Conference call begins at 4:30 p.m. Eastern time today
ANN ARBOR, Mich.–(BUSINESS WIRE)–$NDRA #NAFLD—ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three months and year ended December 31, 2021 and provided a business update. Highlights of the fourth quarter of 2021 and recent weeks include:
“We are pleased to have advanced our operating plan in 2021 and into 2022 under challenging global market conditions facing a resurgence of COVID-19 during that time. ENDRA actively increased commercial awareness for TAEUS through participation in seven global clinical conferences and more than 150 in-person and virtual product demonstrations in Europe. We enlarged the offensive and defensive scope of our IP portfolio to 89 assets, signed new clinical collaborations with leading healthcare institutions and pharmaceutical partners in the U.K., China and Australia and achieved clarity on our U.S regulatory path for the TAEUS liver platform,” stated Francois Michelon, Chairman and Chief Executive Officer of ENDRA. “In 2022, as healthcare operations improve, we are laser-focused on ramping up our remaining global clinical research sites to generate data to support commercialization and converting our pipeline of European sales opportunities to revenue.”
Fourth Quarter 2021 Financial Results
Full Year 2021 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.
Participants are encouraged to pre-register for the conference call using this link. Callers who pre-register will be given a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing (866) 777-2509 (U.S.) or (412) 317-5413 (International). A webcast of the call may also be accessed at ENDRA’s Investor Relations page and here.
A telephone replay will be available until April 6, 2022 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 8208803. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.
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 400,000 cart-based 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 Non-Alcoholic Steatohepatitis (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.
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 terms such as “approximate,” “anticipate,” “attempt,” “believe,” “could,” “estimate,” “expect,” “future,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “seek,” “should,” “will,” or other comparable terms (including the negative of any of the foregoing), although some forward-looking statements are expressed differently. Examples of forward-looking statements for ENDRA include, among others, estimates of the timing of future events and anticipated results of our development efforts, including the timing for receipt of required regulatory approvals and product launches, expectations concerning ENDRA’s business strategy, ENDRA’s ability to find and maintain development partners, market acceptance of its technology and the amount and nature of competition in its industry, and its ability to protect its intellectual property. Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements as a result of various factors including, among others, ENDRA’s ability to develop a commercially feasible technology and its dependence on third parties to design and manufacture its products; receipt of necessary regulatory approvals; the impact of COVID-19 on ENDRA’s business plans; ENDRA’s ability to find and maintain development partners, market acceptance of ENDRA’s technology and the amount and nature of competition in its industry; ENDRA’s ability to protect its intellectual property; and the other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the Company’s most recent Annual Report on Form 10-K and in subsequently filed Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. 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.
[Financial Tables Follow]
ENDRA Life Sciences Inc. Consolidated Balance Sheets |
||||||||
|
|
December 31, |
|
|
December 31, |
|
||
Assets |
|
2021 |
|
|
2020 |
|
||
Current Assets |
|
|
|
|
|
|
||
Cash |
|
$ |
9,461,534 |
|
|
$ |
7,227,316 |
|
Prepaid expenses |
|
|
1,348,003 |
|
|
|
390,800 |
|
Inventory |
|
|
1,284,578 |
|
|
|
589,620 |
|
Total Current Assets |
|
|
12,094,115 |
|
|
|
8,207,736 |
|
Non-Current Assets |
|
|
|
|
|
|
|
|
Fixed assets, net |
|
|
131,130 |
|
|
|
212,242 |
|
Right of use assets |
|
|
643,413 |
|
|
|
339,012 |
|
Other assets |
|
|
5,986 |
|
|
|
5,986 |
|
Total Assets |
|
$ |
12,874,644 |
|
|
$ |
8,764,976 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
1,411,437 |
|
|
$ |
910,183 |
|
Lease liabilities, current portion |
|
|
132,330 |
|
|
|
76,480 |
|
Total Current Liabilities |
|
|
1,543,767 |
|
|
|
986,663 |
|
|
|
|
|
|
|
|
|
|
Long Term Debt |
|
|
|
|
|
|
|
|
Loans |
|
|
28,484 |
|
|
|
337,084 |
|
Lease liabilities |
|
|
518,147 |
|
|
|
271,908 |
|
Total Long Term Debt |
|
|
546,631 |
|
|
|
608,992 |
|
|
|
|
|
|
|
|
|
|
Total Liabilities |
|
|
2,090,398 |
|
|
|
1,595,655 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Series A Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized; 141,397 and 190,288 shares issued and outstanding, respectively |
|
|
1 |
|
|
|
1 |
|
Series B Convertible Preferred Stock, $0.0001 par value; 1,000 shares authorized; no shares issued and outstanding |
|
|
– |
|
|
|
– |
|
Common stock, $0.0001 par value; 80,000,000 shares authorized; 42,554,514 and 34,049,704 shares issued and outstanding, respectively |
|
|
4,254 |
|
|
|
3,404 |
|
Additional paid in capital |
|
|
79,456,938 |
|
|
|
64,493,611 |
|
Stock payable |
|
|
13,863 |
|
|
|
10,794 |
|
Accumulated deficit |
|
|
(68,690,810 |
) |
|
|
(57,338,489 |
) |
Total Stockholders’ Equity |
|
|
10,784,246 |
|
|
|
7,169,321 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
12,874,644 |
|
|
$ |
8,764,976 |
|
ENDRA Life Sciences Inc. Consolidated Statements of Operations |
||||||||
|
|
Year Ended |
|
|
Year Ended |
|
||
|
|
December 31, |
|
|
December 31, |
|
||
|
|
2021 |
|
|
2020 |
|
||
Operating Expenses |
|
|
|
|
|
|
||
Research and development |
|
$ |
5,482,531 |
|
|
$ |
5,917,944 |
|
Sales and marketing |
|
|
1,075,376 |
|
|
|
581,893 |
|
General and administrative |
|
|
4,940,398 |
|
|
|
5,002,080 |
|
Total operating expenses |
|
|
11,498,305 |
|
|
|
11,501,917 |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(11,498,305 |
) |
|
|
(11,501,917 |
) |
|
|
|
|
|
|
|
|
|
Other Expenses |
|
|
|
|
|
|
|
|
Amortization of debt discount |
|
|
– |
|
|
|
(232,426 |
) |
Gain on extinguishment of debt |
|
|
308,600 |
|
|
|
– |
|
Other income (expense) |
|
|
(41,545 |
) |
|
|
8,842 |
|
Total other expenses |
|
|
267,055 |
|
|
|
(223,584 |
) |
|
|
|
|
|
|
|
|
|
Loss from operations before income taxes |
|
|
(11,231,250 |
) |
|
|
(11,725,501 |
) |
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
|
– |
|
|
|
– |
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(11,231,250 |
) |
|
$ |
(11,725,501 |
) |
|
|
|
|
|
|
|
|
|
Deemed dividend |
|
|
(121,071 |
) |
|
|
(395,551 |
) |
|
|
|
|
|
|
|
|
|
Net Loss attributable to common stockholders |
|
$ |
(11,352,321 |
) |
|
$ |
(12,121,052 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share – basic and diluted |
|
$ |
(0.28 |
) |
|
$ |
(0.63 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares – basic and diluted |
|
|
40,922,709 |
|
|
|
19,192,226 |
|
ENDRA Life Sciences Inc. Consolidated Statements of Cash Flows |
||||||||
|
|
Year Ended |
|
|
Year Ended |
|
||
|
|
December 31, |
|
|
December 31, |
|
||
|
|
2021 |
|
|
2020 |
|
||
Cash Flows from Operating Activities |
|
|
|
|
|
|
||
Net loss |
|
$ |
(11,231,250 |
) |
|
$ |
(11,725,501 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
116,238 |
|
|
|
99,342 |
|
Fixed assets write off |
|
|
9,874 |
|
|
|
– |
|
Stock compensation expense including common stock issued for RSUs |
|
|
1,444,572 |
|
|
|
2,102,352 |
|
Amortization of debt discount |
|
|
– |
|
|
|
232,426 |
|
Amortization of right of use assets |
|
|
108,177 |
|
|
|
65,907 |
|
Gain on extinguishment of debt |
|
|
(308,600 |
) |
|
|
– |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Increase in prepaid expenses |
|
|
(957,203 |
) |
|
|
(274,051 |
) |
Increase in inventory |
|
|
(694,958 |
) |
|
|
(476,178 |
) |
Decrease in other current asset |
|
|
– |
|
|
|
124,715 |
|
Increase in accounts payable and accrued liabilities |
|
|
491,104 |
|
|
|
(834,990 |
) |
Increase in lease liability |
|
|
(100,338 |
) |
|
|
(60,617 |
) |
Net cash used in operating activities |
|
|
(11,122,384 |
) |
|
|
(10,746,595 |
) |
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities |
|
|
|
|
|
|
|
|
Purchases of fixed assets |
|
|
(45,000 |
) |
|
|
(75,333 |
) |
Net cash used in investing activities |
|
|
(45,000 |
) |
|
|
(75,333 |
) |
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities |
|
|
|
|
|
|
|
|
Proceeds from warrant exercise |
|
|
2,785,627 |
|
|
|
4,757,011 |
|
Proceeds from loans |
|
|
– |
|
|
|
337,084 |
|
Proceeds from issuance of common stock |
|
|
10,615,975 |
|
|
|
6,780,942 |
|
Net cash provided by financing activities |
|
|
13,401,602 |
|
|
|
11,875,037 |
|
|
|
|
|
|
|
|
|
|
Net increase in cash |
|
|
2,234,218 |
|
|
|
1,053,109 |
|
|
|
|
|
|
|
|
|
|
Cash, beginning of year |
|
|
7,227,316 |
|
|
|
6,174,207 |
|
|
|
|
|
|
|
|
|
|
Cash, end of year |
|
$ |
9,461,534 |
|
|
$ |
7,227,316 |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash items |
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
57,655 |
|
|
$ |
1,920 |
|
Income tax paid |
|
$ |
– |
|
|
$ |
– |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of non-cash items |
|
|
|
|
|
|
|
|
Conversion of convertible notes and accrued interest |
|
$ |
– |
|
|
$ |
493,814 |
|
Exchange of balance in convertible notes and accrued interest for Series A preferred stock |
|
$ |
– |
|
|
$ |
– |
|
Deemed dividend |
|
$ |
121,071 |
|
|
$ |
395,551 |
|
Conversion of Series A Convertible Preferred Stock |
|
$ |
(7 |
) |
|
$ |
(717 |
) |
Conversion of Series B Convertible Preferred Stock |
|
$ |
– |
|
|
$ |
(36 |
) |
Stock issued for financing cost |
|
$ |
– |
|
|
$ |
27,300 |
|
Stock dividend payable |
|
$ |
(3,067 |
) |
|
$ |
(49,649 |
) |
Right of use asset |
|
$ |
643,413 |
|
|
$ |
339,012 |
|
Lease liability |
|
$ |
650,477 |
|
|
$ |
348,388 |
|
Contacts
Company Contact:
Irina Pestrikova
Senior Director, Finance
investors@endrainc.com
www.endrainc.com
Investor Relations Contact:
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
ybriggs@lhai.com
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