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8-K - FORM 8-K - Denali Therapeutics Inc.d503819d8k.htm

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