BioVersys Reports Corporate Highlights and Key Financials for the Full Year 2024
BASEL, Switzerland, March 26, 2025 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LR
BV100: Positive Phase 2 VABP trial read-out with excellent safety and efficacy data
Alpibectir: Phase 2a EBA trial delivered very strong proof of concept
Preclinical candidates from BioVersys' two proprietary platforms continue to progress
Full Year 2024 operating income of CHF 1.2 million and net loss of CHF 18.7 million
Successful financing activities in 2024, including Series C financing round of approximately CHF 15 million and USD 6 million investment from GIBF (Guangzhou Israeli Biotech Fund)
CHF 32.6 million in cash and cash equivalents plus current financial assets on December 31, 2024
Successful IPO on SIX Swiss Exchange on February 7, 2025, further reinforcing BioVersys' financial position with CHF 76.7 million raised, allowing to finance operations into 2028
Outlook: BV100 Phase 3 program to be initiated in H2 2025; additional Alpibectir Phase 2 studies in pulmonary Tuberculosis started in H1 2025 and are to be started H1 2026 in meningeal Tuberculosis
Conference call on March 26, 2025 at 2.00 pm CET (8.00 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 multidrug-resistant (MDR) bacteria, announced today its audited financial results and corporate highlights for the full year 2024, as well as the publication of its 2024 Annual Report.
Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys: "2024 was a truly transformative year for BioVersys. We made significant progress in developing our two lead assets, BV100 and Alpibectir, both delivering strong signs of clinical efficacy and good safety profiles in their respective Phase 2 clinical trials. BV100 was assessed in critically ill patients suffering from ventilator associated bacterial pneumonia (VABP) caused by carbapenem resistant Acinetobacter baumannii and was able to halve the mortality in comparison with the control group of best available therapy. Such strong clinical results confirmed the belief that our products are high value assets in the fight against anti-microbial resistance (AMR) and must be developed fully in order to benefit patients in need eventually. We were also able to progress our earlier stage pipeline with BV200 and BV500 in their preclinical development."
Pipeline HighlightsIn 2024, for the company's lead candidate BV100 a Phase 2 VABP clinical trial showed strong signs of efficacy by halving the mortality rate in critically ill patients suffering from carbapenem resistant Acinetobacter baumannii infections compared to best available therapy. Besides the strong efficacy, BV100 was also considered generally safe and well tolerated. In Part B of the Phase 2 trial, BV100 also proved effective in patients suffering from totally drug-resistant infections.
Furthermore, additional trials were successfully completed for BV100 in 2024: A Phase 1 trial in patients with hepatic impairment and a bronchoalveolar lavage (BAL) confirmed the positive read-outs of the five Phase 1 trials that were previously completed. Based on the different Phase 1 trial data, BV100 is generally safe and well tolerated. The data set initially suggests that BV100 does not require any dose adjustments for special patient populations such as renal or hepatic impaired patients. There does not appear to be any strong potential for drug-drug-interactions and BV100 shows very high drug concentrations in the epithelial lining fluid (ELF) of the lung.
For Alpibectir, the Phase 2a EBA trial was completed in 2024. In this study, Alpibectir delivered a very strong proof of concept in humans, by potentiating the efficacy of Ethionamide at all doses tested. Alpibectir was shown to be generally safe and well tolerated.
In March 2025, BioVersys announced that the first patient has been dosed in a pulmonary TB Phase 2 clinical trial, evaluating the early bactericidal activity (EBA) and safety of alpibectir-ethionamide (AlpE) in combination with first-line TB drugs for the first time. The study is being conducted under the European Union's IMI2 UNITE4TB project.
For the company's preclinical candidate BV200, in 2024 the team identified a topical formulation for the lead compound delivering a good stability and an initial anticipated shelf life of 2 years.
For BioVersys' second preclinical candidate, BV500, the lead optimization progressed very well in the course of 2024. Further pre-clinical studies continued to confirm the best-in-class potential for BV500 on NTM (nontuberculous mycobacteria) related diseases.
2024 Financial HighlightsIn the course of the financial year 2024, BioVersys recognized total operating income of CHF 1.2 million (2023: CHF 1.1 million) and incurred total operating expenses of CHF 19.9 million (2023: CHF 18.8 million). The higher operating expenses were mainly driven by G&A expenditure, as the company prepared its IPO which resulted in a successful transaction in February 2025.
This led to an operating loss of CHF 18.7 million for 2024 (2023: Operating loss of CHF 17.7 million). The net loss in a 2024 amounted to CHF 18.7 million (2023: Net loss of CHF 18.3 million).
The net cash used in operating activities in 2024 was CHF 16.1 million ...
