Conference call begins at 4:30 p.m. Eastern time today
ANN ARBOR, MI / ACCESSWIRE / November 16, 2020 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ:NDRA), the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three months ended September 30, 2020 and provided a business update. Highlights of the third quarter of 2020 and recent weeks include:
- Installed the first TAEUS system at Rocky Vista University College of Osteopathic Medicine (RVUCOM), one of three research partnerships for ENDRA. The data from the RVUCOM study, along with other announced and future studies, will bolster the clinical evidence base and support the clinical utility of the TAEUS system in patients with non-alcoholic fatty liver disease (NAFLD) and inflammation (NASH) to support current and future commercialization efforts.
- Secured the first clinical evaluation reference site in Germany and advanced two more European sites to final legal review, which the Company expects to execute before the end of the year. The Company also continued efforts to build out its strategic salesforce with key hires in the U.K. and Germany, while also identifying leading candidates in other major European markets.
- Showcased TAEUS technology at important clinical conferences and trade shows, including The Digital International Liver Congress (ILC), hosted by the European Association for the Study of the Liver (EASL), and The Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD). ENDRA's participation in these conferences helped to expand its qualified sales pipeline to more than 4,000 global clinicians, highlighting its unique position where there are no other practical clinical tools currently available.
- Increased its intellectual property portfolio to 76 assets, up from 64 at the end of 2019, including adding key platform patents in the United States, Europe and China to protect current and future clinical applications of the Company's technology.
- Received approximately $5 million from the early exercise of common stock warrants. These proceeds extend ENDRA's cash runway through key business inflection points, including establishing evaluation reference sites and initial sales in Europe, as well as the potential receipt of FDA clearance to begin commercialization in the U.S.
- Remained on track to execute key milestones of establishing additional clinical evaluation reference sites in Europe in the fourth quarter of 2020.
Commenting on the quarter and recent weeks, Francois Michelon, chairman and chief executive officer of ENDRA, said, "I'm pleased with our continued progress to keep the company on track during these challenging times, including advancing our key European commercialization initiatives, as well as installing the first TAEUS system at Rocky Vista. In addition, we continue to work with the U.S. Food and Drug Administration to respond to questions related to our 510(k) Premarket Notification submission, with expectations that TAEUS will receive clearance."
Renaud Maloberti, chief commercial officer, added, "The global pandemic is not tempering the enthusiasm of clinicians for our TAEUS solution to the growing NAFLD/NASH challenge, which impacts more than 1 billion people globally. We continue to make meaningful progress toward our first TAEUS system sale."
Financial Results for Quarter Ended September 30, 2020
- Operating expenses increased to $3.3 million in the third quarter of 2020, up from $2.6 million in the same period in 2019. The increase was primarily due to expenses related to the development of the TAEUS product line, regulatory submissions, and costs associated with TAEUS pre-commercialization activities.
- Net loss in the third quarter of 2020 was $3.3 million, or ($0.15) per share, compared with a net loss of $3.4 million, or ($0.46) per share, in the third quarter of 2019.
- The Company had cash and cash equivalents of $3.8 million as of September 30, 2020, compared with $6.2 million as of December 31, 2019, with no long-term debt.
Conference Call and Webcast Access
Management will host a conference call and webcast today at 4:30 p.m. ET to discuss these results and provide an update on recent corporate developments.
Dial-in Number
U.S./Canada Dial-in Number: 844-369-8774
International Dial-in Number: 862-298-0844
Replay Dial-in Number: 877-481-4010
Replay International Dial-in Number: 919-882-2331
Replay Passcode: 38486
A telephone replay will be available from November 16, 2020 through 4:30 p.m. ET on November 23, 2020.
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 is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS), a ground-breaking technology being developed to visualize tissue like MRI, but at 1/50th the cost and at the point of patient care. TAEUS is designed to work in concert with the over one million ultrasound systems in use globally today. TAEUS is initially focused on the measurement of fat in the liver as a means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD) and inflammation (NASH), chronic liver conditions that affect over one 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. For more information, please visit www.endrainc.com. See more. Do more. Live better®.
Forward-Looking Statements
All statements in this news 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 the expectations regarding commercializing the TAEUS device, establishing evaluation reference sites and initial sales in Europe, receipt of U.S. Food and Drug Administration regulatory approval, 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; the impact of COVID-19 on our business plans; our ability to find and maintain development partners, market acceptance of our technology and 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 news release speak only as of the date of issuance, 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]
www.endrainc.com
Investor Relations Contact:
Kim Sutton Golodetz
LHA Investor Relations
(212) 838-3777
[email protected]
ENDRA Life Sciences Inc.
Condensed Consolidated Balance Sheets
|
|
September 30, | December 31, | ||||||
|
Assets
|
2020 | 2019 | ||||||
|
Assets
|
(unaudited) | |||||||
|
Cash
|
$ | 3,793,292 | $ | 6,174,207 | ||||
|
Prepaid expenses
|
561,554 | 116,749 | ||||||
|
Inventory
|
323,208 | 113,442 | ||||||
|
Other current assets
|
101,451 | 130,701 | ||||||
|
Total Current Assets
|
4,779,505 | 6,535,099 | ||||||
|
Other Assets
|
||||||||
|
Fixed assets, net
|
225,620 | 236,251 | ||||||
|
Right of use assets
|
356,060 | 404,919 | ||||||
|
Total Assets
|
$ | 5,361,185 | $ | 7,176,269 | ||||
|
|
||||||||
|
Liabilities and Stockholders' Equity
|
||||||||
|
Current Liabilities
|
||||||||
|
Accounts payable and accrued liabilities
|
$ | 1,325,005 | $ | 1,708,525 | ||||
|
Convertible notes payable, net of discount
|
- | 298,069 | ||||||
|
Lease liabilities, current portion
|
73,624 | 66,193 | ||||||
|
Total Current Liabilities
|
1,398,629 | 2,072,787 | ||||||
|
|
||||||||
|
Long Term Debt
|
||||||||
|
Loans
|
337,084 | - | ||||||
|
Lease liabilities
|
290,489 | 342,812 | ||||||
|
Total Long Term Debt
|
627,573 | 342,812 | ||||||
|
|
||||||||
|
Total Liabilities
|
2,026,202 | 2,415,599 | ||||||
|
|
||||||||
|
Stockholders' Equity
|
||||||||
|
Series A Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized; 190 and 6,338 shares issued and outstanding, respectively
|
1 | 1 | ||||||
|
Series B Convertible Preferred Stock, $0.0001 par value; 1,000 shares authorized; no shares and 352 shares issued and outstanding, respectively
|
- | - | ||||||
|
Common stock, $0.0001 par value; 80,000,000 shares authorized; 25,015,710 and 8,421,401 shares issued and outstanding, respectively
|
2,500 | 842 | ||||||
|
Additional paid in capital
|
58,281,673 | 49,933,736 | ||||||
|
Stock payable
|
224,163 | 43,528 | ||||||
|
Stock receivable
|
(85,626 | ) | - | |||||
|
Accumulated deficit
|
(55,087,728 | ) | (45,217,437 | ) | ||||
|
Total Stockholders' Equity
|
3,334,983 | 4,760,670 | ||||||
|
Total Liabilities and Stockholders' Equity
|
$ | 5,361,185 | $ | 7,176,269 | ||||
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
|
|
Three Months Ended | Three Months Ended | Nine Months Ended | Nine Months Ended | ||||||||||||
|
|
September 30, | September 30, | September 30, | September 30, | ||||||||||||
|
|
2020 | 2019 | 2020 | 2019 | ||||||||||||
|
Operating Expenses
|
||||||||||||||||
|
Research and development
|
$ | 1,769,339 | $ | 1,468,441 | $ | 4,774,534 | $ | 4,546,746 | ||||||||
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Sales and marketing
|
139,751 | 100,203 | 389,469 | 245,364 | ||||||||||||
|
General and administrative
|
1,346,360 | 1,071,889 | 4,083,572 | 2,920,815 | ||||||||||||
|
Total operating expenses
|
3,255,450 | 2,640,533 | 9,247,575 | 7,712,925 | ||||||||||||
|
|
||||||||||||||||
|
Operating loss
|
(3,255,450 | ) | (2,640,533 | ) | (9,247,575 | ) | (7,712,925 | ) | ||||||||
|
|
||||||||||||||||
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Other Expenses
|
||||||||||||||||
|
Amortization of debt discount
|
- | (728,417 | ) | (232,426 | ) | (728,417 | ) | |||||||||
|
Other income (expense)
|
(2,621 | ) | (44,612 | ) | 5,261 | (55,328 | ) | |||||||||
|
Total other expenses
|
(2,621 | ) | (773,029 | ) | (227,165 | ) | (783,745 | ) | ||||||||
|
|
||||||||||||||||
|
Loss from operations before income taxes
|
(3,258,071 | ) | (3,413,562 | ) | (9,474,740 | ) | (8,496,670 | ) | ||||||||
|
|
||||||||||||||||
|
Provision for income taxes
|
- | - | - | - | ||||||||||||
|
|
||||||||||||||||
|
Net Loss
|
$ | (3,258,071 | ) | $ | (3,413,562 | ) | $ | (9,474,740 | ) | $ | (8,496,670 | ) | ||||
|
|
||||||||||||||||
|
Deemed dividend
|
(395,551 | ) | - | (395,551 | ) | - | ||||||||||
|
|
||||||||||||||||
|
Net Loss attributable to common stockholders
|
$ | (3,653,622 | ) | $ | (3,413,562 | ) | $ | (9,870,291 | ) | $ | (8,496,670 | ) | ||||
|
|
||||||||||||||||
|
Net loss per share - basic and diluted
|
$ | (0.15 | ) | $ | (0.46 | ) | $ | (0.41 | ) | $ | (1.14 | ) | ||||
|
|
||||||||||||||||
|
Weighted average common shares - basic and diluted
|
23,889,591 | 7,428,788 | 23,808,012 | 7,424,713 | ||||||||||||
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
|
Nine Months Ended | Nine Months Ended | ||||||
|
|
September 30, | September 30, | ||||||
|
|
2020 | 2019 | ||||||
|
Cash Flows from Operating Activities
|
||||||||
|
Net loss
|
$ | (9,474,740 | ) | $ | (8,496,670 | ) | ||
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
|
Depreciation and amortization
|
45,114 | 59,673 | ||||||
|
Common stock, options and warrants issued for services
|
1,559,232 | 1,020,300 | ||||||
|
Amortization of debt discount
|
232,426 | 728,417 | ||||||
|
Amortization of right of use assets
|
48,859 | - | ||||||
|
Stock payable for investor relations
|
30,000 | - | ||||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Increase in prepaid expenses
|
(444,805 | ) | (61,234 | ) | ||||
|
Decrease in lease liability
|
(44,892 | ) | - | |||||
|
Increase in inventory
|
(209,766 | ) | (68,387 | ) | ||||
|
Decrease (increase) in other asset
|
29,250 | (93,075 | ) | |||||
|
(Decrease) increase in accounts payable and accrued liabilities
|
(444,167 | ) | 229,640 | |||||
|
Net cash used in operating activities
|
(8,673,489 | ) | (6,681,336 | ) | ||||
|
|
||||||||
|
Cash Flows from Investing Activities
|
||||||||
|
Purchases of fixed assets
|
(10,483 | ) | (5,238 | ) | ||||
|
Net cash used in investing activities
|
(10,483 | ) | (5,238 | ) | ||||
|
|
||||||||
|
Cash Flows from Financing Activities
|
||||||||
|
Proceeds from senior secured convertible promissory notes, net of fees
|
- | 2,490,501 | ||||||
|
Proceeds from warrant exercise
|
4,644,084 | - | ||||||
|
Proceeds from loans
|
337,084 | - | ||||||
|
Proceeds from issuance of common stock
|
1,321,890 | - | ||||||
|
Net cash provided by financing activities
|
6,303,058 | 2,490,501 | ||||||
|
|
||||||||
|
Net decrease in cash
|
(2,380,914 | ) | (4,196,073 | ) | ||||
|
|
||||||||
|
Cash, beginning of period
|
6,174,207 | 6,471,375 | ||||||
|
|
||||||||
|
Cash, end of period
|
$ | 3,793,293 | $ | 2,275,302 | ||||
|
|
||||||||
|
Supplemental disclosures of cash items
|
||||||||
|
Interest paid
|
$ | 1,920 | $ | - | ||||
|
Income tax paid
|
$ | - | $ | - | ||||
|
|
||||||||
|
Supplemental disclosures of non-cash items
|
||||||||
|
Discount on convertible notes
|
$ | - | $ | 2,490,501 | ||||
|
Conversion of convertible notes and accrued interest
|
$ | 493,814 | $ | 140,405 | ||||
|
Deemed dividend related to warrant repriced
|
$ | 395,551 | ||||||
|
Conversion of Series A Convertible Preferred Stock
|
$ | (717 | ) | $ | - | |||
|
Conversion of Series B Convertible Preferred Stock
|
$ | (36 | ) | $ | - | |||
|
Stock dividend payable
|
$ | (47,641 | ) | $ | - | |||
|
Right of use asset
|
$ | 356,060 | $ | (420,488 | ) | |||
|
Lease liability
|
$ | 364,113 | $ | 424,210 | ||||
SOURCE: ENDRA Life Sciences Inc.