MinervaX and Wacker Biotech Announce Manufacturing Collaboration for Prophylactic Vaccine Targeting Group B Streptococcus Page 1

• MinervaX expands supply of novel GBS vaccine ahead of Phase III studies
• Wacker Biotech to produce active ingredients for vaccine protein and prepare for commercial supply following regulatory approval
• Vaccine to address the unmet medical burden of GBS, both through maternal vaccination to prevent adverse pregnancy outcomes and life-threatening infections in infants and through vaccination of older/at-risk adults

COPENHAGEN, Denmark And MUNICH, September 17, 2024 /PRNewswire/ — MinervaX ApS, a privately held Danish biotechnology company developing a novel prophylactic vaccine against group B streptococcus (GBS), and Wacker Biotech, a contract development and manufacturing organization (CDMO) and a wholly owned subsidiary of Wacker Chemie AG, today announce a collaboration for the production of MinervaX’s active protein ingredients for the GBS vaccine.

GBS is responsible for nearly 50 percent of all life-threatening infections in newborns. At any given time, approximately 15-25 percent of the population, including pregnant people, are spontaneously colonized with GBS and during pregnancy are at risk of transmitting the bacteria to their infant in utero, during birth and/or during the first months of life. GBS colonization can lead to late-term abortions, preterm birth or stillbirth and in the newborn it can result in sepsis, pneumonia or meningitis, all of which carry a significant risk of serious morbidity, long-term disability or death. Because there is no widely implemented and fully protective preventive treatment available for GBS, this underscores the unmet medical need for the development and provision of a vaccine to prevent adverse pregnancy outcomes and life-threatening infections in infants caused by GBS. In addition, older adults and adults with certain comorbidities such as diabetes or obesity are also at increased risk for severe GBS infections and represent a second population that would benefit from a prophylactic vaccine against this potentially fatal disease.

MinervaX’s lead vaccine candidate is a novel protein-only vaccine based on fusions of highly immunogenic and proactive protein domains from selected GBS surface proteins. The Company is strongly committed and dedicated to further developing its novel vaccine and has successfully completed two Phase II clinical trials of its parent vaccine against GBS and is preparing to initiate Phase III clinical trials in this indication. Data from MinervaX’s GBS vaccine are very positive, demonstrating an acceptable safety profile in pregnant women and their infants, with high immunogenicity leading to functionally active antibodies, with the potential for broad coverage and protection, alleviating the need for excessive use of antibiotics.