“2017 was a transformative year for Calithera as we advanced each of our internally discovered first-in-class, small molecule onco-metabolism clinical candidates into broad clinical programs and announced a partnership with Incyte.” said
Fourth Quarter 2017 and Recent Highlights
- Presented Results of CB-839 in Combination with Cabozantinib in Renal Cell Carcinoma; Randomized Phase 2 Trial Planned. In
February 2018, we presented preliminary results of the Phase Ib trial of CB-839 in combination with cabozantinib, an oral tyrosine kinase inhibitor at the 2018 Genitourinary Cancer Symposium. Preliminary results showed the combination demonstrated 40% overall response rate in advanced clear cell RCC patients, and 100% disease control with the safety profile of CB-839 plus cabozantinib generally consistent with that of cabozantinib monotherapy. On the basis of this efficacy and safety data, we plan to initiate a randomized double-blind placebo controlled trial in approximate 300 clear cell renal cell carcinoma patients who have previously received one or two prior lines of therapy. The Phase 2 trial, known as CANTATA, is planned to begin in the second quarter of 2018 and it is expected to take approximately two years to reach the primary endpoint analysis of progression free survival.
- Presented Results of CB-839 in Combination with Nivolumab. In
November 2017, we announced initial data from the ongoing trial of CB-839 in combination with nivolumab, in patients with melanoma, renal cell carcinoma and non-small cell lung cancer. Responses were observed in three melanoma patients who were progressing on a checkpoint inhibitor at study entry, and disease stabilization was observed in patients with non-small cell lung cancer and renal cell carcinoma patients that had disease progression on a checkpoint inhibitor immediately prior to starting the CB-839/nivolumab combination. The collaboration with Bristol-Myers Squibbwas expanded, and a joint development committee was established to guide the development and regulatory strategy.
- Presented Results of CB-839 in Combination with Paclitaxel for the Treatment of Triple Negative Breast Cancer. In
December 2017, we presented updated clinical data from a Phase 2 expansion cohort of patients with triple negative breast cancer receiving CB-839 in combination with paclitaxel. Among all evaluable patients treated with CB-839 doses of at least 600 mg bid (n=37), there were 8 partial responses (22%) and disease control in 22 patients (59%). Exploratory biomarker analysis showed a trend for the strongest clinical benefit occurring in patients with desmoplastic stromal gene expression signatures. We plan to present an update on our TNBC development program in the fourth quarter of 2018.
- INCB001158 Initiated Combination Dosing. In
October 2017, the first patient was treated in the Phase I cohort of INCB001158 dosed in combination with Keytruda® (pembrolizumab), an anti-PD1 immune checkpoint inhibitor. INCB001158 is currently being evaluated in two Phase 1/2 clinical trials and a third trial is expected to begin in the first half of 2018.
- Augmented Board of Directors and Management Team. In
September 2017, Calithera appointed Blake Wise, President and Chief Operating Officer of Achaogen, to the company’s Board of Directors, and Sumita Rayas General Counsel.
Selected Fourth Quarter 2017 Financial Results
Cash, cash equivalents and investments totaled
Collaboration revenue for the full year 2017 was
Research and development expenses for the full year 2017 were
General and administrative expenses for the full year 2017 were
Net loss from operations for the three months and year ended
Financial Guidance for 2018
Calithera expects its cash, cash equivalents and investments will be between
Conference Call Information
Calithera will webcast a clinical update on CB-839 on
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, 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||15,496||6,593||43,111||27,748|
|General and administrative||3,300||3,011||12,530||10,586|
|Total operating expenses||18,796||9,604||55,641||38,334|
|Loss from operations||(11,542||)||(9,604||)||(29,686||)||(38,334||)|
|Interest income, net||568||84||1,860||330|
|Net loss per share, basic and diluted||$||(0.31||)||$||(0.45||)||$||(0.84||)||$||(1.95||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||35,560||21,045||32,951||19,486|
|Calithera Biosciences, Inc.|
|Selected Consolidated Balance Sheet Financial Data|
|December 31,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||186,154||$||51,781|
|Total stockholders’ equity||150,307||49,906|
Source: Calithera Biosciences, Inc.