Core Viewpoint - ENDRA Life Sciences (NASDAQ:NDRA) stock has experienced a significant increase following an investment from S.H.N. Financial Investments Ltd, which now holds a 9.99% stake in the company [1][8]. Group 1: Stock Performance - NDRA stock is up 35.8% as of Monday morning, although it has declined 93.5% year-to-date as of the previous Friday's close [5]. - Heavy trading activity is noted, with over 52 million shares traded on Monday morning, significantly above the average daily trading volume of approximately 12.2 million shares [9]. Group 2: Investment Details - S.H.N. Financial Investments Ltd has acquired 1.2 million shares and also holds pre-funded warrants for an additional 6,721,648 shares, which are exercisable within 60 days [4][8]. - The investment firm is limited to a 9.99% stake in NDRA stock, and this stake was taken without any intent to influence control of the company [4][9]. - Additional warrants held by S.H.N. Financial Investments Ltd include 12,286,154 Series A Warrants and 12,286,154 Series B Warrants, along with 4,364,506 shares available upon the exercise of other pre-funded warrants [7].

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]

Revenue and Financial Performance - No revenue has been generated by the TAEUS technology as of March 31, 2024[85]. - The net loss for the three months ended March 31, 2024, was $2,775,700, compared to a net loss of $2,942,746 for the same period in 2023[101]. - For the three months ended March 31, 2024, the company incurred net losses of $2,775,700 and used cash in operations of $2,144,312[105]. - Cash used in operating activities for the same period in 2023 was $2,506,847, with a net loss of $2,942,746[107]. - As of March 31, 2024, the accumulated deficit was $94,705,852, with cash reserves of $1,134,701[102]. Expenses - Research and development expenses decreased by 25% to $1,041,526 for the three months ended March 31, 2024, compared to $1,391,314 for the same period in 2023[98]. - Sales and marketing expenses increased by 31% to $238,660 for the three months ended March 31, 2024, compared to $181,616 for the same period in 2023[99]. - General and administrative expenses rose by 10% to $1,500,355 for the three months ended March 31, 2024, compared to $1,366,398 for the same period in 2023[100]. Funding and Capital Needs - The company is considering financing options, including sales of common stock, to continue executing its commercialization plans[103]. - The company anticipates needing to raise substantial additional capital to complete the commercialization of its NAFLD TAEUS application and other TAEUS applications[113]. - The company has no committed external sources of funds and may need to finance future cash needs through public or private equity offerings, debt financings, or corporate collaborations[114]. - The company raised $419,967 from common stock issuances and $77,419 from warrant exercises during the three months ended March 31, 2024[110]. Future Plans and Development - The company plans to submit a new de novo request to the FDA in the first half of 2025 after completing necessary clinical studies by the fourth quarter of 2024[84]. - The company expects to incur significant expenses as it advances the engineering design and development of its TAEUS technology and seeks regulatory approvals for its NAFLD TAEUS application[112]. - The company expects to hire a small internal marketing team to support channel partners and clinical customers for its NAFLD TAEUS application[112]. - The company is building a sales and marketing team to support global ultrasound distributors and plans to expand its sales representation in the EU and the US[88]. Other Financial Information - As of March 31, 2024, the company did not have any off-balance sheet transactions[115]. - The company used $27,000 in investing activities related to purchases of fixed assets during the three months ended March 31, 2024[108]. - The financial statements do not include adjustments that might be necessary if the company is unable to continue as a going concern[105].

EX-99.1 2 ndra_ex991.htm EX-99.1 EXHIBIT 99.1 ENDRA Life Sciences Reports First Quarter 2024 Financial Results and Provides a Business Update Conference call begins at 4:30 p.m. Eastern time today ANN ARBOR, Mich. (May 14, 2024) – ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three months ended March 31, 2024 and provided a business update. Highlights from the first quarter of 2024 and recent weeks include: "We lo ...

ENDRA Life Sciences Inc. (NASDAQ:NDRA) Q4 2023 Earnings Conference Call March 28, 2024 4:30 PM ET Company Participants Yvonne Briggs - LHA Investor Relations Francois Michelon - Chairman and Chief Executive Officer Michael Thornton - Chief Technology Officer Irina Pestrikova - Senior Director of Finance Conference Call Participants Edward Woo - Ascendiant Capital Markets, LLC Operator Good day, and welcome to the ENDRA Life Sciences Fourth Quarter 2023 Financial Results Conference Call. All participants wil ...

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended: December 31, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☐ 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) (State or ...

EX-99.1 2 ndra_ex991.htm PRESS RELEASE Net loss in the fourth quarter of 2023 was $1.5 million, or $0.17 per share, compared with a net loss of $3.3 million, or $1.04 per share, in the fourth quarter of 2022. EXHIBIT 99.1 ENDRA Life Sciences Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update Conference call begins at 4:30 p.m. Eastern time today ANN ARBOR, Mich. (March 28, 2024) – ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound ...

ENDRA Life Sciences Inc. (NASDAQ:NDRA) Q3 2023 Results Conference Call November 14, 2023 4:30 PM ET Company Participants Yvonne Briggs - LHA Investor Relations Francois Michelon - Chairman and Chief Executive Officer Michael Thornton - Chief Technology Officer Irina Pestrikova - Senior Director, Finance Conference Call Participants Edward Woo - Ascendiant Capital Operator Good day, and welcome to the ENDRA Life Sciences Third Quarter 2023 Financial Results Conference Call. All participants will be in a list ...

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 SEPTEMBER 30, 2023 OR ☐ 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) Delaware 26-0579295 (State of incorporation) (I.R.S. Employer Identifica ...

ENDRA Life Sciences Inc. (NASDAQ:NDRA) Q2 2023 Earnings Conference Call August 14, 2023 4:30 PM ET Company Participants Yvonne Briggs - LHA Investor Relations Francois Michelon - Chairman and Chief Executive Officer Michael Thornton - Chief Technology Officer Irina Pestrikova - Senior Director, Finance Conference Call Participants Edward Woo - Ascendiant Capital Operator Good day, and welcome to the ENDRA Life Sciences Second Quarter 2023 Financial Results Conference Call. All participants will be in listen ...