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Aduro Biotech Announces Fourth Quarter and Full Year 2015 Financial Results

BERKELEY, Calif., March 08, 2016 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (NASDAQ:ADRO) today reported financial results for the year ended December 31, 2015.  Net loss was $39.2 million for the year ended December 31, 2015, or $0.88 per share, compared to a net loss of $17.0 million, or $53.06 per share for the year ended December 31, 2014. 

Cash, cash equivalents and marketable securities totaled $431.0 million at December 31, 2015, compared to $119.5 million at December 31, 2014. 

“2015 was a banner year for Aduro,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “We made tremendous progress on all fronts and are now uniquely positioned in the immunotherapy field with three differentiated and diverse platform technologies and a deep pipeline of assets in early and late stages of development.  While our initial therapeutic priorities are in oncology, we believe the power of our technologies to regulate and temper the immune system also offers potential in autoimmune and infectious diseases.”

Key 2015 Accomplishments
Corporate achievements

  • Raised gross proceeds of approximately $137 million in IPO
  • Signed collaboration with Novartis targeting STING pathway in oncology generating $200M cash up front, $50 million in equity investment and potential $500M in future milestones
  • Acquired BioNovion Holding B.V., a monoclonal antibody company; renamed to Aduro Biotech Europe

Clinical achievements

  • Published Phase 2a pancreatic cancer results in the Journal of Clinical Oncology
  • Initiated Phase 2b STELLAR clinical trial in pancreatic cancer
  • Completed enrollment in Phase 2b ECLIPSE clinical trial in pancreatic cancer    
  • Received Orphan Drug Designation in the EU for CRS-207 and GVAX Pancreas in pancreatic cancer
  • Received Orphan Drug Designation in the US and EU for CRS-207 in mesothelioma
  • Completed enrollment in Phase 1b clinical trial in mesothelioma            
  • Reported Phase 1b mesothelioma clinical trial results at ASCO and ESMO/ECC 2015
  • Signed clinical trial agreement with Incyte to develop combination therapy in ovarian cancer
  • Initiated Phase 1 clinical trials in prostate (ADU-741) and lung cancer (ADU-214) in collaboration with Janssen

Significant Upcoming Milestones

  • Report top line results for Phase 2b ECLIPSE clinical trial in pancreatic cancer in the second quarter of 2016
  • Report interim results for Phase 2b STELLAR clinical trial in pancreatic cancer in the second half of 2016
  • Report top line results for Phase 1b clinical trial in mesothelioma in the first half of 2016
  • Initiate randomized Phase 3 clinical trial in mesothelioma in the first half of 2016
  • Initiate Phase 1 clinical trial in cutaneously accessible tumors with ADU-S100 in collaboration with Novartis in the first half of 2016
  • Initiate Phase 1 clinical trial in ovarian cancer in collaboration with Incyte in the first half of 2016

Financial Performance
Revenues were $34.4 million for the fourth quarter of 2015 and $73.0 million for the full year 2015, compared to $9.9 million and $13.4 million, respectively, for the same periods in 2014.  The increase was primarily due to recognition of a portion of the upfront fees and development-related milestones achieved under the Janssen and Novartis agreements.

Research and development expenses were $22.7 million for the fourth quarter of 2015 and $58.6 million for the full year 2015, compared to $7.5 million and $23.5 million, respectively, for the same periods in 2014. This increase was primarily due to clinical development expenses mainly associated with our ongoing trials for our lead indication in pancreatic cancer, manufacturing costs of our clinical product candidates and compensation and related personnel expenses associated with continued workforce growth.

General and administrative expenses were $8.8 million for the fourth quarter of 2015 and $27.8 million for the full year 2015, compared to $3.5 million and $9.0 million, respectively, for the same periods in 2014.  This increase was primarily due to increased consulting and outside professional services and personnel expenses to support the company’s expanding operations, including our acquisition of Aduro Biotech Europe. 

Loss from remeasurement of fair value of warrants was zero for the fourth quarter of 2015 and $26.1 million for the year ended December 31, 2015, due to changes in the fair value of liability-classified warrants to purchase Aduro’s preferred and common stock.  In April 2015, all such warrants ceased being liability-classified as the contingency surrounding the number of shares issuable upon the warrant exercise expired.  In April 2015, all outstanding warrants were equity-classified and not subject to future remeasurement.

About Aduro
Aduro Biotech, Inc. is an immunotherapy company focused on the discovery, development and commercialization of therapies that transform the treatment of challenging diseases. Aduro's technology platforms, which are designed to harness the body's natural immune system, are being investigated in cancer indications and have the potential to expand into autoimmune and infectious diseases. Aduro's LADD technology platform is based on proprietary attenuated strains of Listeria that have been engineered to express tumor-associated antigens to induce specific and targeted immune responses. Based on compelling clinical data in advanced cancers, this platform is being developed as a treatment for multiple indications, including pancreatic, lung and prostate cancers, mesothelioma and glioblastoma. Aduro's STING Pathway Activator platform is designed to activate the intracellular STING receptor, resulting in a potent tumor-specific immune response. Aduro’s B-select monoclonal antibody platform includes a number of immune modulating assets in research and preclinical development. Aduro is collaborating with leading global pharmaceutical companies to expand its products and technology platforms. For more information, please visit www.aduro.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, the potential for our technology, plans and timing of our clinical trials and the potential for eventual regulatory approval of our product candidates. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” or the negative or plural of these words or similar expressions.  Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our history of net operating losses and uncertainty regarding our ability to achieve profitability, our ability to develop and commercialize our product candidates, our ability to use and expand our technology platforms to build a pipeline of product candidates, our dependence on our lead product candidate, CRS-207, and GVAX Pancreas, our ability to obtain and maintain regulatory approval of our product candidates, our inability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, our reliance on third parties, and our ability to obtain and adequately protect intellectual property rights for our product candidates.  We discuss many of these risks in greater detail under the heading “Risk Factors” contained in our annual report on Form 10-K for the year ended December 31, 2015 to be filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

ADURO BIOTECH, INC. 
Condensed Consolidated Statements of Operations 
(In thousands, except share and per share amounts) 
  
  Three Months Ended
December 31,
  Year Ended
December 31,
 
  2015
(unaudited)
  2014
(unaudited)
  2015
(audited)
  2014
(audited)
 
Revenue:                
Collaboration and license revenue $34,108  $9,731  $71,689  $13,038 
Grant revenue  268   162   1,290   351 
Total revenue  34,376   9,893   72,979   13,389 
Operating expenses:                
Research and development  22,657   7,523   58,649   23,513 
General and administrative  8,805   3,496   27,805   8,994 
Amortization of intangible assets  89      89    
Total operating expenses  31,551   11,019   86,543   32,507 
Income (loss) from operations  2,825   (1,126)  (13,564)  (19,118)
Loss from remeasurement of fair value of warrants     (284)  (26,077)  (566)
Gain on extinguishment of convertible promissory notes           3,553 
Interest income (expense), net  338   (20)  494   (2,395)
Other (expense) income, net  (162)  510   (161)  1,512 
Income (loss) before income tax  3,001   (920)  (39,308)  (17,014)
Income tax benefit  99      99    
Net income (loss) $3,100  $(920) $(39,209) $(17,014)
Net income (loss) per common share, basic $0.05  $(2.54) $(0.88) $(53.06)
Net income (loss) per common share, diluted $0.04  $(2.54) $(0.88) $(53.06)
Weighted average common shares outstanding, basic  62,604,226   361,997   44,706,393   320,686 
Weighted average common shares outstanding, diluted  71, 647,930   361,997   44,706,393   320,686 


ADURO BIOTECH, INC. 
Condensed Consolidated Balance Sheets 
(In thousands) 
(Audited) 
  
  December 31, 
  2015  2014 
Assets        
Current assets:        
Cash and cash equivalents $150,456  $119,456 
Short-term marketable securities  265,198    
Accounts receivable  4,846   3,153 
Prepaid expenses and other current assets  4,004   2,612 
Total current assets  424,504   125,221 
Long-term marketable securities  15,391    
Property and equipment, net  3,986   1,053 
Goodwill  8,469    
Intangible assets, net  29,400    
Other assets  75   188 
Total assets $481,825  $126,462 
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)        
Current liabilities:        
Accounts payable $5,086  $5,030 
Accrued clinical trial and manufacturing expenses  5,522   3,350 
Accrued expenses and other liabilities  5,412   2,408 
Deferred revenue  15,046   33,427 
Total current liabilities  31,066   44,215 
Contingent consideration  3,750    
Deferred revenue  178,037   2,592 
Deferred tax liabilities  7,350    
Convertible preferred stock warrant liability     100 
Common stock warrant liability     889 
Total liabilities  220,203   47,796 
Convertible preferred stock      139,963 
Stockholders’ equity (deficit):        
Preferred stock      
Common stock  6    
Additional paid-in capital  362,807   346 
Accumulated other comprehensive loss  (339)   
Accumulated deficit  (100,852)  (61,643)
Total stockholders’ equity (deficit)  261,622   (61,297)
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) $481,825  $126,462 

Contact: 
Sylvia Wheeler
SVP, Corporate Affairs
510 809 9264

Media Contact:
Angela Bitting
925 202 6211
press@aduro.com

Mike Beyer
Sam Brown, Inc.
312 961 2502

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