Moderna (MRNA) Q2 FY26 earnings call: guidance and Q&A

How should investors interpret the Phase III Intismeran melanoma study if it passes the first interim analysis and progresses to a second/final analysis, and what is the read-through to other tumor types like lung cancer, considering tumor mutational burden and neoantigen selection?

Management stated they have not disclosed the statistical powering or thresholds for early interim efficacy. They emphasized that the overall study was designed to evaluate the full commercial profile, and a commercially valuable product could emerge even if only in the final analysis. For read-through, they highlighted the importance of efficacy degree and validated mechanism of action (neoantigen-specific T cells). They believe it translates to tumors where checkpoints work (lung, bladder) but are conducting Phase II/I trials for tumors where checkpoints don't work (pancreatic, gastric). The ASCO data confirmed neoantigen-specific T-cell induction.

“But suffice it to say, it's an interim analysis, and there are still subsequent planned analyses. And ourselves with our partner, Merck designed the overall study to evaluate the full commercial profile of the product. And so we do think that there's a commercially valuable product that could emerge maybe only in the final analysis, but that wouldn't meet the criteria for early efficacy at the interim.”

asked by Salveen Richter · answered by Stephen Hoge

Can you provide more granularity on the timing of the Phase III melanoma INT readout, specifically regarding event accrual and confidence for a 2026 readout? Also, if successful, do you expect standard or priority review, and what is the capacity to treat patients upon approval?

Management declined to provide more specific timing details beyond 'second half' for the interim analysis. They expressed confidence based on strong randomized Phase II data and confirmed mechanism of action. For regulatory review, they hope for priority review and an accelerated process if the data is positive, similar to Phase II. They confirmed manufacturing in Massachusetts can support initial launch and commercial profile for several years, with readiness for next year if all goes perfectly.

“We believe that facility can support our commercial profile that ourselves and our partner, Merck, have articulated for several years to come. We hope we have to build more in the future if there's more demand, if all goes well. But we do believe we can satisfy the initial indication out of that facility and that we'd be ready to go next year if all went perfectly to plan.”

asked by Tyler Van Buren · answered by Stephen Hoge

Have there been discussions with the FDA regarding flu strain selection for 2027, particularly if there's a mismatch, and could Moderna update strains faster? Also, what are the learnings from the ASCO immunogenicity data for INT regarding neoantigen selection and optimization?

For flu, discussions with the FDA have occurred, including at the advisory committee, regarding late strain selection. Moderna's capability is less than 2 months for strain updates, and they are working with public health to define how and when this would be utilized. For INT, about 29% of neoantigens in cassettes are immunogenic, with 1 to 18 reactive neoantigens per patient. They are using AI to improve the algorithm and will link it to efficacy readouts.

“Our demonstrated capability in the COVID context is less than 2 months, and so strain selections have happened as late as early July in the history of COVID, and we've been able to make a full vaccination season to work with millions of doses.”

asked by Eliana Merle · answered by Stephen Hoge

Can you provide insights into potential pricing for the flu vaccine and the inputs considered? Also, what does the norovirus interim analysis imply for potential effect size?

Flu pricing conversations are ongoing and premature before approval. Moderna views its flu vaccine as 'enhanced' due to its efficacy profile and features like lack of egg adaptation, assessing its health economic value. For norovirus, management cannot disclose more as the trial is blinded and continuing. They confirmed the need for additional cases from a further cohort to strengthen statistical analysis, noting slower epidemiology of primary endpoint cases.

“Our demonstrated capability in the COVID context is less than 2 months, and so strain selections have happened as late as early July in the history of COVID, and we've been able to make a full vaccination season to work with millions of doses.”

asked by Terence Flynn · answered by Stephen Hoge

Regarding Intismeran in RCC, what immunogenicity data gives confidence it works in low TMB RCC, similar to melanoma and NSCLC?

The RCC trial is ongoing, so specific immunogenicity data for RCC is not yet available. However, management noted that in the Phase II melanoma study, TMB did not correlate with a difference in effect size, with low TMB melanoma patients showing consistent hazard ratios as high TMB patients. This provides some reason to believe it could translate, but they are awaiting data in other histologies. They also mentioned demonstrating immunogenicity in other hard-to-treat tumors like pancreatic cancer.

“And I think it comes from the lack of a role of TMB high versus low in driving the effect size that we saw in the Phase II and the totality of data we have around that.”

asked by Cory Kasimov · answered by Stephen Hoge