Immunome (IMNM) H.C. Wainwright 28th Annual Global Investment Conference summary

Trial design and efficacy

• Phase 3 RINGSIDE randomized adults with desmoid tumors progressing within 12 months to varegacestat 1.2 mg once daily (n=79) or placebo (n=77); primary endpoint was PFS by BICR.

• Varegacestat reduced the risk of radiographic progression or death by 84% vs placebo (HR 0.16; p<0.0001).

• ORR was 55.7% vs 9.1%; at week 24, tumor volume changed by -109.6 cm³ vs +122.8 cm³ (difference -232.4 cm³; p<0.0001).

• At week 12, worst pain intensity changed by -2.24 points vs +0.18 with placebo (difference -2.42; p<0.0001).

Patient-reported outcomes

• Exploratory analyses showed fast, sustained, clinically meaningful improvements in pain, desmoid tumor symptoms and physical functioning, favoring varegacestat at all prespecified timepoints.

• GODDESS DTSS used a 7-day daily diary and PROMIS Physical Function 10a was completed at baseline and every 4 weeks; analyses used the ITT population.

• Baseline mean worst pain intensity was 4.43 vs 4.94; the clinically meaningful improvement threshold was -1.62.

• Baseline symptom burden was ~4 and baseline physical-function scores averaged ~45; clinically meaningful thresholds were -1.16 for symptoms and +3.10 for physical function.

Portfolio and varegacestat

• Portfolio includes at least 10 ADCs against novel targets and one radioligand program, with development focused mainly on ADCs.

• Varegacestat was developed through Phase III following CMC investment; its application has been filed with a PDUFA date, and plans include a global launch.

• Desmoid tumors affect ~1,650 new U.S. patients annually, with ~11,000 prevalent cases; Phase III average treatment duration was 20 months, while the CEO estimated ~16 months in practice.

• A retreatment study is underway to assess restarting varegacestat after a treatment break and potentially support an FDA label.

• Some patients reported pain relief within 2–3 weeks; the CEO cited dramatic anti-tumor activity in ~95% of patients and a single-pill, once-daily formulation expected shortly after approval.