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Jun 30, 2024
Regulus Therapeutics Q2 2024 Earnings Report
Regulus Therapeutics reported financial results for Q2 2024 and provided corporate updates.
Key Takeaways
Regulus Therapeutics reported a net loss of $11.0 million for the second quarter of 2024 and ended the quarter with $95.9 million in cash, cash equivalents, and investments.
Announced positive topline data from the third cohort of patients in the Phase 1b MAD study of RGLS8429 in ADPKD.
Advanced to the fourth cohort of patients in the Phase 1b MAD study of RGLS8429 in ADPKD.
Appointed Rekha Garg, M.D., M.S., to Chief Medical Officer.
Ended second quarter 2024 with cash, cash equivalents, and investments of $95.9 million, expecting the cash runway to extend into H1 2026.
Regulus Therapeutics
Regulus Therapeutics
Forward Guidance
Regulus is on track for an End-Of-Phase 1 meeting by year-end and expects initial topline data from the fourth cohort of patients in early 2025.
Positive Outlook
- On track for an End-Of-Phase 1 meeting by year-end
- Patients in the fourth cohort will receive an open label, 300 mg fixed dose of RGLS8429 administered every other week for three months.
- Expects initial topline data from the fourth cohort are expected in early 2025
- RGLS8429 was well tolerated with no safety concerns.
- Regulus plans to request an end of Phase 1 meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2024 and discuss the potential for a pivotal Phase 2/3 study of RGLS8429 under an Accelerated Approval regulatory pathway.
Challenges Ahead
- The approach we are taking to discover and develop drugs is novel and may never lead to marketable products
- Preliminary or topline results are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and may not be indicative of future results
- The FDA has not designated RGLS8429 for an Accelerated Approval pathway and such designation may not lead to a faster development, regulatory review or approval process and does not increase the likelihood that RGLS8429 will receive marketing approval
- Preclinical and clinical studies may not be successful
- Additional toxicology data may be negative