Regulus(RGLS) - 2024 Q3 - Quarterly Results

Financial Performance - Regulus Therapeutics ended Q3 2024 with cash, cash equivalents, and investments totaling $87.3 million, providing a cash runway into H1 2026[1][8] - Research and development expenses for Q3 2024 were $11.3 million, up from $5.5 million in Q3 2023, reflecting a 105% increase[9] - General and administrative expenses for Q3 2024 were $3.9 million, compared to $2.6 million in Q3 2023, representing a 50% increase[10] - The net loss for Q3 2024 was $14.1 million, or $0.21 per share, compared to a net loss of $7.8 million, or $0.40 per share, in Q3 2023[11] Clinical Development - Regulus completed enrollment in the fourth cohort of the Phase 1b MAD study of RGLS8429 for ADPKD in October 2024, with plans to share topline data in early 2025[2][3] - Positive topline data from the first three cohorts of the Phase 1b MAD study indicated a mechanistic dose response with increases in urinary polycystins and reductions in height-adjusted total kidney volume[4][5] - RGLS8429 has shown improvements in kidney function and size in preclinical models, with a favorable safety and pharmacokinetic profile demonstrated in earlier studies[13] - The company is on track for an End-of-Phase 1 meeting with the FDA by year-end 2024[4] Partnerships and Market Potential - Regulus entered into a Patent & Technology License Agreement with The University of Texas at Southwestern Medical Center, acquiring exclusive rights for products targeting miR-17 for ADPKD treatment[7] - Approximately 160,000 individuals are diagnosed with ADPKD in the U.S., with a global prevalence estimated between 4 to 7 million[12]