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MINDCURE Develops Proprietary Ketamine-Enhanced Psychotherapy Protocols for Treatment of Pain and Depression

‍MINDCURE will distribute these protocols to therapists through iSTRYM, its digital therapeutics platform. This milestone in protocol development unlocks the company’s protocol distribution platform in time for iSTRYM’s clinical MVP launch in Q3 2021.

VANCOUVER, BC, June 17, 2021 – Mind Cure Health Inc. (CSE: MCUR) (OTCQB: MCURF) (FRA: 6MH) (“MINDCURE” or the “Company”), a leader in advanced proprietary technology and research for psychedelics, is pleased to announce it has developed two proprietary ketamine-enhanced protocols for psychedelic-assisted psychotherapy – one for treating pain and another for treating depression.

These proprietary protocols were developed for MINDCURE by Dr. Mitch Earleywine, Professor of Psychology at the University at Albany, SUNY, and Co-Founder at Wisdom In Nature Consulting Group. Dr. Earleywine has over 250 papers published in peer-reviewed journals that address psychedelic-assisted treatments, substance abuse, depression, health, and personality. He is also the co-developer of Integrative Ketamine-Enhanced Psychotherapy for affective, trauma and stressor-related disorders.

“We have taken the best of the validated treatments for common clinical conditions and made them simpler and easier to implement by adding accessible technology,” said Dr. Earleywine.

“I am proud to have reached this psychedelic-assisted drug protocol milestone with our team and respected collaborator, Dr. Earleywine. Part of our strategic model is to be the distribution network of the psychedelic-assisted psychotherapy industry, enabling scalable treatment by using iSTRYM’s science-backed, evidence-based protocols and AI data systems,” said Kelsey Ramsden, MINDCURE President and CEO. “Delivering on this milestone – having ketamine-enhanced psychotherapy protocols available through our digital therapeutics platform – confirms our end-to-end care model. For clinics, this means access to a broad menu of services. For psychedelic companies, we offer partnership opportunities to distribute their protocols. We’re moving forward with enthusiasm and remain on schedule to launch iSTRYM’s MVP to select clinics in Q3 of this year.”

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. By bringing together a variety of healing solutions, iSTRYM offers therapists global, science-backed protocols, customizable dashboards, integration plans, insights into patient journeys, and real-time assessments for personalized client care.

Developing the distribution network of content and care protocols for psychedelic drugs allows MINDCURE to create value at all levels of the value chain: client, clinic, protocol developer, and drug developer. Currently in development, iSTRYM will be available to a select number of clinics throughout North America in Q3 2021. The software will be launched broadly and commercially to clinics in Q1 2022.

In addition to this news, MINDCURE also announces that as part of recent executive team changes, Dr. Ryan Hartwell will no longer be serving in his position as Chief Science Officer. The Company extends its gratitude and appreciation to Dr. Hartwell for his early contributions and leadership of the scientific team at MINDCURE.

The Company also announces it has granted a total of 100,000 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 $0.385 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

Certain information presented in this news release may constitute “forward-looking information” within the meaning of applicable securities laws regarding MINDCURE and its business. Forward-looking information inherently entails known and unknown risks and uncertainties about the future and actual results, performance or achievements contemplated by forward-looking statements made may be materially different from the results anticipated 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. Some of the specific forward-looking information in this news release includes, but is not limited to, statements with respect to: MINDCURE’s new ketamine-enhanced protocols in treating pain and depression; and iSTRYM.

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; Mind Cure 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; that the ketamine-enhanced protocols for treating pain and depression will get developed and these new protocols proving to be effective in treating pain and depression as contemplated; and iSTRYM functioning as effectively, and providing the benefits, as contemplated.

Although Mind Cure 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 Mind Cure 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.

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:

MINDCURE Investor Relations investors@mindcure.com

1-888-593-8995

Jonathan L. Robinson CFA

Oak Hill Financial Inc. jrobinson@oakhillfinancial.ca

416-669-1001

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Collaboration with the Scientific Research Council (SRC) of Jamaica for Psilocybin Product Development

TORONTO, ON/JAMAICA/ June , 2021 / Psyence Group Inc. (“Psyence” or the “Company”) (PSYG:CSE), a public life science biotechnology company pioneering the use of natural psychedelics, is pleased to announce that through its wholly owned Jamaican subsidiary, Psyence Jamaica Limited (“Psyence Jamaica”), it has entered into a multi-year agreement (“Collaboration Agreement”) with the Jamaican government’s Scientific Research Council (“SRC”). The SRC is Jamaica’s principal public sector agency, charged with fostering scientific research and the commercialization of its results. Projects implemented by the SRC have the potential to assist in the economic and social development of Jamaica. SRC has expertise in various areas including product research and development, chemical and microbial testing, molecular characterization and diagnostics of strains, propagation method development, active ingredient quantification and mushroom cultivation. The SRC’s Quality Management System is certified to ISO 9001 standard and its analytical and microbiological laboratories are accredited to ISO/IEC 17025.

The first collaborative initiative includes the development of nutraceuticals containing a range of psilocybin concentrations from micro-doses to hallucinogenic levels of dosing, as well as producing timed-release formulations. According to Justin Grant, PhD, Psyence’s Chief Scientific Officer, “This collaboration sets the path forward for Psyence’s observational trials, to be followed by more rigorous clinical trials.” He added, “We are honoured to commence work with the SRC on the development and physicochemical characterization of these products to produce consistent and standardized psilocybin mushroom-derived dosage forms.”
The second initiative places special focus on Jamaica’s indigenous mushroom species because Jamaica has long been celebrated as a biodiversity hot spot. This partnership will work in the field to identify, collect, characterize and store local psychedelic and psychoactive mushrooms.
The third initiative includes protocols for optimization of spawn production of rare psychedelic mushroom species and methods of conservation of select germplasm for up to 3 years.

Dr. Ryan Francis, Acting Divisional Manager, Product, Research and Development Division of SRC, commented, “The scientific approach of Psyence is aligned with the SRC’s objectives to preserve Jamaica’s indigenous resources and to develop evidence-based, standardized products. This agreement will facilitate research that has positive implications for the mushroom industry in general, facilitating greater understanding and identification of beneficial properties. We are excited to work with Psyence Jamaica to develop psilocybin nutraceuticals as partnerships of this nature are in keeping with the SRC’s mandate to provide scientific solutions and technical support to industries.”

Psyence’s commitment to Jamaica and Jamaica’s biotech industry goes beyond this collaboration to also include a shared IP agreement with the SRC, according to Psyence’s CEO Jody Aufrichtig. He declared, “Psyence is a global company that practices conscious capitalism; that means we are here as partners for the long term and the greater good. Psyence Jamaica was founded both to build global value and generate Jamaican prosperity and health. Sharing IP with the Jamaican people through Jamaica’s Scientific Research Council is fundamental to Psyence’s most deeply held beliefs that it is essential to build long-term economic and sustainable practices that benefit all.”

About Psyence Group:

The Psyence Group sets the global standard for natural psychedelics. Psyence is the pioneer in natural psilocybin for the treatment of psychological trauma and its mental health consequences in the context of palliative care. The executive team has international experience in business, science and medicine and includes international experts in neurology, neuroscience, mycology and drug development. Psyence has built and operates one of the first federally licensed commercial psilocybin cultivation and production facilities. The Psyence Group has a global footprint that operates across multiple legal jurisdictions with four key divisions: Psyence Production, Psyence Therapeutics, Psyence Function, and Psyence Experience.

Website: www.psyence.com

For more information

 Lisa-Marie Iannitelli

Investor Relations

ir@psyence.com

Media Inquiries: media@psyence.com

General Information: info@psyence.com

Certain statements in this news release related to Psyence Group Inc and its subsidiaries (collectively “the Company“) are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward- looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the future operations of the Company, the perceived opportunities in the psilocybin-based medical and nutraceutical markets globally, the potential to launch mushroom-based and psilocybin-containing products within enabling current and anticipated legal frameworks globally, the success of the joint R&D efforts of the Company and the SRC, the approval of clinical trials from the necessary regulatory and governmental authorities, the optimism surrounding the anticipated positive outcomes of the observational studies, clinical trials and research referred to in the news release, and the obtaining of all such licences, registrations and consents as may be required from regulatory and governmental authorities regulating to the products and activities referred to in this news release. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend to update these forward-looking statements.

The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The

U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products have not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.

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PharmaTher Files FDA Pre-IND Meeting Request and Briefing Package For KETABET™ To Treat Depression

  • Potential for FDA 505(b)(2) regulatory pathway approval and FDA Fast Track designation
  • Advancing Ketamine and KETABET™ alone or in a microneedle patch for intradermal administration
  • Potential next generation treatment for mental health, neurological and pain disorders
TORONTO, June 15, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has filed a pre-Investigational New Drug (“pre-IND”) meeting request and complete pre-IND briefing package with the U.S. Food and Drug Administration (“FDA”) to support the clinical development of KETABET™ and the proposed Phase 2 clinical study as a potential next-generation treatment for depression, and to discuss the product development plan for the Company’s patented hydrogel-forming microneedle patch delivery technology.

KETABET™ has the potential to receive FDA approval under the 505(b)(2) regulatory pathway and Fast Track designation by the FDA for treatment in patients with major depressive disorder.  The hydrogel-forming microneedle patch offers a novel way to deliver ketamine and other psychedelics such as psilocybin, DMT, MDMA and LSD, and has the potential to improve on the safety (i.e. fewer side effects), efficacy (i.e. bioavailability, optimized dosing regimen including continuous system delivery) and compliance (i.e. storage, distribution and self-administration) of these psychedelics that currently must be taken orally, inhaled, injected and intravenously.

Fabio Chianelli, Chief Executive Officer of PharmaTher, commented:  “We have an insatiable focus on developing and commercializing novel uses, formulations and delivery forms of ketamine.  We are committed to solving the ketamine puzzle and unlocking its true potential to treat depression by leveraging our robust intellectual property portfolio, clinical and regulatory experience, and our recently approved IND by the FDA to evaluate ketamine to treat Parkinson’s disease in a Phase 2 study.  We are now in a position to lead the way in reviving ketamine and KETABET™ as a potential FDA-approved prescription-based therapy for mental health, neurological and pain disorders.”
​
The Company has assembled a prolific scientific and clinical team experienced in depression, including Dr. Maurizio Fava, MD, Psychiatrist-in-Chief of the Massachusetts General Hospital and Professor Matthew Macaluso, D.O., Clinical Director of the University of Alabama at Birmingham Depression and Suicide Center.

The Potential of KETABET™

KETABET™, a patented combination formulation of FDA-approved ketamine and betaine anhydrous, has been shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly.1  Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.2  The combination of ketamine and betaine anhydrous produced more robust antidepressant-like responses than their individual effects and that the combination blocked the psychotomimetic effects of ketamine.1  This suggests that betaine anhydrous can be considered as an add-on therapy to ketamine or as a fixed-dose combination therapy for treatment-resistant depression, treatment-resistant bipolar disorder, post-traumatic stress disorder, obsessive-compulsive disorder and chronic pain.

More than 300 million people suffer from major depressive disorder and 100 million people are resistant to available treatments worldwide.  Ketamine is emerging as a viable treatment option for depression. Recent clinical studies have shown that low dose ketamine produces a rapid-acting and sustained antidepressant effect in major depressive disorder,3 bipolar depression,4 depression with suicidal ideation5 and post-traumatic stress disorder.6  Despite this, the potential for abuse and misuse of ketamine and the adverse mental effects of ketamine leads to its limited clinical use and discontinuation.

Betaine anhydrous (CYSTADANE®) was approved by the FDA in 1996 to treat homocystinuria to decrease elevated homocysteine blood concentrations.  There is growing evidence that betaine plays a critical role in regulating brain functions and has an antidepressant-like effect.7  Betaine has been reported to prevent seizures in rodents,8 to improve symptoms of Rett syndrome,9 and to delay the onset of neurologic impairment due to vitamin B12 deficiency10 clinically.  Furthermore, betaine attenuates memory deficits induced by homocysteine.11

The Potential of the Hydrogel-forming Microneedle Patch

The pre-IND briefing package includes a discussion of the product development plan for the patented hydrogel-forming microneedle (“MN”) patch to deliver ketamine and KETABET™ for intradermal administration to treat various mental health, neurological and pain disorders.  The MN patch consists of hydrogel-forming microneedle arrays and an accompanying reservoir that will overcome limitations by the quantity of drug loaded into the needles or onto the needle surfaces. As such, the MN patch can significantly increase the amount of drug that can permeate through the microneedle array and into the skin.12  The MN patch is specifically tailored for ketamine and KETABET™ due to the volume of drug that is required to maximize their therapeutic utility and increase potential market opportunities.

The Company’s proposed MN patch was successfully validated in a proof-of-concept study in delivering esketamine, the S(+) enantiomer of ketamine, which may overcome the drawbacks of ketamine administration in an intravenous or nasal spray format.  Results of this study can be found in a published paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery”.13

The KETABET™ MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than being supervised by a healthcare provider at a certified medical office.  KETABET™ MN patch has the potential for enabling continuous delivery of KETABET™ (without pain) with minimal formulation manipulation into systemic circulation while maintaining constant plasma levels for more than 24 hours that will improve efficacy and compliance for patients.12-13  Also, PharmaTher’s KETABET™ MN patch will incorporate anti-tampering and anti-abuse features that parallel the approach used by commercially available tamper-resistant transdermal fentanyl patches.

Ketamine was approved by the FDA in 1970 and is clinically used for analgesia, sedation, and anesthetic induction.  The FDA granted Fast Track and Breakthrough Therapy designations for SPRAVATO® (esketamine) nasal spray and in March 2019 approved SPRAVATO®, in conjunction with an oral antidepressant, for treatment-resistant depression to Janssen Pharmaceuticals, Inc.  SPRAVATO® requires numerous administration sessions in a certified medical office under medical supervision by a health care provider.14  An equity analyst predicted that SPRAVATO® could generate $3 billion in peak sales.15

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics to treat mental health, neurological and pain disorders.  PharmaTher is currently conducting an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, 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 February 28, 2021 (“MD&A”), dated April 28, 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.

Sources:

  1. J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice, Psychopharmacology (Berl). 233 (2016) 3223–32
  2. Krystal et al. 1994; Perry et al. 2007
  3. Murrough et al. 2013; Wan et al. 2014
  4. Ionescu et al. 2015; Nugent et al. 2014; Rybakowski et al. 2013
  5. Aligeti et al. 2014; Thakurta et al. 2012; Zigman and Blier 2013
  6. Feder et al. 2020
  7. ​Freed 1984; 1985
  8. Kim et al. 2013; Di Pierro et al. 2015
  9. Percy and Lane 2005
  10. van der Westhuyzen and Metz 1984
  11. ​Chai et al. 2013
  12. Donnelly R.F. Hydrogel-forming microneedles prepared from “super swelling” polymers combined with lyophilised wafers for transdermal drug delivery. PLoSONE. 2014 doi: 10.1371/journal.pone.0111547.
  13. Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.
  14. https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified
  15. https://www.fiercepharma.com/pharma/j-j-s-depression-nasal-spray-spravato-carrying-big-expectations-and-restrictions-scores-fda
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Field Trip Health Ltd. Announces Completion of DMPK Studies, Engineering Batch for FT-104, Its Novel Psychedelic Compound

Completion of These Critical Steps Positions Company to Submit Application to Commence Phase 1 Human Trials by Year End

TORONTO, June 15, 2021 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (TSX: FTRP; FTRP.WT; OTCQX: FTRPF) (“Field Trip”), a leader in the development and delivery of psychedelic therapies, today announced that it has completed initial drug metabolism and pharmacokinetic (“DMPK”) studies for FT-104, its novel psychedelic compound in development.

In-vitro preclinical studies confirmed that metabolism of FT-104 is rapid and complete in several animal species, converting FT-104 into the active form of the drug with relatively few metabolites, validating FT-104’s action as a prodrug for the underlying molecule (the “active”) from which FT-104 was derived. The active is a known psychedelic molecule which has yet to be disclosed.

In-vivo pharmacokinetic studies confirmed a fast, efficient, and complete conversion of FT-104 to the active, plus a fast elimination of both prodrug and active compounds from the systemic circulation. Since the active is significantly more active at the 5HT2A receptor, a rapid conversion of the prodrug is needed to ensure a rapid onset of action by the active, while the rapid elimination of the active and prodrug is needed to ensure a short overall trip time of less than 4 hours in people. From the combination of in-vitro and in-vivo results, Field Trip believes that the pharmacology and safety of FT-104 can be fully addressed using well-designed preclinical toxicology models.

The results of the DMPK studies and the pre-clinical studies announced in October 2020, further validate Field Trip’s belief that FT-104 is a strong 5HT2A receptor agonist that can be delivered with high bioavailability and will produce a reliably short-duration of psychedelic experience in the range of two to four hours, which is approximately half the duration of psilocybin.

Field Trip also announced that it has secured a Good Manufacturing Practices compliant (cGMP) contract manufacturer (CMO) for FT-104 manufacturing. Synthesis optimization and scale-up, which commenced in in the fourth calendar quarter of 2020, has resulted in the production of a first kilogram-scale engineering batch of FT-104. The drug substance from the engineering batch will provide the quantities of FT-104 needed to complete formulation and preclinical development. An additional GMP batch will be produced for Phase 1 trials.

“From the inception of our drug development efforts, we set out to develop a novel, next-generation psychedelic molecule that would be easy to synthesize, had low risk for addiction, that offered similar potency and experience to psilocybin, but with a much shorter duration to make it more clinically efficient and accessible,” said Dr. Nathan Bryson, Field Trip’s Chief Science Officer and the inventor of FT-104. “The completion of our DMPK studies confirms that FT-104 meets all of those criteria, and with synthesis and scale-up now complete, we are getting the pieces in place to submit our applications to commence Phase 1 human trials.”

In the coming months, Field Trip will continue to develop its pivotal safety and pharmacology package to finalize and submit its Phase 1 protocols to regulators. Any trial will be subject to regulatory approvals.

About Field Trip Health Ltd.

Field Trip is a global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics and our Field Trip Health division building centers for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale, we help people in need with a simple, evidence-based way to heal and heighten engagement with the world.

Learn more at https://www.meetfieldtrip.com, https://www.fieldtriphealth.com and https://www.fieldtriphealth.nl.

Follow us on Twitter and Instagram: @fieldtriphealth

To receive company updates about Field Trip and to be added to the email distribution list please sign up here.

For further information, contact Ronan Levy, Executive Chairman and a Director at Field Trip, at 1 (833) 833-1967.

Cautionary Note Regarding Forward-Looking Information.

This release includes forward-looking information within the meaning of Canadian securities laws regarding Field Trip and its business. 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 statements are based on the current expectations and views of future events of the management of Field Trip, and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including risks regarding listing of our common shares on NASDAQ, the timing and results of its research and development programs, approval of phase 1 human trials, if any, the risk that future clinical studies may not proceed as expected or may produce unfavorable results, the opening of additional clinics, the COVID-19 epidemic, the medical clinic industry, market conditions, economic factors, management’s ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement 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 Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

Neither the Toronto Stock Exchange, nor its Regulation Services Provider, nor the OTC Markets have approved the contents of this release or accept responsibility for the adequacy or accuracy of this release.

Media contacts:
Rachel Moskowitz
Autumn Communications
202-276-7881
press@fieldtriphealth.com

Nick Opich / McKenna Miller
KCSA Strategic Communications
212-896-1206 / 347-487-6197
press@fieldtriphealth.com

Investor contacts:
Elizabeth Barker
KCSA Strategic Communications
212-896-1203
ebarker@kcsa.com

SOURCE Field Trip Health Ltd.

1. PDSP Database (https://pdsp.unc.edu/databases/kidb.php) which contains values ranging from 10-110 uM from various assays and sources.

2. Chen, J. et al. Journal of Chromatography B, 879 (2011) 2669– 2672,

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Dr. Jeffrey Kamlet Internationally Recognized Expert on Cardiac Safety in Ibogaine Treatment Joins Ehave as Chief Medical Officer

New Position Created to Deepen Clinical Expertise and Advance Pipeline Clinical Programs

MIAMI, June 15, 2021 (GLOBE NEWSWIRE) — Ehave, Inc. (OTC Pink: EHVVF) (the “Company”), a provider of digital therapeutics for the psychedelic and mental health sectors, announced today the appointment of Jeffrey D. Kamlet, MD, FASAM, DABAM to the position of Chief Medical Officer. Dr. Kamlet brings more than 30 years of Internal Medicine, Addiction Medicine and Pain Management experience to Ehave, Inc. during a dynamic time of growth and implementation of long-range strategy.

“We are delighted to welcome Dr. Kamlet to Ehave as our Chief Medical Officer during this exciting time where he will serve in a mission-critical role as we advance our clinical study services on the effects of I.V. Ketamine treatments on anxiety, depression and PTSD using brain mapping technology, stated Ben Kaplan, CEO of Ehave.

Dr. Jeffrey Kamlet, M.D, FASAM, DABAM is recognized as the world’s expert on cardiac safety in ibogaine treatment. He is a fellow of the American Society of Addiction Medicine, and has twice served as President of the Florida Society of Addiction Medicine. Dr. Kamlet served as the Global Ibogaine Therapy Alliance’s Chief Medical Advisor, as well as Editor in Chief on the Global Ibogaine Therapy Alliance’s Clinical Guidelines for Ibogaine-Assisted Detoxification. Additionally, he has worked as an Associate Director and Medical Director for several emergency departments in Southern Florida as well EMS Medical Director for the City of Pembroke Park, FL. He sat on the board of the Florida American Heart Association, where he helped update the Florida EMS/ACLS protocols. He has served as an Adjunct Professor of Medicine at several postgraduate universities and was elected professor of the year at Barry University.

Dr. Kamlet has served as a Principal Investigator on over 20 major pharmaceutical clinical trials, and has achieved accolades in the fields of hormonal replacement therapy, anti-aging medicine and nutraceuticals.

In 1996, Dr. Kamlet was involved in early clinical trials, conducted under the direction of Deborah Mash, Ph.D., of the University of Miami to assess ibogaine’s utility in the rapid-detoxification from opiate and other drug dependences and the reduction of Post-Acute Withdrawal Syndromes.

Over the past 20 years he has witnessed and supervised over 1800 ibogaine treatments without a single adverse event, and continues to believe it to be one of the most important discoveries in the history of addiction medicine.

Dr. Kamlet holds a degree in Medicine and Surgery from the State University of New York. He received further training in neurology and psychiatry in NYC and then Cardiology at the Mount Sinai Medical Center in Miami Beach Florida. He holds additional board certifications and fellowships in other specializations, including Bariatric Medicine, Forensic Medicine, Forensic Examination, and Forensic Psychology.

Dr. Kamlet commented, “I am thrilled to join a dedicated team with a calling to develop a mental health platform for patients with few treatment options. I plan to apply my expertise in cardiac safety of ibogaine treatment and clinical new drug development to help solve the medical problems that devastate myriad of patients who suffer from these conditions.” Dr. Kamlet said, “I have been offered positions like this before with other companies who claim to be on the forefront of the psychedelic renaissance in medicine. I was hesitant until I met Mr. Kaplan and saw we shared a similar vision, of applying ethical, science based, safe treatments using cutting edge medical treatments and clinical studies to prove safety and efficacy through our collaboration.”

Dr. Kamlet’s 30 years of experience in psychedelic research has been featured in international science journals as well as radio, TV and the press including Nat-Geographic’s Break-through series.

Additional Ehave Inc. Information

We are truly grateful for the support of EHVVF shareholders! Please join the conversation on our Ehave supporter’s telegram group at https://t.me/EhaveInc.

The company posts important information and updates through weekly videos from the official company YouTube channel https://www.youtube.com/channel/UCnyW1mgMd0qmYkEMq3O6FWA.

Please follow Ehave on Twitter @Ehaveinc1

About Ehave, Inc.

Ehave, Inc. (EHVVF) is a leader of digital therapeutics delivering evidence-based therapeutic interventions to patients. Our primary focus is on improving the standard care in therapeutics to prevent or treat brain disorders or diseases through the use of digital therapeutics, independently or together, with medications, devices, and other therapies to optimize patient care and health outcomes. Our main product is the Ehave Telemetry Portal, which is a mental health informatics platform that allows clinicians to make objective and intelligent decisions through data insights. The Ehave Infinity Portal offers a powerful machine learning and artificial intelligence platform with a growing set of advanced tools and applications developed by Ehave and its leading partners. This empowers patients, healthcare providers, and payers to address a wide range of conditions through high quality, safe, and effective data-driven involvement with intelligent and accessible tools. Additional information on Ehave can be found on the Company’s website at: www.ehave.com.

About Mycotopia Therapy

Mycotopia Therapy focuses on helping you heal and reclaim your life. Your journey of healing is an understanding of the causes and works to mental wellness through psychedelic enhanced psychotherapy, integrated with a professional team of mental wellness practitioners and cutting-edge technology. Psychedelic therapy is a holistic and spiritual approach providing healing and has shown successful treatment for many years. Additional information on Mycotopia Therapy can be found on the Company’s website at: https://www.mycotopiatherapies.com.

Forward-Looking Statement Disclaimer

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Company’s research, manufacturing and other development efforts; (ii) the Company’s ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Company’s products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Company’s industry and introduction of competing products; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading “Risk Factors” in Ehave, Inc.’s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC’s website, http://www.sec.gov.

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Mindset and InterVivo Solutions Announce Availability of First Preclinical Psychedelic Benchmark Data from COPE Program

TORONTO, June 14, 2021 (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, and InterVivo Solutions (“InterVivo”), today announced the availability of their first data set as part of the Cooperative Psychedelics Evaluation Platform (“COPE”) program. The COPE program, launched in March, aims to create the world’s first preclinical behavioral and pharmacokinetics benchmark data for clinically relevant psychedelic drugs including psilocybin, LSD, DMT, and 5-MeO-DMT, amongst others. COPE data is available to InterVivo sponsors via a partnership between Mindset and InterVivo that will allow all parties to benefit from the use of COPE data.

The preliminary data focuses on psilocybin/psilocin and demonstrates that the clinical exposure levels reported in humans correlates well to exposure and efficacy measures observed in mice – validating the predictive value of InterVivo’s selected behavioral assays and animal models. Assuming these relationships apply to other reference psychedelics, this data should enable back translation of human clinical study data to InterVivo’s behavioral model platform.

“A founding principal of Mindset has been to continuously assemble comprehensive data on both our own novel drugs, as well as reference compounds, to guide and inform our scientific decision making. The COPE program data sets have been carefully built in partnership with InterVivo’s industry leading pre-clinical scientific team. We believe that this data will be of great use to in the broader psychedelic / CNS space. With InterVivo we are developing the tools and metrics with which the industry can benchmark success of new drugs. We’re delighted with the progress and insights driving the efficiency of our drug development engine and are eager to translate that knowledge into real value for the mental health crisis we aim to solve,” commented James Lanthier, CEO of Mindset.

Dr. Guy Higgins, Ph.D., Chief Scientific Officer of InterVivo and a Scientific Advisory Board member of Mindset, commented. “Despite the widespread interest in the therapeutic potential of psychedelics, there is relatively little preclinical data relating their efficacy/safety profiles and how these relate to plasma and CNS exposures, and PK property. Developing this knowledge base for psychedelics such as LSD and psilocybin, currently being evaluated in the clinic, will undoubtedly help the value assessment of newer psychedelics in development. This requires significant expertise in bioanalysis and pharmacokinetics, and we are fortunate to have the expertise and leadership of Drs. Inés de Lannoy and Lilia Magomedova to lead this research.”

For detailed information on the COPE Benchmark data set, please contact Sal Lemus, Director of Sales and Marketing at InterVivo.

About InterVivo Solutions

InterVivo Solutions is Canada’s top neuroscience contract research organization, offering translational research services with a focus on next-generation neuroscience drug discovery. InterVivo offers in vivo proof of concept efficacy, drug metabolism, pharmacokinetics and early safety research studies for a global client base.

www.intervivo.com        

About Mindset Pharma Inc.

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

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

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

InterVivo Contact:
Sal Lemus, Director of Sales and Marketing
Email: sall@intervivo.com

Forward-Looking Information

This news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward looking information is frequently characterized by words 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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PharmaTher Provides Research and Development Update and Milestones for 2021

TORONTO, June 10, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to provide an update on the research and development initiatives of its psychedelic product programs and upcoming milestones for 2021
“We are well-positioned, both financially and operationally, to execute on our remaining milestones for 2021, which includes completing a Phase 2 study with ketamine to treat Parkinson’s disease, a Phase 2 study with KETABET™ for treatment-resistant depression, and the development of our novel microneedle patches for delivering psychedelics such as ketamine, psilocybin, DMT, MDMA and LSD,” said Fabio Chianelli, CEO of PharmaTher.  “The recent FDA acceptance of our IND to proceed to a Phase 2 study in Parkinson’s disease will pave the way for us to confidently submit future IND’s and advance clinical studies evaluating novel uses, formulations and delivery forms of psychedelics to treat various mental health, neurological and pain disorders.”

FDA Phase 2 Clinical Studies

For the rest of 2021, PharmaTher will focus on advancing three promising developments through clinical studies:

Ketamine for Parkinson’s Disease

Following the FDA acceptance of the Company’s investigational new drug application to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease, the Company has begun clinical trial start-up activities to begin enrolling patients in Q3-2021 and to announce clinical results in Q4-2021.

For those interested in the study (ClinicalTrials.gov Identifier: NCT04912115), titled “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease,” please visit https://clinicaltrials.gov/ct2/show/NCT04912115?term=PharmaTher&draw=2&rank=1.

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 Phase 3 clinical study under the 505(b)2 regulatory pathway in 2022.

KETABET™ for Treatment-Resistant Depression

The Company is preparing a pre-IND meeting request and briefing documents to submit to the FDA to support the clinical development of KETABET™ and the Phase 2 study for treatment-resistant depression.  The Company intends to file the pre-IND meeting request this month, obtain FDA feedback on its clinical study design, and file the IND in Q3-2021.

With the overlap of the clinical operations from the Parkinson’s disease study, the Company has already activated start-up activities and identified potential clinical sites to screen and enroll patients for the proposed Phase 2 study in Q3/Q4-2021.  The aim is to share clinical results by the end of this year.

Amyotrophic Lateral Sclerosis (“ALS” or “Lou Gehrig’s Disease”)

Following the Company’s recent submission to receive orphan drug designation for ketamine to treat ALS, the Company is working with its clinical advisors in finalizing a proposed Phase 2 study design. The objective is to request a pre-IND meeting with the FDA in Q3-2021 and submit the IND in Q4-2021.

PharmaTher has an exclusive license agreement with the University of Kansas for the intellectual property protecting the potential use of ketamine to treat ALS, which was discovered by Dr. Richard J. Barohn, M.D., John A. Stanford, Ph.D., and Dr. Matthew Macaluso, D.O.  Preclinical research has shown that the administration of ketamine preserves muscle function in advancing ALS and increases life expectancy when given in the early stages of muscle decline.

Microneedle Patch for the Delivery of Psychedelics

For the second half of 2021, PharmaTher will focus on working with its research and development partners to advance next generation microneedle patches for the delivery of psychedelics:

Hydrogel-Forming Microneedle Delivery System for Ketamine

PharmaTher is working with Professor Ryan Donnelly under a research agreement with The Queen’s University of Belfast to finalize the patented hydrogel-forming microneedle patch development to deliver ketamine and KETABET™.

The research leverages the successful proof of concept achieved in delivering esketamine, the S(+) enantiomer of ketamine, via the microneedle patch, which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format.  Details of the research can be found in a published paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery.”

Validation and tech transfer to support clinical studies will be completed in Q4-2021.  Interim development results will be made available as they arise throughout 2021.

Microdosing Psychedelics with GelMA Microneedle Delivery System

The Company is working with the Terasaki Institute, led by Dr. Ali Khademhosseini, under a research agreement to finalize the development of a proprietary microneedle delivery system comprised of a biocompatible and biodegradable gelatin methacryloy (“GelMA”) composite for use with psychedelics such as psilocybin, DMT, MDMA and LSD.

The GelMA patch delivery system is the driving force of the Company’s psychedelics microdosing program. It is expected that validation results in delivering these psychedelics will be completed in Q4-2021.  Interim development results will be made available as they arise throughout 2021.

Clinical Manufacturing and Supply

The Company entered into a Co-Development Agreement with TSRL, Inc. to jointly develop a patented hydrogel-forming microneedle patch delivery technology licensed from The Queens University of Belfast, to control the manufacturing and supply of microneedle patches for the Companies respective clinical and commercial drug programs.

PharmaTher is focused on incorporating psychedelics (i.e. ketamine, psilocybin, DMT, MDMA and LSD) and TSRL is focused on incorporating antiviral medications (i.e. Zanamivir, other antiviral therapeutics and vaccines) in a microneedle patch with the potential to improve the safety (i.e. fewer side effects), efficacy (i.e. bioavailability, optimized dosing regimen including continuous system delivery) and compliance (i.e. storage, distribution and self-administration) of these compounds that currently must be taken orally, inhaled, injected and intravenously.

Recent activities included the tech transfer for scale-up and manufacturing of clinical supplies to a GMP contract research lab and a pre-IND meeting with the FDA that achieved agreement with the agency on proposed 505(b)2 product development plans.

The Company aims to validate clinical production of the microneedle patch this year and to enter into clinical studies in 2022 to deliver certain psychedelics such as ketamine, psilocybin, DMT, MDMA and LSD.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics to treat mental health, neurological and pain disorders.  PharmaTher is currently conducting an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
​
Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
For more information about PharmaTher, 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 February 28, 2021 (“MD&A”), dated April 28, 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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HAVN LIFE ANNOUNCES RETAIL PARTNERSHIP WITH GROCER, CHOICES MARKETS

Newly-launched line of natural health products to be available at all locations later this month

Vancouver, BC – HAVN Life Sciences Inc. (CSE: HAVN) (OTC: HAVLF) (FSE: 5NP) (the “Company” or “HAVN Life”), a biotechnology company pursuing standardized extraction of psychoactive compounds and the development of natural health products, is pleased to announce it has secured a product listing agreement with Choices Markets for the company’s new line of natural health products, which officially launched on June 3rd. The locally owned and operated grocery chain will carry the full line of HAVN Life natural health products at all locations. The product line is expected to hit shelves later this month.

“We are excited to have our new line of natural health products at Choices Markets,” says Tim Moore, CEO of HAVN Life. “As purveyors of natural, organic, and specialty foods, Choices Markets is aligned with our focus on health and wellness and we are thrilled to be expanding our distribution network to help build and empower healthy communities,” he adds.

Choices Markets is the second retail partner that HAVN Life has secured, as part of the company’s distribution strategy that includes retail, online and subscription channels to reach a broad customer base and deliver a quality product experience. Currently, the seven formulations are available at yourHAVNlife, and later this month through Amazon and at select Nesters Market stores in B.C.

HAVN Life formulations are non-GMO, vegan, bioavailable, naturally-derived from functional mushrooms and other plants and created with human optimization in mind. The natural health product line has been thoughtfully formulated with adaptogens and antioxidants to support overall brain health, with natural compounds that are proven to support memory, focus, energy, and overall cognitive function.

On Behalf of The Board of Directors
Tim Moore
Chief Executive Officer

About HAVN Life Sciences Inc.

HAVN Life Sciences is a Canadian biotechnology company pursuing standardized extraction of psychoactive compounds, the development of natural health products, and innovative mental health treatment to support brain health and enhance the capabilities of the mind. Learn more at: havnlife.com and follow us on Facebook, Twitter, Instagram and Youtube.

Connect

Investor Relations
ir@havnlife.com
(604) 687-7130

Facebook: @havnlife
Twitter: @havnlife
Insta: @havn.life
LinkedIn: @Havn Life
Youtube: @HavnLife

Media Contact
savi@emergence-creative.com
(647) 896-8078

 

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Mindset Selects its Lead Clinical Candidate, MSP-1014, a Next Generation Psychedelic Medicine

TORONTO, June 03, 2021 (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 selected its lead clinical candidate, MSP-1014, a differentiated psilocybin-based compound from its Family 1 of novel, patent-pending psychedelic compounds to move forward into current good manufacturing practice (cGMP) compliant manufacturing and investigational new drug (IND)-enabling studies.

“The selection of Mindset’s first lead candidate, MSP-1014, is a significant milestone in our clinical journey. We are excited to enter the final preclinical development step prior to commencing first-in-human clinical trials. Our next generation psychedelic compounds represent the flourishing evolution of therapeutics to effectively address neurological and neuropsychiatric disorders,” said James Lanthier, CEO of Mindset.

“MSP-1014 demonstrates superior preclinical characteristics in head-to-head comparison with psilocybin and its active metabolite psilocin, including increased safety and efficacy, which we believe will potentially result in lower clinical doses thereby indirectly decreasing safety concerns, and manufacturing advantages. MSP-1014 has the potential to be a safer, more efficacious analog to psilocybin, with reduced potential side effects. Given its chemical profile, we anticipate that MSP-1014 will have the potential to treat mood disorders, including major depressive disorder, substance misuse disorders and end-of-life angst associated with terminal illnesses, including cancer. Therefore, we believe that MSP-1014 has the potential to be a first-in-class psychedelic drug candidate. With our first lead candidate selected, Mindset continues to steadily advance its position in developing innovative next-generation psychedelic therapeutics that couple the life-changing potential of psychedelic drugs with novel and patentable new chemical entities that are more predictable, convenient, and safer than first-generation psychedelics.”

Mindset’s Family 1 compounds leverage state-of-the art modern drug design using conjugated and deuterated psilocybin and psilocin design strategies to improve on psilocybin’s potential toxicity and pharmacokinetic profiles. Rodent preclinical studies showed that MSP-1014 displayed superior in vivo and safety profiles in mice compared to psilocybin at a range of doses, and 5-HT2A subtype activation in rats. The superiority to psilocybin is due in part to the incorporation of a conjugated amplification moiety (CAM) that enhances 5-HT2A specific effects while reducing non-specific effects. In addition, the manufacturing process of MSP-1014 precludes the phosphorylation step, one of the most challenging chemical synthesis steps in psilocybin manufacturing.

The Company’s Family 1 includes patent-pending compounds comprising two patent applications with priority dates of February 2020. The Company has run a comprehensive range of specialized in vitro and in vivo tests on its patent-pending novel compounds to select the optimal psychedelic drug candidate for progressing towards human clinical trials. These studies have revealed a high rate of success among many of its compounds (see Mindset’s news release of April 29, 2021), giving Mindset an exceptional pool of new drug candidates from which it will continue to identify additional suitable compounds. The Company intends to further develop candidates from Mindset Families 2-4 with the goal of selecting additional lead candidates in the near future.

For additional detail on our Family 1 lead candidate MSP-1014, please watch the following interview from Mindset’s management team:
https://youtu.be/ZWl14TPzAek

About Mindset Pharma Inc.

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

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 by words 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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Ehave To Release Vaccine Passport As Part Of Its Medical Passport

Patients to take ownership of health records from various medical providers so other caregivers and care teams can have access to past treatments and procedures.

MIAMI, June 03, 2021 (GLOBE NEWSWIRE) — Ehave, Inc. (OTC Pink: EHVVF) (the “Company”), a provider of digital therapeutics delivering evidence-based therapeutic interventions to patients, announced today its Ehave medical passport will give small businesses a tool to verify Covid-19 vaccination as most small businesses battle to come to terms on how to implement safety precautions. Ehave’s Medical and Vaccine Passport will allow individuals and small businesses to easily access vaccination verification to ease implementing new safety precautions.

On May 16, 2021 the Center for Disease Control (CDC) relaxed its mask recommendation and said individuals who are fully vaccinated can resume activities they did prior to the pandemic. This means fully vaccinated people can resume activities without wearing a mask or physically distancing, except where required by federal, state, local, tribal, or territorial laws, rules, and regulations, including local business and workplace guidance. The CDC went on to say, if you haven’t been vaccinated yet, find a vaccine. Now that the CDC has suggested less stringent mask requirements, a verification system might help identify who has been vaccinated. Such a verification system is currently a hot topic politically, but many people want to be able to prove they have been vaccinated in the most convenient way possible. Ehave’s recent expansion of its Dashboard capabilities through its licensing agreement with Health Wizz could provide a potential solution. Ehave will offer its Dashboard as a HIPAA compliant, decentralized mobile platform providing users access to their medical records management and retrieval over a dedicated instance on the Amazon Web Services platform. According to a May 25, 2021 article in Wired “some state governments are creating verification apps that let people gather safely, others are refusing to allow so-called vaccine passports in their states, and some governors are threatening to bar businesses from using them.” For the millions of individuals who want to voluntarily share their vaccination information, so they know who it’s safe to be around, the Ehave Dashboard could be the perfect vaccine and medical passport.

As a result of its recent licensing agreement with Health Wizz, Ehave now has the necessary access to provide Medical and Vaccine Passports to those individuals who want to have one. The number of potential participants who can access their health data with the Ehave Mobile App is more than 150 million potential users. The Ehave Mobile App should be available in the next 30-days and will allow participants to access their electronic health records (EHRs) and download US Core Data for Interoperability (USCDI) using Fast Healthcare Interoperability Resources (FHIR) APIs. This includes more than 100 million patients and members. The Ehave Mobile App also allows individuals to access claims and billing activities. Participants can use the Ehave Mobile App to connect to a claims database and download claims and billing data using FHIR APIs. This includes more than 60 million Medicare beneficiaries and veterans. The Ehave Mobile App also supports patient generated data including in home use settings, such as surveys, diaries, wearables, and patient reported outcomes (PROs).

Ben Kaplan, CEO of Ehave said, “Our Ehave Mobile App makes it very easy for users and participants to securely store their health and medical records, so they can have them with them at all times. We have added a revolutionary feature that will give patients and participants the ability to combine their health records from multiple institutions along with their patient-generated data.” Mr. Kaplan continued, “We do not want to get involved in politics, but for individuals who want a Medical and Vaccine Passport, we believe the Ehave Mobile App is a potential solution.”

About Ehave, Inc.

Ehave, Inc. (EHVVF) is a leader of digital therapeutics delivering evidence-based therapeutic interventions to patients. Our primary focus is on improving the standard care in therapeutics to prevent or treat brain disorders or diseases through the use of digital therapeutics, independently or together, with medications, devices, and other therapies to optimize patient care and health outcomes. Our main product is the Ehave Telemetry Portal, which is a mental health informatics platform that allows clinicians to make objective and intelligent decisions through data insights. The Ehave Infinity Portal offers a powerful machine learning and artificial intelligence platform with a growing set of advanced tools and applications developed by Ehave and its leading partners. This empowers patients, healthcare providers, and payers to address a wide range of conditions through high quality, safe, and effective data-driven involvement with intelligent and accessible tools. Additional information on Ehave can be found on the Company’s website at: www.ehave.com.

Forward-Looking Statement Disclaimer

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Company’s research, manufacturing and other development efforts; (ii) the Company’s ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Company’s products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Company’s industry and introduction of competing products; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading “Risk Factors” in Ehave, Inc.’s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC’s website, http://www.sec.gov.