On November 2, 2017 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported third quarter financial results (Press release, OncoMed, NOV 2, 2017, View Source [SID1234521520]). As of September 30, 2017, cash, cash equivalents and short-term investments totaled $113.6 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!
“OncoMed remains committed to developing novel anti-cancer therapeutics to improve the lives of patients. With four clinical programs progressing, including the newly initiated Phase 1a study of GITRL-Fc (OMP-336B11), OncoMed is positioned to deliver value for both patients and our shareholders,” commented Sunil Patel, Executive Vice President and Chief Financial Officer. “We look forward to upcoming clinical updates from our navicixizumab, rosmantuzumab and anti-TIGIT programs in 2018.”
Pipeline Highlights
GITRL-Fc (OMP-336B11)
In September, OncoMed dosed the first patient in a Phase 1a single agent study of its wholly-owned GITRL-Fc in patients with advanced or metastatic solid tumors. GITRL-Fc is a fusion protein with an Fc-linked fully human trimer ligand and is designed to activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptor) to enhance T-cell modulated immune responses. The Phase 1a study is designed to assess safety and tolerability of escalating doses.
Anti-TIGIT (OMP-313M32)
OncoMed now plans to initiate the Phase 1b portion of its anti-TIGIT trial to study anti-TIGIT in combination with anti-PD1 in the first half of 2018. The Phase 1b portion of the anti-TIGIT trial will be designed to assess safety and tolerability of escalating doses of the combination treatment.
OncoMed continues enrollment in the Phase 1a single-agent study of anti-TIGIT in patients with advanced or metastatic solid tumors. The Phase 1a study is designed to assess safety and tolerability of escalating doses, and interim data from this trial are expected to be reported by year-end 2018.
Navicixizumab (anti-DLL4/VEGF bispecific; OMP-305B83)
Enrollment continues in two Phase 1b multi-center, open-label, dose escalation and expansion studies of OncoMed’s anti-DLL4/VEGF bispecific antibody in combination with standard-of-care chemotherapies: one in patients with platinum-resistant ovarian cancer who have failed more than two prior therapies or prior bevacizumab and a second in patients with 2nd line metastatic colorectal cancer.
To date, OncoMed has enrolled over 80 patients across the Phase 1a and Phase 1b trials. Interim data are expected to be reported in 2018.
Rosmantuzumab (anti-RSPO3; OMP-131R10)
The Phase 1a/b multi-center, open-label, dose escalation and expansion study of OncoMed’s anti-RSPO3 antibody in patients with advanced solid tumors (Phase 1a) and in patients with previously treated metastatic colorectal or gastric cancer (Phase 1b; in combination with FOLFIRI) continues. As previously announced, enrollment in the study has recently been limited to patients that harbor an RSPO3 gene fusion.
Vantictumab (anti-Fzd; OMP-18R5) and Ipafricept (Fzd8-Fc; OMP-54F28)
OncoMed continues to evaluate potential partnering opportunities for Wnt/IO combinations.
Data were presented at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) demonstrating that a 6-gene breast cancer signature significantly correlated with PFS and OS outcomes in OncoMed’s completed Phase 1b trial in 40 patients with baseline tumor assessments.
Third Quarter 2017 Financial Results
Cash, cash equivalents and short-term investments totaled $113.6 million as of September 30, 2017, compared to $184.6 million as of December 31, 2016.
Revenues were $5.1 million for the third quarter of 2017, a decrease of $0.8 million, compared to $5.9 million for the same period in 2016. The decrease in revenue was primarily due to lower revenue recognized from reimbursement of research and development costs for services performed in the third quarter of 2017.
Research and development (R&D) expenses were $12.2 million for the third quarter 2017, a decrease of $15.2 million, compared to $27.4 million for the same period in 2016. The decrease was primarily due to lower external research and development costs attributable to the decrease in Phase 2 clinical trial costs of demcizumab and tarextumab programs as a result of our discontinuation of the dosing of all patients of these programs, and a decrease in internal program costs due to reduced headcount as a result of the restructuring actions implemented in April 2017.
General and administrative (G&A) expenses were $3.9 million for the third quarter of 2017, a decrease of $0.6 million, compared to $4.5 million for the same period in 2016. The decrease was primarily attributable to a decrease in personnel costs, including stock-based compensation expenses, due to a decrease in headcount as a result of the restructuring actions implemented in April 2017.
Net loss for the third quarter of 2017 was $10.7 million ($0.28 per share), compared to $25.9 million ($0.77 per share) for the same period of 2016. The change in net loss from the prior year quarter was due to lower R&D and G&A expenses.
2017 Financial Guidance
OncoMed anticipates 2017 full-year cash utilization will be approximately $90 million. Based on the current plan, OncoMed anticipates that its current cash balance is sufficient to fund pipeline development and company operations through the third quarter of 2019, before considering potential opt-in milestones.
Corporate Updates
OncoMed Chairman and CEO, Paul Hastings, on Medical Leave: Mr. Hastings continues a personal leave of absence for medical reasons. As previously announced, Mr. Hastings will continue to be the Chief Executive Officer and Chairman of the Board of Directors during his leave of absence. In Mr. Hastings’ absence, OncoMed is led by the Office of the President consisting of Executive Vice President, Research and Development, John Lewicki, and Executive Vice President and Chief Financial Officer, Sunil Patel. In addition, OncoMed’s Board of Directors has appointed a special committee of the Board, consisting of Jack Lasersohn, lead director of the Board, Perry Karsen, Deepa Pakianathan and Rick Winningham, to work closely with Dr. Lewicki and Mr. Patel during Mr. Hastings’ medical leave.
Conference Call Today
OncoMed management will host a conference call today beginning at 4:30 p.m. ET / 1:30 p.m. PT to review third quarter 2017 financial results and corporate updates.
Analysts and investors can participate in the conference call by dialing 1 (855)-859-2056 (domestic) and 1(484) 756-4194 (international) using the conference ID# 4699289. The webcast of the conference call can be accessed live on the Investor Relations section of the OncoMed website, View Source
An audio replay of the conference call can be accessed by dialing 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international) utilizing the conference ID number listed above. The web broadcast of the conference call will be available for replay through the OncoMed website.