Significant clinical and regulatory progress across entire pipeline
BV100:
Initiated global registrational Phase 3 (RIV-TARGET) in HABP/VABP1 program, US FDA green lights IND
Phase 2b (RIV-CARE) to be conducted via Wellcome-funded trial network ADVANCE-ID
First participants dosed in Phase 1 in China, preparing onboarding of China into RIV-TARGET
BV100 patent granted in China, adding to BV100's patent coverage in over 25 countries including the US and Europe
Alpibectir:
Our partner GSK reported first patient first visit for Phase 2b/c trial in pulmonary TB
Phase 2a results published in New England Journal of Medicine
Received EMA Orphan Designation
Corporate:
BV500: Entered global research collaboration with Shionogi for broad-spectrum non-tuberculous mycobacteria
Successful IPO funding operations into 2028 with BV100 Phase 3 read-out by the end of 2027
Conference call on March 18, 2026 at 2.00 pm CET (9.00 am EST)
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 multi-drug resistant (MDR) bacteria, announced today its audited financial results and corporate highlights for the full year 2025, as well as the publication of its 2025 Annual Report.
Dr. Marc Gitzinger, Chief Executive Officer of BioVersys: "Our successful IPO in early 2025 provided us with the funding to progress our entire pipeline of novel antibacterial drugs, including our two lead assets BV100 and alpibectir. 2025 has been a year of substantial clinical and regulatory progress. We initiated a global Phase 3 program for BV100 in HABP/VABP1 caused by carbapenem resistant Acinetobacter baumanni (CRAB), and entered into strategic partnerships with Shionogi for BV500 in non-tuberculous mycobacteria (NTM) infection, and with the ADVANCE-ID clinical trial network for the BV100 Phase 2b (RIV-CARE) study. These agreements validate our rich pipeline and extend our cash runway well beyond the BV100 Phase 3 read-out. In 2025, we also saw significant progress in policy change and reimbursement reforms for novel antibiotics, particularly in Europe, and we believe that BioVersys is ideally positioned to benefit from these long-awaited changes. 2026 has started very strongly with the publication of pre-clinical and clinical data on BV100 and alpibectir in prestigious journals, as well as the US FDA's acceptance of the BV100 Phase 3 IND. As we continue to advance our pipeline, I would like to thank our shareholders, stakeholders and colleagues for supporting us in developing the next generation antibiotics."
Pipeline HighlightsBV100: In 2025, the company's lead candidate BV100 initiated its planned global Phase 3 registrational trial (RIV-TARGET) in HABP/VABP caused by carbapenem resistant Acinetobacter baumannii (CRAB) and received US FDA green light for its IND. The study aims to enroll approximately 300 HABP/VABP patients with suspected or confirmed CRAB infections. Patients will be randomized 1:1 to receive either [1] BV100 combined with low dose polymyxin B or [2] Colistin combined with high-dose ampicillin-sulbactam, with both arms allowing meropenem as background in case of polymicrobial infections. The primary efficacy endpoint is defined as 28-day all-cause mortality (ACM) in the CRABC microbiological modified intention-to-treat (CRABC m-MITT) population. Secondary efficacy endpoints will include clinical cure status at the test of cure (ToC) in CRABC m-MITT, ventilator free days, time spent in intensive care unit (ICU) and time in hospital. As part of the study protocol, data safety monitoring boards (DSMB)2 will be convened at regular intervals to review trial progress.
In parallel to the Phase 3 pivotal trial, an open-label Phase 2b differentiation trial (RIV-CARE) will be initiated in H1 2026, comparing BV100 with BAT in multiple geographies. The Phase 2b trial aims to provide real world evidence of clinical practices in settings with very high drug resistance levels. Interim analysis is planned for end of 2026. In November 2025, BioVersys announced that the ADVANCE-ID clinical trial network will support and collaborate with BioVersys in conducting the Phase 2b study. This support 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).
A Phase 1 safety study in China was also initiated in 2025 prior to enrolling Chinese patients in the global Phase 3 study program in H2 2026. The Chinese Patent Office granted crucial IP protection to BV100, adding to BV100's patent coverage in over 25 countries including the US, Europe and the UK.
Alpibectir:In March 2025, BioVersys announced first patient first visit (FPFV) in part 1 of the alpibectir-ethionamide (AlpE) Phase 2 clinical trial in pulmonary tuberculosis (TB) ...
