- Continued progress in METRIC enrollment: Celldex continues to expect that enrollment will be completed by the end of September 2017. METRIC is a Phase 2b randomized study of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB.
- Single-agent glembatumumab vedotin Phase 2 study in checkpoint-refractory metastatic melanoma accepted for oral presentation at ASCO: Updated data from the single-agent cohort of the Phase 2 study will be presented in an oral presentation at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in June. Enrollment recently completed in the glembatumumab vedotin and varlilumab arm, with data from this portion of the study expected in the fall of 2017. Enrollment continues in the glembatumumab vedotin plus checkpoint inhibitor (Opdivo ® or Keytruda ®) arm in patients who failed prior checkpoint therapy, a population with limited treatment options.
- Phase 1 varlilumab/Opdivo ® study accepted for oral presentation at ASCO: Updated data from the Phase 1 portion of the varlilumab and Opdivo study will be presented in an oral presentation at the 2017 ASCO Annual Meeting in June. The Phase 2 portion of the combination study includes cohorts in colorectal cancer, ovarian cancer, head and neck squamous cell carcinoma, renal cell carcinoma and glioblastoma, and is currently enrolling patients. 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 Bristol-Myers Squibb to present data from the study at a future medical meeting. Data from the Phase 1 single-agent study of varlilumab in solid tumors were recently published in the Journal of Clinical Oncology .
- Phase 1 study of CDX-0158 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 continue to be expected by year-end 2017.
- CDX-3379 advancing to Phase 2: The Company is currently finalizing plans for advancement into a Phase 2 study in combination with cetuximab in patients with cetuximab-resistant advanced head and neck squamous cell carcinoma.
- 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 continues to expect the Phase 1 dose-escalation portion of the study will complete enrollment by year-end 2017.
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)|
|OF OPERATIONS DATA||Ended March 31,|
|and Licensing Agreements||$||556||$||453|
|Contracts and Grants||978||850|
|Research and Development||25,793||27,447|
|General and Administrative||7,229||9,307|
|Loss on Fair Value Remeasurement of Contingent Consideration||3,400||-|
|Amortization of Acquired Intangible Assets||224||253|
|Total Operating Expense||36,646||37,007|
|Investment and Other Income, Net||851||1,031|
|Basic and Diluted Net Loss per|
|Weighted Average Common|
|BALANCE SHEETS DATA||March 31,||December 31,|
|Cash, Cash Equivalents and Marketable Securities||$||167,023||$||189,776|
|Other Current Assets||6,440||5,793|
|Property and Equipment, net||12,411||13,192|
|Intangible and Other Assets, net||174,174||174,597|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total Liabilities and Stockholders' Equity||$||360,048||$||383,358|
Company ContactSarah CavanaughVice President of Investor Relations & Corp CommunicationsCelldex Therapeutics, Inc.(781) email@example.comCharles Liles Associate Director of Investor Relations & Corp Communications Celldex Therapeutics, Inc. (781) 433-3107 firstname.lastname@example.org