Calgary, Alberta and Mountain View, California – August 31, 2022 – Willow Biosciences Inc. ("Willow" or the "Company") (TSX: WLLW; OTCQX: 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."
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 high-purity ingredients for the personal care, food and beverage, and pharmaceutical 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.
For further information, please visit our website at www.willowbio.com or contact:
CPA Chief Financial Officer
CFA Vice President,
202, 1201 5th Street SW, Calgary, Alberta, Canada T2R 0Y6
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 Company's management team and the performance thereof; the ability to accommodate new programs and to expand capabilities, including the expansion of the Company's portfolio of functional ingredients beyond cannabinoids; and the business plan of the Company, generally. 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 licenses; 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 operations in the cannabinoid, personal care, food and beverage and pharmaceutical markets; the size of such markets; competition from other industry participants; adverse U.S., Canadian and global economic conditions; adverse global events and public-health crises, including the evolving 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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