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.

OncoMed continues to estimate ending 2014 with cash, cash equivalents and short-term investments balance of greater than $215 million and expects to have cash to fund operations at least through 2016, without any additional future milestone payments. Anticipated milestone payments from OncoMed's collaborators could extend the company's cash runway through commercialization.

About OncoMed Pharmaceuticals

OncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel therapeutics targeting cancer stem cells.  OncoMed has five anti-cancer product candidates in clinical development, including demcizumab (anti-DLL4, OMP-21M18), anti-Notch2/3 (OMP-59R5), anti-Notch1 (OMP-52M51), vantictumab (anti-Fzd7, OMP-18R5), and Fzd8-Fc (OMP-54F28), which target key cancer stem cell signaling pathways including Notch and Wnt. OncoMed has two other antibodies in preclinical development anti-DLL4/anti-VEGF bispecific (OMP-305B83) and anti-RSPO3, with Investigational New Drug filings planned for late 2014 or early 2015. OncoMed is also pursuing discovery of additional novel anti-CSC product candidates.  OncoMed has formed strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline (GSK). Additional information can be found at the company's website: www.oncomed.com.

Forward-Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including OncoMed's expectations regarding the ability of OncoMed to advance its research and development pipeline, including its discovery and preclinical pipeline and its anti-CSC therapeutics in clinical trials; the scope, validity, and enforceability of patent protection afforded by OncoMed's intellectual property; OncoMed's ability to discover and develop novel anti-CSC therapeutics; the tolerability of OncoMed's product candidates at efficacious doses; the potential of OncoMed's product candidates to significantly impact cancer treatment and the clinical outcome of patients with cancer; the timing of Investigational New Drug filings and clinical trials; the availability and timing of data from ongoing clinical trials; OncoMed's financial guidance regarding the period in which cash will be available to fund its operating expenses and capital expenditure requirements; and the benefit of OncoMed's strategic plan and focus. Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; OncoMed's dependence on its collaboration partners, including Celgene, GSK and Bayer, for the funding of its partnered programs; OncoMed's ability to raise additional capital to support the development of its unpartnered programs; OncoMed's dependence on the development and marketing efforts of its partners for the commercial success of its partnered product candidates; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to validate, develop and obtain regulatory approval for companion diagnostics; OncoMed's ability to achieve market acceptance and commercial success of its product candidates once regulatory approval is achieved; OncoMed's ability to discover, develop and commercialize additional product candidates; the ability of competitors to discover, develop or commercialize competing products more quickly or more successfully; OncoMed's dependence on its Chairman and Chief Executive Officer, its Chief Scientific Officer, its Chief Medical Officer and other key executives; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate OncoMed's patents or proprietary rights; and the ability of OncoMed's proprietary rights to protect its technologies and product candidates. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed's business in general, see OncoMed's Annual Report on Form 10-K for the fiscal year ended December 31, 2013, filed with the Securities and Exchange Commission (SEC) on March 18, 2014, and OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2014, filed with the SEC on May 8, 2014.