Regulus(US:RGLS)2025-03-13 20:15Financial Performance - Regulus reported a net loss of $12.8 million, or $0.20 per share, for Q4 2024, compared to a net loss of $8.1 million, or $0.40 per share, in Q4 2023[8] - Total operating expenses for the year ended December 31, 2024, were $50.0 million, compared to $31.1 million in 2023[15] - General and administrative expenses for Q4 2024 were $4.1 million, up from $2.5 million in Q4 2023[7] Research and Development - Research and development expenses increased to $9.7 million for Q4 2024, up from $5.8 million in Q4 2023, and totaled $35.4 million for the year, compared to $21.2 million in 2023[6] - The Phase 1b MAD trial of farabursen for ADPKD showed a reduction in kidney volume growth rate, with 26 subjects receiving a fixed dose of 300 mg every other week for three months[3] - The interim analysis of the fourth cohort indicated a mechanistic dose response with increases in polycystin biomarker levels[2] Cash and Assets - As of December 31, 2024, Regulus had $75.8 million in cash, cash equivalents, and short-term investments, with an expected cash runway extending into early 2026[6] - The company reported total assets of $84.2 million as of December 31, 2024, compared to $30.8 million in 2023[15] Regulatory and Market Information - The FDA has agreed on key components for a Phase 3 pivotal trial, including a 12-month htTKV endpoint for potential Accelerated Approval[5] - Approximately 160,000 individuals are diagnosed with ADPKD in the United States, with a global prevalence estimated at 4 to 7 million[9]