WILLOW ANNOUNCES MULTI-PRODUCT DEVELOPMENT AND LICENSING PARTNERSHIP WITH LAURUS LABS FOR MANUFACTURING ACTIVE PHARMACEUTICAL INGREDIENTS

Collaboration provides Laurus access to Willow’s AI-driven bioengineering platform

The strategic alliance includes an initial seven high-value advanced intermediates and active pharmaceutical ingredients, including Willow’s corticosteroid programs

The agreement with Laurus is the largest collaboration agreement Willow has signed to date

SUNNYVALE, Calif., May 30, 2024 /PRNewswire/ - Willow Biosciences Inc. (“Willow”) (TSX: WLLW) (OTCQB: CANSF), a leading biotechnology company focused on revolutionizing industrial manufacturing of pure, consistent, and sustainable ingredients, announces a multi-product development and licensing partnership with Laurus Labs (“Laurus”) (Bombay Stock Exchange Code: 540222; LAURUSLABS-IN: National Stock Exchange of India), a leading research-driven pharmaceutical and biotechnology company with a $3.9 billion market cap that serves global pharmaceutical companies and offers CDMO services. Laurus has commercialised 80+ products since its inception. Laurus has nine manufacturing facilities including fermentation capabilities.

Through this partnership, Willow will leverage its AI-driven technology platform and extensive experience in enzyme, strain, and process engineering to deliver biobased processes for high-value Active Pharmaceutical Ingredients (APIs) with existing markets, including Willow’s BioOxi^TM-based corticosteroid processes, for large scale manufacturing, sales, and distribution at Laurus. Willow and Laurus expect these first programs to reach commercial manufacture in 2025.

Under the terms of the collaboration, Willow expects to earn significant annual revenues in research & development and royalties, including $4.0 million in guaranteed research & development payments in year one. Upon commercialization of the APIs, Willow will receive an annual royalty based on worldwide sales.

Laurus recognized the need to employ more sustainable methods to manufacture its APIs with reduced cost and less waste and thus, identified Willow’s expertise and, specifically, its AI-driven BioOxi platform, for developing transformative bioprocesses to key APIs. This new partnership will start with the continued optimization and scaling of Willow’s BioOxi platform, along with development of new processes for targets within Laurus’ API and other ingredient portfolios.

Willow’s BioOxi biological hydroxylation platform solves for selective C-H hydroxylation at industrial scale – often referred to as one of the “Holy Grails” of chemistry. BioOxi-enabled biomanufacturing of ingredients can remove multiple chemical steps and significantly reduce cost and resources.

“We are excited to be partnering with Laurus Labs, one of the most respected and established pharmaceutical ingredient manufacturers in the world. This strategic partnership is the culmination of Willow’s new focus on pharmaceutical ingredients and investment over the past two years,” said Dr. Chris Savile, Willow’s President & CEO. “We are proud our technology platform is being integrated with Laurus to support their commercialization of more sustainable, cost-effective products.”

Commenting on the collaboration partnership, CEO of Laurus Labs Dr. Satyanarayana Chava said, “Willow has demonstrated through its bioengineering technology platform a unique capability to significantly reduce the cost of API production while enabling greater product availability. We look forward to a long and successful partnership, which we believe will further strengthen Laurus’ strong reputation for market innovation.”

With its largest agreement to-date, this multi-product agreement adds both near-term R&D and long-term commercial upside to Willow’s already robust and growing pipeline of commercial opportunities in food, pharmaceuticals, and agriculture.

Willow develops and produces precision fermented functional ingredients for the health and wellness, food and beverage and personal care markets. Willow’s FutureGrown™ and BioOxi™ 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, or to view Willow’s updated corporate presentation, visit www.willowbio.com.

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

Founded in 2005, Laurus Labs is a research-driven pharmaceutical and biotechnology company with an aim to improve the quality of life for millions of people around the world. Laurus has a global leadership position in select APIs including anti-retroviral, oncology drugs (incl High Potent APIs), Cardiovascular, and Gastro therapeutics. Laurus also offers integrated Contract Development and Manufacturing Organization (CDMO) services to Global Innovators from Clinical phase drug development to commercial manufacturing. Laurus is passionate about continuous technological advances for Smart and Green chemistry technologies to drive efficiencies and sustainable manufacturing backed by proven regulatory and quality foundation. Laurus employs 6500+ people, including around 1250+ scientists at more than 11 facilities approved by global agencies USFDA, WHO-Geneva, Japan-PDMA, UK-MHRA, EMA, TGA etc. During FY2023 Laurus generated ₹ 6,041 crore in annual revenue and is listed on the BSE (Bombay Stock Exchange) and the NSE (National Stock Exchange) in India. Laurus’ proactive stance to conduct business with utmost Transparency, Integrity and Respect for environment & communities have earned it a place in Governance benchmark, consistently Certified Great Place to Work and Rated “BBB” by leading MSCI ESG Ratings. Corporate Identification No: L24239AP2005PLC047518.

For more information visit www.lauruslabs.com.

This news release may include forward-looking statements including opinions, assumptions, estimates and the Company’s assessment of future plans, platforms and operations, and, more particularly, statements concerning: the collaboration agreement and development program with Laurus, including the ability to accommodate new programs and to expand capabilities and transition R&D programs to commercial revenue; 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 partnership with Laurus and 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; competition from other industry participants; adverse U.S., Canadian and global economic conditions; adverse global events and public-health crises; 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.

Any financial outlook and future-oriented financial information contained in this document regarding prospective financial performance, financial position, cash balances or revenue, including the anticipated receipt of $4.0 million in guaranteed research & development payments in year one under the collaboration agreement and future annual royalties based on worldwide sales upon commercialization of APIs, 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.

Financial information in this news release is expressed in Canadian dollars.

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.