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Celldex Reports Fourth Quarter and Fiscal 2011 Financial Results
Mar 7, 2012
For the twelve months ended
"Celldex begins 2012 well positioned with our rindopepimut trials actively enrolling patients in a pivotal Phase 3 global study in front line glioblastoma and a Phase 2 combination study with Avastin® in recurrent glioblastoma. Our Phase 2b study of CDX-011 in advanced breast cancer has fully recruited and we expect to unveil data in the second quarter," said
Fourth Quarter and Recent Highlights
- Presented final median overall survival (OS) data from the rindopepimut Phase 2 multi-center ACT III study in patients with newly diagnosed EGFRvIII-positive glioblastoma (GB) at the
Society for Neuro-Oncology (SNO) Annual Meeting in November. The data showed a final median OS of 24.6 months from diagnosis, which is significantly better than 15.2 months for a historical cohort of patients selected to match ACT III eligibility criteria. The median OS data obtained from the 31 centers participating in the ACT III study are very consistent with two previous smaller studies with rindopepimut in GB (ACTIVATE and ACT II). - Initiated patient screening of the ACT IV study, Celldex's pivotal, randomized, double-blind, controlled Phase 3 trial of rindopepimut in patients with surgically resected EGFRvIII-positive GB. The primary endpoint of the study will be OS. The ACT IV study is expected to enroll up to 440 patients to recruit 374 patients with Gross Total Resection (GTR) for the primary OS analysis at over 150 clinical sites internationally. Secondary endpoints include: progression free survival (PFS); safety and tolerability of rindopepimut and GM-CSF in combination with temozolomide; neurologic status; and quality of life.
- Initiated patient screening of the ReACT study, a Phase 2 trial of rindopepimut in combination with Avastin® in patients with recurrent EGFRvIII-positive GB. This study will run in parallel with Celldex's ACT IV study. The ReACT study is expected to enroll approximately 95 patients in a first or second relapse of GB following receipt of standard therapy and will evaluate objective response rates (ORR), PFS and OS endpoints in this patient population. The study will be conducted at approximately 20 sites across
the United States . - Completed accrual of the EMERGE study, a randomized, multi-center, controlled Phase 2b study evaluating CDX-011 (glembatumumab vedotin) in patients with heavily pre-treated metastatic or locally advanced breast cancers that express glycoprotein NMB (GPNMB), including a significant portion of enrolled patients expected to have triple-negative disease.
- Initiated a Phase 1 study of Celldex's therapeutic human antibody candidate, CDX-1127, in patients with selected malignant solid tumors or hematologic cancers. CDX-1127 is a fully human monoclonal antibody that binds CD27, an important co-stimulatory molecule on T cells. CDX-1127, an agonist antibody designed to activate patients' immune cells against their cancer, has shown potent efficacy in several preclinical models. In addition, CD27 is over-expressed in certain lymphomas and leukemias and can be directly targeted by CDX-1127.
- Initiated a Phase 1 dose-escalation and safety study of CDX-301, or MobistaTM, a hematopoietic growth factor, in healthy subjects. The study is being conducted in collaboration with
Rockefeller University . CDX-301 is soluble, recombinant human FMS-like tyrosine kinase 3 ligand (Flt3L) and previous experience has shown that it increases the numbers and activity of blood stem cells and immune cells. CDX-301 is a potent stem cell mobilizer and dendritic cell growth factor. - Raised net proceeds of
$8.5 million through the sale of 2.5 million shares of common stock duringJanuary 2012 through a controlled equity offering facility with Cantor Fitzgerald & Co. - Conducted a successful Research and Development Day in
New York City led by three key opinion leaders, which highlighted our oncology pipeline. The webcast of our January R&D day presentation is available on our website at http://www.celldextherapeutics.com. - Issued 10.5 million shares of our common stock in an underwritten public offering resulting in net proceeds of
$37.7 million and granted the underwriters a 30-day option to purchase up to an aggregate of 1,575,000 additional shares of common stock to cover overallotments, if any.
Key 2012 Objectives
- Continue global recruitment in the ACT IV study of rindopepimut in front-line GB.
- Present topline results from the EMERGE randomized Phase 2b study of CDX-011 at the
American Society of Clinical Oncology (ASCO ) meeting inJune 2012 and make preparations for next steps in this program. - Complete enrollment of the ReACT study of rindopepimut in combination with Avastin in patients with recurrent EGFRvIII-positive glioblastoma.
- Complete enrollment of the Phase 1 dose-escalation study of CDX-1127 in patients with selected malignant solid tumors or hematologic cancers and determine next steps for this program.
- Complete enrollment of the Phase 1 clinical study of CDX-301 in healthy subjects and make preparations for next steps in this program.
- Initiate a Phase 2 pilot study of CDX-1135 (formerly TP10) in dense deposit disease (DDD), an orphan renal disease in children and young adults. The study will determine the appropriate dose and regimen for further clinical development of CDX-1135 based on safety, tolerability and biological activity.
Fourth Quarter and Year-to-Date Financial Highlights
The increase in net loss of
The net loss of
As of
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About
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 STATEMENTS | Quarter Ended | Year Ended | |||||||||||||||||
OF OPERATIONS DATA | December 31, | December 31, | |||||||||||||||||
2011 | 2010 | 2011 | 2010 | ||||||||||||||||
(Unaudited) | |||||||||||||||||||
REVENUE | |||||||||||||||||||
Product Development and | |||||||||||||||||||
Licensing Agreements | $ | 45 | $ | 36,070 | $ | 110 | $ | 40,187 | |||||||||||
Contracts and Grants | 30 | - | 36 | 220 | |||||||||||||||
Product Royalties | 2,358 | 1,651 | 9,119 | 6,386 | |||||||||||||||
Total Revenue | 2,433 | 37,721 | 9,265 | 46,793 | |||||||||||||||
OPERATING EXPENSE | |||||||||||||||||||
Research and Development | 9,824 | 6,741 | 32,439 | 27,650 | |||||||||||||||
Royalty | 2,358 | 6,800 | 9,119 | 12,077 | |||||||||||||||
General and Administrative | 2,343 | 2,581 | 9,243 | 10,428 | |||||||||||||||
Gain on Sale of Assets | - | - | (50 | ) | (50 | ) | |||||||||||||
Amortization of Acquired Intangible Assets | 291 | 483 | 1,913 | 3,143 | |||||||||||||||
Total Operating Expense | 14,816 | 16,605 | 52,664 | 53,248 | |||||||||||||||
Operating Income (Loss) | (12,383 | ) | 21,116 | (43,399 | ) | (6,455 | ) | ||||||||||||
Investment and Other Income, Net | 89 | 1,880 | 396 | 5,259 | |||||||||||||||
Interest Expense | (438 | ) | (335 | ) | (1,796 | ) | (1,337 | ) | |||||||||||
Net Income (Loss) | $ | (12,732 | ) | $ | 22,661 | $ | (44,799 | ) | $ | (2,533 | ) | ||||||||
Net Income (Loss) per Common Share - Basic | $ | (0.29 | ) | $ | 0.71 | $ | (1.13 | ) | $ | (0.08 | ) | ||||||||
Net Income (Loss) per Common Share - Diluted | $ | (0.29 | ) | $ | 0.70 | $ | (1.13 | ) | $ | (0.08 | ) | ||||||||
Weighted Average Common Shares Outstanding: | |||||||||||||||||||
Basic | 44,175 | 32,037 | 39,501 | 31,868 | |||||||||||||||
Diluted | 44,175 | 32,191 | 39,501 | 31,868 | |||||||||||||||
CONDENSED CONSOLIDATED | |||||||||||||||||||
BALANCE SHEETS | December 31, | December 31, | |||||||||||||||||
2011 | 2010 | ||||||||||||||||||
ASSETS | |||||||||||||||||||
Cash, Cash Equivalents and Marketable Securities | $ | 53,312 | $ | 61,098 | |||||||||||||||
Other Current Assets | 1,372 | 1,849 | |||||||||||||||||
Property and Equipment, net | 9,093 | 10,832 | |||||||||||||||||
Intangible and Other Assets, net | 34,217 | 36,164 | |||||||||||||||||
Total Assets | $ | 97,994 | $ | 109,943 | |||||||||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||||||||||||
Current Liabilities | $ | 14,298 | $ | 20,208 | |||||||||||||||
Long-Term Liabilities | 14,974 | 14,480 | |||||||||||||||||
Stockholders' Equity | 68,722 | 75,255 | |||||||||||||||||
Total Liabilities and Stockholders' Equity | $ | 97,994 | $ | 109,943 | |||||||||||||||
CELLDEX THERAPEUTICS, INC. | |||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS DATA | |||||||||||||||||||
(In thousands, except per share amounts) | |||||||||||||||||||
(Unaudited) | |||||||||||||||||||
Quarter Ended | Year Ended | ||||||||||||||||||
December 31, | December 31, | ||||||||||||||||||
2011 | 2010 | 2011 | 2010 | ||||||||||||||||
Reconciliation of basic net income (loss) per |
|||||||||||||||||||
share, in accordance with generally | |||||||||||||||||||
accepted accounting principles, with | |||||||||||||||||||
adjusted results: | |||||||||||||||||||
Net income (loss) per basic share | $ | (0.29 | ) | $ | 0.71 | $ | (1.13 | ) | $ | (0.08 | ) | ||||||||
Adjustment for the termination of the Pfizer | |||||||||||||||||||
license agreement | - | (35,594 | ) | - | (35,594 | ) | |||||||||||||
Net loss per basic share effect | - | (1.11 | ) | - | (1.12 | ) | |||||||||||||
Adjustment for costs capitalized in connection |
|||||||||||||||||||
the Pfizer license agreement | - | 5,089 | - | 5,089 | |||||||||||||||
Net income per basic share effect | - | 0.16 | - | 0.16 | |||||||||||||||
Adjusted net loss per basic share | $ | (0.29 | ) | $ | (0.24 | ) | $ | (1.13 | ) | $ | (1.04 | ) |
The adjusted net loss per basic share presented above is not in accordance with generally accepted accounting principles (GAAP). The above reconciliation identifies one-time items that resulted from Pfizer's termination of its rindopepimut license agreement with Celldex which management believes are not directly related to ongoing operations. Management has excluded these items from its non-GAAP adjusted amounts, thereby providing investors with information that may help them to compare ongoing operating performance.
Source:
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, 917-570-7340
brad@bmccommunications.com