Bayer HealthCare Pharmaceuticals, Inc.

WHIPPANY, N.J.--( BUSINESS WIRE )--Bayer today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the oral androgen receptor inhibitor (ARi) NUBEQA ® (darolutamide) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). “ Simply put, our ambition is to help more patients with prostate cancer,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “ We are proud of the role NUBEQA currently plays in the treatment of mHSPC and with this FDA submission, hope to expand the use of NUBEQA to more patients with the disease, regardless of chemotherapy use.” The submission is based on positive results from the investigational pivotal Phase III ARANOTE trial. Data from the trial were presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The Journal of Clinical Oncology . NUBEQA is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. About the ARANOTE Trial 1 The ARANOTE trial (NCT04736199) was a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of NUBEQA plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). 669 patients were randomized to receive 600mg of NUBEQA twice daily or matching placebo in addition to ADT. The primary endpoint of this study was radiological progression-free survival (rPFS), measured as time from the date of randomization to the date of first documentation of radiological disease progression or death due to any cause, whichever occurs first. Secondary endpoints included overall survival (time from randomization to the date of death from any cause), time from randomization to the date of first castration-resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments. About NUBEQA ® (darolutamide) 2 NUBEQA ® (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. In addition to the ARANOTE trial, NUBEQA is being evaluated in a robust clinical development program, which includes studies across various stages of prostate cancer, including in the ARASTEP Phase III trial evaluating NUBEQA plus ADT versus ADT alone in HSPC patients with high-risk biochemical recurrence (BCR) and no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline, as well as in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating NUBEQA as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. Information about these trials can be found at www.clinicaltrials.gov. INDICATIONS NUBEQA ® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of adult patients with: Non-metastatic castration-resistant prostate cancer (nmCRPC) Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel IMPORTANT SAFETY INFORMATION Warnings & Precautions Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease. Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether antiepileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment. Embryo-Fetal Toxicity – Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose. Adverse Reactions In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure. In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury. Drug Interactions Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use. Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed. Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate. NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates. Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA. For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information . About Metastatic Hormone-Sensitive Prostate Cancer Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. 3 In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, including almost 300,000 cases in the U.S., and about 375,000 died from the disease worldwide. 4,5 At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 10% of men will already present with mHSPC when first diagnosed. 6,7,8 Men with metastatic hormone-sensitive prostate cancer (mHSPC) will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival. About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of 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 cancer is 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 . © 2024 Bayer BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer. Find more information at www.pharma.bayer.com Our online press service is just a click away: www.bayer.us/en/newsroom Follow us on Facebook: http://www.facebook.com/pharma.bayer Follow us on X: https://X.com/BayerUS 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. References NUBEQA (darolutamide) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; October 2023. Journal of Clinical Oncology (ascopubs.org). Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial . https://ascopubs.org/doi/10.1200/JCO-24-01798 . September 2024. Hyuna S et al. Ca Cancer J Clin 2021 ; 71:209–249. Prostate Cancer: Statistic. Cancer.Net. https://www.cancer.net/cancer-types/prostate-cancer/statistics . September 2024. American Cancer Society. Cancer Facts & Figures 2024. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2024-cancer-facts-figures.html . September 2024. Piombino C et al. Cancers (Basel). 2023 Oct 11;15(20):4945. Helgstrand JT et al. Cancer. 2018;124(14):2931-2938. Buzzoni C et al. Eur. Urol. 2015;68:885–890. PP-NUB-US-3569-1 9/24

CINCINNATI, August 11, 2021 /PRNewswire/ -- Blue Water Vaccines, Inc., a biopharmaceutical company, announced today that it has appointed Dr. Ronald R. Cobb as its Head of Science and Discovery. Dr. Cobb brings with him not only exemplary research and development expertise, but also expertise in leading early-stage drug development from the lab to market. His understanding of drug development from inception to supply chain and beyond will be crucial for Blue Water Vaccine's onward journey. "We welcome Ron as an expert strategist with deep knowledge of developing early-stage drugs into successful assets," said Joseph Hernandez, Chairman and CEO of Blue Water Vaccines. "We look forward to him leading Blue Water Vaccines' pipeline initiatives, which focus on treating and preventing pathogen infections." "I am excited to join the growing team at Blue Water Vaccines and to be involved in the critical process of bringing life-saving vaccines to patients globally," noted Dr. Cobb. "Pathogenic infections like Influenza, Streptococcus pneumoniae, and the norovirus are profound global issues that demand effective solutions. As the head of Blue Water Vaccines' scientific initiatives, I plan to propel these ongoing programs forward and establish their clinical path." Dr. Ron Cobb is a geneticist and a molecular biologist with over 25 years of pharmaceutical R&D and manufacturing experience. In his previous roles, Dr. Cobb was responsible for various leadership positions. He was most recently, the Chief Scientific Officer at Ology Bioservices. At Tanabe Research Laboratories, he initiated discovery programs seeking small molecule inhibitors of inflammatory diseases while supporting all internal drug discovery screening efforts with protein expression services. At Berlex Biosciences (U.S. Division of Schering AG) Dr. Cobb led the protein expression division and supported the research and clinical development phase projects. He was also a member of the Scientific Advisory Committee and Worldwide Antibody Development Committee for Schering-Plough Corporation. Dr. Cobb, as principal investigator, has overseen more than $200M in drug development contracts over his career, and has co-authored over 60 peer-reviewed manuscripts. Dr. Cobb earned his BA in Biology from Wake Forest University and his Ph.D. in Biochemistry from the Medical College of Georgia. Blue Water Vaccines is developing a universal influenza vaccine that could potentially provide lifelong protection from influenza, including pandemic strains like the 1918 pandemic and 2009 swine flu. Scientists from the University of Oxford identified epitopes of limited variability in the head domain of the haemagglutinin protein. These epitopes are targeted naturally by the immune system and vaccination studies have shown that regions of influenza viruses that circulated in 2006 and 1977 were able to protect against infection with an influenza virus that last circulated in 1934. About Blue Water Vaccines Blue Water Vaccines, Inc. is a biopharmaceutical company focused on developing transformational vaccines to address significant health challenges globally. Headquartered in Cincinnati, OH, the company holds the rights to proprietary technology developed at the University of Oxford, Cincinnati Children's Hospital Medical Center (CCHMC), and St. Jude Children's Hospital. The company has licensed a novel virus-like particle (VLP) vaccine platform from CCHMC to develop vaccines for multiple infectious diseases. Blue Water Vaccines is developing a Streptococcus pneumoniae (pneumococcus) vaccine candidate, designed to specifically prevent middle ear infections, known as Acute Otitis Media (AOM), in children. The live-attenuated vaccine candidate has been shown to effectively prevent colonization of pneumococcus bacteria in the middle ear of chinchillas regardless of serotype. AOM accounts for approximately 20 million physician visits each year in the United States. Globally, AOM caused by pneumococcus accounts for approximately 300 million cases annually. For more information, visit . Contact Information: Erin Henderson Email: ehenderson@bluewatervaccines.com Olipriya Das (media) Email: olipriya.das@russopartnersllc.com

Effects of finerenone on cardio-kidney outcomes to be analyzed in over 19,000 patients1 Baseline characteristics from FINE-HEART analysis highlight complex interplay between cardiovascular, kidney, and metabolic health, with over 92% of patients presenting two or more conditions1 WHIPPANY, N.J.--(BUSINESS WIRE)-- The study design and baseline characteristics of FINE-HEART, a new prespecified, exploratory pooled analysis of three Phase III trials with finerenone1, were presented today as a Late-Breaking Science Session at Heart Failure 2024, a scientific congress of the European Society of Cardiology (ESC) in Lisbon. Finerenone is marketed as Kerendia® and approved for the treatment of adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 70 countries worldwide, including the United States. The data presented here may discuss a use outside of the approved indication. FINE-HEART is designed to investigate the effects of finerenone on cardio-kidney outcomes based on data from over 19,000 patients with varying combinations of heart failure (HF), CKD and T2D across three Phase III finerenone studies – FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF.1 Over 92% of patients included in the analysis had overlapping cardio-kidney-metabolic (CKM) conditions—78% had two (HF and CKD, HF and T2D or CKD and T2D), while 14.7% had all three. 37% of patients had a history of HF, 81% had a history of T2D, and 89% had a history of CKD.1 The analysis showed that patients across the three studies were at high risk for CKD progression with either reduced estimated glomerular filtration rate (eGFR) [30% with eGFR <45, and 26% with eGFR 45 to 60 mL/min/1.73m2] and/or albuminuria [31% with “A2” urine albumin-to-creatinine ratio (UACR) 30-300mg/g, and 49% with “A3” UACR>300mg/g].1 “The multimorbid patient pro the FINE-HEART study is reflective of the patients seen today in real-world clinical settings, highlighting the critical need for data that investigate the impact of finerenone on cardio-kidney outcomes,” said Dr. Robert Perkins MPH, FACP, Vice President, U.S. Medical Affairs/Cardiovascular-Renal at Bayer. “The 19,000+ individuals investigated under the umbrella of FINE-HEART represent one of the most comprehensive studies of individuals living with an increasingly common and complex set of conditions, and I am optimistic that the FINE-HEART program may help provide key insights for clinicians managing ever-more complex patients.” The prespecified, exploratory pooled analysis FINE-HEART includes data from the FIDELITY program, which encompasses the FIDELIO-DKD and FIGARO-DKD trials, having randomized more than 13,000 patients with CKD associated with T2D and albuminuria (UACR≥30mg/g) on maximally tolerated doses of renin-angiotensin system inhibitors across 48 countries.2 It also includes data from the FINEARTS-HF trial, with more than 6,000 patients with HF with left ventricular ejection fraction (LVEF) ≥40%, elevated natriuretic peptides, and evidence of structural heart disease across 37 countries.1 About Kerendia® (finerenone)3 Kerendia is a non-steroidal mineralocorticoid receptor antagonist (MRA) and was approved by the U.S. Food and Drug Administration (FDA) in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Kerendia was studied in the largest CKD clinical trial program, FIDELIO-DKD (Finerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) and FIGARO-DKD (Finerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease), across a broad range of CKD severity in adults with CKD associated with T2D. In the Kerendia Phase III program for CKD associated with T2D with over 13,000 people, FIDELIO-DKD and FIGARO-DKD showed Kerendia reduced the risk of CKD and cardiovascular events.4 Based on data from the clinical trial program, Kerendia has been recommended for adults with CKD associated with T2D in several major treatment guidelines, including those from the American Diabetes Association® (ADA), the American Association of Clinical Endocrinology®, and the Kidney Disease: Improving Global Outcomes® (KDIGO) Foundation, as well as the ADA/KDIGO Consensus Statement.4 IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Concomitant use with strong CYP3A4 inhibitors Patients with adrenal insufficiency WARNINGS AND PRECAUTIONS: Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5.0 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium. MOST COMMON ADVERSE REACTIONS: From the pooled data of 2 placebo-controlled studies, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% versus 6.9%), hypotension (4.6% versus 3.9%), and hyponatremia (1.3% versus 0.7%). DRUG INTERACTIONS: Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice. Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor and adjust KERENDIA dosage as appropriate. Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers. USE IN SPECIFIC POPULATIONS: Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment. Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B). Please click here for full Prescribing Information for KERENDIA. About Chronic Kidney Disease in Type 2 Diabetes Patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) are three times more likely to die from a CV-related cause than those with T2D alone.5 CKD is a serious and progressive condition that is generally underrecognized.6 CKD is a frequent complication arising from T2D and is also an independent risk factor of CV disease.7,8,9 Approximately 40% of all patients with T2D develop CKD. Despite guideline-directed therapies, patients with CKD associated with T2D remain at high risk of CKD progression and CV events.6,7,9,10 T2D is the leading cause of end-stage kidney disease, which requires dialysis or a kidney transplant to stay alive.10,11,12 About Heart Failure Heart failure (HF) is a highly prevalent chronic condition, affecting approximately 6.5 million adults in the U.S.13 HF is characterized by the progressive decline in the heart’s ability to pump enough blood to meet the body’s needs for blood and oxygen.13 Symptoms can include shortness of breath, fatigue, chest discomfort and swelling in the lower body. Risk factors are hypertension, diabetes mellitus, smoking, a past myocardial infarction and coronary artery disease.13,14 Patients with diabetes have more than two times the risk of developing HF than their healthier peers.15 Further, cardiovascular outcomes, hospitalization and prognosis are worse for patients with diabetes mellitus than those without. While 10% to 15% of the general population has diabetes, a study suggests that 44% of patients hospitalized for HF have diabetes.12 About Bayer’s Commitment in Cardiovascular and Kidney Diseases A leader in the cardiovascular (CV) space, Bayer upholds a long-standing commitment to delivering science for a better life by advancing research and treatment options. Bayer’s cardiorenal franchise, which began with the discovery and development of a number of vital therapies, now includes several products and compounds in various stages of preclinical and clinical development with the potential to impact the way that CV and kidney diseases are treated. Bayer is investigating potential treatment approaches for areas of high unmet medical need. Currently, Bayer is investigating nine CVR-related projects in different stages of development, including heart failure (HF) and non-diabetic chronic kidney disease (CKD).4 Bayer is actively identifying resources and programs aimed at better understanding the real-world management of CKD, expanding screening and early care management for CKD, aligning with and supporting groups and institutions that share the common goals of improving health outcomes, promoting health literacy and education, and promoting research and initiatives that represent the diversity required to address the needs of all patients. 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 approximately 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 . Find more information at Follow us on Facebook: Follow us on X: @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 . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. _________________________ 1 M. Vaduganathan et al. Design and baseline characteristics of FINE-HEART: an integrated pooled analysis of finerenone in >19,000 participants across 3 phase III trials of HF & CKD. Heart Failure 2024, a scientific congress of the European Society of Cardiology.; May 11-14.; Lisbon, Portugal 2 Di Lullo L, Lavalle C, Scatena A, Mariani MV, Ronco C, Bellasi A. Finerenone: Questions and Answers-The Four Fundamental Arguments on the New-Born Promising Non-Steroidal Mineralocorticoid Receptor Antagonist. J Clin Med. 2023 Jun 12;12(12):3992. doi: 10.3390/jcm12123992. PMID: 37373685; PMCID: PMC10299719. 3 KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; September 2022. 4 Data on File. 5 Afkarian M, Sachs MC, Kestenbaum B, et al. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol. 2013;24(2):302-308. 6 Breyer MD, Susztak K. Developing treatments for chronic kidney disease in the 21st century. Semin Nephrol. 2016;36(6):436-447. 7 Anders HJ, Huber TB, Isermann B, et al. CKD in diabetes: diabetic kidney disease versus nondiabetic kidney disease. Nat Rev Nephrol. 2018;14:361-377. 8 Thomas MC, Brownlee M, Susztak K, et al. Diabetic kidney disease. Nat Rev Dis Primers. 2015;1:1-20. 9 Bailey RA, Wang Y, Zhu V, et al. Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging. BMC Res Notes. 2014;7(1):415. doi:10.1186/1756-0500-7-415. 10 National Diabetes Statistics Report 2020: Estimates of Diabetes and Its Burden in the United States. Centers for Disease Control and Prevention. Accessed July 9, 2021. . 11 Stages of CKD. American Kidney Fund. Accessed May 11, 2021. . 12 United States Renal Data System. USRDS Annual Data Report. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2020. Accessed November 2021. . 13 Fine N. Heart failure (HF). MSD Manual Professional Version. 2022 Sept. 14 Dunlay S et al. Risk factors for heart failure: A population-based case-control study. Am J Med. 2009 Nov; 122(11): 1023–1028. 15 Kenny HC, Abel ED. Heart Failure in Type 2 Diabetes Mellitus. Circ Res. 2019 Jan 4;124(1):121-141. doi: 10.1161/CIRCRESAHA.118.311371. PMID: 30605420; PMCID: PMC6447311. COR-KER-US-0076-1 5/24 View source version on businesswire.com: Contacts Media: Elaine Colón Bayer Media Relations Elaine.colon@bayer.com +1-732-236-1587 Source: Bayer View this news release online at: