enVVeno Medical (US:NVNO)2023-03-02 21:47Financial Performance - The company reported a net loss of $24.7 million for the year ended December 31, 2022, compared to a net loss of $16.5 million in 2021, representing an increase of 50% or $8.2 million [183]. - Selling, general and administrative expenses rose by 34% to $15.0 million in 2022 from $11.2 million in 2021, with share-based compensation costs increasing to $9.0 million from $6.0 million [184]. - The company has not generated any revenue and does not expect to do so in the near term, as future revenue depends on the commercialization of product candidates [182]. Research and Development - Research and development expenses increased by 74% to $9.9 million in 2022 from $5.7 million in 2021, primarily due to costs associated with the SAVVE trial and preparation for the enVVe first-in-human trial [187]. Cash and Investments - The company has a cash balance of $4.6 million and $34.5 million in investments, totaling $39.1 million in cash and investments as of December 31, 2022 [194]. - The company expects to have sufficient cash to fund operations through the end of 2024 and into 2025, with a cash burn rate of approximately $4 million to $5 million per quarter [195]. - The company plans to continue investing in U.S. Treasury bills, having purchased $48.1 million in 2022, generating $0.2 million in realized gains and interest income [192]. Product Development - The lead product, VenoValve®, is currently being evaluated in a U.S. pivotal study, with expectations for FDA approval ahead of the enVVe product [179]. - The company anticipates that the VenoValve and enVVe will co-exist post-approval, addressing a significant unmet need in the treatment of deep venous chronic venous insufficiency [180]. Operations - The company operates from a 14,507 sq. ft. ISO 13485-2020 certified facility in Irvine, California, focused on the design and manufacturing of tissue-based implantable medical devices [181].