On August 4, 2022 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer and other serious diseases, reported recent business progress and second-quarter 2022 financial results (Press release, Kronos Bio, AUG 4, 2022, View Source [SID1234617550]).
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"We are continuing to execute across our clinical programs, with the registrational Phase 3 AGILITY study of our lead SYK inhibitor, entospletinib, under way in newly diagnosed patients with NPM1-mutated acute myeloid leukemia (AML)," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "We are also making progress with our CDK9 inhibitor, KB-0742, as we work toward identifying a recommended Phase 2 dose in the fourth quarter."
Second Quarter and Recent Company Updates
SYK Inhibitor Programs
The company continued to enroll patients in the Phase 3 AGILITY clinical trial of entospletinib, a selective inhibitor targeting spleen tyrosine kinase (SYK), in combination with standard of care anthracycline and cytarabine (7+3) chemotherapy in newly diagnosed NPM1-mutated AML. Data are anticipated in the second half of 2023 with a primary endpoint of measurable residual disease negative complete response.
Kronos Bio opened additional sites for its planned Phase 1b/2 clinical trial of lanraplenib, the company’s next generation SYK inhibitor, in combination with gilteritinib in patients with FLT3-mutated AML.
The company shared preclinical data that provide additional support for the biological rationale for the targeting of SYK in patients with genetically defined subsets of AML at the European Hematology Association (EHA) (Free EHA Whitepaper) congress in Vienna in two poster presentations. The first poster described the analysis of mutational and gene expression signatures from bone marrow and peripheral blood samples of patients with NPM1-mutated AML, suggesting that the NPM1 mutation, with or without co-mutation of FLT3, is a strong predictor of entospletinib anti-leukemic activity. That research was conducted as part of a collaboration with scientists at the Oregon Health & Science University.
A second poster described the company’s findings of synergistic activity of lanraplenib in combination with other targeted agents, including gilteritinib, in an NPM1-mutated/FLT3-mutated PDX model.
KB-0742
Kronos Bio is continuing to enroll patients in the dose escalation stage of the Phase 1/2 study of KB-0742 in solid tumors. The company anticipates announcing the recommended Phase 2 dose in the fourth quarter of 2022.
Corporate Update
Kronos Bio believes the company has sufficient runway to fund operations into Q4 2024. This is as a result of ongoing financial prudence measures that have included prioritizing clinical programs to focus on entospletinib and KB-0742.
Second Quarter 2022 Financial Highlights
Cash, Cash Equivalents and Investments: With its ongoing and currently planned clinical programs and $292.4 million in cash, cash equivalents and investments as of June 30, 2022, the company anticipates sufficient resources to fund its planned operations into the second half of 2024.
R&D Expenses: Research and development expenses were $22.7 million for the second quarter of 2022, which includes non-cash stock-based compensation expense of $4.1 million.
G&A Expenses: General and administrative expenses were $10.8 million for the second quarter of 2022, which includes non-cash stock-based compensation expense of $4.2 million.
Net Loss: Net loss for the second quarter of 2022 was $32.9 million, or $0.59 per share, including non-cash stock-based compensation expense of $8.2 million.