On August 8, 2023 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and second-quarter 2023 financial results (Press release, Kronos Bio, AUG 8, 2023, View Source [SID1234633980]).

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"KB-0742 is the first molecule to emerge from our discovery platform and we are looking forward to presenting data from the Phase 1 dose escalation portion of the Phase 1/2 KB-0742 study at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC International Conference," said Norbert Bischofberger, Ph.D., president and chief executive officer of Kronos Bio. "We’ve observed target engagement and have opened expansion cohorts at the 60 milligram dose. Simultaneously, we are further dose escalating to identify the maximum tolerated dose. Strong investigator engagement and patient enrollment in our KB-0742 and lanraplenib clinical programs reinforce the significant unmet need for new and innovative therapies for these difficult-to-treat cancers."

Bischofberger continued, "Our lanraplenib program recently progressed onto the third dosing cohort at 60 milligrams, and we are on track to reach our recommended Phase 2 dose by year end or early 2024. In addition, as a result of strong investigator interest, we will be allowing additional patients to enroll at dose levels that have previously been cleared. We look forward to sharing data from the escalation cohorts in mid-2024."

Second Quarter and Recent Company Updates
•KB-0742
◦Kronos Bio will present data from 28 patients enrolled in the dose escalation portion of the Phase 1/2 KB-0742 study who received up to and including the 60 mg dose at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) taking place from October 11 to 15, 2023, in Boston, Massachusetts. At the 60 mg dose, 10 patients received one or more cycles of KB-0742 (one cycle is 28 days).
◦For the dose escalation, the study enrolled an unselected relapsed/ refractory solid tumor population.
◦The presentation will include data on safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), as well as anti-tumor activity.
◦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 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 1/2 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 and 40 mg dose levels.
◦The Company is now enrolling at the 60 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 60 mg.
◦Kronos Bio anticipates achieving the recommended phase 2 dose in Q4 2023/Q1 2024 and expects to share data from this study in mid-2024.
▪Corporate Update
◦In June 2023, Kronos Bio announced the appointment of Marc Besman, Ph.D., as Senior Vice President of Regulatory Affairs and Clinical Quality Assurance. Dr. Besman will be responsible for developing, implementing and advancing global regulatory strategies for Kronos Bio’s portfolio. Dr. Besman has extensive drug development experience in oncology, and joined Kronos Bio from Coherus BioSciences, where he served as Senior Vice President of Regulatory Affairs.

Second Quarter 2023 Financial Highlights

•Cash, Cash Equivalents and Investments: With its ongoing and currently planned clinical programs and $219.7 million in cash, cash equivalents and investments as of June 30, 2023, the company reiterates its expected cash runway into the second half of 2025.

•R&D Expenses: Research and development expenses were $22.7 million for the second quarter of 2023, which includes non-cash stock-based compensation expense of $3.1 million.

•G&A Expenses: General and administrative expenses were $11.4 million for the second quarter of 2023, which includes non-cash stock-based compensation expense of $3.8 million.

•Net Loss: Net loss for the second quarter of 2023 was $29.7 million, or $0.52 per share, including non-cash stock-based compensation expense of $6.9 million.