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): May
3, 2012
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 May 3, 2012, Celldex Therapeutics, Inc. issued a press release announcing its financial results for the first quarter of 2012. 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 May 3, 2012.
[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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|
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Dated: |
May 3, 2012 | By: |
/s/ Avery W. Catlin |
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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 May 3, 2012. |
Exhibit 99.1
Celldex Reports First Quarter 2012 Financial Results
NEEDHAM, Mass.--(BUSINESS WIRE)--May 3, 2012--Celldex Therapeutics, Inc. (NASDAQ: CLDX) today reported financial results for the first quarter ended March 31, 2012. Celldex reported a net loss of $13.5 million, or $0.27 per share, for the first quarter of 2012 compared to a net loss of $10.1 million, or $0.31 per share, for the first quarter of 2011. At March 31, 2012, Celldex reported cash, cash equivalents and marketable securities of $92.1 million, which the Company believes will be sufficient to meet estimated working capital requirements and fund planned program development into 2014, including enrollment of both the pivotal ACT IV study and the ReACT Phase 2 study for rindopepimut (CDX-110).
“In the first quarter of 2012, Celldex continued to advance multiple late- and mid-stage product candidates,” said Anthony S. Marucci, President and Chief Executive Officer. “First, for rindopepimut, we have made very real progress with our pivotal Phase 3 global registration study in patients with newly diagnosed EGFRvIII-positive glioblastoma (ACT IV) and our randomized Phase 2 study in recurrent EGFRvIII-positive patients (ReACT). Second, in collaboration with Rockefeller University, Celldex initiated a Phase 1 study of CDX-301 (Mobista™), a potent stem cell mobilizer and dendritic cell growth factor, to support subsequent trials for patients requiring hematopoietic stem cell transplantation. On the business front, Celldex raised total net proceeds of $51.9 million which will provide continued financial support, particularly for our later-stage product candidates.”
First quarter and recent highlights:
The Company has
Upcoming events:
Further Financial Highlights
The net loss of $13.5 million for the first quarter of 2012 represents an increased loss of approximately $3.5 million when compared to the net loss for the same period in 2011, primarily due to an increase in research and development (R&D) expense in 2012.
Revenues for the first quarter of 2012 decreased when compared to revenues in 2011, primarily because of lower product royalty revenues related to Rotarix.
In the first quarter of 2012, R&D expense increased by approximately $3.9 million compared to the first quarter of 2011. Changes in R&D expense between 2012 and 2011 reflect higher clinical trial costs of $3.7 million primarily due to initiation and upfront expenses related to the ACT IV and ReACT rindopepimut studies.
General and administrative (G&A) expense in 2012 of $2.3 million was comparable to G&A expense in 2011 and included higher investor relations expenses, offset in part by lower professional services fees in the first quarter of 2012 compared to 2011.
During the quarter ended March 31, 2012, cash, cash equivalents and marketable securities increased by approximately $38.8 million from December 31, 2011, primarily due to our two financing transactions, offset partially by operating expenses incurred during the quarter.
As of March 31, 2012, Celldex had approximately 58.7 million shares outstanding.
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 vaccines 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 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 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.
CELLDEX THERAPEUTICS, INC. | |||||||||
(In thousands, except per share amounts) | |||||||||
CONSOLIDATED STATEMENT | Quarter | ||||||||
OF OPERATIONS DATA | Ended March 31, | ||||||||
2012 | 2011 | ||||||||
(Unaudited) | |||||||||
OPERATING REVENUE | |||||||||
Product Development | |||||||||
and Licensing Agreements | $ | 35 | $ | 14 | |||||
Contracts and Grants | 54 | - | |||||||
Product Royalties | 2,344 | 2,502 | |||||||
Total Revenue | 2,433 | 2,516 | |||||||
OPERATING EXPENSE | |||||||||
Research and Development | 10,769 | 6,853 | |||||||
Royalty | 2,344 | 2,502 | |||||||
General and Administrative | 2,317 | 2,336 | |||||||
Amortization of Acquired Intangible Assets | 291 | 483 | |||||||
Total Operating Expense | 15,721 | 12,174 | |||||||
Operating Loss | (13,288 | ) | (9,658 | ) | |||||
Investment and Other Income, Net | 205 | 84 | |||||||
Interest Expense | (433 | ) | (485 | ) | |||||
Net Loss | $ | (13,516 | ) | $ | (10,059 | ) | |||
Basic and Diluted Net Loss per | |||||||||
Common Share | $ | (0.27 | ) | $ | (0.31 | ) | |||
Weighted Average Common | |||||||||
Shares Outstanding | 50,145 | 32,047 | |||||||
CONDENSED CONSOLIDATED | |||||||||
BALANCE SHEETS DATA | March 31, | December 31, | |||||||
2012 | 2011 | ||||||||
(Unaudited) | |||||||||
ASSETS | |||||||||
Cash, Cash Equivalents and Marketable Securities | $ | 92,129 | $ | 53,312 | |||||
Other Current Assets | 2,107 | 1,372 | |||||||
Property and Equipment, net | 8,447 | 9,093 | |||||||
Intangible and Other Assets, net | 34,057 | 34,217 | |||||||
Total Assets | $ | 136,740 | $ | 97,994 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
Current Liabilities | $ | 12,546 | $ | 14,298 | |||||
Long-Term Liabilities | 16,308 | 14,974 | |||||||
Stockholders' Equity | 107,886 | 68,722 | |||||||
Total Liabilities and Stockholders' Equity | $ | 136,740 | $ | 97,994 |
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
Brad Miles, 646-513-3125
bmiles@bmccommunications.com