conference date: August 8, 2016 @ 1:30 PM Pacific Time
for quarter ending: June 30, 2016 (Q1, second quarter 2016)
Overview: A clinical stage biotechnology company, after the letdown from the cancellation of the Rintega trial, reports progress on its many pipeline projects.
Basic data (GAAP):
Revenue was $1.4 million, up sequentially from $1.3 million but down from $2.2 million year-earlier. All revenue was from license agreements, contract or grants.
Net loss was $32.0 million, up sequentially from $34.7 million and up from a net loss of $32.4 million year-earlier.
EPS was negative $0.32, up sequentially from negative $0.35, and up from negative $0.33 year-earlier.
CEO Anthony Marucci stated "Celldex continues to build one of the most robust pipelines in immuno-oncology, most recently advancing CDX-014 into the clinic in renal cell carcinoma. We continue to enroll patients to the pivotal METRIC study of glembatumumab vedotin in triple negative breast cancer, with a focus on a number of new sites in Europe that were added over the last quarter and look forward to presenting data from the Phase 2 study of glembatumumab vedotin in metastatic melanoma later this year"
In March Celldex had stopped the Phase 3 study of Rintega for glioblastoma after the control arm did better than expected so the drug would not reach statistical significance. The data from the study will be released in the fall. Expects no substantial additional cost.
A Phase 1/2 study of CDX-014 (glembatumumab vedotin), and ADC targeting TIM-1, for renal cell carcinoma was started in July.
Celldex is working with Bristol-Myers to do a broad Phase 1/ 2 combination study of varlilumab (CDX-1127) with nivolumab (Opdivo). Phase 1 completed enrollment for multiple solid tumor types, and Phase 2 started in April. Arms include colorectal cancer, ovarian cancer, head and neck squamous cell carcinoma, renal cell carcinoma, and glioblastoma. The companies are sharing development costs. Data from Phase 1 was released at AACR in April, showing the therapy was safe with some patients showing stable disease or better.
CDZ-1127 is also in a Phase 1 study combined with Tecetriq in multiple solid tumor types, with enrollment completed. The Phase 2 portion of the trial should begin soon. Combination studies with Sutent and Yervoy are also enrolling patients.
A Phase 1/2 study of varlilumab with atezolizumab (anti-PDL1) is enrolling; Phase 2 will be for renal cell carcinoma. Two other Phase 1/2 combination studies are enrolling.
Glembatumumab vedotin (CDX-011) Phase 2 studies continue to enroll patients for metastatic triple negative breast cancer overexpressing gpNMB, but there is competition for patients, so behind on the timeline and opening sites in the EU to compensate.
CDX-011 for metastatic melanoma (post checkpoint therapy) completed enrollment of its Phase 2 trial. Preliminary melanoma data could be presented this October. Another cohort has been added with 011 combined with varlilumab.
A CDX-011 Phase 1 study in squamous cell lung cancer started in April. A Phase 2 expansions study is planned.
CDX-011 is also in NCI sponsored studies for uveal melanoma and pediatric osteosarcoma.
CDX-301 is in several early studies, one for HSCT (hematopoeitic stem cell transplantation) and one for B-cell lymphomas.
Phase 2 results from a study of a combination of CDX-1401 and CDX-301 for malignant melanoma were reported in June at ASCO. The study was conducted by the Cancer Immunotherapy Trials Network. "This study confirms that CDX-1401 is effective at driving NY-ESO-1 immunity and further shows the value of CDX-301 as a combination agent for enhancing tumor-specific immune responses." See the CDX-1401 poster.
CDX-014 started a Phase 1 study in July in renal cell carcinoma.
Cash ended at $220 million, down about $34 million in the quarter.
Operating expenses of $33.8 million consisted of: $25.7 million for R&D; $7.8 million for general and administrative; and $0.3 million amortization. There was $0.4 million other revenue.
Has an ATM. With cash and that should be able to run through 2018.
Any discussion with the FDA on Rintega? We are treating patients under compassionate use. Our regulatory discussions continue.
Glemba in melanoma, monotherapy? We met and exceeded the minimum criteria for success. These patients are checkpoint failures. We need to follow all the patients out to an appropriate time point.
Size of European group for breast cancer? We believe the Europeans will be less than half of the patient population. The criteria for patients are the same for the U.S. and Europe.
Varli combo with Opdivo? We would describe in detail the data from Phase 1, in concert with our partner.
Partnering strategy? We own all of our assets. We are collaborating with entities, at the appropriate time we will decide if we want to partner for the assets.
CDX-014 target selection and enrollment? We want a target that is not expressed on normal tissues and is highly expressed on the cancer cells. We thing TIM1 is a good target for renal cell carcinoma. We may be able to dose higher than other ADCs that have been tried because of its specificity. The patients are refractory.
Combining ADCs with checkpoint inhibitors? We believe there is evidence this will be a good strategy, but there are not clinical results yet. They will be coming out during the coming year. But we believe ADC monotherapy can be effective, and are hoping for that with CDX-014.
Analyst Conference Summaries Main Page