EQS-Adhoc: Pentixapharm Holding AG: Pentixapharm Receives FDA Fast Track Designation for [⁶⁸Ga]Ga-PentixaFor for the Subtyping of Primary Aldosteronism

AD HOC
PUBLIC DISCLOSURE OF INSIDE INFORMATION PURSUANT TO ARTICLE 17 OF REGULATION (EU) NO. 596/2014

Pentixapharm Receives FDA Fast Track Designation for [⁶⁸Ga]Ga-PentixaFor for the Subtyping of Primary Aldosteronism

Berlin, July 9, 2026 – Pentixapharm Holding AG, Berlin (ISIN DE000A40AEG0, WKN A40AEG) (“Company”), was notified by the U.S. Food and Drug Administration (FDA) that Fast Track designation has been granted to its development candidate [⁶⁸Ga]Ga-PentixaFor.

The designation was granted for the diagnostic subtyping of adult patients with confirmed primary aldosteronism. Fast Track designation provides for more frequent interaction with the FDA during development and may support a more efficient regulatory review process if the relevant criteria are met. It does not constitute an approval and makes no statement as to the approvability of [⁶⁸Ga]Ga-PentixaFor.

The designation follows the announcement on 9^th of June 2026 that the Investigational New Drug (IND) application for the registrational U.S. Phase 3 PANDA study was cleared by the FDA upon expiry of the 30-day review period (Study May Proceed).

The Company’s rights issue announced on 1^st of July 2026 remains unaffected. The subscription price, subscription ratio, subscription period and the use of proceeds described therein remain unchanged; the subscription period is expected to end on 21^st of July 2026.

July 09, 2026

Pentixapharm Holding AG, Berlin

The Management Board

Contact: ir@pentixapharm.com

Important Notice: This announcement does not constitute an offer to sell or a solicitation of an offer to purchase or subscribe for any securities. Any public offering will be made solely on the basis of the published subscription offer and the Annex IX document. This announcement is not intended for publication, distribution or release in or into the United States of America, Australia, Canada, Japan or any other jurisdiction where such publication, distribution or release would be unlawful.

The new shares have not been and will not be registered under the U.S. Securities Act of 1933, as amended (“Securities Act”), and may not be offered or sold in the United States of America or to, or for the account or benefit of, U.S. persons absent registration under, or an applicable exemption from the registration requirements of, the Securities Act. There will be no public offering of the shares in the United States of America.

2363024  09-Jul-2026 CET/CEST