Pentixapharm Announces Progress of Pivotal Phase 3 PANDA Study; Will Host Third Quarter Webcast on November 12, 2026

• No FDA comments on the study protocol submitted in August 2026, including the primary endpoints and the planned number of approximately 325 patients; central U.S. ethics committee has approved the protocol and consent documents
• First patient enrollment continues to be expected in the first quarter of 2027; no material impact on the further study timeline expected
• Webcast on third quarter and first nine months 2026 results and PANDA study on November 12, 2026, at 3 p.m. CET

BERLIN, Nov. 4, 2026 /PRNewswire/ -- Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), a clinical-stage biotechnology company developing innovative radiopharmaceutical diagnostics and therapeutics, has completed further key preparations towards the start of its pivotal Phase 3 PANDA study. The Company will publish its third quarter and first nine months of 2026 results on Thursday, November 12, 2026.

The PANDA study is designed to enroll approximately 325 patients. More than ten U.S. study sites have already been selected. The study network includes leading academic medical centers across several U.S. regions and a specialized adrenal center. Clinical investigators have also been identified to conduct the study. Agreements with participating study sites are currently being negotiated so that the sites can open for patient enrollment.

The FDA confirmed in June 2026 that the PANDA study could proceed and granted Fast Track designation in July 2026. The FDA raised no concerns regarding the study protocol submitted in August 2026, which specifies the primary endpoints and the planned number of patients; the study will therefore be conducted on the basis of this protocol.

The central U.S. ethics committee (Institutional Review Board) has since approved the study protocol and the documents used to inform prospective participants about the study and obtain their consent.

As announced on October 19, 2026, first patient enrollment is expected in the first quarter of 2027. The Company currently does not expect any material impact on the further timeline of the study.

Pentixapharm welcomes participants to the webcast at 3:00 p.m. CET (2:00 p.m. GMT / 9:00 a.m. EST) on November 12, 2026. The Management Board will discuss the results, progress on PANDA, the remaining steps towards first patient enrollment and the wider development portfolio. Please register here: https://www.nuways-ag.com/events/pentixapharm-earnings-call-2026-11-12

A recording will be available following the event on the Company's website under Investors.

About PANDA

PANDA is designed to evaluate [⁶⁸Ga]Ga-PentixaFor PET/CT for non-invasive subtyping in adults with confirmed primary aldosteronism in a registrational setting. Primary aldosteronism is a common, underdiagnosed hormonal cause of high blood pressure. Patients with one-sided disease can benefit from surgical removal of the affected adrenal gland, but identifying them currently requires adrenal vein sampling, an invasive catheter procedure. Independent studies from Europe, Asia and Australia, most recently presented at EANM 2026, support the approach of PANDA. PentixaFor is an investigational radiopharmaceutical candidate.

About Pentixapharm

Pentixapharm Holding AG (Frankfurt Prime Standard: PTP) is a clinical-stage biotechnology company headquartered in Berlin developing innovative nuclear medicine approaches to help physicians detect, characterize, and treat serious diseases with greater precision. The Company's compounds are designed to deliver medical radioisotopes specifically to defined biological targets - either for high-resolution molecular imaging or for targeted radioligand therapy.

Pentixapharm's pipeline is built on CXCR4 targeting, a receptor with strong scientific validation across multiple disease areas, and encompasses diagnostic and therapeutic programs in endocrine, cardiovascular, and oncological indications. The lead program, [⁶⁸Ga]Ga-PentixaFor, is being advanced into the registrational Phase 3 PANDA study for non-invasive subtyping of primary aldosteronism. The PENTHERA program advances the CXCR4-directed theranostic platform into Phase I/II in oncology. Complementing the CXCR4 platform, Pentixapharm is also developing a next-generation antibody platform targeting CD24, an emerging immune checkpoint in difficult-to-treat cancers.

Forward-looking statements

This press release contains forward-looking statements based on the current beliefs, expectations and assumptions of the management of Pentixapharm Holding AG. These statements relate to future events, prospects or financial performance and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to differ materially, positively or negatively, from those expressed or implied by such forward-looking statements. Such factors include, among others, changes in general economic and business conditions, competitive pressures, the introduction of competing products, limited market acceptance of new products, services or technologies, regulatory developments and changes in business strategy. Pentixapharm Holding AG does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. Forward-looking statements are made only as of the date of this press release. All information provided in this press release is supplied without any warranty or guarantee as to its accuracy, completeness or timeliness. To the extent permitted by law, Pentixapharm Holding AG assumes no liability in connection with this press release.

Pentixapharm Investor and Media Contact:

Robert-Rössle-Straße 10
13125 Berlin
Germany
E-mail: ir@pentixapharm.com
Website: www.pentixapharm.com 

SOURCE Pentixapharm Holding AG