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Jun 30, 2020
Regulus Therapeutics Q2 2020 Earnings Report
Reported financial results for the second quarter ended June 30, 2020 and provided a corporate update.
Key Takeaways
Regulus Therapeutics reported their Q2 2020 financial results, highlighting the completion of dosing in the Phase 1 MAD clinical study for RGLS4326 and the FDA Orphan Drug Designation for RGLS4326 for ADPKD. They also appointed Dr. Denis Drygin as Chief Scientific Officer and are planning to initiate a Phase 1b study in patients with ADPKD.
Completed dosing in Phase 1 Multiple Ascending Dose Study of RGLS4326 in healthy volunteers for ADPKD.
Received FDA Orphan Drug Designation of RGLS4326 for ADPKD.
Appointed Denis Drygin, Ph.D., as Chief Scientific Officer.
Planning to initiate a Phase 1b study in patients with ADPKD to evaluate short-term treatment of RGLS4326.
Regulus Therapeutics
Regulus Therapeutics
Forward Guidance
Regulus Therapeutics plans to initiate a Phase 1b study in patients with ADPKD to evaluate short-term treatment of RGLS4326 for safety, tolerability, pharmacokinetics, and changes in biomarkers of the disease and commence IND-enabling activities for HBV program.
Positive Outlook
- Initiate a Phase 1b study in patients with ADPKD to evaluate short-term treatment of RGLS4326 for safety, tolerability, pharmacokinetics, and changes in biomarkers of the disease.
- RGLS4326 was well-tolerated with no serious adverse events reported.
- Preliminary results suggest plasma exposure is dose proportional.
- FDA granted Orphan Drug Designation to RGLS4326 for ADPKD.
- The Company has nominated a development candidate for HBV program.
Challenges Ahead
- RGLS4326 IND is currently on a Partial Clinical Hold for treatment of extended duration beyond the current Phase 1b study until the second set of requirements outlined by FDA have been satisfactorily addressed.
- COVID-19 pandemic to adversely affect its business operations and financial results.
- 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
- travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries
- effectiveness of actions taken globally to contain and treat the disease.