WILLOW ANNOUNCES SUCCESSFUL COMPLETION OF R&D PROGRAM ON COST-EFFECTIVE, SUSTAINABLY PRODUCED UDCA

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Sep 06, 2023, 07:00 ET

Company's BioOxi™ Platform solves for selective C-H hydroxylation, one of the "Holy Grails" of chemistry

BioOxi is broadly applicable to manufacturing of intermediates and active pharmaceutical ingredients, particularly for steroid applications

SUNNYVALE, Calif., Sept. 6, 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, announces that it has successfully completed research and development on its program to produce ursodeoxycholic acid ("UDCA"), a large volume active pharmaceutical ingredient ("API") used in nutraceutical and pharmaceutical products. UDCA has applications as a medication for management and treatment of cholestatic liver disease and gallstone conditions, and as an 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).

BioOxi's Breakthrough Technology Provides Commercially Economical Enzymatic Production of UDCA

Through this partnered program with Sandhill One, LLC ("Sandhill"), Willow has now optimized a proprietary enzyme vital to the development of UDCA while solving for selective C-H hydroxylation at industrial scale - often referred to as one of the "Holy Grails" of chemistry. This breakthrough was made possible by Willow's BioOxi technology, and we believe marks the first example of commercially relevant productivities with this class of enzyme. This successful outcome further illustrates that the BioOxi platform is broadly applicable to the manufacturing of intermediates and APIs, particularly steroid APIs. With R&D now complete, Willow anticipates receiving milestone payments and revenue upon commercialization by Sandhill.

"Our proprietary BioOxi platform on which we are commercially focused along with our stellar R&D team continues to showcase Willow's ability to leverage breakthrough technology to disrupt the status quo in producing key ingredients for large global markets," said Dr. Chris Savile, Willow's President and CEO. "As the next step, we look forward toward continuing our rewarding partnership with Sandhill by advancing production of UDCA and continuing to demonstrate Willow's ability to help partners to innovate manufacturing of important APIs and other ingredients."

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^TM and BiOxi™ platforms enable 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.

FutureGrown™ and BiOxi™ are registered trademarks of Willow Biosciences Inc. All other trademarks are trademarks of their respective holders.

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 continued development of Willow's BiOxi™ platform, including the ability to accommodate new programs and to expand capabilities; receipt of milestone payments and revenue from the partnered program with Sandhill; 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. 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; the size of the functional ingredients 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.sedarplus.ca.

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.

SOURCE Willow Biosciences Inc.