WLLW Willow Biosciences Inc

Represents early progress against targeted milestones anticipated for 2023 to expand company growth

CALGARY, AB and MOUNTAIN VIEW, Calif, Jan. 17, 2023 /PRNewswire/ - Willow Biosciences Inc. ("Willow") (TSX: WLLW) (OTCQB: CANSF), a leading biotechnology company focused on revolutionizing industrial manufacturing of pure, consistent and sustainable functional ingredients announced today a follow-on engagement with Sandhill One, LLC (www.sandhillone.com) ("Sandhill") for the next phase in optimizing a proprietary enzyme vital to the development of a large volume Active Pharmaceutical Ingredient ("API") used in nutraceutical and pharmaceutical products. This represents the continuation of the project, the first phase of which the Company announced May 31, 2022.

Sandhill is partnered with a large-cap, multi-national healthcare company and the targeted product is manufacture of the large volume API, ursodeoxycholic acid (UDCA). UDCA is used as a medication for the management and treatment of cholestatic liver disease and gallstone conditions, and as an important intermediate for production of tauroursodeoxycholic acid (TUDCA), a key API in a combination therapy recently approved in Canada and the United States for treatment of amyotrophic lateral sclerosis (ALS). The process under development between the Company and Sandhill represents a step-change in the production of UDCA, as it will not rely on animal-sourced raw materials, as is the case with most current manufacturing of UDCA and other cholic acids, and is expected to be lower in cost.

In this next phase of development, the Company anticipates several hundred thousand U.S. dollars in research fees, along with a milestone payment later this year for initial production batches. Upon successful completion, it is expected that Willow's proprietary, optimized enzyme will be taken toward commercialization for the end market active pharmaceutical ingredients ("APIs"), where Willow will receive additional milestone and production-based royalty payments.

"We are very pleased that following our success on the first phase of development, our partner has seen the tremendous value Willow can provide in leveraging its precision fermentation technology to foster cost effective innovation in the development of APIs," said Dr. Peter Seufer-Wasserthal, Willow's President and CEO. "We are excited to start off the year with this new agreement, which further illustrates our continued portfolio diversification beyond cannabinoids and represents early progress against our stated goals for 2023 to expand our growth with a keen focus on near-term revenue generation."

Willow develops and produces precision fermented functional ingredients for the health and wellness, food and beverage and personal care markets. Willow's FutureGrown^TM 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 more information, visit www.willowbio.com.

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 follow-on engagement with Sandhill, including the achievement of production milestones; the demand and market size potential of the synthetic ingredients industry; and the business plan of the Company, generally, including becoming a leader in precision fermentation, research and production of functional ingredients, including UDCA. 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.

Any financial outlook and future-oriented financial information contained in this document regarding prospective financial performance, financial position, cash balances or revenue, including future revenue from the Sandhill engagement, is based on assumptions about future events, including economic conditions and proposed courses of action based on management's assessment of the relevant information that is currently available. Projected operational information contains forward-looking information and is based on a number of material assumptions and factors, as are set out above. These projections may also be considered to contain future-oriented financial information or a financial outlook. The actual results of the Company's operations for any period will likely vary from the amounts set forth in these projections and such variations may be material. Actual results will vary from projected results. Readers are cautioned that any such financial outlook and future-oriented financial information contained herein should not be used for purposes other than those for which it is disclosed herein.

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.