ANN ARBOR, MI / ACCESSWIRE / August 17, 2020 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ:NDRA), the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today provided a business update and reported second quarter 2020 financial results.
"During the second quarter, we achieved another major milestone on the path to commercializing TAEUS with our 510(k) Premarket Notification submission to the U.S. Food and Drug Administration ("FDA")," said Francois Michelon, Chairman and Chief Executive Officer. "The submission represents the culmination of years of scientific research, quality system implementation, clinical data collection, and biocompatibility and safety testing. I'm very proud of the ENDRA team, especially for working tirelessly through an unprecedented global pandemic to ensure the submission was made on the aggressive schedule we set before COVID-19 was a consideration."
As Renaud Maloberti, Chief Commercial Officer, explained, "The FDA submission builds on the receipt of the CE Mark in Europe for our TAEUS liver system in the first quarter and positions the company to begin commercialization in two major markets in the second half of 2020 to start positively impacting the lives of more than 1 billion people globally affected by Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH)."
Q2 2020 and Recent Business Highlights
- Completed 510(k) Premarket Notification submission to the U.S. Food and Drug Administration ("FDA") for TAEUS Fatty Liver Imaging Probe ("FLIP") on schedule, setting stage for potential clearance and commercialization in the U.S. in 2020.
- Secured new partnership with the Medical College of Wisconsin ("MCW"), a world-renowned healthcare institution, for a clinical study of ENDRA's Thermo-Acoustic Enhanced Ultrasound (TAEUS™) device for assessing Non-Alcoholic Fatty Liver Disease ("NAFLD"). This represents the third research partnership for ENDRA, which will help bolster the clinical evidence and further establish the clinical utility of the TAEUS device in patients with NAFLD, as commercialization gets underway.
- Advanced European commercialization strategy, following CE Mark approval, including advancing to final stages of establishing initial evaluation sites in key markets, as well as hiring an initial salesperson in the U.K. and identifying leading candidates in other key markets.
- Increased intellectual property (IP) portfolio to 72 assets defined, filed and issued, including key platform patents in the United States, Europe and China to defend our technology and current and future clinical applications for which there are currently no practical clinical tools.
- Remain on track with key milestones of establishing clinical evaluation reference sites in Q3 and initial sales in Europe in Q4 2020.
Financial Results for Quarter Ended March 31, 2020
- Operating expenses increased to $2.9 million in the second quarter of 2020, up from $2.3 million in the same period in 2019. The increase in operating expenses was primarily due to expenses related to the development of our TAEUS product line, and costs associated with the pre-commercialization of TAEUS.
- Net loss in Q2 2020 totaled $2.9 million, or ($0.20) per basic and diluted share, as compared to a net loss of $2.3 million, or ($0.31) per basic and diluted share in Q2 2019.
- Cash balance at June 30, 2020 was $749,000 and totaled approximately $2.4 million as of August 14, 2020 due primarily to voluntary early warrant conversions, compared to $6.2 million at December 31, 2019, with no long-term debt outstanding.
Conference Call and Webcast Access
Management will host a conference call and webcast today at 4:30 p.m. ET to discuss the 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: 36535
A telephone replay will be available August 17, 2020 through 4:30 p.m. ET on August 24, 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 Inc. is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology that mirrors some applications similar to MRI, but at 50X lower cost, 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 listed above under the heading "2020 Guidance"; making 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
Media Relations Contact:
Denise DiMeglio
(610) 228-2102
denise@gregoryfca.com
Investor Relations Contact:
Joe Hassett
(484) 686-6600
joeh@gregoryfca.com
ENDRA Life Sciences Inc.
Condensed Consolidated Balance Sheets
| June 30, | December 31, | |||||||
| Assets | 2020 | 2019 | ||||||
| Assets | (unaudited) | |||||||
| Cash | $ | 748,561 | $ | 6,174,207 | ||||
| Prepaid expenses | 1,064,146 | 116,749 | ||||||
| Inventory | 340,687 | 113,442 | ||||||
| Other current assets | 121,951 | 130,701 | ||||||
| Total Current Assets | 2,275,345 | 6,535,099 | ||||||
| Other Assets | ||||||||
| Fixed assets, net | 214,587 | 236,251 | ||||||
| Right of use assets | 372,720 | 404,919 | ||||||
| Total Assets | $ | 2,862,652 | $ | 7,176,269 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current Liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 1,169,237 | $ | 1,708,525 | ||||
| Convertible notes payable, net of discount | - | 298,069 | ||||||
| Lease liabilities, current portion | 71,085 | 66,193 | ||||||
| Total Current Liabilities | 1240,322 | 2,072,787 | ||||||
| Long Term Debt | ||||||||
| Loans | 337,084 | - | ||||||
| Lease liabilities | 308,366 | 342,812 | ||||||
| Total Long Term Debt | 645,450 | 342,812 | ||||||
| Total Liabilities | 1,885,772 | 2,415,599 | ||||||
| Stockholders' Equity | ||||||||
| Series A Preferred Stock , $0.0001 par value; 10,000 shares authorized; 896.225 and 6,338.490 shares issued and outstanding | 1 | 1 | ||||||
| Series B Preferred Stock, $0.0001 par value; 1,000 shares authorized; 0 and 351.711 shares issued and outstanding | - | - | ||||||
| Common stock, $0.0001 par value; 80,000,000 shares authorized; 16,437,491 and 8,421,401 shares issued and outstanding | 1,644 | 842 | ||||||
| Additional paid in capital | 52,227,904 | 49,933,736 | ||||||
| Stock payable | 181,437 | 43,528 | ||||||
| Accumulated deficit | (51,434,106 | ) | (45,217,437 | ) | ||||
| Total Stockholders' Equity | 976,880 | 4,760,670 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 2,862,652 | $ | 7,176,269 | ||||
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
| Three Months Ended | Three Months Ended | Six Months Ended | Six Months Ended | |||||||||||||
| June 30, | June 30, | June 30, | June 30, | |||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating Expenses | ||||||||||||||||
| Research and development | $ | 1,487,049 | $ | 1,304,808 | $ | 3,005,195 | $ | 3,078,306 | ||||||||
| Sales and marketing | 134,763 | 88,343 | 249,718 | 145,161 | ||||||||||||
| General and administrative | 1,269,467 | 932,021 | 2,737,212 | 1,848,924 | ||||||||||||
| Total operating expenses | 2,891,279 | 2,325,172 | 5,992,125 | 5,072,391 | ||||||||||||
| Operating loss | (2,891,279 | ) | (2,325,172 | ) | (5,992,125 | ) | (5,072,391 | ) | ||||||||
| Other Expenses | ||||||||||||||||
| Amortization of debt discount | (3,858 | ) | - | (232,426 | ) | - | ||||||||||
| Other income (expense) | 1,265 | (9,199 | ) | 7,882 | (10,716 | ) | ||||||||||
| Total other expenses | (2,593 | ) | (9,199 | ) | (224,544 | ) | (10,716 | ) | ||||||||
| Loss from operations before income taxes | (2,893,872 | ) | (2,334,371 | ) | (6,216,669 | ) | (5,083,107 | ) | ||||||||
| Provision for income taxes | - | - | - | - | ||||||||||||
| Net Loss | $ | (2,893,872 | ) | $ | (2,334,371 | ) | $ | (6,216,669 | ) | $ | (5,083,107 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.20 | ) | $ | (0.31 | ) | $ | (0.45 | ) | $ | (0.68 | ) | ||||
| Weighted average common shares - basic and diluted | 14,735,662 | 7,422,642 | 13,803,215 | 7,422,642 | ||||||||||||
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| Six Months Ended | Six Months Ended | |||||||
| June 30, | June 30, | |||||||
| 2020 | 2019 | |||||||
| Cash Flows from Operating Activities | ||||||||
| Net loss | $ | (6,216,669 | ) | $ | (5,083,107 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 44,014 | 39,744 | ||||||
| Common stock, options and warrants issued for services | 1,057,120 | 659,217 | ||||||
| Amortization of debt discount | 232,426 | |||||||
| Amortization of right of use assets | 32,199 | |||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses | (947,397 | ) | (98,358 | ) | ||||
| Lease liability | (29,554 | ) | ||||||
| Inventory | (227,245 | ) | (14,837 | ) | ||||
| Other assets | 8,750 | (93,075 | ) | |||||
| Accounts payable and accrued liabilities | (493,676 | ) | 391,809 | |||||
| Net cash used in operating activities | (6,540,032 | ) | (4,198,607 | ) | ||||
| Cash Flows from Investing Activities | ||||||||
| Purchases of fixed assets | (22,350 | ) | (5,238 | ) | ||||
| Net cash used in investing activities | (22,350 | ) | (5,238 | ) | ||||
| Cash Flows from Financing Activities | ||||||||
| Proceeds from warrant exercise | 50,438 | - | ||||||
| Proceeds from loans | 337,084 | - | ||||||
| Proceeds from issuance of common stock | 791,474 | - | ||||||
| Payment for settlement of notes with stock | (42,260 | ) | - | |||||
| Net cash provided by financing activities | 1,136,736 | - | ||||||
| Net decrease in cash | (5,425,646 | ) | (4,203,845 | ) | ||||
| Cash, beginning of period | 6,174,207 | 6,471,375 | ||||||
| Cash, end of period | $ | 748,561 | $ | 2,267,530 | ||||
| Supplemental disclosures of cash items | ||||||||
| Interest paid | $ | 1,920 | $ | - | ||||
| Supplemental disclosures of non-cash items | ||||||||
| Conversion of convertible notes and accrued interest | $ | 493,814 | $ | - | ||||
| Conversion of Series A Convertible Preferred Stock | $ | 636 | $ | - | ||||
| Conversion of Series B Convertible Preferred Stock | $ | 36 | $ | - | ||||
| Stock dividend payable | $ | (137,909 | ) | $ | - | |||
| Stock paid and payable for services | $ | 40,000 | $ | - | ||||
| Lease liability for right of use asset at inception | $ | - | $ | 439,355 | ||||
SOURCE: ENDRA Life Sciences Inc.
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