PRESS RELEASE

Viromed AG: Strategic Update on Operational Focus and Value Creation

Rellingen, January 7, 2026 – Viromed Medical AG (“Viromed”; ISIN: DE000A3MQR65), a medical technology company and pioneer in cold plasma technology, today provides a strategic update on its operational orientation. The focus of the Company’s entrepreneurial activities remains unchanged and is centered on sustainable, technology-driven growth in the international MedTech market. In this context, Viromed concentrates on the development of innovative medical devices as well as on translational research in the field of severe respiratory diseases — in particular ventilator-associated pneumonia (VAP).

Over the past two years, Viromed has developed two novel cold plasma medical devices:

• ViroCAP® — an innovative cold plasma device for medical wound healing
• PulmoPlas® — a globally unique cold plasma system for applications in pneumology and respiratory tract infections

Particular importance is attributed to the next-generation technological platform — PulmoPlas®. This unique cold plasma system forms the basis for future scaling potential across multiple medical indication areas.

In the research domain, Viromed has established a high-performance scientific consortium consisting of Hannover Medical School (MHH), the Helmholtz Centre for Infection Research (HZI) in Braunschweig, and the Leibniz Institute in Jena. This network brings together international top-level expertise in infectiology, pneumology, and translational research and enables the development of novel therapeutic approaches for diseases of the upper and lower respiratory tract.

The comprehensive publication of the results by MHH and HZI is expected at the end of January 2026.

For further technological development, Viromed works closely with Relyon Plasma, a subsidiary of TDK. In addition, international partnerships in Europe, Korea, and Turkey have been established, supporting future market entry and underscoring the global relevance of the technology.

As a result of the strategic focus on research, development, and the establishment of international market structures, longer innovation cycles naturally arise. Viromed therefore deliberately refrains from communicating short-term operational interim updates. Communication with various stakeholders follows the principle of reporting substantial and relevant milestones — in the interest of long-term, sustainable corporate development.

Viromed Medical AG’s corporate strategy is geared toward long-term value generation. Against this backdrop, the Company’s research and development programs are consistently aligned with medical benefit, clinical relevance, and sustainable market potential.

Viromed is recognized as a pioneer in pneumological research and plasma technology. The innovation work of the Company’s scientific network has the potential to significantly shape future therapeutic approaches for severe respiratory infections. According to its own assessment, Viromed will play a significant role in the global fight against pathogenic germs in the coming years — particularly with PulmoPlas®.

In addition, Viromed has successfully overcome the new, stringent regulatory hurdles for the approval of ViroCAP® over the past 18 months. Market acceptance and demand for ViroCAP® are already very high.

About Viromed Medical AG

Viromed Medical AG specializes in the development, manufacture and distribution of medical products. The operating business of the company, which has been listed on the stock exchange since October 2022, focuses on the distribution of innovative cold plasma technology for medical applications via its wholly owned subsidiary Viromed Medical GmbH. Viromed can draw on a broad customer base in the DACH region and beyond. Viromed is pursuing the goal of further advancing the use of cold plasma technology in medicine in the coming years and realizing the corresponding growth potential.

www.viromed-medical-ag.de

Contact Viromed

E-Mail: kontakt@viromed-medical.de
 

Press contact

E-mail: viromed@kirchhoff.de

Immunic Highlights 2025 Accomplishments and Upcoming Milestones

– Completed Enrollment for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected by End of 2026 –

– Phase 2 CALLIPER Data Showed Vidofludimus Calcium Reduced 24-Week Confirmed Disability Worsening and Increased 24-Week Confirmed Disability Improvement Across Progressive Multiple Sclerosis and Its Subtypes, Reinforcing the Drug’s Direct Neuroprotective Mechanism of Action –

 – Long-Term Open-Label Data from Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis Showed Low Rates of Confirmed Disability Worsening Events and Favorable Long-Term Safety and Tolerability –

 – U.S. Patent Allowed for Dose Strengths of Vidofludimus Calcium in Progressive Multiple Sclerosis, Strengthening Intellectual Property Protection Into 2041 –

NEW YORK, January 7, 2026 – Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today highlighted its 2025 accomplishments and upcoming milestones.

“The past year has been transformational for our lead asset vidofludimus calcium (IMU-838),” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “We are pleased to have completed enrollment in our twin phase 3 ENSURE-1 and ENSURE-2 trials of vidofludimus calcium in relapsing multiple sclerosis (RMS) and are deeply grateful to the Immunic team, our clinical investigators, site teams, and especially the participants for making this milestone possible. We now eagerly anticipate the synchronized top-line data readout by the end of 2026. The scale, quality, and geographic breadth of the ENSURE trials give us exceptional confidence that the results will provide a clear and comprehensive picture of vidofludimus calcium’s potential to reshape the RMS treatment paradigm. Additionally, long-term open-label extension (OLE) data from the phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS) showed that a substantial majority of patients remained free of confirmed disability worsening (CDW) over extended follow-ups, underscoring vidofludimus calcium’s potential to meaningfully slow disease progression, giving patients greater independence and a lower burden in managing symptoms over the long term.”

Jason Tardio, President and Chief Operating Officer of Immunic, added, “The ENSURE program represents more than a pivotal clinical milestone—it reflects an opportunity to advance how disease modification in RMS is approached. Today’s oral RMS treatment landscape is largely defined by therapies with complex risk-benefit profiles that primarily target inflammation and relapses, while often falling short of adequately addressing the neurodegeneration that drives long-term disability. With a dual mechanism of action, vidofludimus calcium is designed to provide direct neuroprotection by enhancing neuronal survival and function through Nurr1 activation, as well as limiting new inflammatory injury through selective DHODH inhibition. Together with its favorable safety and tolerability profile to date, we believe vidofludimus calcium has the potential to offer the most compelling benefit-risk profile among oral disease-modifying therapies for RMS.”

“Equally important are the strong signals we continue to see in progressive multiple sclerosis (PMS) from our phase 2 CALLIPER trial,” continued Dr. Vitt. “In particular, the data has demonstrated clinically meaningful reductions in 24-week CDW (24wCDW) across the overall PMS population, supported by consistent trends across PMS subtypes and subpopulations. Notably, there was no dependency of the 24wCDW effect size on the presence of markers of inflammatory disease at baseline, such as gadolinium-enhancing lesions, supporting our hypothesis of clinical neuroprotective effects independent of anti-inflammatory effects. The positive 24-week confirmed disability improvement (24wCDI) results were statistically significant in the overall PMS population, with consistent trends across subtypes. The findings from our CALLIPER trial reinforce vidofludimus calcium’s unique mechanism of action targeting neurodegeneration and help de-risk potential late-stage development in PMS.”

Dr. Vitt concluded, “As we execute our MS strategy with vidofludimus calcium, we also remain committed to advancing IMU-856, our orally available and systemically acting small molecule modulator that targets Sirtuin 6 (SIRT6), as our next pipeline innovation. IMU-856’s potential ability to restore intestinal barrier function and regenerate bowel epithelium has generated compelling early clinical signals in celiac disease patients, supporting potential development in various gastrointestinal disorders. Additionally, we have seen encouraging preclinical and early clinical effects that may indicate the potential for IMU-856 as an oral treatment option for weight management.”

Vidofludimus Calcium 2025 Highlights and Upcoming Milestones

• Completed enrollment for both phase 3 ENSURE trials of vidofludimus calcium in patients with RMS. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 were randomized at more than 100 sites in 15 countries. Top-line data is expected by the end of 2026.
• Announced positive phase 2 CALLIPER data in PMS, highlighting vidofludimus calcium’s neuroprotective potential across PMS as well as PMS subpopulations and subtypes. The data, showing consistent 24wCDW results across patient groups, including those without evidence of baseline inflammatory gadolinium-enhancing (Gd+) lesions, were seen in the overall population and in the key primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (naSPMS) subgroups. 24wCDI data demonstrated more than a two-fold probability of clinical improvement versus placebo, achieving statistical significance in the overall PMS population with consistent trends across subtypes. Vidofludimus calcium also lowered thalamic atrophy and new or enlarging T2 lesion volume versus placebo. No new safety signals were observed and vidofludimus calcium continued to show a favorable safety and tolerability profile. Given that 24wCDW is an accepted regulatory endpoint in PMS, these results strengthen the evidence of clinical activity and should help to de-risk a potential phase 3 program.
• Reported new, positive long-term OLE data from the phase 2 EMPhASIS trial of vidofludimus calcium in patients with RRMS. At week 144, 92.3% of patients remained free of 12wCDW with 92.7% remaining free of 24wCDW. Vidofludimus calcium continued to demonstrate a favorable safety and tolerability profile with long-term data available up to 5.5 years.
• Received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent covering dose strengths of vidofludimus calcium for the treatment of PMS, including PPMS and SPMS. The company’s multilayered intellectual property strategy now provides protection into 2041 in the United States, unless extended further.
• Presented key data highlighting vidofludimus calcium’s therapeutic potential in MS at various scientific and medical conferences, including the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), the 17th International Congress of the International Society of Neuroimmunology (ISNI), the 11th Congress of the European Academy of Neurology (EAN) – Helsinki 2025, the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting 2025, the American Academy of Neurology (AAN) 2025 Annual Meeting and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025. The results from the phase 2 CALLIPER trial in PMS were also selected for the Best of ECTRIMS 2025 slide deck.

IMU-856 2025 Highlights and Upcoming Milestones

• Announced that IMU-856 demonstrated a dose-dependent increase of endogenous glucagon-like peptide-1 (GLP-1) levels in a post hoc analysis of patients from the phase 1b clinical trial in celiac disease. IMU-856 also showed a dose-dependent reduction of body weight gain and food consumption in preclinical in vivo testing. These effects may indicate the potential for IMU-856 as an oral treatment option for weight management.
• Presented further analyses from the phase 1/1b clinical trial of IMU-856 in healthy subjects and celiac disease patients at several key gastroenterology conferences, including at UEGW 2025 – United European Gastroenterology Week, Digestive Disease Week (DDW) and the 19th Congress of ECCO (European Crohn’s and Colitis Organisation).
• The company continues preparing for further clinical testing of IMU-856, contingent on financing, licensing or partnering.

2025 Corporate Highlights

• Closed a $5.1 million registered direct offering led by Aberdeen Investments.
• Closed an oversubscribed $65 million underwritten public offering, co-led by BVF Partners and Coastlands Capital, and including participation from Aberdeen Investments, Adage Capital Partners LP, Janus Henderson Investors, and other institutional investors.

Immunic’s management, business development and investor relations teams will be hosting one-on-one meetings in connection with the 44th Annual J.P. Morgan Healthcare Conference taking place January 12-15, 2026, in San Francisco. To schedule a meeting, please contact Jessica Breu at: jessica.breu@imux.com.

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic’s development programs and the targeted diseases; the potential for Immunic’s development programs to safely and effectively target diseases; preclinical and clinical data for Immunic’s development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure of the company; and the company’s expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company’s products or product candidates, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in the company’s subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.

Contact Information 

Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com

US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com 

US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com

Newron Pharmaceuticals S.p.A.: EA Pharma, a subsidiary of Eisai, Announces the Initiation of its Phase III Clinical Trial with Evenamide, a Novel Treatment for Schizophrenia, in Japan

Milan, Italy, and Morristown, NJ, USA, January 7, 2026 – 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, is pleased to note that its partner EA Pharma Co., Ltd. (EAP), has  announced today the initiation of its Phase III clinical trial with evenamide, a novel excessive glutamate release modulator, in Japan.

Stefan Weber, CEO of Newron Pharmaceuticals, commented: “The initiation of EA Pharma’s Phase III study of evenamide in Japan represents an important step in the global development of the program. This milestone, together with Newron’s ongoing global (excluding EAP territories) ENIGMA-TRS Phase III studies reflects continued progress and momentum for evenamide and further supports its potential as a differentiated add-on therapy in schizophrenia.”

The full text of the announcement from EAP is as follows:

EA Pharma Announces Initiation of Phase III Clinical Trial of EA8001, a Novel Treatment for Schizophrenia, in Japan

EA Pharma Co., Ltd. (Head Office, Chuo-ku, Tokyo, Japan; President, Hidenori Yabune; “EA Pharma”) announced today that Phase III clinical trial of EA8001 (non -proprietary name: evenamide), a novel excessive glutamate release modulator, is now ready to begin in Japan (hereinafter the “Trial”).  

EA Pharma initiates the Trial after review by the institutional review board of the clinical site and other related procedures. This Trial is a multicenter randomized double-blind placebo-controlled clinical trial in patients with treatment-resistant schizophrenia who show poor or inadequate response to at least two different types of antipsychotics, evaluating the efficacy, safety and tolerability of EA8001 as an add-on treatment. EA Pharma is striving to quickly contribute to addressing the needs of, and increasing the benefits provided to, patients with schizophrenia, their families and healthcare providers.

Inquiries

EA Pharma Co., Ltd.
Corporate Communication Dept. Mail: contact_ea@ eapharma.co.jp

《More Information》

1. About schizophrenia

Schizophrenia, which approximately 1% of the Japanese population is affected by, consists of positive symptoms (such as hallucinations and delusions), negative symptoms (such as reduced emotions and avolition), and cognitive impairment (such as memory and decision-making difficulties), and those symptoms may cause difficulty in everyday life and social activities [1]. Current antipsychotics mainly function through the dopamine and/or serotonin pathways, and those antipsychotics are known to show side effects (such as extrapyramidal symptoms, weight gain, and prolactin elevation). Among those patients treated with current antipsychotics, a considerable number of patients become treatment-resistant or poor responsive. Therefore, there is a demand for a drug which can address all those points.

2. About evenamide

Evenamide is the first new chemical entity that has demonstrated significant benefits in this difficult-to-treat patient population, as seen in the potentially pivotal Phase III study 008A trial [2], as an add-on treatment to second generation anti-psychotics, in 291 poorly responding patients with chronic schizophrenia. The primary endpoint, the Positive and Negative Syndrome Scale (PANSS) [3], and the key secondary endpoint, the Clinical Global Impressions Scale – Severity (CGI-S), were met and showed statistical significance compared to placebo. Importantly, evenamide treatment was associated with statistically significant increase in proportion of patients who experienced “clinically meaningful benefit*” on the outcome variables[4]. 

*Against placebo in the two categories: at least 20% improvement in PANSS, and Score 2 or below in Clinical Global Impression Scale – Corrections (CGI-C)

3. About Alliance between EA Pharma and Newron Pharmaceuticals S.p.A.

EA Pharma obtained the right to develop, manufacture and commercialize evenamide in Japan and other key Asian territories [5] under the license agreement with Newron Pharmaceuticals S.p.A. as of December 2024. 

For more details, please see https://www.eapharma.co.jp/en/investors/news/2024/1213.

4. About EA Pharma Co., Ltd.

EA Pharma Co., Ltd. is a subsidiary of Eisai Co., Ltd. It was established in April 2016 by integration of the gastrointestinal business unit with more than 60 year’s history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma Co., Ltd., is a specialty pharmaceutical company with a full value chain covering R&D, production & logistics and sales & marketing. 

For further information on EA Pharma Co., Ltd., please visit   https://www.eapharma.co.jp/en/

[1] National Center of Neurology and Psychiatry （https://www.ncnp.go.jp/en/）

[2] A “pivotal phase III trial” is a key clinical trial to collect definitive evidence of efficacy and safety in primary endpoints that can support a regulatory approval. Usually, data collected from multiple confirmatory trials (pivotal trials) are required for a regulatory approval in many countries. 

[3] Positive and Negative Syndrome Scale (PANSS) is widely used in clinical trials of schizophrenia and is considered the “gold standard” for assessment of antipsychotic treatment efficacy (Innvo Clin Neurosci, 2017: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5788255/)

[4] Efficacy and safety of evenamide, a glutamate modulator, added to a second-generation antipsychotic in inadequately/poorly responding patients with chronic schizophrenia: Results from a randomized, double-blind, placebo-controlled, phase 3, international clinical trial. (Neuropharmacology. 2025: https://pubmed.ncbi.nlm.nih.gov/39708914/)

[5] Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, Vietnam

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.

Pentixapharm Receives FDA Feedback for Phase 3 Diagnostic Study in Hypertension

• Formal written minutes from the U.S. FDA confirms no major concerns identified for the planned Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor in treatment-resistant hypertension and Primary Aldosteronism

• Type B pre-IND meeting provided non-binding guidance on key statistical and methodological aspects, enabling refinement of the Phase 3 study design

• Feedback clarifies evidence requirements relevant to a potential approval pathway, supporting the planned IND submission for the company’s leading CXCR4-directed flagship program

Berlin, Germany, January 07, 2026 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech developing novel radiopharmaceuticals, today announced that it has received the formal written minutes from its recent scientific advice meeting with the U.S. Food and Drug Administration (FDA) for the planned Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor, the company’s leading CXCR4-directed flagship program. The PANDA study will evaluate the radiodiagnostic as a potential new tool to improve the diagnostic pathway for patients with treatment-resistant hypertension and primary aldosteronism (PA). By enabling disease subtyping, PET/CT imaging with [⁶⁸Ga]Ga-PentixaFor has the potential to better guide the most appropriate therapy, supporting more precise and effective treatment decisions.

The FDA’s minutes provide further clarification on several important statistical,  methodological aspects, and criteria for assessing diagnostic performance of the planned Phase 3 study and expand on the preliminary feedback from the meeting,  previously communicated on December 3, 2025.

“The FDA’s formal written feedback provides important clarity on key design and analysis elements of our planned Phase 3 PANDA study with [⁶⁸Ga]Ga-PentixaFor and confirms that no major concerns have been identified,” said Dr. Dirk Pleimes, CEO and CMO of Pentixapharm. “Importantly, the feedback also provides guidance on the evidence requirements toward potential approval, including the role of confirmatory evidence in combination with this single Phase 3 study. This guidance strengthens our preparations for the planned IND submission and further supports the development of a potentially scalable, non-invasive diagnostic tool for patients with primary aldosteronism – the most common cause of secondary hypertension and a condition that remains significantly underdiagnosed.”
 

 About [^⁶⁸Ga]Ga-PentixaForin treatment-resistant hypertension and primary aldosteronism

[⁶⁸Ga]Ga-PentixaFor is a novel, potentially first-in-class gallium-68-labeled radiodiagnostic designed to selectively target the chemokine receptor CXCR4 and to visualize its expression using high-resolution PET/CT imaging. Clinical experience with [⁶⁸Ga]Ga-PentixaFor PET/CT is documented in more than 100 scientific publications encompassing over 2,600 patients across multiple indications, including more than 1,600 patients with primary aldosteronism. In published and ongoing studies, the diagnostic has demonstrated reproducible in vivo imaging of CXCR4 expression with a favorable safety profile.

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

• The cash inflow will strengthen investments in the approval of innovative antibacterial implant technology

aap Implantate AG (“aap” or “Company”) successfully completed the 5.7% capital increase announced on 4 December 2025, excluding subscription rights, at a placement price of EUR 1.34. This will provide the Company with cash proceeds of EUR 1,056,121.00. This cash inflow will strengthen investments in the approval costs for the innovative antibacterial implant technology. The capital increase was oversubscribed.

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aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German stock exchanges –

About aap Implantate AG

aap Implantate AG is a global medical technology company based in Berlin, Germany. The company develops, manufactures and markets products for traumatology. In addition to the innovative LOQTEQ® anatomical plate system, its IP-protected portfolio includes a wide range of screw plates. Furthermore, aap Implantate AG has an innovation pipeline with promising development projects, such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical problems in traumatology that have not yet been adequately solved. aap Implantate AG sells its products in Germany directly to hospitals, purchasing groups and hospital networks, while at the international level it primarily uses a broad network of distributors in around 31 countries. In the USA, the company relies on a sales strategy via distribution agents through its subsidiary aap Implants Inc. The shares of aap Implantate AG are listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For further information, please visit our website at www.aap.de.

The figures presented in this press release may contain technical rounding differences that do not affect the overall statement.

Forward-looking statements

This press release may contain forward-looking statements based on the current expectations, assumptions and forecasts of the Management Board and the information currently available to it. Forward-looking statements are not guarantees of future developments and results. Various known and unknown risks, uncertainties and other factors could lead to the actual results, financial position, development or performance of the company differing materially from the estimates given here. These factors also include those described by aap in published reports. Forward-looking statements are therefore only valid on the day they are made. We undertake no obligation to update the forward-looking statements made in this announcement or to adapt them to future events or developments.

If you have any questions, please contact: aap Implantate AG; Rubino Di Girolamo, Chairman of the Executive Board/CEO, Lorenzweg 5; 12099 Berlin

Tel.: +49 (0)30 75019 – 170 ; Fax : +49 (0)30 75019 – 290 ; Email : r.digirolamo@aap.de

Newron Further Expands Intellectual Property Portfolio for Evenamide with New EU Composition of Matter Patent

EP4615820 – “Crystalline Forms of Evenamide” is expected to extend asset exclusivity in EU into 2044

• Evenamide is currently being investigated in Newron’s global ENIGMA-TRS Phase III development program, enrolling at least 1,000 schizophrenia patients with topline results expected in 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
• ENIGMA-TRS program aims to establish evenamide as the first approved add-on therapy for treatment resistant schizophrenia (TRS), a patient population with high morbidity and mortality

Milan, Italy, and Morristown, NJ, USA, January 6, 2026, 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 that the European Patent Office (EPO) has issued the decision to grant an additional patent covering its lead development compound, evenamide. This composition of matter patent EP4615820 claims crystalline forms of evenamide, processes for their preparation, and their uses. The patent has a scheduled term of 2044.

“This European Patent Office decision is evidence of our comprehensive strategy to continuously strengthen the intellectual property protecting our key assets,” stated Elena Barbanti, Newron’s Senior Director Intellectual Property (IP).

Stefan Weber, Newron’s CEO, added: “This is an important milestone for Newron and a testament to the outstanding work of our IP team. We expect this new patent will extend the exclusivity runway for evenamide, supporting our efforts to maximize its therapeutic and commercial potential. This drug candidate, which is currently progressing through pivotal clinical studies, has the potential to become the first add-on therapy for schizophrenia patients who do not respond adequately, or are resistant to, existing antipsychotic therapies, in our assessment constituting the vast majority of patients suffering from schizophrenia.”

Newron has completed the entry into national phases for counterpart patent applications to EP4615820 in all key countries. This new composition of matter patent adds to the current extensive IP protection around evenamide.

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. A recent study conducted at University of Pittsburg suggests that evenamide’s efficacy in downregulating the hyperdopaminergic state, social deficits, and memory impairment may result from its ability to attenuate vHipp hyperexcitability (Neuropsychopharmacology; https://doi.org/10.1038/s41386-025-02188-y). Importantly, the benefits seemed to persist for a substantial time after evenamide had been degraded, also suggesting neural plasticity possibly explaining accumulating long-term effects observed in clinical studies 014/015. While the exact causes of TRS are complex and multifactorial, hippocampal dysfunction rooted in impaired neural plasticity is considered a strong contributing factor. 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.

Mainz Biomed Provides Review of 2025 Highlights

Initiation of eAArly DETECT 2 – U.S. Clinical Study to Evaluate Performance of Next Generation Test on Advanced Adenomas over Large Patient Population in Preparation for ReconAAsense U.S. FDA Pivotal Trial

Results from Feasibility Study of Biomarker Panel in Pancreatic Cancer Project Study Demonstrated a Sensitivity of 100% and Specificity of 95%

BERKELEY, US – MAINZ, Germany – January 5, 2026 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today reviewed its major accomplishments for the year ended December 31, 2025. The Company expects to release its year-end financial results in March 2026.

Key Highlights During 2025

Colorectal Cancer Business Highlights

• Mainz Biomed launched eAArly DETECT 2, a US feasibility study to evaluate the Company’s next generation colorectal cancer (CRC) test, integrating its proprietary mRNA biomarkers, AI developed algorithm and FIT test, over a population of approximately 2,000 patients, all of average risk, to validate the leading results of previous feasibility studies, which included average risk and identified risk patients.
• ColoAlert®, the Company’s DNA-based colorectal cancer (CRC) screening test, received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing in the United Kingdom.
• ColoAlert® has also been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices.
• The Company entered into a strategic partnership with labor team w ag, a renowned diagnostic laboratory based in Goldach, Switzerland. This collaboration introduces ColoAlert®, a DNA-based colorectal cancer screening test to the Swiss market for the very first time, marking Mainz Biomed’s initial footprint in Switzerland.
• Mainz Biomed signed a Memorandum of Understanding (“MOU”) with OncoVanguard8, a distributor of oncological innovations. The collaboration aims to introduce ColoAlert® to South America, starting with Peru.
• Mainz Biomed collaborated with CARE diagnostica Laborreagenzien GmbH (“CARE”). CARE is currently working with more than 15 statutory health insurance companies as part of special online-based screening concepts based on the widely used fecal immunochemical test (FIT). Thanks to the cooperation with Mainz Biomed, the range of services for risk groups could potentially be expanded to include the ColoAlert® test, which uses molecular genetic analysis of biomarkers in stool using PCR to increase the detection rate, particularly in the early stages of the disease.
• Mainz Biomed also announced that ColoAlert® has been added to the portfolio of DoctorBox, one of Germany’s leading pioneers in digital health. This marks another important milestone in Mainz Biomed’s European growth strategy and highlights the increasing importance of innovative, personalized solutions in preventive medicine. Laboratory analysis will be performed by Mainz Biomed’s long-standing partner, the European Oncology Lab, led by Dr. med. Annette Buhlmann in St. Ingbert, Germany.

Pancreatic Cancer Business Highlights

• In March 2025 the Company entered into a License and Option Agreement with Liquid Biosciences (“Liquid”) to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test. The parties, under the Agreement, plan to develop this blood-based test for potential future FDA applications. The discovery process included multiple independent pancreatic cancer study cohorts. Liquid used their proprietary EMERGE platform to identify a panel of clinically relevant mRNA biomarkers from a blood-based cohort of 285 subjects with 35 pancreatic cancer patients. In the analysis, the biomarkers coupled with the proprietary algorithm developed by Liquid achieved overall sensitivity of 95% and a 98% specificity for the detection of pancreatic cancer. If the statistical results are replicable after the integration into a new product, it has the potential to ultimately position Mainz Biomed’s test to be the most robust and accurate screening test for pancreatic cancer on the market.
• In October 2025 the Company announced positive topline results from its feasibility study, examining a non-invasive blood-based screening test for the early detection of pancreatic cancer, initiated earlier in 2025. The study confirmed the strong clinical accuracy and utility of licensed proprietary biomarkers from Liquid Biosciences for developing an innovative screening test for pancreatic cancer. Researchers evaluated 18 licensed biomarkers across multiple candidate panels to streamline assay complexity. The leading panel achieved 100% sensitivity and 95% specificity, successfully distinguishing pancreatic cancer patients from healthy controls in a 30-subject cohort, reflecting different stages of the disease as well as precursors.
• Mainz Biomed announced that its pancreatic cancer project will receive public funding from the Investitions- und Strukturbank Rheinland-Pfalz (ISB), the development bank of the German federal state of Rheinland-Pfalz. Under the ISB’s Innovation and Technology Support Program (Innovations- und Technologieförderungsprogramm), the state will fund up to 50% of the project’s total costs. This direct governmental support represents a strong endorsement of the scientific and societal value of the Company’s non-invasive, blood-based screening test for the early detection of pancreatic cancer and will accelerate its development.

“I’m extremely pleased with the achievements of our team during 2025 as we advance our ambitious growth strategy, driven by our eAArly DETECT 2 study and continued progress in our pancreatic cancer screening program,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Looking ahead to the first half of 2026, we expect to complete our eAArly DETECT 2 feasibility study, which will be the launching point for our ReconAAsense US FDA pivotal colorectal cancer study in 2026, and to announce our next steps in advancing our blood-based screening test for the early detection of pancreatic cancer.”

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe. The Company is currently running its eAArly DETECT 2 clinical study in preparation for its pivotal FDA study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in blood and stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries as to Mainz Biomed:

MC Services AG
Maximilian Schur / Simone Neeten
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact ir@mainzbiomed.com 

Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on March 31, 2025 and its mid-year report on Form 6-K filed on September 26, 2025. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

Disclosure of an inside Information under Article 17 of Regulation (EU) No 5G6/2014

O3 Holding GmbH (KD Pharma Group) acquires food-grade oil business from dsm- firmenich financed through shareholder loan

BEXBACH, GERMANY – 31 December 2025 – Today, O3 Holding GmbH (the Company), the holding company of KD Pharma Group, through its subsidiary KD Swiss GmbH, signed agreements with dsm-firmenich to acquire the distribution and supply of the

food-grade oil business from dsm-firmenich. The acquisition will be financed through a shareholder loan.

Closing of the transaction is expected for today and not subject to any condition’s precedent.

ABOUT KD PHARMA GROUP

KD Pharma Group is a CDMO that creates health solutions in the pharmaceutical and nutraceutical space. It is also the worldwide leading producer Omega-3 fatty acids for the pharmaceutical and nutraceutical markets, formulation and encapsulation

services, with about 700 employees and a presence in Norway, Germany, Switzerland, Canada, Peru and the US. The KD Pharma Group employs state-of-the-art technology which is protected by numerous patents. Visit www.kdpharmagroup.com to learn more.

IMPORTANT INFORMATION

This release contains forward-looking statements. These statements are based on plans, estimates and projections currently available to KD Pharma Group. Forward- looking statements therefore speak only as of the date they are made. KD Pharma

Group assumes no obligation to update such statements in light of new information or future events. By their nature, forward-looking statements involve risks and

uncertainties. A variety of important factors could cause actual results to differ materially from those in forward-looking statements.

• Creation of new Executive Vice President role integrating Global Communications and Investor Relations to strengthen strategic messaging and stakeholder alignment

Hamburg, Germany, January 1, 2026:
Evotec SE (NASDAQ: EVO; Frankfurt Prime Standard: EVT) today announced the appointment of Dr. Sarah Fakih as Executive Vice President, Head of Global Communications and Investor Relations. In this strategic role, Dr. Fakih will lead Evotec’s newly integrated Global Communications and Investor Relations function.

Reporting directly to CEO Dr. Christian Wojczewski, she will bring together both teams to strengthen alignment, clarity and engagement across stakeholders. The integration of Communications and Investor Relations supports Evotec’s focus on a clear and consistent articulation of its strategy, scientific leadership and value creation. The appointment follows the departure of Volker Braun, who successfully led Evotec’s Investor Relations and ESG function over the past five years.

Dr. Christian Wojczewski, Chief Executive Officer of Evotec, said: “Clear and credible communication is essential as we continue to execute our strategy. Sarah’s extensive experience across science, investor relations and corporate communications makes her ideally suited to this role. I would like to thank Volker for his dedicated contributions to our investor relations and ESG during the past five years and wish him all the best for the future.”

Dr. Fakih brings more than 15 years of experience in life sciences, with a strong leadership track record in capital markets strategy and corporate messaging. She has held senior roles at U.S. listed companies, including QIAGEN, MorphoSys, and most recently at CureVac. She holds a PhD in Chemistry.

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:

Investor Relations and Media Contact

Dr. Sarah Fakih
EVP Head of Global Communications & Investor Relations
Sarah.Fakih@evotec.com