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Dec 31, 2023
Regulus Therapeutics Q4 2023 Earnings Report
Reported financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update.
Key Takeaways
Regulus Therapeutics reported positive topline data from their Phase 1b MAD study of RGLS8429, completed an oversubscribed $100 million private placement extending their cash runway into H1 2026, and completed enrollment of the third cohort of patients in the MAD study.
Shared positive topline data from the second cohort of patients in the Phase 1b MAD study of RGLS8429 for the treatment of ADPKD.
Observed greater biological activity of RGLS8429 at 2 mg/kg based on urinary polycystin levels compared to 1mg/kg and placebo.
Completed an oversubscribed $100 million private placement, expected to extend cash runway into H1 2026.
Completed enrollment of the third cohort of patients in the MAD study, with data anticipated mid-2024.
Regulus Therapeutics
Regulus Therapeutics
Forward Guidance
Regulus anticipates a busy 2024, including sharing top-line data from their third cohort expected in mid-2024, and the initiation of their fourth and final cohort of the MAD study next quarter.
Positive Outlook
- Advancing RGLS8429 program for ADPKD treatment.
- Potential accelerated approval pathway based on FDA feedback.
- Expected data readout from the third cohort in mid-2024.
- Initiation of the fourth cohort of the MAD study planned for Q2 2024.
- Extended cash runway into H1 2026.
Challenges Ahead
- Novel drug approach may not lead to marketable products.
- Preliminary results may not indicate future outcomes.
- Clinical studies may not be successful.
- Reliance on third-party collaborators poses risks.
- Requires additional capital.