On August 10, 2015 Aduro Biotech, Inc. (NASDAQ: ADRO) reported financial results for the second quarter ended June 30, 2015 (Filing, 8-K, Aduro BioTech, AUG 10, 2015, View Source [SID:1234507119]). Net loss was $26.3 million for the second quarter of 2015, or $0.50 per share, and $42.9 million, or $1.61 per share, for the six months ended June 30, 2015, compared to net loss of $3.6 million, or $12.27 per share, and $11.4 million, or $38.61 per share respectively, for the same periods in 2014.
Cash and cash equivalents totaled $465.9 million at June 30, 2015, compared to $119.5 million at December 31, 2014. Total cash at June 30, 2015 included a $200.0 million upfront payment from Novartis Pharmaceuticals Corporation under the companies’ collaboration agreement, $124.2 million in net proceeds from Aduro’s initial public offering and an additional $25.0 million from a private placement to Novartis concurrent with the company’s IPO.
"We are making significant progress in our existing oncology programs driven by our in-house research and development teams and in collaboration with our academic and corporate partners, including Novartis and Janssen, and believe there is tremendous potential to explore new indications with our immunotherapy platform technologies," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We look forward to completing enrollment in our Phase 2b ECLIPSE trial in pancreatic cancer and initiating trials in prostate and lung cancers, as well as multiple other cancers, with immunotherapeutic agents derived from our platforms. In addition, based on continued encouraging data from our Phase 1b trial and following recent meetings with U.S. and European regulatory authorities, we are now planning to advance our mesothelioma program into a randomized global Phase 3 clinical trial next year."
Recent Progress
· Follow up of the seven long-term survivors in Phase 2a pancreatic cancer trial continues, with two patients continuing to receive the combination regimen of CRS-207 and GVAX Pancreas for almost three years
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· Completed patient enrollment in the Phase 1b mesothelioma trial evaluating the combination of CRS-207 and standard chemotherapy
· Presented updated data from Phase 1b mesothelioma trial at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting demonstrating 94% disease control following treatment with CRS-207 and standard chemotherapy
· Conducted meetings with the U.S. FDA and Paul-Ehrlich-Institut to discuss Phase 3 plans for mesothelioma program
· Published notable preclinical results for the STING-targeted CDN immuno-oncology platform in Science and Translational Medicine and Cell Reports
Key Upcoming Milestones
· Complete enrollment in Phase 2b ECLIPSE trial in pancreatic cancer in the third quarter of 2015 and report top line results in the first half of 2016
· Report top line results from the Phase 1b trial in mesothelioma in the first half of 2016
· Complete enrollment in Phase 2 STELLAR trial in pancreatic cancer in the first quarter of 2016 and report interim results in the second half of 2016
· Initiate randomized Phase 3 trial in mesothelioma in the first half of 2016
· Initiate Phase 1 trials in lung and prostate cancer with novel LADD agents in collaboration with Janssen in the first quarter of 2016
· Initiate Phase 1 trial in cutaneously accessible tumors with novel CDNs in collaboration with Novartis in the first half of 2016
Revenues were $9.9 million for the second quarter of 2015 and $19.5 million for the six months ended June 30, 2015, compared to $1.0 million for each of the three and six months ended June 30, 2014. The increase was primarily due to recognition of a portion of the upfront fees and development-related milestones achieved under the Janssen agreements.
Research and development expenses were $13.5 million for the second quarter of 2015 and $24.2 million for the six months ended June 30, 2015, compared to $5.4 million and $10.1 million, respectively, for the same periods in 2014. This increase was primarily due to clinical and manufacturing expenses related to the Phase 2b ECLIPSE clinical trial of CRS-207/GVAX Pancreas immunotherapy in pancreatic cancer, licensing fees and compensation costs due to continued growth in the number of personnel.
General and administrative expenses were $5.9 million for the second quarter of 2015 and $12.1 million for the six months ended June 30, 2015, compared to $2.1 million and $3.5 million, respectively, for the same periods in 2014. This increase was primarily due to increased personnel expenses to support the company’s expanding operations.
Loss from remeasurement of fair value of warrants was $16.7 million for the second quarter of 2015 and $26.1 million for the six months ended June 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. As of June 30, 2015, all outstanding warrants were equity-classified and not subject to remeasurement.