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]

PART I - FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity, cash flows, and their notes [Condensed Consolidated Balance Sheets](index=2&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%E2%80%93%20September%2030%2C%202021%20(unaudited)%20and%20December%2031%2C%202020) This section provides a snapshot of the company's financial position at specific dates, detailing assets, liabilities, and equity Condensed Consolidated Balance Sheets | Metric | Sep 30, 2021 | Dec 31, 2020 | | :--------------------------- | :----------- | :----------- | | Cash | $11,793,189 | $7,227,316 | | Total Current Assets | $14,470,133 | $8,207,736 | | Total Assets | $15,314,206 | $8,764,976 | | Total Current Liabilities | $1,576,826 | $986,663 | | Total Liabilities | $2,158,140 | $1,595,655 | | Total Stockholders' Equity | $13,156,066 | $7,169,321 | | Accumulated Deficit | $(65,586,182) | $(57,338,489) | [Condensed Consolidated Statements of Operations](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20%E2%80%93%20Three%20and%20Nine%20Months%20ended%20September%2030%2C%202021%20and%202020%20(unaudited)) This section outlines the company's financial performance over specific periods, detailing revenues, expenses, and net loss Condensed Consolidated Statements of Operations | Metric | 3 Months Ended Sep 30, 2021 | 3 Months Ended Sep 30, 2020 | 9 Months Ended Sep 30, 2021 | 9 Months Ended Sep 30, 2020 | | :---------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development | $1,173,319 | $1,769,339 | $4,059,730 | $4,774,534 | | Sales and marketing | $275,565 | $139,751 | $693,263 | $389,469 | | General and administrative | $1,201,851 | $1,346,360 | $3,673,771 | $4,083,572 | | Total operating expenses | $2,650,735 | $3,255,450 | $8,426,764 | $9,247,575 | | Operating loss | $(2,650,735) | $(3,255,450) | $(8,426,764) | $(9,247,575) | | Gain on extinguishment of debt | - | - | $308,600 | - | | Net Loss | $(2,658,242) | $(3,258,071) | $(8,126,622) | $(9,474,740) | | Net loss per share – basic and diluted | $(0.06) | $(0.15) | $(0.20) | $(0.41) | [Condensed Consolidated Statements of Equity](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Equity%20%E2%80%93%20Three%20and%20Nine%20Months%20ended%20September%2030%2C%202021%20and%202020%20(unaudited)) This section details changes in the company's equity over specific periods, including net loss and stock issuances Condensed Consolidated Statements of Equity | Metric | Sep 30, 2021 | Sep 30, 2020 | | :---------------------------------- | :----------- | :----------- | | Total Stockholders' Equity (end of period) | $13,156,066 | $3,334,982 | | Common stock issued for cash, net of funding costs (9 months) | $10,294,899 | $1,321,890 | | Common stock issued for warrant exercise (9 months) | $2,785,627 | $4,914,411 | | Net loss (9 months) | $(8,126,622) | $(9,474,740) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%E2%80%93%20Nine%20Months%20ended%20September%2030%2C%202021%20and%202020%20(unaudited)) This section presents the cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Consolidated Statements of Cash Flows | Metric | 9 Months Ended Sep 30, 2021 | 9 Months Ended Sep 30, 2020 | | :---------------------------------- | :-------------------------- | :-------------------------- | | Net cash used in operating activities | $(8,469,653) | $(8,673,489) | | Net cash used in investing activities | $(45,000) | $(10,483) | | Net cash provided by financing activities | $13,080,526 | $6,303,058 | | Net increase (decrease) in cash | $4,565,875 | $(2,380,914) | | Cash, end of period | $11,793,189 | $3,793,293 | [Notes to the Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [Note 1 – Nature of the Business](index=8&type=section&id=Note%201%20%E2%80%93%20Nature%20of%20the%20Business) This note describes the company's core business, focusing on developing technology for clinical diagnostic ultrasound - ENDRA Life Sciences Inc. develops technology to enhance clinical diagnostic ultrasound capabilities, aiming to broaden patient access to diagnosis and treatment for medical conditions where expensive X-ray computed tomography (CT) and magnetic resonance imaging (MRI) technology is unavailable or impractical[25](index=25&type=chunk) [Note 2 – Summary of Significant Accounting Policies](index=8&type=section&id=Note%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles, estimates, and assumptions used in preparing the financial statements - The Company's financial statements are prepared using U.S. GAAP, requiring management to make estimates and assumptions affecting reported amounts[27](index=27&type=chunk)[28](index=28&type=chunk) - The COVID-19 pandemic's ultimate impact on the Company's business and financial results remains uncertain, potentially affecting macroeconomic conditions, capital markets access, and governmental responses[30](index=30&type=chunk)[31](index=31&type=chunk) - The Company adopted ASU 2016-02 'Leases', recording a lease liability of **$680,526** as of September 30, 2021, and a right-of-use asset of **$675,822**[37](index=37&type=chunk) - The Company's financial statements are prepared assuming it will continue as a going concern, despite a cumulative net loss of **$65,586,182** and the need for additional financing to fund future operations[51](index=51&type=chunk)[52](index=52&type=chunk) [Note 3 – Inventory](index=12&type=section&id=Note%203%20%E2%80%93%20Inventory) This note details the composition of the company's inventory, primarily raw materials and subassemblies for the TAEUS system - Inventory consists of raw materials and subassemblies for the TAEUS system[56](index=56&type=chunk) - As of September 30, 2021, there were no pending orders for the sale of a TAEUS system[56](index=56&type=chunk) [Note 4 – Fixed Assets](index=12&type=section&id=Note%204%20%E2%80%93%20Fixed%20Assets) This note provides information on the company's fixed assets, including net values and depreciation expenses Fixed Assets | Metric | Sep 30, 2021 | Dec 31, 2020 | | :--------------------------- | :----------- | :----------- | | Fixed assets, net | $162,265 | $212,242 | | Depreciation expense (9 months) | $94,977 | $45,114 | [Note 5 – Accounts Payable and Accrued Liabilities](index=12&type=section&id=Note%205%20%E2%80%93%20Accounts%20Payable%20and%20Accrued%20Liabilities) This note presents a breakdown of the company's accounts payable and accrued liabilities at specific dates Accounts Payable and Accrued Liabilities | Metric | Sep 30, 2021 | Dec 31, 2020 | | :--------------------------- | :----------- | :----------- | | Accounts payable | $747,762 | $402,910 | | Accrued payroll | $196,079 | $48,260 | | Total | $1,449,130 | $910,183 | [Note 6 – Bank Loans](index=12&type=section&id=Note%206%20%E2%80%93%20Bank%20Loans) This note details the company's bank loans, including PPP loan forgiveness and Canadian emergency loan terms - The U.S. SBA Paycheck Protection Program Loan of **$308,600** was fully forgiven on May 10, 2021[60](index=60&type=chunk)[61](index=61&type=chunk) - The Company has a CAD **40,000** loan from TD Bank under the Canadian Emergency Business Account, due December 31, 2022, with **0% interest** until January 1, 2023, and **25% forgiveness** if 75% is repaid by the initial term date[62](index=62&type=chunk) [Note 7 – Capital Stock](index=12&type=section&id=Note%207%20%E2%80%93%20Capital%20Stock) This note outlines the company's authorized and outstanding capital stock, including common and preferred shares - Authorized capital consists of **90,000,000 shares** (**80,000,000 common**, **10,000,000 preferred**)[64](index=64&type=chunk) Capital Stock Outstanding | Stock Type | Shares Outstanding (Sep 30, 2021) | | :---------------------------------- | :-------------------------------- | | Common stock | 42,165,726 | | Series A Convertible Preferred Stock | 141,397 | | Series B Convertible Preferred Stock | 0 | - During the nine months ended September 30, 2021, the Company issued **8,116,023 shares** of common stock, including **3,914,217 shares** for **$9,798,293** net proceeds under the February 2021 ATM Agreement and **283,953 shares** for **$496,613** net proceeds under the June 2021 ATM Agreement[66](index=66&type=chunk)[69](index=69&type=chunk) [Note 8 – Common Stock Options and Restricted Stock Units ("RSU's")](index=13&type=section&id=Note%208%20%E2%80%93%20Common%20Stock%20Options%20and%20Restricted%20Stock%20Units%20(%22RSU's%22)) This note details the activity and status of common stock options and restricted stock units under the company's Omnibus Plan - On January 1, 2021, the pool of shares available for issuance under the Omnibus Plan automatically increased by **1,599,570 shares**, from **5,861,658** to **7,461,228**[48](index=48&type=chunk)[116](index=116&type=chunk) Stock Options Activity | Stock Options Activity | Number of Options | Weighted Average Exercise Price | | :---------------------------------- | :---------------- | :------------------------------ | | Balance outstanding at Dec 31, 2020 | 3,569,707 | $2.13 | | Granted | 1,679,000 | $1.98 | | Exercised | (37,645) | - | | Cancelled or expired | (114,852) | - | | Balance outstanding at Sep 30, 2021 | 5,096,210 | $2.08 | | Exercisable at Sep 30, 2021 | 2,073,249 | $2.79 | - On January 28, 2021, **22,815 RSUs** were granted to a member of management, vesting immediately, with a total fair value of **$45,858**[70](index=70&type=chunk) [Note 9 – Common Stock Warrants](index=14&type=section&id=Note%209%20%E2%80%93%20Common%20Stock%20Warrants) This note provides information on the company's common stock warrants, including issuances, exercises, and outstanding balances - During the nine months ended September 30, 2021, the Company issued **3,567,899 shares** of common stock upon Private Warrant exercises for net proceeds of **$2,785,626**[74](index=74&type=chunk) - Additionally, **202,887 shares** of common stock were issued upon cashless exercise election by certain warrant holders[74](index=74&type=chunk) Warrants Activity | Warrants Activity | Number of Warrants | Weighted Average Exercise Price | | :---------------------------------- | :----------------- | :------------------------------ | | Balance outstanding at Dec 31, 2020 | 6,251,103 | $2.79 | | Granted | 314,291 | $0.88 | | Exercised | (3,916,996) | $0.83 | | Expired | (211,234) | - | | Balance outstanding at Sep 30, 2021 | 2,437,164 | $5.54 | | Exercisable at Sep 30, 2021 | 2,437,164 | $5.54 | [Note 10 – Commitments & Contingencies](index=14&type=section&id=Note%2010%20%E2%80%93%20Commitments%20%26%20Contingencies) This note discloses the company's contractual commitments, including lease obligations, and any material legal contingencies - On March 15, 2021, the Company amended its office lease, adding approximately **3,248 rentable square feet**, increasing initial monthly rent to **$15,452**, and extending the term to December 31, 2025[77](index=77&type=chunk) Operating Lease Liabilities (Sep 30, 2021) | Operating Lease Liabilities (Sep 30, 2021) | Amount | | :---------------------------------- | :----------- | | Total future minimum lease payments | $839,287 | | Present value of future minimum lease payments | $680,526 | | Long-term lease obligations | $552,830 | - David Wells resigned as Chief Financial Officer effective June 18, 2021; Irina Pestrikova was appointed Senior Director, Finance, and Principal Financial Officer, receiving **75,000 stock options** and an annual salary of **$160,000**[90](index=90&type=chunk)[91](index=91&type=chunk) - As of September 30, 2021, there were no legal matters that management believes would have a material effect on the Company's financial position or results of operations[92](index=92&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion and analysis of financial condition and results of operations, including forward-looking statements and COVID-19 impact [Forward-Looking Statements](index=16&type=section&id=Forward-Looking%20Statements) This section cautions that the report contains forward-looking statements subject to inherent uncertainties and risks - The report contains forward-looking statements based on current beliefs and assumptions, which are subject to inherent uncertainties, risks, and changes in circumstances[94](index=94&type=chunk) - Important factors that could cause actual results to differ materially include limited commercial experience, ability to obtain financing, market acceptance, regulatory approvals, and the impact of COVID-19[94](index=94&type=chunk)[95](index=95&type=chunk) [Available Information](index=17&type=section&id=Available%20Information) This section lists the various channels the company uses to disseminate material information to the public - The Company uses press releases, Twitter (@endralifesci), LinkedIn (www.linkedin.com/company/endra-inc), and its investor relations website (investors.endrainc.com) to distribute material information[96](index=96&type=chunk) [Overview](index=17&type=section&id=Overview) This section provides a general business overview, focusing on the development and regulatory status of the TAEUS technology - ENDRA is developing Thermo Acoustic Enhanced Ultrasound (TAEUS) technology to enhance clinical diagnostic ultrasound, particularly for quantifying fat in the liver (NAFLD)[97](index=97&type=chunk)[98](index=98&type=chunk)[101](index=101&type=chunk) - The TAEUS FLIP System received CE mark approval in March 2020 for sale in the European Union and other CE mark geographies[104](index=104&type=chunk)[105](index=105&type=chunk) - A 510(k) Application for the TAEUS FLIP System was submitted to the FDA in June 2020, but the review process is taking longer than expected due to the technology's advancement[106](index=106&type=chunk) - The Company has a Collaborative Research Agreement with GE Healthcare, extended to December 16, 2022, and clinical evaluation agreements with several research institutions[102](index=102&type=chunk)[107](index=107&type=chunk) [Financial Operations Overview](index=18&type=section&id=Financial%20Operations%20Overview) This section describes the company's financial operational aspects, including R&D, sales, and marketing expenses - No revenue or cost of goods sold has been generated by the TAEUS technology as of September 30, 2021[108](index=108&type=chunk)[109](index=109&type=chunk) - Research and development expenses primarily cover wages, fees, equipment for TAEUS development, and patent protection[110](index=110&type=chunk) - Sales and marketing efforts are expanding with additional headcount in the EU (UK, France, Germany) for pre-selling activities, with plans to staff US sales efforts post-FDA approval[111](index=111&type=chunk) [Critical Accounting Policies and Estimates](index=18&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section highlights significant accounting policies and estimates that require management judgment - Management makes estimates for accounts such as deferred income tax assets, accrued expenses, fair value of equity instruments, and reserves for commitments or contingencies[114](index=114&type=chunk) - Share-based compensation is recorded using the Black-Scholes option valuation model, with the resulting charge expensed over the vesting period[117](index=117&type=chunk) - Debt discounts related to conversion features and warrants are classified as a direct deduction from debt liability and amortized as interest expense[119](index=119&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, comparing key operating expenses and net loss for specified periods [Three months ended September 30, 2021 and 2020](index=19&type=section&id=Three%20months%20ended%20September%2030%2C%202021%20and%202020) This section compares the company's operating expenses and net loss for the three-month periods ended September 30, 2021 and 2020 - No revenue was generated during the three months ended September 30, 2021 and 2020[121](index=121&type=chunk) Operating Expenses and Net Loss (Three Months) | Expense Category | 3 Months Ended Sep 30, 2021 | 3 Months Ended Sep 30, 2020 | Change (%) | | :--------------------------- | :-------------------------- | :-------------------------- | :--------- | | Research and Development | $1,173,319 | $1,769,339 | -34% | | Sales and Marketing | $275,565 | $139,751 | +97% | | General and Administrative | $1,201,851 | $1,346,360 | -11% | | Net Loss | $(2,658,242) | $(3,258,071) | -18.4% | [Nine months ended September 30, 2021 and 2020](index=20&type=section&id=Nine%20months%20ended%20September%2030%2C%202021%20and%202020) This section compares the company's operating expenses and net loss for the nine-month periods ended September 30, 2021 and 2020 - No revenue was generated during the nine months ended September 30, 2021 and 2020[128](index=128&type=chunk) Operating Expenses and Net Loss (Nine Months) | Expense Category | 9 Months Ended Sep 30, 2021 | 9 Months Ended Sep 30, 2020 | Change (%) | | :--------------------------- | :-------------------------- | :-------------------------- | :--------- | | Research and Development | $4,059,730 | $4,774,534 | -15% | | Sales and Marketing | $693,263 | $389,469 | +78% | | General and Administrative | $3,673,771 | $4,083,572 | -10% | | Gain on Extinguishment of Debt | $308,600 | - | N/A | | Amortization of Debt Discount | - | $232,426 | -100% | | Net Loss | $(8,126,622) | $(9,474,740) | -14.2% | [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, funding requirements, and financing activities to support future operations - As of September 30, 2021, the Company had **$11,793,189** in cash, which is believed to be sufficient to fund current operations into the second half of 2022[137](index=137&type=chunk)[138](index=138&type=chunk) - Additional capital will be required to fund future planned operations, including research and development and commercialization of products, with potential financing options including equity offerings and debt financings[138](index=138&type=chunk)[147](index=147&type=chunk) - The Company incurred net losses of **$8,126,622** and used **$8,469,653** in operating activities during the nine months ended September 30, 2021, indicating a dependence on external financing to continue as a going concern[139](index=139&type=chunk)[140](index=140&type=chunk) - Financing activities provided **$13,080,526** during the nine months ended September 30, 2021, primarily from common stock issuance (**$10.3 million**) and warrant exercises (**$2.8 million**)[144](index=144&type=chunk) - Significant expenses are anticipated for advancing TAEUS application development, regulatory filings, marketing, and expanding operational, financial, and management systems[145](index=145&type=chunk) [Coronavirus ("COVID-19") Pandemic](index=22&type=section&id=Coronavirus%20(%22COVID-19%22)%20Pandemic) This section outlines the impact of the COVID-19 pandemic on the company's operations, clinical trials, and regulatory processes - The Company implemented precautionary measures, including remote work and temporary salary reductions for management (offset by RSUs), to minimize risks from COVID-19[149](index=149&type=chunk) - The pandemic has impacted clinical trial activities, causing delays in patient visits and site access, and has led to delays in FDA reviews and approvals for the TAEUS application due to resource reallocation[150](index=150&type=chunk) [Off-Balance Sheet Transactions](index=22&type=section&id=Off-Balance%20Sheet%20Transactions) This section confirms the absence of any off-balance sheet arrangements as of the reporting date - As of September 30, 2021, the Company did not have any off-balance sheet arrangements[151](index=151&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, ENDRA Life Sciences Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The Company is not required to provide information on market risk as it qualifies as a smaller reporting company[152](index=152&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were not effective due to a material weakness in accounting personnel resources - As of September 30, 2021, management concluded that the Company's disclosure controls and procedures were **not effective**[153](index=153&type=chunk) - A material weakness was identified: insufficient personnel resources within the accounting function to segregate duties over financial transaction processing and reporting[154](index=154&type=chunk) - Remediation plans include hiring additional accounting personnel or outside consultants and developing written accounting policies and procedures, contingent upon obtaining additional funding[155](index=155&type=chunk)[164](index=164&type=chunk) PART II – OTHER INFORMATION This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The Company is not currently involved in any legal proceedings that management believes would have a material adverse effect on its business or financial condition - 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[159](index=159&type=chunk) [Item 1A. Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) This section directs readers to the comprehensive 'Risk Factors' discussion in the Company's Annual Report on Form 10-K for a detailed overview of potential business risks - Readers should refer to the 'Risk Factors' section in the Company's Annual Report on Form 10-K for the period ended December 31, 2020, for a detailed discussion of potential risks[160](index=160&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=23&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable to the current report - This item is not applicable[161](index=161&type=chunk) [Item 3. Defaults Upon Senior Securities](index=23&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the current report - This item is not applicable[162](index=162&type=chunk) [Item 4. Mine Safety Disclosure](index=23&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) This item is not applicable to the current report - This item is not applicable[163](index=163&type=chunk) [Item 5. Other Information](index=24&type=section&id=Item%205.%20Other%20Information) This item is not applicable to the current report - This item is not applicable[165](index=165&type=chunk) [Item 6. Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of this Form 10-Q, including various corporate documents and certifications - The exhibits include the Fourth Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, Specimen Certificate for common stock, Certificates of Designations for Series A and B Preferred Stock, Forms of Warrants, and Certifications (31.1, 31.2, 32.1)[166](index=166&type=chunk) [Signatures](index=24&type=section&id=Signatures) The report is duly signed on November 15, 2021, by the Chief Executive Officer and Chairman, and the Senior Director, Finance - The report was signed on November 15, 2021[170](index=170&type=chunk) - Signatories include Francois Michelon, Chief Executive Officer and Chairman, and Irina Pestrikova, Senior Director, Finance (Principal Financial and Accounting Officer)[170](index=170&type=chunk)[171](index=171&type=chunk)

ENDRA Life Sciences, Inc. (NASDAQ:NDRA) Q2 2021 Earnings Conference Call August 12, 2021 4:30 PM ET Company Participants Yvonne Briggs ??? Investor Relations Francois Michelon ??? Chairman and Chief Executive Officer Renaud Maloberti ??? Chief Commercial Officer Irina Pestrikova ??? Senior Director of Finance Conference Call Participants Ed Woo ??? Ascendiant Capital Markets Operator Good day, ladies and gentlemen and welcome to the ENDRA Life Sciences Second Quarter 2021 Financial Results Conference Call. ...

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, 2021 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 Identification ...

ENDRA Life Sciences Inc. (NASDAQ:NDRA) Q1 2021 Earnings Conference Call May 17, 2021 4:30 PM ET Company Participants Yvonne Briggs - Investor Relations Francois Michelon - Chairman and Chief Executive Officer Renaud Maloberti - Chief Commercial Officer David Wells - Chief Financial Officer Operator Good afternoon, ladies and gentlemen and welcome to the ENDRA Life Sciences First Quarter 2021 Financial Results Conference Call. At this time, all participants have been placed on a listen-only mode and we will ...

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, 2021 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 Inc. (NASDAQ:NDRA) Q4 2020 Earnings Conference Call March 25, 2021 4:30 PM ET Company Participants Yvonne Briggs - LHA Investor Relations Francois Michelon - Chairman and Chief Executive Officer Renaud Maloberti - Chief Commercial Officer David Wells - Chief Financial Officer Conference Call Participants Edward Woo - Ascendiant Capital Markets, LLC Operator Good afternoon, ladies and gentlemen, and welcome to the ENDRA Life Sciences Inc. Fourth Quarter 2020 Financial Results Conference C ...

TAEUS Technology and Applications - The TAEUS technology platform aims to enhance clinical ultrasound capabilities, specifically targeting nonalcoholic fatty liver disease (NAFLD) and its progression, which can lead to serious conditions like NASH and liver cancer[25]. - The TAEUS technology uses radio frequency (RF) pulses, utilizing less than 1% of the energy required for an MRI scan, allowing for deeper tissue penetration and improved imaging capabilities[24]. - TAEUS technology enables ultrasound to distinguish fat from lean tissue, facilitating early identification and monitoring of NAFLD[44]. - The TAEUS platform will initially focus on quantifying fat in the liver and staging progression of Nonalcoholic Fatty Liver Disease (NAFLD), which affected over 1.4 billion people in 2015[51]. - The second generation product is expected to provide two-dimensional imaging with a multi-element transducer, allowing applications such as reading tissue composition and vascular flow[49]. - The company is developing TAEUS for incorporation into new ultrasound systems manufactured by companies such as GE Healthcare[41]. - The TAEUS technology is designed to enhance existing ultrasound systems, allowing healthcare providers to increase utilization and generate new revenue without significant capital investments[43]. - The company has conducted various internal ex-vivo laboratory experiments and limited in-vivo large animal studies to demonstrate the capabilities of the TAEUS platform[42]. Market and Financial Overview - The global ultrasound diagnostic equipment market was valued at approximately $4.4 billion in 2017, with an expected annual growth rate of about 4.4%[36]. - There are an estimated one million ultrasound systems in use globally, generating over 400 million annual diagnostic ultrasound procedures[36]. - The addressable market for TAEUS applications is approximately 365,000 cart-based ultrasound systems currently in use worldwide[36]. - The total annual direct medical costs for NAFLD in the United States are estimated to be $103 billion, with a median Medicare inpatient charge per NAFLD patient estimated at $36,000[57]. - The initial NAFLD TAEUS application is expected to be priced between $35,000 and $55,000, allowing purchasers to recoup their investment in less than one year[83]. - The worldwide market for RF surgical ablation procedures was estimated at $3.7 billion in 2015, growing at approximately 18% annually[66]. Regulatory Approvals and Compliance - The company has received CE mark approval for its NAFLD TAEUS application in March 2020 and completed the 510(k) Premarket Notification submission to the FDA in June 2020[25]. - The TAEUS device received CE mark approval for the NAFLD application in March 2020, following the completion of a study with 50 subjects[90]. - The company submitted its FDA application for the NAFLD TAEUS application in June 2020 under Section 510(k) of the FD&C Act, anticipating initial clearance for general imaging claims[92]. - The company plans to seek additional regulatory approvals in China after establishing a presence in the European Union and the United States[89]. - The Medical Device Regulation (MDR) will impose stricter requirements on clinical evidence and pre-market assessments starting in 2021, potentially affecting the company's existing and future products[91]. - The company is required to comply with various international regulations, including obtaining approvals from the FDA and the China Food and Drug Administration before launching new products[184]. - Recertification of products is generally required every five years in most countries outside the United States, which may involve additional testing and compliance evaluations[195]. Intellectual Property and Competition - The company has a patent portfolio consisting of 14 issued patents in the U.S. and 13 issued patents in foreign jurisdictions, with 21 pending applications in the U.S. and 26 pending applications abroad[79]. - The company faces challenges in policing unauthorized use of its intellectual property, which could lead to decreased market share if competitors exploit its technology[170]. - The company relies on a combination of patents, copyrights, and trade secret laws to protect its intellectual property, but challenges to its patents could allow competitors to market similar products[178]. - The company is the only entity developing RF-based thermoacoustic ultrasound products, facing competition from larger corporations in the CT, MRI, and NAFLD diagnosis markets[109]. - The company faces intense competition in the medical imaging market, requiring significant advantages over alternative products to succeed[151]. Financial Risks and Capital Requirements - As of December 31, 2020, the company had an accumulated deficit of $57,338,489, indicating a history of operating losses[114]. - The company requires additional capital to continue as a going concern and to commercialize its planned TAEUS applications[116]. - The company may need to raise funds through equity or debt financings, which could lead to dilution of existing stockholders' ownership[120]. - The company anticipates incurring significant costs related to research and development, marketing, and regulatory approvals for its TAEUS applications[116]. - The company may not remain commercially viable if there is inadequate reimbursement from governmental programs and third-party payors for its planned products[133]. Operational Challenges - The COVID-19 pandemic has adversely impacted the company's clinical trial activities, causing delays in patient visits and regulatory approvals[129]. - The company may face challenges in achieving market acceptance for its TAEUS applications among physicians, patients, and third-party payors[125]. - The company has limited data regarding the efficacy of its TAEUS platform applications, which may hinder successful commercialization if regulatory approved applications do not perform as expected[135]. - The company has limited commercial experience since its incorporation in 2007, making it difficult to predict future results or financial performance[137]. - The company relies on third parties for design, manufacturing, and regulatory approval of TAEUS applications, which poses a risk if these parties fail to meet expectations[143]. Internal Controls and Governance - The company is currently facing material weaknesses in its internal control over financial reporting, which may lead to misstatements in financial statements[219]. - The company has insufficient personnel resources within the accounting function, impacting the segregation of duties over financial transaction processing[219]. - The company’s ability to maintain effective internal controls is complicated and costly, potentially affecting financial reporting accuracy[220]. - The company is exposed to significant risks related to fraud and misconduct by employees and contractors, which could lead to increased compliance costs and potential fines[159]. Market Dynamics and External Factors - Changes in the healthcare industry may reduce market size or necessitate price reductions, adversely impacting financial performance[154]. - The United Kingdom's withdrawal from the European Union (Brexit) may disrupt trade and create legal uncertainties that could adversely affect the company's operations and financial results[164]. - Legislative changes in healthcare, such as the Affordable Care Act, may impact the company's revenues and profitability due to provisions affecting reimbursement and taxation[202]. - The company plans to market TAEUS applications globally, exposing it to various international business risks[156].

ENDRA Life Sciences Inc. (NASDAQ:NDRA) Q3 2020 Earnings Conference Call November 16, 2020 4:30 PM ET Company Participants Kim Golodetz - LHA David Wells - CFO Francois Michelon - Chairman and CEO Renaud Maloberti - Chief Commercial Officer Michael Thornton - Chief Technology Officer Conference Call Participants Brooks O'Neil - Lake Street Capital Ed Woo - Ascendiant Capital Operator Good day, ladies and gentlemen. And welcome to your ENDRA Life Sciences Third Quarter 2020 Earnings Conference Call. All lines ...

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, 2020 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 (Registrant's telephone number, including area code) ...