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Jun 30, 2024
4DMT Q2 2024 Earnings Report
Reported second quarter 2024 financial results and provided operational highlights.
Key Takeaways
4DMT reported second quarter 2024 financial results, highlighting positive interim results from the Phase 2 PRISM clinical trial for 4D-150 in wet AMD, strengthened senior leadership, and $578 million in cash and equivalents as of June 30, 2024.
Announced positive interim results from the Population Extension cohort of the Phase 2 PRISM clinical trial for 4D-150 in a broad wet age-related macular degeneration (wet AMD) population, affirming favorable safety profile and robust clinical activity
Strengthened senior leadership team and announced formation of a world class Ophthalmology Advisory Board to drive late-stage development of 4D-150 in wet AMD and diabetic eye diseases
PRISM Phase 1/2 interim data are expected to be presented at the 24th EURETINA Congress on September 19, 2024
U.S. Food and Drug Administration (FDA) removed clinical hold on the Phase 1/2 INGLAXA study for 4D-310 in Fabry disease cardiomyopathy; enrollment expected to resume in H2 2024
Revenue by Segment
Forward Guidance
4DMT anticipates several milestones, including presenting interim data from the PRISM clinical trial at the EURETINA Congress in September 2024, initiating the first Phase 3 clinical trial for 4D-150 in wet AMD in Q1 2025, and providing interim data from the SPECTRA Phase 2 trial in Q4 2024.
Positive Outlook
- Interim longest available follow up data up to 2.5 years from its Phase 1/2 PRISM clinical trial evaluating intravitreal 4D-150 in wet AMD are expected to be presented at the 24thEURETINA Congress on September 19, 2024
- 52-week landmark analyses for both 1) severe disease activity (Dose Expansion) & 2) broad wet AMD disease activity (Population Extension) cohorts of PRISM expected in February 2025
- First Phase 3 clinical trial initiation expected in Q1 2025
- Interim data from SPECTRA Phase 2 Part 1 Dose Confirmation cohort (n=22) expected in Q4 2024
- Phase 1 enrollment for 4D-175 is expected to begin in H2 2024
Challenges Ahead
- Interim data update from AEROW clinical trial is expected in mid-2025
- Phase 3 initiation for 4D-710 is expected in H2 2025
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