--Calithera to Provide Corporate Update via Conference Call and Webcast at
“We continued our positive momentum from 2019 into the first quarter of 2020, further strengthening our cash position and advancing our key clinical development programs,” said
First Quarter 2020 and Other Recent Program Highlights
- CANTATA randomized trial of telaglenastat and 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). In light of delays associated with COVID-19, Calithera plans to report top-line efficacy and safety data from the trial in the fourth quarter of 2020.
- KEAPSAKE randomized trial in non-small cell lung cancer (NSCLC) patients with a NRF2/KEAP1 genetic mutation. Mutation of the KEAP1/NRF2 pathway is present in approximately 20% of NSCLC and is associated with poor survival and resistance to standard-of-care therapy. Activation of this pathway leads to reliance upon glutaminase activity and sensitizes cells to glutaminase inhibition with telaglenastat. Given the challenges associated with opening new clinical studies during the current stage of the COVID-19 pandemic, Calithera expects to begin enrollment of the first patient in the third quarter of 2020. A trial-in-progress abstract describing the study design has been accepted for presentation at the
American Society of Clinical Oncology2020 Virtual Meeting (ASCO20). Calithera plans to present interim data from this trial in 2021.
- Pfizer clinical collaboration with the CDK4/6 inhibitor IBRANCE®, and the dual-mechanism poly (ADP-ribose) polymerase (PARP) inhibitor TALZENNA®, each in combination with telaglenastat. In
March 2019, Calithera initiated a Phase 1/2 trial of the combination of telaglenastat plus Talzenna in patients with solid tumors including expansion cohorts in renal cell carcinoma and triple-negative breast cancer. In July 2019, the company initiated a Phase 1/2 trial of the combination of telaglenastat plus Ibrance in patients with solid tumors including expansion cohorts in KRAS-mutated colorectal cancer and KRAS-mutated non-small cell lung cancer. Dose escalation has been completed for both trials. Dose expansion cohorts have been temporarily paused due to the COVID-19 situation. Calithera expects enrollment to resume in the second quarter of 2020.
- INCB001158 program. INCB001158, an internally discovered molecule, is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, in combination with anti-PD-1 immunotherapy, and in multiple chemotherapy regimens. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Clinical trials being conducted by Calithera and Incyte evaluating INCB001158 are ongoing as planned.
- CB-280 arginase inhibitor program. Calithera has completed a first-in-human Phase 1 trial evaluating 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 third quarter of 2020, given the challenges associated with opening new clinical studies during the current stage of the COVID-19 pandemic, 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 First Quarter 2020 Financial Results
Cash, cash equivalents and investments totaled
Research and development expenses were
General and administrative expenses were
Interest and other income, net was
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; 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 and cabozantinib, telaglenastat plus Talzenna and telaglenastat plus Ibrance; the development of INCB001158 by Calithera and Incyte; 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
|Research and development||20,125||20,239|
|General and administrative||4,946||4,164|
|Total operating expenses||25,071||24,403|
|Loss from operations||(25,071||)||(24,403||)|
|Interest and other income, net||625||716|
|Net loss per share, basic and diluted||$||(0.38||)||$||(0.61||)|
|Weighted-average common shares used to compute net loss per share, basic and diluted||64,556||38,866|
|Selected Consolidated Balance Sheet Financial Data|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||138,110||$||157,361|
|Total stockholders’ equity||127,665||142,426|
Source: Calithera Biosciences, Inc.