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): November
4, 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 |
|
|
(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 November 4, 2009, Celldex Therapeutics, Inc. issued a press release announcing its financial results for the third 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 November 4, 2009. |
[Remainder of page left blank intentionally]
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. |
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|
|||||
Dated: |
November 4, 2009 | By: |
/s/ Avery W. Catlin |
||
Avery W. Catlin |
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Senior Vice President and |
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Chief Financial Officer |
Exhibit Index
99.1 |
Press Release of Celldex Therapeutics, Inc., dated November 4, 2009. |
Exhibit 99.1
Celldex Therapeutics Reports Third Quarter and Nine Month 2009 Financial Results
NEEDHAM, Mass.--(BUSINESS WIRE)--November 4, 2009--Celldex Therapeutics, Inc. (NASDAQ: CLDX) today reported financial results for the third quarter and nine-month period ended September 30, 2009. Celldex reported a net loss of $7.2 million, or $0.45 per share, for the third quarter of 2009 compared to a net loss of $7.7 million, or $0.49 per share, for the third quarter of 2008. For the nine months ended September 30, 2009, Celldex reported a net loss of $23.6 million, or $1.49 per share, compared to a net loss of $40.0 million, or $2.92 per share, for the nine months ended September 30, 2008. At September 30, 2009, Celldex reported cash and cash equivalents of $26.0 million. At September 30, 2009, CuraGen Corporation, which Celldex acquired on October 1, 2009, had cash and investments of $70.3 million and 4% convertible subordinated debt of $12.5 million, due in February 2011.
“Celldex has made tremendous progress on key strategic initiatives in 2009,” said Anthony S. Marucci, President and Chief Executive Officer. “With the successful completion of the CuraGen acquisition, we added an exciting portfolio of oncology-focused antibodies to our pipeline and significantly strengthened our balance sheet. In the clinic, we have accrued the required 60 patients to the ACT III study for CDX-110 [PF-04948569] and we have further strengthened our pipeline—reporting positive data from Phase 1 studies of CDX-1307 in difficult to treat epithelial cancers and initiating a Phase 1/2 study of CDX-1401 in patients with malignant solid tumors. Both of these candidates originated from our Precision Targeted Immunotherapy Platform and utilize our novel antibody-based vaccine technology to deliver vaccine directly to cancer-associated targets in the body. Looking forward, we will continue the momentum, advancing ongoing studies and initiating a Phase 2 study of CDX-1307 in bladder cancer in the first quarter of 2010.”
Third quarter and recent highlights:
CuraGen Acquisition Financial Details
On October 1, 2009, CuraGen Corporation (“CuraGen”), a former publicly-traded company, merged with a wholly-owned subsidiary of Celldex (the “CuraGen Merger”) in accordance with a definitive merger agreement dated May 28, 2009 (the “CuraGen Merger Agreement”) and as approved at special meetings of Celldex’s and CuraGen’s shareholders on September 30, 2009. In connection with the CuraGen Merger, Celldex (i) issued 0.2739 shares of Celldex in exchange for each share of outstanding CuraGen common stock, plus cash in lieu of fractional shares (the “CuraGen Exchange Ratio”) (Celldex issued a total of 15,722,713 shares of Celldex common stock to the former stockholders of CuraGen), (ii) assumed all of the CuraGen stock options outstanding under the CuraGen 2007 Stock Plan, or options exercisable into 931,315 shares of Celldex common stock, and (iii) CuraGen, as a wholly-owned subsidiary of Celldex, retained its obligation for the $12.5 million in CuraGen 4% convertible subordinated debt due in February 2011. Accordingly, the results of operations of CuraGen will be included in the results of operations of Celldex beginning October 1, 2009.
Further Financial Highlights
The net loss of $7.2 million for the third quarter of 2009 represents a decrease of $0.5 million when compared to the net loss for the same period in 2008 and is primarily due to an increase in revenue, partially offset by an increase in operating expense and a decrease in investment income. R&D expense in the third quarter of 2009 increased by $0.6 million compared to R&D expense in 2008 due primarily to increased personnel-related expenses, laboratory materials and services, and royalty expense and license fees. G&A expenses in the third quarter of 2009 decreased by $0.3 million to $3.9 million as compared to $4.2 million in 2008, primarily due to a decrease in personnel-related expenses in 2009. G&A expenses for this quarter included approximately $2.3 million, or $0.15 per share, of transaction expenses recorded in connection with the CuraGen acquisition. The decrease in cash and cash equivalents of $5.6 million from June 30, 2009 includes one-time cash payments of $0.8 million for CuraGen merger-related costs.
The net loss of $23.6 million for the first nine months of 2009 represents an improvement of $16.4 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 nine months of 2009 increased by $5.0 million compared to R&D expense in 2008 due primarily to the combined operations of AVANT and Celldex for the full nine-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 $1.1 million to $10.7 million in 2009 as compared to G&A expense of $11.8 million in the first nine months of 2008, primarily due to reduced personnel-related expenses.
Revenues for the first nine months of 2009 increased by $6.0 million compared with revenues for 2008. The increase in product development and licensing revenue in 2009 primarily reflects recognition of $3.9 million in Pfizer deferred revenue related to CDX-110 in 2009. The increase in contracts and grants revenue in 2009 compared to 2008 primarily reflects revenues for work performed for Rockefeller University. In 2009, Celldex also recognized $5.1 million in product royalty revenue related to offsetting royalty expense payable to Cincinnati Children’s Hospital.
As of September 30, 2009, which was prior to the closing of the CuraGen Merger, Celldex 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 AVANT/Celldex 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.
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 successfully integrate 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 | Nine Months | |||||||||||||||
OF OPERATIONS DATA | Ended September 30, | Ended September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | ||||||||||||||
(Unaudited) | (Unaudited) | ||||||||||||||||
REVENUE | |||||||||||||||||
Product Development and | |||||||||||||||||
Licensing Agreements | $ | 1,339 | $ | 1,245 | $ | 4,338 | $ | 2,236 | |||||||||
Contracts and Grants | 799 | 138 | 939 | 419 | |||||||||||||
Product Royalties | 1,892 | 975 | 5,170 | 1,812 | |||||||||||||
Total Revenue | 4,030 | 2,358 | 10,447 | 4,467 | |||||||||||||
OPERATING EXPENSE | |||||||||||||||||
Research and Development | 7,241 | 6,626 | 23,729 | 18,743 | |||||||||||||
General and Administrative | 3,850 | 4,206 | 10,701 | 11,825 | |||||||||||||
Gain on Sale of Assets | - | - | (604 | ) | - | ||||||||||||
Charge for Purchased In-Process | |||||||||||||||||
Research and Development | - | - | - | 14,756 | |||||||||||||
Amortization of Acquired Intangible Assets | 95 | 104 | 286 | 257 | |||||||||||||
Total Operating Expense | 11,186 | 10,936 | 34,112 | 45,581 | |||||||||||||
Operating Loss | (7,156 | ) | (8,578 | ) | (23,665 | ) | (41,114 | ) | |||||||||
Investment and Other Income | |||||||||||||||||
(Expense), Net | (18 | ) | 922 | 83 | 1,067 | ||||||||||||
Net Loss | $ | (7,174 | ) | $ | (7,656 | ) | $ | (23,582 | ) | $ | (40,047 | ) | |||||
Basic and Diluted Net Loss per | |||||||||||||||||
Common Share | $ | (0.45 | ) | $ | (0.49 | ) | $ | (1.49 | ) | $ | (2.92 | ) | |||||
Weighted Average Common | |||||||||||||||||
Shares Outstanding | 15,879 | 15,708 | 15,844 | 13,695 | |||||||||||||
CONDENSED CONSOLIDATED | |||||||||||||||||
BALANCE SHEETS | September 30, | December 31, | |||||||||||||||
2009 | 2008 | ||||||||||||||||
(Unaudited) | |||||||||||||||||
ASSETS | |||||||||||||||||
Cash and Cash Equivalents | $ | 25,985 | $ | 44,257 | |||||||||||||
Other Current Assets | 2,025 | 2,819 | |||||||||||||||
Property and Equipment, net | 12,015 | 13,567 | |||||||||||||||
Intangible and Other Assets, net | 8,077 | 9,150 | |||||||||||||||
Total Assets | $ | 48,102 | $ | 69,793 | |||||||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||||||||||
Current Liabilities | $ | 14,107 | $ | 14,101 | |||||||||||||
Long-Term Liabilities | 36,235 | 37,558 | |||||||||||||||
Stockholders' (Deficit) Equity | (2,240 | ) | 18,134 | ||||||||||||||
Total Liabilities and Stockholders' Equity | $ | 48,102 | $ | 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
Matthew Driscoll, 212-477-9007
x20
mdriscoll@bmccommunications.com