“In the quarter, Calithera advanced each of our internally discovered first-in-class, small molecule onco-metabolism clinical candidates. We initiated two new phase 2 trials with our oral glutaminase inhibitor and we recently initiated dosing of our oral arginase inhibitor in combination with a checkpoint inhibitor,” said
Third Quarter 2017 and Recent Highlights
- Oral Presentation Accepted at
SITC. We will present clinical trial results from CB-839 dosed in combination with Opdivo® (nivolumab) in patients with advanced melanoma, renal cell carcinoma or non-small cell lung cancer in an oral presentation at the 32nd Annual Meeting of the Society for Immunotherapy of Cancerwhich is being held from November 10-12, 2017. We will also present the data in a poster format at the meeting, and we will host a clinical update webcast on Saturday, November 11th, 2017.
- Initiated Randomized Phase 2 Combination Trial in Renal Cell Carcinoma. In
August 2017, we initiated 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. The primary endpoint of this trial is progression free survival, and CB-839 has been granted Fast Track designation for this indication.
- Initiated Phase 2 Trial in Triple Negative Breast Cancer. In
July 2017, we initiated a Phase 2 trial of CB-839 with paclitaxel in patients with 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.
- Initiated Combination Dosing. In
October 2017, the first patient was treated in the Phase I cohort of INCB01158 (formerly known as CB-1158) dosed in combination with Keytruda® (pembrolizumab), an anti-PD1 immune checkpoint inhibitor.
- Augmented Board of Directors. In
September 2017, Calithera appointed Blake Wise, President and Chief Operating Officer of Achaogen, to the company’s Board of Directors.
Selected Third Quarter 2017 Financial Results
Cash, cash equivalents and investments totaled
Research and development expenses were
General and administrative expenses were
Net loss from operations for the three months ended
Conference Call Information
Calithera will webcast a clinical update on CB-839 on
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, 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 Consolidated Statements of Operations Financial Data|
|(in thousands, except per share amounts)|
|Three Months Ended
|Nine Months Ended
|Research and development||10,833||6,313||27,615||21,155|
|General and administrative||3,074||2,319||9,230||7,575|
|Total operating expenses||13,907||8,632||36,845||28,730|
|Loss from operations||(6,653||)||(8,632||)||(18,144||)||(28,730||)|
|Interest income, net||582||88||1,292||246|
|Net loss per share, basic and diluted||$||(0.17||)||$||(0.44||)||$||(0.53||)||$||(1.50||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||35,475||19,507||32,072||18,963|
|Calithera Biosciences, Inc.|
|Selected Consolidated Balance Sheet Financial Data|
|September 30,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||196,533||$||51,781|
|Total stockholders’ equity||158,092||49,906|
Source: Calithera Biosciences, Inc.