-- Cash, Cash Equivalents and Investments Totaled
-- Conference Call and Webcast Scheduled for
“In the second quarter, we announced a license agreement with Antengene for the development of CB-708, a potential first-in-class oral small molecule CD73 inhibitor developed internally via our drug discovery engine,” said
Second Quarter 2021 and Recent Highlights
- Continued enrollment of the Phase 2 randomized KEAPSAKE trial in non-small cell lung cancer (NSCLC) patients with genetic mutation in KEAP1/NRF2. The double-blind KEAPSAKE trial is expected to enroll approximately 120 patients with stage IV non-squamous NSCLC with tumors that have a KEAP1 or NRF2 mutation. Patients are randomized to receive telaglenastat or placebo, in combination with pembrolizumab, carboplatin and pemetrexed. The study is evaluating the safety and investigator-assessed progression-free survival (PFS) of telaglenastat plus this standard-of-care chemoimmunotherapy regimen. Calithera anticipates releasing interim data from the KEAPSAKE trial in the fourth quarter of 2021.
- Ongoing enrollment of the Phase 1b clinical trial of CB-280 in patients with cystic fibrosis (CF). CB-280 is a novel oral inhibitor of arginase, an enzyme that depletes the amino acid arginine. The randomized, double blind, placebo-controlled, dose escalation trial is evaluating multiple ascending doses of CB-280, dosed orally twice daily for 14 days, compared to placebo in up to 32 adult CF patients to determine a safe dose range for CB-280. In
October 2020, Calithera was awarded up to $2.4 millionfrom the Cystic Fibrosis Foundationto support clinical development of CB-280. Enrollment in the Phase 1b study is ongoing and Calithera plans to present interim data from this study at the 2021 North American Cystic Fibrosis Conferenceat the end of September.
- Signed Worldwide License Agreement with Antengene for Development & Commercialization of CB-708. CB-708 is a highly potent, selective, orally-bioavailable small molecule inhibitor of CD73, which has demonstrated immune-mediated, single agent activity in syngeneic mouse tumor models. Under the agreement, Calithera received an upfront payment and may receive potential development, regulatory and sales milestones of up to
$252.0 million. Additionally, Calithera is eligible to receive tiered royalties on sales of the licensed product up to low double-digits.
- Final results of CANTATA presented at the
American Society of Clinical Oncology(ASCO) 2021 Annual Meeting. The Phase 2 CANTATA trial was a global, randomized, double-blind clinical trial of telaglenastat combined with cabozantinib, in patients with advanced or metastatic RCC who have received one or two prior treatments. On January 4, 2021, Calithera announced that the trial did not meet the primary endpoint of improving PFS. The complete dataset was presented at the American Society of Clinical OncologyAnnual Meeting on June 7, 2021.
Selected Second Quarter 2021 Financial Results
Cash, cash equivalents and investments totaled
Research and development expenses for the second quarter 2021 were
General and administrative expenses for the second quarter 2021 were
Net loss for the three months ended
Conference Call Information
Calithera will host an update conference call today,
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 timing of enrollment of the KEAPSAKE and CB-280 Ph1b clinical trials, Antengene’s ability to continue the development and future commercialization of CB-708, the receipt by Calithera of future development, regulatory and sales milestones, as well as tiered royalties on sales of CB-708 if successfully commercialized and the overall advancement of Calithera’s product candidates in 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 be 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
|Selected Consolidated Statements of Operations Financial Data|
|(in thousands, except per share amounts)|
|Three Months Ended
||Six Months Ended
|Research and development||$||12,820||$||15,656||$||28,159||$||35,781|
|General and administrative||4,487||5,096||9,915||10,042|
|Total operating expenses||17,307||20,752||38,074||45,823|
|Loss from operations||(14,307||)||(20,752||)||(35,074||)||(45,823||)|
|Interest and other income (expense), net||(4||)||361||368||986|
|Net loss per share, basic and diluted||$||(0.19||)||$||(0.29||)||$||(0.47||)||$||(0.67||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||74,057||69,516||73,157||67,036|
|Selected Consolidated Balance Sheet Financial Data|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||92,205||$||115,151|
|Total stockholders' equity||83,013||102,371|
Source: Calithera Biosciences, Inc.