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Sep 30, 2022
Regulus Therapeutics Q3 2022 Earnings Report
Regulus Therapeutics reported financial results for the third quarter ended September 30, 2022 and provided a corporate update.
Key Takeaways
Regulus Therapeutics reported a net loss of $7.6 million, or $0.50 per share, for the third quarter ended September 30, 2022. The company's cash, cash equivalents, and short-term investments totaled $45.3 million as of September 30, 2022, which is expected to fund planned activities through 2023. The company announced the dosing of the first patient in the Phase 1b MAD study of RGLS8429 for the treatment of ADPKD.
First patient dosed in Phase 1b Multiple-Ascending Dose (MAD) study of RGLS8429 in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Positive topline safety and pharmacokinetic (PK) data from Phase 1 Single-Ascending Dose (SAD) study of RGLS8429 in healthy volunteers for the treatment of ADPKD.
Raised $4.5 million in net proceeds through its At-the-Market (ATM) facility.
RGLS8429 was well-tolerated, with no serious adverse events reported in Phase 1 SAD clinical trial.
Regulus Therapeutics
Regulus Therapeutics
Forward Guidance
Regulus Therapeutics anticipates topline data from the first cohort of patients in mid-2023 and believes its existing cash will fund activities through 2023.
Positive Outlook
- Anticipate topline data from the first cohort of patients in mid-2023.
- Existing cash, cash equivalents, and short-term investments as of September 30, 2022 will provide cash resources to fund current planned activities through 2023.
- RGLS8429 has a favorable safety and PK profile.
- RGLS8429 was well-tolerated with no serious adverse events reported.
- Preliminary results suggest plasma exposure is approximately linear across the four doses evaluated and is similar to the PK data from the first-generation compound.
Challenges Ahead
- 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
- Ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease.
- 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
- The risk additional toxicology data may be negative
- COVID-19 pandemic to adversely affect its business operations and financial results