Pentixapharm Reports Third Quarter and Nine Months 2026 Results, Confirms Revised 2026 Outlook
Published on 11/12/2026 at 08:00 | dgap, AD HOC NEWS| Pentixapharm Holding AG / Key word(s): Quarterly / Interim Statement 12.11.2026 / 08:00 CET/CEST The issuer is solely responsible for the content of this announcement. Berlin, Germany, November 12, 2026 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), a clinical-stage biotechnology company developing radiopharmaceutical diagnostics and therapeutics, today reported financial results for the third quarter and nine months ended September 30, 2026, and provided an update on its development portfolio and strategic priorities. Following the €20.4 million gross capital raise completed during the quarter, the Company continues to expect its available financial resources to fund operations into 2028. Pentixapharm confirmed the revised guidance announced on October 19, 2026, for a full-year net loss of approximately €13 million. Previously, a net loss of approximately €21.6 million had been expected. “The financing completed in the third quarter allows us to plan the next stage of development from a stronger financial position,” said Dr. Dirk Pleimes, Chief Executive Officer of Pentixapharm. “Our task is to direct those resources toward the clinical evidence needed to establish the value of our programs. PANDA is our principal near-term priority, while our oncology portfolio offers further opportunities to apply CXCR4-targeted imaging and therapy. As we prepare for 2027, we are balancing investment in these programs with the partnerships needed to support their development and future commercialization.” Third Quarter and Nine Months 2026 Financial Highlights Cash position: €21.9 million in cash and cash equivalents as of September 30, 2026 (December 31, 2025: €4.6 million). Capital increase: rights offering and significantly oversubscribed private placement completed in July 2026; all 11,020,212 new shares placed at €1.85 per share for gross proceeds of approximately €20.4 million. Convertible bond: €5.0 million drawn; further €13.5 million can be drawn. Cash runway: available financial resources expected to fund operations into 2028. Net loss: €7.7 million for the first nine months (restated prior-year period: €10.4 million) and €2.5 million for the third quarter (Q3 2025: €3.5 million). Operating cash flow: negative €7.3 million for the first nine months (restated prior-year period: negative €15.6 million). Revenue, EBITDA and earnings per share are reported in the interim report. Financial Reporting Review In October 2026, BaFin concluded its review of Pentixapharm’s 2024 consolidated financial statements with findings of errors. BaFin found that intangible assets as of December 31, 2024 were overstated by €34.7 million and the capital reserve by €21.6 million. The intangible asset findings comprise €21.6 million from purchase price allocation carrying amounts at the former shareholder level and €13.1 million of PentixaFor development expenditure incurred in 2021–2024 that did not meet the capitalization criteria in BaFin’s view. The Management Board decided not to appeal and assessed the findings as having no material effect on operations, liquidity or business prospects. The accounting adjustments arising from BaFin’s findings have been implemented internally. Prior periods are restated under IAS 8, with consequential effects reflected in the 2026 accounts, including the elimination of scheduled amortization of the affected intangible assets. The correction is non-cash. The interim report is unaudited. Revised Full Year 2026 Financial Guidance Confirmed Pentixapharm confirms the revised full-year guidance announced on October 19, 2026, after the end of the reporting period. The Company expects a net loss of approximately €13 million for 2026, a decrease of approximately €8.6 million from the previous forecast of €21.6 million. The revision reflects cost deferrals and reductions as well as changes in amortization. Approximately €3 million relates to PANDA study expenses, part of which shift into 2027 following firmed-up service-provider agreements and the adjusted study timeline. Approximately €2 million relates to other effects, including lower personnel costs and data-acquisition expenditure deferred beyond year-end 2026. A further non-cash effect of approximately €3.7 million for full-year 2026 primarily reflects the elimination of scheduled amortization of intangible assets following BaFin’s October findings. The reduction in cash expenses lowers expected cash outflows in 2026. The Company’s assessment that available financial resources will fund operations into 2028 remains unchanged. The revised outlook continues to exclude potential revenues from partnership and out-licensing agreements. Business Highlights PANDA Remains the Principal Clinical Development Priority Following the U.S. study preparation update issued on November 4, Pentixapharm’s focus is on bringing participating PANDA centers into operation ahead of first-patient enrollment, which remains expected in Q1 2027. The Company currently expects no material impact on the subsequent study timeline. PANDA is the principal near-term focus of clinical investment; the revised phasing of expenditure is reflected in the full-year financial outlook. “With Fast Track designation, a final protocol on which the FDA raised no concerns and approval by the central institutional review board in October, the regulatory groundwork for PANDA in the United States is in place,” said Erik Merten, Chief Technology Officer and Chief Operating Officer of Pentixapharm. “After qualification visits, we have selected more than ten centers for final contract negotiations. Our focus now is to activate these sites and enroll the first patient in the first quarter of 2027.” The registrational study will evaluate [??Ga]Ga-PentixaFor PET/CT in approximately 325 adults with confirmed primary aldosteronism. It is designed to establish whether the imaging approach can support treatment selection by identifying patients with unilateral disease who may benefit from surgery. The study addresses subtyping after primary aldosteronism has been confirmed, to help guide the choice between surgical and medical treatment. International Evidence Supports the PANDA Rationale After the reporting period, Pentixapharm highlighted evidence presented at EANM 2026 in Vienna supporting the use of PentixaFor PET in primary aldosteronism. Findings from the French PENTALON study added to investigator-led European and Australian research, with further datasets from China generated independently of Pentixapharm. The evidence supports evaluation of the approach in PANDA; it does not replace the registrational study required for the Company’s product. Oncology Portfolio and Partnership Strategy The planned Phase I/II PENTHERA program combines PentixaFor imaging with [??Y]Y-PentixaTher for targeted bone marrow conditioning before stem cell transplantation in acute myeloid leukemia and multiple myeloma. The FDA cleared the two supporting INDs in February 2026. Initiation remains subject to portfolio priorities, resources and potential strategic partnerships. In October 2026, after the reporting period, the Management Board decided to terminate the Phase I/II PTT101 study in central nervous system lymphoma to focus resources on acute myeloid leukemia and multiple myeloma. The decision was not based on safety or efficacy concerns. Experience with [??Y]Y-PentixaTher from PTT101 feeds directly into the PENTHERA program. The investigator-initiated PENTILULA study evaluates [¹??Lu]Lu-PentixaTher in relapsed or refractory acute myeloid or acute lymphoblastic leukemia. Recruitment and treatment have been completed, including treatment at 12.5 GBq, and one-year follow-up is underway. CHU Nantes expects to publish interim results still in 2026. Recruitment is also complete in PENTIMYELO, which evaluates [??Ga]Ga-PentixaFor imaging at diagnosis and for treatment assessment in multiple myeloma, including comparison with standard [¹?F]FDG PET. Patients remain in follow-up for up to five years. Both investigator-initiated studies are sponsored by CHU Nantes. The Company’s preclinical portfolio also includes the glycan-dependent CD24 antibody platform, including GT-008. Strategic partnerships and out-licensing remain important to the development of both diagnostic and therapeutic programs. In the United States, Pentixapharm is seeking partners for future commercialization while focusing its own activities on development and the work required to support a potential marketing application. Operational Progress and Strategic Outlook Looking toward 2027, Pentixapharm’s priorities are execution of its lead clinical program, continued assessment of the development opportunities across its oncology portfolio and advancement of its partnering strategy. Investment decisions will reflect clinical priorities, available resources and opportunities to share development and commercialization responsibilities with partners. Management will discuss the nine-month financial performance, capital allocation and development priorities in today’s results webcast, including the remaining steps toward PANDA enrollment. Investor Webcast Pentixapharm will host a webcast today, November 12, 2026, at 15:00 CET / 14:00 GMT / 09:00 EST. Management will discuss the financial results and business developments, followed by a question-and-answer session for shareholders, investors, analysts and media. Webcast registration: https://www.nuways-ag.com/events/pentixapharm-earnings-call-2026-11-12 The presentation will be available subsequently on the Company’s website under Investors.  Availability of Financial Statements The interim report for the third quarter and first nine months of 2026 is available on the Company’s Investor Relations website at www.pentixapharm.com/investors/reports . 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, [??Ga]Ga-PentixaFor, is being advanced into the registrational Phase 3 PANDA study for non-invasive subtyping of primary aldosteronism. The planned PENTHERA Phase I/II program is intended to advance the CXCR4-directed theranostic platform 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 Investor Relations Robert-Rössle-Straße 10 13125 Berlin, Germany E-mail: ir@pentixapharm.com Website: www.pentixapharm.com 12.11.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group. The issuer is solely responsible for the content of this announcement. The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. 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| Language: | English |
| Company: | Pentixapharm Holding AG |
| Robert-Rössle-Straße 10 | |
| 13125 Berlin | |
| Germany | |
| E-mail: | info@pentixapharm.com |
| Internet: | https://www.pentixapharm.com/ |
| ISIN: | DE000A40AEG0, DE000A383RV0 |
| WKN: | A40AEG |
| Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate BSX |
| LEI Code: | 3912005VBOVXNDXEQZ36 |
| EQS News ID: | 2433394 |
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en | DE000A40AEG0 | PENTIXAPHARM HOLDING AG | boerse | 70495728 |
