ANN ARBOR, Mich. / Aug 14, 2025 / Business Wire / ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo-Acoustic Enhanced UltraSound (TAEUS^®), today provided a business update and reported financial results for the three and six months ended June 30, 2025.

Business Update

• Advanced development of TAEUS Liver. ENDRA advanced its product development work with enhancements to the TAEUS Liver system’s probe design and proprietary algorithms, which are expected to deliver significantly improved accuracy and repeatability to its liver fat assessments. Initial testing of the new design on a small patient population demonstrated an order-of-magnitude improvement in performance against the gold standard MRI-PDFF measurements. The Company is initiating validation testing of the redesigned probe in a short controlled study to confirm these anticipated performance gains.
  
• Focused strategy for TAEUS Liver De Novo submission. The Company further advanced its regulatory strategy regarding its planned De Novo filing for TAEUS Liver with the U.S. Food and Drug Administration (FDA). ENDRA intends to conduct a hypothesis-driven, statistically powered prospective multisite clinical trial enrolling approximately 250 subjects. The final trial design and sample size will be vetted with the FDA, which will assist in achieving the statistical power necessary for the De Novo submission and for publication of results in peer-reviewed journals. The Company expects that the results from the short controlled study will be used for the FDA meetings to confirm the endpoints and protocol. This regulatory alignment is intended to pave the way for the launch of ENDRA’s pivotal study by year-end.
  
• Expanded the intellectual property portfolio to 85 issued patents globally. During the second quarter of 2025, ENDRA was issued one additional U.S. patent, which covers methods for tuning the thermoacoustic probe. ENDRA’s broad intellectual property portfolio provides protection for the TAEUS system with its novel thermoacoustic technology and supports the exploration of licensing opportunities for indications beyond its core focus.
  
• Implemented cost reductions while advancing TAEUS development. ENDRA has taken decisive steps to strengthen its financial position over the past nine months. These cost reductions were initiated in the fourth quarter of 2024 and included a decrease in headcount and a streamlining of operations, particularly in general and administrative expenses. As a result, second quarter 2025 operating expenses decreased 42% to $1.2 million compared with $2.2 million in the prior-year period.

“Our redesigned TAEUS probe represents a major advancement in our ability to non-invasively assess liver health. The early data are extremely encouraging, and our ongoing validation study is an important step toward aligning with the FDA and beginning our pivotal trial later this year,” said Alexander Tokman, ENDRA’s Chief Executive Officer. “Metabolic diseases—often symptomless until late stages—are the underlying cause of many chronic illnesses, including steatotic liver disease or SLD, which affects more than two billion people worldwide and over 100 million Americans. Due to the absence of practical diagnostic tools for frontline clinicians, SLD remains grossly underdiagnosed. With TAEUS, we aim to bring liver diagnostics into everyday care and enable earlier detection, better treatment decisions and potentially reduce the enormous financial burden metabolic diseases place on the U.S. healthcare system.”

Second Quarter Financial Results

During 2024, the Company implemented significant cost-reduction initiatives to strengthen its financial position while advancing its strategic priorities. In the second quarter of 2025, the Company’s cash burn from operations was $1.1 million, nearly half the $2.1 million reported in the same quarter of 2024.

Total operating expenses for the second quarter of 2025 were $1.3 million, down 42% year-over-year from $2.2 million, reflecting the impact of cost-optimization measures including streamlined staffing, reduced overhead and a leaner operating model.

As a result, net loss for the second quarter of 2025 narrowed to $1.2 million from $2.2 million in the year-ago period.

As of June 30, 2025, ENDRA reported $1.8 million in cash and cash equivalents, providing resources to execute its near-term operational and regulatory milestones.

About ENDRA Life Sciences Inc.

ENDRA Life Sciences is the pioneer of Thermo-Acoustic Enhanced UltraSound (TAEUS^®), a ground-breaking technology being developed to assess tissue fat content and monitor tissue ablation during minimally invasive procedures, at the point of patient care. TAEUS^® is focused on the measurement of fat in the liver as a means to assess and monitor steatotic liver disease and metabolic dysfunction-associated steatohepatitis, chronic liver conditions that affect over two billion people globally, and for which there are no practical diagnostic tools. For more information, please visit www.endrainc.com.

Forward-Looking Statements

All statements in this press 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," “forecast,” “future,” "goal," “hope,” "intend," "may," "plan," “possible,” “potential,” “project,” "seek," "should," "will," “would,” 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: expectations with respect to FDA requirements regarding its clinical trials and De Novo submission for its TAEUS liver device; estimates of the timing of future events and anticipated results of its development efforts, including the timing of submission for and receipt of required regulatory approvals and product launches and sales; statements relating to future financial position and projected costs and revenue; expectations concerning ENDRA's business strategy; and statements regarding ENDRA’s ability to find and maintain development partners. 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: the ability to raise additional capital in order to continue as a going concern; the ability to obtain FDA and other regulatory approvals necessary to sell ENDRA medical devices in certain markets in a timely manner, or at all; the ability to develop a commercially feasible technology and its dependence on third parties to design and manufacture its products; ENDRA’s ability to maintain compliance with Nasdaq listing standards and remain listed on a securities exchange; ENDRA’s dependence on its senior management team; 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 subsequent 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 press 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.

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