Celldex Therapeutics Presents Favorable Safety Profile and Immune Response Data from Phase 1/2 Study of Varlilumab and Nivolumab at the AACR Annual Meeting 2016
-- All varlilumab dose levels showed acceptable tolerability/safety in combination regimen; Phase 2 portion of study now open to enrollment --
-- Celldex and collaborating investigators presenting seven posters on pipeline programs at AACR 2016 --
HAMPTON, N.J., April 18, 2016 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today new safety and immune response data from the Phase 1 portion of a Phase 1/2 dose escalation and cohort expansion study examining the investigational combination of varlilumab, Celldex's CD27 targeting investigational immune-activating antibody, and Bristol-Myers Squibb's anti-PD-1 immunotherapy Opdivo® (nivolumab). The data were presented today in a poster at the American Association for Cancer Research (AACR) Annual Meeting 2016 in New Orleans. The Phase 1 portion of the study, conducted in patients with solid tumors, has completed enrollment (n=36) and primarily enrolled patients with colorectal (n=20) and ovarian cancer (n=8). The primary objective of the Phase 1 portion of the study was to evaluate the safety and tolerability of the combination. The Phase 2 portion of the study is open to enrollment.
G&A Expenses: General and administrative (G&A) expenses were $11.1 million in the fourth quarter of 2015 and $33.8 million for the twelve months ended December 31, 2015, compared to $6.2 million and $20.6 million for the comparable periods in 2014. The increase in G&A expenses was primarily attributable to higher personnel-related expenses as we prepare for potential commercialization and a $6.5 million increase in RINTEGA and glembatumumab vedotin commercial planning costs in 2015 as compared to 2014. G&A expenses include stock-based compensation expense of $2.1 million and $6.6 million in the three- and twelve-month periods ended December 31, 2015 compared to $1.0 million and $3.4 million for the comparable periods in 2014.
Financial guidance: Celldex expects that its cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditure requirements through 2017; however, this could be impacted by our clinical data results from the RINTEGA program and their potential impact on our pace of commercial manufacturing and the rate of expansion of our commercial operations
Revenues: Total revenue was $1.8 million in the fourth quarter of 2015 and $5.5 million for the twelve months ended December 31, 2015, compared to $1.5 million and $3.6 million for the comparable periods in 2014. The increase in revenue was primarily due to our clinical trial collaboration with Bristol-Myers Squibb and our research and development agreement with Rockefeller University.