Ad hoc announcement pursuant to Art. 53LR
BASEL, Switzerland, Dec. 11, 2025 (GLOBE NEWSWIRE) --
- BV100 Phase 3 in Ventilator Associated Bacterial Pneumonia initiated with first country submission completed and first patients to be dosed in the coming months - Phase 3 read-out expected in H2 2027
- Significant value inflection points achieved in 2025 including: Successful IPO on SIX Swiss Exchange extending cash runway to 2028, Strong BV 100 Phase 2 data generated in VABP, Global Research Collaboration with Shionogi for BV500, alpibectir progressed to Phase 2 trial in pulmonary TB, and BV100 selection by ADVANCE-ID for upcoming Phase 2b, mostly financed by Wellcome
- Strong news flow expected in 2026 including: 1st DSMB review for BV100 Phase 3, Interim data read-out for BV100 Phase 2b and Read-out of Phase 2 alpibectir in pulmonary tuberculosis by partner GSK
BioVersys AG, a multi-asset, late-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 initiation of its lead asset BV100 Phase 3 clinical program and provides a business update summarizing the Company's progress in 2025 and the events expected in 2026.
Initial Public Offering in Q1 2025
Following successful capital raising activities in 2024, the promising advancement in the Company's pipeline and the related positive clinical data generated, BioVersys completed its IPO on the SIX Swiss Exchange on February 7, 2025, marking the first IPO of a biotech company in Switzerland in seven years and the largest IPO in the past five years on any European exchange. The IPO added proceeds of CHF 76.7 million and further strengthened BioVersys' financial position, funding the company's operations into 2028, including the completion of the BV100 Phase 3 trial in Ventilator Associated Bacterial Pneumonia (VABP), Hospital acquired Bacterial Pneumonia (HABP) and Blood Stream Infections (BSI).
BV100 Phase 3 initiated following strong Phase 2 data in VABP
BV100, the Company's novel antibiotic candidate, has advanced into a global registration Phase 3 study program in drug-resistant infections. The trial will include clinical sites in the US, Europe, Latin-America, Asia and China. The Phase 3 will employ a similar study design to the successful Phase 2 trial, which demonstrated a clear survival benefit, where BV100 treatment resulted in a 50% relative reduction in all-cause mortality (ACM) in VABP patients suffering from carbapenem resistant Acinetobacter baumannii (CRAB) infections compared with best available therapy, and was generally safe and well tolerated.
Following successful end of Phase 2 meetings with the US FDA and EMA Emergency Task Force, BioVersys initiated the BV100 Phase 3 clinical program in December 2025 by submitting the clinical trial applications (CTA) to first regional and national regulatory authorities. Upon regulatory approvals within the coming months, site initiations and dosing of first patients will follow. This timeline is consistent with previous guidance on last patient last visit and top line data available for the Phase 3 towards the end of H2 2027.
BioVersys had also begun BV100's clinical trial geographic expansion into China, with the first healthy volunteer dosed with BV100 in a mandatory Phase 1 trial. The trial precedes the inclusion of Chinese clinical sites by late 2026 into the just initiated single Global Phase 3 registration program.
In addition to the registrational Phase 3 program necessary to gain regulatory approval in the US, EU and China, BioVersys is also planning to conduct a Phase 2b in a similar patient population, but comparing BV100 to best available therapy instead of Colistin in the Phase 3 program. This different study design compared to the Phase 3 study, aims at providing real world evidence of clinical practices in particular in settings with very high drug resistance levels. While BioVersys was initially expecting to fully finance this Phase 2b trial, we are delighted that the trial was selected for conduct and funding by ADVANCE-ID, a clinical trial network centered at the Saw Swee Hock School of Public Health, National University of Singapore and significantly financed by Wellcome. The Phase 2b trial is expected to start in H1 2026 and will be conducted by ADVANCE-ID under the supervision of BioVersys. Thanks to the generous contribution of Wellcome which is contributing SGD 22 million (c. USD 17m or CHF 14m) to ADVANCE-ID, the financial contribution of BioVersys has been significantly reduced.
BV500 in non-tuberculous mycobacteria (NTM) infections (in collaboration with Shionogi)
The BV500 NTM program aims to develop a potential new, best-in-class medicine for NTM infections in the approximatively 250,000 patients per year affected with this pulmonary disease predominantly in North America and Asia. As announced earlier this year, BioVersys has entered into a global research collaboration and exclusive license option agreement with the Japanese Pharmaceutical leader Shionogi. This partnership ensures accelerated progression of the BV500 program towards jointly selecting candidates for clinical development. BioVersys received a CHF 5 million upfront payment and, upon the license agreement, is eligible for development, regulatory and sales milestone of up to CHF 479 million, as well as royalties on future sales.
Alpibectir in pulmonary and meningeal tuberculosis (partnered with GSK)
This is currently being developed in combination with Ethionamide (AlpE) under partnership with GSK. In Q1 2025, GSK initiated a Phase 2 early bactericidal activity trial for AlpE in combination with first-line TB drugs in pulmonary tuberculosis. This trial is run within UNITE4TB, a European Union and European Pharmaceutical funded Innovative Medicines Initiative (IMI2) joint undertaking. The trial is progressing well and remains on track to report topline data for the first part of the trial by Q2 2026.
BioVersys also reported in 2025 that AlpE was granted Orphan Designation by the EMA Committee for Orphan Medicinal Products, which followed the earlier Orphan Drug Designation by the US FDA.
A Phase 2 trial in meningeal tuberculosis, to be conducted by BioVersys together with a French and African academic consortium, is planned to initiate in 2026.
Upcoming key milestones in 2026 and 2027
- Q1 2026: First patients dosed in the BV100 Phase 3 global registration study
- H1 2026: Alpibectir Phase 2 start in meningeal tuberculosis
- Q2 2026: Alpibectir Phase 2 first part readout in pulmonary tuberculosis
- H2 2026: BV100 Phase 2b interim data analysis
- H2 2026: BV 100 Phase 3 1st Data Safety Monitoring Board (DSMB) review
- H1 2027: BV100 Phase 3 2nd DSMB review
- H2 2027: BV100 Phase 3 top line data
Dr. Marc Gitzinger, Chief Executive Officer of BioVersys: "2025 has been a year of significant achievements and progress for BioVersys. Our IPO early in the year strengthened our financial position, enabling us to deliver multiple value-generating milestones over the next two years towards our first drug approval. The clinical development of our lead asset BV100 is going ahead as planned, with the Phase 3 now started and expecting to dose the first patients in the next few months. We remained focused on cash burn efficiency, notably by entering into a research collaboration with Shionogi, as well as being chosen by the ADVANCE-ID network for conduct of the planned Phase 2b study which significantly reduces our financial contribution. We are also pleased with the significant progress of our second clinical stage asset alpibectir in partnership with GSK. 2026 will provide significant value inflection points of further evidence of the clinical benefit of our differentiated assets. We would like to thank the BioVersys team who is working tirelessly to deliver on our promises, as well as our investors for their continued trust and support."
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
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https://www.linkedin.com/company/bioversys-ag
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.
