ENDRA Life Sciences Reports Full Year 2018 Financial & Operational Results

Management to Host Full Year 2018 Conference Call Today at 4:30 p.m. ET

ANN ARBOR, MI / ACCESSWIRE / March 11, 2019 / ENDRA Life Sciences Inc. (“ENDRA”) (NASDAQ: NDRA), a developer of enhanced ultrasound technologies, reported its financial and operational results for the full year ended December 31, 2018.

Key 2018 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.

• Received approval from Health Canada for an Investigational Testing Authorization (ITA) to commence a first human feasibility study with ENDRA’s TAEUS reference system targeting Non-Alcoholic Fatty Liver Disease (NAFLD).
• Secured a Class II ITA designation, representing a low to medium risk profile for the TAEUS investigational device.
• Commenced human studies in collaboration with Imaging Laboratories at Robarts Research in London, Canada to collect data sets including:
• Integration evaluation of hardware and software design elements of the TAEUS platform;
• User and patient human-factors data, including clinical workflow and ergonomic considerations to support our CE mark application and commercial product design; and
• Quantitative MRI liver fat fraction measurements for each study subject, that will both guide algorithm development and provide data for initial comparison to TAEUS measurements.
• Secured authorization from the Robarts Research Institute to expand in-human study from 25 subjects to 50 subjects to:
• Gain additional workflow and usability information; and
• Expand the pool of study subjects to be representative of the population distribution of liver fat.
• Implemented a formal Quality Management System (QMS) defining and documenting over 40 key business processes, including product development design control and manufacturing, to support ENDRA’s CE application for TAEUS liver product.
• Grew intellectual property (IP) portfolio from 33 to 41 assets in preparation, filed, issued or licensed, encompassing a range of device and method-focused IP in targeted global markets. Six patents were issued in 2018:
• One U.S. patent for correcting fat-induced aberrations;
• One U.S. patent for magnetic resonance imaging (MRI) safety based on TAEUS technology;
• Three U.S. patents related to quantitative fat methodologies; and
• One U.S. patent related to transducer design.
• Commenced pre-commercialization activities to raise industry awareness in anticipation of commercial launch of TAEUS liver product in Europe, including securing exhibit space at notable liver disease and ultrasound industry events including:
• The American Association for the Study of Liver Disease (AASLD) Liver Meeting 2018 Summit in San Francisco, California;
• Interdisciplinary Ultrasound Congress 2018 in Basel, Switzerland;
• Radiological Society of North America (RSNA) 2018 Annual Meeting in Chicago, Illinois; and
• European Association for the Study of the Liver (EASL) Nonalcoholic Fatty Liver Disease (NAFLD) Summit in Geneva, Switzerland.
• Published educational animations through social media and ENDRA’s website: endrainc.com.
• Strengthened ENDRA’s balance sheet and extended the company’s operational runway with approximately $9.6 million in additional capital from three capital raises, including two common stock offerings and one convertible note whose participants included new institutional funds, accredited investors and ENDRA’s management and board of directors.

• Subsequent Events in Q1 2019:

• Grew intellectual property portfolio to 48 assets in preparation, filed, issued or licensed.
• Partnered with the Ladak Laboratory at Western University in Canada to develop artificial intelligence (AI) tools for ENDRA’s TAEUS technology.
• Recruited Amy Sitzler as ENDRA’s Vice President of Engineering and Programs.

Management Commentary

“2018 was a pivotal year as we laid the foundation to bring our game-changing Thermo-Acoustic Enhanced UltraSound (TAEUS™) clinical platform to market,” said Francois Michelon, CEO of ENDRA Life Sciences. “We renewed our partnership with GE Healthcare for an additional two years and grew our IP portfolio from 33 to 41 assets. We also initiated our first-in-human study, strengthened our balance sheet and implemented a quality management system supporting CE regulatory approval and strongly positioning ENDRA for a controlled European launch in 2019.

“Our progress in 2018 supports our overarching goals of broadening access to better healthcare while driving shareholder value. To achieve these goals, our strategy remains focused on the following elements:

• Introduce new point-of-care technologies that increase the utility of ultrasound:
• Initially prove-out market adoption of an accessory device – TAEUS liver – comprised of both hardware and software elements;
• Expand to other software intensive TAEUS and non-TAEUS clinical applications;
• License ENDRA technology to strategic partners; and
• Aggressively grow our IP to ensure ENDRA’s freedom to operate.
• Focus internal resources on the highest value items – fundamental research, intellectual property and software algorithm development.

• Partner with paid services or a strategic in core engineering and commercialization to enable an “asset light” business and amplify our resources,” stated Michelon.

First In-Human Studies

“In October 2018, we received an Investigational Testing Authorization (ITA) from Health Canada to commence the first human studies in healthy volunteers with our TAEUS clinical system targeting NAFLD,” said ENDRA’s Chief Technology Officer, Michael Thornton. “The feasibility study is being conducted in collaboration with the widely respected Robarts Research Institute in London, Canada and will help guide our algorithm development and compare our technology to MRI. We were very happy that the ITA application received a Class II designation, representing a low to medium risk profile for our TAEUS device.

“The Robarts study is an ENDRA-academic collaboration, the first of several planned clinical studies in North America and Europe, as we transition from feasibility to product testing and ultimately to product evaluation studies,” stated Thornton.

“In December 2018, we announced that the Robarts investigators had received approval to expand the study from 25 to 50 subjects. The initial cohort of 25 subjects had predominantly healthy liver fat content and did not sufficiently mirror the distribution of fatty liver in the general population. The study investigators chose to expand the study size to recruit additional study subjects to reflect the stages of fatty liver disease characteristic of the general population. Ironically, since no practical tool exists to gauge liver fat content, the study investigators couldn’t easily screen the distribution of liver fat in the study subjects and couldn’t specify the number of subjects required for the study. When ENDRA’s TAEUS technology becomes widely available, this issue will be largely overcome.

“As of today, we are happy to report that the study is on track and we expect to have a comprehensive update on the Robarts study by the end of the first quarter of 2019. The data collected from the study, including additional usability inputs, will both inform our final commercial product design, and be included in our technical file submission for device CE Mark, which we anticipate filing in the first half of 2019.

“It’s important to note that the heavy lifting involved in a first in-human feasibility study — during which we are optimizing the TAEUS clinical workflow, recruiting a representative distribution of NAFLD subjects and continually improving our TAEUS algorithms — is a normal, time intensive component of bringing a new disruptive technology to market. We are pleased with the TAEUS system’s clinical ease-of-use and we expect to report study findings in March 2019,” concluded Thornton.

Other Achievements

“On the IP front during 2018, we expanded our diverse IP portfolio, with a strong focus on protecting enabling methodologies and technical innovations related to our TAEUS fatty liver application,” continued Michelon. “As of today, ENDRA’s IP portfolio totals 48 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.

“I am proud of the accomplishments the ENDRA Life Sciences’ team has achieved thus far and as we conclude the first quarter of 2019, we believe ENDRA is positioned to deliver on key milestones for ENDRA’s fatty liver application in 2019 including:

• Filing for CE Mark in Europe in the first half of 2019; and

• Controlled launch of the TAEUS liver device in Europe mid-2019.

“2019 is already off to an exciting start with our artificial intelligence (AI) collaboration with Western University in Ontario, Canada. Together we are exploring how we can apply advanced AI tools to variety of computational tasks related to TAEUS imaging applications, such as image segmentation, artifact corrections and measurement calibration.

“As we embark on an exciting 2019 for ENDRA, we now have an increased cash balance following financings in the fourth quarter of 2018, human studies are underway, the necessary foundations for a strong CE application have been secured and we are partnered with the market leader, GE Healthcare, to support our 2019 commercialization activities in Europe. We look forward to updating investors on our human study in the weeks to come,” concluded Michelon.

Full Year 2018 Financial Results

Revenue totaled $6,174 in FY 2018, as compared to $351,622 in FY 2017. The revenue for 2018 was a result of service revenue for our Nexus 128 product line that is now discontinued.

Operating expenses increased to $8.9 million in FY 2018 from $4.8 million in FY 2017. The increase in operating expenses in FY 2018 as compared to FY 2017 was primarily due to research and development costs related to a full year of development for our TAEUS product, and general and administrative spending including costs associated with increased headcount and legal fees.

Total operating expenses in FY 2018 included $1.4 million in non-cash expenses associated with equity issued for services, $0.7 million for the amortization of debt discount associated with the convertible note, and $0.3 million related to the impairment of inventory held for our Nexus 128 product line.

Net loss in FY 2018 totaled $9.7 million, or ($2.16) per basic and diluted share, as compared to a net loss of $5.4 million, or ($1.95) per basic and diluted share in FY 2017.

Cash at December 31, 2018 totaled $6.5 million, as compared to $5.6 million at December 31, 2017 with no long-term debt outstanding. The increase of cash as of December 31, 2018 compared to December 31, 2017 is a result of the gross proceeds of approximately $9.6 million from capital raises throughout 2018.

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: Monday March 11, 2019
Time: 4:30 p.m. EST, 1:30 p.m. PST
Toll-free dial-in number: 844-369-8770
International dial-in number: 862-298-0840

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 https://www.investornetwork.com/event/presentation/44484 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 March 25, 2019.

Toll-free replay number: 877-481-4010
International replay number: 919-882-2331
Replay ID: 44484

About ENDRA Life Sciences Inc.

ENDRA Life Sciences Inc. (“ENDRA”) (NASDAQ: NDRA) is a developer of enhanced ultrasound technologies. ENDRA is developing a next generation Thermo-Acoustic Enhanced UltraSound (TAEUS™) platform 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 (NAFLD). ENDRA’s goal is to bring new capabilities to ultrasound – thereby broadening access to better healthcare. For more information, please visit www.endrainc.com.

About Non-Alcoholic Fatty Liver Disease (NAFLD)

NAFLD is a condition closely associated with obesity, diabetes, hepatitis-C and certain genetic predispositions in which fat accumulates in the liver. NAFLD affects over 1 billion people globally and is estimated to cost the U.S healthcare system over $100 billion annually. NAFLD is often asymptomatic and if left untreated, NAFLD can progress to inflammation (NASH), tissue scarring (fibrosis), cell death (cirrhosis) and liver cancer. By 2025, NAFLD is forecast to be the greatest root cause of liver transplants. The only tools currently available for diagnosing and monitoring NAFLD are impractical: expensive Magnetic Resonance Imaging (MRI) or an invasive surgical biopsy.

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 the results of pending human studies and nature of the data obtained from such studies; the adequacy of protections afforded to us by the patents that we own and the success we may have in, and the cost to us of, maintaining, enforcing and defending those patents; expectations concerning ENDRA’s ability to secure regulatory approvals; anticipated product pricing; expectations with respect to current and future partnerships; 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.
Consolidated Balance Sheets

ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Operations

ENDRA Life Sciences Inc.
Consolidated Statements of Cash Flows

SOURCE: ENDRA Life Sciences Inc.

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