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

Ad hoc announcement pursuant to Art. 53 LR

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.”

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