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Investor Relations14 Oct 2025
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Inozyme Pharma (INZY) investor relations material
Inozyme Pharma Q1 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q1 2025 earnings summary13 May, 2025
Executive summary
Advanced clinical trials of INZ-701 for ENPP1 Deficiency, with strategic focus on this indication and postponement of other programs.
ENERGY 3 trial interim data show INZ-701 increases serum phosphate and maintains a favorable safety and immunogenicity profile in pediatric ENPP1 Deficiency patients, with no dropouts or dose adjustments and no new safety signals.
Announced key regulatory milestones, including FDA and EMA designations, new ICD-10 codes for ENPP1 Deficiency, and regulatory alignment in Japan.
Completed enrollment in the pivotal ENERGY 3 trial for pediatric ENPP1 Deficiency; topline data expected Q1 2026.
Appointed Petra Duda, M.D., Ph.D. as Chief Medical Officer, succeeding Kurt Gunter, M.D., and implemented a 25% workforce reduction to align resources.
Financial highlights
Net loss of $28.0 million ($0.44 per share) for Q1 2025, compared to $23.3 million ($0.38 per share) in Q1 2024.
Operating expenses rose to $27.7 million, driven by higher R&D and restructuring charges.
Cash, cash equivalents, and short-term investments totaled $84.8 million as of March 31, 2025, expected to fund operations into Q1 2026.
R&D expenses were $20.4 million in Q1 2025, up $1.3 million year-over-year, mainly due to increased INZ-701 CMC costs.
Restructuring charges of $1.9 million reflect a 25% workforce reduction.
Outlook and guidance
Current cash and investments expected to fund operations into Q1 2026, but not for the next 12 months from filing date, raising substantial doubt about going concern.
Additional capital will be required to continue operations and support clinical and commercialization activities.
Expenses expected to decrease in 2025 due to program reprioritization, but will rise significantly if INZ-701 is approved and commercialized.
ENERGY 3 topline data anticipated in Q1 2026; regulatory filings planned in the U.S., EU, and Japan.
Assess impact of trade policy changes.
Explain ADA data from ENERGY 3 trial.
When might INZ-701 launch commercially?
Immunogenicity management for high-titer ADAs?
Impact of restructuring on other pipeline programs?
Plans for heterozygous ENPP1 Deficiency patients?
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Frequently asked questions
Inozyme Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for rare diseases that affect the vasculature, soft tissue, and skeleton. The company's research is centered on disorders related to the PPi-Adenosine Axis, a pathway crucial for mineralization and vascular health. Disruptions in this pathway can lead to severe conditions such as ENPP1 and ABCC6 deficiencies, which Inozyme targets with its lead product candidate, INZ-701. This enzyme replacement therapy is designed to address pathologic mineralization and intimal proliferation, aiming to reduce the morbidity and mortality associated with these conditions. The company is headquartered in Boston, Massachusetts, and its shares are listed on the NASDAQ.
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