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Denali Therapeutics Reports First Quarter 2019 Financial Results

SOUTH SAN FRANCISCO, Calif., May 08, 2019 (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 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,
  2019     2018  
Collaboration revenue $ 4,205     $ 641  
Operating expenses:      
Research and development 37,403     20,819  
General and administrative 9,310     5,570  
Total operating expenses 46,713     26,389  
Loss from operations (42,508 )   (25,748 )
Interest and other income, net 3,516     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 diluted 94,984,503     89,560,576  
           



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

  March 31, 2019     December 31, 2018
Assets        
Current assets:        
Cash and cash equivalents $ 39,661     $ 77,123
Short-term marketable securities 445,820     387,174
Prepaid expenses and other current assets 14,052     16,539
Total current assets 499,533     480,836
Long-term marketable securities 97,554     147,881
Property and equipment, net 36,955     25,162
Operating lease right-of-use asset 34,407    
Other non-current assets 8,147     8,105
Total assets $ 676,596     $ 661,984
Liabilities and stockholders' equity        
Current liabilities:        
Accounts payable $ 3,662     $ 1,891
Accrued liabilities 12,114     8,520
Accrued compensation 3,213     9,952
Contract liabilities 23,148     11,427
Other current liabilities 1,107     996
Total current liabilities 43,244     32,786
Contract liabilities, less current portion 44,852     57,350
Operating lease liability, less current portion 71,412    
Deferred rent, less current portion     24,532
Other non-current liabilities 440     471
Total liabilities 159,948     115,139
Total stockholders' equity 516,648     546,845
Total liabilities and stockholders’ equity $ 676,596     $ 661,984
             

Denali Media Relations Contacts:

Morgan Warners
(202) 337-0808
mwarners@gpg.com 

Lizzie Hyland
(646) 495-2706
lhyland@gpg.com 

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