PharmaTher Announces Positive Research Results for Psilocybin Microneedle Patch

PharmaTher Announces Positive Research Results for Psilocybin Microneedle Patch

  • Delivering psilocybin via microneedle patch unlocks potential for desired dosage forms and pharmacokinetic profiles for improved safety and effectiveness.
  • Completing microneedle patch research programs with other psychedelics before year-end.
  • Pursuing Phase 2 clinical studies in 2022 with psilocybin and notable psychedelics.

TORONTO, November 11, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has successfully completed its first research study evaluating MicroDose-MN™, a proprietary microneedle (“MN”) patch for the intradermal delivery of psychedelics, in delivering psilocybin. These results provide support to file for an IND application with the FDA to conduct Phase 2 clinical studies in 2022 with psilocybin for various indications.

The aim of PharmaTher’s research program was to develop a suitable prototype of MicroDose-MN™ patch for transdermal (intradermal) drug delivery to confirm compatibility and suitability to deliver psilocybin. The research program scope included, full characterization of psilocybin conjugated on the microneedle patch backbone, establishment and demonstration of the loading capacity for psilocybin, and release rate evaluations for the psilocybin conjugated materials using appropriate models that will be used to support the Company’s IND application with the FDA.

The Company’s research program with psilocybin conjugated microneedles have been successfully fabricated, optimized, and characterized. Both structural aspects and ex-vivo skin insertion assessments of the psilocybin conjugated microneedles have demonstrated successful fabrication and acceptable performance. The incorporation of psilocybin per microneedle without issue and the ability to demonstrate complete ex vivo skin model release over several days demonstrates potential for larger doses and modified release profiles. With these results, the Company believes it has an acceptable prototype for completing IND-enabling studies with the aim to conduct clinical studies in 2022. Details of the research program will be published in a scientific journal.

The Company previously announced that it has entered into a collaboration agreement with Revive Therapeutics Ltd. (“Revive”) (OTCQB: RVVTF) (CSE: RVV) for the evaluation of the psilocybin MicroDose-MN™ patch and is currently in discussions with Revive in finalizing a definitive agreement to advance the clinical and commercial development. There can be no assurance that a definitive agreement will be entered into between PharmaTher and Revive.

The Company believes that its MicroDose-MN™ patch for delivering psilocybin and other psychedelics may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles. In addition, the MicroDose-MN™ patch for psychedelics aims to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office or hospital. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

The Company is completing its evaluation of MicroDose-MN™ with 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”) and expects to provide results before the end of this year and pursue clinical studies in 2022.

The Company is actively engaged in partnering discussions for the use of its microneedle patch system to deliver psychedelics including, but not limited to, MDMA, LSD, DMT, ibogaine and mescaline. As such, PharmaTher offers potential partners a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards clinical studies in 2022.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.

Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.

For more business development opportunities or information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
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”, “aim”, “may” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. 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 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Psychedelic music studio changes your attachment style: issue 22

Here’s what’s in store for you in today’s issue:

🍄 Psychedelic music studio receives $4.5M in funding

🍄 How your attachment style affects your trip

🍄 First-ever study with direct psilocin

🍄 A new helmet to understand the brain

🍄 And more.

Be sure to check out last week’s Daily Mushroom podcast:

The DMT Cure for Chronic Pain and PTSD

Kieran, a retired black ops vet who magically cured his neck pain with a wild DMT trip. Kieran talks about being in a constant stress state while serving and how psychedelics help him cope with ongoing PTSD.

Therapeutic banner

First-ever study with direct psilocin

When psilocybin is consumed, it’s metabolized into psilocin, which is the compound that produces most (or all) of the psychedelic effects.

Will the experience change if psilocin is administered directly?

Filament Health (FH) just received FDA-approval for a first-of-its kind study that will reveal the answer.

The phase I trial at the University of California San Francisco will compare the effects of psilocybin and psilocin in 20 healthy patients. Psilocybin will be administered orally, whereas psilocin will be administered both orally and sublingually, meaning it will be absorbed through tissues under the tongue.

Researchers predict that direct psilocin could result in faster onset times, greater consistency and bioavailability — with fewer side effects.

A faster treatment for depressed moms

Existing treatments for post-partum depression take up to 8 weeks and often separate the mother from her baby for long periods of time, creating even more stress.

Field Trip Health (FTRP) is developing a proprietary psychedelic to change this.

The formulation, FT-104, could be administered in just one day and lasts 2-3 hours shorter than pure psilocybin. The compound leaves the mother’s system in just 24 hours, allowing her to safely breastfeed again.

FT-104 is currently in preclinical evaluation with phase I trials expected to begin in Q1 of next year.

atai accelerates schizophrenia research after promising findings

atai Life Sciences (ATAI) developed a new compound that could help treat cognitive impairment associated with schizophrenia.

The compound, RL-007, was tested on a cohort of 8 schizophrenic patients while continuing with their antipsychotic treatments. Using brain mapping and other biomarkers, researchers found that formulation improved cognition by activating receptors linked to learning and memory. 

The findings were so promising that atai decided to spend additional resources to accelerate the compound into a Phase 2a trial, which should be completed by the end of the year.

Ending the PTSD crisis

The lack of effective PTSD treatments is “a crisis,” according to the PTSD Psychopharmacology Working Group. About one in 20 people in the UK suffer from PTSD, and current treatment options are ineffective for 40% of patients.

COMPASS Pathways (CMPS) is launching a phase II trial to see if its psilocybin therapy model for treatment-resistant depression can bring relief to patients with PTSD.

The trial will assess 20 patients who experienced trauma as adults. They will be given a single dose of the psilocybin formulation followed by 12 weeks of therapy protocols.

Researchers will measure the safety of the drug as well as improvements in PTSD symptoms, functionality, and quality of life.

inspirational banner

Psychedelic music studio receives $4.5M in funding

When patients have a positive response to music during psychedelic therapy, they’re more likely to have a mystical experience which can lead to a more effective treatment.

That’s why neuroscientist Dr. Mendel Kaelen co-founded Wavepaths – a music studio that uses AI to create customized music—on the fly—in response to a patient’s emotional state!

The implications of Wavepaths go far beyond psychedelic therapy: hospitals, birth clinics, hospice centers, and schools are showing interest in the technology. It is already being used in 30+ countries and over 5,000 practitioners await its public release.

How your attachment style affects your trip

If you’ve ever struggled with attachment anxiety in your relationships, there’s promising evidence that psilocybin could be an effective treatment:

After undergoing individual therapy, group therapy, and a single psilocybin session, a group of 18 male AIDS survivors showed significantly reduced scores for attachment anxiety – an attachment style characterized by clinginess, fear of abandonment, and difficulty trusting others.

There were no significant changes in attachment avoidance, which is characterized by repressing emotions and discomfort with close relationships.

However, high attachment anxiety scores were associated with a greater chance of mystical experiences, whereas high attachment avoidance scores were linked to grief, fear, physical distress, and paranoia during the trip.

What better way to feel more secure in your relationships than through a trip? 🤩

Old Town Road to success

Lil Nas X was honoured as a visionary at the Wall Street Journal’s Innovator Awards after releasing his latest album, ‘Montero.’ Were magic mushrooms the secret behind his success?

The artist says that his first-ever mushroom trip was a pivotal moment while recording the album. The experience helped him reflect on himself and break free from feelings of self-consciousness.

“I was able to open up a lot. I was able to write actual stories about my life and put it into my music. I actually did that for the first time,” Nas explained.

business banner

A new helmet to understand the brain

The LA-based company Kernel developed a brain-imaging helmet that can track what actually happens in the brain during a psychedelic trip.

The device, Kernel Flow, was just approved by the FDA to be used in a ketamine trial sponsored by Cybin (CYBN).

Researchers will use the helmet to measure the neurological activity of 15 patients during a ketamine therapy session compared to baseline activity.

Kernel Flow is much less expensive than other brain-imaging tools and allows the patients to move freely during the session.

Trip at home with a psychedelic patch

PharmaTher (PHRM) and Revive Therapeutics (RVV) are entering into a research agreement to develop psychedelic patches that could be used at home!

The biodegradable patches will use microneedles to deliver both micro and macrodoses of psilocybin, ketamine, MDMA, LSD, DMT, ibogaine, and mescaline.

PharmaTher is currently studying the effects of the psilocybin microdose patch, with results expected by the end of this month.

The companies aim to create a delivery method that’s safe and convenient enough for patients to administer on their own, without supervision.

PharmaTher (PHRM) and Revive Therapeutics (RVV) are entering into a research agreement to develop psychedelic patches that could be used at home!

The biodegradable patches will use microneedles to deliver both micro and macrodoses of psilocybin, ketamine, MDMA, LSD, DMT, ibogaine, and mescaline.

PharmaTher is currently studying the effects of the psilocybin microdose patch, with results expected by the end of this month.

The companies aim to create a delivery method that’s safe and convenient enough for patients to administer on their own, without supervision.

Creating a myriad of drugs with AI

Using an AI drug discovery program, Mydecine (MYCO) successfully added a novel psilocin analogue with improved delivery and stability to its pipeline.

The AI technology synthesizes billions of drug candidates and filters them based on psychedelic-related targets such as how they bind to receptors.

Mydecine also filed a patent for nanoemulsion technology. Nanoemulsion can:

  • help the company develop compounds inspired by traditional plant medicines such as reishi and cordyceps mushrooms
  • improve control in delivery, which is critical in microdosing and customizing dosages
  • advance development of over-the-counter consumer products
legal banner

Detroit decriminalizes psychedelics!

With a 61% to 39% win, Detroit became the fourth city in Michigan to widely decriminalize possession and therapeutic use of psychedelics.

Over 80% voted to establish a reparations committee that will address historical discrimination against Black communities through housing and economic development programs.

Industry Quick Hits

Oct 29 – Oppenheimer initiates COMPASS Pathways (CMPS) with a buy rating and $50 price target Read more…

Oct 29 – Braxia Scientific (BRAX) Announces Voting Results from the Annual General Meeting of Shareholders Read more…

Nov 1 – Blackhawk Growth’s (BLR) MindBio Therapeutics Looks to Expand Microdosing Clinical Trials Read more…

Nov 1 – Algernon Pharmaceuticals (AGN) reports positive pre-clinical data on DMT candidate to treat stroke Read more…

Nov 1 – Small Pharma (DMT) reports second quarter highlights Read more…

Nov 2 – Braxia Scientific (BRAX) Graduates First Cohort of Medical Professionals From Psilocybin-Assisted Therapy Training Program Read more… 

Nov 2 – U.S. FDA Approves Nova Mentis (NOVA) Orphan Drug Application Read more…

Nov 2 – Tryp Therapeutics (TRYP) Submits IND Application for Phase 2a Clinical Trial in Fibromyalgia Read more…

Nov 3 – Amanita Muscaria Mushroom Successfully Added to the Natural Health Products Ingredients Database (NHPID) of Canada Read more…

Nov 4 – Awakn Life Sciences (AWKN) Announces The Findings From Phase II A/B Study Are To Be Published In American Journal Of Psychiatry Read more…

Nov 5 – Novamind (NM) Reports FY2021 Financial Results and Operating Highlights Read more…

Nov 5 – NeonMind (NEON) Biosciences Named As A Top Industry Innovator In Inaugural Issue Of Psychedelia Magazine Read more…

Video of the Week

Playlist of the Week

Trip at home with a psychedelic patch

PharmaTher Enters into Research Collaboration Agreement with Revive Therapeutics for Development of Psilocybin Microneedle Patch

PharmaTher (PHRM) and Revive Therapeutics (RVV) are entering into a research agreement to develop psychedelic patches that could be used at home!

The biodegradable patches will use microneedles to deliver both micro and macrodoses of psilocybin, ketamine, MDMA, LSD, DMT, ibogaine, and mescaline. PharmaTher is currently studying the effects of the psilocybin microdose patch, with results expected by the end of this month.

The companies aim to create a delivery method that’s safe and convenient enough for patients to administer on their own, without supervision.

PDF of article

Revive Therapeutics Enters into Research Collaboration Agreement with PharmaTher for Development of Psilocybin Microneedle Patch

Revive Therapeutics Enters into Research Collaboration Agreement with PharmaTher for Development of Psilocybin Microneedle Patch

Building specialty psilocybin-based product pipeline

Evaluating potential for neuropsychiatric indications for clinical studies in 2022

TORONTO, Nov. 03, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has entered into a research collaboration agreement with PharmaTher Holdings Ltd. (“PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle (“MN”) patch technology for neuropsychiatric disorders.

PharmaTher is currently conducting IND-enabling research studies with MicroDose-MN™, a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin to support an IND application with the FDA for clinicals studies in 2022. Research results with MicroDose-MN™ for psilocybin will be made available in November 2021 by PharmaTher.

Revive is building a specialty psilocybin-based product pipeline with the aim to treat mental illness, substance abuse and neurological disorders. In addition to the proposed psilocybin MicroDose-MN™ patch, the Company has the following development and commercial programs:

  • Feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary psilocybin oral thin film strip;
  • Evaluating psilocybin as a potential treatment for methamphetamine use disorder, traumatic brain injury and stroke in a research collaboration with the University of Wisconsin-Madison;
  • Developing a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform under its research collaboration with North Carolina State University; and
  • Research and commercialization agreement with the University of Health Sciences Antigua to utilize Revive’s novel psychedelic-assisted therapies including its tannin-chitosan delivery system and to pioneer the clinical research and development of psychedelics in Antigua and Barbuda and commercial partnerships with specialty pharmaceutical companies in the Caribbean and Latin America.

The collaboration agreement will give Revive the ability to evaluate the MicroDose-MN™ for psilocybin program to support upcoming clinical and commercial developments globally.

Michael Frank, CEO of the Company commented, “We are maintaining our focus in building a unique psilocybin-based product portfolio through research collaborations, licensing and commercialization agreements with academic research institutions and specialty pharmaceutical companies. The collaboration with PharmaTher complements our psilocybin product offerings as potential treatments for mental illness, substance abuse and neurological disorders. We believe there is no one fits all product profile solution with psilocybin and that for psilocybin to be a next generation therapeutic, it will require different use and delivery forms to achieve the intended target indications. As such, we aim to become a leader in psilocybin-based solutions for unmet medical needs by collaborating with companies that have intellectual property and experience in their delivery technologies.”

“Revive is a valued partner of PharmaTher and we are pleased to collaborate with them to achieve their objective in building a specialty psilocybin-based product pipeline that encompasses various delivery methods including our proprietary microneedle patch, which can deliver various psychedelics via the skin, enable flexible drug load capacity and combinations, and control-release delivery; overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems; maintain constant plasma levels for more than 24 hours; and aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office,” said Fabio Chianelli, CEO of PharmaTher.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.

Learn more at: PharmaTher.com and on 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 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.

PharmaTher Enters into Research Collaboration Agreement with Revive Therapeutics for Development of Psilocybin Microneedle Patch

PharmaTher Enters into Research Collaboration Agreement with Revive Therapeutics for Development of Psilocybin Microneedle Patch

  • Focusing on partnership model for MicroDose-MN™ and MacroDose-MN™ patches to deliver psychedelics.
  • Creating value and intellectual property protection for psychedelic programs.
  • Providing pathways for partners to enter FDA Phase 1 and 2 clinical studies in 2022 with psychedelics.
TORONTO, November 3, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce it has entered into a research collaboration agreement with Revive Therapeutics Ltd. (“Revive”) (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, to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle (“MN”) patch technology for neuropsychiatric disorders.

PharmaTher is currently conducting IND-enabling research studies with MicoDose-MN™, a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin to support an IND application with the FDA for clinical studies in 2022.  Research results with MicroDose-MN™ for psilocybin will be made available in November 2021.

The Company is also conducting research studies with its MicoDose-MN™ and MacroDose-MN™ patch as a next generation delivery system for psychedelics with ketamine, 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”).  Also, the Company has decided to expand research to include ibogaine and mescaline.

Partnership opportunities currently exist with MDMA, LSD, DMT, ibogaine and mescaline for specialty pharmaceutical companies seeking a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards FDA Phase 1 and 2 clinical studies in 2022.

The Company’s MicroDose-MN™ and MacroDose-MN™ patches have the potential to efficiently penetrate the stratum corneum layer (outer layer of the skin), enable flexible drug load capacity and combinations, and control-release delivery, which may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems.  In addition to the potential of maintaining constant plasma levels for more than 24 hours, the MN patches aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

“We are pleased to collaborate with Revive in achieving their product portfolio objectives with psilocybin.  Our microneedle patch technologies aim to become a next generation delivery system for psychedelics for various indications and healthcare environments.  Although our focus remains on building our ketamine-based product pipeline, we will continue to partner with specialty pharmaceutical companies seeking a delivery solution for psychedelics and proprietary drugs to unlock significant value and return on investment for PharmaTher,” said Fabio Chianelli, CEO of PharmaTher.

Michael Frank, CEO of the Company, commented, “Our focus is developing and commercializing a specialty psilocybin-based product portfolio, and the research collaboration with PharmaTher complements our psilocybin product offerings as potential treatments for mental illness, substance abuse and neurological disorders.  We believe there is no one-fits-all product profile solution with psilocybin. For psilocybin to be a next-generation therapeutic, different use and delivery forms will be required to achieve the intended target indications.  As such, we aim to become a leader in psilocybin-based solutions for unmet medical needs by collaborating with companies that have intellectual property and experience in their delivery technologies, such as PharamTher.”

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.
About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.

Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
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”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. 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 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

 

PharmaTher Provides Business Highlights and Releases Annual Financials for Fiscal Year Ended May 31, 2021

PharmaTher Provides Business Highlights and Releases Annual Financials for Fiscal Year Ended May 31, 2021

TORONTO, September 7, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today released business highlights and financial results for its fiscal year ended May 31, 2021.  Unless otherwise indicated, all amounts in this press release are in Canadian dollars. 
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “We had a tremendous year which focused on solidifying exclusive licenses for the development and commercialization of novel ketamine uses and formulations, as well as drug delivery technologies via a microneedle transdermal patch with the aim to change the way how ketamine and psychedelics are used to treat mental health, neurological and pain disorders.  In addition, we have strengthened our intellectual property portfolio and built a formidable clinical and scientific advisory team to support our research collaborations with leading research institutions and our clinical and commercial ambitions.  PharmaTher is now focused on completing its drug delivery research programs and clinical studies for the use of ketamine in Parkinson’s disease, depression, and ALS.  I like to thank the PharmaTher team, our Board of Directors and our shareholders for supporting our objective in unlocking the therapeutic potential of ketamine and psychedelics as next-generation pharmaceuticals for unmet medical needs.”

Business Highlights:

  • Solidified four exclusive license agreements, including the University of Arizona for the development and commercialization of ketamine in the treatment of Parkinson’s disease; BioRAE, Inc. for the development and commercialization of a novel biocompatible and biodegradable gelatin methacryloyl microneedle delivery technology developed at the University of California, Los Angeles (UCLA) for use with psychedelic pharmaceuticals (i.e. psilocybin, MDMA, LSD, DMT); National Health Research Institutes for the development and commercialization of a patented combination formulation of ketamine and betaine (KETABET™); The Queen’s University of Belfast for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to deliver ketamine and KETABET™; and The University of Kansas for the development and commercialization of ketamine in the treatment amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease.
  • Formed essential research and development collaborations, including a sponsored research agreement with the Terasaki Institute to develop a novel microneedle patch that aims to deliver psilocybin, MDMA, LSD and DMT; a sponsored research agreement with The Queen’s University of Belfast for the development of a patented hydrogel-forming microneedle patch to deliver ketamine and PharmaTher’s proprietary ketamine formulation, KETABET™; a collaboration agreement with MediSynergics, LLC. to develop patented ketamine derivatives and to investigate drug discovery and development of next-generation psychedelic derivatives; and a co-development agreement with TSRL, Inc. to jointly develop a microneedle array patch with the aim to control the manufacturing and supply of microneedle patches for the Company’s clinical and commercial drug programs.
  • Closed the sale of PharmaTher’s intellectual property pertaining to psilocybin, via an asset purchase agreement with Revive Therapeutics Ltd. (CSE: RVV, USA: RVVTF), for consideration of up to $10 million satisfied as follows: (i) $3 million in cash (ii) $4 million through the issuance of securities in the capital of Revive and (iii) up to $3 million, in either cash or securities in the capital of Revive for future milestones.
  • Strengthened the Company’s clinical and scientific advisory team with the addition of Maurizio Fava, MD, Psychiatrist-in-Chief in the Department of Psychiatry at Massachusetts General Hospital; Dr. Robert A. Hauser, MD, MBA, Professor of Neurology and Director of the University of South Florida Parkinson’s Disease and Movement Disorders Center; Dr. Alberto J. Espay, MD, MSc, FAAN, Professor and Endowed Chair of the University of Cincinnati James J. and Joan A. Gardner Family Center for Parkinson’s Disease and Movement Disorders; and Professor Matthew Macaluso, D.O., Bee McWane Reid Professor for the Department of Psychiatry and Behavioral Neurobiology in the School of Medicine at The University of Alabama at Birmingham (UAB) and Clinical Director of the UAB Depression and Suicide Center.
  • Announced the FDA approved the Company’s Investigational New Drug application to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.

Financial Highlights
·      Cash and cash equivalents ($2,778,081) and Investment ($3,100,000) for a total of $5,878,081 as of May 31, 2021.
·      Net loss was $2,664,196 for the financial year ended May 31, 2021.
For further information, please refer to the Company’s audited annual financial statements prepared in accordance with International Financial Reporting Standards and the related management’s discussion and analysis for the financial year ended May 31, 2021, which are available under the Company’s profile on SEDAR at www.sedar.com.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.

Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
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”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. 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 May 31, 2021 (“MD&A”), dated September 7, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Revive Therapeutics Signs Exclusive Worldwide License Agreement For Medicinal Mushroom Ganoderma Lucidum To Treat Cancer

  • Novel discovery and research originated from Universidad Central del Caribe and St. Jude Children’s Research Hospital
  • Medicinal mushroom compound with anticancer activities that have minimal effects on normal cells
  • Showed superior potency against aggressive breast cancer with potential to treat aggressive malignancies such as triple negative and inflammatory breast cancers
  • Advancing IND-enabling studies for FDA clinical trials

TORONTO, Aug. 17, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that Revive has entered into an exclusive license agreement (the “Agreement”) with Puerto Rico Science Technology and Research Trust (“PRSTRT”), representing Universidad Central del Caribe (“UCC”) and St. Jude Children’s Research Hospital (“St. Jude”), for the intellectual property (International Patent Application No. PCT/US2020/017053/) titled, Biologically Active Ganoderma Lucidum Compounds and Synthesis of Anticancer Derivatives; Ergosterol Peroxide Probes for Cellular Localization. Researchers at St. Jude and UCC have characterized medicinal mushroom Ganoderma lucidum compounds with anti-cancer activity, specifically significant activity against breast cancer, thus having the potential to treat the most aggressive types of breast cancers such as triple negative breast cancer and inflammatory breast cancer.

Michael Frank, CEO of the Company commented, “We are very excited about the new addition to our clinical-stage product pipeline as part of our long-term strategy of unlocking the therapeutic potential of medicinal mushrooms such as psilocybin and Ganoderma lucidum to treat mental health, substance abuse and aggressive cancers. Our intention is to build off from the research conducted at St. Jude Children’s Research Hospital and UCC by advancing towards FDA IND-enabling studies to allow for human clinical studies.”

Medicinal mushroom Ganoderma lucidum has been used in traditional Chinese medicine for more than two millennia. The Ganoderma lucidum extract (“GLE”) has been linked to improved length and quality of life, and it does not interfere with conventional therapy. Indeed, commercially available GLE is used in the prevention and treatment of hypertension, cancer, and immunological disorders. Furthermore, research suggests that GLE selectively inhibits breast cancer viability, induces apoptosis, reduces invasion, regulates key signaling molecules, and reduces tumor size by approximately 50% in mice xenografts.

Despite the well-established therapeutic uses of GLE, the organic compounds responsible for its biological activity had not been identified. The chemical characterization of the compounds responsible for the biological activity of GLE is imperative to design and test derivatives with improved efficacy and safety profiles.

The licensed invention elucidated the chemical structure of the most abundant chemical constituents of GLE and determined their efficacy in different aggressive breast cancer models. Several natural compounds were identified and three showed significant anticancer activity (ergosterol, 5,6-dehydroergosterol, and ergoesterol peroxide). In particular, one of these compounds, ergoesterol peroxide, exerts selective effects on cancer cell viability, similar to the effects produced when using whole mushroom extract GLE, suggesting an ample therapeutic window. Ergoesterol peroxide displays anti-proliferative effects through G1 phase cell cycle arrest, apoptosis induction via caspase 3/7 activation and PARP cleavage, decreases migration and invasion while inhibiting the expression of total AKT1, AKT2, BCL-XL, Cyclin D1 and c-Myc, induces ROS formation, and inhibits tumor growth in vivo. This technology further includes ergosterol peroxide chemical probes for in vitro anticancer evaluation, live cell studies, and proteomic profiling.

Peer reviewed papers related to the licensed intellectual property includes:

  • Ling, Taotao, Walter H. Lang, Michelle M. Martinez-Montemayor, and Fatima Rivas. 2019. “Development of Ergosterol Peroxide Probes for Cellular Localisation Studies.” Organic & Biomolecular Chemistry 17(21): 5223–29.
  • Martinez-Montemayor, Michelle M. et al. 2019. “Identification of Biologically Active Ganoderma Lucidum Compounds and Synthesis of Improved Derivatives That Confer Anti-Cancer Activities in Vitro.” Frontiers in Pharmacology 10: 115.

Under the terms of the Agreement, Revive gained exclusive worldwide development and commercial rights to intellectual property (International Patent Application No. PCT/US2020/017053/) titled, Biologically Active Ganoderma Lucidum Compounds and Synthesis of Anticancer Derivatives; Ergosterol Peroxide Probes for Cellular Localization.

Revive, PRSTRT and St. Jude agreed to terms consistent with industry standards, including future payments based on clinical trial and revenue milestones.

About Revive Therapeutics Ltd.

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

For more information, please contact:

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

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

Cautionary Statement

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

Revive Confirms No Material Undisclosed Information

TORONTO, Aug. 12, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (Frankfurt:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announces that its management is not aware of any undisclosed material information relating to the Company that may be contributing to the recent increase in its trading activity.

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. Through its subsidiary 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.

Revive Therapeutics Provides Update on Psychedelics Clinical Product Pipeline

  • Focusing on novel uses, production and delivery forms of psilocybin as a next generation solution for mental illness, substance abuse and neurological disorders
  • Advancing to FDA clinical studies for methamphetamine use disorder and stroke

TORONTO, Aug. 10, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s psychedelics development and clinical programs with a focus on psilocybin.

Michael Frank, CEO of the Company, commented, “We are advancing a robust psychedelics-based product pipeline that includes product development, preclinical and clinical studies that aim to unlock the potential therapeutic value of psilocybin in various uses, formulations and delivery methods to treat mental health, substance abuse and neurological disorders.   Revive is embarking on the next stage of growth of its psychedelics strategy by focusing on building key partnerships with US academic institutions and other leading organizations, as well as developing intellectual property and entering into FDA clinical studies with psilocybin.”

Psilocybin in the Treatment of Methamphetamine Use Disorder

The Company is working with the Board of Regents of the University of Wisconsin System under a clinical trial agreement to conduct a Phase I/II clinical study to evaluate the safety and feasibility of psilocybin in adults with methamphetamine use disorder. Study start-up activities have taken place and enrollment activities are to continue throughout the remainder of the year. As a result of the study, clinical data will provide proprietary and valuable information on the safety, efficacy and dosing of psilocybin to support future pivotal FDA clinical studies in oral forms of delivery including oral thin film strips. 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. In addition, the Company will have exclusive access to key intellectual property from this study to support development, regulatory and commercial initiatives.

Psilocybin in the Treatment of Traumatic Brain Injury (TBI) and Stroke

The Company is advancing the research and intellectual property acquired from PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) on psilocybin as a potential solution to managing TBI and stroke. Preclinical studies demonstrated that psilocybin, given after injury, improved cognitive function in TBI mice. The Company is proceeding to an FDA clinical study to be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy. Start-up activities have already begun and patient enrollment is expected to commence in Q4-2021.

Psilocybin Oral Thin Film Strip Development

The Company has initiated the product development program under a feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary psilocybin oral thin film strip for mental illness, substance abuse and neurological disorders.   Research grade prototypes will be available to evaluate dosing and delivery rates in various dosage forms with the expectation to conduct clinical studies in 2022.

Psilocybin Biosynthesis Program

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

Psilocybin International Research and Commercialization

The Company recently entered into an agreement with the University of Health Sciences Antigua to utilize Revive’s novel psychedelic-assisted therapies including its tannin-chitosan delivery system and to pioneer the clinical research and development of psychedelics in Antigua and Barbuda. Clinical research will be conducted at the University in Q4-2021 with the aim for commercialization in 2022 in Antigua and Barbuda. Once approved for sale, the Company will seek commercial partnerships with specialty pharmaceutical companies in the Caribbean and Latin America.

About Revive Therapeutics Ltd.

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

For more information, please contact:

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

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

Cautionary Statement

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