Gerresheimer AG corrects comprehensively revenues from bill-and-hold agreements

Duesseldorf, December 22, 2025. The Management Board of Gerresheimer AG (ISIN: DE000A0LD6E6, “Gerresheimer”) today decided to correct all revenues from bill-and-hold agreements recognized in the 2024 consolidated financial statements in the amount of approximately EUR 28m.

Following the audit of the consolidated financial statements and group management report for the 2024 financial year initiated by BaFin, Gerresheimer AG commissioned an investigation by an independent external law firm. This investigation revealed that the recognition of revenues from bill-and-hold agreements consistently did not comply with IFRS requirements and that these revenues were systematically recognized too early.

Gerresheimer AG will correct this accounting error in the previous year’s figures when preparing the 2025 consolidated financial statements. The revenues from bill-and-hold agreements of around EUR 28 million recognized in the 2024 consolidated financial statements will be corrected and recognized in the revenues for the 2025 financial year. This will be partially offset by the correction of revenues from bill-and-hold agreements from the 2023 financial year amounting to around EUR 10 million, which will now be recognized in revenues for the 2024 financial year.

As a result of the correction of these revenues from bill-and-hold agreements, the revenue of EUR 2.036 billion reported for the 2024 financial year is expected to decrease by around 1% (around EUR 18 million), the reported adjusted EBITDA of EUR 419.4 million by around 1% (around EUR 5 million) and the reported adjusted EPS of EUR 4.67 by around 2% (around EUR 0.10).

Gerresheimer AG will not include any revenues from new bill-and-hold agreements in its 2025 consolidated financial statements and will also refrain from this practice in the future.

To the extent that such revenues were already included in the revenues figures of the financial information published during the 2025 financial year, they will be corrected in the respective subsequent publications in the 2026 financial year by adjusting the previous year’s figures. In the 2025 half-year financial report, this is expected to account for revenues of around 4 million euros.

The company will continue to cooperate fully with BaFin in the audit of the 2024 consolidated financial statements and group management report.

Berlin, 19 December 2025 – Cantourage Group SE (ISIN: DE000A3DSV01), based on an analysis of preliminary, unaudited consolidated financial figures and corresponding current projections, has determined that operating earnings (EBITDA) for the period from January to November 2025 amount to approximately EUR 5.5 million. Current market expectations (consensus of the two analyst firms covering the Company) for the full 2025 financial year stand at EUR 4.8 million EBITDA.

According to the Management Board’s current assessment, EBITDA for the full 2025 financial year is expected to be in a range of EUR 5.5 million to EUR 6.5 million, thereby exceeding current market expectations.

Cantourage Group SE will publish the final and audited figures for the 2025 financial year as scheduled as part of its regular financial reporting.

PRESS RELEASE

Biotest announces US FDA approval of Grifols’ Fesilty™ (fibrinogen, human-chmt)

• Fesilty™ (fibrinogen, human-chmt) approved by the U.S. Food and Drug Administration (FDA)
• This new fibrinogen product was developed and is manufactured by Biotest AG and will be commercialized in the U.S. by Grifols
• U.S. market entry planned in first half of 2026

Dreieich, 19 December 2025. Biotest AG, part of the Grifols group, today announced that Grifols has received approval from the U.S. Food and Drug Administration (FDA) for Fesilty™ (fibrinogen, human-chmt), which is manufactured by Biotest and will be commercialized in the U.S. by Grifols.

Within the U.S., Fesilty™ is indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency (CFD), including hypo- or afibrinogenemia. This approval will allow Grifols to launch this product in the first half of 2026.

Human fibrinogen is one of the Biotest pipeline products that contributes a significant benefit to the whole Grifols group – now and in the future. Biotest received approval for human fibrinogen under the brand name Prufibry^® in Germany in November. Additional approvals in Europe are expected in 2026.

“This FDA approval marks a major achievement for both Biotest and Grifols,” said Dr. Jörg Schüttrumpf, Chief Executive Officer of Biotest AG. “We are proud that our plasma expertise contributes directly to expanding patient access to life-saving fibrinogen therapies in the treatment of critical conditions worldwide.”

Manufactured at Biotest Next Level

Human fibrinogen is produced at the Biotest Next Level (BNL) facility in Dreieich, Germany — one of the most advanced plasma protein production plants in Europe. The plant combines high efficiency, robust viral safety, and sustainability in the use of plasma as a raw material.

A shared success within the Grifols Group

As part of the Grifols group, Biotest plays a key role in advancing plasma-derived therapies from research to large-scale manufacturing. With Prufibry^® already approved in Germany, and now Fesilty™ approved in the United States, the companies together expand access to fibrinogen replacement therapy for patients around the world.

About Fesilty^TM

Fesilty is a human fibrinogen product commercialized in the U.S. by Grifols and indicated for treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia. It was developed and is manufactured by Biotest AG in Dreieich, Germany. The newly developed manufacturing process of the product leads to high-purity fibrinogen with a defined concentration, high level of viral safety and good solubility.

About fibrinogen and fibrinogen deficiency

Fibrinogen is a blood clotting factor that is produced in the liver. It plays a key role in primary haemostasis (stopping blood loss from bleeding wounds) and wound healing. In case of a lack or shortage of fibrinogen blood’s ability to clot is impaired which leads to a much greater risk of bleeding and delayed haemostasis. The fibrinogen concentrate alternatives fresh frozen plasma (FFP) and cryoprecipitate contain variable amounts of fibrinogen and must be thawed prior to treatment. The defined amount of fibrinogen in the fibrinogen concentrate will allow a tailor-made, patient specific and highly effective therapy.

About Biotest

Biotest is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,600 employees worldwide. Since May 2022, Biotest has been a part of the Grifols Group, based in Barcelona, Spain (www.grifols.com).

IR contact

Dr Monika Baumann (Buttkereit)
Phone: +49-6103-801-4406
Mail: ir@biotest.com

PR contact

Miriam Oehme
Phone: +49 -152 07016 992
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
Preference shares: securities’ ID No. 522723; ISIN DE0005227235
Listing: Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

Abivax to be Added to Nasdaq Biotechnology Index

PARIS, France – December 18,  2025 – 10:05 pm CET – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced that it will be added to the Nasdaq Biotechnology Index (Nasdaq: NBI), effective prior to market open on Monday, December 22, 2025.

Didier Blondel, Chief Financial Officer of Abivax commented: “Our inclusion in the Nasdaq Biotechnology Index marks a significant milestone for Abivax. It highlights the meaningful progress we’ve made as a company, particularly in advancing obefazimod through the successful Phase 3 ABTECT Induction trials for ulcerative colitis and reflects the increased visibility and perception of Abivax within the global biotechnology community.”

The NBI is designed to track the performance of a set of securities listed on The Nasdaq Stock Market^® that are classified as either biotechnology or pharmaceutical companies according to the Industry Classification Benchmark. Companies in the Nasdaq Biotechnology Index must meet eligibility requirements, including minimum market capitalization, average daily trading volume and seasoning as a public company, among other criteria. The NBI is evaluated annually in December and is calculated under a modified capitalization-weighted methodology.

For more information about the NBI, visit: https://indexes.nasdaqomx.com/Index/Overview/NBI

About Abivax

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

Q4 & Full-Year 2024/25 (October 2024 – September 2025)

DOUGLAS Group achieves solid sales growth and doubles net income in volatile financial year 2024/25

• Full-year guidance achieved: Sales increased by 3.5% (excluding Disapo) to 4.58 billion euros; adjusted EBITDA margin of 16.8%; net income more than doubled to 175.4 million euros
• Omnichannel remains winning model in beauty retail: Growth stems from both stores and online, with E-Com experiencing a surge towards the end of the financial year
• Q4 influenced by challenging environment: Solid sales growth of 2.6% (excluding Disapo); adjusted EBITDA down 11.4% to 134.3 million euros mainly due to changing consumer behavior, including higher price sensitivity, as well as ongoing promotional competition
• Markets continue to structurally grow, yet at a slower pace: European premium beauty market expected to maintain growth, but likely further characterized by consumer uncertainty
• Guidance for financial year 2025/26 and mid-term targets:
  • Guidance FY 2025/26: Sales of 4.65-4.80 billion euros and adj. EBITDA margin of around 16.5%; net leverage between 2.5x and 3.0x as of 30 September 2026
  • Mid-term targets: Annual sales growth in the low- to mid-single-digits, sustaining a stable adj. EBITDA margin; reduction of net leverage to a range of 2.0x to 2.5x
• Strategic expansion: DOUGLAS Group considers to expand outside of continental Europe and evaluates market entry in the Middle East / GCC countries (Gulf Cooperation Council)

Düsseldorf, 18 December, 2025 – The DOUGLAS Group, Europe’s number one premium beauty retailer, has concluded the financial year 2024/25 with solid growth in sales and in line with its updated guidance. While the financial year got off to a good start in the first quarter (October – December 2024), consumer sentiment and spendings slowed down during the early months of 2025, especially in Germany and France. Following a turnaround in the third quarter, the July to September period saw a push in the E-Com business – overall profitability however was under pressure due to the challenging market conditions. For the full year and thanks in particular to significantly lower debt, the DOUGLAS Group more than doubled its net income. At the same time, it made major progress in the implementation of its targeted omnichannel strategy “Let it Bloom”.

Sander van der Laan, CEO DOUGLAS Group: “In a very volatile and thus challenging year, we have accomplished results within expectations. Going forward, we anticipate solid overall growth in Europe’s premium beauty market, but observe a changing consumer behavior compared to the highly dynamic post-pandemic years. As a leading player, we want to take advantage of the opportunities in this phase of market consolidation and rebalancing. We have the strength and ambition to further grow and also expect momentum from the ongoing expansion of our store network and by tapping into new markets – also outside of continental Europe. That’s why we consider a market entry in the Middle East where we see a great potential for our premium beauty business.”

FY 2024/25 results in line with expectations

In the financial year 2024/25, sales grew by 2.8%, or 3.5% excluding the sold-off online pharmacy Disapo, to 4.58 billion euros. Both stores with 2.5% (lfl: +0.2%) and E‑Com with 5.6% (excluding Disapo) contributed to overall growth. Sales from cross-channel services like Click & Collect Express – allocated to E-Com sales – have also developed exceptionally well.

Reported EBITDA was up 3.6%, amounting to 756.5 million euros and a rep. EBITDA margin of 16.5% (PY: 16.4%). Adjusted EBITDA declined 5.0% to 768.4 million euros and a margin of 16.8% (PY: 18.2%), also reflecting lower adjustments. Net income more than doubled to 175.4 million euros (PY: 84.0 million euros). Free Cash Flow was down -12.0% to 461.0 million euros (PY: 524.0 million euros). Average net working capital as a percentage of LTM Group sales improved to 4.4% (PY: 5.3%).

The DOUGLAS Group therefore achieved its guidance for the financial year 2024/25 – as updated on 20 March 2025 to reflect the changed market environment – across all four KPIs.

Final quarter of the financial year marked by strong E-Com performance

The DOUGLAS Group concluded the financial year with a solid fourth quarter: Group sales increased by 2.3%, or 2.6% excluding Disapo, to 981.9 million euros (lfl: +1.2%). Growth was driven by a  strong E-Com performance, whereas the increase in store sales was attributed to the expansion of the network. All segments contributed positively to total sales. In the French market, which has been facing a downward trend, NOCIBÉ improved its position and gained share, and the DOUGLAS Group also gained share in the slightly growing German premium market year in the financial year 2024/25.

Store sales rose 0.6% year-on-year. Performance varied between segments: Compared to the prior-year period, sales increased in Central Eastern Europe (+6.4%) and Southern Europe (+2.2%), and were in line in the DACHNL region (-0.3%). In France, stationary sales saw a slight decline (-1.5%).

E-Com sales surged almost everywhere in Q4, accumulating to a 6.2% improvement year-on-year, or 7.3% excluding Disapo. Beyond the online pure player segment Parfumdreams / Niche Beauty (+17.5%), Central Eastern Europe (+13.8%) and France (+11.0%) showed the biggest growth rates.

Consistently tight cost management supported profitability in the fourth quarter; however, the gross margin was impacted by changing consumer behavior including higher price sensitivity, ongoing promotional competition and lower supplier bonuses. Reported EBITDA went down 15.1% to 129.8 million euros, corresponding to an EBITDA margin of 13.2% (PY: 15.9%). Adj. EBITDA decreased by 11.4% to 134.3 million euros, resulting in a margin of 13.7% (PY: 15.8%). Net leverage stood at 2.9x as of 30 September 2025 (30 September 2024: 2.8x), or 2.1x before IFRS16.

Targeted investments in growth initiatives and operational efficiency

To support its growth ambitions in a further evolving and rebalancing market environment, the Group continues to invest in strategic initiatives – including in IT capabilities, supply chain excellence and harmonized processes and systems across the entire organization to achieve a higher degree of standardization and operational efficiency. Moreover, the company evaluates and tests the use of artificial intelligence in different areas such as marketing or the user experience in the online shop.

Sander van der Laan: “We firmly believe in ‘Let it Bloom’ as the right strategy for us and omnichannel as the winning model for beauty retail. As we set our eyes on profitable growth, we continue to invest in the initiatives that will drive our business and efficiency – such as IT, E-Com and expansion.”

Potential expansion beyond continental Europe

The DOUGLAS Group is considering to expand beyond continental Europe and currently evaluates a market entry in the Middle East. With their thriving retail landscapes, rapidly developing economies, and a customer base with strong purchasing power, the GCC countries are predestined for the DOUGLAS Group’s premium beauty offering. A final decision will be made in the course of 2026.

Milestones across several strategic initiatives

In line with its commitment to the stationary shopping experience, the DOUGLAS Group continues to develop its store network: It has opened 35 new own stores (net) between July and September 2025, including the first flagship store in Tallinn, Estonia, and a new DOUGLAS store in the Swiss capital Bern. 36 existing own stores were refurbished (including relocations). In total, the company has refurbished 139 existing own stores (including relocations) and opened 74 new own stores (net) in 2024/25, elevating the number of stores as of 30 September 2025 to 1,959 (including franchise).

The Group has also achieved milestones in a number of further strategic initiatives: It has introduced three new exclusive brands (NEST, Iräye, Drybar) in Q4 and launched a new brand campaign platform to drive consistent and coherent communication across all 22 omnichannel countries.

Furthermore, it has made good progress in the rollout of its OWAC (“One Warehouse, All Channels”) supply chain model and getting fulfilment ready for future growth: The fifth OWAC warehouse near Warsaw, Poland, has commenced operations in August, enhancing service quality, delivery times and the customer experience. The OWAC currently handles all B2C orders and store deliveries in Poland and will serve six additional countries in the future. In Italy, OWAC operations transitioned to a modern and highly automated new warehouse: The move, while temporarily affecting the service rate during ramp-up, is expected to lead to significantly reduced logistics expenses. Finally, the company has recently signed a contract for its sixth OWAC warehouse in the Netherlands for the BENE region.

Guidance for financial year 2025/26 and mid-term targets

In light of the economic and market conditions leading to high price sensitivity among consumers, the DOUGLAS Group has provided its guidance for the financial year 2025/26 and expects sales between 4.65 and 4.80 billion euros, an adj. EBITDA margin of around 16.5%, and a net leverage between 2.5x and 3.0x as of 30 September 2026.

As key components to deliver on the latter, the company anticipates positive developments in average net working capital – expected below 4% of LTM sales – and capex (excl. leases), which are expected to be around 150 million euros.

Reflecting the focus on profitable growth, the Group also provided its mid-term targets for the next three years and expects to annually increase sales in the low- to mid-single-digits, sustain a stable adj. EBITDA margin, and reduce the net leverage to a range of 2.0x to 2.5x. The company anticipates to be in a position to consider paying a dividend at a net leverage of 2.0x to 2.5x.

Van der Laan: “Thanks to our dedicated employees, loyal customers and the strong relationships with our business partners, we have weathered a challenging year. Our markets evolve in a difficult environment, and we are well positioned to continue growing due to our effective omnichannel model and outstanding retail brands. We rely on our strengths and the strategic course we have set.”

Solid start into 2025/26 – trading statement on 19 January

The DOUGLAS Group has achieved a solid start into the new financial year 2025/26 and will provide more info on the performance in the first quarter in a trading statement on 19 January 2026.

Overview Financial Results (Q4 2024/25)

1. Sales per channel

2. Sales per segment

3. Key financial figures

Overview Financial Results FY 2024/25

1. Sales per channel

2. Sales per segment

3. Key financial figures

Segment Overview: DACHNL (Austria, Belgium, Germany, Switzerland, The Netherlands), France (France, Monaco), SE / Southern Europe (Andorra, Croatia, Italy, Portugal, Slovenia, Spain), CEE / Central Eastern Europe (Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia), PD/NB (Parfumdreams, Niche Beauty)

X-Channel refers to cross-channel services, e.g. Click & Collect Express.

About the DOUGLAS Group

The DOUGLAS Group, with its commercial brands DOUGLAS, NOCIBÉ, Parfumdreams and Niche Beauty, is the number one omnichannel premium beauty destination in Europe. The DOUGLAS Group is inspiring customers to live their own kind of beauty by offering a unique assortment online and in around 1,960 stores. With unparalleled size and access to customers, the DOUGLAS Group is the partner of choice for brands and offers a premium range of selective and exclusive brands as well as own corporate brands. The assortment includes fragrances, color cosmetics, skin care, hair care, accessories as well as beauty services. Strengthening its successful omnichannel positioning while consistently developing superior customer experience is at the heart of the DOUGLAS Group strategy “Let it Bloom”. The winning business model is underpinned by the Group’s omnichannel proposition, leading brands, and data capabilities. In the financial year 2024/25, the DOUGLAS Group generated sales of 4.58 billion euros and employed more than 19,900 people across Europe. The DOUGLAS Group (Douglas AG) is listed at the Frankfurt Stock Exchange.

For further information please visit the DOUGLAS Group Website.

Press Contact

Peter Wübben
SVP Group Communications & Sustainability
Phone: +49 211 16847 6644
Mail: newsroom@douglas.de

Investor Contact

Dafne Sanac
Director / Senior Principal Investor Relations
Phone: +49 151 55675545
Mail: ir@douglas.de

Conference call on the results for the 4^rd quarter 2024/2025 (ending 30 September 2025) on 18 December 2025
Düsseldorf, December 2025 – The DOUGLAS Group, Europe’s number one omnichannel destination for premium beauty, invites you to an analyst and investor update call on the financial year 2024/2025 on 18 December 2025.

The conference call on the results will be held at 11:00 a.m. CEST on 18 December 2025.
To participate in the conference call, please make use of one of the following options:

• To participate in the audio conference, please use this Link to register for the conference call.
  • Please use this webcast Link to follow the presentation when dialed in and mute the audio line.
• You can follow the webcast with audio via this Link.

About the DOUGLAS Group
The DOUGLAS Group, with its commercial brands DOUGLAS, NOCIBÉ, Parfumdreams and Niche Beauty, is the number one omnichannel premium beauty destination in Europe. The DOUGLAS Group is inspiring customers to live their own kind of beauty by offering a unique assortment online and in around 1,900 stores. With unparalleled size and access to customers, the DOUGLAS Group is the partner of choice for brands and offers a premium range of selective and exclusive brands as well as own corporate brands. The assortment includes fragrances, color cosmetics, skin care, hair care, accessories as well as beauty services. Strengthening its successful omnichannel positioning while consistently developing superior customer experience is at the heart of the DOUGLAS Group strategy “Let it Bloom”. The winning business model is underpinned by the Group’s omnichannel proposition, leading brands, and data capabilities. In the financial year 2023/2024, the DOUGLAS Group generated sales of around 4.5 billion euros and employed around 19,200 people across Europe. The DOUGLAS Group (Douglas AG) is listed at the Frankfurt Stock Exchange.
For further information please visit the DOUGLAS Group Website.

Investor Contact
Dafne Sanac
Director Investor Relations
Phone: +49 151 55675545
Mail: ir@douglas.de
 

Conference call on the results for the 4rd quarter 2024/2025 (ending 30 September 2025) on 18 December 2025

Düsseldorf, December 2025 – The DOUGLAS Group, Europe’s number one omnichannel destination for premium beauty, invites you to an analyst and investor update call on the financial year 2024/2025 on 18 December 2025.

The conference call on the results will be held at 11:00 a.m. CEST on 18 December 2025.

To participate in the conference call, please make use of one of the following options:

• To participate in the audio conference, please use this Link to register for the conference call.
  • Please use this webcast Link to follow the presentation when dialed in and mute the audio line.
• You can follow the webcast with audio via this Link.

About the DOUGLAS Group

The DOUGLAS Group, with its commercial brands DOUGLAS, NOCIBÉ, Parfumdreams and Niche Beauty, is the number one omnichannel premium beauty destination in Europe. The DOUGLAS Group is inspiring customers to live their own kind of beauty by offering a unique assortment online and in around 1,900 stores. With unparalleled size and access to customers, the DOUGLAS Group is the partner of choice for brands and offers a premium range of selective and exclusive brands as well as own corporate brands. The assortment includes fragrances, color cosmetics, skin care, hair care, accessories as well as beauty services. Strengthening its successful omnichannel positioning while consistently developing superior customer experience is at the heart of the DOUGLAS Group strategy “Let it Bloom”. The winning business model is underpinned by the Group’s omnichannel proposition, leading brands, and data capabilities. In the financial year 2023/2024, the DOUGLAS Group generated sales of around 4.5 billion euros and employed around 19,200 people across Europe. The DOUGLAS Group (Douglas AG) is listed at the Frankfurt Stock Exchange.

For further information please visit the DOUGLAS Group Website.

Investor Contact

Dafne Sanac
Director Investor Relations
Phone: +49 151 55675545

Mail: ir@douglas.de

Secarna Pharmaceuticals and Protalix Biotherapeutics Enter into Collaboration and Option Agreement

Partnership combines Protalix’s rare disease and biologics expertise with Secarna’s AI‑powered OligoCreator^® platform to jointly develop pharmaceutical candidates for rare renal indications

Protalix is granted an exclusive option to license any active compounds derived from the research for potential clinical development and commercialization

Martinsried (Munich), Germany, and Carmiel, Israel, December 17, 2025 – Secarna Pharmaceuticals GmbH & Co. KG, a company redefining the discovery and development of best-in-class oligonucleotide therapeutics, and Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the discovery, development, production and commercialization of innovative therapeutics for rare diseases with significant unmet needs, today announced that they have entered into a collaboration and option agreement. Under this agreement, the companies have agreed to partner in the discovery of novel antisense oligonucleotide (ASO) therapies against multiple targets for rare renal indications.

As part of the collaboration, Protalix has selected pharmaceutical targets with fundamental biological roles in rare renal indications and Secarna will apply OligoCreator^®, its proprietary AI-empowered oligonucleotide discovery and development platform, to design and profile ASO candidates against those targets. By jointly applying their research and development expertise, it is the Companies’ goal to advance the programs from preclinical stage to clinical trials. Under the terms of the collaboration agreement, Secarna grants Protalix an option to an exclusive, worldwide milestone and royalty bearing license to further develop, market and commercialize therapeutic programs.

“We are truly excited to collaborate with Protalix, a company with a strong track record in developing and bringing therapies for rare diseases to the market,” said Konstantin Petropoulos, Ph.D., Secarna Pharmaceuticals’ Chief Executive Officer. “This collaboration combines Secarna’s proven expertise in rapidly generating high-quality antisense candidates with Protalix’s deep expertise in advancing programs to patients worldwide. Together, we aim to bring forward precise and differentiated oligonucleotide therapies for people affected by severe kidney disorders.”

“This collaboration represents our first expansion into the rare kidney disease space leveraging RNA technologies, demonstrating the implementation of our previously updated research strategy,” said Dror Bashan, Protalix’s President and Chief Executive Officer. “We have started to leverage our development experience to increase our footprint as a rare disease therapeutics company. Secarna has established itself as a high-quality, innovative partner in the oligonucleotide field, and we are pleased to join forces to explore new biological pathways and advance promising targets toward clinical development, addressing significant unmet medical needs.”

About Secarna Pharmaceuticals
Secarna Pharmaceuticals is a biopharmaceutical company redefining the discovery and development of best-in-class oligonucleotide therapeutics, offering hope to patients facing conditions that are beyond the reach of current approaches and modalities. With the Company’s proprietary AI-empowered OligoCreator^® platform, which includes multiple delivery technologies, Secarna identifies and characterizes oligonucleotide therapeutics with unparalleled speed and excellent safety and efficacy. By delivering these novel therapeutics to the cells, organs, or tissues where they are needed, targeted oligonucleotide therapies have the potential to revolutionize treatments for a wide range of difficult-to-treat disorders. Secarna’s unique OligoCreator^® platform is leveraged to transform untreatable conditions into treatable ones, profoundly changing the future of medicine. www.secarna.com

About Protalix BioTherapeutics, Inc.
Protalix is a biopharmaceutical company focused on the discovery, development, production and commercialization of innovative therapeutics for rare diseases. Protalix has researched, developed and currently manufactures two enzyme replacement therapies that are currently available in multiple markets. These therapies are recombinant therapeutic proteins expressed through Protalix’s proprietary plant cell-based expression system, ProCellEx^®. ProCellEx is a unique plant cell-based system that enables Protalix to produce recombinant proteins in an industrial-scale manner with no exposure to mammalian cells. Protalix is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa, Elelyso^®, for the treatment of Gaucher disease, excluding in Brazil where Protalix retains full rights.

Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio^® which was approved by both the FDA and the European Medicines Agency (EMA) in May 2023. Protalix’s development pipeline includes, among others, two proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; and PRX–119, a plant cell-expressed long-acting DNase I for the treatment of NETs-related diseases. To learn more, please visit www.protalix.com

Protalix Cautionary Statement regarding Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms “anticipate,” “believe,” “estimate,” “expect,” “can,” “continue,” “could,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on Protalix’s current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause material differences include, among others: risks related to the ability to realize the anticipated benefits of the collaboration and option agreement, including the possibility that the expected benefits will not be realized or will not be realized within the expected time period; the uncertainties inherent in the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates; risks associated with initial, preliminary or interim data; the possible disruption of Protalix’s operations due to military actions conducted by Israel with the Hamas terrorist organization located in the Gaza Strip, the Hezbollah in Lebanon, the Houthis which control parts of Yemen, Iran and others, including as a result of the disruption of the operations of certain regulatory authorities and of certain of Protalix’s suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers, and the risk that the current hostilities will result in a greater regional conflict; risks related to Protalix’s expectations with respect to the projected market for the indications targeted in the collaboration; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities and other risks relating to the review process; risks relating to Protalix’s evaluation and pursuit of strategic partnerships; risks relating to Protalix’s ability to manage its relationship with its collaborators, distributors or partners; risks related to the amount and sufficiency of Protalix’s cash and cash equivalents and short-term bank deposits; Protalix’s dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies; potential product liability risks, and risks of securing adequate levels of related insurance coverage; the possibility of infringing a third-party’s patents or other intellectual property rights and the uncertainty of obtaining patents covering Protalix’s products and processes and successfully enforcing Protalix’s intellectual property rights against third-parties; and other factors described in Protalix’s filings with the U.S. Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and Protalix disclaims any obligation to update this information, except as may be required by law.

Secarna Contact
Secarna Pharmaceuticals GmbH & Co. KG
Konstantin Petropoulos, PhD, MBA
CEO
Phone: +49 (0)89 215 46 375
Email: info@secarna.com

Investor Contact–Protalix BioTherapeutics, Inc.
Mike Moyer, Managing Director
LifeSci Advisors
Phone: +1-617-308-4306
Email: mmoyer@lifesciadvisors.com

For Media Inquiries–Secarna
MC Services AG
Anne Hennecke/Lydia Robinson-Garcia
Phone: +49 (0)211 52 92 52 15
Email: secarna@mc-services.eu

Letter from the CEO

Dear shareholders, partners, and friends of Heidelberg Pharma,

The past few months have been turbulent and difficult for Heidelberg Pharma. We have been confronted with events and changes that required swift and decisive action. Today, I am writing to you to explain where we stand – and, above all, why I am deeply convinced that the difficult path we have now embarked upon will be worthwhile.

The expected milestone payment for the approval of the kidney cancer imaging agent TLX250-CDx has been delayed because the FDA’s Complete Response Letter (CRL) to our our Partner Telix Pharmaceuticals has identified deficiencies in the Chemistry, Manufacturing and Controls (CMC) package with no clinical efficacy or safety concerns, noted in Telix’ communication. The medical potential of TLX250-CDx is undisputed, and we share our partner’s assessment that this product will fundamentally change the diagnosis of kidney cancer, which will enhance the therapeutic efficacy. We have now reached an amicable agreement with Telix to ensure a constructive communication and work closely together with the aim to launch the product for the benefit of patients who need it.

To ensure the continued operation of the company, we launched a thorough cost-cutting program at the end of September. This includes the painful decision to part ways with 85 highly qualified and dedicated colleagues and to significantly adjust our science-oriented R&D capacities to the current financial reality. This tough business decision was taken after several long discussions and debates in the Management and Supervisory Board. We made this decision because there was no responsible alternative to saving the operational core of our company. On behalf of myself and my colleague on the Management Board Walter Miller, I would like to express my heartfelt thanks to the employees who have to leave us. Their dedicated and outstanding work has laid the foundation on which we can now continue to build.

I only recently took over as CEO, but I know Heidelberg Pharma and its products in detail from my time on the Supervisory Board. I was and remain convinced of our ATAC technology and the benefits that the product candidates can bring to severely ill patients.

That is why our goal remains unchanged: to continue developing pamlectabart tismanitin (HDP-101) to proof-of-concept. The results from Cohort 8 in our clinical phase I study give us great cause for optimism:

• Four out of seven evaluable patients responded to the therapy in Cohort 8.
• This translates to a response rate of 57%
• Two patients in this cohort showed stringent Complete Remission (sCR), meaning that no tumor cells are detectable – they are currently tumor-free. One more patient had a Very Good Partial Response (VGPR), meaning there is hardly any detectable activity of cancer in this patient’s body.
• The response occurred faster and was deeper than in patients from previous cohorts; we see a dose-dependent improvement here.
• Last but not least, there were no dose-limiting toxicities, or other severe reaction to the treatment in this cohort. The patients tolerated the therapy well.

These results reinforce our belief that our technology works and justify our uncompromising focus on this program. The Orphan Drug Status and the Fast Track Designation granted by the FDA also underscore the importance of pamlectabart tismanitin. Our goal now is to determine the recommended Phase II dose by Q2 2026.

The most pressing corporate task at present remains short- and mid-term financing. Despite our cost-cutting program, our cash reach is currently only secured until mid-2026. We assume that the potential milestone payment from our royalty partner Healthcare Royalty (HCRx) will be only realized after this date, with decreases on a quarterly basis. In the interests of continuing operations and securing our very successful clinical program, we are currently working with the highest priority to discuss various financing options with the Supervisory Board and our partners. We are in advanced talks on this matter and are confident that we will soon be able to report concrete progress.

With the newly established structure, we have laid the necessary foundation for the future. The restructuring of the company is underway, and our focus is now entirely on operational implementation and value enhancement through pamlectabart tismanitin. A second clinical program with HDP-102 is on temporary recruitment hold, and we intend to prepare the clinical trial package for HDP-103 for clinical development.

I have been and will be at the Ladenburg site regularly, closely involved in the activities and leading the transformation process – together with the new Heidelberg Pharma team, my colleague on the Executive Management Board, and the Supervisory Board.

I kindly invite the remaining team and you, our shareholders, to join us in shaping this new chapter in the company’s history. I thank you for your trust and support along the way.

Sincerely,

Dr. Dongzhou Jeffery Liu, Chairman of the Executive Management Board and CEO

17 December 2025

Topadur Appoints Matthias Schäfer as Chief Executive Officer to Lead Next Phase of Company Growth

• Founder and President of the Board Dr. Reto Naef assumes the role of Senior Scientific Advisor, continuing to support the company’s scientific direction
• Company enters next phase of clinical advancement with programs progressing toward strategic milestones

Zurich, Switzerland – Topadur Pharma AG, a clinical-stage biotechnology company developing innovative therapies for vascular regeneration, today announced the appointment of PD Dr. Matthias Schäfer as Chief Executive Officer.

Dr. Schäfer joined Topadur in 2024 as Chief Innovation Officer and Deputy CEO and now assumes executive leadership as the company advances its pipeline into the next stages of clinical development toward commercialization.

Founder Dr. Reto Naef remains on the leadership team as Senior Scientific Advisor and continues to guide the company’s strategy as President of the Board, ensuring continuity in Topadur’s long-term growth.

Matthias Schäfer brings more than 20 years of experience across the life sciences and healthcare sectors. He has directed research and clinical development programs, driven global portfolio expansion, and established strategic partnerships across diverse therapeutic areas. Dr. Schäfer has held senior leadership roles including at Geistlich Pharma AG and pfm medical GmbH, where he translated scientific innovation into sustainable commercial growth and strengthened global market presence. He received a PhD in Biology from the University of Würzburg and completed his habilitation at ETH Zurich.

“Topadur is entering an important phase as we advance toward meaningful clinical milestones,” said Dr. Schäfer. “Our priorities are progressing our lead programs in the clinical phases, increasing liquidity, and strengthening the organizational capabilities and partnerships needed to support continued growth. I look forward to working closely with our outstanding team to build on this momentum and advance our programs through their upcoming inflection points.”

“As a scientist and entrepreneur, I founded Topadur with the conviction that vascular regeneration has the power to treat a variety of aging-related diseases,” said Dr. Naef. “Today, the company stands on a strong scientific and clinical foundation. With Matthias stepping into the CEO role, we are ready to accelerate momentum and advance our programs into the next stage. I look forward to continuing to help shape Topadur’s strategic and scientific direction as President of the Board and in my new role as Senior Scientific Advisor.”

 
Advancing the Technology Platform and Clinical Pipeline

Topadur’s DualTOP^® platform is designed to restore healthy microcirculation and support tissue regeneration across multiple therapeutic areas.

The company’s lead asset, TOP-N53, is in Phase 2a clinical development for treatment of digital ulcers in patients with systemic sclerosis and has received Orphan Drug Designation from both the FDA and EMA. Supported by positive clinical Phase 1 data, TOP-N53 is also being advanced for development in diabetic foot ulcers, a major global health challenge and area of significant unmet clinical need, with one diabetes-related amputation occurring every 20 seconds[i].

Topadur’s second lead asset, TOP-M119, targeting androgenetic and chemotherapy-induced alopecia, is completing toxicology studies ahead of planned clinical entry. Building on the regenerative potential of the DualTOP^® platform, Topadur is also prioritizing innovative applications in skin rejuvenation and longevity, areas with rapidly growing scientific and commercial relevance. Complementary exploratory investigations are underway in oncology and other indications.

About Topadur
Topadur Pharma AG is a Swiss clinical-stage biotechnology company developing first-in-class therapies that restore microvascular function and reactivate tissue regeneration. Founded in 2015, the company focuses on diseases where impaired local blood flow is a key driver of tissue degeneration, impaired repair processes, and progression of chronic conditions with aging.

Topadur’s proprietary DualTOP^® platform targets the signaling cascade of cGMP, a central regulator of blood vessel function and tissue repair, through a dual mechanism designed to improve microcirculation directly at the site of disease. The company is advancing a pipeline of first-in-class candidates in high-need indications, supported by a capital-efficient, partnership-driven R&D model and a global network of scientific collaborators.

Beyond these lead indications, Topadur is pursuing focused preclinical programs in conditions where improved microcirculation may offer therapeutic benefit.

For more information, please visit: www.topadur.com

Contact
Topadur Pharma AG
Yoshita Bhide
Media Communications
+41 44 755 44 66
yoshita.bhide@topadur.com

Disclaimer
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Topadur Pharma AG. This publication may contain certain forward-looking statements and assessments or intentions concerning the company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the company to be materially different from those expressed or implied by such statements. Readers should therefore not place reliance on these statements, particularly not in connection with any contract or investment decision. The company disclaims any obligation to update these forward-looking statements, assessments or intentions.

^[i] Armstrong DG, Boulton AJM, and Bus SA (2017): Diabetic Foot Ulcers and Their Recurrence.
New England Journal of Medicine, 376(24):2367–2375.