Celldex Reports Fourth Quarter and Fiscal 2012 Financial Results

Celldex Reports Fourth Quarter and Fiscal 2012 Financial Results

Management to Host Conference Call to Discuss Results and Provide 2013 Outlook
Today, Thursday, March 7, at 8:30 a.m. Eastern Time

NEEDHAM, Mass., March 7, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc.
(Nasdaq:CLDX) today reported financial results for the fourth quarter and the
year ended December 31, 2012. Celldex reported a net loss of $16.8 million, or
($0.27) per share, for the fourth quarter of 2012 compared to net loss of
$12.7 million, or ($0.29) per share, for the fourth quarter of 2011. For the
twelve months ended December 31, 2012, Celldex reported a net loss of $59.1
million, or ($1.02) per share, compared to a net loss of $44.8 million, or
($1.13) per share, for the twelve months ended December 31, 2011. At December
31, 2012, Celldex reported cash, cash equivalents and marketable securities of
$84.0 million. Following recent financings, as of February 28, 2013, Celldex
had cash, cash equivalents and marketable securities of approximately $189

"Celldex ended 2012 reporting positive data from four clinical programs at
major medical meetings, including final results from our Phase 2b study of
CDX-011 in metastatic breast cancer," said Anthony Marucci, Chief Executive
Officer of Celldex Therapeutics. "Based on the CDX-011 final data package and
subsequent discussions with the FDA, we look forward to initiating a
randomized trial suitable for accelerated approval in patients with triple
negative breast cancer that also over-express GPNMB in the second half of

Marucci continued, "Importantly, we begin 2013 well-financed with a current
cash position that will support operations and clinical development through
2015. To that end, in addition to the CDX-011 accelerated approval study, we
will also initiate new clinical studies and expansion studies for four other
Celldex programs in 2013. We expect data from three clinical studies by year
end—including from our Phase 2 study of rindopepimut with Avastin^® in
refractory glioblastoma. To close what will already be a very busy year, we
also look forward to completing enrollment in the rindopepimut ACT IV
registration trial in frontline glioblastoma."

Fourth Quarter and Recent Highlights

  *Presented positive final results from the Phase 2b EMERGE study of CDX-011
    in patients with GPNMB-expressing, advanced, heavily pretreated breast
    cancer at the San Antonio Breast Cancer Symposium in December. Progression
    free and overall survival benefits were demonstrated in the subgroup of
    patients with triple negative disease that also over-expressed GPNMB, and
    strong trends towards benefits were seen in all patients with
    over-expression of GPNMB.
  *Announced impressive three-year survival data across three Phase 2 studies
    of rindopepimut, in EGFRvIII-positive glioblastoma at the Society for
    Neuro-Oncology Annual Meeting in November. In addition, Celldex announced
    a new contemporary historical control data set compiled from the Radiation
    Therapy Oncology Group (RTOG)'s Phase 3 0525 study that continues to
    demonstrate that patients with EGFRvIII-positive glioblastoma fare worse
    than the general glioblastoma patient population. Importantly, the data
    set provides further confidence in the ACT IV registration study design.
  *Continued to open clinical sites to support enrollment in the Phase 3 ACT
    IV study and the Phase 2 ReACT study of rindopepimut in glioblastoma. In
    total, there are now more than 142 clinical sites around the world that
    are actively screening patients to participate in the ACT IV study. The
    ReACT study is also well-positioned, with all 25 study sites actively
    screening to date.
  *Presented positive results from the Phase 1 study of CDX-1401 in solid
    tumors at the Society for Immunotherapy of Cancer Annual Meeting in
    October 2012. The study identified a well-tolerated and immunogenic
  *Completed enrollment in the Phase1 portion of the CDX-1127 solid tumor
    arm. CDX-1127 was determined to be well-tolerated to date, including at
    the highest dose level. Celldex continues to enroll patients in the dose
    escalation portion of the lymphoma and leukemia arm.
  *Presented final results from a Phase 1 multi-dose study of CDX-301
    (rhuFlt3L) in healthy volunteers in an oral presentation at the American
    Society for Blood and Marrow Transplantation 2013 BMT Tandem Meetings in
    February 2013. The study demonstrated that CDX-301 was well-tolerated and
    can effectively mobilize hematopoietic cell populations in healthy
  *Raised net proceeds of $114.1 million in the first quarter of 2013 to
    support operations and clinical development activities through 2015.

Key 2013 Objectives

  *Complete global recruitment in the ACT IV registration study of
    rindopepimut in front-line glioblastoma and in the ReACT study of
    rindopepimut in combination with Avastin in patients with
    recurrent/refractory EGFRvIII-positive glioblastoma. Announce results from
    the ReACT study by year end.
  *Initiate a pivotal, randomized, accelerated approval study of CDX-011 in
    patients with triple negative breast cancers that over-express GPNMB in
    the second half.
  *Complete enrollment of the Phase 1 dose-escalation and expansion studies
    of CDX-1127 in patients with hematologic cancers and initiate expansion
    cohorts in both solid tumors and hematologic malignancies. Report data
    from this study in the second half.
  *Initiate a pilot study of CDX-1135 in dense deposit disease, an orphan
    renal disease in children and young adults, with data expected by year
  *Initiate a pilot clinical study of CDX-301 in hematopoietic stem cell
    transplant in the second half.
  *Initiate a Phase 2 study of CDX-1401 in combination with CDX-301 sponsored
    by the Cancer Immunotherapy Trials Network of the National Cancer

Fourth Quarter and Year-to-Date Financial Highlights

The increase in net loss of $4.1 million between the fourth quarters of 2012
and 2011 is primarily due to higher research and development (R&D) expense as
a result of higher clinical trials costs for the rindopepimut Phase 3 and
Phase 2 programs. General and administrative (G&A) expense in the fourth
quarter of 2012 increased by $0.3 million from $2.3 million in 2011 due
primarily to higher personnel-related expenses in 2012. The increase in cash,
cash equivalents and marketable securities of $6.3 million from September 30,
2012 primarily reflects the issuance of 3.5 million shares during the quarter
through our Cantor ATM facility that raised net proceeds to Celldex of $20.9
million, partially offset by our fourth quarter operations-related cash burn
of approximately $13.3 million and principal payments on our term loan of $1.3

The net loss of $59.1 million for 2012 represents an increased loss of $14.3
million when compared to the net loss of $44.8 million for the same period in
2011 and is primarily due to increased R&D expense. R&D expense in 2012
increased by $15.0 million compared to 2011 and was primarily a result of
increased later-stage clinical trials costs of $14.3 million in 2012 related
to the rindopepimut program. G&A expenses increased by $0.8 million to $10.0
million in 2012 compared to $9.2 million in 2011, primarily due to increased
personnel-related expenses and rindopepimut-related commercial planning costs
in 2012.

As of December 31, 2012, Celldex had approximately 64.4 million shares
outstanding.As a result of our financing transactions in January and February
2013, we now have 80.6 million shares outstanding.

Webcast and Conference Call

Celldex will host a conference call and live audio webcast at 8:30 a.m. ET on
Thursday, March 7, 2013 to discuss Celldex's fourth quarter and twelve month
2012 financial results and to provide an update on anticipated research and
development and business objectives for 2013. The conference call and
presentation will be webcast live over the Internet and can be accessed by
logging on to "Events & Presentations" under the "Investors & Media" section
of the Celldex Therapeutics' website at www.celldextherapeutics.com. The call
can also be accessed by dialing 888-350-0137 (within the United States) or
970-315-0478 (outside the United States).

A replay of the call will be available approximately two hours after the live
call concludes through March 14, 2013. To access the replay, dial 855-859-2056
(within the United States) or 404-537-3406 (outside the United States). The
passcode is 13866763. The webcast will also be archived on the Company's

About Celldex Therapeutics, Inc.

Celldex Therapeutics is the first antibody-based combination immunotherapy
company. Celldex has a pipeline of drug candidates in development for the
treatment of cancer and other difficult-to-treat diseases based on its
antibody focused Precision Targeted Immunotherapy (PTI) Platform. The PTI
Platform is a complementary portfolio of monoclonal antibodies,
antibody-targeted therapeutics and immunomodulators used in optimal
combinations to create novel disease-specific drug candidates. For more
information, please visit http://www.celldextherapeutics.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of
1995:This release contains "forward-looking statements" made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act of
1995, including those related to the Company's strategic focus and the future
development and commercialization (by Celldex and others) of rindopepimut
(CDX-110), CDX-011, CDX-1135, CDX-1401, CDX-1127, CDX-301, Belinostat and
other products. Forward-looking statements reflect management's current
knowledge, assumptions, judgment and expectations regarding future performance
or events. Although management believes that the expectations reflected in
such statements are reasonable, they give no assurance that such expectations
will prove to be correct and you should be aware that actual results could
differ materially from those contained in the forward-looking statements.
Forward-looking statements are subject to a number of risks and uncertainties,
including, but not limited to, our limited cash reserves and our ability to
obtain additional capital on acceptable terms, or at all, including the
additional capital which will be necessary to complete the clinical trials
that we have initiated or plan to initiate; our ability to adapt APC Targeting
Technology^TM to develop new, safe and effective therapeutics for oncology and
infectious disease indications; our ability to successfully complete product
research and further development of our programs; the uncertainties inherent
in clinical testing; our limited experience in bringing programs through Phase
3 clinical trials; our ability to manage research and development efforts for
multiple products at varying stages of development; the timing, cost and
uncertainty of obtaining regulatory approvals; the failure of the market for
the Company's programs to continue to develop; our ability to protect the
Company's intellectual property; the loss of any executive officers or key
personnel or consultants; competition; changes in the regulatory landscape or
the imposition of regulations that affect the Company's products; and other
factors listed under "Risk Factors" in our annual report on Form 10-K.

All forward-looking statements are expressly qualified in their entirety by
this cautionary notice. You are cautioned not to place undue reliance on any
forward-looking statements, which speak only as of the date of this release.
We have no obligation, and expressly disclaim any obligation, to update,
revise or correct any of the forward-looking statements, whether as a result
of new information, future events or otherwise.

Avastin^® is a registered trademark of Genentech, a member of the Roche Group.

(In thousands, except per share amounts)
CONSOLIDATED STATEMENTS    Quarter Ended           Year Ended
OF OPERATIONS DATA         December 31,            December 31,
                            2012        2011        2012         2011
Product Development and                                      
Licensing Agreements        $43       $45       $146       $110
Contracts and Grants       53         30         281         36
Product Royalties          3,551      2,358      10,775      9,119
Total Revenue              3,647      2,433      11,202      9,265
OPERATING EXPENSE                                            
Research and Development   13,748     9,824      47,398      32,439
Royalty                    3,551      2,358      10,775      9,119
General and Administrative 2,644      2,343      10,016      9,193
Amortization of Acquired    254        291        1,090       1,913
Intangible Assets
Total Operating Expense    20,197     14,816     69,279      52,664
Operating Loss             (16,550)   (12,383)   (58,077)    (43,399)
Investment and Other        94         89         530         396
Income, Net
Interest Expense           (351)      (438)      (1,576)     (1,796)
Net Loss                   $(16,807) $(12,732) $(59,123)  $(44,799)
Basic and Diluted Net Loss                                   
per Common Share            $(0.27)   $(0.29)   $(1.02)    $(1.13)
Weighted Average Common     62,544     44,175     57,713      39,501
Shares Outstanding
CONDENSED CONSOLIDATED                                        
BALANCE SHEETS                                     December 31, December 31,
                                                  2012         2011
Cash, Cash Equivalents and Marketable Securities   $83,962    $53,312
Other Current Assets                             1,152       1,372
Property and Equipment,                           7,205       9,093
Intangible and Other Assets, net                  33,222      34,217
Total Assets                                      $125,541   $97,994
Current Liabilities                              $17,685    $14,298
Long-Term Liabilities                            12,082      14,974
Stockholders' Equity                             95,774      68,722
Total Liabilities and Stockholders'                 $125,541   $97,994

CONTACT: Sarah Cavanaugh
         Vice President of Investor Relations &
         Corp Communications
         Celldex Therapeutics, Inc.
         (781) 433-3161
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