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Dec 31, 2023
Inozyme Q4 2023 Earnings Report
Inozyme Pharma reported its financial results for the full year ended December 31, 2023, and provided recent business highlights.
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