HAMPTON, N.J., May 1, 2014 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported business and financial highlights for the first quarter ended March 31, 2014.
"Celldex continues to advance one of the most robust, well-staged pipelines in immuno-oncology," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "We anticipate completing enrollment in our Phase 3 study of rindopepimut in brain cancer later this year and are making excellent progress with our accelerated approval study of glembatumumab vedotin in triple negative breast cancer with more than 50 sites now open to screen patients. We are also completing the necessary preparations to significantly expand clinical development of glembatumumab vedotin into metastatic melanoma and squamous cell lung cancer and varlilumab into several Phase 1/2 trials and look forward to updating on our progress as new studies begin over the coming months."
Program Updates:
Rindopepimut ("rindo"; CDX-110) in EGFRvIII(v3)-Positive Glioblastoma (GBM):
Glembatumumab vedotin ("glemba"; CDX-011) targeting gpNMB in multiple cancers:
Varlilumab ("varli"; CDX-1127), an immune modulating mAb targeting CD27 in solid tumors and hematologic malignancies:
CDX-1401, an antibody-based dendritic cell targeted vaccine targeting tumors expressing the NY-ESO-1 oncoprotein:
CDX-301 (Flt3L), a potent hematopoietic cytokine that stimulates the expansion and differentiation of hematopoietic stem cells and dendritic cells:
First Quarter 2014 Financial Highlights and 2014 Guidance
Cash position: Cash, cash equivalents and marketable securities as of March 31, 2014 were $274.2 million compared to $303.0 million as of December 31, 2013. The decrease was primarily driven by our first quarter net cash burn of $28.8 million which includes a one-time $2.5 million milestone payment to Seattle Genetics for the METRIC study initiation. As of March 31, 2014 Celldex had 89.4 million shares outstanding.
Revenues: Total revenue was $0.4 million in the first quarter of 2014 compared to $2.4 million for the comparable period in 2013. The decrease in revenue was due to the decrease in Rotarix® royalty revenue; 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.
R&D Expenses: Research and development (R&D) expenses were $27.1 million in the first quarter of 2014 compared to $14.1 million for the comparable period in 2013. The increase in Celldex's R&D investment was primarily due to the continued progression of our late-stage clinical development programs, rindopepimut and glembatumumab vedotin and the continued expansion of the varlilumab program.
G&A Expenses: General and administrative (G&A) expenses were $4.6 million in the first quarter of 2014 compared to $3.1 million for the comparable period in 2013. The increase in G&A expenses was primarily attributable to higher personnel-related expenses, professional services and rindopepimut and glembatumumab vedotin commercial planning costs in 2014.
Net loss: Net loss was $29.9 million, or ($0.33) per share, for the first quarter of 2014 compared to a net loss of $17.3 million, or ($0.23) per share for the comparable period in 2013.
Financial guidance: Celldex expects that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements through 2016.
Avastin® is a registered trademark of Genentech; Yervoy® is a registered trademark of Bristol-Myers Squibb; Rotarix® is a registered trademark of GlaxoSmithKline; Mozobil® is a registered trademark of Genzyme Corporation; Hiltonol® is a registered trademark of Oncovir.
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.
Forward Looking Statement
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), varlilumab (CDX-1127), CDX-1401, CDX-301 and other products and our goals for 2014. 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, glembatumumab vedotin 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; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical and commercial grade materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; 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, | |
2014 | 2013 | |
(Unaudited) | ||
OPERATING REVENUE | ||
Product Development and Licensing Agreements | $ 35 | $ 30 |
Contracts and Grants | 381 | 50 |
Product Royalties | -- | 2,334 |
Total Revenue | 416 | 2,414 |
OPERATING EXPENSE | ||
Research and Development | 27,070 | 14,090 |
Royalty | -- | 2,334 |
General and Administrative | 4,582 | 3,138 |
Amortization of Acquired Intangible Assets | 253 | 253 |
Total Operating Expense | 31,905 | 19,815 |
Operating Loss | (31,489) | (17,401) |
Investment and Other Income, Net | 1,586 | 379 |
Interest Expense | -- | (310) |
Net Loss | $ (29,903) | $ (17,332) |
Basic and Diluted Net Loss per | ||
Common Share | $ (0.33) | $ (0.23) |
Weighted Average Common | ||
Shares Outstanding | 89,270 | 74,027 |
CONDENSED CONSOLIDATED | ||
BALANCE SHEETS DATA | March 31, | December 31, |
2014 | 2013 | |
(Unaudited) | ||
ASSETS | ||
Cash, Cash Equivalents and Marketable Securities | $ 274,226 | $ 302,983 |
Other Current Assets | 2,593 | 2,206 |
Property and Equipment, net | 10,216 | 9,973 |
Intangible and Other Assets, net | 31,664 | 31,933 |
Total Assets | $ 318,699 | $ 347,095 |
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Current Liabilities | $ 19,507 | $ 20,350 |
Long-Term Liabilities | 7,346 | 6,950 |
Stockholders' Equity | 291,846 | 319,795 |
Total Liabilities and Stockholders' Equity | $ 318,699 | $ 347,095 |