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Sep 30, 2021
Regulus Therapeutics Q3 2021 Earnings Report
Regulus Therapeutics reported financial results for the third quarter ended September 30, 2021 and provided a corporate update.
Key Takeaways
Regulus Therapeutics reported a net loss of $8.6 million, or $0.10 per share, for the third quarter ended September 30, 2021. The company had $35.8 million in cash and cash equivalents as of September 30, 2021. The company discontinued development of RGLS4326 to focus on RGLS8429.
Advanced RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Completed validating sections of IND-enabling toxicity studies for RGLS8429.
IND submission and Phase 1 initiation expected in Q2 2022.
Presented data from first cohort of patients in Phase 1b clinical trial of RGLS4326 at ASN Kidney Week and Biomarkers for Rare Diseases Summit.
Regulus Therapeutics
Regulus Therapeutics
Forward Guidance
Regulus Therapeutics expects to have a pre-IND meeting with the FDA for RGLS8429 before year-end and is on track for an IND submission and initiation of clinical development in the second quarter of 2022, subject to FDA clearance of the IND.
Positive Outlook
- RGLS8429 has demonstrated a superior pharmacological profile.
- RGLS8429 has shown equal potency to RGLS4326 for its molecular target (miR-17) in both in-vitro and in-vivo efficacy studies.
- Company expects to have a pre-IND meeting with the FDA for RGLS8429 before year-end.
- Company is on track for an IND submission and initiation of clinical development in the second quarter of 2022.
- Phase 1 plans include a single dose escalation study in healthy volunteers to enable a multi-dose escalation study in ADPKD patients.
Challenges Ahead
- IND submission and initiation of clinical development is subject to FDA clearance of the IND.
- Reporting top-line biomarker data in the first cohort of RGLS8429-treated patients is anticipated in early 2023.
- The COVID-19 pandemic may adversely affect 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
- Additional toxicology data may be negative