Ad hoc announcement pursuant to Art. 17 MAR / Section 15 WpHG

Pentixapharm outlines new clinical development strategy

Clinical pipeline to be refocused on theranostic precision oncology opportunities to enhance value proposition of lead assets

The PTF301 diagnostic trial in Marginal Zone Lymphoma (MZL) will be discontinued.

New CXCR4 trials in hematologic malignancies and Bladder Cancer in preparation

Berlin, Germany, May 27, 2025 – Pentixapharm AG, the operating subsidiary of Pentixapharm Holding AG, a clinical-stage biopharmaceutical company focused on radiopharmaceuticals, today outlined a new clinical development strategy for its CXCR4 therapeutic and diagnostic oncology programs, following a management review led by recently appointed CEO and CMO Dr. Dirk Pleimes and CBO Henner Kollenberg.

The management of Pentixapharm strongly believes the new clinical strategy for the CXCR4 programs will increase the value proposition of the CXCR4 targeting assets. The decision was approved by Pentixapharm’s Supervisory Board at a meeting held earlier today.

Pentixapharm will refocus its clinical development efforts and resource into a theranostic basket program that will evaluate the efficacy of the Company’s CXCR4-targeted therapeutic approach across various hematological malignancies that overexpress the CXCR4 chemokine receptor. An additional clinical Phase I/II in trial in Bladder Cancer is currently in preparation. Pentixapharm will provide further detail on these new trials in due course.

Following implementation of the new clinical development strategy, the Company’s current PTT101 therapeutic trial in the Central Nervous System (CNS) Lymphoma will be integrated into the theranostic basket program. The PTF301 diagnostic trial in Marginal Zone Lymphoma (MZL) will be discontinued due to low patient recruitment.

Outside oncology, Pentixapharm continues its commitment to advance [⁶⁸Ga]Ga-PentixaFor as a first-in-class, non-invasive diagnostic solution for primary aldosteronism (PA) and explores the best route towards realizing the value for the registrational clinical development and commercialization phase. 

“This strategic decision will help us to contribute significantly to the value of our theranostic CXCR4 pipeline. We are deeply grateful to the patients, investigators, and teams who have supported our clinical progress. This work has provided us with an excellent basis for the review and re-design of our clinical pipeline. The basket trial program is designed to systematically identify indications where our CXCR4 theranostic platform can deliver the greatest clinical benefit and value to patients with hematologic malignancies,” said Dr. Dirk Pleimes, CEO of Pentixapharm. “We are looking forward to presenting the new trials in more detail at upcoming scientific and investor conferences.”

“The review of the clinical pipeline will enable us to focus on larger indications with a higher market potential,” added Henner Kollenberg, CBO of Pentixapharm. “While the previous trials delivered supportive data on our compounds and underlined the strengths of our CXCR4 portfolio, the business case for the orphan drug diagnostic and long recruitment times for both programs represented a significant challenge for their future commercialization. We now look forward to progressing with a renewed focus on improving treatment options and outcomes for thousands of patients with aggressive forms of leukemias, myeloma and lymphoma and more broadly in high-value opportunities from the use of radiopharmaceuticals in precision oncology.”

Forward-looking statements

This ad hoc announcement contains forward-looking statements that are based on the current expectations, forecasts and assumptions of Pentixapharm Holding AG. Forward-looking statements are inherently subject to risks and uncertainties because they depend on future events and developments that cannot be fully controlled. Therefore, actual results may differ materially from the expectations expressed herein. Pentixapharm Holding AG assumes no obligation to update forward-looking statements or to adapt them to changes in circumstances, unless required by law.

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with offices in Berlin and Würzburg, Germany. It is committed to developing first-in-class radiopharmaceuticals with strong differentiation and commercialization potential across high-need diagnostic and therapeutic areas. Its pipeline comprises CXCR4-targeted peptides in clinical development and a portfolio of early-stage radionuclide-antibody conjugates, aimed at using precision oncology to treat hematologic malignancies and solid tumors.

For more information, please contact:

Pentixapharm Holding AG
Investor Relations
ir@pentixapharm.com
Tel. +49 30 94892600
www.pentixapharm.com