Moderna (MRNA) investor relations material

Strategic vision, platform innovation, and growth plans

• Focus on expanding mRNA modalities across infectious disease, oncology, autoimmune, and rare diseases, leveraging a unified mRNA platform for rapid development and scalability.

• Multi-horizon R&D strategy: Horizon 1 (established modalities), Horizon 2 (emerging modalities), and Horizon 3 (future modalities with first-in-human trials by 2027).

• AI and automation, including the Lucy Scientific Intelligence Engine, are central to accelerating discovery, experimentation, and data integration for faster learning cycles.

• Expanding global reach through partnerships in the UK, Canada, Australia, LATAM, and APAC, and targeting new approvals in the EU, Japan, Switzerland, and Taiwan.

• Portfolio strategy emphasizes multiplexing, de-risking through sentinel programs, and maintaining diversity to balance risk and maximize R&D leverage.

Pipeline highlights, clinical progress, and innovation

• Infectious disease vaccines: COVID-19, RSV, and flu vaccines are approved or filed; norovirus in Phase 3.

• Oncology: Intismeran in multiple Phase 2/3 trials for melanoma, lung, renal, and bladder cancers; mRNA-4359 shows promising efficacy and safety in melanoma and NSCLC.

• Cancer Antigen Therapies (CATs) are advancing with multiplexed mRNA products targeting validated tumor antigens, with promising early clinical data and expansion into prevention (e.g., Lynch syndrome).

• T-cell engager modality (e.g., mRNA-2808 for myeloma, mRNA-2151 for ovarian cancer) leverages multiplexing to overcome tumor heterogeneity and resistance, with first-in-human studies underway and solid tumor programs advancing.

• In vivo CAR-T (mRNA-6007/007) for autoimmune diseases shows preclinical proof of deep B-cell depletion, broad immune cell targeting, and scalable, off-the-shelf potential, with IND-enabling studies ongoing and clinical entry planned for 2027.

Key clinical data and milestones

• mRNA-4359 plus pembrolizumab demonstrated manageable safety and durable responses in both CPI-refractory and first-line melanoma, with ORR up to 83% and strong T-cell responses.

• mRNA-4194 targets frameshift antigens in Lynch Syndrome, aiming for cancer prevention; Phase 1 study ongoing.

• mRNA-1195 for EBV-associated conditions (including MS) is well tolerated, boosts humoral and cellular immunity, and reduces viral shedding; Phase 2 MS study ongoing.

• Rare disease: Registrational trial for propionic acidemia (PA) and MMA in Phase 2.

• Emerging modalities: Cancer antigen therapies (mRNA-4106, mRNA-4200, mRNA-4194), T-cell engagers (mRNA-2808, mRNA-2151), and cell therapy enhancers are advancing through clinical stages.