Regulus(US:RGLS) Prnewswire·2024-08-08 20:05Core Insights - Regulus Therapeutics announced positive topline data from the third cohort of patients in the Phase 1b MAD study of RGLS8429 for autosomal dominant polycystic kidney disease (ADPKD), showing significant improvements in kidney function and volume [1][2][4] - The company is on track for an End-Of-Phase 1 meeting with the FDA by the end of 2024 to discuss the potential for a pivotal Phase 2/3 study under an Accelerated Approval pathway [1][4] - Regulus ended Q2 2024 with $95.9 million in cash, providing a cash runway into H1 2026 [1][6] Program Updates - The Phase 1b MAD study of RGLS8429 has advanced to the fourth cohort, with patients receiving a fixed dose of 300 mg every other week for three months, and topline data expected in early 2025 [3][11] - In the third cohort, 16 subjects were randomized to receive either 3 mg/kg of RGLS8429 or placebo, with 70% of patients showing reductions in height adjusted total kidney volume [4][11] Financial Performance - Research and development expenses for Q2 2024 were $8.3 million, up from $5.0 million in Q2 2023, reflecting increased costs associated with clinical and preclinical activities [7] - General and administrative expenses for Q2 2024 were $4.0 million, compared to $2.3 million in Q2 2023, indicating higher personnel-related costs [8] - The net loss for Q2 2024 was $11.0 million, or $0.17 per share, compared to a net loss of $7.0 million, or $0.37 per share, in Q2 2023 [9][15] Corporate Developments - Rekha Garg, M.D., M.S., has been appointed as Chief Medical Officer, bringing extensive experience in kidney disease [5] - Regulus has been added to the Russell 3000® and Russell 2000® Indexes, enhancing its visibility in the market [6]