Inozyme Q4 2023 Earnings Report
Key Takeaways
Inozyme Pharma reported a net loss of $71.2 million for the year ended December 31, 2023. The company's cash, cash equivalents, and short-term investments were $188.6 million as of December 31, 2023, expected to fund operations into the fourth quarter of 2025. Topline data from ongoing Phase 1/2 trials of INZ-701 in adults with ABCC6 Deficiency and ENPP1 Deficiency are expected in early April.
Topline data from Phase 1/2 trials of INZ-701 in adults with ABCC6 Deficiency and ENPP1 Deficiency expected in early April.
Phase 1 trial of INZ-701 in end-stage kidney disease (ESKD) patients receiving hemodialysis (SEAPORT-1) is underway, with topline data expected in Q4 2024.
Launched global patient registry (PROPEL) in partnership with GACI Global to advance understanding of ENPP1 Deficiency and infantile-onset ABCC6 Deficiency.
Cash, cash equivalents, and short-term investments as of December 31, 2023, are expected to fund operations into the fourth quarter of 2025.
Inozyme
Inozyme
Forward Guidance
Inozyme Pharma anticipates several milestones for INZ-701 and expects cash to fund operations into Q4 2025.
Positive Outlook
- Topline data from first three cohorts of ongoing Phase 1/2 trial in adults through 48 weeks – Early April 2024
- Initiation of the ENERGY-2 pivotal trial in infants, Ex-U.S. – 2H 2024
- Interim data from the ENERGY-1 Phase 1b trial in infants – 2H 2024
- Topline data from the ENERGY-3 pivotal trial in pediatric patients – Mid-2025
- Initiation of Phase 3 clinical trial, subject to regulatory review and sufficient funding – Q1 2025
Challenges Ahead
- Interim data from SEAPORT-1 Phase 1 trial in patients with ESKD receiving hemodialysis – Q4 2024
- Risks associated with the Company's ability to conduct its ongoing clinical trials of INZ-701 for ENPP1 Deficiency, ABCC6 Deficiency and calciphylaxis
- Risks to enroll patients in ongoing and planned trials
- Risks to obtain and maintain necessary approvals from the FDA and other regulatory authorities
- Risks to continue to advance its product candidates in preclinical studies and clinical trials