On May 10, 2023 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and first-quarter 2023 financial results (Press release, Kronos Bio, MAY 10, 2023, View Source [SID1234631381]).
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"This quarter, we made significant strides in our KB-0742 and lanraplenib clinical studies, and on the discovery side, our collaboration with Genentech is now well underway," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "We remain unwavering in our commitment to deliver meaningful therapies for patients with difficult to treat cancers, and we have the innovative science and people, as well as cash runway, necessary to do so. We continue to recruit significant talent, most recently with the addition of Katherine and Roger to our Board of Directors. We will benefit from their industry experience and clinical development expertise and guidance as we progress our portfolio of product candidates that target deregulated transcription."
First Quarter and Recent Company Updates
•KB-0742
◦Dosed first patient in expansion portion of Phase 1/2 study of KB-0742 in solid tumors. Enrollment is ongoing in both Cohort A, for patients with MYC-dependent tumors, such as triple negative breast cancer, non-small cell lung cancer and ovarian cancer, and Cohort B, for patients with transcriptionally addicted cancers, including chordomas, sarcomas and small cell lung cancer.
◦Dose escalation portion of the study remains ongoing to determine maximum tolerated oral dose.
◦Additional data from the Phase 1/2 study, including initial anti-tumor activity, are expected in the second half of 2023.
•Lanraplenib
◦Initial data, including recommended Phase 2 dose (RP2D), from the combination study of lanraplenib with gilteritinib in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML) are expected in the fourth quarter of 2023 or first quarter of 2024.
▪Corporate Updates
◦In April 2023, Kronos Bio announced the appointment of Katherine Vega Stultz and Roger Dansey, M.D., to its Board of Directors.
◦Ms. Stultz brings more than 25 years of biopharmaceutical experience and currently serves as the President and Chief Executive Officer of Ocelot Bio. Previously, Ms. Stultz was the Chief Operating Officer at Graphite Bio, where she successfully advanced the company’s clinical development program and helped take the company public. She has also held leadership roles at Celgene, Eli Lilly & Company and ConvaTec, a Bristol-Myers Squibb company.
◦Dr. Dansey brings more than 20 years of biopharmaceutical experience and currently serves as President, Research and Development of Seagen Inc. At Seagen, Dr. Dansey has leveraged his extensive drug development experience to progress the company from a single product U.S.-based company to a four-product company with a U.S. and European presence. Previously, Dr. Dansey was Senior Vice President at Merck & Co., Inc., where he led the company’s late-stage oncology development efforts. Earlier in his career, he led oncology clinical research at Gilead Sciences and had multiple oncology and hematology roles at Amgen.
First Quarter 2023 Financial Highlights
•Cash, Cash Equivalents and Investments: With its ongoing and currently planned clinical programs and $241.3 million in cash, cash equivalents and investments as of March 31, 2023, the company reiterates its expected cash runway into the second half of 2025.
•R&D Expenses: Research and development expenses were $19.7 million for the first quarter of 2023, which includes non-cash stock-based compensation expense of $3.1 million.
•G&A Expenses: General and administrative expenses were $10.1 million for the first quarter of 2023, which includes non-cash stock-based compensation expense of $3.5 million.
•Net Loss: Net loss for the first quarter of 2023 was $26.2 million, or $0.46 per share, including non-cash stock-based compensation expense of $6.6 million.