- Topline primary endpoint data from the METRIC study of glembatumumab vedotin in triple negative breast cancer anticipated in the second quarter of 2018: Enrollment was closed in August 2017 with 327 patients whose tumors overexpressed gpNMB. Patients were randomized 2 to 1 to either glembatumumab vedotin or to Xeloda ® (capecitabine). The primary endpoint of the study is progression-free survival (PFS), which is defined as the time from randomization to the earlier of disease progression or death due to any cause. The study calls for 203 progression events for evaluation of the primary endpoint, which will be assessed based on an independent, central reading of patient scans. The sum of the data, including the secondary endpoints of response rate, overall survival (OS), duration of response and safety, will be important in assessing clinical benefit. Efforts to ensure delivery of manufactured drug that is ready for commercialization and a companion diagnostic are underway. As previously disclosed, Celldex made the decision to stage some of the more costly work in these areas to begin after the Company has received results from the study. Assuming positive data, Celldex plans to work with the FDA on a regulatory strategy that would support submitting a Biologics License Application (BLA) in the second half of 2019.
- Fourth arm added to glembatumumab vedotin Phase 2 study in metastatic melanoma: Enrollment has opened in a glembatumumab vedotin plus CDX-301 cohort for patients who failed checkpoint therapy. Enrollment recently completed in the glembatumumab vedotin plus checkpoint inhibitor cohort.
- Enrollment complete in Phase 2 varlilumab/Opdivo ® collaborative study: Enrollment was completed in January 2018. Cohorts include colorectal cancer (n=21), ovarian cancer (n=58), head and neck squamous cell carcinoma (n=24), renal cell carcinoma (n=14) and glioblastoma (n=22). The primary objective of the Phase 2 cohorts is objective response rate (ORR), except glioblastoma, where the primary objective is the rate of 12-month OS. Secondary objectives include pharmacokinetic assessments, determining the immunogenicity of varlilumab when given in combination with Opdivo, evaluating alternate dosing schedules of varlilumab and further assessing the anti-tumor activity of combination treatment. Working with Bristol-Myers Squibb, data from the study will be presented at appropriate medical meetings in 2018.
- Initiated Phase 2 study of CDX-3379/Erbitux ® in head and neck squamous cell carcinoma: In November 2017, Celldex opened enrollment to an open-label Phase 2 study in combination with Erbitux in approximately 30 patients with HPV negative, Erbitux-resistant, advanced head and neck squamous cell carcinoma. Patients must have been treated previously with an anti-PD1 checkpoint inhibitor, a population with limited options and a particularly poor prognosis. The primary objective of the study is ORR. Secondary objectives include assessments of clinical benefit rate, duration of response, PFS and OS, and safety and pharmacokinetics associated with the combination.
- Ongoing Phase 1 study of CDX-014 expanded to include patients with ovarian cancer: Enrollment is ongoing in a Phase 1 study of CDX-014, an antibody-drug conjugate that targets TIM-1. The study initially enrolled patients with both clear cell and papillary renal cell carcinoma. In January 2018, we amended the protocol, expanding enrollment to include patients with ovarian clear cell carcinoma, an indication where TIM-1 expression is also upregulated, and enabling the evaluation of alternate dosing regimens. The study includes a dose-escalation portion across three separate cohorts to determine the maximum tolerated dose (MTD) followed by expansion cohorts of up to 15 patients each to assess the preliminary anti-tumor activity of CDX-014, as measured by ORR. Secondary objectives include safety and tolerability, pharmacokinetics, immunogenicity and additional measures of anti-tumor activity.
- Initiated Phase 1 study of CDX-1140: A Phase 1 study of CDX-1140 was initiated in November 2017. The study is expected to enroll up to approximately 105 patients with recurrent, locally advanced or metastatic solid tumors and is designed to determine the MTD during a dose-escalation phase and to recommend a dose level for further study in a subsequent expansion phase. The expansion is designed to further evaluate the tolerability and biologic effects of selected dose(s) of CDX-1140 in specific tumor types. Secondary objectives include assessments of safety and tolerability, pharmacodynamics, pharmacokinetics, immunogenicity and additional measures of anti-tumor activity, including clinical benefit rate. The Company believes that the potential for CDX-1140 will be best defined in combination studies with other immunotherapies or conventional cancer treatments.
Xeloda ® is a registered trademark of Genentech, Inc. Opdivo ® is a registered trademark of Bristol-Myers Squibb. 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 antibodies, antibody-drug conjugates and other protein-based therapeutics 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 Statement This 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 glembatumumab vedotin and other 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 realize the anticipated benefits from the acquisition of Kolltan and to operate the combined business efficiently; 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 Fast Track designation for glembatumumab vedotin 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.
|CELLDEX THERAPEUTICS, INC.|
|(In thousands, except per share amounts)|
|CONSOLIDATED STATEMENTS||Three Months||Year|
|OF OPERATIONS DATA||Ended December 31,||Ended December 31,|
|Product Development and|
|Contracts and Grants||2,791||1,251||9,590||4,612|
|Research and Development||23,464||24,558||96,171||102,726|
|General and Administrative||5,894||11,933||25,003||35,979|
|In-Process Research and Development Impairment||-||-||13,000||-|
|Gain on Fair Value Remeasurement|
|of Contingent Consideration||(600||)||-||(800||)||-|
|Amortization of Acquired Intangible Assets||224||235||896||997|
|Total Operating Expense||28,982||36,726||134,270||139,702|
|Investment and Other Income, Net||2,603||2,545||4,214||4,386|
|Net Loss Before Income Tax Benefit||(22,923||)||(32,307||)||(117,313||)||(128,530||)|
|Income Tax Benefit||19,082||-||24,282||-|
|Basic and Diluted Net Loss per|
|Shares Used in Calculating Basic|
|and Diluted Net Loss per Share||136,515||107,876||128,543||101,529|
|BALANCE SHEETS DATA||December 31,||December 31,|
|Cash, Cash Equivalents and Marketable Securities||$||139,427||$||189,776|
|Other Current Assets||5,329||5,793|
|Property and Equipment, net||10,372||13,192|
|Intangible and Other Assets, net||160,496||174,597|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total Liabilities and Stockholders' Equity||$||315,624||$||383,358|