Willow Biosciences Announces Commercial Scale Operational Update, CBGA Production Update and Corporate Update

Rhea-AI Summary

Willow Biosciences (CANSF) provided updates on its operations as of Sept. 21, 2021. The company completed its first commercial fermentation run of CBG in March 2021, increasing production titer by over 400%. CBG samples were delivered to Cellular Goods PLC in July 2021. Willow has also developed a process for producing cannabigerolic acid (CBGA), now available for customer evaluation. However, the company faces a patent infringement claim related to CsPT1, which it states is without merit, as it does not use this enzyme in its processes.

Positive

• Increased CBG production titer by over 400%.
• Successful delivery of CBG samples to Cellular Goods PLC.
• Development of a process for producing ultra-pure CBGA.

Negative

• Facing a patent infringement claim related to Canadian Patent No. 2,770,774.

VANCOUVER, BC, Sept. 21, 2021 /PRNewswire/ - Willow Biosciences Inc. ("Willow" or the "Company") (TSX: WLLW) (OTCQX: CANSF), a leading biotechnology company that manufactures ultra-pure, sustainably produced cannabinoids via yeast-based biosynthesis, is pleased to provide the following operational and corporate updates.

Commercial Scale Operational Update

In March 2021, Willow completed its first commercial scale fermentation run of cannabigerol ("CBG") with its manufacturing partner at their European facilities. The product from this first run was primarily used for customer samples and to provide material to Cellular Goods PLC ("Cellular Goods") as a part of their June 2021 supply agreement. The first shipment of CBG was delivered to Cellular Goods in July 2021. Since this initial production run, Willow has increased its production titer by >400% and has carried out additional fermentation runs yielding tens of kilograms of ultra-pure CBG at >10,000 L fermentation scale. The Company continues to make significant titer improvements to its strain, with further production runs planned through the end of the year.

CBGA Production Update

Since launching CBG, Willow has received inquiries for its acidic precursor, cannabigerolic acid ("CBGA"), which is not readily available through extraction. Willow is pleased to announce that it has developed a process for production of ultrapure cannabigerolic acid and samples are now available for customer assessment and product development. CBGA is an exciting, rare cannabinoid with distinctive properties and has been shown to act as an anti-oxidant, anti-inflammatory, anti-microbial and neuroprotectant in research studies. The unique benefit of Willow biosynthetic production process in yeast is that it can efficiently produce the acidic and neutral forms of cannabinoids in high purity.

Corporate Update

A claim alleging infringement of Canadian Patent No. 2,770,774 was served on the Company. Willow is confident the claim is entirely without merit and intends to vigorously defend it.

The patent relates to the aromatic prenyl transferase CsPT1 from cannabis. Willow does not utilize CsPT1 in any of its development programs or commercialized processes. Willow has applied its in-house cannabis genomic databases and enzyme engineering technologies to the discovery and development of novel, proprietary genes for biosynthetic production of cannabinoids in yeast.  Willow has developed distinctly different, proprietary genes for the steps within the primary cannabinoid pathway and filed multiple patent applications relating to key genes within its developed cannabinoid pathway.  

Willow has developed a proprietary cannabinoid biosynthetic pathway for producing ultra-pure cannabinoids that does not involve CsPT1.

About Willow Biosciences Inc.

Willow is a leading biotechnology company that develops and produces high-purity, plant derived ingredients for the consumer care, food and beverage, and pharmaceutical markets. Willow's biotechnology platform allows creation of a consistent, scalable and sustainable product that benefits both B2B and B2C customers. Willow's R&D team has a proven track record of developing and commercializing bio-based manufacturing processes and products for both the consumer and pharmaceutical industries.

Forward-Looking Statements

This news release may include forward-looking statements including opinions, assumptions, estimates and the Company's assessment of future plans and operations, and, more particularly, statements concerning: the progress of Willow's commercial development programs for CBG and CBGA; the therapeutic benefits of CBGA; predictions about the outcome of litigation in which Willow is involved; and the business plan of the Company, generally, including cannabinoid research and production. When used in this news release, the words "will," "anticipate," "believe," "estimate," "expect," "intent," "may," "project," "should," and similar expressions are intended to be among the statements that identify forward-looking statements. The forward-looking statements are founded on the basis of expectations and assumptions made by the Company which include, but are not limited to: the success of Willow's strategic partnerships, including the development of future strategic partnerships; the financial strength of the Company; the ability of the Company to fund its business plan using cash on hand and existing resources; the market for Willow's products; the ability of the Company to obtain and retain applicable licences; the ability of the Company to obtain suitable manufacturing partners and other strategic relationships; and the successful implementation of Willow's commercialization and production strategy, generally. Forward-looking statements are subject to a wide range of risks and uncertainties, and although the Company believes that the expectations represented by such forward-looking statements are reasonable, there can be no assurance that such expectations will be realized. Any number of important factors could cause actual results to differ materially from those in the forward-looking statements including, but not limited to, risks common in all litigation, including that, because of the inherent uncertainty of litigation, the outcome may be unfavorable even if Willow's defense is meritorious, or that material legal fees and expenses may be incurred even if Willow is ultimately successful in its defense; risks associated with: the cannabinoid industry in general; the success of the Company's research and development strategies; infringement on intellectual property; failure to benefit from partnerships or successfully integrate acquisitions; actions and initiatives of federal and provincial governments and changes to government policies and the execution and impact of these actions, initiatives and policies; import/export and research restrictions for cannabinoid-based operations; the size of the medical-use and adult-use cannabinoid market; competition from other industry participants; adverse U.S., Canadian and global economic conditions; adverse global events and public-health crises, including the current COVID-19 outbreak; failure to comply with certain regulations; departure of key management personnel or inability to attract and retain talent; and other factors more fully described from time to time in the reports and filings made by the Company with securities regulatory authorities. Please refer to the Company's most recent annual information form and management's discussion and analysis for additional risk factors relating to Willow, which can be accessed either on Willow's website at www.willowbio.com or under the Company's profile on www.sedar.com.

The forward-looking statements contained in this news release are made as of the date hereof and the Company does not undertake any obligation to update publicly or to revise any of the included forward-looking statements, except as required by applicable law. The forward-looking statements contained herein are expressly qualified by this cautionary statement.

Abbreviations

B2B                                                                                  business to business
B2C                                                                                  business to consumer
R&D                                                                                  research and development

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SOURCE Willow Biosciences Inc.

FAQ

What updates did Willow Biosciences announce on September 21, 2021?

Willow Biosciences announced a successful commercial scale fermentation run of CBG, increased production titer, development of ultra-pure CBGA, and a patent infringement claim.

What is the status of Willow's production of CBG?

Willow reported a production titer increase of over 400% for CBG since its first commercial run in March 2021.

What is the significance of the patent claim against Willow Biosciences?

Willow is facing a patent infringement claim but asserts that it does not utilize the patented enzyme and intends to defend itself vigorously.

When did Willow deliver CBG samples to Cellular Goods PLC?

Willow delivered CBG samples to Cellular Goods PLC in July 2021.

What is CBGA and how is it related to Willow Biosciences?

CBGA, or cannabigerolic acid, is a cannabinoid now being produced by Willow as an ultra-pure precursor, available for customer assessment.