Denali Therapeutics Reports Third Quarter 2019 Financial Results and Business Highlights
November 06 2019 - 3:30PM
Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical
company developing a broad portfolio of product candidates for
neurodegenerative diseases, today reported financial results for
the third quarter ended September 30, 2019, and provided business
highlights.
“Our clinical and preclinical programs continue
to progress and we plan to submit an IND or CTA for two programs by
year-end 2019. One of these programs, ETV:IDS, will be our first
biotherapeutic engineered to cross the blood-brain barrier using
our Transport Vehicle platform. We are also particularly excited
about our LRRK2 program and the potential to make a difference for
patients suffering from Parkinson's disease,” said Ryan Watts,
Ph.D., CEO.
Third Quarter 2019 and Recent Business
Highlights
- First patient dosed in DNL151 Phase 1b clinical
trial - In September 2019, Denali announced initiation of
dosing in a Phase 1b clinical study of LRRK2 inhibitor DNL151 in
patients with Parkinson's disease, and the launch of its Engage
Parkinson's website.
- RIPK1 program update - The DNL747 Phase 1b
trials in Alzheimer's disease and ALS continue to progress,
enrollment of an ALS open label extension in the Netherlands has
commenced, and sites for the Phase 1b ALS study have been expanded
into the United States. Denali intends, together with its partner
Sanofi, to evaluate the full data set from the ongoing clinical and
preclinical studies to inform decisions on further clinical testing
for the RIPK1 program. The timing of such decisions is delayed to
mid-2020.
- First patient enrolled in Hunter Syndrome patient
biomarker study - In October 2019, Denali enrolled the
first patient in a biomarker study for the ETV:IDS program in
Hunter Syndrome. This non-interventional study is expected to yield
critical biomarker and clinical data in patients to inform future
clinical studies with DNL310 (ETV:IDS) and facilitate patient
recruitment into these studies. DNL310 is a CNS-penetrant,
intravenous enzyme replacement therapy that utilizes our Transport
Vehicle platform technology to increase penetration across the
blood-brain barrier.
- Leadership promotions - In November 2019, Zach
Sweeney was promoted to Chief Scientific Officer, and Cindy Dunkle
was promoted to Chief People Officer. Both Zach and Cindy joined
Denali in 2015.
Third Quarter 2019 Financial
Results
For the three months ended September 30, 2019,
Denali reported a net loss of $46.3 million compared with a
net loss of $35.4 million for the three months ended September
30, 2018.
Collaboration revenue was $13.6 million for
the three months ended September 30, 2019, compared with
collaboration revenue of $1.2 million for the three months
ended September 30, 2018. The $12.4 million increase was
due to $12.5 million of revenue recognized under the Sanofi
Collaboration Agreement in the three months ended September 30,
2019, which included a $10 million milestone earned upon Sanofi's
commencement of a DNL758 Phase 1 clinical trial in healthy
volunteers, partially offset by a decrease in revenue recognized
under the Takeda Collaboration Agreement.
Total research and development expenses were
$52.5 million for the three months ended September 30, 2019
compared to $30.3 million for the three months ended September
30, 2018. The $22.2 million increase in total research and
development expenses was primarily attributable to an increase in
external expenses related to the LRRK2 and ETV:IDS programs among
other programs in the Company's portfolio. In addition, there was
an increase in personnel-related expenses, including stock-based
compensation, driven primarily by higher headcount and stock-based
awards. Other increases include external research and development
expenses to support pipeline growth as well as higher rent expense
associated with the new headquarters lease.
General and administrative expenses were
$11.2 million for the three months ended September 30, 2019,
compared to $8.8 million for the three months ended September
30, 2018. The $2.4 million increase in total general and
administrative expenses was primarily attributable to an increase
in personnel-related expenses, including stock-based compensation,
driven primarily by higher headcount and stock-based awards as well
as higher rent expense associated with the new headquarters
lease.
Cash, cash equivalents, and marketable
securities were $502.9 million as of September 30, 2019.
About Denali Therapeutics
Denali is a biopharmaceutical company developing
a broad portfolio of product 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.
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, statements
regarding Denali's progress and business plans; the expected timing
to submit an IND or CTA for two of Denali's programs; Denali’s
expectations regarding its ETV:IDS and LRRK2 programs, including
the non-interventional biomarker study for the ETV:IDS program in
Hunter Syndrome; Denali's intentions and plans regarding the RIPK1
program; and statements made by Denali’s Chief Executive
Officer.
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 and, if approved,
commercialization of its product candidates; the risk of the
occurrence of any event, change or other circumstance that could
give rise to the termination of Denali’s collaboration agreements;
Denali’s dependence on successful development of its blood-brain
barrier 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 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; implementation
of Denali’s strategic plans for its business, product candidates
and blood-brain barrier platform technology; and other risks,
including those described in Denali’s Annual Report on Form 10-K
filed with the SEC on March 12, 2019, Denali’s Quarterly Report on
From 10-Q filed with the SEC on November 6, 2019, 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.
Denali Therapeutics
Inc.Condensed Consolidated Statements of
Operations(Unaudited)(In thousands,
except share and per share amounts)
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Collaboration revenue |
$ |
13,604 |
|
|
$ |
1,195 |
|
|
$ |
22,006 |
|
|
$ |
3,484 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
52,544 |
|
|
30,321 |
|
|
141,831 |
|
|
103,274 |
|
General and administrative |
11,215 |
|
|
8,838 |
|
|
35,601 |
|
|
21,304 |
|
Total operating expenses |
63,759 |
|
|
39,159 |
|
|
177,432 |
|
|
124,578 |
|
Loss from operations |
(50,155 |
) |
|
(37,964 |
) |
|
(155,426 |
) |
|
(121,094 |
) |
Interest and other income,
net |
3,782 |
|
|
2,593 |
|
|
11,411 |
|
|
7,321 |
|
Loss before income taxes |
(46,373 |
) |
|
(35,371 |
) |
|
(144,015 |
) |
|
(113,773 |
) |
Income tax benefit |
113 |
|
|
— |
|
|
426 |
|
|
— |
|
Net loss |
$ |
(46,260 |
) |
|
$ |
(35,371 |
) |
|
$ |
(143,589 |
) |
|
$ |
(113,773 |
) |
Net loss per share, basic and
diluted |
$ |
(0.48 |
) |
|
$ |
(0.38 |
) |
|
$ |
(1.50 |
) |
|
$ |
(1.24 |
) |
Weighted average number of shares outstanding, basic and
diluted |
95,859,048 |
|
|
93,665,231 |
|
|
95,449,570 |
|
|
92,056,812 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Denali Therapeutics
Inc.Condensed Consolidated Balance
Sheets(Unaudited)(In thousands)
|
September 30, 2019 |
|
December 31, 2018 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
82,673 |
|
$ |
77,123 |
Short-term marketable securities |
396,717 |
|
387,174 |
Prepaid expenses and other current assets |
14,987 |
|
16,539 |
Total current assets |
494,377 |
|
480,836 |
Long-term marketable
securities |
23,534 |
|
147,881 |
Property and equipment,
net |
47,481 |
|
25,162 |
Operating lease right-of-use
asset |
34,344 |
|
— |
Other non-current assets |
3,242 |
|
8,105 |
Total assets |
$ |
602,978 |
|
$ |
661,984 |
Liabilities and
stockholders' equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,022 |
|
$ |
1,891 |
Accrued liabilities |
15,467 |
|
8,520 |
Accrued compensation |
7,528 |
|
9,952 |
Contract liabilities |
18,185 |
|
11,427 |
Other current liabilities |
3,483 |
|
996 |
Total current liabilities |
46,685 |
|
32,786 |
Contract liabilities, less
current portion |
47,795 |
|
57,350 |
Operating lease liability,
less current portion |
69,915 |
|
— |
Deferred rent, less current
portion |
— |
|
24,532 |
Other non-current
liabilities |
386 |
|
471 |
Total liabilities |
164,781 |
|
115,139 |
Total stockholders'
equity |
438,197 |
|
546,845 |
Total liabilities and
stockholders’ equity |
$ |
602,978 |
|
$ |
661,984 |
Contacts:
Lizzie Hyland(646)
495-2706lhyland@gpg.com
or
Morgan Warners(202)
295-0124mwarners@gpg.com
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