Pentixapharm Highlights Expanding CXCR4 Radiopharmaceutical Platform with New Clinical Findings at EANM 2025

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• Clinical data from independent investigator-initiated studies using [⁶⁸Ga]Ga-PentixaFor demonstrate potential to improve diagnosis in Primary Aldosteronism

• First-in-human findings with [¹⁷⁷Lu]Lu-PentixaTher in bladder cancer show early therapeutic activity, further validating CXCR4 as a clinically relevant target

Berlin, Germany, October 6, 2025 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech developing novel radiopharmaceuticals, today announced the presentation of extensive clinical data from independent investigator-initiated studies assessing Pentixa­pharm’s CXCR4-targeting diagnostic lead candidate, [68Ga]Ga-PentixaFor, at the ongoing Annual Congress of the European Association of Nuclear Medicine (EANM 2025) in Barcelona, Spain.

At EANM 2025, four oral presentations and seven e-posters feature new data on [68Ga]Ga-PentixaFor PET/CT imaging in Primary Aldosteronism (PA) – a condition frequently under­diagnosed despite being one of the leading causes of secondary hypertension. These presen­tations include comparative clinical trial results, evaluating [68Ga]Ga-PentixaFor against adrenal venous sampling (AVS), the current invasive gold standard for subtyping PA. The data demonstrate the high potential of [68Ga]Ga-PentixaFor to significantly improve subtyping of patients, thereby enabling better therapy decisions, and more precise patient management in PA.

Complementing these results in cardiovascular and endocrine disease, the scientific program at EANM 2025 also showcases the expanding role of Pentixapharm’s CXCR4-targeted platform in oncology. Among the highlights are first-in-human data on Pentixapharm’s therapeutic candidate [¹⁷⁷Lu]Lu-PentixaTher, in patients with bladder cancer. The early findings demonstrate initial signs of therapeutic activity, adding to the growing body of evidence supporting [¹⁷⁷Lu]Lu-PentixaTher as a precision treatment candidate for CXCR4-positive malignancies.

“The strong scientific presence of our CXCR4 program at EANM 2025 reflects both the clinical relevance of our platform and the growing recognition of CXCR4 as a key target across multiple disease areas,” said Dr. Dirk Pleimes, CEO/CMO of Pentixapharm AG. “The findings in Primary Aldosteronism highlight how our lead candidate, [⁶⁸Ga]Ga-PentixaFor, could transform the diagnosis of hypertensive patients while the oncology data further validate CXCR4 as a corner­stone target for our radiopharmaceutical platform. The wealth of CXCR4-directed research presented at EANM highlights the diagnostic value of CXCR4-targeted imaging, reinforcing the strength and versatility of our approach. Together, these findings demonstrate how Pentixapharm is expanding the boundaries of radiopharma­ceuticals across cardiovascular, endocrine, and oncologic diseases.”

About CXCR4

CXCR4 is a well-characterized cell membrane receptor with a pivotal role in the bone marrow microenvironment. It is highly overexpressed in multiple aggressive blood cancers – including acute myeloid leukemia, multiple myeloma, and large B-cell lymphoma – where it drives tumor growth and metastasis. CXCR4 has been clinically validated in multiple of these hematologic cancers, making it a validated high-value target in areas of high unmet medical need.

Beyond oncology, CXCR4 is being explored as a diagnostic imaging target in cardiovascular and endocrine disorders, particularly Primary Aldosteronism (PA), a condition accounting for an estimated 5–10% of all hypertension cases, corresponding to roughly 100–200 million people worldwide. In PA, CXCR4 expression is elevated in benign adrenal tumors, making it a valuable tool for functional diagnosis, PA sub-typing, and lateralization of aldosterone overproduction.

Its dual diagnostic and therapeutic potential illustrates CXCR4’s versatility as a first-in-class target for next-generation radiopharmaceuticals, enabling both precision diagnostics and targeted radioligand therapy.

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharma­ceuticals. Headquartered in Berlin, Germany, the company develops first-in-class ligand- and antibody-based radiopharmaceuticals designed to transform patient care across oncology and beyond. Its late-stage pipeline is anchored by CXCR4-targeted programs, including a Phase 3-ready diagnostic candidate for primary aldosteronism and pioneering therapeutic programs in a number of hematological and solid cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-escape marker over-expressed in multiple hard-to-treat cancers. Complemented by reliable isotope supply from Eckert & Ziegler, and a robust global clinical network, Pentixapharm is uniquely positioned to deliver innovative radiopharmaceuticals that address high unmet need, improve patient outcomes, and create significant growth opportunities in one of the fastest-growing areas of precision medicine.

Pentixapharm Investor and Media Contact

ir@pentixapharm.com

Pentixapharm präsentiert erweiterte CXCR4-Radiopharmazeutika-Plattform mit neuen klinischen Ergebnissen auf EANM 2025 Kongress

• Klinische Daten aus unabhängigen prüferinitiierten Studien mit [⁶⁸Ga]Ga-PentixaFor zeigen Potenzial zur verbesserten Diagnostik des Primären Hyperaldosteronismus (PA)

• Erste klinische Ergebnisse mit [¹⁷⁷Lu]Lu-PentixaTher beim Menschen zeigen erste therapeutische Aktivität bei Blasenkrebs und unterstreichen die klinische Relevanz von CXCR4 als Zielstruktur

Berlin, Deutschland, 6. Oktober, 2025 – Die Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), ein Biotech-Unternehmen in der fortgeschrittenen klinischen Entwicklung von Radio­pharmazeutika, gab heute die Präsentation umfangreicher klinischer Daten aus unabhängigen prüferinitiierten Studien zu ihrem CXCR4-gerichtetem diagnostischem Leitkandidaten [⁶⁸Ga]Ga-PentixaFor auf dem laufenden Jahreskongress der European Association of Nuclear Medicine (EANM 2025) in Barcelona, Spanien, bekannt.

Auf dem EANM-Kongress werden vier Vorträge und sieben E-Poster neue Daten zur [⁶⁸Ga]Ga-PentixaFor-PET/CT-Bildgebung beim Primären Hyperaldosteronismus (PA) vorstellen – einer Erkrankung, die trotz ihrer Bedeutung als eine der häufigsten Ursachen sekundärer Hypertonie oft nicht erkannt wird. Die Präsentationen umfassen vergleichende klinische Studien­ergebnisse, in denen [⁶⁸Ga]Ga-PentixaFor mit der derzeitigen invasiven Referenzmethode zu Diagnose von PA, dem adrenalen Venensampling (AVS), verglichen wurde. Die Ergebnisse zeigen das hohe Potenzial von [⁶⁸Ga]Ga-PentixaFor, die Subtypisierung von PA deutlich zu verbessern und damit Therapieentscheidungen sowie das Patientenmanagement bei PA zu optimieren.

Ergänzend zu diesen Ergebnissen in kardiovaskulären und endokrinen Erkrankungen verdeutlicht das wissenschaftliche Programm der EANM 2025 auch die zunehmende Bedeutung von Pentixa­pharms CXCR4-Plattform in der Onkologie. Zu den Highlights zählen klinische Daten nach Erst­anwendung des Kandidaten [¹⁷⁷Lu]Lu-PentixaTher am Menschen in der Behandlung von Blasen­krebs. Die frühen Ergebnisse zeigen erste Anzeichen therapeutischer Aktivität und er­weitern die wachsende Datengrundlage, die [¹⁷⁷Lu]Lu-PentixaTher als vielversprech­enden Kandi­daten für die Präzisionsbehandlung von CXCR4-positiven Tumorerkrankungen unterstützt.

„Die starke wissenschaftliche Präsenz unseres CXCR4-Programms auf der EANM 2025 unter­streicht die klinische Relevanz unserer Plattform und die zunehmende Anerkennung von CXCR4 als zentrale Zielstruktur in verschiedenen Krankheitsbereichen“, sagte Dr. Dirk Pleimes, CEO/CMO der Pentixapharm AG. „Die Ergebnisse im Primären Hyperaldosteronismus zeigen, wie unser Leitkandidat [⁶⁸Ga]Ga-PentixaFor die Diagnostik von Hypertonie-Patienten grundlegend verbessern könnte. Gleichzeitig bestätigen die Onkologiedaten die Schlüsselrolle von CXCR4 in unserer Radiopharmazeutika-Plattform. Die Vielzahl der auf der EANM präsentierten CXCR4-Forschungs­arbeiten, verdeutlicht den diagnostischen Wert der CXCR4-basierten Bildgebung und bestätigt die Stärke und Vielseitigkeit unseres Ansatzes. Insgesamt zeigen diese Ergebnisse, wie Pentixapharm die Grenzen der Radiopharmazeutika in kardiovaskuläre, endokrine und onkologische Erkrankungen erweitert.“

Über CXCR4

CXCR4 ist ein gut charakterisierter Zellmembranrezeptor mit einer zentralen Rolle in der Mikro­umgebung des Knochenmarks. Er ist in mehreren aggressiven Blutkrebserkrankungen – darunter akute myeloische Leukämie, multiples Myelom und großzelliges B-Zell-Lymphom – stark überexprimiert und fördert dort Tumorwachstum und Metastasierung. CXCR4 ist in ver­schie­denen hämatologischen Krebsarten klinisch validiert und gilt als wichtige Ziel­struktur in Indika­tionen mit hohem medizinischem Bedarf.

Über die Onkologie hinaus wird CXCR4 auch als Zielstruktur für die Bildgebung in der Diagnose von kardiovaskulären und endokrinen Erkrankungen untersucht, insbesondere beim Primären Hyperaldosteronismus (PA), einer Erkrankung, die schätzungsweise 5–10 % aller Bluthochdruckfälle ausmacht und damit weltweit etwa 100–200 Millionen Menschen betrifft. Bei PA zeigt sich eine erhöhte CXCR4-Expression in gutartigen Nebennierentumoren, was CXCR4 zu einem wertvollen Instrument für die funktionelle Diagnostik, die PA-Subtypisierung und die seitliche Bestimmung der Aldosteronüberproduktion macht.

Das diagnostische und therapeutische Potenzial von CXCR4 unterstreicht seine Vielseitigkeit als First-in-Class-Zielstruktur für Radiopharmazeutika der nächsten Generation und ermöglicht sowohl präzise Diagnostik als auch zielgerichtete Radioliganden-Therapie.

Über Pentixapharm

Pentixapharm ist ein Biotech-Unternehmen in der fortgeschrittenen klinischen Entwicklung, das die Grenzen von Radiopharmazeutika erweitert. Mit Hauptsitz in Berlin entwickelt das Unter­nehmen erstklassige ligand- und antikörperbasierte Radiopharmazeutika, die die Patientenver­sorgung in der Onkologie und darüber hinaus transformieren sollen. Seine fortgeschrittene Pipe­line wird von CXCR4-basierten Programmen getragen, darunter ein Phase-3-bereites Dia­gnostikum für primären Hyperaldosteronismus sowie wegweisende therapeutische Programme in verschiedenen hämatologischen und soliden Tumoren. Darüber hinaus entwickelt Pentixa­pharm eine neuartige Antikörperplattform, die auf CD24 abzielt – einen aufkommenden Immun-Escape-Marker, der in zahlreichen schwer behandelbaren Tumoren überexprimiert ist. Ergänzt durch die zuverlässige Isotopenversorgung durch Eckert & Ziegler sowie ein starkes globales klinisches Netzwerk ist Pentixapharm einzigartig positioniert, um innovative Radio­pharmazeutika mit hohem medizinischem Nutzen zu entwickeln, Patientenergebnisse zu verbessern und erhebliches Wachstumspotenzial in einem der am schnellsten wachsenden Bereiche der Prä­zi­sionsmedizin zu erschließen.

Pentixapharm Investor und Medienkontakt

ir@pentixapharm.com

Pentixapharm Announces Advancement of PentixaTher to Fourth Dose Level in Acute Myeloid Leukemia Trial

Deutsche Version weiter unten.

Achieves Key Milestone with CXCR4-based Radiotherapeutic

• Favorable safety profile enables advancement of radiolabeled PentixaTher to fourth of five planned activity dose levels in investigator-initiated PENTILULA Phase 1/2 trial

• Milestone marks important step for novel radiotherapeutic candidate in high unmet need indication with limited treatment options and poor prognosis

Berlin, Germany, September 26, 2025 – Pentixapharm AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech, developing novel radiopharmaceuticals, today announced that its CXCR4-targeting radiolabeled candidate PentixaTher has advanced to the fourth dose level in the investigator-initiated PENTILULA Phase 1/2 study in acute myeloid leukemia (AML).

Based on favorable safety findings at the third dose level of 7.5 GBq, the investigator-initiated trial received approval from the independent Data Safety Monitoring Board (DSMB) to advance to the fourth of five planned dose levels at 10 GBq, underscoring PentixaTher’s tolerability to date. Importantly, this advancement not only reinforces the compound’s safety profile but also moves the study into a dose range with a higher likelihood for meaningful clinical efficacy. If favorable safety signals continue, the study is expected to escalate to a fifth and final dose level of 12.5 GBq.

AML is the most common acute leukemia in adults, with approximately 20,000 new cases annually in the U.S. and 17,000 new cases annually in Europe. Five-year survival rates range between approximately 32 and 37%, respectively.

“Advancing to higher dose levels marks a key step in validating the therapeutic potential and promise of PentixaTher,” said Dirk Pleimes, MD, CEO/CMO of Pentixapharm. “The encouraging results in this investor-led effort highlight the potential of CXCR4 as a powerful target for hematologic cancers and demonstrate the promise of radiopharmaceuticals to expand treatment options where medical need is greatest. The trial is expanding the clinical evidence base for CXCR4-targeted therapy to expand the boundaries of radiopharmaceuticals.”

Professor Françoise Kraeber-Bodéré, Nuclear Medicine Department, CHU Nantes, Principal Investigator, commented: “We are encouraged by the favorable safety profile observed to date, which has enabled us to move to higher activity dose levels. At dose level four, we are now entering a range considered of potentially higher effectiveness, and we look forward to evaluating the clinical impact in this high-need patient population.”

Professor Patrice Chevallier, Hematology Department, CHU Nantes added: “For patients with advanced AML, treatment options are limited, and prognosis in this often heavily pretreated population is poor. Reaching this dose level with an acceptable safety profile provides new hope that CXCR4-targeted radiopharmaceuticals could one day become a meaningful addition to the therapeutic landscape.”

About PentixaTher and the PENTILULA Phase 1/2 Study

Radiolabeled PentixaTher is a novel radiotherapeutic designed to selectively target the chemokine receptor CXCR4, a key player in the bone marrow microenvironment that is frequently over­expressed in aggressive hematological malignancies. The compound is labeled for the PENTILULA study with 177-lutetium, a clinically well-established isotope, enabling precise delivery of a targeted radiation payload. PentixaTher is currently being evaluated in the PENTILULA Phase 1/2 study (ClinicalTrials.gov ID: NCT06356922), initiated in November 2024. The multicenter, open-label, dose-escalation trial is led by an experienced investigator team at the University Hospital of Nantes and conducted at three additional clinical sites in France. It aims primarily to assess the safety and tolerability of PentixaTher, with secondary objectives including preliminary measures of clinical activity such as overall response rate, complete response rate, and overall survival. The study is supported by the French Ministry of Health.

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharma­ceuticals. Headquartered in Berlin, Germany, the company develops first-in-class ligand- and antibody-based radiopharmaceuticals designed to transform patient care across oncology and beyond. Its late-stage pipeline is anchored by CXCR4-targeted programs, including a Phase 3-ready diagnostic candidate for primary aldosteronism and pioneering therapeutic programs in a number of hematological and solid cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-escape marker over-expressed in multiple hard-to-treat cancers. Complemented by reliable isotope supply from Eckert & Ziegler, and a robust global clinical network, Pentixapharm is uniquely positioned to deliver innovative radiopharmaceuticals that address high unmet need, improve patient outcomes, and create significant growth opportunities in one of the fastest-growing areas of precision medicine.

About Nantes University Hospital

Nantes University Hospital (CHU de Nantes) is one of France's leading healthcare institutions, recognized for its excellence in various medical specialties including cardiology, transplants, oncology, and neuroscience. The hospital is also a key player in medical research and innovation, conducting clinical trials and contributing to significant advancements in healthcare, in particular in nuclear medicine and hematology. [177Lu]Lu-PentixaTher is produced by ARRONAX, the hospital radiopharmacy unit (APUI), which is specially authorized for the preparation of the radio­pharmaceutical investigational product.

Pentixapharm Investor and Media Contact

ir@pentixapharm.com

Pentixapharm gibt Fortschreiten von PentixaTher auf die vierte Dosierungsstufe in klinischer Studie zur akuten myeloischen Leukämie bekannt

Wichtiger Meilenstein mit CXCR4-basiertem Radiotherapeutikum erreicht

• Vorteilhaftes Sicherheitsprofil ermöglicht Fortschreiten von radioaktiv markiertem PentixaTher auf die vierte von fünf geplanten Aktivitäts-Dosierungsstufen in der Prüfer-initiierten PENTILULA Phase-1/2-Studie

• Bedeutender Fortschritt für das neuartiges Radiotherapeutikum in Indikation mit hohem ungedecktem medizinischem Bedarf, begrenzten Behandlungsmöglichkeiten und schlechter Prognose

Berlin, Deutschland, 26. September, 2025 – Pentixapharm AG (Frankfurt Prime Standard: PTP), ein Biotech-Unternehmen in der fortgeschrittenen klinischen Entwicklung von Radiopharma­zeutika, gab heute bekannt, dass ihr CXCR4-gerichteter, radioaktiv markierter Kandidat PentixaTher in der Prüfer-initiierten PENTILULA Phase-1/2-Studie bei akuter myeloischer Leukämie (AML) auf die vierte Dosierungsstufe vorangeschritten ist.

Basierend auf vorteilhaften Sicherheitsdaten aus der dritten Dosierungsstufe von 7,5 GBq hat das unabhängige Data Safety Monitoring Board (DSMB) zugestimmt, in der vierten von insgesamt fünf geplanten Dosierungsstufen auf 10 GBq zu erhöhen. Dies unterstreicht die bislang gute Ver­träg­lichkeit von PentixaTher. Entscheidend ist, dass dieser Fortschritt nicht nur das Sicherheits­profil des Wirkstoffs bestätigt, sondern die Studie nun auch einen Dosisbereich erreicht, in dem eine klinisch relevante Wirksamkeit wahrscheinlicher wird. Sollten sich die vorteilhaften Sicher­heits­daten bestätigen, wird eine weitere Eskalation auf die fünfte und letzte Dosierungs­stufe mit 12,5 GBq erwartet.

AML ist die häufigste akute Leukämie bei Erwachsenen, mit jährlich etwa 20.000 neuen Fällen in den USA und ca. 17.000 neuen Fällen in Europa. Die Fünf-Jahres-Überlebensraten liegen in den Regionen bei etwa 32 bis 37 %.

„Die Eskalation auf höhere Dosierungsstufen ist ein entscheidender Schritt, um das thera­peutische Potenzial und die klinische Relevanz von PentixaTher zu bestätigen“, sagte Dr. Dirk Pleimes, CEO/CMO von Pentixapharm. „Die ermutigenden Ergebnisse dieser Prüfer-initiierten Studie verdeutlichen sowohl das Potenzial von CXCR4 als starkem Zielmolekül für hämato­logische Tumoren als auch die Chance von Radiopharmazeutika, Behandlungsoptionen in Bereichen mit hohem medizinischem Bedarf zu erweitern. Die Studie trägt maßgeblich dazu bei, die klinische Datenbasis für CXCR4-gerichtete Therapien zu stärken und die Grenzen der Radiopharmazie zu erweitern.“

Professorin Françoise Kraeber-Bodéré, Abteilung für Nuklearmedizin, CHU Nantes, Studien­leiterin, kommentierte: „Wir sind ermutigt durch das bisher beobachtete vorteilhafte Sicherheits­profil, das uns den Schritt zu höheren Dosisstufen ermöglicht hat. Mit der vierten Stufe kommen wir nun in einen Bereich, der als potenziell wirksamer gilt, und wir sind gespannt, den klinischen Effekt in dieser Hochrisikopopulation zu evaluieren.“

Professor Patrice Chevallier, Abteilung für Hämatologie, CHU Nantes, ergänzte: „Für Patienten mit fortgeschrittener AML sind die Behandlungsmöglichkeiten begrenzt und die Prognose in dieser oft stark vorbehandelten Patientengruppe ist schlecht. Das Erreichen dieser Dosisstufe bei gleichzeitig akzeptablem Sicherheitsprofil gibt neue Hoffnung, dass CXCR4-gerichtete Radiopharmazeutika eines Tages eine bedeutende Erweiterung des therapeutischen Arsenals darstellen könnten.“

Über PentixaTher und die PENTILULA Phase-1/2-Studie

Das radioaktiv markierte PentixaTher ist ein neuartiges Radiotherapeutikum, das gezielt den Chemokinrezeptor CXCR4 adressiert – einen Schlüsselfaktor der Knochenmarksmikroumgebung, der in aggressiven hämatologischen Krebsarten häufig überexprimiert ist. Für die PENTILULA-Studie wurde PentixaTher mit Lutetium-177 markiert, einem klinisch etablierten Isotop, das die gezielte Abgabe einer präzisen Strahlenladung ermöglicht. PentixaTher wird derzeit in der PENTILULA Phase-1/2-Studie (ClinicalTrials.gov ID: NCT06356922) untersucht, die im November 2024 gestartet wurde. Die multizentrische, offene Dosis-Eskalationsstudie wird von einem erfahrenen Prüferteam am Universitätsklinikum Nantes geleitet und an drei weiteren klinischen Standorten in Frankreich durchgeführt. Primäres Ziel ist die Bewertung der Sicherheit und Verträglichkeit von PentixaTher; sekundäre Endpunkte umfassen erste Wirksamkeitsparameter wie Gesamtansprechrate, komplette Remissionen und das Gesamtüberleben. Die Studie wird vom französischen Gesundheitsministerium unterstützt.

Über Pentixapharm

Pentixapharm ist ein Biotech-Unternehmen in der fortgeschrittenen klinischen Entwicklung, das die Grenzen von Radiopharmazeutika erweitert. Mit Hauptsitz in Berlin entwickelt das Unter­nehmen erstklassige ligand- und antikörperbasierte Radiopharmazeutika, die die Patientenver­sorgung in der Onkologie und darüber hinaus transformieren sollen. Seine fortgeschrittene Pipe­line wird von CXCR4-basierten Programmen getragen, darunter ein Phase-3-bereites Dia­gnostikum für primären Hyperaldosteronismus sowie wegweisende therapeutische Programme in verschiedenen hämatologischen und soliden Tumoren. Darüber hinaus entwickelt Pentixa­pharm eine neuartige Antikörperplattform, die auf CD24 abzielt – einen aufkommenden Immun-Escape-Marker, der in zahlreichen schwer behandelbaren Tumoren überexprimiert ist. Ergänzt durch die zuverlässige Isotopenversorgung durch Eckert & Ziegler sowie ein starkes globales klinisches Netzwerk ist Pentixapharm einzigartig positioniert, um innovative Radio­pharmazeutika mit hohem medizinischem Nutzen zu entwickeln, Patientenergebnisse zu verbessern und erhebliches Wachstumspotenzial in einem der am schnellsten wachsenden Bereiche der Prä­zi­sionsmedizin zu erschließen.

Über das Universitätsklinikum Nantes

Das Universitätsklinikum Nantes (CHU de Nantes) gehört zu den führenden Gesundheits­einrichtungen Frankreichs und ist für seine Exzellenz in zahlreichen medizinischen Fachgebieten wie Kardiologie, Transplantationen, Onkologie und Neurowissenschaften anerkannt. Zudem ist das Klinikum ein zentraler Akteur in Forschung und Innovation, führt klinische Studien durch und trägt wesentlich zu Fortschritten in der Gesundheitsversorgung bei – insbesondere in der Nuklear­medizin und Hämatologie. [¹⁷⁷Lu]Lu-PentixaTher wird von ARRONAX, der radiopharmazeutischen Einheit des Klinikums (APUI), hergestellt, die speziell für die Herstellung des radiopharma­zeutischen Prüfpräparats zugelassen ist.

Kontakt für Investoren und Medien

ir@pentixapharm.com

Pentixapharm Publishes Half-Year Figures for 2025

• Loss of the reporting period €8.4 million (attributed to research and development activities, personnel and other operating expenses)

• Revenue of the reported period €38 thousands

• Balance sheet total as of June 30, 2025: €51 million

• Guidance for the fiscal year 2025 published on April 14, 2025 remains unchanged: expected loss approximately €23.5 million

Berlin and Würzburg, Germany, 06 August 2025

The Executive Board of Pentixapharm Holding AG announced the following today:

Based on the newly published interim financial statements, the Group closed the first half of the 2025 fiscal year with a loss of EUR 8.4 million.

Based on current planning, the Company continues to expect a net loss for the full 2025 fiscal year of approximately EUR 23.5 million, consistent with the forecast published in April 2025.

This forecast includes research and development expenses of approximately EUR 11 million and personnel and other operating expenses of approximately EUR 9.5 million. Potential income from out-licensing is not included in the forecast.

The full interim financial statements is available on the Pentixapharm Holding AG Investor Relations website: www.pentixapharm.com/investors/reports.

About Pentixapharm

Pentixapharm is a biopharmaceutical company based in Berlin and Würzburg, dedicated to the development of innovative, targeted radiopharmaceuticals. The company is developing, among other programs, CXCR4 ligand-based radiopharmaceuticals for diagnostic and therapeutic use in various types of blood cancers, solid tumors, and endocrine diseases such as primary aldosteronism.

The pipeline is further complemented by radiolabeled antibodies currently in the preclinical proof-of-concept stage. These antibodies differentiate target proteins on healthy and tumor tissue based on their O-glycosylation patterns. This innovative approach holds the potential for low off-target binding and an improved therapeutic window, offering clear advantages over conventional radiopharmaceuticals. 

For more information, please contact:

Pentixapharm Holding AG
Henner Kollenberg
ir@pentixapharm.com
Tel. +49 30 94892600
www.pentixapharm.com

Pentixapharm Announces Encouraging Preclinical Data for First-in-Class Glycan-Dependent Anti-CD24 mAb Radiopharmaceutical GT-008

• Novel radiopharmaceutical GT-008 demonstrates potential for selective tumor targeting with reduced side effects in preclinical studies

• Single-dose administration of 177Lutetium-labeled GT-008 induced remission of established tumors and was well tolerated

• Initial preclinical proof-of-concept data demonstrate selective tumor targeting, favorable biodistribution, and early signals of anti-tumor activity in breast cancer model 

• Program expansion underway to explore additional tumor types, dosing regimens, and radionuclide formats

Berlin, Germany, June 19, 2025 – Pentixapharm, a clinical-stage biopharmaceutical company focused on radiopharmaceuticals, announces encouraging first results from a preclinical proof-of-concept study with its lead radioimmunotherapeutic candidate, GT-008.

GT-008 is a first-in-class, glycan-dependent monoclonal antibody engineered to selectively target a tumor-associated O-glycoform of the tumor marker CD24 with high prevalence on tumors but limited expression on healthy cells.

Conjugated and radiolabeled with Lutetium-177 [177Lu] to evaluate its suitability for targeted radionuclide therapy, GT-008 showed complete responses after single dose treatment in a breast cancer xenograft mouse model.  Biodistribution data demonstrated specific and stable tumor accumulation leading to pronounced anti-tumor effects in a preliminary tolerability and activity study. Early in vitro data had already demonstrated specific and high affinity binding to breast cancer cell lines in the nM range leading to efficient internalization.

The new study results highlight the enormous potential of radioimmunotherapy with glycosylation-dependent mAbs against novel GlycoTargets for the treatment of solid tumors.

Derived from former Glycotope´s GlycoTarget mAb discovery platform and further engineered to achieve high tumor to organ ratios and low unspecific uptake, the GT-008 program marks Pentixapharm’s expansion beyond its CXCR4-focused theranostic platform into glycan-dependent antibody-based radiopharmaceuticals.

Further preclinical investigations are actively progressing to broaden the dataset, including larger preclinical in vivo study cohorts, different tumor indications (e.g., ovarian, endometrial, and other solid tumors), alternative radioisotopes and dosing schedules.

"The compelling early data with GT-008 validates our strategic acquisition of Glycotope's target discovery platform in 2024, positioning us at the forefront of next-generation radiopharmaceuticals with a highly differentiated approach," said Dirk Pleimes, Chief Executive Officer of Pentixapharm. "By leveraging glycosylation-dependent antibodies, we're developing potentially safer and more selective targeted therapies, addressing a key challenge in the rapidly growing radiopharmaceutical market."

About GT-008

GT-008 is a first-in-class, glycan-dependent monoclonal antibody targeting CD24, a GPI-linked cell surface glycoprotein implicated in tumor progression. By recognizing a tumor-associated O-glycoform of CD24 - limited on healthy cells - the antibody shows high affinity and specificity for cancer cells, while binding to CD24-expressing healthy cells is reduced. This lowers the potential for on-target/off-tumor activity, overcoming key limitations of conventional CD24-targeting antibodies and other binding modalities. GT-008 is Pentixapharm’s first radiopharmaceutical candidate addressing CD24 and may enable additional therapeutic formats beyond radiotherapy.

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals headquartered in Berlin, Germany. It is committed to developing ligand-based, first-in-class radiopharmaceuticals with strong differentiation and commercialization potential across high-need diagnostic and therapeutic areas. Its pipeline comprises CXCR4-targeted compounds in clinical development and a portfolio of early-stage radionuclide-antibody conjugates, aimed at treating hematologic malignancies, solid tumors, and diagnosing diseases of the cardiovascular, endocrine, and immune systems.

For more information, please contact:

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

Pentixapharm outlines new clinical development strategy

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

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

Pentixapharm to Present First-in-Class Glycan-Dependent CD24 Antibody GT-008 for Solid Tumors at AACR 2025

Berlin, Germany, April 25, 2025 – Pentixapharm, a clinical-stage biopharmaceutical company focused on radiopharmaceuticals, will present new pre-clinical data on its novel antibody GT-008 at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25–30 in Chicago. The presentation highlights GT-008’s unique glycan-dependent binding mechanism, a key advancement for immunotherapy and radioconjugate development.

GT-008 is a first-in-class, glycan-dependent monoclonal antibody targeting CD24, a surface protein implicated in tumor progression. By recognizing a tumor-associated O-glycoform of CD24—limited in healthy tissue—the antibody shows high affinity and specificity for cancer cells, while binding to CD24-expressing healthy cells is strongly reduced. This lowers the potential for on-target/off-tumor activity, overcoming key limitations of conventional CD24-targeting antibodies and other binding modalities.

GT-008 retains strong binding and internalization in a range of solid tumors, including endometrial, breast, ovarian, and squamous cell carcinoma of the skin. Its format enables flexible payload integration—ranging from cytotoxics to radiotherapeutics—supporting diverse therapeutic modalities. An in vitro and in vivo proof-of-concept study using a radiolabeled version is currently underway—laying the groundwork for what could become the first radioconjugated antibody in Pentixapharm’s development pipeline.

Presentation Details:

• Abstract Title: Improving druggability of a promising tumor target by the novel glycosylation-dependent mAb GT-008 for treatment of solid tumors

• Session Title: Enhanced Antibodies, TCR Constructs, Cytokines and Chimeric Proteins

• Session Start Time: April 28, 2025, 2PM CDT

• Location: Poster Section 35

• Poster Board Number: 24

• Presentation Number: 3429

• Location: AACR 2025, McCormick Place Convention Center, Chicago, Illinois

The poster can be found here: Link

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 ligand-based, first-in-class radiopharmaceuticals with strong differentiation and commercialization potential across high-need diagnostic and therapeutic areas. Its pipeline comprises CXCR4-targeted compounds in clinical development and a portfolio of early-stage radionuclide-antibody conjugates, aimed at treating hematologic malignancies, solid tumors, and diseases of the cardiovascular, endocrine, and immune systems.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

Pentixapharm Signs Contract Manufacturing Agreement for Yttrium-90-based PentixaTher with Eckert & Ziegler SE

Berlin, Germany, April 24, 2025 – Pentixapharm, a clinical-stage biopharmaceutical company, today announced the signing of a manufacturing agreement with Eckert & Ziegler Radiopharma GmbH (EZR), a 100% subsidiary of Eckert & Ziegler SE. Under the terms of the agreement, EZR will produce and distribute patient-specific doses of Y90-PentixaTher, Pentixapharm’s lead CXCR4-targeting radiotherapeutic, for use in clinical trials.

Y90-PentixaTher is a radiolabeled peptide designed to deliver targeted radiation to cancer cells that overexpress the CXCR4 receptor - commonly found in malignancies such as acute myeloid leukemia, lymphoma, myeloma and various solid tumors. The compound is labeled with Yttrium-90, a high-energy beta emitting radionuclide with deeper tissue penetration and a shorter physical half-life (64 hours) compared to Lutetium-177, enabling effective tumor irradiation with controlled therapeutic duration. Used alongside the radiodiagnostic Ga68-PentixaFor, it supports a theranostic approach that allows physicians to visualize the disease before and after treatment.

As part of the newly signed agreement, EZR will manufacture Y90-PentixaTher under GMP conditions and manage the direct shipment of individual patient doses to trial sites. The agreement is limited to the clinical development phase and does not extend to commercial-scale manufacturing. Pentixapharm retains full strategic flexibility under this agreement to determine its future development and commercial supply.

“With this agreement, we are proud to support the advancement of Pentixapharm’s clinical oncology program,” said Dr. Harald Hasselmann, CEO of Eckert & Ziegler SE (EZAG). “Reliable access to high-quality radioisotopes is critical for the development of next-generation radiopharmaceuticals and we are pleased to contribute our manufacturing excellence to accelerate the delivery of innovative cancer therapies.”

"Securing a reliable Y90-PentixaTher GMP production is a significant milestone for Pentixapharm," said Dr. Dirk Pleimes, CEO of Pentixapharm AG. "This agreement marks a critical step as we advance our targeted radiopharmaceutical therapies toward late-stage development."​

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 ligand-based, first-in-class radiopharmaceuticals with strong differentiation and commercialization potential across high-need diagnostic and therapeutic areas. Its pipeline comprises CXCR4-targeted compounds in clinical development and a portfolio of early-stage radionuclide-antibody conjugates, aimed at treating hematologic malignancies, solid tumors, and diseases of the cardiovascular, endocrine, and immune systems.

About Eckert & Ziegler

Eckert & Ziegler SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.

Contributing to saving lives.

Contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

Eckert & Ziegler SE 
Robert-Rössle-Str. 10, 13125 Berlin, Germany 
Jan Schöpflin, Marketing / Karolin Riehle, Investor Relations 
jan.schoepflin@ezag.com / karolin.riehle@ezag.com   
Tel.: +49 (0) 30 / 94 10 84-138; www.ezag.com

Pentixapharm Holding AG Releases Financial Results for 2024 and Announces Guidance for the 2025 Financial Year

Berlin, April 15, 2025 – The Management Board and Supervisory Board of Pentixapharm Holding AG today announced the following key resolutions:

• The Group closed the 2024 financial year with a net loss of EUR 12.8 million, as reflected in the newly published annual financial statements.

• Based on current planning, the Company expects a net loss of approximately EUR 23.5 million for the 2025 financial year.

This forecast reflects expected research and development expenses of around EUR 11 million and personnel and other operating expenses of around EUR 9.5 million. Potential revenues from out-licensing activities are not included in the forecast.

The full Annual Report for the 2024 financial year was published today, on April 15, 2025. The Company will host an investor call to present the financial results at 2:00 p.m. CEST on the same day. Registration is available at the following link: Link to registration

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 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs. Its pipeline features CXCR4-targeted compounds as well as early-stage radionuclide-antibody conjugates addressing hematological and solid cancers, as well as cardiovascular, endocrine, and inflammatory diseases.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

Changes in the Supervisory Board and Management Board of Pentixapharm Holding AG

Berlin, Germany, March 3, 2025 - Several previously announced personnel changes in the governing bodies of the Pentixapharm Group have taken effect as of March 1, 2025. The Management Board of the parent company Pentixapharm Holding AG is now identical in composition to the Management Board of the wholly owned operational subsidiary Pentixapharm AG. Both companies are now led by Dr. Dirk Pleimes and Henner Kollenberg.

Dr. Andreas Eckert, who was temporarily appointed as sole member of the Management Board of the holding company in November 2024 under § 105(2) of the German Stock Corporation Act following the health-related departure of Pentixapharm founder Dr. Hakim Bouterfa, has returned to the Supervisory Board of Pentixapharm Holding AG. He was re-elected as Chairman there. With his return to the Supervisory Board, Dr. Harald Hasselmann's Supervisory Board mandate in Pentixapharm Holding AG has also been reactivated. Hasselmann had suspended his mandate since October due to potential conflicts of interest. Frank Perschmann, who had been acting as Chairman of the Supervisory Board of Pentixapharm Holding AG in recent months, left the board as planned with Eckert's return.

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 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs. Its pipeline features CXCR4-targeted compounds and early-stage radionuclide-antibody conjugates addressing hematological and solid cancers, as well as cardiovascular, endocrine, and inflammatory diseases.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

First-In-Human Data about the Treatment of Muscle-Invasive Bladder Cancer with Pentixapharm’s Lu177-PentixaTher to be Presented at ASCO-GU 2025

Berlin, Germany, February 13, 2025 – Data from the first-in-human radioligand-therapy for muscle invasive bladder cancer (MIBC) using Pentixapharm’s Lu177-PentixaTher compound will be shown at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO-GU 2025) in San Francisco, CA.

The presentation features a case study of a late-stage MIBC patient who was initially treated with three cycles of neoadjuvant combination chemotherapy followed by intravesical administration of Pentixapharm’s radiopharmaceutical that targets the CXCR4 receptor. Imaging with Ga68-PentixaFor PET/CT had revealed intravesical CXCR4 expression prior to therapy, so a subsequent Lu177-PentixaTher instillation was used to target residual tumor cells. Pathological examination after transurethral resection confirmed a complete response, suggesting a potential for bladder preservation.

Instillation therapy in bladder cancer opens the potential for localized treatment with enhanced precision and minimized systemic exposure, thereby reducing the risk of adverse effects.

This early data adds to the growing body of evidence supporting CXCR4 as a therapeutic target across multiple oncology indications. To date, more than 100 patients have been treated with PentixaTher, providing a basis for a Pentixapharm-sponsored clinical development program. In November of last year, a first patient was enrolled in an investigator initiated Phase I/II trial in patients with acute myeloid and lymphoblastic leukemia (AML/ALL) in Nantes, France.

Presentation Details:

• Presenter: Dr. Ralph Wirtz

• Session: Poster Session B

• Date: February 14, 2025

• Time: 11:30 AM – 12:45 PM (PT)

• Location: ASCO-GU 2025, San Francisco, CA

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 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs. Its pipeline features CXCR4-targeted compounds as well as early-stage radionuclide-antibody conjugates addressing hematological and solid cancers, as well as cardiovascular, endocrine, and inflammatory diseases.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

Pentixapharm Holding AG Closes the 2024 Financial Year With a Loss of EUR 14 Million, Including Risk Provisions for Myelo Amounting to EUR 7 Million

Disclosure of Insider Information according to Article 17 of Regulation (EU) No. 596/2014

Berlin, January 24, 2025 - According to initial preliminary evaluations, Pentixapharm Holding AG will close the 2024 financial year with a loss of around EUR 14 million. In addition to the operating loss of EUR 7 million, the total also includes non-cash write-downs for intangible assets. They result from the termination of development projects at the subsidiary Myelo Therapeutics GmbH, which were previously mainly financed by contracts from various US government agencies. According to the opinion of the Management Board and Supervisory Board, the recent change in the U.S. administration has significantly worsened the conditions for amortization, as previous funding programs have been canceled or not extended.

The annual report for 2024 with details of the development project will be published on April 15, 2025.

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 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs. Its pipeline features CXCR4-targeted compounds as well as early-stage radionuclide-antibody conjugates addressing hematological and solid cancers, as well as cardiovascular, endocrine, and inflammatory diseases.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

Pentixapharm Receives EUR 6.77 Million for Intangible Assets Formerly Developed by Glycotope

Berlin, January 7th, 2025 – Pentixapharm AG, a developer of innovative radiopharmaceuticals, receives 6.77 million Euro for intangible assets formerly developed by Glycotope from undisclosed Asian pharma and biotech companies. The transaction, which will be effective still in 2024, involves rights that had been transferred to Pentixapharm as part of the acquisition of Glycotope’s target discovery business in July 2024.

“The deal eliminates almost all of the remaining obligations from an earn-out that Pentixapharm had accepted with the purchase of the target discovery business”, comments Henner Kollenberg, Chief Business Officer. “While it will not significantly reduce the losses of Pentixapharm in 2024, it paves the way for the monetization other Glycotope assets acquired by Pentixapharm. The transaction also confirms the ongoing interest of major industry players in the know-how maintained and now furthered by Pentixapharm”.

The acquisition of Glycotope’s target discovery business in July 2024 included a portfolio of preclinical antibodies against multiple oncology targets, a unique tumor target database, the equipment needed to exploit a discovery platform, and the related IP. Transferred to Pentixapharm as part of the deal were also a range of patents, licenses and license agreements.

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 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs. Its pipeline features CXCR4-targeted compounds as well as early-stage radionuclide-antibody conjugates addressing hematological and solid cancers, as well as cardiovascular, endocrine, and inflammatory diseases.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

First Patient Treated in Phase I/II Trial in Acute Myeloid and Acute Lymphoblastic Leukemia with Lu177-PentixaTher, Expanding the Evidence Base for Targeted Radiotherapy Approach

Berlin and Würzburg, Germany, November 21, 2024 – Pentixapharm Holding AG, a biopharmaceutical company developing innovative first-in-class radiopharmaceuticals, today announced that the first patient has been treated in a Phase I/II clinical trial evaluating the safety and efficacy of Lu177-PentixaTher, a novel radiopharmaceutical therapy, in adults for relapsed/refractory CXCR4 positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The trial, funded by the French Ministry of Health and led by a renowned investigator team from the University Hospital in Nantes, represents a significant step toward expanding targeted radiotherapy options for hematologic malignancies.

The investor-initiated study, named PENTILULA (ClinicalTrials.gov ID: NCT06356922) is a multicenter, open-label trial in which up to 21 patients with relapsed/refractory AML or ALL will be enrolled over a period of 24 months, with a total study duration of 36 months. The primary objective is to determine the maximal tolerated dose (MTD) of Lu177-PentixaTher, and to examine key efficacy parameters such as overall response rate (ORR) and complete remission (CR) after infusion of the novel radiotherapeutic agent.

Following a peer-reviewed publication in January 2023 in the prestigious Journal of Nuclear Medicine highlighting promising clinical results in the treatment of patients suffering from T-cell lymphoma, further evidence continues to be built up about the potential of Pentixapharm’s lead candidate, PentixaTher, for the treatment of haemato-oncological diseases.

The study is significant for Pentixapharm insofar as the incidence of ALL and AML, and hence the medical need, is much higher than that for T-Cell lymphoma. The PENTILULA trial is the first trial that combines PentixaTher with Lutetium-177, a radioisotope widely and successfully used for the treatment of castration resistant prostate cancer or neuroendocrine tumors.

Acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) are aggressive and life-threatening blood cancers that affect thousands of people worldwide each year. AML is the most common type of acute leukemia in adults, with an incidence of approximately 20,000 new cases per year and low five-year survival rate of 31.9% in the United States [1]. ALL is the most common type of cancer in children, with a high incidence in adults as well. Current treatment options often involve intensive chemotherapy and stem cell transplantation, which can have severe side effects. Effective radiotherapies in other indications are currently reimbursed with more than 100,000 USD per patient.

“Although treatments for acute leukemia have advanced, many patients continue to have limited options and face poor outcomes. We believe PentixaTher holds significant potential to address these unmet needs, offering a valuable radiopharmaceutical theranostic approach tailored to the individual patients with hematologic malignancies.” explains Dr. Dirk Pleimes, Group CEO and CMO at Pentixapharm. “We are delighted that leading experts such as Professor Françoise Kraeber-Bodéré of the Nuclear Medicine Department and Professor Patrice Chevallier of the Hematology Department in Nantes have decided to initiate this study to evaluate this novel radiotherapeutic treatment option. We are committed to providing our full support, leveraging our therapeutic knowledge with PentixaTher and facilitating access to the compound to drive this important research forward."

Professor Françoise Kraeber-Bodéré is the Head of the department of Nuclear Medicine at the University Hospital in Nantes, France, and an expert of the Oncology committee of the French Society of Nuclear Medicine (SFMN) as well as of the Oncology and Therapy committee of the European Association of Nuclear Medicine. She is on the scientific board of the French Lymphoma research group LYSA and expert for PET imaging in lymphoma and myeloma. Professor Patrice Chevallier is a specialist in Hematology and member of the executive committee and scientific council of HéMA, an umbrella organization for hemato-oncological research in Western France.

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases. Its Pipeline includes PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68 based companion diagnostic for blood cancers and cardiovascular diseases.

PentixaTher is an innovative radiotherapeutic that specifically targets the chemokine-4 receptor (CXCR4). Background material about its potential for the treatment of haematooncological diseases can be found at:

https://edoc.mdc-berlin.de/id/eprint/24012/1/24012oa.pdf

About Nantes University Hospital

Nantes University Hospital (CHU de Nantes) is one of France's leading healthcare institutions, recognized for its excellence in various medical specialties including cardiology, transplants, oncology, and neuroscience. The hospital is also a key player in medical research and innovation, conducting thousands of clinical trials and contributing to significant advancements in healthcare, in particular in nuclear medicine and hematology. Lu177-PentixaTher will be produced by ARRONAX, the hospital radiopharmacy unit (APUI), that is specially authorized for the preparation of the radiopharmaceutical investigational product.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

[1] https://seer.cancer.gov/statfacts/html/amyl.html

Pentixapharm Releases Interim Report for the Third Quarter of 2024

• Loss of Pentixapharm Holding AG for the reporting period: €49k

• No revenue realized during the stub fiscal year through the end of Q3

• Current liabilities of €487k, mainly from the purchase of Pentixapharm AG shares

Berlin and Würzburg, Germany, November 12, 2024 – Pentixapharm Holding AG (ISIN: DE000A40AEG0), listed in the Prime Standard of the Frankfurt Stock Exchange, today published its consolidated interim report for the stub fiscal year from March 18 to September 30, 2024. Since the spin-off from Eckert & Ziegler SE, through which Pentixapharm AG and Myelo Therapeutics GmbH will be integrated into the group financial statements, was entered into the commercial register on October 2, 2024, this consolidated report includes only the figures for Pentixapharm Holding AG and does not yet contain results for either company.

During the reporting period, Pentixapharm Holding AG reported a loss of €49k, attributed to other operating expenses, primarily fees and charges related to the company’s establishment, acquisition of financial assets, and the spin-off. The interim report also shows no revenue, as operational business activities will commence only after the formal spin-off of Pentixapharm AG and Myelo Therapeutics GmbH.

For the 2024 consolidated annual financial statements, management anticipates a significant increase in losses in the fourth quarter due to the inclusion of Pentixapharm AG and Myelo Therapeutics GmbH from October 2, 2024, with an expected total loss of approximately –€8 million for the fiscal year.

The full interim report is available on the Pentixapharm Holding AG Investor Relations website: www.pentixapharm.com/investors/reports.

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

Pentixapharm Welcomes CMS Decision to Enhance Reimbursement for Diagnostic Radiopharmaceuticals

Berlin and Würzburg, Germany, November 4, 2024 – Pentixapharm, a biopharmaceutical company developing innovative first-in-class radiopharmaceuticals, welcomes the recent announcement by the U.S. Centers for Medicare & Medicaid Services (CMS) to implement separate payments for specialized diagnostic radiopharmaceuticals used in the hospital outpatient setting, extending beyond the transitional pass-through payment period. This significant policy shift could have a direct impact on future reimbursement streams for Pentixapharm’s Ga68-PentixaFor, a diagnostic radiopharmaceutical for which Pentixapharm intends to start a U.S. centric phase III clinical trial next year. The pivotal clinical trial could lead to a U.S. market authorization in primary aldosteronism (PA), one of the major causes of secondary hypertension, as early as 2028.

The CMS pass-through payment period is a temporary reimbursement mechanism under the Hospital Outpatient Prospective Payment System (OPPS). Lasting up to three years, this period provides additional payments for newly introduced medical devices, drugs, and biologicals, encouraging hospitals to adopt cutting-edge technologies by covering their costs beyond standard rates. However, under previous policies, after the pass-through period ended, products would typically revert to standard OPPS payment bundles. With this new policy announcement, CMS has changed this approach, allowing for separate payments beyond the pass-through period for qualifying high-cost diagnostics.

This decision by CMS is highly significant given the size and impact of the Medicare and Medicaid systems, which together insure more than 140 million Americans. As the primary healthcare payer for older adults and individuals with disabilities, CMS’s reimbursement policies shape access to medical innovations across the country. The new rule, effective in 2025, also has the potential to set a market precedent that may influence private insurers to follow CMS’s lead in reimbursing innovative diagnostic tools, further expanding the accessibility of these advanced diagnostics. By providing consistent reimbursement for diagnostic radiopharmaceuticals that exceed a per-day cost threshold of US$630, CMS encourages other insurers to consider similar reimbursement strategies.

The separate payment rule will most likely apply to Pentixapharm's lead diagnostic compound, Ga68-PentixaFor, following its anticipated approval and the expiration of its pass-through status. Ga68-PentixaFor is a novel tracer for positron emission tomography (PET) imaging used to detect aldosterone-hypersecreting adenomas in patients diagnosed with primary Aldosteronism (PA). With rising prevalence rates for PA, now exceeding 20% in some populations with resistant hypertension, the need for accessible and precise diagnostics is greater than ever.

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

PentixaFor (Gallium (68Ga) boclatixafortide) is an innovative PET tracer that specifically targets the chemokine-4 receptor (CXCR4), with broad applications in oncological, cardiovascular, and inflammatory diseases. Particularly in hypertension, PentixaFor has the potential to significantly improve patient management by identifying the presence of hormone-secreting adenomas through non-invasive and broadly available PET/CT imaging.

Apart from PentixaFor, the clinical pipeline also encompasses PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL). Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Recently, the EMA granted PRIME status to PentixaFor in the indication PA.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

Pentixapharm Holding AG: US National Cancer Institute Starts Advanced Clinical Trial with PentixaFor

Berlin and Würzburg, Germany, October 29, 2024 – The National Cancer Institute (NCI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), two highly respected research organizations belonging to the US government's National Institutes of Health (NIH), have started a clinical trial involving 77 patients to see if Pentixapharm’s new radioactive tracer PentixaFor ([68Ga]Ga-PentixaFor) can make it easier to identify functional adrenal tumors through positron emission tomography (PET) scans.

The FDA-endorsed and US-located investigator-initiated phase II study, conducted by Dr. Liza Lindenberg and Prof. Dr. Peter Choyke (Clinical Trial number: NCT06246357) investigates the performance of PentixaFor in subtyping hormone-secreting adenomas in people suffering from primary aldosteronism (PA) or hypercortisolism (Cushing´s syndrome). The first patient was recently examined.

Primary aldosteronism is among the most common causes of secondary hypertension, a disorder affecting tens of millions of people in the United States alone. In some subtypes PA can be cured completely through a short surgical intervention, so finding a reliable tool for accurate subtyping is important and potentially beneficial to a large segment of the population. In contrast, Cushing's syndrome, also described as hypercortisolism, is a rare endocrine disorder designated as an orphan disease that is caused by chronic exposure of the body's tissues to excess levels of cortisol.

Pentixapharm itself is currently preparing a US-centric Phase III pivotal study to obtain marketing authorization for PentixaFor in PA. The work of the NCI/NIDDK will add to the global clinical evidence about the compound and make it easier to compile the necessary data.

“We are pleased that the NIH investigate the clinical value of PentixaFor at its own initiative and see this as a token of confidence in the potential of CXCR4 targeting imaging in unexplored indications expanding market opportunities for PET/CT diagnostics. In our opinion, PentixaFor has broad potential as a novel imaging modality for adrenal diseases and could be particularly helpful for individuals grappling with primary aldosteronism-induced resistant hypertension or Cushing’s disease,” stated Dr. Dirk Pleimes, Chief Medical Officer at Pentixapharm. 

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

PentixaFor (Gallium (68Ga) boclatixafortide) is an innovative PET tracer that specifically targets the chemokine-4 receptor (CXCR4), with broad applications in oncological, cardiovascular, and inflammatory diseases. Particularly in hypertension, PentixaFor has the potential to significantly improve patient management by identifying the presence of hormone-secreting adenomas through non-invasive and broadly available PET/CT imaging.

Apart from PentixaFor, the clinical pipeline also encompasses PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL). Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Recently, the EMA granted PRIME status to PentixaFor in the indication PA.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

Nuclear Medicine Specialist Ken Herrmann Joins Supervisory Board of Pentixapharm Holding AG

Berlin, Germany, October 28, 2024 – Prof. Dr. Ken Herrmann, a distinguished scientist and Head of the Department of Nuclear Medicine at Universitätsklinikum Essen, Germany, has as of today formally assumed his seat on the Supervisory Board of Pentixapharm Holding AG. While the appointment dates back to the shareholder meeting in June 2024 and has been effective with the registration of the split-off of Pentixapharm AG from Eckert & Ziegler SE in the commercial register, the assumption of his position was up until now hindered by delayed permits to take up secondary employment.

“We are thrilled to welcome Ken Herrmann to our Supervisory Board,” said Dr. Andreas Eckert, Executive Chairman of Pentixapharm Holding AG. “Ken Herrmann is one of the most influential clinicians in the field of radiopharmaceuticals. We look forward to benefiting from his expertise, particularly in advancing our oncology pipeline, which includes Y90-PentixaTher and Ga68-PentixaFor for the treatment and diagnosis of non-Hodgkin lymphomas (NHL).

Prof. Herrmann is an internationally recognized expert in nuclear medicine and theranostics. Apart from his position at the university clinic of Essen, he headed the Chair of the European Association of Nuclear Medicine (EANM) Oncology & Theranostics Committee. He serves as a section editor for The Journal of Nuclear Medicine (JNM) and has (co-)authored over 700 peer-reviewed articles.

After earning his medical degree from Charité Berlin and completing a habilitation in nuclear medicine at Technical University of Munich, Prof. Dr. Herrmann further advanced his education with an executive MBA from the University of Zürich. He frequently shares his expertise at major industry events, including the annual conferences of the EANM and the Society of Nuclear Medicine and Molecular Imaging (SNMMI). Notably, he participated in Pentixapharm’s CXCR4 Symposium at last year's EANM and the 2nd Boston Radionuclide Theranostics Forum hosted by Eckert & Ziegler SE this year.

Prof. Dr. Herrmann joins an esteemed Supervisory Board chaired by Frank Perschmann. Apart from Harald Hasselmann, CEO of Eckert & Ziegler SE and Jens Giltsch, it includes Pentixapharm’s Founder Dr. Hakim Bouterfa and the endocrinologist Prof. Dr. med. Marcus Quinkler, who contributes his experience for the development of Ga68-PentixaFor in the indication of primary aldosteronism, one of the major causes of secondary hypertension.

About Pentixapharm

Pentixapharm is a clinical-stage radiopharmaceutical development company with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceuticals for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a Phase III registration study with PentixaFor in PA that will start in Europe and the United States in 2025.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

Pentixapharm Holding AG: Upcoming Changes in the Management and Supervisory Boards of the Pentixapharm Group

Berlin, Germany, October 25, 2024 - Following the receipt of various approvals, consents, and registrations, Pentixapharm Holding AG will implement, at the end of October 2024, a series of changes to the group's management bodies.

As announced, Dr. Hakim Bouterfa, founder and CEO of Pentixapharm AG, will step down from his positions on the Management Boards of both Pentixapharm AG and Pentixapharm Holding AG, effective October 27, 2024. He will transition to the Supervisory Board of Pentixapharm Holding AG. This transition does not require a shareholder resolution, as the major shareholder, Eckert Wagniskapital und Frühphasenfinanzierung GmbH, exercised its nomination right, and Dr. Bouterfa accepted the appointment.

Simultaneously, with Dr. Bouterfa’s transition, nuclear medicine specialist Prof. Dr. Ken Herrmann will join the Supervisory Board of Pentixapharm Holding AG. He was appointed to this position at the Annual General Meeting in June 2024 and has now received the necessary consents. The physicist Paola Eckert-Palvarini, who temporarily held this role as an elected substitute, will step down at this time.

Until all changes are formally completed, including the execution of various supplementary agreements, Dr. Andreas Eckert will temporarily assume the role of Executive Chairman on the Management Board of Pentixapharm Holding AG. In the interim, Frank Perschmann will serve as Chairman of the Supervisory Board.

Dr. Dirk Pleimes has been appointed as CEO of Pentixapharm AG by the Supervisory Board, effective October 27, 2024. He will continue to serve as Chief Medical Officer, with no changes to the other operational management positions.

These restructuring measures represent the organizational completion of the spin-off from the former parent company, Eckert & Ziegler SE. A full list of the new management and supervisory board members is expected to be available on the company’s website starting Monday. Biographical information on Prof. Herrmann will be provided in a separate press release upon his assumption of office.

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

Pentixapharm’s CXCR4 Core Compound Subject of 17 Abstract Presentations at the Hamburg European Association of Nuclear Medicine (EANM)

Hamburg, Germany, October 19, 2024 - The CXCR4 targeting compounds developed clinically by Pentixapharm in a number of diagnostic and therapeutic indications are subject of 17 abstract presentations at the 37th Annual Congress of the European Association of Nuclear Medicine (EANM) which takes place in Hamburg from 19 – 23 October 2024. The presentations feature the company’s ongoing theranostic development efforts and CXCR4 targeting research initiatives in areas such as primary aldosteronism, high-grade gliomas, muscle invasive bladder cancer, multiple myeloma, as well as in cardiovascular disease and inflammation. On the economic side, there is an assessment of the economic implications of CXCR4-directed molecular imaging.

Dr. Dirk Pleimes, Pentixapharm’s Chief Medical Officer, commented, “We are excited about the opportunity to highlight the many applications of CXCR4 targeting compounds and the work of our collaborators at one the largest gatherings of nuclear medicine professionals globally. The abstracts accepted from investigator-initiated studies supported by Pentixapharm and others also demonstrate the ongoing interest of academia in CXCR4 and the still untapped potential. We look forward to welcoming friends and collaborators at Pentixapharm’s booth in Hall H, stand H19 for updates and discussions”.

A list of abstracts presentations featuring CXCR4 targeting compounds can be found here.

About Pentixapharm

Pentixapharm is a clinical-stage radiopharmaceutical development company with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceuticals for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a Phase III registration study with PentixaFor in PA that will start in Europe and in the United States in 2025.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
phillip.eckert@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com

EMA Grants PRIME Status to Pentixapharm’s Lead Candidate PentixaFor

Disclosure of Insider Information according to Article 17 of Regulation (EU) No. 596/2014

Würzburg and Berlin, Germany, October 18, 2024 - The European Medicine Agency (EMA) has granted PRIME Status to Pentixapharm’s lead candidate Ga68-PentixaFor, thereby granting an early and proactive support for the development of the radiodiagnostic and the possibility of an accelerated approval. The benefits of PRIME status include an early appointment of CHMP or CAT rapporteurs, iterative scientific advice on development plans, introductory meeting on regulatory requirements, and potentially a total fee exemption for scientific advice. The status also confirms that PentixaFor has the potential to address, in primary aldosteronism (PA), an unmet medical need to a significant extent.

PentixaFor is a novel tracer for positron emission tomography (PET) imaging targeting the C-X-C receptor 4 (CXCR4). High expression of CXCR4 has been identified in aldosterone-producing tissue, which is responsible for the aldosterone over-secretion that causes PA. PentixaFor aims to be a non-invasive and accurate alternative to adrenal venous sampling (AVS), the current invasive and difficult Standard of Care procedure, offering the potential to transform diagnostic subtyping in PA.

PRIME is a status granted by the EMA for promising medicines that target an unmet medical need with the goal of optimizing these medicines’ development. The PRIME scheme is based on enhanced interaction and dialogue between EMA and Sponsor, to improve the development plans and speed up the evaluation, so that the medicines can earlier reach the patients. In particular, the PRIME scheme allows iterative scientific advice on the overall development plans and key issues, expedited follow-up scientific advice with shortened timelines, and potential accelerated assessment at the time of application for a marketing authorization. Since the start of the program in 2016, only 139 applications were granted, with Ga68-CXCR4 being the first radiodiagnostic.

Primary aldosteronism, also known as Conn’s syndrome, is an adrenal gland disorder and the most common cause of secondary hypertension. However, it remains difficult to diagnose and to effectively treat with current methods. Pentixapharm is currently preparing a Phase III pivotal study to obtain marketing authorization in PA that will start in 2025.

About Pentixapharm

Pentixapharm is a clinical-stage radiopharmaceutical development company with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceuticals for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

Pentixapharm’s clinical pipeline includes PentixaTher, an Yttrium-90-based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a major cause of hypertension. Pentixapharm is currently preparing a Phase III registration study with PentixaFor in PA that will start in Europe and in the United States in 2025.

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
phillip.eckert@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com