conference date: February 25, 2016 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2015 (Q4, fourth quarter 2015)
Overview: Continued to make progress on the pipeline.
Basic data (GAAP):
Revenue was $1.8 million, up from $1.5 million year-earlier. All revenue was from license agreements, contract or grants.
Net loss was $32.7 million, down from a net loss of $31.8 million year-earlier.
CEO Anthony Marucci stated "We completed the Phase 2 ReACT Study of RINTEGA in recurrent GBM, confirming a highly statistically significant long-term overall survival benefit. RINTEGA continues to tell a very consistent, impressive story across multiple, clinically relevant endpoints in both the recurrent and newly diagnosed setting, supporting our belief that RINTEGA will be an important treatment option for all patients with EGFRvIII-positive glioblastoma. With this in mind, we look forward to completing the Phase 3 ACT IV trial in the newly diagnosed setting and are confident we are preparing appropriately for potential commercialization."
Also "With data reporting from multiple studies across our pipeline in 2016 and into early 2017, we believe the next twelve to eighteen months have the potential to be transformational for the Company."
Believes has an approvable drug in Rintega.
The FDA approved the IND for CDX-014, and ADC targeting TIM-1, so a Phase1/2 trial is planned for renal cell carcinoma this year.
Celldex is working with Bristol-Myers to do a broad Phase 1/ 2 combination study of varlilumab (CDX-1277) with nivolumab (Opdivo). Phase 1 completed enrollment for multiple solid tumor types, and Phase 2 is planned.
The Rintega ACT IV study enrolled 745 patients should report its second interim analysis (75% of deaths) will take place in March, with final data may come before the end of 2016. The prior, Phase 2 study reported a 2-year survival rate of 25% vs. 0% for the control arm. There is a "reasonable" chance that the study could stop early for success.
Rintega studies for earlier glioblastoma treatment and in combination treatments are planned for later this year.
Glembatumumab vedotin (CDX-011) Phase 2 studies continue to enroll patients for metastatic triple negative breast cancer overexpressing gpNMB, and for metastatic melanoma. A new Phase 2 study in squamous cell lung cancer could start in Q2.
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.
CDX-301 is in two early studies, One for HSCT (hematopoeitic stem cell transplantation) and one for B-cell lymphomas.
Cash ended at $290 million, down about $15 million in the quarter. Believes cash is sufficient through 2017.
Operating expenses of $35.2 million consisted of: $23.9 million for R&D; $11.1 million for general and administrative; and $0.3 million amortization. There was $0.8 million other revenue.
Has found an office for its European office.
ACT IV trial median time on study for patients? We closed the study some time ago, so it is in years, but we don't have access to all the data at this point.
Patients on study in trial gross resections for all 745? They all had to have at least an attempt at resection. 745 patients on study, 405 had minimal residual disease following chemo-radiation.
More on Varli - Opdivo program, single or multiple Phase 2 studies? Bristol study has a does escalation phase and then multiple separate Phase 2 cohorts, single-arm, not randomized, with a response rate used to define success.
Rintega preclinical data leading to new trials? The new studies should make treatment more convenient for patients. We want to show the therapeutic potential as early as possible. We want to show the earlier dosing also gives strong immune responses. Imiquimod seems to create immune responses topically, so it might provide a superior approach.
Halting of interim analysis and efficacy tails? We are sensitive to the issue. It is clear that immunotherapy provides both response and long-term survival benefit. Rintega is showing long term survival in some patients. A significant tail could be forming that would drive the hazard ratio and P-value. We would expect it to show up after the interim analysis, or even in a long-term follow up. Interim analysis is meant to spot dramatic responses. The final data is most likely to be positive.
Bulky disease issue in REACT? We did have many bulky disease patients in REACT. We saw huge responses in those patients, which could have been helped by the Avastin. The total population on ACT IV should show benefits, not just the bulky patients.
The data monitoring committee is given the data, then we have a meeting after a few days. If they recommend discontinuation, either for futility or success, we get a yes/no, but not immediate further data.
Combination with Nivo patients can receive 4 cycles.
Rintega already has a high recognition rate, about 90%, among the specialists. We are finalizing our education and sales programs, including for patients.
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