Mara Goldstein

Mara Goldstein asked why 2026 guidance was not provided immediately, when it would be released, and what context (e.g., total revenue, product breakdown, conservative vs. mean) investors should expect for the upcoming guidance.

Answer

Frederick Vogt, Interim CEO and President, explained that due to remarkable growth in the Amtagvi business, more time is needed to ensure projections are well-supported, but guidance will be released very soon. He expects total product guidance, potentially with quarterly breakdowns, and reiterated that Proleukin revenue for 2025 aligned with prior expectations (around 17% of total revenue), with ordering patterns stabilizing.

Asked how FT819 compares to the broader field of CARs in autoimmunity, whether it's seen as a 'bridge' to other constructs, and how many U.S. sites will be initiated for the autoimmune study.

Answer

The company stated it's too early for the field to determine the optimal therapeutic requirements for cell therapies in autoimmunity and that much will be learned in the coming months. Regarding trial sites, they are partnering with their experienced oncology sites (12-15 are open for the 819 oncology study) to collaborate with autoimmune specialists, facilitating a smoother start.

Asked about the timing of potential milestones for XmAb306, the positioning of vudalimab in renal cell carcinoma, and the timeline for the CFO search.

Answer

The company cannot yet speculate on the timing of XmAb306 milestones. They are not planning to pursue RCC with vudalimab despite positive competitor data for the drug class in that indication. The search for a new CFO has already begun.

Mara Goldstein of Cantor Fitzgerald questioned if the SNS-062 trial would still use twice-a-day dosing and how the planned daily dose would compare to levels tested in the healthy volunteer study. She also asked about the commercial strategy for Europe, specifically if the company was considering multiple partners to cover different geographies.

Answer

Debbie Thomas, SVP of Regulatory Affairs, confirmed a twice-a-day dosing regimen for SNS-062, supported by its half-life, and noted that dose escalation could exceed the total daily dose tested in the single-dose study. On the commercial front, President and CEO Dan Swisher stated they are only looking at European-wide partnerships. CFO Eric Bjerkholt added that the company is actively engaged in pre-commercial efforts, including KOL advocacy and supply chain establishment, to position a partner for success.