Moderna: the next act

Moderna’s positive Phase 3 melanoma result suggests its mRNA technology could become a broader, personalised cancer-treatment platform, but regulatory, manufacturing and clinical risks remain.

• Baillie Gifford invested in Moderna’s December 2018 IPO; the shares later gained more than 2,000 percent before falling 95 percent, exposing the risks in its position sizing and conviction.
• Covid vaccine sales reached $36bn through 2022, leaving Moderna with about $18bn in cash and investments, but collapsing demand, excess manufacturing capacity and execution problems subsequently eroded its finances.
• Management responded with cost reductions, a narrower focus on the most promising programmes and stronger commercial execution; Baillie Gifford kept a smaller holding as its conviction and the risk-reward balance changed.
• In August 2026, Moderna’s personalised treatment Intismeran, developed with Merck’s Keytruda, met its primary and a key secondary endpoint in a Phase 3 melanoma trial; the company sequences tumour and healthy DNA to create an mRNA treatment targeting patient-specific mutations.
• Baillie Gifford cut its position by 50 percent the day after the result, partly because the shares were heavily shorted and the firm wanted exposure aligned with its risk assessment; lung and kidney cancer trials with Merck are still under way.

Takeaway: Intismeran is the strongest late-stage evidence so far that Moderna can extend mRNA beyond respiratory vaccines, but investors still need full Phase 3 data, regulatory approval, scalable manufacturing and positive results in other cancers; the failed CMV trial shows success is not assured.