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OncoMed Pharmaceuticals Announces Third Quarter 2013 Financial Results

Stocks in this article: OMED

REDWOOD CITY, Calif., Nov. 12, 2013 (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 recent corporate events for the quarter ended September 30, 2013. For the third quarter of 2013, OncoMed reported total revenue of $12.9 million and a net loss of $3.5 million, or $0.15 per share. As of September 30, 2013, OncoMed's cash, cash equivalents and marketable securities totaled $128.6 million. 

"Following the completion of a successful IPO in July, we have presented safety and anti-tumor activity data in four of our five clinical-stage programs; received three significant patents protecting OncoMed's innovations in cancer stem cell drug discovery and development; and earned $25 million in milestone payments from our partners giving the company a pro forma cash balance of $148.7 million, year to date, as of the end of October. We expect this momentum to continue through this year and into 2014, with at least 11 clinical trials underway across five therapeutic programs by the end of 2013," said Paul J. Hastings, Chairman and Chief Executive Officer. "For a company of our size – currently fewer than 90 employees – this is a significant set of accomplishments and speaks to our operational efficiency and strong financial, clinical and scientific management."

Recent Business Highlights:

Financial

  • Completed in July 2013 an initial public offering (IPO) raising $87.3 million in net proceeds.  
  • Reported a pro forma cash balance as of October 31, 2013 of $148.7 million, including IPO proceeds and milestone payments received to date related to clinical progress.

Demcizumab (OMP-21M18, Anti-DLL4)

  • In July 2013, began dosing patients with Abraxane ® as part of the standard-of-care combination with gemcitabine under an amended protocol in the Phase 1b clinical trial evaluating demcizumab (OMP-21M18, Anti-DLL4) plus standard-of-care for first-line treatment in advanced pancreatic cancer.  
  • In September, OncoMed initiated a Phase 1b clinical trial of demcizumab in combination with paclitaxel in platinum-resistant ovarian cancer. Following a Phase 1b safety run-in, a Phase 2 clinical trial is planned in these patients with the endpoints of progression-free survival and response rates, as well as overall survival, biomarker endpoints and safety. This study is supported in part by resources from the MD Anderson (MDACC) Ovarian Cancer Specialized Program of Research Excellence (SPORE) Grant Funded by the National Cancer Institute (NCI).  
  • Presented data in October at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics from ongoing Phase 1b clinical trials of demcizumab in combination with carboplatin and pemetrexed for advanced non-small cell lung cancer and of demcizumab plus gemcitabine in pancreatic cancer showing that demcizumab can be safely combined with multiple chemotherapy agents. Initial evidence from both studies indicates that the addition of demcizumab is tolerated by patients and potentially improves tumor response rates and disease control. OncoMed has worldwide rights to the demcizumab program. 

Vantictumab (OMP-18R5, Anti-Fzd7)

  • Granted U.S. Patent No. 8,507,442 from the United States Patent and Trademark Office (USPTO in August covering methods of treating cancer with vantictumab (OMP-18R5).  
  • Reported data from the ongoing Phase 1a single-agent study of vantictumab at the European Cancer Congress 2013 (ECC 2013) in September. Vantictumab has been well tolerated at doses higher than the target efficacious dose based on minimally passaged human tumor xenograft models. Evidence of an acceptable safety profile and single-agent activity was also noted in several patients with neuroendocrine tumors. Vantictumab is part of OncoMed's Wnt pathway collaboration with Bayer Pharma AG.  
  • In August, OncoMed earned a $10 million milestone payment related to Phase 1a dose escalation of vantictumab under its collaboration with Bayer.  
  • Presented pharmacodynamic biomarker data for vantictumab demonstrating modulation of the Wnt pathway in patients with refractory solid tumors treated on a Phase 1a trial at the AACR-NCI-EORTC International Conference.  
  • In October, initiated a multi-center Phase 1b clinical trial of vantictumab with paclitaxel in breast cancer. This study is the first of three Phase 1b trials for vantictumab expected to initiate this year. 

OMP-52M51 (anti-Notch1)

  • Presented the first clinical data from its ongoing Phase 1a study of OMP-52M51 at the AACR-NCI-EORTC International Conference in October. OMP-52M51 has been well tolerated, with biomarker evidence of circulating tumor cell reduction and early potential efficacy. OMP-52M51 is part of OncoMed's collaboration with GlaxoSmithKline (GSK).

OMP-54F28 (FZD8-Fc)

  • Presented the first public presentation from the ongoing Phase 1a trial for OMP-54F28 at the AACR-NCI-EORTC International Conference in October. OMP-54F28 was well tolerated among refractory solid tumor patients and dose escalation continues. Biomarker evaluations revealed Wnt pathway modulation. Potential early efficacy was also noted. These data enable initiation of three Phase 1b trials in late 2013 to early 2014.  
  • Earned a $15 million milestone payment from Bayer in October related to achieving a dose-escalation milestone in the ongoing Phase 1a clinical trial of OMP-54F28. 

Discovery

  • Granted its third broad U.S. patent (No. 8,540,989) relating to antibodies that target the RSPO-LGR pathway, which is believed to be an important CSC pathway.  
  • Granted its first U.S. patent (No. 8,551,715) on its MAbTrap™ antibody display technology in September. The MAbTrap™ platform technology enables the rapid identification of monoclonal antibodies that bind a particular target or set of targets with high affinity and specificity.

Corporate

  • Mike Wyzga, President and CEO of Radius Health and previously the Executive Vice President, Finance and CFO of Genzyme Corporation, was appointed to the company's Board of Directors and chair of OncoMed's Audit Committee in October.

Third Quarter 2013 Financial Results

Cash and cash equivalents as of the end of the third quarter were $128.6 million, compared to $66.2 million as of December 31, 2012.  The cash increase was driven by net proceeds of $87.3 million from OncoMed's initial public offering in July 2013 and partner payments received as of September 30, 2013. With the addition of the $15 million milestone achievement from Bayer in October, the pro forma month-end cash for October was $148.7 million.

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