UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 8-K


CURRENT REPORT

Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) August 6, 2014 


Celldex Therapeutics, Inc.
(Exact name of registrant as specified in its charter)

Delaware 000-15006 13-3191702
(State or other jurisdiction
of incorporation)
(Commission File Number) (IRS Employer Identification No.)

Perryville III Building, 53 Frontage Road, Suite 200
Hampton, New Jersey
08827
(Address of principal executive offices) (Zip Code)

Registrant's telephone number, including area code:   (908) 200-7500

________________________________________________________________________________
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

    [   ]   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
    [   ]   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
    [   ]   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
    [   ]   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Item 2.02. Results of Operations and Financial Condition.

On August 6, 2014, Celldex Therapeutics, Inc. (the "Company") issued a press release announcing its financial results for the second quarter of 2014. The full text of the press release is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.

The information in this Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits
99.1 Press Release of Celldex Therapeutics, Inc., dated August 6, 2014.


SIGNATURE

    Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

    Celldex Therapeutics, Inc.
(Registrant)


August 6, 2014
(Date)
  /s/   AVERY W. CATLIN
Avery W. Catlin
Senior Vice President and
Chief Financial Officer


Exhibit Index

99.1 Press Release of Celldex Therapeutics, Inc., dated August 6, 2014.


Celldex Reports Second Quarter 2014 Results

EXHIBIT 99.1

Celldex Reports Second Quarter 2014 Results

Management to Host Conference Call Today, Wednesday, August 6, at 4:30 p.m. Eastern Time

HAMPTON, N.J., Aug. 6, 2014 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported business and financial highlights for the second quarter ended June 30, 2014.

"Celldex has made tremendous progress advancing our pipeline this year—most notably, we will complete patient screening in the coming weeks for our Phase 3 ACT IV study of rindopepimut in newly-diagnosed glioblastoma, an aggressive form of brain cancer," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "The ACT IV study will include 700 patients with EGFRvIII positive glioblastoma from more than 200 clinical trial sites across 22 countries—the most comprehensive study conducted by a biotech company to date in this orphan disease. We are extremely proud of our team and very grateful to the patients, families and physicians who are participating in this study.

In the second quarter, we also accomplished a number of additional, significant milestones—advancing our accelerated approval study of glembatumumab vedotin in triple negative breast cancer, publishing positive data from the CDX-1401 program, presenting positive data from our Phase 1 varlilumab program at ASCO and announcing a clinical trial collaboration with BMS for the varlilumab program. This momentum is expected to continue in the second half of 2014 as we initiate multiple new studies across our pipeline and present data from our Phase 2 ReACT study in recurrent glioblastoma at year-end."

Program Updates:

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

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

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

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

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

Second Quarter and First Six Months 2014 Financial Highlights and 2014 Guidance

Cash position: Cash, cash equivalents and marketable securities as of June 30, 2014 were $252.4 million compared to $274.2 million as of March 31, 2014. The decrease was primarily driven by our second quarter net cash burn of $21.8 million, offset in part by a one-time payment of $5 million from BMS. As of June 30, 2014 Celldex had 89.4 million shares outstanding.

Revenues: Total revenue was $0.6 million in the second quarter of 2014 and $1.0 million for the six months ended June 30, 2014, compared to $0.1 million and $2.5 million for the comparable periods in 2013. The increase in the second quarter of 2014 was primarily due to our clinical trial collaboration with BMS and our research and development agreement with Rockefeller. The decrease in the six months ended June 30, 2014 was primarily due to the decrease in Rotarix® royalty revenue. Our agreement with GlaxoSmithKline terminated upon the anticipated expiration of the last relevant patent right covered by the GlaxoSmithKline agreement. We do not expect additional royalty revenue or royalty expense related to Rotarix.

R&D Expenses: Research and development (R&D) expenses were $24.1 million in the second quarter of 2014 and $51.2 million for the six months ended June 30, 2014, compared to $15.1 million and $29.2 million for the comparable periods in 2013. The increase in Celldex's R&D investment was primarily due to the continued progression of our late-stage clinical development programs, rindopepimut and glembatumumab vedotin, and the continued expansion of the varlilumab program.

G&A Expenses: General and administrative (G&A) expenses were $4.8 million in the second quarter of 2014 and $9.4 million for the six months ended June 30, 2014, compared to $3.4 million and $6.5 million for the comparable periods in 2013. The increase in G&A expenses was primarily attributable to higher personnel-related expenses and rindopepimut and glembatumumab vedotin commercial planning costs in 2014.

Net loss: Net loss was $28.3 million, or ($0.32) per share, for the second quarter of 2014 and $58.2 million, or ($0.65) per share, for the six months ended June 30, 2014, compared to a net loss of $19.0 million, or ($0.24) per share and $36.3 million, or ($0.47) per share for the comparable periods in 2013.

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 4:30 p.m. ET on Wednesday, August 6, 2014, to review the second quarter 2014 financial results and to provide an update on key research and development and business objectives for the remainder of 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 75485305.

A replay of the call will be available approximately two hours after the live call concludes through August 13, 2014. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 75485305. The webcast will also be archived on the Company's website.

Avastin® is a registered trademark of Genentech; Yervoy® and Opdivo® are registered trademarks of Bristol-Myers Squibb; 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 ("rindo"; CDX-110), glembatumumab vedotin ("glemba"; CDX-011), varlilumab ("varli"; 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.

                                                                                                --table follows--

 
 CELLDEX THERAPEUTICS, INC. 
 (In thousands, except per share amounts) 
 
 
CONSOLIDATED STATEMENTS  Quarter Six Months
OF OPERATIONS DATA  Ended June 30, Ended June 30,
  2014 2013 2014 2013
  (Unaudited) (Unaudited)
REVENUE         
Product Development and Licensing Agreements  $ 200  $ 47  $ 235  $ 77
Contracts and Grants   392  50  773  100
Product Royalties   --   --   --   2,334
         
Total Revenue   592  97  1,008  2,511
         
OPERATING EXPENSE         
Research and Development   24,100  15,090  51,169  29,180
Royalty   --   --   --   2,334
General and Administrative   4,787  3,411  9,369  6,549
Amortization of Acquired Intangible Assets   254  254  507  507
         
Total Operating Expense   29,141  18,755  61,045  38,570
         
Operating Loss   (28,549)  (18,658)  (60,037)  (36,059)
         
Investment and Other Income, Net   275  161  1,860  540
Interest Expense   --   (519)  --   (829)
         
Net Loss   $ (28,274)  $ (19,016)  $ (58,177)  $ (36,348)
         
Basic and Diluted Net Loss per Common Share   $ (0.32)  $ (0.24)  $ (0.65)  $ (0.47)
Weighted Average Common Shares Outstanding   89,361  80,899  89,316  77,482
         
         
         
CONDENSED CONSOLIDATED         
BALANCE SHEETS      June 30, December 31,
      2014 2013
      (Unaudited)  
ASSETS         
Cash, Cash Equivalents and Marketable Securities       $ 252,369  $ 302,983
Other Current Assets       3,228  2,206
Property and Equipment, net       10,601  9,973
Intangible and Other Assets, net       31,394  31,933
Total Assets       $ 297,592  $ 347,095
         
LIABILITIES AND STOCKHOLDERS' EQUITY         
Current Liabilities       $ 21,202  $ 20,350
Long-Term Liabilities       11,075  6,950
Stockholders' Equity       265,315  319,795
Total Liabilities and Stockholders' Equity       $ 297,592  $ 347,095
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