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Option for Treatment for Coronavirus Extended

AIkido Extends Option to License Patented Treatment for Coronavirus

NEW YORK, Aug. 11, 2020 /PRNewswire/ — AIkido Pharma Inc. (Nasdaq: AIKI) today announced it has extended its previously disclosed exclusive option agreement (“Option”) with the University of Maryland, Baltimore (UMB) for the technology set forth in Patent number 10,434,116 “Methods of Treating Coronavirus Infection.” The present invention provides methods for treating a coronavirus infection.  The initial Option for Treatment of Coronavirus was previously disclosed on March 6, 2020.  The Option has been extended until December 2, 2020.  All other terms and conditions of the original Option agreement remain in full force and effect.

(PRNewsfoto/AIkido Pharma Incorporated)

This invention was made with government support under Grant Number AI095569 awarded by the National Institutes of Health. As result, the NIH has certain rights in the invention.

About AIkido

AIkido was initially formed in 1967 and is a biotechnology company with a diverse portfolio of small-molecule anti-cancer therapeutics.  The Company’s platform consists of patented technology from leading universities and researchers and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and Wake Forest University. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). In addition, we are constantly seeking to grow our pipeline to treat unmet medical needs in oncology

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the SEC, not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact:

Investor Relations:
Hayden IR
Brett Maas, Managing Partner
Phone: (646) 536-7331
Email: brett@haydenir.com
www.haydenir.com

AIkido:
Phone: 212-745-1373
Email: investorrelations@AIkido.com
www.AIkido.com

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SOURCE AIkido Pharma Inc.

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NEONMIND SUBMITS APPLICATION FOR PSILOCYBIN RESEARCH TO HEALTH CANADA

August 6, 2020 – Vancouver, BC: The Yield Growth Corp. (CSE:BOSS) (OTCQB:BOSQF) (FE:YG3) majority owned subsidiary NeonMind Biosciences Inc. (“NeonMind”) announces submission of an application to Health Canada for an exemption to use a controlled substance for scientific purposes, pursuant to Section 56(1) of the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (a “Section 56 Exemption”) for NeonMind’s planned preclinical trial using psilocybin.

In May 2020, NeonMind completed the design of its preclinical study focused on using psilocybin as a treatment for weight loss and food cravings (the “Study”). NeonMind has identified a laboratory (the “Lab”) at a Canadian university in which to conduct the Study and the Section 56 Exemption application was submitted on July 27, 2020  by the person at the Lab who is expected to be the lead investigator in the Study.

Obesity has been formally recognized by the World Health Organization (WHO) as a global epidemic, with at least 2.8 million people dying each year as a result of being overweight or obese. The WHO reported that in 2016, more than 1.9 billion adults, 18 years and older, were overweight.

“We expect to receive the exemption within several months. Researchers at the Lab have previously successfully obtained Section 56 Exemptions for research involving controlled substances,” said Penny White, CEO of NeonMind. “Obesity is an enormous problem in modern society, increasing incidence of disease and putting a significant strain on our healthcare systems. The treatment of obesity is shifting focus towards root causes of the problem. We are looking at the problem from a more holistic standpoint, and believe that psychedelics may have great potential to make a positive impact in this area.”

The Lab must first obtain a Section 56 Exemption before it can use psilocybin, a controlled substance, in the Study.

“I believe that we are reaching a tipping point when it comes to awareness about what psychedelics can offer. Therapsil has just announced that four terminal cancer patients have been approved by Health Canada to use psilocybin therapy in the treatment of their end-of-life distress,” added White. “These are the first known patients to be able to legally use psilocybin since the compound became illegal in Canada in 1974.”

Theraspil is a non-profit coalition that advocates for legal, compassionate access to psilocybin therapy for palliative Canadians. The Minister of Health, Patty Hajdu, granted the approval for 4 patients to use psilocybin therapy, marking the first publicly-known individuals to receive a legal exemption from the Canadian Drugs and Substances Act.

The goal of NeonMind’s Study is to use preclinical models to generate data to demonstrate that psilocybin can be used as an effective treatment for weight loss. NeonMind plans to use data from the Study to inform dosing strategies in a Phase 2 human clinical trial to demonstrate potential efficacy of psilocybin as a weight loss treatment.

The global projected market for weight loss and weight management according to marketsandmarkets is estimated at US$245 billion.

Section 56 grants the Minister of Health the discretionary power to provide an individual with an exemption to possess a specified quantity of the controlled substance and to administer the controlled substance to human subjects or animals for the purpose of research. Section 56 states:

“The Minister may, on any terms and conditions that the Minister considers necessary, exempt from the application of all or any of the provisions of this Act or the regulations any person or class of persons or any controlled substance or precursor or any class of either of them if, in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest.”

The details of the Section 56 Exemption process are as follows:

An application form for a Section 56 Exemption to use a controlled substance for scientific purposes must be completed, which includes a declaration signed and dated by the person who will be the principal investigator, and sent to the Office of Controlled Substances. According to Health Canada guidelines, exemptions are protocol, principal investigator, site and substance specific. Sufficient information must be supplied to Health Canada to support the use of a controlled substance in the project or protocol and to provide confirmation that the controlled substance will be stored in a secure manner. According to the Government of Canada website, the average processing time for a Section 56 Exemption (once all information required is provided) is 42 working days.  An applicant may be contacted for clarification of information submitted or if the application is incomplete. Exemptions are valid for one year from the issuance date, and applications for extensions may be made if required.

 

About NeonMind Biosciences Inc.

NeonMind aims to be a leader in the fast-growing functional and adaptogenic foods market, and is engaged in research and the development of therapeutic products and services using medicinal and psychedelic mushrooms.  NeonMind has filed U.S. provisional patent applications to protect treatments using psilocin and/or psilocybin and certain other psychedelic substances for weight loss in individuals by reducing food cravings, counteracting compulsive overeating, improving quality of diet, increasing metabolism, treating diabetes, regulating blood glucose and reducing susceptibility to cardiovascular disease, high blood pressure, diabetes mellitus and other illnesses associated with obesity.  Yield Growth owns approximately 68% of the issued and outstanding stock of NeonMind.

 

About The Yield Growth Corp.

The Yield Growth Corp. is a phytoceutical and consumer packaged goods company that develops and acquires intellectual property and other assets related to plant-based products and therapeutics, and develops, manufactures, markets, sells and distributes plant-based products that improve lives. It has over 200 proprietary wellness formulas at various stages of commercialization including over 20 products that are now for sale through  e-commerce or brick and mortar retail stores.  It has 14 patent applications filed in what the Global Wellness Institute reports is a $4.2 trillion-dollar global wellness market.  Its majority owned subsidiary NeonMind Biosciences Inc. is launching a line of medicinal mushroom products and is developing intellectual property in the emerging area of psychedelic medicine.  The Yield Growth management team has deep experience with global brands including Johnson & Johnson, Procter & Gamble, Skechers and Aritzia.

For more information about Yield Growth, visit www.yieldgrowth.com or follow @yieldgrowth on Instagram.

 

Investor Relations Contacts:

Penny White, President & CEO

Kevan Matheson, Investor Relations

invest@yieldgrowth.com

1-833-514-BOSS   1-833-514-2677

1-833-515-BOSS   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 do 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.  Yield Growth cautions readers not to place undue reliance on forward-looking statements provided by Yield Growth, 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 Yield Growth 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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MindMed Adds Psychedelic Assisted Therapy Expert Dr. Peter Gasser As Clinical Advisor For Project Lucy

Applauds Health Canada’s Approval Of Psilocybin Compassionate Access For Patients

New York, NY, August 6, 2020 /PRNewswire/ — Mind Medicine (MindMed) Inc. (NEO: MMED OTCQB: MMEDF), the leading psychedelic pharmaceutical company, has engaged renowned psychedelic assisted therapy expert Dr. Peter Gasser as an advisor to its LSD experiential therapy program Project Lucy.

Dr. Gasser has pioneered the legal, medical use of psychedelics through clinical research and compassionate access in Switzerland. Dr Gasser has served as the President of the Swiss Medical Society for Psycholytic Therapy since 1997. Through compassionate access in Switzerland, Dr Gasser holds several individual treatment permissions to treat patients with MDMA and LSD.

Dr. Gasser and University Hospital Basel’s Dr Matthias Liechti are conducting a Phase 2 trial of LSD assisted therapy for anxiety disorders. MindMed previously acquired the exclusive license to this ongoing Phase 2 trial through its collaboration agreement with the University Hospital Basel.

MindMed’s Project Lucy intends to start a Phase 2b human efficacy trial that will focus on experiential doses of LSD to treat anxiety disorders administered by a therapist.

“Dr. Gasser is one of the leading global experts on psychedelic assisted therapy and it’s an honor for us to work together as we build Project Lucy into a world class commercial drug development program,” said MindMed Co-Founder and Co-CEO JR Rahn. “Dr Gasser’s vast experience and history treating patients as a therapist through compassionate access in Switzerland also interests the company and will have tremendous benefits to our patients.”

Dr. Gasser helped pioneer compassionate access for end of life psychedelic assisted therapy in Switzerland. This week, the Canadian health minister approved compassionate access of psilocybin assisted therapy for terminally ill patients.

Rahn added: “Health Canada’s recognition that psychedelic substances have medicinal value and potential benefit for patients is extremely encouraging for all of us in the psychedelic inspired medical space. It takes a village of dedicated government officials, scientists, therapists and entrepreneurs to make impactful change for patients, and we hope additional clinical trials will compel regulators to further allow psychedelic inspired medicines to help the millions of patients suffering from mental health and addiction.”

‍

About MindMed

Mind Medicine (MindMed) Inc. is a neuro-pharmaceutical company that discovers, develops and deploys psychedelic-inspired medicines to improve health, promote wellness and alleviate suffering. The company has initiated or is initiating studies to evaluate potential treatments to help patients with ADHD, anxiety, cluster headaches and substance abuse. The MindMed executive team brings extensive biopharmaceutical industry experience to this groundbreaking approach to the development of next-generation psychedelic medicines. MindMed trades on the NEO Exchange under the symbol MMED. MindMed can also be traded in the US under the symbol OTC: MMEDF and in Germany under the symbol DE: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 Update Following U.S. FDA Approval of Phase 3 Clinical Trial for Bucillamine in COVID-19

TORONTO, Aug. 05, 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 that following the U.S. Food & Drug Administration (“U.S. FDA”) approval to proceed with the Company’s Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19, the Company is finalizing agreements and aligning resources to initiate the Phase 3 clinical trial in September.

“With the FDA approval of the Phase 3 clinical study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19, our team and partners are working diligently to align our resources and expertise that will fast-track the Phase 3 study,” said Michael Frank, Revive’s Chief Executive Officer.

Revive expects to engage up to 10 clinical trial sites in the U.S. and open the Phase 3 clinical trial for patient screening in Q3-2020.  The Company is finalizing vendor agreements in the project management, medical monitoring, data management and clinical packaging for the  trials.  In addition, Revive and its clinical trial partners will be evaluating potential U.S. clinical sites and clinical  investigators in major COVID-19 affected U.S. states, such as Florida, California, Arizona and Texas.

About the Phase 3 Confirmatory Clinical Study

The Phase 3 confirmatory clinical study 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 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 first dose through Day 28 following randomization.  Efficacy will be assessed by comparison of clinical outcome (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 a total of 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@fbn.436.myftpupload.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).

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AIkido Pharma Inc. Regains Compliance with NASDAQ Listing Requirements

NEW YORK, Aug. 3, 2020 /PRNewswire/ — AIkido Pharma Inc. (Nasdaq: AIKI) (“AIkido” or the “Company”) today announced that on July 31, 2020, the Company received a letter from the Listing Qualifications Department of The NASDAQ Stock Market indicating that it has regained compliance with the $1.00 minimum bid price requirement for continued listing on The NASDAQ Capital Market under Listing Rule 5550(a)(2). The Company regained compliance with the NASDAQ’s requirements when the closing bid price for the Company’s common stock was at or above $1.00 for ten consecutive business days.

(PRNewsfoto/AIkido Pharma Incorporated)

About AIkido

AIkido was initially formed in 1967 and is a biotechnology company with a diverse portfolio of small-molecule anti-cancer therapeutics. The Company’s platform consists of patented technology from leading universities and researchers and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and Wake Forest University. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). In addition, we are constantly seeking to grow our pipeline to treat unmet medical needs in oncology.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the SEC, not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact:

Investor Relations:    

Hayden IR

Brett Maas, Managing Partner

Phone: (646) 536-7331

Email: brett@haydenir.com

www.haydenir.com

AIkido:                    

Phone: 212-745-1373

Email: investorrelations@AIkido.com

www.AIkido.com

 

CisionView original content to download multimedia:http://www.prnewswire.com/news-releases/aikido-pharma-inc-regains-compliance-with-nasdaq-listing-requirements-301104540.html

SOURCE AIkido Pharma Inc.

News Provided by PR Newswire via QuoteMedia

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Revive Therapeutics Announces U.S. FDA Approval of Confirmatory Phase 3 Clinical Trial for Bucillamine in COVID-19

TORONTO, July 31, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV) (OTCQB: 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 the U.S. Food & Drug Administration (“U.S. FDA”) has approved the Company to proceed with a randomized, double-blind, placebo-controlled confirmatory Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19.

“The FDA approval of the Phase 3 study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19 is a tremendous milestone for Revive and I am very proud of the dedication of our team and partners to bring forward a potential new treatment option for patients with a confirmed diagnosis of COVID-19 globally,” said Michael Frank, Revive’s Chief Executive Officer. “We thank the FDA for recognizing the importance of this Phase 3 study and we are now focused on executing on our plans for initiating the clinical trial in an expeditious manner.”

About the Phase 3 Confirmatory Clinical Study

The Phase 3 confirmatory clinical study 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 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 first dose through Day 28 following randomization. Efficacy will be assessed by comparison of clinical outcome (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 a total of 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.

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.

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.

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@fbn.436.myftpupload.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).

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Novamind Sponsors TheraPsil, an Advocate for the Compassionate Use of Psilocybin in Canada

Not for distribution to U.S. Newswire Services or for dissemination in the United States. Any failure to comply with this restriction may constitute a violation of U.S. Securities laws.

TORONTO, ON / ACCESSWIRE / July 31, 2020 / Novamind Ventures Inc. (”Novamind”) a mental health and wellness company specialized in psychedelic-assisted psychotherapy, is pleased to announce its sponsorship of TheraPsil (the ”TheraPsil Coalition”), a British Columbia based non-profit, composed of healthcare professionals, patients and advocates that are dedicated to obtaining legal, compassionate access to psilocybin therapy for terminally-ill Canadians suffering from end-of-life distress.

The TheraPsil Coalition supports Canadians seeking compassionate use of psilocybin by assisting individuals that apply for an exemption of subsection 56(1) of the Controlled Drugs and Substances Act (CDSA) (the ”Applications”). Canadians were first granted legal access to medical cannabis in 1999 through this same exemption.

On August 4, 2020, Canada’s Minister of Health, Patty Hajdu, is expected to respond to the Applications of four Canadians battling cancer who have been assisted by the TheraPsil Coalition.

Psilocybin-assisted psychotherapy for the treatment of end-of-life distress is supported by a growing body of clinical research. A long-term follow-up study of the NYU (New York University) 2016 Psilocybin Cancer Anxiety Study documented significant reductions in anxiety, depression, hopelessness, demoralization, and death-related anxiety nearly five years after participants were treated with psilocybin. Over 70% of study participants attributed positive life changes to the psilocybin-assisted psychotherapy experience and rated it among the most personally meaningful and spiritually significant experiences of their lives.1

“Novamind proudly supports TheraPsil’s efforts to provide compassionate access to psilocybin therapy for Canadians suffering from end-of-life distress” commented Yaron Conforti, Chief Executive Officer of Novamind.

About TheraPsil

TheraPsil is a non-profit coalition of healthcare professionals, patients and advocates that was formed in 2019, in order to change the laws regarding the use of medical psilocybin for terminally-ill patients who are experiencing end-of-life distress. TheraPsil’s mission is based on four pillars: Compassionate Access, Public Education, Professional Training, and Research. For more information visit www.therapsil.ca.

About Novamind

Novamind is building a global network of clinics and retreats that are required for a regulated psychedelics industry. We provide access to safe, legal psychedelic experiences, while advancing research for psychedelic medicine. For more information visit www.novamind.ca.

1: https://journals.sagepub.com/doi/10.1177/0269881119897615

Contact Information

Novamind
Yaron Conforti, CEO and Director
T: +1 (647) 953 9512
E: contact@novamind.ca

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Why Are Psychedelics And Mining Companies Merging In Canada?

Why Are Psychedelics And Mining Companies Merging In Canada?

Since the first psychedelic companies went public in March, an array of other psychedelic start-ups followed along in a trend that can now be safely referred to as the “Psychedelic Rush.”

In the last two months, at least five different psychedelics companies announced plans to go public in Canada, including Cybin Corp., Entheon Biomedical, Novamind Ventures, Silo Wellness and Havn Life Sciences.

With the exception of Havn, each chose to go public by way of reverse take-overs with companies from the mining sector.

As was the case with the boom of cannabis in 2013, mining companies driving the junior capital markets in Canada have laid the grounds for the development of high-risk venture industries.

Today, psychedelics are taking the lead.

Psychedelics, Reverse Acquisitions And… Mining?

What seems like an unusual combination of industries is actually a run-on-the-mill event for Canadian capital markets.

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Richard Carleton, CEO of the Canadian Stock Exchange, explained that the Canadian small-cap space has been largely focused on early-stage mining exploration, including oil and gas.

These companies have two possible outcomes. They either find something worth drilling and raise additional capital to develop a mine, or they don’t find anything.

“And so you have basically a group of companies that have raised some money, explored a property, didn’t succeed and now the management team and the shareholders are looking for another opportunity,” Carleton said.

That’s where psychedelics come in. These companies are trying to raise money quickly, and going public through a reverse acquisition is one of the fastest ways to do it.

In a reverse takeover (RTO), a private company looking to go public will merge with a public company in order to bypass the lengthy and expensive process of an initial public offering.

Alan Friedman, Principal at Bayline Capital Partners adds that the mining companies are available, but they’re not mining companies anymore.

“Once upon a time they were mining operating companies. Today, they’re defunct. They’re just sitting there listed on the stock exchange. And they’re good vehicles to reverse other assets into.”

For Friedman, the mining sector has “hot” cycles that last about seven years.

In 2013, one of these cycles came to an end. That moment happened to coincide with the cannabis boom. Cannabis companies were looking for ways to go public and the mining, oil and gas sector had left the perfect riverbed for a high-risk, junior capital investment market.

The same thing is happening with psychedelics.

“When you see psychedelics come along in 2020, it’s the new hot, trendy business. They can raise money, but they have to go public quick,” says Friedman. “Because a lot of the money that comes in is based on the fact they go public, because those investors like to see liquidity.”

Going Public in Canada: IPOs Vs. RTOs

According to Friedman, the quickest way for a company to go public is by way of a reverse takeover, because the vehicle and the shareholders are already there.

“80% of the companies in Canada go public by way of a reverse takeover,” Carleton said. “So it’s a very well-traveled path.”

It’s also less expensive.

“It could be a good few hundred thousand bucks cheaper,” Friedman added. “And it could be a few months quicker.”

Friedman is currently working with a private psychedelics company called Mind Health, which is in the process of negotiating a reverse takeover, and plans to go public in three months.

RTOs, however, also come with their fair share of challenges.

“When you’re switching industries, the shareholders are not in any way necessarily interested in that story or in that sector. And what can happen in a number of instances is that at the first sign of any kind of buying interest, once the company has gone public, those shareholders tend to sell so that it’s almost like there’s a built-in overhang in the company’s cap table,” Carleton explained.

As a result, when the company goes public, it’s harder to see the same kind of exuberant price moves seen when companies that go public by way of an IPO.

Also, with an RTO, the new company inherits all of the liabilities associated with the former company. And of course, in the case of mining companies, there may well be environmental issues, says Carleton.

It’s crucial to do due diligence and proper research an RTO partner before committing to a deal, Friedman advised. Although — in every case — there’s risk.

Nonetheless, RTOs are the preferred method of going public for small-cap companies in the junior markets/IPOs are reserved for larger, more established players who typically go after senior equity markets.

What To Look For In An RTO Partner?

Cybin CEO Paul Glavine is currently in the process of doing a reverse takeover with a mining company called Clarmin Explorations.

Cybin achieved full support from over 60% of Clarmin’s existing shareholders, Glavine said in an email. In this case, Clarmin’s management team will step out to let Cybin’s team on the helm.

Other psychedelics companies, like Entheon Biomedical — which merged with mining company MPV Exploration — looked for added value in their partner company. CEO Timothy Ko said MPV provided more than just a means to trade their stock on the open market.

“There was no shortage of interested, I guess, ‘shell’ partners. I think Canada has a plentitude of those opportunities available. But ultimately, it was a process of discernment where we had to say, ‘okay, the nature of the investor and the management on the other side, do they have a strategic value to us?'” says Ko.

Entheon found that MPV’s investors could add value to the company by bringing in their shared experiences in biotech, pharma and healthcare, and the management team could offer its experience raising money in the public markets.

Picture based on photos by Photo by Dominik Vanyi and Егор Камелев on Unsplash.

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Novamind Closes the Acquisition of Cedar Psychiatry, a Leading Psychedelic Therapy Organization in the U.S.

Not for distribution to U.S. Newswire Services or for dissemination in the United States. Any failure to comply with this restriction may constitute a violation of U.S. Securities laws.

TORONTO, ON / ACCESSWIRE / July 30, 2020 / Novamind Ventures Inc. (”Novamind”), a mental health and wellness company specialized in psychedelic-assisted psychotherapy, is pleased to announce that it has closed the acquisitions of Cedar Psychiatry LLC (”Cedar Psychiatry”),a specialized provider of ketamine-assisted psychotherapy and Cedar Clinical Research LLC (”Cedar Clinical Research”), a dedicated research center focused on psychedelic medicines, both based near Salt Lake City, Utah (the ”Cedar Acquisitions”). Total consideration paid by Novamind for the Cedar Acquisitions was CAN$3.05 million, consisting of CAN$1 million cash and CAN$2.05 million in Novamind common shares.

With the closing of the Cedar Acquisitions, Reid Robison, MD, MBA, co-founder of Cedar Psychiatry and Cedar Clinical Research, will join Novamind’s senior leadership team.

Cedar Psychiatry by Novamind

Cedar Psychiatry is now the central hub of Novamind’s global network of clinics and retreats offering legal, medically supervised psychedelic experiences. Founded in 2016, Cedar Psychiatry operates four outpatient mental health clinics near Salt Lake City, Utah, providing a wide range of services including psychotherapy, diagnostic evaluations, pharmacogenetic testing, psychiatric medication management and transcranial magnetic stimulation (TMS).

In addition, Cedar Psychiatry is a leading provider of ketamine therapy, having administered over 3,000 ketamine-assisted psychotherapy sessions and over 700 Spravato™ (esketamine) treatments since its inception. Dr. Robison is a thought leader in ketamine-assisted psychotherapy and psychedelic-medicine. He was one of the first clinicians to use ketamine off-label for the treatment of depression in Utah. In 2011, Dr. Robison established a ketamine infusion practice at Intermountain Medical Center, Utah’s largest hospital. Dr. Robison supervises and trains ketamine-assisted psychotherapy practitioners at Cedar Psychiatry’s clinics across Utah, and to date has guided thousands of ketamine therapy journeys and hundreds of Spravato™ treatment sessions.

Through Novamind’s global network of clinics and retreats (operating exclusively in jurisdictions where certain psychedelics are legal), Cedar Psychiatry anticipates expanding its service offerings to provide patients with increased access to psychedelic medicine, along with screening, preparation, and integration services.

Cedar Clinical Research by Novamind

Cedar Clinical Research (”CCR”) now leads Novamind’s clinical research activities. From its dedicated research center in Springville, Utah, CCR has developed a strong track record providing contract research (CRO) services, including hosting clinical trials. In 2012, Dr. Robison led the Utah site for the pivotal ketamine study for treatment-resistant depression by Janssen, leading to the U.S. Food and Drug Administration (FDA) approval of Spravato™. CCR operates at the leading edge of evidence-based care and is currently conducting a variety of clinical research studies examining conditions including depression, eating disorders, PTSD, and end-of-life anxiety.

Cedar Clinical Research is initiating its own research studies, integrating the data and learnings gained from patient treatment experiences and outcomes at Cedar Psychiatry, as well as related international retreats, to advance research on psychedelic medicine. Novamind is evaluating a pipeline of early-stage clinical research opportunities and expects to announce preclinical work on a psychedelic therapeutic protocol during Q3 2020.

About Cedar Psychiatry and Cedar Clinical Research

Cedar Psychiatry is an innovative provider of outpatient mental health services, operating psychiatry clinics specialized in ketamine-assisted psychotherapy. Cedar Clinical Research is a dedicated research organization focused on advancing psychedelic medicine. Both organizations are based near Salt Lake City, Utah, and are committed to evidence-based psychedelic healing. For more information visit www.cedarpsychiatry.com.

About Novamind

Novamind is building a global network of clinics and retreats that are required for a regulated psychedelics industry. We provide access to safe, legal psychedelic experiences, while advancing research for psychedelic medicine. For more information visit www.novamind.ca.

Contact Information

Novamind
Yaron Conforti, CEO and Director
T: +1 (647) 953 9512
E: contact@novamind.ca

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Numinus and Together We Can Partner to Support Addiction Recovery and Mental Wellness

Numinus provides tailored treatments for clients of one of Canada’s largest addiction treatment organizations

VANCOUVER, BC, July 29, 2020 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company“) (TSXV: NUMI), a company creating an ecosystem of health solutions centered around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted therapies, is pleased to announce its partnership with Together We Can Addiction Recovery and Education Society (TWC). TWC is one of Canada’s largest addiction treatment organizations, a registered charity, licensed healthcare provider, and an approved Canadian Federal Government service provider for the veterans’ community. The partnership has enabled TWC to enhance its mental health and addiction recovery support services with tailored mind/body wellness programs. Numinus’s associated wellness clinic is benefitting from the partnership with a dedicated stream of revenue, reinitiated since the clinic’s re-opening post-COVID earlier this month. The active service provider partnership is designed to ultimately support psychedelic-assisted therapies when authorized for use in Canada.

One in five Canadians suffer from addiction in any given year, and deaths from the current overdose crisis attributable to opioid and other addictions are growing. Numinus and TWC share the view that new solutions and integrative approaches are needed to enhance traditional recovery-based approaches to help people make transformative change, heal, and be well. The partnership currently extends the continuum of care provided to TWC clients with specialized mind/body programs which include modalities such as naturopathy, registered massage therapy, trauma and somatic therapies, and breathwork through Numinus’s associated wellness clinic in Vancouver. Individualized programs are continually being developed for TWC clients, including Canadian Forces members and veterans dealing with addiction, PTSD, anxiety, grief and loss, and other diagnoses.

Says Brett S., a TWC client who has already benefited from the partnership, “While I was in treatment at Together We Can for my drug addiction, I was given the opportunity to try out the services of the clinic. They not only supported me through recovery from my addictions but also helped me address my ADHD. I’m so grateful that Numinus’s services were part of my overall recovery.”

Longer term, the partnership also aims to provide TWC clients early-access to safe, evidence-based, regulated psychedelic-assisted therapies through Numinus’s implementation science partnerships and to provide Numinus with a key partner when it is able to provide these therapies in addition to its current services.

Although psychedelic-assisted therapies are not yet available outside of a research context, both parties are optimistic these therapies hold great promise as new treatment options for addiction and mental health care and that they will become increasingly accessible through regulatory approvals. A growing body of evidence suggests psychedelics, especially psilocybin, may dramatically improve outcomes from substance use disorders. While more research is required to fully define the outcomes and safety of the therapeutic use of psychedelic substances, the Canadian federal government is under increasing pressure to provide access to psilocybin-assisted therapy for various mental health and addiction conditions.

“The partnership with Numinus is so important for our clients. There is more demand than we can manage for our services, and our clients need the complementary programs Numinus provides,” says Stacy Wilson, TWC Executive Director. “We are excited to find a partner that is aligned with our mission and to work with a team that is driven by heartfelt passion. We both believe whole body/mind integrated support is critical to recovery, and we are optimistic that psychedelic-assisted therapies will also play a significant role in addressing addiction recovery when they are regulated.”

Adds Numinus Chief Medical Officer, Dr. Evan Wood, an internationally recognized clinician scientist and expert in addiction treatment, “The growing body of research into the role of psychedelic-assisted therapy in the treatment of substance use disorders is incredibly compelling. This partnership creates a wonderful opportunity to consolidate new strategies with an implementation science lens that can ultimately improve safe access to those seeking additional strategies for treatment and recovery.”

About Numinus
Numinus is a Vancouver-based health care company creating an ecosystem of health solutions centred around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted therapies. Numinus’s ecosystem units include Numinus Bioscience, Numinus R&D, and Numinus Health. Each unit is undertaking distinct, synergistic initiatives to hasten approved access to psychedelic-assisted therapy models in Canada and position Numinus as a trusted industry leader for the eventual regulated rollout of these therapies once available. Numinus Bioscience includes a 7,000 square foot research and testing laboratory as well as numerous Health Canada licenses (through its wholly-owned subsidiary Salvation Botanicals), including a cannabis testing license which provides established and growing revenue. It is also a late-stage application for cannabis processing. Additionally, the Company holds a dealer’s licence which allows it to import, export, possess, and test MDMA, psilocybin, psilocin, DMT, and mescaline, and it is the only publicly listed company in Canada to be issued a Health Canada license to produce and extract psilocybin from mushrooms for the purpose of developing proprietary extraction methods. These licences will allow Numinus to support the growing number of studies on the potential benefits of psychedelic therapies through research projects, product development, and the supply and distribution of these substances. Numinus R&D leverages established relationships to position the Company for partnerships to host studies, develop medical and therapeutic protocols, and influence regulatory approval. Numinus Health, with one clinic already prototyping systems for efficiency and profitability, is dedicated to delivering therapies that enhance and supplement existing options—centred around psychedelic-assisted therapies when and where regulated—for people wanting lasting physical, mental, and emotional health. For more information, visit www.numinus.ca.

About TWC
Founded in 1993 and located in both Metro Vancouver and Vancouver Island, Together We Can – Addiction Recovery & Education Society is one of Canada’s premier treatment centres for men battling alcohol and drug addiction. Its mission is to educate and support individuals and their families who desire a new life in recovery. It provides over 310 individuals with an immersive 60-90 day recovery-based primary addiction treatment experience, followed by transitional housing in a therapeutic residential environment. For more information, visit www.twcrecoverylife.org.

Forward Looking Statements
This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking statements.” Forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward looking statements. Such risks and uncertainties include, among others, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and any inability to obtain all necessary governmental approvals licenses and permits to operate and expand the Company’s facilities; regulatory or political change such as changes in applicable laws and regulations, including federal and provincial legalization, due to inconsistent public opinion, perception of the medical-use and adult-use marijuana industry, bureaucratic delays or inefficiencies or any other reasons; any other factors or developments which may hinder market growth; the Company’s limited operating history and lack of historical profits; reliance on management; the Company’s requirements for additional financing, and the effect of capital market conditions and other factors on capital availability; competition, including from more established or better financed competitors; and the need to secure and maintain corporate alliances and partnerships, including with research and development institutions, customers and suppliers. These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company has no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.

SOURCE Numinus Wellness Inc.

For further information: Dana Harvey, VP Communications and Investor Relations, Numinus, dana@numinus.ca, 778-929-3262; Daniel Maceachern, Operations Manager, TWC, dmaceachern@twcrecoverylife.org, (604) 451-9854