Inozyme Pharma(INZY) - 2024 Q4 - Annual Report

Financial Performance - The company reported net losses of $102.0 million and$71.2 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $388.0 million as of December 31, 2024[676]. - Total operating expenses were$104.0 million and $75.6 million for the years ended December 31, 2024 and 2023, respectively[677]. - 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 in 2023, reflecting an increase of$30.9 million[696]. - Interest expense increased by $2.2 million in 2024 compared to 2023, primarily due to additional borrowings under the Loan Agreement[703]. - General and administrative expenses remained consistent at approximately$20.8 million for both 2023 and 2024[692]. - The company has not generated any revenue since inception and plans to finance operations through equity offerings and debt financings[705]. - As of December 31, 2024, there is substantial doubt about the company's ability to continue as a going concern without raising additional capital[716]. Cash and Investments - As of December 31, 2024, the company had cash, cash equivalents, and short-term investments of $113.1 million, which may not be sufficient to fund operations for the next twelve months[678]. - As of December 31, 2024, total cash, cash equivalents, and short-term investments amounted to approximately$113.1 million, down from $188.6 million as of December 31, 2023[710]. - Net cash used in operating activities increased by approximately$21.2 million in 2024, primarily due to a $30.9 million increase in net loss[712]. - Net cash provided by investing activities changed by approximately$120.6 million in 2024, mainly due to a $114.3 million decrease in purchases of marketable securities[713]. - Net cash provided by financing activities decreased by approximately$114.6 million in 2024, primarily due to a $64.4 million decrease related to the July 2023 equity offering[714]. Research and Development - Research and development expenses increased by$28.4 million from $54.8 million in 2023 to$83.2 million in 2024, primarily due to a $25.0 million increase in INZ-701-related expenses[698]. - INZ-701-related research and development expenses rose by$25.0 million, driven by a $10.1 million increase in chemistry, manufacturing, and controls expenses and a$14.9 million increase in clinical development costs[699]. - The company is prioritizing activities to support the planned BLA filing for INZ-701, postponing future trials in ABCC6 Deficiency and calciphylaxis[715]. Clinical Trials and Product Development - The company received fast track designation from the FDA for INZ-701 for the treatment of calciphylaxis in January 2025[673]. - Enrollment in the ENERGY 3 pivotal trial of INZ-701 in pediatric patients with ENPP1 Deficiency was completed in January 2025, with topline data expected in the first quarter of 2026[673]. - Positive interim data for INZ-701 in infants and young children with ENPP1 Deficiency was announced in January 2025[673]. - The company initiated the SEAPORT 1 trial in February 2024, which demonstrated significant increases in PPi levels in ESKD patients receiving hemodialysis[668]. - The company has not yet commercialized any products or generated revenue from product sales[675]. - The company expects to incur significant commercialization expenses if marketing approval for INZ-701 is obtained, necessitating substantial additional funding[715]. Financing and Debt - The loan agreement provides up to $70.0 million in term loans, with a first tranche commitment of$25.0 million[680]. - The term loan carries a variable interest rate with a maximum of 9.60% and matures on August 1, 2026[681]. - The company entered into a Loan Agreement providing up to $70.0 million in term loans, with$45.0 million principal outstanding as of December 31, 2024[708]. - The company closed an underwritten offering in August 2023, selling 14,375,000 shares of common stock, generating net proceeds of approximately $64.4 million[709]. - The company borrowed an additional$20.0 million in February 2023, $7.5 million in June 2023, and$12.5 million in December 2023 under the Loan Agreement[729]. Market and Economic Conditions - The company is not currently exposed to significant market risk related to foreign currency exchange rates, but may face fluctuations in the future due to contracts with foreign vendors in Europe[730]. - Inflation has increased the cost of labor and clinical trial costs, but it did not have a material effect on the company's financial condition or results of operations for the years ended December 31, 2024 and 2023[731].