On May 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 first quarter 2022 financial results (Press release, Kronos Bio, MAY 4, 2022, View Source [SID1234613512]).
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"We continued to advance our three clinical programs this quarter and, in addition, presented preclinical data that support the development strategy for our internally discovered CDK9 inhibitor, KB-0742, at the AACR (Free AACR Whitepaper) Annual Meeting," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "Overall, we are pleased with our progress in executing against our goals and look forward to announcing the recommended Phase 2 dose and presenting additional clinical data for KB-0742 in the fourth quarter of this year."
First Quarter and Recent Company Updates
•SYK Inhibitor Programs
◦During the first quarter, Kronos Bio opened additional sites for its Phase 1b/2 clinical trial of lanraplenib, the company’s next generation spleen tyrosine kinase (SYK) inhibitor, in combination with gilteritinib in patients with FLT3-mutated acute myeloid leukemia (AML). The company anticipates dosing the first patient during the second quarter.
◦Kronos Bio is continuing to enroll patients in the registrational Phase 3 AGILITY clinical trial of entospletinib, a selective inhibitor targeting SYK, in combination with standard of care anthracycline and cytarabine (7+3) chemotherapy in patients with NPM1-mutated AML. Data are anticipated in the second half of 2023 with a primary endpoint of measurable residual disease (MRD) negative complete response.
•KB-0742
◦At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in April, Kronos Bio presented preclinical data that add to growing evidence in support of the company’s approach to the clinical development of KB-0742, its internally discovered, highly selective, oral cyclin dependent kinase 9 (CDK9) inhibitor. Data were presented from multiple preclinical translational model systems that support the development of the compound in triple-negative breast, ovarian and lung cancers, as well as lymphoma, chordoma and sarcoma.
◦The company is continuing with dose escalation in the Phase 1/2 study of KB-0742 and is on track to announce additional Phase 1 data, along with the recommended Phase 2 dose, in the fourth quarter of 2022. Kronos Bio presented initial data in the fourth quarter of 2021. A pharmacokinetic analysis showed oral bioavailability and dose-proportional exposure across the first three dose levels, with low to moderate variability between patients. KB-0742 had a terminal half-life of 24 hours, with approximately 2 to 2.5-fold accumulation between Day 1 and Day 10 among the 12 patients treated in the trial.
•Corporate Updates
◦Kronos Bio has implemented fiscal prudence measures, which provide expected cash runway into the second half of 2024, as announced earlier this year. These measures include deprioritizing a second Phase 1b/2 clinical trial of lanraplenib in combination with venetoclax/azacitidine to better focus the company’s resources on areas of greatest unmet medical need.
◦Kronos Bio announced the appointment of Dr. Elizabeth Olek, DO, MPH, as senior vice president, Clinical Development. Dr. Olek joined Kronos Bio from Loxo Oncology at Lilly.
First Quarter 2022 Financial Highlights
•Cash, Cash Equivalents and Investments: With its ongoing and currently planned clinical programs and $315.4 million in cash, cash equivalents and investments as of March 31, 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 $24.4 million for the first quarter of 2022, which includes non-cash stock-based compensation expense of $3.8 million.
•G&A Expenses: General and administrative expenses were $11.9 million for the first quarter of 2022, which includes non-cash stock-based compensation expense of $4.0 million.
•Net Loss: Net loss for the first quarter of 2022 was $36.3 million, or $0.65 per share, including non-cash stock-based compensation expense of $7.8 million.