Inozyme Pharma(US:INZY)2024-11-05 13:31Clinical Trials - Interim data from the Phase 1b trial of INZ-701 in infants with ENPP1 Deficiency is expected by the end of Q4 2024[1] - Topline data from the pivotal ENERGY 3 trial in pediatric patients with ENPP1 Deficiency is anticipated in early 2026[1] - The company plans to initiate registrational trials in calciphylaxis and ABCC6 Deficiency in 2025, subject to regulatory alignment and sufficient funding[1] - The company aims to complete enrollment of the ENERGY 3 pivotal trial by the end of 2024[8] - The estimated incidence of calciphylaxis is approximately 3.5 per 1,000 patients with end-stage kidney disease, with about 5,000 new patients presenting annually across major markets[17] Financial Performance - Cash, cash equivalents, and short-term investments were $131.6 million as of September 30, 2024, expected to fund operations into Q4 2025[10] - Net loss for Q3 2024 was $24.6 million, or $0.39 net loss per share, compared to a net loss of $16.6 million, or $0.29 net loss per share in the prior-year period[12] - Total assets as of September 30, 2024, were $143.4 million, down from $200.8 million as of December 31, 2023[24] - Total operating expenses for the three months ended September 30, 2024, were $24,851, up from $18,074, reflecting a 37% increase compared to the same period last year[25] - The net loss for the three months ended September 30, 2024, was $24,570, compared to a net loss of $16,638 for the same period in 2023, indicating a 48% increase in losses[25] - Comprehensive loss for the three months ended September 30, 2024, was $24,281, compared to $16,767 in the prior year, marking a 45% increase[25] - For the nine months ended September 30, 2024, research and development expenses totaled $60,758, up from $36,864, a 65% increase year-over-year[26] - Total operating expenses for the nine months ended September 30, 2024, were $76,859, compared to $52,837, reflecting a 45% increase[26] - The net loss for the nine months ended September 30, 2024, was $74,950, compared to $49,625 for the same period in 2023, indicating a 51% increase in losses[26] - Interest expense for the nine months ended September 30, 2024, was $6,182, compared to $5,306 in the previous year, reflecting a 16% increase[26] Research and Development Expenses - R&D expenses for Q3 2024 were $19.9 million, up from $13.3 million in the prior-year period, reflecting a 49.6% increase[11] - Research and development expenses for the three months ended September 30, 2024, increased to $19,890 from $13,341, representing a 49% increase year-over-year[25]