Core Insights - Kronos Bio has nominated KB-7898, a p300 KAT inhibitor, as its first development candidate for autoimmune diseases, specifically targeting Sjögren's disease, which currently lacks approved treatments addressing its underlying causes [1][3] Group 1: Product Development - KB-7898 is being developed as an orally available therapy for Sjögren's disease, which is characterized by autoantibody production and chronic inflammation [2][5] - The company plans to initiate Investigational New Drug (IND)-enabling studies for KB-7898 in Q4 2024 [1][3] Group 2: Mechanism of Action - p300 is a critical cofactor for immune responses, influencing B cells and T cells, which positions KB-7898 as a potential treatment for other autoimmune diseases in the future [2][3] - Preclinical data indicate that KB-7898 can reduce antibody production in B cells and cytokine production in T cells, potentially impacting the etiology of Sjögren's disease [3][5] Group 3: Preclinical Data - The preclinical data supporting KB-7898's efficacy will be presented at ACR Convergence 2024, highlighting its ability to downregulate proinflammatory cytokines and reduce inflammation in animal models [3][4] - Specific findings include decreased levels of TNFα, IL-23, and IL-17A, as well as reduced joint swelling and clinical scores in rat models [3] Group 4: Market Context - Sjögren's disease affects an estimated 2 to 4 million people in the U.S., with only about 1 million diagnosed due to its heterogeneous symptoms [5] - The disease significantly impacts quality of life and can lead to severe complications, including a 50% increase in all-cause mortality [5] Group 5: Company Overview - Kronos Bio is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics targeting deregulated transcription, with a pipeline that includes three drug candidates [6] - The company operates from San Mateo, California, and has a research facility in Cambridge, Massachusetts [6]

Core Insights - Kronos Bio, Inc. presented new preclinical data on istisociclib (KB-0742), a CDK9 inhibitor, demonstrating its potential to induce cell death in platinum and PARP-inhibitor resistant ovarian cancer models [1][3] - The company is currently conducting a Phase 1/2 clinical trial to evaluate istisociclib's efficacy as a single agent in platinum-resistant high-grade serous ovarian cancer (HGSOC) [2] Preclinical Findings - Istisociclib triggered apoptosis and cell death, evidenced by the accumulation of γH2AX, a marker of DNA damage [4] - The drug disrupted homologous recombination DNA repair by downregulating BRCA1 and RAD51, creating a "BRCAness" phenotype in resistant ovarian cancer cells [4] Clinical Trial Insights - New pharmacokinetic/pharmacodynamic (PK/PD) results from the ongoing trial showed that istisociclib administered at 80mg on a 4 days on/3 days off schedule resulted in a long half-life of approximately 24 hours [4] - Clinical exposures were consistent with efficacious levels observed in preclinical models, leading to sustained downregulation of CDK9-dependent genes in peripheral blood mononuclear cells (PBMCs) [4] Company Overview - Kronos Bio is focused on developing small molecule therapeutics targeting deregulated transcription, a key feature of cancer and other diseases [5] - The company has a preclinical pipeline and two drug candidates, including istisociclib targeting CDK9 and KB-9558 targeting p300 for multiple myeloma [5]

Core Viewpoint - Kronos Bio, Inc. (KRON) has experienced a downtrend with a 5.5% decline over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround due to analysts' improved earnings forecasts [1] Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2] - KRON's current RSI reading is 23.37, indicating that the heavy selling pressure may be exhausting itself, suggesting a possible trend reversal [5] Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts regarding KRON's earnings estimates, with a 13.9% increase in the consensus EPS estimate over the last 30 days, which often leads to price appreciation [6] - KRON holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, indicating a strong potential for a near-term turnaround [7]

Core Insights - Kronos Bio, Inc. is focused on developing small molecule therapeutics targeting deregulated transcription associated with cancers and other diseases [2][3] Upcoming Conferences - Kronos Bio will participate in the H.C. Wainwright 26th Annual Global Investment Conference from September 9–11, 2024, in New York, where CEO Norbert Bischofberger will present on September 9 at 2:30 p.m. ET [1] - The company will also present at the American Association for Cancer Research (AACR) 15th Biennial Ovarian Cancer Research Symposium on September 20–21, 2024, in Seattle, with a poster presentation by Luis Carvajal on September 21 [1] - At the International Myeloma Society (IMS) 21st Annual Meeting from September 25–28, 2024, in Rio de Janeiro, Mariateresa Fulciniti will present on the impact of p300 catalytic inhibition on multiple myeloma cell growth on September 28 [1] Company Overview - Kronos Bio is a clinical-stage company with a proprietary discovery engine that decodes transcription factor regulatory networks to identify druggable cofactors [2] - The company has developed a preclinical pipeline and two drug candidates: Istisociclib (KB-0742) targeting CDK9 for MYC deregulation in solid tumors, and KB-9558 targeting p300 for IRF4 dependence in multiple myeloma [2]

Core Viewpoint - Kronos Bio, Inc. (KRON) has experienced a significant decline of 23.5% over the past four weeks, but it is now positioned for a potential trend reversal as it enters oversold territory, with analysts predicting better earnings than previously expected [1]. Group 1: Stock Performance - KRON shares have faced heavy selling pressure, indicated by an RSI reading of 28.81, suggesting that the selling may be exhausting itself and a trend reversal could occur soon [3]. - The stock's recent decline places it in oversold territory, which typically signals a potential rebound opportunity for investors [2]. Group 2: Earnings Estimates - There is a strong consensus among sell-side analysts that earnings estimates for KRON will improve, with a notable increase of 18.3% in the consensus EPS estimate over the last 30 days [3]. - An upward trend in earnings estimate revisions is generally associated with price appreciation in the near term, indicating a positive outlook for KRON [3]. Group 3: Analyst Ratings - KRON currently holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [3].

Core Viewpoint - The market anticipates Kronos Bio, Inc. (KRON) to report a year-over-year increase in earnings despite lower revenues for the quarter ended June 2024, with actual results being crucial for stock price movement [1] Earnings Expectations - The consensus EPS estimate for Kronos Bio is a loss of $0.32 per share, reflecting a year-over-year change of +38.5% [3] - Expected revenues are projected at $1.75 million, which is a decrease of 5.9% from the same quarter last year [3] Estimate Revisions - The consensus EPS estimate has been revised 15.87% higher in the last 30 days, indicating a positive reassessment by analysts [4] - The Most Accurate Estimate for Kronos Bio is higher than the Zacks Consensus Estimate, resulting in an Earnings ESP of +1.03% [10] Earnings Surprise Prediction - A positive Earnings ESP is a strong indicator of an earnings beat, especially when combined with a Zacks Rank of 1 (Strong Buy), 2 (Buy), or 3 (Hold) [8] - Kronos Bio currently holds a Zacks Rank of 2, suggesting a high likelihood of beating the consensus EPS estimate [10] Historical Performance - In the last reported quarter, Kronos Bio was expected to post a loss of $0.43 per share but actually reported a loss of $0.50, resulting in a surprise of -16.28% [11] - Over the past four quarters, the company has only beaten consensus EPS estimates once [12] Industry Context - In the Zacks Medical - Biomedical and Genetics industry, Iovance Biotherapeutics (IOVA) is expected to report a loss of $0.37 per share for the same quarter, indicating a year-over-year change of +21.3% [16] - Iovance's revenue is projected to be $22.59 million, a significant increase of 9312.5% from the previous year [16] - The consensus EPS estimate for Iovance has been revised 6.6% lower, but a higher Most Accurate Estimate has resulted in an Earnings ESP of 7.83%, suggesting a likely earnings beat [17]

Core Insights - Kronos Bio, Inc. has initiated an expansion cohort for KB-0742, targeting platinum-resistant high-grade serous ovarian cancer (HGSOC) patients with a dosing schedule of 80mg on a four-days-on, three-days-off basis [1][5] - The company plans to provide an efficacy update for this cohort in the first half of 2025 [1] - KB-0742 has shown preliminary anti-tumor activity and a safety profile with no grade 3 or 4 neutropenia in over 100 patients [2] Company Overview - Kronos Bio, Inc. is focused on developing small molecule therapeutics that target deregulated transcription, a common feature in cancer and other diseases [3][4] - The company utilizes a proprietary discovery engine to identify druggable cofactors within complex transcription factor regulatory networks [3] - KB-0742 specifically targets CDK9 to address MYC deregulation in solid tumors, while another candidate, KB-9558, targets p300 for treating multiple myeloma [3][5] Clinical Insights - The pharmacokinetic modeling for the 80mg dosing schedule indicates a 1.8-fold increase in AUC over seven days compared to the previous 60mg schedule [2] - In the U.S., there are approximately 22,000 new ovarian cancer cases annually, with a five-year survival rate below 50%, highlighting the significant unmet medical need in this patient population [2] - KB-0742 has provided prolonged stable disease for over 300 days in at least one patient, indicating potential benefits for those with limited treatment options after platinum therapy [3]

Core Insights - Kronos Bio, Inc. is advancing its clinical-stage drug KB-0742, targeting platinum-resistant high-grade serous ovarian cancer (HGSOC) with promising early results [1][4][11] - The company plans to provide an efficacy update on KB-0742 in the first half of 2025, highlighting its potential to offer new treatment options for patients with limited alternatives [1][9] Company Overview - Kronos Bio, Inc. focuses on developing small molecule therapeutics that target deregulated transcription, a common feature in cancer and other diseases [1][4] - The company utilizes a proprietary discovery engine to identify druggable cofactors within complex transcription factor regulatory networks [1] Product Details - KB-0742 is a selective oral inhibitor of CDK9, which is crucial for the activity of the oncogenic MYC transcription factor [11] - The drug is currently in a Phase 1/2 open-label study, specifically targeting MYC-amplified and transcriptionally addicted solid tumors [11] Clinical Trial Information - The first patient in the expansion cohort has been dosed with KB-0742 at an 80mg dose on a four-days-on, three-days-off schedule [4] - The drug has shown preliminary anti-tumor activity in transcriptionally addicted solid tumors at a lower dose of 60mg [9] Market Context - In the U.S., there are approximately 22,000 new cases of ovarian cancer annually, with a five-year survival rate of less than 50% [5] - About 85% of these tumors exhibit MYC amplification or overexpression, and 50% are classified as HRD+ [5]

Core Insights - Kronos Bio, Inc. announced new data from its ongoing Phase 1/2 study of KB-0742, demonstrating a manageable safety profile with no grade 3/4 neutropenia observed [1][6] - The study focuses on patients with relapsed or refractory solid tumors or non-Hodgkin lymphoma, with promising results leading to confidence in the efficacy of the 80mg dose schedule [2][3] Study Details - The ongoing study, KB-0742-1001, is a first-in-human, open-label dose escalation and cohort expansion trial [1][9] - Preliminary efficacy data presented at the 2023 AACR-NCI-EORTC meeting showed anti-tumor activity in transcriptionally addicted tumors, including a partial response at the 60mg dose [4] Dosage and Efficacy - The 80mg four-days-on, three-days-off dosing schedule is currently enrolling patients, with expectations for increased efficacy compared to the 60mg schedule [5][6] - Pharmacokinetic modeling indicates that the 80mg schedule results in over a ten-fold increase in time above a preclinically determined efficacy threshold compared to the 60mg schedule [6] Patient Data - Data from 103 patients treated with KB-0742 at 60mg (n=82) and 80mg (n=21) showed manageable adverse events, with nausea (69.9%) and vomiting (52.4%) being the most common [6] - Patients remained on treatment for an average of over 2 cycles, with a maximum of 14 completed cycles, and less than 10% discontinued due to adverse events [6] Future Plans - The expansion cohort at the 80mg dose is expected to begin enrollment in the third quarter of 2024 [3][5] - The company is optimistic about the potential benefits of the 80mg dosing schedule based on the data presented [2][3]

Core Insights - Kronos Bio, Inc. presented new data on KB-0742, a small molecule therapeutic targeting CDK9, at the 2024 ASCO Annual Meeting, indicating a manageable safety profile and promising efficacy in treating relapsed or refractory solid tumors and non-Hodgkin lymphoma [1][2][4] Company Overview - Kronos Bio, Inc. is focused on developing small molecule therapeutics that target deregulated transcription, a key factor in cancer and other diseases [7] - The company has a proprietary discovery engine that identifies druggable cofactors within complex transcription factor regulatory networks [7] Drug Development - KB-0742 is currently in a Phase 1/2 study (KB-0742-1001) and has shown a deepening reduction of CDK9-sensitive transcripts at the 80mg dose compared to the 60mg dose [2][9] - The ongoing study includes 103 patients with transcription factor fusion or MYC-driven tumors, with a median of three prior treatments [6] - The 80mg four-days-on, three-days-off dosing schedule is expected to enhance efficacy, with enrollment for the expansion cohort anticipated to begin in Q3 2024 [3][5] Efficacy and Safety Data - Preliminary data from the study indicated manageable mild to moderate adverse events, with no grade 3/4 neutropenia observed [6] - Patients treated with KB-0742 exhibited anti-tumor activity, including stable disease responses of 71 days for a non-small-cell lung cancer patient and over 195 days for a platinum-resistant ovarian cancer patient [6] Future Expectations - The company is optimistic about the potential increased patient benefit from the 80mg dosing schedule, supported by pharmacokinetic modeling showing a greater than ten-fold increase in time above a preclinically determined efficacy threshold compared to the 60mg schedule [5][6]