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SOUTH SAN FRANCISCO, Calif., Nov. 12, 2019 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, announced today its financial results for the third quarter ended September 30, 2019. As of September 30, 2019, cash equivalents and investments totaled $133.6 million.
“This was a productive quarter for Calithera, during which we achieved multiple, key milestones in our clinical and pipeline programs,” said Susan Molineaux, PhD, president and chief executive officer of Calithera. “This includes completing enrollment in our registrational CANTATA trial evaluating telaglenastat for the treatment of patients with renal cell carcinoma, and presenting new data on several programs at both the ESMO and SITC annual meetings. In addition, we successfully completed a Phase 1 trial in healthy volunteers of CB-280, an oral arginase inhibitor for the treatment of cystic fibrosis.”
Third Quarter 2019 and Recent Highlights
Selected Third Quarter 2019 Financial Results
Cash, cash equivalents and investments totaled $133.6 million at September 30, 2019.
Research and development expenses were $17.2 million for the three months ended September 30, 2019, compared with $16.4 million for the same period in the prior year. The increase of $0.8 million was primarily due to a $0.7 million increase in the telaglenastat program, including for the CANTATA trial, an increase of $0.4 million in the INCB001158 program, and an increase of $0.5 million in our early-stage research programs, partially offset by a decrease of $0.8 million in our CB-280 program.
General and administrative expenses were $3.9 million for the three months ended September 30, 2019, compared with $3.1 million for the same period in the prior year. The increase of $0.8 million primarily related to higher professional services costs and personnel-related costs.
Net loss for the three months ended September 30, 2019 was $20.3 million, or $0.38 per share.
Conference Call Information
Calithera will host an update conference call today, Tuesday, November 12, at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 and referring to conference ID 6499000. 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 Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially block tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. 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 Calithera’s clinical trials, the clinical and commercial potential of its product candidates; the receipt of top-line efficacy and safety data in the CANTATA trial; the safety and anti-tumor activity of telaglenastat plus palbociclib; the timing that CB-280 will enter clinical trials; and the role of IL4I1 and CD73. 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.
SOURCE: Calithera Biosciences, Inc.
Selected Consolidated Statements of Operations Financial Data
(in thousands, except per share amounts)
Three Months Ended
Nine Months Ended
|Research and development||17,221||16,420||58,388||49,218|
|General and administrative||3,906||3,087||12,054||10,093|
|Total operating expenses||21,127||19,507||70,442||59,311|
|Loss from operations||(21,127||)||(19,507||)||(70,442||)||(37,057||)|
|Interest and other income, net||834||658||2,310||1,927|
|Net loss per share, basic and diluted||$||(0.38||)||$||(0.52||)||$||(1.52||)||$||(0.98||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||53,775||36,405||44,703||36,021|
Selected Consolidated Balance Sheet Financial Data
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||133,594||$||136,153|
|Total stockholders’ equity||120,659||126,714|