Late-breaking data from Phase III OCEANIC-STROKE study accepted for presentation at World Stroke Congress 2025

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WHIPPANY, N.J.--(BUSINESS WIRE)--Oct 21, 2025--

Bayer will present methods and baseline characteristic data from the global Phase III OCEANIC-STROKE study with the investigational agent asundexian, in a late-breaking presentation at the upcoming 17 th World Stroke Congress, being held in Barcelona, Spain from October 22 – 24.

Bayer presentations on OCEANIC-STROKE include:

• Factor XIa (FXIa) inhibition with asundexian after acute non-cardioembolic stroke or high risk transient ischemic attack (TIA): Methods and baseline data for the OCEANIC-STROKE trial
  • Plenary Session, Room 116+117
  • Thursday, October 23, 2025, 10:53 – 11:03 am (CEST)
    
    
• Factors influencing participation in the OCEANIC-STROKE study (FIT sub-study): Enhancing equity in global stroke trials
  • Free Communication Session, Room 115
  • Thursday, October 23, 2025, 08:55 – 09:06 am (CEST)

Additional poster presentations will feature real-world insights into the risk factors and disease burden of non-cardioembolic ischemic stroke in different countries:

• Inclusion of lived experience of stroke across the stroke health ecosystem: Meaningful engagement with people affected by diverse health conditions in treatment and care innovation
  • E-Poster Highlights Session, Station 02
  • Wednesday, October 22, 2025, 11:45 – 12:45 pm (CEST)
    
    
• Risk factors for ischaemic stroke recurrence in patients with a non-cardioembolic ischaemic stroke in Denmark: Observations from ASTRIS
  • E-Poster Highlights Session, Station 02
  • Wednesday, October 22, 2025, 11:45 – 12:45 pm (CEST)
    
    
• ALTEA observational study: Analysis of a large, nationally representative US database on the burden of disease among patients with ischaemic stroke and transient ischaemic attack
  • E-Poster Highlights Session, Station 02
  • Thursday, October 23, 2025, 12:00 – 13:00 pm (CEST)
    
    
• Mortality and vascular events associated with initial and recurrent non-cardioembolic ischaemic stroke in real-world settings in Japan: Observations from ASTRIS
  • E-Poster Viewing Session, see program
    
    
• Antithrombotic treatment and risk of ischaemic stroke recurrence in patients with non-cardioembolic ischaemic stroke in England: Observations from ASTRIS
  • E-Poster Viewing Session, see program

The OCEANIC-STROKE study is investigating the efficacy and safety of the oral FXIa inhibitor asundexian 50 mg once daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) on standard of care antiplatelet therapy. It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that has enrolled over 12,300 patients. Main study results will be presented at an upcoming scientific congress.

Asundexian is an investigational agent and has not been approved by any health authority for use in any country for any indication.

To view the complete program, please visit the World Stroke Congress website.

About FXIa inhibitors and Asundexian
Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa has a minor role in the formation of a hemostatic plug that seals the leak at the site of vessel injury. However, FXIa is thought to contribute to the formation of pathological thrombus growth and vessel blockage. Asundexian, a direct inhibitor of FXIa, is theorized to prevent thrombus formation that can lead to vessel stenosis or blockage, without a significant increase in major bleeding. Asundexian is currently being evaluated as a potential treatment option in thrombosis prevention. Asundexian is a once-daily, oral investigational agent and has not been approved by any health authority for use in any country, for any indication.

About Bayer’s Commitment in Cardiovascular Diseases
Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) diseases of high unmet medical need. The strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high CV disease burden, and driving the long-term growth. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development.

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 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 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.

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CONTACT: Contact for media inquiries:

Sarra Herzog, phone +1 (862) 460-8764

Email:[email protected] for investor inquiries:

Bayer Investor Relations Team, phone +49 214 30-72704

Email:[email protected]

www.bayer.com/en/investors/ir-team

KEYWORD: NEW JERSEY UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL CARDIOLOGY BIOTECHNOLOGY

SOURCE: Bayer

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PUB: 10/21/2025 02:30 AM/DISC: 10/21/2025 02:29 AM

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