Celldex Reports Fiscal 2013 Business/Financial Results and Outlines 2014 Strategy

Celldex Reports Fiscal 2013 Business/Financial Results and Outlines 2014
Strategy

- Management to Host Conference Call Today, Monday, March 3, at 8:30 a.m.
Eastern Time -

HAMPTON, N.J., March 3, 2014 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc.
(Nasdaq:CLDX) today reported business and financial highlights for the fourth
quarter and year ended December 31, 2013 and outlined the Company's major
clinical development goals for 2014.

"This past year was transformational for Celldex as we continued to make
strides in cultivating one of the most robust, well-staged pipelines in
immuno-oncology," said Anthony Marucci, President and Chief Executive Officer
of Celldex Therapeutics. "We enter 2014 with five candidates in the clinic,
including rindopepimut and glembatumumab vedotin in registration studies. By
year-end, we anticipate the initiation of four new Celldex-sponsored clinical
trials and several investigator-sponsored studies, including multiple
combination regimens. These combination studies are designed to address what
we believe is the next great opportunity for the immuno-oncology field—further
unlocking the power of the immune system to deliver the greatest benefit to
the largest population of patients possible. With last year's successful
financing of the Company and current cash projected to fund our planned
activities through 2016, we look forward to what we believe will be an
exceptionally productive year."

2013 Program Updates:

Rindopepimut ("rindo"; CDX-110) in EGFRvIII(v3)-Positive Glioblastoma (GBM):

  *Celldex continues to actively enroll newly diagnosed patients with GBM in
    ACT IV, the Phase 3 registration study. More than 200 sites are currently
    open to enrollment across 24 countries. The Company continues to
    anticipate completion of enrollment in mid-2014.
    
  *Celldex announced the presentation of four- and five-year survival data
    from the Phase 2 rindopepimut clinical program in frontline GBM (3
    studies; pooled n=105) in November. Survival data suggests a substantial
    and continuing survival benefit in comparison to a matched historical
    control dataset, at the median and at all other time points evaluated.
    Eighteen percent (18%) of patients from the Phase 2 frontline rindopepimut
    program were alive at four years and 14% were alive at five years. No
    patients in the matched historical control dataset survived beyond three
    years.
    
  *In November, positive interim data from the ReACT study in recurrent GBM
    were presented in an oral session at the Annual Meeting of the Society for
    Neuro-Oncology. The data demonstrated promising signs of clinical activity
    in advanced patient populations, including patients both naive and
    refractory to Avastin^®. Enrollment in ReACT is expected to be completed
    in late 2014 with data anticipated by year-end 2014.

Glembatumumab vedotin ("glemba"; CDX-011) targeting gpNMB in multiple cancers:

In December, Celldex initiated a randomized, accelerated approval study
(METRIC) of glembatumumab vedotin in patients with metastatic triple negative
breast cancer that overexpresses the tumor associated marker gpNMB. The METRIC
study is expected to include up to 100 sites inthe United States,
CanadaandAustralia. The glembatumumab vedotin program will expand into
additional indications in 2014 (outlined below).

Varlilumab ("varli"; CDX-1127) an immune modulating mAb targeting CD27 in
solid tumors and hematologic malignancies:

In November, Celldex presented interim data from the Phase 1 dose-escalation
study of varlilumab at theSociety for Immunotherapy of Cancer Meeting. The
data established an excellent safety profile, clear biologic activity and
promising signs of clinical activity in an advanced, refractory patient
population, including activation of helper and effector lymphocytes as well as
decreasing regulatory T cells (Tregs). The Company also presented preclinical
data on combination studies of varlilumab, including with chemotherapy or
checkpoint inhibitors. Expansion cohorts have been enrolling in metastatic
melanoma and renal cell carcinoma with initial data anticipated in mid-2014.
Expansion cohorts are planned in hematologic indications as appropriate. New
studies of varlilumab in combination with various agents will be initiated in
2014 (outlined below).

CDX-1401 an antibody-based dendritic cell targeted vaccine targeting tumors
expressing the NY-ESO-1 oncoprotein:

The Phase 1 study of CDX-1401 was completed in 2013, including longer-term
patient follow up. CDX-1401 was well-tolerated and elicited robust antibody
and T cell responses in patients with advanced cancer that had progressed
after any available curative and/or salvage therapies. Some patients had
evidence of clinical benefit with significant stable disease and measurable
tumor shrinkage, despite their advanced stage of metastatic disease. Of note,
long-term patient follow up suggested that treatment with CDX-1401 may
predispose patients to better outcomes on subsequent therapy with checkpoint
inhibitors. In particular, of six melanoma patients that went on to receive
Yervoy^® four had significant clinical benefit (1 immune-related partial
response, 2 RECIST partial responses, and 1 complete response). In addition,
two non-small cell lung cancer patients who received investigational
checkpoint blockade within two months of discontinuing CDX-1401 were also
reported to experience partial responses. These observations will be explored
more fully in clinical studies that Celldex plans to initiate in 2014
(outlined below).

CDX-301 (Flt3L) a potent hematopoietic cytokine that stimulates the expansion
and differentiation of hematopoietic stem cells and dendritic cells:

In December, positive results were presented from a preclinical combination
study of CDX-301 and Mozobil^® demonstrating that the combination of these
agents significantly increased hematopoietic stem cell mobilization and
resulted in improved transplantation of mobilized cells at the American
Society of Hematology Annual Meeting. Based on these data, Celldex plans to
initiate a pilot study of CDX-301 alone and in combination with Mozobil in
hematopoietic transplant. In addition, an investigator-sponsored study of
intratumoral CDX-301 plus Hiltonol in combination with radiation therapy in
patients with advanced, low-grade B-cell lymphoma was also initiated in
December. In 2014, Celldex expects CDX-301 to enter combination studies to
explore its potential for improving hematopoietic stem cell transplantation
and potentiating immune activation (outlined below).

CDX-1135 targeting C3 activation in Dense Deposit Disease (DDD):

In July, Celldex initiated a pilot study of CDX-1135 to explore a potential
opportunity in treating patients with the ultra-orphan indication, DDD. As
previously disclosed, enrollment in the pilot study has been extremely
difficult due to the overall rareness of patients with DDD (300-500 in the
U.S.) further compounded by the need to enroll patients at a very specific
point in their disease course. The study sought to enroll
patients–particularly children–with enough kidney deterioration to be able to
demonstrate clinical benefit/improvement but not so much disease burden that
the kidneys were beyond salvaging. While Celldex has been tracking a number of
patients for potential enrollment, some patients progressed too quickly and
others never progressed at all. To date, only one patient has been enrolled.
While this patient demonstrated initial evidence of clinical improvement, the
effect was not sustained. The results from this one patient combined with our
experience using this agent in the compassionate use setting have not provided
the conclusive results necessary for a feasible approval path in this disease.
Due to these challenges, Celldex has decided to close the study in DDD and
focus resources on our growing immuno-oncology pipeline at this time.

2014 Clinical Development Goals:

Rindopepimut:

  *Complete accrual of ACT IV, the Phase 3 registration study for patients
    with frontline GBM
  *Complete accrual of ReACT, the Phase 2 study for patients with recurrent
    GBM (both Group 1 and 2C); report data in late 2014

Glembatumumab vedotin:

  *Continue accrual of METRIC, the accelerated approval study for patients
    with triple negative breast cancer
  *Initiate a Phase 2 study for patients with metastatic melanoma
  *Initiate a Phase 2 study for patients with squamous cell lung cancer

Varlilumab:

  *Complete the Phase 1 solid tumor expansion cohorts and hematologic
    dose-escalation cohorts; data anticipated in mid-2014. Initiate expansion
    cohorts in lymphocytic malignancies as appropriate
  *Initiate a Phase 1/2 study of varlilumab and Yervoy (and potentially other
    checkpoint inhibitors) plus CDX-1401 in NY-ESO+ patients with metastatic
    melanoma
  *Initiate a Phase 1/2 study of varlilumab plus Tafinlar^® and Mekinist™
    (followed sequentially by a checkpoint inhibitor) for patients with B-raf
    mutated metastatic melanoma

CDX-1401:

  *Support a Phase 2 study of CDX-1401 and CDX-301 for patients with
    metastatic melanoma (NCI sponsored)

CDX-301:

  *Initiate a pilot study of CDX-301 alone and in combination with Mozobil in
    hematopoietic stem cell transplantation
  *Support a Phase 1/2 study of intratumoral injection of CDX-301 and
    Hiltonol^® in combination with low-dose radiotherapy for patients with
    low-grade B-cell lymphomas (investigator sponsored)

Fourth Quarter and Year-to-Date 2013 Financial Highlights and 2014 Guidance

Cash position: Cash, cash equivalents and marketable securities as of December
31, 2013 were $303.0 million compared to $136.6 million as of September 30,
2013. The increase was primarily driven by net proceeds to Celldex of $181.5
million from an underwritten financing and net proceeds from the exercise of
stock options of $2.5 million; partially offset by $2.1 million spent on
leasehold improvements to our new headquarters facility in Hampton, New Jersey
and our fourth quarter net cash burn of $15.5 million. As of December 31,
2013, Celldex had 89.2 million shares outstanding.

Revenues: Total revenue was $0.6 million in the fourth quarter of 2013 and
$4.1 million for the twelve months ended December 31, 2013, compared to $3.6
million and $11.2 million for the comparable periods in 2012. The decrease in
revenue was primarily due to the decrease in Rotarix^® royalty revenue with a
corresponding reduction in royalty expense.

R&D Expenses: Research and development (R&D) expenses were $17.8 million in
the fourth quarter of 2013 and $67.4 million for the twelve months ended
December 31, 2013, compared to $13.7 million and $47.4 million for the
comparable periods in 2012. The increase in Celldex's R&D investment was
primarily due to the continued progression of our late-stage rindopepimut
clinical development program as well as the planning and initiation of the
glembatumumab vedotin METRIC study and the expansion of the varlilumab study.

G&A Expenses: General and administrative (G&A) expenses were $4.7 million in
the fourth quarter of 2013 and $14.8 million for the twelve months ended
December 31, 2013 compared to $2.6 million and $10.0 million for the
comparable periods in 2012. The increase in G&A expenses was primarily
attributable to higher personnel-related expenses, professional services and
rindopepimut-related commercial planning costs in 2013.

Net loss: Net loss was $22.1 million, or ($0.27) per share, for the fourth
quarter of 2013 and $81.6 million, or ($1.02) per share, for the twelve months
ended December 31, 2013, compared to net loss of $16.8 million, or ($0.27) per
share, and $59.1 million, or ($1.02) per share, for the comparable periods in
2012.

Financial guidance: Celldex expects that its cash, cash equivalents and
marketable securities will be sufficient to fund its operating expenses and
capital expenditure requirements through 2016.

Webcast and Conference Call

Celldex will host a conference call and live webcast at 8:30 a.m. ET on
Monday, March 3, 2014, to discuss Celldex's fourth quarter and twelve month
2013 financial results and to provide an update on anticipated research and
development and business objectives for 2014. The conference call and
presentation will be webcast live over the Internet and can be accessed by
logging on to the Events Calendar under the "News & Events" section of the
Celldex Therapeutics website at www.celldextherapeutics.com. The call can also
be accessed by dialing (866) 743-9666 (within the United States) or (760)
298-5103 (outside the United States). The passcode is 39634623.

A replay of the call will be available approximately two hours after the live
call concludes through March 10, 2014. To access the replay, dial (855)
859-2056 (within the United States) or (404) 537-3406 (outside the United
States). The passcode is 39634623. The webcast will also be archived on the
Company's website.

Avastin^® is a registered trademark of Genentech; Yervoy^® is a registered
trademark of Bristol-Myers Squibb; Tafinlar^®, Mekinist™ and Rotarix^® are
registered trademarks of GlaxoSmithKline; Mozobil^® is a registered trademark
of Genzyme Corporation; Hiltonol^® is a registered trademark of Oncovir.

About Celldex Therapeutics, Inc.

Celldex is developing targeted therapeutics to address devastating diseases
for which available treatments are inadequate. Our pipeline is built from a
proprietary portfolio of antibodies and immunomodulators used alone and in
strategic combinations to create novel, disease-specific therapies that
induce, enhance or suppress the body's immune response. Visit www.celldex.com.

Forward Looking Statement

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), glembatumumab vedotin ("glemba"; CDX-011), varlilumab (CDX-1127),
CDX-1401, CDX-301 and other products and our goals for 2014. 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 ability to successfully complete research and further development and
commercialization of rindopepimut, glembatumumab vedotin and other drug
candidates; our ability to obtain additional capital to meet our long-term
liquidity needs 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; the uncertainties inherent in clinical testing
and accruing patients for clinical trials; our limited experience in bringing
programs through Phase 3 clinical trials; our ability to manage and
successfully complete multiple clinical trials and the research and
development efforts for our multiple products at varying stages of
development; the availability, cost, delivery and quality of clinical and
commercial grade materials produced by our own manufacturing facility or
supplied by contract manufacturers, who may be our sole source of supply;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.

CELLDEX THERAPEUTICS, INC.
(In thousands, except per share amounts)

CONSOLIDATED STATEMENTS      Quarter Ended           Year Ended
OF OPERATIONS DATA           December 31,            December 31,
                            2013        2012        2013         2012
                            (Unaudited)             
REVENUE                                                       
Product Development and      $43       $43       $160       $146
Licensing Agreements
Contracts and Grants        577        53         1,617       281
Product Royalties           --        3,551      2,334       10,775
                                                              
Total Revenue               620        3,647      4,111       11,202
                                                              
OPERATING EXPENSE                                             
Research and Development    17,804     13,748     67,401      47,398
Royalty                     --        3,551      2,334       10,775
General and Administrative  4,677      2,644      14,805      10,016
Amortization of Acquired     253        254        1,013       1,090
Intangible Assets
                                                              
Total Operating Expense     22,734     20,197     85,553      69,279
                                                              
Operating Loss              (22,114)   (16,550)   (81,442)    (58,077)
                                                              
Investment and Other Income, 137        94         819         530
Net
Interest Expense            (85)       (351)      (927)       (1,576)
                                                              
Net Loss                    $(22,062) $(16,807) $(81,550)  $(59,123)
                                                              
Basic and Diluted Net Loss   $(0.27)   $(0.27)   $(1.02)    $(1.02)
per Common Share
                                                              
                                                              
Weighted Average Common      83,042     62,544     79,777      57,713
Shares Outstanding
                                                              
                                                              
CONDENSED CONSOLIDATED                                        
BALANCE SHEETS                                      December 31, December 31,
                                                  2013         2012
                                                              
ASSETS                                                        
Cash, Cash Equivalents and                         $302,983   $83,962
Marketable Securities
Other Current Assets                              2,206       1,152
Property and Equipment, net                       9,973       7,205
Intangible and Other Assets,                       31,933      33,222
net
Total Assets                                      $347,095   $125,541
                                                              
LIABILITIES AND                                                
STOCKHOLDERS' EQUITY
Current Liabilities                               $20,350    $17,685
Long-Term Liabilities                             6,950       12,082
Stockholders' Equity                              319,795     95,774
Total Liabilities and                             $347,095   $125,541
Stockholders' Equity
                                                              

CONTACT: Company Contact:
         Sarah Cavanaugh
         Vice President of Investor Relations &
         Corp Communications
         Celldex Therapeutics, Inc.
         (781) 433-3161
         scavanaugh@celldex.com
        
         Media Inquiries:
         Dan Budwick
         Pure Communications, Inc.
         973.271.6085
         dan@purecommunicationsinc.com
 
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