Document


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
May 8, 2019
Denali Therapeutics Inc.
(Exact name of registrant as specified in its charter)

Delaware001-38311 46-3872213 
(State or other jurisdiction of(Commission(I.R.S. Employer
incorporation)File Number)Identification No.)
161 Oyster Point Blvd.
South San Francisco, California 94080  
(Address of principal executive offices, including zip code)

(650) 866-8548  
(Registrant’s telephone number, including area code)

Not Applicable
(Former name or former address, if changed since last reports)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company x 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  x

Title of each classTrading SymbolName of each exchange on which registered
Common Stock, par value $0.01 per shareDNLINASDAQ Global Select Market





Item 2.02  Results of Operations and Financial Condition.
On May 8, 2019, Denali Therapeutics Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2019. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.Description
99.1 




SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

DENALI THERAPEUTICS INC.
Date:May 8, 2019By:/s/ Steve E. Krognes
Steve E. Krognes
Chief Financial Officer


Document
Exhibit 99.1
http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=12890399&doc=3
Denali Therapeutics Reports First Quarter 2019 Financial Results

SOUTH SAN FRANCISCO – May 8, 2019 – Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, today reported financial results for the first quarter ended March 31, 2019.
First Quarter 2019 Financial Results

For the three months ended March 31, 2019, Denali reported a net loss of $39.0 million compared with a net loss of $23.7 million for the three months ended March 31, 2018.

Collaboration revenue was $4.2 million for the three months ended March 31, 2019, compared with collaboration revenue of $0.6 million for the three months ended March 31, 2018. The increase was due to $3.5 million of revenue recognized under the Sanofi Collaboration Agreement in the three months ended March 31, 2019.

Total research and development expenses were $37.4 million for the three months ended March 31, 2019, including non-cash stock-based compensation of $4.0 million, compared to $20.8 million for the three months ended March 31, 2018, including non-cash stock-based compensation of $1.7 million. The increase in total research and development expenses of $16.6 million was primarily attributable to increases in personnel-related expenses, including non-cash stock-based compensation, driven primarily by higher headcount and new option grants. Further, there were increases in external research and development expenses, reflecting both the progress of Denali's most advanced programs and increased investment in growing and developing its pipeline, and facilities-related expenses primarily due to rent expense.

General and administrative expenses were $9.3 million for the three months ended March 31, 2019, including non-cash stock-based compensation of $2.9 million, compared to $5.6 million for the three months ended March 31, 2018, including non-cash stock-based compensation of $1.2 million. The increase in total general and administrative expenses of $3.7 million was primarily attributable to an increase in personnel-related expenses, including non-cash stock-based compensation, driven primarily by higher headcount and new option grants. Further, there were increases in legal and professional services expenses required to support Denali's ongoing operations as a public company, and facilities-related expenses primarily due to rent expense. 

Cash, cash equivalents, and marketable securities were $583.0 million as of March 31, 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.





Denali Therapeutics Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)

Three Months Ended March 31,
20192018
Collaboration revenue$4,205 $641 
Operating expenses:
Research and development37,403 20,819 
General and administrative9,310 5,570 
Total operating expenses46,713 26,389 
Loss from operations(42,508)(25,748)
Interest and other income, net3,516 2,070 
Net loss $(38,992)$(23,678)
Net loss per share, basic and diluted$(0.41)$(0.26)
Weighted average number of shares outstanding, basic and diluted94,984,503 89,560,576 




Denali Therapeutics Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)

March 31, 2019December 31, 2018
Assets
Current assets:
Cash and cash equivalents$39,661 $77,123 
Short-term marketable securities445,820 387,174 
Prepaid expenses and other current assets14,052 16,539 
Total current assets499,533 480,836 
Long-term marketable securities97,554 147,881 
Property and equipment, net36,955 25,162 
Operating lease right-of-use asset34,407 — 
Other non-current assets8,147 8,105 
Total assets$676,596 $661,984 
Liabilities and stockholders' equity
Current liabilities:
Accounts payable$3,662 $1,891 
Accrued liabilities12,114 8,520 
Accrued compensation3,213 9,952 
Contract liabilities23,148 11,427 
Other current liabilities1,107 996 
Total current liabilities43,244 32,786 
Contract liabilities, less current portion44,852 57,350 
Operating lease liability, less current portion71,412 — 
Deferred rent, less current portion— 24,532 
Other non-current liabilities440 471 
Total liabilities159,948 115,139 
Total stockholders' equity516,648 546,845 
Total liabilities and stockholders’ equity$676,596 $661,984