Mr. Craig Goodwin reports

HEALTH CANADA PROVIDES AUTHORIZATION LETTER FOR NATURALLY SPLENDID JV, PLASM PHARMACEUTICAL TO BEGIN COVID-19 PHASE 2 CLINICAL TRIAL

Further to Naturally Splendid Enterprises Ltd.'s earlier announcements, Health Canada has provided a notice of authorization to proceed with a phase 2 clinical trial for a potential COVID-19 treatment utilizing the target drug Cavaltinib.

The authorization letter received on Nov. 2, 2020, follows the completion of a series of information request notices from Health Canada regarding the clinical trial protocols. The company has completed all required submissions and documentation required by Health Canada and has final approval to initiate the strategic execution of the phase 2 clinical trial for a potential COVID-19 treatment.

In this regard, the Plasm Pharmaceutical Inc. team has begun the process of assembling the additional team members and third party organizations that will be required to engage in and complete the clinical trial.

The company is optimistic that Cavaltinib can be a significant resource as part of a successful treatment plan for COVID-19-positive patients. This treatment option, delivered in capsule form, may mitigate the risk for those who are at high risk of morbidity or mortality. The capsule delivery mechanism may be able to provide hope for patients, while reducing the impact on health care services, as this form of treatment can be self-administered at home, rather than patients being forced to seek treatment in hospitals or clinics.

Franco Cavaleri, Biologic Pharmamedical's chief executive officer and chief scientist, commented: "Cytokine storms are a common complication not only of COVID-19, but of other respiratory diseases caused by coronaviruses, such as SARS [severe acute respiratory syndrome] and MERS [Middle East respiratory syndrome]. In fact, this immune system and inflammatory phenomenon is also similar in many ways to how the pathology of autoimmune diseases play a deleterious role in the overall health of patients with these diseases. We are cautiously hopeful that these studies will also shed light on how this drug might play a role in the functional treatment of these other diseases as well."

Cytokines are small proteins released by many different cells in the body, including those of the immune system, where they co-ordinate the immune and inflammatory response against infection or other triggers. Sometimes the body's response to the trigger can go into overdrive, and such is the case in the high-risk patients infected by the SARS-CoV-2 virus behind the COVID-19 pandemic.

Cavaltinib has been shown to inhibit these cytokines. Research has already shown Cavaltinib irrefutably inhibits the NF-kappa-B signalling pathway through mechanisms discovered by Mr. Cavaleri. As a consequence of its down regulation, the inhibition of several downstream cytokines ensues; cytokines central to the cytokine storm phenomenon characteristic of the COVID-19 pathology (IL-1, IL-2, IL-3, IL-6 and several other cytokines). Mitigation of this biological activity can help the patient survive the cytokine storm and make it through to the antibody stage.

Plasm has secured licensing rights for this Biologic-owned patent, which covers 38 countries. Plasm has been conceived and assembled for the purpose of further developing and carrying out clinical trials on the Cavaltinib-branded drug(s) in the specific field described in the licence agreement. The field includes, but is not limited to, the treatment and/or prophylaxis of respiratory indications, including COVID-19.

Naturally Splendid owns 16 per cent of the joint venture and will receive a 10-per-cent royalty on gross sales of all Plasm products.

Plasm is being positioned to take drug candidates through clinical trial and other premarket protocols mandated by regulatory agencies. Plasm's first and current subject drug treatment, Cavaltinib, has shown positive bench results, with published peer-reviewed studies executed and published by Biologic showcasing the drug's inhibition of inflammatory cytokines central to the COVID-19 pathology.

For almost two years, Biologic has supplied Naturally Splendid with versions of the patented technology that Cavaltinib is based on. In this time, the company has gained an excellent overall understanding of the science and technologies that will be utilized in this clinical study. Naturally Splendid's internal research and development scientist, Dr. Mehrab Manteghian, who holds a doctorate of medicine as well as a degree in food science, has reviewed the data from the clinical studies on this technology and will continue to be involved through the clinical trial process.

Naturally Splendid's chief executive officer, Craig Goodwin, commented: "This is, of course, a significant step forward in our pursuit of a COVID-19 treatment, made even more important as we see additional waves of the virus continue to spread. The hope remains high that Cavaltinib will provide relief for those afflicted with COVID. We also anticipate the clinical trial to provide additional indications where Cavaltinib may be effective."

Naturally Splendid cautions that this news release is not making any express or implied claims that the company has the ability to eliminate, cure or contain the SARS-CoV-2 virus at this time.

About Naturally Splendid Enterprises Ltd.

Naturally Splendid Enterprises operates a food manufacturing facility (certified under Safe Quality Food Level 2) just outside of Vancouver, B.C., Canada. The company has established numerous healthy, functional foods under recognized brands, such as: Natera Sport; Natera Hemp Foods; CHII; Elevate Me; and Woods Wild Bar. The company has a myriad of new products and line extensions under development that are approaching launch. Naturally Splendid has also developed proprietary technologies for the extraction of high-demand, healthy omega-3 and omega-6 oils from hemp. Naturally Splendid is the current go-to manufacturer for healthy, functional food products and ingredients focusing on plant-based ingredients. The company provides contract manufacturing services for many global healthy food companies, private-labelling a wide variety of nutritional food products destined for global healthy food markets.

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