Top executives at Moderna have been projecting high confidence in the commercial future of the company's personalized cancer vaccine even as Wall Street holds out for complete trial results.
The market reacted instantly to the initial readout. Moderna shares nearly tripled last Wednesday after a late-stage trial showed a treatment combining Moderna and Merck's experimental vaccine, intismeran autogene, and Merck's Keytruda was more effective at preventing skin cancer recurrence than Keytruda alone.
Notably, investors weren't given a full dataset. Moderna and Merck plan to share more details, including the hazard ratio and subgroup analyses, at an upcoming conference-likely the meeting of the European Society for Medical Oncology in late October.
While the complete trial results remain under wraps for now, Barclays analyst Eliana Merle determined after meeting with Moderna President Stephen Hoge that Moderna "sounds very confident on commercial readiness for intismeran." The company believes it has the capacity to meet demand in melanoma initially before expanding to other tumor types, the analyst said.
Moderna sees significant long-term potential in intismeran, Merle added. As a personalized therapy driven by a proprietary algorithm, management believes the treatment is effectively protected from generic competition and loss of exclusivity.
Wall Street's attention now turns to upcoming trial data in renal cell carcinoma $(RCC)$, another key area of focus. According to Merle, Moderna indicated in recent meetings that it was pivoting its main strategic priority to RCC, stepping back from muscle-invasive bladder cancer (MIBC).
Moderna no longer expects the current Phase 2b trial in MIBC to support an immediate regulatory approval. Instead, the company views it as purely informational, aimed at gathering exploratory safety, dosing, and efficacy data rather than securing commercial clearance.
At current levels are currently "pricing in significant credit" for intismeran across multiple tumor types, Merle pointed out. While positive data in skin cancer make the pipeline less risky, high variability across tumor types warrants caution for now, she added.
Moderna stock slid on Monday as investors continued to collect profits following the previous week's historic rally. Shares fell 8.4% to $133, continuing their descent for a third day.
Leerink Partners analyst Lili Nsongo struck a wary tone in a note last week, citing regulatory scrutiny around mRNA vaccines and commercial challenges with existing products. While regulatory attitudes pose a near-term headwind, Nsongo noted that "historical failures paint a complex picture for mRNA cancer vaccines."