Evan Wang

Evan Wang inquired if the resumption of the Group A Strep program reflects an updated financial position or increased confidence in the vaccine/development path, and asked about VAX-31's pre-commercialization planning and regulatory discussions on post-marketing efficacy studies.

Answer

Andrew Guggenhime, President and CFO of Vaxcyte, clarified that the decision to resume VAX-A1 development was primarily enabled by the recent public equity offering, strengthening the financial runway. Grant Pickering, CEO, explained that VAX-31's post-marketing efficacy studies are consistent with agreements made for currently marketed PCVs, involving a test-negative design surveillance approach.

Evan Wang inquired if resuming Group A Strep development reflected an updated financial position or increased confidence in the vaccine, and asked for details on VAX-31's pre-commercialization planning and regulatory discussions on post-marketing efficacy studies.

Answer

Jim Wassil, EVP and COO, confirmed that the VAX-A1 program's pause was for financial reasons, and recent financing enabled its resumption, extending the cash runway through 2028. Grant Pickering, CEO, stated that VAX-31's post-marketing efficacy studies are consistent with FDA agreements for current PCVs, involving a test-negative design surveillance approach.

Evan Wang of Guggenheim Partners asked for the timing of fuller data from the OTC program and for commentary on the influenza vaccine's immune response relative to its comparator arm.

Answer

President and CEO Joseph Payne stated that detailed comparator data for the influenza vaccine will be released by their partner, CSL, at a later date. For the OTC program, the timing for fuller data depends on the final decision of whether to proceed with the 0.7 mg/kg dose cohort. The immediate focus is on achieving alignment with the FDA on the pivotal trial design in the first half of 2026.

Evan Wang asked about potential policy barriers to vaccine use under a new U.S. administration and the company's confidence in its ex-U.S. RSV vaccine competitiveness, given competitor commentary on data sufficiency.

Answer

CEO Stéphane Bancel stated that Moderna has always worked collaboratively with government leaders and will continue to do so, as its mission to improve public health aligns with any administration's goals. Regarding ex-U.S. RSV, he noted that the ramp-up is slower due to varied approval, recommendation, and pricing negotiation timelines in international markets.

Evan Wang of Guggenheim Securities asked for a framework on the development plan for the next-generation antibody VYD2311 and questioned how the PEMGARDA treatment opportunity fits into a market with established players like PAXLOVID.

Answer

Marc Elia, Chairman, stated that development pathways for new molecules like VYD2311 are being actively designed in collaboration with the FDA, building on the precedent set by PEMGARDA. Mark Wingertzahn, SVP of Clinical Development, positioned PEMGARDA as a valuable treatment option for immunocompromised patients, citing the burdens of remdesivir and the significant drug-drug interactions associated with PAXLOVID.

Evan Wang, on behalf of Seamus Fernandez at Guggenheim Securities, asked about the cedirogant (ROR-gamma) program. He sought details on the Phase I profile that provides confidence for the Phase IIb trial, its competitive positioning against other oral psoriasis treatments, and what other indications might be appropriate for this target.

Answer

Executive Pierre Broqua explained that while the Phase Ib data is not public, it was compelling enough for AbbVie to commit to a large, 200-patient Phase IIb study. He noted that AbbVie may present the data at a future conference. For other potential indications, he highlighted areas where IL-17 inhibition is relevant, such as psoriatic arthritis, ankylosing spondylitis, and potentially rheumatoid arthritis and ulcerative colitis, based on preclinical data.

Evan Wang of Guggenheim Securities LLC asked for a comparison of Audentes' manufacturing process with Spark Therapeutics and for details on recent interactions with the European Medicines Agency (EMA).

Answer

President and CEO Matthew Patterson highlighted that Audentes uses a robust and scalable serum-free suspension culture system at a 1000L scale, which is well-suited for neuromuscular diseases. He also noted that recent feedback from the EMA was highly consistent with the FDA's, suggesting a single data package could likely support regulatory filings in both regions.