BV100 pivotal RIV-TARGET trial actively recruiting, alpibectir Phase 2b/c underway, operations funded into 2028

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 financial results and corporate highlights for the half-year 2026 (H1 2026), as well as the publication of its H1 2026 Report.

Dr. Marc Gitzinger, Chief Executive Officer of BioVersys, said: “We are very pleased with the progress of our clinical development programs. Our global Phase 3 trial RIV-TARGET for BV100 is well under way, and our open-label Phase 2b trial RIV-CARE is scheduled to initiate first sites in September, in collaboration with ADVANCE-ID. In addition, the development of alpibectir in partnership with GSK progresses well. While we focus on advancing our pipeline assets, we also maintain financial discipline. Keeping this momentum is key to bringing our promising development programs closer to patients suffering from life-threatening infections caused by resistant bacteria, where the unmet medical need is high and current treatment options are very limited.”

Pipeline Highlights

BV100:

BV100 is currently being studied in two clinical trials: the pivotal Phase 3 global registration trial, RIV-TARGET and the open-label Phase 2b differentiation trial, RIV-CARE.

BV100 Phase 3 RIV-TARGET updates: The Phase 3 RIV-TARGET trial initiated recruiting, with the FPFV reported in April 2026. In March 2026, the US FDA green lighted the Investigational New Drug application, supporting the continued global roll-out of the trial. In China, successful completion of Phase 1 in April 2026 is expected to enable the onboarding of Chinese sites into RIV-TARGET, with FPFV in China now expected in March 2027. RIV-TARGET aims to enrol approximately 300 HABP/VABP patients with suspected or confirmed CRABC infections. The first Data Safety Monitoring Board (DSMB) review is anticipated by the end of 2026. Guidance remains for last patient enrolled for end of 2027, and first submissions for regulatory approval anticipated by mid-2028. Topline data read-out from RIV-TARGET is anticipated for early 2028.

BV100 Phase 2b RIV-CARE updates: In parallel to the Phase 3 pivotal trial, BioVersys is running the open-label Phase 2b differentiation trial, RIV-CARE, which compares BV100 with best available therapy across multiple geographies. The first site is scheduled to be initiated in September and FPFV is expected in H2 2026. RIV-CARE aims to provide real-world evidence of clinical practice in settings with very high levels of drug resistance, with a first interim read-out in H1 2027 as we aim for a meaningful number of patients enrolled. In November 2025, BioVersys announced that the ADVANCE-ID clinical trial network would support and collaborate with the company in conducting the Phase 2b study, with substantial funding from Wellcome.

Additional enabling activities progressed in parallel. Last Patient Last Visit in a Phase 1 DDI study (of BV100/Polymyxin B) took place in July 2026, with data review ongoing. The US FDA agreed to the initial paediatric study plan (iPSP) and Phase 1 data for BV100 was recently published in the Journal of Antimicrobial Agents and Chemotherapy, and the team presented additional pre-clinical data at ESCMID in Munich in 2026.

As a reminder, these studies follow the successful Phase 2 study that showed BV100 had an overall 50% reduction in mortality compared with best available therapy. In September 2026, BV100 was granted Fast Track Designation by the US FDA, under the Qualified Infectious Disease Product (QIDP) Designation received in 2019. These designations make BV100 eligible for priority FDA review, increased communication on clinical trial design and data requirements, and a five-year extension of market exclusivity in the US.

Alpibectir:

Alpibectir Ethionamide (AlpE) is currently being studied in two clinical trials: A Phase 2b/c (STEP2C) for TB Pneumonia and Phase 2 for TB Meningitis.

AlpE Phase 2b/c TB Pneumonia updates: FPFV for STEP2C was reported in March 2026. During this Phase 2b/c, AlpE is given for 2 months in combination with first-line TB drugs, followed by 18 weeks of Rifampicin and Isoniazid treatment. The progression to STEP2C follows encouraging results from Phase 2a (ENABLE), which reported that AlpE was safe and generally well tolerated, supporting further development progression. Data read-out from the Phase 2a ENABLE trial will be presented in November 2026 at the prestigious Union Conference. The ENABLE and STEP2C trials are being led by our partner GSK within the prestigious UNITE4TB EU IHI consortium.

AlpE Phase 2 TB Meningitis updates: Alongside the development in pulmonary TB, BioVersys has submitted a Phase 2 trial for AlpE in meningeal TB to regulatory authorities. Regulatory interactions progressed well in H1 2026, with the trial expected to be conducted in Zambia, Ivory Coast and Madagascar. FPFV is anticipated in Q4 2026.

Recent scientific and medical journal publications of Alpibectir include proof-of-concept Phase 2a data published in the New England Journal of Medicine in February 2026, while AlpE’s unique mechanism of action was published in Nature Communications in April 2026.

As a reminder, Alpibectir in combination with ethionamide has Orphan Drug Designation from the European Medicine Agency and the US FDA 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 7-year US market exclusivity. The Alpibectir program is also eligible for a tropical neglected diseases priority review voucher of the US FDA.

Hernan Levett, Chief Financial Officer of BioVersys, said: “Bioversys is pleased to report a healthy balance sheet with a cash position of CHF 69.3 million at 30 June 2026. For the first half of the year, approximately 82% of total operating expenses were allocated to R&D activities, and we maintained a lean organization of 38 full-time employees. Reflecting on our first-half performance, we have improved our full-year 2026 financial guidance, reducing expected operating loss to approximately CHF 32 to CHF 34 million, and increasing expected year-end cash guidance to CHF 53 million. We remain focused on disciplined capital allocation and rigorous cost management, as we advance our key clinical programs while maintaining funding into 2028.”

For the six months ended 30 June 2026, BioVersys recognized revenues of CHF 0.8 million (HY 2025: nil) related to the Research Collaboration Agreement entered into with Shionogi in July 2025, as well as CHF 1.2 million in other operating income (HY 2025: CHF 0.6 million), consisting of research tax credits, grants and cost reimbursement leading to total operating income of CHF 2.0 million (HY 2025: CHF 0.6 million).

The successful initiation of the pivotal Phase 3 RIV-TARGET trial for BV100 contributed to an increase in R&D expenses to CHF 13.6 million for the HY 2026 period (HY 2025: CHF 6.2 million) as clinical development activities accelerated. R&D expenses represented approximately 82% of operating expenses for the period (HY 2025: 63%).

G&A expenses decreased by CHF 0.7 million compared to the first half of 2025, primarily due to lower consultancy and advisory fees, as the prior-year period included IPO-related costs associated with the Company's February 2025 listing. Operating loss was CHF 14.6 million for the HY 2026 period (HY 2025: CHF 9.4 million) and the net loss in HY 2026 amounted to CHF 15.6 million (HY 2025: net loss of CHF 11.0 million).

Cash and cash equivalents stood at CHF 69.3 million as of 30 June 2026 (31 December 2025: CHF 82.5 million). Total shareholders’ equity stood at CHF 44.8 million as of 30 June 2026 (31 December 2025: CHF 59.8 million).

As of 30 June 2026, the company employed 38 FTE (full-time equivalents). About 75% of the employees are employed in R&D-related functions.

Corporate updates

In March 2026, BioVersys entered into an exclusive collaboration and license agreement with Hackensack Meridian Health and its Center for Discovery and Innovation to advance ansamycin antimicrobial candidates targeting difficult-to-treat non-tuberculous mycobacterial diseases. The agreement strengthens BioVersys’ Ansamycin Chemistry platform and supports its broader focus on novel antibiotics for serious drug-resistant infections.

Financial Outlook 2026

For the full year 2026, the company improved guidance and expects total operating loss to be in the range of CHF 32 million - CHF 34 million. Cash and cash equivalents at year end are estimated at CHF 53 million. We expect the company’s operations to be funded into 2028, including BV100 RIV-TARGET top line read-out.

H1 2026 Documents

This press release, the Half-Year Report 2026 as well as the webcast presentation are available under the investors section of www.bioversys.com.

BioVersys contact

Anca Cighi, Head of IR and Communication, Tel. +41 79 949 33 09; Mail: anca.cighi@bioversys.com
For IR: IR@bioversys.com; Website: www.bioversys.com