On November 13, 2024 Kronos Bio, Inc. (Nasdaq: KRON), a company developing small molecule therapeutics that address cancers and autoimmune diseases driven by deregulated transcription, reported financial results for the third quarter of 2024 and provided a strategic update following a recent assessment of its ongoing Phase 1/2 expansion cohort of istisociclib in patients with platinum-resistant high-grade serous ovarian cancer (Press release, Kronos Bio, NOV 13, 2024, View Source [SID1234648280]). Based on a review of emerging clinical data in the 80mg four-days-on, three-days-off expansion cohort, the Company and its Board of Directors has determined that the benefit-risk profile does not warrant further clinical evaluation of istisociclib. After an overall review of its business and given the clinical development timelines of its additional pipeline candidates, the Company will explore strategic alternatives with the goal of maximizing stockholder value. Kronos Bio will be implementing significant expense reduction strategies while it explores options for the Company and its remaining internally developed preclinical assets, one of which could include partnering the two p300 lysine acetyltransferase (KAT) inhibitor programs: an oncology candidate, KB-9558, for multiple myeloma and HPV-driven cancers expected to be IND-ready by the end of 2024, and an autoimmune disease candidate, KB-7898, for Sjögren’s disease which has begun IND-enabling studies.
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"While we believe istisociclib has provided benefit to a small number of patients in the Phase 1/2 trial, the emerging profile in patients with platinum-resistant ovarian cancer suggests an unfavorable risk-benefit profile and does not warrant further clinical development," said Norbert Bischofberger, Ph.D., chief executive officer. "We are very grateful to the patients, caregivers and medical staff who dedicated their time and energy to make this clinical trial possible and your commitment to evaluating novel approaches to treat cancer."
Charles Lin, Ph.D., Kronos’ chief scientific officer, added, "We continue to believe in the promise of our proprietary discovery technology’s application focused on targeting IRF4 where we have validated the critical role of this transcription factor in driving tumor cell growth in multiple myeloma and HPV-driven tumors or inflammation in autoimmune disease. Data from our early-stage p300 KAT inhibitor programs demonstrate that inhibition of key signaling pathways leads to restoration of tumor suppression activity in cancer cells or reduction of inflammation in autoimmune disease, underscoring the potential of this approach for patients that have limited or no targeted therapies."
The decision to discontinue the development of istisociclib resulted from a recent safety assessment from the ongoing Phase 1/2 clinical trial patients with platinum-resistant high-grade serous ovarian cancer. Out of seven enrolled patients, five exhibited neurological events as characterized by involuntary movements, confusion and hallucinations ranging from Grade 1 to Grade 3. Of those five patients, three discontinued due to adverse events, and two reduced the dose of istisociclib.
Third Quarter 2024 Financial Highlights
•Cash, cash equivalents and investments: Kronos Bio has $124.9 million in cash, cash equivalents and investments as of September 30, 2024.
•R&D expenses: Research and development expenses were $12.3 million for the third quarter of 2024, which includes non-cash stock-based compensation expense of $0.8 million.
•G&A expenses: General and administrative expenses were $5.8 million for the third quarter of 2024, which includes non-cash stock-based compensation expense of $1.2 million.
•Net loss: Net loss for the third quarter of 2024 was $14.1 million, or $0.23 per share, including non-cash stock-based compensation expense of $2.0 million.
Process to Explore Strategic Alternatives
Kronos Bio has an exclusive engagement with a financial advisor to assist in evaluating strategic alternatives which may include, but is not limited to, an acquisition, merger, reverse merger, other business combination, sales of assets or other strategic transactions. There can be no assurance of a transaction, a successful outcome of these efforts, or the form or the timing of any such outcome. The Company does not intend to make any further disclosures that the exploration of strategic alternatives will result in any agreements or transactions, or that, if executed, any agreement or transaction will be successfully consummated or on attractive terms. The Company does not intend to make any further disclosures regarding the strategic review process unless and until a specific course of action is approved by the Company’s board of directors or until the Company determines that further disclosure is appropriate.