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) 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, 2025 | | | Name of each exchange on which | | --- | --- | --- | | Title of each cl ...

FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) July 9, 2025 ENDRA Life Sciences Inc. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 | Delaware | 001-37969 | 26-0579295 | | --- | --- | --- | | (State or other jurisdiction | (Commission | (IRS Employer | | of incorporation) | File Number) | Identification No.) | | 3600 Green Court, Suite ...

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) The unaudited condensed consolidated financial statements for the three months ended March 31, 2025, show a decrease in total assets and liabilities compared to year-end 2024, reporting a net loss of $1.04 million, a significant reduction from the $2.78 million loss in the same period of 2024, primarily due to lower operating expenses, with cash used in operations at $1.3 million and ending cash at $2.1 million, while notes highlight substantial doubt about the company's ability to continue as a going concern due to recurring losses and the need for additional financing [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets were $3.17 million, a decrease from $4.45 million at December 31, 2024, primarily driven by a reduction in cash, while total liabilities also decreased to $1.42 million from $1.89 million, mainly due to a lower warrant liability, consequently, total stockholders' equity declined to $1.75 million from $2.56 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash | $2,064,874 | $3,229,480 | | Total Current Assets | $2,180,206 | $3,433,665 | | **Total Assets** | **$3,170,598** | **$4,452,362** | | Total Current Liabilities | $565,785 | $605,230 | | Warrant Liability | $390,722 | $799,284 | | **Total Liabilities** | **$1,417,713** | **$1,891,996** | | **Total Stockholders' Equity** | **$1,752,885** | **$2,560,366** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, the company reported a net loss of $1.04 million, or ($1.86) per share, compared to a net loss of $2.78 million, or ($449.58) per share, for the same period in 2024, with the improvement driven by a significant reduction in total operating expenses to $1.47 million from $2.78 million year-over-year, and a $0.41 million gain from the change in fair value of warrant liability Condensed Consolidated Statements of Operations (in thousands) | Metric | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Research and development | $528,685 | $1,041,526 | | Sales and marketing | $68,991 | $238,660 | | General and administrative | $871,606 | $1,500,355 | | **Total operating expenses** | **$1,469,282** | **$2,780,541** | | Operating loss | ($1,469,282) | ($2,780,541) | | Changes in fair value of warrant liability | $408,562 | - | | **Net Loss** | **($1,036,330)** | **($2,775,700)** | | Net loss per share | ($1.86) | ($449.58) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Total stockholders' equity decreased from $2.56 million at the end of 2024 to $1.75 million as of March 31, 2025, primarily due to the net loss of $1.04 million for the quarter, partially offset by equity issued for services and stock options valued at approximately $0.23 million - Stockholders' equity decreased by approximately **$0.81 million** during the first quarter of 2025, driven by the net loss of **$1.04 million**[17](index=17&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the first quarter of 2025, net cash used in operating activities was $1.29 million, net cash used in investing activities was minimal at $17,280, and net cash provided by financing activities was $145,803 from the issuance of common stock, resulting in a net decrease in cash of $1.16 million, with the company ending the period with $2.06 million in cash Cash Flow Summary (in thousands) | Activity | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,293,129) | ($2,144,312) | | Net cash used in investing activities | ($17,280) | ($23,796) | | Net cash provided by financing activities | $145,803 | $468,902 | | **Net decrease in cash** | **($1,164,606)** | **($1,699,206)** | | Cash, end of period | $2,064,874 | $1,134,701 | [Notes to the Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies and provide context for the financial statements, including a going concern warning citing cumulative losses of $104.5 million and the need for additional capital, full reservation of inventory at $0 value, details on capital stock structure including two reverse stock splits in 2024, an At-The-Market (ATM) equity offering program initiated in February 2024, and accounting for certain warrants as a liability re-measured to fair value each period - The company's financial statements are prepared on a going concern basis, but management has identified substantial doubt about its ability to continue due to a cumulative net loss of **$104.5 million** and the need to raise additional capital to fund operations[51](index=51&type=chunk) - The company implemented two reverse stock splits in 2024: a **one-for-50 split** in August and a **one-for-35 split** in November, with all share and per-share amounts retroactively restated[64](index=64&type=chunk)[65](index=65&type=chunk)[66](index=66&type=chunk) - In February 2024, the company entered into an At-The-Market (ATM) sales agreement to sell up to **$6.2 million** in common stock, raising net proceeds of **$145,803** through this program during Q1 2025[61](index=61&type=chunk)[62](index=62&type=chunk) - Certain warrants (Series A and Series B) are classified as a liability and re-measured to fair value each period, resulting in a non-cash income of **$408,562** in Q1 2025 due to a decrease in the liability's fair value[76](index=76&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing its TAEUS® technology platform as a biomarker solution for metabolic diseases, particularly for managing GLP-1 drug therapies, noting the company is pre-revenue with a history of losses and an accumulated deficit of $104.5 million, with operating expenses significantly reduced in Q1 2025 compared to Q1 2024 due to cost-cutting measures, but facing immediate liquidity challenges and requiring additional financing to continue operations, commercialize its technology, and fund development, raising substantial doubt about its ability to continue as a going concern - The company's strategic vision is to establish TAEUS as a leading biomarker solution for metabolic diseases and GLP-1 drug management, targeting pharmaceutical companies, specialty clinics, and primary care providers with a subscription-based business model[107](index=107&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk) Year-over-Year Operating Expense Comparison (Q1 2025 vs Q1 2024) | Expense Category | Q1 2025 | Q1 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Research & Development | $528,685 | $1,041,526 | -49% | | Sales & Marketing | $68,991 | $238,660 | -71% | | General & Administrative | $871,606 | $1,500,355 | -42% | - The company faces significant liquidity constraints with only **$2.1 million** in cash as of March 31, 2025, and without additional funding, it will be forced to delay or curtail operations, raising substantial doubt about its ability to continue as a going concern[131](index=131&type=chunk)[133](index=133&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=21&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, ENDRA Life Sciences Inc. is not required to provide the information for this item - The company is exempt from providing quantitative and qualitative disclosures about market risk because it qualifies as a smaller reporting company[142](index=142&type=chunk) [Item 4. Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were not effective as of March 31, 2025, based on a material weakness in internal control over financial reporting related to insufficient accounting personnel to ensure proper segregation of duties, with plans to remediate this by hiring additional personnel or consultants as financial resources permit - The company identified a material weakness in its internal controls due to insufficient personnel resources within the accounting function, which prevents adequate segregation of duties over financial transaction processing and reporting[144](index=144&type=chunk) - As a result of the material weakness, the principal executive and financial officers concluded that disclosure controls and procedures were not effective as of the end of the quarter[143](index=143&type=chunk) - Remediation plans include hiring additional accounting personnel or consultants and developing written accounting policies, contingent upon obtaining additional funding[145](index=145&type=chunk)[152](index=152&type=chunk) [PART II – OTHER INFORMATION](index=22&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=22&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any pending legal proceedings that are expected to have a material adverse effect on its business or financial condition - As of the filing date, there are no material legal proceedings against the company[148](index=148&type=chunk) [Item 1A. Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors) There are no new risk factors reported in this quarter, and the company directs investors to the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024 - The report refers to the risk factors detailed in the company's Annual Report on Form 10-K filed on March 31, 2025[149](index=149&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=22&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period - No unregistered sales of equity securities occurred during the quarter[150](index=150&type=chunk) [Item 5. Other Information](index=22&type=section&id=Item%205.%20Other%20Information) No directors or officers of the company adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the fiscal quarter ended March 31, 2025 - There were no adoptions, modifications, or terminations of Rule 10b5-1 trading plans by directors or officers during the quarter[154](index=154&type=chunk) [Item 6. Exhibits](index=23&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the CEO and CFO as required by the Sarbanes-Oxley Act, and XBRL data files - Exhibits filed include CEO and CFO certifications (31.1, 31.2, 32.1) and XBRL interactive data files[155](index=155&type=chunk)

EX-99.1 2 endra_ex991.htm PRESS RELEASE EXHIBIT 99.1 ENDRA Life Sciences Provides a Business Update and Reports First Quarter 2025 Financial Results ANN ARBOR, Mich. (May 15, 2025) – ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo-Acoustic Enhanced UltraSound (TAEUS®), today provided a business update and reported financial results for the three months ended March 31, 2025. Business Update Incorporating Liver Diagnostics into the Management of Metabolic Disease ENDRA recently announced a strate ...

Financial Performance - The net loss for 2024 was $11,507,947, compared to a net loss of $10,060,250 in 2023, reflecting an increase in losses of approximately 14.4%[330] - For the year ended December 31, 2023, the net loss was $10,060,250, compared to a net loss of $11,507,947 for the year ended December 31, 2024, indicating a decrease in losses[336] - The total income (loss) before income taxes for 2024 was $(11,507,947), compared to $(10,060,250) for 2023[421] - The Company has not generated any product revenue to date and expects to incur significant expenses and operating losses as it advances product candidates[428] Assets and Liabilities - Total current assets increased to $3,433,665 in 2024 from $3,032,812 in 2023, representing a growth of approximately 13.2%[327] - Total liabilities rose to $1,891,996 in 2024 compared to $1,095,157 in 2023, indicating an increase of about 72.6%[327] - The accumulated deficit grew to $(103,438,099) in 2024 from $(91,930,152) in 2023, an increase of approximately 12.5%[327] - The total stockholders' equity as of December 31, 2023, was $5,658,989, down from $2,560,366 as of December 31, 2024[333] - As of December 31, 2024, the company recorded inventory reserves totaling $2,525,179, compared to $138,045 as of December 31, 2023, indicating a significant increase in inventory devaluation reserves[365] - The Company had a balance of 180,707 warrants outstanding as of December 31, 2024, with a weighted average exercise price of $85.38[397] Expenses - Research and development expenses decreased to $3,190,293 in 2024 from $5,003,695 in 2023, a reduction of about 36.2%[329] - General and administrative expenses increased significantly to $7,055,814 in 2024 from $4,696,486 in 2023, marking an increase of approximately 50.5%[329] - The total operating expenses for 2024 were $10,817,147, slightly higher than $10,520,735 in 2023, an increase of about 2.8%[329] - The Company incurred rent expenses of $203,265 and $218,815 for the years ended December 31, 2024 and 2023, respectively[413] Cash Flow and Financing - Cash and cash equivalents at the end of the period increased to $3,229,480 for the year ended December 31, 2024, compared to $2,833,907 for the year ended December 31, 2023[336] - The cash flows from financing activities provided $7,808,917 in 2024, compared to $7,518,305 in 2023, reflecting an increase in financing[336] - The Company plans to raise additional capital through equity sales and borrowing to fund future operations, including R&D and commercialization efforts[362] - The net proceeds from the Offering on June 5, 2024, amounted to $7,338,333 after deducting offering expenses[377] Stock and Shares - The company reported a weighted average of 202,106 common shares for 2024, compared to 3,636 shares in 2023, indicating a substantial increase in shares outstanding[330] - The Company issued a total of 530,971 shares of common stock during the year ended December 31, 2024, with 495,476 shares from cashless exercise of Series B Warrants[376] - The Company executed two reverse stock splits in 2024, with ratios of one-for-50 and one-for-35, affecting the number of shares and exercise prices[370][371] Audit and Compliance - The company has not identified any critical audit matters in the current period audit of the financial statements[325] - The Company has no unrecognized tax benefits as of December 31, 2024 and 2023, and no penalties or interest were recorded in income tax expense for these years[425] Operational Challenges - The company has expressed substantial doubt about its ability to continue as a going concern due to recurring losses and negative cash flows[320] - The company had no pending orders for the sale of a TAEUS system as of December 31, 2024, indicating potential challenges in sales[364] Tax and Deferred Assets - The expected tax at statutory rates for 2024 was $(2,416,700), reflecting a 21% rate[420] - The net deferred tax assets (liabilities) were $24,573,700 as of December 31, 2024, with a full valuation allowance recorded due to uncertainty in realizing these assets[422] - The domestic U.S. net operating loss carryforward increased from $62,032,405 at December 31, 2023 to $72,521,129 at December 31, 2024[423] - The Company's total state net operating losses increased from $74,926,792 at December 31, 2023 to $84,972,922 at December 31, 2024[423]

[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]