Release Details
Denali Therapeutics Reports Full Year 2018 Financial Results and Business Highlights
“We have made significant progress toward our long-term goal of defeating neurodegenerative diseases. We successfully completed Phase 1 healthy volunteer clinical trials for our LRRK2 inhibitor and RIPK1 inhibitor programs, initiated clinical studies in patients with Parkinson’s disease, ALS and Alzheimer’s disease, and further validated our blood-brain barrier delivery technology,” said
Fourth Quarter 2018 and Recent Business Highlights
- First Patient dosed in Three Phase 1b Studies - In
December 2018 , we announced the first patient dosed in our Phase 1b Study of DNL201 in Parkinson’s disease patients with and without a genetic LRRK2 mutation; in January andFebruary 2019 , in collaboration with our partnerSanofi , we announced the first patient dosed in two Phase 1b studies of DNL747 in ALS and Alzheimer’s patients, respectively.
- Entered into a broad RIPK1 Collaboration Agreement with
Sanofi – InOctober 2018 , Denali entered into a Collaboration and License Agreement withGenzyme Corporation , a wholly owned subsidiary ofSanofi S.A. , (“Sanofi”) to develop and commercialize therapeutic products to treat neurological and systemic inflammatory diseases by targeting RIPK1. Denali received an upfront fee of$125 million inNovember 2018 and is eligible to receive contingent milestone payments that could exceed$1 billion . For products intended to treat neurological diseases, Denali andSanofi will share development costs and commercial profits and losses inthe United States andChina , while Denali will receive a royalty fromSanofi for other territories. For products intended to treat systemic inflammatory diseases,Sanofi will pay all development costs and Denali will receive a royalty worldwide.
- Achieved First Milestone for the Second and Third Programs Under the Takeda Collaboration Agreement - In October and
December 2018 , the first preclinical milestone was met for the second and third program partnered with Takeda, respectively, upon which Takeda paid Denali a milestone payment of$5 million for each program.
Fourth Quarter and Full Year 2018 Financial Results
For the fourth quarter of 2018, Denali reported a net income of
Collaboration revenue was $125.7 million and
Total research and development expenses were
General and administrative expenses were
Cash, cash equivalents, and marketable securities were
About
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
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 potential benefits of the collaborations with
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: the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of the
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
Three Months Ended December 31, |
Twelve Months Ended December 31, |
|||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||
Collaboration revenue | $ | 125,676 | $ | — | $ | 129,160 | $ | — | ||||||
Operating expenses: | ||||||||||||||
Research and development | 39,909 | 18,471 | 143,183 | 74,460 | ||||||||||
General and administrative | 11,045 | 5,069 | 32,349 | 15,680 | ||||||||||
Total operating expenses | 50,954 | 23,540 | 175,532 | 90,140 | ||||||||||
Profit (loss) from operations | 74,722 | (23,540 | ) | (46,372 | ) | (90,140 | ) | |||||||
Interest and other income, net | 2,811 | 653 | 10,132 | 1,955 | ||||||||||
Net income (loss) | $ | 77,533 | $ | (22,887 | ) | $ | (36,240 | ) | $ | (88,185 | ) | |||
Net income (loss) per share, basic | $ | 0.82 | $ | (0.74 | ) | $ | (0.39 | ) | $ | (5.89 | ) | |||
Net income (loss) per share, diluted | $ | 0.79 | $ | (0.74 | ) | $ | (0.39 | ) | $ | (5.89 | ) | |||
Weighted average number of shares outstanding, basic | 94,299,096 | 30,743,980 | 92,621,991 | 14,964,144 | ||||||||||
Weighted average number of shares outstanding, diluted | 97,746,224 | 30,743,980 | 92,621,991 | 14,964,144 |
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
December 31, 2018 | December 31, 2017 | ||||
Assets | |||||
Current assets: | |||||
Cash and cash equivalents | $ | 77,123 | $ | 218,375 | |
Short-term marketable securities | 387,174 | 187,851 | |||
Prepaid expenses and other current assets | 16,539 | 3,381 | |||
Total current assets | 480,836 | 409,607 | |||
Long-term marketable securities | 147,881 | 60,750 | |||
Property and equipment, net | 25,162 | 14,923 | |||
Other non-current assets | 8,105 | 1,441 | |||
Total assets | $ | 661,984 | $ | 486,721 | |
Liabilities and stockholders' equity | |||||
Current liabilities: | |||||
Accounts payable | $ | 1,891 | $ | 2,716 | |
Accrued liabilities | 8,520 | 5,364 | |||
Accrued compensation | 9,952 | 5,166 | |||
Contract liability | 11,427 | — | |||
Deferred rent | 616 | 855 | |||
Other current liabilities | 380 | 63 | |||
Total current liabilities | 32,786 | 14,164 | |||
Contract liability, less current portion | 57,350 | — | |||
Deferred rent, less current portion | 24,532 | 6,294 | |||
Other non-current liabilities | 471 | 467 | |||
Total liabilities | 115,139 | 20,925 | |||
Total stockholders' equity | 546,845 | 465,796 | |||
Total liabilities and stockholders’ equity | $ | 661,984 | $ | 486,721 |
Denali Media Relations Contacts:
Morgan Warners
(202) 337-0808
mwarners@gpg.com
(646) 495-2706
lhyland@gpg.com
Source: Denali Therapeutics Inc.