PHILLIPSBURG, N.J., Nov. 8, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported financial results for the third quarter ended September 30, 2013. Celldex reported a net loss of $23.1 million, or $0.29 per share, for the third quarter of 2013 compared to a net loss of $15.0 million, or $0.25 per share, for the third quarter of 2012. For the nine months ended September 30, 2013, Celldex reported a net loss of $59.5 million, or $0.76 per share, compared to a net loss of $42.3 million, or $0.75 per share, for the nine months ended September 30, 2012. At September 30, 2013, Celldex reported $136.6 million in cash, cash equivalents and marketable securities.
"As we approach year-end, Celldex is well positioned to achieve a number of milestones that will play an important role in advancing our pipeline into 2014 and beyond," said Anthony Marucci, President and Chief Executive Officer. "We remain on track to initiate our accelerated approval study of CDX-011 in triple negative breast cancer and we continue to make excellent progress advancing our Phase 3 study of rindopepimut in frontline glioblastoma. We also recently announced the initiation of an expansion cohort for our ReACT study in refractory glioblastoma and will present data from ReACT in an oral session at the Society for Neuro-Oncology meeting in late November. In addition, we are presenting data from the Phase 1 CDX-1127 study at the Society for Immunotherapy of Cancer Meeting this weekend."
Rindopepimut in EGFRvIII(v3)–Positive Glioblastoma (GBM):
Glembatumumab vedotin ("glemba"; CDX-011) in Breast Cancers that Over-express GPNMB
CDX-1127 Targeting CD27 in Solid Tumors and Hematologic Malignancies
CDX-1135 in Dense Deposit Disease (DDD)
Further Financial Highlights
Third Quarter and First Nine Months 2013 Results
Total revenue in the third quarter of 2013 was $1.0 million, compared to $3.1 million in the third quarter of 2012. Total revenue for the nine months ended September 30, 2013 was $3.5 million, compared to $7.6 million for the nine months ended September 30, 2012. The decrease in revenue was primarily due to the decrease in Rotarix® royalty revenue with a corresponding reduction in royalty expense. Our agreement with GlaxoSmithKline terminated upon the anticipated expiration of the last relevant patent right covered by the GlaxoSmithKline agreement. We do not expect additional royalty revenue or royalty expense related to Rotarix®. Included in revenue for the third quarter of 2013 was $0.9 million recognized from a new services contract with Rockefeller University for the development and manufacture of two anti-HIV antibodies.
Research and development (R&D) expenses in the third quarter of 2013 were $20.4 million, compared to $11.8 million in the second quarter of 2012. R&D expenses for the nine months ended September 30, 2013 were $49.6 million, compared to $33.7 million for the nine months ended September 30, 2012. The increase in Celldex's R&D investment was primarily due to the continued progression of our late-stage rindopepimut clinical development program, including ACT IV and ReACT, as well as planning for the METRIC study and the expansion of the CDX-1127 study. Clinical trial expenses in 2013 increased by $3.1 million and $7.1 million when compared to 2012 for the three- and nine-month periods, respectively. In addition, during 2013, we have substantially expanded our manufacturing activities with our commercial suppliers to support our pivotal studies in rindopepimut and glemba. External contract manufacturing expenses increased by $3.3 million and $5.0 million for the three- and nine-month periods, respectively, in 2013 versus 2012.
General and administrative (G&A) expenses in the third quarter of 2013 were $3.6 million, compared to $2.8 million in the third quarter of 2012. G&A expenses for the nine months ended September 30, 2013 were $10.1 million, compared to $7.4 million for the nine months ended September 30, 2012. The increase in G&A expenses was primarily attributable to higher personnel-related expenses, professional services and rindopepimut-related commercial planning costs in 2013.
At September 30, 2013, Celldex reported cash, cash equivalents and marketable securities of $136.6 million. The decrease of $18.4 million from June 30, 2013 includes $0.9 million spent on leasehold improvements to our future headquarters facility in New Jersey and our third quarter net cash burn of $17.5 million.
As of September 30, 2013, Celldex had 81.1 million shares outstanding.
Avastin is a registered trademark of Genentech, a member of the Roche Group.
About Celldex Therapeutics, Inc.
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 www.celldex.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), Glembatumumab vedotin ("glemba"; 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, glemba 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)|
|CONSOLIDATED STATEMENTS||Quarter||Nine Months|
|OF OPERATIONS DATA||Ended September 30,||Ended September 30,|
|Product Development and|
|Licensing Agreements||$ 40||$ 28||$ 117||$ 103|
|Contracts and Grants||940||79||1,040||228|
|Research and Development||20,417||11,769||49,597||33,650|
|General and Administrative||3,578||2,835||10,128||7,372|
|Amortization of Acquired Intangible Assets||254||254||760||836|
|Total Operating Expense||24,249||17,864||62,819||49,082|
|Investment and Other Income, Net||142||105||682||436|
|Net Loss||$ (23,140)||$ (15,027)||$ (59,488)||$ (42,316)|
|Basic and Diluted Net Loss per Common Share||$ (0.29)||$ (0.25)||$ (0.76)||$ (0.75)|
|Weighted Average Common Shares Outstanding||81,015||59,467||78,676||56,090|
|BALANCE SHEETS||September 30,||December 31,|
|Cash, Cash Equivalents and Marketable Securities||$ 136,588||$ 83,962|
|Other Current Assets||3,358||1,152|
|Property and Equipment, net||8,814||7,205|
|Intangible and Other Assets, net||32,195||33,222|
|Total Assets||$ 180,955||$ 125,541|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Current Liabilities||$ 16,795||$ 17,685|
|Total Liabilities and Stockholders' Equity||$ 180,955||$ 125,541|
CONTACT: Sarah Cavanaugh Vice President of Investor Relations & Corp Communications Celldex Therapeutics, Inc. (781) 433-3161 email@example.com