Denali Therapeutics Announces Early Exercise of Its Option to Acquire F-star Gamma
31 May 2018 - 6:05AM
Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company
developing a broad portfolio of therapeutic candidates for
neurodegenerative diseases, today announced that it has exercised
its option to acquire all outstanding shares in F-star Gamma
pursuant to the Option Agreement dated August 24, 2016 and expanded
its collaboration with F-star on Denali’s biologics Transport
Vehicle (“TV”) blood-brain barrier (“BBB”) platform technology.
Denali entered into a License and Collaboration Agreement with
F-star in August 2016 to support the development of and provide
rights to intellectual property for Denali’s proprietary TV
platform technology to deliver therapeutics across the BBB. Based
on compelling preclinical proof of concept data for the TV platform
technology and substantive progress with Denali’s lead program
enabled by this technology, Denali has decided to exercise its
option to acquire F-star Gamma, a private limited liability company
incorporated under the laws of England and Wales. F-star Gamma
holds certain intellectual property rights to F-star’s Modular
Antibody TechnologyTM which has been used to generate Fcabs against
a transporter in the BBB. In addition, Denali has expanded certain
rights under the existing License and Collaboration Agreement and
has exercised its right to nominate two additional BBB transporter
FcabTM (constant Fc-domains with antigen-binding activity)
targets.
“Our decision to exercise the option to buy F-star Gamma
reflects the progress in our collaboration with F-star and the
generation of preclinical data showing that our proprietary TV
platform technology may enable us to deliver biologics across the
BBB and into the brain. Specifically, recent data demonstrated
robust and sustained peripheral and brain activity for our ETV:IDS
program for Hunter Syndrome and hence preclinical proof of concept.
Furthermore, the expanded collaboration allows us to deepen and
broaden our research efforts supporting our TV platform
technology,” said Ryan Watts, Ph.D., CEO of Denali
Therapeutics.
“With the growing number of patients affected by neurological
disorders, there is an urgent need to efficiently deliver medicines
into the brain. Denali’s approach is well positioned to tackle this
challenge and we firmly believe that its TV platform technology,
enabled by F-star’s Modular Antibody Technology has the potential
to create a new class of disruptive CNS-targeting biological
therapeutics,” said John Haurum, CEO of F-star.
The total consideration for the option exercise and expanded
collaboration amounts to $24 million, plus any net cash held by
F-star Gamma at closing of the transaction. In addition, Denali may
make future contingent payments up to a maximum of $447 million
upon the achievement of defined preclinical, clinical, regulatory
and commercial milestones. There are no royalty payments on net
sales from future products. Through the acquisition of F-star
Gamma, Denali obtains exclusive rights to discover, develop and
commercialize an unlimited number of therapeutic products enabled
by F-star’s intellectual property and utilizing any of the three
BBB transporter Fcab targets nominated by Denali.
About Denali Therapeutics
Denali is a biopharmaceutical company developing a broad
portfolio of therapeutic candidates for neurodegenerative diseases.
Denali pursues new treatments by rigorously assessing genetically
validated targets, engineering delivery across the blood-brain
barrier and guiding development with biomarker monitoring to
demonstrate target engagement and select patients. Denali is based
in South San Francisco. For additional information, please
visit www.denalitherapeutics.com.
Forward-looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements expressed or implied in this press
release include, but are not limited to, statements regarding
Denali’s progress, expectations and business plans; expectations
regarding, and potential benefits of, the F-star collaboration and
the acquisition of F-star Gamma; and statements made by Denali’s
CEO and F-star’s CEO. Actual results are subject to risks and
uncertainties and may differ materially from those indicated by
these forward-looking statements as a result of these risks and
uncertainties, including but not limited to, risks related
to: Denali’s early stages of clinical drug development;
Denali’s ability to complete the development of, and if approved,
commercialization of its product candidates; Denali’s dependence on
successful development of its TV platform technology and product
candidates currently in its core program; Denali’s ability to
conduct or complete clinical trials on expected timelines; the
uncertainty that any of Denali’s product candidates will receive
regulatory approval necessary to be commercialized; Denali’s
ability to continue to create a pipeline of product candidates or
develop commercially successful products; Denali's ability to
obtain, maintain, or protect intellectual property rights related
to its product candidates and TV platform technology;
implementation of Denali’s strategic plans for its business,
product candidates and TV platform technology; and other risks,
including those described in Denali’s Annual Report on Form 10-K
filed with the SEC on March 19, 2018, Denali’s
Quarterly Report on Form 10-Q filed with the SEC on May 11, 2018
and Denali’s future reports to be filed with the SEC. The
forward-looking statements in this press release are based on
information available to Denali as of the date
hereof. Denali disclaims any obligation to update any
forward-looking statements, except as required by law.
Contact:Morgan Warners(202) 337-0808mwarners@gpg.com
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