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Dec 31, 2024
Disc Medicine Q4 2024 Earnings Report
Reported fourth quarter and full year 2024 financial results and provided a business update.
Key Takeaways
Disc Medicine reported its Q4 and full year 2024 financial results, highlighting a strong financial position with $490 million in cash, cash equivalents, and marketable securities. The company is targeting an NDA submission for bitopertin in H2 2025 and anticipates initiating a Phase 2 study for DISC-3405 in H1 2025.
Targeting NDA submission for bitopertin in erythropoietic protoporphyria (EPP) in H2 2025 through accelerated approval pathway.
On track to initiate APOLLO post-marketing confirmatory trial by mid-2025.
Presented positive update from Phase 1b trial of DISC-0974 in patients with anemia of myelofibrosis (MF) at ASH 2024; initial data from ongoing Phase 2 expected in H2 2025.
Presented first-in-human SAD/MAD data from Phase 1 trial of DISC-3405 demonstrating proof-of-mechanism; a Phase 2 study in polycythemia vera (PV) expected to initiate in H1 2025.
Forward Guidance
Disc Medicine anticipates several milestones in the near future, including the NDA submission for bitopertin, initiation of the APOLLO trial, and data readouts for DISC-0974 and DISC-3405.
Positive Outlook
- Targeting NDA submission for bitopertin in EPP in H2 2025.
- Initiating APOLLO post-marketing confirmatory trial by mid-2025.
- Initial data from ongoing Phase 2 of DISC-0974 in MF expected in H2 2025.
- Multiple-dose data from ongoing Phase 1b of DISC-0974 in NDD-CKD expected in H2 2025.
- Phase 2 study of DISC-3405 in PV expected to initiate in H1 2025.
Challenges Ahead
- Potential delays in clinical trial timelines.
- Uncertainties in regulatory approval pathways.
- Risks associated with drug development and commercialization.
- Dependence on successful clinical trial outcomes.
Historical Earnings Impact
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