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enVVeno Medical (NVNO) - 2022 Q4 - Annual Report
NVNOenVVeno Medical (NVNO)2023-03-02 21:47

Financial Performance - The company reported a net loss of 24.7millionfortheyearendedDecember31,2022,comparedtoanetlossof24.7 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 8.2million[183].−Selling,generalandadministrativeexpensesroseby348.2 million [183]. - Selling, general and administrative expenses rose by 34% to 15.0 million in 2022 from 11.2millionin2021,withshare−basedcompensationcostsincreasingto11.2 million in 2021, with share-based compensation costs increasing to 9.0 million from 6.0million[184].−Thecompanyhasnotgeneratedanyrevenueanddoesnotexpecttodosointhenearterm,asfuturerevenuedependsonthecommercializationofproductcandidates[182].ResearchandDevelopment−Researchanddevelopmentexpensesincreasedby746.0 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 5.7millionin2021,primarilyduetocostsassociatedwiththeSAVVEtrialandpreparationfortheenVVefirst−in−humantrial[187].CashandInvestments−Thecompanyhasacashbalanceof5.7 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 34.5millionininvestments,totaling34.5 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 4millionto4 million to 5 million per quarter [195]. - The company plans to continue investing in U.S. Treasury bills, having purchased 48.1millionin2022,generating48.1 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].