--Calithera to Provide Corporate Update via Conference Call and Webcast at
“This year we expect to achieve multiple, key milestones in our clinical development program and several data readouts, including top-line results of the ENTRATA trial mid-year, and with our partner
First Quarter 2019 and Recent Highlights
- Completed enrollment of the Phase 2 renal cell carcinoma ENTRATA trial. The ENTRATA trial (NCT03163667) is a Phase 2 randomized, double blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including at least one prior VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in
the United States. The primary endpoint of ENTRATA is progression-free survival (PFS). Calithera plans to report top-line results including key efficacy and safety data in mid-2019.
- Initiated Phase 1/2 clinical trial of telaglenastat (CB-839) in combination with talazoparib for solid tumors. The Phase 1/2 clinical trial is evaluating telaglenastat in combination with Pfizer’s PARP inhibitor talazoparib in patients with solid tumors. Calithera expects to initiate an additional trial of the combination of telaglenastat plus the CDK4/6 inhibitor palbociclib in patients with KRAS-mutated colorectal cancer and KRAS-mutated non-small cell lung cancer in the second quarter of 2019.
- Initiated Phase 1 trial of arginase inhibitor CB-280 for the treatment of cystic fibrosis. Arginase is believed to be critical in the pathology of cystic fibrosis. It impairs production of nitric oxide and generates metabolites of arginine that may impair lung function. CB-280 is an orally administered small molecule inhibitor of arginase. The first-in-human Phase 1 trial initiated in
February 2019will evaluate the safety, tolerability and pharmacokinetic profile of oral CB-280 in healthy volunteers.
- Presented preclinical data for CB-708 at AACR Annual Meeting 2019. The preclinical data presented at the 2019
American Association for Cancer Research(AACR) Annual Meeting demonstrate that CB-708 is a potent and selective inhibitor of CD73 that has immune-mediated, single-agent activity in syngeneic mouse tumor models. In the pre-clinical studies presented, CB-708 was well-tolerated and shows enhanced anti-tumor activity in combination with checkpoint inhibitors as well as chemotherapy. Calithera anticipates that CB-708 will enter clinical trials in 2019.
Selected First Quarter 2019 Financial Results
Cash, cash equivalents and investments totaled
Research and development expenses were
General and administrative expenses were
Net loss for the three months ended
Conference Call Information
Calithera will host an update conference call today,
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 Calithera’s clinical trials, the clinical and commercial potential of its product candidates, Calithera’s plans to report data from its Phase 2 ENTRATA trial in 2019; the trial design and enrollment of patients in the ENTRATA and CANTATA trials; Calithera’s plan to initiate additional clinical trials of CB-839 in collaboration with Pfizer; and the timing that CB-708 will enter clinical trials in 2019. 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
|Research and development||20,239||15,493|
|General and administrative||4,164||3,508|
|Total operating expenses||24,403||19,001|
|Loss from operations||(24,403||)||(13,812||)|
|Interest income, net||716||606|
|Net loss per share, basic and diluted||$||(0.61||)||$||(0.37||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||38,866||35,779|
|Calithera Biosciences, Inc.|
|Selected Consolidated Balance Sheet Financial Data|
|March 31,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||116,999||$||136,153|
|Total stockholders’ equity||105,974||126,714|
Source: Calithera Biosciences, Inc.