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13 Mar, 2025
Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company specializing in microRNA-targeted medicines, has announced its financial results for the fourth quarter and full year ending December 31, 2024, along with recent corporate developments.
Program Updates
Regulus reported significant progress in the development of farabursen for Autosomal Dominant Polycystic Kidney Disease (ADPKD). An interim analysis of 14 subjects from the fourth cohort in the Phase 1b MAD trial demonstrated encouraging safety and tolerability, as well as signs of a dose-dependent response. The data suggested an increase in polycystin biomarker levels and a potential reduction in kidney volume growth rate. The full topline results from all 26 subjects in the cohort are expected in the coming weeks.
The company also confirmed alignment with the FDA on key aspects of a single pivotal Phase 3 trial design. This includes an interim analysis for potential Accelerated Approval based on a 12-month total kidney volume endpoint, aiming to expedite the availability of farabursen for ADPKD patients with limited treatment options.
Financial Results
As of December 31, 2024, Regulus reported $75.8 million in cash, cash equivalents, and short-term investments, with an expected cash runway extending into early 2026.
Research & Development (R&D) Expenses: $9.7 million in Q4 2024 ($35.4 million for the full year), compared to $5.8 million and $21.2 million in 2023, respectively.
General & Administrative (G&A) Expenses: $4.1 million in Q4 2024 ($14.7 million for the full year), compared to $2.5 million and $10.0 million in 2023.
Net Loss: $12.8 million ($0.20 per share) in Q4 2024, with a full-year net loss of $46.4 million ($0.82 per share), compared to $8.1 million ($0.40 per share) and $30.0 million ($1.58 per share) in 2023.
Regulus remains focused on advancing farabursen through clinical development and continues to strengthen its financial position to support future growth.