Company Overview
Founded in 2012 and headquartered in Ontario, Canada, Revive Therapeutics (“Revive”) is a Specialty Life Sciences company. It focuses on repurposing drugs for rare disorders and infectious diseases. It is also advancing clinical development of Bucillamine for infectious diseases, including COVID-19 (Currently in Phase 3). Additionally, it is developing novel Psilocybin and Cannabidiol therapeutics for various Central Nervous System (“CNS”) and inflammatory disorders.
Revive trades on the Canadian Securities Exchange under “RVV” with a market cap of ~US$20mn as of May 20, 2020.
Psilocybin Capabilities
In February 2020. Revive announced the acquisition of Psilocin Pharma Corp, which owns a portfolio of production solutions for the active compound Psilocybin. Subsequently, Revive will conduct clinical research trials on the Psilocybin formulations developed by Psilocin Pharma for the treatment of Depression, Anxiety, Bi-polar disorder, Bulimia & Anorexia. Furthermore, it has pending patents on a variety of Psilocybin formulations including natural-synthetic derived Capsules, Sublingual Sprays, Gel Caps, Effervescent Tablets, and Oral Strips.
Company Strategy
Upon licensing a product candidate, Revive’s strategy is to apply its expertise to advance the product toward regulatory approval and commercial sale in major markets, including the U.S. and Canada. These include, for instance, implementing intellectual property protection and registration strategies, formulating or reformulating existing drug products, performing or managing clinical trials in target jurisdictions, undertaking or managing the collection & collation and interpretation of research.
Revive may also develop next-generation versions of its product candidates which may have the potential to treat existing diseases more efficiently.
Its relationships with external laboratories enable it to complete pre-clinical testing faster and more efficiently than if performed activities in-house. Additionally, Revive engages with independent contract research organizations specifically equipped to manage future clinical trial and research projects, thus eliminating the need for it to commit redundant internal resources. For them, it seems to be more efficient to outsource product manufacturing to contract manufacturing organizations and third-party suppliers.
Pharma IP Portfolio
Bucillamine
- Indication: Infectious Diseases (COVID-19)
- Regulatory Status: IND for Phase III
- Est. Market Size: US$5bn+
Psilocybin
- Indication: Multiple Indications
- Regulatory Status: Target FDA Orphan Status
- Est. Market Size: US$2bn+
CBD
- Indication: Liver Diseases
- Regulatory Status: Received FDA; IND for Phase II
- Est. Market Size: US$100mn+
Investment Rationale
The biggest positive for Revive is its diverse operations in three different biotech fields including infectious diseases (COVID-19), psilocybin & CBD. Hence, the negatives need to be weighed against the benefits of diversification.
Currently applying for Phase 3 clinical trials for their influenza-based studies (Bucillamine)
- In April 2020, the FDA recommended Revive to proceed into a confirmatory clinical trial
- Also updating its current IND with the FDA for Bucillamine, which allows the IND to serve as the foundation to pursue future programs with Bucillamine in infectious diseases and inflammatory and respiratory disorders
- Target to submit the FDA IND package in June 2020
- Additionally, seeking to conduct a clinical study with Bucillamine in the treatment of COVID-19 in Canada. Following the feedback from Health Canada, it will initiate a clinical study as soon as regulatory clearance is obtained.
Clinical trials for psilocybin-based therapeutics in various diseases and disorder
- Sponsored research partnership agreement with the University of Wisconsin-Madison to assess drug delivery technology focused on psilocybin-based pharmaceuticals. They will work towards the development of composite formulations and physio-chemical characterization of composite materials
- A worldwide license agreement with WARF for development and commercialization of all cannabinoids and hallucinogenic compounds using its delivery technology
- Currently evaluating novel oral dosage forms of psilocybin, such as oral dissolvable thin films or tablets. Additionally, looking to complete formulation development with the intent to pursue clinical studies for indications currently not being evaluated with psilocybin
Granted FDA orphan drug status designation for CBD to treat liver disease
- Exclusive license from South Carolina Research Foundation for its intellectual property for the use of CBD, either in synthetic or natural form, for treating autoimmune hepatitis
- The FDA has also granted orphan drug designation status for CBD in the treatment of AIH. This provides valuable incentives that could accelerate the approval process. For instance, eligible companies would receive seven-year market exclusivity, tax credits on U.S. clinical trials, fast-tracking of regulatory proceedings, and exemption from certain fees, such as waiver of filing fees under the Prescription Drug User Fee Act, and orphan drug grants.
Key Risk Factors
Potential investors should know the risks involved with Revive’s business in order to make an informed decision on investment.
Early Stage Investment
Although, Revive isn’t revenue-making currently, it expects to continue to spend a significant amount of capital for research, development and clinical trials.
Therefore, there can be no assurances that the intellectual property of Revive, or other products or technologies it may acquire, will meet applicable regulatory standards, obtain required regulatory approvals, be capable of being produced in commercial quantities at reasonable costs, or be successfully marketed.
Pre-Clinical Studies and Initial Clinical Trials are not Necessarily Predictive of Future Results
Pre-clinical studies and Phase 1 and Phase 2 clinical trials are primarily designed to test safety, to study pharmacokinetics and pharmacodynamics, and to understand the side effects of product candidates at various doses and schedules.
Clinical results are frequently susceptible to varying interpretations that may delay, limit, or prevent regulatory approvals. As such, negative or inconclusive results or adverse medical events during a clinical trial could cause a clinical trial to be delayed, repeated, or terminated.
Outlook for Psilocybin Stocks
Revive is focussing its efforts on developing drugs in spaces that have strong sector tailwinds. As a result, this optionality gives it a favorable risk/reward profile for biotech investors as they have three routes to unlock shareholder value through each biotech play.
To conclude, there is potential for massive upside albeit coupled with huge risk. In our opinion, the sub-sectors in which the Company operates show tremendous promise going forward and this microcap stock might be a good play for risky investors looking to make big profits from possible positive developments in the psychedelics industry.
Disclaimer: The Author of this report certifies that: (1) He does not hold any equity position in the Company and (2) the views expressed in this report reflect his personal views about the subject matter discussed.
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