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Mar 31
Regulus Therapeutics Q1 2025 Earnings Report
Regulus Therapeutics reported its first quarter 2025 financial results, highlighting its acquisition by Novartis and positive farabursen clinical trial data.
Key Takeaways
Regulus Therapeutics reported a net loss of $9.6 million for Q1 2025, compared to $8.5 million in Q1 2024. The company announced its acquisition by Novartis for an initial payment of $7.00 per share in cash, with potential for an additional $7.00 per share through a CVR. Positive topline data from the Phase 1b MAD study of farabursen for ADPKD was also reported, showing a mechanistic dose response and halted kidney volume growth.
Regulus Therapeutics entered into an agreement to be acquired by Novartis for $7.00 per share in cash, with a potential additional $7.00 per share through a CVR.
The acquisition is expected to be completed in the second half of 2025, subject to customary closing conditions.
Positive topline data from the completed fourth cohort of the Phase 1b MAD study of farabursen for ADPKD showed a mechanistic dose response and halted kidney volume growth.
The company is on track to initiate a Phase 3 single pivotal trial for farabursen in the third quarter of 2025.
Regulus Therapeutics
Regulus Therapeutics
Forward Guidance
Regulus Therapeutics expects its cash runway to extend into early 2026 and plans to initiate a pivotal Phase 3 trial for farabursen in the third quarter of 2025.
Positive Outlook
- Expected completion of the acquisition by Novartis in the second half of 2025, subject to customary closing conditions.
- Initiation of the pivotal Phase 3 trial for farabursen is planned for the third quarter of 2025.
- Alignment with the U.S. Food and Drug Administration (FDA) on the acceptability of the program's CMC, non-clinical, and clinical pharmacology plans.
- Confirmation of key elements of the trial design, including a 12-month htTKV endpoint for Accelerated Approval and a 24-month eGFR endpoint for Full Approval.
- Cash runway expected to extend into early 2026.
Challenges Ahead
- Uncertainties regarding the timing and completion of the tender offer and merger.
- Uncertainties regarding the percentage of Company stockholders tendering their shares.
- Possibility of competing offers being made.
- Risk that closing conditions for the tender offer or merger may not be satisfied or waived, including failure to receive required regulatory approvals.
- Risks related to the Company's liquidity during the pendency of the tender offer or in the event of a termination of the Merger Agreement.