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First Clinical Data on Glutaminase Inhibitor CB-839 in Solid and Hematologic Malignancies
Immuno-oncology Program with Arginase Inhibitor CB-1158 on Track for Preclinical Data Release in Fourth Quarter and IND Filing in 1H 2016
Calithera to Host Conference Call Today at 4:30pm Eastern Time
SOUTH SAN FRANCISCO, Calif., Aug. 10, 2015 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, announced today its financial results for the second quarter ended June 30, 2015. As of June 30, 2015, cash, cash equivalents and investments totaled $88.2 million.
"In the second quarter, we presented data at key medical meetings and expanded our oncology pipeline with a new clinical candidate," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We presented initial clinical data for our lead product CB-839 at the American Society of Clinical Oncology and European Hematology association meetings, and we continue to be pleased with the rate of enrollment of our expansion cohorts. For our lead immuno-oncology program, we selected clinical candidate CB-1158, a small molecule arginase inhibitor with the potential to treat cancer by blocking the immunosuppression of the tumor micro-environment."
Second Quarter 2015 and Recent Highlights
Cancer Metabolism: CB-839, a first-in-class, oral, selective, potent inhibitor of glutaminase
Immuno-Oncology: CB-1158, a first-in-class, oral, selective, potent inhibitor of arginase
Anticipated Upcoming Milestones
Selected Second Quarter 2015 Financial Results
Research and development expenses were $5.5 million for the three months ended June 30, 2015, compared with $4.2 million for the same period in the prior year. The increase of $1.4 million was primarily attributed to higher expenses associated with the continued advancement of CB-839 and investments in the Company's arginase inhibitor program.
General and administrative expenses were $2.3 million for the three months ended June 30, 2015, compared with $1.3 million for the same period in the prior year. The increase of $1.0 million was primarily due to higher employment related expenses, including stock-based compensation expense, professional service fees associated with operating as a publicly-traded company, and a license payment of $0.2 million.
Net loss for the three months ended June 30, 2015 was $7.8 million.
Financial Guidance for 2015
Calithera reiterates its guidance of its cash, cash equivalents and investments to be at least $65 million at the end of 2015, exclusive of any license milestone payments or funds arising from any additional new collaborations or partnerships, equity financings or other new sources.
Conference Call Information
Calithera will host its second quarter financial results and corporate update conference call today, August 10th at 4:30 p.m. Eastern Time. The call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international), and reference to conference ID 5376452. 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 until the Company's conference call to discuss financial results for its third quarter of 2015.
Calithera Biosciences, Inc. is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer. Calithera's lead product candidate, CB-839, is currently being evaluated in three Phase 1 clinical trials in solid and hematological cancers. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com.
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 expected enrollment 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 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 most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, and other 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.
|Calithera Biosciences, Inc.|
|Selected Statements of Operations Financial Data|
|(in thousands, except per share amounts)|
Three Months Ended
Six Months Ended
|Research and development||$ 5,533||$ 4,183||$ 11,163||$ 7,501|
|General and administrative||2,341||1,309||4,578||2,141|
|Total operating expenses||7,874||5,492||15,741||9,642|
|Loss from operations||(7,874)||(5,492)||(15,741)||(9,642)|
|Other income, net||56||1||65||2|
|Net loss||$ (7,818)||$ (5,491)||$ (15,676)||$ (9,640)|
|Net loss per share, basic and diluted||$ (0.44)||$ (24.22)||$ (0.87)||$ (47.14)|
|Weighted average common shares used to compute net loss per share, basic and diluted||17,963||227*||17,955||204*|
|*Pre-IPO conversion of preferred shares to common shares|
|Calithera Biosciences, Inc.|
|Selected Balance Sheets Financial Data|
|June 30,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$ 88,187||$ 101,969|
|Total stockholders' equity||86,315||100,366|
CONTACT: Jennifer McNealey ir@Calithera.com 650-870-1071NEXT ARTICLE
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