The European corporate group for medical cannabis and industrial hemp, SYNBIOTIC SE (ISIN DE000A3E5A59 / WKN A3E5A5), enters the fourth quarter of 2025 with renewed optimism.

“It’s been a good week for the cannabis and hemp industry. The interim report on Germany’s partial legalization of cannabis is, as expected, positive. Additionally, President Trump’s post highlighting the health benefits of cannabis and CBD for seniors has brought this important topic back into the spotlight. These are exactly the kind of encouraging developments our industry needs,” says Daniel Kruse, Managing Director of SYNBIOTIC.

First Scientific Evaluation of the KCanG

“Based on the current preliminary findings, there is no urgent need to amend the KCanG (Cannabis Consumption Act),” the report states. While the initial evaluation does not yet allow for a final assessment, it undermines the arguments of cannabis opponents who are already calling for stricter regulations—backed now by scientific evidence. Claims such as “Cannabis legalization has harmed youth protection and road safety” (CSU parliamentary group leader Alexander Hoffmann in the Augsburger Allgemeine) are refuted by the report. On the contrary, cannabis use among minors has declined, and decriminalization is easing the burden on law enforcement and the judiciary.

The report also suggests improvements, such as reducing the amount of cannabis individuals may carry, which would help combat the black market—currently the main point of criticism, as experts believe it has not yet been sufficiently curbed. “We must trust that society can handle more freedom better than more restrictions. The evaluation supports this view and may help convince even the last skeptics of the benefits of the KCanG and partial legalization in the coming years,” Kruse adds. The final report is expected in April 2028.

Trump Fuels Debate on Cannabis Policy Reform in the U.S.

Not only the interim KCanG report, but also a statement from none other than U.S. President Trump, has sparked momentum. Trump shared a video from the Commonwealth Project by Howard Kessler, highlighting the health benefits of cannabis and CBD for seniors, and emphasized the significant cost-saving potential for the U.S. healthcare system. The groundwork for imminent legislative changes in the U.S. has already been laid. Next steps include training physicians and officially approving CBD/THC-based products as medications.

The impact on public opinion and financial markets was swift. Cannabis stocks, particularly in the U.S., surged by over 60% in the short term. The video shared by Trump proposes that CBD products be covered by Medicare, the U.S. government’s health insurance program—making alternative therapies more accessible to older adults. “While this is still a vision for the future, we’ve long known that CBD can offer significant support for many common ailments,” says Kruse. “What’s needed is scientific attention, societal openness, and policies that promote research and application. While opinions on President Trump’s statements may vary, his current proposal is a step in the right direction and could serve as a model for the EU as well.“

Conclusion: Positive Signals for the Cannabis and Industrial Hemp Sector

SYNBIOTIC views the recent developments and discussions surrounding cannabis policy as highly encouraging. “It’s time to counter the unfounded and unrealistic crusade of cannabis opponents with scientifically grounded facts. Health Minister Nina Warken (CDU) will find it difficult to justify her proposed changes to the KCanG based on the initial evaluation results,” concludes Kruse.

Publisher
SYNBIOTIC SE
Daniel Kruse
CEO
Münsterstraße 336
40470 Düsseldorf
Germany
www.synbiotic.com

Media
Rüdiger Tillmann
SYNBIOTIC Public Relations Manager
Email ruediger.tillmann@synbiotic.com
Mobile +49 171 3677028
c/o JOLE.group

About SYNBIOTIC
SYNBIOTIC is a listed group of companies in the medical cannabis and industrial hemp sector with a buy-and-build investment strategy focussed on Europe. The Group covers the entire value chain from cultivation to production and retail – from the field to shelf. The subsidiaries’ core businesses are research and development, production and the commercialisation of medical cannabis, industrial hemp and CBD products. SYNBIOTIC is pursuing a clear pan-European strategy of further expanding its business areas in order to cover the relevant growth markets while minimising risks and increasing opportunities for investors through diversification.

Press Release // October 2, 2025

Formycon secures U.S. License Date for proposed Aflibercept Biosimilar FYB203 following settlement and license agreement with Regeneron

• Formycon and its partners entered into a settlement and license agreement with Regeneron for FYB203/AHZANTIVE^® (Aflibercept-mrbb)
• Pending litigation at the U.S. District Court for the Northern District of West Virginia fully resolved
• Commercial launch of FDA approved FYB203 in the U.S. expected in Q4/2026 by commercialization partner Valorum Biologics

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”), together with its license partner Klinge Biopharma GmbH (“Klinge”) and Valorum Biologics (“Valorum”), announces a settlement and license agreement (“Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”), resolving all patent disputes related to its FDA-approved Eylea^®2 biosimilar for the U.S. market. Under the terms of the agreement, Valorum may launch AHZANTIVE^® in the United States in the fourth quarter of 2026, or potentially earlier under certain circumstances.

“This agreement marks a significant milestone for Formycon and our partners. It resolves all outstanding patent matters and establishes a clear timeline for the U.S. launch of FYB203/AHZANTIVE^®. Together with Valorum Biologics, our exclusive commercialization partner, we are committed to ensuring that patients and healthcare providers in the United States gain access to a high-quality, affordable biosimilar option for retinal diseases. This achievement highlights our ability to navigate complex regulatory and legal frameworks and reinforces our dedication to expanding patient access in the U.S. market,” says Nicola Mikulcik, Chief Business Officer of Formycon AG.

Regeneron initiated patent infringement proceedings against Formycon in connection with AHZANTIVE^® pursuant to the Biologics Price Competition and Innovation Act (BPCIA) in the US Federal District Court for the Northern District of West Virginia in November 2023. This included infringement claims under about 40 patents protecting the reference product Eylea^® and expiring as late as 2040. All pending litigation has now been resolved by the parties in the agreement.

FYB203/AHZANTIVE^® received FDA approval in July 2024 for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD) and other serious retinal diseases, including diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following retinal vein occlusion (RVO). The active ingredient, aflibercept, inhibits vascular endothelial growth factor (VEGF), targeting abnormal blood vessel formation in the retina.

In June 2025, Formycon announced an exclusive license agreement between Klinge and U.S. biosimilars specialist Valorum for the commercialization of FYB203/AHZANTIVE^® in the United States and Canada.

1) AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
2) Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.

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

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

About Valorum Biologics:
Valorum provides best-in-class execution for the regulatory approval, launch and commercialization of biosimilars in the U.S. The Valorum team brings unparalleled experience and established networks across the U.S. pharmaceutical market and is focused on optimizing commercialization in order to improve access, reach and cost savings for the healthcare system. For further information please visit: www.valorum.bio.

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

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg
Germany

phone +49 (0) 89 – 86 46 67 149
fax + 49 (0) 89 – 86 46 67 110
Mail: sabrina.mueller@formycon.com

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

Newron to present new analyses from and updates on its clinical program evaluating evenamide as an add-on treatment for schizophrenia at the 38^th European College of Neuropsychopharmacology (ECNP) Congress 2025

New post-hoc analyses highlighting the clinical benefit of evenamide for patients with treatment-resistant schizophrenia (TRS) or those inadequately responding to their antipsychotic treatment

Introduction of key features of landmark, potentially pivotal study ENIGMA-TRS 1, designed to demonstrate the short and long-term efficacy of evenamide as an add-on treatment for patients with TRS

Milan, Italy, October 2, 2025 – 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, announced that it will present three posters at the upcoming 38th Congress of the European College of Neuropsychopharmacology taking place in Amsterdam, the Netherlands, from October 11 to 14, 2025.

Results from previous Phase II (study 014/015) and Phase III (study 008A) studies have demonstrated clinically relevant benefits of evenamide. These studies in patients with treatment-resistant schizophrenia (TRS) or in poor responders to antipsychotic medication provided a significant and sustained improvement in TRS patients (up to and including one year) and an improvement in both positive and negative symptoms in poor responders, through evenamide’s glutamatergic modulating activity. In addition, evenamide was extremely well tolerated without the occurrence of any typical antipsychotic adverse events and with a minimal dropout rate.

Additional post-hoc analyses from data of these studies further support the unique long-lasting efficacy of evenamide. Over the course of a year, the proportion of responders increased throughout the study with more than 25% of patients achieving remission (i.e. sustained low symptoms level for at least six consecutive months) and more than 50% no longer meeting the protocol criteria for treatment resistance.

Treatment-resistance to antipsychotics is observed in about 30% of patients with schizophrenia, and clozapine, the most potent second-generation antipsychotic and the only approved medication for TRS, is highly underutilized. This is mainly explained by its serious side effects, need for regular monitoring and low tolerability. In contrast, results from previous studies with evenamide suggest that the drug is safe and well tolerated.

Together, these results paved the way for the launch of a potentially pivotal landmark phase III, randomized, one-year double-blind, placebo-controlled study for TRS: the ENIGMA-TRS 1 study (EveNamIde’s Glutamate Modulation Ameliorates TRS 1). The study’s unique design aims to address previous trials’ limitations by assessing the response to evenamide (15 and 30 mg bid) as an add-on to current second-generation antipsychotic (SGA) medication(s) in patients with TRS.

Poster presentations

PS01-0225 – Saturday, October 11, 2025
12:00 pm – 1:25 pm CEST
Evenamide Phase 3 Program: Study 023 (ENIGMA-TRS 1) evaluates the efficacy of add-on glutamate modulation in patients with documented treatment-resistant schizophrenia

EP08-0712 – Monday, October 13, 2025
8:00 am – 8:30 am CEST
Success in the mechanism-based development of evenamide for patients with inadequate response or treatment-resistant schizophrenia

PS04-3209 – Tuesday, October 14, 2025
12:35 pm – 2:00 pm CEST
Glutamate modulation by evenamide produces statistically significant and clinically relevant improvement in patients with treatment-resistant schizophrenia
 

About treatment-resistant schizophrenia (TRS)
A significant proportion of patients with schizophrenia show virtually no beneficial response to antipsychotics (APs) despite adequate treatment, leading to a diagnosis of treatment-resistant schizophrenia (TRS). TRS is defined as no, or inadequate, symptomatic relief despite treatment with therapeutic doses of two APs from two different chemical classes for an adequate period. About 15% of patients develop TRS from illness onset, and about one-third of patients overall. Increasing evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current APs, along with normal dopaminergic synthesis, to explain the lack of benefit of most typical and atypical antipsychotics.

About evenamide
Evenamide, an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs) and is devoid of biological activity at >130 other 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 ineffective doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide benefit in patients who are poor responders to current APs, including clozapine.

About Newron Pharmaceuticals
Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on developing novel therapies for patients with diseases of the central and peripheral nervous system.

Headquartered in Bresso, near Milan, Italy, Newron is advancing its lead compound, evenamide, a first-in-class glutamate modulator, which 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 in Phase III development and clinical trial results to date demonstrate the benefits of this drug candidate in the TRS patient population, with significant improvements across key efficacy measures increasing over time, as well as a favourable 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 has a proven track record in bringing CNS therapies to market. Its Parkinson’s disease treatment, Xadago® (safinamide), is approved in over 20 markets, including the USA, UK, EU, Switzerland, and Japan, and commercialized in partnerships with Zambon and Meiji Seika.

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.

Immunic to Participate in Scientific and Investor Conferences in October

NEW YORK, October 1, 2025 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific and investor conferences in October:

• October 4-7: UEGW 2025 – United European Gastroenterology Week. Immunic’s R&D team will attend this conference in Berlin, Germany. Data on IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), will be presented in an oral presentation, a publication, and an ePoster, all of which will be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations.

• Title: IMU-856, an Orally Available Epigenetic Modulator of Barrier Regeneration, Showed Positive Effects on Gut Hormone Levels in Celiac Disease Patients in a Phase 1 Clinical Study
• Presenting Author: Amelie Schreieck, Ph.D., Senior Manager Biomarker Development at Immunic
• Presentation Number: OP053
• Publication Number: AS-UEG-2025-01463
• Session Title: Molecular medicine: Understanding the mechanism allows therapy
• Session Date: Monday, October 6, 2025
• Session Time: 8:30 – 9:30 am CEST (2:30 – 3:30 am ET)
• Location: Room A3

• Title: Biomarkers of Extracellular Matrix Remodeling Reflect Pharmacodynamic Effects of IMU-856, an Oral Epigenetic Modulator of Barrier Regeneration
• Presenting Author: Marta Sorokina Alexdόttir, Ph.D., Scientist, Nordic Bioscience
• ePoster Number: PP0290
• Session Title: Posters 3: SMALL INTESTINAL
• Session Date: Saturday, October 4, 2025
• Session Time: 9:00 am – 5:00 pm CEST (3:00 – 11:00 am ET)
• Location: Science Lounge

• October 5-8: 17th International Congress of the International Society of Neuroimmunology (ISNI). Evelyn Peelen, Ph.D., Head of Research at Immunic, will present data on Immunic’s orally available lead-asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in a poster presentation at this conference in Chiba, Japan. The poster will be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations.

• Title: Nurr1 Activator Vidofludimus Calcium Exhibits Signs of Neuroprotection in Preclinical Models
• Presenting Author: Evelyn Peelen, Ph.D., Head of Research at Immunic
• Abstract ID: 213
• Session Title: Poster Session 2
• Session Date: Tuesday, October 7, 2025
• Session Time: 6:20 – 7:40 pm JST (5:20 – 6:40 am ET)
• Location: Room 101B-105

• October 9: Roth’s 4th Annual Healthcare Opportunities Conference. Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, will participate in a panel discussion at this conference in New York. Dr. Vitt and Glenn Whaley, Chief Financial Officer of Immunic, will also participate in one-on-one investor meetings. To schedule a meeting, please contact your Roth representative or Jessica Breu at: jessica.breu@imux.com.
  • Panel 4: Next Wave of Innovation in Underserved Indications
  • Panel Time: 2:00 – 2:55 pm ET
  • Location: Presidents’ Ballroom

• October 23: H.C. Wainwright, HCW @ Home with Immunic. Dr. Vitt and Jason Tardio, President and Chief Operating Officer of Immunic, will participate in a virtual fireside chat at 11:00 am ET. The fireside chat will be available to the public at the following link: https://journey.ct.events/view/c58a0a38-ded6-4b2d-9dc7-629cf83de9d8 and on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations.

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune 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 management’s and employee’s participation in scientific and investor conferences. 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, 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

Gerresheimer Expands Wertheim Site with new Production Facility for Ready-to-fill Vials

• New production hall for RTF vials and innovative EZ-fill Smart packaging platform
• Best possible protection for sensitive biologics
• Total investment volume of around EUR 30 million
• Around 50 new jobs for skilled workers from the region

Düsseldorf/Wertheim, Germany, October 1, 2025. Gerresheimer, an innovative system and solution provider and a global partner for the pharma, biotech and cosmetic industries, has officially started construction of a new production facility at its Wertheim site, Germany with a groundbreaking ceremony. By mid 2027, high-quality ready-to-fill (RTF/RTU) vials are expected to roll off the production line in a new 4,000 m² production hall in the innovative EZ-fill Smart packaging platform. At its Wertheim site, Gerresheimer employs around 160 people to produce injection vials and ampoules. The planned expansion is expected to create a further 50 jobs for skilled workers from the region. Wertheim will be the second Gerresheimer production site, alongside Querétaro, Mexico, to offer RTF vials in the innovative EZ-fill Smart packaging platform. Gerresheimer is investing a total of around EUR 30 million in the construction and technical equipment of the new production building. The expansion underlines Gerresheimer’s position as a leading system and solution provider to the pharma and biotech industry, especially for injectable biopharmaceuticals.

“The expansion in Wertheim is an example of how we are implementing our growth strategy by expanding our portfolio with specialized systems and solutions for biopharmaceuticals,” explains Dietmar Siemssen, CEO of Gerresheimer AG.

“EZ-fill Smart is the next-generation packaging platform for ready-to-fill vials. Together with our Gx Elite RTF Vials, this high-value solution delivers optimal product quality and the best possible protection for sensitive biopharmaceuticals”, adds Volker Rekowski, Senior Vice President Europe & Asia Tubular Glass at Gerresheimer.

Center of excellence for vials and ampoules

The Wertheim site, which has been producing pharmaceutical ampoules since 1957, has been part of the Gerresheimer Group since 1989. It is Gerresheimer’s European Center of Excellence for high-value Gx Elite vials and ampoules, and in the future also for pre-sterilized “ready-to-fill” (RTF) vials. The last investment at the site was made in 2022 in new production lines for Gx Elite vials. The injection vials of the “Elite” performance level are characterized by very high break resistance, precisely maintained tolerances, and maximum surface quality. After about two years of planning, a state-of-the-art production infrastructure for RTF/RTU vials is now being built in Wertheim. The RTF/RTU vial market is expected to grow at a compound annual growth rate of around 13% until 2030¹.

EZ-fill Smart for best possible protection and efficient filling

With the new production hall, the Gx Elite Vials manufactured at the Wertheim Site will also be available as pre-sterilized “ready-to-fill” (RTF/RTU) versions in the EZ-fill Smart packaging platform. EZ-fill Smart is the next-generation packaging platform for RTF vials. Advantages include even less particles and, in the future, the possibility to use vaporized hydrogen peroxide (VHP) as an alternative, environmentally friendly and resource-saving sterilization method. EZ-fill Smart is compatible with all standard fill & finish lines, enabling flexible, safe, and cost-efficient filling processes. Combined with Gx Elite vials, EZ-fill Smart ensures highest protection for sensitive and expensive drugs such as novel biologics.

GMP Class C cleanroom

The RTF processing and packaging of the vials in the EZ-fill Smart format is planned to take place in the new production hall in an approximately 800 m² GMP Class C clean room (GMP = Good Manufacturing Practice). The new production infrastructure will thus meet the highest pharmaceutical requirements, as specified, for example, in Annex 1 of the EU GMP guidelines for the manufacture of sterile medicinal products in the EU.

Energy efficiency and sustainability

The planned new building combines energy efficiency and sustainability in both construction and its technical systems. A 175 kWp photovoltaic system will be installed on the roof of the new building, with the remaining surface being greened. The entire power supply will come from 100% renewable sources.

Around 50 new jobs for professionals from the region

In the first expansion phase, around 50 new jobs for skilled workers from the region will be created by 2028. The production capacity for RTF/RTU vials in the new production hall can be further increased in the coming years.

¹Prescient & Strategic Intelligence: Global RTF/RTU Vials Market (CAGR 14.5% 2021 to 2030) and Gerresheimer estimate

About Gerresheimer 
Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The Group offers a comprehensive portfolio of drug containment solutions including closures and accessories, as well as drug delivery systems, medical devices and solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, cartridges, ampoules, tablet containers, infusion, dropper and syrup bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. Gerresheimer supports its customers with comprehensive services along the value chain and in addressing the growing demand for enhanced sustainability. With over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. Together with Bormioli Pharma, the Group generated revenues of around EUR 2.4bn in 2024 and currently employs around 13,600 people. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).    
www.gerresheimer.com 
 

Contact Gerresheimer AG

PRESS RELEASE

Viromed Medical AG drives forward market launch of new products in the first half of 2025 and expands strategic partnerships

Rellingen, October 01, 2025 – Viromed Medical Group (“Viromed”; ISIN: DE000A3MQR65), a medical technology company and pioneer of cold plasma technology, has published its 2025 half-year report, which includes consolidated interim financial statements for the first time. The company can look back on a successful first half of 2025, which was marked by a strategic acquisition, new collaborations, and promising study results. Operational activities focused on the development of further products based on innovative cold plasma technology, preparations for approvals, and the conduct of preclinical and clinical studies.

With the integration of pharmedix GmbH, Viromed expanded its portfolio to include healthcare products in the fields of medicine, nutrition, and cosmetics. The collaboration with relyon plasma GmbH secured the series production of the innovative cold plasma products ViroCAP® and PulmoPlas®. Viromed also made significant progress in clinical development: initial results in the treatment of ventilator-associated pneumonia (VAP) in intensive care patients confirmed the high potential of PulmoPlas®. This was complemented by exclusive distribution partnerships in Asia, in the veterinary sector, and in the European cosmetics market, which are opening up new growth markets. Recent preclinical study data from the Hannover Medical School (MHH) underscore the great medical potential of cold plasma therapy, which could prevent thousands of deaths each year.

With the first-time consolidation of Viromed Medical AG, Viromed Medical GmbH, and pharmedix GmbH, the economic situation is now presented at group level. Consolidated revenues of EUR 2.4 million were achieved in the first half of 2025. Overall, there was a net loss for the period of EUR 0.8 million, mainly due to expenses for the preparation of the market launch of ViroCAP® and PulmoPlas®. The company’s equity amounted to EUR 6.6 million as of June 30, 2025, corresponding to an equity ratio of 39.9%.

Viromed plans significant growth for 2025 and confirms its forecast for the full year. The Viromed Medical Group’s revenue is expected to rise from EUR 1.37 million in 2024 to between EUR 8 million and EUR 10 million. The company also expects a slightly positive result, primarily driven by the operating business of the acquired pharmedix GmbH.

The 2025 half-year financial statements are available on the Viromed Medical AG website.

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

Not for release, publication or distribution, directly or indirectly, in or into the United States of America, Australia, Canada or Japan or any other jurisdiction in which such release, publication or distribution would be unlawful. The important notices at the end of this release must be observed.

Berlin, October 1, 2025 – Cantourage Group SE (ISIN: DE000A3DSV01, “Cantourage”) today announced a significant step in expanding its capital markets presence. Manuel Taverne, a seasoned capital markets professional, has been appointed as Head of Investor Relations. In this role, he will lead Cantourage’s investor relations activities with a particular focus on strengthening engagement across European financial markets.

With more than 20 years of experience in capital markets and strategic financial communications, Mr. Taverne brings deep expertise in building and maintaining strong investor relations. His appointment underlines Cantourage’s commitment to proactively advancing its capital markets strategy and fostering closer ties with institutional and private investors alike.

“By bringing Manuel Taverne on board, we gain an accomplished capital markets expert with outstanding knowledge and extensive experience. I am excited to work with him as we continue to expand our investor engagement,” said Philip Schetter, CEO of Cantourage.

Cantourage’s goal is to more clearly communicate its position as one of Europe’s leading providers of medical cannabis to the investment community. “Our innovative business model and platform strategy set us apart from the competition – yet the uniqueness of our approach has not been fully recognized by the market to date,” Schetter continued. “That is why we are intensifying our investor relations efforts – to present our equity story with greater clarity, transparency, and proactivity.”

About Cantourage

Cantourage is a leading European company for the production and distribution of medical cannabis. Cantourage enables growers worldwide to sell products in European medical markets. Founded in 2019, the company works with more than 60 cannabis growers from 18 countries. Cantourage ensures the highest pharmaceutical quality standards along the value chain and offers products in all relevant market segments: dried flowers, extracts, dronabinol and cannabidiol. The company has been listed on the Frankfurt Stock Exchange since November 11, 2022 and is listed under the ticker symbol “HIGH”.

More information: www.cantourage.com

This announcement does not constitute an offer to the public or a solicitation of anoffer to sell securities to the public, in particular not within the meaning ofRegulation (EU) 2017/1129 (Prospectus Regulation).

Mainz Biomed to Present the Future of Colorectal Cancer Screening at WEO CRC Screening Committee Meeting

BERKELEY, US and MAINZ, Germany – September 30, 2025 – Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, is pleased to announce its participation in the upcoming Colorectal Cancer (CRC) Screening Committee Plenary Meeting and Expert Working Group (EWG) Sessions hosted by the World Endoscopy Organization (WEO), taking place on October 3^rd, 2025, in Berlin, Germany.

This high-level gathering brings together global leaders in colorectal cancer screening to evaluate emerging technologies, exchange scientific insights, and help shape future strategies for early detection and prevention of CRC. As part of the session titled “Evaluation of New Tests”, Dr. Lena Krammes, Senior Scientist at Mainz Biomed, will present findings from the Company’s ongoing work in RNA-based diagnostics.

Dr. Krammes’ talk, titled “From Detection to Prevention – Early Evidence from RNA-based Screening Test for Precancerous Lesions Compared to Different FIT Cut-offs,” will showcase clinical data from the eAArly DETECT study, generated in 2024 highlighting the potential of stool RNA testing to identify both colorectal cancer and precancerous lesions. Key findings include:

• 97% sensitivity and 97% specificity for detecting colorectal cancer
• 82% sensitivity for advanced adenomas
• 100% detection of advanced adenomas with high-grade dysplasia

These results underline the potential for RNA-based testing to play a significant role not only in early detection of CRC, but also in prevention, by identifying high-risk lesions before cancer develops.

Mainz Biomed’s participation reflects its commitment to contributing to the global effort to improve CRC screening outcomes. The World Endoscopy Organization is a global non-profit organization dedicated to promoting high-quality endoscopy and the advancement of digestive health. Through its Colorectal Cancer Screening Committee, WEO works to promote CRC screening activities worldwide and support the implementation of screening programs, including fecal immunochemical tests (FIT), stool-based tests, and endoscopic procedures.

“We are honored to take part in this prestigious meeting,” said Guido Baechler, CEO of Mainz Biomed. “The invitation to join these expert discussions reinforces our belief that we are making important contributions toward developing effective, next-generation screening tools that can prevent colorectal cancer before it starts.”

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

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. 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.

PRESS RELEASE

Viromed Medical AG launches in vivo and ex vivo study with cold plasma on living lungs

Rellingen, September 30, 2025 – Viromed Medical AG (“Viromed”; ISIN: DE000A3MQR65), a medical technology company and pioneer of cold plasma technology, announces the start of a comprehensive in vivo and ex vivo study on living lungs. The in vivo and ex vivo tests are part of the ongoing study on the treatment of ventilator-associated pneumonia (VAP) using cold atmospheric plasma and are being conducted in collaboration with Hannover Medical School (MHH).

Prof. Dr. Hortense Slevogt, scientific director of the study at Hannover Medical School, emphasizes: “The results so far are groundbreaking. If the use of cold atmospheric plasma also proves safe in living lung tissue, it could potentially revolutionize the treatment of ventilated patients.”

Uwe Perbandt, CEO of Viromed Medical AG, explains: “Our study is the first of its kind and is one of the most comprehensive in the field of pulmonology worldwide. This gives us a significant competitive advantage. Our goal is to use cold plasma therapy to significantly reduce mortality from VAP and all bacterial or viral lung infections worldwide.“

Building on promising in vitro results, which showed 100% effectiveness of cold plasma technology against MRSA without damaging human lung tissue, the study is now entering its decisive next phase. For the first time, the interaction between the respiratory epithelium, bacterial infection, and cold plasma therapy will be investigated under realistic conditions—Viromed is thus closing a significant gap in international medical research.

The detailed results of the in vivo and ex vivo study will be published in a fast-track paper.

Viromed Medical AG is a pioneer in the field of cold plasma technology. With proprietary technologies, globally unique cell culture models, and close collaboration with leading university centers and research institutes, the company has a significant research and development advantage over its competitors.

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