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KRONOS BIO Kronos Bio Reports Recent Business Progress and Second Quarter Financial Results August 12 , 2021 Announced FDA clearance of Investigational New Drug application ( IND ) for lanraplenib ( LANRA ) for treatment of patients with acute myeloid leukemia ( AML ) Unveiled SYK portfolio strategy and highlighted momentum of CDK9 inhibitor and discovery programs at virtual R & D Day $ 419.3 million in cash , cash equivalents and investments as of June 30 , 2021 SAN MATEO , Calif . , and CAMBRIDGE , Mass . , Aug. 12 , 2021 ( GLOBE NEWSWIRE ) -- Kronos Bio , Inc. ( Nasdaq : KRON ) , a company dedicated to transforming the lives of those affected by cancer , today reported recent business progress and second quarter financial results . " At our virtual R & D Day in May , we outlined our vision for expanding and driving progress in our pipeline of clinical programs that target dysregulated transcription factors and the regulatory networks within cancerous cells . This included unveiling the development strategy for our SYK inhibitor portfolio , which comprises entospletinib ( ENTO ) and LANRA . These differentiated clinical - stage investigational development candidates have the potential to address the mutations that are present in more than two - thirds of patients with AML , " said Norbert Bischofberger , Ph.D. , president and CEO . " We are poised to initiate our registrational Phase 3 trial later this year to support potential accelerated approval of ENTO in patients newly diagnosed with NPM1 - mutated AML . With the recent FDA clearance of our IND for LANRA in relapsed or refractory FLT - 3 mutant AML , we plan to launch our second SYK inhibitor clinical trial in the fourth quarter of 2021 , when we also expect to report initial Phase 1 data from our trial of KB - 0742 , our potent oral , highly selective cyclin dependent kinase 9 inhibitor . I am proud of our Company's momentum and anticipate multiple important inflection points in the coming months . " Recent Company Highlights • Received clearance from U.S. Food and Drug Administration ( FDA ) for the IND application of LANRA , a next - generation spleen tyrosine kinase ( SYK ) inhibitor . The first of two planned Phase 1/2 clinical trials is expected to initiate in Q4 2021 in patients with relapsed or refractor FLT3 - mutated AML and will include a dose - escalation and an expansion cohort study design . The first stage will evaluate initial safety , pharmacokinetic ( PK ) and anti - leukemic activity of escalating once - daily doses of LANRA in combination with gilteritinib . Initial data from this first stage of the trial are anticipated to be available in the second half of 2022 . • On track to initiate the Phase 3 trial of ENTO in the second half of 2021 with a pivotal data readout expected in the second half of 2023 . • This trial will assess measurable residual disease ( MRD ) negative complete response ( CR ) as the primary endpoint to support potential accelerated approval in patients newly diagnosed with NPM1 - mutated AML . • Anticipates reporting initial safety , PK and pharmacodynamic ( PD ) data from Phase 1 trial of KB - 0742 , a highly selective , orally bioavailable cyclin dependent kinase 9 ( CDK9 ) inhibitor being developed to treat MYC - amplified solid tumors , in the fourth quarter of 2021. The company presented preclinical data for KB - 0742 at the American Association for Cancer Research ( AACR ) Annual Meeting in April 2021 , which showed CDK9 inhibition on an intermittent dosing schedule with KB - 0742 resulted in sustained inhibition of tumor growth in multiple types of solid tumors . The findings suggest that genomic amplification of MYC , a well - characterized transcription factor and a long - recognized driver of cancer , is a key factor of sensitivity to CDK9 inhibition . • Hosted a virtual R & D Day in May 2021 to discuss the company's development strategy for the SYK inhibitors ENTO and LANRA , expectations for the upcoming Phase 1 data readout for KB - 0742 and potential populations for expansion cohorts of a Phase 1/2 trial , along with an overview of the company's differentiated drug discovery platform and future pipeline programs . Second Quarter Financial Highlights Cash , Cash Equivalents and Investments : As of June 30 , 2021 , cash , cash equivalents and investments totaled $ 419.3 million . R & D Expenses : Research and development expenses were $ 19.8 million for the second quarter of 2021 , which includes non - cash stock - based compensation expense of $ 3.4 million . G & A Expenses : General and administrative expenses were $ 9.3 million for the second quarter of 2021 , which includes non - cash stock - based compensation expense of $ 3.0 million . Net Loss : Net loss for the second quarter of 2021 was $ 29.1 million , or $ 0.53 per share , including non - cash stock - based compensation expense of $ 6.4 million . About Kronos Bio , Inc. Kronos Bio is a clinical - stage biopharmaceutical company dedicated to discovering , developing and commercializing therapies that seek to transform