Bioversys reports corporate highlights and key financials for the first half 2025

Ad hoc announcement pursuant to Art. 53 LR

• BV100: successful end of Phase 2 meeting with US FDA following Positive Phase 2 read-out in Ventilator-Associated Bacterial Pneumonia (VABP); Phase 3 on track to initiate in 2025; Formulation patent granted in China, extending BV100 IP protection to over 25 countries, including the US, Europe and the UK
• Alpibectir: First patient dosed in a Phase 2 combination trial in pulmonary Tuberculosis by partner GSK – first top line data expected in Q2 2026; EMA Orphan Designation received for Alpibectir and ethionamide combination for the treatment of tuberculosis
• BV500: Entered into Global Research Collaboration and exclusive license agreement with Shionogi to jointly develop a broad-spectrum non-tuberculous mycobacteria (NTM) clinical candidate
• Improved FY 2025 Financial Guidance with CHF 29m in expected Operating Loss and CHF 78m in Cash & Cash equivalent – Company funded into 2028

BioVersys AG, 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 financial results and corporate highlights for the first half year 2025. The company will host a conference call and webcast on September 10, 2025 at 2:00 PM CET / 8:00 AM ET where management will review the financial results, provide a business update and outlook. To participate in the call please register under the following link: Registration Link

Dr. Marc Gitzinger, Chief Executive Officer of BioVersys: “The first half of 2025 started with the successful IPO on the SIX Swiss Exchange in February with proceeds allowing us to advance our entire pipeline until early 2028. We are currently preparing to initiate the Phase 3 program for BV100 in VABP in 2025. We also recently announced a landmark research and licensing agreement with Shionogi for BV500, initiated an additional Phase 2 trial for alpibectir in pulmonary Tuberculosis together with our partner GSK and received EU orphan designation for alpibectir. We look forward to generating value-adding impact in the fight against anti-microbial resistance and creating significant shareholder value.”

Pipeline Highlights

BV100 (rifabutin for infusion) for carbapenem resistant Acinetobacter baumannii infections:

As announced in April 2025, the key data from the Phase 2 Ventilator Associated Bacterial Pneumonia (VABP) clinical trial for BV100 were presented at the 2025 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ECSMID). BV100 demonstrated strong signs of efficacy by halving the mortality rate in critically ill patients suffering from carbapenem resistant Acinetobacter baumannii infections compared with best available therapy. Besides the strong efficacy, BV100 was also generally safe and well tolerated. In Part B of the Phase 2 trial, BV100 also proved effective in patients failing best available therapy and those suffering from totally drug-resistant infections. A webcast featuring two internationally renowned key opinion leaders reviewing the data is available here.

Preparations for a global Phase 3 investigating BV100 for the treatment of VABP are progressing well following a successful end of Phase 2 meeting with the US FDA, leading to an aligned Phase 3 study design. The planned study will enroll approximately 250 evaluable patients with ventilator associated bacterial pneumonia (VABP)/hospital-acquired bacterial pneumonia (HABP) or bloodstream infections (BSI), to be randomized 1:1. The study arm for BV100 will be similar in dose and background medicines as during the Phase 2 trial randomized to a Colistin based control arm. The first patient first visit is anticipated for the end of 2025.

Preparations for the planned Phase 2b trial are also on track and a first patient first visit is anticipated for Q1 2026. The Phase 2b trial is designed to enroll a similar patient population, randomizing to best available therapy and exploring additional combination drugs for BV100 with a goal to generate real world evidence around best clinical practice, intended to provide valuable efficacy data to physicians and compare these data to what they observe in their daily practice. The Phase 2b aims to enroll 90 patients in a 2:1 randomization and is designed to also show additional clinical differentiation for BV100 by recruiting in populations where the infecting Acinetobacter baumannii is resistant to even the newest approved drugs.

Both Phase 3 and Phase 2b trials will include a Part B, allowing to recruit totally drug-resistant patients and enabling access to BV100 as rescue therapy.

Besides progress on the clinical development for BV100, the key composition of matter patent of the formulation of BV100 was also granted in China and is now granted in over 25 jurisdictions globally. 

Alpibectir in pulmonary and meningeal Tuberculosis (in partnership with GSK):

Alpibectir is being developed in combination with Ethionamide (AlpE) together with our partner 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 recruiting well and remains on track to report top line data by Q2 2026. A Phase 2 trial in meningeal tuberculosis to be led by BioVersys alongside a French and African academic consortium is planned to initiate in Q1 2026.

As reported earlier this year, the combination of Alpibectir and Ethionamide (AlpE) was also granted orphan designation from the European Medicines Agency (EMA). This recognition is based on strong proof of concept data from the Phase 2a data and the potential to address highly drug-resistant TB bacteria - including those resistant to the newest TB medicines such as bedaquiline. The orphan status provides key incentives, including reduced regulatory fees, research and clinical protocol support, and 10-year EU market exclusivity. The FDA had already granted AlpE orphan drug designation in 2023.

BV500 in non-tuberculous mycobacteria (NTM) infections (in collaboration with Shionogi):

The BV500 NTM program aims at developing a potential new, best-in-class medicine for NTM infections in patients with Cystic Fibrosis (CF) or Chronic Obstructive Pulmonary Disease (COPD). As announced recently, BioVersys has entered into a global research collaboration and exclusive license option agreement with the Japanese Pharma company Shionogi. This partnership ensures accelerated progression of the BV500 program towards clinical development candidates selection jointly by Shionogi and BioVersys. BioVersys receives near term and upfront payments of CHF 5 million 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.

Earlier, BV500 had met the second milestone within the CF AMR syndicate supported Lead optimization program.

Corporate and Management Highlights

BioVersys was listed on the Swiss Exchange (SIX) on February 7, 2025, under the ticker symbol “BIOV”. The IPO was an all-primary listing which raised CHF 76.7 million to conduct the clinical Phase 3 program for BV100 and advance the clinical development of alpibectir and the preclinical pipeline.

Financial Highlights

In the course of the first half of the financial year 2025, BioVersys recognized total operating income of CHF 0.6 million (H1 2024: CHF 0.5 million) and incurred total operating expenses of CHF 9.9 million, broadly in line when compared to the same period in 2024 (H1 2024: CHF 10.9 million), with 63% of these operating expenses related to Research and Development. Excluding IPO related expenses, the ratio of Operating Costs related to R&D would have been 69% for H1 2025.

This led to an operating loss of CHF 9.4 million for the first half of 2025 (H1 2024: Operating loss of CHF 10.4 million). The net loss in the first half of 2025 amounted to CHF 11.0 million (H1 2024: Net loss of CHF 10.4 million).

The net cash used in operating activities in the first half of 2025 was CHF 9.6 million (H1 2024: Net cash used in operating activities CHF 8.5 million).

The cash and cash equivalents position increased to CHF 92.1 million as of June 30, 2025 (December 31, 2024: CHF 26.6 million) as a result of our successful IPO in February 2025.

Total shareholders’ equity stood at CHF 69.9 million as of June 30, 2025 (December 31, 2024: CHF 10.7 million).

As of June 30, 2025, the company employed 29 FTEs (full-time equivalents), up 21% year-over-year. About 75% of the employees are employed in R&D-related functions.

In April 2025, BioVersys and the European Investment Bank (EIB) amended certain terms and conditions of the loan facility whereby the conditions precedent to access the third tranche of the loan have been updated and the amounts drawn from the facility are now subordinated. These amendments provide BioVersys with significant flexibility moving forward. We are thankful to the EIB for their support and look forward to future collaboration as our pipeline progresses.

As a post-period event, in July 2025 we entered into a research collaboration agreement with Shionogi for our preclinical asset BV500. This collaboration adds, in addition to our June 30^th 2025 cash and cash equivalents, CHF 5.0m and it offloads CHF 5.8m of expected expenses until December 2027.

Improved 2025 Financial Guidance

We expect the operating loss at year end to be of CHF 29m, which is an improvement of CHF 3-6m compared to the CHF 32m to CHF 35m range provided during the FY 2024 earnings call.

Cash and cash equivalents at year end are expected at CHF 78 million.

The company is fully funded into 2028.

Key figures 1?
CHF millions

1? Based on the consolidated IFRS Financial Statements

2?     The average net cash burn represents the average monthly cash used for operating activities

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

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.