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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Celldex Therapeutics Inc | NASDAQ:CLDX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
1.51 | 3.84% | 40.86 | 41.30 | 42.00 | 40.99 | 38.75 | 39.76 | 569,465 | 00:10:13 |
"2014 was another important year for Celldex, most notably for our lead product candidate, rindopepimut, which was recently issued the trade name Rintega®," said Anthony Marucci, Co-founder, President and Chief Executive Officer. "We completed enrollment in our Phase 3 study in newly diagnosed glioblastoma and reported positive interim PFS-6 and overall survival data from our Phase 2 ReACT study in patients with recurrent GBM. Most recently, based on these data, Rintega was issued Breakthrough Designation from the FDA."
"In addition to the significant progress made with Rintega, we advanced a number of key programs across our pipeline. The FDA and central European regulatory authorities reviewed the revised protocol design for glembatumumab vedotin in triple negative breast cancer and we continue to believe with positive results that the METRIC study could be suitable for full marketing approval in both the US and Europe. Enrollment is accelerating in the METRIC study and we have initiated a second Phase 2 glemba study in metastatic melanoma. Varlilumab is now active in multiple combination studies, including a study with Opdivo®, and will enter several new studies later this year. Studies have also initiated for combination approaches with CDX-1401 and CDX-301. We look forward to continuing to build on this momentum in 2015 as we drive the Rintega program towards completion and advance what we believe is one of the most robust, well-staged pipelines in immuno-oncology," concluded Marucci.
Program Updates:
Rintega® ("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 aimed at 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:
Fourth Quarter and Twelve Months 2014 Financial Highlights and 2015 Guidance
Cash position: Cash, cash equivalents and marketable securities as of December 31, 2014 were $201.0 million compared to $224.1 million as of September 30, 2014. The decrease was primarily driven by our fourth quarter net cash burn of $23.1 million. As of December 31, 2014 Celldex had 89.6 million shares outstanding.
Revenues: Total revenue was $1.5 million in the fourth quarter of 2014 and $3.6 million for the twelve months ended December 31, 2014, compared to $0.6 million and $4.1 million for the comparable periods in 2013. The increase in the fourth quarter of 2014 was primarily due to our clinical trial collaboration with BMS and our Rockefeller University services agreement. The decrease in the twelve months ended December 31, 2014 was primarily 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 $27.0 million in the fourth quarter of 2014 and $104.4 million for the twelve months ended December 31, 2014, compared to $17.8 million and $67.4 million for the comparable periods in 2013. The increase in Celldex's R&D investment was primarily due to the continued progression of our late-stage clinical development programs, Rintega and glembatumumab vedotin, and the continued expansion of the varlilumab program. During the twelve months ended December 31, 2014 and 2013, we incurred $45.6 million and $32.3 million in clinical trial expense and $20.9 million and $6.6 million in contract manufacturing expense, respectively.
G&A Expenses: General and administrative (G&A) expenses were $6.2 million in the fourth quarter of 2014 and $20.6 million for the twelve months ended December 31, 2014, compared to $4.7 million and $14.8 million for the comparable periods in 2013. The increase in G&A expenses was primarily attributable to higher personnel-related expenses and Rintega and glembatumumab vedotin commercial planning costs in 2014.
Net loss: Net loss was $31.8 million, or ($0.36) per share, for the fourth quarter of 2014 and $118.1 million, or ($1.32) per share, for the twelve months ended December 31, 2014, compared to a net loss of $22.1 million, or ($0.27) per share and $81.6 million, or ($1.02) per share for the comparable periods in 2013.
Financial guidance: Celldex expects that its cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements through 2016, however, this could be impacted by our clinical data results from the Rintega program and their potential impact on our pace of commercial manufacturing and the rate of expansion of our commercial operations.
Rintega® is a registered trademark of Celldex Therapeutics. Opdivo® is a registered trademark of Bristol-Myers Squibb. Mozobil® is a registered trademark of sanofi-aventis U.S. LLC. Rotarix® is a registered trademark of GlaxoSmithKline.
Webcast and Conference Call
Celldex executives will host a conference call at 8:00 a.m. ET today to discuss 2014 financial and business results and to provide an update on key 2015 objectives. The conference call and presentation will be webcast live over the Internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 89115872.
A replay of the call will be available approximately two hours after the live call concludes through March 2, 2015. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 89115872. The webcast will also be archived on the Company's website.
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 Rintega® ("rindopepimut"; "rindo"; CDX-110), glembatumumab vedotin ("glemba"; CDX-011), varlilumab ("varli"; 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 Rintega, 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; our ability to maintain and derive benefit from the Breakthrough Therapy Designation for rindopepimut, which does not change the standards for regulatory approval or guarantee regulatory approval on an expedited basis, or at all; 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 and quarterly reports on Form 10-Q.
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.
--table follows--
CELLDEX THERAPEUTICS, INC. | ||||
(In thousands, except per share amounts) | ||||
CONSOLIDATED STATEMENTS | Quarter Ended | Year Ended | ||
OF OPERATIONS DATA | December 31, | December 31, | ||
2014 | 2013 | 2014 | 2013 | |
(Unaudited) | ||||
REVENUE | ||||
Product Development and Licensing Agreements | $ 320 | $ 43 | $ 838 | $ 160 |
Contracts and Grants | 1,157 | 577 | 2,748 | 1,617 |
Product Royalties | -- | -- | -- | 2,334 |
Total Revenue | 1,477 | 620 | 3,586 | 4,111 |
OPERATING EXPENSE | ||||
Research and Development | 27,026 | 17,804 | 104,381 | 67,401 |
Royalty | -- | -- | -- | 2,334 |
General and Administrative | 6,249 | 4,677 | 20,622 | 14,805 |
Amortization of Acquired Intangible Assets | 253 | 253 | 1,013 | 1,013 |
Total Operating Expense | 33,528 | 22,734 | 126,016 | 85,553 |
Operating Loss | (32,051) | (22,114) | (122,430) | (81,442) |
Investment and Other Income, Net | 230 | 137 | 4,350 | 819 |
Interest Expense | -- | (85) | -- | (927) |
Net Loss | $ (31,821) | $ (22,062) | $ (118,080) | $ (81,550) |
Basic and Diluted Net Loss per Common Share | $ (0.36) | $ (0.27) | $ (1.32) | $ (1.02) |
Weighted Average Common Shares Outstanding | 89,559 | 83,042 | 89,399 | 79,777 |
CONDENSED CONSOLIDATED | ||||
BALANCE SHEETS | December 31, | December 31, | ||
2014 | 2013 | |||
ASSETS | ||||
Cash, Cash Equivalents and Marketable Securities | $ 201,043 | $ 302,983 | ||
Other Current Assets | 3,942 | 2,206 | ||
Property and Equipment, net | 10,535 | 9,973 | ||
Intangible and Other Assets, net | 32,494 | 31,933 | ||
Total Assets | $ 248,014 | $ 347,095 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Current Liabilities | $ 24,491 | $ 20,350 | ||
Long-Term Liabilities | 11,863 | 6,950 | ||
Stockholders' Equity | 211,660 | 319,795 | ||
Total Liabilities and Stockholders' Equity | $ 248,014 | $ 347,095 |
CONTACT: Company Contact: Sarah Cavanaugh Vice President of Investor Relations & Corp Communications Celldex Therapeutics, Inc. (781) 433-3161 scavanaugh@celldex.com Media Inquiries: Dan Budwick Pure Communications, Inc. (973) 271-6085 dan@purecommunicationsinc.com
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