CALGARY,
AB AND MOUNTAIN VIEW,
CA, Aug. 15, 2022 /PRNewswire/ - Willow
Biosciences Inc. ("Willow" or the "Company")
(TSX: WLLW) (OTCQB: CANSF), a leading biotechnology company
focused on revolutionizing industrial manufacturing of pure,
consistent and sustainable functional ingredients, has released its
financial and operating results for the three months ended
June 30, 2022, reporting significant
progress to its operational platform, leadership and strong
liquidity.
"The second quarter saw us take the next step in the evolution
of our product portfolio with a new partnered pharmaceutical
project", said Dr. Peter Seufer-Wasserthal, Willow's Interim
President and Chief Executive Officer. "Over the last three and a
half years we have built out a fully integrated team that covers
the entire production spectrum from the lab to commercialization.
We are in a strong position to continue product development of our
FutureGrown™ CBG and add new partnerships at this time and believe
that the company is set up today to be a leader in the coming
bio-revolution of tomorrow."
Willow's unaudited consolidated interim financial statements and
related management's discussion and analysis for the quarter ended
June 30, 2022 are available on SEDAR
at www.sedar.com.
Highlights for the
Quarter
- On May 11, 2022, Willow announced
that it had successfully completed the initial toxicological
assessment for Generally Recognized as Safe ("GRAS") for its
FutureGrown™ cannabigerol ("CBG") product in the United States. An important milestone for
biosynthetically produced cannabinoids, Willow has successfully
completed the Stage 1 toxicological assessment of its
FutureGrown™ CBG product for oral product applications. The
assessment concluded that FutureGrownTM CBG caused no
adverse effects and was non-mutagenic, non-clastogenic and
non-genotoxic, completing the first step toward designating
Willow's FutureGrown™ CBG as GRAS in the
United States. Willow anticipates initiating its Stage 2
pivotal toxicological assessment in Q3 2022.
- On May 11, 2022, Willow announced
the expansion of its precision fermentation manufacturing network
with the signing of a Manufacturing Services Agreement
("MSA") with a second Contract Development and Manufacturing
Organization ("CDMO"), increasing fermentation capacity to
produce Willow's FutureGrown™ products, including
CBG. Willow's new partner has a strong track record in the
large-scale production of food, nutritional, and pharmaceutical
products and holds all necessary certifications to serve these
markets. This new CDMO partnership allows Willow to accommodate new
programs, both internal and partnered, in addition to its
cannabinoid portfolio.
- On May 31, 2022, Willow announced
that is has been engaged by a specialty pharmaceutical
company (the "Counterparty") to optimize a biosynthetic
pathway vital to the development of a large volume Active
Pharmaceutical Ingredient (API) used in nutraceutical and
pharmaceutical products. The Counterparty is partnered with a
large-cap, multi-national healthcare company. The project consists
of research & development and commercialization phases, with
revenue coming from both research fees and milestone payments.
Following commercialization, Willow anticipates an on-going revenue
stream from license payments.
- Subsequent to the quarter, on July 18,
2022, Willow appointed Dr. Peter Seufer-Wasserthal as
Interim President and Chief Executive Officer, effective
July 17, 2022, in connection with
Trevor Peters' retirement as
President and CEO. Mr. Peters continues to serve as a Director of
the Company. Guided by his extensive experience in biotech, pharma,
nutrition, and consumer care, the Company has already advanced
several partnership discussions in the food and nutrition
sectors. He will continue to build and lead the organization
needed to successfully execute on the Company's mission.
- Willow ended the quarter in a strong financial position, with
approximately $22.1 million in
working capital and $22.1 million of
cash on hand.
Consolidation Of Research &
Development Infrastructure
Willow has begun consolidating Research & Development
(R&D) at its Mountain View,
California site by closing its Burnaby, British Columbia facility. Willow
expects to complete the closure and relocate key personnel to
Mountain View by the end of
September 2022. The motivation for
the consolidation is the operational benefits of having the
Company's entire R&D team under one roof. Our San
Francisco Bay Area site was selected because of its position as the
global biotech hub, where the Company can recruit and retain top
scientific talent.
Outlook
Willow is positioned to become a leader in precision
fermentation 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 R&D team
in California has the full
capabilities to deliver 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 has
not materialized to the extent originally anticipated, Willow
remains optimistic about the long term market potential for these
ingredients and continues to optimize its production process.
While the market for biosynthetically produced cannabinoids
continues to develop, Willow will utilize it's proven
FutureGrownTM platform to partner with companies in the
personal care, food and beverage, and pharmaceutical markets,
providing access to pure, consistent and sustainable functional
ingredients. With our first non-cannabinoid program announced this
year, we are excited to continue adding partnerships and products,
expanding our platform and de-risking our portfolio. We look
forward to updating stakeholders on our progress in the coming
quarters.
About Willow Biosciences
Inc.
Willow develops and produces high-purity ingredients for the
personal care, food and beverage, and pharmaceutical markets.
Willow's FutureGrownÔ 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.
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 MSA, including the ability to
accommodate new programs and to expand capabilities; the continued
development of Willow's FutureGrown™ CBG; 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 or 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.