4D Molecular Therapeutics (FDMT) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Pipeline and clinical development

• Lead program 4D-150 is in phase III for wet AMD, with two fully enrolled trials; first readout expected Q2 next year, second in the second half of next year.

• Phase III trial for DME with 4D-150 to be initiated by end of the month.

• 4D-710 program in CF will have an operational update by year-end.

• Cash position of $458 million as of June 30, with runway into the second half of 2028.

Clinical trial design and differentiation

• 4D-150 expresses aflibercept, aiming for non-inferiority to EYLEA in vision outcomes and significant reduction in injection burden.

• Phase III trials (4FRONT-1 and 4FRONT-2) focus on treatment-naive and mixed populations, aligning with regulatory requirements.

• PRISM data shows 80%+ reduction in treatment burden with vision preservation, especially pronounced in newly diagnosed patients.

• Trial design includes expert-guided retreatment criteria to balance real-world relevance and clinical rigor.

Market landscape and commercial strategy

• Wet AMD treatment has evolved from frequent injections to attempts at extending durability; current therapies offer only incremental improvements.

• Real-world data shows high variability in injection frequency, with many patients receiving more frequent dosing than label recommendations.

• 4D-150 aims for a paradigm shift by offering continuous therapy and substantial reduction in treatment burden.

• Commercial launch planned without a strategic partner, leveraging a nimble team to target a concentrated retina specialist market.