On November 9, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, reported its financial results for the third quarter ended September 30, 2021 (Press release, Calithera Biosciences, NOV 9, 2021, View Source [SID1234594989]).

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"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 Susan Molineaux, PhD, president and chief executive officer of Calithera. "During this quarter, we also announced the disappointing news of the discontinuation of the telaglenastat program based on an interim analysis of the KEAPSAKE trial. Finally, we announced the promotion of Emil Kuriakose to chief medical officer and the strengthening of our board of directors with the addition of Calithera’s former chief medical officer, Keith Orford.

"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.

Promoted Emil Kuriakose, MD, from vice president and head of clinical development to chief medical officer. Dr. Kuriakose succeeds 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 $84.5 million at September 30, 2021. Calithera expects its cash, cash equivalents and investments will be sufficient to meet its current operating plan into 2023.

Revenue was $6.8 million for the three months ended September 30, 2021, and represents the milestone payment received in September 2021 under Calithera’s Incyte Collaboration Agreement.

Research and development expenses for the third quarter 2021 were $11.6 million, compared to $18.2 million in the same period prior year. The decrease of $6.6 million was primarily due to decreases in the telaglenastat and INCB001158 programs, partially offset by investments in early-stage research.

General and administrative expenses for the third quarter 2021 were $6.3 million, compared to $4.7 million in the same period prior year. The increase of $1.6 million was primarily due to increased legal expenses.

Net loss for the three months ended September 30, 2021, was $11.2 million.

Conference Call Information

Calithera will host an update conference call today, Tuesday, November 9, 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 (international) and referring to conference ID 3797324. 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.