Press release
 

Medios AG reports record quarter Q3 2024 with significant increase in earnings and margins

• EBITDA pre¹ reaches €24.6 million (+42.9%) in the third quarter of 2024, setting a new record
• EBITDA pre¹ margin of 5.0% in the third quarter of 2024
• Patient-Specific Therapies segment grows by more than 10% in EBITDA pre¹ compared to the same quarter of the previous year
• Revenue in the nine-month period of 2024 up 4.2%, EBITDA pre¹ up 20.6%
• Cash flow from operating activities significantly improved since the beginning of the year to €27.6 million
• Integration of Ceban on track
• Outlook for 2024 confirmed

Berlin, 12 November 2024 – Medios AG (“Medios”), a leading provider of Specialty Pharma in Europe, recorded a sustained successful business development in the first nine months of 2024. Revenue in the nine-month period increased by 4.2% to €1,400.5 million (previous year: €1,343.5 million). EBITDA pre¹ improved disproportionately by 20.6% to €55.8 million (previous year: €46.3 million). This corresponds to an EBITDA pre¹ margin of 4.0% (previous year: 3.4%). In addition, Medios recorded a significant increase in cash flow from operating activities to €27.6 million.

In the third quarter of 2024, the Group’s revenue increased by 0.7% compared to the previous year to €493.2 million (previous year: €489.9 million, analyst consensus: €523.9 million). In the same period, EBITDA pre¹ rose sharply by 42.9% to €24.6 million (previous year: €17.2 million, analyst consensus: €24.7 million). The EBITDA pre¹ margin was 5.0% (previous year: 3.5%). Medios thus achieved the best quarterly result in its history. This positive development is due in particular to the inclusion of the International Business segment since the beginning of June.

Matthias Gaertner, CEO of Medios AG: “In the third quarter of 2024, we performed exceptionally well, with a particularly strong improvement in the profit margin. On a quarterly basis, our group’s EBITDA pre¹ margin is 5%, which is already at the level we are aiming for in 2025. In the Patient-Specific Therapies segment, we achieved the turnaround and increased earnings by more than 10% compared to the same quarter of the previous year despite all the challenges. I am also particularly pleased with the positive contributions from our new International Business segment with Ceban Pharmaceuticals. This successful development reflects the consistent implementation of our expanded growth strategy.”

Operating segments report different developments

The Pharmaceutical Supply segment increased its revenue by 2.0% to €1,191.2 million (previous year: €1,168.0 million) in the first nine months of 2024. The segment’s EBITDA pre¹ rose by 9.9% to €37.0 million (previous year: €33.7 million). In the third quarter of 2024, the division’s revenues fell by 7.1 %. EBITDA pre¹ rose by 2.7 % year on year due to higher-margin revenues.

In the Patient-Specific Therapies segment, revenue in the third quarter of 2024 fell by 3.5%. EBITDA pre¹ increased by 10.3%, having declined in the previous quarters. In the first nine months of 2024, revenue was €161.6 million (previous year: €175.0 million) and thus 7.7% below the figure for the previous year, with €6.0 million of the decline attributable to the sale of Kölsche Blister GmbH in June 2023. In the first half of 2024 in particular, regulatory price adjustments and higher performance-related expenses for the assumption of compounding volumes were added. As a result, the segment’s EBITDA pre¹ declined by 6.1% to €16.7 million (previous year: €17.8 million) in the period from January to September 2024 despite the increase in earnings in the third quarter.

The new International Business segment, which includes Ceban Pharmaceuticals B.V. (“Ceban”), fully consolidated since June 2024, generated revenue of €47.3 million in the first nine months of 2024 and contributed €9.8 million to the Group’s EBITDA pre¹. The new segment thus achieved an EBITDA pre¹ margin of 20.7%. The integration of Ceban into the Medios Group continues to go according to plan.

In August 2024, Medios announced that it would expand its activities in the area of Advanced Therapies and, in doing so, appoint Dr Andreas Schmiede as Vice President Advanced Therapies. Entering the Advanced Therapies market is the next phase of the expanded growth strategy presented in November 2022.

Positive outlook

Medios confirms its forecast for the 2024 financial year. Accordingly, the Company expects revenues of between €1.9 billion and €2.1 billion and EBITDA pre¹ of between €82 million and €91 million. The EBITDA pre¹ outlook is burdened by the one-month delay in the Ceban control transition as of June 1, 2024 and regulatory price adjustments in Germany; EBITDA pre¹ growth will thus be at least 35% (YoY) with a significantly increased EBITDA pre¹ margin of approx. 4.3%.

Key figures (IFRS)

The Medios Quarterly Statement as of September 30, 2024 will be available for download on the Investor Relations website.

Important dates for Medios AG in the 2024 financial year:

——————-

About Medios AG

Medios is a leading provider of Specialty Pharma in Europe. With locations in Germany, the Netherlands, Belgium and Spain, the company supports key partners in the supply chain with innovative solutions and intelligent services. Medios has focused on pioneering individualized medicine to make the most innovative therapies available to everyone together with pharmacies, specialist practices and pharmaceutical companies.

Medios AG is Germany’s first listed specialty pharmaceutical company. The shares are listed on the regulated market of the Frankfurt Stock Exchange (Prime Standard) and are included in the SDAX selection index.

www.medios.ag

Contact

Claudia Nickolaus

Head of Investor & Public Relations, ESG Communications

Medios AG

Heidestraße 9 | 10557 Berlin

T +49 30 232 566 800

ir@medios.group

www.medios.group

Disclaimer

This communication contains forward-looking statements that are subject to certain risks and uncertainties. Future results could differ materially from those currently anticipated as a result of various risk factors and uncertainties, including, but not limited to, changes in business, economic and competitive conditions, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings and the availability of financing. Medios AG assumes no responsibility to update any forward-looking statements contained in this release.

Marinomed Biotech AG publishes clinical data for decongestant Carragelose nasal spray in peer-reviewed International Journal of General Medicine

• Marinomed’s nasal spray containing Carragelose and Sorbitol significantly improves breathing due to its decongestant effect in patients suffering from allergic rhinitis
• Results of the clinical study showing that the nasal spray is effective and safe were published in the peer-reviewed International Journal of General Medicine
• Data support the application of Carragelose in allergic indications

Korneuburg, Austria, 12. November 2024 – Marinomed Biotech AG (VSE:MARI) has published the results of a clinical trial with a nasal spray combining the protective effect of Carragelose and the decongestant effect of Sorbitol in the peer-reviewed International Journal of General Medicine. In the clinical trial, patients with allergic rhinitis symptoms including nasal congestion were treated with the Carragelose-Sorbitol nasal spray. The product significantly improved breathing compared to placebo based on the decongestant effect of Sorbitol. These results support the application of the product as a treatment to reduce a blocked nose. Whether this is caused by an allergy or a cold is irrelevant. In contrast to the widely used pharmacologic decongestant nasal sprays, the product does not cause a habituation effect.

“The results show that allergic patients have a significant improvement in breathing already after the first use. Furthermore, the product is also suitable for children from one year of age”, Eva Prieschl-Grassauer, CSO of Marinomed, comments. “The clinical data also support the transition of Marinomed’s Carragelose products to the new Medical Device Regulation (MDR) and benefit our partnering activities.”

In the randomized, double-blind, cross-over trial, adults (18 to 65 years) with a history of grass pollen allergy were exposed to the grass pollen allergens in a challenge chamber. Participants developed rhinitis symptoms including nasal congestion. After developing pronounced allergic nasal symptoms, they were treated either with the Carragelose- and Sorbitol-containing nasal spray or placebo. The study participants were then further exposed to the grass pollen and the nasal airflow was measured. A significant improvement in nasal airflow was observed with the Carragelose- and Sorbitol-containing nasal spray compared to the placebo. The Carragelose-Sorbitol nasal spray has been launched in 2018 and is currently distributed in 11 countries.

About Carragelose®

Carragelose® is a sulfated polymer from red seaweed and a unique, broadly active virus- and allergen-blocking compound. It is known as a gentle, effective, and safe prevention and treatment of various viral respiratory infections. Several clinical and preclinical studies have shown that Carragelose® forms a protective layer on the mucosa that prevents viruses from infecting cells. Laboratory and clinical data have demonstrated that Carragelose® can also inhibit the spreading of SARS-CoV-2.^[1],[2] Marinomed is the holder of the IP rights and has licensed Carragelose® for marketing in Europe, North America, Australia, and parts of Asia and Latin America. Marinomed’s portfolio of Carragelose®-containing nasal sprays and oral products can be accessed at https://www.carragelose.com/en/portfolio/launched-products, scientific publications on Carragelose® at https://www.carragelose.com/en/publications.

About Marinomed Biotech AG

Marinomed Biotech AG is an Austrian, science-based biotech company with a growing development pipeline and globally marketed therapeutics. The Company develops innovative patent-protected products in the therapeutic areas immunology and virology based on the platform Marinosolv® and the virus-blocking activity of Carragelose®. The Marinosolv® technology improves the solubility and bioavailability of hardly soluble compounds and is used to develop new therapeutics for autoreactive immune disorders. The virology segment includes Carragelose®-based over-the-counter (OTC) products to prevent and treat respiratory viral infections that are partnered in more than 40 countries. The Company is headquartered in Korneuburg, Austria, and is listed on the Vienna Stock Exchange (VSE:MARI). For further information, please visit: https://www.marinomed.com.

For further inquiries contact:

Disclaimer

This press release contains forward-looking statements, which are based on current views, expectations and projections of the management of Marinomed Biotech AG about future events. These forward-looking statements are subject to risks, uncertainties and assumptions that could cause actual results, performance or events to differ materially from those described in, or expressed or implied by, such statements. The current views, expectations and projections of the management of Marinomed Biotech AG may be identified by the context of such statements or words such as “anticipate,” “believe”, “estimate”, “expect”, “intend”, “plan”, “project” and “target”. Forward-looking statements are only valid as of the date they are made and Marinomed Biotech AG does not assume any obligation to update, review or revise any forward-looking statements contained in this press release whether as a result of new information, future developments or otherwise. Marinomed, Marinosolv® and Carragelose® are registered trademarks of Marinomed Biotech AG. These trademarks may be owned or licensed in select locations only.

^[1]  https://www.dovepress.com/efficacy-of-a-nasal-spray-containing-iota-carrageenan-in-the-postexpos-peer-reviewed-fulltext-article-IJGM

^[2]  https://www.marinomed.com/en/news/marinomed-biotech-ag-shares-positive-clinical-trial-results-for-iota-carrageenan-nasal-spray-in-the-prevention-of-covid-19-1

Ad hoc announcement pursuant to Art. 53 LR

Fribourg, 12 November 2024

AEVIS VICTORIA SA (AEVS.SW) – Continued organic growth in the third quarter of 2024

AEVIS VICTORIA SA (AEVIS) achieved total revenues of CHF 761.0 million as at 30 September 2024, an increase of 7.1% compared to CHF 710.2 million in 2023. On a comparable basis, organic revenue growth was 6.0%, reflecting solid performance in the healthcare, hospitality and real estate segments.

Swiss Medical Network SA, the group’s healthcare segment, generated total revenues of CHF 594.9 million as at 30 September 2024, an increase of 5.1% over the prior year. This includes organic growth of 3.7%, supported by sustained demand for specialized healthcare services.

MRH Switzerland AG (formerly Victoria Jungfrau AG), the group’s hospitality division, achieved total revenues of CHF 151.6 million, an increase of 12.4% compared to the first nine months of 2023. Organic growth was 11.7%, driven by key destinations such as Interlaken and Zermatt.

The real estate segment also posted strong growth with total revenues of CHF 24.0 million, a 24.8% increase from 2023. This segment continues to benefit from the appreciation of the group’s strategic real estate assets.

For further information:
AEVIS VICTORIA SA Media and Investor Relations: c/o Dynamics Group, Zurich
Philippe R. Blangey, prb@dynamicsgroup.ch, +41 (0) 43 268 32 35 or +41 (0) 79 785 46 32
Séverine Van der Schueren, svanderschueren@aevis.com, +41 (0) 79 635 04 10

AEVIS VICTORIA SA – Investing for a better life
AEVIS VICTORIA SA invests in healthcare, hospitality & lifestyle and infrastructure. AEVIS′s main shareholdings are Swiss Medical Network Holding SA (80%, directly and indirectly), the only Swiss private network of hospitals present in the country’s three main language regions, MRH Switzerland AG, a luxury hotel group managing eleven luxury hotels in Switzerland and abroad, Infracore SA (30%, directly and indirectly), a real estate company dedicated to healthcare-related infrastructure, Swiss Hotel Properties SA, a hospitality real estate division, and NESCENS SA, a brand dedicated to better aging. AEVIS is listed on the Swiss Reporting Standard of the SIX Swiss Exchange (AEVS.SW). www.aevis.com.

Press Release // November 11, 2024

Formycon extends Management Board contract for CEO Dr. Stefan Glombitza until 2027 and receives admission to trading in the Prime Standard 

• Dr. Stefan Glombitza has been appointed as CEO for three more years and will lead Formycon through the next phase of the company’s development
• Formycon shares will be admitted to the Prime Standard of the Frankfurt Stock Exchange – trading on the regulated market will start on November 12, 2024

Planegg-Martinsried, Germany – The Supervisory Board of Formycon AG (FSE: FYB; “Formycon” or “The Company”) has extended the contract of CEO Dr. Stefan Glombitza until December 31, 2027. The Board thus acknowledges Dr. Glombitza’s outstanding work as Chief Executive Officer (CEO) in recent years and is committed to the continued success of the company’s management. In addition, the shares of Formycon AG were admitted to the Prime Standard of the Frankfurt Stock Exchange today. Trading is scheduled to start on November 12, 2024.

Dr. Stefan Glombitza has been with Formycon AG since 2016 and during this time, has played a key role in the development and growth of the company. Initially responsible for operational development activities as Chief Operating Officer (COO), he was appointed as Chief Executive Officer (CEO) in July 2022. With over 25 years of experience in the international pharmaceutical industry, at Formycon he has built an excellent development platform leading a dedicated team, which has already resulted in approvals for three biosimilars. With the first product launches, he successfully guided Formycon into the commercial stage and has paved the way for further product launches.

“Dr. Glombitza has decisively shaped the strategic and operational development of Formycon in recent years and has significantly strengthened the company’s position in the biosimilar market,” explains Wolfgang Essler, Chairman of the Supervisory Board of Formycon AG. ”Thanks to his leadership, important milestones have been reached and the company has been set on a course for success.. With Dr. Glombitza at the helm, Formycon will further expand its role as one of the leading developers of biosimilars in the international market.”

“I am very pleased to be able to actively drive the growth phase that lies ahead of us, with the goal of fully realizing the tremendous potential of our company in the coming years. With three market-ready biosimilars and a strong pipeline, we have created a solid foundation for our continued growth. Today’s uplisting to the Prime Standard of the Frankfurt Stock Exchange increases our appeal to international investors and improves the tradability of our shares. I would like to thank the supervisory board and the entire Formycon team for their trust, cooperation and commitment, which are the cornerstones of our success,” said Dr. Stefan Glombitza.

As part of the uplisting, the shares of Formycon AG were admitted for trading in the Prime Standard of the Frankfurt Stock Exchange today. The Prime Standard is the segment with the highest transparency requirements in the regulated market and offers Formycon access to a broader group of investors. Inclusion in this segment isintended  to increased international awareness and higher liquidity of the stock. Trading in the Prime Standard is scheduled to start tomorrow, on November 12, 2024.

The company’s securities prospectus required for uplisting can be found at www.formycon.com/en/investor-relations/uplisting.

Further information can be found on our website at: www.formycon.com/en/investor-relations  

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, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another three biosimilar 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 and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.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 & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +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.

Relief Therapeutics Announces Positive Final Results of RLF-TD011 Clinical Trial in Epidermolysis Bullosa

GENEVA (NOV. 11, 2024) – 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, today announced positive final results from its proof-of-concept, investigator-initiated clinical trial evaluating RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic condition characterized by fragile skin and chronic wounds.

The clinical trial evaluated the effects of RLF-TD011 on microbiome diversity in chronic and acute wounds in EB patients, focusing primarily on the most severe forms of the disease (junctional and dystrophic EB). Effective wound healing is crucial for these patients, as their wounds are vulnerable to colonization or infection by pathogenic microorganisms, which can significantly reduce healing rates, increase the risk of sepsis, and lead to other severe complications. In particular, Staphylococcus aureus frequently colonizes EB wounds, where it contributes to chronic inflammation and disrupts the skin microbiome.

The trial successfully met its primary endpoint. After eight weeks of treatment, RLF-TD011 led to a 24% decrease in S. aureus relative abundance (p=0.01), which correlated strongly (rho=0.64) with wound size reduction. Overall, 78% of treated wounds closed during the treatment period.

Microbiome analysis further showed that RLF-TD011 treatment led to a marked increase in alpha diversity, with an increase in beneficial bacteria within the wound microbiome, effectively reducing S. aureus without disrupting beneficial bacteria. Improvements in microbiome diversity persisted through a four-week post-treatment observation period, evidencing RLF-TD011’s durability effect on the wound environment without signs of regression or exacerbation.

“Epidermolysis bullosa is a devastating blistering skin disease that greatly impairs quality of life, particularly from the pain, itch, and risk of infection associated with open wounds. Evidence of reduction in the load of S. aureus and associated improved wound closure highlights the value of use of an antimicrobial spray during wound care,” said Prof. Amy Paller, Principal Investigator of the study and Chair of Dermatology at Northwestern University in Chicago, U.S.

“These findings support the potential of RLF-TD011 to meaningfully advance wound care for patients with epidermolysis bullosa,” commented Giorgio Reiner, chief scientific officer of Relief. “The data demonstrates RLF-TD011’s antimicrobial efficacy, which is critical for infection management in chronic EB wounds, as well as its role in promoting wound healing. This is an important milestone in the development of RLF-TD011 toward regulatory approval. With this data in hand, we plan to consult with the U.S. Food and Drug Administration to finalize our development and regulatory plan.”

Additional information about this investigator-initiated trial is available at ClinicalTrials.gov (NCT05533866).

ABOUT RLF-TD011
RLF-TD011 is a highly pure, stabilized hypochlorous acid solution developed using Relief’s proprietary TEHCLO™ technology. With strong antimicrobial properties, RLF-TD011 is a sprayable, self-administered solution for targeted wound application while avoiding skin contact and cross-contamination. RLF-TD011 has shown efficacy in accelerating wound closure and reducing infections in certain clinical trials on non-EB wounds. In preliminary cases, EB patients using RLF-TD011 showed improvements in blistering and tissue repair. RLF-TD011 aims to address an unmet need in EB care by efficiently controlling infection and inflammation while reducing antibiotic use and easing the intensive, time-consuming wound care routine required by current treatments. The U.S. Food and Drug Administration granted it orphan drug designation for EB, and Relief plans to seek qualified infectious disease product (QIDP) designation for extended market exclusivity.

ABOUT EPIDERMOLYSIS BULLOSA
Epidermolysis bullosa (EB) is a group of rare, inherited connective tissue disorders characterized by extreme skin fragility, leading to blistering and wounds from minor friction or injury. In severe cases, blisters can develop into chronic wounds or form in internal organs such as the mouth or esophagus, leading to painful wounds, recurrent infections, and a deeply impacted quality of life. EB is classified into several major inherited subtypes, each defined by the depth of blister formation within the skin’s layers: epidermolysis bullosa simplex (EBS), dystrophic epidermolysis bullosa (DEB), junctional epidermolysis bullosa (JEB) and Kindler syndrome (KS). Treatment is intensive and includes wound care, infection prevention, and pain management. Approximately 500,000 individuals worldwide are affected by EB.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. 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

DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief’s filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief’s filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.

SEBASTIAN BRAUN WINS EY ENTREPRENEUR OF THE YEAR

Greifswald, 08. November 2024

• Sebastian Braun wins prestigious entrepreneur award in the ‘family business’ category
• First award winner from the eastern German states since 2014
• The EY Entrepreneur of the Year Award is presented in 60 countries

Sebastian Braun, Chairman of the Supervisory Board, main owner together with his sister Dr Bianca Juha and former CEO of the CHEPLAPHARM Group for many years, is EY Entrepreneur of the Year. He was honoured yesterday evening at a gala ceremony at Motorwerk Berlin in the ‘family business’ category. The EY Entrepreneur of the Year is awarded annually in 60 countries and is considered one of the most prestigious business awards worldwide.

Over the past 20 years, Sebastian Braun has transformed CHEPLAPHARM from a small company with an annual turnover of 600,000 euros into a global market leader in the acquisition of established off-patent branded medicines with an annual turnover of 1.5 billion euros (FY/2023). The group has a global network of 125 contract manufacturers and 100 distribution partners, ensuring a continuous supply of reliable medicines to patients and maintaining global drug diversity. Today, CHEPLAPHARM employs around 750 people at locations in Germany, France, Japan, Russia and Switzerland.

For Sebastian Braun, good entrepreneurship is one thing above all: ‘Success is no coincidence – it’s always a combination of preparation and opportunity. If you want to be successful, you have to constantly educate yourself in your business field, know your stuff – and then act boldly when opportunities arise.’ A maxim that probably also convinced the jury of experts, who selected the winners based on four key criteria: ‘Entrepreneurship’, which represents entrepreneurial thinking and action, ‘Purpose’, which reflects the company’s purpose and vision, ‘Growth’, which stands for growth and future potential, and ‘Impact’, which includes impact and corporate responsibility.

‘Winning this prestigious business award fills me with great pride and I accept it on behalf of my fantastic team. It is the result and at the same time proof of the work we have done together in recent years and a success story that would not have been possible without the CHEPLAPHARM workforce,’ says Sebastian Braun, delighted with the award. ‘As the first award winner from Eastern Germany in ten years, I am particularly pleased to have brought the prize home – for our employees, for our company and for the state of Mecklenburg-Vorpommern.’

Sebastian Braun represents Germany at the EY World Entrepreneur Of The Year 2025

It took ten years before Sebastian Braun to be honoured again as an entrepreneur from eastern Germany (excluding Berlin). In 2014, NOMOS Glashütte/SA Roland Schwertner KG was the last winner from eastern Germany. But that’s not all: This year, Sebastian Braun will receive another honour: he will represent Germany at the EY World Entrepreneur Of The Year in Monaco in 2025.

About the ‘EY Entrepreneur Of The Year’ competition

In addition to Sebastian Braun in the ‘family business’ category, three other entrepreneurial personalities were honoured this year in the categories sustainability, innovation and young company. There were five finalists to choose from in each category. The ‘Entrepreneur Of The Year’ programme was launched by EY in the USA in 1986. Since then, the competition has established itself in around 60 countries and is one of the world’s most prestigious entrepreneur awards. The competition is being organised in Germany for the 28th time this year and is supported by well-known companies and media. These include LGT, the Frankfurter Allgemeine Zeitung and manager magazin. In addition to honouring successful business personalities, EY also promotes the next generation of entrepreneurs with its ‘EY NextGen Academy’ programme. For further information, please visit the following website: http://www.de.ey.com/eoy

About CHEPLAPHARM

CHEPLAPHARM is a family-owned company with headquarters in Greifswald. For over 20 years, the company has been very successful in taking over well-known and well-established medicines from the research-based pharmaceutical industry and transferring them to an existing global network of partners for production and distribution. In this way, CHEPLAPHARM ensures the continuous supply of these medicines to patients worldwide. In addition to its headquarters in Greifswald, CHEPLAPHARM operates further sites in France, Japan, Russia and Switzerland. The company employs around 750 people worldwide.

Please refer to www.cheplapharm.com for additional information.

Press office:

CHEPLAPHARM ǀ Ziegelhof 24 ǀ 17489 Greifswald ǀ press(at)cheplapharm.com

Immunic, Inc. Reports Third Quarter 2024 Financial Results
and Provides Corporate Update

– Positive Interim Analysis of Phase 3 ENSURE Program, Unblinded Independent Data Monitoring Committee Confirmed that Predetermined Futility Criteria Have Not Been Met and Recommended Trials Should Continue as Planned – 

– Ongoing, Twin Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis and Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Remain on Track – 

– Top-Line Data from Phase 2 CALLIPER Trial Expected in April 2025 – 

– Webcast to be Held Today, November 7, at 8:00 am ET –

NEW YORK, November 7, 2024 – 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 financial results for the third quarter and nine months ended September 30, 2024, and provided a corporate update.

“During the third quarter, we have continued to advance both our phase 2 CALLIPER trial in patients with progressive multiple sclerosis (PMS) and our twin phase 3 ENSURE trials in relapsing multiple sclerosis (RMS), for our potentially transformative, orally available lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838),” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “As recently reported, we are progressing, as planned, with our phase 3 ENSURE program in RMS, after an interim, non-binding futility analysis, conducted by an unblinded Independent Data Monitoring Committee (IDMC), recommended that the trials are not futile and should continue as planned, without any sample size increase, marking a key milestone for the program. We continue to expect to complete the ENSURE-1 trial in the second quarter of 2026 and the ENSURE-2 trial in the second half of 2026. Our next important clinical readout for this program is the CALLIPER top-line data in PMS, which we expect to release in April of next year. As previously reported, the CALLIPER interim data supported the potential effectiveness of vidofludimus calcium in slowing disease progression in PMS and further substantiated its neuroprotective capabilities through the activation of Nurr1. Should the top-line data continue to demonstrate this neuroprotective effect, and the phase 2 trial meets its primary and key secondary endpoints, we may be able to position vidofludimus calcium as the first oral treatment option for non-relapsing secondary progressive MS (SPMS).”

“In September, we had the opportunity to present four posters at the prestigious 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), showcasing data on key aspects of vidofludimus calcium’s profile. This included the neurofilament light chain (NfL) interim data from our phase 2 CALLIPER trial, which showed a clear separation from placebo in NfL levels across the PMS patient population, including non-relapsing SPMS, a subtype with the highest unmet medical need. We also presented antiviral data suggesting an effect on reducing fatigue, Nurr1 target data supporting the neuroprotective potential, and pathogenic T cell data further supporting the drug’s anti-inflammatory effects. The presentations at ECTRIMS followed closely on the heels of our MS R&D Day, which featured two world renowned industry experts alongside Immunic’s management team to discuss vidofludimus calcium’s unique profile, including its safety and tolerability, and its potential to significantly elevate today’s standard of care. We continue to believe that, if approved, vidofludimus calcium, with its combined neuroprotective, anti-inflammatory and anti-viral effects, would represent a unique new treatment option targeted to the complex pathophysiology of MS.”

Dr. Vitt continued, “During the quarter, we continued phase 2 clinical preparations for IMU-856, our orally available, systemically acting small molecule modulator targeting Sirtuin 6 (SIRT6), a protein which serves as a transcriptional regulator of intestinal barrier function and physiological regeneration of bowel epithelium, including exploring potential financing, licensing or partnering opportunities to fund this clinical program. As we have noted previously, based on initial clinical proof-of-concept data, we believe that IMU-856 could be an entirely new therapeutic approach to treating gastrointestinal disorders by restoring a healthy gut through renewal of the bowel wall. Data from our phase 1b clinical trial showed that, in patients with celiac disease during periods of gluten-free diet and gluten challenge, IMU-856 demonstrated positive effects over placebo in four key dimensions of celiac disease pathophysiology: protection of the gut architecture, improvement of patients’ symptoms, biomarker response, and enhancement of nutrient absorption. Based on this encouraging data, we are considering additional possible clinical applications in other gastrointestinal disorders.”

Third Quarter 2024 and Subsequent Highlights

• October 2024: Announced a positive outcome of the non-binding, interim futility analysis of the phase 3 ENSURE program of vidofludimus calcium for the treatment of RMS. An unblinded IDMC confirmed that the trials are not futile and recommended that they should continue without changes, including no need for a potential upsizing of the sample size.
• September 2024: Presented key data at the 40^th Congress of ECTRIMS, highlighting vidofludimus calcium’s therapeutic potential in MS, in one oral poster presentation and three ePosters.
• September 2024: Enrolled the first patient in an investigator-sponsored phase 2 clinical trial of vidofludimus calcium, entitled, “Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID_REVIVE).”
• September 2024: Hosted an MS R&D Day in New York, during which management was joined by two renowned experts in the field, Francesca Montarolo, Ph.D., Neuroscience Institute Cavalieri Ottolenghi (NICO) and University of Turin, Italy, and Amit Bar-Or, M.D., FRCPC, Perelman School of Medicine, University of Pennsylvania. The event focused on today’s MS landscape and on vidofludimus calcium’s potential to become the treatment of choice for both relapsing and progressive MS patients.
• July 2024: Announced the appointment of Simona Skerjanec, M.Pharm, MBA, a thought leader in brain health with decades of experience in drug development and commercialization, to the Board of Directors.
• July 2024: Announced the appointment of Jason Tardio, MBA, as Chief Operating Officer and President, to lead internal efforts in positioning the company for the potential launch of vidofludimus calcium and to work closely with Patrick Walsh, Chief Business Officer, to prepare for a range of potential partnership outcomes for vidofludimus calcium and Immunic’s other drug candidates. Additionally, reported that Werner Gladdines, former Vice President, Program Management & Clinical Development Operations, was promoted to Chief Development Officer. 

Anticipated Clinical Milestones

• Vidofludimus calcium in MS:
  • Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April 2025.
  • Completion of ENSURE-1 is anticipated in the second quarter of 2026, with completion of ENSURE-2 expected in the second half of 2026.
• IMU-856 in celiac disease: Based on the positive data from the phase 1b clinical trial, the company is preparing for clinical phase 2 testing of IMU-856, contingent on financing, licensing or partnering. 

Financial and Operating Results 

• Research and Development (R&D) Expenses were $21.4 million for the three months ended September 30, 2024, as compared to $19.8 million for the three months ended September 30, 2023. The $1.6 million increase reflects (i) a $1.4 million increase in external development costs related to the vidofludimus calcium program, (ii) a $0.3 million increase in external development costs related to IMU-856, (iii) a $0.3 million increase in personnel costs due to an increase in headcount and (iv) a $0.3 million increase related costs across numerous categories. The increases were offset by a decrease of $0.7 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer.

For the nine months ended September 30, 2024, R&D expenses were $58.4 million, as compared to $63.9 million for the nine months ended September 30, 2023. The $5.5 million decrease reflects (i) a decrease of $4.1 million from deprioritizing the izumerogant program in psoriasis and castration-resistant prostate cancer, (ii) a $2.6 million decrease in external development costs related to IMU-856 due to the completion of the phase 1 clinical trial in celiac disease and (iii) a $0.5 million decrease related costs across numerous categories. The decreases were offset by (i) a $1.2 million increase in personnel costs, $0.2 million of which is related to non-cash stock compensation and the remainder of which is due to an increase in headcount and (ii) a $0.5 million increase in external development costs related to the vidofludimus calcium program.

• General and Administrative (G&A) Expenses were $4.4 million for the three months ended September 30, 2024, as compared to $3.8 million for the same period ended September 30, 2023. The $0.6 million increase was primarily due to a $0.6 million increase in personnel expense in G&A, $0.2 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount.

For the nine months ended September 30, 2024, G&A expenses were $14.0 million, as compared to $11.9 million for the same period ended September 30, 2023. The $2.1 million increase was primarily due to (i) a $1.7 million increase in personnel expense in G&A, $0.9 million of which is related to non-cash stock compensation expense and the remainder of which is related to an increase in headcount, (ii) $0.3 million in legal and consultancy expenses and (iii) a $0.1 million increase related to costs across numerous categories. 

• Interest Income remained unchanged at $0.8 million during the three months ended September 30, 2024, as compared to the three months ended September 30, 2023. 

Interest income for the nine months ended September 30, 2024 was $2.9 million, as compared to $2.5 million for the nine months ended September 30, 2023. The $0.4 million increase was due to higher interest rates.

• The Change in Fair Value of the Tranche Rights of $4.8 million for the nine months ended September 30, 2024 was a non-cash charge related to the January 2024 Financing from January 8, 2024 until March 4, 2024. These tranches were initially classified as a liability, but were reclassified to equity on March 4, 2024, when stockholders approved the increase in authorized shares from 130 million to 500 million shares of common stock and therefore the tranche 2 and tranche 3 rights needed to be revalued to fair value upon the reclass to equity.
• Other Income (Expense) was $0.6 million for the three months ended September 30, 2024, as compared to $35 thousand for the same period ended September 30, 2023. The $0.5 million increase was primarily attributable to a $0.6 million increase in R&D tax incentives for clinical trials in Australia.

For the nine months ended September 30, 2024, other income (expense) was ($1.1 million), as compared to $1.3 million for the same period ending September 30, 2023. The $2.4 million decrease was primarily attributable to (i) a $1.7 million expense related to the portion of deal costs from the January 2024 Financing related to the tranche rights that were established at the time of the deal closing, (ii) the German Federal Ministry of Finance grant of $1.1 million being recognized in the fourth quarter of 2023 and (iii) a $0.4 million decrease in other grants which were received in 2023. The decrease was offset by a $0.9 million increase in foreign exchange gains.

• Net Loss for the three months ended September 30, 2024, was approximately $24.4 million, or $0.24 per basic and diluted share, based on 101,272,580 weighted average common shares outstanding, compared to a net loss of approximately $22.8 million, or $0.51 per basic and diluted share, based on 44,574,377 weighted average common shares outstanding for the same period ended September 30, 2023.

Net loss for the nine months ended September 30, 2024, was approximately $75.3 million, or $0.75 per basic and diluted share, based on 99,998,245 weighted average common shares outstanding, compared to a net loss of approximately $72.0 million or $1.63 per basic and diluted share, based on 44,227,264 weighted average common shares outstanding for the same period ended September 30, 2023.

• Cash and Cash Equivalents as of September 30, 2024 were $59.1 million. With these funds, Immunic expects to be able to fund its operations into the third quarter of 2025.

Webcast Information

Immunic will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_v2_K1Ze-QKS34X6c9W9ywg or on the “Events and Presentations” section of Immunic’s website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial-in access.

An archived replay of the webcast will be available approximately one hour after completion on Immunic’s website at: 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 and phase 2 clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis and moderate-to-severe ulcerative colitis. 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, for which it is currently in preparations for a phase 2 clinical trial. 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, new management hires and promotions, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic’s development programs and the targeted diseases; the potential for Immunic’s development programs to safely and effectively target diseases; preclinical and clinical data for Immunic’s development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure of the company; and the company’s expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, 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, including the ability to satisfy the minimum average price and trading volume conditions required to receive funding in tranche 2 and 3 of the January 2024 private placement, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, 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, 2023, filed with the SEC on February 22, 2024, and in the company’s subsequent filings with the Securities and Exchange Commission. 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 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

CureVac to Report Third Quarter and First Nine Months 2024 Financial Results
and Business Update on November 12, 2024
 

TÜBINGEN, Germany/BOSTON, USA – November 7, 2024 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), will report financial results, and provide business updates for the third quarter and first nine months 2024 on Tuesday, November 12, 2024. The company will host a conference call and webcast on the same day at
3 p.m. CET / 9 a.m. EST.

Dial-in numbers to participate in the conference call:

U.S. Toll-Free: +1-877-407-0989

International: +1-201-389-0921

Germany: 0800-182-0040 (landline access) / 0800-184-4713 (cell phone access)

The live webcast link can be accessed via the newsroom section of the CureVac website at https://www.curevac.com/en/newsroom/events/

Corresponding presentation slides will be posted shortly before the start of the webcast. A replay will be made available at this website after the event.

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 cancer vaccine product candidates. 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

Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@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 discussion of the potential efficacy of the company’s vaccine and treatment candidates and the company’s strategies, financing plans, cash runway expectations, 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 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, 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, 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, different judicial outcomes or other factors. 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 U.S. Securities and Exchange Commission (the “SEC”). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.