ADRO Aduro Biotech

Aduro Biotech Reports First Quarter 2019 Financial Results

Aduro Biotech Reports First Quarter 2019 Financial Results

BERKELEY, Calif., May 07, 2019 (GLOBE NEWSWIRE) -- Aduro Biotech, Inc. (NASDAQ: ADRO), a clinical-stage biopharmaceutical company focused on developing therapies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways for the treatment of cancer, autoimmune and inflammatory diseases, today reported financial results for the first quarter ended March 31, 2019.

“We are pleased with our progress over the last several months to advance our development programs as well as achieve several corporate objectives, and we look forward to the contributions of our newest board members and chief medical officer,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “Importantly, we have maintained a strong cash position of $266.9 million at the end of the first quarter and will continue to invest purposefully in our lead assets, STING agonist ADU-S100 and anti-APRIL antibody BION-1301. This includes making data-driven decisions to execute our clinical development plans in indications that we believe have the greatest potential to impact unmet patient need.”

Recent Highlights

  • First patient dosed in the Phase 1 clinical trial of ADU-S100 (MIW815) in combination with YERVOY® (ipilimumab), an approved anti-CTLA-4 antibody for the treatment of relapsed and refractory melanoma

     
  • Data abstract on the Phase 1b study of ADU-S100 (MIW815) in combination with spartalizumab (PDR001) in patients with advanced, metastatic treatment-refractory solid tumors or lymphomas selected for oral presentation at the upcoming 2019 American Society of Clinical Oncology (ASCO) Annual Meeting

     
  • Phase 1 clinical trial of BION-1301 initiated for the treatment of IgA nephropathy, the primary indication Aduro is pursuing for the BION-1301 program 

     
  • Two data abstracts on the dose escalation portion of the Phase 1/2 study in relapsed or refractory multiple myeloma (MM) patients whose disease progressed after at least three prior therapies to be presented at the 2019 ASCO Annual Meeting. Given the current competitive landscape and data generated to date, Aduro will not continue the Phase 1/2 study as designed or sponsor further studies in the MM patient setting, and will work closely with investigators on the future direction of the BION-1301 program in MM.

     
  • Three abstracts presented at the American Association for Cancer Research (AACR) Annual Meeting 2019, including updated preclinical data on ADU-S100

     
  • Immuno-oncology drug development expert, Dimitry Nuyten, M.D., Ph.D., appointed as chief medical officer

     
  • Life sciences industry veterans, David H. Mack, Ph.D. and Frank Karbe, appointed to the board of directors

Financial Results

  • Cash Position – Cash, cash equivalents and marketable securities totaled $266.9 million at March 31, 2019, compared to $277.9 million at December 31, 2018. Cash spend for the first quarter of 2019 included $2.2 million in one-time charges resulting from the company’s strategic reset and was offset by receipt of a $12 million upfront payment from the 2018 license agreement with Eli Lilly.

     
  • Revenue – Revenue was $3.9 million for the first quarter of 2019 compared to $6.6 million for the same period in 2018. The decrease in revenue for the period was primarily due to a $3.0 million milestone payment received from Merck in 2018 for initiation of the Phase 1 trial for the anti-CD27 antibody. The decrease was partially offset by $1.4 million in revenue recognized under the Lilly agreement.

     
  • Expenses –

     
    • Research and development expenses were $19.5 million for the first quarter of 2019 compared to $20.1 million for the same period in 2018. The first quarter of 2019 included $1.7 million in one-time costs associated with the strategic reset, which partially offsets a $2.3 million reduction in stock-based compensation and personnel costs as compared to 2018. 

       
    • General and administrative expenses were $9.2 million for the first quarter of 2019 compared to $9.0 million for the same period in 2018. The first quarter of 2019 included $0.8 million in one-time costs associated with the strategic reset, which partially offsets a $1.1 million reduction in stock-based compensation and personnel costs as compared to 2018. In addition, general and administrative expenses for the period were higher due to professional services and consulting costs.

       
  • Net Loss – Net loss for the first quarter of 2019 was $23.4 million or $0.29 per share compared to net loss of $21.5 million or $0.28 per share for the same period in 2018.

About Aduro

Aduro Biotech, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies that are designed to harness the body’s natural immune system for the treatment of patients with challenging diseases. Aduro’s product candidates in the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) pathways are being investigated in cancer, autoimmune and inflammatory diseases. ADU-S100 (MIW815), which potentially activates the intracellular STING receptor for a potent tumor-specific immune response, is being evaluated in patients with cutaneously accessible metastatic solid tumors or lymphomas. BION-1301, a first-in-class humanized IgG4 monoclonal antibody that fully blocks APRIL binding to both the BCMA and TACI receptors, is being evaluated in IgA nephropathy. Aduro is collaborating with a number of leading global pharmaceutical companies to help expand and drive its product pipeline. For more information, please visit

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 current intentions or expectations concerning, among other things, the potential for our technology, clinical data presentations, our ability to invest purposefully and make data driven decisions to execute our clinical development plans in indications that we believe have the greatest potential to impact unmet patient need and our ability to advance our drug development programs and expand and drive our product pipeline on our own or with our collaborators. In some cases, you can identify these statements by forward-looking words such as “may,” “will,” “continue,” “anticipate,” “intend,” “could,” “project,” “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 ability to obtain and maintain regulatory approval of our product candidates, our ability 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 quarterly report on Form 10-Q for the quarter ended March 31, 2019, to be filed with the Securities and Exchange Commission (SEC), and our other filings with the SEC. 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.

Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(Unaudited)

 Three Months Ended March 31, 
 2019  2018 
Revenue:       
Collaboration and license revenue$3,938  $6,627 
Total revenue 3,938   6,627 
Operating expenses:       
Research and development 19,530   20,128 
General and administrative 9,182   9,045 
Amortization of intangible assets 140   152 
Total operating expenses 28,852   29,325 
Loss from operations (24,914)  (22,698)
Interest income 1,471   1,199 
Other loss (19)  (16)
Loss before income tax (23,462)  (21,515)
Income tax benefit 35   21 
Net loss$(23,427) $(21,494)
Net loss per common share, basic and diluted$(0.29) $(0.28)
Shares used in computing net loss per common share, basic and diluted 79,673,294   77,906,645 





ADURO BIOTECH, INC.

Consolidated Balance Sheets

(In thousands)

(Unaudited)

  March 31,  December 31, 
  2019  2018 
Assets        
Current assets:        
Cash and cash equivalents $113,114  $126,310 
Short-term marketable securities  153,794   140,129 
Accounts receivable  707   12,037 
Prepaid expenses and other current assets  4,839   4,500 
Total current assets  272,454   282,976 
Long-term marketable securities     11,434 
Property and equipment, net  28,169   29,157 
Operating lease right-of-use assets  21,828    
Goodwill  8,168   8,334 
Intangible assets, net  24,499   25,135 
Restricted cash  468   468 
Total assets $355,586  $357,504 
Liabilities and Stockholders Equity        
Current liabilities:        
Accounts payable $1,573  $1,457 
Accrued clinical trial and manufacturing expenses  2,742   2,542 
Accrued expenses and other liabilities  8,049   10,518 
Operating lease liabilities  1,539    
Deferred revenue  16,000   16,000 
Total current liabilities  29,903   30,517 
Deferred rent     11,063 
Contingent consideration  978   998 
Deferred revenue  169,497   172,671 
Deferred tax liabilities  5,948   6,104 
Operating lease liabilities  33,030    
Other long-term liabilities  841   840 
Total liabilities  240,197   222,193 
Commitments and contingencies        
Stockholders’ equity:        
Preferred stock      
Common stock  8   8 
Additional paid-in capital  542,849   538,895 
Accumulated other comprehensive income  491   940 
Accumulated deficit  (427,959)  (404,532)
Total stockholders’ equity  115,389   135,311 
Total liabilities and stockholders’ equity $355,586  $357,504 

 

Contact:Media Contact:
Noopur LiffickAljanae Reynolds
Investor Relations & Corporate Affairs510-809-2452
510-809-2465
EN
07/05/2019

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