On March 1, 2017 Aduro Biotech, Inc. (NASDAQ:ADRO) reported financial results for the year ended December 31, 2016 (Press release, Aduro Biotech, MAR 1, 2017, View Source [SID1234517919]). Net loss for the fourth quarter and year ended December 31, 2016 was $29.6 million, or $0.44 per share, and $91.1 million, or $1.40 per share, respectively. This compared to net income of $3.1 million, or $0.05 per share, and net loss of $39.2 million, or $0.88 per share, respectively, for the same periods in 2015. Schedule your 30 min Free 1stOncology Demo! Cash, cash equivalents and marketable securities totaled $361.9 million at December 31, 2016, compared to $431.0 million at December 31, 2015.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In 2016, we made a number of advancements to position us as a leader in the discovery and development of immunotherapies, and in 2017, we expect to have multiple agents across all three of our platforms advancing through the clinic," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "With a diversified and robust pipeline, strong cash position and validating pharmaceutical partnerships for each of our technologies, we believe we are poised to bring innovative therapies to patients."
Key 2016 Accomplishments
Development achievements
Unprecedented disease control rate in Phase 1b mesothelioma trial presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting
First patient dosed in a Phase 1 study of ADU-S100, the first STING Pathway Activator compound to enter the clinic, for treatment of cutaneously accessible tumors and receipt of $35 million development milestone from Novartis
Preclinical data demonstrated acute and systemic immune activation with ADU-S100
Anti-CD27 agonist advancing through preclinical development towards the clinic under licensing agreement with Merck
Preclinical data presented supporting clinical development of anti-APRIL antibody in multiple myeloma
Personalized LADD therapy (pLADD) featured in an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (STIC) meeting
Investigational New Drug application cleared for pLADD clinical development
Preclinical data demonstrated synergy of Aduro’s immunotherapies with checkpoint inhibitors
Corporate achievements and notable news
Steve Isaacs named 2016 Visionary Leader by Berkeley Chamber of Commerce
Oncology expert and industry veteran Natalie Sacks, M.D. joined as chief medical officer
Hans van Eenennaam, Ph.D., and John Dulos, Ph.D., honored with award for contributions in discovery of KEYTRUDA
Launched industry-leading Immunotherapeutics and Vaccine Research Initiative with U.C. Berkeley
Expanded patent portfolio with key composition and methods patents
Anticipated 2017 Milestones
Initiate Phase 2 mesothelioma trial with CRS-207 in combination with anti-PD1 in the first half of 2017 and report early results in the second half of 2017
Initiate Phase 2 gastric trial with CRS-207 in combination with anti-PD1 in the first half of 2017
Initiate Phase 1 pLADD trial in advanced gastro-intestinal cancers in the second half of 2017
Janssen to assess data from Phase 1 trial of ADU-741 in prostate cancer
Janssen expected to initiate Phase 1b/2 trial of ADU-214 in lung cancer in the second half of 2017
Report top-line findings from Phase 1 monotherapy trial of ADU-S100 (STING) in the second half of 2017
In collaboration with Novartis, initiate Phase 1b trial of ADU-S100 in combination with anti-PD1 in the second half of 2017
File Investigational New Drug Application for BION-1301, anti-APRIL antibody, in the second half of 2017
Initiate Phase 1 multiple myeloma trial with anti-APRIL antibody in the second half of 2017
Financial Performance
Revenues were $3.9 million for the fourth quarter of 2016 and $50.7 million for the full year 2016, compared to $34.4 million and $73.0 million, respectively, for the same periods in 2015. The decrease in revenue for the fourth quarter of 2016 was primarily due to recognition of milestones and a portion of upfront fees under Aduro’s research and license agreements with Janssen in 2015. The decrease in revenue for the full year 2016 was also due to recognition of milestones and a portion of upfront fees under the Janssen agreements in 2015 partially offset by a $35.0 million payment recognized in 2016 upon achievement of a milestone under Aduro’s collaboration and license agreement with Novartis.
Research and development expenses were $20.9 million for the fourth quarter of 2016 and $87.7 million for the full year 2016, compared to $22.7 million and $58.6 million, respectively, for the same periods in 2015. The decrease in research and development expenses for the fourth quarter of 2016 was primarily due to higher licensing fees paid in 2015. The increase in research and development expenses for the full year 2016 was primarily due to contract manufacturing and research expenses associated with our ongoing studies and increased personnel and facility-related costs.
General and administrative expenses were $8.0 million for the fourth quarter of 2016 and $34.3 million for the full year 2016, compared to $8.8 million and $27.8 million, respectively, for the same periods in 2015. The decrease in general and administrative expenses for the fourth quarter of 2016 was primarily due to lower professional fees in 2016. The increase in general and administrative expenses for the full year 2016 was primarily due to higher personnel and facility related costs. There was no loss from remeasurement of fair value of warrants during the fourth quarter or full year 2016. There was a $26.1 million loss from remeasurement of fair value of warrants in the full year 2015 that occurred in April 2015 when certain outstanding warrants were no longer subject to future remeasurement.
Provision for income taxes was $5.1 million for the fourth quarter of 2016 and $21.5 million for the full year 2016. There was no provision for income taxes for the comparable periods in 2015. The income tax expense recorded for the fourth quarter and full year 2016 was primarily related to current and deferred federal income taxes.