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WILLOW BIOSCIENCES PROVIDES CBG UPDATE

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Willow Biosciences Inc. (OTCQB: CANSF) announced updates on its cannabigerol (CBG) product, focusing on operational advancements and regulatory progress. The Company is expanding its manufacturing network and expects to produce the first commercial CBG batches in H1 2023. Willow has successfully completed Stage 1 of the Generally Recognized as Safe (GRAS) assessment for its FutureGrown™ CBG and aims to initiate Stage 2 by Q3 2022. The Company has filed 12 patent applications related to cannabinoid production, positioning itself for sustained growth in the biosynthetic market.

Positive
  • Expansion of precision fermentation manufacturing network, increasing capacity for CBG production.
  • Successful completion of Stage 1 GRAS assessment for FutureGrown™ CBG.
  • Filing of 12 patent applications strengthens intellectual property position.
Negative
  • None.

CALGARY, AB and MOUNTAIN VIEW, Calif, Aug. 31, 2022 /PRNewswire/ - Willow Biosciences Inc. ("Willow" or the "Company") (TSX: WLLW) (OTCQB: CANSF), a leading biotechnology company focused on revolutionizing industrial manufacturing of pure, consistent and sustainable functional ingredients, is pleased to provide an update on cannabigerol ("CBG"), the Company's first commercialized functional ingredient in its portfolio.

"As we expand our portfolio of products and partnerships, we also remain committed to maximizing the value of our first functional ingredient, CBG, through continued development, operational improvements, and marketing efforts", said Dr. Peter Seufer-Wasserthal, Willow's Interim President and Chief Executive Officer.  "We remain optimistic on the future opportunity for CBG and other cannabinoids and will be well-positioned to capture that value as the markets develop."

Manufacturing Update

Willow previously announced the expansion of its precision fermentation manufacturing network with the signing of a Manufacturing Services Agreement ("MSA") with a second Contract Development and Manufacturing Organization ("CDMO"), increasing fermentation capacity to produce Willow's FutureGrown™ products, including CBG.  Willow has completed the initial phases of technology transfer with the CDMO and anticipates running its first commercial batches in the first half of 2023. Willow continues to supply current and prospective partners through its first previously announced CDMO, Curia Global, Inc. (formerly AMRI).  Willow has also refined and advanced its industry leading downstream process ("DSP"), which allows for significantly reduced costs and optionality for working with additional CDMO's in the future. As the market for biosynthetically produced CBG continues to develop, Willow will be in a strong position to deliver commercial scale volumes. When the regulatory environment permits, Willow is also well-positioned to develop additional cannabinoids beyond CBG.

Update on GRAS Status

Willow previously announced that it had successfully completed the initial toxicological assessment for Generally Recognized as Safe ("GRAS") for its FutureGrown™ CBG product. The Company has successfully completed the Stage 1 toxicological assessment for oral product applications. The assessment concluded that FutureGrown™ CBG caused no adverse effects and was non-mutagenic, non-clastogenic and non-genotoxic, completing the first step toward GRAS designation in the United States. Willow anticipates initiating its Stage 2 pivotal toxicological assessment in Q3 2022 and attaining an independent conclusion of GRAS in the first half of 2023.

Intellectual Property Update

Willow has filed 12 patent applications to-date and will continue to file patent applications relating to its proprietary genes, proteins, and microorganisms and their use for the biosynthetic production of cannabinoids and other ingredients. Willow will continue to provide CBG to potential partners worldwide to support development of their formulations in various health and wellness markets.

About Willow Biosciences Inc.

Willow develops and produces precision fermented functional ingredients for the health and wellness, food and beverage and personal care markets.  Willow's FutureGrown™ biotechnology platform allows large-scale production with sustainability at its core. Willow's R&D team has a proven track record of developing and commercializing bio-based manufacturing processes and products to benefit our B2B partners and their customers.

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 MSA, including the ability to accommodate new programs and to expand capabilities; the continued development of Willow's FutureGrown™ CBG, including the ability to obtain GRAS certification; the demand and market size potential of the synthetic ingredients industry; intellectual property protection; and the business plan of the Company, generally, including becoming a leader in precision fermentation, research and production of functional ingredients. 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 biotechnology 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.

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SOURCE Willow Biosciences Inc.

FAQ

What is the latest update from Willow Biosciences regarding CBG?

Willow Biosciences announced updates on its CBG product, including manufacturing expansions and GRAS assessment progress.

When does Willow Biosciences expect to produce its first commercial CBG batches?

Willow anticipates producing its first commercial CBG batches in the first half of 2023.

What is the status of Willow Biosciences' GRAS assessment for CBG?

Willow has completed the Stage 1 toxicological assessment for GRAS for its FutureGrown™ CBG and plans to start Stage 2 in Q3 2022.

How many patent applications has Willow Biosciences filed?

Willow has filed 12 patent applications related to cannabinoid production.

What is Willow Biosciences' stock symbol?

The stock symbol for Willow Biosciences is CANSF.

WILLOW BIOSCIENCES INC

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