Revive Therapeutics Archives - Green Market Report

StaffJanuary 21, 2021
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No sooner had Revive Therapeutics Ltd. (OTC: RVVTF) announce it had raised $10, then it stopped trading to say the deal was upsized to $20 million. Revive is a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders. The company entered into an agreement with Canaccord Genuity Corp. and Leede Jones Gable Inc. to pay $0.50 per Equity Unit. Under the amended terms, the Underwriters have agreed to purchase, on a bought deal basis, 40 million Equity Units for gross proceeds to the Company of $20 million. The stock was lately selling at $0.47. The closing of the offering is expected to occur on or about the week of February 8, 2021. 

The company said that the net proceeds would be used for Phase 3 ‎clinical costs for Bucillamine for COVID-19, Phase 1 clinical ‎costs for Psilocybin for methamphetamine use disorder ‎study, and other Psychedelic formulation development work as well as working capital and general corporate purposes. ‎

Revive has also granted the Underwriters an over-allotment option at any time until 30 days following the Closing, to purchase up to that number of additional Equity Units, Common Shares or Warrants, or any combination thereof, as is equal to 15% of the aggregate number of Equity Units sold in the Offering to cover over-allotments, if any.

The company announced last week that it had entered into a sponsored research agreement and an exclusive option to license agreement with North Carolina State University to develop 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  will provide a potentially simple and efficient method for rapidly producing natural products, such as psilocybin, using an engineered enzymatic pathway in E. coli.

Revive seeks to develop and commercialize its own pharmaceutical-grade psilocybin with this biosynthesis technology at scale to support the Company’s current psilocybin-based product pipeline that includes an oral thin film product currently being developed in collaboration with the University of Wisconsin-Madison and the intellectual property and research with psilocybin being developed by PharmaTher Inc. (CSE: PHRM, OTCQB: PHRRF). The company also recently acquired Psilocin Pharma Corp. and 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

Terms

Each Equity Unit will consist of one (1) common share of the Company (a “Common Share“) and one (1) Common Share purchase warrant (a “Warrant“). Each Warrant will entitle the holder thereof to purchase one Common Share at an exercise price of $0.70 (the “Exercise Price“) at any time up to thirty-six (36) months following Closing (as defined below). The expiry of the Warrants may be accelerated by the Company at any time prior to the expiry date of the Warrants if the volume-weighted average price of the Common Shares on the Canadian Securities Exchange (the “Exchange“) is greater than $1.10 for any ten (10) consecutive trading days, at which time the Company may, within ten (10) business days, accelerate the expiry date of the Warrants by issuing a press release announcing the reduced warrant term whereupon the Warrants will expire on the 30th calendar day after the date of such press release.

 


Debra BorchardtApril 29, 2020
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Specialty life science company Revive Therapeutics Ltd. (CSE: RVV) has said that it will investigate novel oral dosage forms of psilocybin, such as oral dissolvable thin films or tablets, based on its wholly-owned patent-pending psilocybin formulations and its exclusive licensed drug delivery technology from the Wisconsin Alumni Research Foundation.

“We are expanding our psilocybin-based pharmaceutical portfolio with unique oral dosage and drug delivery forms that will target and have the potential to treat diseases and disorders currently not investigated with psychedelic compounds,” said Michael Frank, Revive’s, Chief Executive Officer. “We are combining our robust intellectual property portfolio in both psychedelic formulations and our drug delivery technology which is unique within the industry, and leveraging our research partnership with the University of Wisconsin-Madison to establish a specialty portfolio of psilocybin-based pharmaceuticals that we can advance to clinical trials and partnerships with other life sciences companies.”

The company said in a statement that through initial evaluations with its research team, it has found there are several unique parallels between the company’s intellectual property portfolio of psilocybin-based formulations and delivery mechanism and the drug delivery technology, which is comprised of tannin-chitosan composites that have been studied with cannabidiol in the past.  Revive said it intends to research both delivery mechanisms in parallel as each provides its own unique qualities such as the potential of rapid onset of action and time-release compositions.

New Interest in Psilocybin

Psilocybin is being viewed as a treatment for several conditions including drug-resistant depression. Studies have been performed to illustrate the efficacy of psilocybin for this specific purpose. One completed study found that psilocybin produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer. The study was published in 2016, and wrote that “At 6-month follow-up, these changes were sustained, with about 80% of participants continuing to show clinically significant decreases in depressed mood and anxiety. Participants attributed improvements in attitudes about life/self, mood, relationships, and spirituality to the high-dose experience, with >80% endorsing moderately or greater increased well-being/life satisfaction.”

According to the World Health Organization, almost 350 million people worldwide were affected by depression in 2016. Common antidepressant drugs help maintain the balance of various hormones and chemicals in the brain, which assists in the treatment of depression.

The Center for Disease Control and Prevention (CDC), reported that the percentage of people above the age of 12 years using antidepressants in the U.S. rose to 12.7% in 2011-2014. According to MedGadget, the antidepressant drug market was valued at $13.69 billion in 2018 and is expected to reach $15.88 billion by 2025. The CDC said that in the U.S., antidepressants were the most commonly prescribed drugs in 2013 and from over 16 million long term users, around 70% are female.

Psilocin Acquisition

In March, Revive completed its acquisition of Psilocin Pharma Corp., a specialty psychedelic sciences company focused on the development of Psilocybin-based therapeutics for significant unmet medical needs including rare and orphan indications. Psilocin developed patent-pending formulation and production solutions for the active compound Psilocybin.  The process encompassed with its intellectual property cover methods of production of Psilocybin-based formulations.

In a statement, the company noted that Psilocin has also developed formulations to date which include the Hydroxy Line.  The line will include PSY-0.1 -Capsules- PSY-0.2 -Sublingual Spray- PSY-0.3 -Gel Cap- PSY-0.4/0.5 -Effervescent Tablets-and PSY-0.6 -Breath Strips.  The precisely dosed formulations will work with both natural and synthetically derived Psilocybin which will be targeted for clinical research and subject to U.S. Food and Drug Administration (“FDA”) approval in the treatment of depression, anxiety, bi-polar disorder, bulimia and anorexia nervosa, and a number of other diseases.  Psilocin’s range of products have been engineered to work synergistically with the body’s own natural pathways of absorption while offering a contemporary approach to consumption

Best Delivery Method

Revive believes that the most optimal delivery method to deliver psilocybin will be in the form of both an oral dissolvable tablet and an oral thin film strip, commonly recognized as a ‘Breath Strip’.  The company said that it is preparing its formulation development plans to pursue clinical studies for indications currently not being evaluated with psilocybin.

The company reported that it has key provisional patent applications with the U.S. Patent and Trademark Office that cover methods of production of psilocybin-based formulations, including sublingual sprays, effervescent tablets, hard-shell capsules, sublingual and transmucosal delivery systems (i.e. gum drops, oral strips, dosing pens). In addition to those patent applications, Revive has a patent-pending portfolio that includes Psilocybin extraction and crystallization methodologies.

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.

Revive is also exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza strains including COVID-19.


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