On November 9, 2015 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 third quarter ended September 30, 2015. As of September 30, 2015, cash, cash equivalents and investments totaled $81.9 million (Filing, 8-K, Calithera Biosciences, NOV 9, 2015, View Source [SID:1234508336]).
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"In the third quarter, we continued to move clinical programs forward with presentations of data at key medical meetings," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We presented dose expansion monotherapy cohorts for our lead product CB-839 at the AACR (Free AACR Whitepaper)-EORTC-NCI meeting, and we are currently opening enrollment across six combination cohorts. For our lead immuno-oncology program, we presented initial preclinical data for CB-1158, an oral, small molecule arginase inhibitor with the potential to treat cancer by blocking the immunosuppression of the tumor micro-environment. We believe that we have multiple opportunities to positively impact clinical outcomes for cancer patients by building a pipeline of novel therapeutic product candidates."
Third Quarter 2015 and Recent Highlights
• CB-839 Solid Tumor Phase 1 data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting. On November 8, 2015, solid tumor phase 1 data were presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper)-National Cancer Institute (NCI)-European Organization for Research and Treatment of Cancer (EORTC) meeting that demonstrated the clinical activity, tolerability and unique mechanism of action of CB-839 as a single agent in patients with solid tumors. Among efficacy-evaluable patients across a range of tumor types treated on the twice daily schedule of CB-839 administered with food, 22 of 50 patients (44%) had stable disease (SD) or better lasting at least 3 cycles (63 days). One renal cell carcinoma (RCC) patient has an ongoing partial response (PR; on study > 5 months); this patient showed a 32% reduction in target lesions by RECIST with generalized shrinkage of lymph node metastases. Among the 15 evaluable patients with RCC, 9 (60%) had SD or PR, with four patients remaining on study.
• Arginase inhibitor CB-1158 preclinical data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Meeting. Calithera selected CB-1158 as the clinical candidate for Calithera’s first immuno-oncology program targeting inhibition of arginase, a critical T-Cell immunosuppressive enzyme produced by myeloid-derived suppressor cells in tumors. On November 6, 2015, Calithera presented data at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting showing that CB-1158 is a highly selective, orally bioavailable, small molecule inhibitor of human arginase with nanomolar potency. Administration of CB-1158 to mice results in a dose-dependent increase in tumor arginine levels, consistent with target inhibition. Evaluation of anti-tumor efficacy in immunocompetent syngeneic mouse models has shown that oral administration of CB-1158 results in significant inhibition of tumor growth, and it combines well with checkpoint inhibitors with no evidence of additional toxicity.
• Augmented Board of Directors. In September 2015, Calithera appointed Sunil Agarwal, M.D., Senior Vice President and Chief Medical Officer at Ultragenyx, to the company’s Board of Directors.
Anticipated Upcoming Milestones
• Hematologic Phase 1 clinical trial data by year end 2015
• Initiation of six CB-839 combination expansion cohorts by year end 2015
• CB-839 combination therapy data in mid-2016
• Filing of investigational new drug application (IND) for arginase inhibitor CB-1158 in the first half of 2016
Selected Third Quarter 2015 Financial Results
Research and development expenses were $6.8 million for the three months ended September 30, 2015, compared with $3.9 million for the same period in the prior year. The increase of $2.9 million was primarily attributed to higher expenses associated with the continued advancement of CB-839 and investments in the Company’s arginase inhibitor program.
General and administrative expenses were $2.2 million for the three months ended September 30, 2015, compared with $1.3 million for the same period in the prior year. The increase of $0.9 million was primarily due to higher employment-related expenses, including stock-based compensation expense and professional service fees associated with operating as a publicly-traded company.
Net loss for the three months ended September 30, 2015 was $8.9 million.
Financial Guidance for 2015
Calithera is updating its guidance of its cash, cash equivalents and investments to be at least $70 million at the end of 2015, exclusive of any license milestone payments or funds arising from any additional new collaborations or partnerships, equity financings or other new sources.