Revenue and Financial Performance - No revenue has been generated by the TAEUS technology as of March 31, 2024[85]. - The net loss for the three months ended March 31, 2024, was $2,775,700, compared to a net loss of $2,942,746 for the same period in 2023[101]. - For the three months ended March 31, 2024, the company incurred net losses of $2,775,700 and used cash in operations of $2,144,312[105]. - Cash used in operating activities for the same period in 2023 was $2,506,847, with a net loss of $2,942,746[107]. - As of March 31, 2024, the accumulated deficit was $94,705,852, with cash reserves of $1,134,701[102]. Expenses - Research and development expenses decreased by 25% to $1,041,526 for the three months ended March 31, 2024, compared to $1,391,314 for the same period in 2023[98]. - Sales and marketing expenses increased by 31% to $238,660 for the three months ended March 31, 2024, compared to $181,616 for the same period in 2023[99]. - General and administrative expenses rose by 10% to $1,500,355 for the three months ended March 31, 2024, compared to $1,366,398 for the same period in 2023[100]. Funding and Capital Needs - The company is considering financing options, including sales of common stock, to continue executing its commercialization plans[103]. - The company anticipates needing to raise substantial additional capital to complete the commercialization of its NAFLD TAEUS application and other TAEUS applications[113]. - The company has no committed external sources of funds and may need to finance future cash needs through public or private equity offerings, debt financings, or corporate collaborations[114]. - The company raised $419,967 from common stock issuances and $77,419 from warrant exercises during the three months ended March 31, 2024[110]. Future Plans and Development - The company plans to submit a new de novo request to the FDA in the first half of 2025 after completing necessary clinical studies by the fourth quarter of 2024[84]. - The company expects to incur significant expenses as it advances the engineering design and development of its TAEUS technology and seeks regulatory approvals for its NAFLD TAEUS application[112]. - The company expects to hire a small internal marketing team to support channel partners and clinical customers for its NAFLD TAEUS application[112]. - The company is building a sales and marketing team to support global ultrasound distributors and plans to expand its sales representation in the EU and the US[88]. Other Financial Information - As of March 31, 2024, the company did not have any off-balance sheet transactions[115]. - The company used $27,000 in investing activities related to purchases of fixed assets during the three months ended March 31, 2024[108]. - The financial statements do not include adjustments that might be necessary if the company is unable to continue as a going concern[105].
ENDRA Life Sciences(NDRA) - 2024 Q1 - Quarterly Report