Workflow
enVVeno Medical (NVNO) - 2025 Q1 - Quarterly Report
NVNOenVVeno Medical (NVNO)2025-04-30 21:28

Financial Performance - The company reported net losses of 4.5millionforQ12025,adecreaseof104.5 million for Q1 2025, a decrease of 10% from 5.0 million in Q1 2024[56]. - Other income decreased by 0.1millionor250.1 million or 25% to 0.4 million for the three months ended March 31, 2025, compared to 0.5millionforthesameperiodin2024[60].−Thecompanyincurredlossesfromoperationsof0.5 million for the same period in 2024[60]. - The company incurred losses from operations of 5.0 million and used 4.0millioninoperatingactivitiesforthethreemonthsendedMarch31,2025,anincreaseof4.0 million in operating activities for the three months ended March 31, 2025, an increase of 0.4 million from 3.6millioninthesamequarterof2024[61].−Theincreaseincashusageisprimarilyduetoproductresearchanddevelopmentactivities,includingclinicalstudiesforVenoValveandenVVe[62].−ThecompanydoesnotcurrentlygeneraterevenueanddoesnotexpectsignificantrevenueuntilsuccessfulcommercializationofproductcandidatesafterFDAapproval[63].ResearchandDevelopment−Researchanddevelopmentexpensesdecreasedby3.6 million in the same quarter of 2024[61]. - The increase in cash usage is primarily due to product research and development activities, including clinical studies for VenoValve and enVVe[62]. - The company does not currently generate revenue and does not expect significant revenue until successful commercialization of product candidates after FDA approval[63]. Research and Development - Research and development expenses decreased by 0.5 million or 19% to 2.6millioninQ12025,primarilyduetolowercostsrelatedtotheVenoValvepivotalstudy[58].−TheVenoValvepivotalstudyreachedfullenrollmentonSeptember1,2023,andiscurrentlyinthepost−enrollmentfollow−upperiod[47].−ThecompanyexpectstofileforIDEapprovalfortheenVVepivotalstudyinQ32025[54].−TheVenoValvehasshownan852.6 million in Q1 2025, primarily due to lower costs related to the VenoValve pivotal study[58]. - The VenoValve pivotal study reached full enrollment on September 1, 2023, and is currently in the post-enrollment follow-up period[47]. - The company expects to file for IDE approval for the enVVe pivotal study in Q3 2025[54]. - The VenoValve has shown an 85% clinical meaningful benefit at one year, with an average improvement of 7.91 points in the revised Venous Clinical Severity Score (rVCSS)[50]. - The VenoValve is estimated to be eligible for FDA approval in the second half of 2025[51]. - The increase in cash usage is primarily due to product research and development activities, including clinical studies for VenoValve and enVVe[62]. Financial Position and Capital Requirements - The company finished 2024 with approximately 43.2 million in cash and investments, with an expected increase in cash burn rate to 4millionto4 million to 5 million per quarter[55]. - Future capital requirements will depend on the success of clinical studies and product development costs, with an anticipated cash burn rate increasing to 5millionperquarter[65].−ThecompanyhassufficientcapitalresourcestomeetobligationsforatleastoneyearafterMarch31,2025,basedoncurrentcashandworkingcapital[66].−ThecompanyexpectsamodestincreaseinpropertyandequipmentpurchasesasitcontinuesclinicalstudiesandplansforcommercializationofVenoValve[64].MarketContext−ThetotaldirectmedicalcostsfromvenousulcersufferersintheU.S.exceed5 million per quarter[65]. - The company has sufficient capital resources to meet obligations for at least one year after March 31, 2025, based on current cash and working capital[66]. - The company expects a modest increase in property and equipment purchases as it continues clinical studies and plans for commercialization of VenoValve[64]. Market Context - The total direct medical costs from venous ulcer sufferers in the U.S. exceed 3 billion annually[45]. - Approximately 20 million people in the U.S. are estimated to suffer from severe deep venous CVI (C4 to C6 disease) with reflux[45].