Inozyme Pharma, Inc. reported a net loss of $28.0 million for the first quarter of 2025, an increase from a net loss of $23.3 million during the same period in 2024. The company's total operating expenses rose to $27.7 million, up from $24.3 million year-over-year, primarily driven by increased research and development costs associated with its lead product candidate, INZ-701. Research and development expenses increased by $1.3 million to $20.4 million, reflecting heightened activity in clinical trials and preparations for potential commercialization. General and administrative expenses remained relatively stable at $5.4 million.

The company’s financial position showed a decline in total assets, which decreased to $95.2 million as of March 31, 2025, from $123.2 million at the end of 2024. This decline was attributed to a reduction in short-term investments, which fell to $58.9 million from $92.0 million. Inozyme's cash and cash equivalents increased to $25.8 million, up from $21.1 million, indicating a slight improvement in liquidity. However, the accumulated deficit grew to $416.0 million, reflecting ongoing operational losses since the company's inception.

In terms of strategic developments, Inozyme announced a workforce reduction of approximately 25% in March 2025 as part of a restructuring effort to focus resources on the ENPP1 Deficiency program. This restructuring resulted in $1.9 million in charges for severance and related costs. The company is prioritizing activities to support the planned Biologics License Application (BLA) filing for INZ-701, which targets ENPP1 Deficiency, a rare genetic disorder. Future trials for ABCC6 Deficiency and calciphylaxis have been postponed to concentrate on this lead indication.

Operationally, Inozyme is advancing its clinical trials for INZ-701, with ongoing studies in both pediatric and adult populations. The company completed enrollment in the ENERGY 3 trial, which is designed to assess the efficacy and safety of INZ-701 in pediatric patients with ENPP1 Deficiency. Preliminary data from this trial indicated positive trends in serum phosphate levels and anti-drug antibody responses, which are critical for the drug's therapeutic profile. The company expects to report topline data from this pivotal trial in early 2026.

Looking ahead, Inozyme's management expressed concerns regarding its ability to continue as a going concern, citing the need for additional capital to fund operations beyond the first quarter of 2026. The company plans to explore various funding avenues, including public or private equity financings and collaboration agreements, to support its ongoing clinical development and operational needs. The successful commercialization of INZ-701 remains contingent on achieving regulatory approvals and demonstrating clinical efficacy in its ongoing trials.

About Inozyme Pharma, Inc.

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