Category: Revive Therapeutics

TORONTO, April 03, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV), a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, announced today that it has filed its Pre-Investigational New Drug (“pre-IND”) meeting request with the U.S. Food and Drug Administration (“FDA”) for Bucillamine in the treatment of the coronavirus disease (“COVID-19”). The Company will rely on its previous FDA IND submissions of Bucillamine to expedite communications and obtain FDA acceptance to proceed to a phase 2 clinical study. The Company has previously been granted Phase 2 study approval for the treatment of Gout and Cystinuria with Bucillamine.

Revive, along with the assistance of Pharm-Olam, LLC. is finalizing the clinical study protocol to advance to a Phase 2 clinical trial in the U.S. The proposed Phase 2 clinical study contemplates a multi-center, randomized, double-blind, placebo-controlled, clinical study of Bucillamine in patients with mild to moderate symptoms. The proposed objectives of the study are to evaluate disease course in patients receiving Bucillamine therapy compared to a placebo, the safety of Bucillamine therapy when administered up to 14 days, and the time to clinical improvement in patients with symptoms receiving Bucillamine compared with a placebo.

“We are excited to expedite the clinical investigation of Bucillamine in a proposed phase 2 clinical study in the U.S., and we believe our history with the FDA for Bucillamine will provide a compelling case”, said Michael Frank, Revive’s Chief Executive Officer. “We will also seek to expand the clinical investigation of Bucillamine in Asian regions, with a particular interest in Japan and South Korea where Bucillamine has been prescribed for treating arthritis for over 30 years. We are in discussion with various contract research organizations (‘CRO’) in these regions.”

Innovative therapies to treat and modify the natural course of the disease are urgently needed. 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 restore antioxidant and to reduce the activity of cellular glutathione ^2,3,4,5. 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 restoration of glutathione activity and other anti-inflammatory activity, to lessen the negative consequences of influenza and SARS CoV2 infection in the lungs and to help treat these conditions.

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 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 was previously 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).

TORONTO, March 30, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV), a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, is pleased to provide a corporate update on its plans for the Company’s coronavirus disease (“COVID-19”) and infectious diseases programs. The Company seeks to advance its product pipeline to human clinical studies in regions where its products have regulatory approval to investigate in clinical studies and are approved for sale, such as the U.S. and in Asia-Pacific Countries (“APAC”).

“We have strengthened our scientific and clinical team that will allow us to pursue the clinical development of Bucillamine in the potential treatment of not only COVID-19 but also other infectious diseases and we are seeking to advance Bucillamine for COVID-19 towards a potential U.S. FDA Phase 2 clinical study and a clinical study in one of the APAC countries,” said Michael Frank, Revive’s Chief Executive Officer. “Revive has built a robust product pipeline that has a particular focus on infectious diseases and rare disorders and is discovering and developing new therapeutic uses of drugs such as Bucillamine, Psilocybin and Cannabidiol.  We are steadily advancing our product development programs that will unlock the potential value of Revive and we are continuing to expand our product pipeline in infectious diseases and rare disorders.”

The Company is currently focused on advancing the clinical development for Bucillamine, which has a proven safety profile and has been prescribed for arthritis in Japan and South Korea for over 30 years and is being repurposed by the Company as a potential treatment of infectious diseases, including COVID-19.  Revive has applied for a provisional patent with the U.S. Patent and Trademark Office entitled “Use of Bucillamine in the Treatment of Infectious Diseases” (Serial No. 62/991,996) and the Company is targeting COVID-19 as its lead indication.  In the past, the Company has explored the use of Bucillamine in the treatment of acute gout flares in a Phase 2 study in the U.S. under its Investigational New Drug (“IND”) application that was granted and accepted by the U.S. Food and Drug Administration (“FDA”).  Additionally, the Company has explored the use of Bucillamine in the treatment of cystinuria where it has received FDA orphan drug status and its IND was also accepted by the FDA to conduct a Phase 2 study in the U.S.

The Company is leveraging its U.S. FDA regulatory and clinical experience with Bucillamine to further its clinical initiatives with Bucillamine for the potential treatment of COVID-19 and other infectious diseases.  Revive has taken the necessary steps to unlock the full potential of Bucillamine for infectious diseases, including COVID-19, by strengthening its scientific and clinical development team to realize the potential commercial value of the Company’s product pipeline. The Company recently announced it has engaged Dr. David Boulware, MD, MPH, an internationally recognized infectious disease expert and Professor of Medicine, Division of Infectious Diseases and International Medicine at The University of Minnesota, who is currently the Principal Investigator of a globally recognized COVID-19 clinical trial (ClinicalTrials.gov Identifier: NCT04308668).  The Company has also retained Pharm-Olam, LLC, with proven clinical experience in infectious diseases completing over 100 clinical studies in approximately 19,000 patients at over 2,000 clinical sites, to serve as the Company’s Contract Research Organization (“CRO”) to advance the future clinical study for Bucillamine in the treatment of COVID-19 and potentially other infectious diseases.  In addition, Revive has added Dr. Kelly McKee, Jr., MD, MPH as Chief Scientific Officer consultant, bringing over 30 years of experience in research and development expertise in vaccines, emerging diseases, biodefense, respiratory viral infections,  and Dr. Onesmo Mpanju, PhD as Regulatory Affairs consultant, having nearly 30 years of drug regulatory experience and a past reviewer at the U.S. FDA, Center for Biologics Evaluation & Research and a key consultant to the Bill & Melinda Gates Foundation.

The Company is finalizing its regulatory package and clinical study plan for Bucillamine in the treatment of COVID-19 and it will submit for regulatory approval, by way of an IND application submission to the U.S. FDA, to investigate Bucillamine in a proposed Phase 2 clinical study.  Revive will also seek to expand the clinical investigation of Bucillamine for COVID-19 in APAC regions, with a particular interest in Japan and South Korea.

Scientific Rationale for the Investigation of Bucillamine to Treat Infectious Diseases including COVID-19

Current antiviral interventions for influenza have exhibited modest efficacy, especially in improving mortality in at-risk populations, such as the elderly.1,2  Novel antivirals have been plagued by poor oral bioavailability and lack of efficacy when not delivered early.1 This is because these drugs mostly act to prevent the early processes of virus binding to cells or viral replication.2  Thiols, particularly N-acetylcysteine (NAC), with antioxidant and reducing activity have been investigated as effective therapies that abrogate the potential for influenza to cause severe disease.3,4,5  Restoration of glutathione, the major intracellular thiol antioxidant, is a critical functional activity of NAC.6  Reactive oxygen species (ROS) generation during influenza virus infection aggravate destructive inflammation and programmed death of epithelial cells.7  Studies in human cells and animal models have shown that NAC works to prevent acute lung injury caused by influenza virus infection through inhibition of these ROS-mediated mechanisms.4,7  NAC has been investigated clinically and found to significantly attenuate clinical symptoms associated with influenza infection, especially in elderly at-risk patients.5  While NAC is easily taken up by cells and has low toxicity, clinical efficacy has required long-term and high-dose administration because of modest relative potency, limiting its clinical applicability.

Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine), which has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years, is a cysteine derivative with 2 thiol groups that is 16-fold more potent than NAC as a thiol donor in vivo, giving it vastly superior function in restoring glutathione and therefore greater potential to prevent acute lung injury during influenza infection.8  Bucillamine has also been shown to prevent oxidative and reperfusion injury in heart and liver tissues8 and is highly cell permeable for efficient delivery into cells.8,9  Bucillamine has unrealized potential for the treatment of influenza with both proven safety and proven mechanism of action similar to that of NAC, but with much higher potency, mitigating the previous obstacles to using thiols therapeutically. It is also reasonable to hypothesize that similar processes related to ROS are involved in acute lung injury during nCov-19 infection, possibly justifying the investigation of bucillamine as an intervention for 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 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 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. Muthuri SG, Venkatesan S, Myles PR et al. Effectiveness of neuraminidase inhibitors in reducing mortality in patients admitted to hospital with influenza A H1N1pdm09 virus infection: a meta-analysis of individual participant data Lancet Respir Med. 2014 May;2(5):395-404. doi: 10.1016/S2213-2600(14)70041-4.

2. Duwe S. Influenza viruses – antiviral therapy and resistance. GMS Infect Dis. 2017; 5: Doc04.

3. Zhang RH, Li CH, Wang CL 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. doi: 10.1016/j.intimp.2014.06.013.

4. Ungheri D, Pisani C, Sanson G 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. De Flora S, Grassi C, and Carati L. Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment. Eur Respir J 1997; 10: 1535–1541 DOI: 10.1183/09031936.97.10071535

6. Poole LB. The Basics of Thiols and Cysteines in Redox Biology and Chemistry. Free Radic Biol Med. 2015 Mar; 0: 148–157. doi: 10.1016/j.freeradbiomed.2014.11.013.

7. Mata M, Morcillo E, Gimeno C, Cortijo J. 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 1;82(5):548-55. doi: 10.1016/j.bcp.2011.05.014.

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

9. Sagawa A, Fujisaku A, Ohnishi K et al. A multicentre trial of bucillamine in the treatment of early rheumatoid arthritis (SNOW study). Mod Rheumatol. 2011 Jun;21(3):251-7. doi: 10.1007/s10165-010-0385-4

TORONTO, March 25, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV), a life sciences company focused on the research and development of therapeutics for rare disorders and infectious diseases, is pleased to announce that the Company has retained Pharm-Olam, LLC, with proven clinical experience in infectious diseases completing over 100 clinical studies in approximately 19,000 patients at over 2,000 clinical sites, to serve as the Company’s Contract Research Organization (“CRO”) to advance the future clinical study for Bucillamine in the treatment of infectious diseases, including the coronavirus disease (“COVID-19”).  In addition, Revive has added Dr. Kelly McKee, Jr., MD, MPH as Chief Scientific Officer consultant and Dr. Onesmo Mpanju, PhD as Regulatory Affairs consultant to the Company’s clinical development team.

“We are very pleased to have Pharm-Olam as our partner in guiding us towards our goal to investigate Bucillamine as a potential treatment for COVID-19 in a U.S. FDA clinical study and in other infectious diseases clinical studies in the future,” said Michael Frank, Chief Executive Officer of Revive. “Pharm-Olam has the proven experience in managing infectious disease clinical studies,  a scalable ecosystem  for expediting and completing clinical studies on time and on budget, and most importantly they have an infectious disease team of experts with the addition of  Dr. McKee and Dr. Mpanju who will develop and oversee Revive’s clinical study and its expeditious submission of our IND with the FDA.”

Dr. McKee is currently Senior Scientific and Medical Advisor for Pharm-Olam. Previously, Dr. McKee served Pharm-Olam’s Chief Medical Officer, and as Vice President, Vaccines and Public Health, in the Infectious Diseases and Vaccines Center of Excellence at IQVIA (previously QuintilesIMS).  He brings over 30 years of experience in research and development from the bench to the bedside, with specific expertise in vaccines, emerging diseases, biodefense, respiratory viral infections, and sexually transmitted infections. His progressive clinical research experience began in 1981 at Fort Detrick, Frederick, Md., United States, where he served as a research virologist, immunologist, and Head of the Dept of Clinical Investigation and Medical Division at the US Army Medical Research Institute of Infectious Diseases (USAMRIID).

Dr. Onesmo Mpanju, PhD has over 28 years of experience in biopharmaceutical R&D, including 18 years as a regulatory scientist. Previously, Dr. Mpanju was a Reviewer at the U.S. FDA, Center for Biologics Evaluation & Research. His consulting experience includes non-commercial entities such as the U.S. National Institutes of Health, US Army Medical Materiel Development Activity (USAMMDA), the Bill & Melinda Gates Foundation, and others. Dr. Mpanju holds a Ph.D. in Experimental Medicine (Infectious Diseases) from the University of British Columbia, Vancouver, Canada.

About Pharm-Olam, LLC.

Pharm-Olam is Helping Create a Healthier World as a global, midsized CRO that offers flexible, innovative, and highly personalized clinical solutions to pharmaceutical, biotechnology, and life science companies. The Company is well-known for producing quality results with reduced risk, costs, and timelines in challenging international trials. Learn more about their full-service solutions, data protection services, and expertise in oncology, infectious diseases and vaccines, rare and orphan diseases, pediatrics, and general medicine at pharm-olam.com.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for rare disorders and infectious diseases.  Revive’s technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory areas such as liver disease. The Company was granted FDA orphan drug status designation for the use of CBD to treat auto-immune hepatitis (liver disease) and FDA orphan drug status designation for the use of CBD to treat ischemia and reperfusion injury from organ transplantation. With its recent acquisition of Psilocin Pharma Corp., Revive will advance Psilocybin-based therapeutics in various diseases and disorders and will prioritize 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. The Company is also exploring the use of Bucillamine for the potential treatment of infectious diseases.  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.

TORONTO, March 24, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV), a life sciences company, is pleased to announce that Dr. David Boulware, MD, MPH, CTropMed, FIDSA, will join the Company as a Scientific Advisor to guide on the Company’s current and future clinical programs including its research and development strategy for infectious diseases, including the coronavirus disease (“COVID-19”).

Dr. Boulware is an infectious disease physician-scientist and Professor of Medicine, Division of Infectious Diseases and International Medicine at The University of Minnesota.  Dr. Boulware is currently the Principal Investigator of a globally recognized COVID-19 clinical trial to determine if post-exposure prophylaxis with hydroxychloroquine can prevent progression development of symptomatic COVID-19 disease after known exposure to the SARS-CoV2 virus (ClinicalTrials.gov Identifier: NCT04308668).  His primary research interests are in meningitis in resource-limited areas including diagnosis, prevention, treatment, and quality improvement initiatives incorporating cost-effectiveness analyses in order to translate knowledge into improved care. Dr. Boulware’s current research is focused on improving the clinical outcomes of HIV-infected persons with cryptococcal meningitis and TB meningitis. Dr. Boulware has active research collaborations in Uganda, South Africa, and Ethiopia leading a multidisciplinary, international research team. He serves on US and WHO panels for cryptococcal meningitis and WHO panels for advanced HIV disease.

“We are pleased to have Dr. Boulware join us to assist in advancing the research and clinical development of our infectious disease initiatives including exploring the use of Bucillamine as a potential novel treatment for COVID-19,” said Michael Frank, Chief Executive Officer of Revive. “Dr. Boulware brings comprehensive clinical expertise in infectious diseases and he will be valuable in guiding our clinical development strategy and product pipeline in infectious diseases.”

“I am excited to assist Revive in their objective in pursuing the clinical development of Bucillamine for infectious diseases and its prospect as a potential solution for COVID-19,” said Dr. Boulware.

As previously announced, the Company is exploring the use of Bucillamine as a potential novel treatment for infectious diseases including COVID-19. The Company has applied for a provisional patent with the U.S. Patent and Trademark Office entitled “Use of Bucillamine in the Treatment of Infectious Diseases” (Serial No. 62/991,996).  Revive plans to file an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for the use of Bucillamine in the treatment of COVID-19.  Parts of the IND will be supported and referenced by the Company’s previous INDs accepted by the FDA and its Phase II grant for the clinical investigation of Bucillamine in the treatment of acute gout flares and cystinuria.

About Revive Therapeutics Ltd.

Revive is a company focused on the research, development and commercialization of novel psychedelic and cannabinoid-based life sciences products and drug repurposing for infectious diseases. Revive’s technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory areas such as liver disease. The Company was granted FDA orphan drug status designation for the use of CBD to treat auto-immune hepatitis (liver disease) and FDA orphan drug status designation for the use of CBD to treat ischemia and reperfusion injury from organ transplantation. With its recent acquisition of Psilocin Pharma Corp., Revive will advance Psilocybin-based therapeutics in various diseases and disorders and will prioritize 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. The Company is also exploring the use of Bucillamine for the potential treatment of infectious diseases.

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.

TORONTO, March 20, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV), a life sciences company, is pleased to announce that it is exploring the use of the drug Bucillamine as a potential novel treatment for infectious diseases including influenza and the coronavirus disease (COVID-19). The Company has applied for a provisional patent with the U.S. Patent and Trademark Office entitled “Use of Bucillamine in the Treatment of Infectious Diseases” (Serial No. 62/991,996).

“Revive was founded on the premise of finding new uses for known drugs, and we are expanding on our rich product portfolio to target infectious diseases such as the coronavirus disease or COVID-19,” said Michael Frank, Revive’s Chief Executive Officer. “Revive has a history in the clinical development with Bucillamine in the treatment of acute gout flares and cystinuria, and we will advance our efforts in reviving and exploring new uses of Bucillamine for unmet medical needs.”

Revive has explored the use of Bucillamine in the treatment of acute gout flares and has completed a Phase 2 study in the U.S. under its Investigational New Drug (“IND”) application that was accepted by the U.S. Food and Drug Administration (“FDA”). Also, the Company explored the use of Bucillamine in the treatment of cystinuria where it has received FDA orphan drug status and its IND was accepted by the FDA to conduct a Phase 2 study in the U.S.

Scientific Rationale for the Investigation of Bucillamine to Treat Infectious Diseases including Influenza or COVID-19

Current antiviral interventions for influenza have exhibited modest efficacy, especially in improving mortality in at-risk populations, such as the elderly.^1,2 Novel antivirals have been plagued by poor oral bioavailability and lack of efficacy when not delivered early.¹ This is because these drugs mostly act to prevent the early processes of virus binding to cells or viral replication.² Thiols, particularly N-acetylcysteine (NAC), with antioxidant and reducing activity have been investigated as effective therapies that abrogate the potential for influenza to cause severe disease.^3,4,5 Restoration of glutathione, the major intracellular thiol antioxidant, is a critical functional activity of NAC.⁶ Reactive oxygen species (ROS) generation during influenza virus infection aggravate destructive inflammation and programmed death of epithelial cells.⁷ Studies in human cells and animal models have shown that NAC works to prevent acute lung injury caused by influenza virus infection through inhibition of these ROS-mediated mechanisms.^4,7 NAC has been investigated clinically and found to significantly attenuate clinical symptoms associated with influenza infection, especially in elderly at-risk patients.⁵ While NAC is easily taken up by cells and has low toxicity, clinical efficacy has required long-term and high-dose administration because of modest relative potency, limiting its clinical applicability.

Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine), which has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years, is a cysteine derivative with 2 thiol groups that is 16-fold more potent than NAC as a thiol donor in vivo, giving it vastly superior function in restoring glutathione and therefore greater potential to prevent acute lung injury during influenza infection.⁸ Bucillamine has also been shown to prevent oxidative and reperfusion injury in heart and liver tissues⁸ and is highly cell permeable for efficient delivery into cells.^8,9 Bucillamine has unrealized potential for the treatment of influenza with both proven safety and proven mechanism of action similar to that of NAC, but with much higher potency, mitigating the previous obstacles to using thiols therapeutically. It is also reasonable to hypothesize that similar processes related to ROS are involved in acute lung injury during nCov-19 infection, possibly justifying the investigation of bucillamine as an intervention for COVID-19.

Revive is developing a product and clinical development plan intending to unlock the full potential of Bucillamine. The Company will announce its initiatives as they unfold.

About Revive Therapeutics Ltd.

Revive is a company focused on the research, development and commercialization of novel psychedelic and cannabinoid-based life sciences products and drug repurposing for infectious diseases. Revive’s technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory areas such as liver disease. The Company was granted FDA orphan drug status designation for the use of CBD to treat auto-immune hepatitis (liver disease) and FDA orphan drug status designation for the use of CBD to treat ischemia and reperfusion injury from organ transplantation. With its recent acquisition of Psilocin Pharma Corp., Revive will advance Psilocybin-based therapeutics in various diseases and disorders and will prioritize 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. The Company is also exploring the use of Bucillamine for the potential treatment of infectious diseases.

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. Muthuri SG, Venkatesan S, Myles PR et al. Effectiveness of neuraminidase inhibitors in reducing mortality in patients admitted to hospital with influenza A H1N1pdm09 virus infection: a meta-analysis of individual participant data Lancet Respir Med. 2014 May;2(5):395-404. doi: 10.1016/S2213-2600(14)70041-4.

2. Duwe S. Influenza viruses – antiviral therapy and resistance. GMS Infect Dis. 2017; 5: Doc04.

3. Zhang RH, Li CH, Wang CL 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. doi: 10.1016/j.intimp.2014.06.013.

4. Ungheri D, Pisani C, Sanson G 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. De Flora S, Grassi C, and Carati L. Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment. Eur Respir J 1997; 10: 1535–1541 DOI: 10.1183/09031936.97.10071535

6. Poole LB. The Basics of Thiols and Cysteines in Redox Biology and Chemistry. Free Radic Biol Med. 2015 Mar; 0: 148–157. doi: 10.1016/j.freeradbiomed.2014.11.013.

7. Mata M, Morcillo E, Gimeno C, Cortijo J. 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 1;82(5):548-55. doi: 10.1016/j.bcp.2011.05.014.

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

9. Sagawa A, Fujisaku A, Ohnishi K et al. A multicentre trial of bucillamine in the treatment of early rheumatoid arthritis (SNOW study). Mod Rheumatol. 2011 Jun;21(3):251-7. doi: 10.1007/s10165-010-0385-4.

TORONTO, March 05, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”), a company focused on the research, development and commercialization of novel psychedelic and cannabinoid-based life sciences products, is pleased to announce that, further to its press release of February 12, 2020, the Company has completed its acquisition of all of the issued and outstanding securities in the capital of Psilocin Pharma Corp. (“Psilocin”), a specialty psychedelic sciences company focused on the development of Psilocybin-based therapeutics for significant unmet medical needs including rare and orphan indications.

Pursuant to the terms of a share exchange agreement dated March 4, 2020, Revive acquired all of the issued and outstanding securities of Psilocin for an aggregate purchase price of $2.75 million (the “Purchase Price”).  The Purchase Price was satisfied through the issuance of an aggregate of 55 million common shares in the capital of Revive at a deemed price of $0.05 per share, of which 10 million common shares (the “Escrowed Shares”) were issued on the execution of the letter of intent.

About Psilocin Pharma Corp.

Psilocin has developed patent-pending formulation and production solutions for the active compound Psilocybin.  The process encompassed with its intellectual property cover methods of production of Psilocybin-based formulations.  Psilocin has developed formulations to date which include the Hydroxy Line.  The line will include PSY-0.1 -Capsules- PSY-0.2 -Sublingual Spray- PSY-0.3 -Gel Cap- PSY-0.4/0.5 -Effervescent Tablets-and PSY-0.6 -Breath Strips.  The precisely dosed formulations will work with both natural and synthetically derived Psilocybin which will be targeted for clinical research and subject to U.S. Food and Drug Administration (“FDA”) approval in the treatment of depression, anxiety, bi-polar disorder, bulimia and anorexia nervosa, and a number of other diseases.  Psilocin’s range of products have been engineered to work synergistically with the body’s own natural pathways of absorption while offering a contemporary approach to consumption.

Psilocin has filed key provisional patent applications with the U.S. Patent and Trademark Office that cover methods of production of Psilocybin-based formulations.  This includes sublingual sprays, effervescent tablets, hard-shell capsules, sublingual and transmucosal delivery systems (i.e. gum drops, oral strips, dosing pens).  Furthermore, Psilocin has a patent-pending portfolio that includes Psilocybin extraction and crystallization methodologies.  Specifically, the Psilocin patent applications relate to the following:

• Solid Oral Pharmaceutical Compositions, United States Provisional Application Serial No. 62/985,052 – Psilocybin effervescent and psilocybin tablet designed to be placed under the tongue or dissolved in water. Allowing for improved taste and controlled release profiles.
• Pharmaceutical Capsule Compositions, United States Provisional Application Serial No. 62/985,070 – Psilocybin hard-shell capsules containing dry, powdered ingredients in 2-piece capsules. Allowing for contemporary consumption familiar to the user (Gelatin and vegetarian enclosure options in addition to unique nutrient delivery combination options).
• Pharmaceutical Gumdrop Compositions, United States Provisional Application Serial No. 62/985,084 – Psilocybin gum drops for improved administration of compounds. Offers unique delivery methods for fat and water soluble options.
• Thin-Film Pharmaceutical Delivery System and Formulations, United States Provisional Application Serial No. 62/985,098 – Psilocybin oral strips and psilocybin transmucosal delivery system. Proprietary oral fast-dissolving drug delivery system rapidly releases though the buccal pathway.
• Pharmaceutical Formulations and Methods for Sublingual and Buccal Administration, United States Provisional Application Serial No. 62/984,590 – Formulation for spray/pump/dosing pen.
• Methods for the Extraction and Crystallization of Psilocybin, United States Provisional Application Serial No. 62/985,360 – Psilocybin extraction and psilocybin re-crystallization method patent allows for the extraction of Psilocybin from raw form of magic mushrooms or magic truffles. Psilocin’s proprietary extraction process allows for the extraction of whole fungi extract with the option to selectively pull out pure Psilocybin Isolate in the downstream process.

Revive intends to take advantage of a number of regulatory incentives awarded by the FDA, such as orphan drug, fast track, breakthrough therapy and rare pediatric disease designations, and will also categorize opportunities that have FDA priority review voucher potential, which historically have been valued between $67.5 and $350 million.  This strategy is complementary to Revive’s cannabinoid-based pharmaceutical portfolio, specifically clinical development of Cannabidiol in the treatment of Autoimmune Hepatitis, which already has FDA orphan drug designation.  Revive is currently in the process of preparing an investigational new drug application for submission to the FDA.

For more information, visit www.ReviveThera.com.

About Revive Therapeutics Ltd.

Revive is a company focused on the research, development and commercialization of novel psychedelic and cannabinoid-based life sciences products. Revive’s cannabinoid delivery technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory areas such as liver disease. The company has been granted FDA orphan drug status designation for the use of CBD to treat auto-immune hepatitis (liver disease) and FDA orphan drug status designation for the use of CBD to treat ischemia and reperfusion injury from organ transplantation.  With its recent acquisition of Psilocin Pharma Corp., Revive will advance Psilocybin-based therapeutics in various diseases and disorders and will prioritize development efforts to take advantage of a number of regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations.

In addition, Revive, at the request of the Investment Industry Regulatory Organization of Canada (IIROC), would like to confirm that Revive’s management is not aware of any material undisclosed development with respect to Revive that would account for the recent increase in market activity.

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 Proposed Acquisition, including the timing for closing and the receipt of required regulatory approvals. 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. Factors that may cause actual results to differ materially from those anticipated by these forward looking statements include: the risk that the Company may not be able to close the Proposed Acquisition; the failure of the Company to effectively obtain the approval of the Canadian Securities Exchange for the Proposed Acquisition; the inability of the Company to satisfy all conditions to the completion of the Proposed Acquisition and the risk of unforeseen delays in the completion of the Proposed Acquisition. Reference is also 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.

TORONTO, Feb. 18, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”), a company focused on the research, development and commercialization of novel cannabinoid-based and life sciences products, is pleased to provide an update on the Company’s clinical development plan for Cannabidiol (“CBD”) in the treatment of Autoimmune Hepatitis (AIH).

Revive is currently in the process of preparing its Investigational New Drug (“IND”) application for submission to the U.S. Food and Drug Administration (“FDA”) for CBD in the treatment of AIH.  The Company plans to submit the IND within ninety days with the objective to proceed with a proposed Phase 1/2a clinical study to determine the recommended dose of CBD for future clinical studies of AIH, to assess its safety, efficacy and clinical benefit, as well as to support a New Drug Application (“NDA”) for FDA approval.  The Company aims to initiate a clinical study by the end of Q2 or early Q3-2020.

“Revive is focused on advancing its cannabinoid-based product pipeline towards human clinical studies with our lead program being CBD in the treatment of AIH, a rare liver disease that represents a large market opportunity globally,” said Michael Frank, Chief Executive Officer of Revive.  “Our objective in proceeding with a first-in-kind human clinical trial under a U.S. IND will further support our cannabinoid pharmaceutical initiatives by expanding into other rare diseases that Revive is pursuing such as the use of CBD in the prevention of ischemia and reperfusion injury (“IRI”) resulting from solid organ transplantation, which includes liver, kidney, heart and lung.  The Company has received FDA orphan drug designation for CBD in both AIH and IRI.”

Revive’s program is to meet a clear unmet medical need in patients with AIH.  AIH is a rare inflammatory condition of the liver that can affect all ages and gender across the world.  If not treated properly, may cause liver fibrosis or cirrhosis, liver failure requiring a liver transplant, and even death.  The prevalence of AIH is estimated at 75,000 patients in the U.S.  The current standard of care for AIH is the use of steroids alone or steroids combined with azathioprine.  It has been noted in medical literature that the current standard of care when used in a certain period of time has caused severe treatment-related side effects in 13%, treatment failure in 9%, incomplete response in 13%, and relapse after drug withdrawal up to 86% of patients with AIH (Source: World J Gastroenterol. 2010 Feb 28; 16(8): 934–947).  Therefore, given the unwanted outcomes associated with a steroid-based therapy, an alternative steroid-free treatment option such as CBD, with its known safety profile, may provide a potential solution for an improved treatment strategy for those patients unresponsive to, intolerant of, or non-adherent with a steroid-based therapy for AIH.

Revive has an exclusive license from South Carolina Research Foundation for its intellectual property for the use of CBD, either in synthetic or natural form, in the treatment of autoimmune hepatitis (U.S. patent No. 8242178).  Also, the FDA has granted to Revive orphan drug designation for CBD in the treatment of AIH, which provides valuable incentives that could accelerate the approval process, including seven-year market exclusivity, tax credits on U.S. clinical trials, fast-tracking of regulatory proceedings, and exemption from certain fees, such as waiver of filing fees under the Prescription Drug User Fee Act (PDUFA), and orphan drug grants.

About Revive Therapeutics Ltd.

Revive is a company focused on the research, development and commercialization of novel cannabinoid-based and life sciences products. Revive’s cannabinoid delivery technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory areas such as liver disease. The company has been granted FDA orphan drug status designation for the use of CBD to treat auto-immune hepatitis (liver disease) and FDA orphan drug status designation for the use of CBD 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: 905.605.5535
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 IND submission to the FDA, including plans to submit the IND within sixty to ninety days,  a proposed Phase 1/2a clinical study, and the aim to initiate a clinical study by the end of Q2-2020.  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. Factors that may cause actual results to differ materially from those anticipated by these forward looking statements include: the risk that the Company may not be able to submit the IND to the FDA; the Company many not obtain approval to proceed with a human clinical study; the inability of the Company to satisfy all conditions to proceed with a human clinical study and the risk of unforeseen delays in the submission of the IND. Reference is also 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.

TORONTO, Feb. 12, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) is pleased to announce that it has entered into a letter of intent, dated February 11, 2020 (the “LOI”) with Psilocin Pharma Corp. (“Psilocin”), an arm’s length party incorporated pursuant to the laws of the Province of Ontario. Pursuant to the terms of the LOI, Revive will acquire all of the issued and outstanding securities of Psilocin (the “Proposed Acquisition”) for an aggregate purchase price of $2.75 million (the “Purchase Price”). The Purchase Price will be satisfied through the issuance of an aggregate of 55 million common shares in the capital of Revive at a deemed price of $0.05 per share.

 

Upon the execution of the LOI, Revive agreed to deposit an aggregate of 10 million common shares (the “Deposit Shares”) in the capital of Revive, for an aggregate consideration of $500,000, into escrow as a deposit of the Purchase Price. In the event that the Proposed Acquisition does not close, the Deposit Shares will be returned to Revive for cancellation.

 

The closing of the Proposed Acquisition is subject to, among things, the successful completion of  Revive’s due diligence review of Psilocin and the execution of a definitive share exchange agreement between Revive and the shareholders of Psilocin.

 

“Psilocin Pharma has the platform, relationships, and know-how to develop psylocibin-based products that are key to this emerging psychedelics industry. We feel this acquisition will complement Revive and be a strong addition to our current clinical initiatives in liver disease and inflammation,” says Michael Frank, CEO of Revive Therapeutics.

 

About Psilocin Pharma Corp.

 

Psilocin has developed production solutions for the active compound Psilocybin. Our process encompassed with our intellectual property cover methods of production of Psilocybin based formulations. Psilocin has developed 6 formulations to date the Hydroxy Line. The line PSY-0.1 -Capsules- PSY-0.2 -Sublingual Spray- PSY-0.3 -Gel Cap- PSY-0.4/0.5 -Effervesce Tablets- PSY-0.6 -Breath Strip. The precisely dosed formulations work with both natural and synthetically derived Psilocybin which will be targeted for clinical research and subject to eventually FDA approval in the treatment of Depression, Anxiety, Bi-polar disorder, Bulimia & Anorexia Nervosa, etc.  Psilocin Pharma Corp’s range of products have been engineered to work synergistically with the body’s own natural pathways of absorption while offering a contemporary approach to consumption. Psilocin Pharma also has strong relationships with specific lab partners in certain areas like Brazil, where these formulations are legally approved and plan to sell products in these jurisdictions.

 

About Revive Therapeutics Ltd.

 

Revive is a company focused on the research, development and commercialization of novel cannabinoid-based and life sciences products. Revive’s cannabinoid delivery technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory areas such as liver disease. The company has been granted FDA orphan drug status designation for the use of CBD to treat auto-immune hepatitis (liver disease) and FDA orphan drug status designation for the use of CBD 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: 905.605.5535
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 Proposed Acquisition, including the timing for closing and the receipt of required regulatory approvals. 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. Factors that may cause actual results to differ materially from those anticipated by these forward looking statements include: the risk that the Company may not be able to close the Proposed Acquisition; the failure of the Company to effectively obtain the approval of the Canadian Securities Exchange for the Proposed Acquisition; the inability of the Company to satisfy all conditions to the completion of the Proposed Acquisition and the risk of unforeseen delays in the completion of the Proposed Acquisition. Reference is also 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.

NOT FOR DISSEMINATION IN THE UNITED STATES OR FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES AND DOES NOT CONSTITUTE AN OFFER OF THE SECURITIES DESCRIBED HEREIN

TORONTO, Feb. 11, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”), a cannabis life sciences company focused on novel cannabinoid-based treatments for rare inflammatory diseases, is pleased to announce that it has engaged Hampton Securities Limited, as sole lead agent (the “Agent”), in connection with a private placement offering, on a “commercially reasonable efforts” basis, of up to 40,000,000 units of Revive (the “Units”) at a price of $0.05 per Unit (the “Unit Price”) for gross proceeds of up to $2,000,000 (the “Offering”).

Each Unit shall consist of one common share (“Share”) in the capital of the Company and one common share purchase warrant (“Warrant”). Each Warrant will entitle the holder thereof to acquire one common share of the Company (each a “Warrant Share”) at a price of $0.07 per Warrant Share for a period of 36 months following the Closing Date.

The Company intends to use the net proceeds of the Offering for the repayment of debt and for general corporate purposes.

In connection with the Offering, the Agent will receive a cash commission equal to 9.0% of the gross proceeds raised under the Offering and will be issued on the Closing Date compensation ‎warrants (the “Compensation Warrants”) entitling the Agent to subscribe for that number of units (each a‎‎ “Compensation Unit”) as is equal to 9.0% of the total number of Units sold pursuant to the Offering. Each ‎Compensation Warrant shall entitle the holder thereof to purchase one Compensation Unit at a price of ‎‎$0.05 per Compensation Unit for a period of 24 months ‎from the Closing Date. Each Compensation Unit shall be comprised of one common share in the capital of ‎the Corporation and one common share purchase warrant (each a ‎‎“Compensation Unit Warrant”). Each Compensation Unit Warrant shall entitle the holder thereof to ‎purchase one common share in the capital of the Corporation (each a “Compensation Warrant Share”) ‎at a price of $0.07 per Compensation Warrant Share for the period of 36 months from the Closing Date.‎‎ The Company has also agreed to pay the Agent a corporate finance fee equal to ‎‎$20,000, payable in cash on the Closing Date.

The closing date of the Offering is expected to occur on or about February 28, 2020 (the “Closing Date”), and is subject to a number of conditions, including, without limitation, receipt of all regulatory approvals. All securities issued pursuant to the Offering are subject to a statutory hold period of four months and one day.

This press release shall not constitute an offer for the sale of securities, nor a solicitation for offers to buy securities in any jurisdiction. The securities referred to in this press release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, or state securities laws 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. federal and state registration or an applicable exemption from the U.S. registration requirements. 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 cannabis life sciences company focused on the research, development and commercialization of novel cannabinoid-based products. Revive’s novel cannabinoid delivery technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory and liver diseases. For more information, visit www.ReviveThera.com.

For more information please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.

Tel: 905.605.5535
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. Actual future results may differ materially. Forward looking information in this press release includes information with respect to the proposed Offering, including the amount of proceeds expected to be raised, the timing for closing, the receipt of required regulatory approvals and the intended use of proceeds. Although Revive believes the assumptions underlying these statements are reasonable, they may prove to be incorrect. Forward-looking information 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. Factors that may cause actual results to differ materially from those anticipated by these forward looking statements include: uncertainties associated with obtaining regulatory approvals; the need to establish additional corporate collaborations, distribution or licensing arrangements; the Company’s ability to raise additional capital if and when necessary; intellectual property disputes; increased competition from pharmaceutical and cannabis-centred companies; changes in equity markets, inflation, and changes in exchange rates; and other factors, including the risk factors discussed or referred to in the Company’s disclosure documents filed with the securities regulatory authorities in certain provinces of Canada and available at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. Except as required by law, Revive disclaims any intention and assumes no obligation to update or revise any forward-looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking statements or otherwise.