CureVac Announces Financial Results for the Third Quarter and First Nine Months of 2021 and Provides Business Update

CureVac N.V., a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced financial results for the third quarter and first nine months of 2021 and provided a business update.

CureVac Presents Promising Data at SITC from Phase 1 Study of Oncology Candidate CV8102 Showing Systemic Immune Response

• Immune profiling of clinical trial participants in Phase 1 dose-escalation study shows immune response in both injected and non-injected lesions
• Expansion part of Phase 1 study fully recruited; results expected in the second half of 2022

CureVac N.V., a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced promising data from the completed dose-escalation part of the Phase 1 clinical trial of CV8102, the company’s lead oncology candidate.

CureVac Streamlines European Network for mRNA Product Manufacturing

• CureVac right-sizes manufacturing network to adapt to changes in vaccine peak demands
• Demand reassessed for first-generation COVID-19 vaccine candidate, CVnCoV, currently under regulatory review with EMA
• Contracts with manufacturing partners WACKER and Celonic terminated; Rentschler Biopharma and Novartis contracts unaffected

CureVac N.V., a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced its strategic decision to adjust the long-term footprint of the external European manufacturing network for its mRNA product pipeline. The decision was made in response to the reduced short-term peak demand for vaccines following the first wave of the pandemic vaccination efforts and corresponding changes in the demand of its first-generation COVID-19 vaccine candidate, CVnCoV, currently under regulatory review with the European Medicines Agency (EMA). As a result, the existing contracts with WACKER for the manufacturing of the mRNA drug substance of CVnCoV and Celonic for the manufacturing and formulation of the mRNA drug substance of CVnCoV will be terminated. CureVac’s existing agreements with Rentschler Biopharma and Novartis for mRNA production and formulation are unaffected by this adjustment and remain in place. Streamlining of capacity does not limit availability of clinical trial material for CV2CoV, the second- generation COVID-19 vaccine candidate jointly developed with GSK, expected to enter the clinic in the fourth quarter of 2021.

CureVac Preclinical Data Demonstrates Significant Reduction of Liver Fibrosis with mRNA Therapeutic

• Findings in preclinical mouse models provide first direct proof of efficacy of HNF4A mRNA therapeutics in the treatment of liver fibrosis and cirrhosis
• Further research aimed at optimizing mRNA therapeutic candidates for non-clinical and clinical development are ongoing

CureVac N.V., a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced the publication entitled “Therapeutic HNF4A mRNA attenuates liver fibrosis in a preclinical model” in the peer-reviewed Journal of Hepatology. The study was conducted in collaboration with experts of the highly renowned REBIRTH-Research Center for Translational Regenerative Medicine and Department of Gastroenterology, Hepatology and Endo-crinology at the Hannover Medical School, Hannover (Germany), which allowed access to well-established preclinical liver disease models. It provides the first preclinical data demonstrating the therapeutic applicability of mRNA-encoded HNF4A (hepatocyte nuclear factor 4 alpha) transcription factor in the treatment of liver fibrosis and cirrhosis.

Second-Generation mRNA COVID-19 Vaccine Candidate, CV2CoV, Demonstrates Improved Immune Response and Protection in Preclinical Study

• Preclinical study provides evidence for strongly improved immune responses with second-generation mRNA backbone jointly developed by CureVac and GSK compared to CureVac’s first-generation mRNA backbone
• Data demonstrate high protective efficacy of second-generation lead candidate, CV2CoV, in animal model during SARS-CoV-2 challenge study
• Neutralizing capacity of induced antibodies tested against a range of variants, including the Beta, Delta and Lambda variant

CureVac N.V., a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), and GSK today announced the publication of preclinical data investigating immune responses as well as the protective efficacy of CureVac’s first-generation vaccine candidate, CVnCoV, and second-generation vaccine candidate, CV2CoV, against SARS-CoV-2 challenge in non-human primates. The study assessed cynomolgus macaques vaccinated with 12µg of either the first or second-generation vaccine candidate. Better activation of innate and adaptive immune responses was achieved with CV2CoV, resulting in faster response onset, higher titers of antibodies and stronger memory B and T cell activation as compared to the first-generation candidate, CVnCoV. Higher antibody neutralizing capacity was observed with CV2CoV across all selected variants, including the Beta, Delta and Lambda variants. During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the virus in the lungs and nasal passages. The full manuscript of the preclinical data is available on the preprint server bioRxiv.