ENDRA Life Sciences(NDRA) - 2021 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q3 2021, operating expenses decreased to $2.7 million from $3.3 million in the same period of 2020, primarily due to reduced spending on product development and investor relations [26] - Research and development expenses decreased by approximately $600,000 year-over-year, while sales and marketing expenses increased by approximately $140,000 as the company expanded its sales efforts [27] - General and administrative costs decreased by approximately $145,000, and the net loss per share for Q3 2021 was $0.06 compared to a loss of $0.15 per share a year ago [28][29] Business Line Data and Key Metrics Changes - The company is focusing on expanding its commercial channel and marketing activities, despite challenges posed by COVID-19 [6][30] - The TAEUS system is being marketed to clinicians and pharmaceutical companies, with a focus on enhancing efficiencies in liver drug trials [12][14] Market Data and Key Metrics Changes - The company has established six clinical evaluation partnerships globally, three in the U.S. and three in Europe, to collect real-world data for the TAEUS system [10] - The sales team in Europe is actively increasing in-person sales visits as COVID-19 restrictions ease, with a total of four people on the commercial team [20][21] Company Strategy and Development Direction - The company aims to secure initial sales in Europe while working closely with the FDA to clarify the regulatory path for the TAEUS system [30] - ENDRA is pursuing pharmaceutical collaborations to facilitate the adoption of TAEUS beyond the clinical end-user market [14][30] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about regulatory clearance for the TAEUS system, despite the review process taking longer than expected due to the unique technological attributes of the device [19][37] - The tone of discussions with the FDA is characterized as collaborative and rigorous, focusing on intended use, technological characteristics, and safety [36][37] Other Important Information - The company has a current cash and cash equivalents balance of $11.8 million and plans to utilize its ATM facility opportunistically [29] - ENDRA's intellectual property portfolio has grown to 89 assets, with four patents issued in Q3 2021 [15] Q&A Session Summary Question: Will GE's restructuring affect ENDRA's agreement with GE? - Management confirmed that the restructuring will not change the relationship, as the agreement is with GE Healthcare, which is a separate entity [34] Question: How would you characterize the tone of conversations with the FDA? - The tone is collaborative and rigorous, focusing on various aspects of the TAEUS system, and management is optimistic about achieving regulatory clearance [36][37] Question: What is the current capacity for in-person visits in Europe? - Management indicated that they are not at full capacity due to COVID-19 but are seizing every opportunity for in-person interactions [39][40] Question: Any updates on the Rocky Vista study? - Management stated that they have not disclosed the number of patients screened in real-time but aim for 200 patients in the study, with ongoing learning from the clinical workflow [52][58]