Mainz Biomed to Present the Future of Colorectal Cancer Screening at WEO CRC Screening Committee Meeting

BERKELEY, US and MAINZ, Germany – September 30, 2025 – Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, is pleased to announce its participation in the upcoming Colorectal Cancer (CRC) Screening Committee Plenary Meeting and Expert Working Group (EWG) Sessions hosted by the World Endoscopy Organization (WEO), taking place on October 3^rd, 2025, in Berlin, Germany.

This high-level gathering brings together global leaders in colorectal cancer screening to evaluate emerging technologies, exchange scientific insights, and help shape future strategies for early detection and prevention of CRC. As part of the session titled “Evaluation of New Tests”, Dr. Lena Krammes, Senior Scientist at Mainz Biomed, will present findings from the Company’s ongoing work in RNA-based diagnostics.

Dr. Krammes’ talk, titled “From Detection to Prevention – Early Evidence from RNA-based Screening Test for Precancerous Lesions Compared to Different FIT Cut-offs,” will showcase clinical data from the eAArly DETECT study, generated in 2024 highlighting the potential of stool RNA testing to identify both colorectal cancer and precancerous lesions. Key findings include:

• 97% sensitivity and 97% specificity for detecting colorectal cancer
• 82% sensitivity for advanced adenomas
• 100% detection of advanced adenomas with high-grade dysplasia

These results underline the potential for RNA-based testing to play a significant role not only in early detection of CRC, but also in prevention, by identifying high-risk lesions before cancer develops.

Mainz Biomed’s participation reflects its commitment to contributing to the global effort to improve CRC screening outcomes. The World Endoscopy Organization is a global non-profit organization dedicated to promoting high-quality endoscopy and the advancement of digestive health. Through its Colorectal Cancer Screening Committee, WEO works to promote CRC screening activities worldwide and support the implementation of screening programs, including fecal immunochemical tests (FIT), stool-based tests, and endoscopic procedures.

“We are honored to take part in this prestigious meeting,” said Guido Baechler, CEO of Mainz Biomed. “The invitation to join these expert discussions reinforces our belief that we are making important contributions toward developing effective, next-generation screening tools that can prevent colorectal cancer before it starts.”

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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About Mainz Biomed NV

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe. The Company is currently running its eAArly DETECT 2 clinical study in preparation for its pivotal FDA study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in blood and stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries

MC Services AG
Maximilian Schur / Simone Neeten
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact ir@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on March 31, 2025. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

PRESS RELEASE

Viromed Medical AG launches in vivo and ex vivo study with cold plasma on living lungs

Rellingen, September 30, 2025 – Viromed Medical AG (“Viromed”; ISIN: DE000A3MQR65), a medical technology company and pioneer of cold plasma technology, announces the start of a comprehensive in vivo and ex vivo study on living lungs. The in vivo and ex vivo tests are part of the ongoing study on the treatment of ventilator-associated pneumonia (VAP) using cold atmospheric plasma and are being conducted in collaboration with Hannover Medical School (MHH).

Prof. Dr. Hortense Slevogt, scientific director of the study at Hannover Medical School, emphasizes: “The results so far are groundbreaking. If the use of cold atmospheric plasma also proves safe in living lung tissue, it could potentially revolutionize the treatment of ventilated patients.”

Uwe Perbandt, CEO of Viromed Medical AG, explains: “Our study is the first of its kind and is one of the most comprehensive in the field of pulmonology worldwide. This gives us a significant competitive advantage. Our goal is to use cold plasma therapy to significantly reduce mortality from VAP and all bacterial or viral lung infections worldwide.“

Building on promising in vitro results, which showed 100% effectiveness of cold plasma technology against MRSA without damaging human lung tissue, the study is now entering its decisive next phase. For the first time, the interaction between the respiratory epithelium, bacterial infection, and cold plasma therapy will be investigated under realistic conditions—Viromed is thus closing a significant gap in international medical research.

The detailed results of the in vivo and ex vivo study will be published in a fast-track paper.

Viromed Medical AG is a pioneer in the field of cold plasma technology. With proprietary technologies, globally unique cell culture models, and close collaboration with leading university centers and research institutes, the company has a significant research and development advantage over its competitors.

About Viromed Medical AG

Viromed Medical AG specializes in the development, manufacture and distribution of medical products. The operating business of the company, which has been listed on the stock exchange since October 2022, focuses on the distribution of innovative cold plasma technology for medical applications via its wholly owned subsidiary Viromed Medical GmbH. Viromed can draw on a broad customer base in the DACH region and beyond. Viromed is pursuing the goal of further advancing the use of cold plasma technology in medicine in the coming years and realizing the corresponding growth potential.

www.viromed-medical-ag.de

Contact Viromed

E-Mail: kontakt@viromed-medical.de
 

Press contact

E-mail: viromed@kirchhoff.de

PL BioScience Announces Conferences Attendance

Aachen, Germany, September 30, 2025 – PL BioScience GmbH, a German life science company specializing in the production and development of Human Platelet Lysate (HPL) for cell expansion, today announced its participation in six life sciences conferences this fall.

Meet our management team and marketing colleagues at one of the upcoming conferences:

Festival of Biologics
September 30 – October 2 in Basel, Switzerland
Anna Kolkmann (Sales Manager) and Maria Noronha (Marketing Specialist) will be present
Booth: 501C
Scheduling meetings is possible through the Terrapinn Event App

BioJapan
October 8 – 10 in Yokohama, Japan
Jungsoo Park (VP Marketing & Sales) and Kana Miyakubi (Sales Account Manager) will be present
Booth: B-68 at the EU-Japan Centre for Industrial Cooperation Pavilion

Innovative Therapies Days 2025
October 9 – 10 in Besançon, France
Silver Sponsor of the conference
Cécilia Mesa (Sales Manager) will be present and exhibit a poster
Booth: 6
Scheduling meetings is possible through the B2Match platform

CPHI Frankfurt 2025
October 28 – 30 in Frankfurt, Germany
Hatim Hemeda (CEO & Co-Founder), Christian Wilkes (CFO & Co-Founder) and Jungsoo Park will be present
Booth: 4S115
Scheduling meetings and contacting are possible through the CPHI Event Planner App

BIO-EUROPE 2025
November 3 – 5 in Vienna, Austria
Hatim Hemeda and Christian Wilkes will be present
Scheduling meetings through the partneringONE system

Cell 2025
November 11 – 12 in London, United Kingdom
Network & Programme Sponsors
Silke Isenhardt (Field Application Scientist) and Maria Noronha (Marketing Specialist) will be present and exhibit a poster
Booth: 54
Contact will be possible through the event app from November

About PL BioScience:

PL BioScience GmbH, a life science company located in Aachen, Germany, specializes in the production and development of Human Platelet Lysate (HPL). The company has pioneered proprietary technology to produce fully artificial HPL, allowing for a fully lab-made, scalable supply of HPL. PL BioScience currently offers a comprehensive portfolio of donor-derived, natural HPL products tailored for a range of applications – the ELAREM^TM platform. From academic and preclinical research to cell therapy and biopharmaceutical manufacturing, ELAREM™ ensures seamless translations of regenerative medicine breakthroughs – from the lab to patients in need. PL BioScience is the only company worldwide holding a patent for the gamma-irradiation of HPL, covering the manufacturing process for ELAREM™ Ultimate-FD PLUS.

For more information on PL BioScience and the ELAREM™ platform, visit: https://www.pl-bioscience.com/

Contact:
Dr. Hatim Hemeda, CEO
PL BioScience GmbH
+49(0)24195719-100
info@pl-bioscience.com

Media contact:
MC Services AG
Raimund Gabriel, Dr. Regina Lutz
+49 (0)89 210 228 0

U.S.: Catherine Featherston
+1-203-444-4393
E-Mail: plbioscience@mc-services.eu

REPRONOVO ANNOUNCES CLINICAL TRIAL APPROVAL NOTICE FOR RPN-001 IN CHINA

• The approval enables initiation of RPN-001 Phase 1 trial in China
   
• Key regulatory milestone in the global development of RPN‑001
   

Lausanne, Switzerland and Copenhagen, Denmark, September 30, 2025 – ReproNovo, a company dedicated to developing innovative treatments for reproductive medicine and women’s health, today announced that China’s National Medical Products Administration (NMPA) has issued a clinical trial approval notice for RPN-001 (leflutrozole). This approval enables the initiation of a Phase 1 trial in China, marking a key regulatory milestone in the global development of RPN‑001 as a potential treatment for male infertility associated with low serum testosterone.

“Entering China with our first approved clinical study marks a meaningful geographic expansion for ReproNovo,” said Joan-Carles Arce, MD, PhD, Chief Scientific & Medical Officer of ReproNovo. “With this approval, we will soon have active clinical programs in the U.S. and China, two of the world’s largest healthcare markets, which reinforces our commitment to global development in reproductive medicine.”

RPN-001 is being studied to show improvements in testicular function and promotion of sperm production (spermatogenesis). The latest approval in China aligns with ReproNovo’s global development strategy and follows recent progress in the U.S., where a Phase 2 trial is underway.

“We are committed to expanding access to innovative therapies where few treatment options currently exist,” said Jean Duvall, Chief Executive Officer of ReproNovo. “With clinical activities now advancing in both the U.S. and China, we are building the foundation for a truly global approach to reproductive medicine and women’s health innovation.”
 

ABOUT REPRONOVO:
ReproNovo is a cutting-edge biopharmaceutical company developing innovative solutions to address critical gaps in reproductive medicine and women’s health. Our team is composed of proven experts with deep experience in reproductive medicine, drug development, regulatory affairs and business development who have throughout their careers successfully brought multiple therapies to market. Lead clinical compound, RPN-001 (leflutrozole), is being developed to treat male infertility. RPN-002 (nolasiban) is a first-in-disease and first-in-class molecular entity being developed to manage adenomyosis and increase the probability of embryo implantation in women undergoing assisted reproductive technology (ART) treatments. Both assets are Phase 2 ready. ReproNovo is financed by Jeito Capital, AXA IM Alts, founding investor M Ventures, Ysios Capital and ALSA Ventures. Headquartered in Lausanne, Switzerland, the company has its primary development team in Copenhagen, Denmark and an additional development site in Barcelona, Spain. For more information, visit the Company’s website at www.repronovo.com or follow us on LinkedIn.
 

ABOUT RPN-001 (leflutrozole):
RPN-001 is a novel orally administered compound being developed for the treatment of infertility in men with low serum testosterone. The small molecule inhibits the enzyme aromatase, suppressing testosterone conversion to estradiol, thereby normalizing testosterone levels. Low testosterone levels are becoming more prevalent, even in younger men, highlighting the urgent demand for new treatments. RPN-001 is currently being evaluated in a U.S. Phase 2 trial (https://clinicaltrials.gov/study/NCT06993155?term=Leflutrozole&rank=1). ReproNovo has an exclusive global license agreement with Mereo BioPharma for the development and commercialization of leflutrozole.
 

CONTACT INFORMATION:
ReproNovo
Rue de Langallerie 11
1003 Lausanne, Switzerland
info@repronovo.com
 

MEDIA CONTACT:
MC Services AG
Brittney Sojeva
repronovo@mc-services.eu
+49 211 529 252 14

Abivax Announces Acceptance of Additional Late-Breaking Abstract from the ABTECT Phase 3 Induction Trials to be Presented at 2025 United European Gastroenterology (UEG) Meeting

• Late Breaking Abstract titled EFFICACY AND SAFETY OF OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM TWO, PHASE 3, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 8-WEEK INDUCTION TRIALS (ABTECT-1 & 2) to be presented Sunday, October 5 at 5pm CEST

PARIS, France – September 29, 2025 – 10:05 PM CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company developing innovative therapies to address chronic inflammatory diseases, today announced the presentation of a second late breaking abstract for its lead drug candidate, obefazimod, for the treatment of moderately to severely active ulcerative colitis (UC) at The United European Gastroenterology Congress, taking place October 4-7, 2025, in Berlin, Germany.

“The acceptance of this additional late-breaking abstract underscores the significance of the ABTECT Phase 3 induction trial results which demonstrate the statistically significant and clinically meaningful clinical activity and impressive safety and tolerability profile of obefazimod in patients with moderately to severely active ulcerative colitis during the 8-week induction trials.  These findings are crucial steps towards potentially offering a novel, first-in-class oral treatment option for patients who urgently need new therapeutic approaches to achieve and maintain remission,” said Fabio Cataldi, MD, Chief Medical Officer of Abivax.

Obefazimod data to be presented:

 
About Abivax
Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis.

Contact:
Patrick Malloy
SVP, Investor Relations
Abivax SA
patrick.malloy@abivax.com
+1 847 987 4878

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business. Words such as “anticipate,” “expect,” “potential” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the Company’s expectations for the potential therapeutic benefit of obefazimod, and the Company’s participation at industry conferences. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in its Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 24, 2025 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development, including further assessment by the Company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are made only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell or the solicitation of an offer to purchase or subscribe for securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

PRESS RELEASE

Heidelberg Pharma Advances to Cohort 9 in Phase I/IIa Trial of Lead ATAC Candidate HDP-101 in Multiple Myeloma

• HDP-101 continues to demonstrate a favorable safety profile with no dose-limiting toxicities observed
• Early evidence of clinical activity observed in Cohort 8, highlighted by a very good partial response observed in one patient

Ladenburg, Germany, 25 September 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced the initiation of Cohort 9 in its ongoing Phase I/IIa dose escalation trial of HDP-101, the Company’s lead ATAC candidate for the treatment of relapsed or refractory multiple myeloma.

The Safety Review Committee (SRC) has confirmed that the 140 µg/kg dose level administered in Cohort 8 was safe and well tolerated. Based on these findings, the study is now progressing into Cohort 9 with an escalated dose of 175 µg/kg, administered in one dosing arm. Cohort 9 has already opened.

Eight patients were dosed in Cohort 8 and all patients completed the observation period, demonstrated a favorable safety and tolerability profile throughout. Encouraging signs of clinical activity have also emerged. Patients showed biological activity of HDP-101, and a very good partial response has already been observed in one patient. This adds to earlier positive outcomes, including one patient from Cohort 5 who is still on treatment and achieved complete remission, with no detectable tumor cells after ongoing HDP-101 monotherapy following multiple prior treatments. In addition, several patients across different cohorts have shown objective responses and promising anti-tumor activity, further supporting the therapeutic potential of HDP-101 in heavily pretreated patients with relapsed or refractory multiple myeloma.

Dr. András Strassz, Chief Medical Officer at Heidelberg Pharma, said: “Our lead ATAC candidate HDP-101 continues to demonstrate a strong safety and tolerability profile across all treated patients. The results from Cohort 8 demonstrate encouraging signs of clinical activity of HDP-101, including a very good partial response in one patient. These early efficacy signals are promising as we advance HDP-101 through the ongoing dose escalation study.”

Heidelberg Pharma’s Phase I/IIa clinical study is a non-randomized, open-label trial actively enrolling patients with relapsed or refractory multiple myeloma or other BCMA-expressing plasma cell disorders. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HDP-101 in this patient population.

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology.

The lead candidate HDP-101 is a BCMA ATAC in clinical development for multiple myeloma. A second ATAC candidate, HDP-102, has recently started clinical development in Non-Hodgkin Lymphoma. HDP-103 against metastatic castration-resistant prostate cancer and HDP-104 targeting gastrointestinal tumors such as colorectal cancer have completed preclinical development. Heidelberg Pharma is open for partnering.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com

ATAC^® is a registered trademark of Heidelberg Pharma Research GmbH.

ITAC™, ETAC™ are pending trademark applications of Heidelberg Pharma Research GmbH.

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will” “should” “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.

 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

NEW YORK, United States of America, September 26, 2025/APO Group/ — African Heads of State and Government convened global leaders on Wednesday at a high-level event on the margins of the 80th United Nations General Assembly, sounding the alarm on escalating threats to global health security.

Convened under the theme “Uniting for Global Health Security”, the joint event brought together the Global Leaders Network for Women’s, Children’s and Adolescents’ Health, chaired by H.E. President Cyril Ramaphosa of South Africa, and the African Leaders Malaria Alliance (ALMA), chaired by President Advocate Duma Gideon Boko of Botswana. Discussions were moderated by the Rt Hon. Helen Clark, chair of the Partnership for Maternal, Newborn, and Child Health and former prime minister of New Zealand.

Amid growing concern over stagnating progress toward the Sustainable Development Goals for health, leaders called for urgent financial commitments, stronger partnerships, and bold, united action to protect the world’s most vulnerable, including women, children, and adolescents, from preventable diseases such as malaria.

“The fight against malaria is becoming increasingly complex,” said President Advocate Duma Gideon Boko. “Shrinking budgets, rising biological resistance, humanitarian crises, and the impact of climate change are all contributing towards creating a perfect storm of challenges,” he added.

Funding declines threaten progress

Recent years have seen a dramatic erosion of official development assistance (ODA) for health, with African leaders warning that life-saving programmes risk collapse in the absence of urgent and sustained financing. Between 2021 and 2025 alone, ODA for health in Africa declined by an estimated 70%, even as widening equity gaps, conflict, and displacement have expanded both needs and vulnerability.

H.E. President Cyril Ramaphosa highlighted the impact of these cuts, “essential programmes to eliminate malaria have been compromised. This leaves millions without care and erodes decades of progress that has been made so far.”

A successful Global Fund Replenishment is vital

Leaders reiterated support for the upcoming 8th replenishment of the Global Fund to Fight AIDS, Tuberculosis and Malaria, which aims to raise US$18 billion at its November 2025 conference. The Global Fund, established in 2002, has been central to progress against the three diseases, saving more than 70 million lives. Leaders stressed that the upcoming replenishment is critical, not only to sustain momentum but also to prevent a reversal of hard-won gains amid rising threats.

The ALMA chair issued a rallying call on the upcoming replenishment, “I call on all countries and donors to invest boldly in the Global Fund replenishment. If we all come together, we will save 23 million lives from malaria, AIDS and TB, while strengthening our health systems.”

Strengthening national ownership, innovative resource mobilisation and local manufacturing

While underscoring the importance of global solidarity, the African leaders noted that African ownership and accountability must be at the centre of the response, with H.E. President William Ruto of the Republic of Kenya saying “the future of Africa health financing lies in our own hands. Encouragingly, across the continent, change is already underway.”

Through initiatives like national End Malaria Councils and Funds, countries are embracing innovative financing approaches to expand the pool of resources for malaria, with 11 African countries already having mobilised over US$166 million, illustrating the power of multi-sectoral collaboration. 

At the same time, African leaders recommended tried and tested innovations, calling for the World Bank’s International Development Association (IDA) to set up a 2^nd Malaria Booster Programme. The first malaria booster program (phase I and phase II) between 2005 and 2015 saw millions invested in malaria control and millions of cases prevented and lives saved. This vital programme helped “reinforce local health systems, such as community health workers, and enhance data systems and surveillance” said H.E. Muhammed B.S Jallow, vice president of the Republic of The Gambia.

With the recent IDA21 replenishment, there’s an opportunity to deliver a similar programme to address the challenges we face today, with the ALMA chair, President Advocate Duma Gideon Boko saying, “as ALMA, we are calling on the World Bank International Development Association to establish a second Malaria Booster Programme.” he said.

A push for national ownership was made by Dr Sania Nishtar, CEO of GAVI, who said “we strongly believe countries and not global health institutions should be at the centre of global health.” Dr Nishtar highlighted GAVI’s African Vaccine Manufacturing Accelerator which she said “promotes African self-reliance in vaccine manufacturing.” The GAVI CEO also shared that the vaccine alliance is “implementing the fastest vaccine rollout in Gavi’s 25-year history” with the introduction of malaria vaccines across 23 African countries, with early evidence showing a 13% drop in all-cause child mortality in vaccinated areas.

The need for public-private partnerships to deliver sustainable financing

Leaders called for the establishment of a Public-Private Partnership Health Accelerator to respond to declining traditional funding, with President Advocate Duma Gideon Boko encouraging fellow leaders to “think bigger and cast our net wider to mobilise even more resources to respond to the critical health challenges.”

This partnership will deliver new investments and drive progress toward universal health coverage. The accelerator is expected to leverage partnerships with the private sector, philanthropic foundations, high networth individuals and the diaspora, whilst reinforcing domestic commitments.

“We need a private-public partnership health accelerator that will drive whole-of-society progress towards the SDGs through sustainable high-value investments,” shared the ALMA chair.

This call for public private partnerships was endorsed by fellow leaders, with the vice president of the Republic of the Gambia saying these partnerships “can help us deliver sustainable financing at this critical moment and lead our continent to prosperity.”

The Big Push against Malaria

Earlier this year, the Africa Centre for Disease Control and Prevention (Africa CDC) unveiled a bold strategy to transform health financing across the continent amidst the volatile and ever-evolving global financing landscape. This momentum was amplified in Abuja with the launch of the “Big Push” to End Malaria in early September, placing malaria elimination at the heart of Africa’s health and development agenda. Building on this, African leaders at the UN General Assembly called for a paradigm shift in investments to sustain the fight against malaria and broader health challenges across the continent.

The joint event signalled renewed determination to confront overlapping crises with urgency, innovation, and unity, with H.E Dr Jean Kaseya, Director General of the Africa-Centres for Disease Control and Prevention, urging leaders to continue to turn these crises into opportunities to “start to raise sustainable financing, to build our own data system owned by the continent, to start to manufacture our own vaccines, medicines, and to build strong surveillance system. Now Africa is leading the world.”

As African countries moves towards greater ownership of our health systems and development agenda, Professor Senait Fisseha, a champion of sexual and reproductive health rights encouraged leaders to “to ensure it reflect our values, what we believe and is right, and is needed for our people” so that “we can create a continent in which every woman, every girl, every child can live to her fullest potential.”

“Together, let us rise to this moment. Let us prove that resilient health systems are the cornerstone of dignity, security and prosperity,” said H.E. President William Ruto of the Republic of Kenya at the conclusion of his remarks, echoing ALMA chair, President Advocate Duma Gideon Boko who said “we can make malaria elimination a reality. We can deliver a healthy tomorrow for women, babies, children and adolescents. The time to start is now.”

Distributed by APO Group on behalf of African Leaders Malaria Alliance (ALMA).

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Image Caption: L-R : H.E. President Advocate Duma Gideon Boko of Botswana, Chair of the African Leaders Malaria Alliance; H.E. President Cyril Ramaphosa of South Africa and Chair of the Global Leaders Network; H.E. President William Ruto of Kenya ;and the Rt. Hon. Helen Clark at the UNGA80 side-event on Global Health Security at the United Nations