Regulus Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing microRNA-targeted therapies, reported a net loss of $46.4 million for the fiscal year ending December 31, 2024, compared to a loss of $30.0 million in the previous year. The company's total operating expenses increased to $50.0 million, up from $31.1 million in 2023, primarily driven by a significant rise in research and development costs, which reached $35.4 million, reflecting the advancement of clinical trials, particularly for its lead product candidate, farabursen, aimed at treating autosomal dominant polycystic kidney disease (ADPKD).
As of December 31, 2024, Regulus had cash, cash equivalents, and short-term investments totaling approximately $75.8 million. The company raised $93.9 million in net proceeds from a private placement of common stock and non-voting convertible preferred stock in March 2024. This funding is crucial as Regulus anticipates needing additional capital to support ongoing clinical trials and operational activities. The company has incurred cumulative losses of $559.6 million since its inception in 2007 and has never generated revenue from product sales, raising concerns about its ability to continue as a going concern.
In terms of operational developments, Regulus is advancing its clinical pipeline, with farabursen currently in Phase 1b trials. The FDA granted orphan drug designation for farabursen in June 2022, and the company has reported positive topline data from multiple cohorts of the ongoing clinical study. The company also entered into a Patent & Technology License Agreement with the University of Texas Southwestern Medical Center in October 2024, enhancing its intellectual property portfolio related to microRNA therapeutics.
Regulus's workforce consisted of 34 full-time employees as of December 31, 2024, with a focus on research and development. The company continues to face significant competition in the biotechnology sector, particularly in the development of therapies for ADPKD, where existing treatments are limited. The market landscape includes several competitors with more substantial resources, which could impact Regulus's ability to capture market share if its product candidates receive regulatory approval.
Looking ahead, Regulus's management has indicated that the company will need to raise additional capital to fund its operations and clinical development programs. The ability to secure funding will depend on various factors, including the success of ongoing clinical trials, regulatory developments, and market conditions. The company is exploring multiple avenues for financing, including equity and debt offerings, but acknowledges the uncertainty surrounding future capital availability.
About Regulus Therapeutics Inc.
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