--Calithera to Provide Corporate Update via Conference Call and Webcast at
“In the second quarter, we achieved clinical proof of concept for our glutaminase inhibitor telaglenastat, with positive topline results of the randomized phase 2 ENTRATA study,” said
Second Quarter 2019 and Recent Highlights
- Achieved positive topline results in randomized Phase 2 ENTRATA study of telaglenastat (CB-839) with everolimus in renal cell carcinoma. The ENTRATA trial (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 ENTRATA was progression-free survival (PFS). The combination doubled the median PFS in heavily pretreated patients with advanced RCC. Telaglenastat, when added to everolimus, doubled the median PFS 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 primary endpoint of the trial was PFS per investigator assessment with a predetermined threshold of p≤0.2 one-sided. The secondary endpoint of overall survival is not yet mature.
- Initiated Phase 1/2 clinical trial of telaglenastat in combination with palbociclib for solid tumors. The Phase 1/2 clinical trial is evaluating telaglenastat in combination with Pfizer’s CDK4/6 inhibitor palbociclib, also known as Ibrance®. The study will evaluate the safety and anti-tumor activity of telaglenastat plus palbociclib in patients with KRAS-mutated colorectal cancer (CRC) and KRAS-mutated non-small cell lung cancer (NSCLC).
- Advanced INCB001158 arginase inhibitor immuno-oncology program. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with cancer both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with
Incyte. Data from INCB001158 are expected to be presented at the European Society for Medical Oncology (ESMO) Congressin September.
- Presented new preclinical data for CB-708 at AACR Annual Meeting. CB-708 is a selective, oral inhibitor of CD73, an enzyme that synthesizes the immunosuppressive agent adenosine and is over expressed in multiple tumor types. By blocking adenosine production in the tumor, CB-708 is designed to enhance T-cell activation leading to anti-tumor activity. Calithera anticipates that CB-708 will enter clinical trials in the second half of 2019.
- Completed public offering of common stock. In
June 2019, Calithera completed an underwritten public offering of common stock. Gross proceeds from the offering, before underwriting discounts and commissions and offering expenses, were $57.5 million.
Selected Second Quarter 2019 Financial Results
Cash, cash equivalents and investments totaled
Research and development expenses were
General and administrative expenses were
Net loss for the three months ended
Conference Call Information
Calithera will host an update conference call today,
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to Calithera’s clinical trials, the clinical and commercial potential of its product candidates; the trial design and enrollment of patients in the CANTATA and ENTRATA trials; clinical trials for INCB001158 and Calithera’s agreement with
|Calithera Biosciences, Inc.|
|Selected Consolidated Statements of Operations Financial Data|
|(in thousands, except per share amounts)|
|Three Months Ended
|Six Months Ended
|Research and development||20,928||17,305||41,167||32,798|
|General and administrative||3,984||3,498||8,148||7,006|
|Total operating expenses||24,912||20,803||49,315||39,804|
|Loss from operations||(24,912||)||(3,738||)||(49,315||)||(17,550||)|
|Interest and other income, net||760||663||1,476||1,269|
|Net loss per share, basic and diluted||$||(0.58||)||$||(0.09||)||$||(1.19||)||$||(0.45||)|
|Weighted average common shares used to compute
net loss per share, basic and diluted
|Calithera Biosciences, Inc.|
|Selected Consolidated Balance Sheet Financial Data|
|June 30,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||153,212||$||136,153|
|Total stockholders’ equity||139,382||126,714|
Source: Calithera Biosciences, Inc.