Regulus Therapeutics Reports $9.6 Million Net Loss in Q1 2025 Amid Increased Expenses

Regulus Therapeutics Inc. reported a net loss of $9.6 million for the first quarter of 2025, compared to a loss of $8.5 million in the same period of 2024. The company's total operating expenses increased to $10.5 million from $8.8 million year-over-year, driven primarily by higher research and development costs, which rose to $6.8 million from $6.0 million. General and administrative expenses also saw an increase, reaching $3.7 million, up from $2.8 million, largely due to non-cash stock-based compensation. The company has not generated any revenue from product sales and continues to anticipate significant losses as it advances its clinical programs.

In terms of liquidity, Regulus reported cash, cash equivalents, and short-term investments totaling approximately $65.4 million as of March 31, 2025. This represents a decrease from $82.3 million at the end of 2024. The company’s cash position is expected to fund operations only through the first quarter of 2026, raising concerns about its ability to continue as a going concern if additional capital is not secured. The company has indicated that it may need to raise further capital through equity or debt financing, particularly if its pending merger with Novartis AG does not proceed as planned.

Regulus is currently focused on the development of its lead product candidate, farabursen, which targets microRNA-17 for the treatment of autosomal dominant polycystic kidney disease (ADPKD). The company has made progress in its clinical trials, with positive results reported from multiple cohorts in a Phase 1b study. The FDA has granted orphan drug designation for farabursen, and the company is exploring an accelerated approval pathway based on its clinical findings. However, the success of these programs remains uncertain, and the company acknowledges that the novel approach to drug development may not lead to marketable products.

The company is also navigating a significant strategic development with its proposed merger with Novartis AG, announced on April 29, 2025. The merger agreement includes a cash tender offer for Regulus' outstanding shares, with a proposed price of $7.00 per share, plus contingent value rights. The completion of this transaction is subject to customary closing conditions and is expected to occur in the second half of 2025. If the merger does not close, Regulus may face challenges in securing the necessary funding to continue its operations and advance its product candidates.

Overall, Regulus Therapeutics is in a critical phase of its operations, balancing the advancement of its clinical programs with the need for additional capital and the potential impact of the merger with Novartis. The company continues to face significant risks, including the uncertainty of clinical trial outcomes, the need for regulatory approvals, and the competitive landscape in the biotechnology sector.