Form 8-K

 

 

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 11, 2018

 

 

Denali Therapeutics Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38311   46-3872213

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

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 May 11, 2018, Denali Therapeutics Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 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    Press Release dated May 11, 2018.


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 11, 2018

   By:   

/s/ Steve E. Krognes

     

Steve E. Krognes

Chief Financial Officer

EX-99.1

Exhibit 99.1

LOGO

Denali Therapeutics Reports First Quarter 2018 Financial Results

May 11, 2018

SOUTH SAN FRANCISCO, Calif., May 11, 2018 – Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today reported financial results for the first quarter ended March 31, 2018.

First Quarter 2018 Financial Results

For the three months ended March 31, 2018, Denali reported a net loss of $23.7 million, compared with a net loss for the three months ended March 31, 2017 of $21.3 million.

Collaboration Revenue was $0.6 million for the three months ended March 31, 2018, with no revenue recognized for the three months ended March 31, 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 $20.8 million for the three months ended March 31, 2018 compared to $18.5 million for the three months ended March 31, 2017, including non-cash stock-based compensation of $1.7 million and $0.5 million in the first quarter of 2018 and 2017, respectively. The increase in total research and development expenses of $2.3 million was primarily attributable to an increase in personnel related expenses, including stock-based compensation, and an increase in lab consumable costs and facilities related expenses. The main drivers of these increases are an increase in research and development headcount and the increased value of Denali’s common stock.

General and administrative expenses were $5.6 million for the three months ended March 31, 2018 compared to $3.3 million for the three months ended March 31, 2017, including non-cash stock-based compensation of $1.2 million and $0.2 million in the first quarter of 2018 and 2017, respectively. The increase in total general and administrative expenses of $2.3 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 main drivers of these increases are an increase in general and administrative headcount and the increased value of Denali’s common stock, as well as the increased professional services required as a public company.

Cash, cash equivalents, and marketable securities were $592.8 million as of March 31, 2018, compared to $467.0 million as of December 31, 2017. The increase of $125.8 million was primarily attributable to $155.0 million in cash received related to the Option and Collaboration Agreement and Stock Purchase Agreement with Takeda.

About Denali Therapeutics

Denali is a biopharmaceutical company developing a broad portfolio of therapeutic 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 per share amounts)

 

     Three Months Ended
March 31,
 
     2018     2017  

Collaboration revenue

   $ 641     $ —    

Operating expenses:

    

Research and development

     20,819       18,470  

General and administrative

     5,570       3,274  
  

 

 

   

 

 

 

Total operating expenses

     26,389       21,744  
  

 

 

   

 

 

 

Loss from operations

     (25,748     (21,744

Interest income, net

     2,070       424  
  

 

 

   

 

 

 

Net loss

   $ (23,678   $ (21,320
  

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (0.26   $ (2.36
  

 

 

   

 

 

 

Weighted average number of shares outstanding, basic and diluted

     89,560,576       9,017,425  
  

 

 

   

 

 

 

Denali Therapeutics Inc.

Condensed Consolidated Balance Sheet Data

(Unaudited)

(In thousands)

 

     March 31,
2018
     December 31,
2017
 

Assets

     

Current assets:

     

Cash and cash equivalents

   $ 44,001      $ 218,375  

Short-term marketable securities

     329,401        187,851  

Prepaid expenses and other current assets

     4,020        3,381  
  

 

 

    

 

 

 

Total current assets

     377,422        409,607  
  

 

 

    

 

 

 

Long-term marketable securities

     219,406        60,750  

Property and equipment, net

     14,860        14,923  

Other non-current assets

     2,265        1,441  
  

 

 

    

 

 

 

Total assets

   $ 613,953      $ 486,721  
  

 

 

    

 

 

 

Liabilities and stockholders’ equity

     

Current liabilities:

     

Accounts payable

   $ 1,377      $ 2,716  

Accrued liabilities

     4,425        5,364  

Accrued compensation

     1,994        5,166  

Contract Liability

     8,434        —    

Deferred rent

     874        855  

Other current liabilities

     63        63  
  

 

 

    

 

 

 

Total current liabilities

     17,167        14,164  

Contract liability, less current portion

     51,519        —    

Deferred rent, less current portion

     6,051        6,294  

Other non-current liabilities

     188        467  
  

 

 

    

 

 

 

Total liabilities

     74,925        20,925  

Total stockholders’ equity

     539,028        465,796  
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 613,953      $ 486,721