Ad hoc announcement pursuant to Article 17 MAR

RHÖN-KLINIKUM Aktiengesellschaft

Schlossplatz 1

97616 Bad Neustadt a. d. Saale

ISIN DE0007042301 / WKN 704230

Bad Neustadt a. d. Saale | 14 January 2026

RHÖN-KLINIKUM Aktiengesellschaft adjusts the EBITDA forecast for the financial year 2025

RHÖN-KLINIKUM Aktiengesellschaft announces that the Group’s projected EBITDA (earnings before interest, taxes, depreciation, and amortization – as defined on page 35 of the Annual Report 2024) for the financial year 2025 will likely not be achieved. Due to unforeseen business developments, the Company now expects, based on preliminary and unaudited figures that still need to be consolidated at Group level, an EBITDA in the range of EUR 100 million to EUR 105 million, instead of the previously projected EBITDA between EUR 110 million and EUR 125 million. The management board maintains its forecast for the past financial year with regard to the other key performance indicators.

The preliminary and unaudited figures available to the management board indicate that the expected effects from the refinancing of increased personnel and material costs for the provision of hospital services, such as immediate transformation costs, and the planned agreement with health insurance companies regarding legacy cases, will only have a delayed impact.

RHÖN-KLINIKUM AG is one of the largest healthcare providers in Germany. The hospitals offer excellent medical care with a direct tie-in to universities and research facilities. Each year some 913,000 patients are treated at our five sites of Campus Bad Neustadt, Klinikum Frankfurt (Oder), Universitätsklinikum Gießen and Universitätsklinikum Marburg (UKGM) as well as Zentralklinik Bad Berka. The Company employs over 18,700 persons. The innovative RHÖN Campus approach for cross-sector and future-oriented healthcare delivery in rural areas, the steadfast continuation of the gradual digital transformation within the Company as well as the strategic partnership with ASKLEPIOS are important elements of our corporate strategy. RHÖN-KLINIKUM AG is an independent Company operating under the umbrella of Asklepios Kliniken GmbH & Co. KGaA. www.rhoen-klinikum-ag.com

Contact:

RHÖN-KLINIKUM AG | Head of Group Finance

Norman Dittes | T. +49 9771 65-12210 | norman.dittes@rhoen-klinikum-ag.de

RHÖN-KLINIKUM AG | Corporate Communications
Heike Ochmann | T. +49 9771 65-12130 | heike.ochmann@rhoen-klinikum-ag.com
 

RHÖN-KLINIKUM AG | Schlossplatz 1 | 97616 Bad Neustadt a. d. Saale

Mainz Biomed to Present Results of Pancreatic Cancer Verification Study at AACR 2026 Annual Meeting

First data on blood-based mRNA signature for pancreatic ductal adenocarcinoma (PDAC) detection and intraductal papillary mucinous neoplasms (IPMN) differentiation to be presented in San Diego

BERKELEY, US – MAINZ, Germany – January 14, 2026 — Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, is excited to announce its participation in the upcoming American Association for Cancer Research (AACR) 2026 Annual Meeting. This prestigious conference will be held April 17 to 22, 2026, in San Diego, California. Organized by the American Association for Cancer Research, this premier event gathers scientists, clinicians, and industry leaders from around the world to share groundbreaking cancer research and explore new approaches in oncology.  

At AACR the Company will present the results of its verification study evaluating a compact proprietary combination of blood-derived mRNA biomarkers and an AI-assisted modeling approach designed to differentiate PDAC from benign conditions including IPMNs in a 30-subject cohort.

Further details will be published in the online Proceedings of the AACR.

The Company looks forward to present the results of this study at AACR as it aims to revolutionize pancreatic cancer screening practices and contribute to a reduction in cancer mortality rates worldwide.

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 as to Mainz Biomed:

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 and its mid-year report on Form 6-K filed on September 26, 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.

FY 2024/25: BRAIN Biotech AG benefits from successful monetization of projects and strong corporate cost control

• Challenging sales environment, but strong corporate cost control
• Successful monetization of projects from the BRAINBioIncubator pipeline
• Group’s cash position remains solid at € 6.2 million

ZWINGENBERG, Germany, January 14, 2026 – BRAIN Biotech AG, a leading provider of specialized enzymes and innovative biosolutions for industry, has published the BRAIN Biotech Group´s financial figures for the fiscal year 2024/25.

Consolidated revenue in the 2024/25 financial year fell from € 54.6 million to € 49.6 million. This largely results from the business segment BRAINBioIncubator that has been impacted by the adverse business environment in pharma-related contract services. Thanks to the successful cost containment measures, Group adjusted EBITDA remained at around last year’s level. The Group has maintained a solid cash position of € 6.2 million while significantly reducing cash debt over the same period.

Adriaan Moelker, CEO of BRAIN Biotech AG, commented on the results: “BRAIN Biotech continues to move forward in a world full of volatility, uncertainty and complexity. The past financial year had its ups and downs. We have not generated the revenue growth, also in our core segment, BRAINBiocatalysts, we were planning for. At the same time, the team has delivered very well on the project execution from the BRAINBioIncubator pipeline, leading to significant future upside, and it successfully kept costs under control.” Adriaan adds on the strategic direction of the company: “We have stayed true to our core in exciting biotechnology, working with a strong network of partners to deliver innovations to customers and consumers. We continue our path becoming a leading enzyme company, along with investment in and monetization of our BRAINBioIncubator to deliver breakthrough innovations.”

Development of the operational segments

Revenues in the core segment BRAINBiocatalysts (enzymes, microorganisms, and ingredients) slightly declined to € 45.4 million versus € 47.5 million in the previous financial year. While some subsegments have been growing handsomely, other business activities within the segment performed below expectations. The translation effects relating to the weak USD/EUR exchange rate, which softened by around 14 per cent compared to the planning horizon, explain larger parts of the deviation from the previous year. Fermentation output has increased with the second large-scale fermenter being fully available. The segment’s adjusted EBITDA was at € 4.4 million versus € 5.1 million last financial year. This decline is mainly attributable to lower sales volume in contrast to a cost base which had been set up for growth.

The management has initiated several actions to boost growth. Execution on our main investments was very satisfactory with major factory upgrades in Cardiff for workplace as well as food safety and Nieuwkuijk with the new site under construction.

Revenue in the BRAINBioIncubator segment (comprising research-intensive R&D projects with industrial partners and internal projects) decreased from € 7.3 million to € 4.2 million. This is attributable to a weak environment for contract research and library sales in the pharma sector. In addition, the previous financial year was marked by significant milestone income of around € 1.5 million which could not be repeated in the 2024/25 reporting year as forecasted. The segment’s adjusted EBITDA stood at – € 1.3 million after – € 2.2 million in the previous financial year thanks to very strong cost containment measures. These measures included the strategic spin-out and licensing of the therapeutic related proprietary CRISPR-Cas technology to Akribion Therapeutics GmbH.

Key financial data

¹ Revenues + change in inventories + other income including R&D grants
² The reconciliation from adjusted to unadjusted EBITDA can be found in the Annual Report 2024/25

Outlook

For the financial year 2025/26, BRAIN Biotech expects a small increase in group revenues vs. the previous financial year. The segment BRAINBiocatalysts is expected to show revenues similar to those of the previous financial year, with an associated adjusted EBITDA margin of around ten percent. The business segment BRAINBioIncubator is expected to grow markedly, with revenues of around € 5 million.

A more detailed quantitative guidance for the financial year 2025/26 will be issued with the 3M reporting on February 25, 2026.

Link to BRAIN Biotech AG Annual Report 2024/25:

https://www.brain-biotech-group.com/en/investors/financial-publications-calendar/financial-reports/

+++

Contact Media

Dr. Stephanie Konle, PR & Corporate Communications
Phone: +49 6251 9331-70
Email: stk@brain-biotech.com

Contact Investor Relations

Martina Schuster, Investor Relations
Phone: +49 6251 9331-69
Email: ms@brain-biotech.com

BRAIN Biotech

The BRAIN Biotech Group is a leader in researching, developing, and producing specialty enzymes, focusing on the food and life sciences industries. In addition, the group develops microbial production strains and scalable bioprocesses for the economic production of specialty enzymes and other proteins. BRAIN Biotech also offers customized biological solutions to the industry for more sustainable products and efficient processes.

BRAIN Biotech AG is the parent company of the BRAIN Biotech Group. The company´s activities are divided into two business segments: BRAINBiocatalysts (development, production, and distribution of specialty enzymes, microorganisms, and ingredients) and BRAINBioIncubator (research-intensive development projects and pharmaceuticals).

BRAIN Biotech operates its own fermentation facilities in the UK and has additional production sites in continental Europe and the US. BRAIN Biotech AG has been listed on the Frankfurt Stock Exchange since February 9, 2016 (Ticker symbol: BNN; ISIN: DE0005203947 / WKN: 520394). In the 2024/25 fiscal year, the group generated revenue of € 49.6 million with around 280 employees. For more information, visit: www.brain-biotech-group.com.

The BRAIN Biotech Group on social media and on the internet:

BRAIN Biotech Gruppe

Web: www.brain-biotech-group.com

LinkedIn: https://www.linkedin.com/company/brainbiotech

Threads: https://www.threads.net/@brainbiotechag

Bluesky: https://bsky.app/profile/brain-biotech-group.com

X: https://x.com/BRAINbiotech

Youtube: https://www.youtube.com/channel/UCS33HJqku674X22UQ8QIsyg

Biocatalysts Ltd (Production, Distribution)

Website: https://www.biocatalysts.com/

LinkedIn: Biocatalysts Ltd on LinkedIn / BRAIN-Biocatalysts Life Science Solutions on LinkedIn

BRAIN Biotech Zwingenberg (Technologies & R&D Services)

Website: www.brain-biotech.com

LinkedIn: BRAIN Biotech Technologies & Services

AnalyticonDiscovery (R&D)

Web: https://ac-discovery.com/

LinkedIn: https://www.linkedin.com/company/analyticon-discovery/

Disclaimer

This press release contains forward-looking statements. These statements reflect the current views, expectations, and assumptions of the management of BRAIN Biotech AG, and are based on information currently available to the management.

Forward-looking statements are no guarantees of future performance, and entail both known and unknown risks as well as uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Numerous factors exist that could influence the future performance of and future developments at BRAIN Biotech AG and the BRAIN Biotech Group. Such factors include, but are not limited to, changes in the general economic and competitive environment, risks associated with capital markets, currency exchange rate fluctuations, changes in international and national laws and regulations, in particular with respect to tax laws and regulations, as well as other factors.

BRAIN Biotech AG does not undertake any obligation to update or revise any forward-looking statements.

Berlin, 12 January 2026. Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) will participate in the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, 14 January 2026, at the Westin St. Francis in San Francisco, CA, USA. Dr Harald Hasselmann, CEO of Eckert & Ziegler SE, will present the company at 17:15 PST.

The presentation will be available as an audio livestream on the company’s website: https://www.ezag.com/investors/presentations/
After the event, the recording will be available for approximately 30 days.

About Eckert & Ziegler.
Eckert & Ziegler SE, with more than 1.000 employees, is a leading specialist for isotope-related components in 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.

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

Peer-reviewed study demonstrates LEON’s FR-JET^® modular mixer enables stable high-concentration mRNA-LNPs with enhanced in vivo activity

Planegg/Munich (Germany), January 9^th, 2026 – A new study published in Pharmaceutics (https://doi.org/10.3390/pharmaceutics18010050) shows that LEON’s FR-JET^® modular mixer addresses key manufacturing challenges by enabling the production of highly concentrated lipid nanoparticles (LNPs). The study demonstrates that LNP formulation at significantly higher lipid mixture concentrations, beyond those currently reported in the literature and industry sources, can improve biological function in vivo, streamline manufacturing, and improve storage stability.

Overcoming the bottleneck

“There is growing recognition across the industry that LNP manufacturing challenges are not solely scientific, but are also largely operational in nature,” said Dr. Blerina Shkodra, lead author of the study. “Using LEON’s FR-JET^® technology, we show that LNPs can be formulated at lipid mixture concentrations above 50 mg/mL, not only retaining product quality but also enhancing potency in vivo. These findings indicate a practical approach to simplified manufacturing and increased throughput, enabling drug innovators to bring life-saving mRNA therapies to patients faster and more efficiently.”

Traditional microfluidic mixers are frequently limited by clogging, poor robustness, and scalability barriers, while conventional T-mixers can exhibit inconsistent reproducibility often associated with scaling-out strategies that can complicate manufacturing. In contrast, LEON’s FR-JET^® modular mixer delivers a robust mixing, unlocking process intensification while supporting a predictable and direct scale-up.
 

Why formulation at significantly higher lipid mixture concentrations matters for LNP developers:

Manufacturability – process intensification: Manufacturing at higher starting material concentrations can shorten, or even eliminate, the initial rate-limiting ultrafiltration step in tangential flow filtration (TFF), reducing overall downstream process time and buffer consumption during diafiltration.

Product Performance – potency and dosing: Cryogenic transmission electron microscopy (Cryo-TEM) revealed more uniform, solid-core particles. Increased lipid and RNA concentrations can enhance in vivo potency, which may translate into improved tolerability and more efficient dosing strategies.

Product Quality – morphology and stability: Higher solid-core fractions indicate more uniform particle morphologies, alongside demonstrated colloidal stability for 3 to 6 months in two different buffer systems.

CMC Scalability – development to manufacturing: This approach supports smoother translation from formulation development to manufacturing scale, enabling more robust processes and easier technology transfer.

“This peer-reviewed study validates the science behind the FR-JET^® technology and confirms that our commercially available manufacturing systems are making a big difference,” said Dr. Wolfgang Hofmann, CEO of LEON. “It marks the beginning of a new phase for LNP manufacturing, and it paves the way for what LEON has prepared to deliver in 2026.”

ABOUT LEON (leon-nanodrugs GmbH)

Based in Planegg/Munich, leon-nanodrugs GmbH is a Pharmatech company specializing in the development and commercialization of equipment for the encapsulation of genetic material and other pharmaceutical active substances into nanoparticles, such as lipid nanoparticles (LNPs). The company leverages its proprietary FR-JET^® technology to build innovative solutions. Its equipment portfolio includes NANOscreen^® for formulation screening, NANOlab^® for process development, as well as NANOme^® and NANOus^® for GMP manufacture. These systems are suitable for both individualized scales and commercial production, and the company further supports its clients by offering formulation and process development services. LEON’s platform aims to empower pharmaceutical companies, small biotech, research institutes, and CDMOs to capitalize on advancements in advanced therapies.

For further information, please visit https://leon-nanodrugs.com/ and follow us on LinkedIn.

During J. P. Morgan Healthcare Week, Biotech Showcase™ Provides Private and Micro- to Mid-Cap Public Company Executives One-Stop Access to Investors,
Pharma Partners and Media

Join Bristol Myers Squibb, Genentech, Google, J.P. Morgan, Novo Nordisk, Pappas Capital, Amazon Web Services, BIO, Members of the Media, and 1,200+ Investors

Registration and Partnering Platform Access Now Open

SAN FRANCISCO — January 9, 2026 — More than 3,000 leaders within biotechnology are registered to attend Biotech Showcase 2026 during J.P. Morgan Healthcare Week for unmatched opportunity to forge critical investment and partnering relationships as well as industry and financial media covering the event. Hosted by Demy-Colton and EBD Group, the event returns to the Hilton San Francisco Union Square January 12-14, 2026. A virtual event extends access to networking and insights January 20-21, 2026. Registration and partnering are now open for both.

Sara Jane Demy, Founder & CEO of Demy-Colton, said, “We anticipate renewed investment and dealmaking momentum in 2026, driven by rapid scientific advancement, evolving funding models, and the convergence of technology and biology. At the same time, policy changes are influencing how companies approach regulation, R&D strategy, capital deployment, and partnering. This is our 18th year for Biotech Showcase, and we’re so pleased it’s become a premier venue for dealmaking during JPM Week.”

Biotech Showcase attendees have the opportunity to:

• Engage in partnering and investment meetings among attending investors and pharma companies.
• Get to know emerging private and small-cap public biotech and TechBio companies through company presentations and partnering meetings.
• Meet with members of industry media including Endpoints, STAT, BioSpace, Fast Company, and others.
• Join curated discussions with leaders from companies like Novo Nordisk, Astellas, J.P. Morgan, Regeneron, Ipsen, Stifel, Sofinnova Investments, Cellino, Envisagenics, Syneos Health, and Angelini Ventures, among many others.

Tina Elder, Global Managing Director, EBD Group US, said, “As the premier investor conference for private and micro- to mid-cap biotechnology companies, Biotech Showcase offers unmatched opportunities for networking, dealmaking, and partnering across biotech, pharma, and the global investment community. As the industry looks toward 2026, Biotech Showcase provides a timely forum for engaging with the companies and leaders driving the industry’s evolution, offering direct exposure to emerging science, differentiated platforms, and the TechBio capabilities now essential to competitive drug development.”

Opening day highlights: 

Healthcare Innovation: Strategic Adaption to the New Policy Landscape

• Michael Margolis – Senior Managing Director, Head, Healthcare Investment Banking, Oppenheimer & Co. Inc.
• Thomas Barker – Partner, Co-Chair, Healthcare Department, Foley Hoag
• Fritz Bittenbender – Board Chair, BIO & SVP, Genentech
• Jeremy Levin – Chairman & CEO, Ovid Therapeutics Inc.
• Lori Reilly – COO, PhRMA
• Joe Shonkwiler – Head, Healthcare & Life Science, Venture Capital BD, Google

The 2026 Pharma Perspective: Dealmaking Driving Therapeutic Development

• David Schull – President, Russo Partners
• Tamara Darsow – SVP, Global Business Development, Novo Nordisk
• David Jenkins – SVP, Head, External Innovation and Research, Ipsen
• Amanda Kay – Senior Partner & Chief Business Development Officer, Flagship Pioneering
• Adam Pearson – Chief Strategy Officer, Astellas
• Konstantina Katcheves – SVP & Chief Business and Strategy Officer, Acadia Pharmaceuticals

New Breakthroughs in Drug Discovery & Target Identification

• Ignacio Guerrero-Ros – VP, Russo Partners
• Sean Lin – CEO, ChemLex
• Ravit Netzer – Co-Founder & CEO, Scala Biodesign
• Ritish Patnaik – CEO, Curve Biosciences
• Cameron Pye – Co-Founder & CEO, Unnatural Products Inc.
• Adrian Woolfson – Founder, President & CEO, Genyro

Closing day highlights:

Media Round-Up: Heard Around the Hilton

• Virginia Amann – CEO & Founder, ENTENTE Network
• Alex Philippidis – Senior Business Editor, GEN
• Allison DeAngelis – Reporter, Biotech Startups & Venture Capital, STAT News
• Ron Leuty – Senior Reporter, San Francisco Business Times
• Kyle LaHucik – Senior Reporter, Endpoints News
• Annalee Armstrong – Senior Editor, BioSpace

For information about registering for Biotech Showcase or to apply to present or sponsor, please visit www.informaconnect.com/biotech-showcase/. 

About Demy-Colton

Demy-Colton is a leading life sciences and digital health events organization at the forefront of building networks between innovative life sciences companies and industry stakeholders. Its unique events facilitate networking on a global scale, including Biotech Showcase™, BioFuture™, Global Biotech CEO Summit™, Executive Clinics™, and Demy-Colton Virtual Salons™. These events build networking communities that transcend geographical boundaries and establish ongoing, high-value relationships among the industry’s top decision-makers, investors and thought leaders. For more information, visit www.demy-colton.com. 

About Life Sciences Partnering and Investment by Informa

Our mission is to help collaborations get started across the life science value chain. Our range of partnering conferences has grown to become the largest and most productive conference platform in the industry. Each one of our landmark events held in key life science markets around the world is powered by our state-of-the-art partnering software, partneringONE®, that enables delegates to efficiently identify and engage with new opportunities via one-to-one meetings. Today, our events (BIO-Europe®, BIO-Europe Spring®, Biotech Showcase™, ChinaBio® Partnering Forum, Asia Bio Partnering Forum, BioEquity Europe, LSX USA Congress, Investival Showcase Europe, European Lifestars Awards, Investival Showcase USA, LSX Europe Congress, LSX Nordic Congress) annually attract more than 14,000 senior life science executives who engage in over 83,000 one-to-one partnering meetings. These vital one-to-one engagements are the wellspring of deals that drive innovation in our industry.

Contact
Katie Morris
ENTENTE Network of Companies
katiemorris@ententeinc.com

MC Services, Inc.
Laurie Doyle
Phone: +1-339-832-0752
E-mail: EBDGroup@mc-services.eu

Bad Homburg, January 9, 2026 – Fresenius Medical Care AG (“Company”) has decided to continue the share buyback program announced in an ad-hoc release on June 17, 2025, by repurchasing a second tranche. The share buyback program has a total volume of EUR 1 billion (excluding ancillary costs).

The first tranche of the Company’s share buyback program was completed ahead of schedule on December 29, 2025.

With the second tranche it is intended to repurchase own shares for a total amount of around EUR 415 million from January 12, 2026, to May 8, 2026 (inclusive). The share buyback program is therefore expected to be completed significantly earlier. The shares shall be acquired on the stock exchange and are to be predominantly redeemed and, to a significantly lesser extent, may be used for allocations under incentive-based compensation plans.

The share buyback program is based on the authorization to purchase and use treasury shares granted by the Company’s Annual General Meeting on May 20, 2021.

Contact:
Dr. Dominik K. Heger
Executive Vice President
Global Head of Investor Relations, Market & Competition, Sustainability
& Head of Investor Relations

Fresenius Medical Care AG
Else-Kroener-Strasse 1, 61352 Bad Homburg v.d. Hoehe, Germany
P +49 6172 2685822
Dominik.Heger@FreseniusMedicalCare.com
www.FreseniusMedicalCare.com

VarmX and Rentschler Biopharma partner to advance novel coagulation therapy toward Phase 3 and commercialization

• VarmX and Rentschler Biopharma expand collaboration from early development to late‑stage and commercial manufacturing of VMX-C001
• VMX‑C001 builds on strong regulatory momentum, including FDA Fast Track Designation and PMDA Phase 1 waiver, as it progresses toward a global Phase 3 trial
• Manufacturing will be transferred from Rentschler Biopharma site in Laupheim (Germany) to Milford, MA (USA)

Laupheim, Germany; Leiden, The Netherlands and Milford, MA USA. January 8, 2026 – Rentschler Biopharma, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, and VarmX, a biotech company developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and treatment of inherited coagulation disorders, today announced a collaboration to manufacture VarmX’s lead program, VMX-C001, for Phase 3 development and potential commercialization. VMX-C001 is a novel treatment to restore blood coagulation in patients requiring urgent surgery or experiencing severe bleeding while on FXa DOACs.

Rentschler Biopharma began supporting early development of VMX-C001 in 2022 at its Laupheim, Germany site and VarmX has since initiated its Phase 3 program using GMP material from Rentschler Biopharma. Building on the successful collaboration between both companies, all subsequent Phase 3 clinical supply, including process validation, will be manufactured at Rentschler Biopharma’s Milford, MA site as part of the seamless transition into late-stage clinical and commercial production. The CDMO brings strong expertise in producing a variety of biologics, including proven capabilities in intensified, perfusion-based processes, while also supporting fed-batch strategies. Rentschler Biopharma provides clients with continuity, speed and reliability from early development through commercialization and beyond.

VMX-C001 is a modified, human factor X protein, designed to be insensitive to FXa DOACs, effectively bypassing their anticoagulant activity and swiftly restoring the coagulation cascade. The product candidate was granted Fast Track Designation by the U.S. Food & Drug Administration (FDA) and a Phase 1 waiver from Japanese regulator PMDA in September 2025, recognizing the unmet need for treatments that can rapidly restore coagulation in patients receiving FXa DOACs. VarmX signed a global strategic collaboration and option agreement with CSL in September 2025. VarmX plans to initiate its global Phase 3 EquilibriX-S trial in urgent surgery in early 2026.

John Glasspool, Chief Executive Officer of VarmX, said: “Manufacturing readiness is key as we prepare to commence our landmark global EquilibriX-S Phase 3 trial, evaluating the ability of VMX-C001 to rapidly restore coagulation in patients taking any FXa DOAC undergoing urgent surgery. We’re pleased to extend our partnership with Rentschler Biopharma as we drive VMX-C001 towards becoming a new treatment option for the substantial number of patients on FXa DOACs who need emergency surgery.”

Benedikt von Braunmühl, Chief Executive Officer of Rentschler Biopharma, commented: “We are honored to continue our collaboration with VarmX, which reflects exactly what Rentschler Biopharma stands for: high‑impact technical expertise, long‑term partnership grounded in trust, and tailored solutions that bring breakthrough therapies to patients. As VMX‑C001 advances toward Phase 3, we remain fully committed to delivering seamless continuity, leveraging our FDA‑licensed sites in the EU and the U.S. and deep experience in late‑stage development and market approval. Guided by our vision of advancing medicine to save lives – together, we look forward to supporting VarmX on the path to commercialization.”

By 2030, approximately 30 million patients in the U.S., Europe and Japan are expected to receive FXa DOACs as a chronic anticoagulation therapy, including stroke prevention in atrial fibrillation and the prevention of deep vein thrombosis. Each week, more than 30,000 of these patients experience severe life-threatening bleeding or require emergency surgery, where the risk of bleeding poses a critical challenge¹.

VMX-C001 has been developed with significant clinical advantages, including universal dosing regardless of the specific FXa DOAC used, rapid and easy administration, compatibility with common anticoagulants like heparin, and no additional thrombotic risk. This strengthens the position of VMX-C001 to potentially become a new option for the substantial number of patients on FXa DOACs who need emergency surgery.

1: RBC and Cowen (2018–2024), Syneos Health Consulting (incl. Japan), and clinical literature

About Rentschler Biopharma SE

Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma’s high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. Rentschler Biopharma is a family-owned company with about 1,400 employees, headquartered in Laupheim, Germany, with operations in Milford, MA, USA. In 2024, the company joined the United Nations Global Compact, emphasizing Rentschler Biopharma’s focus on sustainability. For further information about the company, please visit www.rentschler-biopharma.com. Follow Rentschler Biopharma on LinkedIn.

About VarmX

VarmX is a spin-off from the Leiden University Medical Center (LUMC), founded in 2016 by Professor Pieter Reitsma, a world leading expert in hemostasis and thrombosis. VarmX’s lead compound VMX-C001 is a modified recombinant blood factor X. The compound is being developed for the treatment of severe spontaneous bleeding and for the prevention of bleeding during urgent surgery in patients taking oral factor Xa inhibitors (FXa DOACs) as anticoagulation therapy. The Company is supported by a strong syndicate of investors including Sound Bioventures, EIC, EQT Life Sciences (formerly LSP), Inkef, Lundbeckfonden BioCapital, Ysios Capital, BioGeneration Ventures and InnovationQuarter, as well as CSL. For more information, please visit www.varmx.com.

Contact:

Rentschler Biopharma SE
Dr. Latika Bhonsle-Deeng
Global Head of Communications
Phone: +49-7392-701-467
communications@rentschler-biopharma.com

Media inquiries

VarmX Media inquiries
Vigo Consulting
Rozi Morris
Phone: +44 20 7390 0230
VarmX@vigoconsulting.com