“This is a time of significant progress for Calithera’s clinical development program as we continue to advance our novel onco-metabolism clinical candidates through robust clinical studies,” said
Fourth Quarter 2018 and Recent Highlights
- Completed patient enrollment in the randomized phase 2 ENTRATA trial of telaglenastat (CB-839) and everolimus in renal cell carcinoma (RCC). 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 a 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 efficacy and safety data from the trial in the second half of 2019.
- Announced two new clinical trial collaborations to evaluate Pfizer’s CDK4/6 inhibitor palbociclib, also known as IBRANCE®, and the dual-mechanism poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib, also known as TALZENNA®, each in combination with Calithera’s glutaminase inhibitor telaglenastat. Preclinical data suggest that telaglenastat synergizes with PARP inhibitors to impair DNA synthesis, enhance DNA damage, and block cancer cell proliferation. Calithera will initiate a Phase 1/2 clinical trial of the combination of telaglenastat plus talazoparib in patients with RCC and TNBC in the first quarter of 2019. Telaglenastat also synergizes with CDK4/6 inhibitors by enhancing cell cycle arrest and blocking cancer cell proliferation. Calithera will initiate a Phase 1/2 clinical trial of the combination of telaglenastat plus palbociclib in patients with KRAS-mutated colorectal cancer (CRC) and patients with KRAS-mutated non-small cell lung cancer (NSCLC) in the second quarter of 2019.
- 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 the INCB001158 program are expected to be presented at a medical meeting in the second half 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. The study will be conducted under a United States Food and Drug Administration( FDA) Investigational New Drug (IND) application.
- Initiated IND-enabling studies with CB-708, an oral small molecule CD73 inhibitor. The immuno-oncology target CD73 is an enzyme that plays a critical role in the process of ATP conversion to adenosine. Initiation of a Phase 1 study of CB-708, an orally administered small molecule inhibitor of CD73, is planned for 2019. A preclinical abstract describing CB-708 has been accepted for presentation at the 2019
American Association for Cancer Researchannual meeting in March.
Selected Fourth Quarter 2018 Financial Results
Cash, cash equivalents and investments totaled
Collaboration revenue for the full year 2018 was
Research and development expenses for the full year 2018 were
General and administrative expenses for the full year 2018 were
Interest Income, net for the full year 2018 was
Net loss from operations for the three months and year ended
Conference Call Information
Calithera will host an update conference call today,
Calithera is a clinical-stage biopharmaceutical company focused on fighting cancer by discovering, developing, and commercializing novel small molecule drugs that target tumor and immune cell metabolism. Calithera is headquartered in
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, the safety, tolerability and efficacy of CB-839, INCB001158, CB-280 and CB-708, and the overall advancement in clinical trials, Calithera’s collaborations with
|Calithera Biosciences, Inc.|
|Selected Consolidated Statements of Operations Financial Data|
|(in thousands, except per share amounts)|
|Three Months Ended
|Twelve Months Ended
|Research and development||16,977||15,496||66,195||43,111|
|General and administrative||3,247||3,300||13,340||12,530|
|Total operating expenses||20,224||18,796||79,535||55,641|
|Loss from operations||(20,224||)||(11,542||)||(57,281||)||(29,686||)|
|Interest income, net||725||568||2,652||1,860|
|Net loss per share, basic and diluted||$||(0.51||)||$||(0.31||)||$||(1.49||)||$||(0.84||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||38,333||35,560||36,604||32,951|
|Calithera Biosciences, Inc.|
|Selected Consolidated Balance Sheet Financial Data|
|December 31,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||136,153||$||186,154|
|Total stockholders’ equity||126,714||150,307|
Source: Calithera Biosciences, Inc.