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Dec 31, 2022
Regulus Therapeutics Q4 2022 Earnings Report
Reported financial results for the fourth quarter and year ended December 31, 2022, and provided a corporate update.
Key Takeaways
Regulus Therapeutics reported its Q4 and year-end 2022 financial results, highlighting the progress of its Phase 1b MAD study of RGLS8429 in ADPKD patients and key leadership appointments. The company ended the year with $39.2 million in cash, cash equivalents, and short-term investments.
Enrollment is progressing in the Phase 1b Multiple-Ascending Dose (MAD) study of RGLS8429 in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Top-line data in the first cohort of RGLS8429-treated ADPKD patients is anticipated in the second half of 2023.
The team was expanded with key leadership appointments in clinical development, regulatory, and clinical operations.
As of December 31, 2022, Regulus had $39.2 million in cash, cash equivalents and short-term investments.
Regulus Therapeutics
Regulus Therapeutics
Forward Guidance
Regulus Therapeutics is focused on advancing the development of RGLS8429 and expects to report top-line data from the first cohort of the Phase 1b MAD study in the second half of 2023.
Positive Outlook
- Enrollment progressing in Phase 1b MAD study of RGLS8429 in ADPKD patients.
- Top-line data in the first cohort of RGLS8429-treated ADPKD patients anticipated in the second half of 2023.
- No CNS toxicity was observed in the 27-week chronic mouse toxicity study for RGLS8429.
- The Phase 1 SAD study demonstrated that RGLS8429 has a favorable safety and PK profile.
- RGLS8429 was well-tolerated with no serious adverse events reported and plasma exposure was approximately linear across the four doses tested.
Challenges Ahead
- The company expects the 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
- The company's actual results may differ materially from those expressed or implied by forward-looking statements due to various risks and uncertainties
- Risk 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
- The risk additional toxicology data may be negative