Renewed Global Collaboration Agreement with GE Healthcare Drives Successful NASDAQ Listing & Closing of Initial Public Offering
ANN ARBOR, MI / ACCESSWIRE / August 8, 2017 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ: NDRA), a developer of enhanced ultrasound technologies, reported its financial and operational results for the three months ended June 30, 2017.
Key Second Quarter 2017 and Subsequent Highlights:
- Completed initial public offering, as well as the exercise of its over-allotment option, which generated $8.6 million in net proceeds.
- Renewed global collaboration agreement with GE Healthcare to accelerate development of ENDRA's Thermo-Acoustic Enhanced UltraSound (TAEUS™) clinical platform.
- Filed one additional patent in the U.S.
- Presented at two institutional investor conferences in New York and California.
- Hired strategic personnel:
- IP Specialist; and
- Head of Engineering; and
- Head of Human Resources.
- Engaged MZ Group to lead investor relations in the U.S. and abroad.
- Rang the Nasdaq Stock Market Closing Bell at the Nasdaq MarketSite in Times Square with company management, board of directors and IPO investors.
- The company's units, which traded under NDRAU on The Nasdaq Capital Market, separated into common stock and warrants, and are trading under NDRA and NDRAW, respectively.
Management Commentary
"During the second quarter of 2017, we made excellent progress securing the necessary funds to execute our business plan to bring to market our first enhanced ultrasound application focused on liver disease," said Francois Michelon, ENDRA's CEO.
"Today's reported revenues are derived from ENDRA's Nexus 128 laboratory imaging system currently used by global medical researchers to screen and modify disease models with high image quality and volume scanning speed. The springboard of our IPO, beginning in 2016, was to leverage the IP and technology of our laboratory system and bring to market a disruptive technology for the clinical market. Leveraging a world-class customer base from Stanford University to the University of Michigan, ENDRA is now developing a Thermo-Acoustic Enhanced UltraSound (TAEUS™) clinical platform that utilizes RF pulses and ultrasound. Our innovative, non-invasive technology will enable clinicians to visualize human tissue composition, function and temperature in ways previously possible only on CT & MRI - but at a fraction of the cost, on ultrasound. Our first application will focus on the quantification of fat in the liver, for early detection and monitoring of Non-Alcoholic Fatty Liver Disease (NAFLD), which affects over 1 billion people globally.
"According to The LANCET, NAFLD has become the most common chronic liver disease, affecting 15-40% of the general adult population, and an important precursor of cirrhosis and liver cancer worldwide. Its cause is not exactly known, but it is strongly linked to diabetes and obesity, making it the most common liver disorder in Western industrialized countries. By 2030 the condition will be the most common reason for liver transplants in the United States, according to a 2014 study by researchers at the Cleveland Clinic," continued Michelon.
"The second quarter was highlighted with the renewal of our global collaboration agreement with GE Healthcare, the global ultrasound market leader. ENDRA and GE are passionate about bringing new capabilities to clinical ultrasound, to broaden access to better healthcare and help address the global health crisis of liver disease. We want our TAEUS™ technology to become as ubiquitous as a blood pressure cuff, but for liver disease.
"Already in the third quarter of 2017 we are aggressively laying the groundwork to achieve key milestones in 2018, including commercialization of ENDRA's Fatty Liver application in Europe. This is just one of several milestones that we expect to announce over the next 12 months as we look across the liver disease landscape our technology can help address.
"In 2017 look for ENDRA announcements regarding:
- Presenting research at the World Molecular Imaging Conference (WMIC)
- Contract manufacturing partnership for TAEUS utilizing an asset-light operating model
- Institutional Review Board (IRB) partnership for collection of human data
"In 2018 anticipated key milestones for ENDRA's Fatty Liver application include:
- First human data
- CE Mark in Europe
- Commercial launch in Europe
"We look forward to sharing more on our developing story at the upcoming Dougherty & Co. Institutional Investor Conference on September 19, 2017 in Minneapolis, Minnesota and the 3rd Annual Dawson James Small Cap Growth Conference on October 18-19, 2017 in Jupiter, Florida. We expect to begin quarterly conference calls in November for the third quarter of 2017, and welcome all current and prospective ENDRA Life Sciences shareholders to join these calls," concluded Michelon.
Second Quarter 2017 Financial Results
Revenue totaled $58,000 in Q2 2017 with associated direct costs of $51,000. The revenue was a result of product service fees generated from the company's installed base of Nexus 128 laboratory imaging systems.
Operating expenses increased to $1.1 million in Q2 2017 from $0.5 million in Q2 2016. The increase in operating expenses was primarily due to higher research and development, and general & administrative expenses associated with an increase in advisory and accounting fees related to the initial public offering.
Net loss totaled $1.4 million, or ($0.59) per basic and diluted share in Q2 2017, compared to a net loss of $0.7 million, or ($1.01) per basic and diluted share in Q2 2016.
Cash at June 30, 2017 totaled $7.5 million, as compared to $0.1 million at December 31, 2016. The increase of cash as of June 30, 2017 compared to December 31, 2016 are a result of the net proceeds of $8.6 million from the Company's initial public offering in May 2017.
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's next generation Thermo-Acoustic Enhanced UltraSound ("TAEUS") will enable clinicians to visualize human tissue composition, function and temperature in ways previously possible only on 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. 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." While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. 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 those risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on June 21, 2017, which can be found on the SEC's website at www.sec.gov. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
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
Balance Sheets
(Unaudited)
| June 30, | December 31, | |||||||
| Assets | 2017 | 2016 | ||||||
| Assets | (Unaudited) | |||||||
| Cash | $ | 7,524,071 | $ | 144,953 | ||||
| Prepaid expenses | 4,200 | - | ||||||
| Inventory | 133,422 | 40,105 | ||||||
| Other current assets | 10,806 | 10,535 | ||||||
| Total Current Assets | 7,672,500 | 195,594 | ||||||
| Other Assets | ||||||||
| Fixed assets, net | 272,066 | 295,168 | ||||||
| Total Assets | $ | 7,944,565 | $ | 490,761 | ||||
| Liabilities and Stockholders' Equity (Deficit) | ||||||||
| Current Liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 162,302 | $ | 434,552 | ||||
| Notes payable | - | 50,000 | ||||||
| Convertible notes payable, related party, net of discount | - | 99,804 | ||||||
| Convertible notes payable, net of discount | - | 800,172 | ||||||
| Total Current Liabilities | 162,302 | 1,384,528 | ||||||
| Total Liabilities | 162,302 | 1,384,528 | ||||||
| Stockholders' Equity (Deficit) | ||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued or outstanding at June 30, 2017 and December 31, 2016 | - | - | ||||||
| Common stock, $0.0001 par value; 50,000,000 shares authorized; 3,907,027 and 723,335 shares issued and outstanding at June 30, 2017 and December 31, 2016 | 390 | 72 | ||||||
| Stock payable | - | 81,000 | ||||||
| Additional paid in capital | 22,473,759 | 11,543,634 | ||||||
| Accumulated deficit | (14,691,886 | ) | (12,518,473 | ) | ||||
| Total Stockholders' Equity (Deficit) | 7,782,263 | (893,767 | ) | |||||
| Total Liabilities and Stockholders' Equity (Deficit) | $ | 7,944,565 | $ | 490,761 | ||||
Statements of Operations
(Unaudited)
| Three Months Ended | Three Months Ended | Six Months Ended | Six Months Ended | |||||||||||||
| June 30, | June 30, | June 30, | June 30, | |||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenue | $ | 57,772 | $ | - | $ | 57,772 | $ | - | ||||||||
| Cost of Goods Sold | 51,427 | - | 51,427 | - | ||||||||||||
| Gross Profit | $ | 6,345 | $ | - | $ | 6,345 | $ | - | ||||||||
| Operating Expenses | ||||||||||||||||
| Research and development | 174,726 | 103,640 | 270,540 | 198,877 | ||||||||||||
| Sales and marketing | 6,904 | 5,724 | 8,028 | 10,157 | ||||||||||||
| General and administrative | 882,570 | 384,948 | 1,146,330 | 658,734 | ||||||||||||
| Total operating expenses | 1,064,200 | 494,312 | 1,424,898 | 867,768 | ||||||||||||
| Operating loss | (1,057,855 | ) | (494,312 | ) | (1,418,553 | ) | (867,768 | ) | ||||||||
| Other Expenses | ||||||||||||||||
| Loss on warrant exercise | - | - | - | (5,823 | ) | |||||||||||
| Interest expense | (373,936 | ) | (234,802 | ) | (754,860 | ) | (235,000 | ) | ||||||||
| Total other expenses | (373,936 | ) | (234,802 | ) | (754,860 | ) | (240,823 | ) | ||||||||
| Loss from operations before income taxes | (1,431,791 | ) | (729,114 | ) | (2,173,413 | ) | (1,108,591 | ) | ||||||||
| Provision for income taxes | - | - | - | - | ||||||||||||
| Net Loss | $ | (1,431,791 | ) | $ | (729,114 | ) | $ | (2,173,413 | ) | $ | (1,108,591 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.59 | ) | $ | (1.01 | ) | $ | (1.37 | ) | $ | (1.53 | ) | ||||
| Weighted average common shares - basic and diluted | 2,437,010 | 723,335 | 1,584,906 | 723,233 | ||||||||||||
Statement of Cash Flows
(Unaudited)
| Six Months Ended | Six Months Ended | |||||||
| June 30, | June 30, | |||||||
| 2017 | 2016 | |||||||
| Cash Flows from Operating Activities | ||||||||
| Net loss | $ | (2,173,413 | ) | $ | (1,108,591 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 30,964 | 32,272 | ||||||
| Common stock, options and warrants issued for services | 306,184 | 87,240 | ||||||
| Additional warrants issued during exchange | - | 5,823 | ||||||
| Amortization of discount of convertible debt | 711,472 | 215,693 | ||||||
| Imputed interest on promissory notes | 1,480 | - | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Increase in prepaid expenses | (4,200 | ) | - | |||||
| Increase in inventory | (93,317 | ) | (21,375 | ) | ||||
| Increase in other assets | (271 | ) | (439 | ) | ||||
| Increase (decrease) in accounts payable and accrued liabilities | (157,619 | ) | 19,918 | |||||
| Net cash used in operating activities | (1,378,720 | ) | (769,459 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Purchases of fixed assets | (7,862 | ) | - | |||||
| Net cash used in investing activities | (7,862 | ) | - | |||||
| Cash Flows from Financing Activities | ||||||||
| Proceeds from issuance of common stock | 8,590,700 | 5,000 | ||||||
| Proceeds from notes payable | - | 50,000 | ||||||
| Repayment of notes payable | (50,000 | ) | - | |||||
| Proceeds from convertible notes | 225,000 | 1,199,448 | ||||||
| Net cash provided by financing activities | 8,765,700 | 1,254,448 | ||||||
| Net increase in cash | 7,379,118 | 484,989 | ||||||
| Cash, beginning of period | 144,953 | 19,128 | ||||||
| Cash, end of period | $ | 7,524,071 | $ | 504,117 | ||||
| Supplemental disclosures: | ||||||||
| Interest paid | $ | - | $ | - | ||||
| Income tax paid | $ | - | $ | - | ||||
| Supplemental disclosures of non-cash Items: | ||||||||
| Discount on convertible notes | $ | 225,000 | $ | - | ||||
| Common shares to be issued for accrued salaries - related parties | $ | - | $ | 60,910 | ||||
| Conversion of convertible notes | $ | 1,951,200 | $ | - | ||||
SOURCE: ENDRA Life Sciences Inc.