On March 15, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported its financial results for the fiscal fourth quarter and year ended December 31, 2015 (Press release, Calithera Biosciences, MAR 15, 2016, View Source;p=RssLanding&cat=news&id=2148507 [SID:1234509553]). As of December 31, 2015, cash, cash equivalents and investments totaled $71.9 million.
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"In 2015, we made significant progress executing on our clinical development plan for CB-839, enrolling several monotherapy cohorts on our Phase 1 trials, while remaining on track with our IND-enabling studies for our immunotherapy arginase inhibitor, CB-1158, all while advancing internal preclinical programs," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "Looking forward to 2016, we expect to highlight new clinical data and scientific progress at oncology meetings, including CB-839 Phase 1b updates from our ongoing trials, dosing CB-839 in combination with other therapies. This is expected to occur initially in the second quarter of 2016, with further updates in the second half of the year. In addition, we plan on initiating a clinical trial of CB-839 in combination with a checkpoint inhibitor by mid-year. Our arginase inhibitor, CB-1158, is progressing towards the clinic with an IND filing expected mid-year."
Fourth Quarter 2015 and Recent Highlights
CB-839 clinical date presented at major medical meetings. The three phase I clinical trials with CB-839 in solid tumors and hematological malignancies continued to enroll throughout 2015, with 184 patients enrolled as of January 2016, across the three trials. New data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting in November demonstrate stable disease across a variety of tumor types, as well as a single agent partial response in a renal cell carcinoma (RCC) patient. This patient showed a 32% reduction in target lesions by RECIST with generalized shrinkage of lymph node metastases. Among the fifteen evaluable patients with RCC, nine (60%) had stable disease or better, with stable disease lasting three cycles (63 days). Among efficacy-evaluable patients across a range of tumor types treated on the current dosing schedule of twice-daily, 22 of 50 patients (44%) experienced stable disease or better. Five stable disease patients currently on study have been treated with CB-839 for over 8 months without progression (2 triple negative breast cancer, 1 RCC, 1 mesothelioma and 1 IDH1 mutant chondrosarcoma). In addition, the first results of CB-839 dosed in combination therapy were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Arginase inhibitor CB-1158 preclinical data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Meeting. CB-1158, a highly selective, orally bioavailable, small molecule inhibitor of human arginase with nanomolar potency, demonstrated single agent efficacy in animal models. Inhibition of tumor growth was accompanied by a rapid increase in the local concentration of arginine, and the induction of multiple pro-inflammatory changes in the tumor microenvironment. CB-1158, when administered with anti-CTLA-4, increased CD8+ T-cell infiltrates in the tumor. The addition of CB-1158 to anti-CTLA-4 and anti-PD-1, significantly inhibited tumor growth in a mouse model that was resistant to dual checkpoint inhibitor therapy. CB-1158 was well tolerated as a single agent and in combination with checkpoint inhibitors in animal studies.
Selected Fourth Quarter and Year-end 2015 Financial Results
Cash, cash equivalents and investments totaled $71.9 million at December 31, 2015 compared with $102.0 million at December 31, 2014.
Research and development expenses for the full year 2015 were $23.7 million, compared with $16.4 million in the prior year. The increase of $7.4 million in 2015 was primarily attributed to higher expenses associated with Calithera’s arginase inhibitor program, including the selection of CB-1158 and its advancement through preclinical development, and continued enrollment of CB-839, Calithera’s first-in-class glutaminase inhibitor, in phase 1 clinical trials. Calithera expects to file an IND for the arginase inhibitor program mid-2016. Research and development expenses for the fourth quarter of 2015 were $5.8 million, compared to $5.0 million for the same period last year.
General and administrative expenses for the full year 2015 were $9.1 million, compared with $5.4 million in the prior year. The increase of $3.7 million in 2015 was primarily due to higher employment related expenses, including stock based compensation expense, and professional service fees relating to Calithera’s costs associated with operating as a publicly traded company. General and administrative expenses for the fourth quarter of 2015 were $2.3 million, compared to $1.9 million for the same period last year.
Loss from operations for the three months and year end ended December 31, 2015 was $8.1 million and $32.6 million, respectively.
Financial Guidance for 2016
Calithera expects that its cash, cash equivalents and investments will be at least $35 million at the end of 2016, exclusive of any funds arising from new collaborations or partnerships, equity financings or other new sources.