BioVersys BV100 Phase 2B to be conducted via Wellcome Funded Trial Network

 

Trial to be conducted by ADVANCE-ID, a national university of singapore led trial network, in partnership with BioVersys

 

Basel, Switzerland, November 10, 2025, 7am CET

 

  • Panel of independent experts selected BioVersys’ BV100 out of 24 candidates to participate in the ADVANCE-ID and National University of Singapore (NUS) Asia clinical trial network of 130 sites across 35 countries
  • Wellcome funds ADVANCE-ID/NUS with SGD 22 million (c. CHF 14 million) to conduct their first Sponsor (BioVersys) driven Phase 2 trial
  • Non-dilutive funding received for the trial strengthens BioVersys’ cash position and extends the company’s cash runway further into 2028
  • This partnership allows the BV100 Phase 2b open-label study to increase patient size to 90 patients with an interim data read-out expected in H2 2026

 

BioVersys AG (SIX: BIOV), a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multidrug-resistant (MDR) bacteria, announced today that its lead asset BV100, an innovative anti-infective developed for hospital infections caused by Acinetobacter baumannii, including carbapenem resistant strains (CRAB), has been selected to participate in the ADVANCE-ID clinical trial network which has its hub at the Saw Swee Hock School of Public Health, National University of Singapore. BV100 was selected by an independent expert panel out of 24 applications to be awarded this Phase 2b support.

BioVersys had announced its plan to conduct a Phase 2b study in parallel to the upcoming Phase 3 study in order to generate additional clinical data to support the future BV100 new drug application, collect additional clinical evidence in real world settings in countries with very high drug resistance levels and allow the comparison with some of the newest approved drugs.

This Phase 2b will now be conducted by the ADVANCE-ID clinical trial network in several countries in Southeast Asia, in settings with very high levels of drug-resistant infections and in close collaboration with BioVersys. This Phase 2b study has been made possible thanks to the generous contribution of Wellcome who strengthened the ADVANCE-ID network with SGD 22 million (c. USD 17m or CHF 14m), enabling the first sponsor driven clinical trial run by ADVANCE-ID in close collaboration with an industry sponsor, BioVersys. In addition to significantly reducing the financial cost to BioVersys, conducting the Phase 2b in partnership with the ADVANCE-ID clinical trial network increases the number of treatment arms from two to three treatment arms, including two arms for BV100 combined with either Ceftazidime/avibactam or with Cefiderocol, and one arm for Best Available Therapy. Consequently, the total number of evaluable patients increases from 60 patients to 90 patients in Part A, compared to the initial Phase 2b development plan. This Phase 2b will enroll patients with VABP/HABP and BSI suffering from CRAB (Part A), and patients with CRAB ventriculitis and meningitis (Part B, additional 10 patients).

Professor David Paterson, Director of ADVANCE-ID: “Carbapenem-resistant Acinetobacter baumannii (CRAB) has been classified as a “Critical” priority pathogen by WHO since 2017. BV100 is an attractive anti-infective which has already delivered very promising results in a Phase 2 VABP trial and we are very happy with the choice made by our independent expert panel. We look forward to collaborating with BioVersys, with our clinical trial network providing the infrastructure, expertise and access to a large population of patients with life-threatening CRAB infections. These are exactly the patients who need the kind of innovative anti-infective potential that BV100 represents.”

This Phase 2b open label randomized trial is expected to dose the first patient in H1 2026 and to include an interim data read-out in H2 2026. The data generated are expected to contribute to the BV100 Phase 3 program aimed at regulatory submission in the US, Europe and China.

The mission of ADVANCE-ID (ADVANcing Clinical Evidence in Infectious Diseases) is to conduct high-quality clinical trials that globally impact the management of infections. The network has already conducted clinical research in over 10,000 patients including over 3,000 in Ventilator Associated Bacterial Pneumonia (VABP) and Hospital Acquired Bacterial Pneumonia (HABP) and over 7,000 in Blood Stream Infections (BSI), finding that carbapenem-resistant Acinetobacter baumannii was the most common cause of these life-threatening infections across Asia. Wellcome originally supported the ADVANCED-ID set-up with funding in 2022 and has now provided a further 22 million SGD contribution to build clinical trial capacity and support this first Sponsor driven Phase 2 trial.

 

Alex Pym, Director of Infectious Disease at Wellcome: “To ensure new antibiotics work where they’re needed most, it’s essential they are tested in the countries with the highest levels of antimicrobial resistance (AMR). It’s very exciting to see this trial for a first-in-class new antibiotic being tested in the Southeast Asia region – one of the hardest hit by drug resistance, as highlighted in the WHO GLASS report. This will be vital to ensuring an equitable, effective approach to tackling the growing global threat of AMR. ADVANCE-ID, through fostering collaboration between academics, clinicians, and industry can accelerate innovation as well as building our capacity to reduce the impact of AMR worldwide, ultimately getting effective treatments to the communities and regions where they can have the biggest impact.”

 

Dr. Glenn Dale, Chief Development Officer of BioVersys:We are delighted that BV100 was selected by ADVANCE-ID to participate in their clinical trial network in Asia and for the outstanding commitment and support that Wellcome continues to show globally in the advancement of medicines addressing unmet human health challenges. BV100 has already demonstrated in its first Phase 2 trial the potential for a significant mortality benefit for patients with life-threatening CRAB infections. In this next Phase 2b trial, we aim to show a benefit over any currently available drug in real world conditions, which will provide further evidence of the value of BV100 to patients and health care systems. We are excited to collaborate with Professor Paterson and his team. This Phase 2b trial will add additional data to our global Phase 3 trial that is currently being initiated.”

About BV100

BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including Carbapenem-Resistant ABC (CRABC) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.

 

About Acinetobacter baumannii

Acinetobacter baumannii calcoaceticus complex (ABC) are Gram-negative bacteria found in the environment (e.g., in soil and water) and an opportunistic pathogen in humans, typically infecting critically ill and immunocompromised patients, that can result in severe pneumonia and bloodstream infections in addition to affecting other parts of the body. ABC is considered a significant worldwide threat in the healthcare setting given its ability to survive for prolonged periods on surfaces, combined with its ability to develop or acquire resistance to standard of care antibiotics, e.g. carbapenems. Carbapenem-resistance as well as multidrug-resistance (MDR) rates for ABC are among the highest recorded for any bacteria in current times (The Lancet 2022; 399: 629–55). Incidence and resistance rates for ABC are trending upwards and COVID-19 has exacerbated this significantly. The WHO list CRAB as “critical” in the highest priority group. BioVersys forecasts the annual number of carbapenem-resistant A. baumannii infections in hospitals to have surpassed one million globally and due to the limited treatment options, such infections come with high (up to 50%) mortality rates.

 

About ADVANCE-ID

ADVANcing Clinical Evidence in Infectious Diseases (ADVANCE-ID) is a clinical research network involving more than 50 hospitals across Asia, with a base at the National University of Singapore (NUS). The mission of ADVANCE-ID is to conduct high-quality clinical trials that have a global impact on management of infections. ADVANCE-ID was set up in March 2022 with a grant from Wellcome and funds from other institutions including, NUS Saw Swee Hock School of Public Health, NUS Yong Loo Lin School of Medicine, Duke-NUS Medical School, NTU Lee Kong Chian School of Medicine, and the National Centre for Infectious Diseases. 

Email: hello@advance-id.network Tel : +65 6516 4988  https://www.advance-id.network/

 

 

About National University of Singapore (NUS)

The National University of Singapore (NUS) is Singapore’s flagship university, which offers a global approach to education, research and entrepreneurship, with a focus on Asian perspectives and expertise. We have 15 colleges, faculties and schools across three campuses in Singapore, with more than 40,000 students from 100 countries enriching our vibrant and diverse campus community. We have also established more than 20 NUS Overseas Colleges entrepreneurial hubs around the world.

 

Our multidisciplinary and real-world approach to education, research and entrepreneurship enables us to work closely with industry, governments and academia to address crucial and complex issues relevant to Asia and the world. Researchers in our faculties, research centres of excellence, corporate labs and more than 30 university-level research institutes focus on themes that include energy; environmental and urban sustainability; treatment and prevention of diseases; active ageing; advanced materials; risk management and resilience of financial systems; Asian studies; and Smart Nation capabilities such as artificial intelligence, data science, operations research and cybersecurity.

For more information on NUS, please visit nus.edu.sg.

 

About Wellcome

Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.

Email: mediaoffice@wellcome.org Tel: +44 (0)20 7611 8866, https://wellcome.org  

 

About BioVersys

BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3), and tuberculosis (alpibectir, Phase 2, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland.

BioVersys contact

Hernan Levett, CFO, Tel. +41 61 633 22 50; Mail: Hernan.levett@bioversys.com

For Media: media@bioversys.com

www.bioversys.com

 

 

 

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

 

Biotest AG: Extraordinary general meeting convened again at the request of Grifols S.A.

Biotest AG

/ Key word(s): AGM/EGM

Biotest AG: Extraordinary general meeting convened again at the request of Grifols S.A.

07.11.2025 / 15:19 CET/CEST

The issuer is solely responsible for the content of this announcement.


 

PRESS RELEASE

 

Biotest AG: Extraordinary general meeting convened again at the request of Grifols S.A.

 

  • Renewed request for convocation dated 21 October 2025
  • Resolution on the change of legal form to a partnership limited by shares (KGaA)

Dreieich, 7 November 2025. Biotest AG announces that, after careful consideration, the Management Board has deemed admissible the new request received in writing from Grifols S.A. on 28 October 2025 pursuant to Section 122 (1) of the German Stock Corporation Act (AktG) to convene an extraordinary general meeting to resolve on the change of legal form of the company to a partnership limited by shares (KGaA). In compliance with the statutory requirements, the Management Board, with the approval of the Supervisory Board, has decided to convene an extraordinary general meeting of Biotest AG for 17 December 2025. The invitation to the extraordinary general meeting with further details was published today in the Federal Gazette and on the company’s website.

On the agenda of the extraordinary general meeting on 17 December 2025 will be again the resolution on the change of legal form of Biotest AG to a partnership limited by shares (KGaA) under the name Biotest GmbH & Co. KGaA. It is planned that Biotest Management GmbH, in which Grifols S.A. indirectly holds all shares, will assume the position of general partner.

The items of another request for addition to the agenda received by the company were also put on the agenda.

 

About Biotest

Biotest is a provider of biological therapeutics derived from human plasma. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,500 employees worldwide. Since May 2022, Biotest has been a part of the Grifols Group, based in Barcelona, Spain (www.grifols.com).

 

IR contact

Dr Monika Baumann (Buttkereit)

Phone: +49-6103-801-4406
Mail: ir@biotest.com

 

PR contact

Miriam Oehme

Phone: +49 -152 07016 992
Mail: pr@biotest.com

 

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

 

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201

Preference shares: securities’ ID No. 522723; ISIN DE0005227235

Listing: Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

 

Disclaimer

This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.Über Biotest

Biotest ist ein Anbieter von biologischen Arzneimitteln, die aus menschlichem Plasma gewonnen werden. Mit einer Wertschöpfungskette, die von der vorklinischen und klinischen Entwicklung bis zur weltweiten Vermarktung reicht, hat sich Biotest vorrangig auf die Anwendungsgebiete Klinische Immunologie, Hämatologie und Intensiv- und Notfallmedizin spezialisiert. Biotest entwickelt und vermarktet Immunglobuline, Gerinnungsfaktoren und Albumin, die auf Basis menschlichen Blutplasmas produziert werden und bei Erkrankungen des Immunsystems oder der blutbildenden Systeme zum Einsatz kommen. Biotest beschäftigt weltweit mehr als 2.500 Mitarbeiter. Seit Mai 2022 ist Biotest Teil der Grifols Gruppe, Barcelona, Spanien (www.grifols.com).

 


07.11.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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2225420  07.11.2025 CET/CEST

STRATEC REPORTS DEFINITIVE RESULTS FOR FIRST NINE MONTHS OF 2025

STRATEC SE

/ Key word(s): Quarter Results

STRATEC REPORTS DEFINITIVE RESULTS FOR FIRST NINE MONTHS OF 2025

07.11.2025 / 06:55 CET/CEST

The issuer is solely responsible for the content of this announcement.


STRATEC REPORTS DEFINITIVE RESULTS FOR FIRST NINE MONTHS OF 2025

  • Despite supply chain-induced interruption to production, consolidated sales at constant currency up 2.5% (nominal: +1.5%) to € 175.6 million in 9M/2025 (9M/2024: € 173.0 million)
  • Scale effects and higher earnings contributions from the realization of high-margin development sales are expected to drive significantly more dynamic earnings momentum in the fourth quarter of 2025
  • Ongoing great momentum and strong demand for system solution development cooperations; new partnerships initiated
  • 2025 guidance: sales at constant currency expected at around previous year’s level with adjusted EBIT margin at lower end of forecast corridor of 10.0% to 12.0%

Birkenfeld, November 7, 2025

STRATEC SE, Birkenfeld, Germany, (Frankfurt: SBS; Prime Standard, SDAX) today announced its financial results and major events for the period from January 1, 2025 to September 30, 2025 with the publication of its Quarterly Statement 9M|2025.

KEY FIGURES 1

€ 000s 9M/2025 9M/20242 Change Q3/2025 Q3/20242 Change
Sales 175,588 172,958 +1.5%
(cc: +2.5%)
56,998 60,267 -5.4%
(cc: -3.4%)
Adj. EBITDA 24,235 26,623 -9.0% 8,165 9,197 -11.2%
Adj. EBITDA margin (%) 13.8 15.4 -160 bps 14.3 15.3 -100 bps
Adj. EBIT 12,824 15,149 -15.3% 4,337 5,269 -17.7%
Adj. EBIT margin (%) 7.3 8.8 -150 bps 7.6 8.7 -110 bps
Adj. consolidated net income 7,104 8,434 -15.8% 2,126 2,831 -24.9%
Adj. earnings per share (€) 0.58 0.69 -15.9% 0.17 0.23 -26.1%
Earnings per share (€) 0.34 0.39 -12.8% 0.13 0.06 +116.7%

Adj. = adjusted / bps = basis points / wb = constant currency

1 To facilitate comparison, figures for 2025 have been adjusted to exclude amortization resulting from purchase price allocations in the context of acquisitions and other non-recurring items (including one-off advisory expenses, fees, and restructuring expenses). The figures for 2024 have additionally been adjusted to exclude one-off personnel expenses of € 1.7 million in connection with the departure of a member of the Board of Management.
2 Restated pursuant to IAS 8.

“Despite a challenging environment, STRATEC can report consolidated sales growth for the first nine months of 2025. Driven by trade policy tensions, temporary interruptions are apparent in the supply chains for some of our system lines. These particularly relate to the supply situation for a specific type of magnet. This already led to delays in planned system deliveries in the third quarter. Production volumes will also be adversely affected by this factor in the fourth quarter of 2025, meaning that we only expect to be able to make up for most of these delivery backlogs in the first quarter of 2026. As a result, we recently made a slight adjustment to our sales guidance for 2025. Despite the lower benefits of scale now expected and continuing unfavorable exchange rates, it is nevertheless pleasing to note that we can confirm the lower end of the forecast corridor for the adjusted EBIT margin. This confirms the program of efficiency measures we have initiated. The renewed increase in demand and our customers’ greater willingness to engage in new development partnerships in the area of systems give us additional confidence. Our power of innovation and great competitiveness enable us to react flexibly to market changes and draw on those opportunities arising in a demanding climate”, comments Marcus Wolfinger, Chief Executive Officer of STRATEC SE.

BUSINESS PERFORMANCE
STRATEC increased its consolidated sales year-on-year by 2.5% on a constant-currency basis (nominal: +1.5%) to € 175.6 million in the first nine months of 2025 (9M/2024: € 173.0 million). Systems sales at constant currency virtually matched the previous year’s level. Alongside start-up curves for new product launches remaining flatter than usual, the third quarter also brought supply chain interruptions in connection with trade policy tensions and thus delivery backlogs with some system lines. By contrast, the stabilization in demand for system lines which had seen disruptions in the wake of the COVID-19 pandemic continued apace. Constant-currency sales with Service Parts and Consumables fell slightly short of the previous year’s high figure. In the third quarter of 2025, this division felt the effects of volatile order behavior and logistics optimization measures taken by customers to account for changeable global tariff restrictions. Conversely, sales with Development and Services showed double-digit percentage growth, benefiting from a high volume of development activities and numerous customer projects currently underway.

Adjusted EBIT amounted to € 12.8 million in the first nine months of 2025 (9M/2024: € 15.1 million). Compared with the previous year, the adjusted EBIT margin thus fell by 150 basis points from 8.8% to 7.3%. This was particularly due to product mix effects within the Systems operating division, as well as to a temporary dip in the share of high-margin Service Parts and Consumables in the third quarter of 2025. The margin performance was additionally held back by negative exchange rate effects.

Adjusted consolidated net income stood at € 7.1 million in the first nine months of 2025, compared with € 8.4 million in the previous year. Here, STRATEC witnessed a year-on-year improvement in its net financial expenses and an increase in its adjusted tax rate. Adjusted earnings per share (basic) amounted to € 0.58 (9M/2024: € 0.69).

The key earnings figures for the first nine months of 2025 have been adjusted to exclude amortization resulting from purchase price allocations in the context of acquisitions and other non-recurring items (including one-off advisory expenses, fees, and restructuring expenses). A reconciliation of the adjusted figures with those reported in the consolidated statement of comprehensive income can be found in the Quarterly Statement 9M|2025 also published today.

FINANCIAL GUIDANCE
As already communicated in the announcement published on October 30, 2025, STRATEC expects to witness temporary interruptions to the supply of input materials for some system lines in the fourth quarter of 2025. In particular, in connection with trade policy tensions supply chain interruptions have arisen for a specific type of magnet with impurities relating to export-restricted rare earths (share of rare earths in affected production batch: 0.1%). Against this backdrop, delivery backlogs already arose for system deliveries in the third quarter of 2025. STRATEC does not expect to receive sufficient quantities of input materials to make up for these delivery backlogs or for the production volumes originally planned for the fourth quarter of 2025. Furthermore, global tariff conflicts are leading to higher fluctuations in customers’ order behavior and to associated logistics optimization measures. These particularly affect the Service Parts and Consumables division. In view of these factors, on October 30, 2025 the Board of Management decided to adjust its sales guidance for the 2025 financial year. STRATEC now expects its consolidated sales at constant currency to approximately match the previous year’s figure. Despite the lower sales base hereby forecast and negative currency items, STRATEC confirmed the lower end of the forecast corridor of around 10.0% to 12.0% for its adjusted EBIT margin. The expected intra-year rise in profitability in the fourth quarter of 2025 is attributable to benefits of scale, efficiency measures, and higher earnings contributions from the realization of high-margin development sales.

Based on updated planning, STRATEC assumes that its investments in property, plant and equipment and intangible assets in the 2025 financial year will fall slightly short of the originally forecast range of a total of 8.0% to 10.0% of sales (2024: 7.1%).

PROJECTS AND OTHER DEVELOPMENTS
Together with its partners, in the third quarter of 2025 STRATEC once again made further scheduled progress with numerous development projects and paved the way for additional cooperation agreements. The increasing willingness shown by customers in recent months to reach decisions concerning cooperations in the systems development business continued. Among other aspects, STRATEC has observed growing demand for lifecycle transfers. Furthermore, customers are increasingly looking for partners who are able to assume full responsibility for design, production, and delivery for the entire product lifecycle. The background to this development involves reorganization measures and M&A activities at customers, as well as their strategic focus on products already established in the market. These factors are supplemented by changed market conditions and growing requirements in terms of materials procurement. Against this backdrop, STRATEC recently initiated a partnership for a well-established high-throughput product in the field of molecular diagnostics.

The third quarter of 2025 also saw the market launch of the P780, a next-generation analyzer system offered under the Diatron brand in the field of clinical chemistry. To address a wide range of target customers, the P780 was developed for medium to large laboratories, offering an innovative and scalable solution characterized by great reliability.

DEVELOPMENT IN PERSONNEL
Including personnel hired from temporary employment agencies and trainees, the STRATEC Group had a total of 1,420 employees as of September 30, 2025 (previous year: 1,462 employees). This corresponds to a reduction of 2.9% compared with the previous year’s reporting date and is to be viewed in connection with the continuation in 2025 of the measures taken to enhance efficiency and improve earnings.

QUARTERLY STATEMENT 9M|2025
The Quarterly Statement 9M|2025 of STRATEC SE has been published on the company’s website at www.stratec.com/financial_reports.

CONFERENCE CALL AND AUDIO WEBCAST
To mark the publication of the definitive results for the first nine months of 2025, STRATEC will be holding a conference call in English at 2.00 p.m. (CET) today, Friday, November 7, 2025.

You will receive the dial-in data (telephone number, password + individual PIN) following brief registration at the following link: www.stratec.com/registration

The conference call will also be available at the same time as an audio webcast at http://www.stratec.com/audiowebcast20251107 (brief registration required). Please note that no questions can be submitted via the audio webcast. Clicking this link also enables you to follow or download the slide presentation.

ABOUT STRATEC
STRATEC SE (www.stratec.com) designs and manufactures fully automated analyzer systems for its partners in the fields of clinical diagnostics and life sciences. Furthermore, the company offers complex consumables for diagnostic and medical applications. For its analyzer systems and consumables, STRATEC covers the entire value chain – from development to design and production through to quality assurance.

The partners market the systems, software, and consumables, in general together with their own reagents, as system solutions to laboratories, blood banks and research institutes around the world. STRATEC develops its products on the basis of patented technologies.

Shares in the company (ISIN: DE000STRA555) are traded in the Prime Standard segment of the Frankfurt Stock Exchange and are listed in the SDAX select index of the German Stock Exchange.

FURTHER INFORMATION IS AVAILABLE FROM:
STRATEC SE
Jan Keppeler, CFA | Investor Relations, Sustainability & Corporate Communications
Tel: +49 7082 7916-6515
ir@stratec.com
www.stratec.com


07.11.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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Language: English
Company: STRATEC SE
Gewerbestr. 37
75217 Birkenfeld
Germany
Phone: +49 (0)7082 7916 0
Fax: +49 (0)7082 7916 999
E-mail: info@stratec.com
Internet: www.stratec.com
ISIN: DE000STRA555
WKN: STRA55
Indices: SDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2225406

 
End of News EQS News Service

2225406  07.11.2025 CET/CEST

Pentixapharm Holding AG: Pentixapharm significantly reduces projected loss for financial year 2025

Pentixapharm Holding AG / Key word(s): Annual Results

Pentixapharm Holding AG: Pentixapharm significantly reduces projected loss for financial year 2025

06-Nov-2025 / 19:55 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group.

The issuer is solely responsible for the content of this announcement.


Ad-hoc Disclosure of Inside Information Pursuant to Article 17 Regulation (EU)
No. 596/2014

 

Pentixapharm significantly reduces projected loss for financial year 2025

 

Berlin, Germany, November 6, 2025 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech developing radiopharmaceuticals, announces that its projected consolidated loss for the financial year 2025, based on an updated projection, will be significantly lower than previously anticipated.

 

The company now forecasts an annual loss of approximately €18 million instead of the previously expected €23.5 million. The forecasts for the separate financial statements of Pentixapharm Holding AG as well as the expected cash reach until the first quarter of 2027 remain unchanged.

 

The revised forecast reflects the realignment of the clinical development programs initiated in May 2025. In particular, the earlier-than-planned termination of the slow-recruiting diagnostic study in marginal zone lymphoma and optimized study design have lowered clinical spending more significantly than initially expected. With the sharpened focus on the clinically most value driving programs implemented in October 2025, the company is continuing to execute on its optimization course.

 

 About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops precision diagnostics and therapeutics in oncology and cardiology to transform patient care. Its clinical pipeline is anchored by CXCR4-targeted PET-CT programs, including a Phase 3-ready candidate for the improved diagnosis of hypertensive patients with primary aldosteronism, which is intended to enable targeted treatment of the underlying causes of hypertension. CXCR4-based developments also include pioneering therapeutic programs in hematological cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-checkpoint marker over-expressed in multiple hard-to-treat cancers. Complemented by CXCR4 and CD24 intellectual property protection and a reliable isotope supply chain, Pentixapharm is poised to deliver meaningful patient benefit and sustainable growth in one of the fastest-growing areas of precision medicine.

 

Pentixapharm Investor and Media Contact

ir@pentixapharm.com

End of Inside Information


06-Nov-2025 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Language: English
Company: Pentixapharm Holding AG
Robert-Rössle-Straße 10
13125 Berlin
Germany
E-mail: info@pentixapharm.com
Internet: https://www.pentixapharm.com/
ISIN: DE000A40AEG0
WKN: A40AEG
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2225518

 
End of Announcement EQS News Service

2225518  06-Nov-2025 CET/CEST

RHÖN-KLINIKUM AG closes third quarter of 2025 with solid results

RHÖN-KLINIKUM Aktiengesellschaft

/ Key word(s): Quarter Results/Quarter Results

RHÖN-KLINIKUM AG closes third quarter of 2025 with solid results

06.11.2025 / 09:00 CET/CEST

The issuer is solely responsible for the content of this announcement.


Bad Neustadt a. d. Saale | 6 November 2025

RHÖN-KLINIKUM AG closes third quarter of 2025 with solid results
 

  • Revenues up by 7.8% while patient numbers increased by 2.5%
     
  • EBITDA declined slightly to EUR 71.8 million due to the end to relief from the legislator for higher energy prices and challenges in cost trends
     
  • Consolidated profit of EUR 25.1 million with a decrease in finance result keeps equity ratio stable
     
  • Board of Management focused on managing  the Group in a consistent, flexible and sustainable manner at times of a difficult financial and economic environment for hospitals in Germany

RHÖN-KLINIKUM AG closed the third quarter of 2025 once again with an increase in revenues of 7.8% to EUR 1,262.1 million (9M 2024: EUR 1,171.1 million). From January to September 2025 a total of 705,830 patients were treated on an inpatient and outpatient basis in the Group’s hospitals and medical care centres, 2.5% more compared with the same period of the previous year (9M 2024: 688,787). At EUR 71.8 million, EBITDA was below the previous year’s level (9M 2024: EUR 75.1 million). Consolidated profit decreased to EUR 25.1 million (9M 2024: EUR 30.4 million). The equity capital ratio stands at 71.9% (FY 2024: 71.4%).

Despite stable performance indicators, consolidated profit was impacted by the end to reimbursements by the legislator for higher energy expenditures recognised in the amount of EUR 13 million in the previous year as well as the continuing downward trend in interest rates. Moreover, the first nine months of financial year 2025 continued to be characterized by indirect effects of geopolitical risks and resulting high purchasing prices, tariff increases and political developments associated with the hospital reform in Germany.

Dr. Stefan Stranz, member of the Board of Management of RHÖN-KLINIKUM AG: “Our Company’s performance continues to be stable, particularly as compared with the overall demanding situation of hospitals and the sector in Germany. Our high equity capital ratio underscores the Company’s sound financial structure.”   

Dr. Gunther K. Weiß, member of the Board of Management of RHÖN-KLINIKUM AG: “What the hospitals need from the government are clear statements on where the hospital sector is heading in future and on urgently needed solutions to key issues of the sector, such as structural underfunding and excessive red tape. These points have not yet been sufficiently addressed in the current drafts of the Hospital Reform Adjustment Act (Krankenhausreformanpassungsgesetz, KHAG).”

Outlook for 2025 confirmed

For the current financial year, the Group expects revenues of EUR 1.7 billion within a range of plus or minus 5%. For earnings before interest, tax and depreciation/amortisation (EBITDA), a level of between EUR 110 million and EUR 125 million is expected. In addition to the financial numbers, RHÖN-KLINIKUM AG also takes account of the non-financial performance indicators of number of cases and cost weights in the management of the Company. These are expected to see a moderate increase compared with the previous year.

This forecast reflects the heightened regulatory interference by the German legislator and the political implementation of the necessary hospital reform.

The Group notes that the outlook is subject to considerable uncertainties in connection with the numerous global crises resulting among other things in higher prices and supply chain issues, as well as any further regulatory measures impacting the remuneration structure for medical services in 2025.
 

The Quarterly Statement for Q3 2025 is published on the Internet.

 

RHÖN-KLINIKUM AG is one of the largest healthcare providers in Germany. The hospitals offer excellent medical care with a direct tie-in to universities and research facilities. Each year some 913,000 patients are treated at our five sites of Campus Bad Neustadt, Klinikum Frankfurt (Oder), Universitätsklinikum Gießen and Universitätsklinikum Marburg (UKGM) as well as Zentralklinik Bad Berka. The Company employs over 18,700 persons. The innovative RHÖN Campus approach for cross-sector and future-oriented healthcare delivery in rural areas, the steadfast continuation of the gradual digital transformation within the Company as well as the strategic partnership with ASKLEPIOS are important elements of our corporate strategy. RHÖN-KLINIKUM AG is an independent Company operating under the umbrella of Asklepios Kliniken GmbH & Co. KGaA. www.rhoen-klinikum-ag.com

Contact:

RHÖN-KLINIKUM AG | Head of Group Finance
Norman Dittes | T. +49 9771 65-12210 | norman.dittes@rhoen-klinikum-ag.de
 

RHÖN-KLINIKUM AG | Corporate Communications
Heike Ochmann | T. +49 9771 65-12130 | heike.ochmann@rhoen-klinikum-ag.com
 

RHÖN-KLINIKUM AG | Schlossplatz 1 | 97616 Bad Neustadt a. d. Saale | Germany


06.11.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
View original content: EQS News


Language: English
Company: RHÖN-KLINIKUM Aktiengesellschaft
Salzburger Leite 1
97616 Bad Neustadt a. d. Saale
Germany
Phone: +49 (0)9771 – 65-0
Fax: +49 (0)9771 – 97 467
E-mail: rka@rhoen-klinikum-ag.com
Internet: www.rhoen-klinikum-ag.com
ISIN: DE0007042301
WKN: 704230
Listed: Regulated Market in Frankfurt (Prime Standard), Munich; Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Stuttgart, Tradegate Exchange
EQS News ID: 2224834

 
End of News EQS News Service

2224834  06.11.2025 CET/CEST

Heidelberg Pharma’s Lead ATAC Candidate HDP-101 Shows Progress in Phase I/IIa Trial in Multiple Myeloma

Heidelberg Pharma AG

/ Key word(s): Study results

Heidelberg Pharma’s Lead ATAC Candidate HDP-101 Shows Progress in Phase I/IIa Trial in Multiple Myeloma

06.11.2025 / 07:09 CET/CEST

The issuer is solely responsible for the content of this announcement.


PRESS RELEASE

Heidelberg Pharma’s Lead ATAC Candidate HDP-101 Shows Progress in Phase I/IIa Trial in Multiple Myeloma

  • Evidence of clinical activity observed in Cohort 8, including stringent complete remission in two patients from Cohort 8
  • HDP-101 continues to demonstrate a favorable safety profile with no dose-limiting toxicities observed in Cohort 8
  • R&D Webinar to be hosted on 11 November 2025 at 05:00 pm CET (08:00 am PST)

Ladenburg, Germany, 6 November 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced that HDP-101 (INN: pamlectabart tismanitin), the Company’s lead ATAC candidate for the treatment of relapsed or refractory multiple myeloma, shows further clinical activity in Cohort 8 at a dose level of 140 µg/kg. These findings are highlighted by observed stringent complete remissions in two patients from Cohort 8.

Seven patients were evaluated in Cohort 8, and all patients demonstrated a favorable safety and tolerability profile throughout. Encouraging signs of clinical activity have also emerged. Four patients showed biological activity of HDP-101 (INN: pamlectabart tismanitin), with one partial response, one very good partial response and two stringent complete remissions (sCR). For sCR, no tumor cells are detectable in blood and bone marrow.

Dr András Strassz, Chief Medical Officer at Heidelberg Pharma, said: “We are very delighted by the data seen so far. Several patients across different cohorts have shown objective responses and promising anti-tumor activity. Observing two stringent complete remissions is an encouraging validation of our therapeutic approach. We have previously seen complete remission in one patient from Cohort 5, but in Cohort 8 onset of the response was more rapid. These findings further strengthen our confidence in the therapeutic potential of HDP-101 in heavily pretreated patients with relapsed or refractory multiple myeloma, and we are now progressing with Cohort 9 with an escalated dose of 175 µg/kg to continue its clinical evaluation.”

Heidelberg Pharma’s Phase I/IIa clinical study is a non-randomized, open-label, dose escalation trial actively enrolling patients with relapsed or refractory multiple myeloma or other BCMA-expressing plasma cell disorders. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HDP-101 (INN: pamlectabart tismanitin) in this patient population.

Heidelberg Pharma will discuss these findings in an R&D webinar on 11 November 2025 at 05:00 pm CET (11:00 am ET; 08:00 am PST), for investors, analysts, and media.

The webinar will feature presentations by the Heidelberg Pharma management team and Key Opinion Leader (KOL) Professor Marc-Steffen Raab, Head of the Myeloma Center at the University Hospital Heidelberg and clinical investigator of the study.

For further information on the R&D webinar, or to register your attendance, please use the link below:

https://us06web.zoom.us/webinar/register/WN_AG_mESPaT-aSsm8_O2DllA

A recording of the R&D webinar will be accessible via the press & investor section of the Company website after the event.

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology.

The lead candidate HDP-101 (INN: pamlectabart tismanitin) is a BCMA ATAC in clinical development for multiple myeloma. The candidate has been granted Orphan Drug Designation and Fast Track Designation from the FDA. A second ATAC candidate, HDP-102 is in clinical development stage in Non-Hodgkin Lymphoma. HDP-103 against metastatic castration-resistant prostate cancer and HDP-104 targeting gastrointestinal tumors such as colorectal cancer have completed preclinical development. Heidelberg Pharma is open for partnering.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com

ATAC® is a registered trademark of Heidelberg Pharma Research GmbH.

Contact
Heidelberg Pharma AG
Sylvia Wimmer
Director Corporate Communications
Tel.: +49 89 41 31 38-29
E-Mail: investors@hdpharma.com
Gregor-Mendel-Str. 22, 68526 Ladenburg
 
IR/PR-Support
MC Services AG
Katja Arnold (CIRO)
Managing Director & Partner
Tel.: +49 89 210 228-40
E-Mail: katja.arnold@mc-services.eu
International IR/PR-Support
Optimum Strategic Communications
Mary Clark, Zoe Bolt, Aoife Minihan
Tel: +44 20 3882 9621
Email: HeidelbergPharma@optimumcomms.com
 

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will” “should” “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.


06.11.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
View original content: EQS News


Language: English
Company: Heidelberg Pharma AG
Gregor-Mendel-Str. 22
68526 Ladenburg
Germany
Phone: +49 (0)89 41 31 38 – 0
Fax: +49 (0)89 41 31 38 – 99
E-mail: investors@hdpharma.com
Internet: www.heidelberg-pharma.com
ISIN: DE000A11QVV0
WKN: A11QVV
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2224624

 
End of News EQS News Service

2224624  06.11.2025 CET/CEST

SKAN will miss sales and profit expectations for 2025 – order intake and backlog are developing very positively and laying a strong foundation for 2026

SKAN AG / Key word(s): Profit Warning

SKAN will miss sales and profit expectations for 2025 – order intake and backlog are developing very positively and laying a strong foundation for 2026

06-Nov-2025 / 07:00 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

The issuer is solely responsible for the content of this announcement.


Ad hoc announcement pursuant to Art. 53 LR

SKAN will miss sales and profit expectations for 2025 – order intake and backlog are developing very positively and laying a strong foundation for 2026

Allschwil, November 6, 2025 – The SKAN Group conducted a planned review of its project portfolio in the last days. This assessment identified delays in several projects that will affect sales and earnings in the current financial year. The SKAN Group will therefore not meet its sales and profit expectations for 2025. Order intake continues to develop very positively and lays the foundation for a strong 2026 financial year, which will be significantly above 2024 and 2025. The medium-term targets are confirmed.

The SKAN Group now expects net sales for the 2025 financial year to decline by a high single-digit percentage compared to the previous year. The EBITDA margin for 2025 is expected to be in the low double-digit range. This is significantly below the guidance for 2025, which had targeted net sales growth in the mid-single-digit range and an EBITDA margin between 14% and 16%.

The reason for this is that additional projects have been postponed since the summer, pushing significant portions of the highest turnover month of December into 2026. As a result of the lost sales, this year’s EBITDA is correspondingly lower.

The SKAN Group’s order intake continues to develop very positively in the current financial year, with particular demand for filling lines for oncology applications and biotechnologically produced injectable large molecules. It is already foreseeable that the order backlog will very likely reach a new high by the end of the year. This provides a strong basis for a successful 2026 financial year.

The medium- and long-term growth prospects for the SKAN Group remain positive, supported by structural market growth, a strong global competitive position, and a solid project pipeline. SKAN is therefore confirming its medium-term targets: It expects net sales to grow at an annual rate in the mid- to upper teens. The EBITDA margin is to be gradually increased to the upper teens in the mid-term, with potential for further increase beyond the mid-term period.

 

Contacts:

Thomas Balmer, ir@skan.com, +41 79 703 87 28
Alexandre Müller, ir@skan.com, +41 79 635 64 13

Financial calendar:

24 March 2026 Publication Annual Results 2025
7 May 2026 Annual General Meeting 2026

 

SKAN – together always one step ahead

SKAN is a pioneer in the field of aseptic and aseptic-toxic manufacturing processes for the (bio)pharmaceutical industry. The company is the market and technology leader for high-quality, process-critical isolator systems for filling drugs according to strict sterility standards. In addition, the company offers its customers process support, services and consumables. Innovative solutions and an efficient life-cycle support organisation make SKAN an important partner for the pharmaceutical and biotech industry, CMOs (Contract Manufacturing Organisations) and research laboratories worldwide. Founded in 1968, SKAN today employs close to 1700 people. More than half of them work at the Allschwil headquarters in the Life Sciences Hub of the Basel region. The other employees are located among the subsidiaries in Switzerland, Germany, Belgium, France, Slovenia, Croatia, Japan, the USA and Brazil.

 


End of Inside Information


Language: English
Company: SKAN AG
Kreuzstrasse 5
4123 Allschwil
Switzerland
Phone: +41 43 268 32 32
E-mail: info@skan.com
ISIN: CH0013396012
Valor: 1339601
Listed: SIX Swiss Exchange
EQS News ID: 2224704

 
End of Announcement EQS News Service

2224704  06-Nov-2025 CET/CEST

DocMorris announces the start of the tender offer period for its Outstanding Convertible Bonds due 2026

DocMorris AG

/ Key word(s): Bond

DocMorris announces the start of the tender offer period for its Outstanding Convertible Bonds due 2026

06.11.2025 / 07:00 CET/CEST


Frauenfeld, 6 November 2025

Press release

DocMorris announces the start of the tender offer period for its Outstanding Convertible Bonds due 2026

After publication of the Offer Notice on 22 October 2025 and the end of the cooling-off period, DocMorris announces the start of the tender offer period for its Outstanding Convertible Bonds due 2026. The Tender Offer price for each of the Outstanding Convertible Bonds due 2026 amounts to CHF 1,035 per bond, corresponding to 103.50% of the par value, plus accrued and unpaid interest.

The tender offer period starts today and is expected to expire on 12 November 2025 at 4:00pm CET. Settlement of the Tender Offer is expected to occur on 17 November 2025. The bonds are listed and traded on SIX Swiss Exchange (ISIN: CH1210198169; SSN: A3K86S).

This press release is not an offer for the repurchase of the Outstanding Convertible Bonds due 2026 but only discloses the most important terms of the planned Tender Offer. The Tender Offer is solely made based on the Tender Offer notice published on 22 October 2025 in accordance with Swiss Tender Offer rules.

 

Investors and analyst contact
Dr. Daniel Grigat, Head of Investor Relations & Sustainability
Email: ir@docmorris.com, phone: +41 52 560 58 10

Media contact
Torben Bonnke, Director Communications
Email: media@docmorris.com, phone: +49 171 864 888 1

Agenda

20 January 2026 Full-year 2025 revenue
19 March 2026 Full-year 2025 results and outlook 2026 (conference call/webcast)
16 April 2026 Q1/2026 Trading update
12 May 2026 Annual General Meeting, Zurich

 

DocMorris
The Swiss-based DocMorris AG is a leading company in the fields of online pharmacy, telemedicine and marketplace with strong brands in Germany and other European countries. Deliveries are mainly from the highly automated logistics centre in Heerlen, the Netherlands. TeleClinic is Germany’s largest telemedicine platform, connecting patients with more than 5,000 physicians. DocMorris operates leading marketplaces for health and personal care products in Southern Europe. With its broad range of products and services, DocMorris is pursuing its vision of becoming the leading digital health companion for everyone to manage their health in one click. Around 1,600 employees in Germany, the Netherlands, Spain, France, Portugal and Switzerland generated an external revenue of CHF 1,085 million serving more than10 million active customers in 2024. The shares of DocMorris AG are listed on the SIX Swiss Exchange (securities number 4261528, ISIN CH0042615283, ticker DOCM). For further information, please visit corporate.docmorris.com.

 

Disclaimer

THE CONTENTS OF THIS ANNOUNCEMENT HAVE BEEN PREPARED BY AND ARE THE SOLE RESPONSIBILITY OF DOCMORRIS AG (THE “COMPANY”) AND DOCMORRIS FINANCE B.V. (THE “ISSUER”). THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS FOR BACKGROUND PURPOSES ONLY AND DOES NOT PURPORT TO BE FULL OR COMPLETE. NO RELIANCE MAY BE PLACED BY ANY PERSON FOR ANY PURPOSE ON THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT OR ITS ACCURACY, FAIRNESS OR COMPLETENESS.

THIS INFORMATION DOES NOT CONSTITUTE AN OFFER OR INVITATION TO SUBSCRIBE FOR OR PURCHASE ANY SECURITIES TO ANY PERSON IN THE UNITED STATES, AUSTRALIA, CANADA, ITALY, JAPAN, SOUTH AFRICA OR IN ANY JURISDICTION TO WHOM OR IN WHICH SUCH OFFER OR SOLICITATION IS UNLAWFUL. IT IS NOT BEING ISSUED IN COUNTRIES WHERE THE PUBLIC DISSEMINATION OF THE INFORMATION CONTAINED HEREIN MAY BE RESTRICTED OR PROHIBITED BY LAW.

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THIS ANNOUNCEMENT MAY INCLUDE STATEMENTS THAT ARE, OR MAY BE DEEMED TO BE, “FORWARD-LOOKING STATEMENTS”. THESE FORWARD-LOOKING STATEMENTS MAY BE IDENTIFIED BY THE USE OF FORWARD-LOOKING TERMINOLOGY, INCLUDING THE TERMS “BELIEVES”, “ESTIMATES”, “PLANS”, “PROJECTS”, “ANTICIPATES”, “EXPECTS”, “INTENDS”, “MAY”, “WILL” OR “SHOULD” OR, IN EACH CASE, THEIR NEGATIVE OR OTHER VARIATIONS OR COMPARABLE TERMINOLOGY, OR BY DISCUSSIONS OF STRATEGY, PLANS, OBJECTIVES, GOALS, FUTURE EVENTS OR INTENTIONS. FORWARD-LOOKING STATEMENTS MAY AND OFTEN DO DIFFER MATERIALLY FROM ACTUAL RESULTS. ANY FORWARD-LOOKING STATEMENTS REFLECT THE ISSUER’S OR THE COMPANY’S CURRENT VIEW WITH RESPECT TO FUTURE EVENTS AND ARE SUBJECT TO RISKS RELATING TO FUTURE EVENTS AND OTHER RISKS, UNCERTAINTIES AND ASSUMPTIONS RELATING TO THE GROUP’S BUSINESS, RESULTS OF OPERATIONS, FINANCIAL POSITION, LIQUIDITY, PROSPECTS, GROWTH OR STRATEGIES. FORWARD-LOOKING STATEMENTS SPEAK ONLY AS OF THE DATE THEY ARE MADE. EACH OF THE ISSUER, THE COMPANY, THE JOINT BOOKRUNNERS AND THEIR RESPECTIVE AFFILIATES EXPRESSLY DISCLAIMS ANY OBLIGATION OR UNDERTAKING TO UPDATE, REVIEW OR REVISE ANY FORWARD LOOKING STATEMENT CONTAINED IN THIS ANNOUNCEMENT WHETHER AS A RESULT OF NEW INFORMATION, FUTURE DEVELOPMENTS OR OTHERWISE.

THIS PUBLICATION CONSTITUTES NEITHER A PROSPECTUS OR A SIMILAR COMMUNICATION WITHIN THE MEANING OF THE ARTICLES 35 ET SEQQ. AND 69 OF THE SWISS FINANCIAL SERVICES ACT OR UNDER ANY OTHER LAW OR A LISTING PROSPECTUS WITHIN THE MEANING OF THE APPLICABLE LISTING RULES OF ANY STOCK EXCHANGE. ANY PURCHASE OF SHARES OF THE COMPANY IN THE PROPOSED OFFERING SHOULD BE MADE SOLELY ON THE BASIS OF PUBLICLY AVAILABLE INFORMATION. THE INFORMATION IN THIS ANNOUNCEMENT IS SUBJECT TO CHANGE. THE JOINT BOOKRUNNERS ARE ACTING EXCLUSIVELY FOR ISSUER AND THE COMPANY AND NO-ONE ELSE IN CONNECTION WITH THE OFFERING. THEY WILL NOT REGARD ANY OTHER PERSON AS THEIR RESPECTIVE CLIENTS IN RELATION TO THE OFFERING AND WILL NOT BE RESPONSIBLE TO ANYONE OTHER THAN ISSUER AND THE COMPANY FOR PROVIDING THE PROTECTIONS AFFORDED TO THEIR RESPECTIVE CLIENTS, NOR FOR PROVIDING ADVICE IN RELATION TO THE OFFERING, THE CONTENTS OF THIS ANNOUNCEMENT OR ANY TRANSACTION, ARRANGEMENT OR OTHER MATTER REFERRED TO HEREIN.

THE JOINT BOOKRUNNERS, AND ANY OF THEIR AFFILIATES MAY ENTER INTO FINANCING ARRANGEMENTS (INCLUDING SWAPS, WARRANTS OR CONTRACTS FOR DIFFERENCES) WITH INVESTORS IN CONNECTION WITH WHICH THE JOINT BOOKRUNNERS AND ANY OF THEIR AFFILIATES MAY FROM TIME TO TIME ACQUIRE, HOLD OR DISPOSE OF SECURITIES OF THE ISSUER OR THE COMPANY. THE JOINT BOOKRUNNERS DO NOT INTEND TO DISCLOSE THE EXTENT OF ANY SUCH INVESTMENT OR TRANSACTIONS OTHERWISE THAN IN ACCORDANCE WITH ANY LEGAL OR REGULATORY OBLIGATIONS TO DO SO.

NONE OF THE JOINT BOOKRUNNERS OR ANY OF THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, ADVISERS OR AGENTS ACCEPTS ANY RESPONSIBILITY OR LIABILITY WHATSOEVER FOR OR MAKES ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, AS TO THE TRUTH, ACCURACY OR COMPLETENESS OF THE INFORMATION IN THIS ANNOUNCEMENT (OR WHETHER ANY INFORMATION HAS BEEN OMITTED FROM THE ANNOUNCEMENT) OR ANY OTHER INFORMATION RELATING TO THE ISSUER OR THE COMPANY, THEIR SUBSIDIARIES OR ASSOCIATED COMPANIES, WHETHER WRITTEN, ORAL OR IN A VISUAL OR ELECTRONIC FORM, AND HOWSOEVER TRANSMITTED OR MADE AVAILABLE OR FOR ANY LOSS HOWSOEVER ARISING FROM ANY USE OF THIS ANNOUNCEMENT OR ITS CONTENTS OR OTHERWISE ARISING IN CONNECTION THEREWITH.

NEITHER THIS ANNOUNCEMENT NOR ANYTHING CONTAINED HEREIN SHALL FORM THE BASIS OF, OR BE RELIED UPON IN CONNECTION WITH, ANY OFFER OR COMMITMENT WHATSOEVER TO ACQUIRE SECURITIES IN ANY JURISDICTION. ANY INVESTOR SHOULD MAKE HIS INVESTMENT DECISION FOR THE PURCHASE OF THE SHARES ON PUBLICLY AVAILABLE INFORMATION.

 


End of Media Release
View original content: EQS News


Language: English
Company: DocMorris AG
Walzmühlestrasse 49
8500 Frauenfeld
Switzerland
ISIN: CH0042615283
Listed: SIX Swiss Exchange
EQS News ID: 2224592

 
End of News EQS News Service

2224592  06.11.2025 CET/CEST

Bioversys ANNOUNCES FIRST SUBJECTS DOSED IN PHASE 1 CLINICAL TRIAL OF BV100 in CHInA

 

Ad hoc announcement pursuant to Art. 53 LR

Basel, Switzerland. November 06, 2025, 7am CEST

  • First healthy volunteer dosed with BV100 in China in mandatory Phase 1 trial
  • Inclusion of Chinese clinical sites by H2 2026, into single global Phase 3 registration trial as planned

 

BioVersys AG, a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria, announced today the dosing of the first subject in a Phase 1 clinical trial with BV100 in China.

The mandatory Phase 1 clinical trial in healthy volunteers in China precedes the inclusion of Chinese clinical sites by late 2026 into the single Global Phase 3 registration trial of BV100 in Ventilator Associated Bacterial Pneumonia (VABP). Recruitment in other geographies will start earlier.

BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex. BV100 is being developed for multi-drug resistant (“MDR”) hospital infections caused by Acinetobacter baumannii, including carbapenem resistant strains (CRAB).

 

While CRAB infections are a serious health threat throughout the world, incidence rates for Acinetobacter infections are particularly high in China and Asia. Combined with very high resistance rates of 60-80% to carbapenems, Acinetobacter baumannii is the leading cause of death attributable to antimicrobial resistance in China[1]. Based on recent epidemiology data, BioVersys estimates that over 1 million patients annually are at risk of severe CRAB pneumonia and blood stream infections in China alone.

In April 2025, BioVersys presented outstanding Phase 2 clinical data for BV100 in Ventilator Associated Bacterial Pneumonia (VABP) at the 2025 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in Vienna, Austria. In that Phase 2, BV100 demonstrated strong signs of efficacy by halving the mortality rate in critically ill patients suffering from CRAB infections compared with best available therapy. Besides the strong efficacy signal, BV100 was also generally safe and well tolerated. In Part B of the Phase 2 trial, BV100 also proved effective in patients failing best available therapy and those suffering from totally drug-resistant infections.

Dr. Glenn E Dale, Chief Development Officer: “There is a high burden of CRAB in China and South-East Asia. As such, we are working with regulatory agencies from US, Europe and China to include patients from the three regions into a single global Phase 3 registration trial. The timely initiation of the Phase 1 safety and pharmacokinetic study in China demonstrates that the process to eventually include Chinese clinical sites into our global Phase 3 clinical program is progressing well. BioVersys is committed to bringing BV100 to patients in need in as many regions of the world as possible”

 

About BV100

BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, the BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including Carbapenem-Resistant ABC (CRAB) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.

 

About Acinetobacter baumannii

Acinetobacter baumannii calcoaceticus complex (ABC) are Gram-negative bacteria found in the environment (e.g., in soil and water) and an opportunistic pathogen in humans, typically infecting critically ill and immunocompromised patients, that can result in severe pneumonia and bloodstream infections in addition to affecting other parts of the body. ABC is considered a significant worldwide threat in the healthcare setting given its ability to survive for prolonged periods on surfaces, combined with its ability to develop or acquire resistance to standard of care antibiotics, e.g. carbapenems. Carbapenem-resistance as well as multidrug-resistance (MDR) rates for ABC are among the highest recorded for any bacteria in current times (The Lancet 2022; 399: 629–55). Incidence and resistance rates for ABC are trending upwards and COVID-19 has exacerbated this significantly. BioVersys forecasts the annual number of carbapenem-resistant A. baumannii infections in hospitals to have surpassed one million globally and due to the limited treatment options, such infections come with high (up to 50%) mortality rates.

 

About BioVersys

BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3), and tuberculosis (alpibectir, Phase 2, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland.

BioVersys contact

Hernan Levett, CFO, Tel. +41 61 633 22 50; Mail: Hernan.levett@bioversys.com

For Media: media@bioversys.com

www.bioversys.com

 

 

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

 


[1] J Adv Res. 2025 Jun 11:S2090-1232(25)00430-8. Burden of bacterial antimicrobial resistance in China: a systematic analysis from 1990 to 2021 and projections to 2050

SCHOTT Pharma AG & Co. KGaA: Christian Mias to succeed Andreas Reisse as CEO

SCHOTT Pharma AG & Co. KGaA / Key word(s): Personnel

SCHOTT Pharma AG & Co. KGaA: Christian Mias to succeed Andreas Reisse as CEO

05-Nov-2025 / 17:56 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group.

The issuer is solely responsible for the content of this announcement.


The Supervisory Board of SCHOTT Pharma Management AG has today appointed Christian Mias as the new Chief Executive Officer (CEO) of SCHOTT Pharma, effective May 1, 2026. He will succeed Andreas Reisse, who will retire as planned at the end of April 2026. Christian Mias has held various management positions within the SCHOTT Group since 2007, most recently serving as Head of the Business Unit Electronic Packaging.
 

End of Inside Information


05-Nov-2025 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
View original content: EQS News


Language: English
Company: SCHOTT Pharma AG & Co. KGaA
Hattenbergstraße 10
55122 Mainz
Germany
ISIN: DE000A3ENQ51
WKN: A3ENQ5
Indices: SDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2224602

 
End of Announcement EQS News Service

2224602  05-Nov-2025 CET/CEST