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Mar 31, 2022
Regulus Therapeutics Q1 2022 Earnings Report
Regulus Therapeutics reported financial results for the first quarter ended March 31, 2022 and provided a corporate update.
Key Takeaways
Regulus Therapeutics reported a net loss of $6.7 million, or $0.05 per share, for the first quarter ended March 31, 2022. The company's cash and cash equivalents totaled $53.9 million as of March 31, 2022. The FDA accepted the IND application for RGLS8429, and a research collaboration was entered with Brigham and Women’s Hospital.
FDA accepted IND application for RGLS8429 for ADPKD, with Phase 1 study initiation on track for Q2 2022.
Collaboration agreement established with Brigham and Women’s Hospital to explore miR-155 inhibitors for ALS.
Research and development expenses were $3.7 million for the three months ended March 31, 2022.
Net loss was $6.7 million, or $0.05 per share, for the three months ended March 31, 2022.
Regulus Therapeutics
Regulus Therapeutics
Forward Guidance
Regulus expects to advance its pipeline, initiate a Phase 1 study for RGLS8429 in Q2 2022, and provide updates on its collaboration with Brigham and Women’s Hospital.
Positive Outlook
- Initiate Phase 1 study for RGLS8429 in the second quarter of 2022.
- Advance clinical and preclinical pipeline.
- Top-line data from the healthy volunteer study are expected in the second half of 2022.
- Top-line biomarker data for the first cohort of RGLS8429-treated patients with ADPKD are expected in the first half of 2023.
- Final data from Sanofi's Phase 2 HERA clinical study evaluating lademirsen for Alport Syndrome are expected in the first half of 2023 and, if successful, could earn the Company a $25 million milestone.
Challenges Ahead
- Risks associated with discovering, developing, and commercializing drugs.
- Risk that additional toxicology data may be negative.
- COVID-19 pandemic could adversely affect business operations and financial results.
- Dependence on future developments related to the COVID-19 pandemic.
- Travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries.