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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

The Company submits Data Access Plan to the FDA to determine potential new clinical endpoints to support Emergency Use Authorization

TORONTO, June 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, 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.

Following the Company recently receiving positive comments from the FDA in regards to the Company’s request to determine and agree on the Study’s potential new primary efficacy endpoints, the Company has now submitted a Data Access Plan to the FDA with the aim to unblind the pre-dose selection data and submit the amended Study protocol with the new primary efficacy endpoints. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization. The FDA has agreed that the Company may unblind the pre-dose-selection data for the first 210 patients of the Study to further support the new primary endpoint.

In addition, the Data Safety and Monitoring Board (“DSMB”) are scheduled to meet thereafter to evaluate the interim clinical and safety data and may make a recommendation on continuing the Study or advise on halting the Study early due to positive efficacy based on other clinical outcomes such as the rate of sustained clinical resolution of symptoms of COVID-19. The DSMB supported the continuation of the Study in its last meeting as there were no serious adverse events or safety concerns reported.

The Company believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant, there is an urgent need to treat symptom resolutions in addition to preventing hospitalizations.

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 Advances Inflammatory Liver Disorders Programs for Autoimmune Hepatitis and Liver Transplantation

Revive Therapeutics Advances Inflammatory Liver Disorders Programs for Autoimmune Hepatitis and Liver Transplantation

WHO reports 650 probable cases of acute hepatitis of unknown aetiology in children from 33 countries

Company received FDA orphan drug designation for Bucillamine in the prevention of ischemia-reperfusion injury during liver transplantation and Cannabidiol for autoimmune hepatitis

Company intends to move its head office to the US to better support growing drug programs with Bucillamine, Cannabidiol, and Psilocybin

TORONTO, May 31, 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, today announced that in light of the growing cases of acute hepatitis in children reported by the World Health Organization (“WHO”), the Company will advance its drug pipeline for inflammatory liver disorders including Bucillamine in the prevention of ischemia-reperfusion injury during liver transplantation and Cannabidiol for autoimmune hepatitis.

As of May 26, 2022, six hundred and fifty probable cases of acute hepatitis of unknown aetiology in children have been reported to WHO from 33 countries in five WHO Regions between 5 April and 26 May 2022. The aetiology of this severe acute hepatitis remains unknown and under investigation; as the cases are more clinically severe and a higher proportion develops acute liver failure than previous reports of acute hepatitis of unknown aetiology in children. At least 38 children have required a liver transplant, nine have died, and 99 cases pending classification, according to a statement from WHO (https://www.who.int/emergencies/disease-outbreak-news/item/DON-389).

The Company has a diverse product pipeline in development for rare inflammatory liver disorders, including receiving FDA orphan drug designation for Bucillamine to prevent ischemia-reperfusion injury during liver transplantation and Cannabidiol for autoimmune hepatitis. Revive has entered into a clinical trial agreement with The Trustees of Indiana University (“TIU ”) to develop and manage a proposed Phase 2 clinical study using Cannabidiol as an adjunct therapy for difficult to treat autoimmune hepatitis. 

Revive will also explore the use of Bucillamine for liver transplantation with clinical investigators on the protocol design and regulatory pathway to obtain FDA acceptance to proceed with a clinical study under an investigational new drug application. The Company 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 ischemia-reperfusion injury. Bucillamine, a cysteine derivative that contains two donatable thiol groups, in the context of ischemia-reperfusion injury is capable of replenishing the thiol group in glutathione, thereby reactivating this endogenous defense against oxidant injury. Bucillamine also has the potential to improve graft function and patient outcome by preventing or lessening IRI.

In addition, the Company intends to move its head office to the US to better access and support growing drug programs with Bucillamine and other products.

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

The Company submitted request to the FDA to determine potential new clinical endpoints for FDA consideration for EUA

TORONTO, May 16, 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 has submitted a request to the FDA to determine and agree on the Study’s potential new primary efficacy endpoints, including the rate of sustained clinical resolution of symptoms of COVID-19 which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization. The Company expects to obtain FDA agreement on the potential new primary efficacy endpoints in June 2022. The Company believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant and COVID-19 hospitalizations in the U.S. are in the decline, there is an urgent unmet need to treat symptom resolutions in addition to preventing hospitalizations. In addition, the Data Safety and Monitoring Board are scheduled to meet in June 2022 to evaluate the interim clinical and safety data and may make recommendation on continuing the Study or advise on halting the Study early due to positive efficacy based on other clinical outcomes such as the rate of sustained clinical resolution of symptoms of COVID-19.

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

About Revive Therapeutics Ltd.

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

TORONTO, April 25, 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 has been in discussions with the Biomedical Advanced Research and Development Authority (“BARDA”) for Bucillamine to explore the potential of securing advanced development and possible commercial scale-up funding. Discussions surrounding Bucillamine’s attributes and clinical potential were determined to be relevant for consideration, which could provide support to the Company’s current efforts. In parallel, the Company is working with its statistical advisory team for the planning of the data analysis and interpretation of statistical outcomes from its current clinical and safety data acquired from the Study for the Data Safety and Monitoring Board (“DSMB”). This will allow for the DSMB to make a recommendation on the Study or advise on halting the Study early due to positive efficacy based on other clinical outcomes evaluated such as the rate of sustained clinical resolution of symptoms of COVID-19. The Company has made efforts in determining the appropriate primary and secondary clinical endpoints for FDA consideration, which potentially could allow for an objective path to meet with the FDA for Emergency Use Authorization.

“We continue to advance our efforts in positioning Bucillamine as a potential treatment for COVID-19 that is relevant to the current state of the disease and our ongoing discussions with BARDA are promising for potential development and commercial support as we progress in our Phase 3 study,” said Michael Frank, CEO of Revive.

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 Announces Publication of Research Data with Bucillamine in COVID-19

Revive Therapeutics Announces Publication of Research Data with Bucillamine in COVID-19

TORONTO, April 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, today announced the publication of a scientific article evaluating the impact of medication, including Bucillamine, on antibody response to SARS-CoV-2 mRNA vaccines in Japanese patients with rheumatic diseases. The article titled, “Antibody Response to SARS-CoV-2 mRNA Vaccines in Patients with Rheumatic Diseases in Japan: Interim Analysis of a Multicenter Cohort Study”, is published in Modern Rheumatology and can be found here.

The article described that antibody levels were significantly lower in the groups treated with TNF inhibitor (TNFi) with methotrexate (MTX), abatacept, mycophenolate mofetil (MMF), MMF or mizoribine (MMF/MZR) combined with calcineurin inhibitor (CNI), and rituximab or cyclophosphamide (RTX/CPA) compared with those treated with sulfasalazine and/or Bucillamine or CNI (p<0.01). The newly published study further validates the potential of Bucillamine in the treatment course for COVID-19.

Bucillamine, an oral drug with anti-inflammatory and antiviral properties, is currently being evaluated in a Phase 3 clinical trial (the “Study”) (NCT04504734) in patients with mild to moderate COVID-19. The Company intends to seek U.S. Food & Drug Administration (“FDA”) Emergency Use Authorization.

“The potential of Bucillamine for COVID-19 is evident with its anti-inflammatory and antiviral properties and its potential use in patients who have taken SARS-CoV-2 mRNA vaccines,” said Michael Frank, CEO of Revive.

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

TORONTO, April 11, 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 Data Safety and Monitoring Board (“DSMB”) are scheduled to meet this quarter to evaluate the current clinical and safety data to either make recommendations on the Study or advise on potentially halting the Study early due to positive efficacy based on other clinical outcomes evaluated such as the rate of sustained clinical resolution of symptoms of COVID-19. The Company believes that with the Omicron variant, including the BA.2 variant, being the dominant strain over the Delta variant and COVID-19 hospitalizations in the U.S. in decline, there is an urgent unmet need to treat symptom resolutions in addition to preventing hospitalizations. The Company has made efforts in determining the appropriate revised primary and secondary clinical endpoints for FDA consideration for potential Emergency Use Authorization. In parallel, the Company will continue enrollment activities in the U.S. and Turkey and is still targeting Q2-2022 to meet the enrollment goals.

“With COVID-19 cases on the rise and the need for alternative oral treatments that is relevant to the current state of the disease, we believe that Bucillamine’s anti-inflammatory and antiviral properties offers an alternative potential solution that is urgently needed globally to fight COVID-19 and allow for people to improve their quality of life,” said Michael Frank, CEO of Revive.

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

Expected to seek DSMB approval to proceed with EUA application to the FDA in Q2-2022

Ongoing regulatory package activities for submission to international regulatory authorities for drug approvals

TORONTO, March 29, 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.

In collaboration with Delta Health, the Study is targeting clinicals sites operated by 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. As previously mentioned, the Company has selected 13 clinical research sites to complete enrollment of the Study.

The Company now expects to complete full enrollment in Q2-2022 and to also submit the Study data for 800 subjects to the data safety monitoring board (“DSMB”) to seek DSMB approval to proceed with an Emergency Use Authorization (“EUA”) application to the Food and Drug Administration (“FDA”). The Company is preparing its regulatory package for submission to the FDA and international regulatory authorities for drug approvals.

“With the emergence of BA.2 and other possible variants coming we feel there is still a vital need for a strong anti-inflammatory and anti-oxidant oral drug to coincide with other treatments,” said Michael Frank, CEO of Revive Therapeutics.

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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HAVN Life Secures Purchase Order for Controlled Substance Sale to Revive Therapeutics Ltd. for Use in Clinical Research

HAVN Life Secures Purchase Order for Controlled Substance Sale to Revive Therapeutics Ltd. for Use in Clinical Research

The naturally derived GMP psilocybin will be exported through distribution partner Mycrodose Therapeutics Inc. to the University of Wisconsin-Madison, Contract Research Organization for Revive Therapeutics

VANCOUVER, BC, Feb. 24, 2022  – 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 investigational research as potential APIs to support brain health and cognitive function, is pleased to announce it has successfully secured a purchase order for naturally derived psilocybin from their Canadian supply partner, Revive Therapeutics Ltd. (CSE: RVV) (OTC: RVVTF) (FSE: 31R) (“Revive”) for use in clinical research studies. The Company previously signed a supply agreement with Revive in October, 2021.

In fulfilling of the purchase order, HAVN Life will export naturally derived GMP psilocybin extract from its facility in Jamaica into the U.S. through its distribution partner, Mycrodose Therapeutics Inc. (“Mycrodose”) for use by the University of Wisconsin-Madison (“UW-Madison”), a Contract Research Organization (“CRO”) for Revive. This shipment of naturally derived psilocybin will allow UW-Madison to conduct research and formulation work to finalize dosing and delivery mechanisms in support of the various studies to be sponsored by Revive using an oral-thin and Hydra-gel delivery systems of psychedelics to treat mental health disorders.

“We are so pleased to be able to supply our naturally derived, GMP psilocybin for this potentially ground-breaking research related to addiction disorders,” says HAVN Life CEO Tim Moore. “It is our hope that research like this will help in the push toward the rescheduling of Schedule I compounds like psilocybin and psilocin, making treatment more accessible and helping to ease the growing mental health and addiction crisis we are facing today,” he adds.

“We are excited to work with HAVN Life to move forward with our investigational clinical trials including our project in Antigua“, says Revive CEO Michael Frank. He adds, “we are eager to advance the science on botanically-derived ingredients such as psilocin and psilocybin”.

“Mycrodose is very pleased to continue our efforts to progress the use of therapies based on botanically-derived psilocybin products with HAVN Life by expanding the use of psilocybin in research across the United States. Our DEA authorization to legally distribute psilocybin for authorized research purposes helps us facilitate the ease and access of using this Schedule I substance by DEA-licensed Universities, CROs, and other institutions in the United States,” says Chad Conner, Chief Executive Officer, Mycrodose Therapeutics. “We wish Revive Therapeutics and The University of Wisconsin-Madison continued success as they further progress their clinical trials investigation treatments,” he adds.

Revive Therapeutic Ltd. is a life sciences company focused on the research and development of therapeutics for rare disorders and infectious diseases. With its acquisition of Psilocin Pharma Corp. and advancements of its novel oral-thin film delivery system of psychedelic compounds, Revive is working to advance psilocybin-based therapeutics for mental health and abuse disorders.

Mycrodose is one of only a few US-pharmaceutical companies that has been authorized by the United States Drug Enforcement Agency (“DEA”), State of California Attorney General’s Research Advisory Board, and The Food & Drug Administration (“FDA”) to research and develop a total of eight (8) Schedule I and III compounds. In addition, the DEA has granted Mycrodose authorization to import and distribute for resale the controlled substances of psilocybin and psilocin to approved organizations for clinical trials, research and development, and analytical purposes.

HAVN Life’s operations in Jamaica are facilitated by strategic partnerships with Hypha Wellness and P.A. Benjamin Manufacturing Company to provide cultivation and processing facilities for psilocybe mushrooms.

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

About HAVN Life Sciences Inc.

HAVN Life Sciences is a biotechnology company pursuing standardized extraction of psychedelic compounds for investigational research as potential 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 investigational research in an effort to define the future of modern medicine. HAVN Life offers a full range of high-quality mushroom and plant extracts that help support immune function and support a healthy lifestyle.

Purchase our plant-based Natural Health Products and find out more at yourhavnlife.com, and follow us on Facebook, Twitter,  Instagram and Youtube.

About Revive Therapeutics Ltd.

Revive Therapeutics Ltd. Therapeutics Ltd 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.

About Mycrodose Therapeutics Inc.

Mycrodose Therapeutics Inc. is a U.S.-Based pharmaceutical company headquartered in San Diego, California specializing in the development of advanced drug delivery systems utilizing DEA Schedule I & III drugs and other compounds to treat cancer related conditions, mental health, and cognitive degenerative diseases. The company believes that its IP-Protected Sustained Microdosing Technology™ is a smarter and safer approach to delivering pharmaceutical compounds to patients of all ages and allows for an expandable and scalable business model.

Forward-Looking Information: This news release contains “forward-looking information” within the meaning of applicable securities laws relating to statements regarding the purchase order for naturally derived psilocybin from Revive (the “Purchase Order“), the exportation naturally derived GMP psilocybin extract from the Company’s facility in Jamaica into the U.S. through Mycrodose (the “Exportation“) and delivery of the naturally derived GMP psilocybin extract to UW-Madison in order for UW-Madison to conduct research and formulation work (the “Delivery and Use“), Revive’s business, products and future of Revive’s business, Mycrodose’s business, products and future of Mycrodose’s business and 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 risks that the Purchase Order may not be completed as contemplated, or at all, the risks that the Exportation may not be completed as contemplated, or at all, risks that the Delivery and Use may not be completed as contemplated, or at all, risks that Revive’s products and plan will vary from those stated in this news release and Revive may not be able to carry out its business plans as expected, risks that Mycrodose’s products and plan will vary from those stated in this news release and Mycrodose may not be able to carry out its business plans as expected and 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.

SOURCE HAVN Life Sciences Inc.

For further information: Investor Relations: ir@havnlife.com, Media: savi@emergence-creative.com

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HAVN Life Secures Purchase Order For Controlled Substance Sale To Revive Therapeutics Ltd. For Use In Clinical Research

HAVN Life Secures Purchase Order For Controlled Substance Sale To Revive Therapeutics Ltd. For Use In Clinical Research

The naturally derived GMP psilocybin will be exported through distribution partner Mycrodose Therapeutics Inc. to the University of Wisconsin-Madison, Contract Research Organization for Revive Therapeutics

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 investigational research as potential APIs to support brain health and cognitive function, is pleased to announce it has successfully secured a purchase order for naturally derived psilocybin from their Canadian supply partner, Revive Therapeutics Ltd. (CSE: RVV) (OTC: RVVTF) (FSE: 31R) (“Revive”) for use in clinical research studies. The Company previously signed a supply agreement with Revive in October, 2021.

In fulfilling of the purchase order, HAVN Life will export naturally derived GMP psilocybin extract from its facility in Jamaica into the U.S. through its distribution partner, Mycrodose Therapeutics Inc. (“Mycrodose”) for use by the University of Wisconsin-Madison (“UW-Madison”), a Contract Research Organization (“CRO”) for Revive. This shipment of naturally derived psilocybin will allow UW-Madison to conduct research and formulation work to finalize dosing and delivery mechanisms in support of various studies to be sponsored by Revive using an oral-thin and Hydra-gel delivery systems of psychedelics to treat mental health disorders.

“We are so pleased to be able to supply our naturally derived, GMP psilocybin for this potentially ground-breaking research related to addiction disorders,” says HAVN Life CEO Tim Moore. “It is our hope that research like this will help in the push toward the rescheduling of Schedule I compounds like psilocybin and psilocin, making treatment more accessible and helping to ease the growing mental health and addiction crisis we are facing today,” he adds.

“We are excited to work with HAVN Life to move forward with our investigational clinical trials including our project in Antigua”, says Revive CEO Michael Frank. He adds, “we are eager to advance the science on botanically-derived ingredients such as psilocin and psilocybin”.

“Mycrodose is very pleased to continue our efforts to progress the use of therapies based on botanically-derived psilocybin products with HAVN Life by expanding the use of psilocybin in research across the United States. Our DEA authorization to legally distribute psilocybin for authorized research purposes helps us facilitate the ease and access of using this Schedule I substance by DEA-licensed Universities, CROs, and other institutions in the United States,” says Chad Conner, Chief Executive Officer, Mycrodose Therapeutics. “We wish Revive Therapeutics and The University of Wisconsin-Madison continued success as they further progress their clinical trials investigation treatments,” he adds.

Revive Therapeutic Ltd. is a life sciences company focused on the research and development of therapeutics for rare disorders and infectious diseases. With its acquisition of Psilocin Pharma Corp. and advancements of its novel oral-thin film delivery system of psychedelic compounds, Revive is working to advance psilocybin-based therapeutics for mental health and abuse disorders.

Mycrodose is one of only a few US-pharmaceutical companies that has been authorized by the United States Drug Enforcement Agency (“DEA”), State of California Attorney General’s Research Advisory Board, and The Food & Drug Administration (“FDA”) to research and develop a total of eight (8) Schedule I and III compounds. In addition, the DEA has granted Mycrodose authorization to import and distribute for resale the controlled substances of psilocybin and psilocin to approved organizations for clinical trials, research and development, and analytical purposes.

HAVN Life’s operations in Jamaica are facilitated by strategic partnerships with Hypha Wellness and P.A. Benjamin Manufacturing Company to provide cultivation and processing facilities for psilocybe mushrooms.

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

About HAVN Life Sciences Inc.
HAVN Life Sciences is a biotechnology company pursuing standardized extraction of psychedelic compounds for investigational research as potential 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 investigational research in an effort to define the future of modern medicine. HAVN Life offers a full range of high-quality mushroom and plant extracts that help support immune function and support a healthy lifestyle.

Purchase our plant-based Natural Health Products and find out more at yourhavnlife.com, and follow us on Facebook, Twitter, Instagram and Youtube.

About Revive Therapeutics Ltd.
Revive Therapeutics Ltd. 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.

About Mycrodose Therapeutics Inc.
Mycrodose Therapeutics Inc. is a U.S.-Based pharmaceutical company headquartered in San Diego, California specializing in the development of advanced drug delivery systems utilizing DEA Schedule I & III drugs and other compounds to treat cancer related conditions, mental health, and cognitive degenerative diseases. The company believes that its IP-Protected Sustained Microdosing Technology™ is a smarter and safer approach to delivering pharmaceutical compounds to patients of all ages and allows for an expandable and scalable business model.

Contact:
Investor Relations: ir@havnlife.com
Media: savi@emergence-creative.com

Forward-Looking Information: This news release contains “forward-looking information” within the meaning of applicable securities laws relating to statements regarding the purchase order for naturally derived psilocybin from Revive (the “Purchase Order”), the exportation naturally derived GMP psilocybin extract from the Company’s facility in Jamaica into the U.S. through Mycrodose (the “Exportation”) and delivery of the naturally derived GMP psilocybin extract to UW-Madison in order for UW-Madison to conduct research and formulation work (the “Delivery and Use”), Revive’s business, products and future of Revive’s business, Mycrodose’s business, products and future of Mycrodose’s business and 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 risks that the Purchase Order may not be completed as contemplated, or at all, the risks that the Exportation may not be completed as contemplated, or at all, risks that the Delivery and Use may not be completed as contemplated, or at all, risks that Revive’s products and plan will vary from those stated in this news release and Revive may not be able to carry out its business plans as expected, risks that Mycrodose’s products and plan will vary from those stated in this news release and Mycrodose may not be able to carry out its business plans as expected and 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 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.