BASEL, Switzerland, March 18, 2026 (GLOBE NEWSWIRE) --
-- 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/VABP(1) 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 Highlights
BV100:
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) in combination with 1(st) line tuberculosis drugs. This part 1 of the study delivered top line data showed that alpibectir is generally safe and well tolerated warranting progression into part 2 of the study. Part 2 of the study is a Phase 2b in which AlpE is given for 2 months in combination with first-line TB drugs, followed by 18 weeks of Rifampicin and Isoniazid treatment. FPFV for the Phase 2b was reported in March 2026.
Alongside the development in pulmonary TB, BioVersys has also submitted a Phase 2 trial for AlpE in meningeal TB to regulatory authorities. FPFV is expected in H1 2026.
In August 2025, BioVersys received European Medicine Agency Orphan Designation for alpibectir combined with ethionamide for the treatment of tuberculosis. This Designation provides key incentives, including reduced fees, research and clinical protocol support, and 10-year EU market exclusivity, and follows alpibectir ethionamide receiving US FDA Orphan Drug Designation in 2023.
Alpibectir is being developed in strategic partnership with GSK, who leads clinical development in Tuberculosis Pneumonia while BioVersys leads development in Tuberculosis Meningitis. Both partners share equal economics.
BV500:
In July 2025, BioVersys entered a global research collaboration with Shionogi for its broad-spectrum non-tuberculous mycobacteria (NTM) program BV500.
The collaboration provides a research and exclusive license option agreement with Shionogi to jointly develop novel ansamycin leads from BioVersys' BV500 program into clinical candidates. Under the terms of the agreement, BioVersys is eligible to receive upfront and near-term research payments of CHF 5.0 million and, upon exercise of the license option, regulatory and sales milestones of up to CHF 479 million as well as royalties on future sales.
2025 Financial Highlights
For the year ended 31 December 2025, BioVersys recognized revenues of CHF 0.8 million (2024: nil) related to the Research Collaboration Agreement entered with Shionogi in July 2025 as well as CHF 2.5 million in other operating income made of research tax credits, grants and subsidies (2024: CHF 1.2 million) leading to a total operating income of CHF 3.3 million (2024: CHF 1.2 million).
As a result of BioVersys pipeline progressing through the stages of development, operating expenses were CHF 23.2 million in 2025 compared to CHF 19.9 million in 2024 and leading to an operating loss of CHF 20 million (2024: CHF 18.7m) for the financial year 2025. Operating expenses in 2025 included CHF 16.5 million in R&D expenses, representing approximately 71% of operating expenses for the year (2024: 64.9%).
The net loss in 2025 amounted to CHF 21.8 million (2024: Net loss of CHF 18.7 million).
The net cash used in operating activities in 2025 was CHF 22.0 million (2024: CHF 16.1 million).
The company raised approximately CHF 76.7 million as part of its February 2025 Initial Public Offering. The cash and cash equivalents position increased to CHF 82.5 million as of December 31, 2025 (December 31, 2024: CHF 26.6 million).
Total shareholders' equity stood at CHF 59.8 million as of December 31, 2025 (December 31, 2024: CHF 10.7 million).
As of December 31, 2025, the company employed 33 FTE (full-time equivalents) (end 2024: 27). About 75% of the employees are employed in R&D-related functions.
Key Figures as of December 31, 2025
CHF million FY 2025 FY 2024 Change Operating income 3.3 1.2 2.1 R&D expenses (16.5) (12.9) (3.6) G&A expenses (6.7) (7.0) 0.3 Operating loss (20.0) (18.7) (1.3) Net loss (21.8) (18.7) (3.1) Basic net loss per share (in CHF) (3.89) (5.62) 1.73 Net cash used in operating activities (22.0) (16.1) (5.9) Cash & cash equivalents 82.5 26.6 55.9 Total shareholders' equity 59.8 10.7 49.1 Number of registered shares 5,848,011 3,692,285 2,155,726 Number of FTE 33 27 6
Initial Public Offering in Q1 2025
On the back of the promising advancement of the company's pipeline and the related positive clinical data generated, BioVersys successfully completed its IPO on the SIX Swiss Exchange on February 7, 2025.
(MORE TO FOLLOW) Dow Jones Newswires
March 18, 2026 02:00 ET (06:00 GMT)
Comments