“Calithera continues to advance the development of our novel oncometabolism clinical candidates,” said
Third Quarter 2018 and Recent Highlights
- 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 CB-839. Calithera will initiate Phase 1/2 clinical studies in the first quarter of 2019. Preclinical data suggest that CB-839 synergizes with CDK4/6 inhibitors by enhancing cell cycle arrest and blocking cancer cell proliferation. CB-839 also synergizes preclinically with PARP inhibitors to impair DNA synthesis, enhance DNA damage, and block cancer cell proliferation.
- Two Randomized Combination Trials of CB-839 in Combination for the Treatment of Renal Cell Carcinoma. The ENTRATA trial, a randomized double-blind study of late line patients, will enroll approximately 66 patients to receive either CB-839 plus everolimus or everolimus alone. Topline results are expected in 2019. The CANTATA trial is a randomized, global, double-blind trial comparing patients treated with cabozantinib and CB-839 to patients treated with cabozantinib alone. Topline results are expected in 2020. The trial will enroll patients with clear cell renal cell carcinoma who have previously received one or two prior lines of therapy. The trial, originally designed to enroll 300 patents has been enlarged to approximately 400 patients.
The U.S. Food and Drug Administration( FDA) has granted Fast Track designation for CB-839 in combination with cabozantinib for the treatment of this patient population. Updated Phase 1b data of CB-839 combined with cabozantinib presented in the quarter demonstrated a disease control rate of 100%, and response rate of 50% in 10 evaluable patients with clear cell RCC.
- INCB001158 Arginase Inhibitor Immuno-oncology Program. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with solid tumors 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 is expected to be presented at a medical meeting in the first half of 2019.
- CB-280 Arginase Inhibitor 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. An investigational new drug (IND) application for CB-280 with the
FDAis planned for the first half of 2019.
- CB-708 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. An IND application for CB-708, an orally administered small molecule inhibitor of CD73, is planned for 2019.
Selected Third Quarter 2018 Financial Results
Cash, cash equivalents and investments totaled
Research and development expenses were
General and administrative expenses were
Net loss from operations for the three months 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 and enrollment of Calithera’s clinical trials, the clinical and commercial potential of its product candidates, Calithera’s collaboration with Pfizer and
|Calithera Biosciences, Inc.|
|Selected Consolidated Statements of Operations Financial Data|
|(in thousands, except per share amounts)|
|Three Months Ended
|Nine Months Ended
|Research and development||16,420||10,833||49,218||27,615|
|General and administrative||3,087||3,074||10,093||9,230|
|Total operating expenses||19,507||13,907||59,311||36,845|
|Loss from operations||(19,507||)||(6,653||)||(37,057||)||(18,144||)|
|Interest income, net||658||582||1,927||1,292|
|Net loss per share, basic and diluted||$||(0.52||)||$||(0.17||)||$||(0.98||)||$||(0.53||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||36,405||35,475||36,021||32,072|
|Calithera Biosciences, Inc.|
|Selected Consolidated Balance Sheet Financial Data|
|September 30,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||141,456||$||186,154|
|Total stockholders’ equity||135,910||150,307|
Source: Calithera Biosciences, Inc.