Moderna Reports Second Quarter 2023 Financial Results and Provides Business Updates

At a median five-year pre-planned follow-up of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, intismeran autogene in combination with KEYTRUDA reduced the risk of recurrence or death by 49% (HR=0.510; [95% CI, 0.294-0.887]) compared to KEYTRUDA alone

The Companies plan to present further data from follow up analyses of the study's primary and secondary endpoints at a future medical conference

Eight Phase 2 and Phase 3 clinical trials underway across multiple tumor types including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma

Expects 2025 revenue of approximately $1.9 billion (unaudited), $100 million above midpoint communicated on 3Q25 Earnings Call

Improves 2025 expected GAAP operating expenses by $200 million since 3Q25 Earnings Call

Increases 2025 projected year-end cash balance to approximately $8.1 billion (unaudited)

Reiterates plan to deliver up to 10% revenue growth and GAAP operating expense reductions in 2026

Anticipates potential first approvals of flu and flu/COVID combination products in 2026

Expects pivotal trial data readouts in oncology, rare disease and infectious disease in 2026

Moderna has filed for marketing authorization in the U.S., EU, Canada and Australia for mRNA-1010