BioVersys Announces BV100 Phase 3 Initiation and Provides a Business Update

Core Insights - BioVersys AG has initiated its lead asset BV100 Phase 3 clinical program, focusing on novel antibacterial products for serious infections caused by multi-drug resistant bacteria [2][4] - The company completed a successful IPO on February 7, 2025, raising CHF 76.7 million, marking the largest biotech IPO in Switzerland in seven years [3][8] - Significant clinical advancements were made in 2025, including strong Phase 2 data for BV100, which demonstrated a 50% relative reduction in all-cause mortality in patients with drug-resistant infections [4][8] Financial Developments - The IPO proceeds will fund BioVersys' operations into 2028, including the completion of the BV100 Phase 3 trial [3][8] - BioVersys received a CHF 5 million upfront payment from Shionogi as part of a global research collaboration for the BV500 program, with potential milestones of up to CHF 479 million [10] Clinical Trials and Research - The BV100 Phase 3 trial will include sites in the US, Europe, Latin America, Asia, and China, with first patient dosing expected in the coming months [5][8] - A Phase 2b trial comparing BV100 to best available therapy is planned, with funding from ADVANCE-ID, significantly reducing BioVersys' financial contribution [7][8] - The company is also advancing the alpibectir program in partnership with GSK, with a Phase 2 trial in pulmonary tuberculosis expected to report topline data by Q2 2026 [11][12] Future Milestones - Key upcoming milestones include the first patients dosed in the BV100 Phase 3 study in Q1 2026, interim data read-out for the Phase 2b trial in H2 2026, and top line data for the Phase 3 trial expected in H2 2027 [16]