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Edge16 Oct 2026
Winner, Winner: The Chicken McNugget Story
How a 1940s breeding contest, a Cornell food scientist, and a hedge by Ray Dalio helped McDonald's turn the Chicken McNugget into a fast-food icon.
Regulus Therapeutics
Regulus Therapeutics (RGLS) investor relations material
Regulus Therapeutics has been delisted
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.
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Latest events from Regulus Therapeutics
- RGLS8429 shows promising safety and efficacy in ADPKD, with pivotal trials and FDA talks ahead.RGLS
Piper Sandler 36th Annual Healthcare Conference - Promising miR-17 inhibitor for ADPKD shows kidney volume reduction; pivotal trial set for 2024.RGLS7th Annual Evercore ISI HealthCONx Healthcare Conference
- Pivotal ADPKD trial for RGLS8429 set for mid-next year, targeting high unmet need and FDA alignment.RGLSH.C. Wainwright 26th Annual Global Investment Conference 2024
- Lead ADPKD therapy shows strong early results; pivotal trial and FDA alignment expected by 2025.RGLS2024 Wells Fargo Healthcare Conference
- Phase 1b data show kidney volume reduction and strong safety, de-risking pivotal ADPKD trials.RGLSCanaccord Genuity 44th Annual Growth Conference & Private Company Showcase 2024
- Phase I-B data show RGLS8429 reduces kidney volume in ADPKD, de-risking phase II pivotal trial.RGLSH.C. Wainwright 3rd Annual Kidney Virtual Conference
- RGLS8429 at 3 mg/kg improved polycystin and reduced kidney volume in most ADPKD patients.RGLSStudy Update
- Phase III trial for Farabursen in ADPKD to start in 2025, aiming for accelerated FDA approval.RGLSLeerink’s Global Healthcare Conference 2025
- Farabursen advances to phase III for ADPKD, showing strong safety, efficacy, and market potential.RGLSOppenheimer 35th Annual Healthcare Life Sciences Conference (Virtual) 2025
- FDA-aligned Phase III trial of farabursen in ADPKD shows strong safety and efficacy signals.RGLSStatus Update
Regulus Therapeutics
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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.