Celldex Reports Second Quarter 2013 Financial Results
"In the second quarter, Celldex continued to advance multiple clinical programs towards key inflection points," said
Rindopepimut in EGFRv3—Positive Glioblastoma (GBM):
- Celldex continues to actively enroll newly diagnosed patients with GBM in the Phase 3 ACT IV study with a goal to complete enrollment by the end of 2013.
The Company continues to advance the ReACT study in recurrent GBM. The study includes two groups—group 1 is comprised of patients who are Avastin® naïve and group 2 is comprised of patients who are Avastin refractory. Celldex anticipates reporting data from the ReACT study at the
Society for Neuro-Oncology(SNO) Annual Meeting in November 2013.
CDX-011 (Glembatumumab vedotin) in Breast Cancers that Over-express GPNMB
- Celldex continues to advance plans for the initiation of a randomized, accelerated approval study (the METRIC study) of CDX-011 in patients with triple negative breast cancers that over-express GPNMB and expects to initiate METRIC in the second half of 2013.
The study will be conducted in approximately 100 sites, primarily in
the United Stateswith additional sites in Canadaand Australia.
- Celldex has selected a partner to develop the diagnostic for the METRIC study.
CDX-1127 Targeting CD27 in Solid Tumors and Hematologic Malignancies
- Celldex has completed enrollment of the solid tumor dose-escalation portion of the ongoing Phase 1 study and recently initiated expansion cohorts in metastatic melanoma and renal cell carcinoma. The study continues to enroll patients in the dose-escalation portion of the lymphoma and leukemia arm and expansion studies are planned when this phase of the study completes. Celldex anticipates presenting data from the solid tumor dose-escalation portion of the study and the corresponding expansion cohorts by the end of 2013. Reporting of data from the hematologic arm is anticipated in 2014.
- The Company announced the issuance of a seminal patent for CD27 agonists (US Patent No: 8,481,029) which broadly supports the Company's product candidate CDX-1127. The patent includes 18 claims covering various methods of treating cancer using agonistic anti-human CD27 antibodies.
- Celldex presented results from an in vitro study of CDX-1127 at AACR 2013 that further confirmed that CDX-1127 elicits potent activation of T cells by inducing their proliferation and release of important immune modulating cytokines. Most importantly, the data demonstrated that this activation is highly regulated, which limits any safety concerns related to non-specific stimulation of the immune system that similar candidates in this class have faced. This finding is supported by the favorable safety profile observed to date in the Phase 1 study.
CDX-1135 in Dense Deposit Disease (DDD)
- The Company announced that the first patient in the pilot study of CDX-1135 (a soluble form of human complement receptor type 1) in DDD has been dosed. DDD is an ultra-rare, progressive kidney disease that ultimately results in kidney failure in the majority of affected individuals. The study will continue to enroll patients and the Company anticipates presenting preliminary data by the end of 2013.
- Celldex continues to advance plans to initiate a pilot clinical study of CDX-301 (Flt3L) in hematopoietic stem cell transplant (HSTC) in the second half of 2013.
The Company recently finalized a cooperative research and development agreement (CRADA) with the Cancer Immunotherapy Trials Network (CITN) of the
National Cancer Instituteto initiate a Phase 2 study of CDX-1401 in combination with CDX-301 in malignant melanoma.
Further Financial Highlights
Second Quarter and First Six Months 2013 Results
Total revenue in the second quarter of 2013 was
Research and development (R&D) expenses in the second quarter of 2013 were
General and administrative (G&A) expenses in the second quarter of 2013 were
Avastin is a registered trademark of
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 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 ability to successfully complete research and further development and commercialization of rindopepimut, CDX-011 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; our ability to adapt our 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)|
OF OPERATIONS DATA
|Product Development and Licensing Agreements||$ 47||$ 40||$ 77||$ 75|
|Contracts and Grants||50||96||100||149|
|Research and Development||15,090||11,114||29,180||21,881|
|General and Administrative||3,411||2,219||6,549||4,536|
|Amortization of Acquired Intangible Assets||254||291||507||583|
|Total Operating Expense||18,755||15,497||38,570||31,218|
|Investment and Other Income, Net||161||126||540||331|
|Net Loss||$ (19,016)||$ (13,773)||$ (36,348)||$ (27,289)|
|Basic and Diluted Net Loss per Common Share||$ (0.24)||$ (0.23)||$ (0.47)||$ (0.50)|
|Weighted Average Common Shares Outstanding||80,899||58,733||77,482||54,439|
|Cash, Cash Equivalents and Marketable Securities||$ 154,983||$ 83,962|
|Other Current Assets||1,447||1,152|
|Property and Equipment, net||7,338||7,205|
|Intangible and Other Assets, net||32,465||33,222|
|Total Assets||$ 196,233||$ 125,541|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Current Liabilities||$ 12,503||$ 17,685|
|Total Liabilities and Stockholders' Equity||$ 196,233||$ 125,541|
Sarah CavanaughVice President of Investor Relations & Corp Communications Celldex Therapeutics, Inc.(781) 433-3161 firstname.lastname@example.org
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