Vivani Medical(US:VANI)2023-11-12 16:00Financial Performance - General and administrative expenses rose by $1.1 million, or 71%, to $2.7 million in Q3 2023 from $1.6 million in Q3 2022, driven by increased costs from the acquisition and higher public company expenses [121]. - General and administrative expenses surged by $4.8 million, or 129%, to $8.5 million in the first nine months of 2023 from $3.7 million in the same period of 2022, reflecting higher costs from the acquisition and public company operations [124]. - Other income increased to $1.1 million for the nine months ended September 30, 2023, compared to $6.9 million for the same period in 2022 due to the merger acquisition [125]. - Cash, cash equivalents, and restricted cash decreased by $20.2 million from $46.4 million as of December 31, 2022, to $26.2 million as of September 30, 2023 [132]. - Operating activities used $20.2 million in cash during the nine months ended September 30, 2023, primarily due to a net loss of $19.6 million [133]. - Financing activities generated $110,000 in the nine months ended September 30, 2023, compared to $63.4 million in the same period of 2022 [135]. Research and Development - Research and development expenses increased by $0.5 million, or 15%, to $4.4 million in Q3 2023 from $3.9 million in Q3 2022, primarily due to costs associated with the acquired company Second Sight [120]. - For the first nine months of 2023, research and development expenses increased by $2.6 million, or 26%, to $12.3 million from $9.7 million in the same period of 2022, largely due to the inclusion of Second Sight's costs [123]. - The company intends to utilize research and development incentives from the Australian government to support clinical trials while seeking to lift the clinical hold with the FDA [105]. - The company expects expenses to increase as it initiates clinical trials and seeks marketing approval for product candidates, particularly for NPM-119 [130]. Clinical Trials and Regulatory Matters - An Investigational New Drug Application for NPM-119 was filed with the FDA on July 14, 2023, but the study is currently on full clinical hold due to insufficient Chemistry, Manufacturing, and Controls information [105][112]. - The company received a $6.4 million NIH grant for a clinical trial, with the final year grant of $1.0 million approved in March 2023 [110]. Company Strategy and Future Outlook - The company plans to focus exclusively on the drug implant business, subject to the completion of Cortigent's initial public offering [102]. - The company is subject to risks associated with having no revenue while developing novel pharmaceutical products and medical devices, expecting to incur operating losses and negative cash flows for the foreseeable future [111]. - The company has incurred recurring operating losses and negative operating cash flows since inception, with expectations to continue this trend for the foreseeable future [128]. - The company anticipates seeking funding through public or private equity or debt financings, grants, collaborations, or strategic partnerships [131]. - As of September 30, 2023, the company did not have any off-balance sheet arrangements [136]. Cash Position - The company reported $53.3 million in net assets, including approximately $55.4 million in cash, following the reverse merger with Second Sight [109]. - Cash balance as of September 30, 2023, was $24.8 million, excluding $3.2 million of reimbursable tenant improvements, with a cash runway expected to extend into early 2025 [128].