SOUTH SAN FRANCISCO, Calif., March 19, 2018 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today announced that it has commenced dosing of its small molecule inhibitor of RIPK1 in a Phase 1 clinical trial in healthy volunteers and achieved proof of concept of its large molecule blood-brain barrier delivery platform technology in nonhuman primates. In addition, the Company reported financial results for the fourth quarter and full year ended December 31, 2017 and appointed Peter Klein to the Board of Directors.
"The recent clinical progress with our RIPK1 inhibitor and LRRK2 inhibitor programs, along with achieving proof of concept for our blood-brain barrier delivery platform for biologics in nonhuman primates, are important milestones towards our goal of developing medicines for patients suffering from neurodegenerative diseases," said Ryan Watts, Ph.D., CEO. "Furthermore, we are very excited about initiating our collaboration with Takeda, which has allowed us to expand efforts on our blood-brain barrier delivery technology platform."
Fourth Quarter 2017 and Recent Corporate Highlights
Fourth Quarter and Full Year 2017 Financial Results
For the fourth quarter of 2017, Denali reported a net loss of $22.9 million, compared with a net loss for the fourth quarter of 2016 of $19.4 million. For the year ended December 31, 2017, net loss was $88.2 million, compared with a net loss for the same period in 2016 of $86.7 million.
Total operating expenses for the fourth quarter of 2017 were $23.5 million compared with $19.8 million for the same period in 2016 including non-cash stock-based compensation of $1.5 million and $0.7 million in the fourth quarter of 2017 and 2016, respectively. Total operating expenses for the year ended December 31, 2017 were $90.1 million compared with $87.4 million for the same period in 2016, including non-cash stock-based compensation of $4.4 million and $3.0 million in 2017 and 2016, respectively. The increase in total operating expenses is due to the increase in research, development, and general and administrative costs as Denali's pipeline expanded and advanced.
Cash, cash equivalents, and marketable securities were $467.0 million as of December 31, 2017.
About Denali Therapeutics
Denali is a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases. 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 and business plans; clinical trial plans, timelines and expectations, including regarding proof of concept for future human studies; Denali’s expectations regarding collaborations; and statements made by Denali’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 stage 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 BBB 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; implementation of Denali’s strategic plans for its business, product candidates and BBB 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, the final prospectus related to Denali’s initial public offering filed with the SEC on December 8, 2017, 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. | |||||||||||||||
Unaudited Consolidated Statements of Operations | |||||||||||||||
(In thousands, except per share amounts) | |||||||||||||||
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 18,471 | $ | 16,730 | $ | 74,460 | $ | 75,702 | |||||||
General and administrative | 5,069 | 3,046 | 15,680 | 11,731 | |||||||||||
Total operating expenses | 23,540 | 19,776 | 90,140 | 87,433 | |||||||||||
Loss from operations | (23,540 | ) | (19,776 | ) | (90,140 | ) | (87,433 | ) | |||||||
Interest income (expense), net | 653 | 422 | 1,955 | 781 | |||||||||||
Net loss | $ | (22,887 | ) | $ | (19,354 | ) | $ | (88,185 | ) | $ | (86,652 | ) | |||
Net loss per share, basic and diluted | $ | (0.74 | ) | $ | (2.41 | ) | $ | (5.89 | ) | $ | (13.49 | ) | |||
Weighted average number of shares outstanding, basic and diluted1 | 30,743,977 | 8,022,066 | 14,964,144 | 6,424,720 |
1 Share numbers have been adjusted, as appropriate, for the 4-for-1 reverse stock split that occurred on November 28, 2017. The increase in the weighted average number of common shares outstanding from 2016 to 2017 is primarily due to the conversion of preferred stock into common stock, and issuance of additional shares of common stock, both of which occurred at the time of our initial public offering in December 2017.
Denali Therapeutics Inc. | |||||||
Unaudited Consolidated Balance Sheets | |||||||
(In thousands) | |||||||
December 31, | |||||||
2017 | 2016 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 218,375 | $ | 39,853 | |||
Short-term marketable securities | 187,851 | 138,478 | |||||
Prepaid expenses and other current assets | 3,381 | 3,624 | |||||
Total current assets | 409,607 | 181,955 | |||||
Long-term marketable securities | 60,750 | 72,580 | |||||
Property and equipment, net | 14,923 | 15,262 | |||||
Other non-current assets | 1,441 | 1,270 | |||||
Total assets | $ | 486,721 | $ | 271,067 | |||
Liabilities, convertible preferred stock and stockholders’ equity (deficit) | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 2,716 | $ | 1,963 | |||
Accrued liabilities | 5,364 | 3,850 | |||||
Accrued compensation | 5,166 | 2,592 | |||||
Deferred rent | 855 | 538 | |||||
Other current liabilities | 63 | 163 | |||||
Total current liabilities | 14,164 | 9,106 | |||||
Deferred rent | 6,294 | 7,045 | |||||
Other non-current liabilities | 467 | 397 | |||||
Total liabilities | 20,925 | 16,548 | |||||
Convertible preferred stock | — | 348,673 | |||||
Total stockholders’ equity (deficit) | 465,796 | (94,154 | ) | ||||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | $ | 486,721 | $ | 271,067 | |||
Contact
Morgan Warners
(202) 337-0808
[email protected]
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