-Single Agent Solid Tumor Clinical Benefit Seen With Tumor Metabolism Inhibitor CB-839
-Continued Signs of Activity, Tolerability, and Durability
-First Preclinical Data Presented For Immuno-Oncology Arginase Inhibitor CB-1158
-IND filing Remains on Track for 1H 2016
-Calithera to Host Conference Call Today at
“In the third quarter, we continued to move clinical programs forward with presentations of data at key medical meetings,” said
Third Quarter 2015 and Recent Highlights
- CB-839 Solid Tumor Phase 1 data presented at the AACR-NCI-EORTC meeting. On
November 8, 2015 , solid tumor phase 1 data were presented at theAmerican Association of Cancer Research (AACR)-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-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-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 appointedSunil 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
General and administrative expenses were
Net loss for the three months ended
Financial Guidance for 2015
Calithera is updating its guidance of its cash, cash equivalents and investments to be at least
Conference Call Information
Calithera will host its third quarter financial results and corporate 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 Calithera’s ability to build a pipeline of novel therapeutic product candidates, the timing and expected enrollment 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 and Calithera’s receipt of clinical data from its clinical trials. 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 most recent Quarterly Report on Form 10-Q filed with the
Calithera Biosciences, Inc. | |||||||||||||||
Selected Statements of Operations Financial Data | |||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||
(unaudited) | |||||||||||||||
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 6,752 | $ | 3,894 | $ | 17,915 | $ | 11,395 | |||||||
General and administrative | 2,198 | 1,347 | 6,776 | 3,488 | |||||||||||
Total operating expenses | 8,950 | 5,241 | 24,691 | 14,883 | |||||||||||
Loss from operations | (8,950 | ) | (5,241 | ) | (24,691 | ) | (14,883 | ) | |||||||
Other income, net | 50 | 2 | 115 | 4 | |||||||||||
Net loss | $ | (8,900 | ) | $ | (5,239 | ) | $ | (24,576 | ) | $ | (14,879 | ) | |||
Net loss per share, basic and diluted | $ | (0.49 | ) | $ | (16.85 | ) | $ | (1.36 | ) | $ | (61.90 | ) | |||
Weighted average common shares used to compute net loss per share, basic and diluted | 18,105 | 311* | 18,005 | 240* | |||||||||||
*Pre-IPO conversion of preferred shares to common shares | |||||||||||||||
Calithera Biosciences, Inc. | |||||||
Selected Balance Sheets Financial Data | |||||||
(in thousands) | |||||||
(unaudited) | |||||||
September 30, | December 31, | ||||||
2015 | 2014 | ||||||
Balance Sheet Data: | |||||||
Cash, cash equivalents and investments | $ | 81,887 | $ | 101,969 | |||
Working capital | 77,926 | 99,742 | |||||
Total assets | 84,530 | 104,770 | |||||
Total liabilities | 5,935 | 4,404 | |||||
Accumulated deficit | (76,430 | ) | (51,854 | ) | |||
Total stockholders’ equity | 78,595 | 100,366 | |||||
Contact:Jennifer McNealey ir@Calithera.com 650-870-1071