[ENDRA Life Sciences 2024 Q4 and Full-Year Financial Report](index=1&type=section&id=ENDRA%20Life%20Sciences%202024%20Q4%20and%20Full-Year%20Financial%20Report) [Business Update](index=1&type=section&id=Business%20Update) In late 2024, ENDRA Life Sciences significantly advanced its TAEUS® Liver device's FDA regulatory path, accelerated clinical data collection, revised its strategy, and implemented substantial cost reductions [FDA Regulatory Process and Product Refinement](index=1&type=section&id=FDA%20Regulatory%20Process%20and%20Product%20Refinement) In Q4 2024, the company refocused resources to advance the TAEUS® Liver device's FDA regulatory path, gathering data to optimize design and prepare for a pivotal De Novo trial - ENDRA is prioritizing the advancement of its TAEUS Liver device on its FDA regulatory path, focusing on data collection to optimize design and prepare for a pivotal clinical trial necessary for a De Novo submission[2](index=2&type=chunk) - The TAEUS device is undergoing continuous development, with enhancements to its hardware and software to improve both accuracy and usability[2](index=2&type=chunk) [Acceleration of Clinical Data Collection](index=1&type=section&id=Acceleration%20of%20Clinical%20Data%20Collection) Two new clinical sites activated in October 2024 have scanned over 110 subjects, providing crucial data across diverse liver disease states for product optimization and De Novo submission - Two new clinical sites have acquired TAEUS scan data from over **110 subjects**, which is being assessed against the gold standard MRI-PDFF test[2](index=2&type=chunk) - The new data covers a wider range of liver disease states, with about **20% of subjects** having moderate and severe steatosis (S2 and S3), which is foundational for regulatory, clinical, and commercial success[2](index=2&type=chunk) [Revised Regulatory Strategy](index=1&type=section&id=Revised%20Regulatory%20Strategy) ENDRA revised its TAEUS Liver device regulatory strategy to a prospective, multicenter clinical trial with approximately 250 subjects, planning pre-submission FDA engagement for alignment - The company will conduct a prospective, multicenter pivotal trial with approximately **250 subjects** for its De Novo submission, a change from previous plans to use retrospective data[2](index=2&type=chunk) - ENDRA plans a pre-submission engagement with the FDA to align on study design, sample size, hypothesis, and statistical analyses before initiating the trial[2](index=2&type=chunk) [Cost Reduction Initiatives](index=1&type=section&id=Cost%20Reduction%20Initiatives) Significant cost reductions in H2 2024 lowered average monthly cash burn from $0.8 million in 2023 to $0.5 million in Q4 2024, with further reductions expected Reduction in Monthly Cash Used for Operations | Period | Average Monthly Cash Used | | :--- | :--- | | Full Year 2023 | $0.8 million | | Q4 2024 | $0.5 million | | Q2 & Q3 2025 (Expected) | $0.35 million | [New Operating Team Achievements](index=1&type=section&id=New%20Operating%20Team%20Achievements) Since late Q3 2024, ENDRA's new operating team has focused the business on the De Novo submission, defined a new strategy, and significantly reduced cash burn - The new operating team has achieved several key objectives since Q3 2024: - Focused the business on the new multicenter clinical study for the De Novo submission[2](index=2&type=chunk) - Defined a new mission, product strategy, and business model[2](index=2&type=chunk) - Executed a business optimization that significantly reduced monthly cash burn[2](index=2&type=chunk) - Implemented a more cohesive FDA De Novo strategy[2](index=2&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) ENDRA significantly reduced cash used in operations in 2024, though net loss increased due to $3.1 million in one-time non-cash charges, indicating underlying operational improvement [Fourth Quarter 2024 Financial Results](index=2&type=section&id=Fourth%20Quarter%202024%20Financial%20Results) In Q4 2024, cash used in operations decreased to $1.5 million, but net loss increased to $4.2 million primarily due to $3.3 million in one-time non-cash items Q4 Financial Performance Comparison | Metric | Q4 2024 | Q4 2023 | Change | | :--- | :--- | :--- | :--- | | Cash Used in Operations | $1.5 million | $2.2 million | ($0.7 million) | | Operating Expenses | $4.3 million | $1.5 million | +$2.8 million | | Net Loss | $4.2 million | $1.5 million | +$2.7 million | - The increase in Q4 2024 net loss was primarily due to a **$3.3 million swing** from one-time non-cash items, including a **$2.3 million inventory charge** in 2024 and a **$1.0 million gain** from reversing bonuses in 2023[5](index=5&type=chunk)[11](index=11&type=chunk) [Full-Year 2024 Financial Results](index=2&type=section&id=Full-Year%202024%20Financial%20Results) Full-year 2024 cash used in operations decreased to $7.4 million, while net loss increased to $11.5 million primarily due to $3.1 million in non-cash charges Full-Year Financial Performance Comparison | Metric | FY 2024 | FY 2023 | Change | | :--- | :--- | :--- | :--- | | Cash Used in Operations | $7.4 million | $9.5 million | ($2.1 million) | | Total Operating Expenses | $10.8 million | $10.5 million | +$0.3 million | | Net Loss | $11.5 million | $10.1 million | +$1.4 million | - Excluding **$3.1 million** in one-time, non-cash items (inventory and warrant charges), the company's financial performance showed notable improvement in 2024[7](index=7&type=chunk) [Financial Position](index=2&type=section&id=Financial%20Position) As of the end of the fiscal year 2024, ENDRA Life Sciences held $3.2 million in cash and cash equivalents on its balance sheet - As of December 31, 2024, the Company had **$3.2 million** in cash and cash equivalents[8](index=8&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) The consolidated financial statements for 2024 detail a decrease in total assets to $4.5 million, an increase in liabilities, and a net loss of $11.5 million [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2024, the balance sheet shows total assets decreased to $4.5 million, total liabilities increased to $1.9 million, and stockholders' equity decreased to $2.6 million Consolidated Balance Sheet Summary (as of Dec 31) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Cash | $3,229,480 | $2,833,907 | | Total Assets | $4,452,362 | $6,754,146 | | Total Liabilities | $1,891,996 | $1,095,157 | | Total Stockholders' Equity | $2,560,366 | $5,658,989 | [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) For 2024, total operating expenses were $10.8 million, resulting in a net loss of $11.5 million or ($56.94) per share, reflecting increased shares outstanding Consolidated Statement of Operations Summary (Year Ended Dec 31) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Total operating expenses | $10,817,147 | $10,520,735 | | Operating loss | ($10,817,147) | ($10,520,735) | | Net Loss | ($11,507,947) | ($10,060,250) | | Net loss per share | ($56.94) | ($2,766.85) | | Weighted average common shares | 202,106 | 3,636 | [About ENDRA Life Sciences & Forward-Looking Statements](index=2&type=section&id=About%20ENDRA%20Life%20Sciences%20%26%20Forward-Looking%20Statements) ENDRA Life Sciences develops TAEUS® technology for steatotic liver disease, with the report containing forward-looking statements subject to inherent risks and uncertainties - ENDRA's core focus is the development of its TAEUS® technology for measuring liver fat to assess and monitor steatotic liver disease, a condition affecting over **two billion people globally**[9](index=9&type=chunk) - The report contains forward-looking statements regarding future plans, including FDA submissions, product launches, and financial projections, which are subject to inherent risks and uncertainties[10](index=10&type=chunk)

Core Viewpoint - ENDRA Life Sciences Inc. (NDRA) has received an upgrade to a Zacks Rank 1 (Strong Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][4][6]. Earnings Estimates and Revisions - The Zacks rating system focuses on the consensus measure of EPS estimates from sell-side analysts, which reflects the changing earnings picture of a company [2]. - For the fiscal year ending December 2024, ENDRA Life Sciences is expected to earn -$47.46 per share, representing a 98.3% change from the previous year's reported number [9]. - Over the past three months, the Zacks Consensus Estimate for ENDRA Life Sciences has increased by 95.1%, indicating a strong upward trend in earnings estimates [9]. Impact of Institutional Investors - Changes in a company's future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements, largely due to institutional investors adjusting their valuations based on these estimates [5]. - Institutional investors typically react to changes in earnings estimates, leading to significant buying or selling actions that affect stock prices [5]. Zacks Rating System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of ENDRA Life Sciences to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [11].

Financial Performance - ENDRA Life Sciences reported a net loss of $2.23 million for Q2 2024, compared to a net loss of $2.56 million in Q2 2023, representing a 13% improvement year-over-year[12]. - Operating expenses decreased by 26% year-over-year, from $2.99 million in Q2 2023 to $2.23 million in Q2 2024, primarily due to reduced research and development expenses[4][12]. - The company reported a significant reduction in annualized operating expenses by $3.1 million compared to the prior-year second quarter[3]. Capital and Cash Position - The company raised approximately $8.0 million in gross proceeds from a public offering, enhancing its cash position to $6.4 million as of June 30, 2024[3][5]. - Cash and cash equivalents increased from $2.83 million at the end of 2023 to $6.4 million by June 30, 2024, reflecting successful capital raising efforts[10][5]. - Total current assets rose to $6.71 million as of June 30, 2024, up from $3.03 million at the end of 2023[10]. Intellectual Property and Technology Development - ENDRA expanded its intellectual property portfolio to 81 issued patents globally, with five additional patents granted in Q2 2024[3]. - The company initiated new pilot clinical trials at two North American sites and plans to start one in Europe to support the TAEUS technology's clinical value[2]. - The acting CEO emphasized the priority of securing clinical data for a new De Novo regulatory filing with the FDA, while revisiting the go-to-market strategy for TAEUS[4]. - ENDRA's TAEUS technology aims to provide non-invasive assessments of fatty tissue in the liver, addressing a market need affecting over two billion people globally[7].

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].

Financial Performance - Net loss for Q1 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 Q1 2023[5]. - Operating expenses for Q1 2024 were $2.8 million, a decrease from $2.9 million in Q1 2023, primarily due to lower research and development expenses[4]. - Research and development expenses for Q1 2024 were $1.04 million, down from $1.39 million in Q1 2023[17]. - The company reported a net cash used in operating activities of $2.14 million for Q1 2024, compared to $2.51 million in Q1 2023[20]. Cash Position - Cash and cash equivalents as of March 31, 2024, were $1.1 million, down from $2.8 million at the end of Q1 2023[6]. - Total assets decreased to $5.06 million as of March 31, 2024, from $6.75 million at the end of Q1 2023[15]. - Total current liabilities increased to $1.22 million as of March 31, 2024, compared to $0.90 million at the end of Q1 2023[15]. Product Development - The first TAEUS system was installed in the UK at King's College Hospital for clinical evaluation, with a study expected to include approximately 75 subjects[10]. - ENDRA is preparing for a pre-submission meeting with the FDA to align on clinical study design and statistical analysis for the TAEUS system[3]. Intellectual Property - The company expanded its intellectual property portfolio to 80 issued patents globally, with eight additional patents granted in Q1 2024[10].

☒ 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 ...