REDWOOD CITY, Calif., Aug. 7, 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 June 30, 2014.
"We continue to execute on our research and development objectives, advancing our product candidates and building our portfolio of proprietary and innovative discovery programs," said OncoMed's Chairman and Chief Executive Officer, Paul J. Hastings. "The recent start of the Phase 2 ALPINE trial of tarextumab in pancreatic cancer represents an important milestone for the company, and we expect further pipeline progress and presentations of clinical and preclinical data in the second half of 2014."
Recent Business Highlights
- Initiated the Phase 2 component of the ALPINE clinical trial for tarextumab (Anti-Notch 2/3, OMP-59R5) in combination with Abraxane® (paclitaxel protein-bound particles for injectible suspension) (albumin bound) plus gemcitabine in patients with previously untreated stage IV pancreatic cancer. This is the first of several planned randomized placebo-controlled proof-of-concept clinical studies for OncoMed's anti-cancer stem cell candidates.
- Presented clinical trial data for three programs at the 2014 American Society for Clinical Oncology (ASCO) Annual Meeting:
- Updated demcizumab (Anti-DLL4, OMP-21M18) Phase 1b data in non-small cell lung cancer patients in support of an upcoming randomized Phase 2 trial
- First presentation of tarextumab Phase 1b data in small cell lung cancer patients in support of an upcoming randomized Phase 2 trial
- Oral presentation of ipafricept (FZD8-Fc, OMP-54F28) Phase 1a data in advanced solid tumor patients
- Presented data at the 19th European Hematology Association (EHA) Congress on a Notch1 mutation biomarker assay developed as a companion diagnostic to identify patients whose cancer may be more likely to benefit from treatment with the company's anti-Notch1 (OMP-52M51) antibody
- Received orphan drug designation for demcizumab for the treatment of pancreatic cancer from the US FDA Department of Orphan Products Development
- Presented data at the 2014 American Association for Cancer Research (AACR) Annual Meeting in nine presentations highlighting OncoMed's drug discovery platforms, as well as preclinical and biomarker discoveries on its clinical-stage product candidates and emerging product candidates
- Granted broad composition-of-matter and use patent in U.S. relating to FZD-Fc soluble receptors, including OncoMed's clinical-stage candidate ipafricept
- Voluntarily halted vantictumab (Anti-Fzd7, OMP-18R5) and ipafricept clinical trials due to observed mild-to-moderate bone adverse safety events. The FDA concurred with the company's actions and placed the programs on partial clinical hold. The company continues to dose vantictumab and ipafricept to existing patients in their respective single-agent Phase 1a clinical trials who have remained on treatment for extended periods of time without disease progression and without significant drug-related adverse events. The company is working diligently with investigators and the FDA towards restarting all trials.
Second Quarter 2014 Financial Results
Revenues for the second quarter 2014 totaled $6.0 million, as compared to $2.9 million in the second 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 second quarter 2014 were $18.2 million compared with $10.5 million for the same period in 2013. Increases in R&D expenditures during the second quarter were mainly 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 second quarter 2014 were $3.4 million, compared to $2.0 million for the same period in 2013. Increased costs during the second quarter were primarily attributable to higher employee-related and public company expenses.
Net loss for the second quarter 2014 was $15.6 million ($0.53 per share), compared to $9.6 million ($8.83 per share, pre-IPO and reverse split) for the same period of 2013. Total second quarter expenses include $1.9 million in non-cash charges related to stock-based compensation and depreciation expenses.
Cash, cash equivalents and short-term investments totaled $266.3 million as of June 30, 2014, compared to $283.9 million as of March 31, 2014.
Anticipated Second Half 2014 Milestones
Upcoming clinical milestones include the following:
- Initiate the randomized Phase 2 portion of the PINNACLE clinical trial of tarextumab in small cell lung cancer
- Initiate randomized Phase 2 clinical program for demcizumab
- Work with clinical investigators and the FDA to resume enrollment and dosing in vantictumab and ipafricept programs
- 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 including the European Society of Medical Oncology (ESMO) Congress and the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics meetings
About OncoMed Pharmaceuticals
OncoMed Pharmaceuticals is a clinical-stage company focused on discovering and developing novel therapeutics targeting cancer stem cells (CSCs). OncoMed has five anti-cancer product candidates in clinical development, including demcizumab (anti-DLL4, OMP-21M18), tarextumab (anti-Notch 2/3, OMP-59R5), anti-Notch1 (OMP-52M51), vantictumab (anti-FZD7, OMP-18R5), and iprafricept (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 (OMP-131R10), 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.
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; OncoMed's ability to continue dosing existing patients and resume enrollment and dosing of new patients in its vantictumab and ipafricept programs; the scope, validity, and enforceability of patent protection afforded by OncoMed's intellectual property relating to ipafricept; OncoMed's ability to discover and develop additional novel product candidates; the timing of Investigational New Drug filings for OncoMed's anti-DLL4/anti-VEGF bispecific and anti-RSPO3 antibodies; the timing of OncoMed's clinical trials, including the timing of initiation of randomized Phase 2 clinical trials for OncoMed's product candidates such as tarextumab and demcizumab; and the availability and timing of data from preclinical studies and ongoing clinical trials. 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, OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2014, filed with the SEC on May 8, 2014, and OncoMed's Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2014, filed with the SEC on August 7, 2014.
|ONCOMED PHARMACEUTICALS, INC.|
|Statement of Operations|
|(Amount in thousands, except per share data)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Collaboration revenue||$ 6,015||$ 2,439||$ 12,030||$ 4,878|
|Collaboration revenue—related party||—||493||—||985|
|Research and development||18,167||10,475||34,876||20,051|
|General and administrative||3,440||1,952||6,653||3,936|
|Total operating expenses||21,607||12,427||41,529||23,987|
|Loss from operations||(15,592)||(9,495)||(29,499)||(18,124)|
|Interest and other income (expense), net||(5)||(149)||31||(118)|
|Net loss||$ (15,597)||$ (9,644)||$ (29,468)||$ (18,242)|
|Net loss per common share, basic and diluted||$ (0.53)||$ (8.83)||$ (1.00)||$ (16.77)|
|Shares used to compute net loss per common share, basic and diluted||29,601,010||1,091,782||29,522,556||1,087,863|
|ONCOMED PHARMACEUTICALS, INC.|
|Condensed Balance Sheets|
|(Amount in thousands)|
|June 30,||December 31,|
|Cash, cash equivalents and short-term investments||$ 266,348||$ 316,194|
|Prepaid and other assets||17,956||17,491|
|Total assets||$ 284,304||$ 333,685|
|Deferred revenue||$ 171,900||$ 183,930|
|Total liabilities and stockholders' equity||$ 284,304||$ 333,685|
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Source:OncoMed Pharmaceuticals, Inc.