NEW YORK, May 1, 2025 /PRNewswire/ -- Monteverde & Associates PC (the "M&A Class Action Firm"), has recovered millions of dollars for shareholders and is recognized as a Top 50 Firm in the 2024 ISS Securities Class Action Services Report. We are headquartered at the Empire State Building in New York City and are investigating Kronos Bio, Inc. (NASDAQ: KRON), relating to the proposed merger with Concentra Biosciences, LLC. Under the terms of the agreement, Concentra will acquire Kronos Bio for $0.57 in cash ...

CAMBRIDGE, Mass., May 01, 2025 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. ("Kronos Bio") (Nasdaq: KRON), a biotechnology company that has been developing small molecule therapeutics to address cancers and other diseases driven by deregulated transcription, today announced that it has entered into a definitive merger agreement (the “Merger Agreement”) with Concentra Biosciences, LLC ( “Concentra”), whereby Concentra will acquire Kronos Bio for $0.57 in cash per share of Kronos Bio common stock (“Kronos Bio Common ...

Clinical Trials and Product Development - In November 2024, the company announced the discontinuation of its clinical trial for istisociclib (KB-0742) due to an unfavorable benefit-risk profile based on adverse events observed in the trial[27]. - The company has paused the development of both KB-9558 and KB-7898 as of the end of 2024[46][47]. - The development candidate KB-9558 is an orally bioavailable small molecule with excellent pharmacological properties, and its Phase 1 study in multiple myeloma is expected to start in the first half of 2025[46]. - KB-7898 was announced as a development candidate for treating Sjogren's disease, with IND-enabling studies initiated in October 2024[47]. - The FDA cleared the IND for KB-0742 in December 2020, and the company initiated a Phase 1/2 clinical trial in February 2021[32]. - The company has faced significant challenges in its discovery and development activities, particularly in obtaining regulatory approval for its product candidates[22]. - The company must submit progress reports to the FDA during the IND phase, summarizing clinical trial results and safety reports[86]. - Clinical trials are conducted in three phases, with Phase 3 trials providing statistically significant evidence of clinical efficacy[82]. - The FDA requires companion diagnostics to be approved simultaneously with therapeutic products, impacting the approval timeline[124]. - The PMA process for medical devices can take several years and requires extensive clinical data[126]. Strategic Alternatives and Business Model - The company is conducting a comprehensive review of strategic alternatives, including potential acquisitions, mergers, or divestitures, to maximize stockholder value[28]. - The company’s historical business model focused on developing small molecule modulators for cancer and serious diseases, utilizing a proprietary product engine[31]. - The company’s strategy includes evaluating potential strategic alternatives that may involve a sale, merger, or licensing transactions[30]. - The company is exploring options for its product candidates KB-9558 and KB-7898, including potential partnerships and divestitures, without a set timetable for completion[28]. Financial Performance and Workforce - The company has incurred significant net losses since inception and expects to continue incurring substantial losses over the next several years[22]. - Following a decision to suspend clinical, research, and development activities, the company reduced its workforce by approximately 83% to conserve capital[30]. - The company has 10 full-time employees as of March 13, 2025, with no labor union representation[130]. Intellectual Property and Regulatory Compliance - The company actively assesses its intellectual property portfolio to align with product candidates and discovery programs[71]. - The company seeks to maintain proprietary protection for its product candidates through patents, trademarks, and trade secrets[67]. - The patent portfolio includes pending applications for KB-9558 and KB-7898, providing potential patent protection through 2045 and 2044 respectively if granted[72][73]. - The nominal patent term is generally 20 years from the earliest non-provisional filing date, with potential extensions under the Hatch-Waxman Act for FDA-approved drugs[75][88]. - Regulatory compliance is critical throughout the drug development process, with potential sanctions for non-compliance[78]. Market and Competitive Landscape - The pharmaceutical and biotechnology industries are characterized by intense competition, with larger companies having significantly greater resources and expertise[66]. - The company faces challenges in obtaining coverage and reimbursement for new products, which can be a time-consuming process[115]. - Third-party payors are increasingly reducing reimbursements for pharmaceutical products, impacting sales potential[116]. Employee Relations and Company Culture - Kronos Bio emphasizes the importance of employee diversity and inclusion, believing it strengthens the company[132]. - The company offers competitive compensation packages, including market-competitive salaries, bonuses, stock awards, healthcare, and retirement benefits[133]. - Employee safety and well-being are prioritized, with resources for physical, financial, and mental health support[135]. - Kronos Bio maintains open communication with employees through various channels, including monthly updates and engagement surveys[134]. Regulatory and Legislative Environment - The FDA may issue a Complete Response Letter if the NDA does not meet regulatory criteria, outlining specific deficiencies[92]. - The Pediatric Research Equity Act (PREA) mandates pediatric clinical trials for most drugs, requiring assessments of safety and effectiveness in relevant pediatric subpopulations[94]. - The FDA's fast track designation program aims to expedite the review process for new drugs intended to treat serious conditions and address unmet medical needs[95]. - Products may also qualify for priority review if they offer significant improvements over existing therapies, with a review timeline of approximately six months[96]. - Accelerated approval is available for drugs that show effects on surrogate endpoints likely to predict clinical benefits, with post-marketing studies required[98]. - Breakthrough therapy designation allows for expedited development and review for drugs showing substantial improvement over existing therapies[99]. - Marketing exclusivity provisions under the FDCA provide a five-year exclusivity period for new chemical entities, preventing approval of similar drugs during this time[105]. - Pediatric exclusivity can grant an additional six months of marketing exclusivity if clinical trials in children are conducted in response to FDA requests[107]. - Violations of healthcare laws may result in significant penalties, including fines, imprisonment, and exclusion from government healthcare programs[111]. - The company is subject to various data privacy laws, including the CCPA, which can impose fines of up to $7,500 per intentional violation[113]. - The GDPR can result in fines of up to €20 million or 4% of total global annual turnover for certain breaches[114]. - The ACA increased the minimum level of Medicaid rebates from 15.1% to 23.1% for brand name drugs[118]. - The Inflation Reduction Act of 2022 eliminates the "donut hole" under Medicare Part D starting in 2025, significantly lowering out-of-pocket costs for beneficiaries[120]. - The company must comply with significant regulatory requirements post-market, including maintaining FDA compliance for manufacturing processes[128].

Financial Performance - Net loss for Q4 2024 was $25.8 million, or $0.43 per share, with a total net loss of $86.1 million, or $1.43 per share for the full year, an improvement from $112.7 million in 2023[2][4] - Total operating expenses for Q4 2024 were $29.4 million, with a total of $102.7 million for the full year, down from $128.4 million in 2023[4] - Research and development expenses for Q4 2024 were $8.4 million, with a total of $48.7 million for the full year, a decrease from $84.5 million in 2023[2][4] - General and administrative expenses for Q4 2024 were $4.9 million, totaling $24.6 million for the full year, down from $39 million in 2023[2][4] - Impairment of long-lived assets and restructuring charges for Q4 2024 were $16.1 million, with a total of $29.5 million for the full year, compared to $4.9 million in 2023[2][4] Assets and Liabilities - Cash, cash equivalents, and investments as of December 31, 2024, were $112.4 million, down from $175 million in 2023[6] - Total assets as of December 31, 2024, were $124.4 million, a decrease from $213.3 million in 2023[6] - Total liabilities as of December 31, 2024, were $36.8 million, down from $54.2 million in 2023[6] Strategic Alternatives - The company is evaluating potential strategic alternatives, including acquisitions and mergers, to maximize stockholder value[1] Securities - The company reported a net unrealized loss on available-for-sale securities of $15, compared to a gain of $274 in Q4 2023[4]

Core Insights - Kronos Bio, Inc. reported its fourth quarter and full year 2024 financial results, highlighting a strategic evaluation process aimed at maximizing stockholder value [1][3]. Financial Performance - For Q4 2024, Kronos Bio generated revenue of $2.27 million, slightly down from $2.29 million in Q4 2023. For the full year 2024, revenue increased to $9.85 million from $6.29 million in 2023, marking a growth of approximately 56% [5][6]. - Total operating expenses for Q4 2024 were $29.42 million, compared to $29.88 million in Q4 2023. For the full year, operating expenses decreased to $102.74 million from $128.37 million in 2023 [5][6]. - The net loss for Q4 2024 was $25.81 million, or $0.43 per share, compared to a net loss of $25.32 million in Q4 2023. The full year net loss was $86.08 million, or $1.43 per share, down from $112.67 million in 2023 [6][7]. Research and Development - Research and development expenses for Q4 2024 were $8.41 million, including $0.7 million in non-cash stock-based compensation. For the full year, R&D expenses totaled $48.66 million, with $3.4 million in non-cash stock-based compensation [6][9]. Balance Sheet Highlights - As of December 31, 2024, Kronos Bio had cash, cash equivalents, and investments totaling $112.42 million, a decrease from $174.99 million in 2023. Total assets were $124.36 million, down from $213.28 million, while total liabilities decreased to $36.78 million from $54.20 million [6][9]. - Total stockholders' equity as of December 31, 2024, was $87.58 million, compared to $159.08 million in 2023 [9].

Leadership Changes - Norbert Bischofberger, Ph.D., is stepping down as President & CEO of Kronos Bio, effective December 3, 2024, and will remain on the Board of Directors as an advisor [1] - Deborah Knobelman, Ph.D., currently COO & CFO, has been appointed as President and Interim CEO, effective December 3, 2024 [1] Workforce Reduction - The company announced a workforce reduction of approximately 83 percent by year-end as part of its cost reduction strategies [2] - This decision is part of a broader plan to explore strategic alternatives, including potential business combinations and divestiture of remaining preclinical assets, aimed at maximizing stockholder value [2][3] Company Overview - Kronos Bio is a biopharmaceutical company focused on developing small molecule therapeutics targeting deregulated transcription, which is associated with cancer and autoimmune diseases [4] - The company utilizes a proprietary discovery engine to decode transcription factor regulatory networks and identify druggable cofactors [4]

Kronos Bio, Inc. (KRON) came out with a quarterly loss of $0.23 per share versus the Zacks Consensus Estimate of a loss of $0.26. This compares to loss of $0.54 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 11.54%. A quarter ago, it was expected that this company would post a loss of $0.32 per share when it actually produced a loss of $0.27, delivering a surprise of 15.63%.Over the last four quarters, the company has surpass ...

Financial Performance - The company reported net losses of $14.1 million for the three months ended September 30, 2024, compared to $31.4 million for the same period in 2023, indicating a reduction in losses [102]. - Revenue for the three months ended September 30, 2024, was $2.4 million, an increase of $1.5 million compared to $0.9 million for the same period in 2023 [125]. - For the nine months ended September 30, 2024, revenue was $7.6 million, an increase of $3.6 million from $4.0 million in the same period of 2023 [132]. - Total operating expenses for the nine months ended September 30, 2024, were $73.3 million, down from $98.5 million in 2023, a decrease of $25.2 million [131]. - Research and development expenses decreased to $12.3 million for the three months ended September 30, 2024, down from $25.3 million in 2023, a reduction of $13.1 million [128]. - General and administrative expenses were $5.8 million for the three months ended September 30, 2024, compared to $9.4 million in 2023, a decrease of $3.6 million [129]. - Research and development expenses for the nine months ended September 30, 2024, were $40.3 million, a decrease of $25.6 million from $65.8 million in 2023 [134]. - General and administrative expenses for the nine months ended September 30, 2024, were $19.7 million, down from $29.8 million in 2023, a decrease of $10.1 million [135]. - The company recognized a non-cash impairment charge of $7.1 million during the nine months ended September 30, 2024 [136]. - The company recorded total restructuring costs of $6.2 million during the nine months ended September 30, 2024, including non-cash stock-based compensation of $4.4 million [138]. Cash Flow and Capital Resources - As of September 30, 2024, the company had an accumulated deficit of $569.1 million and cash, cash equivalents, and investments totaling $124.9 million [102]. - Cash used in operating activities for the nine months ended September 30, 2024, was $52.6 million, with a net loss of $60.3 million adjusted for non-cash charges of $12.7 million [146]. - Cash provided by investing activities for the nine months ended September 30, 2024, was $63.1 million, primarily from purchases and maturities of marketable securities [148]. - The company incurred cash used in operating activities of $53.6 million for the nine months ended September 30, 2023, with a net loss of $87.4 million adjusted for non-cash charges of $22.6 million [147]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $0.2 million, compared to $0.4 million for the same period in 2023 [150][151]. - The company intends to raise additional capital through equity securities or debt financing to continue operations, with potential dilution of existing stockholders' interests [143]. - The company’s future viability depends on its ability to generate cash from operations or raise additional capital, with significant risks if financing is not available [144]. - As of September 30, 2024, the company had cash, cash equivalents, and investments totaling $124.9 million, expected to fund operations for the next 12 months [140]. Strategic Initiatives - The company announced the discontinuation of its clinical trial for istisociclib due to safety concerns, with five out of seven patients experiencing neurological events [96]. - The company has initiated a formal process to evaluate potential strategic alternatives, including acquisitions or mergers, following the discontinuation of istisociclib [96]. - The company entered into a collaboration agreement with Genentech, receiving an upfront payment of $20.0 million and being eligible for up to $177.0 million in milestone payments [105]. - The term of the discovery research programs with Genentech is up to 24 months, with a possible six-month extension [106]. - The increase in revenue was primarily due to the Collaboration and License Agreement with Genentech, which began in January 2023 [125]. Research and Development - KB-9558 is in preclinical development for multiple myeloma and HPV-driven tumors, while KB-7898 is being developed for Sjogren's disease [98][99]. - The company’s primary use of cash has historically been for research and development expenditures related to therapeutic discovery and clinical development [141]. - The company has not yet commercialized any products and does not expect to generate revenue from product sales for several years [140]. Financial Obligations and Risks - The company has significant contractual obligations, including lease agreements with escalating payments, impacting future cash flows [152][154]. - Stock-based compensation is recognized over the requisite service period, generally the vesting period, using the straight-line method [169]. - The fair value of stock options is estimated using the Black-Scholes model, considering expected term, expected volatility, risk-free interest rate, and expected dividend yield [170][171][172]. - Impairment of long-lived assets is evaluated when events indicate that carrying amounts may not be recoverable, with losses recognized when future cash flows are less than carrying amounts [173]. - The company has never paid dividends on its common stock and has no plans to do so, resulting in an expected dividend yield of zero [172]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [176].

Financial Performance - Kronos Bio reported a net loss of $14.1 million for Q3 2024, or $0.23 per share, compared to a net loss of $31.4 million in Q3 2023[4]. - Total operating expenses for Q3 2024 were $18.1 million, compared to $34.7 million in Q3 2023[10]. Cash and Assets - As of September 30, 2024, Kronos Bio had $124.9 million in cash, cash equivalents, and investments, down from $175 million at the end of 2023[3][11]. - Kronos Bio's total assets decreased to $150.0 million as of September 30, 2024, from $213.3 million at the end of 2023[11]. Expenses - Research and development expenses for Q3 2024 were $12.3 million, including $0.8 million in non-cash stock-based compensation[3]. - General and administrative expenses for Q3 2024 were $5.8 million, which included $1.2 million in non-cash stock-based compensation[4]. Strategic Decisions - The company has decided to discontinue the development of istisociclib due to an unfavorable risk-benefit profile observed in clinical trials[1][2]. - Kronos Bio is exploring strategic alternatives to maximize stockholder value, which may include acquisitions or mergers[5]. - The company plans to implement significant expense reduction strategies while evaluating options for its remaining preclinical assets[1]. Product Development - The oncology candidate KB-9558 is expected to be IND-ready by the end of 2024, while KB-7898 for autoimmune disease has begun IND-enabling studies[1].

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]