17:05:53 EDT Wed 08 May 2024
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Naturally Splendid Enterprises Ltd
Symbol NSP
Shares Issued 141,438,513
Close 2020-05-19 C$ 0.05
Market Cap C$ 7,071,926
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Naturally to form JV with Biologic for COVID-19 trial

2020-05-19 17:06 ET - News Release

Mr. Craig Goodwin reports

NATURALLY SPLENDID ANNOUNCES LOI FOR JOINT VENTURE WITH BIOLOGIC PHARMAMEDICAL RESEARCH FOR COVID-19 CLINICAL TRIAL

Naturally Splendid Enterprises Ltd. has entered into a letter of intent with Vancouver-based Biologic Pharmamedical Research to form a joint venture for the purpose of further developing and pursuing phase 2 clinical studies, utilizing one of Biologic's patented technologies as a candidate for a potential COVID-19 treatment.

The joint venture entity will be granted certain rights from Biologic's patents relating to applications for treating COVID-19 infections. The categories to be licensed will include, but are not limited to, COVID-19 applications as well as additional respiratory indications that may arise out of the fast-tracked phase 2 clinical trial.

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

Naturally Splendid will own 16 per cent of the joint venture as well as be granted a 10-per-cent royalty on gross sales of all products and applications arising from the clinical study. Biologic will own 82 per cent of the joint venture, with 2 per cent assigned to key personnel within Biologic at its discretion.

The company has been working co-operatively to support Biologic on its plan to conduct COVID-19 phase 2 clinical studies in Canada, the United States and abroad with its patented pharmacological technology. Although no guarantee to be accepted, Biologic has been given the go-ahead to fast-track a CTA (clinical trial application) with Health Canada, after its preliminary review of the data.

Biologic has supplied Naturally Splendid with versions of this patented technology for almost two years. In this time, the company has gained an excellent overall understanding of the science and technologies that will be utilized in this clinical study. The company's internal R&D (research and development) scientist, Dr. Mehrab Manteghain, who holds a doctorate of medicine degree as well as a degree in food science, has reviewed the data from the clinical studies on this technology and will be actively involved as the company pursues and completes clinical trials.

Terms of the joint venture

The joint venture entity will be granted certain licence rights from Biologic patents relating to applications for treating COVID-19 infections. The categories to be licensed will include, but are not be limited to, COVID-19 applications as well as additional respiratory indications that may arise out of the fast-tracked clinical trial. Biologic will also continue to run an in vitro program on tissue and cell models to further expand knowledge on pharmacological mechanisms associated with the treatment of other indications, such as: rheumatoid arthritis; ulcerative colitis; Crohn's disease; and/or other autoimmune or autoinflammatory diseases of which the technologies and/or products related to the findings of the clinical study will be licensed into the joint venture on similar terms.

It is expected the initial clinical trial phase directly related to COVID-19 will take 30 to 90 days, with the balance of the studies over the 12-month period intended to further expand the pharmacology. Under the proposed joint venture, Naturally Splendid Enterprises will invest $500,000 (cash) into the joint venture for the purposes of:

  1. Preparing documentation for submission of the CTA to Health Canada;
  2. Preparation of formal phase 2 clinical trials;
  3. $100,000 for inventory of the COVID-19 treatment product for phase 2 clinical trials;
  4. Continuing clinical trials and further research and development for a period of 12 months overseen by Biologic;
  5. Preparing documentation for pre-IND (investigational new drug) application for a phase 2 COVID-19 clinical trial with the U.S. Food and Drug Administration;
  6. Preparing and executing the company's own internal pilot trial.

The pandemic has placed a strain on the health care system at multiple levels, including the well-defined ventilator and intensive care unit (ICU) bottlenecks.

This proposed treatment is an amplified variant of a current Biologic technology that leverages the Biologic patent that, taken in capsule form, would greatly reduce or eliminate the need for virus-infected patients to congregate in hospitals or clinics for infusions or other complex treatments. The resulting benefit of this type of capsule delivery mechanism would make distribution of the treatment far more effective at a fraction of the cost of treatment requiring hospitalization, which, in turn, could provide an extra layer of safety for front-line medical staff.

The scientific content of this news release has been reviewed and approved by Biologic.

About Naturally Splendid Enterprises Ltd.

Naturally Splendid Enterprises has established numerous healthy, functional foods under recognized brands, such as: Natera Sport; Natera Hemp Foods; CHII; Elevate Me; and Woods Wild Bar.

We seek Safe Harbor.

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