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Mar 31, 2021
Regulus Therapeutics Q1 2021 Earnings Report
Regulus Therapeutics' financial results for Q1 2021 and recent updates were reported, highlighting target engagement in the first-ever study of RGLS4326 in patients with ADPKD.
Key Takeaways
Regulus Therapeutics reported financial results for the first quarter ended March 31, 2021. Noteworthy is the data from the first cohort of the phase 1b clinical trial of RGLS4326 for ADPKD treatment, where mean increases in Polycystin 1 (PC1) and Polycystin 2 (PC2) were observed.
RGLS4326 demonstrated target engagement in ADPKD patients, showing increases in Polycystin 1 and 2.
The second cohort of the RGLS4326 study is underway, with data expected mid-2021.
RGLS4326 was well tolerated in the first cohort of patients with no serious adverse events reported.
Regulus plans to submit data from the first cohort to the FDA this summer.
Regulus Therapeutics
Regulus Therapeutics
Forward Guidance
Regulus Therapeutics plans to submit data from the first cohort to the FDA this summer and discuss its approach to addressing the remaining Partial Clinical Hold requirements with FDA in mid-2021.
Positive Outlook
- RGLS4326 was well tolerated by all nine patients with no serious adverse events reported.
- All reported adverse events were mild and generally transient in nature.
- Concentrations of RGLS4326 in plasma were greater in patients, suggesting a lower dose in patients could achieve the desired exposure in the kidney.
- Data from this first cohort is planned to be submitted for presentation at PKD Connect in June 2021 and at Kidney Week in November 2021.
- Move into the new corporate headquarters was completed in April 2021.
Challenges Ahead
- RGLS4326 IND is currently on a partial clinical hold for treatment of extended duration by FDA
- The Company will use information from the Phase 1 clinical studies to address the second set of requirements outlined in the Partial Clinical Hold letter
- The extent of the impact on Regulus’ ability to achieve its preclinical and clinical development objectives and the value of and market for its common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time
- Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and in the endeavor of building a business around such drugs, and feedback from the FDA.
- Regulus expects the COVID-19 pandemic to adversely affect its business operations and financial results