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Sep 30, 2024
Inozyme Q3 2024 Earnings Report
Inozyme reported financial results for the third quarter ended September 30, 2024, and provided business highlights.
Key Takeaways
Inozyme Pharma reported a net loss of $24.6 million for Q3 2024, with cash, cash equivalents, and short-term investments expected to fund operations into the fourth quarter of 2025. The company is advancing INZ-701 across its clinical programs and plans to initiate registrational trials in calciphylaxis and ABCC6 Deficiency in 2025, subject to regulatory alignment and sufficient funding.
Interim data from the ENERGY 1 Phase 1b trial of INZ-701 in infants with ENPP1 Deficiency is on track for release in the fourth quarter of 2024.
Topline data from the ENERGY 3 pivotal trial of INZ-701 in pediatric patients with ENPP1 Deficiency is expected in early 2026.
The company plans to initiate registrational trials in calciphylaxis and ABCC6 Deficiency in 2025, contingent on regulatory alignment and sufficient funding.
Cash, cash equivalents, and short-term investments as of September 30, 2024, are projected to fund operations into the fourth quarter of 2025.
Forward Guidance
Inozyme anticipates completing enrollment of the ENERGY 3 pivotal trial in pediatric patients by the end of 2024, initiating the ENERGY 2 pivotal trial in infants with ENPP1 Deficiency outside the United States in Q4 2024, releasing interim data from the ENERGY 1 Phase 1b trial in infants in Q4 2024, and releasing topline data from the ENERGY 3 pivotal trial in pediatric patients in early 2026. The company also plans to initiate pivotal clinical trials of INZ-701 in pediatric patients with ABCC6 Deficiency and in patients with calciphylaxis in 2025, subject to regulatory alignment and sufficient funding.
Positive Outlook
- Complete enrollment of ENERGY 3 pivotal trial in pediatric patients by the end of 2024
- Initiation of the ENERGY 2 pivotal trial in infants with ENPP1 Deficiency outside the United States in the fourth quarter of 2024
- Release interim data from the ENERGY 1 Phase 1b trial in infants in the fourth quarter of 2024
- Release topline data from the ENERGY 3 pivotal trial in pediatric patients in early 2026
- Initiation of pivotal clinical trial of INZ-701 in pediatric patients with ABCC6 Deficiency in 2025, subject to regulatory alignment and sufficient funding
Challenges Ahead
- Registrational trials in calciphylaxis and ABCC6 Deficiency are subject to regulatory alignment.
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