Posted on

Professor Celia Morgan joins Awakn Life Sciences

The appointment continues to strengthen Awakn’s industry leading Scientific Advisory Board

Awakn is pleased to announce the appointment of Professor Celia Morgan to its Scientific Advisory Board (SAB).

Celia Morgan is a Professor of Psychopharmacology at the University of Exeter in the United Kingdom. She is one Europe’s leading Ketamine researchers & investigators and the academic lead for the Exeter Translational Addiction Partnership. Prof. Morgan’s research focuses on examining both the benefits and side effects of recreational drugs on cognition, mental health and neurobiology and includes leading the ground-breaking Ketamine for reduction of Alcoholic Relapse clinical trial.

Awakn’s SAB provides strategic scientific counsel as the company implements its vision and strategy across three business lines of clinical research, therapeutic clinics and practitioner training.

Prof. Morgan stated, “I’m very excited to join such a distinguished team with a unique breadth of expertise across the spectrum of psychedelic assisted therapies. Through this synergy, and their vision, Awakn have the potential to rapidly transform the field, and to oversee the realisation of these compounds as the medicines they richly deserve to be. It’s a great privilege to be a part of this.”

Dr. Ben Sessa, Awakn CMO, commented, “Celia Morgan has been a long-time friend and colleague whom I respect and admire; from her earliest days when she conducted highly unique and creative research observing real-life ketamine users in their homes in London, to her latest project; spearheading the UK’s largest clinical trial with ketamine psychotherapy for the treatment of alcoholism. Her interests align perfectly with those of us at Awakn; using psychedelics not purely as pharmacological agents or for managing wellness issues in non-clinical populations; but rather using these important drugs in combination with psychotherapy to develop the best therapies for our worthy patients. She will be a valuable addition to our team, and we are grateful to have her aboard. Welcome Celia!”

Anthony Tennyson, Awakn CEO, stated, “I am also very pleased that we are adding an advisor with such a deep level of relevant psychedelic experience and pedigree to our Scientific Advisory Board. Celia is working at the leading edge of ketamine research and I am looking forward to working with her and seeking her guidance and counsel on our continued journey.”

Posted on

Mind Cure Announces Eligibility for DTC Trading

December 2, 2020

Mind Cure’s common shares now able to meet US demand with more simplicity

VANCOUVER, BC, Dec. 2, 2020 /PRNewswire/ – Mind Cure Health Inc. (CSE: MCUR) (OTCQB: MCURF) (FRA: 6MH) (“Mind Cure” or the “Company“) is pleased today to announce that its common shares are now eligible for electronic clearing and settlement through the Depository Trust Company (DTC) in the United States. Mind Cure common shares will be listed on the DTC under the symbol MCURF.

Mind Cure CEO and President Kelsey Ramsden stated, “We have seen overwhelming support from investors in Canada over the past few months, and with today’s news we are able to increase access to Mind Cure for US investors as well. We are moving aggressively to initiate our digital therapeutics and research with psychedelics and psychoactive substances.”

Mind Cure’s common shares will continue to trade under the following ticker symbols on other markets: (CSE: MCUR) (OTCQB: MCURF) (FRA: 6MH). DTC is a subsidiary of the Depository Trust & Clearing Corp., a U.S. company that manages the electronic clearing and settlement of publicly traded companies.

About Mind Cure Health Inc.

Mind Cure exists as a response to the current mental health crisis and urgent calls for effective treatments. Mind Cure 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.

Mind Cure is focused on identifying and developing pathways and products that ease suffering, increase productivity, and enhance mental health. Mind Cure 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
Philip Tapley, Chairman
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: Mind Cure receiving DTC eligibility; Mind Cure moving fast to achieve its strategic goals; Mind Cure receiving more investor support and increasing access to US investors; Mind Cure moving aggressively to initiate its digital therapeutics and research with psychedelics and psychoactive substances.

Forward-looking information is based on a number of key expectations and assumptions made by Mind Cure, including, without limitation: the COVID-19 pandemic impact on the Canadian and global economy and Mind Cure’s business, and the extent and duration of such impact; Mind Cure receiving DTC eligibility; no change to laws or regulations that negatively affect Mind Cure’s business; there will be a demand for Mind Cure’s services and products in the future; all necessary approvals will be received and all conditions will be satisfied or waived; and Mind Cure will be able to operate its business as planned. Although the forward-looking information contained in this news release is based upon what Mind Cure 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 and global economy, Mind Cure’s industry and its business, which may negatively impact, and may continue to negatively impact, Mind Cure and may materially adversely affect its investments, results of operations, financial condition and Mind Cure’s ability to obtain additional equity or debt financing, and satisfy its financial obligations; Mind Cure receiving DTC eligibility; the ability for Mind Cure to continue to list its shares on the CSE or another exchange; circumstances may change resulting in the use of proceeds set out in this news release; general economic conditions; future growth potential; common share prices; liquidity; tax risk; tax laws currently in effect remaining unchanged; ability to access capital markets; competition for mental health and wellness investments; environmental matters; 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 Mind Cure can be found under “Risk Factors” in Mind Cure’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 Mind Cure. The forward-looking information is stated as of the date of this news release and Mind Cure assumes no obligation to update or revise such information to reflect new events or circumstances, except as may be required by applicable law.

United States Advisory

The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), may be offered and sold outside the United States to eligible investors pursuant to Regulation S promulgated under the U.S. Securities Act, and may not be offered, sold, or resold in the United States or to, or for the account of or benefit of, a U.S. Person (as such term is defined in Regulation S under the United States Securities Act) unless the securities are registered under the U.S. Securities Act, or an exemption from the registration requirements of the U.S. Securities Act is available. Hedging transactions involving the securities must not be conducted unless in accordance with the U.S. Securities Act. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in the state in the United States in which such offer, solicitation or sale would be unlawful.

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.

‍

Posted on

Field Trip Health Ltd. Completes Reverse Take-Over Transaction and Prepares for Listing on the Canadian Securities Exchange

Public listing of combined company expected to occur on or about October 7, 2020

Field Trip Psychedelics Inc. upsizes its Series B financing from $11.0 million to $12.6 million

TORONTO, Oct. 2, 2020 /CNW/ — Field Trip Health Ltd. (formerly Newton Energy Corporation) (“Field Trip” or the “Company“) is pleased to announce that it has completed its previously announced reverse take-over of Field Trip Psychedelics Inc. (“FTP“) by way of a three-cornered amalgamation (the “Transaction“). The Company will carry on the business of FTP, which is a global leader in the development and delivery of technology-enabled psychedelic therapies. Prior to the closing of the Transaction (the “Closing“), the Company changed its name to “Field Trip Health Ltd.” and consolidated the outstanding common shares of the Company (each, a “Share“), on the basis of one post-consolidation Share for every eight pre-consolidation Shares.

Pursuant to the Transaction, FTP was amalgamated with a wholly owned subsidiary of the Company and all Class A Shares and convertible securities of FTP were exchanged for post-consolidation Shares on a one for one basis.

The pre-consolidation Shares of Newton Energy Corporation (formerly NTN.H on TSXV) were delisted from the NEX board of the TSX Venture Exchange effective September 30, 2020. The Company anticipates that the Shares will commence trading on the Canadian Securities Exchange (the “CSE“) on or about October 7, 2020, under the symbol “FTRP”, subject to customary conditions, including the final approval of the CSE.

Joseph del Moral, CEO of the Company, commented, “This is a watershed moment for Field Trip and our shareholders. Completing the Transaction and our expected public listing on the CSE will give us a public vehicle to increase our exposure to the investment community as we execute against our strategy, which is centered around the development of novel psychedelic molecules, such as FT-104, our first molecule in development, and the therapeutic application of psychedelics and psychedelic-assisted therapy using our technology-enabled Field Trip Health clinical hubs and telehealth remote care.”

“Adopting the name Field Trip Health reflects our commitment to fundamentally transforming attitudes and approaches to mental, emotional and behavioural health by developing patient-centric, evidence-based, integrative solutions through psychedelics,” added Ronan Levy, Field Trip’s Executive Chairman. “We are building a diversified, yet deeply integrated, platform that combines psychedelic-enhanced psychotherapy, technology-enabled virtual care solutions, and drug and product development. It is a business model and a mission that is clearly resonating with investors, as demonstrated by the upsizing of FTP’s Series B financing.”

In connection with the Closing, all of the directors and officers of the Company resigned and were replaced by nominees of FTP. The board of directors of the Company is now comprised of Joseph del Moral, Ronan Levy, Hannan Fleiman, Mujeeb Jafferi, Ryan Yermus, Helen Boudreau and Dieter Weinand, all of which were nominees of FTP. The officers of the Company are as follows:

Joseph del Moral

–

Chief Executive Officer

Donna Wong

–

Chief Financial Officer

Ronan Levy

–

Executive Chairman

Hannan Fleiman

–

President

Mujeeb Jafferi

–

Chief Operating Officer

Dr. Ryan Yermus

–

Chief Clinical Officer

Paula Amy Hewitt

–

Vice President, General Counsel and Corporate Secretary

Dr. Nathan Bryson

–

Chief Science Officer

Amardeep Manhas

–

Chief Technology Officer

Tyler Dyck

–

Treasurer & Director of Finance

Additional information regarding the business of the Company and the biographical details of management and the board of directors can be found in the Company’s CSE Form 2A Listing Statement, which will be filed on SEDAR prior to the commencement of trading on the CSE.

Immediately prior to the Closing, DeVisser Gray LLP, of Vancouver, British Columbia, served as auditor of the Company. As contemplated in the Company’s management information circular dated August 21, 2020, which is available under the Company’s profile on SEDAR at www.sedar.com, MNP LLP, being the auditor of FTP, will be appointed as the auditor of the Company for the Company’s current fiscal year.

Upsizing of Series B Financing

Prior to the Closing, FTP completed an upsizing of its previously announced Series B financing, from $11.0 million to $12.6 million, a portion of which was completed by way of a brokered private placement for which Canaccord Genuity Corp. and Stifel Nicolaus Canada Inc. jointly served as lead agents. The proceeds from the financing will be used to continue the rollout across North America of the Company’s Field Trip Health clinical hubs for psychedelic therapies, and to further advance its pioneering work with its next generation psychedelic molecule, FT-104, and its advanced research and development on psilocybin producing mushrooms in partnership with the University of West Indies.

None of the securities issued in connection with the Transaction or FTP’s Series B financing have been or will be registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities, in any jurisdiction in which such offer, solicitation or sale would require registration or otherwise be unlawful.

Early Warning

Immediately prior to the Transaction, Joseph del Moral and his affiliates (collectively, “Mr. del Moral“) held no Shares. As a result of the Closing, Mr. del Moral exercises control and direction over 14.59% of the issued and outstanding Shares. Mr. del Moral does not currently own any convertible securities of the Company.

The Shares were acquired for investment purposes and Mr. del Moral has no current intention to acquire control or direction over additional securities of the Company as of the date of this news release, either alone or together with any joint actors.

Further details regarding Mr. del Moral’s holdings will be set forth in an early warning report which will be available for viewing on the Company’s SEDAR profile, available at www.sedar.com.

About Field Trip Health Ltd.

Field Trip is the global leader in the development and delivery of psychedelic therapies. With Field Trip Discovery leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics, Field Trip Health hubs for psychedelic therapies opening across North America, and Field Trip Digital building the digital and technological tools to support psychedelic experiences and consciousness expansion, we help people, from those in treatment to those seeking accelerated personal growth, with a simple, evidence-based way to heal and heighten engagement with the world.

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

Follow us on Twitter and Instagram:  @fieldtriphealth

Cautionary Note Regarding Forward Looking Information

This release includes forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which may include, but are not limited to, statements with respect to the listing of the common shares of the Company on the Canadian Securities Exchange, and the timing of such events. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of the Company, and are based on assumptions and subject to risks and uncertainties. Although the management of the Company 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 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 the Company 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 the Company 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.

The CSE has neither approved nor disapproved the contents of this news release.

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. 

SOURCE Field Trip Health Ltd.

For further information: Media contacts: Nick Opich / McKenna Miller, KCSA Strategic Communications, 212-896-1206 / 347-487-6197, nopich@kcsa.com / mmiller@kcsa.com; Investor Contact: Elizabeth Barker, KCSA Strategic Communications, 212-896-1203, ebarker@kcsa.com

Posted on

HAVN LIFE JOINS UK PSYCHEDELICS WORKING GROUP WITH LEADING INTERNATIONAL SCIENTISTS

The working group consists of over 35 academics, researchers and policy specialists from four countries.

Vancouver, BC – Havn Life Sciences Inc. (CSE : HAVN) (FSE : 5NP)(the “Company” or “Havn Life”), a biotechnology company focused on unlocking human potential using evidence-informed research, and developing standardized psychoactive compounds derived from plants and fungi, is pleased to announce that it has joined the Drug Science Medical Psychedelics Working Group consortium.

The working group was launched by Drug Science, UK’s leading independent scientific body on drugs that provides an evidence base that is free from political or commercial influence, which creates a foundation for sensible and effective drug laws, by delivering, reviewing and investigating scientific evidence relating to psychoactive drugs.

“Havn Life is thrilled to be supporting Drug Science’s research on psychedelics,” said Dr. Ivan Casselman (Ph.D., FLS), Havn Life’s Chief Psychedelic Officer. “We are committed to advancing research in psychedelics, as well as collaborating with organizations and academic institutions around the world to tap into world class, quality research. The development of sensible drug policy reform is a mission that both the working groups and Havn Life are highly aligned with.”

The Drug Science team includes:

  • Founder Prof. David Nutt, who serves as Chair of the Scientific Committee, and is also the Edmond J. Safra Professor of Neuropsychopharmacology at Imperial College London.
  • Colonel Rakesh Jetly, whose role in the Canadian military has included time as senior psychiatrist and mental health clinical advisor to the CF Surgeon General and who has published numerous articles in professional journals and presents nationally and internationally on such topics as post traumatic stress disorder and operational psychiatry
  • Joanna Neil who has served as the Professor of Psychopharmacology in the Manchester Pharmacy School at the University of Manchester since January 2013 and who has authored over 70 peer-reviewed publications in top scientific journals. Neil has been conducting research in psychopharmacology for almost 30 years, specifically in the area of development of preclinical models of psychiatric disorders.

A consortium of Drug Science experts, industry partners, patient representatives and policy makers, the group aims to break the barriers of 50 years of medical censorship by creating a rational and enlightened approach to psychedelic research and clinical treatment.

On Behalf of The Board of Directors
Susan Chapelle & Tim Moore
Co-CEOs

About Havn Life Sciences Inc.

Havn Life Sciences is a biotechnology company on a mission to unlock human potential using evidence-informed research. The Company is focused on standardized, quality-controlled extraction of psychoactive compounds from plants and fungi, and the development of natural health care products from non-regulated compounds. Learn more at: havnlife.com and follow us on Facebook, Twitter and Instagram.

Connect

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

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

Media Contact
Brittany@exvera.com
778-238-6096

Posted on

Vireo Health Announces Sale of Assets of Ohio Medical Solutions to Ayr Strategies for Total Consideration of $4.85 Million

– Transaction improves Vireo’s cash position and reduces operating losses –
– Company maintains expectation to become cash flow positive in fiscal 2021 –

MINNEAPOLIS, Oct. 1, 2020 /PRNewswire/ — Vireo Health International, Inc. (“Vireo” or the “Company”) (CNSX: VREO, OTCQX: VREOF), the science-focused, multi-state cannabis company with active operations in exclusively medical-only markets and licenses in seven states and the Commonwealth of Puerto Rico, today announced that it has reached a definitive agreement with Ayr Strategies Inc. (CSE:AYR.A)(OTCQX:AYRSF), to sell all of the assets and liabilities of its affiliated company, Ohio Medical Solutions, LLC (“OMS”), for total consideration of $4.85 million.

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

“This transaction allows Vireo to monetize a license acquired at minimal cost through a merit-based award process, and reallocate the proceeds to our core markets, where we see significant opportunities to improve revenue growth and future cash flow generation,” said Founder & Chief Executive Officer, Kyle Kingsley, M.D. “We’re especially pleased to achieve yet another milestone for our shareholders without the dilutive impacts of other forms of financing. We’re continuing to scale our operations in high-value markets like Arizona, New York, New Mexico, Maryland and Minnesota, and expect to generate stronger performance across each of these markets in fiscal year 2021.”

Ohio Medical Solutions holds a permit for the processing of medical cannabis in the state of Ohio. This permit was initially awarded to OMS through a merit-based application process in 2019. Based in Akron, OMS manufactures cannabis-based products in a 11,300 square foot processing facility. The transaction’s total consideration of $4.85 million includes $1.15 million in cash and $3.7 million in the form of Right of Use liabilities associated with lease obligations. The transaction is subject to regulatory approvals and other conditions.

About Vireo Health International, Inc.

Vireo Health International, Inc. (“Vireo” or the “Company”) is a physician-led cannabis company focused on bringing the best of technology, science, and engineering to the cannabis industry. Vireo manufactures proprietary, branded cannabis products in environmentally-friendly, state-of-the-art greenhouses and distributes its products through its growing network of Green GoodsTM retail dispensaries and through hundreds of third-party dispensaries in seven states. Vireo’s team of more than 400 employees, led by scientists, engineers, and cultivation experts, is focused on efficiency and the creation of best-in-class products, while driving scientific innovation within the cannabis industry and developing meaningful intellectual property. Today, Vireo is licensed to grow and/or process cannabis in 9 markets. The Company is operational in 7 of those 8 markets – including the core markets of Arizona, Maryland, Minnesota, New Mexico, New York, Pennsylvania. The Company holds 32 total retail dispensary licenses, of which 13 are currently open for business. For more information about Vireo Health, please visit www.vireohealth.com.

About Ayr Strategies Inc.

Ayr Strategies (“Ayr”) is an expanding vertically integrated, U.S. multi-state cannabis operator, focusing on high-growth markets. With anchor operations in Massachusetts and Nevada, the company cultivates and manufactures branded cannabis products for distribution through its network of retail outlets and through third-party stores. Ayr strives to enrich and enliven consumers’ experience every day – helping them to live their best lives, elevated. Ayr’s leadership team brings proven expertise in growing successful businesses through disciplined operational and financial management, and is committed to driving positive impact for customers, employees and the communities they touch. For more information, please visit www.ayrstrategies.com.

Forward-Looking Statement Disclosure

This news release contains “forward-looking information” within the meaning of applicable United States and Canadian securities legislation. To the extent any forward-looking information in this news release constitutes “financial outlooks” within the meaning of applicable United States or Canadian securities laws, such information is being provided as preliminary financial results and the reader is cautioned that this information may not be appropriate for any other purpose and the reader should not place undue reliance on such financial outlooks. Forward-looking information contained in this press release may be identified by the use of words such as “plans,” “expects” or “does not expect,” “is expected,” “look forward to,” “budget” “scheduled,” “estimates,” “forecasts,” “will continue,” “intends,” “anticipates,” “does not anticipate,” “believes,” “should,” “should not,” or variations of such words and phrases or indicates that certain actions, events or results “may,” “could,” “would,” “might,” or “will” “be taken,” “occur,” or “be achieved.”  Forward-looking information may include, without limitation, statements regarding the operations, business, financial condition, expected financial results, performance, prospects, opportunities, priorities, targets, goals, ongoing objectives, milestones, strategies and outlook of Vireo, and includes statements about, among other things, the value of assets, the amount of liabilities, the designation of certain businesses or assets as “core” or “non-core,” decisions about allocation of capital and other resources, future developments, the future operations, potential market opportunities including the potential effects of the approval of adult-use cannabis in one or more markets, potential opportunities to monetize assets, strengths and strategy of the Company. 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. These statements should not be read as guarantees of future performance or results. Forward-looking information includes statements with respect to the opportunities for the Company to leverage increasing scale to improve sales growth and operating performance; the anticipation that the medical-only state markets in which the Company’s subsidiaries operate could enact recreational-use legislation over the near-to mid-term future; the anticipated benefits of strategic initiatives; the effects of reduction of corporate overhead and SG&A expenses; improvement to unit economics; expansion of retail dispensaries in key markets; and the expectation that such expansion will drive stronger revenue growth, operating margins and free cash flow. Forward-looking information includes both known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release including, without limitation, the impact on the Company’s businesses and financial results of epidemics and pandemics, including the COVID-19 pandemic. Financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to various risks as set out herein. Our actual financial position and results of operations may differ materially from management’s current expectations and, as a result, our revenue and cash on hand may differ materially from the revenue and cash values provided in this news release. Forward-looking information is based upon a number of estimates and assumptions of management, believed but not certain to be reasonable, in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment; and the availability of licenses, approvals and permits.

Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that they will prove to be correct, including preliminary financial expectations regarding the annualized reduction of corporate overhead and SG&A expenses. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to, risks related to preliminary financial results being subject to the completion of the Company’s financial closing procedures and not being audited or reviewed by the Company’s independent registered public accounting firm; the timing of recreational-use legislation in markets where the Company currently operates; current and future market conditions, including the market price of the subordinate voting shares of the Company; federal, state, local and foreign government laws, rules and regulations, including federal and state laws in the United States relating to cannabis operations in the United States; limited operating history; changes in laws, regulations and guidelines; operational, regulatory and other risks; execution of business strategy; management of growth; difficulty to forecast; conflicts of interest; risks inherent in an agricultural business; liquidity and additional financing; foreign private issuer status and the risk factors set out in the Company’s listing statement dated March 19, 2019, filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com.

The statements in this news release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

Media Inquiries

Investor Inquiries

Albe Zakes

Sam Gibbons

Vice President, Corporate Communications

Vice President, Investor Relations

albezakes@vireohealth.com

samgibbons@vireohealth.com

(267) 221-4800

(612) 314-8995

 

CisionView original content to download multimedia:http://www.prnewswire.com/news-releases/vireo-health-announces-sale-of-assets-of-ohio-medical-solutions-to-ayr-strategies-for-total-consideration-of-4-85-million-301144073.html

SOURCE Vireo Health International, Inc.

Posted on

Public coverage of AbbVie’s SKYRIZI® for the treatment of Moderate to Severe Plaque Psoriasis is now available across additional jurisdictions

  • SKYRIZI® is an interleukin-23 (IL-23) inhibitor used for the treatment of moderate to severe plaque 1
  • In clinical studies, SKYRIZI® significantly improved levels of skin clearance after just 16 weeks and maintained clearance at one year (52 weeks).1
  • New Brunswick lists SKYRIZI® on its provincial formulary effective March 19,
  • Yukon lists SKYRIZI® on its formulary effective April 1,
  • British Columbia lists SKYRIZI® on its provincial formulary effective May 05,
  • Newfoundland and Labrador lists SKYRIZI® on its provincial formulary effective September 16,

 

MONTRÉAL, QC, October 01, 2020 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced today that SKYRIZI® (risankizumab) is now listed as a special authorization drug or exception drug status on the formularies of New Brunswick, Yukon, British Columbia, and Newfoundland and Labrador for the treatment of moderate to severe plaque psoriasis.

 

SKYRIZI® is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally, and is the only IL-23 inhibitor to arrive at a positive conclusion with the pCPA.

 

“I have been fortunate to be involved in the clinical trials. SKYRIZI® has improved the quality of life of

my patients with psoriasis by offering them clear skin,” states Dr. Irina Turchin, MD, FRCPC, Fredericton, NB. “It is great to see that this treatment is now available to more patients in New Brunswick.”

 

Psoriasis is a chronic condition affecting 125 million people worldwide, including 1 million Canadians, and many patients despite treatment still do not reach their goals or lose treatment response over time.2-4 The most common form is plaque psoriasis, which affects approximately 90% of patients. 5

 

“I am excited to be able to offer SKYRIZI® to patients with moderate to severe psoriasis in British Columbia as it is now listed on the provincial Pharmacare formulary. Having experience with the medication in clinical trials, I have personally seen how it provides durable and complete skin clearance for many patients. Patients are particularly happy with the dosing schedule,” explains Dr Chih-ho Hong, MD, FRCPC, Dermatologist.

 

Psoriasis has a genetic basis and about one-third of people with psoriasis have at least one family member with the disease. 5 Of note, the prevalence of psoriasis is 5- to 10-fold higher in Newfoundland and Labrador than in the rest of Canada. 6

 

“PsoriasisNL is pleased to learn of this listing of another treatment for Psoriasis for the patients of our province. We would like to thank the Government of Newfoundland and Labrador for their continued support of advanced therapeutics for the patients of this province who suffer from severe Psoriasis. As the province with

 

the highest prevalence of this disease, the availability of these treatments have greatly increased the quality of life for those who suffer from psoriasis”, explains Deva Murthy, President, PsoriasisNL.

 

Information regarding specific reimbursement criteria may be found by consulting the links below:

 

 

About SKYRIZI®

SKYRIZI® is a novel, humanized immunoglobulin monoclonal antibody designed to selectively inhibit IL-23, a naturally occurring cytokine involved in inflammatory and immune responses.1 On April 17, 2019, SKYRIZI™ received a NOC from Health Canada for the treatment of moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy, based on results from clinical studies showing significant improvement in levels of skin clearance after just 16 weeks and at 52 weeks with every 3-month dosing in more than 2000 adult patients.1 Four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluated more than 2,000 patients with moderate to severe plaque psoriasis.4 Canadians living with moderate to severe plaque psoriasis were well represented in all four of the pivotal clinical trials leading to Health Canada’s approval, showing the Canadian leadership in this clinical development program.

 

About AbbVie in Dermatology

For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases. With a broad clinical trial program, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease.

 

About AbbVie Care

The AbbVie Care program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment journey. For more information, consult abbviecare.ca

 

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

– 30 –

 

Media:

Kim Hogan AbbVie Canada

 

(514) 832-7288

kim.hogan@abbvie.com

 

References:

 

  1. SKYRIZI® (risankizumab) [Canadian Product Monograph]. AbbVie Corporation, April 17,
  2. International Federation of Psoriasis Associations. Accessed March 22, 2019. Available at: https://ifpa-pso.com/wp- content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf.
  3. Mroweitz, , et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan; 303(1): 1–10.
  4. Levin, et Biologic fatigue in psoriasis. J Dermatolog Treat. 2014 Feb;25(1):78-82. doi: 10.3109/09546634.2013.826341.
  5. Canadian Dermatology Association – Psoriasis. Accessed on September 30,
  6. Nall, L., Gulliver, W., Charmley, P. and Farber, E.M. (1999) Search for the psoriasis susceptibility gene: The Newfoundland Cutis, 64, 323–329.)
Posted on

HAVN LIFE SCIENCES INC. REPORTS Q1 FINANCIAL STATEMENTS

Vancouver, BC – Havn Life Sciences Inc. (CSE : HAVN) (FSE : 5NP)(the “Company” or “Havn Life”), is pleased to announce Its financial results for the three month period ended July 31, 2020. Please note that all references to currency are in CDN dollars.

First Quarter Results for three months ended July 31, 2020 – Financial highlights:

The Company incurred net and comprehensive loss of $1,159,642 consisting primarily of:

  • Non-cash fair value of equity grants and shares issued for services included in share-based payments of $341,823 and finder’s fees of $199,500;
  • Professional fees of $198,309 and management fees of $128,000 incurred pursuant to the efforts and to enter into the securities acquisition agreement with HAVN Research Inc. and first submission of the Company’s prospectus on June 9, 2020.

Since inception on April 8, 2020, the Company has raised $4.6M through three rounds of financing.

On September 2, 2020, the Company received a receipt of acceptance from the British Columbia Securities Commission for its long-form prospectus.

On September 4, 2020, the Company acquired 100% of HAVN Research Inc. in consideration for 100% of the issued and outstanding shares of HAVN Research Inc. in exchange for 15,233,333 common shares of the Company.

The Company began trading on the CSE under the symbol, HAVN and the FSE under the symbol 5NP.

The Company received a Section 56 Exemption from Health Canada, pursuant to which it now can possess certain amounts of pure psilocybin for scientific purpose, specifically for the research and development of quality control methods.

On Behalf of The Board of Directors
Susan Chapelle & Tim Moore
Co-CEOs

About Havn Life Sciences Inc.

Havn Life Sciences is a biotechnology company on a mission to unlock human potential using evidence-informed research. The Company is focused on standardized, quality-controlled extraction of psychoactive compounds from plants and fungi, and the development of natural health care products from non-regulated compounds. Learn more at: havnlife.com and follow us on Facebook, Twitter and Instagram.

Connect

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

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

Media Contact
Brittany@exvera.com
778-238-6096

Posted on

New Wave Holdings Enters Into Letter of Intent to Create a CPG Focused Digital Marketing and Ecommerce Joint Venture

TORONTO, Sept. 29, 2020 /CNW/ – NEW WAVE HOLDINGS CORP. (the “Company” or “New Wave”) (CSE: SPOR) (FWB: 0XM2) (OTC:TRMND) an investment issuer that provides capital and support services, announced it has entered into a letter of intent to form a joint venture with Joshua Neilly and Branislav Nikolic to form an Ireland based digital marketing company. New Wave will acquire a 50% interest in the operations in this co-venture named N2 Logics Inc (“N2 Logics”) or similar name. N2 Logics is a private company that supports digital marketing and online growth. The technical team are uniquely suited to support online e-commerce platforms to maximize exposure and reach parties interesting in making an online purchase.

New Wave Holdings Corp. Logo (CNW Group/New Wave Holdings Corp.)
New Wave Holdings Corp. Logo (CNW Group/New Wave Holdings Corp.)

New Wave will purchase 10,000,000 shares in N2 Logics by way of a private placement for a purchase price of CDN $150,000. This will give New Wave a 50% ownership in the joint venture with N2 Logics.

N2 Logics Highlights include:

The N2 Logics team brings over 10 years of experience in the field of online e-commerce and digital marketing, they utilize established and true methodologies to attract high quality traffic online through lead generation and conversion optimization. Based on the current digital marketing needs, they focus on world class tactics and digital optimization to provide return on investments.

N2 Logics team covers various avenues of online growth and digital marketing that has an established track record of exponential growth. The collaborative effort has grown online sales for ventures by 10x in less than 2 years. The team specializes in various products such as; CBD oils, CBD capsules, CBD vape pens, vaporizers, CBD edibles, CBD coffee, CBD drinks, hemp protein, lifestyle businesses, skin organics and alternative medicines. N2 Logics will support enterprise growth for New Wave and its subsidiaries by enhancing distribution and marketing across the globe of functioning mushroom line of products.

Based in Northern Ireland, N2 Logics offers premium services and backed up with access to industry leading advice and guidance.

ABOUT NEW WAVE HOLDINGS CORP.

New Wave Holdings Corp. (CSE: SPOR, FWB: 0XM2, OTC:TRMND) is an investment issuer focused on the burgeoning psychedelic and esports sectors. In the psychedelic sector, New Wave will focus on supporting research on active psychedelic compounds, creation of consumer products based on functional mushrooms, and developing an IP portfolio focusing on psilocybin, LSD, MDMA, and ketamine derived treatments for neuropsychiatric diseases.

Investors interested in connecting with New Wave Holdings can learn more about the company and contact the team at http://newwavecorp.com

Information relating to N2 Logics contained in this news release was provided by N2 Logics and/or its agent and has not been independently verified by the Company. The Company does not take responsibility for the accuracy of such information.

The CSE has not in any way passed on the merits of the Acquisition, and neither has approved nor disapproved the contents of this press release. Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

FORWARD-LOOKING INFORMATION DISCLAIMER

Certain statements contained in this news release may constitute forward–looking information, including but not limited to, applicable regulatory approval in connection with the Acquisition, the closing of the Acquisition, expansion of operations, size and quality of future tournaments and projections regarding attendance at future events. Forward–looking information is often, but not always, identified by the use of words such as “anticipate”, “plan”, “estimate”, “expect”, “may”, “will”, “intend”, “should”, and similar expressions. Forward–looking information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward–looking information. The Company’s actual results could differ materially from those anticipated in this forward–looking information as a result of competitive factors and competition for investment opportunities, challenges relating to operations in international markets, transaction execution risk, changes to the Company’s strategic growth plans, and other factors, many of which are beyond the control of the Company. The Company believes that the expectations reflected in the forward–looking information are reasonable based on current expectations and potential investment pipeline, but no assurance can be given that these expectations will prove to be correct and such forward–looking information should not be unduly relied upon. Any forward–looking information contained in this news release represents the Company’s expectations as of the date hereof, and is subject to change after such date. The Company disclaims any intention or obligation to update or revise any forward–looking information whether as a result of new information, future events or otherwise, except as required by applicable securities legislation.

Cision
Cision

View original content to download multimedia:http://www.prnewswire.com/news-releases/new-wave-holdings-enters-into-letter-of-intent-to-create-a-cpg-focused-digital-marketing-and-ecommerce-joint-venture-301140041.html

SOURCE New Wave Holdings Corp.

Cision
Cision

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/September2020/29/c1024.html

Posted on

NEONMIND SIGNS PSILOCYBIN SUPPLY AGREEMENT FOR CLINICAL TRIALS

Vancouver, B.C. – September 29, 2020: Better Plant Sciences Inc. (CSE: PLNT) (OTCQB: VEGGF) (FSE: YG3) (“Better Plant”) or (the “Company”) is pleased to announce that its majority owned subsidiary NeonMind Biosciences (“NeonMind”) has entered into a definitive agreement with Psygen Labs Inc. (“Psygen”) for the supply of psilocybin for NeonMind’s planned  preclinical, and clinical trials  to study the use of a drug product including Psilocybin for the treatment of food cravings and anxiety. The agreement was signed on September 28th, 2020.

Psygen is currently acting as broker between NeonMind and a licensed dealer of restricted drugs (the “Licensed Dealer“). The Licensed Dealer holds a dealer’s licence issued under Part J of the Food and Drug Regulations (a “Dealer’s Licence“). The Supply Agreement provides that Psygen will supply the psilocybin directly once Psygen holds a Dealer’s License. Psygen currently has a pending application for a Dealer’s License.

“Psilocybin is known to activate serotonin receptors,” says Dr. William Panenka, lead scientific advisor to NeonMind. “As a neurotransmitter, serotonin helps to relay messages from one area of the brain to another. Serotonin is responsible for some of the drivers which govern eating. We are very interested in furthering studies to test various dosing regimens for NeonMind to see the effects that psilocybin may have on the serotonin receptors that regulate food cravings.”

“Psygen’s mission is to fill a supply gap for restricted drug substances and restricted drug products for use in clinical trials and in pre-clinical research,” says Danny Motyka, CEO of Psygen Labs Inc. “We have brokered supply of various restricted drugs for pre-clinical studies and clinical trials through our relationship with a Licensed Dealer. Psygen is currently building out a commercial manufacturing facility designed for high-volume output of psychedelic drug substances and drug products, filling a niche in the evolving psychedelic medicine ecosystem. Today these psychedelic drug substances are classified as restricted drugs, meaning no recognized medical use in Canada, and we are playing our part in moving those substances to the controlled drugs schedule of the Food and Drug Regulations or otherwise providing compliant access to psilocybin and other psychedelics.”

In December 2019, NeonMind filed a U.S. provisional patent application in the United States for the invention relating to therapeutic administration of psilocybin to provide weight loss benefits and potential treatment or regulation of diabetes, and regulation of blood glucose, and to reduce susceptibility to cardiovascular disease, high blood pressure, diabetes mellitus, hypertension, multiple sclerosis, erectile dysfunction, urinary incontinence, chronic renal failure, sleep apnea, asthma, and certain forms of cancer.

In May 2020, NeonMind completed the design of a preclinical trial to confirm that psilocybin is an effective treatment for weight loss and food cravings (the “Trial“). In July 2020, the scientific investigator chosen to lead NeonMind’s preclinical trial submitted a Section 56 Exemption application to Health Canada for the use of psilocybin in the Trial. An exemption must be granted and a final agreement entered into with the laboratory before the Trial can begin.

According to the World Health Organization, in 2016, more than 1.9 billion adults or 39% of adults, 18 years and older, were overweight. Grandview Research projects that the global weight management market is expected to grow at a compound annual growth rate of 8.3% from 2019 to 2025 to reach USD $442.3 billion by 2025.

 

About Psygen Labs Inc.

Psygen is a privately held company based in Calgary, Alberta. Psygen specializes in synthetic manufacture of psychedelic drug substances and drug products. Psygen provides non-exclusive access to GMP compliant psychedelic drug substances and drug products for clinical trials, therapeutic applications and pre-clinical studies. Psygen has entered into a number of definitive agreements for ongoing supply of drug substances and is positioned to be a lead supplier in the emerging commercial market for psychedelic drug substances and drug products. Psygen has sponsored a Licensed Dealer who holds a license for the manufacture, sale, import, export, and analysis of LSD, psilocybin, MDMA, DMT, 2C-B, and mescaline. Chemists working with Psygen currently operate from a manufacturing laboratory at the University of Alberta. Psygen has applied to Health Canada for a Dealer’s License that will allow Psygen to manufacture, possess, sell, import, export, research, develop, and analyze psychedelic drug substances and drug products. Psygen is currently building out a 6,000 square foot lab capable of large-scale synthesis, formulation and distribution of the above and additional psychedelics to a GMP standard. Psygen intends to be the leader in psychedelic medicine supply chain solutions and is committed to supporting the renaissance in use of psychedelics for research and clinical treatment of a wide variety of mental health issues.

 

About NeonMind Biosciences Inc.

NeonMind is engaged in research and development of products that use functional and psychedelic mushrooms to optimize human health and performance. The company is launching a line of coffees infused with health optimizing functional mushrooms including reishi, cordyceps, lion’s mane and turkey tail mushrooms. NeonMind is also engaged in research into developing a psilocybin (psychedelic mushroom) based product for weight loss and has applied for a Section 56 Exemption to begin preclinical trials to study its pending psychedelic medicine patents. NeonMind owns 18% of Translational Life Sciences Inc. Better Plant Sciences owns approximately 69% of the issued and outstanding stock of NeonMind.

 

About Better Plant Sciences Inc.

Better Plant develops and acquires intellectual property and other assets related to plant-based products and therapeutics. Through its integrated business model, Better Plant develops, manufactures, markets, sells and distributes plant-based products. It has over 200 proprietary wellness formulas at various stages of commercialization, including over 20 proprietary products that are now for sale via eCommerce or brick-and-mortar retail stores. It operates websites and oversees eCommerce and Amazon sales for over 200 JUSU plant based products for body, baby and home and has announced it will acquire all JUSU Bar Inc. assets. Its majority-owned subsidiary NeonMind Biosciences Inc. is launching a line of coffees infused with health optimizing functional mushrooms including reishi, cordyceps, lion’s mane and turkey tail mushrooms. NeonMind is also engaged in research into developing a psilocybin (psychedelic mushroom) based product for weight loss and has applied for a Section 56 Exemption to begin preclinical trials to study its pending psychedelic medicine patents.

For more information about Better Plant, visit www.betterplantsciences.com or follow @betterplantsciences on Instagram.

 

Investor Relations Contact:

Penny White, President & CEO

Kevan Matheson, Investor Relations

invest@betterplantsciences.com

1-833-514-2677

The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.

 

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking information and statements (collectively, “forward looking statements”) under applicable Canadian securities legislation. Forward-looking statements are necessarily based upon a number of estimates, forecasts, beliefs and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks, uncertainties and factors include, but are not limited to: risks related to the development, testing, licensing, brand development, availability of packaging, intellectual property protection, reduced global commerce and reduced access to raw materials and other supplies due to the spread of the Coronavirus, the potential for not acquiring any rights as a result of the patent application and any products making use of the intellectual property may be ineffective or the company may be unsuccessful in commercializing them; and other approvals will be required before commercial exploitation of the intellectual property can happen. Demand for the company’s products, general business, economic, competitive, political and social uncertainties, delay or failure to receive board or regulatory approvals where applicable, and the state of the capital markets. Better cautions readers not to place undue reliance on forward-looking statements provided by Better, as such forward-looking statements are not a guarantee of future results or performance and actual results may differ materially. The forward-looking statements contained in this press release are made as of the date of this press release, and Better expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

Posted on

Revive Therapeutics Announces Update on FDA Phase 3 Clinical Trial for Bucillamine in COVID-19

TORONTO, Sept. 29, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce an update on the Company’s U.S. Food & Drug Administration (“U.S. FDA”) Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19. The Company has selected and finalized with five clinical sites in Florida, Texas and California for enrollment of patients in the Phase 3 clinical study, and is finalizing agreements with an additional ten clinical sites in these states including Arizona and Ohio where patient enrollment should start in October within these other locations.

“We have made significant progress in advancing the Phase 3 clinical trial since the FDA approval allowed us to proceed with the study, and we are expanding on and engaging with clinical sites in high prevalence COVID-19 infected states, which will enable us to meet our enrollment goals and expedite the potential FDA approval and commercialization of Bucillamine for the treatment of COVID-19,” said Michael Frank, Revive’s Chief Executive Officer.

About the Phase 3 Clinical Trial

The Phase 3 confirmatory clinical trial titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days. The primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of the first dose through Day 28 following randomization. Efficacy will be assessed by comparing clinical outcomes (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID‑19 between patients receiving standard-of-care plus Bucillamine (high dose and/or low dose) and patients receiving standard-of-care plus placebo. Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.

An interim analysis will be performed by an Independent Data and Safety Monitoring Board (“DSMB”) after 210 patients have been treated and followed up for 28 days after randomization. The better performing Bucillamine dose at the interim analysis will be selected and patients will then be randomized 2:1 to the selected Bucillamine dose or placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint. The independent DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping or changes to the conduct of the study based on the interim analysis reports.

The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.

Scientific Rationale of Bucillamine for COVID-19

Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV2 infection in the lungs and attenuate the clinical course of COVID-19.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.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” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive 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 Revive 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. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

References

1. S Ye et al, Inhibition of Reactive Oxygen Species Production Ameliorates Inflammation Induced by Influenza A Viruses via Upregulation of SOCS1 and SOCS3., American Society for Microbiology. 2015 Mar;89(5):2672-2683).

2. L. Carati et al, Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment., Eur Respir J. 1997 Jul;10(7):1535-41).

3. M Mata et al, N-acetyl-L-cysteine (NAC) inhibit mucin synthesis and pro-inflammatory mediators in alveolar type II epithelial cells infected with influenza virus A and B and with respiratory syncytial virus (RSV)., Biochem Pharmacol. 2011 Sep;82(5):548-55.

4. D Ungheri et al, Protective effect of n-acetylcysteine in a model of influenza infection in mice., Int J Immunopathol Pharmacol. 2000 Sep-Dec;13(3):123-128.

5. RH Zhang et al, N-acetyl-l-cystine (NAC) protects against H9N2 swine influenza virus-induced acute lung injury., Int Immunopharmacol. 2014 Sep;22(1):1-8).

6. LD Horwitz, Bucillamine: a potent thiol donor with multiple clinical applications, Cardiovasc Drug Rev. 2003 Summer;21(2):77-90).