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ENDRA Life Sciences(NDRA) - 2019 Q2 - Quarterly Report
2019-08-08 20:47
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER 001-37969 ENDRA LIFE SCIENCES INC. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2019 OR Securities registered pursuant to Section 12(b) of the Act: Delaware 26-05792 ...
ENDRA Life Sciences(NDRA) - 2019 Q1 - Earnings Call Transcript
2019-05-15 03:03
ENDRA Life Sciences Inc. (NASDAQ:NDRA) Q1 2019 Results Earnings Conference Call May 14, 2019 4:30 PM ET Company Participants Chris Tyson - Managing Director, MZ North America Francois Michelon - CEO David Wells - CFO Michael Thornton - Chief Technology Officer Conference Call Participants Kyle Bauser - Dougherty and Company Brooks O'Neil - Lake Street Financial Advisors Ed Woo - Ascendiant Capital Operator Good day, and welcome to the ENDRA Life Sciences??? First Quarter 2019 Conference Call and Webcast. To ...
ENDRA Life Sciences(NDRA) - 2019 Q1 - Quarterly Report
2019-05-14 21:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2019 OR COMMISSION FILE NUMBER 001-37969 ENDRA LIFE SCIENCES INC. (Exact name of registrant as specified in its charter) Delaware 26-0579295 (State of incorporation) (I.R.S. Employer Identification No.) 3600 Green Court, Suite 350, Ann Arbor, MI 48105-1570 (Address of principal executive ...
ENDRA Life Sciences(NDRA) - 2018 Q4 - Earnings Call Transcript
2019-03-12 02:15
Financial Data and Key Metrics Changes - Revenue for the year ended December 31, 2018, totaled approximately $6,000, compared to approximately $350,000 for the year ended December 31, 2017, indicating a significant decrease in revenue [43] - Operating expenses increased to $8.9 million for the year ended December 31, 2018, up from $4.8 million for the same period in 2017, primarily due to research and development costs for the TAEUS product line [44] - The net loss for the year ended December 31, 2018, was $9.7 million or $2.16 per basic and diluted share, compared to a net loss of $5.4 million for the year ended December 31, 2017 [46] Business Line Data and Key Metrics Changes - The company secured approval from Health Canada to begin the first in-human feasibility study with the TAEUS reference system, designated as a class two device for the study [9] - The company expanded its intellectual property portfolio to 41 assets by the end of 2018, with six patent applications issued [9] Market Data and Key Metrics Changes - The company aims to address the unmet clinical need for diagnosing non-alcoholic fatty liver disease (NAFLD), which affects over 1 billion people globally [12] - The company has identified a strong market opportunity for TAEUS technology, particularly in the context of the upcoming pharmacological therapies for liver disease expected to be introduced in 2020 [19] Company Strategy and Development Direction - The company's strategy involves introducing new point-of-care technologies, focusing on high-value items such as fundamental research and intellectual property, and partnering with strategic partners to enable an asset-light business model [10][11] - The company plans to leverage its partnership with GE Healthcare to enhance the utility of ultrasound technology for liver disease assessment [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum heading into 2019, highlighting the importance of the upcoming CE mark application and the controlled launch of the TAEUS liver product in Europe [51] - The management noted that the current study at the Robarts Research Institute is on track, with findings expected to be reported at the end of March [30] Other Important Information - The company raised approximately $10 million in additional capital in 2018, which helped clean up its balance sheet and eliminate debt [9][47] - The company has implemented a formal quality management system encompassing key business processes, which is critical for securing ISO 1345 certification [29] Q&A Session Summary Question: Can you talk about internal plans to continue building clinical evidence beyond this initial CE mark application? - Management indicated that the Canadian study is the first of several sites for testing, with plans to achieve approximately 200 subjects scanned to develop a clinical value proposition [54] Question: Can you elaborate on the ability to go back and rescan patients after refining the algorithm? - Management explained that the feasibility study allows for understanding measurement variations and refining the system based on real patient data [58] Question: What is the outlook for regulatory approval in the United States? - Management anticipates filing a 510(k) for a class 2 device in the US mid-year, with a potential approval by the end of the year or early 2020 [67] Question: Are there plans to work with other partners besides GE? - Management confirmed that while they are committed to working with GE, they are open to exploring partnerships with pharmaceutical companies and other entities in the healthcare space [70] Question: What would it take for the test to become the standard of care? - Management emphasized the importance of building clinical evidence and advocacy from key clinical groups to influence guidelines and reimbursement [91]
ENDRA Life Sciences(NDRA) - 2018 Q4 - Annual Report
2019-03-11 21:26
(Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2018 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number: 001-37969 ENDRA Life Sciences Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 26 ...