Denali Therapeutics Announces Closing of Collaboration and Share Purchase Agreements with Biogen
October 07 2020 - 8:30AM
Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical
company developing a broad portfolio of product candidates
engineered to cross the blood-brain barrier (BBB) for
neurodegenerative diseases, today announced the signing of a
Definitive LRRK2 Collaboration and License Agreement and a Right of
First Negotiation, Option and License Agreement with Biogen, in
connection with its previously announced binding provisional
collaboration and license agreement for neurodegenerative diseases
with Biogen, and the closing of the related common stock purchase
agreement.
In connection with the signing of the agreements with Biogen,
Denali will receive a $560 million upfront payment. In addition, on
September 22, 2020, in a private placement transaction, Biogen made
an equity investment of $465 million in Denali through the purchase
of 13,310,243 newly issued shares of Denali common stock at
approximately $34.94 per share in connection with its previously
announced stock purchase agreement.
Under the terms of the Definitive LRRK2 Collaboration and
License Agreement, the companies will co-develop Denali’s small
molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for
Parkinson’s disease, and will co-commercialize Denali’s LRRK2
products in the United States and China, with shared responsibility
for worldwide development costs (60 percent Biogen; 40 percent
Denali), as well as profits and losses for commercialization in the
United States (50 percent Biogen; 50 percent Denali) and China (60
percent Biogen; 40 percent Denali). Outside the United States and
China, Biogen will be responsible for commercialization and will
pay Denali tiered royalties. Should the LRRK2 program achieve
certain development and commercial milestones, Denali will be
eligible to receive up to $1.125 billion in potential milestone
payments.
Mutations in LRRK2 can cause Parkinson’s disease. LRRK2 is a
regulator of lysosomal function, which is impaired in Parkinson’s
disease and may contribute to neurodegeneration. As previously
announced, Denali’s small molecule inhibitor of LRRK2, DNL151, has
been selected to progress into late-stage clinical studies, which
are expected to commence in 2021.
Under the terms of the Right of First Negotiation, Option and
License Agreement with Biogen, Biogen has exclusive option rights
to two programs for neurodegenerative diseases using Denali’s
BBB-crossing transport vehicle (TV) technology platform, including
for amyloid beta, plus right of first negotiation for two
additional unnamed TV platform programs should Denali decide to
seek a collaboration for such programs. These rights are limited to
certain modalities and indications and are also exercisable during
a limited time period. Denali’s proprietary TV technology is
designed to effectively deliver large therapeutic molecules such as
antibodies, enzymes, proteins and oligonucleotides across the BBB
after intravenous administration.
The closing of the common stock purchase agreement and the
definitive collaboration agreements were subject to the
satisfaction of customary closing conditions, including the
expiration of the waiting period under the Hart-Scott-Rodino (HSR)
Antitrust Improvements Act of 1976. Additional details regarding
the financial terms can be found in Denali’s Form 8-K filed with
the Securities and Exchange Commission on October 7, 2020.
About Denali’s LRRK2 DNL151 Program
DNL151 is a small molecule inhibitor of LRRK2 invented at Denali
which has completed dosing of 162 healthy volunteers in an ongoing
Phase 1 clinical study and completed dosing in 25 Parkinson’s
patients in a Phase 1b clinical study. Denali is currently
completing further dose escalation cohorts in an expanded Phase 1
and an additional cohort in the Phase 1b study to define the full
therapeutic window of the molecule. Based on the clinical data to
date that has been generated in Europe, DNL151 appears to have an
acceptable safety and tolerability profile and has met desired
target engagement goals. An Investigational New Drug application
for DNL151 was cleared by the U.S. Food and Drug Administration in
July 2020 and enables expansion of Denali clinical trials for
DNL151 globally.
About Denali Therapeutics
Denali Therapeutics is a biopharmaceutical company developing a
broad portfolio of product candidates engineered to cross the
blood-brain barrier (BBB) for neurodegenerative diseases. Denali
pursues new treatments by rigorously assessing genetically
validated targets, engineering delivery across the BBB and guiding
development through biomarkers that demonstrate target and pathway
engagement. Denali is based in South San Francisco. For additional
information, please visit www.denalitherapeutics.com.
Cautionary Note Regarding 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, plans, timelines and
expectations related to DNL151 and other LRRK2 inhibitor molecules,
Denali’s TV technology platform and TV programs; LRRK2 inhibitors
as modifying therapy for Parkinson’s disease; the ability of the TV
technology to effectively deliver large therapeutic molecules
across the BBB; expectations regarding the collaboration with
Biogen, including financial aspects of the collaboration; the
potential benefits and results of the transaction with Biogen;
expectations regarding the commencement of clinical trials;
expectations regarding ongoing clinical trials; and plans to
conduct development and commercialization activities.
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: any and all risks to Denali’s business and
operations caused directly or indirectly by the evolving COVID-19
pandemic; the risk of the occurrence of any event, change or other
circumstance that could give rise to the termination of the
agreements with Biogen; risks related to the effect of the
announcement of the transaction on Denali’s business relationships,
operating results, stock price and business generally; Denali’s
early stages of clinical drug development; Denali’s and its
partners’ ability to complete the development and, if approved,
commercialization of its product candidates; Denali’s and its
partners’ ability to enroll patients in clinical trials; Denali’s
reliance on third parties for the manufacture and supply of its
product candidates for clinical trials; Denali’s dependence on
successful development of its BBB platform technology and whether
the platform technology effectively delivers large therapeutic
molecules across the BBB; Denali’s and its partners’ ability to
conduct or complete clinical trials on expected timelines; the risk
that preclinical profiles and results of early clinical trials of
Denali’s product candidates, such as DNL151, may not translate in
later clinical trials; the risk that DNL151 and Denali’s other
LRRK2 inhibitors may not sufficiently modify Parkinson’s disease;
the uncertainty that 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; developments relating to Denali’s
competitors and its industry, including competing product
candidates and therapies; Denali’s ability to obtain, maintain or
protect intellectual property rights related to its product
candidates; implementation of Denali’s strategic plans for its
business, product candidates and BBB platform technology; Denali’s
ability to obtain additional capital to finance its operations, as
needed; Denali’s ability to accurately forecast future financial
results in the current environment; general economic and market
conditions; and other risks and uncertainties, including those
described in Denali’s most recent Annual Report on Form 10-K, most
recent Quarterly Report on Form 10-Q 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.
Investor Relations
Contact:
Laura Hansen, Ph.D.Vice President, Investor Relations(650)
452-2747hansen@dnli.com
Media Contacts:
Lizzie Hyland(646) 495-2706lhyland@gpg.com
or
Morgan Warners(202) 295-0124mwarners@gpg.com
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