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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 | |
---|---|---|---|---|---|---|---|---|---|---|
0.04 | 0.11% | 36.30 | 35.22 | 37.20 | 36.74 | 35.65 | 36.31 | 324,978 | 22:30:00 |
“Celldex presented positive data across multiple programs at AACR in April, including from our promising CDX-1140 program,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “We have successfully cleared a critical hurdle for CD40 agonists, reaching dose levels with good systemic exposure that are biologically active and well tolerated. Importantly, these dose levels exceed the maximum tolerated dose levels reported with other CD40 agonists, which we believe may support enhanced tissue and tumor penetration. We are also pleased with the results to date in our unique combination of CDX-1140 with CDX-301, where CDX-301 amplifies the numbers of dendritic cells in patients prior to their activation with CDX-1140. To this end, we continue to believe that CDX-1140 can play a very important role in cancer immunotherapy, especially in combination with drugs that target other key immune pathways and are actively planning additional combination cohorts to begin later this year.”
“We also recently completed the first stage of the Phase 2 study of CDX-3379 and are pleased that this portion of the study met the clinical criteria that are required to progress the study to the next stage. We look forward to presenting more detailed data from this study at ASCO in early June. We are currently conducting a thorough analysis of the overall CDX-3379 program in collaboration with our clinical advisors to determine the optimal path for this candidate. In conclusion, we continue to make considerable progress across our entire pipeline and look forward to updating shareholders over the course of the year,” said Marucci.
Recent Highlights:
First Quarter 2019 Financial Highlights and 2019 Guidance
Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2019 were $85.1 million compared to $94.0 million as of December 31, 2018. The decrease was primarily driven by first quarter cash used in operating activities of $13.2 million, partially offset by $4.2 million in net proceeds from sales of common stock under the Cantor agreement. At March 31, 2019, Celldex had 12.8 million shares outstanding.
Revenues: Total revenue was $1.4 million in the first quarter of 2019 compared to $4.1 million for the comparable period in 2018. The decrease in revenue was primarily due to lower revenue from the contract manufacturing and research and development agreement with the International AIDS Vaccine Initiative and the collaboration agreement with Bristol-Myers Squibb Company.
R&D Expenses: Research and development (R&D) expenses were $11.2 million in the first quarter of 2019 compared to $21.9 million for the comparable period in 2018. The decrease in R&D expenses was primarily due to lower clinical trial, personnel and contract manufacturing costs.
G&A Expenses: General and administrative (G&A) expenses were $4.9 million in the first quarter of 2019 compared to $5.6 million for the comparable period in 2018. The decrease in G&A expenses was primarily due to lower personnel and commercial planning costs.
Intangible Asset and Goodwill Impairments: During the quarter ended March 31, 2018, the Company recorded $18.7 million in non-cash impairment charges related to fully impaired glembatumumab vedotin-related intangible assets and $91.0 million in goodwill impairment charges as the carrying value of the Company’s net assets exceeded the Company’s fair value by an amount in excess of the goodwill asset.
Changes in Fair Value Remeasurement of Contingent Consideration: During the quarter ended March 31, 2019, the Company recorded a $1.5 million loss on fair value remeasurement of contingent consideration primarily due to changes in discount rates and the passage of time. During the quarter ended March 31, 2018, the Company recorded a $13.6 million gain on the fair value remeasurement of contingent consideration primarily due to updated assumptions for glembatumumab vedotin-related milestones as a result of the METRIC study failure and discontinuation of the glembatumumab vedotin program.
Net Loss: Net loss was $17.2 million, or ($1.40) per share, for the first quarter of 2019 compared to a net loss of $118.1 million, or ($12.61) per share, for the comparable period in 2018.
Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2019, combined with the anticipated proceeds from future sales of common stock under the Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2020. This could be impacted if Celldex elects to pay Kolltan contingent milestones, if any, in cash.
Erbitux® is a registered trademark of Eli Lilly & Co.
About Celldex Therapeutics, Inc.Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline includes immunotherapies and other targeted biologics derived from a broad set of complementary technologies which have the ability to engage the human immune system and/or directly inhibit tumors to treat specific types of cancer or other diseases. Visit www.celldex.com.
Forward Looking StatementThis release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These 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 or that those goals will be achieved, 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 Company 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 maintain compliance with Nasdaq listing requirements; our ability to realize the anticipated benefits from the acquisition of Kolltan; 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 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.
Company ContactSarah CavanaughSenior Vice President, Corporate Affairs & AdministrationCelldex Therapeutics, Inc.(781) 433-3161scavanaugh@celldex.com
CELLDEX THERAPEUTICS, INC. | |||||||
(In thousands, except per share amounts) | |||||||
CONSOLIDATED STATEMENTS | Three Months | ||||||
OF OPERATIONS DATA | Ended March 31, | ||||||
2019 | 2018 | ||||||
(Unaudited) | |||||||
REVENUES: | |||||||
Product Development and Licensing Agreements | $ | 129 | $ | 992 | |||
Contracts and Grants | 1,296 | 3,076 | |||||
Total Revenue | 1,425 | 4,068 | |||||
OPERATING EXPENSES: | |||||||
Research and Development | 11,151 | 21,875 | |||||
General and Administrative | 4,896 | 5,593 | |||||
Goodwill Impairment | - | 90,976 | |||||
Intangible Asset Impairment | - | 18,677 | |||||
Other Asset Impairment | 1,800 | - | |||||
Loss/(Gain) on Fair Value Remeasurement of Contingent Consideration | 1,519 | (13,600 | ) | ||||
Amortization of Acquired Intangible Assets | - | 224 | |||||
Total Operating Expense | 19,366 | 123,745 | |||||
Operating Loss | (17,941 | ) | (119,677 | ) | |||
Investment and Other Income, Net | 702 | 780 | |||||
Net Loss Before Income Tax Benefit | (17,239 | ) | (118,897 | ) | |||
Income Tax Benefit | - | 765 | |||||
Net Loss | $ | (17,239 | ) | $ | (118,132 | ) | |
Basic and Diluted Net Loss per Common Share | $ | (1.40 | ) | $ | (12.61 | ) | |
Shares Used in Calculating Basic and Diluted Net Loss per Share | 12,297 | 9,370 | |||||
CONDENSED CONSOLIDATED | |||||||
BALANCE SHEETS DATA | March 31, | December 31, | |||||
2019 | 2018 | ||||||
(Unaudited) | |||||||
ASSETS | |||||||
Cash, Cash Equivalents and Marketable Securities | $ | 85,068 | $ | 94,022 | |||
Other Current Assets | 3,783 | 5,057 | |||||
Property and Equipment, net | 5,462 | 6,111 | |||||
Intangible and Other Assets, net | 53,264 | 50,619 | |||||
Total Assets | $ | 147,577 | $ | 155,809 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current Liabilities | $ | 11,989 | $ | 12,602 | |||
Long-Term Liabilities | 22,895 | 19,147 | |||||
Stockholders' Equity | 112,693 | 124,060 | |||||
Total Liabilities and Stockholders' Equity | $ | 147,577 | $ | 155,809 | |||
1 Year Celldex Therapeutics Chart |
1 Month Celldex Therapeutics Chart |
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