Bayer to present new analyses from FINEARTS-HF with finerenone

A new analysis of FINEARTS-HF evaluated the effects of finerenone on systolic blood pressure in patients with heart failure and mildly reduced or preserved ejection fraction / Additional analyses assessed the impact of finerenone across specific patient subgroups, including those with outpatient worsening heart failure events, as well as patients categorized by varying ejection fraction levels and body mass index ranges / Another analysis evaluated the effects of finerenone in patients with heart failure and mildly reduced or preserved ejection fraction across three Phase III clinical trials Berlin, December 9, 2024 – Bayer announced today that new analyses from the Phase III FINEARTS-HF trial evaluating finerenone (Kerendia™) in patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥ 40% will be presented at the Cardiovascular Clinical Trials (CVCT) Forum, taking place in Washington, D.C. from December 9-11, 2024. Data being presented at CVCT 2024 include the following. All posters will be presented at the poster session on Tuesday, December 10th from 7:30 - 9:00 pm EST: Blood Pressure Effects of Finerenone in HFmrEF/HFpEF Blood pressure optimization is a guideline-recommended priority of heart failure (HF) care. A new prespecified analysis of the FINEARTS-HF trial in patients with HF and mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) evaluated the effect of finerenone, a non-steroidal MRA, on systolic blood pressure overall and in individuals with apparent treatment-resistant hypertension, as well as the relationship between the effects of finerenone on blood pressure and clinical outcomes. Blood pressure effects of finerenone in heart failure with mildly reduced or preserved ejection fraction: A prespecified analysis of the FINEARTS-HF trial Effect of Finerenone on Outpatient Worsening Heart Failure Events Outpatient worsening HF events are common and associated with poor subsequent prognosis. This analysis investigated the effect of finerenone on outpatient worsening HF events in patients with HF and mildly reduced or preserved ejection fraction. Effect of Finerenone on Outpatient Worsening Heart Failure Events in Patients with Mildly Reduced or Preserved Ejection Fraction Effect of Finerenone and Number of Hospitalizations Recency of a heart failure hospitalization is associated with readmission and death in patients with heart failure. Number of prior hospitalizations due to heart failure may be an additional predictor of outcomes. Number of hospitalizations and effect of Finerenone in FINEARTS-HF Impact of Body Mass Index on Finerenone’s Efficacy Obesity is associated with increased aldosterone secretion, making mineralocorticoid receptor antagonists (MRAs) potentially more effective in obese heart failure patients. This study compared the effects of finerenone versus placebo across different BMI categories in the FINEARTS-HF trial. Effect of Finerenone in Patients With HFmrEF/HFpEF According to Body Mass Index: A Prespecified Analysis of the FINEARTS-HF Trial Initial eGFR Decline with Finerenone An initial decline in estimated glomerular filtration rate (eGFR) often leads to reluctance to continue the life-saving therapy in patients with HF. However, this early dip in eGFR has been shown to predict a favorable response to several HF therapies. This study analyzed early change in eGFR and outcomes in patients treated with finerenone versus placebo. Initial decline (dip) in estimated glomerular filtration rate with initiation of finerenone in patients with mildly reduced or preserved ejection fraction: A prespecified analysis of FINEARTS-HF Trial Finerenone and Frailty in Heart Failure Patients with frailty are often perceived to have a less favorable benefit-risk profile, and therefore may be less likely to receive new treatments. This study investigated the efficacy and tolerability of finerenone according to frailty status in patients with HF with mildly reduced or preserved ejection fraction in the FINEARTS-HF trial. Finerenone and frailty in heart failure with mildly reduced or preserved ejection fraction: An analysis from FINEARTS-HF Participant-level Pooled Analysis of Finerenone in Heart Failure Across Three Phase III trials (FINE-HEART) In this prespecified participant-level pooled analysis, efficacy and safety of finerenone in patients with heart failure and mildly reduced or preserved ejection fraction was evaluated across three Phase III studies, using Cox proportional hazards models stratified by trial. Efficacy and Safety of Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction: A Prespecified Participant-Level Pooled Analysis of Three Randomized Clinical Trials About Kerendia™ (finerenone) / Firialta™ (finerenone) Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. Finerenone is marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S. Finerenone is not approved for the treatment of heart failure. The study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD, respectively. The MOONRAKER program includes FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD and FIGARO-DKD, as well as the ongoing studies FIND-CKD, FIONA, FIONA-OLE, FINE-ONE, and the Phase II study CONFIDENCE. About Bayer’s Commitment in Cardiovascular and Kidney Diseases Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com. Find more information at https://pharma.bayer.com Follow us on Facebook: http://www.facebook.com/bayer Follow us on Twitter: @BayerPharma Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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