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) ...

ENDRA Life Sciences Inc. (NASDAQ:NDRA) Q2 2020 Results Earnings Conference Call August 17, 2020 4:30 PM ET Company Participants David Wells - Chief Financial Officer Francois Michelon - Chairman and CEO Renaud Maloberti - Chief Commercial Officer Michael Thornton - Chief Technology Officer Conference Call Participants Brooks O'Neil - Lake Street Capital Vernon Bernardino - H.C. Wainwright Ed Woo - Ascendiant Capital Operator Good day, ladies and gentlemen. And welcome to your ENDRA Life Sciences Second Quar ...

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, 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 | | --- | --- | | (State of incorporation) | (I.R.S. ...

Financial Data and Key Metrics Changes - Operating expenses increased to $3.1 million for Q1 2020, up from $2.7 million in Q1 2019 [19] - Net loss for Q1 2020 was $3.3 million compared to a net loss of $2.7 million in Q1 2019 [20] - Cash balance as of March 31, 2020, was approximately $3.1 million, down from approximately $6.2 million as of December 31, 2019 [21] Business Line Data and Key Metrics Changes - Research and development spending decreased year-over-year by $255,000, while sales and marketing costs increased by $214,000 [19] - General and administrative costs rose by $551,000 due to employment-related costs and increased expenses associated with being a publicly traded company [19] Market Data and Key Metrics Changes - The company received CE Mark approval for the TAEUS Fatty Liver Imaging Probe (FLIP) ahead of schedule in March 2020, allowing for commercialization in Europe [11] - The company is on track to submit its 510(k) application to the FDA during the current quarter, aiming for approval in the second half of 2020 [14] Company Strategy and Development Direction - The company aims to capitalize on its CE Mark approval and first-mover advantage by launching clinical education tools and establishing evaluation sites in Europe [12] - The strategy includes building a small team of clinical market development specialists in Europe to support commercialization efforts [30] - The company is focused on two key milestones: ramping up commercialization activities in Europe and finalizing the 510(k) submission to the FDA in the U.S. [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to file the 510(k) in June and anticipates FDA approval by the end of the year [36] - The company is encouraged by the gradual return to normal operations in healthcare facilities, which aligns with their clinical partners' feedback [16] Other Important Information - The company has taken proactive actions to align its cost structure with the current economic environment, including a 33% cash salary reduction for management [22] - The company received approximately $308,000 from the Small Business Administration's Paycheck Protection Program [23] Q&A Session Summary Question: How does the company view the speed to commercialization in Europe and the U.S. against cash burn? - Management indicated a careful ramp-up of commercial spending while reducing engineering costs, ensuring a balanced approach to cash management [34] Question: Will COVID-19 impact the U.S. regulatory approval pathway? - Management believes that the submission is on track and that the FDA is remaining efficient, with confidence in filing the 510(k) in June [36] Question: What is the commercialization strategy in the U.S.? - The strategy mirrors that of Europe, focusing on building a small commercial team and leveraging clinical data from evaluation sites [40] Question: Will there be live demonstrations of the product? - Management confirmed plans for testimonials and video demonstrations once the product is in reference sites in Europe [45] Question: What are the criteria for selecting evaluation sites in the U.S.? - Evaluation sites must be centers of excellence in liver health, with a focus on early adopters and leading clinicians [52]

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) ENDRA Life Sciences Inc. reported a **$3.3 million net loss** for Q1 2020, an increase from $2.7 million in Q1 2019, with **$3.1 million cash** and going concern uncertainty [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$4.4 million** from $7.2 million, driven by a **$3.1 million cash balance** as of March 31, 2020 Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2020 ($) | December 31, 2019 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash | $3,102,728 | $6,174,207 | | Total Current Assets | $3,772,868 | $6,535,099 | | Total Assets | $4,398,887 | $7,176,269 | | **Liabilities & Equity** | | | | Total Current Liabilities | $1,551,045 | $2,072,787 | | Total Liabilities | $1,876,849 | $2,415,599 | | Total Stockholders' Equity | $2,522,038 | $4,760,670 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss increased to **$3.32 million** (or **$0.29 per share**) in Q1 2020, up from $2.75 million in Q1 2019, due to higher G&A Statement of Operations Summary (Unaudited) | Metric | Three Months Ended March 31, 2020 ($) | Three Months Ended March 31, 2019 ($) | | :--- | :--- | :--- | | Research and development | $1,518,146 | $1,773,498 | | General and administrative | $1,467,745 | $916,903 | | Total operating expenses | $3,100,846 | $2,747,219 | | Operating loss | $(3,100,846) | $(2,747,219) | | Net Loss | $(3,322,797) | $(2,748,736) | | Net loss per share | $(0.29) | $(0.37) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to **$3.09 million** in Q1 2020, leading to a cash balance decrease to **$3.10 million** Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2020 ($) | Three Months Ended March 31, 2019 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(3,088,367) | $(2,540,662) | | Net cash used in investing activities | $(22,350) | $(5,239) | | Net cash provided by financing activities | $39,238 | $0 | | **Net decrease in cash** | **$(3,071,479)** | **$(2,545,901)** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail TAEUS technology, **going concern doubt** due to insufficient cash, and subsequent events including a PPP loan - The company is developing technology to enhance clinical diagnostic ultrasound capabilities, aiming to provide a cost-effective alternative to CT and MRI scans[18](index=18&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern for one year, as its cash resources are insufficient to meet anticipated needs without additional financing[44](index=44&type=chunk)[45](index=45&type=chunk) - Subsequent to the quarter's end, the company received a **$308,600** loan under the Paycheck Protection Program (PPP)[99](index=99&type=chunk) - During Q1 2020, the company issued over **4.5 million shares** of common stock upon conversion of Series A Preferred Stock and over **234,000 shares** upon conversion of Series B Preferred Stock[62](index=62&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) MD&A focuses on TAEUS technology commercialization, **$3.3 million net loss**, critical liquidity issues, **going concern doubt**, and impacts from COVID-19 and Nasdaq non-compliance - The company's primary focus is on its TAEUS technology, intended to enhance clinical ultrasound. The first application targets nonalcoholic fatty liver disease (NAFLD)[107](index=107&type=chunk)[111](index=111&type=chunk) - In March 2020, the company received **CE mark approval** for its TAEUS FLIP System, allowing for commercialization in the European Union and other CE mark geographies[115](index=115&type=chunk) - Cash on hand of **$3.1 million** as of March 31, 2020, is projected to fund operations only into the third quarter of 2020, necessitating additional financing[135](index=135&type=chunk)[137](index=137&type=chunk) - On April 24, 2020, the company received a **deficiency notice from Nasdaq** for failing to maintain a minimum bid price of **$1.00 per share**[150](index=150&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q1 2020 saw no revenue, **R&D expenses decreased by 14%**, while **sales & marketing rose by 102%** and **G&A by 60%**, leading to a **$3.3 million net loss** Comparison of Operating Expenses (Q1 2020 vs Q1 2019) | Expense Category | Q1 2020 ($) | Q1 2019 ($) | Change (%) | | :--- | :--- | :--- | :--- | | Research & Development | $1,518,146 | $1,773,498 | -14% | | Sales & Marketing | $114,955 | $56,818 | +102% | | General & Administrative | $1,467,745 | $916,903 | +60% | | **Net Loss** | **$3,322,797** | **$2,748,736** | **+21%** | [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) Cash of **$3.1 million** as of March 31, 2020, is sufficient only into Q3 2020, raising **going concern doubt** and necessitating additional capital - The company believes its cash on hand at March 31, 2020, will only be sufficient to fund operations into the third quarter of 2020, and it will need to raise additional capital[137](index=137&type=chunk) - In March 2020, the company established an **at-the-market (ATM) equity offering agreement** to sell up to **$7.2 million** of common stock, though no shares were sold under this program as of March 31, 2020[135](index=135&type=chunk) - In response to COVID-19's economic impact, the company reduced cash salaries for management by **33%** for the remainder of 2020, compensating with restricted stock units[149](index=149&type=chunk) [Quantitative and Qualitative Disclosure About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) As a smaller reporting company, ENDRA is not required to provide market risk disclosures - As a smaller reporting company, ENDRA is not required to provide quantitative and qualitative disclosures about market risk[154](index=154&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were **not effective** as of March 31, 2020, due to a **material weakness** in internal control over financial reporting - Management concluded that disclosure controls and procedures were **not effective** as of March 31, 2020[155](index=155&type=chunk) - A **material weakness** was identified due to insufficient accounting personnel to segregate duties over financial transaction processing and reporting[156](index=156&type=chunk) [PART II – OTHER INFORMATION](index=31&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to materially affect its business or financial condition - There are currently no legal matters that management believes would have a material effect on the Company's financial position or results of operations[95](index=95&type=chunk)[160](index=160&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) The **COVID-19 pandemic** poses significant risks, potentially disrupting clinical trials, regulatory approvals, supply chains, and pre-sales activities - The **COVID-19 pandemic** could severely impact business operations, including clinical trials, regulatory timelines, and supply chains[162](index=162&type=chunk)[163](index=163&type=chunk) - Specific potential disruptions from the pandemic include delays in patient enrollment for clinical trials, interruptions in FDA operations, supply chain issues, and limited access to capital[165](index=165&type=chunk) [Other Items (Items 2, 3, 4, 5)](index=31&type=section&id=Item%202.%20Recent%20Sales%20of%20Unregistered%20Securities%3B%20Use%20of%20Proceeds%20from%20Registered%20Securities) Items 2, 3, 4, and 5, covering various disclosures, are reported as not applicable for the period - No information was reported for Item 2, 3, 4, and 5, as they were not applicable[166](index=166&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk)[169](index=169&type=chunk) [Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance, securities, agreements, and certifications

ENDRA Life Sciences, Inc. (NASDAQ:NDRA) Q4 2019 Earnings Conference Call March 26, 2020 4:30 PM ET Company Participants Francois Michelon - Chairman and Chief Executive Officer David Wells - Chief Financial Officer Michael Thornton - Chief Technology Officer Renaud Maloberti - Chief Commercial Officer Conference Call Participants Brooks O'Neil - Lake Street Capital Ed Woo - Ascendiant Capital Operator Good day, ladies and gentlemen and welcome to the ENDRA Life Sciences Fourth Quarter 2019 Financial Results ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2019 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number: 001-37969 ENDRA Life Sciences Inc. (Exact Name of Registrant as Specified in Its Charter) | Delaware ...