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Bayer to Present New Cardiac Amyloidosis and Heart Failure Data at the Heart Failure Society of America (HFSA) Annual Scientific Meeting

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Bayer

Summary

Bayer today announced that one late-breaking presentation along with five posters across its cardiovascular programs will be featured at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Phoenix, Arizona, from October 9-12, 2026.

Key Facts

  • A post-hoc analysis from the Phase III REVEAL study, which evaluated the investigational PET radiotracer I 124 evuzamitide for the sensitivity and specificity of cardiac amyloidosis based on visual scan interpretation, will be presented in a late-breaking session.

  • Study designs from three ongoing trials investigating KERENDIA® (finerenone) in patients with heart failure will be presented.

    • KERENDIA is currently approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40%.

  • Results from two retrospective cohort studies describing steroidal mineralocorticoid receptor antagonist (sMRA) use in patients with heart failure, including treatment initiation and persistence, will be presented.

Why This Matters

“The HFSA Annual Scientific Meeting is an ideal platform to raise awareness of the essential role that clinical trials play in advancing cardiovascular disease care,” said Robert Perkins, MD, Vice President CVR, U.S. Medical Affairs. “We look forward to sharing our science with the community and advancing the industry’s mission of potentially improving patient care.”

BAYER PRESENTATIONS AT THE HFSA ANNUAL SCIENTIFIC MEETING 2026:

Cardiac Amyloidosis

Heart Failure

ABOUT INVESTIGATIONAL IODINE 124 EVUZAMITIDE

Iodine 124 evuzamitide (I 124 evuzamitide) is an investigational PET radiotracer being studied in patients with suspected cardiac amyloidosis. I 124 evuzamitide has received FDA Breakthrough Therapy Designation for PET imaging in patients with suspected or known cardiac amyloidosis as well as Orphan Drug designation for both light-chain amyloidosis (AL) and transthyretin amyloidosis (ATTR) in the U.S. and EU. I 124 evuzamitide is an investigational compound and has not been approved by any health authority for use in any country for any indication.

ABOUT KERENDIA

INDICATIONS:

KERENDIA (finerenone) 10 mg, 20 mg, 40 mg tablets is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40%

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

  • Hypersensitivity to any component of this product

  • 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 estimated glomerular filtration rate (eGFR) in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 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.

  • Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed.

    Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m2 is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function.

MOST COMMON ADVERSE REACTIONS:

  • The adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%). Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%) in patients with HF LVEF ≥40%.

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.

  • Sensitive CYP2C8 Substrates at KERENDIA 40 mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40 mg is coadministered with such substrates, since minimal concentration changes may lead to serious adverse reactions.

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 see the full Prescribing Information for KERENDIA.

ABOUT BAYER’S COMMITMENT IN CARDIOVASCULAR, KIDNEY AND CEREBROVASCULAR MEDICINE

Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments for cardiovascular, kidney and cerebrovascular diseases with high unmet medical needs. The company has set a clear focus on developing therapies to treat such diseases (e.g., heart failure, cardiomyopathies, chronic kidney disease and secondary stroke prevention), and it is our ambition to take a leading role in the care of patients with these diseases. Bayer’s portfolio already includes several innovative products and 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, kidney and cerebrovascular 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 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

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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.

PP-EVU-US-0017-2 10/26

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