Vivani Medical(US:VANI)2025-11-13 13:10Product Development - Vivani Medical is developing a portfolio of miniature, ultra long-acting subdermal drug implants using its proprietary NanoPortal™ technology, aimed at improving medication adherence and drug tolerability for chronic diseases [128]. - The lead program, NPM-139, a six-month GLP-1 (semaglutide) implant, demonstrated approximately 20% weight loss in preclinical studies, maintained for over seven months [131]. - NPM-115, an exenatide implant, showed comparable weight loss results of approximately 20% in obese mice, indicating potential for similar outcomes in human trials [135]. - The FDA lifted the clinical hold on NPM-119, allowing the initiation of a first-in-human study for the exenatide implant in type 2 diabetes patients [140]. - Vivani plans to initiate a Phase 1 clinical study for NPM-139 in the first half of 2026, pending regulatory clearance [146]. - The company established Vivani Medical Australia Pty Ltd. to support studies of its product candidates in the fourth quarter of 2023 [134]. - The NPM-139 program is expected to provide annual dosing potential, enhancing its commercial viability [145]. - Vivani's GLP-1 implant technology aims to deliver therapeutic drug levels for up to six months or longer, addressing the issue of medication non-adherence [130]. Financial Performance - Vivani's cash, cash equivalents, and restricted cash decreased by $15.7 million from $19.7 million as of December 31, 2024, to $4.0 million as of September 30, 2025 [164]. - Working capital decreased by $17.1 million from $14.5 million as of December 31, 2024, to negative $2.7 million as of September 30, 2025 [164]. - Research and development expense for the three months ended September 30, 2025, was $4.5 million, an increase of $0.3 million or 8% compared to the same period in 2024 [168]. - General and administrative expense for the three months ended September 30, 2025, was $2.2 million, an increase of $0.1 million or 5% compared to the same period in 2024 [169]. - Research and development expense for the nine months ended September 30, 2025, was $13.5 million, an increase of $2.1 million or 18% compared to the same period in 2024 [171]. - General and administrative expense for the nine months ended September 30, 2025, was $7.3 million, an increase of $0.5 million or 7% compared to the same period in 2024 [172]. - The company incurred a net loss of $20.0 million during the nine months ended September 30, 2025 [174]. - Other income, net during the three months ended September 30, 2025, was $0.2 million, a decrease of $0.1 million compared to the same period in 2024 [170]. - The company expects to continue incurring operating losses and negative operating cash flows for the foreseeable future [159]. - The company estimates that currently available cash will provide sufficient funds to meet its planned obligations into 2027 [160]. - For the nine months ended September 30, 2024, the company reported a net loss of $17.4 million, with cash used in operating activities amounting to $15.0 million [175]. - Cash used for investing activities during the nine months ended September 30, 2025 and 2024 was $0.9 million and $0.3 million respectively, primarily for the purchase of property and equipment [176]. - Cash provided by financing activities was $2.7 million during the nine months ended September 30, 2025, mainly from the issuance of common stocks in private financing agreements [177]. - Cash provided by financing activities was $14.2 million during the nine months ended September 30, 2024, primarily due to a securities purchase agreement with an institutional investor [178]. - As of September 30, 2025, the company had no off-balance sheet arrangements [179]. - The company invests excess cash in money market funds and short-term certificates of deposits to maintain liquidity and safety of principal [180]. - The majority of the company's operating expenses are denominated in U.S. dollars, with no current foreign currency hedging strategies in place [181]. Corporate Structure - Vivani's merger with Second Sight Medical Products and Nano Precision Medical was completed on August 30, 2022, creating a focused biopharmaceutical entity [132]. - The company is pursuing a spin-off of its neurostimulation assets into Cortigent, with a Form 10 registration statement filed with the SEC on May 29, 2025 [149].