Adhoc: BioVersys AG: BioVersys Announces Important BV100 Patent Granted By Chinese Patent Office

BioVersys AG / Key word(s): Patent
BIOVERSYS ANNOUNCES IMPORTANT BV100 PATENT GRANTED BY CHINESE PATENT OFFICE

31-March-2025 / 07:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.

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Ad hoc announcement pursuant to Art. 53 LR

Basel, Switzerland. March 31, 2025, 7am CET

• Important patent around BioVersys' BV100 drug candidate has been granted, protecting the proprietary rifabutin IV formulation technology in China
• BV100 patents have now been granted in over 25 countries, including in US, Europe, UK and China

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, that the company was granted important patent claims in China for its BV100 technology.

BV100 is a novel formulation of rifabutin which is suitable for intravenous administration. BV100 is based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex and is being developed for resistant hospital infections caused by Acinetobacter baumannii, including carbapenem resistant strains (CRAB).

There is a serious lack of effective and safe treatment options for CRAB infections and mortality rates in hospitals can be as high as 50%. CRAB has been designated a priority pathogen by the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC).

While CRAB infections are a serious health threat throughout the world, incidence rates for Acinetobacter infections are particularly high in China and Asia, combined with very high resistance rates of 60-80%. Based on recent epidemiology data, BioVersys expects > 1 million patients annually in China alone suffering from severe CRAB pneumonia and blood stream infections.

Dr. Marc Gitzinger, Chief Executive Officer: "With the addition of China, we now have patents protecting BV100 granted in all the major markets, covering more than 25 countries. In our commitment to bring BV100 as life-saving medicine to patients as fast as possible, this addition to our patent coverage is key due to the absolute numbers of patients affected by Acinetobacter infections in China. We are preparing to start a Phase 1 clinical trial in China soon, which will enable us to include China in our BV100 Phase 3 registration trial which is planned to start in H2 2025. Accessing the Chinese market will allow BV100 to target a global peak sales potential of USD 800 million and tackle unacceptably high carbapenem resistance rates and associated high mortality rates of up to 50%, from Acinetobacter baumannii hospital infections."

About BV100
BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, the lead candidate allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including Carbapenem-Resistant ABC (CRAB) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.

About Acinetobacter baumannii
Acinetobacter baumannii calcoaceticus complex (ABC) are Gram-negative bacteria found in the environment (e.g., in soil and water) and an opportunistic pathogen in humans, typically infecting critically ill and immunocompromised patients, that can result in severe pneumonia and bloodstream infections in addition to affecting other parts of the body. ABC is considered a significant worldwide threat in the healthcare setting given its ability to survive for prolonged periods on surfaces, combined with its ability to develop or acquire resistance to standard of care antibiotics, e.g. carbapenems. Carbapenem-resistance as well as multidrug-resistance (MDR) rates for ABC are among the highest recorded for any bacteria in current times (The Lancet 2022; 399: 629-55). Incidence and resistance rates for ABC are trending upwards and COVID-19 has exacerbated this significantly. BioVersys forecasts the annual number of carbapenem-resistant A. baumannii infections in hospitals to have surpassed one million globally and due to the limited treatment options, such infections come with high (up to 50%) mortality rates.

About BioVersys
BioVersys 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.

BioVersys contact
Hernan Levett, CFO, Tel. [phone]; Mail: [e-mail]
For Media: [e-mail]
Website: www.bioversys.com

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End of Inside Information

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2108628 31-March-2025 CET/CEST