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 5, 2009

CELLDEX THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)


Delaware

0-15006

13-3191702

(State or other jurisdiction

of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

119 Fourth Avenue
Needham, Massachusetts 02494-2725

 

(Address of principal executive offices)(Zip Code)

(781) 433-0771
(Registrant’s telephone number, including area code)

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 5, 2009, Celldex Therapeutics, Inc. issued a press release announcing its financial results for the second quarter of 2009.  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 5, 2009.





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SIGNATURE

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


Celldex Therapeutics, Inc.

 

 

Dated:

August 5, 2009 By:  

/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 5, 2009.

Exhibit 99.1

Celldex Reports Second Quarter and Six Month 2009 Financial Results

- Conference Call Wednesday, August 5, at 9:00 a.m. Eastern Time -

NEEDHAM, Mass.--(BUSINESS WIRE)--August 5, 2009--Celldex Therapeutics, Inc. (NASDAQ: CLDX) today reported financial results for the second quarter and six-month period ended June 30, 2009. Celldex reported a net loss of $8.7 million, or $0.55 per share, for the second quarter of 2009 compared to a net loss of $10.3 million, or $0.67 per share, for the second quarter of 2008. For the six months ended June 30, 2009, Celldex reported a net loss of $16.4 million, or $1.04 per share, compared to a net loss of $32.4 million, or $2.56 per share, for the six months ended June 30, 2008. At June 30, 2009, Celldex reported cash and cash equivalents of $31.6 million.

On May 29, 2009, Celldex Therapeutics announced that the Company has entered into a definitive agreement to acquire CuraGen Corporation (NASDAQ: CRGN). The transaction, subject to shareholder approval, is expected to close in the third quarter of 2009.

“Celldex launched a major strategic initiative one year ago to acquire a series of selected assets to fuel our Precision Targeted Immunotherapy Platform for future growth,” said Anthony S. Marucci, Celldex’s President and Chief Executive Officer. “The proposed acquisition of CuraGen - the fourth and most significant transaction of the last twelve months - fulfills this initiative and adds a portfolio of oncology-focused antibodies to our platform and substantial cash resources.

The second quarter also brought considerable progress in our current clinical development programs as we presented data on multiple studies at the American Society of Clinical Oncology Annual Meeting including poster presentations on updated results from Phase 2 studies of our lead candidate, CDX-110 in glioblastoma multiforme, and an oral presentation on CDX-1307, the first antibody-based dendritic cell targeted vaccine resulting from our platform. As we transition to the second half of 2009, we believe we are very well positioned with a pipeline of immunotherapy-based product candidates, multiple upcoming value-driving milestones and a strong balance sheet, made stronger by the CuraGen merger,” concluded Marucci.


Second quarter and recent highlights:

Further Financial Highlights

The net loss of $8.7 million for the second quarter of 2009 represents a decrease of $1.6 million when compared to the net loss for the same period in 2008 and is primarily due to an increase in revenue and a decrease in operating expense. R&D expense in the second quarter of 2009 increased by $0.2 million compared to R&D expense in 2008 due primarily to increased personnel-related expenses, laboratory materials and services and clinical trials costs for CDX-110 and CDX-1307. G&A expenses in the second quarter of 2009 decreased by $1.1 million to $3.5 million as compared to $4.6 million in 2008, primarily due to a decrease in personnel-related expenses in 2009. G&A expenses for this quarter included approximately $1 million, or $0.06 per share, of transaction expenses recorded in connection with the CuraGen acquisition.


The net loss of $16.4 million for the first six months of 2009 represents an improvement of $16.0 million when compared to the net loss for the same period in 2008, primarily due to the non-cash charge of $14.8 million for purchased in-process R&D recorded in 2008. R&D expense in the first six months of 2009 increased by $4.4 million compared to R&D expense in 2008 due primarily to the combined operations of AVANT and Celldex for the full six-month period in 2009, including increased personnel-related expenses, royalty and license fee expenses, clinical trials costs for CDX-110 and CDX-1307 and facility-related costs. G&A expenses decreased by $0.8 million to $6.9 million in 2009 as compared to G&A expense of $7.6 million in the first six months of 2008, primarily due to reduced personnel-related expenses.

Revenues for the first six months of 2009 increased by $4.3 million compared with revenues for 2008. The increase in product development and licensing revenue in 2009 primarily reflects recognition of $2.1 million in Pfizer deferred revenue related to CDX-110 in 2009. The decrease in contracts and grants revenue in 2009 compared to 2008 primarily reflects the deferral of certain revenues billable to Rockefeller University. In 2009, Celldex also recognized $3.2 million in product royalty revenue related to offsetting royalty expense payable to Cincinnati Children’s Hospital.

As of June 30, 2009, the Company had approximately 15.9 million shares outstanding.

Important Information Related to Celldex’s Financial Results

On March 7, 2008, privately-held Celldex Therapeutics, Inc. completed its merger with a wholly-owned subsidiary of AVANT Immunotherapeutics, Inc. and, effective October 1, 2008, AVANT changed its name to Celldex Therapeutics, Inc. In connection with the merger, the Company implemented a 1-for-12 reverse stock split of its common stock on March 7, 2008.

The merger was accounted for using the purchase method of accounting and was treated as an acquisition by Celldex of AVANT, with Celldex being considered the accounting acquirer even though AVANT was the issuer of common stock and surviving legal entity in the transaction. Because Celldex was determined to be the acquirer for accounting purposes, the historical financial statements of Celldex became the historical financial statements of the Company. Accordingly, the financial statements of the Company prior to the merger reflect the financial position, results of operations and cash flows of pre-merger, privately-held Celldex only.


Webcast and Conference Call

Celldex will host a conference call and live audio webcast at 9:00 AM ET on Wednesday, August 5, 2009, to discuss Celldex’s second quarter and six month 2009 financial results. The conference call will be webcast live over the Internet and can be accessed by logging on to the "News & Events" section of the Celldex Therapeutics website at http://www.celldextherapeutics.com. The call can also be accessed by dialing 888-713-4216 (within the U.S.) or 617-213-4868 (if calling from outside the U.S.). The passcode for participants is 31965468. An audio replay will be available approximately two hours after the call for approximately one week and can be accessed by dialing 888-286-8010 (within the U.S.) or 617-801-6888 (if calling from outside the U.S.). The passcode I.D. number is 59806260. The replay will also be available via the Company’s website, http://www.celldextherapeutics.com, after the live call. Additionally, a copy of this press release is available by contacting Investor Relations at 781-433-0771.

About Celldex Therapeutics, Inc.

Celldex Therapeutics is an integrated biopharmaceutical company that applies its comprehensive Precision Targeted Immunotherapy Platform to generate a pipeline of candidates to treat cancer and other difficult-to-treat diseases. Celldex’s immunotherapy platform includes a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators 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 of CDX-110, CDX-1307, Ty800, CDX-1135 (formerly TP10), CDX-1401 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 ability to close the merger of our wholly-owned subsidiary with CuraGen Corporation; the successful integration of the businesses, multiple technologies and programs of CuraGen and Celldex; our ability to adapt APC Targeting TechnologyTM to develop new, safe and effective vaccines against 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 ability to manage research and development efforts for multiple products at varying stages of development; Pfizer’s and our strategy and business plans concerning the continued development and commercialization of CDX-110; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; the inability to obtain additional capital; the inability 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 risks detailed from time to time in the Company's filings with the Securities and Exchange Commission, including the Company's Form 10-K for the fiscal year ended December 31, 2008, and its Forms 10-Q and 8-K.

-table follows-


CELLDEX THERAPEUTICS, INC.
(In thousands, except share and per share amounts)
         
 
CONSOLIDATED STATEMENTS Quarter Six Months
OF OPERATIONS DATA   Ended June 30,   Ended June 30,
2009 2008 2009 2008
(Unaudited) (Unaudited)
REVENUE
Product Development and
Licensing Agreements $ 1,497 $ 871 $ 2,999 $ 990
Contracts and Grants - 254 139 282
Product Royalties     1,188       837       3,279       837  
 
Total Revenue     2,685       1,962       6,417       2,109  
 
OPERATING EXPENSE
Research and Development 7,802 7,612 16,488 12,117
General and Administrative 3,511 4,606 6,851 7,620
Gain on Sale of Assets - - (604 ) -
Charge for Purchased In-Process
Research and Development - - - 14,756
Amortization of Acquired Intangible Assets     95       104       191       153  
 
Total Operating Expense     11,408       12,322       22,926       34,646  
 
Operating Loss (8,723 ) (10,360 ) (16,509 ) (32,537 )
 
Investment and Other Income, Net     18       99       101       146  
 
Net Loss   $ (8,705 )   $ (10,261 )   $ (16,408 )   $ (32,391 )
 
Basic and Diluted Net Loss per
  Common Share   $ (0.55 )   $ (0.67 )   $ (1.04 )   $ (2.56 )
Weighted Average Common
  Shares Outstanding     15,834       15,227       15,826       12,677  
 
 
 
CONDENSED CONSOLIDATED
BALANCE SHEETS           June 30,   December 31,
2009 2008
(Unaudited)
ASSETS
Cash and Cash Equivalents $ 31,633 $ 44,257
Other Current Assets 1,876 2,819
Property and Equipment, net 12,551 13,567
Intangible and Other Assets, net   8,352     9,150  
Total Assets $ 54,412   $ 69,793  
 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities $ 12,856 $ 14,101
Long-Term Liabilities 37,253 37,558
Stockholders' Equity   4,303     18,134  
Total Liabilities and Stockholders' Equity $ 54,412   $ 69,793  

CONTACT:
Celldex Therapeutics, Inc.
Anthony S. Marucci, 781-433-0771
President and CEO
or
Avery W. Catlin, 781-433-0771
Chief Financial Officer
IR@celldextherapeutics.com
or
For Media:
BMC Communications Group
Dan Budwick, 973-271-6085
dbudwick@bmccommunications.com