Regulus(US:RGLS)2024-05-09 20:27Financial Overview - The company has received $530.1 million from equity and convertible debt securities, $101.8 million from collaborations, and $19.8 million from a Term Loan as of March 31, 2024[86]. - As of March 31, 2024, the company had cash, cash equivalents, and investments totaling $107.7 million[86]. - Cash, cash equivalents, and investments totaled $107.7 million as of March 31, 2024, following a private placement financing that raised approximately $93.9 million in net proceeds[109]. - Net cash used in operating activities was $8.7 million for the three months ended March 31, 2024, an increase from $8.1 million in the same period of 2023[115]. - Net cash used in investing activities was $78.5 million for the three months ended March 31, 2024, compared to net cash provided of $15.0 million in the same period of 2023[116]. - Net cash provided by financing activities was $93.1 million for the three months ended March 31, 2024, compared to net cash used of $0.8 million in the same period of 2023[117]. - The outstanding principal amount of the Term Loan was $0.6 million as of March 31, 2024, with a floating interest rate[121]. - The company anticipates needing to raise additional capital to fund future operations, which may include equity or debt financings[112]. Research and Development - The company has incurred approximately $436.8 million in research and development expenses since inception through March 31, 2024[98]. - Research and development expenses increased to $6.0 million for the three months ended March 31, 2024, up 23% from $4.9 million in the same period of 2023[104]. - The company is focused on developing therapeutics targeting microRNAs, which may provide a new class of drugs for complex diseases[85]. Clinical Development - RGLS8429, targeting autosomal dominant polycystic kidney disease (ADPKD), is in Phase 1b clinical development, with positive top-line data showing 36%-41% increases in mean PC1 levels at Day 85 and Day 86[90]. - The second cohort of the Phase 1b study showed greater biological activity of RGLS8429 at 2 mg/kg, with encouraging imaging-based biomarker results indicating potential impact on kidney volume[91]. - The ongoing Phase 1b study is evaluating RGLS8429 at 3 mg/kg in cohort 3 and a 300 mg fixed dose in cohort 4, with an increased sample size to up to 30 patients in cohort 4[92]. - The FDA granted orphan drug designation to RGLS8429 for the treatment of ADPKD in June 2022[81]. - The company aims to explore an accelerated approval pathway for RGLS8429 based on a single pivotal Phase 2 study, confirmed in a Type D meeting with the FDA in December 2023[94]. - RGLS8429 was well-tolerated in clinical trials, with no serious adverse events reported[89]. Expenses - General and administrative expenses rose to $2.8 million for the three months ended March 31, 2024, compared to $2.4 million in the same period of 2023, primarily due to non-cash stock-based compensation[107]. - Net interest and other income was $0.4 million for the three months ended March 31, 2024, compared to $0.2 million for the same period in 2023[108].