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, Calif., April 18,
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 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.
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 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.
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SOURCE Willow Biosciences Inc.