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 Highlights In 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 Highlights In 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 (2023: Net cash used in operating activities CHF 12.0 million).
The positive newsflow from the company’s pipeline was the base to achieve important financing milestones in 2024. The company raised approximately CHF 20 million as part of the Series C extension, onboarding the long-term partner GSK as investor and including a strategic investment from GIBF (Guangzhou Israeli Biotech Fund). The financing was also supported by multiple existing shareholders, such as the AMR Action Fund. The cash and cash equivalents position increased to CHF 26.6 million as of December 31, 2024 (December 31, 2023: CHF 24.4 million) as a result of successful financing activities in the course of 2024. In addition, the company had short-term deposits of CHF 6.0 million recorded under current financial assets (December 31, 2023: CHF 4.0 million), that together with the cash and cash equivalent position amounted to a total cash of CHF 32.6 million. Total shareholders’ equity stood at CHF 10.7 million as of December 31, 2024 (December 31, 2023: CHF 8.6 million).
As of December 31, 2024, the Company employed 27 FTE (full-time equivalents), up 17% year-over-year. About 75% of the employees are employed in R&D-related functions.
Key Figures as of December 31, 2024
CHF million
FY 2024
FY 2023
Change
Operating income
1.2
1.1
0.1
R&D expenses
(12.9)
(14.8)
1.9
G&A expenses
(7.0)
(4.0)
(3.0)
Operating loss
(18.7)
(17.7)
(1.0)
Net loss
(18.7)
(18.3)
(0.4)
Basic net loss per share (in CHF)
(5.62)
(6.13)
0.51
Net cash used in operating activities
(16.1)
(12.0)
(4.1)
Cash & cash equivalents
26.6
24.4
2.2
Total shareholders’ equity
10.7
8.6
2.1
Number of registered shares
3,692,285
3,059,242
633,043
Number of FTE
27
23
4
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.
Hernan Levett, CFO of BioVersys, comments: “2024 was a strong year for BioVersys, raising CHF 20 million as part of the Series C extension, and including a strategic investment from GIBF, which led to a cash position at year end of CHF 32.6 million. In February 2025, we successfully completed an IPO on the Swiss Stock Exchange, which added proceeds of CHF 76.7 million, to further strengthen our financial position and funding the company’s operations into 2028. In times in which financing of biotech companies and the IPO market continue to remain challenging, the successful listing represented the first IPO of a biotech company in Switzerland in seven years and the largest in the past five years on any European exchange. This achievement is testament to very robust clinical data and the strong team at BioVersys.”
Outlook BioVersys plans for the initiation of the first global Phase 3 registration trial for BV100 in the second half of 2025. The company also plans to conduct a Phase 1 study in China with BV100. Moreover, the company plans the initiation of additional Phase 2 studies in pulmonary and meningeal Tuberculosis for Alpibectir. For BV200 and BV500, BioVersys expects to generate additional pre-clinical data in the course of 2025. In addition, the BioVersys team will continue to engage with industry alliances and will be working with global regulatory and political leaders towards a sustainable policy framework ensuring adequate reimbursement and access mechanisms for novel antibiotics.
Financial Outlook 2025 For the full year 2025, the company expects total operating loss to be in the range of CHF 32.0 to CHF 35.0 million.
Full Year 2024 Documents This press release, the Annual Report 2024 as well as the webcast presentation are available under the investors section of www.bioversys.com.
Full Year 2024 Conference Call & Audio Webcast BioVersys will host a conference call and webcast at 2:00 PM CET to discuss the financial results, provide an update on the company’s performance, outline its strategic outlook, and share insights into BioVersys' therapeutic pipeline.
Event details for Investors, Media and Interested Parties:
Conference Call Registration: Link (Participants will receive dial-in details upon registration)
The scheduled events for BioVersys are also available on the investor section of the company’s website.
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 ready), and tuberculosis (alpibectir, Phase 2a, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland.
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.
