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Vivani Medical(VANI) - 2024 Q1 - Quarterly Report
VANIVivani Medical(VANI)2024-05-13 21:27

Product Development - Vivani Medical's lead program NPM-115, a miniature GLP-1 implant for chronic weight management, is under further development with a focus on addressing medication non-adherence [110]. - In a preclinical study, NPM-115 demonstrated approximately 20% weight loss in high-fat diet-induced obese mice after 28 days, comparable to semaglutide injections [118]. - The company filed an Investigational New Drug Application for NPM-119 on July 14, 2023, but the study is currently on clinical hold due to insufficient Chemistry, Manufacturing, and Controls information [115]. - Vivani's NanoPortal technology allows for long-term, near constant-rate delivery of medications, aiming to improve medication adherence for chronic diseases [109]. Financial Performance - Vivani raised gross proceeds of 15.0millionfromaregistereddirectofferingof3,947,368sharesat15.0 million from a registered direct offering of 3,947,368 shares at 3.80 per share on March 5, 2024 [121]. - The company has experienced recurring operating losses and negative cash flows since inception, relying on equity sales for funding [123]. - Vivani's current cash is estimated to meet planned obligations into the second half of 2025, but additional capital will be needed for continued operations [125]. - The company used 4.5millionincashforoperatingactivitiesinQ12024,comparedto4.5 million in cash for operating activities in Q1 2024, compared to 7.0 million in Q1 2023 [140][141]. - Cash provided by financing activities was 13.7millioninQ12024,primarilyfromasecuritiespurchaseagreement[143].−Thecompanyanticipatesthatavailablecashwillmeetitsobligationsintothesecondhalfof2025,butfutureprofitabilityremainsuncertain[136].OperationalUpdates−ThecompanyestablishedVivaniMedicalAustraliaPtyLtd.tosupportstudiesofitsproductcandidatesinthefourthquarterof2023[117].−Cortigent,awhollyownedsubsidiary,isadvancingVivani′sneurostimulationtechnologyandisexpectedtorepay13.7 million in Q1 2024, primarily from a securities purchase agreement [143]. - The company anticipates that available cash will meet its obligations into the second half of 2025, but future profitability remains uncertain [136]. Operational Updates - The company established Vivani Medical Australia Pty Ltd. to support studies of its product candidates in the fourth quarter of 2023 [117]. - Cortigent, a wholly owned subsidiary, is advancing Vivani's neurostimulation technology and is expected to repay 1.5 million to Vivani by the end of 2024 [116]. - The company has a total of 36 full-time employees and operates from its headquarters in Alameda, California [111]. Expenses - Research and development expenses for Q1 2024 were 3.7million,adecreaseof63.7 million, a decrease of 6% from 4.0 million in Q1 2023, primarily due to reduced costs in the neurostimulation division [131]. - General and administrative expenses for Q1 2024 were 2.5million,down52.5 million, down 5% from 2.6 million in Q1 2023, mainly due to decreased costs in the neurostimulation division [132]. Cash Flow and Working Capital - Cash, cash equivalents, and restricted cash increased by 9.0millionfrom9.0 million from 22.0 million as of December 31, 2023, to 31.0millionasofMarch31,2024[139].−Workingcapitalroseto31.0 million as of March 31, 2024 [139]. - Working capital rose to 25.4 million as of March 31, 2024, an increase of 8.0millionfrom8.0 million from 17.3 million as of December 31, 2023 [139]. Future Outlook - The company expects research and development expenses to increase in the future as it pursues enhancements and develops new technologies [130]. - The company has not entered into foreign currency forward contracts to hedge operating expense exposure but may consider doing so in the future [148].