enVVeno Medical (NVNO) - 2025 Q4 - Annual Report

Financial Performance - The company reported net losses of $19.5 million for the year ended December 31, 2025, a decrease of 11% from a net loss of $21.8 million in 2024[177]. - The company incurred losses from operations of $20.9 million and used $15.6 million in cash for operating activities in 2025, a decrease from $16.8 million in 2024[182]. Expenses - Research and development expenses decreased by $2.2 million or 19%, to $10.0 million in 2025 from $12.2 million in 2024, primarily due to lower costs related to the VenoValve study[179]. - Selling, general and administrative expenses decreased by $0.7 million or 6%, to $10.9 million in 2025 from $11.6 million in 2024, driven by non-recurring legal costs incurred in 2024[180]. Cash Position - The cash balance as of December 31, 2025, was $3.1 million, with total cash and investments amounting to $28.2 million[182]. - The company anticipates an increase in cash burn rate to between $4 million and $5 million per quarter in 2026, while having sufficient cash to fund operations through mid-2027[185]. Product Development - The enVVe System, a next-generation non-surgical venous valve product, has completed pre-clinical testing and discussions with the FDA regarding the pivotal trial are expected to begin in 2026[173]. - The company is focused on obtaining FDA approval for the enVVe System, with no current devices approved for surgical or non-surgical replacement venous valves[172]. - The company will continue to incur costs related to clinical trials for the VenoValve and enVVe System as it seeks regulatory approval for its product candidates[183]. Corporate Actions - A reverse stock split of one-for-thirty-five (1:35) was approved and became effective on January 20, 2026[175].

enVVeno Medical (NVNO) - 2025 Q4 - Annual Report - Reportify