Jeff Meacham

Jeff Meacham from Citigroup Inc. questioned if monthly dosing is the longest feasible interval for 3944 while preserving efficacy, or if longer intervals like every two months are possible. He also asked about the nature of planned Phase 3 studies, specifically if they would include standard metabolic studies, inflammation/neuropsych indications, or GLP-1 active comparator studies to differentiate the program.

Answer

Dr. Chris Boshoff, Chief Scientific Officer, Pfizer, confirmed that 3944 is aimed at monthly maintenance therapy, but mentioned another peptide in Phase 1 with potential for three-monthly administration. He outlined initial Phase 3 programs (VESPER-4, VESPER-5, VESPER-6) for patients with and without type 2 diabetes, including monthly dosing, and indicated that beyond cardiovascular and metabolic studies, Pfizer is exploring other opportunities for differentiation, including combinations and new indications.

An analyst on behalf of Jeff Meacham inquired about physician feedback on the use of pTau217 blood testing during the screening process for Alzheimer's patients.

Answer

Chief Medical Officer Dr. Eric Siemers stated that using pTau217 testing in the ALPITUDE study was highly effective, reducing the PET scan screen failure rate from over 60% to 17% and cutting screening costs by approximately 40%. He reported positive feedback from clinicians, noting that the FDA-approved test is expanding the diagnostic pipeline, with adoption seen even among primary care physicians.

On behalf of Jeff Meacham at Citigroup, an analyst asked how the push for a universal vaccine might impact partnership discussions for Novavax's flu and CIC candidates. They also inquired how the company plans to fund its expansion into new areas like oncology, based on projected cash flow from the Sanofi collaboration.

Answer

President, CEO & Director John Jacobs dismissed concerns about a universal vaccine, noting it has been an unsuccessful scientific endeavor for decades and does not impede current partnership talks. EVP, CFO & Treasurer Jim Kelly addressed funding, explaining the strategy is not for Novavax to become an oncology company, but to generate compelling data to encourage oncology-focused firms to license its Matrix-M adjuvant. Jacobs confirmed that these exploratory R&D efforts are fully accounted for within the company's current lean financial plan.

Jeff Meacham of Citigroup asked if positive data for tirzepatide in broader settings, like diabetes prevention or a successful CVOT, would be a tipping point for reimbursement.

Answer

Executive Patrik Jonsson noted such data would help drive employer opt-in. CEO David Ricks added that reimbursement will grow steadily from an accumulation of data over time, not from a single event, though these data sets would be compelling.