WLLW Willow Biosciences Inc

Estimated FY 2023 revenues in excess of $1.3 million is a record year for the Company

Anticipate closing at least three new partnership development agreements including one for our corticosteroid API program, and one new commercial agreement under an existing partnership development program

FY 2024 revenues are expected to increase by more than 100%, which would be another record year for Willow

SUNNYVALE, Calif., Jan. 10, 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, is pleased to provide a summary of its successes in 2023 and outline its plans for growth across all aspects of its business in 2024.

"2023 was a transformative year for Willow with the successful development of our highly valuable BioOxi technology platform which we believe will support significant growth in 2024. We also generated record revenue growth through partnerships and implemented a successful corporate and operational reorganization to support the future growth of Willow," said Dr. Chris Savile, Willow's President & CEO. "In 2024, the Company will capitalize on its platform to bring our exciting corticosteroids program to commercial readiness and identify strategic partners for expansion and acceleration of its pipeline of opportunities."

2023 Achievements

• Record revenues in 2023: Revenues increased approximately 60% to an estimated $1.3 million in 2023.
  
  
• Launched BioOxi™ bio-oxidation platform technology: BioOxi is an AI-driven selective hydroxylation platform that has been proven to remove multiple chemical steps and significantly reduce cost to manufacture target molecules. By focusing on this platform, the Company accelerated its path to nearer-term and potentially larger revenue opportunities while reducing operational expenses.
  
  
• Significantly strengthened its portfolio of both partnered and proprietary programs: The Company expanded and diversified its portfolio, driven primarily by the positive industry reception to the BioOxi platform. New programs include multiple partnerships with both innovators, such as Kalsec and an undisclosed Nasdaq-listed biopharmaceutical company, generic pharmaceutical companies, such as Suanfarma, along with our internal program focused on multiple high value corticosteroids.
  
  
• Advanced existing partnered development programs: Successful technical execution on UDCA, Kalsec's savory ingredient program, and a Nasdaq-listed biopharma company's active pharmaceutical ingredient ("API") program led to the next steps toward commercialization. The Kalsec and biopharma programs continue through optimization while UDCA has been successfully transferred for scaling at a contract development manufacturing organization ("CDMO").
  
  
• Successful corporate and operational reorganization: In 2023, Willow announced the consolidation of operations in the San Francisco Bay area, announced a more focused team and transitioned both its Board of Directors and its Management to a team of experienced biotech professionals, while significantly reducing the Company's burn-rate and transitioning to near-term revenue opportunities. In parallel, Willow's research and development ("R&D") team accelerated development timelines and increased efficiency through improvements to its AI-based technology platform and high throughput automation capabilities.

2024 Growth Plans

In 2024, Willow looks to progress all aspects of its business including:

• Execution of commercial agreements on its existing programs: With the continued success on its existing partnered R&D programs, the Company anticipates the execution of at least one commercial agreement in the first half of 2024 and additional agreements in the second half that could include milestone, profit share, license or royalty payments.
  
  
• Transition of R&D programs to commercial revenue: With multiple R&D programs now complete or nearing completion, the Company anticipates generating first commercial revenues from at least two products as they transition to commercial production. Commercial revenue is expected to be potentially milestone, royalty, and ingredient supply revenue. 
  
  
• Significant increase in revenues: Full year R&D revenues for 2024 are expected to increase by over 100% compared to 2023. In addition, commercial stage revenue is expected to commence on multiple programs.
  
  
• Closing at least one partnership agreement on its corticosteroid programs: Given the ongoing discussions with potential partners with regards to our transformative manufacturing process for hydrocortisone, prednisolone, budesonide and other corticosteroids, the Company anticipates execution of one large strategic partnership or multiple product specific partnerships to bring these target molecules to commercial scale manufacturing.
  
  
• Announcing additional new partnerships with a focus on innovators: Based on the proven applicability and scalability of the BioOxi platform and ongoing dialog with multiple potential parties, the Company anticipates signing two or more additional partnerships in the first half of 2024 and additional partnerships in the second half to develop biobased manufacturing processes for innovator-owned targets.
  
  
• Continued advancement of its core technology platform: The Company continues to advance its platform through development of generative AI-powered enzyme discovery and design capabilities coupled with proprietary HTP gene editing tools to enable rapid development of industrially relevant enzymes and organisms. Continuous improvements toward leaner and more cost-effective development cycles include onboarding rapid DNA sequencing capabilities and developing protocols to multiplex thousands of reactions in a single run with the goal of doubling output with current resources.

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, visit www.willowbio.com.

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

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 development programs with existing partners and pipeline of potential partners, including the ability to accommodate new programs and to expand capabilities and transition R&D programs to commercial revenue; closing at least three new partnership development agreements in 2024; 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; 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 expectations for FY 2024 revenue to increase by more than 100% over the prior year, 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.

Certain financial and operating results included in this press release, including revenue, are based on unaudited estimated results. These estimated results are subject to change upon completion of the Company's audited financial statements for the year ended December 31, 2023, and changes could be material.

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SOURCE Willow Biosciences Inc.