- Kolltan Pharmaceuticals acquisition completed: In late November, Celldex completed the acquisition of Kolltan Pharmaceuticals, Inc., adding a unique platform of antibodies targeting receptor tyrosine kinases (RTKs) to the Company's pipeline. Clinical and preclinical data suggest these candidates can help overcome tumor resistance mechanisms associated with current tyrosine kinase inhibitors and seen in patients who have failed other cancer therapies.
- Considerable progress in METRIC enrollment: Enrollment in the Phase 2b randomized study (METRIC) of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB has accelerated consistently over the last several months across the United States, Canada, Australia and the European Union. Assuming the current rate of enrollment continues, Celldex expects enrollment will be completed by the end of September 2017.
- Third arm added to glembatumumab vedotin Phase 2 study in metastatic melanoma: Enrollment has initiated in a glembatumumab vedotin plus checkpoint inhibitor (Opdivo ® or Keytruda ®) arm in patients who failed prior checkpoint therapy. Enrollment also continues in the glembatumumab vedotin and varlilumab arm, with data from this portion of the study expected in the fall of 2017. Positive data from the single-agent arm of this study in patients who had previously progressed on checkpoint therapy were presented at the European Society for Medical Oncology (ESMO) Congress in October 2016.
- Continued progress in Phase 2 varlilumab/Opdivo ® study: The Phase 2 study of varlilumab and Opdivo continues to enroll patients across multiple indications [colorectal cancer (n=18), ovarian cancer (n=54), head and neck squamous cell carcinoma (n=54), renal cell carcinoma (n=25), glioblastoma (n=20)]. The Company anticipates that data from the Phase 1 study of varlilumab and Opdivo will be presented mid-year 2017. The Company plans to complete enrollment across all cohorts in the Phase 2 portion of the study in the first quarter of 2018 and will work with BMS to present data from the study at a future medical meeting. Given the advancement of varlilumab into a broad Phase 2 study with BMS, including in renal cell carcinoma, and efforts to identify areas for cost-containment, Celldex has decided not to advance the varlilumab/Tecentriq ® and the varlilumab/Sutent ® combination studies in renal cell carcinoma to Phase 2.
- Phase 1 study of CDX-0158 (formerly KTN0158) continues to enroll patients: This dose-escalation study in patients with advanced refractory gastrointestinal stromal tumors (GIST) and other KIT-positive tumors is designed to determine the maximum tolerated dose, recommend a dose for further study and characterize the safety profile of CDX-0158. Data from the study are expected by year-end 2017.
- CDX-3379 (formerly KTN3379) advancing to Phase 2: The Company is currently exploring plans for advancement into Phase 2 study.
- Enrollment ongoing in Phase 1 study of CDX-014: The study in advanced renal cell carcinoma (clear cell and papillary) is designed to determine the maximum tolerated dose and to recommend a dose level for further study. Celldex expects the Phase 1 dose-escalation portion of the study will complete enrollment by year-end 2017.
Opdivo ® is a registered trademark of Bristol-Myers Squibb. Keytruda ® is a registered trademark of Merck Sharp & Dohme Corp. Sutent ® is a registered trademark of Pfizer. Tecentriq ® is a registered trademark of Genentech.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 integrate the business and programs of Kolltan with our business and programs; 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; 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)|
|STATEMENTS||Quarter Ended||Year Ended|
|OF OPERATIONS DATA||December 31,||December 31,|
|Product Development and|
|Contracts and Grants||1,251||1,401||4,612||4,038|
|Research and Development||24,558||23,900||102,726||100,171|
|General and Administrative||11,933||11,075||35,979||33,837|
|Amortization of Acquired Intangible Assets||235||253||997||1,013|
|Total Operating Expense||36,726||35,228||139,702||135,021|
|Investment and Other Income, Net||2,545||754||4,386||2,344|
|Basic and Diluted Net Loss|
|per Common Share||$||(0.30||)||$||(0.33||)||$||(1.27||)||$||(1.31||)|
|Weighted Average Common Shares Outstanding||107,876||98,633||101,529||97,051|
|CONDENSED BALANCE SHEETS||December 31,||December 31,|
|Cash, Cash Equivalents and Marketable Securities||$||189,776||$||289,889|
|Other Current Assets||5,793||5,047|
|Property and Equipment, net||13,192||11,461|
|Intangible and Other Assets, net||174,597||31,187|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total Liabilities and Stockholders' Equity||$||383,358||$||337,584|
Company ContactSarah CavanaughVice President of Investor Relations & Corp CommunicationsCelldex Therapeutics, Inc.(781) firstname.lastname@example.orgCharles LilesAssociate Director of Investor Relations & Corp CommunicationsCelldex Therapeutics, Inc.(781) email@example.com