On November 13, 2023 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and third-quarter 2023 financial results (Press release, Kronos Bio, NOV 13, 2023, View Source [SID1234637545]).

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"This quarter, we made great strides in advancing our clinical programs as well as our discovery projects and Genentech collaboration," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "At the AACR (Free AACR Whitepaper)-NCI-EORTC and CTOS conferences we shared KB-0742 data that demonstrated on-mechanism, single agent anti-tumor activity in pre-treated patients with transcriptionally addicted solid tumors. We are encouraged by the strong investigator interest in KB-0742, and the potential impact of this positive preliminary efficacy data and manageable safety profile for patients."

Dr. Bischofberger continued, "With our resource optimization and extended cash runway, I’m confident that we are well positioned to deliver on our mission to bring forward new and innovative therapies for difficult-to-treat cancers. Our team is committed to realizing the potential of drugging transcription in cancer."

Third Quarter and Recent Company Updates

•Corporate update
◦On November 2, 2023, Kronos Bio announced its plan to optimize its resource allocation, restructure, and contain costs in light of the positive preliminary safety and efficacy clinical data from its Phase 1/2 study of KB-0742.
◦This plan positions the company to maximize the potential of KB-0742 while continuing to advance the development of lanraplenib, currently in the dose escalation portion of a Phase 1b/2 study.
◦The company will also focus its discovery efforts on maturing projects and its Genentech collaboration activities.
◦Kronos Bio expects that these efforts, which include a 19% reduction in force, will extend its cash runway into 2026.

•KB-0742
◦Kronos Bio presented positive preliminary data from the phase 1 dose escalation portion of the ongoing phase 1/2 KB-0742 study at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference in October and at the Connective Tissue Oncology Society Annual Meeting in

November, where it also presented corresponding data from the pre-clinical mechanistic studies.
◦KB-0742 demonstrated on-mechanism, single agent anti-tumor activity and a manageable safety profile in pre-treated patients with transcriptionally addicted solid tumors.
◦Enrollment in two expansion cohorts is ongoing, including 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 transcription factor fusion-driven cancers and other transcriptionally addicted cancers, including chordomas, sarcomas and small cell lung cancer.
◦The Company plans to share data from both the ongoing dose escalation, beyond the 60 mg dose, and from the expansion portions of the Phase 1/2 KB-0742 study, in mid-2024.

•Lanraplenib
◦Lanraplenib is currently in the dose escalation portion of a Phase 1b/2 trial in combination with gilteritinib in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia.
◦Three patients have cleared the 28-day safety window at each of the 20 mg, 40 mg and 60 mg dose levels.
◦The Company is now enrolling at the 90 mg dose. To better understand safety, PK and PD, and to accommodate investigator and patient interest, additional patients may be enrolled at dose levels below 90 mg.
◦Kronos Bio anticipates announcing the recommended expansion phase dose in Q4 2023/Q1 2024 and plans to share data from the phase 1b/2 study in mid-2024.

Third Quarter 2023 Financial Highlights

•Cash, Cash Equivalents and Investments: With its ongoing and currently planned clinical programs and $198.4 million in cash, cash equivalents and investments as of September 30, 2023, the Company reiterates its expected cash runway into 2026.

•R&D Expenses: Research and development expenses were $25.3 million for the third quarter of 2023, which includes non-cash stock-based compensation expense of $3.2 million.

•G&A Expenses: General and administrative expenses were $9.4 million for the third quarter of 2023, which includes non-cash stock-based compensation expense of $3.1 million.

•Net Loss: Net loss for the third quarter of 2023 was $31.4 million, or $0.54 per share, including non-cash stock-based compensation expense of $6.3 million.