On August 9, 2016 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported second quarter financial results (Press release, OncoMed, AUG 9, 2016, View Source [SID:1234514562]). As of June 30, 2016, cash, cash equivalents and short-term investments totaled $171.5 million.
Schedule your 30 min Free 1stOncology Demo!
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!
"With seven OncoMed-discovered drugs in fourteen clinical trials, we enter the second half of this year following the presentation of encouraging data from across our pipeline at the AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper) annual meetings," said Paul J. Hastings, Chairman and Chief Executive Officer. "In the next several months we expect to report additional Phase 1b data for vantictumab and ipafricept, our first-in-class Wnt inhibitors, as well as Phase 1 clinical data for our anti-DLL4/VEGF bispecific antibody and our first-in-class anti-RSPO3 antibody. As we approach the end of the year and enter into 2017, we look forward to significant milestones, including data from our PINNACLE and YOSEMITE randomized Phase 2 clinical trials, potential opt-ins totaling over $172 million in 2017 from our partnerships with GSK, Bayer and Celgene, and two IND filings for novel immuno-oncology agents."
Development Program Highlights
Presented data on four clinical-stage programs at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting in June
Initial Phase 1b safety and efficacy data for the company’s Wnt pathway inhibitors in combination with standard of care, vantictumab (anti-Fzd, OMP-18R5) in breast cancer and ipafricept (Fzd8-Fc, OMP-54F28) in ovarian cancer
Updated Phase 1b survival data for demcizumab (anti-DLL4, OMP-21M18) in non-small cell lung cancer (NSCLC) and for tarextumab (anti-Notch2/3, OMP-59R5) in small cell lung cancer
Completed enrollment of the dose escalation cohorts in the Phase 1b trial of demcizumab plus pembrolizumab (Keytruda)
Approximately ten patients each with second-line NSCLC, anti-PD1 refractory solid tumors or castrate-resistant prostate cancers are to be enrolled in the expansion cohorts
Presented data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2016 Annual Meeting in April for GITRL-Fc, anti-RSPO3 (OMP-131R10), vantictumab and demcizumab
Upcoming Milestones
Enrollment of the Phase 2 PINNACLE and YOSEMITE clinical trials expected to complete in the third quarter
Topline results from the PINNACLE study of tarextumab in small cell lung cancer expected by year-end 2016 or early 2017
Topline results from the YOSEMITE study of demcizumab in pancreatic cancer in the first-half of 2017
Presentations of Phase 1 data at upcoming medical conferences
Initial clinical data from the ongoing Phase 1b trials of vantictumab and ipafricept in combination with standard of care for the treatment of pancreatic cancer have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress being held October 7-11, 2016
Present first in-human data from ongoing Phase 1 clinical trials of anti-RSPO3 and the anti-DLL4/VEGF bispecific (OMP-305B83) this fall pending abstract acceptance
File an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) before year-end for one of two immuno-oncology therapeutic candidates: IO#2, partnered with Celgene, or GITRL-Fc, a wholly owned asset
A second IND is expected to follow in the first half of 2017
Second Quarter 2016 Financial Results
Cash, cash equivalents and short-term investments totaled $171.5 million as of June 30, 2016, compared to $193.5 million as of March 31, 2016.
Revenues for the three months ended June 30, 2016 were $6.7 million, an increase of $2.0 million, compared to total revenue of $4.7 million for the three months ended June 30, 2015. This increase was primarily due to amortization of the $70.0 million safety milestone achieved in the fourth quarter of 2015.
Research and development (R&D) expenses were $29.7 million for the second quarter of 2016 compared with $22.0 million for the same period in 2015. Higher R&D expenditures during the second quarter 2016 were attributable to increased manufacturing and clinical costs for the Phase 2 demcizumab program, increased clinical costs for the Phase 1a/b anti-RSPO3 program, as well as IND-enabling manufacturing and toxicology costs for the IO#2 and GITRL-Fc programs.
General and administrative (G&A) expenses for the quarter ended June 30, 2016 were $4.8 million, compared to $4.3 million for the same period in 2015. Increased G&A costs during the second quarter 2016 were due to higher employee-related costs including stock-based compensation expenses.
Net loss for the second quarter 2016 was $27.7 million ($0.91 per share), compared to $21.6 million ($0.72 per share) for the same period of 2015. The change in net loss from the same quarter in 2015 was primarily due to an increase in research and development expenses.