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SOUTH SAN FRANCISCO, Calif., March 07, 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 fourth quarter and year ended December 31, 2018. As of December 31, 2018, cash, cash equivalents and investments totaled $136.2 million.
“This is a time of significant progress for Calithera’s clinical development program as we continue to advance our novel onco-metabolism clinical candidates through robust clinical studies,” said Susan M. Molineaux, PhD, president and chief executive officer of Calithera. “In the fourth quarter, we broadened development of the novel glutaminase inhibitor telaglenastat through two new clinical trial collaborations with Pfizer. We recently completed enrollment of the ENTRATA trial of telaglenastat for the treatment of patients with renal cell carcinoma. We anticipate that this momentum will continue in 2019 with data from the ENTRATA trial and, with our partner Incyte, data from the INCB001158 program, both expected in the second half of the year.”
Fourth Quarter 2018 and Recent Highlights
Selected Fourth Quarter 2018 Financial Results
Cash, cash equivalents and investments totaled $136.2 million at December 31, 2018.
Collaboration revenue for the full year 2018 was $22.2 million, compared with $26.0 million in the prior year. In June 2018, we completed the manufacturing services and technology transfer under our 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 for the full year 2018 were $66.2 million, compared with $43.1 million in the prior year. The increase of $23.1 million was due to an increase in the telaglenastat program to support our new and ongoing clinical trials, including for our Phase 2 CANTATA trial which opened in 2018, increases in the INCB001158 and CB-280 programs, as well as investment in early stage research. Research and development expenses for the fourth quarter of 2018 were $17.0 million, compared to $15.5 million for the same period last year.
General and administrative expenses for the full year 2018 were $13.3 million, compared with $12.5 million in the prior year. The increase of $0.8 million in 2018 was primarily due to higher personnel-related costs to support our clinical trials, offset partially by lower outside professional services, including activities related to our Incyte collaboration and license agreement and sublease in 2017. General and administrative expenses for the fourth quarter of 2018 were $3.2 million, compared to $3.3 million for the same period last year.
Interest Income, net for the full year 2018 was $2.7 million, compared with $1.9 million in the prior year. The increase of $0.8 million related to higher returns on our investments, partially offset by lower cash equivalents and investment balances. Interest income, net for the fourth quarter of 2018 was $0.7 million, compared to $0.6 million for the same period last year.
Net loss from operations for the three months and year ended December 31, 2018 was $19.5 million and $54.6 million, respectively.
Conference Call Information
Calithera will host an update conference call today, Thursday, March 7th at 4:30 p.m. Eastern Time/ 1:30 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international), and referring to conference ID 9577446. 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 of Calithera’s clinical trials, the safety, tolerability and efficacy of CB-839, INCB001158, CB-280 and CB-708, and the overall advancement in clinical trials, Calithera’s collaborations with Incyte and Pfizer, 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.
|Calithera Biosciences, Inc.|
|Selected Consolidated Statements of Operations Financial Data|
|(in thousands, except per share amounts)|
Three Months Ended
Twelve Months Ended
|Research and development||16,977||15,496||66,195||43,111|
|General and administrative||3,247||3,300||13,340||12,530|
|Total operating expenses||20,224||18,796||79,535||55,641|
|Loss from operations||(20,224||)||(11,542||)||(57,281||)||(29,686||)|
|Interest income, net||725||568||2,652||1,860|
|Net loss per share, basic and diluted||$||(0.51||)||$||(0.31||)||$||(1.49||)||$||(0.84||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||38,333||35,560||36,604||32,951|
|Calithera Biosciences, Inc.|
|Selected Consolidated Balance Sheet Financial Data|
|December 31,||December 31,|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||136,153||$||186,154|
|Total stockholders’ equity||126,714||150,307|