ENDRA Life Sciences Provides Business Update and Reports Third Quarter 2019 Financial Results

Conference call scheduled for 4:30 p.m. ET today

ANN ARBOR, MI / ACCESSWIRE / November 13, 2019 / ENDRA Life Sciences Inc. (“ENDRA”) (NASDAQ:NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS™), today provided a business update and reported third quarter 2019 financial results.

“ENDRA has made important clinical and operational progress this quarter as we move towards commercialization during 2020,” said Francois Michelon, chairman and chief executive officer. “Completion of part two of the feasibility study at Robarts Research Institute represented a major milestone in the advancement of our pioneering TAEUS technology. Initial findings support our belief that TAEUS is positioned to be a practical tool for use with other biomarkers in the management of NAFLD and NASH at the point of patient care, and we are moving ahead with additional clinical study sites and regulatory filings. We also continue to engage with our key clinical audiences as we ramp up commercialization efforts heading into 2020.”

Business Highlights

  • Reported top level findings from part two of the feasibility study at Robarts Research Institute.
  • Showcased the pre-production TAEUS liver device[1] for the first time at the Annual 2019 AASLD Liver Meeting.
  • Hosted Key Opinion Leader (KOL) event in conjunction with the Annual 2019 AASLD Liver Meeting featuring a presentation by Dr. Raza Malik, M.D., Ph.D. Director of Hepatology and Associate Chief, Division of Gastroenterology at Tufts Medical Center.
  • Increased intellectual property (IP) portfolio to 60 assets defined, filed and issued.

Financial Results for Quarter Ended September 30, 2019

  • Operating expenses increased to $2.6 million in the third quarter of 2019, up from $2.4 million in the third quarter of 2018. The increase in operating expenses was primarily due to expenses related to the development of our TAEUS product line, and costs associated with the pre-commercialization of TAEUS.
  • Net loss in Q3 2019 totaled $3.4 million, or ($0.46) per basic and diluted share, as compared to a net loss of $2.8 million, or ($0.70) per basic and diluted share in Q3 2018.
  • Cash at September 30, 2019 totaled $2.3 million, as compared to $6.5 million at December 31, 2018, with no long-term debt outstanding.

Conference Call and Webcast Access

Management will host a conference call and webcast at 4:30 p.m. ET to discuss the results and provide an update on recent corporate developments.

Dial-in Number
U.S./Canada Dial-in Number: 844-602-0380
International Dial-in Number: 862-298-0970

Replay Dial-in Number: 877-481-4010
Replay International Dial-in Number: 919-882-2331
Replay Passcode: 56751

A telephone replay will be available November 13, 2019 through 4:30 p.m. ET on November 27, 2019.

A live audio webcast will be available through the Events and Presentations page of the Investors section of the company’s website at www.endrainc.com. A replay of the webcast will be available on the website for 90 days.

About ENDRA Life Sciences Inc.

ENDRA Life Sciences Inc. is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS™), a ground-breaking technology that mirrors some applications similar to CT or MRI, but at 50Xlower cost, at the point of patient care. TAEUS is designed to work in concert with one million ultrasound systems in global use today. TAEUS is initially focused on the measurement of fat in the liver, as a means to assess and monitor NAFLD and NASH, chronic liver conditions that affect over 1 billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS, including visualization of tissue temperature during energy-based surgical procedures. www.endrainc.com

Forward-Looking Statements

All statements in this release that are not based on historical fact are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate” or other comparable terms. Examples of forward-looking statements include, among others, estimates of the timing of future events and achievements, such as obtaining a CE Mark and commercializing the TAEUS device; and expectations concerning ENDRA’s business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, among others, our ability to develop a commercially feasible technology; receipt of necessary regulatory approvals; our ability to find and maintain development partners, market acceptance of our technology, the amount and nature of competition in our industry; our ability to protect our intellectual property; and the other risks and uncertainties described in ENDRA’s filings with the Securities and Exchange Commission. The forward-looking statements made in this release speak only as of the date of this release, and ENDRA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.

Company Contact:

David Wells
Chief Financial Officer
(734) 997-0464
[email protected]

Media & Investor Relations Contact:

Christi Waarich
(781) 235-3060
[email protected]

[1] Regulatory disclaimer: The TAEUS device is not yet approved for sale.

ENDRA Life Sciences Inc.
Condensed Consolidated Balance Sheets

  September 30,     December 31,  
  2019     2018  
  $ 2,275,302     $ 6,471,375  
Prepaid expenses
    206,658       145,424  
    127,831       59,444  
Other current assets
    366,390       273,315  
Total Current Assets
    2,976,181       6,949,558  
Other Assets
Fixed assets, net
    218,798       273,233  
Right of use assets
Total Assets
  $ 3,615,467     $ 7,222,791  
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued liabilities
  $ 1,198,487     $ 974,583  
Convertible notes payable, net of discount
Lease liabilities, current portion
Total Current Liabilities
    1,853,808       974,583  
Long Term Liabilities:
Lease liabilities
Total Long Term Liabilities
Total Liabilities
    2,212,723       974,583  
Stockholders’ Equity
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding
Common stock, $0.0001 par value; 50,000,000 shares authorized; 7,516,875 and 7,422,642 shares issued and outstanding
    751       742  
Additional paid in capital
    37,590,359       33,939,162  
Accumulated deficit
    (36,188,366 )     (27,691,696 )
Total Stockholders’ Equity
    1,402,744       6,248,208  
Total Liabilities and Stockholder’ Equity
  $ 3,615,467     $ 7,222,791  

ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Operations

  Three Months Ended     Three Months Ended     Nine Months Ended     Nine Months Ended  
  September 30,     September 30,     September 30,     September 30,  
  2019     2018     2019     2018  
  $     $     $     $ 6,174  
Cost of Goods Sold
Gross Profit
  $     $     $     $ 6,174  
Operating Expenses
Research and development
    1,468,441       1,162,911       4,546,746       3,671,490  
Sales and marketing
    100,203       72,179       245,364       220,713  
General and administrative
    1,071,889       832,884       2,920,815       2,842,631  
Impairment of inventory
          287,541             287,541  
Total operating expenses
    2,640,533       2,355,515       7,712,925       7,022,375  
Operating loss
    (2,640,533 )     (2,355,515 )     (7,712,925 )     (7,016,201 )
Other Expenses
Amortization of debt discount
    (728,417 )     (377,606 )     (728,417 )     (383,428 )
Other expense
    (44,612 )     (25,455 )     (55,328 )     (31,022 )
Total other expenses
    (773,029 )     (403,061 )     (783,745 )     (414,450 )
Loss from operations before income taxes
    (3,413,562 )     (2,758,576 )     (8,496,670 )     (7,430,651 )
Provision for income taxes
Net Loss
  $ (3,413,564 )   $ (2,758,576 )   $ (8,496,670 )   $ (7,430,651 )
Net loss per share – basic and diluted
  $ (0.46 )   $ (0.70 )   $ (1.14 )   $ (1.89 )
Weighted average common shares – basic and diluted
    7,428,788       3,927,933       7,424,713       3,924,662  

ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows

  Nine Months Ended     Nine Months Ended  
  September 30,     September 30,  
  2019     2018  
Cash Flows from Operating Activities
Net loss
  (8,496,670 )   (7,430,651 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
    59,673       48,246  
Common stock, options and warrants issued for services
    1,020,300       1,060,012  
Amortization of debt discount
    728,417       383,428  
Impairment of inventory
Changes in operating assets and liabilities:
Increase in accounts receivable
          (5,425 )
Increase in prepaid expenses
    (61,234 )     (260,550 )
Increase in inventory
    (68,387 )     (95,861 )
Increase in other asset
    (93,075 )     (6,918 )
Increase in accounts payable and accrued liabilities
    229,640       220,124  
Net cash used in operating activities
    (6,681,336 )     (5,800,054 )
Cash Flows from Investing Activities:
Purchases of fixed assets
    (5,238 )     (100,000 )
Net cash used in investing activities
    (5,238 )     (100,000 )
Cash Flows from Financing Activities
Proceeds from senior secured convertible promissory notes, net of fees
    2,490,501       935,300  
Net cash provided by financing activities
    2,490,501       935,300  
Net Increase/(Decrease) in cash
    (4,196,073 )     (4,964,754 )
Cash, beginning of period
    6,471,375       5,601,878  
Cash, end of period
  2,275,302     637,124  
Supplemental disclosures of cash items:
Interest paid
Income tax paid
Supplemental disclosures of non-cash items:
Discount on convertible notes
  2,490,501     587,541  
Conversion of convertible notes and accrued interest
  140,405     50,000  
Right of use asset
Lease liability

SOURCE: ENDRA Life Sciences Inc.


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