Financial Data and Key Metrics Changes - The company raised $7.3 million in net proceeds from the sale of common stock and warrants in a public offering during the quarter [15] - As of June 30, 2024, cash and cash equivalents stood at $6.4 million, providing a cash runway into the first half of 2025 [15] - Total operating expenses decreased to $2.2 million from $3 million for the same period in 2023, primarily due to declines in research and development and sales and marketing expenses [15][16] - Year-over-year, R&D expenses decreased by $684,000 or 49%, while sales and marketing costs decreased by $85,000 or 34% [16] Business Line Data and Key Metrics Changes - The company is shifting resources and spending from development to clinical activities, focusing on executing a statistically powered multi-center prospective clinical trial [8][16] - Initial data collection for the clinical program is limited to three pilot sites, with data already acquired on 25 subjects [13] Market Data and Key Metrics Changes - The company is revisiting its go-to-market strategy for the TAEUS liver device, indicating that hepatology may not be the primary target market [10] Company Strategy and Development Direction - The company plans to implement six specific changes to enhance operations, including a stronger operating team, a new approach with the FDA, and improved financial execution [5][11] - The strategic direction will focus on adding more value to customers beyond the liver fat test, aiming to become a metabolic disease biomarker company [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the technology and market opportunity, anticipating improved performance following the implementation of the six initiatives [21] - The goal is to complete the clinical study this year and initiate a pivotal study early next year, with a submission targeted for mid-2025 [19] Other Important Information - The company has issued five additional patents during the second quarter, bringing the total to 81 issued patents globally [13][14] - The management team has been enhanced with experienced operators to navigate the company through its critical phase [6][7] Q&A Session Summary Question: How quickly will the new strategic path be implemented? - Management indicated a clear priority for the next 9 to 12 months, focusing on completing the clinical study and preparing for regulatory submission [17] Question: Is there a specific time in 2025 for the FDA application? - Management stated that the goal is to complete the clinical study this year and submit the application by mid-2025, although no specific date was provided [19]
ENDRA Life Sciences(NDRA) - 2024 Q2 - Earnings Call Transcript