-CB-839 Combination Data submitted for Presentation at
-IND to be submitted for Immuno-Oncology Candidate CB-1158 in mid-2016
-Calithera to Host Conference Call Today at
“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
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-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 theAmerican Society of Hematology Annual Meeting in December.
- Arginase inhibitor CB-1158 preclinical data presented at the AACR-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
Research and development expenses for the full year 2015 were
General and administrative expenses for the full year 2015 were
Loss from operations for the three months and year end ended
Financial Guidance for 2016
Calithera expects that its cash, cash equivalents and investments will be at least
Conference Call Information
Calithera will host an update conference call today,
About Calithera
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the timing of initiation of Calithera’s clinical trials, Calithera’s ability fund its clinical programs, Calithera’s filing of an investigational new drug application for its arginase inhibitor, Calithera’s receipt of clinical data from its clinical trials, and Calithera’s cash and investments balance at the end of 2016. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera's stock price. Additional information concerning these and other risk factors affecting Calithera's business can be found in Calithera's periodic filings with the
Calithera Biosciences, Inc. | |||||||||||||||
Selected Statements of Operations Financial Data | |||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||
(unaudited) | |||||||||||||||
Three Months Ended December 31, |
Year Ended December 31, |
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2015 | 2014 | 2015 | 2014 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 5,833 | $ | 4,972 | $ | 23,748 | $ | 16,367 | |||||||
General and administrative | 2,295 | 1,866 | 9,071 | 5,354 | |||||||||||
Total operating expenses | 8,128 | 6,838 | 32,819 | 21,721 | |||||||||||
Loss from operations | (8,128 | ) | (6,838 | ) | (32,819 | ) | (21,721 | ) | |||||||
Interest income, net | 60 | 5 | 175 | 9 | |||||||||||
Net loss | $ | (8,068 | ) | $ | (6,833 | ) | $ | (32,644 | ) | $ | (21,712 | ) | |||
Net loss per share, basic and diluted | $ | (0.44 | ) | $ | (0.39 | ) | $ | (1.81 | ) | $ | (4.67 | ) | |||
Weighted average common shares used to compute net loss per share, basic and diluted | 18,163 | 17,743 | 18,045 | 4,652* | |||||||||||
*Pre-IPO conversion of preferred shares to common shares | |||||||||||||||
Calithera Biosciences, Inc. | |||||||
Selected Balance Sheets Financial Data | |||||||
(in thousands) | |||||||
(unaudited) | |||||||
December 31, | |||||||
2015 | 2014 | ||||||
Balance Sheet Data: | |||||||
Cash, cash equivalents and investments | $ | 71,925 | $ | 101,969 | |||
Working capital | 68,662 | 99,742 | |||||
Total assets | 75,750 | 104,770 | |||||
Total liabilities | 3,962 | 4,404 | |||||
Accumulated deficit | (84,498 | ) | (51,854 | ) | |||
Total stockholders’ equity | 71,788 | 100,366 | |||||
Contact:Jennifer McNealey ir@Calithera.com 650-870-1071