Regulus(US:RGLS)2024-11-07 21:26Financial Overview - The company has received a total of $530.1 million from equity and convertible debt securities, $101.8 million from collaborations, and $19.8 million in net proceeds from a Term Loan as of September 30, 2024[90]. - Cash, cash equivalents, and investments totaled $87.3 million as of September 30, 2024, following a capital raise of approximately $93.9 million in March 2024[118]. - Net cash used in operating activities was $29.8 million for the nine months ended September 30, 2024, compared to $20.6 million for the same period in 2023, indicating an increase of 44%[124]. - Net cash used in investing activities was $60.0 million for the nine months ended September 30, 2024, compared to net cash provided of $9.6 million in the same period of 2023[125]. - Net cash provided by financing activities was $92.4 million for the nine months ended September 30, 2024, significantly higher than $12.7 million for the same period in 2023[126]. - The company anticipates needing to raise additional capital to fund future operations, with no assurance that financing will be available on favorable terms[120]. Research and Development - Research and development expenses incurred since inception total approximately $456.4 million through September 30, 2024[106]. - Research and development expenses increased to $11.3 million for the three months ended September 30, 2024, compared to $5.5 million for the same period in 2023, reflecting a 107% increase[114]. - Total research and development expenses for the nine months ended September 30, 2024, were $25.7 million, up from $15.4 million in the same period of 2023, reflecting a 67% increase[115]. Product Development - The product candidate RGLS8429 is in Phase 1b clinical development for the treatment of autosomal dominant polycystic kidney disease (ADPKD), with positive topline results reported from multiple cohorts[96][97][98]. - The FDA granted orphan drug designation to RGLS8429 for the treatment of ADPKD in June 2022[85]. - The company anticipates reporting topline data from the fourth cohort of RGLS8429-treated patients in early 2025[99]. - The company held a Type D meeting with the FDA in December 2023 to discuss the potential for an accelerated approval pathway for RGLS8429[100]. - RGLS8429 has shown clear improvements in kidney function and disease severity measures in preclinical models[93]. - The market for ADPKD has an estimated global prevalence of 4 to 7 million, with approximately 160,000 diagnosed individuals in the United States[92]. - The company is focused on orphan kidney diseases where microRNA genetic drivers are implicated, addressing significant unmet medical needs[84]. - The company is exploring target organ-selective delivery strategies in its preclinical research[101]. Expenses - General and administrative expenses rose to $3.9 million for the three months ended September 30, 2024, up from $2.6 million in the same period of 2023, representing a 50% increase[116]. - Net interest and other income was $1.1 million for the three months ended September 30, 2024, compared to $0.3 million for the same period in 2023, marking a 267% increase[117]. Debt and Loans - The Term Loan, which bore interest at a floating rate, fully matured on May 1, 2024, eliminating associated interest expenses going forward[130].