“Recent highlights included the presentation of clinical trial results of CB-1158, a first-in-class small molecule arginase inhibitor, in an oral presentation at the
Second Quarter 2017 and Recent Highlights
- CB-839 Randomized Phase 2 Combination Trial in Renal Cell Carcinoma Initiated. In
August 2017 , Calithera announced the initiation of a randomized, double blind, placebo controlled trial to evaluate the safety and efficacy of CB-839 in combination with everolimus versus placebo in approximately 250 patients with metastatic, clear cell renal cell carcinoma who have been treated with at least two lines of prior systemic therapy including a VEGFR-targeting tyrosine kinase inhibitor and at least one of either CABOMETYX™ (cabozantinib) or an active PD-1/PD-L1 inhibitor. CB-839 has been granted Fast Track designation for this indication. - CB-839 Triple Negative Breast Cancer Phase 2 Trial Initiated. In
July 2017 , Calithera initiated a Phase 2 trial of CB-839 with paclitaxel in triple negative breast cancer patients. Four single arm, open label, cohorts of African American and non-African American patients will be treated in both the early stage setting, where patients have no prior treatment for metastatic disease, as well as the late stage setting, after at least two prior therapies for metastatic disease including prior taxane therapy. The primary endpoint of this trial is objective response rate. Additional data from the triple negative breast cancer development program are expected in the fourth quarter of 2017. - Collaboration with
Bristol-Myers Squibb expanded. InMay 2017 , Calithera’s existing collaboration evaluating Opdivo® (nivolumab) in combination with CB-839 was expanded to include additional renal cell carcinoma cohorts as well as non-small cell lung cancer and melanoma. Initial results of CB-839 dosed in combination with Bristol Myers Squibb’s Opdivo® are expected in the fourth quarter of 2017. - CB-1158 (INCB01158) Phase I Solid Tumor Data Presented at the
American Society of Clinical Oncology Annual Meeting. InJune 2017 , data was presented from the first 17 patients with advanced solid tumors dosed with CB-1158 as a single agent. Plasma levels of arginase were inhibited > 90% in all patients, and in 10 of 11 patients plasma arginine increased 1.5-fold or more. CB-1158 was generally well tolerated with no drug-related serious adverse events. The trial is continuing to enroll patients in the dose escalation phase of the study, and expansion cohorts in pre-defined tumor types, to be followed by combination studies with an anti-PD-1 antibody.
Selected Second Quarter 2017 Financial Results
Cash, cash equivalents and investments totaled
Revenue was
Research and development expenses were
General and administrative expenses were
Net loss from operations for the three months ended
Conference Call Information
Calithera will host an update conference call today,
About Calithera
Forward Looking Statements
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 Calithera’s clinical trials, the clinical and commercial potential of its product candidates, Calithera’s ability to fund its clinical programs, 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 periodic filings with the
Calithera Biosciences, Inc. | |||||||||||||||
Selected Statements of Operations Financial Data | |||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||
(unaudited) | |||||||||||||||
Three Months Ended June 30, |
Six Months Ended June 30, |
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2017 | 2016 | 2017 | 2016 | ||||||||||||
Revenue: | |||||||||||||||
Collaboration revenue | $ | 7,255 | $ | — | $ | 11,447 | $ | — | |||||||
Total revenue | 7,255 | — | 11,447 | — | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 10,142 | 7,776 | 16,782 | 14,842 | |||||||||||
General and administrative | 2,848 | 2,665 | 6,156 | 5,256 | |||||||||||
Total operating expenses | 12,990 | 10,441 | 22,938 | 20,098 | |||||||||||
Loss from operations | (5,735 | ) | (10,441 | ) | (11,491 | ) | (20,098 | ) | |||||||
Interest income, net | 541 | 83 | 710 | 158 | |||||||||||
Net loss | $ | (5,194 | ) | $ | (10,358 | ) | $ | (10,781 | ) | $ | (19,940 | ) | |||
Net loss per share, basic and diluted | $ | (0.15 | ) | $ | (0.55 | ) | $ | (0.36 | ) | $ | (1.07 | ) | |||
Weighted average common shares used to compute net loss per share, basic and diluted | 35,348 | 18,987 | 30,342 | 18,688 | |||||||||||
Calithera Biosciences, Inc. | ||||||||
Selected Balance Sheets Financial Data | ||||||||
(in thousands) | ||||||||
(unaudited) | ||||||||
June 30, | December 31, | |||||||
2017 | 2016 | |||||||
Balance Sheet Data: | ||||||||
Cash, cash equivalents and investments | $ | 208,184 | $ | 51,781 | ||||
Working capital | 135,953 | 49,108 | ||||||
Total assets | 214,082 | 54,796 | ||||||
Deferred revenue | 45,553 | — | ||||||
Total liabilities | 51,618 | 4,890 | ||||||
Accumulated deficit | (133,287 | ) | (122,502 | ) | ||||
Total stockholders’ equity | 162,464 | 49,906 | ||||||
Contact:Jennifer McNealey ir@Calithera.com 650-870-1071