Berlin, 5 December 2025. The Supervisory Board of Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) has decided to reduce the size of the Executive Board from three to two members as of 1 January 2026. The contract of Frank Yeager, member of the Executive Board and responsible for the Isotope Products segment, will end as planned on 31 December 2025. Mr Yeager will continue to head the Isotope Products segment in a leading role.

As of 1 January 2026, the company’s Executive Board will therefore consist of Dr Harald Hasselmann (Chairman of the Executive Board) and Dr Gunnar Mann (Member of the Executive Board).

About Eckert & Ziegler.
Eckert & Ziegler SE, with more than 1.000 employees, is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

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

Today, SCHOTT Pharma issues its financial guidance for fiscal year 2026: The company expects revenue growth at constant currencies in the range of 2-5% and an EBITDA margin of around 27%. This projection deviates from current market expectations (source: Vara consensus as of December 3, 2025) of 8.2% growth at constant currencies and an EBITDA margin of 28.8%.

Further, SCHOTT Pharma updates its mid-term outlook for 2027 to 2029 to a revenue CAGR of 6-8% and expects the EBITDA margin to improve over the coming years towards 30%.

Preliminary results for fiscal year 2025 are in line with market expectations and will be published in a press release later today. The full set of results for fiscal 2025 will be published on December 11, 2025, at 07:00 a.m. CET.

• Preliminary FY 2025 results in line with specified guidance:
  • Revenue of EUR 986.2m (+5.8% at constant currencies)
  • EBITDA margin of 28.4% (prior year: 26.9%) at constant currencies 
• Guidance for FY 2026: 2-5% revenue growth at constant currencies and EBITDA margin of around 27%
• Mid-term guidance (FY 2027-2029): Revenue CAGR of 6-8%; EBITDA margin increasing towards 30%

Based on preliminary results, SCHOTT Pharma expects revenues of EUR 986.2m for fiscal year 2025, representing an increase of 5.8% at constant currencies. EBITDA is expected to amount to EUR 280.3m, representing an increase of 11.5%. This corresponds to an EBITDA margin of 28.4%.

For fiscal year 2026, SCHOTT Pharma expects revenue growth at constant currencies in the range of 2-5% and an EBITDA margin of around 27%.

“2026 will be a bridge year for SCHOTT Pharma as we navigate a challenging market environment and prepare for the next phase of growth. Short-term headwinds persist, especially in the Drug Delivery Systems segment. It will be impacted by the revised market outlook of a key customer resulting in lower glass syringes demand. Nevertheless, we remain confident that our strong innovation pipeline, strategic investments, and robust customer partnerships position us well for future success. The fundamentals of our business remain solid, and we see opportunities to accelerate growth beyond 2026,” says Andreas Reisse, CEO of SCHOTT Pharma.

Based on this, SCHOTT Pharma updates its mid-term outlook for 2027 to 2029 to a revenue CAGR of 6-8% and expects the EBITDA margin to improve over the coming years towards 30%.

All results are preliminary and unaudited. The full set of results for fiscal year 2025 will be published on December 11, 2025, at 07:00 a.m. CET. Andreas Reisse (CEO) and Reinhard Mayer (CFO) will discuss details of the FY 2025 results in an analyst and investor conference call at 11:00 a.m. CET.

About SCHOTT Pharma
Human health matters. That is why SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world. Every minute, more than 25,000 people receive an injection packed in a SCHOTT Pharma product. The portfolio comprises drug containment solutions and delivery systems for injectable drugs ranging from prefillable glass and polymer syringes to cartridges, vials, and ampoules. Every day, a team of around 4,700 people from over 60 nations works at SCHOTT Pharma to contribute to global healthcare. The company is represented in all main pharmaceutical hubs with 17 manufacturing sites in Europe, North and South America, and Asia. With over 1,000 patents and technologies developed in-house and a state-of-the-art R&D center in Switzerland, the company is focused on developing innovations for the future. SCHOTT Pharma AG & Co. KGaA is headquartered in Mainz, Germany and listed on the Frankfurt Stock Exchange as part of the SDAX. It is majority owned by SCHOTT AG, which is owned by the Carl Zeiss Foundation. In light of this spirit, SCHOTT Pharma is committed to sustainable development for society and the environment. Currently, SCHOTT Pharma has over 1,800 customers including the top 30 leading pharma manufacturers for injectable drugs and generated revenue of EUR 957 million in the fiscal year 2024. Further information at www.schott-pharma.com.   

Contact
Katrin Schreyer
Corporate Communications
Tel.: +49 (0) 6131 66-4932
E-Mail: katrin.schreyer@schott.com 
 
Lea Kaiser
Media Relations
Tel.: +49 (0) 6131 66-2422
E-Mail: lea.kaiser@schott.com 
 
Tobias Erfurth
Head of Investor Relations
E-Mail: Tobias.Erfurth@schott.com
 
Jasko Terzic, CFA
Senior Manager Investor Relations
E-Mail: Jasko.Terzic@schott.com

Galimedix Therapeutics presents compelling Phase 1 study results showing excellent safety and pharmacokinetics with oral small molecule GAL-101 at CTAD 2025

• GAL-101 was safe and well tolerated, with no dose-limiting adverse events observed
• Pharmacologically relevant GAL-101 concentrations were detected in cerebrospinal fluid (CSF), confirming blood-brain barrier penetration
• Phase 2 proof-of-concept study in Alzheimer’s disease is planned

Kensington, MD, USA and Munich/Martinsried, Germany, December 4, 2025 – Galimedix Therapeutics, Inc. (Galimedix), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious brain and retinal diseases, presented further data from its Phase 1 study with orally administered GAL-101, a small molecule specifically designed to target misfolded amyloid beta (Aβ) monomers, thereby preventing the formation of soluble, toxic aggregates (Aβ oligomers and protofibrils) present in the brains of patients with Alzheimer’s disease (AD). The data were presented at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) Conference, held in San Diego, California, USA, December 1-4, 2025.

The presentation, “Oral GAL-101 Demonstrates Excellent Tolerability and Favorable Pharmacokinetics in Phase 1, Paving the Way for Phase 2 Development”, highlighted results from the randomized, double-blind Phase 1 study involving approximately 100 healthy volunteers. GAL-101 showed a favorable safety and tolerability profile at all investigated single and multiple ascending (SAD and MAD) doses and under all investigated conditions. Lumbar CSF concentrations measured after multiple dose treatment confirmed that GAL-101 effectively crosses the blood-brain barrier and support once daily dosing for future clinical trials.

“We are pleased to see such favorable pharmacokinetic results from our first-in-human trial with the oral formulation of lead compound, GAL-101,” said Hermann Russ, MD, PhD, Co-founder and Chief Scientific Officer of Galimedix. “The trial results showed that this novel small molecule was safe and well tolerated and effectively crossed the blood-brain barrier. Based on these clinical results, and the robust pre-clinical data package, we are now planning a Phase 2 proof-of-concept study in Alzheimer’s disease. We believe that GAL-101 tablets have the potential to one day become standard of care for all stages of Alzheimer’s disease, and we are excited to move forward in development.”

No dose-limiting adverse events were observed; all dose levels were well tolerated. GAL-101 was quickly absorbed, and plasma levels were significantly higher than the levels expected to be necessary for clinical efficacy. There was no accumulation of the drug after multiple administrations, and no relevant food effect was observed. Elderly subjects (>65 years) experienced a slightly higher exposure than younger subjects and tolerated the drug equally well.

A Phase 2 study is being planned and will include cognitive functional endpoints and incorporate plasma and CSF biomarkers. Continuous cognitive at-home monitoring is planned to capture any early cognitive functional improvement, which is expected due to the rapid inactivation of toxic Aβ species by GAL-101 observed in pre-clinical testing.

The slides can be accessed here: Stopping Neurodegeneration at its Source with GAL-101

About GAL-101
GAL-101 is a small molecule targeting misfolded amyloid beta (Aβ) monomers and thus preventing the formation of toxic Aβ oligomers and protofibrils. It is being developed in both oral and topical (eyedrops) formulations. Many studies have indicated that these Aβ aggregates are a major underlying cause of neurodegenerative diseases of the brain and retina, and recent approvals of anti-Aβ drugs have also validated them as a key target in Alzheimer’s disease. GAL-101 is being developed for the treatment of Alzheimer’s disease, dry age-related macular degeneration (dAMD) and glaucoma.

In pre-clinical testing, the compound has been shown to prevent and eliminate all forms of toxic Aβ species while leaving healthy Aβ forms intact. GAL-101 has also demonstrated the potential for neuroprotection and for symptomatic alleviation in pre-clinical models of Alzheimer’s disease. Additionally, orally available GAL-101 has shown no antibody-specific immunological side effects (e.g., ARIA), very low systemic toxicity, robust storage stability, and easy and inexpensive manufacturing. Strong efficacy has also been demonstrated in relevant ophthalmic pre-clinical models, protecting neuronal retinal cells from toxic damage. In a previous Phase 1 study, GAL-101 eyedrops demonstrated an excellent safety and tolerability profile. The eDREAM Phase 2 study (NCT06659549) in dAMD/geographic atrophy with GAL-101 eyedrops is ongoing.

About Galimedix Therapeutics, Inc. 
Galimedix is a Phase 2 clinical-stage private company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious brain and retinal diseases. Founded by a seasoned and highly dedicated team of bio-entrepreneurs, pharmaceutical executives and scientists, Galimedix’s groundbreaking small molecules offer the hope of changing the course of disease where amyloid beta (Aβ) plays a role, such as in Alzheimer’s disease, dry age-related macular degeneration (dAMD) and glaucoma – Galimedix’s initial areas of focus.

Contact 

Alexander Gebauer, MD, PhD 
Galimedix Therapeutics, Inc. 
Co-founder and Executive Chairman  
info@galimedix.com  

Media inquiries: 

The Management Board of aap Implantate AG (the “Company”) today resolved, with the approval of the Supervisory Board, to increase the Company’s share capital from its current level of EUR 13,909,408.00 by EUR 788,150.00 to EUR 14,697,558 by issuing 788150 new no-par value bearer shares, each with a proportional amount of EUR 1.00 in the share capital (“New Shares”), against cash contributions, partially utilizing the authorized capital 2024/I and excluding shareholders’ subscription rights (“cash capital increase“). The issue price per New Share is EUR 1.34. The cash capital increase corresponds to approximately 5% of the existing share capital. The New Shares will be issued by way of a private placement to selected investors. The New Shares will be entitled to dividends from January 1, 2025.

The cash capital increase serves to strengthen the company’s equity base. The gross proceeds from the cash capital increase will amount to EUR 1,056,121.00.

*****

Contact:
aap Implantate AG; R. Di Girolamo; Vorsitzender des Vorstands / CEO; Lorenzweg 5; D-12099 Berlin
Tel.: +49/30/750 19 – 170; Fax: +49/30/750 19 – 290; r.digirolamo@aap.de

Hamburg, Germany, 04 December 2025:
Evotec SE (Frankfurt Stock Exchange: EVT, SDAX/TecDAX, Prime Standard, ISIN: DE0005664809, WKN 566480; NASDAQ: EVO) today announced that its partner Bayer AG has initiated a Phase 2 clinical study of a kidney disease program originating from the multi-target research collaboration between Evotec and Bayer in kidney diseases. Under the terms of the collaboration agreement, Evotec is eligible to receive a milestone payment upon first patient dosing, which is expected in early 2026. The study drug, BAY 3401016, a monoclonal antibody (“mAb”) targeting the protein Semaphorin-3A (“Sema3A”) is being developed as a potential treatment for Alport syndrome, a rare genetic kidney disease.

Bayer’s ASSESS study is a randomized, double-blind, placebo-controlled, parallel group Phase 2a study with an extension phase to evaluate the efficacy and safety of BAY 3401016 in participants aged 18 to 45 with Alport syndrome. The program originates from a strategic collaboration, which Evotec and Bayer entered in August 2016. Under the terms of the agreement, Evotec is eligible to receive further development and sales milestones as well as tiered royalties of net sales contingent upon the future progress during clinical development and potential commercialization of a drug in the future.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are very pleased that our jointly developed antibody, BAY 3401016, for the treatment of Alport syndrome has advanced into Phase 2 of clinical development. Alport syndrome primarily damages the kidney, often starting at childhood and worsening through life. This debilitating disease significantly impacts patient’s quality of life through both the symptoms and disease management, especially in later stages of kidney disease. New therapeutic options that enable better quality of life are urgently needed for individuals and families affected by this disease. The initiation of this study represents an important and hopeful step forward. We congratulate Bayer on the Phase 2 launch and are proud to support the advancement of this program.”

About Semaphorin-3A
Semaphorin-3A (“Sema3A”) is an extracellular guidance protein and a well-known regulator of the actin cytoskeleton. Alterations of the actin cytoskeleton, particularly of podocytes, are a key pathophysiological feature of Alport syndrome, a rare genetic kidney disease with progressive loss of filtration capacity, leading to end stage renal disease, progressive hearing loss and variable vision impairment. Sema3A is upregulated in injured human kidneys and implicated in the development and progression of acute and chronic kidney diseases. The monoclonal antibody (“mAb”) developed by Bayer in partnership with Evotec blocks Sema3A activity and is currently investigated as a potential treatment of Alport syndrome, aiming to delay disease progression and onset of end-stage renal disease.

About Alport Syndrome
Alport syndrome is a genetic condition characterized by kidney disease, hearing loss, and eye abnormalities. Most affected individuals experience progressive loss of kidney function, which may lead to end-stage kidney disease. People with Alport syndrome also frequently develop sensorineural hearing loss in late childhood or early adolescence. The eye abnormalities characteristic of this condition seldom lead to vision loss. In 80% of cases, Alport syndrome is inherited in an X-linked manner and is caused by genetic changes in the COL4A5 gene. In the remaining cases, it may be inherited in either an autosomal recessive, or rarely in an autosomal dominant manner. In these cases, the condition is caused by genetic changes in the COL4A3 or COL4A4 genes. Diagnosis of the condition is based on family history of the condition, clinical signs, and specific testing such as a kidney biopsy. The diagnosis can be confirmed by genetic testing.

About Evotec SE
Evotec is a life science company that is pioneering the future of drug discovery and development. By integrating breakthrough science with AI-driven innovation and advanced technologies, we accelerate the journey from concept to cure — faster, smarter, and with greater precision.

Our expertise spans small molecules, biologics, cell therapies and associated modalities, supported by proprietary platforms such as Molecular Patient Databases, PanOmics and iPSC-based disease modeling.

With flexible partnering models tailored to our customers’ needs, we work with all Top 20 Pharma companies, over 800 biotechs, academic institutions, and healthcare stakeholders. Our offerings range from standalone services to fully integrated R&D programs and long-term strategic partnerships, combining scientific excellence with operational agility.

Through Just – Evotec Biologics, we redefine biologics development and manufacturing to improve accessibility and affordability.

With a strong portfolio of over 100 proprietary R&D assets, most of them being co-owned, we focus on key therapeutic areas including oncology, cardiovascular and metabolic diseases, neurology, and immunology.

Evotec’s global team of more than 4,800 experts operates from sites in Europe and the U.S., offering complementary technologies and services as synergistic centers of excellence. Learn more at www.evotec.com and follow us on LinkedIn and X/Twitter @Evotec.

Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

For further information, please contact:

Media
Susanne Kreuter 
VP Head of Strategic Marketing 
Susanne.Kreuter@evotec.com 

Investor Relations
Volker Braun
EVP Head of Global Investor Relations & ESG
Volker.Braun@evotec.com

Presse Release // December 04, 2025

Formycon and MS Pharma sign exclusive commercialization partnership for Keytruda^® biosimilar candidate FYB206 for the MENA Region
 

Planegg-Martinsried, Germany / Amman, Jordan – Formycon AG (FSE: FYB, Prime Standard) and MS Pharma jointly announce that they have entered into an exclusive licensing and supply agreement for the commercialization of FYB206, Formycon’s biosimilar candidate to the blockbuster drug Keytruda^®1 (pembrolizumab), in the Middle East and North Africa (“MENA region”). The agreement includes an option for future technology transfer.

“This licensing deal for the MENA region represents the start of the commercial partnering activities for our Keytruda^® biosimilar candidate. Further agreements for additional regions and countries shall follow in due time. With MS Pharma, we are leveraging the well-established excellent collaboration that has already been successfully implemented for our biosimilars FYB201, FYB202, and FYB203. MS Pharma is a strong player that can sustainably improve access to this important cancer drug across the MENA region. FYB206 is currently approaching the end of its clinical development phase, and we expect results for the primary endpoint in the first quarter of 2026”, said Nicola Mikulcik, CBO of Formycon AG.

“Extending our partnership with Formycon for FYB206 (pembrolizumab), is a strategically important milestone for MS Pharma. This collaboration not only strengthens our position as a leader in biosimilars across the MENA region but also demonstrates our commitment to expanding access to innovative cancer therapies. Leveraging Formycon’s scientific expertise and our advanced manufacturing facility in Saudi Arabia, we are well-positioned to deliver high-quality biosimilars that meet the needs of patients and healthcare systems in the MENA region”, commented Kalle Känd, CEO of MS Pharma.

Upon signature of the agreement, Formycon will receive an upfront remuneration and will be eligible for further payments contingent on the achievement of certain development and regulatory milestones, which are expected to total up to the high single-digit million Euro range. Formycon will further receive a significant share of the gross profits generated in the region.

Pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology and global sales of US$ 29.5 billion in 2024², Keytruda^® is currently one of the world’s best-selling drugs. In the MENA region, estimated sales reached approximately US$ 240 million, positioning it as the highest-selling biologic in the region and underscoring the substantial oncology demand and market potential across MENA³.
 

————
 

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com/

About MS Pharma:
MS Pharma is a leading regional pharmaceutical company in the MENA region, specializing in the development, production, and distribution of a broad portfolio of generic and biologic therapies. Positioned for rapid growth, the company operates five manufacturing facilities across Jordan, Algeria, and Saudi Arabia – home to a newly launched biologics plant, all serving the broader MENA market. Headquartered in Amman, Jordan, with management offices in Zug, Switzerland, MS Pharma employs over 2,000 people across 12 countries. For more information, please visit: www.mspharma.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com

Contact:
Orayb Akeel
Corporate Communications Director
MS Pharma
Amman – Jordan

Tel: +962 (0) 77- 680 1114
Orayb.Akeel@mspharma.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the 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, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

Berlin, Germany & Seoul, South Korea, 3 December 2025 – Eckert & Ziegler (ISIN DE0005659700, TecDAX) has signed a supply agreement with SK Biopharmaceuticals, a biotech company specializing in research, development, and commercialization of treatments of central nervous system (CNS) disorder, active in the field of radiopharma and based in South Korea. Eckert & Ziegler will supply SK Biopharmaceuticals with Actinium-225 (Ac-225) to accelerate their research and development activities in radiopharmaceutical therapies.

SK Biopharmaceuticals’ development pipeline includes SKL35501, an innovative radiopharmaceutical labeled with Ac-225 with potential in the treatment of multiple types of cancer, including colorectal, breast, pancreatic, and head and neck cancers. By securing reliable supply of the alpha emitting radioisotope from Eckert & Ziegler, the company will be able to drive forward this as well as further programs from their expanding pipeline.

“We are happy to support SK Biopharmaceuticals with our supply of GMP compliant Ac-225 in their promising preclinical and clinical programs,” stated Dr. Harald Hasselmann, CEO of Eckert & Ziegler. “Ac-225 remains one of the most in-demand radioisotopes for the development of next-generation radiopharmaceuticals, and we are pleased to contribute to the advancement of these cancer therapies.”

“Securing a stable supply of Ac-225, the key source material for radiopharmaceutical therapy, is a prerequisite for success. We are pleased to have concluded this agreement with Eckert & Ziegler, a reliable provider with long time track record for high-quality radioisotopes to be used in pharma,” said Donghoon Lee, CEO of SK Biopharmaceuticals. “Building on our proactive global partnership and diversified supply chain, we will take a major step forward in advancing into the global oncology treatment market.”

Eckert & Ziegler reliably supplies Gallium-68, Lutetium-177, Yttrium-90, and Actinium-225 in GMP quality to leading pharmaceutical companies and research institutions worldwide. With expertise in radioisotope production as well as global logistics and CDMO services, the company is committed to continuously supporting the development and delivery of innovative radiopharmaceuticals.

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

About SK Biopharmaceuticals 
SK Biopharmaceuticals Co., Ltd. is part of SK Group, South Korea’s second-largest conglomerate. SK Group is a collection of global industry-leading companies driving innovations in energy, advanced materials, biopharmaceuticals, and digital business. Based in Seoul, SK invests in building sustainable businesses around the world with a shared commitment to reducing global greenhouse gas emissions. SK companies combined have $151 billion in global annual revenue and employ more than 100,000 people worldwide. SK Group is one of TIME’s 100 Most Influential Companies of 2023. SK Inc., the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Inc. is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information about SK Inc., visit https://sk-inc.com/en/main/mainpage.aspx. For more information about SK Biopharmaceuticals, visit www.skbp.com/eng

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

SK Biopharmaceuticals Public Relations Team
skbp.pr@sk.com

Pentixapharm Advances Regulatory Preparations for Phase 3 PANDA Study with Radiodiagnostic Candidate ⁶⁸Ga-PentixaFor in Hypertension

• FDA scientific advice meeting provides guidance on planned Phase 3 study of radiodiagnostic lead candidate in treatment-resistant hypertension / primary aldosteronism
• Further details on Phase 3 clinical setup expected upon receipt of the FDA’s official meeting minutes

Berlin, Germany, December 03, 2025 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), a clinical-stage biotech developing first-in-class radiopharmaceuticals, has received encouraging feedback from a TypeB pre‑IND meeting with the U.S. Food and Drug Administration (FDA). The discussion addressed key elements of Pentixapharm’s planned Phase 3 PANDA study with [⁶⁸Ga]Ga-PentixaFor, a CXCR4-directed radiodiagnostic intended to significantly improve the diagnostic pathway for patients with treatment-resistant hypertension and primary aldosteronism. Despite its substantial clinical and societal impact, primary aldosteronism remains widely underdiagnosed, and earlier, more accurate detection represents a significant unmet medical need.

During the meeting, the FDA provided initial, non-binding feedback on key components of Pentixapharm’s draft Phase 3 clinical protocol, including proposed inclusion criteria and design as well as statistical parameters. The FDA’s input is considered essential for the Phase 3 study to meet effectiveness and shaping the final Investigational New Drug (IND) submission.

“We appreciate the constructive dialogue with the FDA and the opportunity to align on technical details and clarify outstanding questions,” said Dr. Dirk Pleimes, CEO and CMO of Pentixapharm. “The preliminary feedback supports our plan to advance [⁶⁸Ga]Ga-PentixaFor into Phase 3 and provides an important step toward bringing a potentially scalable and non-invasive diagnostic tool to patients with primary aldosteronism who currently lack reliable, non-invasive options. Once we have received and reviewed the formal FDA meeting minutes, we will refine our Phase 3 study design accordingly and continue to update the market as we progress along our IND strategy.”

About ⁶⁸Ga-PentixaFor in treatment-resistant hypertension and primary aldosteronism

[⁶⁸Ga]Ga-PentixaFor is a novel gallium-68-labeled radiodiagnostic designed to selectively target and visualize the chemokine receptor CXCR4 using high-resolution PET/CT imaging. Clinical experience with [⁶⁸Ga]Ga-PentixaFor PET/CT in approximately 1,600 patients across different indications has demonstrated its ability to non-invasively image CXCR4 expression in vivo.

Recent research has shown strong CXCR4 overexpression in aldosterone-producing adrenal tumors, a hallmark of unilateral primary aldosteronism. Primary aldosteronism is a common but historically underdiagnosed cause of secondary hypertension, largely because reliably distinguishing unilateral from bilateral disease remains challenging with current diagnostic tools. Unilateral disease is typically treated by surgical removal of the affected adrenal gland whereas bilateral disease requires life-long medical therapy. By visualizing CXCR4 expression in aldosterone-producing tissue, [⁶⁸Ga]Ga-PentixaFor has the potential to support more reliable subtyping of primary aldosteronism and thereby better guide appropriate treatment decisions.

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops precision diagnostics and therapeutics in oncology and cardiology to transform patient care. Its clinical pipeline is anchored by CXCR4-targeted PET-CT programs, including a Phase 3-ready candidate for the improved diagnosis of hypertensive patients with primary aldosteronism, which is intended to enable targeted treatment of the underlying causes of hypertension. CXCR4-based developments also include pioneering therapeutic programs in hematological cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-checkpoint marker over-expressed in multiple hard-to-treat cancers. Complemented by CXCR4 and CD24 intellectual property protection and a reliable isotope supply chain, Pentixapharm is poised to deliver meaningful patient benefit and sustainable growth in one of the fastest-growing areas of precision medicine.

Pentixapharm Investor and Media Contact

ir@pentixapharm.com