EQS-Adhoc: Bayer Aktiengesellschaft: OCEANIC-AF study stopped early due to lack of efficacy

Leverkusen/Berlin, November 19, 2023 – OCEANIC-AF, a phase III study investigating asundexian compared to apixaban (a direct oral anticoagulant) in patients with atrial fibrillation at risk for stroke is being stopped early. This decision is based on the recommendation of the study’s Independent Data Monitoring Committee (IDMC) as part of ongoing surveillance which showed an inferior efficacy of asundexian versus the control arm. Bayer will further analyze the data to understand the outcome and publish the data.

Available safety data are consistent with previously reported safety profiles of asundexian. The IDMC recommends continuing the OCEANIC-STROKE phase III study as planned. Appropriate measures will be taken to close the OCEANIC-AF study and patients will be contacted by their treating physicians/investigators to discuss next steps.

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

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.

Contact:
Mr. Peter Dahlhoff, Bayer AG, Investor Relations, Tel.: +49 214 60001494 , e-mail: peter.dahlhoff@bayer.com