"In 2014, Calithera's successful IPO significantly strengthened our cash position, providing a strong financial base from which to fund our first-in-class clinical programs in tumor metabolism and immuno-oncology. Our lead molecule CB-839, a first-in-class glutaminase inhibitor, entered clinical development, and two additional programs were in-licensed to broaden our oncology pipeline and solidify our leadership," said
Fourth Quarter 2014 and Recent Highlights
Successful completion of initial public offering. In
October 2014, Calithera raised net proceeds of $71.6 million.
Continued execution of phase I program for CB-839. In 2014, three phase I clinical trials were initiated with CB-839 in solid tumors and hematological malignancies, with 61 patients enrolled as of
January 2015, across the three trials. A twice a day dose for expansion cohorts has been selected based on pharmacodynamic data, and all three trials continue to enroll.
- Preclinical findings in multiple myeloma presented at the American Society of Hematology. In December 2014, Calithera presented preclinical data that could ultimately direct development of CB-839 in multiple myeloma, including potential biomarkers and preclinical synergy studies.
- Enhanced immuno-oncology program with exclusive license to arginase inhibitors. In December 2014, Calithera enhanced its immuno-oncology program with a portfolio or arginase inhibitors, discovered as part of Mars Symbioscience's cocoa flavanol research program.
- Presented novel pharmacodynamic assay at the San Antonio Breast Cancer Symposium. In December 2014, Calithera demonstrated glutaminase inhibition using a novel pharmacodynamic assay in patient post dose biopsy samples.
Licensed additional research program in tumor metabolism. In
March 2015, Calithera gained exclusive rights to hexokinase II inhibitors from TransTech Pharma. Hexokinase II is the first enzyme in the pathway that enables cancer cells to convert glucose to energy and building blocks that feed cancer cell growth.
Augmented Board of Directors and management team. In December 2014, Calithera appointed H. Ward Wolff to the company's Board of Directors, where he chairs the Company's Audit Committee. In
January 2015, Calithera appointed Dr. Keith Orford, M.D. Ph.D., as Vice President of Clinical Development.
Selected Fourth Quarter and Year-end 2014 Financial Results
Cash and cash equivalents totaled
Research and development expenses for the full year 2014 were
General and administrative expenses for the full year 2014 were
Loss from operations for the three months and year end ended
Financial Guidance for 2015
Calithera expects that its cash, cash equivalents and investments will be at least
Conference Call Information
Calithera will host an update conference call today,
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 ability fund its clinical programs, Calithera's receipt of clinical data from its clinical trials, and Calithera's cash balance at the end of 2015. 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 Quarterly Report on Form 10-Q for the period ended
|Calithera Biosciences, Inc.|
|Selected Statements of Operations Financial Data|
Three Months Ended
Twelve Months Ended
|Research and development||$ 4,972||$ 3,096||$ 16,367||$ 9,900|
|General and administrative||1,866||992||5,354||2,478|
|Total operating expenses||6,838||4,088||21,721||12,378|
|Loss from operations||(6,838)||(4,088)||(21,721)||(12,378)|
|Net loss and comprehensive loss||$ (6,833)||$ (4,087)||$ (21,712)||$ (12,377)|
|Calithera Biosciences, Inc.|
|Selected Balance Sheets Financial Data|
|Balance Sheet Data:|
|Cash and cash equivalents||$ 101,969||$ 33,820|
|Total stockholders' equity (deficit)||100,366||(20,813)|
Jennifer McNealeyir@Calithera.com 650-870-1071