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Jun 30, 2023
Design Therapeutics Q2 2023 Earnings Report
Design Therapeutics reported second quarter 2023 financial results and provided pipeline update.
Key Takeaways
Design Therapeutics reported initial data from Phase 1 multiple-ascending dose trial of DT-216 for Friedreich Ataxia showed significant increase in FXN mRNA Levels in Skeletal Muscle. The company had $303.1 million in cash and securities, expected to support operating runway through 2026.
Reported initial data from Phase 1 MAD trial demonstrating proof-of-concept for DT-216 for FA.
Design plans to resume a multiple dose Phase 1 clinical study with DT-216 with an improved formulation in the second half of 2024 and report data in the first half of 2025.
IND submission for FECD GeneTAC™ Program is on-track for the second half of 2023.
Cash and securities of $303.1 million are expected to support operating runway through 2026.
Forward Guidance
Design Therapeutics anticipates several milestones and continued progress in its GeneTAC™ pipeline, including IND submissions and clinical trial advancements.
Positive Outlook
- Resuming clinical development in FA and announcing data therefrom and the timing thereof
- Design’s ability to improve the formulation of DT-216 to prevent injection site thrombophlebitis or other limiting side effects
- Design’s anticipated timeline to submit an IND for DT-168 in the second half of 2023
- Design’s anticipated timeline to select a development candidate and submit an IND for its GeneTAC™ program for the treatment of DM1 in the second half of 2024
- The potential of Design’s GeneTAC™ small molecules to be a new class of therapies for patients suffering from devastating genetic diseases
Challenges Ahead
- Risks associated with the acceptance of INDs by the FDA for the conduct of planned clinical trials of our product candidates and our proposed design of future clinical trials
- Risks associated with designing and implementing investigational drug product formulation improvements
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