Moderna, Inc. (NASDAQ:MRNA)*

As of March 2025

Oncology Portfolio Updates

INT (Individualized Neo-antigen Therapy) Program

Three Phase 3 studies ongoing: adjuvant melanoma, adjuvant NSCLC, and perioperative NSCLC

Phase 2 studies in adjuvant renal cell carcinoma, muscle invasive bladder cancer, and non-muscle invasive bladder cancer

Melanoma Phase 3 study enrollment completed September 2024, data readout expected in 2026

Continuing to enroll for NSCLC Phase 3 studies with Merck

INT approach differs from BioNTech's approach in technology and setting:

Uses proprietary algorithm selecting 34 neoepitopes (vs BioNTech's 20)

Different delivery method (intramuscular vs intravenous)

Focus on adjuvant setting (earlier in treatment journey) rather than later-line patients

Emerging Oncology Portfolio

Cancer antigen therapies (off-the-shelf), including:

Checkpoint AMT program (encodes PD-L1 and IDO epitopes) in Phase 2 studies with pembrolizumab for melanoma and NSCLC

Tumor antigen program moving to Phase 1 later this year

T-cell engagers targeting both surface and intracellular antigens with multiplexing capability

In vivo cell therapies including CAR-M in development

Cell therapy enhancer program in collaboration with Immatics

Rare Disease Programs

Propionic acidemia (PA) pivotal trial ongoing with data expected in 2026

Methylmalonic acidemia (MMA) pivotal study to start later in 2025 with possible data in 2026

CMV Vaccine

Final analysis results expected in 2025 (event-driven)

Currently blinded to efficacy outcomes

112 events needed for final analysis

2025 Financial Guidance

Revenue guidance of $1.5-2.5 billion

Low end accounts for uncertainties in vaccination rates, competitive pressure, and facility licensure delays

High end assumes flat vaccination rates, 40% US market share, and timely facility approvals

Break-even goal for 2028

Cost reduction progress: $9B (2023) → $6.4B (2024) → $5.5B (2025) → $5B (2026)

Additional Pipeline Updates

Norovirus vaccine: Clinical hold due to single GBS case; Northern Hemisphere enrollment completed (20,000+ patients), Southern Hemisphere continuing

RSV vaccine: FDA decision for 18-59 year-olds expected June 12, 2025, with commercial focus for 2026

The company emphasized their expanding oncology portfolio beyond INT as an underappreciated aspect of their pipeline.