Vivani Medical(VANI) - 2024 Q3 - Quarterly Report

Product Development - Vivani Medical, Inc. is focused on developing NPM-115, a miniature GLP-1 implant for chronic weight management, targeting a weight loss of approximately 20% in preclinical studies[119] - An Investigational New Drug Application for NPM-119 was filed with the FDA on July 14, 2023, and the IND was cleared on June 13, 2024, allowing for the initiation of first-in-human studies[116][124] - Vivani's NanoPortal™ technology allows for miniaturized implants to deliver therapeutic drugs for up to six months, minimizing fluctuations in drug levels[113] - The LIBERATE-1 clinical trial is set to investigate the safety and pharmacokinetics of the exenatide implant, with data expected in 2025[125][127] - In a preclinical study, Vivani's GLP-1 implant demonstrated an 82% reduction in liver fat in obese mice, indicating potential efficacy for chronic weight management[126] Financial Performance - The Company raised gross proceeds of $15.0 million from the issuance of 3,947,368 shares of common stock at a purchase price of$3.80 per share on March 1, 2024, resulting in net proceeds of $13.7 million after issuance costs[128] - The Company entered into an Open Market Sale Agreement with Jefferies LLC to offer and sell shares of common stock with an aggregate offering price of up to$75.0 million[129] - Research and development expenses for the three months ended September 30, 2024, were $4.2 million, a decrease of$0.2 million, or 5%, compared to $4.4 million for the same period in 2023[140] - General and administrative expenses for the three months ended September 30, 2024, were$2.1 million, a decrease of $0.6 million, or 22$2.7 million for the same period in 2023[141] - The Company used $15.0 million of cash in operating activities during the nine months ended September 30, 2024, consisting primarily of a net loss of$17.4 million[153] - Cash, cash equivalents, and restricted cash decreased by $1.0 million from$22.0 million as of December 31, 2023, to $21.0 million as of September 30, 2024[153] - Working capital decreased by$2.2 million from $17.3 million as of December 31, 2023, to$15.1 million as of September 30, 2024[153] - The Company expects to continue incurring operating losses and negative operating cash flows for the foreseeable future[151] - The Company anticipates that currently available cash will be sufficient to meet its planned obligations for at least the next twelve months[134] - The Company received grants totaling $0.2 million and$0.4 million during the nine months ended September 30, 2024, and 2023, respectively, to offset operating expenses[131] - Cash used for investing activities was $0.3 million for the nine months ended September 30, 2024, compared to$0.1 million in the same period of 2023, primarily for property and equipment purchases[154] - Cash provided by financing activities was $14.2 million during the nine months ended September 30, 2024, mainly due to a securities purchase agreement with an institutional investor[154] - Cash provided by financing activities was$110,000 during the nine months ended September 30, 2023, from the exercise of options[155] Corporate Structure and Strategy - Vivani established a wholly-owned subsidiary, Vivani Medical Australia Pty Ltd., to support studies of its product candidates in Australia[118] - The company has committed to advancing its neurostimulation technology through its subsidiary Cortigent, which is preparing for an initial public offering[114] - Vivani's management team is exploring strategic options to further develop its pioneering neurostimulation systems from legacy company Second Sight[110] Cash Management - As of September 30, 2024, the company had no off-balance sheet arrangements[157] - The company invests excess cash in certificates of deposit and money market funds to maintain principal safety and liquidity[157] - The majority of operating expenses were denominated in U.S. dollars, with no foreign currency forward contracts currently in place to hedge exposure[158] Market Challenges - The company reported that 64% of patients discontinue therapy with Wegovy® within the first year, highlighting the need for improved medication adherence solutions[109]