Financial Data and Key Metrics Changes - For the quarter ended March 31, 2024, operating expenses decreased to $2.8 million from $2.9 million for the same period in 2023, primarily due to lower research and development expenses [7][15] - The net loss in the first quarter of 2024 was $2.8 million or $0.26 per share, compared to a net loss of $2.9 million or $0.93 per share in the first quarter of 2023 [15] Business Line Data and Key Metrics Changes - Research and development expenses decreased year-over-year by approximately $350,000 as the development of the initial TAEUS product was completed [15] - Sales and marketing expenses increased by approximately $57,000, mainly due to higher consulting fees [15] - General and administrative expenses increased by approximately $134,000, mainly due to higher professional fees [15] Market Data and Key Metrics Changes - The prevalence of liver disease affects over 2 billion people globally, highlighting the need for accessible diagnostic tools [4] - Major insurers are requiring adherence to specific prescribing authorization criteria for new liver disease therapies, emphasizing the complexity of managing this disease [13][25] Company Strategy and Development Direction - The company is focused on leveraging clinical partner sites in Europe and the US to build clinical evidence and achieve successful adoption of its technology [17] - ENDRA is engaging closely with the FDA to advance its regulatory submission in the US [17] - The company aims to explore collaborations and strategic pathways to expand the applications of its TAEUS platform beyond liver disease [26] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of building a body of clinical evidence to support commercial success and the need for precision in diagnosis and treatment of liver disease [11][13] - The company is actively preparing for an in-person pre-submission meeting with the FDA to discuss clinical trial design [27][28] - Management expressed optimism about the advancements in diagnosing and managing liver disease, which provide opportunities for ENDRA [25] Other Important Information - Cash and cash equivalents were $1.1 million as of March 31, 2024, with the company raising $420,000 in gross proceeds from the sale of common stock [30] - ENDRA has issued eight new patents this year, bringing its total to 80 issued patents worldwide, reinforcing its competitive edge [26] Q&A Session Summary Question: Is the company considering expansion into other parts of Asia? - Management indicated that while there is a distribution agreement in Vietnam, the focus will be on establishing a strong presence in Europe and the US before expanding into Asia [19][34] Question: What are the next steps following the FDA meeting? - Management expressed anticipation for the outcomes of the FDA meeting and the next steps in the regulatory process [28][35]
ENDRA Life Sciences(NDRA) - 2024 Q1 - Earnings Call Transcript