On August 15, 2022 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, reported its financial results for the second quarter ended June 30, 2022 (Press release, Calithera Biosciences, AUG 15, 2022, View Source,the%20same%20period%20prior%20year. [SID1234618347]).

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"We continue to deliver on our commitment to efficiently advance our clinical programs, successfully initiating two new clinical trials and sharing program updates at two important medical conferences," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "We look forward to sharing data from the ongoing mivavotinib and sapanisertib phase 2 trials by the first quarter of 2023, as well as providing an update on the progress of our preclinical synthetic lethality VPS4 program by the end of 2022."

Second Quarter 2022 and Other Recent Highlights

Initiated patient enrollment in phase 2 trial evaluating mivavotinib (SYK inhibitor) in r/r non-GCB DLBCL. In June, Calithera announced enrollment of the first patient in a multicenter phase 2 clinical trial (NCT05319028) evaluating the spleen tyrosine kinase (SYK) inhibitor mivavotinib (CB-659) in patients with relapsed/refractory non-germinal center B-cell like (non-GCB) diffuse large B-cell lymphoma (DLBCL), a DLBCL subpopulation that primarily comprises patients with activated B-cell like disease (ABC). The main study objectives are to confirm previously seen single-agent activity in non-GCB DLBCL patients, evaluate activity according to MYD88/CD79b mutational status, and refine dose/schedule in this patient population. The primary endpoints of the study are overall response rate as assessed by an independent radiology review committee and safety. Mivavotinib has the potential to be the first treatment specifically for non-GCB DLBCL, a population of patients with a historically poorer prognosis and therefore high unmet need, and potential to be the first treatment for a genetically-defined subset of ABC in patients with MyD88/CD79 mutations. Approximately 50% of all ABC DLBCL tumors have one or both of these mutations. Data from the ongoing phase 2 trial could position Calithera to initiate a study with registrational intent in biomarker-specific DLBCL populations. Calithera plans to share data from this trial by the first quarter of 2023.

In July, Calithera presented a trial-in-progress poster at the Pan Pacific Lymphoma Conference detailing the design of this phase 2 study.
Initiated patient enrollment in phase 2 trial sapanisertib (dual mTORC 1/2 inhibitor) in sqNSCLC. In July, Calithera announced enrollment of the first patient in a phase 2 clinical trial (NCT05275673) of the dual mTORC 1/2 inhibitor sapanisertib (CB-228) in patients with relapsed/refractory NRF2 (NFE2L2)-mutated squamous non-small cell lung cancer (sqNSCLC). The study is designed to confirm the selective activity of sapanisertib in NRF2-mutated tumors compared to wild-type tumors, and to refine dose in this biomarker-defined population. The primary endpoints of the study are investigator-assessed overall response rate (ORR) per RECIST v1.1, and safety. Data from this study could position Calithera to initiate a study with registrational intent in biomarker-specific sqNSCLC populations. Calithera plans to share data from this trial by the first quarter of 2023.

Announced presentation of phase 1/2 data from sapanisertib/telaglenastat combination study. In a mini oral session at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC), Jonathan W. Riess, MD, MS, director of Thoracic Oncology and associate professor at UC Davis Comprehensive Cancer Center, presented dose-escalation findings from a multi-center phase 1/2 investigator-initiated study evaluating sapanisertib in combination with telaglenastat, an investigational glutaminase inhibitor, in biomarker-defined cohorts of patients with advanced non-small cell lung cancer (NSCLC). After evaluating five combination dosing levels in 13 patients, researchers determined that the sapanisertib/telaglenastat combination has a favorable tolerability profile at the recommended expansion dose. Early evidence of clinical benefit was observed in the dose-escalation cohort, including a partial response in a patient with NRF2-mutant squamous NSCLC and stable disease in a patient with KEAP1/NRF2-mutant adenosquamous NSCLC. As a next step, study investigators plan to enroll patients into one of four expansion cohorts evaluating sapanisertib plus telaglenastat in squamous NSCLC with and without NRF2 or KEAP1 mutations, and adenocarcinoma NSCLC with KRAS and KEAP1 or NRF2 mutations.

Continued to advance VPS4 program through lead optimization. Calithera previously announced internal discovery of a novel series of small-molecule inhibitors of vacuolar protein sorting-associated protein 4A (VPS4A) and VPS4B, as well as the presentation of data validating the synthetic-lethal interaction between the gene paralogs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting. Calithera believes these VPS4 inhibitors are the first active, on-target inhibitors of VPS4. Potent, selective, and pharmacologically active VPS4 inhibitors are expected to be well-tolerated and have strong single-agent activity in tumors with these mutations. Calithera continues to advance multiple VPS4 series through lead optimization and plans to share updates on this program by the end of the year.
Selected Second Quarter 2022 Financial Results

Cash and cash equivalents totaled $41.8 million at June 30, 2022.

Research and development expenses for the second quarter 2022 were $7.8 million, compared to $12.8 million in the same period prior year. The decrease of $5.0 million was primarily due to decreases in the telaglenastat and CB-280 programs, partially offset by increases in the sapanisertib and mivavotinub programs.

General and administrative expenses for the second quarter 2022 were $3.6 million, compared to $4.5 million in the same period prior year. The decrease of $0.9 million was primarily due to decreased personnel-related costs.

Other income, net for the second quarter 2022 was $2.3 million, compared to other expense of $4,000 in the same period prior year, primarily attributable to the decrease in fair value of warrant liabilities.

Net loss was $9.1 million for the three months ended June 30, 2022.

Conference Call Information

Calithera will host an update conference call today, Monday, August 15, at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time. To register for dial-in access to the call, please use this link. 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.