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WILLOW BIOSCIENCES ANNOUNCES EXPANSION OF ITS FERMENTATION MANUFACTURING NETWORK AND PROGRESS ON ITS CBG GRAS DETERMINATION

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Willow Biosciences Inc. (CANSF) announced significant developments on May 11, 2022. The company entered a Manufacturing Services Agreement with a second Contract Development and Manufacturing Organization (CDMO), enhancing its fermentation production capacity for FutureGrown™ products, including cannabigerol (CBG). In addition, Willow has completed the initial Stage 1 toxicological assessment of FutureGrown™ CBG, indicating it is non-mutagenic, a crucial step towards obtaining Generally Recognized as Safe (GRAS) status in the United States.

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  • Entered a Manufacturing Services Agreement with a new CDMO, increasing fermentation production capacity.
  • Completed Stage 1 toxicological assessment for FutureGrown™ CBG, indicating non-mutagenic safety.
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  • None.

VANCOUVER, BC, May 11, 2022 /PRNewswire/ - Willow Biosciences Inc. ("Willow" or the "Company") (TSX: WLLW) (OTCQB: CANSF), a leading biotechnology company focused on revolutionizing industrial manufacturing of high-value molecules traditionally derived from plants, announces expanded production capacity with a new manufacturing partnership and progress with respect to its Generally Recognized as Safe ("GRAS") determination.

Expansion of Fermentation Manufacturing Network

Willow is pleased to announce the signing of a Manufacturing Services Agreement ("MSA") with a second Contract Development and Manufacturing Organization ("CDMO"), which will offer increased fermentation capacity to produce Willow's FutureGrown™ products, including cannabigerol ("CBG"). Willow's new partner has a strong track record in the large-scale production of food, nutritional, and pharmaceutical products and holds all necessary certifications to serve these markets. This new CDMO partnership allows Willow to accommodate new programs, both internal and partnered, in addition to its cannabinoid portfolio.

Willow's Chief Operating Officer Dr. Chris Savile noted, "with the unprecedented demand for precision fermentation assets, having a global network of CDMOs with diverse capabilities is an absolute requirement. The addition of this premier CDMO with large scale fermentation assets will ensure Willow's manufacturing capabilities can readily expand to meet market demand."

Successful Completion of Initial Toxicological Assessment for GRAS Determination

Willow has successfully completed the Stage 1 toxicological assessment of its FutureGrown™ CBG product for oral product applications, an important milestone for biosynthetically produced cannabinoids. The assessment concluded that FutureGrownTM CBG was non-mutagenic, non-clastogenic, non-genotoxic, which, is the first step toward concluding Willow's FutureGrown™ CBG as GRAS in the United States. Willow is engaging AIBMR Life Sciences, Inc. to perform the toxicology studies, with Stage 2 studies to be initiated shortly.

Willow produces its FutureGrown™ CBG through precision fermentation, drastically reducing production time and carbon footprint when compared to traditionally grown cannabis extracts.

About Willow Biosciences Inc.

Willow is a leading biotechnology company that develops and produces high-purity, plant derived ingredients for the personal care, food and beverage, and pharmaceutical markets. Willow's FutureGrown™ biotechnology platform allows large-scale production of pure, consistent, and sustainable 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 ability to obtain GRAS certification for Willow's FutureGrownÔ CBG; 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 CDMO; 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 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.

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SOURCE Willow Biosciences Inc.

WILLOW BIOSCIENCES INC

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