Rentschler Biopharma Receives the Business Medal of the State of Baden-Wuerttemberg

• Prestigious award recognizes Rentschler Biopharma’s entrepreneurial achievements and contribution to Baden-Wuerttemberg’s economy
• Minister of Economic Affairs Dr. Nicole Hoffmeister-Kraut presented the medal at an awards ceremony on November 5, 2026
• Honor underscores the company’s longstanding ties to Laupheim and its importance to the international biopharmaceutical industry

Laupheim, Germany, November 6, 2026 – Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, has been awarded the Business Medal of the State of Baden-Wuerttemberg. The award was presented by Dr. Nicole Hoffmeister-Kraut, Minister of Economic Affairs, Labor and Tourism. The distinction recognizes outstanding entrepreneurial achievements and exceptional contributions to Baden-Wuerttemberg’s economy. Dr. Torsten Woehr, Chief Executive Officer (CEO) accepted the award on behalf of the company.

In her laudatory remarks, Dr. Nicole Hoffmeister-Kraut highlighted Rentschler Biopharma’s foresight, its importance to the region, and its commitment to combining economic success with social responsibility: “Today, the company looks back on more than 150 years of history and has become a leading specialist in the development and manufacturing of biopharmaceuticals.” Addressing the 14 individuals and companies honored, the Minister added: “You are an impressive testament to the strength and diversity of Baden-Wuerttemberg’s economy and its future readiness.”

Dr. Torsten Woehr, CEO of Rentschler Biopharma, commented: “The Business Medal is a special honor for Rentschler Biopharma. Above all, I see it as recognition for the people who have shaped and advanced our company over many years. Their expertise, dedication, and reliability are the foundation of our success and our long-standing partnerships with our clients. Together with our employees, we are proud to contribute to the global supply of life-saving biopharmaceuticals.”

The Business Medal of the State of Baden-Wuerttemberg has been awarded since 1987 to individuals and companies that have made outstanding contributions to the state’s economy.

As an independent family-owned company with deep roots in Laupheim, Rentschler Biopharma has evolved into a global biopharmaceutical CDMO. Today, the company supports pharmaceutical and biotechnology companies in translating innovative ideas into life-saving biopharmaceuticals, guiding complex biopharmaceutical programs from process development through commercial supply. These therapies address a wide range of diseases, including serious and rare conditions such as cancer, autoimmune diseases, hereditary disorders, and cardiovascular diseases. Rentschler Biopharma combines decades of experience and expertise with a commitment to high-quality standards and reliable execution.

Rentschler Biopharma continues to invest strategically in infrastructure and technologies to support the long-term development of its sites. A recent example is the new buffer media station in Laupheim, representing the company’s largest single investment in Germany to date. Covering 3,400 square meters, the facility will provide additional capacity for the production of buffer and media solutions, along with modern infrastructure designed to meet stringent quality standards. Completion and operational launch are scheduled for the end of 2027, with full utilization to be realized by 2028. The new infrastructure will thus provide an important foundation for further sustainable growth at the Laupheim site.

The award underscores Rentschler Biopharma’s strong ties to Baden-Wuerttemberg and its commitment to the region’s long-term economic strength. The company remains guided by its vision: Advancing medicine to save lives. Together.

About Rentschler Biopharma SE

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and production of biopharmaceuticals, including novel therapies, as well as related consulting services, project planning, and regulatory support. Many years of experience and excellent solution expertise ensure high-quality standards for Rentschler Biopharma’s clients. A professional quality management system, a proven philosophy of operational excellence, and advanced technologies ensure product quality and productivity at every stage of development and production. Rentschler Biopharma is an independent family-owned company with approximately 1,400 employees at its headquarters in Laupheim, Germany, and its site in Milford, MA, USA. In 2024, the company joined the United Nations Global Compact, underscoring its commitment to sustainability. For more information, please visit www.rentschler-biopharma.com. Follow Rentschler Biopharma on LinkedIn.

Contact:

Rentschler Biopharma SE
Dr. Latika Bhonsle-Deeng
VP Global Marketing and Corporate Communications
Phone: +49-7392-701-467
communications@rentschler-biopharma.com

Media inquiries:

For high-resolution images, please contact communications@rentschler-biopharma.com.

MEDACTA GROUP SA UPDATES GUIDANCE FOR 2026 AND REITERATES 2024-2027 MID-TERM OUTLOOK

• Updated FY 2026 Outlook: revenue growth of around 9% in constant currency[1], with the adjusted EBITDA margin expected to be broadly in line with 2025 in constant currency¹, subject to unforeseen events
• Mid-term Outlook reiterated: revenue CAGR of 12% to 15% for 2024-2027 in constant currency¹, with a gradual improvement in the adjusted EBITDA margin compared with 2025, in constant currency¹, subject to unforeseen events

CASTEL SAN PIETRO, Switzerland, November 5, 2026 – Medacta Group SA (“Medacta,” SIX: MOVE) today updates its FY 2026 guidance and reaffirms the 2024-2027 mid-term outlook.

The Group now expects FY 2026 revenue growth of around 9% in constant currency¹ (before: 10% to 14% in constant currency¹) and an adjusted EBITDA margin broadly in line with 2025 in constant currency¹ (before: expansion of approximately 50 basis points compared with 2025 in constant currency¹), subject to unforeseen events.

The revision primarily reflects generally softer US healthcare market conditions. Based on the trends observed in the first half of 2026, Medacta expected an improvement in the second half of the year, which has not materialized. Nevertheless, Medacta’s customer conversion rates in the US remain strong and in line with management’s expectations and historical levels, significantly above market growth.

These indicators underpin Medacta’s confidence in the market’s medium- to long-term potential and reinforce the US’s importance as a key market for the Group’s future development.

Moreover, the Group remains committed to growing across all its business lines at rates above those of their respective markets, supported by its established product portfolio, continuous innovation and surgeon-specific medical education, all of which remain central to its strategy.

Taking into account the results achieved to date and the outlook for each business line, Medacta confirms that its 2024-2027 mid-term guidance remains unchanged, with revenue CAGR of 12% to 15% in constant currency¹ and a gradual improvement in the adjusted EBITDA margin compared with 2025 in constant currency¹, subject to unforeseen events.

Management will host a conference call for investors and analysts today, November 5, 2026 at 6:30 p.m. CET. To pre-register for and join the call, please click here.

CONTACTS
Riccardo Fava
Group VP Investor Relations, Sustainability & Media Relations
r.fava@medacta.ch

ABOUT MEDACTA GROUP SA
Medacta Group SA (“Medacta”, SIX: MOVE) is a global key player specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgery. Established in 1999 in Switzerland, Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Through close collaboration with expert surgeons globally, continuous investments in R&D, and the adoption of cutting-edge technologies, Medacta’s innovation prioritizes minimally invasive surgery and personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 70 countries. Follow us on Medacta.com, Medacta TV, YouTube, LinkedIn and X.

DISCLAIMER

This media release has been prepared by Medacta Group SA (‘Medacta’ and together with its subsidiaries, ‘we’, ‘us’ or the ‘Group’). The information contained in the media release does not purport to be comprehensive and is not to be taken as containing any securities advice, recommendation, offer or invitation to subscribe for, purchase or redeem any securities regarding Medacta.

FORWARD-LOOKING INFORMATION

This media release has been prepared by Medacta and includes forward-looking information and statements concerning the outlook for its business. These statements are based on current expectations, estimates and projections about the factors that may affect its future performance. These expectations, estimates and projections are generally identifiable by statements containing words such as ‘expects’, ‘believes’, ‘estimates’, ‘targets’, ‘plans’, ‘outlook’ or similar expressions. Although Medacta believes that its expectations reflected in any such forward-looking statement are based upon reasonable assumptions, it can give no assurance that those expectations will be achieved.

^[1] Alternative Performance Measures: this press release contains certain information that it refers to as “constant currency” or c.c., which is a non-IFRS financial measure and represents the total change between periods excluding the effect of changes in foreign currency exchange rates. The Group believes that the reconciliations of changes in constant currency provide useful supplementary information to investors in light of fluctuations in foreign currency exchange rates. Furthermore, the Group believes that constant currency measures provide additional useful information on the Group’s operational performance and is consistent with how the business performance is measured internally. Definitions of Alternative Performance Measures and reconciliations between these measures and their IFRS counterparts are available in the financial reports on our website.

VeonGen Announces FDA Alignment on Pivotal Phase 3 Development and Clinical Progress of VG801 for Stargardt Disease

• FDA alignment on pivotal Phase 3 study design and CMC strategy marks an important milestone in VG801’s clinical development
• VG801 demonstrates consistent and sustained functional improvements through Month 12 across best-corrected visual acuity (BCVA), Virtual Reality Visual Test (VRVT) and microperimetry fixation, alongside a favorable safety profile to date
• All 13 patients with measurable baseline BCVA showed improvements from baseline to Month 6 or Month 12, with 11 achieving gains of ≥5 ETDRS letters, including 7 achieving ≥10 letters and 4 achieving ≥15 letters

Munich, Germany, November 5, 2026 –– VeonGen Therapeutics, a clinical-stage genetic medicine company developing next-generation gene therapies, today announced significant regulatory and clinical progress for VG801, its investigational dual-AAV gene therapy for Stargardt disease and other ABCA4-associated retinal dystrophies.

VeonGen reached alignment with the U.S. Food and Drug Administration (FDA) at a Regenerative Medicine Advanced Therapy (RMAT) Type B meeting on key clinical and Chemistry, Manufacturing and Controls (CMC) aspects of the VG801 pivotal Phase 3 program. The FDA meeting minutes document alignment on the pivotal study design, including the primary endpoint, study duration, and control arm. Regarding CMC, FDA alignment includes the use of the existing clinical batch for the pivotal Phase 3 study and key aspects of the commercial manufacturing strategy. These outcomes provide important regulatory clarity and support preparations for global pivotal Phase 3 development.

In parallel, VeonGen is advancing the Virtual Reality Visual Test (VRVT) through the FDA’s Rare Disease Endpoint Advancement (RDEA) Pilot Program to support its development as a functional vision measure in Stargardt disease. VG801 has also received Phase 1/2 clinical trial authorizations in Europe and China, supporting its global development strategy.

The ongoing first-in-human Phase 1/2 clinical study (NCT07002398) has dosed 15 patients across three dose cohorts, including adults and pediatric patients. VG801 has demonstrated consistent and sustained functional improvements through Month 12 across multiple assessments, including best-corrected visual acuity (BCVA), VRVT and microperimetry fixation. Among the 13 patients with measurable baseline BCVA, all demonstrated improvements from baseline to Month 6 or Month 12, with 11 achieving gains of at least 5 ETDRS letters, including 7 achieving at least 10 letters and 4 achieving at least 15 letters. These findings, together with stable retinal structures and favorable safety profile to date, support VG801’s therapeutic potential.

“FDA alignment on the pivotal Phase 3 clinical and CMC strategy represents an important de-risking milestone for VG801 and a significant step toward global pivotal development,” said Dr. Caroline Man Xu, Co-founder and Chief Executive Officer of VeonGen Therapeutics. “The consistent and sustained functional improvements observed in both adult and pediatric patients reinforce our confidence in the program. Our differentiated technologies are designed to address the underlying genetic cause of Stargardt disease, with the potential to preserve or improve vision for affected patients. We remain focused on advancing VG801 toward global pivotal development and ultimately delivering this innovative therapy to patients worldwide.”

VG801 leverages VeonGen’s proprietary gene therapy platforms, combining its novel vgAAV2 capsid with vgRNA REVeRT (Reconstitution Via mRNA Trans-splicing) to enable delivery and reconstitution of a full-length functional human ABCA4 gene in retinal photoreceptor cells. This differentiated dual-AAV approach is designed to address the underlying genetic cause of Stargardt disease across different ABCA4 mutations, offering the potential for a genotype-agnostic therapeutic approach and functional benefit to patients.     

About VG801

VG801 is an investigational dual-AAV gene therapy developed for Stargardt disease and other ABCA4-associated retinal dystrophies. It combines VeonGen’s proprietary vgAAV capsid technology for efficient photoreceptor transduction and vgRNA REVeRT large-gene delivery technology to deliver and reconstitute a full-length functional human ABCA4 gene in retinal photoreceptor cells. VG801 has received FDA Regenerative Medicine Advanced Therapy (RMAT), Rare Pediatric Disease (RPD), and Orphan Drug (ODD) designations, and has been selected for the FDA’s Rare Disease Endpoint Advancement (RDEA) pilot program.

About Stargardt Disease

Stargardt disease is one of the most common inherited macular dystrophies, affecting approximately 1 in 8,000–10,000 individuals worldwide. Caused by mutations in the ABCA4 gene, Stargardt disease is characterized by progressive central vision loss, often beginning in childhood or adolescence, leading to a gradual decline in visual acuity and, in some cases, legal blindness. There are currently no approved treatments for Stargardt disease, highlighting a significant unmet medical need.

About VeonGen Therapeutics

Headquartered in Munich, Germany, VeonGen Therapeutics is a clinical-stage genetic medicine company developing innovative therapies that address the underlying causes of disease. Its ophthalmology clinical pipeline includes VG801 for Stargardt disease and ABCA4-associated retinal dystrophies, and VG901, an intravitreal AAV gene therapy for retinitis pigmentosa caused by CNGA1 mutations. VeonGen’s three proprietary technology platforms (vgAAV, vgRNA REVeRT, and AAV Transactivation) address key challenges in gene therapy, including cellular transduction, large gene delivery beyond AAV size limits, and regulation of disease-relevant gene expression. VeonGen is also exploring applications and partnerships in ophthalmology, cardiovascular, central nervous system (CNS), and other therapeutic areas.

For more information, please visit www.veongen.com.

Ad hoc announcement pursuant to Article 17 MAR

Formycon AG recognizes non-cash impairments on FYB201 and FYB202 and revises its guidance for adjusted EBITDA

Planegg-Martinsried, Germany, November 05, 2026 – The Management Board of Formycon AG (FSE: FYB, ISIN DE000A1EWVY8) (“Formycon” or the “Company”) today resolved to recognize impairments for the biosimilars FYB201 (ranibizumab) and FYB202 (ustekinumab) in the consolidated figures as of September 30, 2026. The impairments result from the regular impairment test at quarter-end and reflect lower revenue expectations of the commercialization partners for both products. The guidance for adjusted EBITDA is being revised.

For fiscal year 2026, Formycon continues to expect revenue of EUR 60 million to EUR 70 million and EBITDA of EUR 0 million to EUR 10 million, each at the lower end of the range of the previous guidance, as well as net working capital at year-end of EUR 20 million to EUR 30 million. The Management Board now expects adjusted EBITDA of EUR -15 million to EUR -5 million (previously EUR 5 million to EUR 15 million). The reason for this is the result from the investment in Bioeq AG, which is included in adjusted EBITDA and declines with the revenue expectations for FYB201.

The adjusted revenue expectations of the commercialization partners result in impairments under IFRS in the consolidated figures on the rights to FYB202 and on the investment in Bioeq AG (FYB201). This is partly offset by the remeasurement of the contingent purchase price liabilities from the acquisition of the rights in 2022. On a net basis, the impairments reduce consolidated net income for 2026 by EUR 82 million for FYB202 and EUR 39 million for FYB201. However, the impairments are non-cash.

The other development projects of Formycon are not affected by the impairments.

As planned, Formycon will publish its figures for the first nine months of 2026 on November 12, 2026, and will explain the impairments and the guidance in a conference call at 3:00 p.m. CET that day; the dial-in details are available at www.formycon.com in the Investor Relations section.

^{———————————————}

Disclaimer
This release neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG in any jurisdiction, including the United States of America, Canada, Australia and Japan. No public offering of securities of Formycon AG will be made, or is intended, in connection with this release.

This release may contain forward-looking statements and information, which are based on the current expectations, estimates and assumptions of the management of Formycon AG. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of Formycon AG, development of the products and the estimates given here.

Such known and unknown risks and uncertainties include, among others, risks relating to research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, tariffs and trade policy, product quality, patient safety, the conclusion and performance of commercialization partnerships, market acceptance, pricing and competition, manufacturing and supply, including by third-party manufacturers, financing, including compliance with the covenants of the bond of Formycon AG, and the patents and exclusivities protecting reference products, including related litigation. With respect to pipeline products, Formycon AG does not make any representation, give any warranty or provide any other guarantee that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. Forward-looking statements should not be relied upon as predictions of future events. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated, except as required by law.

Contact
Formycon AG
Fraunhoferstrasse 15 · 82152 Planegg-Martinsried · Germany

+49 89 864667485
ir@formycon.com

Q3 Report
MEDICLIN continues to show stable business performance
 

• A total of 82,265 patients treated in the first nine months of 2026 (previous year: 81,564)
• Group operating result rose to EUR 585.9 million (previous year: EUR 563.0 million)
• Consolidated EBIT amounts to EUR 52.7 million (previous year: EUR 48.9 million)
• Full-year forecast confirmed despite a market environment that remains challenging

Offenburg, 5 November 2026 – MEDICLIN Aktiengesellschaft (Ticker: MED; WKN 65 9 510)) achieved group operating result of EUR 585.9 million in the first nine months of 2026 (previous year: EUR 563.0 million), representing an increase of EUR 22.9 million, or 4.1 per cent, compared with the same period last year. Consolidated EBIT rose by EUR 3.8 million to EUR 52.7 million (previous year: EUR 48.9 million).

 “The business performance in the first nine months of 2026 confirms the robustness of our business model in a market environment that remains challenging. On this basis, we are consistently pursuing our strategy for the remainder of the financial year and consolidating our operational performance. We are therefore well positioned to meet our full-year forecast for 2026,” commented Tino Fritz, CFO of MEDICLIN AG.

Performance by segment
In the Post-Acute segment, operating result rose by EUR 13.6 million, or 3.5 per cent, to EUR 399.6 million (previous year: EUR 386.1 million).  The cost of materials ratio fell slightly to 18.9 per cent (previous year: 19.4 per cent). The absolute cost of materials, at EUR 75.6 million, was also 1.0 per cent higher than the previous year’s figure (previous year: EUR 74.9 million). Staff costs increased by EUR 14.6 million, or 7.3 per cent, compared with the same period last year to EUR 215.4 million (previous year: EUR 200.8 million), primarily as a result of standard pay rises and a higher number of employees. The staff cost ratio rose by 1.9 percentage points to
53.9 per cent (previous year: 52.0 per cent). EBIT in the Post-acute segment fell by EUR 2.8 million, or 5.9 per cent, compared with the same period last year to EUR 44.8 million (previous year: 47.6 million), due to higher expenses and staff costs.

The Acute segment reported an increase in segment operating result of EUR 9.6 million, or 6.0 per cent, to EUR 168.3 million (previous year: EUR 158.7 million). The cost of materials rose by a total of EUR 5.6 million, or 11.8 per cent, compared with the same period last year. The cost of materials as a percentage of revenue rose by
1.6 percentage points to 31.4 per cent (previous year: 29.8 per cent). Staff costs rose by EUR 6.1 million, or 6.6 per cent, to EUR 99.3 million (previous year:
EUR 93.2 million), primarily due to standard pay rises. The staff cost ratio stood at 59.0 per cent, compared with 58.7 per cent in the same period of the previous year. EBIT improved by EUR 2.4 million to EUR 3.1 million (previous year: EUR 0.7 million).

Operating result in the Care segment amounted to EUR 18.1 million, which was EUR 0.1 million below the previous year’s figure (previous year: EUR 18.2 million). The segment’s EBIT rose by EUR 1.0 million to EUR 0.6 million (previous year: EUR –0.4 million). This increase is attributable, amongst other things, to the fall in cost of materials (EUR –0.9 million).

In the Service segment, revenue is reported under ‘Other income’. This amounted to EUR 103.6 million, up from EUR 102.1 million, representing an increase of
EUR 1.5 million or 1.5 per cent. The segment reported an EBIT of EUR 4.2 million, representing an increase of EUR 3.2 million.

Outlook
For the current financial year, the Executive Board continues to expect an increase in group operating result of between 3.5 per cent and 6.5 per cent, as well as a consolidated EBIT of between EUR 57.0 million and EUR 72.0 million.

The interim report as at 30 September 2026 is available from today at www.mediclin.de in German and English.

CONTACT
Head of Investor Relations and Sustainability
Ender Gülcan | Tel. +49 781488326 | ender.guelcan@mediclin.de
MEDICLIN Aktiengesellschaft | Okenstraße 27 | 77625 Offenburg

MEDICLIN Aktiengesellschaft is one of Germany’s leading healthcare providers, with a clear focus on medical rehabilitation. MEDICLIN comprises 31 clinics, six care homes and ten medical care centres across Germany. MEDICLIN employs around 9,900 staff. Through a strong network, MEDICLIN offers integrated care, from the initial doctor’s appointment through to surgery and subsequent rehabilitation, right through to outpatient aftercare. Medical and therapeutic staff, as well as nursing staff, work together in close coordination. MEDICLIN tailors the care and support it provides to people in need of care to their individual needs and personal requirements. MEDICLIN is a company within the ASKLEPIOS Group. www.mediclin.de
 

Press Release // November 05, 2026

Formycon maintains 2026 guidance for revenue, EBITDA and working capital, revises adjusted EBITDA and reassesses FYB201 and FYB202

• 2026 guidance: revenue of EUR 60 to 70 million, EBITDA of EUR 0 to 10 million and working capital of EUR 20 to 30 million unchanged, revenue and EBITDA each at the lower end of the ranges; adjusted EBITDA revised to EUR -15 million to EUR -5 million due to the Bioeq result (previously EUR 5 to 15 million)
• FYB201 (ranibizumab) and FYB202 (ustekinumab): commercialization partners expect lower revenues due to the competitive market environment, with additional competitors and rising price pressure
• Impairments on both products, with no cash outflow: net EUR 82 million for FYB202 and EUR 39 million for FYB201, charged to consolidated net income for 2026
• Next product generation not affected: FYB206 (pembrolizumab) under FDA review, decision expected in the third quarter of 2027; FYB208 (dupilumab) in development; FYB286 funded in advance by a partner
• Nine-month results and conference call on November 12, 2026, as planned

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”), an independent developer of biosimilars, is adjusting the valuation of its first two products to current market developments. Additional competitors have entered the markets for ranibizumab and ustekinumab, further increasing price pressure. The commercialization partners for FYB201 (ranibizumab) and FYB202 (ustekinumab) therefore expect lower revenues. As announced today in an ad hoc release, Formycon has incorporated these updated expectations into its planning as part of the regular quarter-end impairment test and is recognizing non-cash impairments on both products. Three of the four guidance metrics for 2026 remain unchanged: revenue, EBITDA and working capital. For revenue and EBITDA, Formycon expects to be at the lower end of the ranges. For adjusted EBITDA, which also includes the result from the investment in Bioeq, Formycon now expects EUR -15 million to EUR -5 million. The other revenue streams are developing in line with plan. The next product generation, led by FYB206, the biosimilar candidate to Keytruda®, is not affected by the adjustment.

Dr. Stefan Glombitza, CEO of Formycon AG, said: “FYB201 and FYB202 have made Formycon what it is today: a company that develops biosimilars with high quality and reliability, takes them through approval and currently markets them with 14 partners worldwide. Both markets have now changed significantly. Today we are taking this into account, in our planning and on our balance sheet. The next generation of our portfolio is built on these experiences: diversified markets, smart development approaches and manufacturing costs that hold up even as price discounts increase. With FYB206, our biosimilar candidate to Keytruda®, we are in the leading group of the field. FYB208 targets the fastest-growing market we have ever addressed, and we are developing FYB286 together with a strategically important manufacturer and a partner that is funding the development in advance. Today’s adjustment does not change our conviction that Formycon is one of the world’s leading biosimilar developers.”

The markets for FYB201 and FYB202

The markets for ranibizumab and ustekinumab have changed considerably. Prices are falling, and additional competitors have entered the market with steep discounts. For healthcare systems, that is the purpose of biosimilars. For these two molecules, therapy alternatives are also gaining share. In the US, sales of ustekinumab also depend on access to the formularies of pharmacy benefit managers, which remains difficult. The commercialization partners have therefore lowered their revenue expectations for both products. Formycon has incorporated them into its planning and is adjusting the carrying amounts. Both products remain on the market and continue to generate revenue for Formycon.

What changes on the balance sheet

In 2022, Formycon acquired the rights to FYB201 and FYB202 from Athos and paid for them with new shares and a share for Athos in future revenues from both products (contingent purchase price obligations). The rights are carried in the consolidated balance sheet at their amortized carrying amount. If expected revenues decline, this carrying amount declines and Formycon recognizes impairments. In the consolidated figures as of September 30, 2026, this affects FYB202 and FYB201, and for FYB201 the investment in the joint venture Bioeq. At the same time, the contingent purchase price obligations decline, because they too depend on expected revenues. On a net basis, the impairments reduce consolidated net income for 2026 by EUR 82 million for FYB202 and EUR 39 million for FYB201. The impairments do not affect EBITDA for 2026. There is no cash outflow, and the agreements with the partners remain unchanged.

2026 guidance

For fiscal year 2026, the Management Board continues to expect revenue of EUR 60 to 70 million and EBITDA of EUR 0 to 10 million, each at the lower end of the previously communicated ranges, as well as working capital at year-end of EUR 20 to 30 million. The Management Board now expects adjusted EBITDA of EUR -15 million to EUR -5 million (previously EUR 5 to 15 million). The reason is the result from the investment in Bioeq, which is included in adjusted EBITDA and declines with the revenue expectations for FYB201. The guidance is based on the plans of the commercialization partners, which are responsible for selling the products and in whose revenues Formycon participates. Their plans for the fourth quarter are reflected in the ranges.

Enno Spillner, CFO of Formycon AG, said: “Our planning is based on the plans and input of our commercialization partners. Now that they have lowered their expectations for FYB201 and FYB202, we are reflecting this on our balance sheet. The impairments involve no cash outflow. For revenue, EBITDA and working capital, we are within our previous guidance. For revenue and EBITDA, we expect the lower end, in a challenging environment. Only for adjusted EBITDA will we not reach the range, because the result of our investment in Bioeq declines with the revenue expectations for FYB201.”

The next product generation

The adjustment concerns the first two products that Formycon has brought to market. The next generation of the portfolio is designed for today’s conditions: diversified markets, optimized development and manufacturing costs that hold up even as prices fall. FYB206, the biosimilar candidate to Keytruda®, the world’s best-selling biologic medicine, was accepted for review by the FDA in October 2026. A decision is expected in the third quarter of 2027. Formycon was the first company worldwide to publicly announce the FDA’s acceptance of a pembrolizumab biosimilar for review. The optimized clinical development without a comparative Phase III study saves development costs in the high double-digit millions of euros. Unlike ustekinumab, pembrolizumab is not distributed in the US through the formularies of pharmacy benefit managers but is purchased and billed directly by physicians and hospitals (buy-and-bill). Pricing dynamics there are different. Commercialization partners are Zydus Lifesciences for the US and Canada, MS Pharma for the Middle East and North Africa, and Lotus Pharmaceutical for parts of the Asia-Pacific region. FYB208 (dupilumab) is in technical development; with revenue growth of 26 percent in 2025, its reference product Dupixent® is the fastest-growing market in the portfolio. Formycon is developing FYB286 together with its strategic manufacturing partner Biocelys for Santo Biosimilar, which is funding the development in advance. In 2025, the reference products of FYB206 and FYB208 generated combined sales of almost USD 50 billion, more than three times as much as the reference products of the three products Formycon currently markets.

Conference call

The Management Board will explain the impairments and the guidance in the conference call on the nine-month results on November 12, 2026, at 3:00 p.m. CET, held in English with a webcast. Registration at https://webcast.meetyoo.de/register/6P6Ir00BfxpL is required to participate; participants will then receive a confirmation email with their individual dial-in details. The presentation and audio can be accessed via the webcast at https://www.webcast-eqs.com/formycon-2026-9m. A recording will subsequently be available at www.formycon.com in the Investor Relations section.
 

^{———————————————}
 

Keytruda^® is a registered trademark of Merck Sharp & Dohme, a subsidiary of Merck & Co.
Lucentis^® is a registered trademark of Genentech. 
Stelara^® is a registered trademark of Johnson & Johnson.
Dupixent^® is a registered trademark of Sanofi Biotechnology.

About Formycon:
Formycon AG is a listed, independent developer of biosimilars based in Planegg-Martinsried, one of the leading life sciences locations in Europe, near Munich, Germany. Its 200 employees from 27 countries cover the entire development chain, from laboratory analysis through manufacturing and clinical testing to the documents for approval. Three Formycon biosimilars are approved in ophthalmology and immunology and are marketed worldwide through commercialization partners. Five further candidates are in development, among them biosimilars to two of the best-selling biologic medicines in the world. With its products, Formycon makes highly effective therapies affordable for more people.

Formycon AG is listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: www.formycon.com

About FYB4Growth:
With FYB4Growth, Formycon is pursuing a growth strategy along four strategic pillars aimed at sustainable value creation. First, geographic diversification: in addition to Europe and the US, Formycon is specifically opening up high-growth regions such as MENA, APAC and Latin America through strong regional partners. Second, Formycon relies on a smart portfolio strategy that combines blockbuster molecules with selected niche products and, through efficient regulatory development pathways, lays the foundation for sustainable value creation. Third, Formycon is positioning itself as a technological and regulatory development powerhouse that achieves strong competitive differentiation through innovative product solutions and new regulatory approaches. Fourth, Formycon is committed to consistent cost efficiency through lean processes, optimized development structures and the increased use of digital technologies, in order to sustainably strengthen the scalability of its business model and its competitiveness. Learn more at: www.fyb4growth.de

About Biosimilars:
Biosimilars are successor products to biologic medicines. They are not copies; each one is developed from the ground up and must demonstrate to the health authorities that it has no clinically meaningful differences from the reference product in terms of safety and efficacy. According to the IQVIA Institute, 118 biologic medicines with sales of USD 232 billion will lose their exclusivity in the US alone by 2034, and for only twelve of them is a biosimilar in development. In Europe, biosimilars have saved EUR 75 billion and made more than seven billion days of treatment possible.

Disclaimer:
This release neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG in any jurisdiction, including the United States of America, Canada, Australia and Japan. No public offering of securities of Formycon AG will be made, or is intended, in connection with this release.

FYB206 is an investigational product and has not yet received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities and is not claimed.

This release may contain forward-looking statements and information, which are based on the current expectations, estimates and assumptions of the management of Formycon AG. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of Formycon AG, development of the products and the estimates given here.

Such known and unknown risks and uncertainties include, among others, risks relating to research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, tariffs and trade policy, product quality, patient safety, the conclusion and performance of commercialization partnerships, market acceptance, pricing and competition, manufacturing and supply, including by third-party manufacturers, financing, including compliance with the covenants of the bond of Formycon AG, and the patents and exclusivities protecting reference products, including related litigation. With respect to pipeline products, Formycon AG does not make any representation, give any warranty or provide any other guarantee that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. Forward-looking statements should not be relied upon as predictions of future events. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated, except as required by law.

• Third strategic partner: With the successful EU-GMP certification of 1530076 BC Ltd., the exclusive processing partner of cannabis cultivators such as FN Canna, Cantourage has completed the certification of another internationally sought-after manufacturer of premium cannabis products, following Green Karat and LOT420.
• Long-term competitive advantage: Through exclusivity agreements with established premium producers, Cantourage secures long-term exclusive access to high-quality cannabis products, further strengthening its competitive position in the European market.
• Strong positioning in Europe: Leveraging its regulatory expertise, Cantourage is establishing itself as a key gateway to the European market for international premium producers.

Cantourage Group SE (hereinafter “Cantourage”, ISIN: DE000A3DSV01) is further strengthening its position in the European medical cannabis market. With the successful EU-GMP certification of Canadian licensed processor 1530076 BC Ltd., Cantourage has now successfully completed its third strategic certification project, following Green Karat and LOT420.

1530076 BC Ltd. operates production facilities in British Columbia, Canada, and provides production services to premium cannabis cultivators in the province, including 1235009 BC LTD d.b.a. FN Canna, a cultivator whose products are available under All Nations and Uncle Bob brands. Cantourage has represented FN Canna in the European market since 2023.

“This milestone belongs to our team. Achieving EU-GMP certification required months of rigorous preparation, documentation and process refinement, and our people met that challenge at every step. We are extremely proud of what they have accomplished. Our thanks also go to Cantourage, whose guidance and collaboration were instrumental in reaching this standard,” says Hendrick Ng, Director of Quality of FN Canna.

“Following Green Karat and LOT420, 1530076 BC Ltd. is now the third partner we have successfully supported through the EU-GMP certification process. Through our exclusivity agreements, we have secured long-term access to a strategically important part of our premium portfolio, including our well-established All Nations products, but also many more premium cannabis products manufactured in British Columbia. This represents a significant strategic competitive advantage. At the same time, we are demonstrating that Cantourage’s regulatory expertise not only opens the door to the European market for international premium producers, but also enables us to secure long-term access to some of the most sought-after products,” says Philip Schetter, CEO of Cantourage Group SE.

Through the long-term partnerships Cantourage has secured exclusive access to high-quality cannabis products from three internationally sought-after premium producers for a period of five years. This sustainably strengthens the company’s competitive position while providing greater planning certainty regarding the availability of premium products that are in high demand.

About 1530076 BC Ltd.

1530076 BC Ltd. Is a joint venture between Phyton Biotech LLC and First Nations Processing Corporation and is a licensed processor of cannabis products based in British Columbia, Canada. Its EU-GMP certification (certificate no. DE-ST-01-GMP-2026-36) covers the processing, primary packaging and in-process quality control of medicinal cannabis flowers that have not been treated with ionizing radiation for microbial reduction. The certification confirms that the company’s processing facility has been assessed as meeting the EU standard for good manufacturing practices applicable to medicinal cannabis. The company currently processes on behalf of its client 1235009 B.C. Ltd. d.b.a. FN Canna and intends to extend its processing services to further premium growers.

About Cantourage

Cantourage is a leading European company specializing in the production and distribution of cannabis-based medical preparations and pharmaceutical products. With its experienced management team and its “Fast Track Access” platform, Cantourage enables producers from around the world to enter the growing European medical cannabis market more quickly, easily and cost-effectively by processing and distributing their cannabis raw materials and extracts. In doing so, Cantourage consistently ensures compliance with the highest European pharmaceutical quality standards. The company offers pharmaceutical-grade products across all relevant market segments: dried cannabis flower, extracts, dronabinol and cannabidiol. Cantourage was listed on the Frankfurt Stock Exchange on 11 November 2022 (ISIN: DE000A3DSV01).

CORPORATE NEWS

RHÖN-KLINIKUM AG reports results for the third quarter of 2026

• Group makes targeted investments in state-of-the-art medical technology
• Number of patients treated up 8.3%, with revenues increasing to
  EUR 1,304 million
• Increase in the operating result is driven by a 3.25% surcharge on hospital services, which is accounted for in 2026
• Strong capital base with high equity ratio provides solid foundation for optimising inpatient and outpatient care structures

Bad Neustadt, 5 November 2026 – RHÖN-KLINIKUM AG closed the first nine months of 2026 with strong earnings growth. Despite healthcare policy challenges and a difficult economic environment, the number of patients was increased and consolidated profit was improved.

From January to September 2026 a total of 764,248 patients were treated on an inpatient and outpatient basis in the Group’s hospitals and medical care centres, an increase of 8.3% (9M 2025: 705,830). Consolidated revenue of EUR 1,303.8 million exceeded the previous year’s level (9M 2025: EUR 1,262.1 million), and EBITDA was EUR 83.9 million (9M 2025: EUR 71.8 million). The result is impacted by a billing surcharge (3.25% on hospital services) that is accounted for and reported under “other income” through October 2026. It is intended to offset the increases in personnel and non-personnel costs experienced in previous years. Consolidated profit increased to EUR 32.7 million (9M 2025: EUR 25.1 million).

The increase is primarily the result of higher capacity utilization at clinics and medical care centers, as well as an increase in patient numbers, particularly in the outpatient sector. The company’s strong capital base with an equity ratio of 74.7% moreover provides a solid foundation for optimising inpatient and outpatient care structures.

Dr. Gunther K. Weiß, member of the Board of Management of RHÖN-KLINIKUM AG: “Our successful third quarter shows that financial stability and medical excellence are inseparable, going hand in hand. Underlying this success is the tremendous trust out patients put in us. This sustainable basis is what allows us to continue making targeted investments in state-of-the-art medical technology and care offerings.”

This course of innovation is evident in two selected investments: at Universitätsklinikum Marburg, a state-of-the-art photon-counting computer tomograph was put into service. That makes RHÖN-KLINIKUM AG the only hospital group in Germany having four newest-generation units of this kind in operation. With the new hybrid operating theatre in Frankfurt (Oder), the hospital has expanded its treatment range, thus strengthening its interdisciplinary structures and giving a further major boost to the maximum care facility’s care offerings in the Ostbrandenburg region.

Dr. Stefan Stranz, member of the Board of Management of RHÖN-KLINIKUM AG: “This forward-looking investment strategy ensures that we can continue to operate effectively in a market environment facing far-reaching and sweeping change. Thanks to our solid financial basis and our collaboration within the ASKLEPIOS Group network, we can take on and actively shape this transformation process from a position of strength.”

Outlook for 2026

For the current financial year, we expect revenues of EUR 1.7 billion within a range of plus or minus 5%. For earnings before interest, tax and depreciation/ amortisation (EBITDA), we expect a level of between EUR 110 million and EUR 125 million. In addition to financial performance indicators, we also take account of the non-financial performance indicators of number of cases and cost weights in the management of the company and expect these to show a moderate improvement over the previous year.

The financial year will be significantly impacted by the unfolding legislation process and the considerable uncertainties it holds. Particularly the Hospital Reform Adjustment Act (Krankenhausreformanpassungsgesetz, KHAG) that entered into force on 15 April 2026 and the Statutory Health Insurance (SHI) Contribution Rate Stabilisation Act (GKV-Beitragsstabilisierungsgesetz, GKV-BstabG) (GKV-BStabG) adopted by the German Federal Parliament on 10 July 2026 seek to further enhance quality and efficiency in the healthcare system, but at the same time will put hospitals under greater financial pressure in the short term.

The company’s forecast is therefore subject to particular uncertainties. It is not yet possible at this time to reliably forecast what overall impact the ongoing regulatory interference, implementation of the hospital reform as well as further possible adjustments by the legislator will have. On top of that, ongoing global crises and negative economic impacts are resulting among other things in higher prices, supply bottlenecks and general market volatility.

The Quarterly Statement for Q3 2026 is published on the Internet.

CONTACT

RHÖN-KLINIKUM AG | Head of Group Finance
Norman Dittes | T. +49 9771 65-12210 | norman.dittes@rhoen-klinikum-ag.com

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

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

RHÖN-KLINIKUM AG is one of the largest healthcare providers in Germany, with five highly specialised maximum- and intermediate-care facilities: Campus Bad Neustadt, Zentralklinik Bad Berka, Klinikum Frankfurt (Oder) as well as the Giessen and Marburg University Hospitals (UKGM). As a modern, diverse and future-oriented Company, RHÖN-KLINIKUM AG is attractive both as a provider of training and an employer. With over 19,100 employees, the Group offers excellent medical care with a direct tie-in to research and teaching. Each year, we treat a total of 938,000 patients at our hospitals and medical care centres (MVZs) on an outpatient and inpatient basis. Die RHÖN-KLINIKUM AG is a company of the ASKLEPIOS Group. www.rhoen-klinikum-ag.com

Mallia Aesthetics and Neomed Enter Exclusive Middle East Partnership with First 8T3 Essentials Approval Granted

• Partnership combines Mallia’s science-based products for hair regeneration with Neomed’s strong expertise in aesthetics and deep regional market network
• Neomed has already secured regulatory approval for 8T3 Essentials Hair Serum in Saudi Arabia
• Neomed to lead further regulatory approvals, distribution and market launches across several Middle Eastern markets
• 8T3 Essentials Hair Serum and 8T3 Essentials Lash & Brow Serum to be marketed directly to consumers and through dermatologists and pharmacists

Erlangen, Germany, November 05, 2026 – Mallia Aesthetics GmbH, a company focusing on the development and commercialization of cosmetic products to stimulate hair growth, and Neomed Group, a regional provider of medical, healthcare and aesthetics services in the Middle East, today announced an exclusive market access and distribution partnership to bring Mallia’s 8T3 Essentials Hair Serum and 8T3 Essentials Lash & Brow Serum to several markets across the region.

Under the agreement, Neomed will take responsibility for the regulatory approval process for both 8T3 Essentials products and, subject to approval, will lead their market launches. Neomed has already secured regulatory approval for 8T3 Essentials Hair Serum in Saudi Arabia and is preparing to launch the product there. Further approvals and launches are expected in early 2027, including in the United Arab Emirates. Neomed will leverage its established regional network and market expertise to distribute the products via a combination of direct-to-consumer channels and through dermatologists and pharmacists in the respective markets.

For Mallia, the partnership represents its first commercial collaboration outside of Europe and is an important step in the international development of its 8T3 Essentials portfolio. For Neomed, the collaboration adds to its offering a hormone-free hair growth product portfolio that is backed by decades of scientific research and successful consumer studies.

“Entering the Middle East with 8T3 Essentials is a major milestone for Mallia, and we could not imagine a stronger partner for this next phase. We have seen strong interest in our 8T3 Essentials products since their launch in Europe, and we are now taking the next step in making them available in additional markets, starting with Saudi Arabia,” said Dr. Manfred Gröppel, Co-founder and Managing Director of Mallia Innovations. “The combination of our science-based products and Neomed’s deep understanding of the regional aesthetics market, outstanding network and commercial expertise creates an excellent opportunity to bring 8T3 Essentials to a much broader audience. We look forward to together building a strong presence for the portfolio in the region.”

Elie Helou, Managing Director of Neomed, said: “We are excited to bring 8T3 Essentials to the Middle East and to partner with Mallia on this important market opportunity. We are particularly pleased to have already secured regulatory approval for 8T3 Essentials Hair Serum in Saudi Arabia. The combination of a compelling scientific foundation, an innovative approach to hair growth and convincing consumer study results makes these products particularly exciting for the region. We see strong potential for the products and are confident that our established relationships with healthcare professionals and consumers will provide an excellent platform for their launch. We look forward to introducing 8T3 Essentials to the market and building the brand together with Mallia.”

8T3 Essentials Hair Serum and 8T3 Essentials Lash & Brow Serum contain MAL-838, a proprietary cosmetic ingredient based on the naturally occurring immunomodulatory protein sCD83. The product is the result of more than 25 years of research on sCD83 led by Mallia Co-founder Prof. Dr. Alexander Steinkasserer. Positive results from a six-month consumer study with 8T3 Essentials Hair Serum showed measurable new hair growth in 70% of participants and an average increase in hair density of 30%. 8T3 Essentials Lash & Brow Serum has also shown positive results in a 12-week consumer study, with 81% of participants reporting visibly longer lashes and objective measurements showing individual increases in lash length of up to 39%.

The 8T3 Essentials Hair Serum and 8T3 Essentials Lash & Brow Serum are currently available in the European Union. With Saudi Arabia, 8T3 Essentials Hair Serum will enter its first market in the Middle East. The products will continue to be manufactured in Europe by Mallia and its manufacturing partners, with Neomed responsible for distribution and market launches in the respective Middle Eastern markets.

Mallia and Neomed will provide updates on additional markets and launch timing as further regulatory approvals are obtained.

About sCD83

Soluble CD83 (sCD83) is an immunomodulatory protein currently being developed for the topical treatment of hair loss (MAL‑856) and stimulation of hair growth (MAL‑838). The soluble CD83 protein was first identified in 2001 by Prof. Steinkasserer, a co-founder of Mallia. It possesses anti-inflammatory properties by inducing resolution of inflammation, which promotes wound healing and induces new hair growth¹. In addition, sCD83 has been shown to activate regulatory T cells (Tregs)², which can directly interact with and activate hair follicles.³ Furthermore, sCD83 inhibits cell death of hair follicle cells and directly activates follicular stem cells, as well as keratin production, thereby stimulating new hair growth. This multimodal mechanism distinguishes sCD83 from other topically applied hair growth products.

When topically applied, sCD83 directly enters the hair follicles but does not penetrate through the skin and thus does not enter the bloodstream. The effect is localized, which is a significant advantage over systemic treatment options, which can cause severe side effects.

About hair loss

Hormone-related hair loss in men and women (androgenetic alopecia, or AGA) is the most common form of hair loss. Worldwide, more than 70% of men and 50% of postmenopausal women are affected by androgenetic alopecia. An additional 147 million people suffer from immune-mediated, circular hair loss (alopecia areata, or AA^4,5).

Androgenetic alopecia usually progresses gradually and is caused by genetic and hormonal factors. In men, it often leads to a receding hairline and baldness on the top of the head, while in women it leads to thinning hair along the part. Alopecia areata causes circular patches of hair loss on the scalp, face, or other parts of the body. It occurs when the immune system erroneously attacks hair follicles, leading to immune-mediated hair loss.

About Mallia

Mallia Innovations GmbH, based in Erlangen, Germany, is the holding company strategically driving the proprietary development and commercialization of biopharmaceutical therapies and cosmetic applications based on the immunomodulatory sCD83 protein. These are aimed at hair growth, hair loss, and other dermatological indications, including wound healing.

Mallia Therapeutics GmbH focuses on the clinical development of novel therapies for patients suffering from androgenetic alopecia or alopecia areata. The active ingredient, MAL-856 is based on the scientifically proven immunomodulatory mode of action of sCD83, which has been investigated for over 25 years by Mallia Co‑founder Prof. Dr. Alexander Steinkasserer.⁶

Mallia Aesthetics GmbH focuses on cosmetic applications designed to stimulate hair growth, which are also based on the scientifically validated sCD83 protein. The company develops innovative cosmetic products based on MAL-838, which are marketed to professionals and consumers.

To purchase products from the 8T3 Essentials line, please visit our online shop: https://8t3.com/en/

For more information, visit www.mallia.com and follow us on LinkedIn, Instagram, and Facebook.

About Neomed Group

Over 20 years of experience in the Medical, Healthcare, and Aesthetics industries across the Middle East. With a forged background through multinational companies, entrepreneurships, and startups, we offer a wide range of solutions and services to be your trusted partner on your journey to better health and well-being. For more information, visit https://neomedgroup.com/

¹ Royzman, D., Peckert-Maier, K., Stich, L., König, C., Wild, A. B., Tauchi, M., … & Steinkasserer, A. (2022). Soluble CD83 improves and accelerates wound healing by the induction of pro-resolving macrophages. Frontiers in Immunology, 13, 1012647. DOI: 10.3389/fimmu.2022.1012647

² Bock, F., Rössner, S., Onderka, J., Lechmann, M., Pallotta, M. T., Fallarino, F., … & Zinser, E. (2013). Topical application of soluble CD83 induces IDO-mediated immune modulation, increases Foxp3+ T cells, and prolongs allogeneic corneal graft survival. The Journal of Immunology, 191(4), 1965-1975. DOI: 10.4049/jimmunol.1201531

³ Ali, N., Zirak, B., Rodriguez, R. S., Pauli, M. L., Truong, H. A., Lai, K., … & Rosenblum, M. D. (2017). Regulatory T cells in skin facilitate epithelial stem cell differentiation. Cell, 169(6), 1119-1129. DOI: 10.1016/j.cell.2017.05.002

⁴ Feinstein, R. P. (2022). Androgenetic alopecia.: https://emedicine.medscape.com/article/1070167-overview

⁵ Mostaghimi, A., Gandhi, K., Done, N., Ray, M., Gao, W., Carley, C., … & Sikirica, V. (2022). All-cause health care resource utilization and costs among adults with alopecia areata: A retrospective claims database study in the United States. Journal of Managed Care & Specialty Pharmacy, 28(4), 426-434: DOI: 10.18553/jmcp.2022.28.4.426

⁶ Lechmann, M., Krooshoop, D. J., Dudziak, D., Kremmer, E., Kuhnt, C., Figdor, C. G., … & Steinkasserer, A. (2001). The extracellular domain of CD83 inhibits dendritic cell–mediated T cell stimulation and binds to a ligand on dendritic cells. The Journal of experimental medicine, 194(12), 1813-1821. DOI: 10.1084/jem.194.12.1813

MRM Health and Biocodex establish strategic partnership to strengthen future commercial supply capabilities for CORAL®-based medicines

Collaboration combines MRM Health’s cutting-edge microbiome science and proprietary CORAL® platform with Biocodex’s industrialization and manufacturing capabilities

Planned €15 million investment by Biocodex in specialized anaerobic manufacturing infrastructure will establish an additional pathway for MH002 and other MRM Health programs, from clinical development toward potential commercial supply

The specialized manufacturing capacity strengthens MRM Health’s readiness for pharmaceutical partnerships while preserving manufacturing flexibility and ownership of its platform and product-related innovations    

Ghent, Belgium – November 5, 2026 – MRM Health, a clinical-stage biotech developing microbiome-based therapies for immune-mediated diseases, and Biocodex, an independent French pharmaceutical company with more than 70 years of experience in the microbiome field, today announced the launch of a strategic partnership to establish specialized manufacturing capabilities for live biotherapeutic products. The collaboration combines MRM Health’s cutting-edge microbiome science and proprietary CORAL® platform with Biocodex’s pharmaceutical development, industrialization and manufacturing capabilities.

The partnership is designed to support both MRM Health’s lead asset MH002 and other CORAL®-based programs across the product lifecycle, from process development and clinical manufacturing toward potential future commercial supply. By establishing access to specialized manufacturing infrastructure alongside the clinical development of its pipeline, MRM Health is addressing an important future manufacturing and supply requirement for complex live biotherapeutic products and further strengthening the readiness of its programs for pharmaceutical partnerships and commercialization.

Biocodex will invest €15 million over the coming years in a new manufacturing infrastructure dedicated to live biotherapeutic products, including anaerobic manufacturing capabilities at its state-of-the-art pharmaceutical site in Beauvais, France. Biocodex will fund, build, own and operate the facility, while MRM Health will contribute its proprietary anaerobic manufacturing expertise to its design and implementation. The infrastructure will be designed to support the specific manufacturing requirements of products derived from MRM Health’s proprietary CORAL® platform, while also supporting other live biotherapeutic programs.

“Developing next-generation live biotherapeutics into successful medicines requires manufacturing capabilities that are just as sophisticated as the underlying science,” said Dr. Sam Possemiers, Chief Executive Officer of MRM Health. “Together with Biocodex we are establishing a specialized and scalable manufacturing pathway from clinical development to future commercial production. This partnership strengthens the readiness of both our own pipeline and CORAL® programs developed with pharmaceutical partners for future commercialization, bringing us closer to delivering microbiome-based therapeutics to patients.”

“This strategic collaboration strengthens the partnership we began last year with MRM Health,” added Nicolas Coudurier, Chief Executive Officer of Biocodex. “By combining our expertise, we are helping to strengthen European industrial capabilities in the field of live biotherapeutics. This is an important step in supporting the development of these new therapeutic approaches and ultimately enabling patients to benefit from them.”

A platform-enabling partnership supporting multiple MRM programs

The partnership establishes a framework under which Biocodex may provide process development, analytical testing and GMP manufacturing services for individual CORAL® programs under program-specific agreements. MRM Health will have access to the manufacturing infrastructure for its proprietary, partnered and out-licensed CORAL® programs. The non-exclusive nature of the collaboration preserves MRM Health’s flexibility to engage additional or alternative manufacturing partners where appropriate. This flexible partnership provides an additional manufacturing pathway for its lead candidate MH002 and its broader pipeline while reducing the need for its pharmaceutical partners to establish specialized manufacturing pathways independently as programs advance toward commercialization.

Scalable industrial support, from development to commercial supply

MRM Health has developed proprietary expertise in the scalable manufacturing of complex bacterial consortia through its single-process CORAL® production technology. The new infrastructure will build on this proficiency, as well as on the industrial experience of Biocodex, and provide a coordinated pathway for technology transfer, process development, clinical manufacturing and future commercial supply.

The facility will provide flexible manufacturing infrastructure across multiple scales. For MRM Health, it will enable the progression of both MH002 and other pipeline programs from development through later-stage clinical manufacturing and ultimately toward commercial-scale production. Capacity supporting CORAL® programs will expand in line with the clinical and commercial progress of MRM Health’s portfolio. Initial process development and pilot manufacturing activities are expected to begin by 2027, with commercial-scale manufacturing targeted from 2030.

***

About MRM Health

MRM Health is a clinical-stage biotech developing innovative live biotherapeutic products (LBPs) for immune-mediated diseases with high unmet needs. The Company’s lead program, MH002, for inflammatory bowel diseases (IBD), is currently being evaluated in the 204-patient STARFISH-UC Phase 2b study in patients with mild-to-moderate ulcerative colitis, following positive Phase 2a clinical data in ulcerative colitis and pouchitis. MH002 received FDA Fast Track designation in April 2026. MRM Health is expanding its pipeline across other inflammatory diseases and immuno-oncology, leveraging AI-guided discovery and deep expertise in microbiome ecosystem biology. Its CORAL® platform enables the rational design and manufacture of disease-focused microbial consortia with enhanced efficacy and scalability. In September 2025, MRM Health successfully closed a €55 million Series B round led by Biocodex, with strong support from ATHOS, BNP Paribas Fortis Private Equity and existing investors SFPIM, AvH, OMX Europe VF, QBIC II and VIB.

For more information, please follow us on LinkedIn or visit the website at www.mrmhealth.com.

About Biocodex

Biocodex is an independent French pharmaceutical company operating in more than 100 countries through its subsidiaries or partners. As a pioneer in gut microbiota research, the company has made it a central strategic focus, driven by the conviction that this ecosystem plays a key role in overall health and a more holistic approach to care.

The Group develops innovative healthcare solutions across four complementary areas: microbiota, women’s health, rare diseases, and established products addressing everyday health needs (mental health, sleep, pain, etc.). True to its family-owned identity, Biocodex promotes a committed vision of health that combines scientific excellence, a strong industrial base in France, international reach, and corporate social responsibility. This commitment has been recognized with the “Engagé RSE” label – Confirmed level (★★), awarded by AFNOR Certification and recognized across Europe through Responsibility Europe.

Empowering everyone to live fully is Biocodex’s purpose, embodied by its 1,900 employees worldwide.

Contacts