OncoMed Pharmaceuticals Announces Full Year and Fourth Quarter 2013 Financial Results

OncoMed Pharmaceuticals Announces Full Year and Fourth Quarter 2013 Financial
Results

 Year-End Cash and Cash Equivalents Balance of $316.2 Million Reflecting IPO
            and Celgene Multi-Product Co-Development Collaboration

   Names Sunil Patel Chief Financial Officer, SVP Corporate Development and
                                   Finance

REDWOOD CITY, Calif., March 18, 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 year
and quarter ended December 31, 2013.

"2013 was a year of significant accomplishments across all aspects of our
business. Our successful initial public offering in July and the signing of a
transformational drug development collaboration with Celgene in December
significantly strengthened our financial resources and provided further
momentum for our scientific approach and progress," said Paul J. Hastings,
Chairman and Chief Executive Officer. "We now have 15 clinical trials
currently underway across multiple tumor indications for five distinct
anti-cancer stem cell therapeutics, two additional INDs on novel CSC
antibodies expected in the next 6-12 months, and a growing pipeline of novel
preclinical biologic candidates. We expect this year to be one of continued
execution on plan as we advance our portfolio and generate new data."

Recent Business Highlights

-- In January, presented safety and early efficacy data from two
clinical-stage programs at the 2014 Gastrointestinal Cancers Symposium (ASCO
GI).

  *Updated data from the Phase 1b clinical trial of demcizumab plus
    Abraxane^® (nab-paclitaxel) and gemcitabine in first-line Stage IV
    pancreatic cancer patients showed the triple combination was generally
    well tolerated with fatigue, hypertension, nausea and vomiting being the
    most common drug-related toxicities.No demcizumab-related reversible
    cardiotoxicity events have occurred with the truncated treatment
    approach.Three of the six (50%) evaluable patients who received the
    demcizumab/gemcitabine/Abraxane combination had partial responses as
    measured by RECIST, and two patients had stable disease resulting in a
    clinical benefit rate of 83%.Demcizumab is part of OncoMed's
    collaboration with Celgene.
    
  *Interim results from the Phase 1b clinical study of OMP-59R5 (anti-Notch
    2/3) in combination with Abraxane and gemcitabine in pancreatic cancer
    patients demonstrated that the combination was well tolerated. The most
    common adverse events were mild to moderate diarrhea, fatigue and nausea,
    all easily managed with supportive care.Thirteen patients were treated
    with Abraxane, gemcitabine and OMP-59R5 (at doses from 5mg/kg to
    12.5mg/kg).Six of these patients (46%) treated with the three-drug
    combination achieved a RECIST, partial response and an additionalfour
    patients achieved stable disease, for an overall disease control rate of
    77%.OMP-59R5 is part of OncoMed's collaboration with GlaxoSmithKline
    (GSK).

-- Initiated three multi-center Phase 1b clinical trials of OMP-54F28
(Fzd8-Fc) in combination with Abraxane and gemcitabine in pancreatic cancer,
with sorafenib (Nexavar^®) in hepatocellular cancer and with carboplatin and
paclitaxel in patients with platinum-sensitive ovarian cancer.OMP-54F28 is
part of OncoMed's collaboration with Bayer Pharma AG.

-- Initiated three multi-center Phase 1b clinical trials of vantictumab
(OMP-18R5, anti-Fzd7) in combination with standard-of-care
treatment:vantictumab plus docetaxel in non-small cell lung cancer (NSCLC),
vantictumab combined withpaclitaxel in Her2-negative breast cancer and
vantictumab with Abraxane and gemcitabine in pancreatic cancer.Vantictumab is
part of OncoMed's Wnt pathway collaboration with Bayer.

-- Granted a fourth broad U.S. patent (No. 8,628,744) relating to antibodies
that target the RSPO-LGR pathway, which is believed to be an important CSC
pathway.

-- In December, announced an agreement with Celgene Corporation to jointly
develop and commercialize up to six anti-cancer stem cell biologic product
candidates, including demcizumab (OMP-21M18, anti-DLL4).Celgene also has an
option to discover and develop small molecule compounds in an undisclosed
cancer stem cell pathway.

  *OncoMed will lead early clinical development efforts and retain worldwide
    co-development, U.S. co-commercialization and profit-sharing rights for up
    to five of the six biologic programs encompassed in the agreement.
    
  *OncoMed received a $177.25 million upfront payment from Celgene, which
    included a $22.25 million equity investment. The collaboration also
    includes option exercise payments and payments for achievement of
    development, regulatory and commercial milestones, paid on a per-program
    basis.

-- Presented data for four clinical-stage programs in October at the
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer
Therapeutics, including safety and efficacy data from Phase 1b clinical
studies of demcizumab, pharmacodynamic biomarker data from a Phase 1a clinical
study of vantictumab, the first clinical data from ongoing Phase 1a clinical
studies of OMP-52M51 (anti-Notch1) and OMP-54F28.

-- In October, OncoMed earned a $15 million milestone payment from Bayer
related to achieving a dose-escalation milestone in the ongoing Phase 1a
clinical trial of OMP-54F28.

Full Year and Fourth Quarter 2013 Financial Results

Cash, cash equivalents and marketable securities totaled $316.2 million as of
December 31, 2013, 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 the upfront and equity payments of $177.25
million from the signing of the company's collaboration with Celgene in
December 2013.

Revenues for the full year 2013 totaled $37.8 million, as compared to $24.7
million in 2012.Fourth quarter 2013 revenues were $19.0 million, compared to
$6.9 million for the fourth quarter of 2012.The year-over-year and
quarter-over-quarter increases were attributable to collaborative revenues in
the form of milestone payments from Bayer associated with the vantictumab and
OMP-54F28 programs received in the fourth quarter 2013 and the amortization of
upfront payments from OncoMed's agreements with GSK, Bayer and Celgene.

Research and development (R&D) expenses for the full year ended December 31,
2013, were $50.0 million compared with $39.9 million for the same period in
2012.For the fourth quarter of 2013 R&D expenses were $16.9 million, compared
to $9.5 million for the fourth quarter of 2012. Increases in R&D expenditures
during 2013 and the fourth quarter were primarily attributable to an increase
in program costs associated with the advancement of OncoMed's clinical-stage
product candidates and preclinical pipeline.

General and administrative (G&A) expenses for the years ended December 31,
2013 and 2012, were $11.6 million and $7.2 million, respectively.For the
fourth quarter of 2013 G&A expenses were $4.5 million, compared to $1.8
million for the fourth quarter of 2012.Increased costs for 2013 and the
quarter ended December 31, 2013 were primarily attributable to higher one-time
employee-related costs, higher legal fees associated with SEC filings and
consulting fees from third-party vendors associated with public company
operations and multiple business development activities.

Net loss for the year ended December 31, 2013 was $26.1 million ($1.93 per
share), compared to $22.2 million ($21.30 per share, pre-IPO and reverse
split) for the same period of 2012.The change in net loss for the year was
due to an increase of collaboration revenue, more than offset by an increase
in operational expenses, primarily research costs.Net loss in the fourth
quarter of 2013 was the same for the fourth quarter 2012 at $4.3 million.Net
loss per share available to common stockholders for the fourth quarter of 2013
was $0.15 per share, compared to $4.01 per share (pre-IPO and reverse split)
for the fourth quarter of 2012.The number of shares outstanding of OncoMed's
common stock as of March 11, 2014 was 29,480,494.

Chief Financial Officer

OncoMed also announced that Sunil Patel, Chief Financial Officer, Senior Vice
President Corporate Development and Finance, will succeedWilliam Waddill, who
is leaving at the end of this month to join a private company. Mr. Patel has
been with OncoMed since 2009, most recently as Senior Vice President, Chief
Business Officer. In his new role, Mr. Patel will lead finance,
administration, corporate development, alliance management and strategic
marketing activities.

Mr. Patel has more than 19 years of experience in the biopharmaceutical
industry. Prior to OncoMed, Mr. Patel held executive roles with multiple
biotechnology companies, including BiPar Sciences, Connetics Corporation and
Abgenix, Inc. He has played a leadership role in driving more than $8 billion
in strategic licensing and M&A transactions, including leading OncoMed's
strategic transactions with Bayer and Celgene and managing the collaborative
efforts with GSK. Earlier in his career, he was a management consultant with
McKinsey & Company. He currently serves on the Board of Directors and is a
member of the audit committee of Ligand Pharmaceuticals, Inc. Mr. Patel holds
a B.S. in Chemistry from the University of California, Berkeley, and an M.S.
in Molecular Biotechnology / Bioengineering from the University of Washington.

"Sunil has played a critical role here at OncoMed for the last five years.In
structuring our collaborations and overseeing our alliances, he has
significantly contributed to the company's operations and the management of
financial resources.Sunil's deep understanding of our business and the
industry position him well for success in this expanded role," said Mr.
Hastings. "On behalf of OncoMed's Board of Directors and the entire company, I
want to thankWill for his significant contribution to OncoMed's success over
the past seven years. We all wish him the best as he takes on a new
opportunity with a private company."

Anticipated 2014 Milestones and Guidance

Upcoming clinical milestones include the following:

  *Initiate the randomized Phase 2 portion of the ALPINE and PINNACLE
    clinical trials of OMP-59R5 in pancreatic cancer and small cell lung
    cancer, respectively
  *Begin randomized Phase 2 clinical studies of demcizumab in non-small cell
    lung cancer and pancreatic cancer
  *Complete patient enrollment in the ongoing Phase 1a clinical studies of
    vantictumab and OMP-54F28
  *File an Investigational New Drug (IND) application with the US Food and
    Drug Administration for OMP-305B83 (anti-DLL4/anti-VEGF bispecific)
  *Present clinical and preclinical data at upcoming scientific and medical
    conferences

OncoMed estimates 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 estimates ending 2014 with a cash and cash equivalents 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), OMP-59R5 (anti-Notch2/3), OMP-52M51 (anti-Notch1),
vantictumab (anti-Fzd7, OMP-18R5), and OMP-54F28 (Fzd8-Fc), which target key
cancer stem cell signaling pathways including Notch and Wnt.OncoMed has two
other antibodies in preclinical development, OMP-305B83 (anti-DLL4/anti-VEGF
bispecific) 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; 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 Prospectus filed with the
Securities and Exchange Commission (SEC) on July 18, 2013, and OncoMed's
Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2013,
filed with the SEC on November 13, 2013, and OncoMed's periodic reports on
Form 10-K and Form 10-Q that OncoMed files from time to time in the future.

ONCOMED PHARMACEUTICALS, INC.
Statement of Operations
(Amount in thousands, except per share data)

                          Three Month Ended         Twelve Months Ended
                          December 31, December 31, December 31, December 31,
                           2013         2012         2013         2012
                                                              
                                                              
Total Revenue              $18,983    $6,930     $37,779    $24,681
                                                              
Operating expenses:                                            
Research and development   16,871       9,502        50,048       39,893
General and administrative 4,518        1,764        11,630       7,157
Total operating expenses   21,389       11,266       61,678       47,050
Loss from operations       (2,406)      (4,336)      (23,899)     (22,369)
Interest and other income  7            41           (228)        134
(expense), net
Loss before provision for  (2,399)      (4,295)      (24,127)     (22,235)
income taxes
Provision for income taxes (1,944)      —            (1,944)      —
Net loss                   $(4,343)   $(4,295)   $(26,071)  $(22,235)
                                                              
Net loss per common share, $(0.15)    $(4.01)    $(1.93)    $(21.30)
basic and diluted
                                                              
Shares used to compute net
loss per common shares,    28,360,571   1,069,984    13,530,239   1,044,059
basic and diluted
                                                              
                                                              
Note: As of March 11, 2014, OncoMed has 29,480,494 shares of common stock
outstanding.
                                                              

ONCOMED PHARMACEUTICALS, INC.
Condensed Balance Sheets
(Amount in thousands)

                                                    December 31, December 31,
                                                     2013         2012
                                                                
Cash, cash equivalents and short-term investments    $316,194   $66,239
Prepaid and other assets                             17,491      5,146
Total assets                                         $333,685   $79,768
                                                                
Deferred revenue                                     $183,930   $32,046
Other liabilities                                    31,633      9,176
Convertible preferred stock                          —            182,773
Stockholders' equity (deficit)                       118,122     (144,227)
Total liabilities and stockholders' equity (deficit) $333,685   $79,768

CONTACT: Investor Contact:
         OncoMed Pharmaceuticals
         Shari Annes
         Investor Relations
         (650) 888-0902
         shari.annes@oncomed.com
        
         Media Inquiries:
         BCC Partners
         Karen L. Bergman or
         Michelle Corral
         (650) 575-1509 or (415) 794-8662
         kbergman@bccpartners.com or
         mcorral@bccpartners.com

OncoMed Pharmaceuticals, Inc. Logo
 
Press spacebar to pause and continue. Press esc to stop.