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Revive Therapeutics Receives FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation

Revive Therapeutics Receives FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation

TORONTO, Feb. 15, 2022 – 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 announce that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) for Bucillamine for the prevention of ischemia–reperfusion injury (“IRI”) during liver transplantation.  

Michael Frank, CEO of Revive commented: “We are very pleased to receive orphan drug designation from the FDA for Bucillamine for the prevention of ischemia–reperfusion injury during liver transplantation. The ODD validates our strategy in pursuing novel uses of Bucillamine for rare disorders and life-threatening conditions, including infectious diseases and preventing IRI during other organ transplantations.”

Currently, there is no approved treatments available for IRI. Liver ischemia-reperfusion injury is a major complication of liver transplantation and is one of the leading causes for post-surgery hepatic dysfunction leading to an increased risk of post-operative morbidity and mortality. According to the United Network for Organ Sharing (“UNOS”) there were 8,906 liver transplants in 2020 and at the time of the ODD submission there were 11,664 on the waiting list for a liver transplant. Although many therapeutic strategies have been shown to be effective in controlled experimental models, most have yielded equivocal results in clinical practice or have yet to reach human clinical trials.        

Revive believes the use of Bucillamine during liver transplantation has the potential to be a safe and effective approach to address the unmet medical need for a novel strategy to limit or prevent IRI. Bucillamine, a cysteine derivative that contains two donatable thiol groups, in the context of IRI is capable of replenishing the thiol group in glutathione, thereby reactivating this endogenous defense against oxidant injury. In addition, Bucillamine appears to have anti-inflammatory effects unrelated to its antioxidant effect. Bucillamine has the potential to address the shortage of quality organs by reducing the susceptibility to IRI of steatotic livers thereby making these livers available for transplants. Bucillamine also has the potential to improve graft function and patient outcome by preventing or lessening IRI.

The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). The FDA grants ODD status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. ODD would qualify bucillamine for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately USD $2,400,000.

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 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, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com. 

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

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

  • Ethics Committee approval to proceed with Phase 3 clinical trial in Turkey
  • 13 clinical sites selected to date in Turkey

TORONTO, Feb. 14, 2022 – 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”) (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.

The Company, in collaboration with Delta Health, has recently received approval for the Study by the Ethics Committee of Istinye University in Turkey where the study activities are ongoing. The Company is working with MLP Care, the largest hospital group in Turkey, and Istinye University with access to 30 clinical research sites and over 6000 in-patient hospital beds.

The Company has initially selected the following 13 clinical research sites in Turkey:

  • Istinye University Faculty of Medicine
  • Liv Hospital Vadi İstanbul
  • VM Medical Park Samsun Hospital
  • Liv Hospital Samsun
  • Medical Park Ankara Hospital
  • VM Medical Park Maltepe Hospital
  • Istinye University Research Hospital
  • Medical Park Göztepe Hospital Complex
  • Aydin University Research Hospital
  • VM Medical Park Pendik Hospital
  • Medical Park Bahçelievler Hospital
  • VM Medical Park Mersin Hospital
  • Medical Park Antalya Hospital Complex

Covid-19 infections in Turkey continues to grow. Turkey has recorded 12.8 million Covid-19 infections and about 90,000 deaths. The seven-day average of daily Covid-19 infections and Covid-19 deaths is approximately 98,000 and 250, respectively.

Michael Frank, CEO of the Company commented, “Our expansion to Turkey is important to our enrollment goals and commercialization initiatives in the U.S. and international markets.”

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

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its 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 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, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

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

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

  • 701 subjects dosed to date
  • Initiating enrollment activities in Turkey as part of its clinical diversification plans to support global regulatory approvals
  • On-track to complete enrollment in Q1-2022 and FDA submission thereafter
  • Commencing regulatory package activities for submission to international regulatory authorities for drug approvals

TORONTO, Jan. 18, 2022 – 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”) (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.

A total of 701 subjects have been dosed to date in the Study. The Company, in collaboration with Delta Health, has initiated the enrollment activities in Turkey at MLP Care, the largest hospital group in Turkey, and Istinye University with access to 30 research sites and over 6000 in-patient hospital beds.

The Study’s expansion into Turkey complements the Company’s global commercialization plan for Bucillamine as a potential treatment for mild to moderate COVID-19. As previously reported, in light of Phase 3 clinical studies and FDA approvals of oral antiviral treatments by Pfizer and Merck, it was evident that to improve the Study’s outcome, a diversified patient population from different countries is important to support future global regulatory submissions. In addition, a diversified subject population supports ongoing discussions with pharmaceutical companies in Turkey and international markets.

The Company is on-track to complete study enrollment in Q1-2022. Also, the Company is preparing its regulatory package for submission to the FDA and international regulatory authorities for drug approvals thereafter.

Michael Frank, CEO of the Company commented, “We are now in the final stages in our Phase 3 study and we are focused on completing enrollment, preparing the regulatory packages for the FDA and international health authorities, and negotiating manufacturing and marketing agreements with pharmaceutical companies for commercialization.”

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

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its 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 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, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

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Revive Therapeutics Provides Update of Psilocybin Pharmaceutical Programs

Revive Therapeutics Provides Update of Psilocybin Pharmaceutical Programs

IRB approval to initiate Phase 2 study for methamphetamine abuse disorders

Advancing psilocybin oral thin film, microneedle patch and biosynthesis programs

TORONTO, Jan. 17, 2022 – 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 psilocybin pharmaceutical development programs.

“Revive is building a specialty psilocybin-based product pipeline to treat mental illness, substance abuse and neurological disorders. We are embarking on our first clinical study evaluating psilocybin in the treatment of methamphetamine use disorder and advancing the development of an oral psilocybin thin file strip and psilocybin microneedle patch, which will offer flexible therapeutic solutions of psilocybin for unmet medical needs.”

Psilocybin for Methamphetamine Use Disorder

The Company is evaluating psilocybin as a potential treatment for methamphetamine use disorder with the University of Wisconsin-Madison through a clinical trial agreement. Under an investigator-initiated IND, led by Dr.’s Christopher Nicholas and Paul Hutson, the Phase I/II clinical study to evaluate the safety and feasibility of psilocybin in adults with methamphetamine use disorder received Institutional Review Board (“IRB”) approval. As a result of the study, clinical data will provide proprietary and valuable information on the safety, efficacy and dosing of psilocybin to support future pivotal FDA clinical studies in the Company’s proposed oral psilocybin thin film strip. The clinical study will be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy. In addition, the Company will have exclusive access to key intellectual property from this study to support development, regulatory and commercial initiatives.

Psilocybin for Stroke

The Company is evaluating psilocybin as a potential treatment for stroke with the University of Wisconsin-Madison. Under the same investigator-initiated IND, led by Dr.’s Christopher Nicholas and Paul Hutson, the proposed Phase I/II clinical study protocol to evaluate the safety and feasibility of psilocybin for stroke is expected to be submitted to the IRB in February. As a result of the study, clinical data will provide proprietary and valuable information on the safety, efficacy and dosing of psilocybin to support future pivotal FDA clinical studies in the Company’s proposed oral psilocybin thin film strip. The clinical study will be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy. In addition, the Company will have exclusive access to key intellectual property from this study to support development, regulatory and commercial initiatives.

Psilocybin Oral Thin Film Strip        

The Company has initiated the product development program under a feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary psilocybin oral thin film strip for mental illness, substance abuse and neurological disorders. Research prototype development is underway to support IND-enabling studies with the expectation to conduct a clinical study in Q4-2022.

Psilocybin Microneedle Patch        

The Company entered into a research collaboration agreement with PharmaTher Holdings Ltd. (“PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM) to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle patch technology for neuropsychiatric disorders. The project plan has been finalized and the Company will initiate IND-enabling studies with the expectation to conduct a clinical study in Q4-2022.

Psilocybin Biosynthesis        

The Company is developing a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform under its research collaboration with North Carolina State University developed by Dr. Gavin Williams, Professor and Researcher at NC State. The biosynthetic platform provides a potentially simple and efficient method for rapidly producing natural products, such as psilocybin, using an engineered enzymatic pathway in E. coli. Certain technical milestones have been achieved to date, offering a clear path towards completing validation methods to demonstrate a novel yet simple production process of biosynthetic psilocybin that can be used at a critical scale for clinical and commercial use. The Company expects to complete a research-grade batch of psilocybin for research in Q2-2022 with the aim to conduct clinical studies in 2023.

Psilocybin International Research        

The Company entered into an agreement with the University of Health Sciences Antigua to utilize Revive’s novel psychedelic-assisted therapies, including its tannin-chitosan delivery system and to pioneer the clinical research and development of psychedelics in Antigua and Barbuda. Clinical research is expected to begin shortly with the aim for commercialization in 2022 in Antigua and Barbuda. Once approved for sale, the Company will seek commercial partnerships with specialty pharmaceutical companies in the Caribbean and Latin America.

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 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 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, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

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Revive Therapeutics Clarifies Status of Its Phase 3 Clinical Trial for Bucillamine in COVID-19

Revive Therapeutics Clarifies Status of Its Phase 3 Clinical Trial for Bucillamine in COVID-19

  • Approximately 700 subjects participated in the enrollment period
  • Expected to begin subject enrollment in Turkey by mid-February
  • Expected to complete enrollment in Q1-2022

TORONTO, Jan. 06, 2022 – 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, wishes to clarify certain disclosures in its press release titled “Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19,” issued on December 29, 2021 that provided an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.

As of December 29, 2021, there were approximately 700 subjects that participated in the enrollment period of the Study. In addition, the Company has begun the process to expand the Study’s patient population in Turkey in collaboration with Delta Health, which will add research sites from the largest hospital group in Turkey, MLP Care and Istinye University.

The Company expects patient enrollment in Turkey to occur by mid-February and completion of the Study’s enrollment in Q1-2022.

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

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its 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, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

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

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

  • Screened approximately 700 subjects and expanding to Eastern Europe, including Turkey, as part of its clinical diversification plans to support global regulatory approvals
  • No serious adverse events and safety concerns reported to date in the Phase 3 clinical trial
  • Expected to complete enrollment in Q1-2022

TORONTO, Dec. 29, 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”) (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.

To date, the Study has screened approximately 700 subjects. The Independent Data and Safety Monitoring Board supported the continuation of the Study in its last meeting as there were no serious adverse events or safety concerns.

In light of Phase 3 clinical studies and FDA approvals of oral antiviral treatments by Pfizer and Merck, it was evident that to ensure a diversified patient population to support future global regulatory submissions for Bucillamine, including the FDA, the Company has decided to fill a part of its patient enrollment quota outside of the U.S. and target Eastern Europe, such as in Turkey, where the reported cases of COVID-19 are high with 32,176 new COVID-19 infections reported on December 28, 2021 (https://covid19.saglik.gov.tr/TR-66935/genel-koronavirus-tablosu.html). In addition, the Company in collaboration with Delta Health will add research sites from the largest hospital group in Turkey, MLP Care and Istinye University, which has 30 directly owned hospitals in 15 cities and its affiliated university medical centers (including state-of-the-art certified laboratories) for a combined capacity of over 6000 in-patient hospital beds across Turkey.

As a result of the Company’s plans to diversify its patient population globally, incorporate viral load and anti-inflammatory markers, and its ongoing discussions with international pharmaceutical companies seeking to obtain commercial rights to Bucillamine as a treatment for COVID-19 in various countries in Europe, India and Asia, the Phase 3 clinical study enrollment completion period is expected in Q1-2022. The Company still expects to file an Emergency Use Authorization (“EUA”) with the FDA if the blinded results provide evidence to the DSMB’s final review to recommend to pursue EUA for Bucillamine to treat mild to moderate COVID-19.        

Michael Frank, CEO of the Company commented, “We are now focused on completing the Phase 3 study in a manner which will provide practical antiviral, anti-inflammatory and a diversified patient population. With the recent onset of the Omicron variant we have made some of the above adjustments to the trial.”        

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

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its 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 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, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

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Revive Therapeutics Expands Bucillamine Research to Treat Omicron Variant and Adds Inflammatory Markers to FDA Phase 3 Clinical Trial

Revive Therapeutics Expands Bucillamine Research to Treat Omicron Variant and Adds Inflammatory Markers to FDA Phase 3 Clinical Trial

  • Expanding the potential of Bucillamine as an effective treatment for Omicron variant (B.1.1.529)
  • Bucillamine shown to inhibit SARS-CoV-2 infection in vitro for the Delta variant (B.1.617.2)
  • Adding inflammatory markers along with viral load testing to current Phase 3 clinical study for COVID-19 aiming to strengthen Bucillamine’s profile as both an anti-viral and anti-inflammatory agent for infectious diseases

TORONTO, Dec. 03, 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 announce that the Company has decided to expand research with Bucillamine, an oral drug shown to have promising anti-viral and anti-inflammatory capabilities and is being evaluated in a current Phase 3 clinical study for COVID-19, as a potential treatment for the Omicron variant (B.1.1.529).

The expansion to explore Bucillamine’s therapeutic potential for the Omicron variant is supported from a recent research study published, titled “Thiol drugs decrease SARS-CoV-2 lung injury in vivo and disrupt SARS-CoV-2 spike complex binding to ACE2 in vitro” from the University of California, San Francisco, which revealed that potent thiol drugs, like Bucillamine, inhibit SARS-CoV-2 infection in vitro, specifically the Delta variant (B.1.617.2) and also reduces SARS-CoV-2-related lung injury in vivo and provides a strong rationale for trials of systemically delivered thiol drugs as COVID-19 treatments. In addition, thiol-based drugs, like Bucillamine, have been shown in research models to decrease the binding of SARS-CoV-2 spike protein to its receptor, decrease the entry efficiency of SARS-CoV-2 spike pseudotyped virus, and inhibit SARS-CoV-2 live virus infection. The Company supported recent research to explore the utility of thiol-based drugs under its sponsored research agreement with the University of California, San Francisco (“UCSF”) in the laboratory of Dr. John Fahy. For a copy of the research paper, visit https://www.biorxiv.org/content/10.1101/2020.12.08.415505v2.full.pdf

In a study that evaluated the role of pro-inflammatory cytokines that are highly upregulated in patients with COVID-19 in inducing inflammatory cell death, inflammation, tissue and organ damage, and mortality showed that the specific combination of tumor necrosis factor α (TNF-α) and interferon γ (IFN-γ) is critical for these processes. Furthermore, it was found that inhibiting TNF-α and IFN-γ protected against death in SARS-CoV-2 infection and models of sepsis, hemophagocytic lymphohistiocytosis (HLH), and cytokine shock, suggesting that this pathway can be applicable beyond COVID-19 in infectious and inflammatory diseases where TNF-α and IFN-γ-mediated inflammatory cell death drive the pathology (Karki, Rajendra et al. 2020).

There is evidence that Bucillamine inhibits pro-inflammatory cytokine production and transendothelial T-cell migration, both of which could further dampen disease course in COVID-19 (Horowitz LD. 2003, Munakata Y. 2000). As a result of the research and the rise of the Delta variant and Omicron variant, the Company has decided that in addition to incorporating viral load testing, which it announced on November 16, 2021, it will also be adding inflammatory markers to complement the ongoing Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT04504734) evaluating the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19. These inflammatory markers will allow the Company to understand Bucillamine’s potential as an anti-inflammatory agent in the treatment course and provide confidence in the potential utility and effectiveness of Bucillamine in COVID-19.

Michael Frank, CEO of the Company, commented, “Bucillamine has thus far shown in published research to be agnostic as a potential treatment to certain COVID-19 variants, including the Delta variant, and with the rise of the Omicron variant, we are motivated in expanding research with Bucillamine to explore its therapeutic utility for the Omicron variant. In addition, we are incorporating inflammatory markers to complement the viral load testing to our remaining patients in our ongoing Phase 3 study to support Bucillamine as a safe and effective anti-inflammatory and anti-viral oral agent for mild to moderate COVID-19.”

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

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its 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, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

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Revive Therapeutics Files for FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation

Revive Therapeutics Files for FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation

TORONTO, Nov. 23, 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 announce it has filed an application with the U.S. Food and Drug Administration (“FDA”) to receive Orphan Drug Designation (“ODD”) for Bucillamine for the prevention of ischemia–reperfusion injury (IRI) during liver transplantation.

Currently, there is no approved treatments available for IRI. Liver ischemia-reperfusion injury is a major complication of liver transplantation and is one of the leading causes for post-surgery hepatic dysfunction leading to an increased risk of post-operative morbidity and mortality. According to the United Network for Organ Sharing (“UNOS”) there were 8,906 liver transplants in 2020 and at the time of the ODD submission there were 11,664 on the waiting list for a liver transplant. Although many therapeutic strategies have been shown to be effective in controlled experimental models, most have yielded equivocal results in clinical practice or have yet to reach human clinical trials.

Revive believes the use of Bucillamine during liver transplantation has the potential to be a safe and effective approach to address the unmet medical need for a novel strategy to limit or prevent IRI. Bucillamine, a cysteine derivative that contains two donatable thiol groups, in the context of IRI is capable of replenishing the thiol group in glutathione, thereby reactivating this endogenous defense against oxidant injury. In addition, Bucillamine appears to have anti-inflammatory effects unrelated to its antioxidant effect. Bucillamine has the potential to address the shortage of quality organs by reducing the susceptibility to IRI of steatotic livers thereby making these livers available for transplants. Bucillamine also has the potential to improve graft function and patient outcome by preventing or lessening IRI.

Michael Frank, CEO of Revive commented: “We are continuing to advance novel uses of Bucillamine not only as a treatment for infectious diseases, but also for rare conditions that have no treatment options such as IRI. The FDA orphan drug application for Bucillamine as a potential solution in preventing IRI during liver transplantation and subsequently to other organ transplants complements our overall strategy of developing Bucillamine as a strong platform for other conditions.”

The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). The FDA grants ODD status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. ODD would qualify bucillamine for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately USD $2,400,000.

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 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, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

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HAVN Life Successfully Exports Psilocybin From Its Jamaica Facility Into Canada

HAVN Life Successfully Exports Psilocybin From Its Jamaica Facility Into Canada

The Company Signs Supply Agreement with Nectar Health Sciences Laboratory Division Inc. to provide naturally derived psilocybin for research and development of therapeutic products

Vancouver, BC – Havn Life Sciences Inc. (CSE: HAVN) (OTC: HAVLF) (FSE: 5NP) (the “Company” or “Havn Life”)a biotechnology company pursuing standardized extraction of psychedelic compounds for the creation of APIs that support brain health and enhance the capabilities of the mind, is pleased to announce it has successfully exported naturally derived psilocybin from its facility in Jamaica.

The importation of the naturally derived psilocybin into Canada was completed after the Company entered into a supply agreement with Nectar Health Sciences Laboratory Division Inc., a wholly-owned subsidiary of Psilobrain Therapeutics Inc. Based out of Victoria, British Columbia, Nectar Health Sciences Laboratory Division Inc. has a Controlled Substance Dealer’s License for the relevant psychedelic compounds issued by Health Canada. Under that license, Nectar was granted an import permit, pursuant to the provisions of the Controlled Drugs and Substances Act and the Food and Drugs Regulations.

The agreement with Nectar Health Sciences Laboratory Division Inc. paves the way for HAVN Life’s successful exportation of naturally derived psilocybin from Jamaica. Additionally, it validates the Company’s supply chain business model of providing psilocybin for clinical use and research, adding to previously announced supply partnerships this year with Mycrodose Therapeutics, Mycotopia Therapies, Cube Psytech, Allied Health, ATMA Journey Centers, Revive Therapeutics and HealthTech Connex.

“This partnership is a huge win for us as we look to secure additional supply agreements with Canadian companies, now that the integrity of our supply chain from Jamaica has been demonstrated,” says HAVN Life CEO, Tim Moore. “As the research and drug development work on psilocybin moves forward, HAVN Life continues to position itself as a supply chain leader, able to meet the demand for naturally derived psilocybin,” he adds.

“We are pleased to be one of HAVN Life Sciences preferred supply partners,” says Kevin Coft, CEO of Psilobrain Therapeutics Inc. “Our Nectar Health Sciences Laboratory Division has been at the forefront of synthetic psychedelic research, and our supply agreement with HAVN Life Sciences compliments and initiates our next stage of comprehensive testing, analytics, extraction, and product development from psychedelic mushrooms cultivated and processed under stringent quality control protocols,” he adds.

The agreement and supply of psilocybin to Nectar Health Sciences Laboratory Division Inc. will be in compliance with all applicable Health Canada regulations.

###

 On Behalf of The Board of Directors
Tim Moore
Chief Executive Officer

About Psilobrain Therapeutics Inc.

Psilobrain Therapeutics Inc. is a Canadian biotech company that draws on the latest advances in psychedelic medicine to produce scientifically designed products to facilitate evidence-based healing and wellness. Backed by our 3 Health Canada licenses, we ensure the highest quality of standard by integrating and controlling all aspects of the supply chain from sourcing our naturally derived psilocybin for research-developed formulations through our licensed R&D laboratory.

Psilobrain is committed to our Drug Development Program, with 3 provisional patents and numerous preclinical studies in various stages of research and data collection. and is an active contributor in the pharmaceutical, nutraceutical and psychedelic wellness industries. In addition to drug development, Psilobrain has partnered with Psychedelic Wellness Clinics to support emerging psychedelic therapies by collaborating with Clinical Counsellors on psychedelic prescription research, product development & data collection.

Our Management and Advisory team are industry veterans in the pharmaceutical & consumer goods industries. Members of our team have held C-suite and other senior positions within companies such as Med BioGene, Aspreva Pharmaceuticals, Teva Pharmaceutical Industries, Mount Sinai, Social Creatures, Green Sky Labs, Jimmy Pattison Group, and the British Columbia Association of Clinical Counsellors. Psilobrain Therapeutics is committed to our research-based approach of developing new modalities for healing and is well-positioned to bring that wellness to the community.

About HAVN Life Sciences Inc.

HAVN Life Sciences is a biotechnology company pursuing standardized extraction of psychedelic compounds for the creation of APIs, the development of natural health products, and innovative therapies to support brain health and enhance the capabilities of the mind.

Through its research division, HAVN Labs, the company has developed an end-to-end supply chain of standardized, naturally derived psychedelic compounds for research that will define the future of modern medicine. With its new line of natural health products, HAVN Life offers a full range of high-quality mushroom and plant extracts that help boost immune function, reduce inflammation and support a healthy lifestyle.

Purchase our products and find out more at yourhavnlife.com, and follow us on Facebook, Twitter,  Instagram and Youtube.

Contact:

Investor Relations: ir@havnlife.com  604 687-7130
Media: savi@emergence-creative.com 647 896-8078

Forward-Looking Information: This news release contains “forward-looking information” within the meaning of applicable securities laws relating to statements regarding the supplying agreement with Nectar Health Sciences Laboratory Division Inc. (the “Supply Agreement”), the exportation and importation of psilocybin-containing mushrooms, compliance with Health Canada regulations (the “Health Canada Compliance”), the Company’s business, products and future of the Company’s business. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking information. Such forward-looking statements are subject to risks and uncertainties that may cause actual results, performance and developments to differ materially from those contemplated by these statements depending on, among other things, the risk that the anticipated benefits of the Supply Agreement will not be realized as contemplated, or at all, risks that the continued exportation and importation of psilocybin-containing mushrooms may not be completed as contemplated, or at all, risks that the Company may not be able to obtain or maintain Health Canada Compliance as contemplated, or at all, risks that the Company’s products and plan will vary from those stated in this news release and the Company may not be able to carry out its business plans as expected. Except as required by law, the Company expressly disclaims any obligation and does not intend to update any forward-looking statements or forward-looking information in this news release. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. The statements in this news release are made as of the date of this release.

The CSE has not reviewed, approved or disapproved the content of this press release

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Revive Therapeutics Announces Published Research Results on Bucillamine as Potential Inhibitor of SARS-CoV-2 Infection Delta Variant

Revive Therapeutics Announces Published Research Results on Bucillamine as Potential Inhibitor of SARS-CoV-2 Infection Delta Variant

TORONTO, Nov. 16, 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, announced today a research study, titled “Thiol drugs decrease SARS-CoV-2 lung injury in vivo and disrupt SARS-CoV-2 spike complex binding to ACE2 in vitro” from the University of California, San Francisco, showing that potent thiol drugs, like Bucillamine, inhibit SARS-CoV-2 infection in vitro, specifically the Delta variant (B.1.617.2), which is now globally dominant, and also reducing SARS-CoV-2-related lung injury in vivo and providing strong rationale for trials of systemically delivered thiol drugs as COVID-19 treatments. In addition to its anti-oxidant and anti-inflammatory properties that could limit lung injury in COVID-19, thiol drugs have promising antiviral effects.

The Company is currently exploring oral Bucillamine in a Phase 3 clinical study to treat mild-to-moderate COVID-19, and based on the published paper and the University work, the Company will also seek to develop a reformulated version of Bucillamine as a potential treatment for severe COVID-19 disease and related infectious diseases.

“We are excited to see another published paper supporting potent thiol drugs, like Bucillamine, for COVID-19, including the Delta variant, as we continue in our Phase 3 clinical study with Bucillamine to treat mild-to-moderate COVID-19. We are also gathering new scientific evidence to support Bucillamine’s potential for severe COVID-19,” said Michael Frank, CEO of the Company.

The research work was funded by an intramural grant from UCSF -The COVID-19 Rapid Response Pilot Grant Initiative Funding Collaborative (JVF), a research grant from Revive Therapeutics (JVF) and the US National Institutes of Health P01 HL128191 (JVF).

For a copy of the research paper, visit https://www.biorxiv.org/content/10.1101/2020.12.08.415505v2.full.pdf

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

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its 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, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.