ENDRA Life Sciences Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides a Business Update

Rhea-AI Summary

ENDRA Life Sciences (NASDAQ: NDRA) reported its Q4 and full-year 2024 financial results, highlighting significant progress in its TAEUS Liver device development. The company has implemented a new strategy focusing on TAEUS as a biomarker solution for metabolic diseases in GLP-1 drug patients.

Key operational highlights include: acquiring data from over 110 subjects across new evaluation sites, implementing a revised FDA De Novo submission strategy with a planned multicenter study of approximately 250 subjects, and significant cost reductions bringing monthly operational cash burn down to $0.5 million in Q4 2024 from $0.8 million in 2023.

Financial results show Q4 2024 net loss of $4.2 million (vs $1.5 million in Q4 2023), including a $2.3 million non-cash inventory charge. Full-year 2024 saw reduced cash burn at $7.4 million (vs $9.5 million in 2023), with a net loss of $11.5 million. Cash position stood at $3.2 million as of December 31, 2024.

Positive

• Significant reduction in cash burn from $9.5M to $7.4M year-over-year
• Monthly operational expenses reduced from $0.8M to $0.5M
• Successfully collected clinical data from 110+ subjects across new evaluation sites
• Clear regulatory pathway established with planned 250-subject multicenter trial

Negative

• Net loss increased to $11.5M in 2024 from $10.1M in 2023
• Took $2.3M non-cash inventory valuation charge
• Cash position to $3.2M as of December 31, 2024
• Operating expenses increased to $10.8M from $10.5M year-over-year

Insights

Financial Analyst

ENDRA Life Sciences' Q4 and FY 2024 results reflect a company making significant operational improvements while navigating financial constraints. The reduced cash burn is noteworthy—$1.5 million used in Q4 2024 operations versus $2.2 million in Q4 2023, with projected monthly burn decreasing to $0.35 million for Q2-Q3 2025 from $0.5 million in Q4 2024.

While operating expenses increased to $4.3 million in Q4 (vs $1.5 million in Q4 2023), this was primarily due to a $2.3 million non-cash inventory valuation charge reflecting strategic repositioning. When adjusting for this charge and comparing to the artificially low Q4 2023 (which benefited from a $1.0 million reversal of accrued bonuses), the underlying cost structure shows substantial improvement.

The $3.2 million cash position as of December 31, 2024, represents approximately 9 months of runway at projected burn rates. This timeline creates urgency for either accelerated regulatory progress or additional capital raising, introducing potential dilution risk for current shareholders.

The revised regulatory strategy—shifting to a prospective multicenter clinical trial rather than using retrospective data—likely extends the path to commercialization but strengthens the eventual submission. This trade-off between timing and quality of submission reflects a calculated strategic decision.

The company's targeting of the GLP-1 therapeutic market for metabolic disease monitoring represents an opportunistic market alignment, though commercial success remains contingent on both regulatory approval and market adoption.

Medical Device Expert

ENDRA's strategic shift for its TAEUS Liver device represents a material improvement in their regulatory approach. The pivot from retrospective data analysis to a hypothesis-driven prospective clinical trial with approximately 250 subjects demonstrates a more robust methodology aligned with FDA expectations for novel diagnostic technologies.

The acceleration of data collection (110+ subjects across multiple sites) with a wider range of liver disease states—particularly the inclusion of moderate (S2) and severe (S3) steatosis cases—provides critical validation across the disease spectrum. This broader dataset enables more comprehensive algorithm training and validation, essential for diagnostic accuracy.

Particularly significant is the company's strategic repositioning of TAEUS as a biomarker solution for patients using GLP-1 medications. This application addresses an emerging clinical need, as these rapidly-adopted weight loss and diabetes drugs require ongoing metabolic monitoring, creating potential clinical utility for non-invasive liver fat assessment.

The planned pre-submission FDA engagement to align on study design, endpoints, and statistical analyses before initiating the pivotal trial represents sound regulatory strategy, potentially reducing later-stage complications. However, this thorough approach extends the timeline to potential approval compared to the previous strategy.

The non-cash inventory valuation charge ($2.3 million) reflects necessary product realignment but suggests previous configuration issues requiring resolution. While the enhanced hardware and software configurations may improve accuracy and usability, execution risks remain as the company finalizes its technical approach prior to the pivotal trial.

ANN ARBOR, Mich.--(BUSINESS WIRE)-- ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo-Acoustic Enhanced UltraSound (TAEUS^®), today reported financial results for the fourth quarter and full-year ended December 31, 2024, and provided a business update.

Business Update

ENDRA made significant progress against many of the new initiatives discussed during the Company’s August 22, 2024, conference call to advance its TAEUS Liver device along the development and regulatory process. In addition, ENDRA separately announced today a revamped strategy for TAEUS as a biomarker solution for the early detection and management of metabolic diseases in patients being treated with glucagon-like peptide-1 (GLP-1) drugs. ENDRA’s progress against the key initiatives is summarized below.

• Prioritization to advance TAEUS Liver along the FDA regulatory process. In the fourth quarter of 2024, the Company re-focused its resources to refine and advance its TAEUS Liver device on its regulatory path. This included obtaining the necessary baseline data from subjects across a range of steatotic liver disease states in order to optimize the TAEUS Liver design and be in a position to commence the pivotal clinical trial necessary for a De Novo submission to the U.S. Food and Drug Administration (FDA). As part of the process, TAEUS continues to undergo further development, with enhancements to its hardware and software configurations to improve both accuracy and usability.
  

• Acceleration of TAEUS scans at evaluation sites. In October 2024, ENDRA signed and activated two new sites, The Ludwig Maximilian University of Munich (LMU) and ENDRA’s onsite clinical facility in Ann Arbor, to conduct a multisite pilot study to assess TAEUS’ liver fat measurement capabilities against the gold standard MRI-PDFF test. To date, these sites have acquired TAEUS scan data from more than 110 subjects, which are being assessed against the corresponding MRI-PDFF results. These new data cover a wider range of steatotic liver disease states than previous TAEUS studies, with approximately 20% of the newly acquired data from subjects with moderate and severe steatosis, known as S2 and S3, respectively. The additional data are a foundational element for the TAEUS Liver’s regulatory, clinical and commercial success. They provide important feedback to optimize product design for accuracy and repeatability, as well as the pivotal clinical trial design to position the TAEUS Liver for a successful De Novo submission. As more data are expected over the next few months, the technical team has begun analyzing this wider range of data and optimizing the TAEUS Liver’s design. Upon approval of ENDRA’s planned De Novo submission, the data are also expected to support commercialization efforts for the TAEUS Liver device.
  

• Revised regulatory strategy for De Novo submission for TAEUS Liver device. The Company made several significant changes to its regulatory strategy regarding the approach to its planned De Novo filing with the FDA. ENDRA intends to conduct a hypothesis-driven, statistically powered prospective clinical trial as opposed to prior plans to use retrospective data. In addition, the pivotal trial is expected to be a multicenter study enrolling approximately 250 subjects. The final trial design and sample size will be vetted with the FDA prior to initiation, which will be invaluable in achieving the statistical power necessary for the De Novo submission and for publications in peer-reviewed journals. This pre-submission engagement with the FDA is intended to attain alignment on study details, including design, site selection, sample size, hypothesis, secondary endpoints and statistical analyses prior to data collection.
  

• Implemented cost reductions without impacting TAEUS development. During the second half of 2024, the Company implemented significant reductions in its operating expenses. These initiatives did not significantly impact TAEUS’ primary deliverables. Due to these activities, ENDRA’s cash used for operations was on average $0.5 million per month in the fourth quarter of 2024, a significant decrease compared with $0.8 million per month for all of 2023. In the first quarter of 2025, the Company further reduced expenses, and expects the cash used in operations to average approximately $0.35 million per month for the second and third quarters of 2025.
  

• New operating team. Since late in the third quarter of 2024, the new ENDRA operating team has made strong progress on the Company’s key initiatives discussed in August 2024, including:
  • Focused the business on the single most important deliverable – a new multicenter clinical study to support the planned De Novo submission for the TAEUS Liver device;
  • Defined ENDRA’s new mission, multi-generational product strategy and business model;
  • Defined the new go-to-market strategy for the TAEUS Liver device;
  • Defined and executed a business optimization, which yielded a significant reduction in monthly cash burn; and
  • Defined and executed a more cohesive FDA De Novo strategy centered around a multicenter clinical study to validate and improve TAEUS’ performance prior to commencing the De Novo pivotal study.

Fourth Quarter Financial Results

ENDRA continues to make strong progress in reducing its cash burn. In the fourth quarter of 2024, cash used in operations declined to $1.5 million, a major improvement from $2.2 million in the fourth quarter of 2023.

Operating expenses in the fourth quarter of 2024 rose to $4.3 million, compared with $1.5 million in the same period last year. As a result, the net loss for the fourth quarter of 2024 was $4.2 million, compared with $1.5 million in the fourth quarter of 2023. This increase was due to one-time non-cash items, including:

• A $2.3 million non-cash inventory valuation charge in the fourth quarter of 2024, reflecting the Company's strategic shift to align the TAEUS Liver device with larger market opportunities; and
• A $1.0 million non-cash gain in the fourth quarter of 2023 for reversing accrued management bonuses for 2023, which were not paid and had the effect of making the fourth quarter of 2023 look artificially low.

When excluding these non-cash items, representing a total swing of $3.3 million, the Company’s underlying financial performance improved significantly over the previous year, due to aggressive cost-cutting measures implemented in the second half of 2024.

Full-Year 2024 Financial Results

For the 2024 full year, the Company significantly reduced its cash burn with cash used in operations declining to $7.4 million from $9.5 million in 2023.

Total operating expenses in 2024 were $10.8 million, slightly higher than $10.5 million in 2023, due to the previously mentioned $2.3 million inventory valuation charge.

The Company reported a net loss of $11.5 million for 2024, compared with a net loss of $10.1 million in 2023. This increase was primarily due to the $2.3 million non-cash inventory valuation charge in 2024 and an additional $0.8 million non-cash warrant charge in 2024. When excluding these one-time, non-cash items, representing a total of $3.1 million, the Company’s financial performance experienced notable improvement, highlighting the impact of cost-cutting measures implemented in the second half of 2024.

As of December 31, 2024, the Company had $3.2 million in cash and cash equivalents.

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.

[Financial Tables Follow]

ENDRA Life Sciences Inc.
Consolidated Balance Sheets
		December 31,				December 31,
Assets			2024				2023
Current Assets
Cash		$	3,229,480			$	2,833,907
Prepaid expenses			204,185				198,905
Total Current Assets			3,433,665				3,032,812
Non-Current Assets
Inventory			-				2,622,865
Fixed assets, net			69,281				111,782
Right of use assets			578,013				354,091
Prepaid expenses, long term			365,417				626,610
Other assets			5,986				5,986
Total Assets		$	4,452,362			$	6,754,146
Liabilities and Stockholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities		$	508,293			$	700,754
Lease liabilities, current portion			96,937				173,857
Loans			-				28,484
Total Current Liabilities			605,230				903,095
Long Term Debt
Loans, long term			-				-
Lease liabilities			487,482				192,062
Warrant Liability			799,284				-
Total Long Term Debt			1,286,766				192,062
Total Liabilities			1,891,996				1,095,157
Stockholders’ Equity
Series A Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized; 17.488 and 141.397 shares issued and outstanding, respectively			-				1
Series B Convertible Preferred Stock, $0.0001 par value; 1,000 shares authorized; no shares issued and outstanding			-				-
Series C Convertible Preferred Stock, $0.0001 par value; 100,000 shares authorized; no shares issued and outstanding			-				-
Common stock, $0.0001 par value; 20,000,000 shares authorized; 536,908 and 5,937 shares issued and outstanding, respectively			53				1
Additional paid in capital			105,998,412				97,583,906
Stock payable			-				5,233
Accumulated deficit			(103,438,099	)			(91,930,152	)
Total Stockholders’ Equity			2,560,366				5,658,989
Total Liabilities and Stockholders’ Equity		$	4,452,362			$	6,754,146

ENDRA Life Sciences Inc.
Consolidated Statements of Operations
		Year Ended				Year Ended
		December 31,				December 31,
			2024				2023
Operating Expenses
Research and development		$	3,190,293			$	5,003,695
Sales and marketing			571,040				820,554
General and administrative			7,055,814				4,696,486
Total operating expenses			10,817,147				10,520,735
Operating loss			(10,817,147	)			(10,520,735	)
Other (expenses) income
Other income			108,484				460,485
Warrant expense			(7,323,685	)			-
Changes in fair value of warrant liability			3,447,737				-
Gain on settlement of warrant exercise			3,076,664				-
Total other expenses			(690,800	)			460,485
Loss from operations before income taxes			(11,507,947	)			(10,060,250	)
Provision for income taxes			-				-
Net Loss		$	(11,507,947	)		$	(10,060,250	)
Net loss per share – basic and diluted		$	(56.94	)		$	(2,766.85	)
Weighted average common shares – basic and diluted			202,106				3,636

 

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Company Contact:

Investor relations

investors@endrainc.com

www.endrainc.com

Investor Relations Contact:

Yvonne Briggs

Alliance Advisors IR

(310) 691-7100

ybriggs@allianceadvisors.com

Source: ENDRA Life Sciences Inc.

FAQ

What is ENDRA's new regulatory strategy for TAEUS Liver device FDA approval?

ENDRA plans to conduct a hypothesis-driven, prospective clinical trial with approximately 250 subjects across multiple centers, replacing previous plans for retrospective data use. The design will be vetted with FDA before initiation.

How much did ENDRA (NDRA) reduce its monthly cash burn in Q4 2024?

ENDRA reduced its monthly cash burn to $0.5 million in Q4 2024, down from $0.8 million in 2023, with further reductions expected to $0.35 million per month in Q2-Q3 2025.

What progress has ENDRA made in TAEUS clinical evaluations?

ENDRA has collected data from over 110 subjects at two new sites: The Ludwig Maximilian University of Munich and Ann Arbor facility, with 20% of data from moderate to severe steatosis cases.

What caused ENDRA's increased net loss in Q4 2024?

The increased net loss was primarily due to a $2.3 million non-cash inventory valuation charge related to strategic shifts in TAEUS Liver device market positioning.