Commercial agreement follows the early success on the development phase of the UDCA program with Sandhill One
Solid execution on development phases leads to execution of agreement; illustrates company progress against targeted milestones anticipated for 2023 to expand company growth
Willow’s unique combination of strain engineering, precision fermentation and its newly developed BioOxi™ bio-oxidation platform has accelerated the timeline to reach commercial agreement
Mountain View, California – April 18, 2023 – 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 execution of a commercial agreement with Sandhill One, LLC (“Sandhill”). Willow previously announced the successful results from the application of its BioOxiTM bio-oxidation platform to the development of a key step for the large volume active pharmaceutical ingredient (“API”), ursodeoxycholic acid (“UDCA”), used in nutraceutical and pharmaceutical products.
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: it is expected to be lower in cost and will not rely on animal-sourced raw materials, unlike most current manufacturing of UDCA and other cholic acids.
Willow now expects that, upon completion of its development project with Sandhill and assuming the optimized enzyme is utilized in Sandhill’s end-market manufacture, following receipt of milestone payments, it may receive a reasonably significant percent of Sandhill’s end-market revenues. This royalty-bearing agreement would be more attractive than Willow originally expected and highlights the Company’s rapid steps to bring in nearer term revenue.
“We are very pleased to have executed this agreement so quickly following our partnership with Sandhill and highly appreciate their collaborative work with us to create an alternative, more sustainable and less expensive source of UDCA to battle several significant health conditions in an era of escalating healthcare costs,” said Dr. Chris Savile, Willow’s President and CEO. “I am also proud of our R&D team’s hard work and accomplishments to bring this commercial agreement to fruition, which further endorses our reputation in helping our partners sustainably solve their commercial challenges and in bringing cost-effective innovation to their end markets.”
“We are delighted with Willow’s rapid progress in successfully executing the development phases of this project. Our confidence in their results and the ensuing value has accelerated our decision to put in place a mutually rewarding commercial agreement,” said J. Gregory Reid, Ph.D., Chief Scientific Officer of Sandhill. “We look forward to converting this value-added technology package into commercial reality and broadening the availability of sustainably sourced UDCA to support better health for people and our planet.”
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 FutureGrownTM 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.
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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 commercial agreement with Sandhill; the continued development of the UDCA program; 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 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, royalties or other revenue 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.