Relief Therapeutics and NeuroX Unveil Joint Presentation and Financial Outlook Ahead of Anticipated Business Combination

GENEVA (Nov. 25, 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, announced today that, in anticipation of the expected closing of its business combination with NeuroX Group SA (NeuroX) in mid-December 2025, it has published a joint presentation deck.

This deck will be discussed during today’s press conference, offering stakeholders a comprehensive overview of the strategic vision and initial financial guidance.

The combined company expects to generate revenues over CHF 40 million in 2027 and to exceed CHF 200 million in 2031. In addition, it anticipates achieving a normative EBITDA margin of approximately 55% by 2028. This financial outlook is based on the expected adoption and scaling of NeuroX’s digital neurotherapeutics suite as the organization builds its commercial foundation following the consolidation of the MindMaze assets.

The presentation deck is available for download on Relief’s website. The joint press conference will take place today at 3:00 p.m. CET, and the access details remain unchanged: https://mindmaze.zoom.us/j/81345965910; Passcode: 374338.

Participants joining by phone may use Webinar ID 813 4596 5910 and can find international dial-in numbers at https://mindmaze.zoom.us/u/kcYGXs92CP

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.

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. MindMaze pioneered first-of-its-kind digital neurotherapeutics that provide disease-modifying motor and cognitive treatments for neurological diseases and brain disorders. Built on an advanced brain technology platform integrating software, sensors, and telehealth, NeuroX solutions are deployed globally across clinics and home settings. The company’s clinically validated technology has demonstrated significant medico-economic outcomes across conditions such as stroke, Parkinson’s disease, and at-risk aging. NeuroX continues to expand its R&D pipeline into adjacent neurological indications, including multiple sclerosis, spinal cord injury, traumatic brain injury, and Alzheimer’s disease.

CONTACT
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.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. In particular, the financial guidance presented herein is based on management’s current expectations and internal estimates; actual future results may differ materially from these projections and are subject to the Company’s ability to secure adequate funding to execute its plans. There can also be no assurance that the contemplated business combination will be completed. 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.

Ad hoc announcement

Disclosure of inside information under Article 17 of Regulation (EU) No 596/2014

Heidelberg Pharma Announces Changes to the Executive Management Board – Dr Dongzhou Jeffery Liu Appointed as Chairman of the Executive Board and Chief Executive Officer

Ladenburg, Germany, 24 November 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced that the Supervisory Board has revoked the appointment of Professor Andreas Pahl as member of the Executive Management Board and Chief Executive Officer, and has instead appointed Dr Dongzhou Jeffery Liu as Chairman of the Executive Management Board and new Chief Executive Officer, with immediate effect. 

Dr Liu has stepped down from his position as a member of the Supervisory Board of Heidelberg Pharma, with effect as of 23 December 2025. His permanent appointment as Chairman of the Executive Management Board and Chief Executive Officer will become effective as of 24 December 2025. For the transition period from today until 23 December 2025 he will be seconded as a deputy member to the Executive Management Board pursuant to section 105 (2) of the German Stock Corporation Act (Aktiengesetz)

Dr Liu is Chief Scientific Officer (CSO) and President of Huadong Global Development at Huadong Medicine in Hangzhou, China. Prior to that he held various leading positions in the pharma industry in the US, including GlaxoSmithKline, Wyeth (now Pfizer) and Forest Labs (now Abbvie). His more than 25 years of industry experience include clinical and preclinical research & development of medicinal products, including ADC products.

 

CureVac Announces Financial Results for the Third Quarter and First Nine Months of 2025 and Provides Business Updates

• German Federal Cartel Office clearance obtained for the planned BioNTech – CureVac transaction announced on June 12, 2025, marking an important step toward the expected closing later this year

• Offer period for BioNTech’s public exchange offer for all outstanding CureVac N.V. shares began on October 21, 2025, and is scheduled to expire on December 3, 2025

• German litigation with Pfizer/BioNTech related to mRNA-based COVID-19 vaccines has been paused pending completion of BioNTech’s public exchange offer

• Received Clinical Trial Application (CTA) clearance from the European Medicines Agency (EMA) for CVHNLC squamous non-small cell lung cancer (sqNSCLC)

• CVGBM (glioblastoma) Phase 1 Part B remains on track

• Strong cash and cash equivalents position of €416.1 million as of September 30, 2025, confirming expected cash runway into 2028

• CureVac received final audit report relating to the Advance Purchase Agreement with the European Commission for CureVac’s first-generation COVID-19 vaccine candidate

 

TÜBINGEN, Germany / BOSTON, USA – November 24, 2025 – CureVac N.V. (Nasdaq: CVAC), a pioneering multinational biotech company developing a new class of transformative medicines based on messenger RNA (mRNA), today announced financial results for the third quarter and first nine months of 2025 and provided a business update.

 “This quarter, we have made continued progress toward completing the planned transaction with BioNTech, bringing us closer to realizing our shared vision of bringing together two pioneers in mRNA science with complementary capabilities and technologies,“ said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. “Together, we aim to accelerate the development of innovative and transformative mRNA-based therapies for patients in need.”

Selected Business Updates

Definitive Purchase Agreement with BioNTech

• The German Federal Cartel Office granted clearance for the planned transaction between BioNTech and CureVac announced on June 12, 2025, marking an important milestone toward the expected closing later this year.

• The offer period for BioNTech’s public exchange offer for all outstanding CureVac N.V. shares began on October 21, 2025, and is scheduled to expire on December 3, 2025.
   
• In connection with the offer, CureVac has convened an Extraordinary General Meeting of shareholders (EGM), which will take place on November 25, 2025.

Protection of Intellectual Property Rights

• Litigation in Germany with Pfizer/BioNTech related to mRNA-based COVID-19 vaccines has been paused pending completion of BioNTech’s public exchange offer, which is expected to close in 2025.
   

2025 Oncology Milestones

• CVGBM (glioblastoma): Data from Part B of the Phase 1 study remain on track.
• CVHNLC (sqNSCLC): The EMA has granted CTA clearance for this off-the-shelf cancer immunotherapy candidate targeting squamous non-small cell lung cancer (sqNSCLC).
• Individualized precision cancer immunotherapy: The program continues to progress. CureVac’s proprietary FRAMEpro antigen identification algorithm, automated manufacturing via the RNA Printer®, and cloud-based data handling system are being integrated into a streamlined, end-to-end workflow.

Financial Update for the Third Quarter and First Nine Months of 2025

Cash Position

Cash and cash equivalents totaled €416.1 million as of September 30, 2025, compared with €481.7 million at year-end 2024. During the first nine months of 2025, cash was mainly used for operating activities, primarily to support ongoing research and development (R&D) in oncology precision immunotherapies, prophylactic vaccines, and continued development of CureVac’s mRNA technology.

Cash outflow decreased significantly compared to the same period in 2024, mainly due to:

• Non recurrence of extraordinary payments in the prior year related to the termination of raw material commitments and contract manufacturing organization (CMO)-related arbitration awards for the first-generation COVID-19 vaccine CVnCoV, and
• the strategic restructuring initiated in July 2024 reduced personnel expenses and introduced broader cost-saving measures across the organization.

The company reaffirms its expected cash runway into 2028.

Further Balance Sheet Developments

On the assets side, changes compared to December 31, 2024, related to a decrease in non-current assets, mainly reflecting depreciation of existing property, plant and equipment (PPE) and right-of-use assets. Current assets increased due to the receivable from BioNTech associated with the U.S. settlement agreement (U.S. Settlement Agreement) and the U.S. license agreement (U.S. License Agreement) each entered into by and among CureVac SE and CureVac Manufacturing GmbH on the one hand and BioNTech SE, BioNTech Manufacturing GmbH and Pfizer, Inc. on the other hand on August 7, 2025.

On the liabilities side, the primary change compared to December 31, 2024, was an increase in other liabilities which included €120.9 million related to value added tax on the U.S. Settlement recognized in August 2025.

Revenues

Revenues were €54.1 million for the third quarter and €56.3 million for the first nine months of 2025, compared with €493.9 million and €520.7 million in the respective periods of 2024. This represents year-over-year decreases of €439.8 million and €464.4 million, both 89%, respectively.

The decline was primarily driven by the absence of the €480.4 million one-time revenue recognized in the third quarter of 2024 in connection with the new license agreement with GlaxoSmithKline Biologicals SA (GSK) closed in July 2024. Under the new license agreement CureVac received a non-refundable upfront payment of €400.0 million with no obligation to perform R&D work in connection with the newly granted licenses and CureVac and GSK agreed that all unfulfilled performance obligations from prior collaborations relating to R&D services had expired. As a result, the remaining €80.4 million contract liabilities for prior collaborations were also recognized as revenue in the third quarter of 2024.

In the third quarter of 2025 $50.0 million were recognized following the first amendment to the GSK license agreement concluded in August 2025. In addition, CureVac recognized €11.1 million in Q3 2025 related to royalties under the U.S. License Agreement with BioNTech and Pfizer, also closed in August 2025.

For the nine months ended September 30, 2025, CureVac recorded revenues of €43.3 million from GSK, €11.1 million from BioNTech, and €1.8 million from CRISPR Therapeutics, compared with €508.3 million, €0 million, and €12.4 million, respectively, in the prior-year period.

 

Operating Profit

Operating profit was €310.2 million for the third quarter and €193.7 million for the first nine months of 2025, compared with €368.4 million and €221.4 million in the respective prior-year periods. Operating profit was impacted by a positive one-time effect of $420.0 million for the three and nine months ended September 30, 2025, resulting from the net effect of the U.S. Settlement Agreement amounting to $370.0 million and $50.0 million related to the first amendment to the GSK license agreement closed in August 2025, compared to a positive one-time effect of €480.4 million in the respective prior year periods related to the new license agreement with GSK closed in July 2024.

The operating profit for 2025 reflects several drivers, partly influenced by the strategic restructuring initiated in July 2024, the proposed transaction with BioNTech, and the U.S. Settlement Agreement finalized in August 2025:

• Cost of sales decreased substantially following the shift in organizational activities toward R&D associated with the new GSK license agreement. As the manufacturing organization now supports only the R&D pipeline, related costs are no longer recognized as cost of sales. The prior-year period also included extraordinary CMO arbitration expenses associated with the first-generation COVID-19 vaccine and raw material write-downs associated with inventory which would have been realizable under the previous GSK collaboration.

• Research and development expenses increased primarily because manufacturing-related costs are now recorded as R&D rather than cost of sales. This increase was partly offset by cost reductions from the 2024 restructuring, while the prior year included elevated litigation expenses to enforce intellectual property rights.

• General and administrative expenses were higher than in the prior year due to increased legal and advisory costs related to the proposed BioNTech transaction, partially offset by lower personnel expenses following the workforce reduction in 2024.

• Other operating income rose significantly due to the recognition of $370 million from the U.S. Settlement Agreement executed in August 2025 between BioNTech, Pfizer, GSK and CureVac.

• Other operating expenses declined compared to 2024, which had been impacted by a partial impairment of the production facility amounting to €36.6 million.

Financial Result

The net financial result for the three and nine months ended September 30, 2025, was a loss of €2.6 million and a gain of €2.2 million, respectively, compared with gains of €2.2 million and €8.0 million in the respective prior-year periods. The year-over-year changes were primarily due to unrealized foreign exchange losses.

 Net Profit

 Net profit for the three and nine months ended September 30, 2025, was €273.2 million and €161.6 million, respectively, compared with €338.0 million and €194.9 million in the same periods in 2024.

Basic And Diluted Earnings Per Share

Basic and diluted earnings per share for the third quarter of 2025 were €1.21, compared with €1.51 (basic) and €1.50 (diluted) in the prior-year quarter. For the first nine months of 2025, basic earnings per share were €0.72 and diluted earnings per share were €0.71, compared with €0.87 (basic) and €0.86 (diluted) for the prior-year period.

EU Advance Purchase Agreement Update

Final audit report relating to the Advance Purchase Agreement with the European Commission for CureVac’s first-generation COVID-19 vaccine candidate

On November 30, 2020, CureVac entered into an Advance Purchase Agreement (APA) with the European Commission (the EU Commission) for the supply of its first-generation COVID-19 vaccine candidate (CVnCoV). Under the APA, CureVac received an upfront payment of €450 million, for development and commercial supply activities of CVnCoV.

On July 24, 2024, the EU Commission informed CureVac that it had engaged Deloitte, S.L. (Deloitte) to conduct an audit of CureVac’s compliance with the APA. On September 17, 2025, the EU Commission provided CureVac with Deloitte’s draft audit report, which included preliminary findings alleging missing documentation, absence of project cost allocation, cost traceability and reconciliations, as well as inconsistencies between information submitted during the audit and financial information previously provided to the EU Commission. CureVac submitted objections to the findings of Deloitte’s draft audit report on October 17, 2025. On November 18, 2025, the EU Commission delivered to CureVac Deloitte’s final audit report, which was consistent with their draft audit report.

CureVac contested, and will continue to contest, the findings in Deloitte’s audit reports. If the European Commission will seek recovery of any portion or all of the €450 million upfront payment or to impose any fines related thereto, CureVac will defend itself against any such payment request or imposed fines to the fullest extent legally possible.

  

About CureVac

CureVac (Nasdaq: CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized precision immunotherapy candidates to treat cancer. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

CureVac Media and Investor Relations Contact

CureVac, Tübingen, Germany

Corporate Communications
communications@curevac.com

 

Forward-Looking Statements of CureVac

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the “company”) regarding future events or future results, in contrast with statements that reflect historical facts. Examples include the settlement of all pending patent disputes in the United States between the company, Pfizer, and BioNTech relating to mRNA-based COVID-19 vaccines, the Company’s expectations regarding the outcome of pending litigation in other global jurisdictions, the expected completion of the public exchange offer between BioNTech and the Company, the discussion of the potential efficacy of the company’s vaccine and treatment candidates and the company’s strategies, financing plans, cash runway expectations, the timing and impact of restructuring, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including risks related to the proposed acquisition by BioNTech, negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, ability to implement our pipeline strategy, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, the effects of the COVID-19 pandemic on the company’s business and results of operations, ability to manage growth, ability to implement, maintain and improve effective internal controls, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, the impact of adverse settlements or other judicial outcomes and other important factors discussed under the caption “Risk Factors” in the company’s annual report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 11, 2025, as such factors may be updated form time to time in its other filings with the SEC. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company’s reports and documents filed with the SEC. You may get these documents by visiting EDGAR on the SEC website at www.sec.gov. 

 

Unaudited Interim Condensed Consolidated Statements of Operations and

Other Comprehensive Income

 

 

 

 

Interim Condensed Consolidated Statements of Financial Position

 

 

 

 

Unaudited Interim Condensed Consolidated Statements of Cash Flows

 

 

 

Basis of presentation

The Unaudited Interim Condensed Consolidated Statements of Operations and Other Comprehensive Income, Financial Position, and Cash Flows have been prepared in accordance with International Financial Reporting Standards, as adopted by the European Union and in accordance with IAS 34 “Interim Financial Reporting”. The selected explanatory notes and the statement of changes in equity required by IAS 34 are not provided. The same accounting policies were applied as used for the Consolidated Financial Statements as of December 31, 2024.

Press Release // November 24, 2025
 

NTC becomes commercialization partner for Formycon’s Eylea^® biosimilar FYB203/Baiama^® in Italy
 

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and NTC s.r.l. (“NTC”) jointly announce that Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon’s Eylea^®1 biosimilar FYB203 (aflibercept), concluded an exclusive agreement with NTC for the commercialization of FYB203/Baiama^®2 in Italy.

As part of the agreement, Klinge is eligible to receive royalties on net sales. Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge. Furthermore, Formycon will act as authorized designee to organize the supply chain for FYB203 and will receive additional service payments and a volume-based profit component for organizing the commercial market supply on behalf of Klinge.

Nicola Mikulcik, CBO of Formycon AG commented: „Age-related diseases such as wet macular degeneration (“nAMD”) are on the rise in Europe due to the continuously increasing number of people over the age of 65. Our Eylea^® biosimilar FYB203 provides ophthalmologists with a safe, effective and cost-efficient treatment option for such serious conditions. For Italy, we are very pleased to present NTC as our partner for the exclusive distribution of FYB203/Baiama^®. NTC is a local specialist in ophthalmology with a deep understanding of the specific market landscape and a strong customer network.“

NTC is a leading R&D driven pharmaceutical company based in Italy with a strong focus on disease areas like ophthalmology, gastroenterology, pediatrics, and gynecology. The company’s growing portfolio consists of brand R_X products, generic and biosimilar drugs, nutraceuticals and medical devices.

In June 2024, the aflibercept biosimilar FYB203 was approved by the US Food and Drug Administration (“FDA”). Approval by the European Commission under the brand names AHZANTIVE^®3 and Baiama^® followed in January 2025.One month later FYB203 also received marketing authorization by the British MHRA.⁴

Eylea^® (aflibercept) is used to treat nAMD and other severe retinal diseases. The active ingredient inhibits vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina.

———————–

¹⁾  Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
²⁾  Baiama^® is a registered trademark of Klinge Biopharma GmbH
³⁾  AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
⁴⁾  The commercial launch of FYB203 in Europe depends on the progress and
outcome of ongoing or potential future patent litigation or possible settlement
agreements.

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

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

About NTC:
NTC is a pharmaceutical company based in Milan, with products available in over 100 countries through a network of distributors and partners. NTC is engaged in the research, development, registration and marketing of drugs, medical devices and food supplements in the field of ophthalmology, as well as in other therapeutic areas such as pediatrics, gynecology and gastroenterology.

NTC offers more than 250 partners innovative pharmaceutical products of the highest quality standards. Further information at www.ntcpharma.com

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

Contact:
Sabrina Müller
Director Investor Relations 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
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.

Leverkusen / Berlin, November 23, 2025 – Bayer today announced positive topline results from the global Phase III study OCEANIC-STROKE, with its investigational, once daily, oral FXIa inhibitor asundexian. The study met its primary efficacy and safety endpoints. Asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). There was no increase in the risk of ISTH major bleeding in patients treated with asundexian compared to placebo, both in combination with antiplatelet therapy. Bayer will globally engage with health authorities in preparation for the submission of marketing authorization applications. Detailed results of OCEANIC-STROKE will be presented at an upcoming scientific congress.
 
The OCEANIC-STROKE study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) in combination with antiplatelet therapy. It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that has enrolled over 12,300 patients.
 
Asundexian, a direct inhibitor of FXIa, is theorized to reduce thrombus formation that can lead to vessel stenosis or blockage, without a significant increase in major bleeding. Asundexian is currently being evaluated as a potential treatment option in thrombosis prevention. Asundexian is a once-daily, oral investigational agent and has not been approved by any health authority for use in any country, for any indication. 

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Contact: Mrs. Kristina Pollok, Bayer AG, Investor Relations, phone: +49-214-30-72704, e-mail: kristina.pollok@bayer.com

FamiCord AG accelerates profitable growth in the third quarter of 2025 and further strengthens quality and visibility of revenues

• Group revenues increase by around 2.5 percent to EUR 22.8 million in Q3 2025 and by roughly 10 percent to around EUR 66.4 million in the first nine months
• EBITDA from continuing operations at EUR 3.8 million, on par with the previous year; 9M EBITDA reaches EUR 8.7 million with a margin of 13.1 percent
• Share of recurring revenues grows noticeably faster than prepaid contracts, further increasing visibility and stability of the long-term revenue base

Leipzig, 21 November 2025 – FamiCord AG, Europe’s leading cell bank and the third largest worldwide, accelerated its profitable growth path in the third quarter of 2025 and further strengthened the quality of its revenues. Despite an environment still characterized by economic uncertainty, subdued consumer sentiment and comparatively low birth rates in many European countries, the Company again increased its revenues with an attractive margin profile and further improved its profitability. 

In the third quarter of 2025, Group revenues rose to EUR 22.8 million, corresponding to growth of around 2.5 percent compared with the previous year’s period (Q3 2024: EUR 22.2 million). For the first nine months of 2025, revenues increased by 10.1 percent to around EUR 66.4 million (9M 2024: EUR 60.3 million). Gross profit developed very positively both in the quarter and in the year to date, supported by a favorable product mix with higher-value packages and price adjustments implemented in recent periods. At the same time, the Company continued to keep its costs under control. 

The net amount of invoiced services (B2C) continued to develop positively, rising by around 4.0 percent to EUR 57.4 million in the first nine months of 2025 (9M 2024: EUR 55.2 million). Within this, annually recurring payments grew even more dynamically by around 6.9 percent to EUR 17.3 million (9M 2024: EUR 16.2 million). This underlines the growing weight of subscription-based revenues in the Group’s business model.

EBITDA from continuing operations in the third quarter remained at the previous year’s level at EUR 3.8 million (Q3 2024: EUR 3.8 million). At 16.5 percent, the EBITDA margin was slightly below the previous year’s level (Q3 2024: 17.3 percent). In the first nine months of 2025, EBITDA rose significantly to EUR 8.7 million (9M 2024: EUR 7.4 million), with the corresponding margin rising to over 13.1 percent (9M 2024: 12.2 percent). The significant improvement in profitability is primarily based on the sustained improvement in sales performance, the optimization of contract structures, and strict cost discipline in administration, marketing, and sales. Net income from continuing operations developed very positively both in the quarter and over the course of the year.

A key element in the business development remains the structure of the Company’s contracts. The trend already visible in the first half of 2025 continued in the third quarter: recurring revenues from subscription contracts grew significantly more strongly than prepaid contracts and prolongations. Unlike a year ago, when growth was driven by prepaid contracts, the share of subscriptions has now increased markedly.  The higher share of subscription models further increases the stability and visibility of the Company’s long-term revenue base. 

“Over the past quarters we have deliberately shifted our contract mix towards subscription models,” explains Jakub Baran, CEO of FamiCord AG. “The fact that recurring revenues are now growing significantly faster than prepaid contracts materially increases the visibility and stability of our long-term revenue base and makes our business model structurally more robust.”

The key figures for business development are as follows:

IFRS, in EUR ´000	Q3	Q3	9M	9M	9M
	2025	2024	2025	2024	∆
Group revenue	22,789	22,232	66,365	60,261	10.1%
Gross profit	9,773	9,035	27,627	23,645	16.8%
EBITDA (cont. operations)	3,759	3,844	8,716	7,373	18.2%
EBITDA margin [%]	16.5%	17.3%	13.1%	12.2%	+0.9PP
EBIT	1,695	1,686	2,451	869	182.2%
Net profit (cont. operations)	1,225	1,311	1,755	-131	1907.3%
Earnings per share [in EUR]	0.07	0.09	0.10	-0.01	796.9%
Operating cash flow	—	—	3,427	7,789	-56.0%
Cash & cash equivalents (vs. 31.12.2024)	—	—	11,296	16,823	-32.9%

This contract mix also has an impact on the cash flow profile. Reflecting the shift in contract mix towards subscription models, operating cash flow remained clearly positive at EUR 3.4 million for the first nine months of 2025 (9M 2024: EUR 7.8 million). As expected, this was below the very strong prior-year figure, which was still dominated by a high share of prepaid contracts and additionally benefited from an income tax refund already mentioned in previous releases. The lower operating cash flow in the current year must therefore be seen primarily as a consequence of the shift towards recurring revenues, which in turn improves the predictability and resilience of future cash inflows. 

The balance sheet of FamiCord remains solid. Total assets increased compared with year-end 2024, mainly due to the further expansion of the contract portfolio and the resulting higher contract liabilities. As a consequence, the equity ratio is below the prior-year level, which is a mechanical effect of the balance sheet extension and the increase in deferred revenues. At the same time, however, the equity ratio improved again compared with the end of the second quarter of 2025, even though the Company continued to grow its business. Liquidity remains comfortable at around EUR 11.3 million, providing adequate financial flexibility. The full consolidation of the subsidiaries in Slovakia and the Czech Republic – following the increase in ownership stakes in the end of the first half of the year – is progressing according to plan and further strengthens FamiCord’s position in Eastern Europe. 

In line with the strategic decisions taken in the first half of 2025, FamiCord continues to focus stronger on its core business of family stem cell banking. Activities relating to CAR-T cell therapies are no longer prioritized at Group level and, as already communicated, are excluded from Group EBITDA and reported separately as discontinued operations. This clear focus allows the Company to concentrate management attention and financial resources on areas that offer the best combination of growth potential and earnings quality. In its CDMO activities, FamiCord observed a tangible pick-up in demand, signing three new agreements in the third quarter with a total volume of around EUR 1 million, which are expected to contribute mainly to 2026 revenues.

On the basis of the performance in the first nine months of 2025, the Management Board looks to the remaining months of the year with confidence. The combination of solid revenue growth with attractive gross margins, a strong improvement in EBITDA, a positive operating cash flow despite the shift towards recurring revenues and a stable financial position provides a robust foundation. Against this backdrop, the Management Board confirms its outlook for the full year 2025, which continues to assume revenues of between EUR 85 million and EUR 95 million with EBITDA of between EUR 8.7 million and EUR 10.3 million.

The Management Board of FamiCord AG will be available to institutional investors, analysts and members of the press today at 10:00 a.m. CEST in a video conference to provide additional information on business development. To register for the video conference, please send an email to the Investor Relations department (ir@famicord.com).

Further information on FamiCord and its affiliated subsidiaries can be found at www.famicord.com.

Contact: 
FamiCord AG
Ingo Middelmenne
Head of Investor Relations
Phone: +49 (0174) 9091190
Email: ingo.middelmenne@famicord.com

Company profile

FamiCord (formerly Vita 34) was founded in Leipzig in 1997 and today is by far the leading cell bank in Europe and the third largest worldwide. As the first private umbilical cord blood bank in Europe and a pioneer in cell banking, the company has since offered the collection, logistics, processing and storage of stem cells from umbilical cord blood, umbilical cord tissue and other postnatal tissues as a full-service provider for cryopreservation. The donor’s own cells are either applicable directly as a medicine or constitute as a valuable starting material for medical cell therapy and are kept alive in the vapor of liquid nitrogen. Customers from about 50 countries have already provided for the health of their families with far over one million units of stored biological material at FamiCord. Furthermore, the Company is active in the area of Cell and Gene CDMO.