Pentixapharm Reports First Quarter 2026 Results and Highlights Clinical and Regulatory Momentum

Pentixapharm Reports First Quarter 2026 Results and Highlights Clinical and Regulatory Momentum

Berlin, Germany, May 7, 2026 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), a clinical-stage biotech company developing novel radiopharmaceuticals, today reported financial results for the first quarter ended March 31, 2026, and provided a business update highlighting significant progress across its pipeline, regulatory strategy, and organizational development.

“During the first quarter, we made substantial progress advancing our lead programs toward late-stage development while further strengthening the clinical, regulatory, and operational foundation of the company,” said Dirk Pleimes, Chief Executive Officer of Pentixapharm. “Regulatory feedback from the US FDA for our Phase 3 PANDA study, strong peer-reviewed clinical data, and multiple IND-related milestones marked important progress across our pipeline, while disciplined cost management allowed us to continue focusing resources on our lead CXCR4-targeted programs.”

First Quarter 2026 Financial Highlights

• No revenue was generated in the first quarter of 2026 (Q1 2025: €19 thousand).
• Net loss for the period was €3.2 million, compared to €4.0 million in the prior-year period, reflecting improved cost discipline, including lower research and development, personnel and operating expenses, as well as focused portfolio prioritization.
• EBITDA improved to €-2.1 million from €-3.2 million in the prior-year period. Depreciation and amortization expenses amounted to €0.9 million.
• Operating cash flow improved to €-2.5 million, compared to €-5.2 million in Q1 2025.
• Cash and cash equivalents amounted to €5.2 million as of March 31, 2026.
• Total assets amounted to €41.2 million as of March 31, 2026.

The reduction in operating expenses compared to the prior year was driven by lower research and development spending, reduced personnel expenses, and overall cost optimization measures implemented as part of the company’s strategic focus on its lead programs.

In February 2026, the company drew €3.0 million under its existing convertible bond facility. Pentixapharm retains access to additional funding of up to €15.5 million under this facility.

Based on its current financial planning, the company expects its existing cash resources to fund operations to the end of first quarter of 2027.

Full Year 2026 Financial Guidance

Pentixapharm reaffirms its financial outlook for the full year 2026 and continues to expect a net loss of approximately €21.6 million.

The forecast reflects planned research and development investments and operating costs. Potential revenues from out-licensing agreements are not included in the current guidance.

Business Highlights

Regulatory Alignment Supports Phase 3 Cardiovascular Program

In January 2026, Pentixapharm received formal written minutes from the U.S. Food and Drug Administration (FDA) following a Type B pre-IND meeting for its Phase 3 PANDA study evaluating [⁶⁸Ga]Ga-PentixaFor in treatment-resistant hypertension and primary aldosteronism. The feedback confirmed that no major concerns were identified regarding the planned study and provided guidance on key statistical and methodological aspects as well as evidence requirements relevant to a potential approval pathway.

Building on this regulatory alignment, the Company intends to submit an Investigational New Drug (IND) application to enable the initiation of the Phase 3 PANDA study in the United States.

Peer-Reviewed Phase 2 Data Strengthen Clinical Foundation

In February 2026, Pentixapharm announced the publication of Phase 2 clinical data in the Journal of Nuclear Medicine demonstrating the potential of [⁶⁸Ga]Ga-PentixaFor PET/CT as a non-invasive imaging modality for subtyping primary aldosteronism.

The study demonstrated high specificity and moderate sensitivity for identifying unilateral aldosterone-producing adenomas compared to adrenal vein sampling and surgical outcomes. The imaging approach was well tolerated and strongly preferred by patients, supporting its potential as a scalable and patient-friendly diagnostic alternative.

These results further strengthen the clinical foundation for the company’s Phase 3 PANDA development program and support the role of molecular imaging in guiding treatment decisions in hypertension.

Advancement of CXCR4-Based Theranostic Program in Hemato-Oncology

In February 2026, the U.S. FDA completed its review of two IND applications for Pentixapharm’s CXCR4-targeted theranostic program, confirming that the proposed Phase I/II PENTHERA study may proceed.

The study evaluates the combination of PentixaFor imaging and [⁹⁰Y]Y-PentixaTher as a targeted bone marrow conditioning approach prior to stem cell transplantation in patients with acute myeloid leukemia and multiple myeloma. This approach is designed to enable more precise and potentially less toxic conditioning compared to conventional chemotherapy-based regimens.

Strengthening of Executive Leadership to Support Next Phase

In March 2026, Pentixapharm appointed Erik Merten as Chief Technology Officer and member of the Executive Board.

Mr. Merten brings extensive experience in radiopharmaceutical development, manufacturing, and commercialization, including leadership roles in the development and global supply of marketed radiopharmaceuticals. His appointment strengthens the company’s leadership capabilities as it prepares for its Phase 3 execution and potential future commercialization.

Operational Progress and Strategic Outlook

Pentixapharm continues to advance its manufacturing and supply infrastructure to support late-stage clinical development and potential commercialization. The company is also evaluating strategic partnerships and financing options to support its Phase 3 execution and pipeline advancement.

Availability of Financial Statements

The full interim financial statements for the first quarter of 2026 are available on the company’s Investor Relations website at www.pentixapharm.com/investors/reports.

About Pentixapharm

Pentixapharm is a clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops precision diagnostics and therapeutics in oncology and cardiology to transform patient care. Its clinical pipeline is anchored by CXCR4-targeted PET-CT programs, including a Phase 3-ready candidate for the improved diagnosis of hypertensive patients with primary aldosteronism, which is intended to enable targeted treatment of the underlying causes of hypertension. CXCR4-based developments also include pioneering therapeutic programs in hematological cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-checkpoint marker over-expressed in multiple hard-to-treat cancers. Complemented by CXCR4 and CD24 intellectual property protection and a reliable isotope supply chain, Pentixapharm is poised to deliver meaningful patient benefit and sustainable growth in one of the fastest-growing areas of precision medicine.

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

ir@pentixapharm.com