ENDRA Life Sciences Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
- ENDRA installed the first TAEUS system in the UK at King's College Hospital for clinical evaluation.
- FDA's review of ENDRA's De Novo request is ongoing, with an in-person meeting confirmed for the second quarter of 2024.
- The company showcased the TAEUS system at major medical conferences in the U.S. and Europe.
- ENDRA expanded its intellectual property portfolio with seven additional patents globally.
- A new ICD-10-CM code was issued for improved NAFLD diagnostics, facilitating standardized billing and promoting consistency in medical documentation and insurance processes.
- Operating expenses decreased in Q4 2023, resulting in a lower net loss compared to the same period in 2022.
- Full-year 2023 financial results also showed a decrease in operating expenses and net loss compared to 2022.
- Cash and cash equivalents as of December 31, 2023, were $2.8 million.
- None.
Insights
The installation of ENDRA Life Sciences' TAEUS system at King's College Hospital for clinical evaluation marks a significant step in the company's efforts to penetrate the UK market and validates the technology's potential in a clinical setting. The comparison of TAEUS liver system's fat assessment accuracy with MRI, the current research standard, could have substantial implications for the company's valuation if the results demonstrate comparable or superior performance. The ongoing FDA review of the De Novo request for the TAEUS liver system is also a critical factor, as FDA approval would open up the lucrative U.S. market for ENDRA's technology. The confirmation of an in-person FDA meeting suggests progress in regulatory discussions, which is a positive sign for investors.
The expansion of the intellectual property portfolio, with seven additional patents, indicates a strategic focus on protecting the technology and potentially increasing revenue streams through licensing. The new ICD-10-CM code for NAFLD could enhance the adoption of the TAEUS system by simplifying reimbursement processes for healthcare providers, thereby potentially increasing the demand for ENDRA's diagnostic tool.
ENDRA Life Sciences' reported decrease in operating expenses and net loss for both the fourth quarter and full year of 2023, compared to the same periods in 2022, reflects an improved cost structure and operational efficiency. The reduction in research and development expenses could indicate that the company's TAEUS technology has matured to a stage where less investment is required for development, shifting focus towards commercialization efforts.
With a net loss of $1.5 million in the fourth quarter of 2023, down from $3.3 million in the same quarter of the previous year and a lower loss per share year-over-year, ENDRA appears to be moving towards a more sustainable financial position. However, the cash and cash equivalents balance of $2.8 million as of December 31, 2023, raises concerns about the company's ability to fund its operations without seeking additional capital, which could lead to dilution for current shareholders.
The momentum in the non-invasive liver diagnostics market, as highlighted by the recent FDA approval of the first therapeutic for MASH and updated guidelines for fatty liver screening, positions ENDRA's TAEUS system favorably in an expanding market. The increased awareness and the potential for integration into standard medical practice due to the new ICD-10-CM code could drive adoption rates.
ENDRA's strategic engagement at key medical conferences and the hosting of panel discussions with key opinion leaders are important for building credibility and awareness among potential customers. The expected activation of other clinical evaluation sites in Europe and North America should provide additional data to support the TAEUS system's efficacy and assist in the commercialization process. However, the success of these efforts will ultimately depend on the clinical study outcomes and the ability to demonstrate clear advantages over existing diagnostic methods.
Conference call begins at 4:30 p.m. Eastern time today
Highlights from the fourth quarter of 2023 and recent weeks include:
-
Installed first TAEUS system in the
UK at King’s College Hospital for clinical evaluation. King's College Hospital NHS Foundation Trust (KCH) inLondon is one of the leading centers of excellence in theUnited Kingdom's National Health Service (NHS). KCH will use ENDRA's TAEUS liver system in a clinical study to compare its liver fat assessment accuracy with MRI, the acknowledged research standard. This study is expected to include approximately 75 subjects and is intended to provide essential data to evaluate the TAEUS technology's performance.
-
FDA’s review of ENDRA's De Novo request is ongoing. In the third quarter of 2023, ENDRA submitted a De Novo request for its TAEUS liver system to the FDA. In the fourth quarter of 2023, the FDA issued an Additional Information (AI) request to ENDRA. As a result, ENDRA has had several interactions with and provided additional details to the FDA. These efforts have fostered a better understanding of the FDA’s expectations, which ENDRA is working to achieve. ENDRA has confirmed an in-person FDA meeting in the second quarter of 2024.
-
Showcased the TAEUS system at key hepatology, endocrinology and radiology medical conferences in the
U.S. andEurope . During the fourth quarter and recent weeks, the ENDRA team met with prospective customers, industry leaders and key partners at four major clinical conferences, including The Liver Meeting by the American Association for the Study of Liver Diseases. During The Liver Meeting. ENDRA also hosted an offsite panel discussion with multidisciplinary key opinion leaders in the fields of hepatology, endocrinology and radiology to share their unique perspectives on managing Metabolic Dysfunction-Associated Steatohepatitis (MASH).
-
Expanded intellectual property portfolio to 75 issued patents globally. During the fourth quarter of 2023 and recent weeks, ENDRA was issued seven additional patents, including three in the
U.S. , one inEurope and three inChina . The company is actively exploring licensing opportunities in non-core indications to augment the value of its growing intellectual property portfolio.
-
New ICD-10-CM code issued, which paves the way for improved NAFLD diagnostics. The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), a global coding system used to indicate a diagnosis for reimbursement purposes and issued by the World Health Organization, included NAFLD under the ICD-10 K76.0 code. This facilitates standardized billing for the diagnosis of NAFLD, is applicable across the
U.S. ,Europe and other regions, and promotes consistency in medical documentation and insurance processes. ENDRA believes the issuance of the ICD-10 K76.0 code specifically for NAFLD measurement represents a significant opportunity for innovation in liver health diagnostics as healthcare providers now have a clearer pathway to integrate advanced diagnostic technologies, including the TAEUS system.
"With the first therapeutic to treat MASH recently approved by the FDA, updated guidelines that include the screening of fatty liver in adults with type 2 diabetes, pre-diabetes and obesity, and new codes that aid reimbursement, there is accelerating momentum in the marketplace for a non-invasive diagnostic tool to assess liver fat like the TAEUS system,” said Francois Michelon, Chairman and Chief Executive Officer of ENDRA. "We continue to collaborate with the FDA and look forward to advancing the regulatory process. In addition, we continue to drive commercial efforts to build awareness of the TAEUS system in
Fourth Quarter 2023 Financial Results
Operating expenses in the fourth quarter of 2023 were
Net loss in the fourth quarter of 2023 was
Full Year 2023 Financial Results
Operating expenses in 2023 were
Net loss in 2023 was
Cash and cash equivalents were
Conference Call and Webcast
Management will host a conference call and webcast today at 4:30 p.m. Eastern time to discuss these results, provide an update on recent corporate developments and answer questions.
Participants are encouraged to pre-register for the conference call using this link. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the start of the call. Those unable to pre-register may participate by dialing (844) 868-8846 (
A telephone replay will be available until April 4, 2024 by dialing (877) 344-7529 (
About ENDRA Life Sciences Inc.
ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology which characterizes tissue similar to an MRI, but at 1/50th the cost and at the point of patient care. TAEUS® is designed to work in concert with the more than 700,000 ultrasound systems in use globally today. TAEUS® is initially focused on the measurement of fat in the liver as a means to assess and monitor steatotic liver disease (SLD) (formerly known as NAFLD-NASH), a chronic liver disease spectrum that affects over two 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. 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: 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 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; 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.
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December 31, |
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December 31, |
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Assets |
|
|
2023 |
|
|
|
2022 |
|
Current Assets |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
2,833,907 |
|
|
$ |
4,889,098 |
|
Prepaid expenses |
|
|
198,905 |
|
|
|
490,299 |
|
Total Current Assets |
|
|
3,032,812 |
|
|
|
5,379,397 |
|
Non-Current Assets |
|
|
|
|
||||
Inventory |
|
|
2,622,865 |
|
|
|
2,644,717 |
|
Fixed assets, net |
|
|
111,782 |
|
|
|
235,655 |
|
Right of use assets |
|
|
354,091 |
|
|
|
505,816 |
|
Prepaid expenses, long term |
|
|
626,610 |
|
|
|
502,576 |
|
Other assets |
|
|
5,986 |
|
|
|
5,986 |
|
Total Assets |
|
$ |
6,754,146 |
|
|
$ |
9,274,147 |
|
|
|
|
|
|
||||
Liabilities and Stockholders’ Equity |
|
|
|
|
||||
Current Liabilities |
|
|
|
|
||||
Accounts payable and accrued liabilities |
|
$ |
700,754 |
|
|
$ |
1,523,012 |
|
Lease liabilities, current portion |
|
|
173,857 |
|
|
|
152,228 |
|
Loans |
|
|
28,484 |
|
|
|
28,484 |
|
Total Current Liabilities |
|
|
903,095 |
|
|
|
1,703,724 |
|
|
|
|
|
|
||||
Long Term Debt |
|
|
|
|
||||
Loans, long term |
|
|
- |
|
|
|
- |
|
Lease liabilities |
|
|
192,062 |
|
|
|
365,919 |
|
Total Long Term Debt |
|
|
192,062 |
|
|
|
365,919 |
|
|
|
|
|
|
||||
Total Liabilities |
|
|
1,095,157 |
|
|
|
2,069,643 |
|
|
|
|
|
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Stockholders’ Equity |
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|
|
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||||
Series A Convertible Preferred Stock, |
|
|
1 |
|
|
|
1 |
|
Series B Convertible Preferred Stock, |
|
|
- |
|
|
|
- |
|
Series C Convertible Preferred Stock, |
|
|
- |
|
|
|
- |
|
Common stock, |
|
|
1,039 |
|
|
|
317 |
|
Additional paid in capital |
|
|
97,582,868 |
|
|
|
89,068,015 |
|
Stock payable |
|
|
5,233 |
|
|
|
6,073 |
|
Accumulated deficit |
|
|
(91,930,152 |
) |
|
|
(81,869,902 |
) |
Total Stockholders’ Equity |
|
|
5,658,989 |
|
|
|
7,204,504 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
6,754,146 |
|
|
$ |
9,274,147 |
|
ENDRA Life Sciences Inc.
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Year Ended |
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Year Ended |
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December 31, |
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December 31, |
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|
|
2023 |
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|
|
2022 |
|
Operating Expenses |
|
|
|
|
||||
Research and development |
|
$ |
5,003,695 |
|
|
$ |
6,554,194 |
|
Sales and marketing |
|
|
820,554 |
|
|
|
1,429,150 |
|
General and administrative |
|
|
4,696,486 |
|
|
|
5,174,215 |
|
Total operating expenses |
|
|
10,520,735 |
|
|
|
13,157,559 |
|
|
|
|
|
|
||||
Operating loss |
|
|
(10,520,735 |
) |
|
|
(13,157,559 |
) |
|
|
|
|
|
||||
Other Income (Expenses) |
|
|
|
|
||||
Other income (expenses) |
|
|
460,485 |
|
|
|
(21,533 |
) |
Total other income (expenses) |
|
|
460,485 |
|
|
|
(21,533 |
) |
|
|
|
|
|
||||
Loss from operations before income taxes |
|
|
(10,060,250 |
) |
|
|
(13,179,092 |
) |
|
|
|
|
|
||||
Provision for income taxes |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
||||
Net Loss |
|
$ |
(10,060,250 |
) |
|
$ |
(13,179,092 |
) |
|
|
|
|
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Net loss per share – basic and diluted |
|
$ |
(1.58 |
) |
|
$ |
(4.56 |
) |
|
|
|
|
|
||||
Weighted average common shares – basic and diluted |
|
|
6,363,759 |
|
|
|
2,891,292 |
|
ENDRA Life Sciences Inc.
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||||||||
|
|
Year Ended |
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Year Ended |
||||
|
|
December 31, |
|
December 31, |
||||
|
|
|
2023 |
|
|
|
2022 |
|
Cash Flows from Operating Activities |
|
|
|
|
||||
Net loss |
|
$ |
(10,060,250 |
) |
|
$ |
(13,179,092 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
||||
Depreciation and amortization |
|
|
123,726 |
|
|
|
96,661 |
|
Fixed assets write off |
|
|
24,868 |
|
|
|
1,391 |
|
Inventory reserve |
|
|
138,045 |
|
|
|
- |
|
Stock compensation expense including common stock issued for RSUs |
|
|
996,430 |
|
|
|
1,199,838 |
|
Amortization of right of use assets |
|
|
151,725 |
|
|
|
137,597 |
|
Changes in operating assets and liabilities: |
|
|
|
|
||||
Decrease in prepaid expenses |
|
|
167,360 |
|
|
|
355,128 |
|
Increase in inventory |
|
|
(116,193 |
) |
|
|
(1,360,139 |
) |
Decrease in accounts payable and accrued liabilities |
|
|
(822,258 |
) |
|
|
111,575 |
|
Decrease in lease liability |
|
|
(152,228 |
) |
|
|
(132,330 |
) |
Net cash used in operating activities |
|
|
(9,548,775 |
) |
|
|
(12,769,371 |
) |
|
|
|
|
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Cash Flows from Investing Activities |
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|
|
|
||||
Purchases of fixed assets |
|
|
(33,884 |
) |
|
|
(202,577 |
) |
Proceeds from sale of fixed assets |
|
|
9,163 |
|
|
|
- |
|
Net cash used in investing activities |
|
|
(24,721 |
) |
|
|
(202,577 |
) |
|
|
|
|
|
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Cash Flows from Financing Activities |
|
|
|
|
||||
Proceeds from issuance of common stock |
|
|
6,483,393 |
|
|
|
8,399,512 |
|
Proceeds from issuance of warrants |
|
|
20,053 |
|
|
|
- |
|
Proceeds from warrant exercise |
|
|
1,014,859 |
|
|
|
- |
|
Net cash provided by financing activities |
|
|
7,518,305 |
|
|
|
8,399,512 |
|
|
|
|
|
|
||||
Net decrease in cash |
|
|
(2,055,191 |
) |
|
|
(4,572,436 |
) |
|
|
|
|
|
||||
Cash, beginning of year |
|
|
4,889,098 |
|
|
|
9,461,534 |
|
|
|
|
|
|
||||
Cash, end of year |
|
$ |
2,833,907 |
|
|
$ |
4,889,098 |
|
|
|
|
|
|
||||
Supplemental disclosures of cash items |
|
|
|
|
||||
Interest paid |
|
$ |
44,985 |
|
|
$ |
59,113 |
|
Income tax paid |
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
||||
Supplemental disclosures of non-cash items |
|
|
|
|
||||
Stock dividend payable |
|
$ |
840 |
|
|
$ |
7,790 |
|
Right of use asset |
|
$ |
354,091 |
|
|
$ |
505,816 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240328043502/en/
Company Contact:
Irina Pestrikova
Senior Director, Finance
investors@endrainc.com
www.endrainc.com
Investor Relations Contact:
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
ybriggs@lhai.com
Source: ENDRA Life Sciences Inc.
FAQ
What did ENDRA report for Q4 2023?
What is the status of FDA's review of ENDRA's De Novo request?
Where did ENDRA showcase the TAEUS system?
How many additional patents did ENDRA obtain during Q4 2023?
What is the significance of the new ICD-10-CM code issued for improved NAFLD diagnostics?
What was the net loss in Q4 2023 compared to the same period in 2022?
What were the full-year 2023 financial results for ENDRA?
How much cash and cash equivalents did ENDRA have as of December 31, 2023?
