--Calithera to Provide Corporate Update via Conference Call and Webcast at
“In the fourth quarter, we maintained a strong cash position and continued to advance our key clinical development programs, including the KEAPSAKE clinical trial evaluating telaglenastat in non-small cell lung cancer in patients with NRF2/KEAP1 genetic mutations, and the Ph1b trial of our arginase inhibitor CB-280 in cystic fibrosis patients,” said
Fourth Quarter 2020 and Recent Highlights
- Announced top-line results of randomized CANTATA trial of telaglenastat with cabozantinib in advanced renal cell carcinoma (RCC). The Phase 2 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. On
January 4, 2021, Calithera announced topline results from the CANTATA clinical study and reported the trial did not meet the primary endpoint of improving progression free survival (PFS) in the study population.
- Continued enrollment of the Phase 2 randomized KEAPSAKE trial in non-small cell lung cancer (NSCLC) patients with genetic mutation NRF2/KEAP1. The double-blind KEAPSAKE trial will enroll approximately 120 patients with stage IV non-squamous NSCLC with tumors that have the KEAP1 or NRF2 mutation. Patients will be randomized to receive telaglenastat or placebo, in combination with pembrolizumab, carboplatin and pemetrexed. The study will evaluate the safety and investigator-assessed progression-free survival (PFS) of telaglenastat plus this standard-of-care chemoimmunotherapy regimen. Calithera anticipates sharing interim data from the KEAPSAKE trial in the second half of 2021.
- Initiated a Phase 1b clinical trial of CB-280 in patients with cystic fibrosis. In October, Calithera presented a trial in progress poster at the North American Cystic Fibrosis 2020
Virtual Conference. The presentation included preclinical study results which suggest CB-280 significantly improved lung function and reduced Pseudomonas aeruginosa colony-forming units in pre-clinical models. Arginase inhibition with CB-280 resulted in improved central airway resistance in CFTR knockout mice, and decreased lung infection in wild type and DeltaF508-CFTR-expressing mice infected with Pseudomonas aeruginosa. Enrollment in the Ph1b study is ongoing and Calithera expects to share data in the second half of 2021. In November 2020, Calithera was awarded up to $2.4Mfrom the Cystic Fibrosis Foundationto support clinical development of CB-280.
- Presented preclinical data for CB-668 IL4I1 program at the
Society for Immunotherapy of Cancer(SITC) Annual Meeting in November. CB-668 is a potent, selective, small-molecule, oral inhibitor of IL4I1, an amino acid oxidase that inhibits anti-tumor immunity and promotes tumor growth. IL4I1 regulates several aspects of adaptive immunity, including inhibition of cytotoxic T cells through its production of both hydrogen peroxide and activators of the aryl hydrocarbon receptor. CB-668 increases pro-inflammatory gene expression in tumors leading to an anti-tumor effect in mouse tumor models.
Selected Fourth Quarter and Full Year 2020 Financial Results
Cash, cash equivalents and investments totaled
Research and development expenses for the full year 2020 were
General and administrative expenses for the full year 2020 were
Interest and other income, net for the full year 2020 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 timing of enrollment of the randomized trial in NSCLC patients with genetic mutation NRF2/KEAP1 and the presentation of interim data from this trial; 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 be 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||$||17,077||$||17,902||$||71,015||$||76,290|
|General and administrative||5,586||4,551||20,372||16,605|
|Total operating expenses||22,663||22,453||91,387||92,895|
|Loss from operations||(22,663||)||(22,453||)||(91,387||)||(92,895||)|
|Interest and other income, net||97||725||1,250||3,035|
|Net loss per share, basic and diluted||$||(0.32||)||$||(0.39||)||$||(1.31||)||$||(1.90||)|
|Weighted-average common shares used to compute
net loss per share, basic and diluted
|Selected Consolidated Balance Sheet Financial Data|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||115,151||$||157,361|
|Total stockholders’ equity||102,371||142,426|
Source: Calithera Biosciences, Inc.