Oncology pipeline and intismeran
Q: Salveen Richter with Goldman Sachs asked about confidence in the renal cell carcinoma interim data and the role of LNP in immunogenicity.
A: David Berman stated the renal cell carcinoma trial is event-driven and likely to read out late this year or early next year, noting confidence due to the T-cell sensitive nature of the disease. Regarding LNP, he noted that evidence is not strong enough to claim it drives immunogenicity.
Q: Terence Flynn with Morgan Stanley asked about pricing inputs for intismeran and if Phase II renal cell carcinoma data could support registration.
A: Stephen Hoge said it is premature to discuss pricing, while David Berman noted that while the renal cell carcinoma study is a large Phase II, it is primarily practice-informing, though strong results could lead to FDA discussions.
Q: Eliana Merle with Barclays asked about next steps for pancreatic cancer and disclosure plans for renal cell carcinoma.
A: David Berman said they are discussing next steps for pancreatic cancer with Merck, and they have not decided how to handle disclosure for the renal cell carcinoma interim analysis.
Q: Edward Tenthoff with Piper Sandler asked about the BLA status for intismeran and lung cancer study timelines.
A: Stephen Hoge confirmed they are working with Merck to submit the BLA this year, while David Berman noted the lung cancer program is comprehensive and it is too soon to provide specific timing for readouts.
Q: Alec Stranahan with Bank of America asked about the 2808 ASH data and the broader oncology opportunity.
A: David Berman explained that 2808 targets three antigens, and the ASH data will include more patients and longer follow-up, demonstrating the platform's ability to multiplex.
Q: Tyler Van Buren with TD Cowen asked about renal cell carcinoma immunogens and endogenous retroviral elements.
A: David Berman stated their algorithm includes indels and neoantigens, and that endogenous retroviral elements are speculative and require more research.
Q: Andrew Tsai with Jefferies asked about FDA approval for the algorithm and the competitive moat.
A: Stephen Hoge noted the algorithm is part of the drug and proprietary, and that their data is a gold mine that provides a significant advantage.
Q: Michael Yee with UBS asked about renal cell carcinoma protocol assumptions and melanoma filing timing.
A: David Berman declined to comment on protocols and said to stay tuned for filing updates.
Q: Courtney Breen with Bernstein asked about pancreatic cancer efficacy signals.
A: David Berman stated it is too early to discern an efficacy signal, though immunogenicity and safety data are positive.
Q: Alexandria Hammond with Wolfe Research asked about the optimal number of neoantigens.
A: David Berman said they are decoding this with Phase III data, noting that 34 was sufficient in melanoma.
Q: Jess Fye with JPMorgan asked about data availability for neoantigen analysis.
A: David Berman confirmed they have more patients available and are developing novel ways to decode T-cell reactivity.
Q: Luca Issi with RBC asked about renal cell carcinoma stratification and subpopulations.
A: David Berman stated they believe the approach can work across multiple subpopulations.
Financials and guidance
Q: Alec Stranahan with Bank of America asked how much of the 2026 growth guidance increase came from timing.
A: Jamey Mock stated the growth is broad-based across U.S. and international markets and is not just a timing issue.
Q: Courtney Breen with Bernstein asked about the durability of international revenue.
A: Jamey Mock noted that a significant portion of international revenue is durable and represents over 50% of total revenue.
Infectious disease portfolio
Q: Myles Minter with William Blair asked about changes to the norovirus program.
A: Stephen Hoge explained that because the program did not meet early success criteria, they decided not to enroll an additional cohort and will consult with regulators first.
Q: Luca Issi with RBC asked about the timeline for the COVID plus flu combo vaccine in the U.S.
A: Stephen Hoge said they will engage with the FDA after the current flu and COVID vaccine launch and will provide an update in the coming months.
