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Moderna (MRNA) investor relations material

Moderna Status Update summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Status Update summary17 Oct, 2025

Pipeline and Program Updates

  • The oncology pipeline includes individualized neoantigen therapies, off-the-shelf cancer antigen therapies, T-cell engagers, and cell therapy enhancers, with multiple programs in late-stage development and expansion into additional indications such as NSCLC and combinations with immunotherapies.

  • Intismeran (mRNA-4157/V940) is being evaluated in multiple tumor types, with Phase 2 and 3 studies ongoing or completed in melanoma, NSCLC, RCC, and bladder cancer, and phase III data expected in 2026.

  • Two off-the-shelf cancer antigen therapies, mRNA-4359 and mRNA-4106, are in clinical trials for advanced solid tumors, with mRNA-4359 advancing as a late-stage asset.

  • T-cell engager mRNA-2808 is in Phase 1/2 for multiple myeloma, and cell therapy enhancer mRNA-4203 is entering clinical studies for solid tumors.

  • The oncology pipeline has doubled in size over recent years, with ongoing studies in solid tumors and hematologic malignancies.

Key Clinical Data: Intismeran (mRNA-4157/V940)

  • In Phase 2 adjuvant melanoma, mRNA-4157/V940 plus KEYTRUDA showed 74.8% recurrence-free survival at 3 years versus 55.6% for KEYTRUDA alone, reducing risk of recurrence or death by 49%.

  • Distant metastasis-free survival improved, with a 62% reduction in risk of metastasis or death at 3 years.

  • Safety profile was manageable and consistent with prior analyses, with no potentiation of immune-related adverse events.

  • Phase 3 trial in adjuvant melanoma is fully enrolled, with data readout expected in 2026.

  • INT is being evaluated across several cancer types, with phase III data expected in 2026, and has shown promising results in high-risk melanoma patients.

Key Clinical Data: mRNA-4359 (Off-the-Shelf Cancer Antigen Therapy)

  • mRNA-4359 targets PD-L1 and IDO, aiming to enhance immune response and overcome tumor immune evasion, with a mechanism distinct from failed IDO inhibitors by using these as immune flags rather than enzymatic inhibition.

  • In a phase I-II trial with 29 CPI-resistant melanoma patients, mRNA-4359 plus pembrolizumab showed a 24% overall response rate and over 50% disease control, with higher responses (67% ORR) in PD-L1 positive tumors and durable responses with median duration not reached.

  • Safety profile was manageable, with no dose-limiting toxicities and immune-related adverse events consistent with single-agent pembrolizumab, mostly grade 1/2 AEs.

  • mRNA-4359 elicited specific T-cell responses and novel clonal expansion, supporting the proposed mechanism and suggesting new immune education in responders.

  • Phase 2 expansion includes arms in first-line and refractory melanoma and NSCLC, with endpoints including safety, ORR, DCR, and quality of life.

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Frequently asked questions

Pioneering mRNA technology

Moderna was founded on the notion that messenger RNA (mRNA), the molecule sending genetic information from DNA to the cell’s protein factory, could be re-engineered into a versatile set of drugs and vaccines.

With these instructions from the mRNA, our cells could be taught to make whatever our bodies need to treat or prevent disease - virus-slaying antibodies, metabolism-improving enzymes, or heart-caring treats.

Wide range of treatments and vaccines

Founded in September 2010 as “ModeRNA Therapeutics,” named from the combined terms “modified” and “RNA,” the company today has produced 44 different treatments and vaccine candidates, of which 21 have entered clinical trials.

In their pipeline are, among others, vaccines and treatments for influenza, HIV, COVID-19, cancer, and coronary heart disease (CHD). With a market cap of $57 billion, many undoubtedly believe in Moderna's future products.

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