Globe Newswire 8-Nov-2018 4:30 PM
SOUTH SAN FRANCISCO, Nov. 08, 2018 (GLOBE NEWSWIRE) -- 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, 2018, provided business highlights and announced the appointment of Jennifer Cook to the Board of Directors.
"The recent clinical progress with our LRRK2 inhibitor and RIPK1 inhibitor programs 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 to partner with Sanofi and expand our RIPK1 program into new indications."
Third Quarter 2018 and Recent Business Highlights
Third Quarter 2018 Financial Results
For the three months ended September 30, 2018, Denali reported a net loss of $35.4 million compared with a net loss of $21.8 million for the three months ended September 30, 2017.
Collaboration revenue was $1.2 million for the three months ended September 30, 2018, with no collaboration revenue recognized for the three months ended September 30, 2017. The increase was due to revenue recognized under the Option and Collaboration Agreement with Takeda Pharmaceutical Company Limited, which was entered into in January 2018.
Total research and development expenses were $30.3 million for the three months ended September 30, 2018, including non-cash stock-based compensation of $2.9 million, compared to $18.5 million for the three months ended September 30, 2017, including non-cash stock-based compensation of $0.7 million. The increase in total research and development expenses of $11.8 million was primarily attributable to an increase in personnel-related expenses, including non-cash stock-based compensation, driven primarily by higher headcount and new options granted at higher exercise prices subsequent to the Company's initial public offering. Further, there was an increase in other external research and development expenses, reflecting Denali's growing and maturing pipeline, increased LRRK2 program expenses due to increased costs associated with Phase 1 clinical trials in healthy volunteers with DNL201 and DNL151, and an increase in other research and development expenses primarily due to rent expense associated with the new headquarters lease and an increase in lab consumable expenses.
General and administrative expenses were $8.8 million for the three months ended September 30, 2018, including non-cash stock-based compensation of $2.6 million, compared to $3.8 million for the three months ended September 30, 2017, including non-cash stock-based compensation of $0.4 million. The increase in total general and administrative expenses of $5.0 million was primarily attributable to an increase in personnel-related expenses, including non-cash stock-based compensation, driven primarily by higher headcount and new options granted at higher exercise prices subsequent to the Company's initial public offering, and an increase in legal and professional service expenses required to support Denali's ongoing operations as a public company.
Cash, cash equivalents, and marketable securities were $517.1 million as of September 30, 2018, compared to $467.0 million as of December 31, 2017. The increase of $50.1 million was primarily attributable to $155.0 million in cash received related to the Option and the Collaboration Agreement and Stock Purchase Agreement with Takeda, both entered into in January 2018, partially offset by operating and investing cash payments.
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, the potential benefits of the collaboration with Sanofi; the expectation as to when such transaction will close; expectations regarding clinical development activities; plans for Sanofi and Denali to collaborate on global clinical development; 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: the risk that the Sanofi transaction may not close in a timely manner or at all; risks related to obtaining the requisite regulatory approvals; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of the collaboration agreement (including without limitation the failure to timely obtain requisite regulatory approvals); risks related to the effect of the announcement of the transaction on Denali's business relationships, operating results and business generally; Denali's early stages of clinical drug development; Denali's ability to complete the development and, if approved, commercialization of its product candidates; Denali's ability to conduct or complete clinical trials on expected timelines; 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, Denali's Quarterly Report on Form 10-Q filed with the SEC on November 8, 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.
Denali Therapeutics Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||30,321||18,515||103,274||55,989|
|General and administrative||8,838||3,773||21,304||10,611|
|Total operating expenses||39,159||22,288||124,578||66,600|
|Loss from operations||(37,964||)||(22,288||)||(121,094||)||(66,600||)|
|Interest and other income, net||2,593||444||7,321||1,302|
|Net loss per share, basic and diluted||$||(0.38||)||$||(2.14||)||$||(1.24||)||$||(6.77||)|
|Weighted average number of shares outstanding, basic and diluted||93,665,231||10,231,036||92,056,812||9,643,686|
Denali Therapeutics Inc.
Condensed Consolidated Balance Sheets
|September 30, 2018||December 31, 2017|
|Cash and cash equivalents||$||43,651||$||218,375|
|Short-term marketable securities||331,307||187,851|
|Prepaid expenses and other current assets||8,445||3,381|
|Total current assets||383,403||409,607|
|Long-term marketable securities||142,173||60,750|
|Property and equipment, net||16,245||14,923|
|Other non-current assets||2,654||1,441|
|Liabilities and stockholders' equity|
|Other current liabilities||138||63|
|Total current liabilities||31,617||14,164|
|Contract liability, less current portion||44,452||—|
|Deferred rent, less current portion||7,103||6,294|
|Other non-current liabilities||124||467|
|Total stockholders' equity||461,179||465,796|
|Total liabilities and stockholders' equity||$||544,475||$||486,721|
Denali Media Relations Contacts:
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