Gerresheimer AG: Business performance and slower market growth require adjustment of guidance for 2025

Duesseldorf, October 8, 2025. Gerresheimer AG (ISIN: DE000A0LD6E6, “Gerresheimer”) is adjusting its guidance for the financial year 2025.

This is due to lower business performance in the third quarter of 2025, continued subdued demand in the cosmetics market as well as in containment solutions for oral liquid medications.

According to preliminary figures, revenue in the third quarter of 2025 amounted to EUR 560.7 million, adjusted EBITDA to EUR 103.4 million, and fx normalized adjusted EPS to EUR 0.77. Organic revenue growth in the third quarter of 2025 was -1.2% compared to the same period last year, with an organic adjusted EBITDA margin of 18.8%. According to preliminary results, Gerresheimer generated positive free cash flow of EUR 21 million in the third quarter of 2025.

According to preliminary results for the third quarter, revenue growth and the adjusted EBITDA margin for the first nine months of the 2025 financial year are lower than expected overall. Even taking into account the expected stronger fourth quarter of 2025 compared to the third quarter of 2025, the guidance for the 2025 financial year is therefore not achievable.

For the 2025 financial year, the company now expects organic revenue to decline by between -4% and -2% compared with the previous year (previously organic revenue growth: 0% to 2%) and an adjusted EBITDA margin around 18.5 to 19% (previously: around 20%). The company expects adjusted EPS to decline in the mid-double-digit percentage range compared to the previous year (previously: low double-digit percentage range).

Against the backdrop of the business performance and weaker market growth, Gerresheimer has initiated measures to reduce costs, increase performance, and improve free cash flow. The company will implement a comprehensive transformation program. The program includes more selective investment planning, measures to increase operational and sales performance, and optimization of the global production network. A newly created Transformation Office reporting directly to the CFO will drive the program forward.

_______________________

End of inside information

Gerresheimer will publish its preliminary results for the third quarter and the first nine months of the financial year 2025 today due to the guidance adjustment.

A conference call on the preliminary results will take place on Thursday, October 9, 2025, at 8:30 a.m. CEST.

Registration under:
https://www.webcast-eqs.com/gerresheimer-2025-09

Gerresheimer will publish its quarterly statement for the third quarter of 2025 with the final results on its website on October 10.

Contact Gerresheimer AG

Investor Relations

Guido Pickert
Vice President Investor Relations

T +49 152 900 14145
gerresheimer.ir@gerresheimer.com

Media

Jutta Lorberg
Head of Corporate Communication
T +49 211 6181 264

jutta.lorberg@gerresheimer.com

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 notes at the end of this announcement must be observed.

Berlin, October 8, 2025 – The German government today passed a cabinet resolution that includes far-reaching changes to the prescription and distribution of medical cannabis. According to the draft bill, prescriptions will initially only be issued after a personal doctor-patient consultation. For repeat prescriptions, a personal consultation must take place once every four quarters – under this condition, a prescription can also be issued via telemedicine in the following quarters. In addition, medical cannabis flowers may only be sold directly in local pharmacies.

The proposed changes will be discussed in the Bundestag in the next step. Amendments to the law are to be expected in the further parliamentary process. However, if the draft law is passed in its current form, this could at least temporarily weigh on demand for medical cannabis flowers in Germany – especially since many patients currently use telemedicine services for prescriptions.

“The medical use of cannabis is an expression of sustainable development and has already become widely accepted in society. We consider the proposed legal changes to be inappropriate, as they would make access to medical cannabis more difficult, potentially reduce demand for cannabis flowers, at least temporarily, and thus jeopardize a growing industry and jobs in Germany. At Cantourage, we remain committed to providing safe, high-quality, and responsible medical care to patients,” says Philip Schetter, CEO of Cantourage.

Cantourage has taken a position on the proposed legislative changes in a statement dated August 1, 2025: Details can be found here.

Cantourage is closely monitoring legislative developments in Germany. The company has been responding to the changing environment for quite some time with a consistent strategy of expansion and diversification.

Cantourage has recently expanded its business activities significantly, particularly in the dynamically growing markets of Poland and the United Kingdom. These international activities not only contribute to further strengthening the company, but also offer additional resilience to possible changes in the German market environment.

At the same time, Cantourage is continuously adapting its product portfolio in Germany to meet changing requirements and continue to ensure the supply of patients. Cantourage thus remains a reliable partner in the field of medical cannabis supply and will continue to respond flexibly and solution-oriented to regulatory changes in the future.

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, under the ticker symbol “HIGH”.

Contact Investor Relation
ir@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 of Regulation (EU) 2017/1129 (Prospectus Regulation).

Relief Therapeutics and NeuroX, Successor to MindMaze, Sign Definitive Agreement for Business Combination

• Companies sign definitive agreement following previously announced binding term sheet
• Transaction to create an expanded, SIX-listed, commercial-stage, AI-driven, scalable health tech company
• Combined company to be renamed MindMaze Therapeutics Holding SA upon closing
• Positioned as a global leader in evidence-based neurotherapeutic solutions for neurological diseases and brain disorders
• Over 250 hospitals and rehabilitation centers, thousands of home sessions deployed, and multiple pharma collaborations establish robust commercialization footprint
• Proprietary neuro-data engine and responsible AI framework will enable scalable precision medicine for neurological diseases based on more than 30,000 patients
• Secured a unique reimbursement code (CAT-3) to support the delivery of its home-based neurotherapeutic training in the United States
• Over the past decade MindMaze has raised and invested more than USD 350 million to establish clinical evidence, demonstrate significant medico-therapeutic outcomes and market disease-modifying platforms including stroke, Parkinson’s and at-risk aging
• Closing expected in December 2025, subject to customary conditions and approvals

GENEVA and LAUSANNE (Oct. 8, 2025) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, and NeuroX Group SA (NeuroX), a privately held company focused on digital neurotherapeutics and brain health technologies, today announced they have entered into a definitive agreement to combine their businesses.

The proposed combination will create a publicly listed, AI-based therapeutics platform integrating software-delivered, disease-modifying clinical interventions with pharmacological treatments and a comprehensive brain health platform. NeuroX contributes a clinically validated, de-risked portfolio supported by multiple milestones achieved across technological development, regulatory approvals, and market access, as well as a solid network of pharmaceutical partners.

AI and Data Platform for Precision Neurology

The MindMaze proprietary technology stack integrates multimodal data collected across thousands of patients in clinical and real-world settings. In the future, the platform will build on advanced machine learning and federated AI models to personalize neurorehabilitation, predict recovery trajectories, and optimize pharmacological and digital treatment combinations.

All technologies are developed in compliance with EU AI Act principles, GDPR, MDR, and FDA Software as a Medical Device (SaMD) frameworks, ensuring transparency and clinical-grade data integrity.

Commercial-Stage Footprint and Reimbursement Readiness

NeuroX’s clinically validated digital neurotherapeutic suite is currently deployed in over 250 clinics and rehabilitation centers globally. Its solutions are supported by a unique U.S. Category III reimbursement code (CAT-3), enabling scalable and recurring revenue generation.

Over the past decade, more than USD 350 million has been invested to build this data-rich therapeutic platform, supported by strong evidence of improved clinical and medico-economic outcomes in stroke, Parkinson’s disease, and at-risk aging. Additional R&D initiatives target multiple sclerosis, spinal cord injury, traumatic brain injury, and Alzheimer’s/dementia.

Gregory Van Beek, vice-chairman of the board of directors of Relief, said: “Over the past months, our collaboration with NeuroX has confirmed the potential of combining our businesses. With today’s signing, we are advancing a transaction that represents a compelling and risk-balanced, high-growth investment case. The combined company will stand as an attractive complement to other innovative technology and healthcare SMEs listed on SIX, while offering Relief shareholders exposure to a differentiated therapeutic platform. We are confident this is a well-structured and value-creating transaction for our investors.”

Tej Tadi, founder of MindMaze, added: “Finalizing this agreement is a pivotal step in our ongoing journey. Over the years we have built a de-risked platform through sustained investment, clinical validation, regulatory approvals and reimbursement milestones, and we are now ready to scale. Partnering with Relief and accessing the public markets will enable us to broaden adoption of our precision neurology solutions and expand collaborations across pharma and healthcare.”

Leadership and Governance

Upon completion of the transaction, the combined company will be guided by Tej Tadi, founder of MindMaze, supported by NeuroX’s current executive leadership team and additional key hires underway. Relief’s chief financial officer will continue in that role. Other members of Relief’s current executive committee will assume management positions, focusing on Relief’s existing business and supporting the NeuroX platform.

At an upcoming extraordinary general meeting, Relief’s board of directors will propose the election of four new members. Gregory Van Beek, the sole incumbent director, will continue to serve on the board of directors to ensure continuity and support the integration of the two companies.

Transaction Terms

The transaction is based on agreed equity valuations of CHF 100 million for Relief, a premium to its current market capitalization, and CHF 1 billion for NeuroX.

Under the terms of the agreement, NeuroX shareholders shall contribute all their NeuroX shares to Relief in exchange for newly issued SIX-listed Relief shares, at a fixed exchange ratio of 140 Relief shares per NeuroX share. Based on this exchange ratio and reflecting an agreed relative valuation of 10-to-1 on a fully diluted basis in favor of NeuroX, Relief will issue 140,000,000 new ordinary shares to acquire NeuroX. Following completion, Relief expects to have 152,584,419 ordinary shares outstanding, excluding 1,500,398 treasury shares and subject to adjustments for any outstanding options exercised prior to closing.

The transaction has been approved by the boards of directors of both companies and is expected to close in December 2025. Completion remains subject, inter alia, to approval of the transaction by Relief’s shareholders and to the admission of the newly issued Relief shares for listing and trading on the SIX Swiss Exchange. Upon closing, Relief will be renamed MindMaze Therapeutics Holding SA.

NeuroX is in advanced discussions to secure a new CHF 200 million equity commitment through a share subscription facility with Relief’s shareholder Global Emerging Markets (GEM), in addition to an existing equity commitment to be contributed by Relief representing an additional CHF 50 million.

The combined company will also seek to uplist its OTC ADR program to a Level III as soon as practicable after closing the business combination, expanding visibility and access to U.S. investors.

Additional Information

Relief will convene an extraordinary general meeting to submit to shareholders the proposals required to implement the contemplated transaction, including the issuance of new shares to NeuroX shareholders and the election of new members to the board of directors.

Relief and NeuroX intend to host a joint press conference on or around the day of the extraordinary general meeting. An investor presentation with additional information on the combined company is currently available for download on Relief’s website.

YUMA Capital is acting as financial advisor for the transaction.

ABOUT NEUROX
NeuroX is a Swiss-based, commercial-stage company that in 2025 acquired strategic assets of MindMaze Group SA and MindMaze SA (MindMaze), including intellectual property and the MindMaze® brand, through a pre-pack transaction in connection with MindMaze’s debt restructuring moratorium.

MindMaze has developed first-of-its-kind neurotherapeutics that provide disease-modifying motor and cognitive treatments for neurological diseases and brain disorders. These neurotherapeutics are delivered through proprietary software and hardware, underpinned by an advanced brain technology platform that integrates wearables and sensors, and provides digital assessments as well as telehealth services. The unique suite of MindMaze solutions is delivered globally across the continuum-of-care, both in-clinic and in patients’ home, to successfully address some of neurology’s major unmet needs. NeuroX has already partnered with leading pharmaceutical companies that use its proprietary technology across multiple clinical trials.

Over the last decade, MindMaze has raised and invested more than USD 350 million to establish clinical evidence, demonstrate significant medico-economic outcomes, and market MindMaze’s disease-modifying therapeutic platform across neurological diseases, including stroke, Parkinson’s disease, and at-risk aging. In the United States, MindMaze has received a unique reimbursement code (CAT-3) to support the delivery of its home-based neurotherapeutic training. Its R&D pipeline focuses on adjacent neurological diseases, such as spinal cord injury, multiple sclerosis, traumatic brain injury, and Alzheimer’s disease/dementia.

Moved by the mission to accelerate the brain’s ability to recover, the MindMaze platform innovates by combining software-delivered behavioral treatments, drugs, devices, data, and AI to establish a new paradigm of precision medicine in neurology and neural repair.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company dedicated to advancing treatment paradigms and improving the lives of patients with rare and debilitating diseases. With core expertise in drug delivery systems and drug repurposing, Relief’s clinical pipeline includes innovative treatments designed to address critical unmet medical needs in rare dermatological, metabolic and respiratory conditions. The Company has also successfully brought several approved products to market through licensing and distribution partnerships. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

CONTACT
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

MindMaze
pr@mindmaze.com

DISCLAIMER
This press release contains forward-looking statements, which may be identified by words such as “believe,” “assume,” “expect,” “intend,” “may,” “could,” “will,” or similar expressions. These statements are based on current plans and assumptions and are subject to risks and uncertainties that could cause actual results, financial condition, performance, or achievements to differ materially from those expressed or implied. Such factors include, but are not limited to, changes in economic conditions, market developments, regulatory changes, competitive dynamics, and other risks or changes in circumstances. There can be no assurance that the proposed business combination will be completed on the terms described herein or at all. This communication is provided as of the date hereof, and Relief undertakes no obligation to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

No offer or solicitation – This press release does not constitute (i) a prospectus within the meaning of the Swiss Financial Services Act or under any other applicable laws, (ii) a solicitation of proxy, consent or authorization with respect to any securities or in respect of the proposed business combination or (iii) an offer to sell, a solicitation of an offer to buy, or a recommendation to buy any security of Relief, NeuroX, or any of their respective affiliates. No securities may be sold in any jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration, exemption from registration, or qualification under the securities laws of such jurisdiction. This press release should not be regarded as investment advice or offering material of any kind and is provided for information purposes only, nor shall it or any part of it form the basis of, or be relied upon in connection with, any contract or investment decision.

This announcement is not for publication or distribution, directly or indirectly, in or into the United States, Canada, Australia, Japan, or any other jurisdiction in which such distribution would be unlawful.

Ad hoc announcement – Disclosure of inside information under Article 17 of Regulation (EU) No 596/2014

Heidelberg Pharma AG Announces Updated Guidance

Ladenburg, Germany, 6 October 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announces that it has adjusted its guidance for the current fiscal year published on 21 March 2025, due to current focus and cost-saving measures.

The Heidelberg Pharma Group expects sales and other income for the financial year 2025 between EUR 7.5 million and EUR 9 million (previously: EUR 9 million to EUR 11 million). Operating expenses are expected to range between EUR 36 million and EUR 40 million (previously: EUR 40 million to EUR 45 million).

Based on these adjustments, an operating result (EBIT) between EUR -28.5 million and EUR -31 million is expected (previously: EUR -30 million to EUR -35 million).

As part of the strategic focus, long-term and short-term assets are still being reviewed for impairment. They could prove to be only partially or no longer recoverable, resulting in value adjustments. Such non-cash depreciation on assets would lead to additional operating expenses in the current fiscal year, which in turn could have a negative impact on the operating result beyond the aforementioned range of between EUR -28.5 million and EUR -31 million.

For 2025, Heidelberg Pharma anticipates cash requirements of EUR 14 million to EUR 17 million (previously: EUR 50 million to EUR 55 million anticipated inflow). Monthly cash consumption is expected to range between EUR 1.2 million and EUR 1.5 million per month (previously: EUR 4.2 million and EUR 4.6 million inflow). Based on current planning and available funds, the Company’s financing is secured until mid-2026.

Pentixapharm Highlights Expanding CXCR4 Radiopharmaceutical Platform with
New Clinical Findings at EANM 2025
 

• Clinical data from independent investigator-initiated studies using [⁶⁸Ga]Ga-PentixaFor demonstrate potential to improve diagnosis in Primary Aldosteronism
• First-in-human findings with [¹⁷⁷Lu]Lu-PentixaTher in bladder cancer show early therapeutic activity, further validating CXCR4 as a clinically relevant target
   

Berlin, Germany, October 6, 2025 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech developing novel radiopharmaceuticals, today announced the presentation of extensive clinical data from independent investigator-initiated studies assessing Pentixapharm’s CXCR4-targeting diagnostic lead candidate, [⁶⁸Ga]Ga-PentixaFor, at the ongoing Annual Congress of the European Association of Nuclear Medicine (EANM 2025) in Barcelona, Spain.

At EANM 2025, four oral presentations and seven e-posters feature new data on [⁶⁸Ga]Ga-PentixaFor PET/CT imaging in Primary Aldosteronism (PA) – a condition frequently underdiagnosed despite being one of the leading causes of secondary hypertension. These presentations include comparative clinical trial results, evaluating [⁶⁸Ga]Ga-PentixaFor against adrenal venous sampling (AVS), the current invasive gold standard for subtyping PA. The data demonstrate the high potential of [⁶⁸Ga]Ga-PentixaFor to significantly improve subtyping of patients, thereby enabling better therapy decisions, and more precise patient management in PA.

Complementing these results in cardiovascular and endocrine disease, the scientific program at EANM 2025 also showcases the expanding role of Pentixapharm’s CXCR4-targeted platform in oncology. Among the highlights are first-in-human data on Pentixapharm’s therapeutic candidate [¹⁷⁷Lu]Lu-PentixaTher, in patients with bladder cancer. The early findings demonstrate initial signs of therapeutic activity, adding to the growing body of evidence supporting [¹⁷⁷Lu]Lu-PentixaTher as a precision treatment candidate for CXCR4-positive malignancies.

“The strong scientific presence of our CXCR4 program at EANM 2025 reflects both the clinical relevance of our platform and the growing recognition of CXCR4 as a key target across multiple disease areas,” said Dr. Dirk Pleimes, CEO/CMO of Pentixapharm AG. “The findings in Primary Aldosteronism highlight how our lead candidate, [⁶⁸Ga]Ga-PentixaFor, could transform the diagnosis of hypertensive patients while the oncology data further validate CXCR4 as a cornerstone target for our radiopharmaceutical platform. The wealth of CXCR4-directed research presented at EANM highlights the diagnostic value of CXCR4-targeted imaging, reinforcing the strength and versatility of our approach. Together, these findings demonstrate how Pentixapharm is expanding the boundaries of radiopharmaceuticals across cardiovascular, endocrine, and oncologic diseases.”

About CXCR4

CXCR4 is a well-characterized cell membrane receptor with a pivotal role in the bone marrow microenvironment. It is highly overexpressed in multiple aggressive blood cancers – including acute myeloid leukemia, multiple myeloma, and large B-cell lymphoma – where it drives tumor growth and metastasis. CXCR4 has been clinically validated in multiple of these hematologic cancers, making it a validated high-value target in areas of high unmet medical need.

Beyond oncology, CXCR4 is being explored as a diagnostic imaging target in cardiovascular and endocrine disorders, particularly Primary Aldosteronism (PA), a condition accounting for an estimated 5–10% of all hypertension cases, corresponding to roughly 100–200 million people worldwide. In PA, CXCR4 expression is elevated in benign adrenal tumors, making it a valuable tool for functional diagnosis, PA sub-typing, and lateralization of aldosterone overproduction.

Its dual diagnostic and therapeutic potential illustrates CXCR4’s versatility as a first-in-class target for next-generation radiopharmaceuticals, enabling both precision diagnostics and targeted radioligand therapy.

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops first-in-class ligand- and antibody-based radiopharmaceuticals designed to transform patient care across oncology and beyond. Its late-stage pipeline is anchored by CXCR4-targeted programs, including a Phase 3-ready diagnostic candidate for primary aldosteronism and pioneering therapeutic programs in a number of hematological and solid cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-escape marker over-expressed in multiple hard-to-treat cancers. Complemented by reliable isotope supply from Eckert & Ziegler, and a robust global clinical network, Pentixapharm is uniquely positioned to deliver innovative radiopharmaceuticals that address high unmet need, improve patient outcomes, and create significant growth opportunities in one of the fastest-growing areas of precision medicine.

Pentixapharm Investor and Media Contact

ir@pentixapharm.com

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:
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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.