Conference call begins at 4:30 p.m. Eastern time today
ANN ARBOR, MI / ACCESSWIRE / March 25, 2021 / ENDRA Life Sciences Inc. (“ENDRA”) (NASDAQ:NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three and twelve months ended December 31, 2020 and provided a business update. Highlights of the fourth quarter of 2020 and recent weeks include the following:
“Despite the challenges related to COVID-19 we faced throughout most of 2020, I am delighted with the progress the ENDRA team made to advance our commercialization strategy for the TAEUS system. We finished the year strong and are doing everything within our control to prepare for success when the healthcare system resumes services at pre-pandemic levels. This includes actively communicating with the FDA regarding our 510(k) submission in preparation for the potential clearance to begin commercialization in the U.S.,” stated Francois Michelon, Chairman and Chief Executive Officer of ENDRA. “At the same time, we remain focused on gathering additional data to bolster TAEUS’ clinical utility to assess and monitor chronic liver conditions. While unrelated to our FDA application, we believe these independent evaluations will assist our future commercialization efforts by documenting TAEUS’ clinical and economic value versus MRI.”
Renaud Maloberti, Chief Commercial Officer, added, “As we experience an improving environment with the easing of restrictions as COVID-19 cases decrease globally, our clinical study partners are enthusiastic to move forward with their TAEUS evaluations, a key part of our launch strategy. In parallel, we are building our European sales team, members of which are collaborating with GE Healthcare and engaging with clinicians via Zoom. We believe ENDRA is poised to begin reporting commercial sales in 2021 as we address this significant market opportunity with a differentiated product and compelling benefits to physicians, patients and healthcare systems.”
Fourth Quarter 2020 Financial Results
Full Year 2020 Financial Results
Conference Call and Webcast
Management will host a conference call and webcast today at 4:30 p.m. Eastern time to discuss these results, provide an update on recent corporate developments and answer questions.
Dial-in Numbers
U.S./Canada: 888-506-0062
International: 973-528-0011
Replay Dial-in Numbers
U.S./Canada: 877-481-4010
International: 919-882-2331
Replay Passcode: 40227
The telephone replay will be available through 4:30 p.m. Eastern time on April 1, 2021
A live audio webcast will be available through the Events & 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 50x lower cost and 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 the expectations regarding milestones and future sales, our 510(k) submission with the FDA 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; the impact of COVID-19 on our business plans; 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
investors@endrainc.com
www.endrainc.com
Investor Relations Contact:
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
ybriggs@lhai.com
ENDRA Life Sciences Inc.
Balance Sheets
|
December 31, | December 31, | ||||||
Assets
|
2020 | 2019 | ||||||
Current Assets
|
||||||||
Cash
|
$ | 7,227,316 | $ | 6,174,207 | ||||
Prepaid expenses
|
390,800 | 116,749 | ||||||
Inventory
|
589,620 | 113,442 | ||||||
Other current assets
|
5,986 | 130,701 | ||||||
Total Current Assets
|
8,213,722 | 6,535,099 | ||||||
Non-Current Assets
|
||||||||
Fixed assets, net
|
212,242 | 236,251 | ||||||
Right of use assets
|
339,012 | 404,919 | ||||||
Total Assets
|
$ | 8,764,976 | $ | 7,176,269 | ||||
|
||||||||
Liabilities and Stockholders’ Equity
|
||||||||
Current Liabilities
|
||||||||
Accounts payable and accrued liabilities
|
$ | 910,183 | $ | 1,708,525 | ||||
Convertible notes payable, net of discount
|
– | 298,069 | ||||||
Lease liabilities, current portion
|
76,480 | 66,193 | ||||||
Total Current Liabilities
|
986,663 | 2,072,787 | ||||||
|
||||||||
Long Term Debt
|
||||||||
Loans
|
337,084 | – | ||||||
Lease liabilities
|
271,908 | 342,812 | ||||||
Total Long Term Debt
|
608,992 | 342,812 | ||||||
|
||||||||
Total Liabilities
|
1,595,655 | 2,415,599 | ||||||
|
||||||||
Stockholders’ Equity
|
||||||||
Preferred stock series A, $0.0001 par value; 10,000 shares authorized; 190.288 and 6,338.490 shares issued and outstanding, respectively
|
1 | 1 | ||||||
Preferred stock series B, $0.0001 par value; 1,000 shares authorized; no shares and 351.711 shares issued and outstanding, respectively
|
– | – | ||||||
Common stock, $0.0001 par value; 80,000,000 shares authorized; 34,049,704 and 8,421,401 shares issued and outstanding, respectively
|
3,404 | 842 | ||||||
Additional paid in capital
|
64,488,558 | 49,933,736 | ||||||
Stock payable
|
15,847 | 43,528 | ||||||
Accumulated deficit
|
(57,338,489 | ) | (45,217,437 | ) | ||||
Total Stockholders’ Equity
|
7,169,321 | 4,760,670 | ||||||
Total Liabilities and Stockholders’ Equity
|
$ | 8,764,976 | $ | 7,176,269 | ||||
|
ENDRA Life Sciences Inc.
Statements of Operations
|
Year Ended | Year Ended | ||||||
|
December 31, | December 31, | ||||||
|
2020 | 2019 | ||||||
Operating Expenses
|
||||||||
Research and development
|
$ | 5,917,944 | $ | 6,574,999 | ||||
Sales and marketing
|
581,893 | 412,434 | ||||||
General and administrative
|
5,002,080 | 3,856,159 | ||||||
Total operating expenses
|
11,501,917 | 10,843,592 | ||||||
|
||||||||
Operating loss
|
(11,501,917) | (10,843,592) | ||||||
|
||||||||
Other Expenses
|
||||||||
Amortization of debt discount
|
(232,426) | (2,355,469) | ||||||
Other income (expense)
|
8,842 | (106,903) | ||||||
Total other expenses
|
(223,584) | (2,462,372) | ||||||
|
||||||||
Loss from operations before income taxes
|
(11,725,501) | (13,305,964) | ||||||
|
||||||||
Provision for income taxes
|
– | – | ||||||
|
||||||||
Net Loss
|
$ | (11,725,501) | $ | (13,305,964) | ||||
|
||||||||
Fair value adjustment related to warrants repricing
|
(395,551) | – | ||||||
Deemed dividend related to preferred stock
|
– | (4,219,777) | ||||||
|
||||||||
Net Loss attributable to common stockholders
|
$ | (12,121,052) | $ | (17,525,741) | ||||
|
||||||||
Net loss per share – basic and diluted
|
$ | (0.63) | $ | (2.34) | ||||
|
||||||||
Weighted average common shares – basic and diluted
|
19,192,226 | 7,499,984 | ||||||
|
ENDRA Life Sciences Inc.
Statement of Cash Flows
|
Year Ended | Year Ended | ||||||
|
December 31, | December 31, | ||||||
|
2020 | 2019 | ||||||
Cash Flows from Operating Activities
|
||||||||
Net loss
|
$ | (11,725,501) | $ | (13,305,964) | ||||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation and amortization
|
99,342 | 80,577 | ||||||
Common stock, options and warrants issued for services
|
2,102,353 | 1,399,547 | ||||||
Amortization of debt discount
|
232,426 | 2,355,469 | ||||||
Impairment of other assets
|
– | 249,256 | ||||||
Amortization of right of use assets
|
65,907 | 34,434 | ||||||
Changes in operating assets and liabilities:
|
||||||||
Increase in prepaid expenses
|
(274,051) | 28,675 | ||||||
Decrease in lease liability
|
(60,617) | (30,348) | ||||||
Increase in inventory
|
(476,178) | (53,998) | ||||||
Decrease in Other Current Assets
|
124,715 | (106,642) | ||||||
Decrease in accounts payable and accrued liabilities
|
(858,991) | 760,143 | ||||||
Net cash used in operating activities
|
(10,770,595) | (8,588,851) | ||||||
|
||||||||
Cash Flows from Investing Activities
|
||||||||
Purchases of fixed assets
|
(51,333) | (43,595) | ||||||
Net cash used in investing activities
|
(51,333) | (43,595) | ||||||
|
||||||||
Cash Flows from Financing Activities
|
||||||||
Proceeds from senior secured convertible promissory notes, net of fees
|
– | 2,490,501 | ||||||
Proceeds from issuance of Series A Convertible Preferred Stock
|
– | 5,344,257 | ||||||
Proceeds from issuance of Series B Convertible Preferred Stock
|
– | 375,520 | ||||||
Proceeds from warrant exercise
|
4,757,011 | – | ||||||
Proceeds from loans
|
337,084 | – | ||||||
Proceeds from issuance of common stock
|
6,780,942 | 125,000 | ||||||
Net cash provided by financing activities
|
11,875,037 | 8,335,278 | ||||||
|
||||||||
Net decrease in cash
|
1,053,109 | (297,168) | ||||||
|
||||||||
Cash, beginning of period
|
6,174,207 | 6,471,375 | ||||||
|
||||||||
Cash, end of period
|
$ | 7,227,316 | $ | 6,174,207 | ||||
|
||||||||
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 | $ | 140,406 | ||||
Exchange of balance in convertible notes and accrued interest for Series A preferred stock
|
$ | – | $ | 1,943,195 | ||||
Deemed dividend
|
$ | 395,551 | $ | 4,219,777 | ||||
Conversion of Series A Convertible Preferred Stock
|
$ | (717) | $ | – | ||||
Conversion of Series B Convertible Preferred Stock
|
$ | (36) | $ | – | ||||
Stock dividend payable
|
$ | (49,649) | $ | – | ||||
Right of use asset
|
$ | 339,012 | $ | 404,919 | ||||
Lease liability
|
$ | 348,388 | $ | 409,005 | ||||
SOURCE: ENDRA Life Sciences Inc.
View source version on accesswire.com:
https://www.accesswire.com/637486/ENDRA-Life-Sciences-Reports-2020-Fourth-Quarter-and-Full-Year-Financial-Results-Provides-Business-Update
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