Geron (GERN) H.C. Wainwright 28th Annual Global Investment Conference summary

Commercial performance and growth strategy

• RYTELO, a first-in-class telomerase inhibitor for low-risk MDS, launched in July 2024 and has shown consistent quarterly growth, with Q2 net revenue reaching $57.5 million, the highest since launch.

• Revenue guidance for 2026 is $220 million-$240 million, with current trends indicating results toward the higher end of this range.

• Focus has shifted from academic centers to high-volume community accounts, with 34% of business now from first- and second-line settings.

• New account acquisition remains strong, with 100-200 new accounts per quarter, while efforts are increasing to deepen penetration within existing accounts.

• The addressable U.S. patient population is significant, and international expansion is under consideration, with a European strategy update expected by year-end.

Market dynamics and medical positioning

• NCCN Guidelines have been updated twice to position RYTELO as a second-line therapy, supporting its uptake as treatment paradigms shift.

• Luspatercept's move to first-line has created more opportunities for RYTELO in the second-line setting, with ongoing ELEMENT study potentially expanding the market.

• Physician education and simplified messaging are prioritized to drive adoption in community settings, where most patients are treated.

• The company expects gradual, sustained growth in line with hematology market trends, aiming to match or exceed benchmarks set by other therapies in the space.

Pipeline and future catalysts

• The IMpactMF phase III trial in relapsed/refractory myelofibrosis is fully enrolled, with an interim overall survival readout expected in the second half of the year.

• Regulatory discussions are ongoing to align on interim analysis criteria, with confidence in the final analysis based on prior IMbark trial data.

• Imetelstat is currently the only drug with potential approval in the post-JAK myelofibrosis setting within the next 24 months.

• The company is preparing for long-term growth, leveraging a strong cash position and new business development leadership to explore additional opportunities.

• Key upcoming catalysts include continued U.S. growth, ex-U.S. strategy announcement, and major phase III trial readouts.