23:19:48 EDT Thu 18 Apr 2024
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Naturally Splendid Enterprises Ltd
Symbol NSP
Shares Issued 184,295,672
Close 2020-09-02 C$ 0.07
Market Cap C$ 12,900,697
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Naturally Splendid, Biologic to work on COVID treatment

2020-09-02 11:59 ET - News Release

Mr. Craig Goodwin reports

NATURALLY SPLENDID ANNOUNCES BIOLOGIC DEFINITIVE AGREEMENT AND PRIVATE PLACEMENT

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

The joint venture entity will be granted certain rights from Biologic's patents as it relates 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.

Previously, Naturally Splendid announced that Health Canada had issued a no-objection letter for Cavaltinib, the target drug, in response to the clinical trial application as prepared by Biologic. The company awaits further direction from Health Canada.

Biologic has supplied Naturally Splendid with versions of the patented technology that Cavaltinib is based on 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. Naturally Splendid's internal research and development scientist, Dr. Mehrab Manteghian, who holds a doctorate of medicine as well a degree in food science, has reviewed the data from the clinical studies on this technology and will be actively involved through the clinical trial process.

Cavaltinib is an amplified variant of a current Biologic patented technology 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 company cautions that this news release is not making any express or implied claims that the company has the ability to eliminate the COVID-19 virus at this time.

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

Private placement

Naturally Splendid has arranged a fully subscribed non-brokered private placement financing of up to 14,166,667 units at a price of six cents per unit for gross proceeds of up to $850,000.

Each unit in the non-brokered private placement consists of one common share of Naturally Splendid and one-half of a common share purchase warrant, with each warrant entitling the holder to purchase one additional common share for a period of two years from the date of the issue at an exercise price of 10 cents per share. Naturally Splendid has the right to accelerate the expiry date of the warrants if, at any time, the average closing price of Naturally Splendid's common shares is equal to or greater than 15 cents for 10 consecutive trading days. In the event of acceleration, the expiry date will be accelerated to a date that is 10 days after Naturally Splendid issues a news release announcing that it has elected to exercise this acceleration right.

Naturally Splendid may pay finders a fee in cash and/or share purchase warrants in connection with the offering.

The securities issued under the offering will be subject to a hold period pursuant to applicable securities laws and the rules of the TSX Venture Exchange.

The proceeds of the offering will be directed toward preparation of the phase 2 clinical trial, to retire corporate indebtedness and for general working capital purposes.

Terms of joint venture

The joint venture entity has been granted certain licence rights from Biologic patents as they relate 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 clinical trial.

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.

Biologic will also continue to run an in vitro program on tissue and cell models to further expand knowledge on pharmacological mechanisms associated with 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 a 12-month period intended to further expand the pharmacology.

Under the terms of the joint venture, Naturally Splendid will invest $500,000 for the purpose 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.

Naturally Splendid chief executive officer Craig Goodwin stated: "We continue to make progress on several fronts, including significant steps towards beginning a phase 2 clinical trial for a potential COVID-19 treatment. Most unfortunately, the pandemic has continued to have widespread negative effects on the health and economies in many countries. We believe that a treatment, while vaccines are being developed, is a critical component to an overall strategy of coping with this new reality. Although a vaccine is certainly the long-term goal of the medical community, an effective treatment is very much needed. We remain optimistic that Cavaltinib will have a positive effect to reduce the health complications arising from COVID-19 and thus potentially reducing strains on health care systems."

We seek Safe Harbor.

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