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- Two Novel Programs Entering Clinical Development
-Calithera to Host Conference Call Today at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time
SOUTH SAN FRANCISCO, Calif., Aug. 07, 2018 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage pharmaceutical company focused on discovering and developing small molecule drugs that target novel and critical metabolic pathways in tumor and cancer-fighting immune cells, announced today its financial results for the second quarter ended June 30, 2018. As of June 30, 2018, cash, cash equivalents and investments totaled $152.2 million.
“In the second quarter we continued to execute our clinical development plans for our glutaminase inhibitor and arginase inhibitor programs, while deepening our pipeline with two novel programs entering clinical development,” said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. “We have advanced CB-280, a novel arginase inhibitor into development for the treatment of cystic fibrosis and we announced today our next oncometabolism drug candidate, CB-708, an orally bioavailable small molecule CD73 inhibitor.”
Second Quarter 2018 and Recent Highlights
Selected Second Quarter 2018 Financial Results
Cash, cash equivalents and investments totaled $152.2 million at June 30, 2018.
Revenue was $17.1 million for the three months ended June 30, 2018, compared with $7.3 million for the same period in the prior year. In the second quarter of 2018, the Company completed the manufacturing services and technology transfer under its collaboration and license agreement with Incyte, which satisfied the performance obligation under ASC 606 and as a result all remaining deferred revenue was recognized.
Research and development expenses were $17.3 million for the three months ended June 30, 2018, compared with $10.1 million for the same period in the prior year. The increase of $7.2 million was due to an increase in the CB-839 program, including for the Phase 2 CANTATA trial which opened in 2018, an increase in the INCB001158 program, including Incyte’s co-funding of development costs, an increase in the CB-280 program, including to support the IND application, as well as investment in early stage research.
General and administrative expenses were $3.5 million for the three months ended June 30, 2018, compared with $2.8 million for the same period in the prior year. The increase of $0.7 million was primarily due to increases in personnel-related costs.
Net loss from operations for the three months ended June 30, 2018 was $3.1 million, or $0.09 per share.
Conference Call Information
Calithera will host an update conference call today, August 7th at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time. The call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international), and referring to conference ID 2057667. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.
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 South San Francisco, California. For more information about Calithera, please visit www.calithera.com.
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 ability to fund its clinical programs, and Calithera’s receipt of clinical data from its 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 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 Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
1 Research supported by a Stand Up To Cancer Colorectal Cancer Dream Team Translational Research Grant (Grant Number: SU2C-AACR-DT22-17). Stand Up To Cancer is a program of the Entertainment Industry Foundation. Research grants are administered by the American Association for Cancer Research, the scientific partner of SU2C.
|Calithera Biosciences, Inc.|
Selected Consolidated Statements of Operations Financial Data
|(in thousands, except per share amounts)|
Three Months Ended
Six Months Ended
|Research and development||17,305||10,142||32,798||16,782|
|General and administrative||3,498||2,848||7,006||6,156|
|Total operating expenses||20,803||12,990||39,804||22,938|
|Loss from operations||(3,738||)||(5,735||)||(17,550||)||(11,491||)|
|Interest income, net||663||541||1,269||710|
|Net loss per share, basic and diluted||$||(0.09||)||$||(0.15||)||$||(0.45||)||$||(0.36||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||35,874||35,348||35,827||30,342|
|June 30,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||152,242||$||186,154|
|Total stockholders’ equity||147,165||150,307|