Management to Host Conference Call Today at 4:30 p.m. EDT
ANN ARBOR, MI / ACCESSWIRE / May 15, 2018 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ: NDRA), a developer of enhanced ultrasound technologies, reported its financial and operational results for the first quarter ended March 31, 2018.
Key First Quarter 2018 and Subsequent Highlights:
- Renewed and extended terms of global collaboration agreement with GE Healthcare to accelerate development of ENDRA's Thermo-Acoustic Enhanced UltraSound (TAEUS™) clinical platform.
- Granted two U.S. patents for non-invasive fat assessment to support TAEUS™ clinical product targeting Non-Alcoholic Fatty Liver Disease.
- Showcased Photoacoustic Imaging Technology at the American Association for Cancer Research (AACR) Annual Meeting in Chicago.
- Presented TAEUS clinical technology to radiologists and hepatologists at the European Association for the Study of the Liver (EASL) - The International Liver Congress on April 11-15 in Paris.
- Prepared to conduct human studies with ENDRA's TAEUS™ clinical system targeting Non-Alcoholic Fatty Liver Disease (NAFLD), pending approval from Health Canada with expected human data mid-2018.
- Advanced product development with outside engineering partners.
- Strengthened ENDRA's total Q1 2018 intellectual property portfolio to 39 patents and patent applications that are in preparation, filed, issued or licensed, encompassing a range of device and method-focused IP in targeted global markets.
Management Commentary
"The first quarter of 2018 was a period of continued execution and foundation building," said Francois Michelon, ENDRA's CEO. "Both the human study and productization of the TAEUS liver product continue to advance towards our goal of a successful commercial launch in the second half of 2018.
"We believe that the accelerated renewal of our collaboration agreement with GE Healthcare continues to reflect the intrinsic value that industry leaders see in our proprietary technology, which I believe bodes well for ENDRA's future commercial efforts.
"On a business development front, and subsequent to the closing of the first quarter of 2018, ENDRA presented its TAEUS clinical technology to several thought leaders in radiology and hepatology at the International Liver Congress (ILC) in Paris. We look forward to leveraging the positive feedback and growing relationships with these potential early adopters to lay the groundwork for our commercialization efforts in Europe later this year.
"Related to our human studies, previously targeted for completion by Q2 2018, we understand that applications to Health Canada are currently seeing longer-than-normal review times, which may push our study results out by one month, to July. While there is the possibility for an earlier approval, ENDRA believes it is prudent to be completely transparent regarding our progress.
"In fact, ENDRA's study protocol is ready and once we receive Health Canada's approval, we are prepared to schedule and complete the scanning procedures over the course of approximately one week," continued Michelon.
"In parallel with our human studies, our internal team has also been advancing the TAEUS product engineering to support our Class lla CE regulatory mark," said Michael Thornton, ENDRA's CTO. "We recently completed a safety analysis of our TAEUS fatty liver procedure to support a targeted 'low risk' classification, and remain confident with our European regulatory strategy," concluded Thornton.
"As we now move towards the close of the second quarter of 2018, we believe ENDRA is positioned to deliver key milestones for ENDRA's Fatty Liver application in 2018, including:
- First human study completed mid-year; and
- CE Mark and commercial launch in the second half of 2018.
"We look forward to sharing more on our developing story at upcoming, to-be-announced investor and industry conferences in key global markets," concluded Michelon.
First Quarter 2018 Financial Results
Revenue totaled $6,174 in Q1 2018, as compared to $0 in Q1 2017. The revenue in Q1 2018 is composed of service revenues related to the placement and sale of Nexus 128 systems for use in pre-clinical applications.
Operating expenses increased to $2.8 million in Q1 2018 as compared to $0.4 million in Q1 2018. The increase in operating expenses in Q1 2018 as compared to Q1 2017 was primarily due to higher research and development expenses, and general & administrative expenses associated with an increase in headcount.
Net loss in Q1 2018 totaled $2.8 million, or ($0.72) per basic and diluted share, as compared to a net loss of $0.7 million in Q1 2017.
Cash at March 31, 2018 totaled $3.2 million, as compared to $5.6 million at December 31, 2017 with no long-term debt outstanding.
Conference Call
ENDRA CEO Francois Michelon, CFO David Wells and CTO Michael Thornton will host a conference call, followed by a question and answer period.
To access the call, please use the following information:
Date: Tuesday, May 15, 2018
Time: 4:30 p.m. ET, 1:30 p.m. PT
Toll-free dial-in number: 1-877-407-8035
International dial-in number: 1-201-689-8035
Please call the conference telephone number 5-10 minutes prior to the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact MZ Group at 1-949-491-8235.
The conference call will be broadcast live and available for replay at http://www.investorcalendar.com/event/28316 and via the investor relations section of the Company's website at www.endrainc.com.
A replay of the conference call will be available after 7:30 p.m. Eastern time through May 29, 2018.
Toll-free replay number: 1-877-481-4010
International replay number: 1-919-882-2331
Replay ID: 28316
About ENDRA Life Sciences Inc.
ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ: NDRA) is a developer of enhanced ultrasound technologies. ENDRA's Photo-Acoustic Nexus-128 system is currently used by leading global medical researchers to screen and modify disease models with high image quality and volume scanning speed. ENDRA is developing a next generation Thermo-Acoustic Enhanced UltraSound (TAEUS™) system to enable clinicians to visualize human tissue composition, function and temperature in ways previously possible only with CT & MRI - at a fraction of the cost, and at the point-of-care. ENDRA's first TAEUS application will focus on the quantification of fat in the liver, for early detection and monitoring of Non-Alcoholic Fatty Liver Disease, which affects over 1 billion people globally, representing an estimated $13 billion global ultrasound market opportunity. ENDRA's goal is to bring new capabilities to ultrasound - thereby broadening access to better healthcare. For more information, please visit 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, statements we make regarding expectations concerning ENDRA's ability to secure regulatory approvals; anticipated product pricing; expectations with respect to current and future partnerships, including those with CIMTEC, StarFish and Critech; estimates of the timing of future events and achievements; 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, the following: 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
investors@endrainc.com
www.endrainc.com
Media & Investor Relations Contact:
MZ North America
Chris Tyson
Managing Director
(949) 491-8235
NDRA@mzgroup.us
www.mzgroup.us
ENDRA Life Sciences Inc.
Condensed Consolidated Balance Sheets
|
March 31,
|
December 31,
|
|||||||
|
Assets
|
2018
|
2017
|
||||||
|
Assets
|
(Unaudited)
|
|||||||
|
Cash
|
$ | 3,149,988 | $ | 5,601,878 | ||||
|
Accounts receivable
|
11,770 | 6,850 | ||||||
|
Prepaid expenses
|
38,598 | 67,497 | ||||||
|
Inventory
|
245,962 | 191,680 | ||||||
|
Other current assets
|
17,542 | 14,249 | ||||||
|
Total Current Assets
|
3,463,961 | 5,882,154 | ||||||
|
Other Assets
|
||||||||
|
Fixed assets, net
|
226,210 | 241,549 | ||||||
|
Total Assets
|
$ | 3,690,070 | $ | 6,123,702 | ||||
|
Liabilities and Stockholders' Equity
|
||||||||
|
Current Liabilities:
|
||||||||
|
Accounts payable and accrued liabilities
|
$ | 860,196 | $ | 848,214 | ||||
|
Total Liabilities
|
860,196 | 848,214 | ||||||
|
Stockholders' Equity (Deficit)
|
||||||||
|
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; 3,923,027 shares issued and outstanding
|
392 | 392 | ||||||
|
Additional paid in capital
|
23,550,220 | 23,170,531 | ||||||
|
Accumulated deficit
|
(20,720,738) | (17,895,435) | ||||||
|
Total Stockholders' Equity
|
2,829,874 | 5,275,488 | ||||||
|
Total Liabilities and Stockholders' Equity
|
$ | 3,690,070 | $ | 6,123,702 | ||||
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
|
Three Months Ended
|
Three Months Ended
|
|||||||
|
March 31,
|
March 31,
|
|||||||
|
2018
|
2017
|
|||||||
|
Revenue
|
$ | 6,174 | $ | - | ||||
|
Cost of Goods Sold
|
- | - | ||||||
|
Gross Profit
|
$ | 6,174 | $ | - | ||||
|
Operating Expenses
|
||||||||
|
Research and development
|
1,668,040 | 95,814 | ||||||
|
Sales and marketing
|
107,177 | 1,124 | ||||||
|
General and administrative
|
1,067,792 | 263,759 | ||||||
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Total operating expenses
|
2,843,792 | 360,697 | ||||||
|
Operating loss
|
(2,837,618) | (360,697) | ||||||
|
Other Expenses
|
||||||||
|
Loss on warrant exercise
|
- | - | ||||||
|
Other income (expense)
|
12,315 | (380,926) | ||||||
|
Total other expenses
|
12,315 | (380,926) | ||||||
|
Loss from operations before income taxes
|
(2,825,303) | (741,623) | ||||||
|
Provision for income taxes
|
- | - | ||||||
|
Net Loss
|
$ | (2,825,303) | $ | (741,623) | ||||
|
Net loss per share - basic and diluted
|
$ | (0.72) | $ | (1.03) | ||||
|
Weighted average common shares - basic and diluted
|
3,923,027 | 723,335 | ||||||
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
Three Months Ended
|
Three Months Ended
|
|||||||
|
March 31,
|
March 31,
|
|||||||
|
2018
|
2017
|
|||||||
|
Cash Flows from Operating Activities
|
||||||||
|
Net loss
|
$ | (2,825,303) | $ | (741,623) | ||||
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
|
Depreciation and amortization
|
15,339 | 15,690 | ||||||
|
Common stock, options and warrants issued for services
|
379,689 | 29,698 | ||||||
|
Interest on discount of convertible debt
|
- | 351,727 | ||||||
|
Imputed interest on promissory notes
|
- | 987 | ||||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Increase in accounts receivable
|
(4,920) | - | ||||||
|
Increase (decrease) in prepaid expenses
|
28,899 | (76,138) | ||||||
|
Decrease in inventory
|
(54,283) | (132) | ||||||
|
Decrease in other assets
|
(3,293) | (5,059) | ||||||
|
Increase in accounts payable and accrued liabilities
|
11,982 | 188,576 | ||||||
|
Net cash used in operating activities
|
(2,451,890) | (236,274) | ||||||
|
Cash Flows from Investing Activities:
|
||||||||
|
Purchases of fixed assets
|
- | - | ||||||
|
Net cash used in investing activities
|
- | - | ||||||
|
Cash Flows from Financing Activities:
|
||||||||
|
Proceeds from convertible notes
|
- | 225,000 | ||||||
|
Net cash provided by financing activities
|
- | 225,000 | ||||||
|
Net Decrease in cash
|
(2,451,890) | (11,274) | ||||||
|
Cash, beginning of period
|
5,601,878 | 144,953 | ||||||
|
Cash, end of period
|
$ | 3,149,988 | $ | 133,679 | ||||
|
Supplemental disclosures:
|
||||||||
|
Interest paid
|
$ | - | $ | - | ||||
|
Income tax paid
|
$ | - | $ | - | ||||
|
Supplemental disclosures of non-cash Items:
|
||||||||
|
Discount on convertible notes
|
$ | - | $ | 225,000 | ||||
SOURCE: ENDRA Life Sciences Inc.