Financial Performance - The company recorded a net loss of $2,557,132 for Q2 2023, compared to a net loss of $3,591,067 for Q2 2022, reflecting an improvement[98]. - The net loss for the six months ended June 30, 2023, was $5,499,878, an improvement from a net loss of $6,449,269 for the same period in 2022[105]. - As of June 30, 2023, the accumulated deficit was $87,369,780, with cash reserves of $4,819,459[106]. - Cash used in operating activities was $4,775,442 for the six months ended June 30, 2023, compared to $6,433,852 for the same period in 2022[109][110]. Expenses - Research and development expenses for Q2 2023 were $1,400,182, a decrease of 24% from $1,847,560 in Q2 2022[94]. - Sales and marketing expenses for Q2 2023 were $247,773, down 28% from $342,039 in Q2 2022, attributed to the departure of the Chief Commercial Officer[95]. - General and administrative expenses for Q2 2023 were $1,346,610, a decrease of 3% from $1,382,094 in Q2 2022[96]. - Research and development expenses for the six months ended June 30, 2023, were $2,791,496, a decrease of 9% from $3,060,582 in the same period of 2022[101]. - Sales and marketing expenses decreased by $252,553, or 37%, to $429,389 for the six months ended June 30, 2023, compared to $681,942 for the same period in 2022[102]. - General and administrative expenses increased by $28,570, or 1%, to $2,713,008 for the six months ended June 30, 2023, compared to $2,684,438 for the same period in 2022[103]. Revenue and Income - As of June 30, 2023, the company generated no revenue from its TAEUS technology, which has not been commercially sold[82]. - Other income for Q2 2023 was $437,433, primarily from the completion of the Employer Retention Tax Credit[97]. Regulatory and Development Plans - The company plans to submit a de novo application for the TAEUS FLIP System to the FDA as soon as practicable in 2023[81]. - The first-generation TAEUS application is designed to quantify fat in the liver, addressing nonalcoholic fatty liver disease (NAFLD) without the need for surgical biopsies[77]. - The company intends to seek initial regulatory approvals for its applications in the EU and the United States, followed by China[79]. - The company expects to continue incurring significant expenses and will need to raise substantial additional capital to complete the commercialization of its NAFLD TAEUS application[114]. - The company plans to hire a small internal marketing team to support channel partners and clinical customers for the NAFLD TAEUS application[117]. Internal Controls - A material weakness in internal control over financial reporting was identified due to insufficient personnel resources within the accounting function[119]. - Management intends to implement measures to remediate the material weakness as financial means allow[120].
ENDRA Life Sciences(NDRA) - 2023 Q2 - Quarterly Report