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):
August 9, 2018
_______________________________________
Denali Therapeutics Inc.
(Exact name of registrant as specified in its charter)
_______________________________________ 
Delaware
 
001-38311
 
46-3872213
(State or other jurisdiction of
 
(Commission
 
(I.R.S. Employer
incorporation)
 
File Number)
 
Identification No.)
151 Oyster Point Blvd., 2nd Floor
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 ☒
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. ☒
 
 
 
 
 





Item 2.02     Results of Operations and Financial Condition.
On August 9, 2018, Denali Therapeutics Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2018. 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:
August 9, 2018
By:
/s/ Steve E. Krognes
 
 
 
Steve E. Krognes
 
 
 
Chief Financial Officer



Exhibit

Exhibit 99.1


http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=12401437&doc=3
Denali Therapeutics Reports Second Quarter 2018 Financial Results

SOUTH SAN FRANCISCO – August 9, 2018 – Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, today reported financial results for the second quarter ended June 30, 2018.

Second Quarter 2018 Financial Results

For the three months ended June 30, 2018, Denali reported a net loss of $54.7 million compared with a net loss of $22.1 million for the three months ended June 30, 2017.

Collaboration revenue was $1.6 million for the three months ended June 30, 2018, with no collaboration revenue recognized for the three months ended June 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 $52.1 million for the three months ended June 30, 2018, including non-cash stock-based compensation of $2.6 million, compared to $19.0 million for the three months ended June 30, 2017, including non-cash stock-based compensation $0.7 million. The increase in total research and development expenses of $33.1 million was primarily attributable to a $26.7 million increase in BBB platform external expenses, the majority of which related to expense associated with the acquisition of F-star Gamma Limited and the nomination of two additional Fcab targets under the F-star Collaboration Agreement. Additionally, there was an increase in personnel related expenses including stock-based compensation driven by increased headcount and options granted at higher valuations subsequent to the IPO, as well as an increase in lab consumable costs and facilities related expenses.

General and administrative expenses were $6.9 million for the three months ended June 30, 2018, including non-cash stock-based compensation of $2.1 million, compared to $3.6 million for the three months ended June 30, 2017, including non-cash stock-based compensation of $0.4 million. The increase in total general and administrative expenses of $3.3 million was primarily attributable to an increase in personnel related expenses, including stock-based compensation, and an increase in legal and professional service expenses. The increases were primarily attributable to an increase in general and administrative headcount and options granted at higher valuations subsequent to the IPO, as well as the increased professional services required to support Denali's ongoing operations as a public company.

Cash, cash equivalents, and marketable securities were $551.3 million as of June 30, 2018, compared to $467.0 million as of December 31, 2017.  The increase of $84.3 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, 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.




Denali Therapeutics Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
2018
 
2017
 
2018
 
2017
Collaboration revenue
$
1,648

 
$

 
$
2,289

 
$

Operating expenses:
 
 
 
 
 
 
 
Research and development
52,134

 
19,004

 
72,953

 
37,474

General and administrative
6,896

 
3,564

 
12,466

 
6,838

Total operating expenses
59,030

 
22,568

 
85,419

 
44,312

Loss from operations
(57,382
)
 
(22,568
)
 
(83,130
)
 
(44,312
)
Interest and other income, net
2,658

 
434

 
4,728

 
858

Net loss
$
(54,724
)
 
$
(22,134
)
 
$
(78,402
)
 
$
(43,454
)
Net loss per share, basic and diluted
$
(0.59
)
 
$
(2.29
)
 
$
(0.86
)
 
$
(4.65
)
Weighted average number of shares outstanding, basic and diluted
92,899,524

 
9,670,449

 
91,239,274

 
9,346,051






Denali Therapeutics Inc.
Condensed Consolidated Balance Sheet Data
(Unaudited)
(In thousands)
 
June 30, 2018
 
December 31, 2017
Assets
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
33,088

 
$
218,375

Short-term marketable securities
339,503

 
187,851

Prepaid expenses and other current assets
4,827

 
3,381

Total current assets
377,418

 
409,607

Long-term marketable securities
178,703

 
60,750

Property and equipment, net
13,323

 
14,923

Other non-current assets
2,611

 
1,441

Total assets
$
572,055

 
$
486,721

Liabilities and stockholders' equity
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
9,176

 
$
2,716

Accrued liabilities
5,537

 
5,364

Accrued compensation
2,751

 
5,166

Contract liability
8,715

 

Deferred rent
4,782

 
855

Other current liabilities
47

 
63

Total current liabilities
31,008

 
14,164

Contract liability, less current portion
49,590

 

Deferred rent, less current portion
1,029

 
6,294

Other non-current liabilities
156

 
467

Total liabilities
81,783

 
20,925

Total stockholders' equity
490,272

 
465,796

Total liabilities and stockholders’ equity
$
572,055

 
$
486,721