Vivani Medical(US:VANI)2024-08-13 20:20Product Development - Vivani Medical, Inc. is focused on developing NPM-115, a miniature GLP-1 implant for chronic weight management, with a target of delivering therapeutic drug levels for up to six months [92]. - In a preclinical study, NPM-115 demonstrated a weight loss of approximately 20% in obese mice, comparable to semaglutide injections [99]. - The LIBERATE-1 study for NPM-115 is anticipated to begin in Q4 2024, pending regulatory clearance, with results expected in 2025 [104]. - An Investigational New Drug Application for NPM-119 was filed with the FDA on July 14, 2023, and the clinical hold was lifted on June 13, 2024 [97]. - Vivani established a wholly-owned subsidiary, Vivani Medical Australia Pty Ltd., to support studies of its product candidates [99]. Financial Performance - The company reported a net loss of $11.4 million for the first half of 2024, with cash used in operating activities amounting to $9.3 million [128]. - Cash, cash equivalents, and restricted cash increased by $4.3 million to $26.3 million as of June 30, 2024, with working capital rising to $20.6 million [128]. - Research and development expenses decreased by $0.4 million, or 9%, to $3.5 million for Q2 2024 compared to Q2 2023, primarily due to staffing reductions [117]. - General and administrative expenses decreased by $1.0 million, or 31%, to $2.2 million for Q2 2024 compared to Q2 2023, mainly due to staffing reductions and lower legal services [117]. - The company anticipates needing to raise additional capital to continue operations, with no assurance of favorable terms [110]. - The company has experienced recurring operating losses and negative cash flows since inception, with expectations to continue this trend for the foreseeable future [126]. Funding and Capital Strategy - 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 [105]. - The company raised gross proceeds of $15.0 million from a securities purchase agreement, resulting in net proceeds of $13.7 million after issuance costs [122]. - The company has entered into a sales agreement to offer up to $75.0 million in common stock, enhancing its capital funding strategy [106]. Market Need and Technology - Approximately 50% of patients do not adhere to their prescribed medication regimens, highlighting a significant market need for Vivani's drug delivery solutions [91]. - Vivani's NanoPortal™ technology allows for long-term, near constant-rate delivery of medications, minimizing fluctuations in drug levels [94]. - Cortigent, a subsidiary of Vivani, is advancing neurostimulation technology and has a funding support agreement with Vivani [95]. Grants and Funding Support - The company received a $1.6 million grant from the NIH to fund a clinical trial, with total grants offsetting operating expenses of $0.1 million in the first half of 2024, down from $0.3 million in 2023 [108]. Future Expectations - The company expects research and development expenses to increase in the future as it pursues product enhancements and new technology development [115]. - The company has not entered into foreign currency forward contracts to hedge operating expense exposure to foreign currencies but may consider doing so in the future [133].