-- Company strengthened precision oncology clinical pipeline through acquisition of mTORC 1/2 inhibitor sapanisertib and SYK inhibitor mivavotinib from
-- Cash, cash equivalents and investments totaled
-- Conference call and webcast scheduled for
“The last month has been one of significant change for Calithera, following the acquisition of two clinical-stage investigational therapies, sapanisertib and mivavotinib, and the presentation of interim data from our cystic fibrosis program for CB-280 that supports our approach to the treatment of CF via this mechanism,” said
“We move into the end of 2021 with a keen focus on biomarker-defined cancer patient populations and remain committed to our pursuit of developing medicines to improve outcomes for people with diseases of high unmet need. Our near-term clinical development plans include leveraging our clinical and biomarker expertise in the KEAP1/NRF2 pathway by developing our mTORC1/2 inhibitor sapanisertib in squamous non-small cell lung cancer, and advancing the development of our SYK inhibitor mivavotinib in specific biomarker-defined populations of diffuse large B-cell lymphoma. By focusing on well-characterized genetic vulnerabilities with molecules that have already shown single-agent activity, we will be able to generate phase 2 data with targeted, efficient study designs over the next 12 to 18 months.”
Third Quarter 2021 and Recent Highlights
- Acquired clinical stage dual mTORC 1/2 inhibitor sapanisertib and SYK inhibitor mivavotinib from
Takeda Pharmaceuticals. The acquisition significantly strengthens Calithera’s precision oncology pipeline with addition of two drugs that have both demonstrated single-agent activity in the clinic, with the greatest potential in biomarker-defined cancer patient populations. Calithera plans to initiate a phase 2 study to begin in the first quarter of 2022 that will strengthen the existing data on sapanisertib as an active single-agent drug in patients with squamous non-small cell lung cancer (NSCLC) harboring a NRF2 or KEAP1 mutation. In addition, Calithera will initiate a phase 2 study of mivavotinib in the first quarter of 2022 for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) with and without mutations in MyD88 and CD79. Data from these studies generated over the next 12 to 18 months could position the company to initiate registrational studies for both molecules.
- Presented interim data from the Phase 1b clinical trial of CB-280 in patients with cystic fibrosis (CF) at
North American Cystic Fibrosis Conference. Data showed CB-280 was well-tolerated, had linear PK, and demonstrated robust dose-related PD effects. Encouraging trends were seen in disease biomarkers, including increased fractional exhaled nitric oxide (FeNO) and decreased sweat chloride. A pooled analysis of treatment vs. placebo showed a positive trend in forced expiratory volume in one second (FEV1) compared to placebo. Dose escalation is ongoing with cohort 4 (300mg BID) and on track to complete enrollment by the end of the year, with the option for an additional dose cohort to enroll in 2022 if warranted.
- Announced discontinuation of phase 2 telaglenastat KEAPSAKE clinical trial in patients with NSCLC with genetic mutations in KEAP1/NRF2. Interim analysis from 40 patients demonstrated lack of clinical benefit among patients treated with telaglenastat. No differences in safety profile were seen between the two arms.
Emil Kuriakose, MD, from vice president and head of clinical development to chief medical officer. Dr. Kuriakosesucceeds Keith Orford, MD, PhD who has resigned from his position and joined the Calithera Board of Directors.
- Preclinical focus on synthetic lethality targets. In addition to the company’s clinical programs, Calithera continues to leverage its discovery engine to build a robust preclinical pipeline of undisclosed synthetic lethality targets with a focus on paralog genes. These will be announced as Calithera advances preclinical development.
Selected Third Quarter 2021 Financial Results
Cash, cash equivalents and investments totaled
Research and development expenses for the third quarter 2021 were
General and administrative expenses for the third quarter 2021 were
Net loss for the three months ended
Conference Call Information
Calithera will host an update conference call today,
Calithera is headquartered in
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, timing of enrollment of the CB-280 Ph1b, sapanisertib Phase 2 and mivavotinib Phase 2 clinical trials, and the overall advancement of Calithera’s product candidates in clinical trials and Calithera’s plans to continue development of its product candidates. 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
||Nine Months Ended
|Research and development||11,556||18,157||39,715||53,938|
|General and administrative||6,344||4,744||16,259||14,786|
|Total operating expenses||17,900||22,901||55,974||68,724|
|Loss from operations||(11,150||)||(22,901||)||(46,224||)||(68,724||)|
|Interest and other income (expense), net||(22||)||167||346||1,153|
|Net loss per share, basic and diluted||$||(0.15||)||$||(0.32||)||$||(0.62||)||$||(0.99||)|
|Weighted average common shares used to compute net loss per share, basic and diluted||74,114||70,559||73,480||68,219|
|Selected Consolidated Balance Sheet Financial Data|
|Balance Sheet Data:|
|Cash, cash equivalents and investments||$||84,493||$||115,151|
|Total stockholders’ equity||74,419||102,371|
Source: Calithera Biosciences, Inc.