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): November 23, 2015

 

 

Aduro Biotech, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

Registrant’s telephone number, including area code: (510) 848-4400

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

 

 

 

 

 

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On November 23, 2015, Aduro Biotech, Inc. (“Aduro”) announced its financial results for the third quarter ended September 30, 2015. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing, regardless of any general incorporation language in any such filing, unless Aduro expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.

 

 

 

 

 

2.

 

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SIGNATURES

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.

 

 

 

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INDEX TO EXHIBITS

  

 

 

4.

 

Exhibit 99.1

 

 

Aduro Biotech Announces Third Quarter 2015 Financial Results

 

Aduro Makes Significant Progress in Broadening Therapeutic Focus with Ovarian Cancer Collaboration and Strengthening Core Business with Completion of Acquisition of Monoclonal Antibody Platform

 

BERKELEY, Calif., November 23, 2015 – Aduro Biotech, Inc. (NASDAQ: ADRO) today reported financial results for the third quarter and nine months ended September 30, 2015.  Net income was $0.6 million for the third quarter of 2015, or $0.01 per share, and net loss was $42.3 million, or $1.09 per share, for the nine months ended September 30, 2015. This compares to a net loss of $4.7 million, or $14.24 per share, and $16.1 million, or $52.47 per share respectively, for the same periods in 2014.  

 

Cash, cash equivalents and marketable securities totaled $448.4 million at September 30, 2015, compared to $119.5 million at December 31, 2014.  

 

“We believe a major strength of our company is in the versatility and broad applicability of our platforms and technologies which we have enhanced even further through our collaboration with Incyte in ovarian cancer and our acquisition of monoclonal antibody company, BioNovion, which we’ve renamed Aduro Biotech Europe,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro.  “We currently have ongoing trials in pancreatic cancer, mesothelioma, and glioblastoma and plan to initiate trials in lung and prostate cancer, ovarian cancer and cutaneously accessible tumors in collaboration with our partners at Janssen, Incyte and Novartis.  In addition, we look forward to working with the Aduro Europe team of experts to advance monoclonal antibody candidates towards the clinic. Given our broad portfolio of immunotherapy candidates, we believe we are well positioned to offer patients novel therapeutic options and combinations that may be attractive alternatives to traditional therapies.”

 

Recent Progress

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Upcoming Milestones

 

Revenues were $19.1 million for the third quarter of 2015 and $38.6 million for the nine months ended September 30, 2015, compared to $2.5 million and $3.5 million, respectively, for the same periods in 2014.  This increase was primarily due to recognition of a portion of the upfront fees and development-related milestones achieved under the Janssen and Novartis agreements.

 

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Research and development expenses were $11.8 million for the third quarter of 2015 and $36.0 million for the nine months ended September 30, 2015, compared to $5.9 million and $16.0 million, respectively, for the same periods in 2014. This increase was primarily due to clinical development expenses associated with our ongoing trials for our lead product candidate in pancreatic cancer, manufacturing costs of our clinical product candidates, and compensation and related personnel expenses associated with continued growth in the number of personnel.

 

General and administrative expenses were $6.9 million for the third quarter of 2015 and $19.0 million for the nine months ended September 30, 2015, compared to $2.0 million and $5.5 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.  

 

Loss from remeasurement of fair value of warrants was zero for the third quarter of 2015 and $26.1 million for the nine months ended September 30, 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 a clinical-stage 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 cyclic dinucleotide (CDN) 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,

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plans and timing of our clinical trials and availability of data 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 quarterly report on Form 10-Q for the quarter ended September 30, 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.

 

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ADURO BIOTECH, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(Unaudited)

 

 

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ADURO BIOTECH, INC.

Condensed Consolidated Balance Sheets

(In thousands)

(Unaudited)