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ENDRA Life Sciences(NDRA) - 2020 Q1 - Earnings Call Transcript
2020-05-16 17:46
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]
ENDRA Life Sciences(NDRA) - 2020 Q1 - Quarterly Report
2020-05-14 21:24
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER 001-37969 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 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(NDRA) - 2019 Q4 - Earnings Call Transcript
2020-03-27 03:48
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 ...
ENDRA Life Sciences(NDRA) - 2019 Q4 - Annual Report
2020-03-26 21:21
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 ...
ENDRA Life Sciences(NDRA) - 2019 Q3 - Earnings Call Transcript
2019-11-14 04:19
ENDRA Life Sciences Inc. (NASDAQ:NDRA) Q3 2019 Results Earnings Conference Call November 13, 2019 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 Frank Takkinen - Lake Street Capital Markets Kyle Bauser - Dougherty & Company Vernon Bernardino - H.C. Wainwright Ed Woo - Ascendiant Capital Operator Good afternoon. M ...
ENDRA Life Sciences(NDRA) - 2019 Q3 - Quarterly Report
2019-11-13 22:02
[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) For the nine months ended September 30, 2019, ENDRA Life Sciences reported no revenue and an increased net loss of $8.5 million, with significant declines in cash and stockholders' equity raising substantial doubt about its going concern ability [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2019, total assets decreased to $3.6 million, liabilities increased to $2.2 million, and stockholders' equity sharply dropped to $1.4 million Key Balance Sheet Figures | | Sep 30, 2019 (Unaudited) | Dec 31, 2018 | | :--- | :--- | :--- | | **Total Current Assets** | $2,976,181 | $6,949,558 | | **Total Assets** | **$3,615,467** | **$7,222,791** | | **Total Current Liabilities** | $1,853,808 | $974,583 | | **Total Liabilities** | **$2,212,723** | **$974,583** | | **Total Stockholders' Equity** | **$1,402,744** | **$6,248,208** | - Cash decreased significantly from **$6,471,375** at the end of 2018 to **$2,275,302** as of September 30, 2019[7](index=7&type=chunk) - The company reported new liabilities in 2019, including **$590,026** in convertible notes payable and total lease liabilities of **$424,210**[7](index=7&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported no revenue, with net losses widening to $3.4 million for Q3 2019 and $8.5 million for the nine-month period, driven by increased R&D and new debt discount amortization expenses Key Statements of Operations Figures | | Three Months Ended Sep 30, 2019 | Three Months Ended Sep 30, 2018 | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | **Revenue** | $ - | $ - | $ - | $6,174 | | **Operating loss** | $(2,640,533) | $(2,355,515) | $(7,712,925) | $(7,016,201) | | **Net Loss** | **$(3,413,562)** | **$(2,758,576)** | **$(8,496,670)** | **$(7,430,651)** | | **Net loss per share** | $(0.46) | $(0.70) | $(1.14) | $(1.89) | - Research and development expenses increased to **$1,468,441** in Q3 2019 from **$1,162,911** in Q3 2018[10](index=10&type=chunk) - A significant new expense in Q3 2019 was the amortization of debt discount, amounting to **$728,417**, which was not present in the same period of 2018[10](index=10&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $6.7 million for the nine months ended September 30, 2019, leading to a $4.2 million net decrease in cash and an ending balance of $2.3 million Key Statements of Cash Flows Figures | | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(6,681,336) | $(5,800,054) | | **Net cash used in investing activities** | $(5,238) | $(100,000) | | **Net cash provided by financing activities** | $2,490,501 | $935,300 | | **Net Decrease in cash** | **$(4,196,073)** | **$(4,964,754)** | | **Cash, end of period** | **$2,275,302** | **$637,124** | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail the company's focus on TAEUS technology, a significant going concern warning due to a cumulative net loss of $36.2 million and insufficient cash, and a July 2019 private placement of $2.8 million in convertible notes - The company is developing **Thermo-Acoustic Enhanced Ultrasound (TAEUS)** technology to enhance clinical diagnostic ultrasound capabilities[17](index=17&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern due to a cumulative net loss of **$36,188,366** and insufficient cash resources to meet anticipated needs for the next twelve months[44](index=44&type=chunk)[45](index=45&type=chunk)[46](index=46&type=chunk) - In July 2019, the company raised approximately **$2.8 million** in gross proceeds through a private placement of senior secured convertible promissory notes and warrants[51](index=51&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic shift to focus on TAEUS technology, increased net losses from higher R&D, and a critical liquidity situation requiring additional capital to avoid delisting [Overview](index=17&type=section&id=Overview) ENDRA is strategically focusing on developing its TAEUS technology for liver fat quantification, having ceased production of its legacy Nexus 128 system, and completed a human feasibility study for CE Mark submission - The company has ceased production and support for its legacy Nexus 128 system to focus resources on the development of its **TAEUS technology**[77](index=77&type=chunk) - The first-generation TAEUS application is designed to quantify fat in the liver to address **nonalcoholic fatty liver disease (NAFLD)**[79](index=79&type=chunk) - A human feasibility study for the TAEUS liver device was completed on September 26, 2019, with data to be used for a **CE Mark submission anticipated in the first half of 2020**[83](index=83&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) The company reported no revenue, with Q3 2019 net loss widening to $3.4 million and nine-month net loss to $8.5 million, primarily due to increased R&D expenses and new debt discount amortization Key Operating Expenses | Expense Category | Q3 2019 | Q3 2018 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $1,468,441 | $1,162,911 | +26% | | Sales and marketing | $100,203 | $72,179 | +39% | | General and administrative | $1,071,889 | $832,884 | +29% | - The company incurred a new non-cash expense of **$728,417** in Q3 2019 for the amortization of debt discount related to convertible notes issued in July 2019[102](index=102&type=chunk) - For the nine months ended September 30, 2019, the company recorded a net loss of **$8,496,670** compared to a net loss of **$7,430,651** for the same period in 2018[111](index=111&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) The company's critical financial condition, with $2.3 million cash sufficient only into Q1 2020, necessitates additional capital to continue operations and execute its commercialization plan - As of September 30, 2019, the company had **$2,275,302** in cash, believed to be sufficient to fund operations only into the **first quarter of 2020**[112](index=112&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern for one year from the issuance of the financial statements[114](index=114&type=chunk) - In July 2019, the company raised net proceeds of approximately **$2,490,501** through a private placement of senior secured convertible promissory notes and warrants[113](index=113&type=chunk) [Quantitative and Qualitative Disclosure About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) As a smaller reporting company, ENDRA Life Sciences is exempt from providing this specific market risk disclosure - The company is a smaller reporting company and is not required to provide the information for this item[124](index=124&type=chunk) [Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective as of September 30, 2019, due to a material weakness in accounting personnel resources, with remediation contingent on additional funding - Management concluded that the company's disclosure controls and procedures were **not effective** as of September 30, 2019[125](index=125&type=chunk) - A material weakness was identified due to insufficient personnel resources in the accounting function, leading to a lack of segregation of duties[126](index=126&type=chunk) - Remediation plans, which include hiring additional personnel, are contingent upon the company's ability to obtain additional funding[127](index=127&type=chunk) [PART II – OTHER INFORMATION](index=26&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any pending legal proceedings expected to materially affect its business or financial condition - The company reports no pending legal proceedings that would have a material effect on its financial position or results of operations[131](index=131&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) Critical risk factors include the urgent need for additional capital to fund operations and repay $2.6 million in convertible notes, alongside a Nasdaq delisting warning for failing to maintain minimum stockholders' equity - The company needs to raise additional capital to maintain operations and repay senior secured convertible promissory notes of **$2,587,895** maturing on **April 26, 2020**[133](index=133&type=chunk) - On August 14, 2019, the company received a notification from Nasdaq for failing to maintain the minimum stockholders' equity of **$2,500,000**, which could result in the delisting of its common stock[137](index=137&type=chunk) [Exhibits](index=28&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, forms of securities from a recent financing, and certifications by the CEO and CFO
Endra Life Sciences (NDRA) Presents At H.C. Wainwright 21st Annual Global Investment Conference - Slideshow
2019-09-16 16:48
ENDRA Life Sciences Overview - ENDRA Life Sciences is pioneering breakthrough ultrasound applications[2] - The company focuses on visualizing human tissue like CT or MRI but at a 50X lower cost at the point of patient care[9] - ENDRA's platform technology initially focuses on NAFLD-NASH, representing a $13B greenfield opportunity to expand clinical applications for 1M+ installed ultrasound systems[9] - The company has a strong technology position with 58 IP assets[9] TAEUS™ Technology and Applications - ENDRA's Thermo Acoustic Enhanced UltraSound (TAEUS™) differentiates tissues in concert with ultrasound[18] - The initial application is focused on diagnosing NAFLD by tissue composition[21] - TAEUS™ platform has multiple potential revenue streams including accessories, software, licensing, service, and disposables[21] Market and Commercialization - The addressable market for ENDRA's TAEUS platform is approximately 338,000 cart-based non-prenatal ultrasound systems, representing a $13B+ market opportunity[25, 26] - Over 1.4 billion people globally are affected by NAFLD-NASH, creating a significant clinical need for a non-invasive, cost-effective diagnostic tool[9, 27] - ENDRA has a partnership with GE Healthcare focused on early assessment of non-alcoholic fatty liver disease[31] Financials and Key Statistics - As of August 30, 2019, ENDRA's common stock price was $1.70, with a market capitalization of $12.6M[45] - Management and director ownership was 12.9%[45]
ENDRA Life Sciences(NDRA) - 2019 Q2 - Earnings Call Transcript
2019-08-10 07:32
ENDRA Life Sciences Inc. (NASDAQ:NDRA) Q2 2019 Earnings Conference Call August 8, 2019 4:30 PM ET Company Participants Chris Tyson ??? Managing Director-MZ North America 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 Jacob Barrie ??? Dougherty and Company Ed Woo ??? Ascendiant Capital Operator Good d ...
ENDRA Life Sciences(NDRA) - 2019 Q2 - Quarterly Report
2019-08-08 20:47
☐ 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, 2019 OR Securities registered pursuant to Section 12(b) of the Act: Delaware 26-05792 ...
ENDRA Life Sciences(NDRA) - 2019 Q1 - Earnings Call Transcript
2019-05-15 03:03
ENDRA Life Sciences Inc. (NASDAQ:NDRA) Q1 2019 Results Earnings Conference Call May 14, 2019 4:30 PM ET Company Participants Chris Tyson - Managing Director, MZ North America Francois Michelon - CEO David Wells - CFO Michael Thornton - Chief Technology Officer Conference Call Participants Kyle Bauser - Dougherty and Company Brooks O'Neil - Lake Street Financial Advisors Ed Woo - Ascendiant Capital Operator Good day, and welcome to the ENDRA Life Sciences??? First Quarter 2019 Conference Call and Webcast. To ...