• Phase 3 clinical trial ongoing with next DSMB meeting at 600 completed patients.
• Currently at 41 clinical sites and to engage a minimum of 50 clinical sites.
• Aim to complete enrollment in Q3-2021 and FDA EUA submission in late-Q3/Q4-2021.
• Preparing commercial activities for international drug approvals.

TORONTO, July 15, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19.

The Study is a randomized, double-blind, placebo-controlled trial and the safety and efficacy data at each remaining interim analysis timepoint, which currently are 600 and 800 completed patients, are only made available to the Independent Data and Safety Monitoring Board (“DSMB”) for review and recommendations on continuation, stopping or changes to the conduct of the Study.

The next DSMB meetings will take place at 600 and 800 completed patients, which are expected to be held in Q3-2021. The Company is continuing the Phase 3 clinical trial with the recent recommended 600 mg high dose as selected by the DSMB.

To date, the ongoing Study has not seen any serious adverse events or safety concerns that required the DSMB to be notified or take action on. In the event of any serious safety concerns, the DSMB would be notified to determine any risks and provide its recommendations.

The Company currently has partnered with 40 clinical sites in fourteen states including: Alabama, Arkansas, California, Florida, Georgia, Illinois, Michigan, Nevada, New York, North Carolina, Ohio, South Carolina, Tennessee and Texas; also one clinical site in Puerto Rico. Revive will continue to expand to a minimum of 50 clinical sites within the current states and in COVID-19 hot spot states.

Further to the DSMB review and recommendations on each interim analysis periods, the Company is preparing for the potential of filing an Emergency Use Authorization (“EUA”) with the FDA in the event that the blinded results provide evidence to the DSMB to recommend to pursue EUA for Bucillamine to treat mild to moderate COVID-19. The Company is on track to meet its planned enrollment goal for the Study in Q3-2021 and aim to file EUA with the FDA.

The Company is in discussions with reputable international pharmaceutical companies seeking to obtain commercial rights to Bucillamine as a treatment for COVID-19 in various countries in Europe, India and Asia. In light of these discussions, Revive is pursuing a commercialization plan that would leverage the clinical results from the U.S. Phase 3 study to allow for drug approvals globally.

Michael Frank, CEO of the Company commented, “We are pleased with the status of our Phase 3 study in COVID-19 with the aim to seek EUA approval from the FDA for Bucillamine in the treatment of mild to moderate COVID-19 patients. We have made tremendous progress over the last few months by engaging over 40 clinical sites and completing patient enrollment to meet its completed and future DSMB interim analysis timepoints which will allow for the Study to continue and to have potential to seek EUA approval from the FDA. We are continuing to add to our clinical site roster in the U.S. and patient enrollment that would expedite the completion of the Phase 3 study. Also, we are in discussions with international pharmaceutical companies seeking to obtain commercialization rights in various countries around the world.”

About the Phase 3 Clinical Trial (ClinicalTrials.gov Identifier: NCT04504734)

The Phase 3 confirmatory clinical trial titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, will enroll up to 1,000 patients that will be randomized to Bucillamine or Placebo for up to 14 days. The primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of the first dose through Day 28 following randomization. Efficacy will be assessed by comparing clinical outcomes (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID-19 between patients receiving standard-of-care plus Bucillamine 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. 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.

About Revive Therapeutics Ltd.

Revive Therapeutics Ltd. (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R) is a biotech company focused on the research, development and commercialization of therapeutics for infectious diseases and rare disorders, and psychedelics to treat mental health and substance abuse disorders. Revive prioritizes its drug development programs to take advantage of various regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track and Breakthrough Therapy designations, as well as Emergency Use Authorizations. Currently, the Company is exploring the use of an oral drug, Bucillamine, for the potential treatment of infectious diseases, with an initial focus on COVID-19, which is currently being evaluated in an FDA Phase 3 clinical trial to treat mild to moderate COVID-19. The Company has a robust psychedelics pharmaceutical program with the development of an oral thin film strip delivering psilocybin to treat mental health and substance abuse disorders and advancing the novel use of psilocybin to treat traumatic brain injury and stroke. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the Company was granted FDA orphan drug designation for the use of Cannabidiol to treat autoimmune hepatitis and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts 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 Company’s cannabinoids, psychedelics and infectious diseases programs. 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, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

TORONTO, June 25, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF, FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that its common shares have been approved for trading on the OTCQB^® Market (“OTCQB”) effective Monday June 28, 2021.

The Company’s U.S. listing will trade under the symbol “RVVTF” while the Company’s primary Canadian listing will continue to trade on the Canadian Securities Exchange under “RVV”.

Michael Frank, CEO of the Company commented, “We are focused on completing our Phase 3 study in COVID-19 with the aim to seek EUA approval from the FDA for Bucillamine in the treatment of mild to moderate COVID-19 patients, and advancing our proprietary psychedelics program in developing novel uses and delivery forms of psilocybin to treat mental health and substance abuse disorders. With our common shares listed on the OTCQB it will help us to broaden our awareness and shareholder base with institutional and retail investors in the U.S.”

Investors can find real-time quotes and market information on the Company at https://www.otcmarkets.com/stock/RVVTF/overview.

About Revive Therapeutics Ltd.

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

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts 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 Company’s cannabinoids, psychedelics and infectious diseases programs. 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, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

TORONTO, June 17, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF, Frankfurt: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has entered into an agreement with the University of Health Sciences Antigua (“UHSA”) to collaborate on utilizing Revive’s novel psychedelic-assisted therapies and pioneering the clinical research and development of psychedelics in Antigua and Barbuda.

“We are excited to partner with UHSA as the relationship complements and accelerates our research and commercial goals with psychedelics and advances our patented drug delivery technology to deliver psychedelics in an oral thin film patch and topical forms in human clinical studies to support regulatory approvals globally,” said Derrick Welsh, COO of Psilocin Pharma, a division of the Company.

Dr. Adedayo Akande, President of UHSA, commented: “Through our partnership with Revive Therapeutics, we have the unique opportunity to become a regional leader in the research of psychoactive therapies for mental health. Our medical students will now have access to the scientific knowledge and uses of treatments long before joining the physician workforce, which is a great benefit. We too are excited to partner with Revive as we contribute to the future of medicine.”

As part of the proposed collaboration, Revive and UHSA aims to accomplish the following activities:

• Development of a Psychedelic treatment center in Antigua and Barbuda using Revive’s novel formulations and delivery forms of psychedelics, including its proprietary psilocybin oral-thin film product to treat mental health and substance abuse disorders;
• Research on UHSA’s campus will exclusively use Revive’s intellectual property, developed at the University of Wisconsin-Madison, with the aim to be the foundation for novel psychedelic therapies for research and commercial use in Antigua and Barbuda;
• Conduct clinical studies to support regulatory drug approvals in the Caribbean and to accelerate U.S. FDA clinical development plans; and
• Establishment of a Master’s in Psychedelic Medicine for Doctor of Medicine students and for those seeking to expand their knowledge of the field of psychedelic medicine.

Founded in 1982, the University of Health Sciences Antigua located in Dow’s Hill, Piccadilly Antigua is an outstanding academic institution dedicated to educating exemplary physicians, nurses, postgraduates, and researchers in accordance with the highest professional standards who will integrate clinical, biomedical and behavioral knowledge to promote the health and well-being of patients and communities. For more information, visit www.UHSA.ag.

About Revive Therapeutics Ltd.

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

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts 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 Company’s cannabinoids, psychedelics and infectious diseases programs. 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, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

TORONTO, June 14, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF, Frankfurt: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, today announced that Derrick Welsh, COO of Psilocin Pharma Corp., a division of the Company, will be presenting at the H.C. Wainwright Psychedelics in Psychiatry and Beyond Virtual Conference on June 17, 2021.

The corporate presentation will be available on-demand starting at 7:00 am ET. For more information about this event and to attend, visit: https://hcwevents.com/psychedelics/.

For more information on Revive, visit https://www.revivethera.com/.

About Revive Therapeutics Ltd.

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

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts 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 Company’s cannabinoids, psychedelics and infectious diseases programs. 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, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

TORONTO, June 08, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF, Frankfurt: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has entered into a memorandum of understanding dated June 7, 2021 with Supriya Lifescience Ltd. (“Supriya”), a specialty pharmaceutical company based in India, to pursue manufacturing of the API, conducting clinical registration and commercialization for Bucillamine to treat COVID-19 through Emergency Use Authorization (“EUA”) in India. The relationship also sets the foundation for Revive to expand commercialization efforts globally by leveraging Supriya’s extensive manufacturing and commercial network and Revive’s ongoing US FDA Phase 3 clinical study results of Bucillamine to treat mild-to-moderate COVID-19.

“While our Phase 3 clinical study for COVID-19 is ongoing in the USA, we  are laying the ground work by partnering with Supriya to execute on our global manufacturing and commercialization plans and leveraging their regulatory expertise and commercial reach with 78 countries they currently supply pharmaceutical products to,” said Michael Frank, CEO of Revive. “We are focused on completing our current Phase 3 study in the USA and also obtaining EUA. These results will support drug approval registrations globally, including India, Europe, and Canada.”

Dr. Satish Wagh, CMD, Supriya Lifescience Ltd. said, “Through this collaboration, we aim to join our forces with Revive  to accelerate access to Bucillamine in India at a time when it is most needed. This is a step towards making more treatment options available to patients in India in dealing with the pandemic. With this partnership, Supriya aims to enter into a niche area of chemistry and products thereby bolstering its CMO and research capabilities.”

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 Supriya Lifescience Ltd.

Based in Mumbai, India, Supriya Lifescience Ltd. is EUGMP and USFDA approved manufacturer and supplier of active pharmaceuticals ingredients and pharmaceutical products. Supriya exports to 78 countries (in Fiscal 2021) and has niche product offerings of 39 APIs focused on diverse therapeutic segments such as antihistamine, analgesic, anesthetic, vitamin, anti-asthmatic and anti-allergic. Supriya’s manufacturing facility is approved by various international regulatory authorities such as USFDA, EUGMP, EDQM, SFDA NMPA, ANVISA, KFDA, PMDA, TGA and Taiwan FDA. For more information, visit www.supriyalifescience.com.    

About Revive Therapeutics Ltd.

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

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts 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 Company’s cannabinoids, psychedelics and infectious diseases programs. 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, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

Supriya Lifescience Limited is proposing, subject to receipt of requisite approvals, market conditions and other considerations, an initial public offering of its equity shares (the “Equity Shares”) and has filed a draft red herring prospectus dated May 15, 2021 (the “DRHP”) with the Securities and Exchange Board of India (“SEBI”) and with the Registrar of Companies, Maharashtra at Mumbai. The DRHP is available on the website of SEBI at www.sebi.gov.in and the website of the Lead Managers at www.icicisecurities.com and www.axiscapital.co.in, and the websites of BSE Limited and National Stock Exchange of India Limited at www.bseindia.com and www.nseindia.com, respectively.