09:11:53 EDT Sun 19 May 2024
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Bioharvest Sciences Inc
Symbol BHSC
Shares Issued 478,688,168
Close 2024-02-26 C$ 0.23
Market Cap C$ 110,098,279
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Bioharvest signs contracts to develop complex molecules

2024-02-26 15:55 ET - News Release

Mr. Ilan Sobel reports

BIOHARVEST SCIENCES SIGNS FIRST CONTRACTS WITH TWO INDUSTRIAL CUSTOMERS TO DEVELOP COMPLEX MOLECULES VIA ITS NEWLY LAUNCHED BOTANICAL SYNTHESIS CDMO BUSINESS UNIT

Bioharvest Sciences Inc. has officially launched its new contract development and manufacturing organization (CDMO) business unit. This new unit has recently signed two contracts to develop complex molecules -- for a Nasdaq-listed pharmaceutical company and for a leading player in the nutrition and ingredient industry.

The new business unit allows pharmaceutical, cosmeceutical, nutraceutical and nutrition industry leaders the opportunity to partner with Bioharvest to utilize its botanical synthesis process technology through a typical CDMO contracting model. This proprietary process technology enables the development and manufacturing of patentable plant-based small molecules, complex molecules, and unique compositions that include both small and complex molecules. The company's botanical synthesis process is able to develop complex molecules, otherwise known as biologics, which have a number of unique advantages for the industry, including lower costs of development and manufacturing, a much faster speed of development and non-immunogenic properties that enhance safety. As a result of these advantages, the company has decided to call these unique plant-derived complex molecules Biologics+. Biologics+ will help address unmet needs in the health industry across pharmaceutical, nutraceutical, cosmeceutical and nutrition verticals.

The CDMO business offers the botanical synthesis process technology in three major steps to its customers. Step 1 (three to six months) is capable of producing a small biomass of the plant-based Biologics+ from the source plant. This step requires the customer to pay Bioharvest non-recurring engineering expenses (NRE) between $150,000 (U.S.) and $500,000 (U.S.). Step 2 (six to nine months) provides for delivery of an increased amount of biomass to enable clinical trials and other tests and requires NRE of $350,000 (U.S.) to $700,000 (U.S.). Step 3 (nine to 12 months) is the last development step that brings the molecules to a large-scale production capability and requires NRE between $1-million (U.S.) and $1.5-million (U.S.). In summary, full successful development using the botanical synthesis process will take 15 to 24 months and between $1.5-million (U.S.) to $2.5-million (U.S.) in NRE. Should the customer decide to produce the developed molecule(s) at industrial scale following successful completion of step 3, Bioharvest would enter a royalty-based payment model for industrial manufacturing of the molecule(s).

The CDMO's first contract is with a Nasdaq-traded pharmaceutical company, which, for strict confidentiality reasons, cannot be disclosed. This pharmaceutical entity has contracted Bioharvest to develop particular complex molecules that would form the base of its patented drug development. The contract is for step 1 of the botanical synthesis process and is priced at the lower level of the aforementioned range. The second agreement is with a major player in the food nutrition and ingredient industry and, for strict confidentiality reasons, cannot be disclosed. This industry leader has contracted Bioharvest to develop unique plant-based molecules for the use in the multibillion-dollar sweetener industry. The contract is for step 1 of the botanical synthesis process and is priced at the lower level of the aforementioned range. Given the commercial potential of this specific sweetener molecule, Bioharvest has decided to take a 50-per-cent stake in the molecule ownership rights through contributing 50 per cent to the step 1 development costs. Both contracts have the potential to progress to step 2, step 3 and the production phase.

Ilan Sobel, chief executive officer, said: "Our mission to turn thousands of plants into scientifically reliable sources of therapeutic molecules will be accelerated by our CDMO business model. The launch of this new business unit will, for the first time, offer our proprietary botanical synthesis process technology to pharmaceutical companies as well as to other key industry verticals who are actively searching for new complex molecules to drive their innovation and growth agendas. These two contracts with established industry players are a major validation of the critical market need for our botanical synthesis process and Biologics+ molecules." Mr. Sobel added: "Bioharvest is actively engaging with other potential CDMO customers. Early feedback has validated our strategy thesis that industry leaders are aggressively searching for the next high-impact molecules to drive value in their respective businesses, and it has confirmed the strength of the Bioharvest botanical synthesis CDMO proposition for that purpose."

Dr. Zaki Rakib, the company's co-founder and chairman, has applied his scientific and business background to play a critical role in the mathematical development of key proprietary elements of the botanical synthesis process and will be leading the CDMO business unit. Dr. Rakib commented: "The botanical synthesis CDMO is the realization of the biotech vision we started with 15 years ago. We could not have reached this stage of offering our botanical synthesis process technology to multiple industries without the experience and ingenuity of Dr. Yochi Hagai (CTO [chief technology officer] and co-founder), Dr. Malkit Azahi (VP of R&D [vice-president of research and development]) and our leading scientists. In addition, the success of our own red grape cell complex molecule product, Vinia, has been instrumental in giving the CDMO the required credibility to assure customers of the consistency and economic efficiency of producing patentable molecules using the botanical synthesis process. I look forward to updating you on key executive hires and new customer contracts in the near future."

About Bioharvest Sciences Inc.

Bioharvest Sciences is a leader in botanical synthesis, leveraging its patented technology process to grow the active ingredients in plants without the need to grow the underlying plant. Bioharvest is leveraging its botanical synthesis technology to develop the next generation of science-based and clinically proven therapeutic solutions within two major business verticals: as a contract development and production organization (CDMO) on behalf of customers seeking complex molecules; and as a creator of proprietary nutraceutical health and wellness products, including dietary supplements.

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