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Inozyme Pharma Inc. (INZY-5.62%) has submitted its 10-K filing for the fiscal year ended December 31, 2024.
The company reported a net loss of $102.0 million for the year ended December 31, 2024, compared to a net loss of $71.2 million for the prior year. The accumulated deficit as of December 31, 2024, was $388.0 million.
Inozyme's lead product candidate, INZ-701, is in clinical development for the treatment of ENPP1 Deficiency, ABCC6 Deficiency, and calciphylaxis. The company has prioritized activities to support a planned Biologics License Application (BLA) filing for INZ-701 for ENPP1 Deficiency.
The company has ongoing Phase 1/2 clinical trials for adults with ENPP1 and ABCC6 Deficiencies, a Phase 1b clinical trial for infants with ENPP1 Deficiency, and a pivotal trial in pediatric patients with ENPP1 Deficiency.
Inozyme's cash, cash equivalents, and short-term investments as of December 31, 2024, were approximately $113.1 million. The company has $45.0 million of outstanding principal indebtedness under its loan agreement.
The company anticipates that its cash resources will fund operations into the first quarter of 2026, but there is substantial doubt about its ability to continue as a going concern without additional capital.
Inozyme is focused on developing therapies for rare diseases affecting bone health and blood vessel function, specifically targeting the PPi-Adenosine Pathway.
The company retains worldwide exclusive development and commercialization rights to its pipeline and programs, including INZ-701. It has obtained orphan drug designation for INZ-701 for the treatment of ENPP1 Deficiency and ABCC6 Deficiency from both the FDA and the European Medicines Agency.
Inozyme plans to establish a sales and marketing infrastructure to commercialize INZ-701, if approved, and is considering various collaboration and distribution arrangements for commercialization outside the United States.
The company acknowledges the risks associated with its business, including its limited operating history, dependence on INZ-701, and the need for additional funding to support its operations and development programs.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Inozyme Pharma Inc. annual 10-K report dated March 10, 2025. To report an error, please email earnings@qz.com.