“2016 was a transformative year for Calithera as our lead product candidate CB-839 entered into multiple novel combination trials and progressed towards Phase II, and CB-1158 advanced into clinical development leading to a partnership with
Fourth Quarter 2016 and Recent Highlights
Global Research, Development and Commercialization Collaboration with Incyte. In January 2017, Incyteand Calithera announced the global collaboration and license agreement for the research, development and commercialization of the first in class, small molecule arginase inhibitor CB-1158. Under the terms of the collaboration and license agreement, Calithera has received an up-front payment of $45 millionfrom Incytein addition to an $8 millionequity investment. CB-1158 entered clinical trials in September 2016, and pharmacodynamic data on the first three patients was presented at the Society for Immunotherapy of Cancer( SITC) meeting in November 2016.
- CB-839: Phase I Triple Negative Breast Cancer Combination Data at the 2016 San Antonio Breast Cancer Symposium (SABCS). New data was presented at the 2016 SABCS in
December 2016on 28 triple negative breast cancer patients treated with CB-839 in combination with paclitaxel; 23 patients were evaluable for efficacy. Among evaluable patients treated with CB-839 doses of at least 600 mg bid (n=16), there were 5 partial responses (31%) and disease control (response or stable disease) in 11 patients (69%). In addition, the combination overcame resistance to paclitaxel in heavily pretreated TNBC patients. There was a 38% response rate and 50% disease control rate in patients who received prior taxanes in the metastatic setting. There was a 50% response rate among taxane-refractory African American patients.
- CB-839: Phase I Renal Cell Carcinoma Combination Data at the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. In a plenary session at the EORTC-NCI-AACR Symposium in
November 2016, new data was presented with CB-839 in combination with everolimus. Fifteen renal cell carcinoma patients were treated and evaluable for response, including 12 clear cell patients, and three papillary patients. Ninety-three percent (93%) had disease control; one patient had a partial response, one patient had progressive disease, and 13 patients had stable disease. The median progression free survival was 8.5 months and for the majority of patients, their time on therapy was longer than their time on treatment in their prior therapy. In the clear cell patient population the disease control rate was 100%.
- At-the-Market Program. In 2017, Calithera received approximately
$38.0 millionin gross proceeds, $36.9 millionin net proceeds, from the sale of common stock pursuant to its at-the-market offering program with Cowen.
- Key Management Appointments. Curtis Hecht was named Senior Vice President of Business and Corporate Development,
Frank Parlatiwas named Vice President of Research, and Jennifer McNealeywas named Vice President of Investor Relations and Strategy.
Selected Fourth Quarter and Year-end 2016 Financial Results
Cash, cash equivalents and investments totaled
Research and development expenses for the full year 2016 were
General and administrative expenses for the full year 2016 were
Financial Guidance for 2017
Calithera expects that its cash, cash equivalents and investments will be between
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 the timing of initiation of Calithera’s clinical trials, Calithera’s ability fund its clinical programs, Calithera’s filing of an investigational new drug application for its arginase inhibitor, Calithera’s receipt of clinical data from its clinical trials, and Calithera’s cash and investments balance at the end of 2017. 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 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
|Calithera Biosciences, Inc.
|Selected Balance Sheets Financial Data
|December 31,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||51,781||$||71,925|
|Total stockholders’ equity||49,906||71,788|
|Calithera Biosciences, Inc.|
|Selected Statements of Operations Financial Data|
|(in thousands, except per share amounts)|
|Three Months Ended
|Research and development||$||6,593||$||5,833||$||27,748||$||23,748|
|General and administrative||3,011||2,295||10,586||9,071|
|Total operating expenses||9,604||8,128||38,334||32,819|
|Loss from operations||(9,604||)||(8,128||)||(38,334||)||(32,819||)|
|Interest income, net||84||60||330||175|
|Net loss per share, basic and diluted||$||(0.45||)||$||(0.44||)||$||(1.95||)||$||(1.81||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||21,045||18,163||19,486||18,045|
Jennifer McNealeyir@Calithera.com 650-870-1071