IGM Biosciences (IGMS) Jefferies 2024 Global Healthcare Conference summary

Recent clinical progress and updates

• Completed enrollment in a randomized aplitabart study for mCRC, exceeding the target with 127 patients enrolled; data expected by end of 2024 or early 2025.

• First dose cohort completed in the rheumatoid arthritis study using imvotamab, with data anticipated in a similar timeframe.

• Over-enrollment in trials reflects strong investigator interest and momentum.

Aplitabart program and regulatory strategy

• Interim PFS data from the randomized mCRC trial expected in Q1 2025, with historical control arm median PFS at six months.

• A 20% or greater improvement in PFS over control is considered a clinically meaningful and potentially approvable endpoint.

• Accelerated approval may be possible if robust PFS data are observed, but a pivotal study with substantial enrollment will still be required.

• Final approval is expected to rely on PFS as the primary endpoint, with overall survival less emphasized.

• Accelerated approval would not significantly alter the overall timeline due to the short PFS window.

Dose selection and Project Optimus

• 10 mg/kg arm in third-line mCRC is fully enrolled; data readout expected by end of 2024 or early 2025.

• Lower 3 mg/kg dose is preferred for pivotal studies unless 10 mg/kg shows substantially superior efficacy.

• Higher doses may increase infusion times and risk of reactions, so FDA acceptance of the lower dose is anticipated if efficacy is comparable.