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Dec 31, 2021
Regulus Therapeutics Q4 2021 Earnings Report
Regulus Therapeutics reported financial results for Q4 2021 and year-end, highlighting the successful completion of a Pre-IND meeting with the FDA for ADPKD program, being on track to submit IND and initiate Phase 1 study in Q2 2022, completion of enrollment in Phase 2 clinical trial of Lademirsen for Alport Syndrome, and closing a $34.6 million private placement of equity.
Key Takeaways
Regulus Therapeutics reported a net loss of $7.1 million for Q4 2021. The company successfully completed a Pre-IND meeting with the FDA for its ADPKD program and closed a $34.6 million private placement of equity.
Successfully completed Pre-IND meeting with FDA for Autosomal Dominant Polycystic Kidney Disease (ADPKD) Program
On track to submit IND and Initiate Phase 1 study in second quarter 2022
Enrollment completed in Phase 2 clinical trial of Lademirsen for Alport Syndrome
Closed $34.6 million private placement of equity extending cash runway through 2023
Regulus Therapeutics
Regulus Therapeutics
Forward Guidance
The company is on track with an IND filing and initiation of our Phase 1 clinical study and with the recent equity financing we believe the Company is poised and capitalized to deliver on upcoming milestones.
Positive Outlook
- On track to submit IND and Initiate Phase 1 study in second quarter 2022
- Company anticipates reporting top-line data from the healthy volunteer portion of the study in the second half of 2022
- Company anticipates reporting top-line biomarker data in the first cohort of RGLS8429-treated patients with ADPKD in the first half of 2023.
- Final data is expected in the first half of 2023 and if successful could provide further validation of the Company’s platform technology designed to address genetic kidney diseases and earn the Company a $25 million milestone, furthering the cash runway into 2024.
- SVB Leerink acted as the lead placement agent for the financing and H.C. Wainwright and Co. acted as co-placement agent.
Challenges Ahead
- 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 the risk additional toxicology data may be negative.
- 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
- Travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries
- The effectiveness of actions taken globally to contain and treat the disease.
- All forward-looking statements contained in this press release speak only as of the date on which they were made