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COMPASS Pathways launches proposed public offering

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the launch of a proposed public offering of 4,000,000 American Depositary Shares (“ADSs”), each representing one ordinary share.

Each of the ADSs is being offered by COMPASS. COMPASS expects to grant the underwriters a 30-day option to purchase up to an additional 600,000 ADSs. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

Cowen, Evercore ISI and Berenberg are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co. and BTIG, LLC are acting as lead managers for the offering.

The proposed offering will be made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at PostSaleManualRequests@broadridge.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, telephone: (888) 474-0200, or email: ecm.prospectus@evercore.com; or Berenberg Capital Markets LLC, Attention: Investment Banking, 1251 Avenue of the Americas, 53rd Floor, New York, New York 10020, or by telephone at +1 (646) 949-9000, or by e-mail at prospectusrequests@berenberg-us.com. For the avoidance of doubt, such prospectus will not constitute a “prospectus” for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and will not have been reviewed by any competent authority in any EU member state or the UK.

Important information

A registration statement relating to these securities has been filed with the US Securities and Exchange Commission (the “SEC”), but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

For readers in the European Economic Area (“EEA”) and the UK

In any EEA member state and the UK (each, a “Relevant State”), this press release and any offering are only addressed to and directed at persons who are qualified investors (“Qualified Investors”) in that Relevant State within the meaning of the Prospectus Regulation. The term “Prospectus Regulation” means Regulation (EU) 2017/1129.

For readers in the UK

In the UK, this press release, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended (the “FSMA”), and any offering are only addressed to and directed at Qualified Investors (i) who are investment professionals as described in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”), (ii) persons and entities who fall within Article 49(2)(a) to (d) of the Order, or (iii) to whom it may otherwise lawfully be communicated (all such persons being referred to as “relevant persons”).

This press release must not be acted on or relied on (i) in the UK, by persons who are not relevant persons, and (ii) in any EEA member state, by persons who are not Qualified Investors. Any investment or investment activity to which this press release relates is available only to and will only be engaged with (i) in the UK, relevant persons, and (ii) in any EEA member state, Qualified Investors. This press release does not contain an offer or constitute any part of an offer to the public within the meaning of sections 85 and 102B of the FSMA or otherwise.

About COMPASS Pathways

COMPASS is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, US. Our vision is a world of mental wellbeing.

Forward-looking statements

This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, express or implied statements relating to, among other things, COMPASS’s ability to complete the proposed offering and its anticipated use of proceeds. Forward-looking statements are based on COMPASS’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the satisfaction of customary closing conditions and the completion of the offering, and the risks inherent in mental health care clinical trials. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the offering to be filed with the SEC. Forward-looking statements contained in this announcement are made as of this date, and COMPASS undertakes no duty to update such information except as required under applicable law.

Enquiries:

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401-290-7324

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Bright Minds Biosciences Appoints Industry Experts for Key Roles and Expands Scientific Advisory Team

VANCOUVER, British Columbia, April 27, 2021 (GLOBE NEWSWIRE) — Bright Minds Biosciences (“Bright Minds” or the “Company”), a biotechnology company focused on developing novel transformative treatments for neuropsychiatry disorders, epilepsy and pain, today announced two additions to its leadership team and one new scientific advisor as follows:

  • Jianmin Duan, PhD, Vice President, Pharmacology, will lead Bright Minds’ preclinical testing work.
  • Thomas Grizzle, Vice President, Toxicology, will lead Bright Minds’ efforts around the safety and biological effects of its therapeutics.
  • Krista Lanctot, PhD, Advisor, will join Bright Minds’ Scientific Advisory team.

 

“The additions of Jianmin, Tom and Krista to the Bright Minds team will help us to accelerate the advancement of our development pipeline as we broaden our core scientific strengths. Jianmin is a well-respected PK/PD specialist whose experience will guide our drug development program. Similarly, Tom has been a sought-after consultant and renowned toxicologist who has helped many companies navigate the complexities of ensuring drug safety standards. As a Key Opinion Leader studying Alzheimer’s disease, Krista’s work focuses on cognitive and neuropsychiatric symptoms associated with dementia. Each of these talented individuals brings decades of experience that will help us progress our approach of using serotonin agonists to develop improved therapeutics to address a variety of mental health, epilepsy and pain management needs,” stated Ian McDonald, Chief Executive Officer of Bright Minds.

 

Jianmin Duan, PhD, is an experienced pharmaceutical research and development scientist with expertise in drug absorption, distribution, metabolism, excretion, pharmacokinetics and pharmacology. Prior to joining Bright Minds, Dr. Duan was an independent consultant to pharmaceutical and biotechnology companies, guiding R&D evaluations, regulatory submissions, implementing and validating novel biological assays, CMC, experimental design, data analysis, formulation design, cross-species predictions, and selecting and implementing PK/PD/Tox models to inform drug development decisions. Previously, Dr. Duan spent more than 20 years at Boehringer Ingelheim (Canada) Ltd. in roles of increasing responsibility, most recently as Director, Preclinical ADMEPK/Pharmacology. He has authored more than 50 papers that have appeared in peer-reviewed journals and holds three patents. Dr. Duan received a B.Sc. in Biology from Shandong Normal University and a PhD in Pharmacology from Dalhousie University.

 

Thomas Grizzle is an experienced toxicologist, specializing in pharmacokinetics; safety pharmacology; absorption, distribution, metabolism, and excretion (ADME); bioanalytical chemistry; project management; and report writing. Before joining Bright Minds, Mr. Grizzle was a successful consultant, advising clients across these critical domains and helping them achieve successful outcomes. Prior to establishing his consultancy, he was a Senior Toxicologist at Icagen, Inc. and Triangle Pharmaceuticals. He received an MS in Physiology/Biochemistry from North Carolina State University and holds Diplomate Certifications in General Toxicology and Safety Pharmacology.

 

Krista Lanctot, PhD, is a Senior Scientist at Sunnybrook Research Institute and a professor of psychiatry and pharmacology at the University of Toronto. Her research interests include optimizing the treatment of neuropsychiatric symptoms associated with illness, including mood changes, apathy, aggression, and cognitive changes. Dr. Lanctot’s broad experience includes running clinical trials for cognitive and neuropsychiatric symptoms associated with dementia, including neuropsychiatric symptoms secondary to central nervous system pathology; neuroimaging, serum protein, lipid and metabolite biomarkers; and medical, dietary and exercise interventions. Dr. Lanctot’s work focuses on determining the underlying neurobiology of neuropsychiatric symptoms, examining predictors of treatment response, using novel pharmacological agents, and carefully considering adverse drug events. Dr. Lanctot received a BSc in Pharmacology and Toxicology, an MS in Clinical Pharmacology and a PhD in Clinical Pharmacology from the University of Toronto.

 

About Bright Minds

 

Bright Minds is focused on developing novel transformative treatments for neuropsychiatry disorders, epilepsy and pain. Bright Minds has a portfolio of next generation serotonin agonists designed to precisely target abnormalities in neurocircuitry that lead to dysfunctional behaviors. The Company is developing targeted therapies with the potential to improve the treatment of mental health and neurological disorders through the use of serotonergic compounds leveraging its world class scientific and drug development expertise to bring forward the next generation of safe and efficacious drugs. Bright Minds’ drugs extenuate the therapeutic aspects of psychedelic and other serotonergic compounds while minimizing the side effects thereby creating superior drugs to first-generation compounds, such as psilocybin.

 

Forward-Looking Statements

This news release contains forward-looking statements, including statements regarding the date of listing of the Shares and the advancement of the Company’s drug development program, and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. 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.

The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, and which are described in the Company’s public filings available under its profile at www.sedar.com. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. 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 does not intend to update any of the included forward-looking statements except as required by Canadian securities laws.

 

Investor Contact:
Judy DiClemente
jdiclemente@insitecony.com

Originally published on globenewswire.com

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MINDCURE Announces Partnership with SOMA Breath Inc. to License its Breathwork Program and Develop Custom Breathwork for Psychedelic-Assisted Psychotherapies within iSTRYM

Breathwork has shown promise at both replicating the experience of psychedelics and helping patients to integrate psychedelic-assisted psychotherapy into their lives

VANCOUVER, BC, April 27, 2021 /CNW/ – Mind Cure Health Inc. (CSE: MCUR) (OTCQB: MCURF) (FRA: 6MH) (“MINDCURE” or the “Company”) a leader in advanced proprietary technology for psychedelic therapy, is pleased to announce that it has entered into a partnership and licensing agreement with SOMA Breath Inc. (“SOMA Breath”). The term breathwork refers to breathing exercise techniques that manipulate the depth and rate of breath, and SOMA Breath is a global school that combines ancient breathwork techniques based on pranayama with modern science.

MINDCURE will license SOMA Breath’s 21-day mental health-designed breathwork program and will also build a custom breathwork track targeted towards psychedelic-assisted psychotherapies, both within iSTRYM, its psychedelics digital therapeutics platform. SOMA’s breathwork programs have been proven to help patients manage stress and reduce anxiety, and have been shown to produce brainwave activity in patients comparable to the effect of psychedelics.1 MINDCURE intends to create opportunities for therapists and patients to utilize SOMA Breath breathwork programs to foster psychedelic-like experiences without the need for psychedelics themselves, while also enhancing the effectiveness of post-session integration for psychedelic-assisted psychotherapies.

With existing partnerships to develop technology integrations and custom services in place with Speak Ai, LUCID and now Soma Breath, MINDCURE is building iSTRYM into the go-to resource that therapists and patients will turn to for science-backed, personalized mental health support at scale. The Company anticipates a late July release of the beta version of the iSTRYM application and platform.

“We think it is important to give individuals options in building their mental wealth, both when they are engaged in psychedelic-assisted psychotherapy as well as when they are not and are simply seeking better mental performance,” said Kelsey Ramsden, MINDCURE President and CEO. “SOMA Breath’s validated techniques and protocols will enable therapists to design psychedelic-like treatments without the need for actual psychedelics, and also to enhance the effectiveness of post-session integration, which is a key area of focus for us within iSTRYM.”

“At SOMA Breath, we have seen firsthand the transformational power of breathwork, and are eager to bring our scientifically-validated program into iSTRYM for therapists and patients around the world, and to work alongside MINDCURE to further the connection between breathwork and psychedelic-like experiences,” said Niraj Naik, the Founder and CEO of SOMA Breath. “We believe that the breath is the key to unlocking peak performance and also can serve an important role in the treatment of many debilitating mental health illnesses, and it can be accessed anywhere, by anyone, at any time.”

Dr. Jeff Tarrant, the founder of the Neuro Meditation Institute in Eugene, Oregon,2 studied the impact of SOMA Breath breathwork techniques on the brain, and then compared the results with available research on traditional psychedelics. The results showed that breathwork meditation is able to produce similar experiences to those of traditional psychedelics.3

_______________________

1

https://www.counselling-directory.org.uk/blog/2020/10/23/how-breathwork-can-help-to-manage-stress-and-anxiety

2

https://www.neuromeditationinstitute.com/about-nmi

3

https://www.somabreath.com/wp-content/uploads/2019/10/Can-Breathing-Be-a-Psychedelic-1.pdf

About SOMA Breath Inc.

SOMA Breath’s overall mission is to empower people with knowledge, tools, and techniques to make positive and lasting change in their lives. SOMA Breath techniques have the power to transform someone even down to a cellular level. SOMA Breath, considered as a whole, with its range of possible uses and applications, is a framework for total life transformation.

SOMA Breath is a complete holistic system of Pranayama techniques, which can be arranged into different sequences depending on the type of workshop you are attending as well as tailored to your specific needs. There is no one size fits all, and we take into account the fact that everyone is different and requires different breathing techniques depending on their needs. SOMA Therapeutic Breathwork techniques are the core Pranayama techniques that have the most scientific evidence to support their function.

About iSTRYM™ Digital Therapeutics

iSTRYM is a first-of-its-kind software application that optimizes the healing journey for both patients and clinicians — before, during, and after therapy sessions. iSTRYM enhances therapy by bringing together a variety of healing solutions, such as convenient user dashboards, integrative music, guided breathwork, intelligent language processing, secure data analysis, and more.

Offering real-world data in real-time, iSTRYM enables clinicians and their clients access to personalized technology that provides AI-driven data insights for improved clinical outcomes. From mindful integrative content to a repository of world-class treatment plans, iSTRYM provides the best in psychedelic therapy software. iSTRYM drives personalized, quantified and best-in-class outcomes in psychedelic therapy, making Mental Wealth™ accessible.

The Company also announces it has granted a total of 50,000 stock options to certain employees pursuant to the terms the Company’s incentive stock option plan (“Plan”). The stock options are exercisable at a price of $0.60 per share and subject to the terms of the Plan.

About Mind Cure Health (MINDCURE) Inc.

MINDCURE exists as a response to the current mental health crisis and urgent calls for effective treatments. MINDCURE believes in the need to reinvent the mental health care model for patients and practitioners to allow psychedelics to advance into common and accepted care.

MINDCURE is focused on identifying and developing pathways and products that ease suffering, increase productivity, and enhance mental health. MINDCURE is interested in exploring diverse therapeutic areas beyond psychiatry, including digital therapeutics, neuro-supports, and psychedelics, all to improve mental health.

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

Forward-Looking Information

Certain statements in this news release may constitute “forward-looking information” within the meaning of applicable securities laws (also known as forward-looking statements). Forward-looking information involves known and unknown risks, uncertainties and other factors, and may cause actual results, performance or achievements or industry results, to be materially different from any future results, performance or achievements or industry results expressed or implied by such forward-looking information. Forward-looking information generally can be identified by the use of terms and phrases such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “feel”, “intend”, “may”, “plan”, “predict”, “project”, “subject to”, “will”, “would”, and similar terms and phrases, including references to assumptions. Some of the specific forward-looking information in this news release includes, but is not limited to, statements with respect to: SOMA Breath developing custom breathwork for MINDCURE; MINDCURE licensing SOMA Breath’s existing 21-day mental health designed breathwork program; iSTRYM will meet its target beta release of late July 2021; SOMA Breath’s programs enabling therapists to design psychedelic-like treatments without the need for actual psychedelics; and SOMA Breath’s programs helping patients to integrate post-therapy session.

Forward-looking information is based on a number of key expectations and assumptions made by 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 the functional mushroom industry will continue to grow; SOMA Breath will develop a custom breathwork track for iSTRYM; iSTRYM’s beta version will be ready by late July, 2021; breathwork will help patients to manage stress and reduce anxiety; MINDCURE will create opportunities for therapists and patients to utilize breathwork programs to foster psychedelic-like experiences without the need for psychedelics; and that breathwork will enhance post-session integration for patients; and MINDCURE will be able to operate its business as planned. Although the forward-looking information contained in this news release is based upon what MINDCURE believes to be reasonable assumptions, it cannot assure investors that actual results will be consistent with such information.

Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. Forward-looking information involves significant risks and uncertainties and should not be read as a guarantee of future performance or results as actual results may differ materially from those expressed or implied in such forward-looking information. Those risks and uncertainties include, among other things, risks related to: the impacts of the COVID-19 pandemic on the Canadian economy, MINDCURE’s industry and MINDCURE’s business, which may negatively impact, and may continue to negatively impact, MINDCURE and may materially adversely affect MINDCURE’s investments, results of operations, financial condition, and MINDCURE’s ability to obtain additional equity or debt financing, and satisfy its financial obligations; general economic conditions; future growth potential; competition for mental health and wellness investments; SOMA Breath may not develop a custom breathwork track for iSTRYM; iSTRYM’s beta version may not be ready by late July, 2021; breathwork may not help patients to manage stress and reduce anxiety; MINDCURE may not create opportunities for therapists and patients to utilize breathwork programs to foster psychedelic-like experiences without the need for psychedelics; breathwork may not enhance post-session integration for patients; and changes in legislation or regulations. Management believes that the expectations reflected in the forward-looking information contained herein are based upon reasonable assumptions and information currently available; however, management can give no assurance that actual results will be consistent with such forward-looking information. Additional information on the risk factors that could affect MINDCURE can be found under “Risk Factors” in MINDCURE’s final prospectus which is available on SEDAR at www.sedar.com.

The forward-looking information contained herein is expressly qualified in its entirety by this cautionary statement. Forward-looking information reflects management’s current beliefs and is based on information currently available to MINDCURE. The forward-looking information is stated as of the date of this news release and MINDCURE assumes no obligation to update or revise such information to reflect new events or circumstances, except as may be required by applicable law.

The CSE has neither approved nor disapproved the contents of this press release and the CSE does not accept responsibility for the adequacy or accuracy of this release.

SOURCE Mind Cure Health Inc.

For further information: Connect: Investor Relations: investors@mindcure.com, 1-888-593-8995; Jonathan L. Robinson, CFA, Partner, Oak Hill Financial Inc., jrobinson@oakhillfinancial.ca, 416-669-1001

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Mydecine to Report Full Year 2020 Financial Results on May 3, 2021

DENVER, April 26, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, announced today that it will report its financial results for the full year ended December 31, 2020, before the market open on Monday, May 3, 2021.

The Company will host a conference call and audio webcast that morning at 10:30 a.m. ET featuring remarks by Josh Bartch, CEO and Dean Ditto, CFO.

Event: Mydecine Full Year 2020 Financial Results Conference Call

Date: Monday, May 3, 2021

Time: 10:30 a.m. Eastern Time

Live Call: (877) 407-4018 (U.S. Toll Free) or (201) 689-8471 (International)

Webcast address: http://public.viavid.com/player/index.php?id=144246

For interested individuals unable to join the conference call, a replay of the call will be available through May 17, 2021, at (844) 512-2921 (U.S. Toll Free) or (412) 317-6671 (International). Participants must use the following code to access the replay of the call: 13718466. The online archive of the webcast will be available on https://www.mydecine.com/#investors after the conclusion of the call.

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About Mydecine Innovations Group

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

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

‍

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

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Core One Labs Vocan Biotechnologies Enters into Collaborative Research Agreement with UBC

Vancouver, British Columbia, Canada – April 24, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company”) is pleased to announce its wholly owned subsidiary Vocan, has entered into a Collaborative Research Agreement with the University of British Columbia (“UBC” or the “University”). Research will be conducted in a 10,000 square foot well-equipped, technologically diverse and well funded lab located at the Lower Mall Research Station at the University. The Research Faculty has an extensive team including a principal investigator, Post-Doctoral fellows, lab manager, research technicians, and research associates.

The collaboration gives the company access to cutting edge research facilities and innovation capabilities at UBC. The UBC research team’s history of strong research and development efforts provides an opportunity for Vocan to accelerate its position as a powerful player in the emerging psychedelic medicines space. Psychedelic compounds have recently transitioned into the mainstream medicine market. Psilocybin, MDMA and LSD have shown significant therapeutic benefits when it comes to addressing depression, anxiety, addiction and obsessive-compulsive disorder.

The collaboration with UBC will assist Vocan in individually optimizing the expression of enzymes allowing the production of the prodrug psilocybin from the Psilocybe genus of mushrooms. Vocan will supply its developed technology, and the UBC lab will utilize its proven expertise to optimally express critical enzymes to enable their recombinant synthesis in an suitable bacteria host. This will increase the efficiency and cost effectiveness of the process, and assist Vocan scientists in enabling the production of psilocybin using fermentation. Using bacteria as “biological factories” in this way is a well-established method for producing commercial products, having been employed for insulin and human growth hormone, but needs to be individually optimized for each product.

“The collaboration with UBC Research Faculty enables Vocan to fast track its production method of biosynthesized psilocybin.  The state-of-the-art equipment will allow for enhanced analysis of the compound, and the additional personnel exponentially increases the capacity of Vocan’s Research Team,” stated Joel Shacker CEO of the Company.

About UBC

The University of British Columbia was established in 1908, is the largest university in Western Canada and has an annual research budget of $600,000,000.00.  It is ranked in the top 3 universities in Canada and is 27th in the world for academic ranking.  The University has a history of producing esteemed graduates, including 3 Canadian Prime Ministers, including Justin Trudeau, 8 Nobel Laureates, 71 Rhodes scholars, 65 Olympians, and 273 fellows to the Royal Society of Canada.  UBC has an academic staff of 5500, over 50,000 Undergraduate students and 10,000 Postgraduate students.

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 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 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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MINDCURE Partners its iSTRYM Technology with LUCID to Discover and Create Proprietary Music Experiences for Use During Psychedelic-Assisted Therapy Sessions

LUCID’s technology platform unites music, AI and research in neuroscience to create personalized digital music therapy managed in real-time by therapists based on patient feedback

VANCOUVER, BC, April 21, 2021 /CNW/ – Mind Cure Health Inc. (CSE: MCUR) (OTCQB: MCURF) (FRA: 6MH) (“MINDCURE” or the “Company”) a leader in advanced proprietary technology for psychedelic therapy, is pleased to announce a partnership with LUCID Inc. (“LUCID”). LUCID’s mission is to help people optimize their mental wellness through music, and they will be designing custom psychedelic music experiences for iSTRYM.

After announcing its data partnership with Speak Ai last week, MINDCURE continues to integrate world-class technologies into and create proprietary experiences within iSTRYM, its psychedelics digital therapeutics platform. LUCID’s platform is a key differentiator for iSTRYM as therapists and patients seek out scientifically validated tools to enhance the effectiveness of psychedelic-assisted therapies. It will enable the therapist to alter the music within a therapy session based on real-time feedback and data collected from the patient, all within iSTRYM.

“We look forward to working with MINDCURE’s team and bringing our expertise to psychedelic-assisted therapies,” said Zach McMahon, LUCID CEO and Co-Founder. “Our team will be researching and taking into consideration the therapeutic targets and mechanisms of action associated with each psychedelic while leveraging our machine learning systems to optimize the music experiences in iSTRYM for personalization and efficacy.”

Music has been shown to be effective as a stress and anxiety management tool and also has shown efficacy for diverse outcomes, including chronic and acute pain.1 Listening to music evokes a wide range of emotions,2 and because of this, music listening has been a component of several psychological interventions in the area of anxiety and depression, such as post-traumatic stress disorder.3,4 With this integration, therapists will have access to music designed for psychedelic-assisted therapies and specific psychedelic compounds that is changing in real-time based on patient feedback, AI and collected data to deepen or alter the experience.

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1 Choi et al.. 2018; Vaajoki et al., 2010; Shabanloei et al., 2010; Good et al., 2005; Smyth et al., 2018; Chai et al., 2020;
Jangsirikul et al., 2017

2 Bandelow, B., & Michaelis, S. (2015). Epidemiology of anxiety disorders in the 21st century. Dialogues in Clinical
Neuroscience, 17(3), 327–335.

3 Bensimon, M., Amir, D., & Wolf, Y. (2012). A pendulum between trauma and life: Group music therapy with post-
traumatized soldiers. The Arts in Psychotherapy, 39, 223–233. doi:10.1016/j. aip.2012.03.005

4 Panteleeva, Y., Ceschi, G., Glowinski, D., Courvoisier, D. S., & Grandjean, D. (2018). Music for anxiety? Meta-analysis of
anxiety reduction in non-clinical samples. Psychology of Music, 46(4), 473–487.

“We are building first-of-its-kind functionality by pairing AI-driven music scapes with a therapist’s art of directing the experience for patients in psychedelic-assisted therapy sessions,” said Kelsey Ramsden, MINDCURE President and CEO. “Integrating LUCID will further enhance iSTRYM’s capabilities and its potential as the validated backbone of the roll-out of psychedelic therapy and trusted wingman for therapists and patients who want a digital therapeutic partner that allows for quantified medicine with personalization at scale.”

“Music interventions have well-indicated positive effects on anxiety and depression, and are frequently used alongside psychedelic therapies. We recently concluded a randomized controlled trial of LUCID’s personalized music technology and found it to be more effective than comparator technologies in alleviating symptoms of anxiety in adults diagnosed with moderate trait anxiety. We plan to continue building this body of evidence in diverse use-cases, including as an adjunct to psychedelic therapy,” said Dr. Frank Russo, Professor of Psychology and Director of the SMART Lab at Ryerson University.

LUCID’s core technology is based on the use of quantitative measurement of mood and physiological state, coupled with robust personalization techniques made possible by machine learning, to optimize music interventions for specific cognitive outcomes. Using psychometric and biometric measurement to determine the user’s current mental state and machine learning agents, LUCID systems adaptively predict the optimal musical sequence to help an individual reach their desired state.

These tools are further leveraged to intelligently compose, produce, and remix music with the highest possible therapeutic potential for precise outcomes. In addition to the music, LUCID employs a novel method to seamlessly integrate auditory beat stimulation (including binaural beats) within the fabric of the music for additional benefit.

About LUCID Inc. (LUCID):

LUCID‘s mission is to transform the mental health industry by unlocking the potential of music therapy through innovative AI technology. LUCID emphasizes non-invasive and accessible tools to help people with their mental health, by providing evidence-based and scientifically-validated personalized music therapies based on real-time mood assessment. With patented technology and a clinical research pipeline, LUCID is committed to scientifically validating music as medicine.

LUCID’s partners and collaborators include Mitacs, the Ontario Brain Institute, Ontario Centres of Excellence, Next Canada, MaRS, and Ryerson University. LUCID’s advisors include Dr. Rébecca Kleinberger from MIT Media Lab,  CAMH’s Chief of General and Health Systems Psychiatry Dr. Farooq Naeem, Ryerson SMART Lab’s Dr. Frank Russo, and Dr. Sageev Oore of Dalhousie’s Vector Institute of AI.

The Company also announces it has granted a total of 610,000 stock options to certain employees or consultants pursuant to the terms the Company’s incentive stock option plan (“Plan”). The stock options are exercisable at a price of $0.60 per share and subject to the terms of the Plan.

About Mind Cure Health (MINDCURE) Inc.

MINDCURE exists as a response to the current mental health crisis and urgent calls for effective treatments. MINDCURE believes in the need to reinvent the mental health care model for patients and practitioners to allow psychedelics to advance into common and accepted care.

MINDCURE is focused on identifying and developing pathways and products that ease suffering, increase productivity, and enhance mental health. MINDCURE is interested in exploring diverse therapeutic areas beyond psychiatry, including digital therapeutics, neuro-supports, and psychedelics, all to improve mental health.

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

Forward-Looking Information

Certain statements in this news release may constitute “forward-looking information” within the meaning of applicable securities laws (also known as forward-looking statements). Forward-looking information involves known and unknown risks, uncertainties and other factors, and may cause actual results, performance or achievements or industry results, to be materially different from any future results, performance or achievements or industry results expressed or implied by such forward-looking information. Forward-looking information generally can be identified by the use of terms and phrases such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “feel”, “intend”, “may”, “plan”, “predict”, “project”, “subject to”, “will”, “would”, and similar terms and phrases, including references to assumptions. Some of the specific forward-looking information in this news release includes, but is not limited to, statements with respect to: LUCID creating proprietary music experiences for MINDCURE; music enhancing a patient’s experience during psychedelic-assisted therapy sessions; and that this integration further enhancing iSTRYM’s capabilities and its potential as the validated backbone of psychedelic therapy.

Forward-looking information is based on a number of key expectations and assumptions made by 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 the functional mushroom industry will continue to grow; LUCID will develop custom psychedelic music experiences for MINDCURE; music will help therapists using iSTRYM as well as patients during psychedelic-assisted therapy sessions; iSTRYM will become the validated backbone of psychedelic therapy; and MINDCURE will be able to operate its business as planned. Although the forward-looking information contained in this news release is based upon what MINDCURE believes to be reasonable assumptions, it cannot assure investors that actual results will be consistent with such information.

Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. Forward-looking information involves significant risks and uncertainties and should not be read as a guarantee of future performance or results as actual results may differ materially from those expressed or implied in such forward-looking information. Those risks and uncertainties include, among other things, risks related to: the impacts of the COVID-19 pandemic on the Canadian economy, MINDCURE’s industry and MINDCURE’s business, which may negatively impact, and may continue to negatively impact, MINDCURE and may materially adversely affect MINDCURE’s investments, results of operations, financial condition, and MINDCURE’s ability to obtain additional equity or debt financing, and satisfy its financial obligations; general economic conditions; future growth potential; competition for mental health and wellness investments; LUCID may not develop custom psychedelic music experiences for MINDCURE; music may not help therapists using iSTRYM as well as patients during psychedelic-assisted therapy sessions; iSTRYM may not become the validated backbone of psychedelic therapy; and changes in legislation or regulations. Management believes that the expectations reflected in the forward-looking information contained herein are based upon reasonable assumptions and information currently available; however, management can give no assurance that actual results will be consistent with such forward-looking information. Additional information on the risk factors that could affect MINDCURE can be found under “Risk Factors” in MINDCURE’s final prospectus which is available on SEDAR at www.sedar.com.

The forward-looking information contained herein is expressly qualified in its entirety by this cautionary statement. Forward-looking information reflects management’s current beliefs and is based on information currently available to MINDCURE. The forward-looking information is stated as of the date of this news release and MINDCURE assumes no obligation to update or revise such information to reflect new events or circumstances, except as may be required by applicable law.

The CSE has neither approved nor disapproved the contents of this press release and the CSE does not accept responsibility for the adequacy or accuracy of this release.

SOURCE Mind Cure Health Inc.

For further information: Connect: Investor Relations, investors@mindcure.com, 1-888-593-8995; Jonathan L. Robinson CFA, Partner, Oak Hill Financial Inc., jrobinson@oakhillfinancial.ca, 416-669-1001

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Novamind Collaborates with Center for Change

Novamind working with Center for Change to treat patients, conduct research

TORONTO, ON / ACCESSWIRE / April 21, 2021 / Novamind Inc. (CSE: NM | OTC: NVMDF | FSE: HN2) (“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine, has shared preliminary findings from two studies using ketamine-assisted psychotherapy protocols to treat eating disorders: Emotion-Focused Ketamine-Assisted Psychotherapy (EF-KAP) and Group-based Ketamine-Assisted Psychotherapy (G-KAP). Novamind collaborated on the study with Center for Change, a specialty psychiatric hospital and leading treatment facility for eating disorders.

In a webinar held by Center for Change on April 8th, 2021, Dr. Reid Robison, Novamind’s Chief Medical Officer, discussed early findings from the two studies for eating disorders. The collaboration with Center for Change examines the novel use of Novamind’s ketamine-assisted psychotherapy (“KAP”) protocols for the treatment of eating disorders. There are no FDA-approved medication options currently available for individuals suffering from Anorexia Nervosa, an often-debilitating mental health condition.

“Novamind is dedicated to researching, developing and delivering new therapeutic protocols to answer unmet needs in mental healthcare,” said Dr. Robison, who also serves as Medical Director for Center for Change. “Our treatment protocols are designed to improve patient outcomes, and we’re proud that renowned facilities like Center for Change recognize that we can provide new options for individuals struggling with eating disorders.”

Novamind offers its clients access to several KAP protocols through Cedar Psychiatry, its wholly owned network of psychiatry clinics. Specialized KAP protocols currently available at Cedar Psychiatry include Emotion-Focused Ketamine-Assisted Psychotherapy and Group Ketamine-Assisted Psychotherapy. Cedar Psychiatry has administered over 7,000 ketamine treatments since 2016 and is undergoing an expansion of its clinic network in the United States.

“Novamind’s psychedelic protocols are informed by the expertise gained from our operating clinics, as well as collaborating with leading medical institutions. We’re pleased to work with Center for Change to advance innovation in mental healthcare,” said Yaron Conforti, CEO and Director of Novamind.

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, visit novamind.ca.

About Center for Change
Center for Change was founded on October 28th, 1994, by a team of psychologists and a physician with a long history together. From those first days, Center for Change began to design the current facility and develop its core treatment programs. A handpicked team of experts forms the backbone of what we do, and they are committed to helping each person get back their life and restore a sense of freedom that may have been absent for far too long.

The Center is licensed with the State of Utah as a Specialty Psychiatric Hospital, and in April 1998, Center for Change received accreditation from The Joint Commission. This accreditation is limited to top organizations delivering high levels of patient service, reducing patient risk and creating an environment for continuous improvement. The Joint Commission has recognized Center for Change for its high standards of patient care and commitment to ongoing education.

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

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

Center for Change
Tamara Bingham Noyes, Director of Business Development
Telephone: +1 (888) 224 8250 ext. 267
Email: Tamara.Noyes@uhsinc.com

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.

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Core One Labs’ Vocan Initiates Engineering and Design of a Proprietary Production System for Manufacturing of API-Grade DMT

Vancouver, British Columbia, Canada – April 21, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company” or ”Core One”) a life sciences research and technology company focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic-assisted psychotherapy is pleased to announce its wholly owned subsidiary Vocan Biotechnologies Inc. (“Vocan”) has initiated the engineering and design of a proprietary enzymatic production system for the manufacturing of API-grade N,N-dimethyltryptamine (DMT).  DMT, a naturally occurring psychedelic substance, is currently under clinical investigation for the treatment of certain mood disorders. The compound is a primary component of traditional South American entheogenic brews and is traditionally derived from the leaves of a variety of plants endemic to equatorial regions across the globe.

The Vocan team has outlined a genetic pathway that could result in potentially elevated levels of DMT biosynthesis compared to the naturally occurring production pathway in the plants from which the compound is commonly extracted. With further development the research team plans to construct a high-throughput production system based on the same recombinant enzyme fermentation platform the company is already developing for API-psilocybin. The addition of this biosynthetic target to its development pipeline will allow Vocan to broaden its offerings of clinical-quality psychedelic medicines and enable advancement of the therapeutic use of psychedelic substances in medicine.

This proprietary approach to DMT production will preserve the highly specific molecular structure of naturally occurring plant-derived DMT and allow the Company’s fermentative biosynthesis platform to be optimized for maximum DMT output at production scale. The team intends to accelerate the current development stage of its DMT production system within a few weeks in order to fast-track the first DMT provisional patent filling with the US Patent and Trademark Office. Early patent protection of its proprietary DNA sequences and enhanced-activity enzymes will ensure API-grade DMT can be manufactured by a repeatable and reliable process without any requirement for more costly chemical synthesis or cultivation, extraction, and purification from plant sources.

“Core One’s research and development division, through the leadership of Dr. Robert Hancock, continues to achieve significant scientific milestones in the production of biosynthesized and stereochemically sound psychedelic compounds. There is a growing body of scientific research and empirical evidence surrounding the benefits of using various psychedelic compounds to treat mental health afflictions and Core One endeavours to support the scientific community by providing psychedelic compounds for their research at a fraction of the cost of other producers.  We will continue to develop and expand our psychedelic product offerings, to provide the scientific research community with the compounds they need, and the successful engineering of enzymatic DMT is another example of how we can do this,” Stated Joel Shacker CEO of the Company.

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 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 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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PharmaTher Announces Submission of IND Application with the FDA for Phase 2 Clinical Trial Evaluating Ketamine in the Treatment of Parkinson’s Disease

TORONTO, April 20, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (CSE: PHRM) (OTCQB: PHRRF), a specialty psychedelic pharmaceutical company, today announced it submitted an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for the initiation of a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of low-dose ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease (“LID-PD”).
“The submission of our IND application with the FDA is an important milestone as it provides us with a solid foundation to advance our ambition in commercializing ketamine and unlocking its therapeutic potential through novel uses, formulations and delivery methods in the treatment of neurodegenerative diseases (ie. Parkinson’s disease and Lou Gehrig’s disease), mental illness (ie. Depression and PTSD) and chronic pain,” said Fabio Chianelli, CEO of PharmaTher.

Ketamine is an FDA-approved N-methyl-D-aspartate (“NMDA”) receptor-modulating drug that is widely used as an anesthetic agent either alone or in combination with other anesthetic agents [Smith et al, 1987; Pacheco et al, 2014]. The possible therapeutic effect of low-dose ketamine on LID was noted in a retrospective analysis of PD patients who received ketamine for pain relief. During this analysis, it was observed that the patients experienced an improvement in LID lasting several weeks beyond treatment [Sherman et al, 2016]. These results were corroborated in a test of low-dose ketamine in a rodent LID model, and this possible effect has also been examined in a controlled study [Bartlett et al, 2016]. Ketamine may also have additional benefits in the treatment of pain [Niesters et al, 2014] and depression [Diamond et al, 2014; Murrough et al, 2013], which are frequent comorbidities of Parkinson’s disease.

The clinical trial is titled “A Multi-Center, Phase IIA, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease.” It is anticipated that up to eight clinical sites in the U.S. will randomize a total of up to 36 subjects to the investigational product (ketamine) or active control (midazolam). The primary end-point of the study is the change in the Unified Dyskinesia Rating Scale (“UDysRS”) total score from Baseline to Week 8. Secondary endpoints of the study include the change in Total Objective Scores of the UDysRS, total daily OFF times as assessed by subject-completed 24-hour diaries and change in the UPDRS total and sum scores of motor and dyskinesia from Baseline to Week 8. Because LID can markedly affect a Parkinson patient’s everyday activities, a reduction in LID could improve the patient’s quality of life.

Assuming the Phase 2 clinical trial is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a pivotal Phase 3 clinical study under the 505(b)(2) regulatory pathway. However, there can be no assurance that the FDA will support any potential request for an expedited path to approval or further development.

About Parkinson’s Disease

Parkinson’s disease is a debilitating disorder that affects over 1 million people in the U.S. and more than 7 million people worldwide. There is currently no cure for Parkinson’s disease. Although the etiology of PD is not fully understood, it is thought to result from loss of pigmented dopaminergic neurons in the Substantia nigra and their striatal projections, leading to dopamine deficiency in the striatum [Schapira and Jenner, 2011]. This ultimately affects the cortico-striatal system that controls movement.

As a progressive neurogenerative disorder of the central nervous system that primarily affects the motor nerve system, symptoms of Parkinson’s disease may emerge slowly and include tremors, rigidity, bradykinesia, and postural instability [Paulson and Stern, 2004]. Also, patients may experience non-motor symptoms such as autonomic dysfunction (orthostatic hypotension, constipation, bladder dysfunction), psychiatric (depression), cognitive and sensory symptoms (pain) [Olanow, et al, 2009]. These non-motor symptoms become more common as the disease progresses.

Treatments, including levodopa and dopamine agonists, which restore the dopamine deficits in the brain, have been employed for almost 50 years. However, with continued treatment using levodopa, dose-limiting motor side-effects often emerge. This includes the emergence of abnormal involuntary movements termed Levodopa Induced Dyskinesias, which can be
identified in about 50% of patients within five years after initiation of levodopa treatment and in almost all patients within ten years post-treatment initiation. These side effects often limit further dose increases in dopaminergic therapy.​

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF) is a specialty psychedelic pharmaceutical company focused on the research, development and commercialization of ketamine and novel microneedle patches for delivering psychedelics to treat neuropsychiatric, neurodegenerative and pain disorders.

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

For more information, please contact:

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

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
​
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of November 30, 2020 (“MD&A”), dated January 27, 2021, which is available on the Company’s profile at www.sedar.com.
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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Core One Labs Negotiates Milestone Acquisition With Akome Biotech Ltd.

Vancouver, British Columbia, Canada – April 17, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company”) a biotechnology research and development life sciences enterprise focused on advancing psychedelic medicines to market, is pleased to announce it has signed letter of intent (the “LOI”) to acquire all of the outstanding share capital (the “Proposed Transaction”) of Akome Biotech Ltd. (“Akome”)..

Akome is a developer of psychedelic-based pharmaceuticals for rare diseases and mental disorders targeting treatments for Cluster Headaches (CH), Alzheimer’s Disease (AD), and Depression. Akome holds provisional matter of composition patents based on a formulation of non-psychedelic 2 Bromo-Lysergic Acid Diethylamide (LSD), also called BOL148 – “app. #63068963” and a psilocybin-based formulation – “app. #63123838,” and a ketamine-based formulation – “app. # 63128302.”

Akome’s Founder and CEO, Dr. Fadia Saad is the inventor of five patents and has over 25 years of experience in product and business development in the life science industry.  Dr. Saad is a Mycologist by training with a PhD from McGill University and an MBA from the University of Montreal.  At Aspreva Pharmaceuticals, as Head of Business Development, she played an integral role in negotiating potential M & A’s of a cumulative value exceeding $2B.

The formulation for the treatment of pain related to Cluster Headaches (CH), is noteworthy due to CH’s classification as a rare disease which may qualify for accelerated development and market exclusivity through orphan drug status. Akome’s efforts include extensive research and development efforts to alleviate the advancement of mental state psychopathy. According to Mental Health America (mhanational.org), at any given time, up to 18.57% of adults are experiencing a mental health illness, equivalent to 45 million Americans with approximately 4.38% are experiencing a severe mental health illness. This equates to billions of dollars in lost productivity and additional treatment costs every year.

[1]The Global Alzheimer’s therapeutics market is projected to reach USD $13.57 billion by 2027 from USD $7.42 billion in 2019 with a substantial CAGR of 9.2% through the forecasted period.  This is primarily attributed to the increasing pipeline drug development, rise in investments for drug development biomarkers that are expected to boost the global market.  The Alzheimer’s Therapeutics market in North America held the highest market share of about 29.3% in 2019.  Due to advanced healthcare services and infrastructure in the developed countries like the US along with high purchase power for expensive drugs and reimbursements policies are expected to drive the market expansion.

[2]The global anxiety disorders and depression treatment market size was valued at USD 15.2 billion in 2015 and is anticipated to show steady growth due to the increasing prevalence of anxiety disorder and depression worldwide. According to estimates published by the World Health Organization in 2012, depressive disorder affected 350 million people globally, which is expected to increase due to the upward trend in the adoption of sedentary lifestyles. Depression is the second-leading cause of disabilities globally, raising the need for the development of innovative medications in the near future.

Under the terms of the LOI, in consideration for all of the outstanding share capital of Akome, the Company is expected to issue 3,500,000 common shares to the existing shareholders of Akome.  It is anticipated that the shares will be subject to the terms of a pooling arrangement, during which time they may not be transferred or traded without the prior consent of the Company.  The shares will be released from the arrangement in tranches over a period of twenty-four months following completion of the Proposed Transaction.

Joel Shacker, CEO of Core One Labs states, “The acquisition of Akome will broaden and accelerate several new avenues of investigation and overall growth potential for our Company. New formulations and access to such an experienced team provide a unique opportunity to build shareholder value in this exciting sector.”

Completion of the acquisition of Akome remains subject to a number of conditions, including: the satisfactory completion of due diligence, the receipt of any required regulatory approvals, and the negotiation of definitive documentation.  The Company and Akome have agreed to a thirty day exclusivity period during which they will negotiate exclusively with each other with a view to settling a definitive agreement.

The Company is at arms-length from Akome and each of its shareholders.  The Proposed Transaction is not expected to constitute a fundamental change for the Company, nor is it expected to result in a change of control of the Company, with the meaning of applicable securities laws and the policies of the Canadian Securities Exchange.

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 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 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.

[1] https://www.medgadget.com/2021/01/alzheimers-therapeutics-market-to-reach-usd-13-57-billion-by-2027-size-share-industry-analysis-and-global-forecast-to-2027.html

[2] https://www.grandviewresearch.com/industry-analysis/anxiety-disorders-and-depression-treatment-market