On May 7, 2020 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, reported its financial results for the first quarter ended March 31, 2020 (Press release, Calithera Biosciences, MAY 7, 2020, View Source [SID1234557281]).

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"We continued our positive momentum from 2019 into the first quarter of 2020, further strengthening our cash position and advancing our key clinical development programs," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "This included significant progress toward the initiation of our first clinical trial evaluating telaglenastat in non-small cell lung cancer patients with NRF2/KEAP1 genetic mutations. In addition, we plan to announce top-line results from the randomized CANTATA trial in the fourth quarter."

First Quarter 2020 and Other Recent Program Highlights

CANTATA randomized trial of telaglenastat and cabozantinib in advanced renal cell carcinoma (RCC). The CANTATA trial is 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. The CANTATA trial enrolled 444 patients at multiple centers globally. The primary endpoint is progression-free survival (PFS). In light of delays associated with COVID-19, Calithera plans to report top-line efficacy and safety data from the trial in the fourth quarter of 2020.

KEAPSAKE randomized trial in non-small cell lung cancer (NSCLC) patients with a NRF2/KEAP1 genetic mutation. Mutation of the KEAP1/NRF2 pathway is present in approximately 20% of NSCLC and is associated with poor survival and resistance to standard-of-care therapy. Activation of this pathway leads to reliance upon glutaminase activity and sensitizes cells to glutaminase inhibition with telaglenastat. Given the challenges associated with opening new clinical studies during the current stage of the COVID-19 pandemic, Calithera expects to begin enrollment of the first patient in the third quarter of 2020. A trial-in-progress abstract describing the study design has been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Meeting (ASCO20). Calithera plans to present interim data from this trial in 2021.

Pfizer clinical collaboration with the CDK4/6 inhibitor IBRANCE, and the dual-mechanism poly (ADP-ribose) polymerase (PARP) inhibitor TALZENNA, each in combination with telaglenastat. In March 2019, Calithera initiated a Phase 1/2 trial of the combination of telaglenastat plus Talzenna in patients with solid tumors including expansion cohorts in renal cell carcinoma and triple-negative breast cancer. In July 2019, the company initiated a Phase 1/2 trial of the combination of telaglenastat plus Ibrance in patients with solid tumors including expansion cohorts in KRAS-mutated colorectal cancer and KRAS-mutated non-small cell lung cancer. Dose escalation has been completed for both trials. Dose expansion cohorts have been temporarily paused due to the COVID-19 situation. Calithera expects enrollment to resume in the second quarter of 2020.

INCB001158 program. INCB001158, an internally discovered molecule, is being evaluated in multiple clinical trials for the treatment of patients with solid tumors both as a monotherapy, in combination with anti-PD-1 immunotherapy, and in multiple chemotherapy regimens. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Clinical trials being conducted by Calithera and Incyte evaluating INCB001158 are ongoing as planned.

CB-280 arginase inhibitor program. Calithera has completed a first-in-human Phase 1 trial evaluating the safety, tolerability and pharmacokinetic profile of oral CB-280 in healthy volunteers. A Phase 1b clinical study in people with cystic fibrosis (CF), which is expected to start enrollment in the third quarter of 2020, given the challenges associated with opening new clinical studies during the current stage of the COVID-19 pandemic, will test multiple doses of CB-280 compared to placebo in approximately 30 adults with CF to determine a safe dose range, and evaluate pharmacodynamic effects of arginase inhibition in this population.

Selected First Quarter 2020 Financial Results

Cash, cash equivalents and investments totaled $138.1 million at March 31, 2020. In April 2020, Calithera completed an underwritten public offering of 5,750,000 shares of common stock. Cash, cash equivalents and investments as of March 31, 2020 exclude the approximately $33.5 million in net proceeds from the April offering.

Research and development expenses were $20.1 million for the three months ended March 31, 2020, compared to $20.2 million for the same period in the prior year. The decrease of $0.1 million was primarily due to a $1.2 million decrease in the INCB001158 program and a decrease of $0.8 million for investment in our early stage research programs, partially offset by an increase of $1.4 million in the telaglenastat program and an increase of $0.5 million in our CB-280 program.

General and administrative expenses were $4.9 million for the three months ended March 31, 2020, compared with $4.2 million for the same period in the prior year. The increase of $0.7 million was primarily related to $0.5 million higher professional services costs mainly for legal and consulting services, and $0.2 million in higher facility costs related to the expiration of our sublease in February 2020.

Interest and other income, net was $0.6 million for the three months ended March 31, 2020, compared to $0.7 million for the same period in the prior year.

Net loss for the three months ended March 31, 2020 was $24.4 million, or $0.38 per share.

Conference Call Information

Calithera will host an update conference call today, Thursday, May 7, 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 and referring to conference ID 7543049. 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.