Newron announces the US initiation of its ENIGMA-TRS 2 Phase III global clinical study with evenamide as an add-on therapy for patients with treatment-resistant schizophrenia (TRS)

ENIGMA-TRS 2 is a global, randomized, double-blind, placebo-controlled 12-week Phase III clinical study designed to enroll at least 400 patients; topline results are expected by Q4 2026

Evenamide is a first-in-class glutamate modulator with a novel mechanism of action for patients who do not respond adequately or are resistant to existing antipsychotic therapies

Newron’s ENIGMA-TRS program (ENIGMA-TRS 1, started in August 2025, and ENIGMA TRS 2) aims to establish evenamide as the first approved add-on therapy for TRS, providing a new treatment option for a patient population with high morbidity and mortality

Morristown, NJ, USA, and Milan, Italy, December 8, 2025, 07:00 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced the initiation of its ENIGMA-TRS 2 Phase III clinical study in the US, following approvals from the US Food and Drug Administration (FDA) and the Institutional Review Board (IRB). The first site to initiate the study will be the Semel Translational Research Center for Neuropsychiatry (TRCN), University of California, Los Angeles (UCLA). The remaining US sites participating in ENIGMA-TRS 2 are expected to initiate the study shortly. Regulatory submissions are currently being made in the other countries that are expected to participate in this trial in the coming months.

“This study addresses a significant unmet medical need in patients with treatment-resistant schizophrenia who are not responding to their current second-generation antipsychotic medication. Previous studies in patients who are inadequate responders and with treatment-resistant schizophrenia have demonstrated clinically meaningful benefits of evenamide with no evidence of intolerance”, said Prof. Stephen Marder, Director of the Section on Psychosis at the UCLA Semel Institute for Neuroscience and Human Behavior, principal investigator for the study. 

ENIGMA-TRS 2: A Global Phase III Study Bringing New Hope to Patients with TRS in the US and other countries

ENIGMA-TRS 2 is a Phase III, global, 12-week, randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of evenamide 15 mg twice daily as an add-on therapy to current antipsychotics, including clozapine, compared to placebo, in patients suffering from TRS. Eligible patients must meet the Treatment Response and Resistance In Psychosis (TRRIP) international consensus criteria for TRS.

The ENIGMA-TRS 2 study design has been approved by the US FDA and the study will enroll at least 400 patients across the US, Europe, Asia, and Latin America. Prior to randomization, patients undergo a 42-day screening period, during which their TRS diagnosis, plasma levels of their background antipsychotic medication, and adherence to protocol-defined eligibility criteria will be evaluated by an Independent Eligibility Assessment Committee (IEAC) comprising leading international experts in the field of schizophrenia research.

The primary assessment of efficacy and safety will be performed 12 weeks after randomization to treatment; topline results are expected in Q4 2026.

Earlier clinical trials (Phase II studies 014/015 and Phase III study 008A) demonstrated that evenamide, when added to standard antipsychotic therapy, was well tolerated and safe. Importantly, evenamide may lead to clinically meaningful improvements for people who fail to respond or become resistant to other antipsychotic treatments. Patients in previous trials experienced increasing and sustained symptom improvement, suggesting that evenamide’s unique mechanism of action of modulating excessive glutamatergic activity in the brain could represent a crucial novel approach in the treatment of schizophrenia.

The ENIGMA-TRS pivotal Phase III program consists of ENIGMA-TRS 1 and ENIGMA-TRS 2. ENIGMA-TRS 1, initiated in August 2025 and currently enrolling patients on all three target continents, is an international, one-year, double-blind, placebo-controlled study in at least 600 patients to evaluate the efficacy, tolerability, and safety of two daily doses: 15mg and 30mg. Both studies represent a key component of Newron’s global development strategy for evenamide, targeting patients with schizophrenia, experiencing treatment resistance to current antipsychotics. According to current literature, up to 50% of patients suffering from schizophrenia are classified as treatment-resistant, underscoring the urgent need for new, effective therapeutic options.

Prof. Marder’s comments reflect his professional assessment as a study investigator and do not constitute an endorsement by the University of California, Los Angeles.

About treatment-resistant schizophrenia (TRS)

A significant proportion of patients with schizophrenia show virtually little to no beneficial response to currently available antipsychotic (AP) treatments, leading to a diagnosis of treatment-resistant schizophrenia (TRS). TRS is defined as no or inadequate symptom relief despite treatment with therapeutic doses of two APs from two different chemical classes for an adequate period. It is estimated that approximately 15% of patients develop TRS from the onset of illness, and about one-third to 50% of patients with schizophrenia overall. Emerging scientific evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current APs, along with normal dopaminergic synthesis, to explain the lack of clinical benefit of most typical and atypical antipsychotics, which act primarily on dopamine receptors. These insights underline the need for novel therapeutic approaches that target the underlying glutamatergic dysfunction in schizophrenia, offering hope for patients who currently have limited or no effective treatment options.

About evenamide

Evenamide is a novel, orally available new chemical entity with a unique mechanism of action distinct from all currently marketed antipsychotics. It acts by selectively blocking voltage-gated sodium channels (VGSCs) and exhibits no biological activity at more than 130 other central nervous system (CNS) targets. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels, due to inhibition of VGSCs. Combinations of subtherapeutic doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide meaningful benefits for patients who do not adequately respond to current APs, including those on clozapine. Importantly, the benefits seemed to persist for a substantial time after evenamide had been degraded, explaining the long-term effects seen in clinical studies. Through its novel glutamatergic modulation, evenamide represents a first-in-class approach aimed at addressing the unmet needs of patients with schizophrenia who are resistant to existing treatments.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently developed in the global pivotal ENIGMA-TRS Phase III development program. Clinical trial results to date demonstrate the benefits of this drug candidate in the TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. For more information, please visit: www.newron.com

For more information, please contact:

Newron
Stefan Weber – CEO; +39 02 6103 46 26, pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com  

Switzerland
Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu

USA
Paul Sagan, LaVoieHealthScience; +1 617 865 0041, psagan@lavoiehealthscience.com

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

Hamburg, Germany, 08 December 2025:
Evotec SE (Frankfurt Stock Exchange: EVT, SDAX/TecDAX, Prime Standard, ISIN: DE0005664809, WKN 566480; NASDAQ: EVO) today announced the closing of its previously reported sale of the Just – Evotec Biologics Toulouse site plus an indefinite technology license to Evotec’s continuous manufacturing platform technology to Sandoz AG (SIX: SDZ / OTCQX: SDZNY), effective 05 December 2025. In total, potential payments may exceed US$ 650 m plus royalties on a portfolio of up to 10 biosimilar molecules, of which six have an originator net sales value of US$ 90 bn.

The transaction with Sandoz is accelerating the implementation of Evotec’s strategy through better monetization of its technology and transitioning to an asset-lighter business model. Evotec is delivering on sharpening its focus on its core strengths and is well on track for sustainable and profitable growth. Sandoz’s acquisition of Just – Evotec Biologics’ Toulouse site is an endorsement of the pioneering J.POD platform and its potential to revolutionize biologics manufacturing. 

Dr Christian Wojczewski, Chief Executive Officer of Evotec, said: “This transaction is a pivotal step in Evotec’s transition to a scalable technology provider for next-generation biologics development. By selling the Just – Evotec Biologics Toulouse site and a license for using our pioneering continuous manufacturing technology to Sandoz, we are not only unlocking significant value today but also paving the way for a more efficient, sustainable, and accessible future for biologic medicines.“

With the closing of the transaction, Evotec will continue to serve its customers in the U.S. and Europe with capacity for molecular design, upstream, downstream, analytical and formulation development as well as first-in-human to commercial biologics GMP manufacturing. In parallel, Evotec plans to enable its partners to lower the time and costs of biologics manufacturing with its paradigm shifting continuous manufacturing technology and assets beyond its own capacity via a technology license model.

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

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