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OncoMed Pharmaceuticals Announces First Quarter 2014 Financial Results

REDWOOD CITY, Calif., May 8, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today reported financial results and reviewed corporate events for the quarter ended March 31, 2014.

"2014 is off to a strong start. Demonstrable progress is being achieved across OncoMed's clinical and discovery portfolio. With 15 ongoing clinical trials, we are focused on enrolling patients, enhancing our understanding of the therapeutic opportunities that can be addressed by anti-cancer stem cell therapeutics and advancing multiple candidates toward randomized Phase 2 studies," said OncoMed's Chairman and Chief Executive Officer, Paul J. Hastings. "We will have a number of opportunities throughout this year to present data at major oncology congresses as we did during the first quarter at ASCO GI and AACR. Looking ahead, we will report new data from three programs – the Phase 1b study of demcizumab in non-small cell lung cancer, the Phase 1b/2 PINNACLE trial of anti-Notch2/3 in small-cell lung cancer and the Phase 1a trial of Fzd8-Fc in patients with advanced solid tumors – at the 2014 ASCO Annual Meeting in June."

Recent Business Highlights
  • Announced three abstracts accepted for presentation at the upcoming American Society for Clinical Oncology (ASCO) Annual Meeting being held May 30- June 3, 2014:
    • An oral presentation of Phase 1a data of Fzd8-Fc (OMP-54F28) in patients with advanced solid tumors
    • A poster presentation of interim Phase 1b PINNACLE study data on anti-Notch2/3 (OMP-59R5) in combination with etoposide and cisplatin in patients with untreated extensive-stage small-cell lung cancer
    • A poster presentation of updated Phase 1b data on demcizumab (anti-DLL4, OMP-21M18), pemetrexed, and carboplatin in patients with first line nonsquamous non-small cell lung cancer
  • Received orphan drug designation for demcizumab for the treatment of pancreatic cancer from the U.S. Food and Drug Administration (FDA) Department of Orphan Products Development
  • In April, released nine presentations at the 2014 American Association for Cancer Research (AACR) Annual Meeting. Research presented at AACR highlighted OncoMed's drug discovery platforms, along with preclinical and biomarker discoveries on its clinical-stage product candidates and emerging product candidates.
  • Completed patient enrollment in the ongoing Phase 1a clinical studies of vantictumab (anti-Fzd7, OMP-18R5) and Fzd8-Fc. These programs are part of OncoMed's Wnt pathway collaboration with Bayer.
  • Initiated three Phase 1b clinical trials of Fzd8-Fc in combination with standard of care in January and February. Fzd8-Fc is being studied in combination with sorafenib (Nexavar ®) in hepatocellular cancer, with carboplatin and paclitaxel in platinum-sensitive ovarian cancer and with Abraxane ® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) plus gemcitabine in pancreatic cancer.  In addition to the three Phase 1b clinical studies of Fzd8-Fc, OncoMed is conducting three Phase 1b trials with vantictumab in combination with standard of care in Her2- breast cancers, non-small cell lung cancer and pancreatic cancer.
  • Presented updated data from the Phase 1b clinical trial of demcizumab plus Abraxane in combination with gemcitabine in first-line Stage IV pancreatic cancer and interim results from the Phase 1b ALPINE clinical study of anti-Notch 2/3 in combination with Abraxane plus gemcitabine in pancreatic cancer at the 2014 Gastrointestinal Cancers Symposium (ASCO GI). Demcizumab is part of OncoMed's collaboration with Celgene.  Anti-Notch2/3 is part of OncoMed's collaboration with GlaxoSmithKline (GSK).
  • Appointed Sunil Patel as Chief Financial Officer, Senior Vice President Corporate Development & Finance.
  • Granted a fourth broad U.S. patent (No. 8,628,774) relating to antibodies that target the RSPO-LGR pathway, which is believed to be an important CSC pathway.

First Quarter 2014 Financial Results

Cash, cash equivalents and short-term investments totaled $283.9 million as of March 31, 2014, compared to $316.2 million as of December 31, 2013. The decrease in cash included the impact of a previously disclosed, potentially recapturable income tax payable of $10.8 million paid during the quarter that resulted mainly from the receipt of the Celgene upfront payment in December 2013.

Revenues for the first quarter 2014 totaled $6.0 million, as compared to $2.9 million in the first quarter of 2013. The increase over the same period in 2013 was primarily due to an increase in recognized revenue of the upfront payments received in 2013 under the OncoMed-Celgene collaboration agreement.

Research and development (R&D) expenses for the first quarter 2014, were $16.7 million compared with $9.6 million for the same period in 2013. Increases in R&D expenditures during the first quarter were primarily attributable to an increase in program costs associated with the advancement of OncoMed's clinical-stage product candidates and preclinical pipeline, as well as increased personnel expenses. 

General and administrative (G&A) expenses for the first quarter 2014 were $3.2 million, compared to $2.0 million for the same period in 2013. Increased costs during the first quarter were primarily attributable to higher employee-related and public company expenses. 

Net loss for the first quarter 2014 was $13.9 million ($0.47 per share), compared to $8.6 million ($7.92 per share, pre-IPO and reverse split) for the same period of 2013. The change in net loss for the quarter was due to an increase of collaboration revenue, offset by an increase in operational expenses, primarily research and development costs. 

Anticipated 2014 Milestones and Guidance Reiterated

Upcoming clinical milestones include the following:
  • Initiate the randomized Phase 2 portions of the ALPINE and PINNACLE clinical trials of anti-Notch2/3 in pancreatic cancer and small cell lung cancer, respectively
  • Initiate randomized Phase 2 clinical program for demcizumab
  • File an Investigational New Drug (IND) application with the FDA for anti-DLL4/anti-VEGF bispecific (OMP-305B83)
  • Present clinical and preclinical data at upcoming scientific and medical conferences

OncoMed continues to estimate operating expenses for 2014 to be between $90-95 million dollars, driven primarily by the advancement of OncoMed's collaborative and independent product pipeline candidates.

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