VANCOUVER, BC, March 29, 2022 /CNW/ - Willow Biosciences Inc. ("Willow" or the "Company") (TSX: WLLW) (OTCQB: CANSF), a leading biotechnology company that develops technology to manufacture pure, consistent and sustainable compounds via yeast biosynthesis, is pleased to announce its financial and operating results for the three months and year ended December 31, 2021, and filing of its Annual Information Form ("AIF"). Selected financial and operational information is outlined below and should be read with Willow's audited consolidated financial statements (the "Financial Statements") and management's discussion and analysis (the "MD&A") as of December 31, 2021, which are available on SEDAR at www.sedar.com and on Willow's website at www.willowbio.com.

Willow Biosciences Inc. Logo (CNW Group/Willow Biosciences Inc.)

Statement from the CEO

"2021 was both an exciting and challenging year for Willow", said Trevor Peters, Willow's President and Chief Executive Officer. "The progress that we continue to make building out our core platform technology is setting the company up to be a leader in the bio revolution that is unfolding around us. While our platform build out is on schedule, the market for cannabinoids, the company's first group of compounds, has seen headwinds due to the lack of clarity around the regulatory future of cannabis, predominantly in the United States. This is causing larger consumer companies to remain on the sidelines until more certainty is given by lawmakers. Willow management believes this to only be temporary, given the bipartisan support, for instance, seen in the United States toward decriminalization and ultimate legalization. The message for our stakeholders in 2022 is that we will continue to progress the cannabinoid program to a state of readiness for when market opportunities open, and start to leverage the platform technology to access new compounds in more well defined markets. The value of Willow is in the addressable market opportunities that our platform technology is able to access."

Cannabinoid Program Update

On March 31, 2021, Willow completed the first commercial scale fermentation of its first cannabinoid for market, cannabigerol ("CBG"), at its contract manufacturing organization's ("CMO") facilities in Europe. Willow manufactured product through 2021 while also continuing to optimize its CBG process for improved yield and efficiency. On June 10, 2021, Willow announced a multi-year supply agreement with Cellular Goods PLC ("Cellular Goods"), whereby Willow will supply Cellular Goods with its proprietary, ultra-pure, biosynthetically produced CBG to be used in their premium cannabinoid-based skin care products. The limited volumes of CBG produced throughout 2021 were primarily used for delivery to Cellular Goods to meet their demand, to provide samples to prospective partners, and to support our continued internal development efforts.

Willow as an organization is set up to service the companies that prioritize consistency, purity, and sustainability as their priorities for their suppliers. Based on the scale at which we can produce cannabinoids and the favourable supply chain dynamics its technology offers, the primary counterparties for Willow's precision fermented cannabinoids are consumer packaged goods companies and their ingredient suppliers. While many of these companies have publicly expressed an interest in cannabinoids, until regulations globally, and especially in the United States, become clearer, they are reluctant to make new or additional commitments. At this time, Willow has not executed any long term supply agreements with the large, multi-national CPG customers we are targeting. The Company has begun discussions and negotiations with respect to long term supply agreements, but cannot provide any guidance at this time.

Throughout 2021, the Company continued to evaluate additional manufacturing partnerships with the goal of expanding its CMO network in 2022 to ensure it has access to sufficient commercial scale fermentation assets. Willow has begun to incorporate a second CMO into its manufacturing network that offers greater economies of scale and optionality regarding diversity of compounds to produce. The manufacturing runs in 2021 provided continued improvements in our process at scale, while allowing for the initiation of sales to smaller customers and sampling to larger customers. Implementation of the improvements has brought the Company to a point where management is comfortable scaling production into larger, more fit-for-purpose assets. The addition of a second CMO will allow Willow to accommodate new programs, both internal and partnered, in addition to its cannabinoid portfolio.

On January 13, 2021, the Company engaged a regulatory consulting group to perform a comprehensive safety assessment to independently conclude that CBG is Generally Recognized As Safe (GRAS) for use as an ingredient in food and beverage applications. The global demand for non-clinical contract research organization ("CRO") work has been unprecedented, resulting in delayed toxicology results. We now expect our initial toxicology studies to finish in the first half of 2022 and the pivotal trial to be completed in the second half of 2022. The final conclusion by an independent panel is expected in late 2022 or early 2023.

Since its formation, Willow's R&D team has placed significant focus on the development of its core strain engineering technology platform that enables the generation of key intellectual property, such as proprietary genes, proteins and microorganisms for the biosynthesis of cannabinoids. To that end, the Company has filed ten cannabinoid-related patent applications to-date, with additional applications being drafted. There is no guarantee that any or all of these patents will be granted.   

Technology Platform Update

Since its inception, Willow has had a mandate as a synthetic biology company to focus on the development of biobased processes for production of ingredients, including those for consumer care, food & beverage, and pharmaceuticals. Willow's first compound, CBG, opened the door for its entrance into the multi-billion dollar global cannabis sector. Towards the end of 2021, the R&D effort devoted to Willow's CBG producing yeast strain was nearing completion, allowing its team to evaluate new compounds that could benefit from its platform. Development of synthetic biology enabled commercial fermentation processes requires a combination of multiple technologies and capabilities for efficient and successful execution. Willow combines three key development pillars: (i) state-of-the-art rapid strain engineering technologies, (ii) fermentation & downstream process development capabilities, and (iii) an established manufacturing network. Having all of these components at Willow allows for expansion of our technology offering beyond cannabinoids. Willow is currently in discussions with multiple parties to develop precision fermentation based processes for compounds outside of cannabis that directly leverage the R&D capabilities established on cannabinoids. While there is no guarantee that these will lead to partnerships, Willow is encouraged with the status of engagement.

Financial Update

Willow ended the year in a strong financial position, with approximately $29.9 million in working capital and $30.1 million of cash on hand. As Willow transitions to a larger CMO through the course of this 2022, revenue from product sales will continue to be limited, but will position the Company well to meet demand for CBG and other products in 2023 and beyond.

Outlook

Willow is positioned to become a leader in precision fermentation, including cannabinoid biosynthesis, by capturing key intellectual property around what the Company anticipates being the most cost-effective methods to produce highly pure ingredients. The Company's operational capabilities, along with its strategic partners, span the entire product development pathway, and Willow's integrated team in Canada and the United States has full capabilities to underpin achievement at all stages of the development cycle. The Company's established technology, capabilities, and manufacturing network can now enable biobased production for a diverse set of industries. While the market for biosynthetically produced cannabinoids is not where the Company thought it would be a year ago, Willow remains bullish at the long term market potential. While the Company waits for the cannabinoid biosynthesis market to develop, Willow will utilize the platform it has built to work with ingredient and pharmaceutical companies to provide access to technology that augments existing manufacturing techniques to build out a better supply chain for compounds that have strong market potential. This will ultimately allow Willow to generate early stage revenue based on research and development, as well as longer term revenue in the form of royalties or profit sharing. Willow anticipates being able to add new compounds to its product offering in 2022 to generate revenue for the company.

The underlying fundamentals for the global cannabis industry are trending upwards. As the future growth in the industry comes from increased product offerings, it is management's ultimate belief that the purity, consistency, and above all else, the sustainable nature in which biosynthetically produced cannabinoids are made, will be paramount for enabling large multi-national CPG companies to participate. While Willow can't control the regulatory environment and ultimate timing of these companies entering the space, the Company can control the development and commercial production associated with its cannabinoids, and having all the necessary safety work needed to be a global supplier. Willow is ready when the market unfolds.

As the platform expands to include development of new compounds funded by partners, Willow is in a strong financial position with $30.1 million cash on the balance sheet as at January 1, 2022.

About Willow Biosciences Inc.

Willow is a leading biotechnology company that develops and produces high-purity, plant derived ingredients for the consumer care, food and beverage, and pharmaceutical markets. Willow's FutureGrown™ biotechnology platform allows scale production of pure, consistent, and sustainable product to benefit both B2B customers. Willow's R&D team has a proven track record of developing and commercializing bio-based manufacturing processes and products for both the consumer and pharmaceutical industries.

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: timing of revenue generation; discussions with consumer-packaged goods entities; expanding its CMO network; ability to meet demand for CBG and other products in 2023 and beyond; the demand and market size potential of the synthetic cannabinoid industry; Willow's entry into new global markets; regulatory changes effecting the cannabinoid industry; and the business plan of the Company, generally, including becoming a leader in precision fermentation, including cannabinoid biosynthesis. 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 to differ materially from those in the forward-looking statements including, but not limited to, risks associated with: the cannabinoid 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 AIF and MD&A 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 cash flows 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.

SOURCE Willow Biosciences Inc.

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