January 18, 2022.
  2. atai Life Sciences launches TryptageniX to further expand atai’s robust intellectual property portfolio and strengthen atai’s supply chain. [Press release] https://ir.atai.life/news-releases/news-release-details/atai-life-sciences-launches-tryptagenix-further-expand-atais. Published December 9, 2021. Accessed January 18, 2022.
  3. Rehm J, Shield KD. Global Burden of Disease and the Impact of Mental and Addictive Disorders. Curr Psychiatry Rep. 2019;21(2):10.
  4. U.S. Food and Drug Administration. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products. Accessed January 5, 2022. https://www.fda.gov/drugs/development-approval-process-drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products.

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 vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: statements regarding Invyxis and NCE development, the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those clinical trials, including progress and related milestones, may be impacted by several factors including the failure by such third parties to meet deadlines for the completion of such trials, research, or testing, changes to trial sites and other circumstances; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates; if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus, dated June 17, 2021, filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.

Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.


Contact Information

Media Contact:
Camilla Dormer
VP, Communications
Email: camilla@atai.life

Investor Contact:
Chad Messer
VP, Investor Relations
Email: chad@atai.life

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atai Life Sciences Launches Invyxis to Accelerate Discovery of Next-Generation Mental Health Treatments

atai Life Sciences Launches Invyxis to Accelerate Discovery of Next-Generation Mental Health Treatments

Invyxis will add proven medicinal chemistry and comprehensive biological evaluation capabilities to grow atai’s portfolio of new chemical entities (NCEs)

Early focus will be on designing unique, novel compounds aimed at the serotonin 5-HT2A receptor with other central nervous system (CNS) targets to follow

This new platform company is a further step-up in atai’s commitment to next-generation treatments, complementing its machine learning-powered computational chemistry with EntheogeniX and biosynthesis-based drug discovery approaches with TryptageniX

NEW YORK and BERLIN, Jan. 27, 2022 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today launched Invyxis, a new, wholly owned platform company committed to developing new chemical entities (NCEs) and to further pioneering next-generation mental health treatments. Invyxis will bring proven medicinal chemistry tools and comprehensive biological screening approaches to atai’s growing enterprise of drug discovery and design.

The launch of Invyxis is a further step-up in atai’s growth and commitment to innovation in the treatment of mental health disorders. The new atai platform company has entered into a strategic collaboration with Dalriada Drug Discovery, specialists in the discovery of small molecule therapeutics. Invyxis will harness a broad array of methods including structure-based design, synthetic chemistry, high-throughput screening, and in vivo characterization.

Invyxis’ goal will be to discover new agents with potential in treating mental health disorders, generating NCEs to progress into atai’s research & development pipeline of psychedelic and non-psychedelic compounds. The platform company will initially focus on agonists at the 5-HT2A receptor, recognizing the importance of this key serotonin receptor system in treating a range of mental health disorders.

Expanding intellectual property (IP) has been essential to atai’s strategy since inception, with key investments made to unlock NCEs. In 2019, atai launched EntheogeniX to pursue novel compounds using machine learning-based drug discovery, and the recent launch of TryptageniX added biosynthetic capabilities to atai’s discovery efforts.1,2 atai has already made substantial progress in its drug discovery efforts to date, synthesizing and screening approximately 300 compounds and identifying novel scaffolds that display potential in targeting mental health disorders.

“The global mental health crisis continues to escalate at an alarming rate and many patients do not find sufficient relief from currently available treatments. We urgently need newer, better options and innovative drug discovery is integral to this,” said Florian Brand, Chief Executive Officer and Co-Founder of atai Life Sciences. “With the addition of Invyxis, atai is now even more equipped to bring forward revolutionary new treatments and optimize next-generation therapies to better meet patient needs.”

“Expanding IP and growing our library of NCEs has been essential to our strategy since our inception,” said Srinivas Rao, Chief Scientific Officer and Co-Founder of atai Life Sciences. “By establishing differentiated potential treatments, with near, middle, and long-term developmental timelines, we add value and sustainability to our extensive pipeline of novel compounds with potential in targeting mental health indications. We are uniquely positioned, as a leading developer of psychedelic therapeutics, with the resources necessary to commit to and deliver this forward-looking strategy.”

“The use of psychedelic compounds to create improved next-generation mental health therapies is a highly promising and emerging field,” said Diana Kraskouskaya, Dalriada Chief Executive and Co-Founder. “We’re delighted to be partnering with atai to make an impact in this area. This creation of Invyxis brings together Dalriada’s ability to provide a rapid set-up and advancement of NCE discovery pipelines and atai’s expertise in the preclinical and clinical development of psychedelic therapeutics.”

Mental health disorders impact over 1 billion people around the world, representing a growing global crisis, but medical innovation has failed to offer recent novel solutions.3 Only 7 treatments have been approved by the FDA for psychiatry disorders since 2015; a time in which approximately 100 have been advanced in oncology.4 atai Life Sciences is proud to be a driving force in mental health innovation and to make Invyxis the latest addition to its diversified platform, to develop new therapeutic options in key areas of patient unmet need.

References:

  1. ATAI Life Sciences and Cyclica Launch Joint Venture to Revolutionize Drug Development for Mental Health Disorders. [Press Release] https://www.businesswire.com/news/home/20191111005299/en/ATAI-Life-Sciences-and-Cyclica-Launch-Joint-Venture-to-Revolutionize-Drug-Development-for-Mental-Health-Disorders. Published November 11, 2019. Accessed January 18, 2022.
  2. atai Life Sciences launches TryptageniX to further expand atai’s robust intellectual property portfolio and strengthen atai’s supply chain. [Press release] https://ir.atai.life/news-releases/news-release-details/atai-life-sciences-launches-tryptagenix-further-expand-atais. Published December 9, 2021. Accessed January 18, 2022.
  3. Rehm J, Shield KD. Global Burden of Disease and the Impact of Mental and Addictive Disorders. Curr Psychiatry Rep. 2019;21(2):10.
  4. U.S. Food and Drug Administration. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products. Accessed January 5, 2022. https://www.fda.gov/drugs/development-approval-process-drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products.

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 vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: statements regarding Invyxis and NCE development, the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those clinical trials, including progress and related milestones, may be impacted by several factors including the failure by such third parties to meet deadlines for the completion of such trials, research, or testing, changes to trial sites and other circumstances; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates; if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus, dated June 17, 2021, filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.

Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.


Contact Information

Media Contact:
Camilla Dormer
VP, Communications
Email: camilla@atai.life

Investor Contact:
Chad Messer
VP, Investor Relations
Email: chad@atai.life

Posted on

Awakn Life Sciences Files Patent Application For A New Class Of Entactogen-Like Molecules To Treat A Broad Range Of Addictions

Awakn Life Sciences Files Patent Application For A New Class Of Entactogen-Like Molecules To Treat A Broad Range Of Addictions

Novel Entactogen NCE series enhances the potential for improved treatment of addiction

TORONTO, CANADA, 26 January 2022 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company, researching, developing and delivering psychedelic therapeutics to treat addiction, announces the filing of a patent application for a new chemical series of entactogen-like molecules, further strengthening Awakn’s intellectual property portfolio and pipeline for the treatment of a broad range of addictions including, but not limited to substance addictions such as Alcohol, and behavioural addictions, such as Gambling Disorder and Compulsive Sexual Behaviour.

The new chemical series patented by Awakn, delivers a significant step forward in the development of entactogens and provides a key milestone in Awakn’s drug discovery R&D activities. Awakn’s innovative pipeline of NCE’s further adds to existing patent applications and active clinical development programmes (KARE: completed phase-IIa/b trial and BIMA: completed phase-IIa trial), strengthens Awakn’s position as a global leader in the psychedelic-biotechnology industry.

Chief Scientific Officer at Awakn, Shaun McNulty commented, “The new chemical series of entactogen-like molecules being developed at Awakn will deliver the best characteristics of existing entactogens, with a shorter duration of action. This can improve clinical utility in a research space and has significant potential for the delivery of the treatments. These improved entactogens will enable us to treat more patients and has the potential to increase the range of disorders we can treat.  This will enable us to make rapid progress towards treating a broad range of addictions, a condition with huge unmet medical needs and significant negative impact on society.”

Awakn announced in October they would progress the NCE program into lead optimization with their research partner Evotec. These novel entactogen-like molecules which the patent has been filed for will be an integral part of this research program, with the aim to develop one or more compounds and progress them into clinical development. 

Anthony Tennyson, Awakn’s CEO commented, “Our ambition is to fully integrate effective psychedelic-based treatment into mainstream healthcare to better treat addiction. We are fortunate to have many of the world’s leading researchers and drug discovery experts supporting and delivering our vision at Awakn. Our clinical team has unparalleled experience in treating addiction, and now with the development of a new entactogen series and a world-class entactogen discovery pipeline, Awakn’s place as a global leader in this space is strengthened.”

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company, researching, developing, and delivering psychedelic therapeutics to better treat addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are advancing the next generation of psychedelic drugs and therapies to be used in combination.

Awaknlifesciences.com  |  Twitter  |  LinkedIn  |  Facebook

Notice Regarding Forward Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating to the proposed NEO listing, and the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include: whether conditions to the listing on NEO will be satisfied; the business plans and strategies of the Company, the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities 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 within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:

KCSA Strategic Communications 
Valter Pinto / Tim Regan 
Phone: +1 (212) 896-1254
Awakn@KCSA.com

Media Enquiries:

America and Canada: KCSA Strategic Communications  
Anne Donohoe 
Adonohoe@KCSA.com

Rest of World: ROAD Communications 
Paul Jarman / Nora Popova
Awakn@roadcommunications.co.uk

Posted on

MINDCURE Announces Financial Results for the Second Quarter of Fiscal 2022

MINDCURE Announces Financial Results for the Second Quarter of Fiscal 2022

VANCOUVER, BC, Jan. 25, 2022 – Mind Cure Health Inc. (CSE: MCUR) (OTCQX: MCURF) (FRA: 6MH) (“MINDCURE” or the “Company”), a leader in advanced proprietary technology and research for psychedelics, today announced its financial results and operational highlights for the three and six months ended November 30, 2021. All amounts are stated in Canadian dollars unless otherwise indicated.  

Fiscal Q2 2022 Business Highlights

  • Commenced trading on the OTCQX Best Market on September 30, 2021, the highest tier of OTC Markets Group, under the ticker symbol “MCURF”.
  • Closed an exclusive data licensing agreement with ATMA Journey Centers Inc., a pioneer in the psychedelic therapy industry, and was granted exclusive access to ATMA data from patients using iSTRYM, the Company’s digital therapeutics technology. The data will be leveraged to further optimize iSTRYM and position it as the industry’s distribution network for science-based, evidence-backed protocols and AI data systems.
  • Signed a letter of intent with Awakn Life Sciences (NEO: AWKN) (OTCQB: AWKNF) to be a distributor of its ketamine-assisted psychotherapy for Alcohol Use Disorder protocol in the US and Canada.
  • Partnered with 20 ketamine clinics in nine states in the U.S. and three provinces in Canada to release the minimum viable product version of iSTRYM, with plans to further expand in 2022.
  • Introduced the “Desire Project”, a clinical research program focused on the treatment of female hypoactive sexual desire disorder with MDMA-assisted psychotherapy. This is the first psychedelics-based treatment program targeted at addressing Hypoactive Sexual Desire Disorder.
  • Joined the Digital Therapeutics Alliance, a non-profit association of industry leaders with a mission to drive awareness and adoption of digital therapies.
  • Advanced preparations to ship ibogaine drug material to its pre-clinical research partner.
  • Included in the AdvisorShares Psychedelics ETF, which trades on the NYSE Arca under the ticker symbol “PSIL”.

Recent Events

  • The Company and its digital therapeutics technology, iSTRYM, were certified as Health Insurance Portability and Accountability Act (HIPAA) compliant, making a further step toward commercial deployment in the second quarter of 2022.
  • Appointed Dr. Doron Sagman, MD, FRCPC, as the Company’s new Chief Medical Officer (“CMO”). Dr. Joel Raskin who was acting CMO will transition into an advisory role.

“During the second quarter of fiscal 2022, we achieved several key milestones across our digital technology and research projects, further proving our ability to successfully execute against our strategic growth strategy,” said Kelsey Ramsden, President & CEO of MINDCURE. “We are continuing to build out our team with key industry leaders, positioning the Company to develop innovative treatments that promote healing and improve mental health.”

Financial Highlights

  • Net loss for the three months ended November 30, 2021 was $2.95 million, comprised of cash operating expenses of $2.9 million, non-cash operating expenses of $0.3 million and an unrealized gain of $0.2 million.
  • Cash and cash equivalents totalled $13.4 million as of November 30, 2021.

A copy of the Company’s financial statements for the three and six months ended November 30, 2021 and the related management’s discussion and analysis are available under the Company’s profile on SEDAR at www.sedar.com.

In other news, the Company also announces it has granted a total of 110,000 stock options to certain employees pursuant to the terms the Company’s long term incentive plan (“Plan”). The stock options are exercisable at a price of $0.21 per share, and are subject to the terms of the Plan.

About Mind Cure Health Inc.
MINDCURE is a life sciences company focused on innovating and commercializing new ways to promote healing and improve mental health. The company is developing digital therapeutics technology and researching psychedelic compounds to support access to safe, evidence-based psychedelic-assisted therapies globally. Learn more at mindcure.com, and follow us on Facebook, Twitter, and Instagram.

On Behalf of the Board of Directors
Kelsey Ramsden, President & CEO
Phone: 1-888-593-8995

Forward-Looking Information
Forward-looking information is based on a number of key expectations and assumptions made by management of MINDCURE, including, without limitation: the COVID-19 pandemic impact on the Canadian economy and MINDCURE’s business, and the extent and duration of such impact; no change to laws or regulations that negatively affect MINDCURE’s business; there will be a demand for MINDCURE’s products in the future; no unanticipated expenses or costs arise; MINDCURE will be able to continue to identify products that make them ideal candidates for providing solutions for treating mental health; that iSTRYM will be developed, optimized and operate as contemplated within the psychedelics industry; that the Company will be effective in obtaining the patents applied for synthesizing ibogaine, or synthesizing ibogaine, or developing synthesized ibogaine for research, medical or commercial use; that MINDCURE will advance wellness worldwide; that iSTRYM will be brought to commercial deployment in the near term or otherwise or that it will reduce symptoms, improve quality of life, or support transformation and healing, or that the deployment may not occur at the scale or within the time frame contemplated.

Although MINDCURE has attempted to identify important factors that could cause actual results, performance or achievements to differ materially from those described in forward-looking information presented, there may be other factors that cause results, performance or achievements to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements as no forward-looking information can be guaranteed.

Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and MINDCURE does not undertake any obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.

For further information: MINDCURE Investor Relations, Daniel Kim, VP Investor Relations, dkim@mindcure.com, 1-888-593-8995

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Mindset Pharma Enters Manufacturing Agreement with Leading CDMO to Produce Pharmaceutical Grade Batches of Next-Generation Psilocybin Drug Candidate, MSP-1014

Mindset Pharma Enters Manufacturing Agreement with Leading CDMO to Produce Pharmaceutical Grade Batches of Next-Generation Psilocybin Drug Candidate, MSP-1014

TORONTO, Jan. 25, 2022 (GLOBE NEWSWIRE) — Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (“Mindset” or the “Company”), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today announced that it has entered into a pharmaceutical manufacturing agreement with a leading contract development and manufacturing organization (CDMO), for the production of pharmaceutical grade batches of Mindset’s next-generation psilocybin drug candidate, MSP-1014.

“Following our co-development announcement with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies, for our short-duration compounds (Mindset Families 2 & 4), we continue to receive interest from potential partners for our wider portfolio of differentiated next-generation drug candidates. As such, our manufacturing agreement with a leading CDMO positions MSP-1014 well for partnership opportunities to advance this optimized compound to human clinical trials,” said James Lanthier, Chief Executive Officer of Mindset. “In preclinical trials, MSP-1014 has shown improved efficacy and safety compared to first-generation psilocybin. Also, it has demonstrated pharmacological diversity making it potentially suitable for both in clinic treatment approaches and as a take-home medicine.”

“Notably, MSP-1014 is not a scheduled substance based on current guidance from regulators in Canada and the USA. With MSP-1014’s unique structure and Mindset’s innovative synthesis process, we anticipate a lower cost and more simple manufacturing process than psilocybin that well positions MSP-1014 for rapid commercialization,” concluded Mr. Lanthier.

About Mindset Pharma
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next-generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next-generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds.

For further information on Mindset, please visit our website at www.mindsetpharma.com.

For more information, please contact:

Investor Contact:
Allison Soss/Tim Regan
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 212-896-1267/ 347-487-6788

Media Contact:
McKenna Miller
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 949-606-6585

Company Contact:
James Lanthier, CEO
Email: jlanthier@mindsetpharma.com

Jason Atkinson, VP, Corporate Development
Email: jatkinson@mindsetpharma.com
Phone: 416-479-4094

‍Forward-Looking Information

This news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward looking information is frequently characterized bywords such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “would”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company’s business are contained under the heading “Risk Factors” in the Company’s annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

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Core One Labs Announces Successful Proof of Concept and Files Patent for Protection of its Recombinant Production System for Optimized Biosynthesis of Psilocybin

Core One Labs Announces Successful Proof of Concept and Files Patent for Protection of its Recombinant Production System for Optimized Biosynthesis of Psilocybin

Vancouver, British Columbia, Canada – January 21, 2022 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (“Core One” or the “Company”) is pleased to announce that its wholly owned subsidiary, Vocan Biotechnologies Inc. of Victoria, British Columbia, has optimized its recombinant production system (the “System”), successfully testing its proof of concept for the biosynthesis of psilocybin suitable for use in future scale-up and has filed a patent application with the United States Patent and Trademark Office (“USPTO”) titled “Production of Psychedelic Compounds” for protection of its novel psilocybin production system. Psilocybin is a psychedelic compound that is showing enormous promise in treating addiction and depression.

The Company’s team of scientists at Vocan have constructed optimized DNA sequences that can produce enzymes replicating the biosynthetic pathway used by Psilocybe mushrooms. This allows bacteria to become factories for psilocybin production. Under the leadership of Dr. Jan Burian, Chief Scientist, and Dr. Robert EW Hancock, Vocan CEO, Vocan scientists have used DNA modeling to improve and optimize design and produce unique DNA sequences that improve the efficiency and expression of these enzymes, allowing for rapid and cost-effective psilocybin production.
Currently, most companies use chemically synthesized psilocybin as the only available cGMP compliant product that is available in large volumes. The chemical process carries significant costs and is less efficient when compared to a biologically derived psilocybin. Vocan’s biosynthetic process retains the stereochemistry of the natural psilocybin molecules found in hallucinogenic mushrooms, which are known to have a more positive effect than the chemically synthetized counterpart. However, these tiny mushrooms are not an efficient source of psilocybin since the amount produced is quite small and variable.
Vocan’s successful production system engineers bacteria incorporating optimized biosynthetic genes from the Psilocybe mushroom and other species and enables the bacteria to act as a biological factory and synthesize psilocybin.

Additionally, the Company’s team of scientists hypothesise that by using a gene mimicry process and simple chemical modifications to enable the creation of bioidentical compounds, there is potential to produce other known and novel analogs of psilocybin and related psychedelics. The analog compounds may potentially be more effective, targeted, and safer than the natural compounds.

The patent application entitled “Production of Psychedelic Compounds” includes claims that Vocan’s technology will enable the production of cGMP API grade psilocybin, which can be used by pharmaceutical companies, API manufacturers and organizations conducting clinical trials and, where permitted by law, consumers, and patients. Vocan’s method of psilocybin production will provide more affordable access to organizations looking to acquire cGMP API grade psilocybin. Vocan’s psilocybin production method utilizes the well-established industrial process of fermentation and thus can be scaled up while consistently producing a high-quality cGMP product.

“I am very pleased to say that we are fulfilling our promise to our shareholders and to the medical and research sectors, in general, that we have successfully produced biosynthesized psilocybin. Our team of scientists continue to achieve significant and astounding scientific milestones. Our goal is to play a significant role in furthering mental health research and the benefits of psychedelic medicines, and our cost-effective psychedelic compounds will go a long way towards allowing otherwise cost prohibitive medicines to be widely used,” Stated Dr. Hancock, Chairman of the Company, and CEO of Vocan. “This successful proof of concept for development and production of cost effective and stereochemically sound psilocybin puts Core One in a very unique position. It not only potentially positions the Company as first to market with a biosynthetic psychedelic, it positions us to become market-leaders with regards to cost efficiency, as well.

ABOUT CORE ONE LABS INC.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One 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. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

CORE ONE LABS INC.
Joel Shacker
Chief Executive Officer

FOR FURTHER INFORMATION:
Email: info@core1labs.com
Telephone: 1-866-347-5058

FOLLOW US:
Website: https://core1labs.com/
Twitter: https://twitter.com/Coreonelabs
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Instagram: https://www.instagram.com/coreonelabsinc/

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 strict regulatory 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 or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One 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 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 does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

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Global Wellness’ Shanti Therapeutics Announce Psychedelic Drug Development Agreement

Global Wellness’ Shanti Therapeutics Announce Psychedelic Drug Development Agreement

Vancouver, British Columbia, January 20, 2022 – Global Wellness Strategies Inc. (CSE:GWS) (OTCQB: GWSFF) (Frankfurt:O3X4) (“Global” or the “Company”) announces that it has signed an agreement with Next Frontier Pharmaceuticals, Inc.’s subsidiary Benuvia Manufacturing, Inc.; a merger partner of Jupiter Wellness (NASDAQ: JUPW) to work with Shanti Therapeutics as the manager of their novel psychedelic development program using MDMA.

Benuvia, based in Round Rock, Texas, is a leading drug developer and provider of cannabinoid and psychedelic APIs. Benuvia has a growing portfolio of drug products and intellectual property, and an 83,000 square foot synthetic compound manufacturing facility that is permitted by the U.S. DEA for Schedule I to III controlled substances, and is FDA registered. Benuvia also has a platform of drug master files and drug development libraries, manufacturing process technologies, and intellectual property, including patents, for the development and manufacture of organic and synthetic cannabinoids, and has a pending application for quota with the U.S. DEA to manufacture psychedelic APIs. Benuvia has begun focusing on three primary psychedelic ingredients: Psilocybin, N,N-Dimethyl-5-Methoxy-Tryptamine, or DMT, and 3,4-Methylenedioxymethamphetamine, or MDMA.

“Shanti chose Benuvia as its development partner due to its proven track record and best in class status as a developer and manufacturer of synthetic APIs.  We are creating a pipeline of novel agonists as a new class of therapeutics designed to treat the root causes of mental illness disorders and chronic pain.” said Meris Kott, CEO, Global Wellness Strategies Inc. “By partnering with Benuvia, Shanti will continue with its strategy of collaborating with the emerging leaders in the field to realize our mission to provide innovative new medicines to patients.”

“We are excited to announce our entry into the global psychedelic market and our partnership program with emerging providers of psychedelic-based drugs focused on mental illness and chronic pain indications,” said Shannon Soqui, Executive Chairman of Next Frontier Pharmaceuticals. “As pharmaceutical companies become more aware of the positive effects of cannabinoids and psychedelic compounds for therapeutic use, the demand for APIs is expected to grow. Our diversified portfolio of APIs and entry into the development of novel psychedelic compounds aims to increase Next Frontier Pharmaceuticals’ and Benuvia’s position as a leading drug developer and provider of APIs focused on cannabinoids and psychedelics.”

As part of its launch into the market, Benuvia has signed an agreement to provide life cycle management services to Shanti Therapeutics for their psychedelic development program which uses MDMA. Benuvia will develop and file intellectual property on formulations of MDMA, and will provide full toxicology, and chemistry, manufacturing and controls, or CMC, and full data analysis. In addition, Benuvia, through its partners, will manage all research and development, manufacturing, analytical methods, intellectual property capture, placebo manufacture, randomization, and assistance with clinical trials. This will enable Benuvia to create custom technologies that allow rapid and cost-effective scale up of commercial operations for production in anticipation of research success.

“We are excited to partner with Shanti Therapeutics as we have a shared vision to develop and commercialize innovative medicines that provide an alternative treatment option for health care providers and their patients,” said Brandon Kidd, Chief Business Development Officer of Next Frontier Pharmaceuticals. “As pharmaceutical companies look to optimize the life cycle management of their cannabinoid and psychedelic drug products, Benuvia is an ideal partner to facilitate all facets of the process from drug development and formulation to manufacturing.”

About Global Wellness Strategies

Global Wellness Strategies is a prospect generator that provides high growth companies with financial, operational, and management assistance in the fast-growing market for wellness consumer products. The focus of the Company is on global wellness, psychedelics, mycology, hemp and CBD, healthcare-related target companies.

About Shanti Therapeutics Pty Ltd
Shanti Therapeutics Pty Ltd, is a subsidiary of Global Wellness Strategies Inc. and  is a clinical stage drug development company focused on identifying novel uses for MDMA in the treatment of acute and chronic pain management.  Its core strategy involves identifying innovative uses for entheogen drugs and pushing them into in-human clinical trials.  Its lead asset is scheduled to commence Phase 2 clinical trials in late 2022.

About Next Frontier Pharmaceuticals, Inc.
Next Frontier Pharmaceuticals, Inc., through its wholly owned subsidiary, Benuvia Manufacturing, Inc., is a leading drug developer and provider of cannabinoid and psychedelic APIs.  Benuvia owns the FDA approved cannabinoid drug SYNDROS® (dronabinol oral solution CII), and the largest captive synthetic cannabinoid manufacturing facility in the U.S.  SYNDROS® is FDA approved as a prescription drug for the treatment of chemotherapy-induced nausea and vomiting in cancer patients and loss of appetite in AIDS patients who have lost weight. Next Frontier Pharmaceuticals is also pursuing a 505(b)(2) approval pathway with the FDA for six Investigational New Drugs (INDs). The Company’s 83,000 square foot manufacturing facility in Texas is permitted by the U.S. DEA to manufacture and export Schedule I to III controlled substances and is FDA registered. The facility has received millions in manufacturing infrastructure investments and currently operates for Benuvia’s internal capacity needs and as a contract manufacturer of APIs.  Next Frontier Pharmaceuticals also has a robust portfolio of patents and patents pending on organic and synthetic cannabinoids and provides life cycle management services for drug development companies focused on cannabinoids and psychedelics.

For further information visit websites:

www.globalwellnessstrategies.com and  www.shantitherapeutics.com

Or Contact Meris Kott CEO 604.484.0355 or email to info@globalwellnessstrategies.com

Further information about the Company is available on www.SEDAR.com under the Company’s profile.

Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. Certain statements contained in this release may constitute “forward–looking statements” or “forward-looking information” (collectively “forward-looking information”) as those terms are used in the Private Securities Litigation Reform Act of 1995 and similar Canadian laws. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “anticipates” 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 Company’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, this release contains forward-looking information relating to the business of the Company, its financing and certain corporate changes. The forward-looking information contained in this release is made as of the date hereof and the 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. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein

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Optimi Health Submits Natural Psilocybin Combined Drug Delivery and Extraction Formulations for Provisional Patent

Optimi Health Submits Natural Psilocybin Combined Drug Delivery and Extraction Formulations for Provisional Patent

Company identifies unique two-part extraction and transdermal delivery process

VANCOUVER, BC (GLOBE NEWSWIRE – January 18, 2022) — Optimi Health Corp. (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), developers of a vertically integrated mushroom brand targeting functional and novel psychedelic compounds for the health and wellness sector, is pleased to announce a second provisional patent for a proprietary two-part processing method that involves the extraction and transdermal delivery of psilocybin active components.

The extraction process uses a highly viscous material to isolate key components of psychedelic mushrooms and dissolves the psilocybin into a molecular solution. Using the same energy, the active ingredients are then repelled into the skin when applied topically. Due to the skin’s highly permeable membrane, Optimi’s solution has a natural time-release effect, which allows for a more sustained release into the body and provides a patient with the ability to experience the desired outcome for longer periods of time.

As Chief Science Office Justin Kirkland explains, “The most novel part of this process is that we are performing two very different functions with a single unique component. This component works much like the attraction and repulsion properties of a magnet with a North and South end. We leverage this energy to perform two functions. First, the attraction energy will extract psilocybin out of the mushroom. Second, when this same material is applied to the skin, it will advance the drug through the skin and into the bloodstream.”

Containing all GRAS certified ingredients, this solution can then be loaded into our proprietary drug delivery system for direct passage through the skin into the bloodstream. Transdermal application avoids the first pass metabolism and degradation of psilocybin by the liver that occurs with traditional oral drug delivery, which increases bioavailability of the active ingredient.

In the continued effort to champion all things natural, Optimi’s delivery system has been designed to require no additional shuttling agents. Instead, the repulsion technology steadily pushes the active ingredient through the various layers of the skin, and treatment begins almost immediately upon application. This new process will help to reduce costs and resources while providing patients with a superior product.

Optimi is focused on providing patients with a safe, consistent, and pure psychedelic product. Developing multiple extraction and delivery system methods is part of the Company’s commitment to ensuring patients have options when deciding their treatment.

“This unique chemistry provides improved bioavailability of Optimi’s psilocybin,” said Optimi CEO Bill Ciprick. “Our IP is evidence of Optimi Health’s continued commitment to sustainability by using green chemistry to achieve both the extraction and topical formulations.” Mr. Ciprick adds, “As patient access remains the focal point among regulators, lobbyists and Companies such as our own, we look forward to being able to provide our variety of therapies to those in need.”

On Behalf of the Board of Directors,

Bill Ciprick
Chief Executive Officer
Optimi Health Corp.

ABOUT OPTIMI (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN)

Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion in Princeton, British Columbia. To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also applied for a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production. Find out more at: https://optimihealth.ca/.

FOR FURTHER INFORMATION CONTACT:

Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (778) 930-1321
Web: https://optimihealth.ca/

FORWARD‐LOOKING STATEMENTS

This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to the Company’s potential Nasdaq listing, the dealer’s license application, activities proposed to be conducted under the Company’s research exemption and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.

Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Final Prospectus dated February 12, 2021. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement. Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

The CSE does not accept responsibility for the adequacy or accuracy of this release.Search

CATEGORIES

OPTIMI HEALTH SUBMITS NATURAL PSILOCYBIN COMBINED DRUG DELIVERY AND EXTRACTION FORMULATIONS FOR PROVISIONAL PATENT

18 JANUARY 2022

OPTIMI HEALTH PROVIDES DEALER LICENSE UPDATE AND COMMENTS ON HEALTH CANADA’S AMENDMENTS TO THE SPECIAL ACCESS PROGRAM (SAP)

5 JANUARY 2022

OPTIMI HEALTH RECEIVES DEALERS LICENSE INSPECTION AND INTRODUCES QUALITY ASSURANCE DEPARTMENT

21 DECEMBER 2021

OPTIMI HEALTH REQUESTS FINAL INSPECTION FOR DEALER’S LICENSE

7 DECEMBER 2021

OPTIMI HEALTH ENGAGES EXPERT MANAGEMENT CONSULTANCY TO DRIVE CORPORATE VISIBILITY

3 NOVEMBER 2021

OPTIMI HEALTH APPOINTS PRINCIPAL INVESTIGATOR FOR CLINICAL DOSING STUDY

19 OCTOBER 2021Email

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Telescope Files Patent Cooperation Treaty Application on Scalable Psilocybin and Tryptamine Synthesis

Telescope Files Patent Cooperation Treaty Application on Scalable Psilocybin and Tryptamine Synthesis

Vancouver, BC — January 17, 2022 — Telescope Innovations Corp. (“Telescope” or the “Company”) (CSE: TELI) announces that it has filed a Patent Cooperation Treaty (“PCT”) patent application for its scalable manufacturing methods to produce psilocybin and related tryptamine compounds. This application claims the priority date of a preceding provisional application filed with the United States Patent and Trade Office on December 31, 2020.

This PCT filing covers novel synthetic routes for the production of psilocybin and psilocin along with their precursors, analogs, and derivatives. These molecules belong to the tryptamine class of compounds that has been gaining momentum in the psychedelic medicine space in recent years. The processes outlined in this patent application are positioned to enable scalable manufacturing because they require fewer synthetic steps than current methods, utilize cost effective and readily available starting materials, and leverage chemical manufacturing processes that are already standard practice in the pharmaceutical industry. Telescope’s synthetic methods are therefore well-poised for compatibility with the standards of current Good Manufacturing Practices (cGMP) ultimately required for pharmaceutical deployment.

Jason Hein, CEO of Telescope, noted, “the demand for pharmaceutical-grade psilocybin and psychedelic tryptamines is rising. We are seeing increased numbers of trials and studies advancing these compounds along the drug development pipeline, but there has been relatively little focus on how these molecules will be reliably produced at a large scale. Telescope’s patent represents a significant milestone in addressing the impending manufacturing bottleneck.”

The synthetic processes described in the PCT application are not limited to the production of psilocybin, but enable access to a wide variety of tryptamines and can be easily adapted to produce specific derivatives. Derivatives are currently being explored by drug development companies seeking to tune the predictability, potency, or pharmacokinetic profiles of psychedelic therapeutics. Telescope’s intellectual property portfolio is therefore flexible and amenable to changing demands as different molecules are targeted throughout pharmaceutical development in the psychedelic space. Indeed, while developing proprietary synthesis processes, Telescope has discovered new molecules (Novel Chemical Entities; “NCEs“) that may become candidates for preclinical development. These NCEs are also captured within the PCT application.

“We’re very pleased with Telescope’s research results this year,” added Hein. “The Company is set up very well to continue developing our intellectual property portfolio and bringing our discoveries closer to deployment.”

About Telescope

Telescope is a chemical technology company developing scalable, widely deployable synthetic processes to manufacture pharmaceuticals for the treatment of mental health. The Company develops new enabling technology to achieve these goals, including flexible robotic platforms and artificial intelligence software that improves experimental throughput, efficiency, and data quality. Research and development efforts are currently focused on medicines from the under-utilized tryptamine class of compounds, leveraging innovative process chemistry both to optimize synthetic procedures and access novel molecules. Our aim is to bring modern chemical solutions to meet the most serious challenges in human health. 

On behalf of the Board,

Telescope Innovations Corp.

Jason Hein, Chief Executive Officer

E: jason@telescopeinn.com 

Forward-Looking Information

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of the prospectus filed by the Company and available at www.sedar.com.

Forward-looking statements in this document include expectations surrounding the patent filing process and the timing thereof, anticipated trends in the demand for psychedelic medical treatments and the ability of the intellectual property portfolio of the Company to respond to this demand, and all other statements that are not statements of historical fact.

Examples of such assumptions, risks and uncertainties include, without limitation, assumptions, risks and uncertainties associated with the global COVID-19 pandemic, including the risk that the Company be deemed a non-essential business and asked to temporarily cease operations; general economic conditions; adverse industry events; future legislative and regulatory developments involving psilocybin; the Company’s ability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favorable terms; the psilocybin industry in Canada and generally; the ability of the Company to implement its business strategies; competition; and other assumptions, risks and uncertainties.

These factors are not intended to represent a complete list of the factors that could affect the Company; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and the Company expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

The CSE has neither approved nor disapproved the contents of this news release. Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

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Universal Ibogaine Announces World-class Clinical Trial Partners In Advance Of Clinical Trial Application For Ibogaine In Opioid Use Disorder

Universal Ibogaine Announces World-class Clinical Trial Partners In Advance Of Clinical Trial Application For Ibogaine In Opioid Use Disorder

Calgary, AB – January 14, 2022 – Universal Ibogaine Inc. (TSXV:IBO) (“UI” or the “Company”) a life sciences company with a mission to develop and deliver medicalized ibogaine-centered addiction care, is pleased to introduce its contract research organization (“CRO”) partners who will enable UI’s planned clinical trial in Canada to be conducted, subject to the required approval by Health Canada. UI is currently working with its CRO partners to finalize UI’s study design in advance of an anticipated pre-clinical trial application meeting to soon be held with Health Canada.

UI has selected Intrinsik Corp. (“Intrinsik”), an internationally recognized regulatory affairs consulting firm, to provide regulatory strategy and support for the preparation and submission of UI’s Canadian Clinical Trial Application (“CTA”), as well as follow-up and monitoring if a No Objection Letter (“NOL”) is received from Health Canada. Intrinsik is comprised of an experienced team who have driven hundreds of successful clinical trials and investigational new drug applications and have collectively contributed to more than 20 new drug marketing applications. The group has over 25 regulatory affairs professionals based in its Canadian headquarters located in the greater Toronto area, and unparalleled expertise and experience related to Central Nervous System Disorders (CNS: the therapeutic area to which addiction and mental health disorders belong). 

Support for the development of the substance of the CTA package, as well as ultimately the operation of the clinical trial itself, is being provided by the world-class team at CATO Research Canada Inc.(“CATO SMS”). The CATO SMS team of experts have over 30-years’ experience optimizing the design and execution of clinical trials for life sciences companies such as UI. CATO SMS has successfully conducted over 500 clinical trials in over 25 countries and have enrolled more than 60,000 patients at over 5,500 sites. 

The CATO SMS engagement team, along with UI’s team, involves a variety of experts in Canada, the US and Europe, providing critical expertise ranging from clinical study designs to biostatistics to clinical operations (e.g., patient recruitment, study startup, budgeting, site management, data management, etc.). CATO SMS’ contributions will also include the analysis and synthesis of proprietary real-world data and evidence ( “RWD” and “RWE”, respectively) stemming from the application of ibogaine for the treatment of opioid use disorder in approximately 200 patients who have been treated in Cancun, Mexico by UI’s licensing partner – Clear Sky Recovery Cancun SA de CV.  UI believes that the presentation of RWD and RWE as part of the CTA package will strengthen the application, particularly the preliminary claim to safety, and is aligned with emerging guidance by regulators, such as the US Food and Drug Administration (“FDA”), to acknowledge and incorporate RWD and RWE in clinical development, and generally in evidence-based medicine.    

Finally, UI is lining up prominent academic and medical centres to support the CTA to Health Canada, as well as potentially serve as sites to undertake the ultimate clinical trial. Notably, UI has engaged the research office of a leading Canada-based academic and teaching institution in the therapeutic area of addiction to support the design of the study protocol and generate interest in trial site selection.

Nick Karos – Universal Ibogaine CEO

Nick Karos (CEO) noted “Our engagement with Health Canada to date has clearly highlighted the road UI must take to provide practitioners and patients access to authorized ibogaine in Canada to treat opioid use disorder. The conduct of clinical trials is a very precise business requiring solid partnerships with the right expertise and players, and Universal Ibogaine is pleased that we have now secured these partnerships. We are confident that that with our partners expertise, we will move towards our goal of conducting clinical trials with Health Canada.”

About Universal Ibogaine Inc.

UI is a life sciences company, with a mission to develop and acquire a network of addiction treatment clinics throughout Canada, and to eventually use ibogaine as a primary modality for the interruption and ideally cessation of addictions: primarily opioids such as oxycodone, heroin, fentanyl, as well as alcohol, cocaine, and other stimulants.  

As such, UI concurrently plans to clinically develop ibogaine, a plant derived substance, as an authorized addiction interruption medicine for the treatment of Opioid Use Disorder.  A Clinical Trial Application to Health Canada is being developed to undertake clinical trials in Canada, aimed at proving the safety and efficacy of the use of ibogaine for this purpose.  In the longer term, and once approved as planned, UI will introduce ibogaine into the addiction treatment protocols to be used in its future facilities.

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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS 

‎This news release may contain forward-looking statements and information. Forward-looking information is frequently characterized by words such ‎as “plans”, “expect”, “project”, “intend”, “will”, “believe”, “anticipate”, “estimate”, “scheduled”, ‎‎”potential”, or other similar words, or statements that certain events or conditions “may”, “should” or ‎‎”could” occur.  The forward-looking statements and information are based on certain key expectations ‎and assumptions made by UI.  Although UI believes that the expectations and assumptions on which the forward-‎looking statements are based are reasonable, undue reliance should not be placed on the forward-‎looking statements because UI can give no assurance that they will prove to be correct. 

Since ‎forward-looking statements address future events and conditions, by their very nature they involve ‎inherent risks and uncertainties. Actual results could differ materially from those currently anticipated ‎due to a number of factors and risks, which include, but are not limited to, risks that required ‎regulatory approvals are not obtained. The reader is cautioned that assumptions used in the ‎preparation of such information, although considered reasonable by UI at the time of ‎preparation, may prove to be incorrect and readers are cautioned not to place undue reliance on ‎forward-looking information, which speaks only to conditions as of the date hereof.  UI does not ‎undertake any obligation to release publicly any revisions to forward-looking information contained ‎herein to reflect events or circumstances that occur after the date hereof or to reflect the occurrence ‎of unanticipated events, except as may be required under applicable securities laws. ‎

For further information: 

Investor Relations: Dugan Selkirk, IR Manager

dugan.selkirk@universalibogaine.com

Media Contact: Cathy Fernandes, Director – Marketing & Communications cathy.fernandes@universalibogaine.com