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PharmaTher Provides Update on its Psychedelic Pharmaceuticals Programs

TORONTO, Nov. 24, 2020 (GLOBE NEWSWIRE) — PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (“PharmaTher”) (CSE: PHRM) and a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to provide a corporate update on its psychedelic pharmaceuticals program. Since its inception, the Company has built a unique product pipeline for novel uses of ketamine, psilocybin and undisclosed psychedelics. PharmaTher is positioning itself to partner its psilocybin program and panaceAI™, and focus on advancing its novel ketamine product pipeline in Parkinson’s disease, depression and pain via the U.S. Food and Drug Administration (“FDA”) regulatory pathway.

“We have made tremendous progress over the last several months that saw our product pipeline evolve to focus on the massive opportunity and potential of ketamine, an FDA approved drug with a known safety profile, to treat significant unmet medical needs for Parkinson’s disease, depression and pain,” said Fabio Chianelli, CEO of PharmaTher. “With our focus on ketamine through repurposing, combining it with an FDA approved drug and delivering it with our novel microneedle delivery system, we are now positioned to expedite our clinical development objectives by taking advantage of the FDA’s 505(b)(2) regulatory pathway and commercializing disruptive ketamine treatments for mental health and pain disorders.”

Ketamine for Parkinson’s Disease
The Company entered into an exclusive license agreement with the University of Arizona for the development and commercialization of ketamine in the treatment of Parkinson’s disease. PharmaTher has applied for FDA Orphan Drug Designation for ketamine in the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease, and is expected to be granted in Q1-2021. In addition, PharmaTher will shortly file its pre-investigational new drug (“IND”) request to the FDA with the aim to conduct a Phase II clinical study in the U.S. Prior clinical reports suggest that low-dose ketamine infusions are well tolerated and can improve pain and depression, both often comorbidities in Parkinson’s disease patients. Preclinical data and human case studies in Parkinson’s disease showed that low-dose sub-anesthetic ketamine infusion indicates tolerability, safety and the potential of long-term therapeutic benefit to reduce Levodopa-induced dyskinesia, improve on time, and reduce depression.1-5   The global Parkinson’s Disease market is expected to grow from USD $5 billion in 2019 to USD $7.5 billion by the end of 20256 and it is estimated that the potential market opportunity for LID-PD to be over USD $3 billion in the U.S. alone.

Ketamine Combination Formulation for Depression
The Company is preparing to advance a novel combination formulation with ketamine and an undisclosed FDA approved drug for the treatment of depression. The combination drug has shown in pre-clinical models to enhance the antidepressant effect of ketamine, while attenuating the side effects (i.e., hallucinations, memory defects, addiction, cognitive function, social and motor disorders, etc.), thus offering a potentially safer and effective treatment option that can be used by patients for home use to treat their depression.   The global prevalence of depression is over 300 million patients and the annual cost to the U.S. is $200 billion, with current treatment options being ineffective and sub-optimal. The Company aims to conduct an FDA Phase II study for depression in 2021. In addition, this novel combination formulation paves the way for a distinctive product franchise targeting the multi-billion dollar and underserved market opportunities in mental health disorders.

Ketamine Microneedle Patch for Pain
The Company entered into an exclusive license agreement for the development and commercialization of a proprietary microneedle delivery system, developed in Khademhosseini Lab at the University of California, Los Angeles (“UCLA”), for use with psychedelic pharmaceuticals, including, ketamine.

The microneedle delivery system in the form of a patch, is biocompatible and biodegradable, shown to deliver both water-soluble and insoluble drugs with desirable release profiles, can efficiently penetrate the stratum corneum layer (outer layer of the skin), enable flexible drug load capacity and combinations, and control-release delivery. The microneedle patch is minimally invasive, painless, and may overcome the potential drawbacks of oral administration, subcutaneous injections and other transdermal delivery systems. In addition, it will open up new market opportunities in multi-billion dollar categories such as pain, skin cancer, wounds, mucosal diseases and surgical applications.

PharmaTher is focused on realizing the potential of its proprietary microneedle patch by delivering ketamine to treat pain disorders such as neuropathic pain and post-operative pain. The Company has filed an application with the FDA to receive Orphan Drug Designation for ketamine in the treatment of Postherpetic neuralgia (“PHN”), a chronic neuropathic pain syndrome resulting from an outbreak of the herpes zoster virus, also known as shingles. According to Persistence Market Research, the global PHN market is expected to be valued at USD $908.4 million by 2026.
In addition, the novel ketamine microneedle patch will have the potential to treat the over 25 million chronic pain patients and the over 65 million surgical procedures in the U.S. The ketamine patch aims to overcome the serious side effects and abuse with opioids to treat chronic pain.

panaceAI™ and Psilocybin Partnering Programs
The Company is developing and commercializing panaceAI™, a drug repurposing artificial intelligence (“AI”) platform focusing on psychedelic pharmaceuticals, with the intention to expand PharmaTher’s product pipeline and intellectual property portfolio. The Company has built a psilocybin product pipeline, which includes the potential treatment of traumatic brain injury and stroke, and its recently discovered novel uses of psilocybin in the potential to treat certain cancers, for which a provisional patent was filed with the U.S. Patent and Trademark Office. This discovery led to PharmaTher to enter into an exclusive research collaboration with Revive Therapeutics Ltd. (CSE: RVV, USA: RVVTF) to advance the psilocybin program and to discover novel uses of undisclosed psychedelic compounds using panaceAI™. The research collaboration with Revive is PharmaTher’s first partnership with panaceAI™ and it validates PharmaTher’s business model in discovering novel uses of psychedelics and partnering these discoveries with life sciences companies seeking to expand their product pipeline with psychedelics.

The partnership model for panaceAI™ and psilocybin allows PharmaTher to become a specialty life sciences company focused on its disruptive product pipeline with ketamine.

About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals. PharmaTher repurposes psychedelic pharmaceuticals, such as ketamine and psilocybin, for FDA approval to treat disorders of the brain and nervous system. Our goal is to advance the commercialization of panaceAI™, our drug repurposing artificial intelligence platform, and our ketamine focused product pipeline in the treatment of Parkinson’s Disease, depression, and pain.

Learn more at:  PharmaTher.com and follow us on Facebook, Twitter and LinkedIn.
​
For more information, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Inc.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Newscope Capital Corporation’s (the “Company) 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 U.S. patent application of psilocybin to treat cancer, psychedelic drug repurposing, drug combinations and discovery, U.S. Food and Drug Administration (“FDA”) approval, panaceAI™, psilocybin and ketamine programs towards human clinical studies under the FDA regulatory pathway and product developments. Forward-looking information is based on reasonable assumptions that have been made by the Company 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 Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 30, 2020 (“MD&A”), dated October 1, 2020, which is available on the Company’s profile at www.sedar.com.

References:

  1. UA Clinical Trial to Repurpose Ketamine for Parkinson’s Patients.
  2. US20190060254A1— Compositions and methods for treating motor disorders.
  3. Bartlett, et al, 2020. Preclinical evidence in support of repurposing sub-anesthetic ketamine as a treatment for L-DOPA-induced dyskinesia. Experimental Neurology. Volume 333.
  4. Bartlett, M.J., Joseph, R.M., LePoidevin, L.M., Parent, K.L., Laude, N.D., Lazarus, L.B., Heien, M.L., Estevez, M., Sherman, S.J., Falk, T., 2016. Long-term effect of sub-anesthetic ketamine in reducing L-DOPA-induced dyskinesias in a preclinical model.
  5. Sherman, S.J., Estevez, M., Magill, A.B., Falk, T., 2016. Case reports showing a long-term effect of subanesthetic ketamine infusion in reducing L-DOPA-induced dyskinesias. Case Rep. Neurol. 8, 53–58.
  6. 360iResearch 2020.
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Revive Therapeutics Announces Research Collaboration with PharmaTher for Development of Psilocybin in Cancer and Discovery of Novel Uses of Psychedelics

TORONTO, Nov. 18, 2020 – Revive Therapeutics Ltd. (“Revive”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has entered into an exclusive research collaboration agreement with PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (“PharmaTher”) (CSE: PHRM) and a specialty psychedelics pharmaceutical company, to accelerate the development of psilocybin in the treatment of cancer and the discovery of novel uses of undisclosed psychedelic compounds.

“Revive continues to be focused on developing novel uses for psilocybin that leverages our proprietary oral thin film delivery technology as a differentiated therapeutic approach,” said Michael Frank, CEO of Revive. “We are excited to advance the development of PharmaTher’s recent discovery in the potential of psilocybin to treat certain cancers such as Liver Carcinoma, Melanoma, Breast Neoplasms, Kidney Neoplasms and Acute Myeloid Leukemia. We are also leveraging PharmaTher’s panaceAI™ discovery AI platform to discover new uses of undisclosed psychedelic compounds to be potentially used with our oral thin film delivery technology and expand our psychedelics drug pipeline.”

“We are excited to partner with Revive Therapeutics on our psilocybin cancer program and our psychedelics discovery platform, panaceAI™, to unlock the potential of novel uses of psychedelic compounds in diseases that have sub-optimal or no treatment options,” said Fabio Chianelli, CEO of PharmaTher. “We recently achieved an important milestone in expanding our patent portfolio with the potential of psilocybin to treat certain cancer indications. Our research collaboration with Revive validates our business model in discovering novel uses of psychedelics with panaceAI™ and partnering these discoveries with life sciences companies seeking to expand their product pipeline with psychedelics. We are happy to accelerate Revive’s objective in building a unique psychedelic drug pipeline via the FDA development and approval process.”

The collaboration will give Revive the exclusivity to advance the research of psilocybin in the treatment of cancer and leverage PharmaTher’s panaceAI™ psychedelic discovery AI platform to screen, identify and evaluate undisclosed psychedelic compounds directed at pre-specified targets for use with Revive’s drug delivery technology.

About Revive Therapeutics Ltd.

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

About PharmaTher Inc.

PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals. PharmaTher repurposes psychedelic pharmaceuticals, such as ketamine and psilocybin, for FDA approval to treat cancer and disorders of the brain and nervous system. Our goal is to advance the commercialization of panaceAI™, our drug repurposing artificial intelligence platform, and our clinical product pipeline with ketamine and psilocybin in the treatment of Parkinson’s Disease, depression, pain, traumatic brain injury and stroke. Learn more at: PharmaTher.com and follow us on Facebook, Twitter and LinkedIn.

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 have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

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PharmaTher Enters Into Research Collaboration with Revive Therapeutics for Psilocybin and panaceAI™ Psychedelic Discovery AI Platform

TORONTO, Nov. 18, 2020 (GLOBE NEWSWIRE) — PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (“PharmaTher”) (CSE: PHRM) and a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce it has entered into an exclusive research collaboration agreement with Revive Therapeutics Ltd. (“Revive”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for unmet medical needs, to expand Revive’s development plans with psilocybin to treat cancer and to discover novel uses of undisclosed psychedelic compounds.

PharmaTher recently announced the filing of a U.S. provisional patent application outlining the potential novel use of psilocybin to treat cancer, which was discovered by panaceAI™, PharmaTher’s proprietary drug repurposing artificial intelligence platform. The patent application, entitled “Use of Psilocybin in the Treatment of Cancers”, outlines psilocybin’s potential use for Liver Carcinoma, Melanoma, Breast Neoplasms, Kidney Neoplasms and Acute Myeloid Leukemia.

“We are excited to partner with Revive Therapeutics on our psilocybin cancer program and on panaceAI™ to unlock the potential novel uses of psychedelic compounds in diseases that have sub-optimal or no treatment options,” said Fabio Chianelli, CEO of PharmaTher Inc. “We have been focused on advancing the clinical development of ketamine in the treatment of Parkinson’s disease, while also discovering novel uses of psychedelics using panaceAI™ with the aim to partner these developments. The partnership with Revive allows us to focus on expanding our ketamine programs such as the combination of ketamine with an FDA approved drug and the delivery of ketamine via our proprietary microneedle delivery technology targeting large market opportunities in depression, post-operative and neuropathic pain and disorders of the brain and nervous system.”

The research collaboration with Revive is PharmaTher’s first partnership with panaceAI™ and it validates PharmaTher’s business model in discovering novel uses of psychedelics and partnering these discoveries with life sciences companies seeking to expand their product pipeline with psychedelics.

“Revive continues to be focused on developing novel uses for psilocybin that leverages our proprietary oral thin film delivery technology as a differentiated therapeutic approach,” said Michael Frank, CEO of Revive. “We are excited to advance the development of PharmaTher’s recent discovery in the potential of psilocybin to treat certain cancers and leveraging PharmaTher’s panaceAI™ discovery AI platform to discover new uses of undisclosed psychedelic compounds to expand our psychedelics drug pipeline.”

The collaboration will give Revive the exclusivity to advance the research of psilocybin in the treatment of cancer and leverage PharmaTher’s panaceAI™ psychedelic discovery AI platform to screen, identify and evaluate undisclosed psychedelic compounds directed at pre-specified targets for use with Revive’s drug delivery technology.

About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals. PharmaTher repurposes psychedelic pharmaceuticals, such as ketamine and psilocybin, for FDA approval to treat disorders of the brain and nervous system. Our goal is to advance the commercialization of panaceAI™, our drug repurposing artificial intelligence platform, and our ketamine focused product pipeline in the treatment of Parkinson’s Disease, depression, and pain. Learn more at: PharmaTher.com and follow us on Facebook, Twitter and LinkedIn.

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

For more information, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Inc.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Newscope Capital Corporation’s (the “Company) 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 U.S. patent application of psilocybin to treat cancer, psychedelic drug repurposing, drug combinations and discovery, U.S. Food and Drug Administration (“FDA”) approval, panaceAI™, psilocybin and ketamine programs towards human clinical studies under the FDA regulatory pathway and product developments. Forward-looking information is based on reasonable assumptions that have been made by the Company 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 Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 30, 2020 (“MD&A”), dated October 1, 2020, which is available on the Company’s profile at www.sedar.com.

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Revive Therapeutics Provides Update on Oral Thin Film Product with Psilocybin

TORONTO, Nov. 11, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on its oral thin-film delivery system with psilocybin being developed under a research partnership agreement with Reed Research Group out of the University of Wisconsin-Madison.

Following several months of prototyping on a wide range of dosage forms, the Company has completed an oral thin-film strip product with psilocybin with dosage forms ranging between 1 mg and 20 mg and demonstrating its versatility through physio-chemical characterization (e.g. tensile strength of films) of bio comparable tannin-chitosan composite materials, dissolution and disintegration testing, and rate of psilocybin release from composites.   Currently technical and scientific data is being processed and finalized.

“We are very pleased to have achieved this development milestone of our orally dissolvable thin film strip for psilocybin, which can be used in FDA human clinical studies and as a unique product for medical use in states where psilocybin therapy use is permitted, such as Oregon following the passage of Measure 109,” said  Michael Frank, CEO of Revive.  “There is a significant market opportunity for our unique oral thin film strip technology for not only delivering psilocybin but also delivering numerous psychedelic-based medicines to treat various diseases and disorders that would benefit from such a delivery method. Also, we are in a position to begin partnering with life sciences companies seeking to add unique offerings in their psychedelic-based product pipeline and with companies operating in the U.S. where psilocybin therapy use is legal.”

Psilocybin Oral Thin-film Product

Under its sponsored research partnership with the Reed Research Group out of the University of Wisconsin-Madison, the Company is developing its tannin-chitosan composite of orally dissolvable thin films which offers a unique delivery platform for therapeutic doses (1-20mg) of psilocybin into the oral cavity. The Company has finalized the prototypes and is preparing to scale for manufacturing for future clinical studies involving psilocybin and other psychedelic-derived medicines.

There are a number of advantages and benefits of an orally dissolvable psilocybin thin film such as the rapid dissolving and onset of action to the bloodstream, the ease and convenience for patients to administer without the need of water, chewing or swallowing, the potential of improved therapeutic outcomes and efficacy for underserved diseases and disorders including the flexibility to create accurate dosing and tasteful options.

Revive’s Drug Delivery Technology

The drug delivery technology aims to deliver both synthetic and natural extract of psilocybin in a potential number of ways such as orally dissolvable thin films, topical gels, creams or ointments, oral or transdermal patches, oral dosages and foams.

The delivery technology is a natural, non-toxic, biodegradable and biocompatible composite that combines a tannin material, which is derived from a plant group having antibacterial, antifungal, antioxidant and wound healing properties, and a chitosan material, which is derived from the crustacean group having blood-clotting and antimicrobial properties. The delivery technology has a rapid onset of action and controlled or sustained release potential capabilities and may allow combining multiple extracts from mushrooms in one formulation.

About Revive Therapeutics Ltd.

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

For more information, please contact:

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

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2020, 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 FDA Phase 3 Clinical Trial for Bucillamine in COVID-19

TORONTO, Oct. 26, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce an update on the Company’s U.S. Food & Drug Administration (“U.S. FDA”) Phase 3 clinical trial (the “Study”) to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19. The Company has committed to ten clinical sites across Florida, Texas, Nevada, Arizona and California, and it is estimated that over 200 patients will have completed the Study for the interim analysis by the end of December 2020. The interim analysis will determine the better performing Bucillamine dose arm for the remainder of the trial and future complementary studies evaluating it in more severe cases, thus making Bucillamine a potential treatment option.

“We are one of a few life sciences companies evaluating an investigational drug in a Phase 3 clinical trial for COVID-19 and with the rising prevalence of cases throughout the U.S., we are confident that our targets will be achieved to support the potential FDA approval and commercialization of Bucillamine for the treatment of the virus,” said Michael Frank, Revive’s Chief Executive Officer.

The recent publication of the potential of N-acetyl-cysteine (“NAC”) in the treatment of COVID-191 serves as further validation for Bucillamine. NAC has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione.

In comparison, Bucillamine, with its well-established safety record in over 30 years of use in the treatment of rheumatoid arthritis, has been shown to be 16 times more potent as a thiol donor in vivo than NAC. Bucillamine also has the potential, via increasing glutathione activity and other antioxidant and anti-inflammatory activities,2 to lessen the destructive consequences of more advanced SARS CoV2 infections, and attenuate the clinical course of severe COVID-19.

About the Phase 3 Clinical Trial

The Phase 3 confirmatory clinical trial titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days. The primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of the first dose through Day 28 following randomization. Efficacy will be assessed by comparing clinical outcomes (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID‑19 between patients receiving standard-of-care plus Bucillamine (high dose and/or low dose) and patients receiving standard-of-care plus placebo. Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.

An interim analysis will be performed by an Independent Data and Safety Monitoring Board (“DSMB”) after 210 patients have been treated and followed up for 28 days after randomization. The better performing Bucillamine dose at the interim analysis will be selected and patients will then be randomized 2:1 to the selected Bucillamine dose or placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint. The independent DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping or changes to the conduct of the study based on the interim analysis reports.

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

Scientific Rationale of Bucillamine for COVID-19

Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.3 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione.4-7 Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC.2 The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other antioxidant and anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV2 infection in the lungs and attenuate the clinical course of COVID-19.

About Revive Therapeutics Ltd.

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

For more information, please contact:

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

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

References

1. H Ibrahim et al, Therapeutic blockade of inflammation in severe COVID-19 infection with intravenous N-acetylcysteine., Clinical Immunology. Volume 219, October 2020, 108544.

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

3. S Ye et al, Inhibition of Reactive Oxygen Species Production Ameliorates Inflammation Induced by Influenza A Viruses via Upregulation of SOCS1 and SOCS3., American Society for Microbiology. 2015 Mar;89(5):2672-2683).

4. L. Carati et al, Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment., Eur Respir J. 1997 Jul;10(7):1535-41).

5. M Mata et al, N-acetyl-L-cysteine (NAC) inhibit mucin synthesis and pro-inflammatory mediators in alveolar type II epithelial cells infected with influenza virus A and B and with respiratory syncytial virus (RSV)., Biochem Pharmacol. 2011 Sep;82(5):548-55.

6. D Ungheri et al, Protective effect of n-acetylcysteine in a model of influenza infection in mice., Int J Immunopathol Pharmacol. 2000 Sep-Dec;13(3):123-128.

7. RH Zhang et al, N-acetyl-l-cystine (NAC) protects against H9N2 swine influenza virus-induced acute lung injury., Int Immunopharmacol. 2014 Sep;22(1):1-8).

Posted on

HAVN LIFE SCIENCES SIGNS AGREEMENT TO SUPPLY PSYCHEDELIC COMPOUNDS FOR USE IN RESEARCH AND DEVELOPMENT TO REVIVE THERAPEUTICS

Havn Life will export naturally derived psilocybin to the United States, for use in IND-enabling studies and future clinical trials under FDA guidelines

Vancouver, BC – Havn Life Sciences Inc. (CSE : HAVN) (FSE : 5NP) (the “Company” or “Havn Life”),  a biotechnology company focused on unlocking human potential using evidence-informed research and developing standardized psychoactive compounds derived from plants and fungi, is pleased to announce it has signed an agreement (the “Agreement”) to supply Revive Therapeutics Ltd. (CSE: RVV, USA: RVVTF) (“Revive Therapeutics”) with psychedelic compounds for use in investigational new drug (“IND”) enabling studies and future clinical trials under the Food and Drug Administration (“FDA”) guidelines.

Revive Therapeutics is a life sciences company focused on the research and development of therapeutics for rare disorders and infectious diseases. With its recent 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.

Revive’s psilocybin research for its oral-thin film delivery system and its clinical study in the treatment of methamphetamine use disorder are being run under FDA guidelines at the University of Wisconsin-Madison.

Although the psychedelic industry is in its infancy, the signing of a supply agreement serves as a validation for the Havn Life team and the Company’s business objectives and revenue streams. Havn Life recently announced the submission of its Licensed Dealer application to Health Canada.

“This agreement with Revive Therapeutics is just the beginning, the demand for naturally-derived psilocybin is there and it is growing,” said Havn Life Co-CEO Susan Chapelle. “Our path at Havn Life has always been very clear: to supply standardized, quality controlled compounds to researchers so they can do the research that’s necessary to document health and wellness benefits of psychedelic medicine and ultimately help the industry with the knowledge required to legalize these compounds . We are thrilled to have signed this supply agreement with Revive Therapeutics to help further their work in this field. Both of our companies are leading innovators in the space, and we look forward to helping Revive achieve their goals with our compound supply”

Michael Frank, CEO of Revive, added: “We are excited about our strategic partnership with Havn Life as one of our suppliers of psychoactive compounds that we intend to develop and commercialize using our established tannin-chitosan based proprietary oral-thin film delivery system, for the pharmaceutical and wellness markets.”

The Agreement is reliant on Havn Life obtaining its Controlled Drugs and Substances Dealers Licence from Health Canada, which the company applied for earlier this month. This is the Company’s first contract for the sale of psychedelic compounds.

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

About Havn Life Sciences Inc.

Havn Life Sciences is a biotechnology company on a mission to unlock human potential using evidence-informed research. The Company is focused on standardized, quality-controlled extraction of psychoactive compounds from plants and fungi, and the development of natural health care products from non-regulated compounds. Learn more at: havnlife.com and follow us on Facebook, Twitter and Instagram.

Connect

Investor Relations
ir@havnlife.com
604 (687)-7130

Facebook: @havnlife
Twitter: @havnlife
Insta: @havn.life
LinkedIn: @Havn Life

Media Contact
Brittany@exvera.com
778-238-6096

Posted on

Revive Therapeutics Signs Supply Agreement With Havn Life Sciences for Psychedelic Compounds

Expanding research and development of naturally-derived psilocybin for future FDA IND-enabling and clinical studies

 

TORONTO, Oct. 20, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has signed a supply agreement (the “Agreement”) with Havn Life Sciences Inc. (CSE : HAVN) (FRA: 5NP) (“Havn Life”) to source naturally-derived psychedelic compounds, such as psilocybin, for use in future investigational new drug (“IND”) enabling studies and clinical trials under the Food and Drug Administration (“FDA”) guidelines.

“We are excited about our strategic partnership with Havn Life as one of our suppliers of psychoactive compounds that we intend to develop and commercialize using our established tannin-chitosan based proprietary oral-thin film delivery system, for the pharmaceutical and wellness markets,” said Michael Frank, Revive’s Chief Executive Officer. “We are developing unique products with both synthetic and naturally-derived psilocybin and building relationships with companies and institutions that support our objectives in the psychedelic space including our established relationship with the University of Wisconsin-Madison in the research and clinical development of our novel Psilocybin oral-thin film product and the Phase 1 clinical study using psilocybin in the treatment of methamphetamine use disorder.”

Havn Life Sciences is focused on standardized, quality-controlled extraction of psychoactive compounds from plants and fungi, and the development of natural health care products from non-regulated compounds.

Susan Chapelle, Co-CEO, Havn Life added: “Our path at Havn Life has always been very clear: to supply standardized, quality controlled compounds to researchers so they can do the research that’s necessary to document health and wellness benefits of psychedelic medicine and ultimately help the industry with the knowledge required to legalize these compounds. We are thrilled to have signed this supply agreement with Revive Therapeutics to help further their work in this field. Both of our companies are leading innovators in the space, and we look forward to helping Revive achieve their goals with our compound supply.”

Revive’s Psilocybin Oral Thin-film Product

Under its sponsored research partnership with the Reed Research Group out of the University of Wisconsin-Madison, the Company is developing its tannin-chitosan composite of orally dissolvable thin films which offers a unique delivery platform for therapeutic doses (1-20mg) of psilocybin into the oral cavity. There are a number of advantages and benefits of an orally dissolvable psilocybin thin film such as the rapid dissolving and onset of action to the bloodstream, the ease and convenience for patients to administer without the need of water, chewing or swallowing, the potential of improved therapeutic outcomes and efficacy for underserved diseases and disorders including the flexibility to create accurate dosing and tasteful options. The Company’s delivery technology is a natural, non-toxic, biodegradable and biocompatible composite that combines a tannin material, which is derived from a plant group having antibacterial, antifungal, antioxidant and wound healing properties, and a chitosan material, which is derived from the crustacean group having blood-clotting and antimicrobial properties. The delivery technology has a rapid onset of action and controlled or sustained release potential capabilities and may allow combining multiple extracts from mushrooms in one formulation.

Revive’s Clinical Study of Psilocybin in the Treatment of Methamphetamine Use Disorder

The Company has entered into a Clinical Trial Agreement with the Board of Regents of the University of Wisconsin System to conduct a clinical study entitled “Phase I Study of the Safety and Feasibility of Psilocybin in Adults with Methamphetamine Use Disorder.” The Phase I study Principal Investigator is Dr. Christopher R. Nicholas, Ph.D., Assistant Professor of Program for Research Outreach Therapeutics and Education in the Addictions in the Department of Family Medicine and Community Health at University of Wisconsin School of Medicine and Public Health. The clinical study will be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health, and School of Pharmacy, which holds a Wisconsin special authorization and DEA license to perform clinical research with psilocybin. The Company will have exclusive access to key intellectual property from this study.

About Revive Therapeutics Ltd.

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

For more information, please contact:

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

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

Posted on

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

TORONTO, Sept. 29, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce an update on the Company’s U.S. Food & Drug Administration (“U.S. FDA”) Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19. The Company has selected and finalized with five clinical sites in Florida, Texas and California for enrollment of patients in the Phase 3 clinical study, and is finalizing agreements with an additional ten clinical sites in these states including Arizona and Ohio where patient enrollment should start in October within these other locations.

“We have made significant progress in advancing the Phase 3 clinical trial since the FDA approval allowed us to proceed with the study, and we are expanding on and engaging with clinical sites in high prevalence COVID-19 infected states, which will enable us to meet our enrollment goals and expedite the potential FDA approval and commercialization of Bucillamine for the treatment of COVID-19,” said Michael Frank, Revive’s Chief Executive Officer.

About the Phase 3 Clinical Trial

The Phase 3 confirmatory clinical trial titled, “A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19”, will enroll up to 1,000 patients that will be randomized 1:1:1 to receive Bucillamine 100 mg three times a day (“TID”), Bucillamine 200 mg TID or placebo TID for up to 14 days. The primary objective is to compare the frequency of hospitalization or death in patients with mild-moderate COVID-19 receiving Bucillamine therapy with those receiving placebo. The primary endpoint is the proportion of patients meeting a composite endpoint of hospitalization or death from the time of the first dose through Day 28 following randomization. Efficacy will be assessed by comparing clinical outcomes (death or hospitalization), disease severity using the 8-category NIAID COVID ordinal scale, supplemental oxygen use, and progression of COVID‑19 between patients receiving standard-of-care plus Bucillamine (high dose and/or low dose) and patients receiving standard-of-care plus placebo. Safety will be assessed by reported pre-treatment adverse events and treatment-emergent adverse events (including serious adverse events and adverse events of special interest), laboratory values (hematology and serum chemistry), vital signs (heart rate, respiratory rate, and temperature), and peripheral oxygen saturation.

An interim analysis will be performed by an Independent Data and Safety Monitoring Board (“DSMB”) after 210 patients have been treated and followed up for 28 days after randomization. The better performing Bucillamine dose at the interim analysis will be selected and patients will then be randomized 2:1 to the selected Bucillamine dose or placebo. Additional interim analyses will be performed after 400, 600, and 800 patients have reached this same post-treatment timepoint. The independent DSMB will actively monitor interim data for the ongoing safety of patients and will recommend continuation, stopping or changes to the conduct of the study based on the interim analysis reports.

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

Scientific Rationale of Bucillamine for COVID-19

Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV2 infection in the lungs and attenuate the clinical course of COVID-19.

About Revive Therapeutics Ltd.

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

For more information, please contact:

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

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

References

1. S Ye et al, Inhibition of Reactive Oxygen Species Production Ameliorates Inflammation Induced by Influenza A Viruses via Upregulation of SOCS1 and SOCS3., American Society for Microbiology. 2015 Mar;89(5):2672-2683).

2. L. Carati et al, Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment., Eur Respir J. 1997 Jul;10(7):1535-41).

3. M Mata et al, N-acetyl-L-cysteine (NAC) inhibit mucin synthesis and pro-inflammatory mediators in alveolar type II epithelial cells infected with influenza virus A and B and with respiratory syncytial virus (RSV)., Biochem Pharmacol. 2011 Sep;82(5):548-55.

4. D Ungheri et al, Protective effect of n-acetylcysteine in a model of influenza infection in mice., Int J Immunopathol Pharmacol. 2000 Sep-Dec;13(3):123-128.

5. RH Zhang et al, N-acetyl-l-cystine (NAC) protects against H9N2 swine influenza virus-induced acute lung injury., Int Immunopharmacol. 2014 Sep;22(1):1-8).

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

Posted on

Revive Therapeutics Provides Corporate Update on its Psychedelics Therapeutics Programs

TORONTO, Sept. 21, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, US: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide a corporate update on its psychedelics therapeutics programs specifically as it relates to the Company’s oral thin-film delivery system and clinical studies with psilocybin at the University of Wisconsin-Madison.

“We are expanding our product pipeline with a focus on psychedelic therapeutics incorporating our novel oral thin-film delivery technology with psilocybin, in which we have prototypes developed and we will move towards clinical studies with the University of Wisconsin-Madison along with other key industry partners,” said Michael Frank, CEO of Revive. “In addition, we are advancing our Phase I clinical study to evaluate the safety and feasibility of psilocybin in adults with Methamphetamine Use Disorder. Our initiatives in product development and clinical studies gives us a leading position in the psychedelic space.”

Psilocybin Oral Thin-film Product

Under its sponsored research partnership with the Reed Research Group out of the University of Wisconsin-Madison, the Company is developing its tannin-chitosan composite of orally dissolvable thin films which offers a unique delivery platform for therapeutic doses (1-20mg) of psilocybin into the oral cavity. The Company has received its final set of prototypes and is preparing to scale for manufacturing for future clinical studies involving psilocybin and other psychedelic-derived medicines. There are a number of advantages and benefits of an orally dissolvable psilocybin thin film such as the rapid dissolving and onset of action to the bloodstream, the ease and convenience for patients to administer without the need of water, chewing or swallowing, the potential of improved therapeutic outcomes and efficacy for underserved diseases and disorders including the flexibility to create accurate dosing and tasteful options.The Company’s delivery technology is a natural, non-toxic, biodegradable and biocompatible composite that combines a tannin material, which is derived from a plant group having antibacterial, antifungal, antioxidant and wound healing properties, and a chitosan material, which is derived from the crustacean group having blood-clotting and antimicrobial properties. The delivery technology has a rapid onset of action and controlled or sustained release potential capabilities and may allow combining multiple extracts from mushrooms in one formulation.

Clinical Study of Psilocybin in the Treatment of Methamphetamine Use Disorder

The Company recently announced that it has entered into a Clinical Trial Agreement with the Board of Regents of the University of Wisconsin System to conduct a clinical study entitled “Phase I Study of the Safety and Feasibility of Psilocybin in Adults with Methamphetamine Use Disorder.” The Phase I study Principal Investigator is Dr. Christopher R. Nicholas, Ph.D., Assistant Professor of Program for Research Outreach Therapeutics and Education in the Addictions in the Department of Family Medicine and Community Health at University of Wisconsin School of Medicine and Public Health. The clinical study will be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health, and School of Pharmacy, which holds a Wisconsin special authorization and DEA license to perform clinical research with psilocybin. The Company will have exclusive access to key intellectual property from this study.

About Revive Therapeutics Ltd.

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

For more information, please contact:

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

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

Posted on

Revive Therapeutics Announces IRB Approval of US Expanded Access Treatment Program (Compassionate Use) for Bucillamine in COVID-19

TORONTO, Sept. 16, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that the Company’s expanded access protocol (“EAP”) for compassionate use of Bucillamine in the treatment of COVID-19 received approval from the independent Institutional Review Board (“IRB”). The EAP for compassionate use is a multi-center, open label study of Bucillamine in hospitalized patients with severe COVID-19 and is being done to complement the Company’s Phase 3 COVID-19 study in the U.S.  Revive expects to have patients enrolled in the United States this month.

“With the IRB approval of the expanded access protocol by Advarra, a premier IRB services company in North America, hospitalized patients with severe COVID-19 may access Bucillamine under the FDA compassionate use program under medical supervision by their physician,” said Michael Frank, Revive’s Chief Executive Officer. “The EAP serves as an option for patients that are not eligible for inclusion criteria in our Phase 3 clinical study in COVID-19 and the resulting data from the EAP will be valuable in supporting our clinical development of Bucillamine.”

The EAP for compassionate use provides physicians with access to Bucillamine under Revive’s existing Investigational New Drug (“IND”) application for COVID-19.  According to the FDA, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

About the Expanded Access Study

The expanded access study is titled, “Multi-Center, Open-Label, Expanded Access Study of Bucillamine in Hospitalized Patients with Severe COVID-19 (EA-ARISE)”.  Patients will receive Bucillamine 200 mg orally, 3 times a day (TID), for up to 14 days. The objective is to monitor the safety and efficacy of Bucillamine (600 mg/day) and any clinical symptoms when administered up to 14 days in hospitalized patients with severe COVID-19.  Following completion of the treatment course, follow up safety assessments will be performed by a study nurse 14 and 42 days following the end of treatment.

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

Scientific Rationale of Bucillamine for COVID-19

Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via increasing glutathione activity and other anti-inflammatory activity, to lessen the destructive consequences of SARS-CoV-2 infection in the lungs and attenuate the clinical course of COVID-19.

About Revive Therapeutics Ltd.

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

For more information, please contact:

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

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

References

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3. M Mata et al, N-acetyl-L-cysteine (NAC) inhibit mucin synthesis and pro-inflammatory mediators in alveolar type II epithelial cells infected with influenza virus A and B and with respiratory syncytial virus (RSV)., Biochem Pharmacol. 2011 Sep;82(5):548-55.

4. D Ungheri et al, Protective effect of n-acetylcysteine in a model of influenza infection in mice., Int J Immunopathol Pharmacol. 2000 Sep-Dec;13(3):123-128.

5. RH Zhang et al, N-acetyl-l-cystine (NAC) protects against H9N2 swine influenza virus-induced acute lung injury., Int Immunopharmacol. 2014 Sep;22(1):1-8).

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