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Regulus Therapeutics (RGLS) investor relations material
Regulus Therapeutics Q1 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q1 2025 earnings summary8 May, 2025
Executive summary
Entered into a definitive merger agreement with Novartis AG for $7.00 per share in cash plus a $7.00 CVR, for total equity value up to $1.7 billion, pending regulatory and shareholder approval, expected to close in H2 2025.
Farabursen (RGLS8429) for ADPKD advanced through Phase 1b with positive topline results across all cohorts, showing mechanistic dose response and halted kidney volume growth, with constructive FDA feedback on an accelerated approval pathway.
On track to initiate a pivotal Phase 3 trial for farabursen in Q3 2025, following FDA alignment on trial design and endpoints.
Cash, cash equivalents, and short-term investments totaled $65.4 million as of March 31, 2025, expected to fund operations through Q1 2026.
Net loss increased to $9.6 million for Q1 2025, up from $8.5 million in Q1 2024, driven by higher R&D and G&A expenses.
Financial highlights
Q1 2025 research and development expenses were $6.8 million, up from $6.0 million in Q1 2024, mainly due to clinical advancement of the ADPKD program and increased stock-based compensation.
General and administrative expenses rose to $3.7 million, a 33% increase year-over-year, primarily from higher stock-based compensation.
Interest and other income was $0.9 million, up from $0.4 million in Q1 2024, reflecting higher interest income.
Net cash used in operating activities was $10.6 million for Q1 2025, compared to $8.7 million in Q1 2024.
No revenue from product sales; accumulated deficit reached $569.2 million as of March 31, 2025.
Outlook and guidance
Existing cash resources expected to fund operations through Q1 2026; additional capital will be required if the Novartis merger is not completed.
If the merger fails, the company may need to scale back operations, seek additional financing, or consider strategic alternatives.
Phase 3 pivotal trial for farabursen in ADPKD planned to start in Q3 2025, with a 12-month htTKV endpoint for Accelerated Approval and a 24-month eGFR endpoint for Full Approval.
Farabursen is positioned for a pivotal Phase 3 trial, with potential for accelerated approval based on FDA feedback.
What milestone triggers the CVR payment?
Assess farabursen's safety profile at 300mg.
When is the Novartis acquisition expected to close?
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Frequently asked questions
Regulus Therapeutics Inc. is a clinical-stage biopharmaceutical company specializing in the development of innovative drugs that target microRNAs. These microRNAs play a crucial role in regulating gene expression, and by modulating them, Regulus aims to treat a variety of diseases. The company's primary focus is on developing treatments for genetically based kidney diseases, particularly Autosomal Dominant Polycystic Kidney Disease (ADPKD), with its lead candidate RGLS8429 currently in clinical trials. The company is headquartered in San Diego, California, and its shares are listed on the NASDAQ.
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