产品管线和研发进展 - 公司正在开发两个内部候选药物istisociclib (KB-0742)和KB-9558[120][121][122] - istisociclib (KB-0742)是一种CDK9抑制剂,正在进行II期临床试验,用于治疗MYC扩增和其他转录依赖型实体瘤[121] - KB-9558是一种p300抑制剂,正在进行IND使能研究,针对多发性骨髓瘤中的关键转录因子IRF4[122] - 公司正在利用自身的产品引擎开展多个肿瘤学发现项目,针对失调的转录因子及其相关的转录调控网络[123] - 公司正在开展一项针对istisociclib (KB-0742)的1/2期临床试验，以及其他产品候选的临床前和临床开发[231] 公司重组和人员变动 - 公司于2024年2月和3月进行了两次重组,涉及裁员21%和三名高管离职[125] - 公司于2023年第四季度实施了企业重组计划,以优化资源配置和控制成本[236] - 公司于2023年11月和2024年3月分别裁减了约19%和21%的员工[236] - 公司还裁减了3名高管职位,包括首席医疗官、首席科学官和首席运营官兼总法律顾问[236] 合作与收购 - 公司于2023年1月与Genentech签订了合作协议,获得2000万美元的预付款,有机会获得更多里程碑付款和销售分成[128][129][130] - 公司与Tempus签订了为期4年的研发服务协议,用于推进istisociclib (KB-0742)和KB-9558的开发[132][133][134] - 公司收购吉利德的资产组合后,由于临床试验遇到挑战而决定停止进一步开发[241] - 公司未来收购或战略交易可能带来的风险包括未预料的负债、整合困难、关键员工流失等[242][243][244] 财务状况 - 公司自成立以来一直亏损,截至2024年6月30日累计亏损5.55亿美元,预计未来将继续大幅投入研发[127] - 2024年第二季度收入为268.8万美元,同比增长44%,主要由于与Genentech的合作协议带来的收入增加[154] - 2024年第二季度研发费用为1376.5万美元,同比下降34%,主要由于人员成本和直接成本的减少[156][157] - 2024年上半年公司确认了713.1万美元的长期资产减值和重组费用[170][172] - 公司在2024年6月30日结束的六个月内经营活动使用现金4,022.9万美元[178] - 公司在2024年6月30日结束的六个月内投资活动提供现金4,594.6万美元[180] - 公司在2024年6月30日结束的六个月内筹资活动提供现金16.4万美元[182] - 公司在2024年6月30日结束的六个月内现金及现金等价物净增加588.1万美元[177] 风险因素 - 多种因素可能会对产品候选药物的开发时间和持续时间产生不利影响,从而增加研发费用[146] - 公司可能会遇到临床试验延迟或失败的风险,包括监管机构不批准、患者入组缓慢、临床试验结果不理想等[249][250][251][252][253][254][255][256][257][258][259][260] - 公司尚未完成任何临床试验,正在进行istisociclib (KB-0742)的1/2期临床试验,但由于样本量较小可能会影响结果的可靠性[290,292,293] - 公司产品的市场机会可能较小,因为适用人群可能仅限于无法接受或未能从既有治疗中获益的患者[294,295,296,297,298] - 即使获批上市,公司产品也可能无法获得医生、患者及支付方的充分认可,从而影响商业化成功[299,300,301] - 公司产品可能面临不利的第三方支付和报销政策,这可能会限制产品的商业化[308,309,310,311,312,313] 其他 - 公司存在多项租赁合同和研发合作协议[184,185,186,187] - 公司采用关键会计政策和估计包括收入确认、应计研发费用、股份支付和长期资产减值[188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204] - 公司自2017年6月成立以来一直亏损,预计未来几年内仍将持续亏损,可能无法实现收入和盈利[221,223,224] - 公司目前尚未从任何产品销售中获得收入,未来能否实现盈利存在很大不确定性[225,228] - 公司需要大量额外资金支持研发和商业化活动,如果无法及时筹集资金可能会延迟或终止产品开发计划[229,230,231,234] - 公司需要获得监管机构的批准才能实现产品商业化,存在诸多不确定性因素[225,226,227] - 公司需要建立销售、营销和分销渠道以实现产品商业化[226] - 公司需要保护知识产权以确保产品的商业价值[218] - 公司高度依赖第三方合作伙伴开展临床试验和生产活动[219] - 公司的成功很大程度上依赖于吸引和留住高技能的管理团队和员工[219]

The market expects Kronos Bio, Inc. (KRON) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended June 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if th ...

— KB-0742 cleared 80mg four-days-on, three-days-off dosing schedule in dose escalation — — Company expects to provide an efficacy update on this expansion cohort in 1H 2025 — SAN MATEO, Calif. and CAMBRIDGE, Mass., July 23, 2024 (GLOBE NEWSWIRE) --  Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and other diseases driven by deregulated transcription, today announced the first patient dosed in an expansion cohort with KB-0742 at a dose of 8 ...

— KB-0742 cleared 80mg four-days-on, three-days-off dosing schedule in dose escalation — — Company expects to provide an efficacy update on this expansion cohort in 1H 2025 — SAN MATEO, Calif. and CAMBRIDGE, Mass., July 23, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and other diseases driven by deregulated transcription, today announced the first patient dosed in an expansion cohort with KB-0742 at a dose of 80 ...

— KB-0742 continues to demonstrate a manageable safety and tolerability profile with no grade 3/4 neutropenia observed — — KB-0742 continues to show dose linear pharmacokinetics up to 80mg three-days-on, four-days-off dose, including increased target engagement at the 80mg vs. 60mg doses — — The escalation cohort at 80mg four-days-on, three-days-off is currently enrolling, and the expansion cohort at this dose is expected to begin enrollment in the third quarter of 2024 — SAN MATEO, Calif. and CAMBRIDGE, Ma ...

— KB-0742 continues to demonstrate a manageable safety and tolerability profile with no grade 3/4 neutropenia observed — — KB-0742 continues to show dose linear pharmacokinetics up to 80mg three-days-on, four-days-off dose, including increased target engagement at the 80mg vs. 60mg doses — — The escalation cohort at 80mg four-days-on, three-days-off is currently enrolling, and the expansion cohort at this dose is expected to begin enrollment in the third quarter of 2024 — SAN MATEO, Calif. and CAMBRIDGE, Ma ...

SAN MATEO, Calif. and CAMBRIDGE, Mass., May 22, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (NASDAQ:KRON), a company dedicated to developing small molecule therapeutics that address cancers and other diseases driven by deregulated transcription, today announced that the company would participate in three upcoming healthcare conferences and events. Norbert Bischofberger, Ph.D., president and chief executive officer, will represent the company at these events. May 28th, 2024, Dr. Bischofberger will participate ...

SAN MATEO, Calif. and CAMBRIDGE, Mass., May 22, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and other diseases driven by deregulated transcription, today announced that the company would participate in three upcoming healthcare conferences and events. Norbert Bischofberger, Ph.D., president and chief executive officer, will represent the company at these events. May 28th, 2024, Dr. Bischofberger will participate ...

SAN MATEO, Calif. and CAMBRIDGE, Mass., May 21, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and other diseases driven by deregulated transcription, today announced that it has appointed Deborah Knobelman, Ph.D., as Chief Operating Officer and Chief Financial Officer effective June 3, 2024. Dr. Knobelman will oversee the finance, accounting, business development, investor relations and corporate strategy function ...

SAN MATEO, Calif. and CAMBRIDGE, Mass., May 21, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and other diseases driven by deregulated transcription, today announced that it has appointed Deborah Knobelman, Ph.D., as Chief Operating Officer and Chief Financial Officer effective June 3, 2024. Dr. Knobelman will oversee the finance, accounting, business development, investor relations and corporate strategy function ...