“As a whole, 2019 was a productive and positive year in which we made significant progress on our clinical programs. In addition to reading out positive topline data from the
Fourth Quarter 2019 and Recent Highlights
- Completed patient enrollment of randomized CANTATA trial of telaglenastat with cabozantinib in advanced renal cell carcinoma (RCC). The CANTATA trial is a global, randomized, double-blind clinical trial of telaglenastat combined with cabozantinib, in patients with advanced or metastatic RCC who have received one or two prior treatments. The CANTATA trial enrolled 444 patients at multiple centers globally. The primary endpoint is progression-free survival (PFS). Calithera plans to report top-line efficacy and safety data from the trial in late third quarter or fourth quarter 2020.
- Advancement toward initiation of a randomized trial in non-small cell lung cancer (NSCLC) patients with genetic mutation NRF2/KEAP1. The NRF2/KEAP1 pathway is known to drive the development of certain cancers, including a significant proportion of NSCLC, through the management of oxidative stress in a manner that makes the cancer cell highly dependent upon glutaminase activity. Recently presented clinical data demonstrate that activation of this pathway, either through the loss of KEAP1 function or activation of NRF2, results in very poor outcomes in NSCLC patients. In addition, preclinical data demonstrated that activation of the KEAP1/NRF2 pathway make NSCLC cancer more aggressive but also much more sensitive to telaglenastat. The clear mechanistic rationale, strong preclinical data, and high unmet medical need in the NSCLC population have led Calithera to design a clinical study that will evaluate telaglenastat in combination with standard of care chemo-immunotherapy in first line NSCLC patients with tumors that harbor mutations in either KEAP1 or NRF2. This trial is expected to begin enrollment in the first half of 2020. We plan to present interim data from this trial in 2021.
- Presented results of Phase 2
ENTRATAstudy of telaglenastat (CB-839) with everolimus in RCC at the ESMO 2019 Congress. The ENTRATAtrial (NCT03163667) was 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 the trial was PFS per investigator assessment with a predetermined threshold of p≤0.2 one-sided. Telaglenastat, when added to everolimus, doubled the median PFS in heavily pretreated patients with advanced RCC to 3.8 months as compared to 1.9 months for everolimus alone, and reduced the risk of disease progression or death by 36% (HR=0.64, p=0.079 one-sided). The secondary endpoint of overall survival is not yet mature.
- Presented new INCB001158 data at the ESMO 2019
Congress. Calithera and Incyte are collaborating to conduct this Phase 1 study evaluating INCB001158 as monotherapy and in combination with the PD-1 inhibitor pembrolizumab in checkpoint inhibitor refractory and naïve advanced/metastatic solid tumors. Responses were observed in patients with microsatellite stable (MSS) colorectal cancer, a disease not historically sensitive to checkpoint inhibition.
- Completed a Phase 1 clinical trial of CB-280 in healthy volunteers. The first-in-human Phase 1 trial evaluated the safety, tolerability and pharmacokinetic profile of oral CB-280 in healthy volunteers. A Phase 1b clinical study in people with cystic fibrosis (CF), which is expected to start enrollment in the first half of 2020, will test multiple doses of CB-280 compared to placebo in approximately 30 adults with CF to determine a safe dose range, and evaluate pharmacodynamic effects of arginase inhibition in this population.
Selected Fourth Quarter and Full Year 2019 Financial Results
Cash, cash equivalents and investments totaled
Research and development expenses for the full year 2019 were
General and administrative expenses for the full year 2019 were
Interest and other income, net for the full year 2019 was
Net loss for the three months and year 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; the receipt of top-line efficacy and safety data in the CANTATA trial; the timing of enrollment of the randomized trial in NSCLC patients with genetic mutation NRF2/KEAP1 and the presentation of interim data from this trial; the safety and anti-tumor activity of telaglenastat plus palbociclib; and the timing that CB-280 will enter 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
Selected Consolidated Statements of Operations Financial Data
(in thousands, except per share amounts)
|Three Months Ended
||Twelve Months Ended
|Research and development||17,902||16,977||76,290||66,195|
|General and administrative||4,551||3,247||16,605||13,340|
|Total operating expenses||22,453||20,224||92,895||79,535|
|Loss from operations||(22,453||)||(20,224||)||(92,895||)||(57,281||)|
|Interest and other income, net||725||725||3,035||2,652|
|Net loss per share, basic and diluted||$||(0.39||)||$||(0.51||)||$||(1.90||)||$||(1.49||)|
|Weighted-average common shares used to compute net loss per share, basic and diluted||55,055||38,333||47,312||36,604|
Selected Consolidated Balance Sheet Financial Data
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||157,361||$||136,153|
|Total stockholders’ equity||142,426||126,714|
Source: Calithera Biosciences, Inc.