Pentixapharm Reports Second Quarter and First Half 2026 Results and Advances Phase 3 Panda Program
Idag, 08:00
Pentixapharm Holding AG / Key word(s): Half Year Report
Pentixapharm Reports Second Quarter and First Half 2026 Results and Advances Phase 3 Panda Program Regulatory milestones advance PANDA toward Phase 3 initiation while oncology programs and completed financing support the broader development strategy Berlin, Germany, August 6, 2026 - Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), a clinical-stage biotech company developing novel radiopharmaceuticals, today reported financial results for the second quarter and first half ended June 30, 2026, and provided a business update highlighting progress across its pivotal Phase 3 cardiovascular program, oncology pipeline, financing strategy and organizational development. “During the first half of 2026, we achieved several important milestones as we advanced our lead program toward pivotal Phase 3 execution while continuing to build the broader value of our oncology portfolio,” said Dirk Pleimes, Chief Executive Officer of Pentixapharm. “The FDA clearance of the PANDA IND and the subsequent Fast Track designation for [⁶⁸Ga]Ga-PentixaFor provide a strong regulatory foundation for our principal near-term value driver. At the same time, the activation of the two U.S. INDs supporting PENTHERA, the continued PENTILULA clinical program and new preclinical findings for GT-008 demonstrate progress across our oncology pipeline.” “Following the reporting period, we successfully completed our capital increase, strengthening our financial position as we prepare for PANDA Phase 3 execution and expand our activities in the United States. We have also aligned our leadership responsibilities with the Company’s next phase of development, with Erik Merten assuming responsibility for Quality Management, Human Resources and Information Technology alongside his existing role as Chief Technology Officer.” Second Quarter and First Half 2026 Financial Highlights
The year-on-year reduction in operating expenses reflected lower research and development spending, personnel expenses and other operating expenses, as well as the effect of the cost optimization and portfolio prioritization measures implemented as part of the Company’s focus on its lead clinical programs. In February 2026, the Company drew €3.0 million and in May 2026 an additional €1.0 million under its existing convertible bond facility. As of June 30, 2026, Pentixapharm retained access to additional funding of up to €14.5 million under this facility. Following the reporting period, Pentixapharm completed a capital increase comprising a rights offering and subsequent private placement. All 11,020,212 new shares were placed at €1.85 per share, generating gross proceeds of approximately €20.4 million and expected net proceeds of approximately €19.65 million after estimated transaction costs. These proceeds are not included in cash and cash equivalents as of June 30, 2026. Based on its current financial planning and following completion of the capital increase, the Company expects its available financial resources to fund operations into 2028. The financial reporting enforcement review by the German Federal Financial Supervisory Authority (BaFin) of the Company’s consolidated financial statements as of December 31, 2024 remains ongoing. As previously disclosed, the matters under review primarily concern balance sheet items and financial statement disclosures; any correction would be non-cash and, based on the current Company’s assessment, would not materially affect its operating activities, liquidity or business prospects. 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 partnership or out-licensing agreements are not included in the current guidance. Business Highlights FDA Clearance and Fast Track Designation Advance Phase 3 PANDA Program In May 2026, Pentixapharm submitted an Investigational New Drug application to the U.S. Food and Drug Administration for the pivotal Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor. In June 2026, the FDA completed its 30-day review and confirmed that the study may proceed. PANDA is a U.S.-focused, multicenter registrational study currently expected to enroll approximately 325 adult patients with confirmed primary aldosteronism. Following recent refinement of the study’s statistical assumptions and operational planning, the expected enrollment has been updated from approximately 270 to approximately 325 patients. The Company does not currently expect the updated enrollment target to have a material impact on the anticipated study timeline or the previously communicated cash runway. The study is designed to evaluate [⁶⁸Ga]Ga-PentixaFor PET/CT as a non-invasive imaging approach for disease subtyping and to support treatment decisions between surgical intervention and long-term medical management. Preparations for site activation are under way, with first-patient enrollment expected in the second half of 2026. In July 2026, following the end of the reporting period, the FDA granted Fast Track designation to [⁶⁸Ga]Ga-PentixaFor for the diagnostic subtyping of adult patients with confirmed primary aldosteronism. The designation provides opportunities for more frequent interaction with the FDA during development and may support a more efficient regulatory review process if the relevant criteria are met. The Phase 3 program is supported by three independent investigator-initiated Phase 2 programs and their respective clinical datasets. Results from one of these studies were published in a peer-reviewed journal in February 2026 and demonstrated high specificity and moderate sensitivity for identifying unilateral aldosterone-producing adenomas compared with adrenal vein sampling and surgical outcomes. The imaging procedure was well tolerated and was strongly preferred by study participants over adrenal vein sampling. Oncology Programs Advance Across Clinical and Preclinical Development In February 2026, the FDA completed its review of two IND applications supporting Pentixapharm’s CXCR4-targeted theranostic program in hemato-oncology and confirmed that the proposed Phase I/II PENTHERA study may proceed. The study is designed to evaluate the combined use of PentixaFor imaging and [⁹⁰Y]Y-PentixaTher as targeted bone marrow conditioning before stem cell transplantation in patients with acute myeloid leukemia and multiple myeloma. Pentixapharm will determine the timing of study initiation in line with its portfolio priorities, available resources and potential strategic partnerships. In parallel, the investigator-initiated PENTILULA Phase I/II dose-escalation study continues to evaluate [¹⁷⁷Lu]Lu-PentixaTher in patients with relapsed or refractory CXCR4-positive acute leukemia. The study is designed to assess safety and tolerability and to determine a recommended dose for further clinical development. Pentixapharm also continued to advance its glycan-dependent CD24 antibody platform. Preclinical findings presented at the 2026 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging compared different formats of GT-008 for the selective delivery of radioisotopes to solid tumors. The evaluated variants retained glycosylation-dependent, high-affinity CD24 binding and demonstrated tumor-selective binding and internalization, providing further guidance for the selection of a suitable format for continued non-clinical and potential first-in-human development. Capital Increase Strengthens Financial Position for Phase 3 Execution In July 2026, Pentixapharm completed its capital increase through a rights offering and subsequent private placement. The offering was substantially oversubscribed and all new shares were placed with existing shareholders and new investors, generating gross proceeds of approximately €20.4 million. Pentixapharm intends to use the net proceeds primarily to finance key steps of the PANDA Phase 3 study, support the Company’s further development and expansion in the United States, strengthen manufacturing and supply infrastructure and continue development of its CXCR4-based theranostic platform, including PentixaTher in hematologic oncology indications. The financing also provides a stronger starting point for the Company’s evaluation of partnership and out-licensing opportunities, particularly in the United States. Executive Leadership Aligned with Next Phase of Development Henner Kollenberg stepped down from the Executive Boards of Pentixapharm Holding AG and Pentixapharm AG with effect from June 30, 2026, and left the Company. Pentixapharm thanks Mr. Kollenberg for his contribution, including his role in establishing the Company as an independently listed organization. Following his departure, responsibilities within the Executive Board were realigned. Erik Merten assumed responsibility for Quality Management, Human Resources and Information Technology alongside his existing responsibilities as Chief Technology Officer. The Executive Board of Pentixapharm Holding AG now consists of Dirk Pleimes, Chief Executive Officer and Chief Medical Officer, and Erik Merten, Chief Technology Officer and now also acting as Chief Operating Officer, while assuming the responsibility of the above mentioned departments. Operational Progress and Strategic Outlook Pentixapharm continues to advance the clinical, manufacturing and supply activities required to support initiation of the PANDA Phase 3 study. The Company is also expanding its engagement in the United States and evaluating potential strategic partnerships and out-licensing opportunities to support Phase 3 execution and further pipeline development. For the remainder of 2026, the Company’s operational focus will remain on PANDA site and supply readiness, first-patient enrollment, regulatory engagement under the Fast Track designation, disciplined capital allocation and continued development of the Company’s clinical-stage CXCR4 theranostic programs and differentiated CD24 antibody platform. Availability of Financial Statements The full interim financial statements for the second quarter and first half of 2026 are 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, [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 Investor Relations Robert-Rössle-Straße 10 13125 Berlin Germany E-Mail: ir@pentixapharm.com Website: www.pentixapharm.com Additional features:File: 20260805 Pentixapharm_H1_Q2_PR_ENG_FINAL 06.08.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group.
| ||
PRESS RELEASE |
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 |
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: | 2378250 |
End of News | EQS News Service |
2378250 06.08.2026 CET/CEST
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Pentixapharm Reports Second Quarter and First Half 2026 Results and Advances Phase 3 Panda Program
Idag, 08:00
Pentixapharm Holding AG / Key word(s): Half Year Report
Pentixapharm Reports Second Quarter and First Half 2026 Results and Advances Phase 3 Panda Program Regulatory milestones advance PANDA toward Phase 3 initiation while oncology programs and completed financing support the broader development strategy Berlin, Germany, August 6, 2026 - Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), a clinical-stage biotech company developing novel radiopharmaceuticals, today reported financial results for the second quarter and first half ended June 30, 2026, and provided a business update highlighting progress across its pivotal Phase 3 cardiovascular program, oncology pipeline, financing strategy and organizational development. “During the first half of 2026, we achieved several important milestones as we advanced our lead program toward pivotal Phase 3 execution while continuing to build the broader value of our oncology portfolio,” said Dirk Pleimes, Chief Executive Officer of Pentixapharm. “The FDA clearance of the PANDA IND and the subsequent Fast Track designation for [⁶⁸Ga]Ga-PentixaFor provide a strong regulatory foundation for our principal near-term value driver. At the same time, the activation of the two U.S. INDs supporting PENTHERA, the continued PENTILULA clinical program and new preclinical findings for GT-008 demonstrate progress across our oncology pipeline.” “Following the reporting period, we successfully completed our capital increase, strengthening our financial position as we prepare for PANDA Phase 3 execution and expand our activities in the United States. We have also aligned our leadership responsibilities with the Company’s next phase of development, with Erik Merten assuming responsibility for Quality Management, Human Resources and Information Technology alongside his existing role as Chief Technology Officer.” Second Quarter and First Half 2026 Financial Highlights
The year-on-year reduction in operating expenses reflected lower research and development spending, personnel expenses and other operating expenses, as well as the effect of the cost optimization and portfolio prioritization measures implemented as part of the Company’s focus on its lead clinical programs. In February 2026, the Company drew €3.0 million and in May 2026 an additional €1.0 million under its existing convertible bond facility. As of June 30, 2026, Pentixapharm retained access to additional funding of up to €14.5 million under this facility. Following the reporting period, Pentixapharm completed a capital increase comprising a rights offering and subsequent private placement. All 11,020,212 new shares were placed at €1.85 per share, generating gross proceeds of approximately €20.4 million and expected net proceeds of approximately €19.65 million after estimated transaction costs. These proceeds are not included in cash and cash equivalents as of June 30, 2026. Based on its current financial planning and following completion of the capital increase, the Company expects its available financial resources to fund operations into 2028. The financial reporting enforcement review by the German Federal Financial Supervisory Authority (BaFin) of the Company’s consolidated financial statements as of December 31, 2024 remains ongoing. As previously disclosed, the matters under review primarily concern balance sheet items and financial statement disclosures; any correction would be non-cash and, based on the current Company’s assessment, would not materially affect its operating activities, liquidity or business prospects. 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 partnership or out-licensing agreements are not included in the current guidance. Business Highlights FDA Clearance and Fast Track Designation Advance Phase 3 PANDA Program In May 2026, Pentixapharm submitted an Investigational New Drug application to the U.S. Food and Drug Administration for the pivotal Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor. In June 2026, the FDA completed its 30-day review and confirmed that the study may proceed. PANDA is a U.S.-focused, multicenter registrational study currently expected to enroll approximately 325 adult patients with confirmed primary aldosteronism. Following recent refinement of the study’s statistical assumptions and operational planning, the expected enrollment has been updated from approximately 270 to approximately 325 patients. The Company does not currently expect the updated enrollment target to have a material impact on the anticipated study timeline or the previously communicated cash runway. The study is designed to evaluate [⁶⁸Ga]Ga-PentixaFor PET/CT as a non-invasive imaging approach for disease subtyping and to support treatment decisions between surgical intervention and long-term medical management. Preparations for site activation are under way, with first-patient enrollment expected in the second half of 2026. In July 2026, following the end of the reporting period, the FDA granted Fast Track designation to [⁶⁸Ga]Ga-PentixaFor for the diagnostic subtyping of adult patients with confirmed primary aldosteronism. The designation provides opportunities for more frequent interaction with the FDA during development and may support a more efficient regulatory review process if the relevant criteria are met. The Phase 3 program is supported by three independent investigator-initiated Phase 2 programs and their respective clinical datasets. Results from one of these studies were published in a peer-reviewed journal in February 2026 and demonstrated high specificity and moderate sensitivity for identifying unilateral aldosterone-producing adenomas compared with adrenal vein sampling and surgical outcomes. The imaging procedure was well tolerated and was strongly preferred by study participants over adrenal vein sampling. Oncology Programs Advance Across Clinical and Preclinical Development In February 2026, the FDA completed its review of two IND applications supporting Pentixapharm’s CXCR4-targeted theranostic program in hemato-oncology and confirmed that the proposed Phase I/II PENTHERA study may proceed. The study is designed to evaluate the combined use of PentixaFor imaging and [⁹⁰Y]Y-PentixaTher as targeted bone marrow conditioning before stem cell transplantation in patients with acute myeloid leukemia and multiple myeloma. Pentixapharm will determine the timing of study initiation in line with its portfolio priorities, available resources and potential strategic partnerships. In parallel, the investigator-initiated PENTILULA Phase I/II dose-escalation study continues to evaluate [¹⁷⁷Lu]Lu-PentixaTher in patients with relapsed or refractory CXCR4-positive acute leukemia. The study is designed to assess safety and tolerability and to determine a recommended dose for further clinical development. Pentixapharm also continued to advance its glycan-dependent CD24 antibody platform. Preclinical findings presented at the 2026 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging compared different formats of GT-008 for the selective delivery of radioisotopes to solid tumors. The evaluated variants retained glycosylation-dependent, high-affinity CD24 binding and demonstrated tumor-selective binding and internalization, providing further guidance for the selection of a suitable format for continued non-clinical and potential first-in-human development. Capital Increase Strengthens Financial Position for Phase 3 Execution In July 2026, Pentixapharm completed its capital increase through a rights offering and subsequent private placement. The offering was substantially oversubscribed and all new shares were placed with existing shareholders and new investors, generating gross proceeds of approximately €20.4 million. Pentixapharm intends to use the net proceeds primarily to finance key steps of the PANDA Phase 3 study, support the Company’s further development and expansion in the United States, strengthen manufacturing and supply infrastructure and continue development of its CXCR4-based theranostic platform, including PentixaTher in hematologic oncology indications. The financing also provides a stronger starting point for the Company’s evaluation of partnership and out-licensing opportunities, particularly in the United States. Executive Leadership Aligned with Next Phase of Development Henner Kollenberg stepped down from the Executive Boards of Pentixapharm Holding AG and Pentixapharm AG with effect from June 30, 2026, and left the Company. Pentixapharm thanks Mr. Kollenberg for his contribution, including his role in establishing the Company as an independently listed organization. Following his departure, responsibilities within the Executive Board were realigned. Erik Merten assumed responsibility for Quality Management, Human Resources and Information Technology alongside his existing responsibilities as Chief Technology Officer. The Executive Board of Pentixapharm Holding AG now consists of Dirk Pleimes, Chief Executive Officer and Chief Medical Officer, and Erik Merten, Chief Technology Officer and now also acting as Chief Operating Officer, while assuming the responsibility of the above mentioned departments. Operational Progress and Strategic Outlook Pentixapharm continues to advance the clinical, manufacturing and supply activities required to support initiation of the PANDA Phase 3 study. The Company is also expanding its engagement in the United States and evaluating potential strategic partnerships and out-licensing opportunities to support Phase 3 execution and further pipeline development. For the remainder of 2026, the Company’s operational focus will remain on PANDA site and supply readiness, first-patient enrollment, regulatory engagement under the Fast Track designation, disciplined capital allocation and continued development of the Company’s clinical-stage CXCR4 theranostic programs and differentiated CD24 antibody platform. Availability of Financial Statements The full interim financial statements for the second quarter and first half of 2026 are 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, [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 Investor Relations Robert-Rössle-Straße 10 13125 Berlin Germany E-Mail: ir@pentixapharm.com Website: www.pentixapharm.com Additional features:File: 20260805 Pentixapharm_H1_Q2_PR_ENG_FINAL 06.08.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group.
| ||
PRESS RELEASE |
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 |
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: | 2378250 |
End of News | EQS News Service |
2378250 06.08.2026 CET/CEST
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