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Delic Corp Announces U. S. OTCQB Listing on OTC Markets & DTC Eligibility

VANCOUVER, BC, Jan. 20, 2021 /CNW/ – Delic Holdings Corp. (“DELIC” or the “Company“) (CSE: DELC) (OTCQB: DELCF), a psychedelic wellness-focused company, is pleased to announce that its common shares are now trading on the OTCQB Venture Market under the symbol OTC: DELCF.

The OTCQB Venture Market is the premiere marketplace for early stage and developing U.S. and international companies. Participating companies must be current in their reporting and undergo an annual verification and management certification process. Investors can find real-time quote and market information at https://www.otcmarkets.com/stock/DELCF/overview. DELIC is also pleased to announce that it has received DTC eligibility by The Depository Trust Company (“DTC”) for electronic settlement and transfer of its common shares in the United States.

Matt Stang, Founder of DELIC commented “Now that DELIC is fully listed on the OTCQB, and has attained DTC eligibility for trade, we’ve made it significantly easier for US-based investors who are intrigued by the emerging psychedelic sector to buy shares in our growing company. This is an important step in our plans to tell our compelling story to a wider audience and materially grow our investor base across multiple markets.

DELIC shares will continue to trade on the Canadian Securities Exchange (CSE) under the symbol CSE:  DELC, and now adds a U.S. trading component.

About OTC Markets Group Inc.
OTC Markets Group Inc. operates the OTCQX Best Market, the OTCQB Venture Market, and the Pink Open Market for 10,000 U.S. and global securities. Through OTC Link ATS and OTC Link ECN, the OTC Markets Group connects a diverse network of broker-dealers that provide liquidity and execution services. OTC Markets Group enables investors to easily trade through the broker of their choice and empowers companies to improve the quality of information available for investors.

About The Depository Trust Company
The Depository Trust Company (“DTC”), a subsidiary of the Depository Trust & Clearing Corporation (“DTCC”) and manages the electronic clearing and settlement of publicly traded companies. Securities that are eligible to be electronically cleared and settled through the DTC are considered “DTC eligible.” This reduces costs and accelerates the settlement process for investors and brokers, allowing the stock to be traded over a much wider selection of brokerage firms by coming into compliance with their requirements.

About DELIC
DELIC Always Expanding. In All Ways.

DELIC was formed in 2019 to address the growing ‎interest in psychedelic science. DELIC was the ‎first psychedelic umbrella platform and is currently a trusted source for those interested in ‎psychedelic culture. ‎DELIC’s offerings include “The Delic”, an e-commerce lifestyle brand, ‎‎”Reality Sandwich”, a free public education platform providing psychedelic guides, news and ‎culture and “Meet Delic”, the first ever psychedelic wellness summit. ‎For more information, check out www.deliccorp.com.

The Canadian Securities Exchange ‎has neither approved nor disapproved the contents of this news release and does not accept responsibility ‎for the adequacy or accuracy of this release.‎

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities ‎in the United States. The securities have not been and will not be registered ‎under the United States ‎Securities Act of 1933, as amended (the “U.S. Securities Act“), or any state ‎securities laws and may not be offered or ‎sold within the United States unless registered under the U.S. ‎Securities Act and applicable state securities laws or an ‎exemption from such registration is available.‎

Forward-Looking Information and Statements

This press release contains certain “forward-looking information” within the meaning of applicable ‎Canadian securities ‎legislation and may also contain statements that may constitute “forward-looking ‎statements” within the meaning of ‎the safe harbor provisions of the United States Private Securities ‎Litigation Reform Act of 1995. Such forward-looking ‎information and forward-looking statements are not ‎representative of historical facts or information or current ‎condition, but instead represent only the ‎Company’s beliefs regarding future events, plans or objectives, many of ‎which, by their nature, are ‎inherently uncertain and outside of DELIC’s control. Generally, such forward-looking ‎information or ‎forward-looking statements can be identified by the use of forward-looking terminology such as ‎‎”plans”, ‎‎”expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, ‎‎‎”anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may ‎contain ‎statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be ‎taken”, “will continue”, ‎‎”will occur” or “will be achieved”. The forward-looking information and forward-‎looking statements contained herein ‎may include, but are not limited to, information concerning listing on the Canadian Securities Exchange, anticipated continued growth in the health and wellness sector (and, in particular, related to psychedelics), the continued emergence of psychedelics from stigmas, the ability of the Company to maintain sensible messaging, the ability of the Company to avoid dogmatic practices and binary rhetoric‎, the ability of DELIC to successfully achieve business ‎objectives, ‎and expectations ‎for other economic, ‎business, and/or competitive factors.‎

By identifying such information and statements in this manner, DELIC is alerting the reader that ‎such ‎information and statements are subject to known and unknown risks, uncertainties and other factors ‎that may cause ‎the actual results, level of activity, performance or achievements of DELIC to be ‎materially different from those ‎expressed or implied by such information and statements. In addition, in ‎connection with the forward-looking ‎information and forward-looking statements contained in this press ‎release, DELIC has made certain ‎assumptions.

Should one or more of these risks, uncertainties or other factors materialize, or should assumptions ‎underlying the ‎forward-looking information or statements prove incorrect, actual results may vary ‎materially from those described ‎herein as intended, planned, anticipated, believed, estimated or ‎expected.‎

Although DELIC believes that the assumptions and factors used in preparing, and the expectations ‎contained ‎in, the forward-looking information and statements are reasonable, undue reliance should not ‎be placed on such ‎information and statements, and no assurance or guarantee can be given that such ‎forward-looking information and ‎statements will prove to be accurate, as actual results and future events ‎could differ materially from those anticipated ‎in such information and statements. The forward-looking ‎information and forward-looking statements contained in this ‎press release are made as of the date of ‎this press release, and DELIC does not undertake to update any ‎forward-looking information ‎and/or forward-looking statements that are contained or referenced herein, except in ‎accordance with ‎applicable securities laws. All subsequent written and oral forward- looking information and ‎statements ‎attributable to DELIC or persons acting on its behalf is expressly qualified in its entirety by this ‎‎notice.‎

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Roadman Announces Closing of First Tranche Private Placement

Vancouver, British Columbia — January 20, 2021 — Roadman Investments Corp. (TSXV:LITT) (FWB:1QD) (OTC:RMANF) (“Roadman Investments” or the “Company”) a Canadian Venture Capital and Advisory Firm,  is very pleased to announce that it has closed its first tranche non-brokered private placement of 4,300,000 shares (“Share”) at a price of $0.03 per Share for aggregate gross proceeds of $129,000.

The Company would like to thank Shawn Moniz, a director of Roadman, for his support.  Mr. Moniz has subscribed for $30,000 of the private placement and increases his holdings from 9,551,222 shares to 10,551,222 shares.

The proceeds of the Offering will be used for general working capital and general corporate expenditure purposes.  All the securities issued will be subject to a four-month hold period.

About Roadman Investments

Roadman Investments is a Canadian Venture Capital and Advisory Firm that strives to actively drive innovation and accelerate growth within its portfolio holdings. Roadman looks for companies and investments that offer breakthrough products, devices, treatments and health supplements with a focus on health and wellness.

For further information please contact:

Luke Montaine CEO,
Director Roadman Investments Corp.
Luke@roadmancorp.com

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This press release contains “forward-looking statements” within the meaning of applicable securities laws. Forward-looking statements can be identified by any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, using words or phrases such as “expects” or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “estimates” or “intends”, or stating that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved), and variations of such words, and similar expressions are not statements of historical fact and may be forward-looking statements. Examples of forward-looking statements include, among others, statements we make about the Company, its subsidiaries or other Company’s that the Company has invested in or is otherwise affiliated with, regarding planned research and development activities, financing arrangements, investment strategies, returns on investments, contractual obligations including but not limited to obligations to purchase materials or meet sales milestones, strategy for customer retention, growth, product development, market position, financial results and reserves, other statements relating to the financial and business prospects, management’s ability it identify and evaluate investments, management’s ability to obtain the necessary funding or obtain the necessary licenses and approvals to operate, specifically, the necessary licenses and approvals to open any such facilities in California or the United States of America.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: economic and financial conditions, including volatility in interest and exchange rates, commodity and equity prices and the value of financial assets, continued volatility in the capital or credit markets the adequacy of our cash flow to fund the operations of the Company or its affiliates, strategic actions, including acquisitions and dispositions and our success in evaluating acquired businesses and our success in developing the businesses underlying these acquisitions, the occurrence of hostilities, political instability or catastrophic events, changes in customer demand, the extent to which we are successful in gaining new long-term relationships with customers or retaining existing ones and the level of service failures that could lead customers to use competitors’ services, developments and changes in laws and regulations, including increased regulation of the medical, health and wellness industries through legislative action and revised rules and standards applied by the international medical, pharmaceutical, health and wellness regulatory bodies, changes in the price of inventory and other key materials and disruptions in supply chains for these materials, closures or slowdowns and changes in contracted service provider costs and labor difficulties, including stoppages affecting either our operations or our service providers abilities to conduct research and develop and produce products, management’s ability to operate our business models, availability of financing to provide sufficient working capital maintain the business as a going concern, availability of financing to fund the Company’s or it is subsidiaries business operations, including but not limited to, meeting the Company’s obligations under the agreement with Psychedelic insights, compliance and approvals under the appropriate State and Federal laws and other factors as discussed in the Company’s filings with Canadian securities regulators, which are available at www.sedar.com. Investors are cautioned that forward-looking statements are not guarantees of future performance or events and, accordingly are cautioned not to put undue reliance on forward-looking statements due to the inherent uncertainty of such statements. The forward-looking statements included in this news release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities legislation. This news is not for dissemination in the United States of America.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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MindMed Announces the Start of the First-Ever Clinical Trial Combining MDMA and LSD

BASEL, Switzerland, Jan. 20, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company, announced today the start of the first ever clinical trial measuring and evaluating MDMA and LSD used in combination in the human body. The trial will be conducted at the University Hospital Basel Liechti Lab, in Basel, Switzerland.

If administered in combination with LSD, MDMA may increase positive subjective drug effects, including positive mood and empathy, and reduce the negative emotions and anxiety that are sometimes associated with LSD – producing an overall more positive experience.

MindMed is undertaking a Phase 1 clinical trial to evaluate if MDMA, when balanced and used in combination with LSD, can help offset some of the known potential unpleasant effects of LSD that occur in therapy or clinical settings. MindMed is interested in understanding how to balance both MDMA and LSD in a cohesive way to create better patient outcomes, and develop more advanced psychedelic assisted therapies, as MindMed expands both its R&D and commercial drug development pipeline. The study is anticipated to take around one year to complete.

President of MindMed, Dr. Miri Halperin Wernli added, “I believe that when LSD and MDMA are taken together they have exceptional potential to open a window into our mind which will awaken it to new levels of awareness by changing the fluidity of the ‌state‌ ‌of‌ ‌consciousness, amplifying‌ ‌changed‌ ‌perceptions,‌ ‌intensifying ‌emotions‌, ‌and‌ stimulating ‌novel‌ ‌thoughts. It is like a gateway to a multidimensional universe.‌”

The Phase 1 double-blind, placebo-controlled, 4-period crossover design study officially began this week and will assess subjective and autonomic effects aiming to determine the qualitative emotional differences between a combined MDMA and LSD experience, a pure LSD experience and a pure MDMA experience, versus a placebo.

LSD in other Phase 1 clinical trials has demonstrated an acute subjective effect on the serotonin 5-HT2A receptor stimulation, leading to ego dissolution and neuroplasticity. These properties of LSD are thought to have therapeutic effects on patients suffering from mental disorders. However, in some instances unpleasant effects can occur in therapy, causing distress to the subject through acute anxiety.

If MindMed finds the Phase 1 trial results promising, it will work with expert clinicians to undertake patient studies with treatments combining MDMA and LSD for various potential indications and mental disorders. With its recent capital raise resulting in a total of CAD $237.2m (USD $183.8m) raised to date and the essential addition of Robert Barrow as Chief Development Officer, MindMed is well positioned to capitalize on research advancements resulting from groundbreaking studies such as this.

More details on the clinical trial can be found here: https://clinicaltrials.gov/ct2/show/NCT04516902

About MindMed

MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company’s groundbreaking approach to developing the next-generation of psychedelic inspired medicines and therapies.

MindMed trades on the Canadian exchange NEO under the symbol MMED. MindMed is also traded in the United States under the symbol MMEDF and in Germany under the symbol MMQ. For more information: www.mindmed.co

MindMed Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and performance of Mind Medicine (MindMed) Inc. (“MindMed”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, MindMed’s and its collaborators’ ability to continue to conduct research and clinical programs, MindMed’s ability to manage its supply chain, product sales of products marketed by MindMed and/or its collaborators (collectively, “Products”), and the global economy; the nature, timing, and possible success and therapeutic applications of Products and Product candidates and research and clinical programs now underway or planned; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Product candidates and new indications for Products; unforeseen safety issues resulting from the administration of Products and Product candidates in patients, including serious complications or side effects in connection with the use of MindMed’s Products and product candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict MindMed’s ability to continue to develop or commercialize Products; ongoing regulatory obligations and oversight impacting Products, research and clinical programs, and business, including those relating to patient privacy; uncertainty of market acceptance and commercial success of Products and Product candidates and the impact of studies on the commercial success of Products and Product candidates; the availability and extent of reimbursement of Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; competing drugs and product candidates that may be superior to Products and Product candidates; the extent to which the results from the research and development programs conducted by MindMed or its collaborators may be replicated in other studies and lead to therapeutic applications; the ability of MindMed to manufacture and manage supply chains for multiple products and product candidates; the ability of MindMed’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labelling, distribution, and other steps related to MindMed’s Products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of MindMed to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, other litigation and other proceedings and government investigations relating to MindMed and its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on MindMed’s business, prospects, operating results, and financial condition. Any forward-looking statements are made based on management’s current beliefs and judgment. MindMed does not undertake any obligation to update publicly any forward-looking statement.

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Revive Therapeutics Announces $10 Million Bought Deal Offering of Units

TORONTO, Jan. 20, 2021  – 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 that is has entered into an agreement with Canaccord Genuity Corp. and Leede Jones Gable Inc. as the co-lead underwriters (collectively, the “Underwriters“), pursuant to which the Underwriters have agreed to purchase, on a bought-deal basis, 20,000,000 units (the “Equity Units“) at a price of $0.50 per Equity Unit for gross proceeds to the Company of $10,000,000 (the “Offering“).

Each Equity Unit will consist of one (1) common share of the Company (a “Common Share“) and one (1) Common Share purchase warrant (a “Warrant“).  Each Warrant will entitle the holder thereof to purchase one Common Share at an exercise price of $0.70 (the “Exercise Price“) at any time up to thirty-six (36) months following Closing (as defined below). The expiry of the Warrants may be accelerated by the Company at any time prior to the expiry date of the Warrants if the volume weighted average price of the Common Shares on the Canadian Securities Exchange (the “Exchange“) is greater than $1.10 for any ten (10) consecutive trading days, at which time the Company may, within ten (10) business days, accelerate the expiry date of the Warrants by issuing a press release announcing the reduced warrant term whereupon the Warrants will expire on the 30th calendar day after the date of such press release.

The Company has granted the Underwriters an option (the “Over-Allotment Option“), exercisable in part or in whole at the Underwriter’s sole discretion, at any time until 30 days following the Closing, to purchase up to that number of additional Equity Units, Common Shares or Warrants, or any combination thereof, as is equal to 15% of the aggregate number of Equity Units sold in the Offering to cover over-allotments, if any.

The Equity Units will be offered by way of a short form prospectus to be filed in those provinces of Canada other than Quebec as the Underwriters and the Company may designate pursuant to National Instrument 44-101 – Short Form Prospectus Distributions.

The net proceeds of the Offering will be used by the Company for Phase 3 ‎clinical costs for Bucillamine for COVID-19, Phase 1 clinical ‎costs for Psilocybin for methamphetamine use disorder ‎study, and other Psychedelic formulation development work as well as working capital and general corporate purposes. ‎

The Underwriters shall be paid a cash commission equal to 7.0% of the aggregate gross proceeds of the Offering payable in cash or Equity Units, or any combination thereof, at the option of the ‎Underwriters, and warrants exercisable at any time up to thirty-six (36) months following Closing to acquire that number of Equity Units which is equal to 7.0% of the aggregate number of Equity Units issued pursuant to the Offering, at an exercise price of $0.50. Additionally, the Company shall pay the Underwriter’s a corporate finance fee payable in Units equal to 2.0% of the aggregate number of Units issued pursuant to the Offering.

Additionally, the Company intends to pay Hampton ‎Securities Limited a cash fee equal to 1.0% of the aggregate gross proceeds of the Offering and warrants exercisable at any time up to thirty-six (36) months following Closing to acquire that number of Equity Units which is equal to 1.0% of the aggregate number of Equity Units issued pursuant to the Offering, in consideration of a waiver of their right of first refusal.

The closing of the Offering is expected to occur on or about the week of February 8, 2021 (the “Closing“) and is subject to the Company receiving all necessary regulatory approvals, including the approval of the Exchange.

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements.

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 Food and Drug Administration in the United States 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

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 timing and ability of the Company to close the Offering, receipt of all regulatory and stock exchange approvals and 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. Examples of such risk factors include, without limitation: the inability of the Company to close the Offering or to obtain all necessary approvals; credit; market (including equity, foreign exchange and interest rate); liquidity; operational (including technology and infrastructure); reputational; insurance; strategic; regulatory; legal; environmental; capital adequacy; the general business and economic conditions in the regions in which the Company operates; the ability of the Company to execute on key priorities, including the successful development of its product candidates, and strategic plans and to attract, develop and retain key executives; the ability to implement business strategies and pursue business opportunities; disruptions in or attacks (including cyber-attacks) on the Company’s information technology; the failure of third parties to comply with their obligations to the Company or its affiliates; the impact of new and changes to, or application of, current laws and regulations; possible new drug discoveries; dependence on key suppliers; granting of permits and licenses in a highly regulated business; increased competition; changes in foreign currency rates; increased funding costs and market volatility due to market illiquidity and competition for funding; the availability of funds and resources to pursue operations; critical accounting estimates and changes to accounting standards, policies, and methods used by the Company; the occurrence of natural and unnatural catastrophic events and claims resulting from such events; risks related to COVID-19 including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, nonessential business closures, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions including a possible national or global recession; as well as those risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com. 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.

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BETTER PLANT AFFILIATE NEONMIND LISTS ON THE FRANKFURT STOCK EXCHANGE (FSE: 6UF)

Vancouver, B.C. – January 19, 2021: Better Plant Sciences Inc. (CSE: PLNT) (OTCQB: VEGGF) (FSE: YG3) (“Better Plant”) or (the “Company”) is pleased to announce its partially owned subsidiary NeonMind (CSE: NEON) (“NeonMind”) has common shares now trading on the Frankfurt Stock Exchange (the “FSE”) under the symbol “6UF“. As a result, NeonMind’s common shares are now cross-listed on the Canadian Securities Exchange and the FSE.  Shares of Better Plant are available on the FSE under the symbol “YG3”.

The Frankfurt Stock Exchange is one of the world’s largest trading centres for securities. With a share in turnover of around 90 per cent, it is the largest of Germany’s seven stock exchanges and it is an international trading centre, which is reflected in the structure of its participants. Of the approximately 200 market participants, roughly 50% are from countries other than Germany.

The FSE facilitates advanced electronic trading, settlement and information systems, allowing it to meet the growing requirements of cross-border trading.

 

About NeonMind Biosciences Inc.

NeonMind is a preclinical psychedelic drug development company. Its first proposed drug candidate involves the administration of psilocybin (a complex organic compound found in psychedelic mushrooms) as a treatment for obesity and related illnesses for which NeonMind is conducting a preclinical trial at the University of British Columbia. NeonMind has filed five U.S. provisional patent applications claiming methods of aiding in weight loss, treating compulsive eating disorder, treating obesity or a complication of obesity, and/or altering the diet of an individual by administering psilocybin and/or other psychedelic compounds or their analogues or by administering psilocybin or its analogue in conjunction with therapy or other treatments.  NeonMind is also pursuing commercialization of its catalogue of proprietary medicinal mushroom product formulas. It recently launched a collection of four mushroom-infused coffees containing medicinal mushrooms Lion’s Mane, Turkey Tail, Reishi and Cordyceps which are available for purchase online in Canada at www.neonmind.com.

For more information on NeonMind, go to www.NeonMindbiosciences.com or buy NeonMind mushroom infused coffee at www.NeonMind.com.

 

 

About Better Plant Sciences Inc.

Better Plant offers plant-based products for optimum health and wellness. It is a vertically integrated company with a team whose complementary experience enables acquisition, development, manufacturing, and direct-to-consumer distribution of its products. Its all-natural products vary in use from pain treatment to disease prevention to skin care, all without chemicals or harmful ingredients. It has an extensive catalogue of over 400 proprietary product formulas. Better Plant currently has over 70 plant-based products for sale through eCommerce and/or in retail stores under the brands Jusu, Urban Juve, and Wright & Well. Better Plant also owns approximately 29.2% of NeonMind.

 

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

 

Penny White, President & CEO

penny@betterplantsciences.com

1-833-515-2677

 

Investor Relations:

Alexandra Dumanski

invest@betterplantsciences.com

1-833-515-2677

 

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 COVID-19, 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.

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Awakn Strengthens Scientific and Medical Leadership Team

Awakn announces today the appointment of Dr. Shaun McNulty, formerly at GlaxoSmithKline (GSK), as Chief Science Officer and Prof. Celia Morgan, from Exeter University, as Head of Ketamine-Assisted Psychotherapy for the company’s Alcohol Use Disorder (AUD) Practice; both effective January 2021.

Dr. McNulty joins as an experienced biotechnology executive with over 20 years’ experience in drug development having previously held positions at Pfizer, GSK, Syntaxin, ImmBio, Biosceptre and Inflection Biosciences. He will be responsible at leadership level for executing Awakn’s research programmes and clinical trials.

“I am delighted to join Awakn at this exciting time in its expansion. The company has established a world class team to develop psychedelics for the treatment of patients. This highly innovative proven approach has the potential to address poorly met medical needs to improve the lives of millions of patients and their families,” said Dr. McNulty.

Prof. Morgan will be responsible for leading Awakn’s newly established Ketamine-Assisted Psychotherapy for AUD Practice. Prof. Morgan is a Professor of Psychopharmacology at the University of Exeter in the United Kingdom, where she led the Ketamine for Reduction of Alcoholic Relapse (KARE) clinical trial, one of the world’s leading trials assessing Ketamine as a pharmacological treatment for Alcohol Use Disorder.

“I’m extremely excited to work with Awakn to take our Ketamine-Assisted therapy forward. We have shown potential to help the huge numbers of people struggling with alcohol problems in our first Medical Research Council funded phase II trial and now it is time to take it forward to the next stage,” said Prof. Morgan.

Anthony Tennyson, Awakn CEO, said, “We are delighted to welcome professionals of the calibre of Shaun and Celia to Awakn. Their experience and expertise will help us accelerate as we build and scale our business across our three divisions of Research, Clinics, and Platforms”.

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PharmaTher Signs Exclusive Worldwide License Agreement for Patented Ketamine Formulation Targeting Mental Health, Neurological and Pain Disorders

TORONTO, Jan. 19, 2021 (GLOBE NEWSWIRE) — Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), who through its wholly-owned subsidiary, PharmaTher Inc. (“PharmaTher”), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce that PharmaTher has entered into an Exclusive Worldwide License Agreement (the “Agreement”) with the National Health Research Institutes (“NHRI”) for the development and commercialization of a patented combination formulation of FDA-approved ketamine and betaine (“KETABET™”) as a potential next-generation ketamine treatment for mental health, neurological and pain disorders.

KETABET™ has shown in clinical research to enhance the antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine.1 Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.

Through a proprietary microneedle (“MN”) patch, KETABET™ aims to empower patients to dose their medication remotely, safely and conveniently rather than being under supervision by a healthcare provider at a certified medical office.   KETABET™ MN patch has the potential to incorporate anti-tampering and anti-abuse features because of the combined presence of ketamine and betaine and the delivery format of the product that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

PharmaTher will seek FDA approval to conduct a Phase II clinical study for KETABET™ targeting the more than 300 million people who suffer from major depressive disorder and 100 million people who are resistant to available treatments worldwide.

“We believe KETABET™ has the potential to change the way mental health, neurological and pain disorders will be treated for the hundreds of millions of people globally who are suffering from these debilitating conditions,” said Fabio Chianelli, CEO of PharmaTher. “We are pursuing the clinical development of KETABET™ to overcome the current limitations of ketamine and to unlock the known potential therapeutic value of ketamine for FDA approval.”

Currently, pharmaceutical companies are developing new types of antidepressants. Approved antidepressants have significant limitations, including delayed response rates and unwanted side effects causing poor patient compliance and low remission rates.

Ketamine was approved by the FDA in 1970 and is clinically used for analgesia, sedation, and anesthetic induction.

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 disorder2, bipolar depression3, depression with suicidal ideation4 and post-traumatic stress disorder5. Despite this, the potential for abuse and misuse of ketamine and the adverse mental effects of ketamine use such as dissociative, hallucinogenic, and amnesic effects6 leads to its limited clinical use and discontinuation.

The FDA granted Fast Track and Breakthrough Therapy designations for SPRAVATO® (esketamine) nasal spray. In March 2019, the FDA approved SPRAVATO®, in conjunction with an oral antidepressant, for treatment-resistant depression to Janssen Pharmaceuticals, Inc. According to the FDA, “because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy.”7 The estimated annual cost per patient for SPRAVATO® could cost up to $49 thousand with limited reimbursement, whereas intravenous ketamine could cost up to $5,000 per patient annually without any reimbursement. Both require numerous administration sessions in a certified medical office under medical supervision by a health care provider.

COMPASS Pathways plc is developing COMP360 psilocybin therapy to be administered in conjunction with psychological support for treatment-resistant depression. In 2019, Compass Pathways plc completed a Phase I clinical trial and is currently evaluating COMP360 in a Phase IIb trial. The therapy protocol for COMP360, which would last approximately six to eight hours, includes the presence of a therapist and assisting therapist throughout the treatment session.8

PharmaTher aims to develop KETABET™ in a proprietary microneedle patch for FDA approval in certain mental health, neurological and pain disorders and provide the patient with a potentially convenient, safe and effective ketamine treatment through the combination of two FDA-approved drugs, ketamine and betaine.

Betaine anhydrous (CYSTADANE®) was approved by the FDA in 1996 for the treatment of 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.9   Betaine has been reported to prevent seizures in rodents10, to improve symptoms of Rett syndrome11, and to delay the onset of neurologic impairment due to vitamin B12 deficiency12 clinically. Furthermore, betaine attenuates memory deficits induced by homocysteine.13

Based on preclinical studies that supported the granted patent and patent applications of KETABET™, the combination of ketamine and betaine 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 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.

Under the terms of the Agreement, PharmaTher gained exclusive worldwide development and commercial rights to an intellectual property portfolio consisting of a granted patent (Taiwan patent: I648049) and patent applications (International Publication Number: WO2017205666A1) titled, “Method and composition for decreasing the psychotomimetic side effect and addictive disorder of ketamine” in the U.S., Europe, Japan, Canada, Israel and China.

Consistent with industry standards, PharmaTher paid a one-time fee for entering into the Agreement, and all other future payments will be based on clinical trial and revenue milestones reached by PharmaTher.
​

About The National Health Research Institutes
The National Health Research Institutes (NHRI) is a non-profit foundation established in 1995 by the government of Taiwan. Being an autonomous research organization under the supervision of the Department of Health, the NHRI is dedicated to the enhancement of medical research and the improvement of health care in this country. Scientists at the NHRI conduct mission-oriented medical research and investigate many aspects of the basic biomedical sciences, as well as specific diseases. These range from the common problems such as aging, cancer, infectious diseases, mental disorders, occupational diseases, to health policy. For more information about the NHRI visit www.nhri.edu.tw.

About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, such as ketamine and psilocybin, for FDA approval to treat mental health, neurological and pain disorders.

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

​For more information, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Inc.
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” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Newscope Capital Corporation’s (the “Company) 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 development and commercialization of a patented combination formulation of FDA-approved ketamine and betaine (“KETABET™”) as a potential next-generation ketamine treatment for mental health, neurological and pain disorders, KETABET™ aims to empower patients to dose their medication remotely, safely and conveniently rather than being under supervision by a healthcare provider at a certified medical office, KETABET™ MN patch has the potential to incorporate anti-tampering and anti-abuse features, seek FDA approval to conduct a Phase II clinical study, intellectual property portfolio, psychedelic pharmaceuticals, psilocybin and ketamine programs and product developments. 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 August 30, 2020 (“MD&A”), dated October 1, 2020, 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.

​References:

  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. Murrough et al. 2013; Wan et al. 2014
  3. Ionescu et al. 2015; Nugent et al. 2014; Rybakowski et al. 2013
  4. Aligeti et al. 2014; Thakurta et al. 2012; Zigman and Blier 2013
  5. Feder et al. 2020
  6. Krystal et al. 1994; Perry et al. 2007
  7. https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified
  8. Compass Pathways pls F-1 Filing dated 2020-08-28
  9. Freed 1984; 1985
  10. Kim et al. 2013; Di Pierro et al. 2015
  11. Percy and Lane 2005
  12. van der Westhuyzen and Metz 1984
  13. Chai et al. 2013
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Former LifeLabs COO Joins Novamind Leadership Team

Pierre Bou-Mansour is former COO of LifeLabs, one of Canada’s largest medical service companies

TORONTO, ON / ACCESSWIRE / January 19, 2021 / Novamind Inc., (CSE: NM) (“Novamind” or the “Company”) a mental health company specialized in psychedelic medicine, announces the expansion of its leadership team with the appointment of Pierre Bou-Mansour, P.Eng., to the role of Chief Operating Officer. Effective immediately, Mr. Bou-Mansour will assume responsibility for ensuring operational excellence as Novamind develops its network of clinics, retreats, and research sites in 2021 and beyond.

An accomplished senior executive and leader, Pierre brings a wealth of experience managing large and complex healthcare organizations. Most recently, he served as the Chief Laboratory Operations Officer of Public Health Ontario, serving Canada’s largest province with over 14 million residents. In this role, Bou-Mansour successfully led the expansion of Public Health Ontario’s testing capacity for the COVID-19 response.

Pierre Bou-Mansour said, “Novamind’s Cedar Psychiatry clinics and Cedar Clinical Research sites are both well-positioned to scale as regulated access to psychedelic medicine continues to expand rapidly in jurisdictions around the world. I look forward to working with the leadership team to ensure strategic expansion of our operating model for clinical care and clinical research in psychedelic medicine.”

Pierre has a proven track record for growing and transforming healthcare companies. He spent eight years at LifeLabs, serving as the COO from 2017 to 2019, and successfully led the integration of two acquired competitors. During this period, LifeLabs grew into one of the largest medical service companies in Canada, with over 5,700 employees, 370 patient access sites, and over US $977 million in annualized revenue (dnb.com).

Yaron Conforti, Chief Executive Officer and Director of Novamind, added, “Pierre brings a distinguished operational track record in healthcare to drive the expansion of Novamind’s network of mental health clinics and clinical research sites. His role is critical as we execute against our pipeline of growth opportunities.”

Pierre joins Novamind amid several milestones. The Company commenced trading on the Canadian Securities Exchange on January 5th, and on January 13th, Novamind announced that its Cedar Psychiatry network of clinics saw a record 20,000 client visits during 2020, twice the number in 2019.

Novamind also announces that it has granted incentive stock options to certain employees of the Company to purchase up to 400,000 common shares in the capital of the Company pursuant to the share option plan of the Company. The options are exercisable on or before January 19, 2026 at an exercise price of $1.40 per share.

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

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

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

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

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HAVN LIFE TO SUPPORT CANADIAN COUNTERPART OF VETERANS’ ORGANIZATION HEROIC HEARTS

Havn Life to grow its partnership with the US-based veterans’ organization by funding and supporting the launch of its Canadian counterpart.

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 healthcare products, is pleased to announce that it is supporting the founding of a Canadian counterpart to Heroic Hearts (“Heroic Hearts Canada”). The Company will provide support and funding to help Heroic Hearts Canada promote education and research to support Canadian veterans.

Heroic Hearts is a registered 501(c)(3) non-profit organization operating in the United States that connects military veterans who are struggling with mental health issues resulting from trauma to therapy options such as psychotherapy supported by ayahuasca, psilocybin and ketamine.

Heroic Hearts also provides professional counseling and support to veterans and is working to advance scientific research on the benefits of psychedelics through studies with the University of Georgia and the University of Colorado, Boulder.

With support and funding from Havn Life, Heroic Hearts will set up its Canadian counterpart in 2021, with the goal of obtaining charitable status in Canada. Heroic Hearts Canada will serve Canadian veterans through education and advocacy for increased access to psychedelic treatment options. Heroic Hearts Canada will also develop an observational study to explore the effects of psilocybin mushrooms on post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI). The observational study is planned to begin in the summer of 2021 and will take place in a jurisdiction where psilocybin is not a controlled substance.

In December of 2020, Havn Life announced it would supply psychedelic compounds for an observational study run by Heroic Hearts in a jurisdiction where psilocybin is not a controlled substance. The observational study will investigate effects of psilocybin mushrooms on veterans suffering from PTSD, TBI and other mental health issues that are common among veterans. This research may help develop formulations that will be used in clinical trials to assess use of these compounds in recovery from PTSD, TBI and other trauma-related mental health conditions.

Two-thirds of Canadian military personnel with PTSD do not respond completely to the best available evidence-based therapies, according to a 2018 study that examined recovery, rehabilitation and reintegration of injured service members and veterans. Further, suicide risk is higher in Canadian Armed Forces (CAF) veterans than the Canadian general population, found a “Life After Service” study published in 2016.

“Our continued collaboration with Heroic Hearts has the potential to make an extraordinary impact on the mental health and overall wellbeing of military veterans,” said Tim Laidler, Havn Life Director.

“As a veteran working in the mental health field, I understand the challenge of managing day-to-day activities and mental health when returning to civilian life. I am hopeful for better outcomes for veterans managing PTSD and Havn Life is looking forward to working closely with veterans and others with military backgrounds.”

“I am excited to live in a time where effective mental health options are finally on the horizon for the veteran community. Heroic Hearts Project is confident that psychedelics will lead this next revolution of care. We are happy to be working with great organizations like Havn Life to make this a reality. ” said Jesse Gould, CEO of Heroic Hearts Project.

Havn Life encourages other organizations to support Heroic Hearts and Heroic Hearts Canada. Future donations going to Heroic Hearts Canada will directly fund education and research to support Canadian veterans.

Visit Heroic Hearts Project for more information and to donate to Heroic Hearts.

Futhermore, Havn Life announces the departure of Executive Vice President of Research & Development, Susan Chapelle. The Company thanks Miss. Chapelle for her service and wishes her luck in future endeavors.

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 healthcare 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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Awakn Life Sciences Appoints CRO to Conduct Phase II Study of MDMA as a Treatment for Alcohol Use Disorder

PRA Health Sciences selected for the study which will position Awakn at the Forefront of Psychedelic Research for Addiction Treatment

Awakn announces today the selection of contract research organization (‘CRO’), PRA Health Sciences (NASDAQ: PRAH), to conduct a Phase IIb trial studying the effectiveness of MDMA-Assisted Psychotherapy as a treatment for patients with Non-Physically Dependent (‘Harmful Use’) Alcohol Use Disorder (“AUD”).

Awakn’s Phase IIb study will take place in the United Kingdom and will be a double-blind, placebo-controlled clinical trial designed to investigate the safety and efficacy of MDMA as a pharmacological treatment for Alcohol Use Disorder.

Alcohol use disorder is the most prevalent substance use disorder, with alcohol use as one of the top five causes of disease and disability in almost all countries throughout Europe. In the UK, alcohol and related diseases are the leading cause of death in men aged between 16 and 54 years, accounting for over 20% of the total UK adult population.

While there are current treatment methods available, which are effective for some segments of the population, relapse rates are high.

Principal investigator for the Phase II trial will be Dr. Ben Sessa, Chief Medical Officer of Awakn, who previously led the world’s only MDMA and AUD study. Dr. Sessa commented, “The prevalence of AUD, and the poor outcomes from contemporary psychiatry at treating this significant public health problem, have always been worrying. This situation has significantly worsened during Covid. With drinking habits increasing during lock-down, we are now facing a significant increase in mental disorders and addictions to all substances, of which AUD is by far the most concerning. Now is the time for innovative, safe, and effective approaches to tackle AUD. MDMA-Assisted Psychotherapy, as evidenced from our world’s-first pilot study on the subject, is well-placed to help patients with AUD tackle rigidly held narratives surrounding their history of trauma that maintains their harmful drinking. I am pleased that we at Awakn are spear-heading the global initiative to develop new efficacious strategies for tackling this condition. Our patients deserve the best that cutting-edge psychopharmacology research can offer.”

The study team is chaired by Prof. David Nutt, Edmund J. Safra Professor of Neuropsychopharmacology in the Division of Brain Science, Dept of Medicine, Imperial College London and Chair of Awakn’s Scientific Advisory Board.

Prof. Nutt stated, “I am pleased with what is an exciting opportunity to conduct regulatory-level trials that I hope will turn our discovery of MDMA as a treatment for alcoholism into a clinical therapy.”

Anthony Tennyson, CEO of Awakn also stated, “We are incredibly pleased with our rapid progress to date. Partnering with a CRO is a key step on our journey to be the leader in using psychedelic medicines to treat addiction and other mental health disorder indications. The data from this trial will be used to progress into our phase III study.”