Vivani Medical(VANI) - 2024 Q4 - Annual Report

Product Development - Vivani Medical is developing a portfolio of miniature, subdermal drug implants aimed at improving medication adherence for chronic diseases, with a focus on delivering therapeutic drug levels for up to six months or longer [405][406]. - The lead program, NPM-115, is a six-month GLP-1 (high-dose exenatide) implant currently in clinical-stage testing for chronic weight management in obese and overweight individuals [407]. - In February 2024, Vivani announced positive preclinical weight loss data showing approximately 20% weight loss in obese mice with the exenatide implant, comparable to semaglutide [415]. - The company has filed an IND for NPM-119 (GLP-1 implant) with the FDA, which was initially on clinical hold but was lifted on June 13, 2024, allowing the study to proceed [412][420]. - Vivani established a wholly owned subsidiary, Vivani Medical Australia Pty Ltd., in the fourth quarter of 2023 to support studies of its product candidates [414]. - The company reported receiving regulatory approval to initiate its first-in-human clinical trial, LIBERATE-1, for the GLP-1 implant in Australia, with data expected in mid-2025 [424][426]. - Vivani's GLP-1 (exenatide) implant demonstrated an 82% reduction in liver fat in preclinical studies, indicating potential for significant health benefits in chronic weight management [422]. Financial Performance - The net loss for the year ended December 31, 2024, was $23.5 million, a reduction of$2.2 million compared to a net loss of $25.7 million in 2023 [450]. - Research and development expenses for the year ended December 31, 2024, were$15.7 million, a decrease of 7% from $17.0 million in 2023 [446]. - General and administrative expenses decreased by 11$8.9 million in 2024, down from $10.0 million in 2023 [448]. - The Company has experienced recurring operating losses and negative operating cash flows since inception, relying on equity securities sales for working capital [437]. - The company expects to continue incurring operating losses and negative cash flows for the foreseeable future [456]. Cash Flow and Financing - Cash, cash equivalents, and restricted cash decreased by$2.3 million from $22.0 million as of December 31, 2023, to$19.7 million as of December 31, 2024 [459]. - Working capital was $14.5 million as of December 31, 2024, compared to$17.3 million as of December 31, 2023 [459]. - Cash used in operating activities during 2024 was $20.8 million, primarily due to a net loss of$23.5 million [460]. - Cash used in operating activities during 2023 was $23.7 million, primarily due to a net loss of$25.7 million [461]. - Net cash used in investing activities during 2024 was $0.6 million for the purchase of equipment [462]. - Financing activities provided$19.1 million of cash in 2024, primarily from securities purchase agreements [463]. - Financing activities provided $0.1 million of cash in 2023, primarily from stock option exercises [464]. - The company anticipates seeking funding through public or private equity or debt financings, grants, collaborations, and strategic partnerships [458]. Capital Raising Activities - On March 1, 2024, Vivani entered into a securities purchase agreement to sell 3,947,368 shares of common stock at a price of$3.80 per share, raising significant capital [417]. - The Company raised gross proceeds of $15.0 million from a registered direct offering of 3,947,368 shares at a price of$3.80 per share, resulting in net proceeds of $13.7 million after issuance costs of$1.3 million [430]. - The Company entered into a Sales Agreement with Jefferies LLC to offer and sell shares of common stock with an aggregate offering price of up to $75.0 million [431]. - During the twelve months ended December 31, 2024, the Company issued 287,970 shares under the Sales Agreement, generating net proceeds of$160,000 after expenses of $344,000 [432]. - A private sale transaction on November 8, 2024, resulted in gross proceeds of$5.0 million from the sale of 3,968,253 shares at a price of $1.26 per share [425]. - Another private sale transaction on March 26, 2025, is expected to generate approximately$8.25 million from the sale of 7,366,071 shares at a price of $1.12 per share [435]. Future Outlook - The company estimates that currently available cash will be sufficient to meet its planned obligations for at least the next twelve months [439]. - The company has not entered into foreign currency forward contracts to hedge operating expense exposure to foreign currencies [468]. - The company aims to create two focused entities through the spin-off of Cortigent, which will allow for dedicated development in their respective therapeutic areas [409].