ENDRA Life Sciences Reports First Quarter 2024 Financial Results and Provides a Business Update
ENDRA Life Sciences (NASDAQ: NDRA) announced its Q1 2024 financial results, reporting a net loss of $2.8 million, or $0.26 per share, a slight improvement from a $2.9 million net loss in Q1 2023. Operating expenses decreased to $2.8 million from $2.9 million due to lower R&D costs. Cash and cash equivalents stood at $1.1 million as of March 31, 2024.
Key developments include the installation of the first TAEUS system in the UK at King’s College Hospital for clinical evaluation, aimed at assessing its liver fat measurement accuracy against MRI. The study will involve approximately 75 subjects. ENDRA is also advancing its FDA De Novo application for TAEUS, with a pre-submission meeting scheduled for Q2 2024. The company expanded its intellectual property portfolio, obtaining eight new patents in Europe and China, bringing the total to 80 issued patents globally. ENDRA is exploring licensing opportunities in non-core indications to enhance its IP portfolio value.
- Installed first TAEUS system at King's College Hospital for clinical evaluation.
- Scheduled Q2 2024 pre-submission meeting with FDA for De Novo application.
- Expanded intellectual property portfolio to 80 patents globally.
- Issued eight new patents in Q1 2024, including four in Europe and four in China.
- Net loss improvement from $2.9 million to $2.8 million year-over-year.
- Operating expenses decreased by $0.1 million due to lower R&D costs.
- Net loss remains high at $2.8 million for Q1 2024.
- Cash and cash equivalents are low at $1.1 million as of March 31, 2024.
Insights
ENDRA Life Sciences' financial results for Q1 2024 reveal an operating expense reduction to $2.8 million from $2.9 million in Q1 2023, mainly due to lower research and development costs. This reduction suggests tighter cost control strategies, which is positive in the short term. However, with a net loss of $2.8 million and minimal
The initial deployment of the TAEUS system at King’s College Hospital for clinical evaluation marks a significant progression for ENDRA in validating its technology. This study, involving 75 subjects, aims to compare the liver fat assessment accuracy of TAEUS with MRI, a well-established diagnostic tool. Success in this clinical evaluation could offer robust scientific validation and enhance market acceptance, aiding future regulatory approvals and commercial adoption. Nevertheless, until conclusive data is available, the impact on the stock remains speculative. Investors should closely monitor updates from this clinical evaluation for potential shifts in market sentiment.
ENDRA's ongoing interactions with the FDA and the submission of a comprehensive package indicating a structured approach towards the De Novo application for the TAEUS system is pivotal. The pre-submission meeting scheduled for Q2 2024 could be a turning point if alignment with the FDA is achieved. This step is important for paving the way towards regulatory approval which could significantly enhance the company's market position. However, the regulatory pathway is often fraught with uncertainties; hence, while the strategic steps are commendable, the outcome remains uncertain. Investors should be aware of the risks associated with regulatory delays and possible requirements for additional data.
Expanding the intellectual property portfolio to 80 patents, including eight recent additions in Europe and China, strategically strengthens ENDRA's competitive position. This expansion not only safeguards their TAEUS technology but also opens up potential licensing opportunities in non-core areas such as monitoring tissue temperature during surgeries. These licensing opportunities could provide additional revenue streams and leverage their existing technology. However, the ability to capitalize on these patents remains contingent on successfully negotiating favorable licensing agreements.
Conference call begins at 4:30 p.m. Eastern time today
Highlights from the first quarter of 2024 and recent weeks include:
-
Installed the 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. KCH will use ENDRA's TAEUS liver system in a clinical study to compare its liver fat assessment accuracy with MRI. This study is expected to include approximately 75 subjects and is intended to provide essential data to evaluate the TAEUS technology's performance. -
ENDRA is working closely with the
U.S. Food and Drug Administration (FDA) to achieve alignment on clinical requirements for our TAEUS system’s De Novo application. ENDRA has had several interactions with the agency since the fourth quarter of 2023 and provided additional information about its technology and historical clinical testing. To advance the review process and further align expectations, with the aim of ultimately achieving a successful regulatory outcome, ENDRA has submitted a comprehensive package for FDA consideration and scheduled an in-person pre-submission meeting during the second quarter of 2024 focusing on clinical requirements. -
Expanded intellectual property portfolio to 80 issued patents globally. During the first quarter of 2024 and in recent weeks ENDRA was issued eight additional patents, including four in
Europe and four inChina . The company is actively exploring licensing opportunities in non-core indications, such as monitoring tissue temperature during surgical procedures, to augment the value of its growing intellectual property portfolio.
"We look forward to the pre-submission meeting with the FDA with the aim of achieving alignment on the clinical study design and statistical analysis plan. We have been preparing diligently with multiple experts, including a biostatistician, and imaging and liver specialists, to ensure alignment with the FDA. Our pre-submission package included historical clinical performance data used to inform the proposed clinical study design, a statistically powered, prospective multicenter clinical trial,” said Francois Michelon, Chairman and Chief Executive Officer of ENDRA. "We remain committed to advancing TAEUS through the
First Quarter 2024 Financial Results
Operating expenses in the first quarter of 2024 were
Net loss in the first quarter of 2024 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 May 21, 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 1/40th 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. |
||||||||
Condensed Consolidated Balance Sheets |
||||||||
|
|
March 31, |
|
|
December 31, |
|
||
Assets |
|
2024 |
|
|
2023 |
|
||
Current Assets |
|
(unaudited) |
|
|
|
|
||
Cash |
|
$ |
1,134,701 |
|
|
$ |
2,833,907 |
|
Prepaid expenses |
|
|
135,821 |
|
|
|
198,905 |
|
Total Current Assets |
|
|
1,270,522 |
|
|
|
3,032,812 |
|
Non-Current Assets |
|
|
|
|
|
|
|
|
Inventory |
|
|
2,711,923 |
|
|
|
2,622,865 |
|
Fixed assets, net |
|
|
111,470 |
|
|
|
111,782 |
|
Right of use assets |
|
|
313,715 |
|
|
|
354,091 |
|
Prepaid expenses, long term |
|
|
647,085 |
|
|
|
626,610 |
|
Other assets |
|
|
5,986 |
|
|
|
5,986 |
|
Total Assets |
|
$ |
5,060,701 |
|
|
$ |
6,754,146 |
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
1,038,465 |
|
|
$ |
700,754 |
|
Lease liabilities, current portion |
|
|
178,239 |
|
|
|
173,857 |
|
Loans |
|
|
- |
|
|
|
28,484 |
|
Total Current Liabilities |
|
|
1,216,704 |
|
|
|
903,095 |
|
|
|
|
|
|
|
|
|
|
Long Term Debt |
|
|
|
|
|
|
|
|
Loans, long term |
|
|
- |
|
|
|
- |
|
Lease liabilities |
|
|
145,825 |
|
|
|
192,062 |
|
Total Long Term Debt |
|
|
145,825 |
|
|
|
192,062 |
|
|
|
|
|
|
|
|
|
|
Total Liabilities |
|
|
1,362,529 |
|
|
|
1,095,157 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Series A Convertible Preferred Stock, |
|
|
- |
|
|
|
1 |
|
Series B Convertible Preferred Stock, |
|
|
- |
|
|
|
- |
|
Series C Convertible Preferred Stock, |
|
|
- |
|
|
|
- |
|
Common stock, |
|
|
1,092 |
|
|
|
1,039 |
|
Additional paid in capital |
|
|
98,402,631 |
|
|
|
97,582,868 |
|
Stock payable |
|
|
301 |
|
|
|
5,233 |
|
Accumulated deficit |
|
|
(94,705,852 |
) |
|
|
(91,930,152 |
) |
Total Stockholders’ Equity |
|
|
3,698,172 |
|
|
|
5,658,989 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
5,060,701 |
|
|
$ |
6,754,146 |
|
ENDRA Life Sciences Inc. |
||||||||
Condensed Consolidated Statements of Operations |
||||||||
|
|
Three Months Ended |
|
|
Three Months Ended |
|
||
|
|
March 31, |
|
|
March 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Operating Expenses |
|
|
|
|
|
|
||
Research and development |
|
$ |
1,041,526 |
|
|
$ |
1,391,314 |
|
Sales and marketing |
|
|
238,660 |
|
|
|
181,616 |
|
General and administrative |
|
|
1,500,355 |
|
|
|
1,366,398 |
|
Total operating expenses |
|
|
2,780,541 |
|
|
|
2,939,328 |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(2,780,541 |
) |
|
|
(2,939,328 |
) |
|
|
|
|
|
|
|
|
|
Other Expenses |
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
4,841 |
|
|
|
(3,418 |
) |
Total other expenses |
|
|
4,841 |
|
|
|
(3,418 |
) |
|
|
|
|
|
|
|
|
|
Loss from operations before income taxes |
|
|
(2,775,700 |
) |
|
|
(2,942,746 |
) |
|
|
|
|
|
|
|
|
|
Provision for income taxes |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(2,775,700 |
) |
|
$ |
(2,942,746 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share – basic and diluted |
|
$ |
(0.26 |
) |
|
$ |
(0.93 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares – basic and diluted |
|
|
10,804,625 |
|
|
|
3,169,103 |
|
ENDRA Life Sciences Inc. |
||||||||
Condensed Consolidated Statements of Cash Flows |
||||||||
|
|
Three Months Ended |
|
|
Three Months Ended |
|
||
|
|
March 31, |
|
|
March 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
Cash Flows from Operating Activities |
|
|
|
|
|
|
||
Net loss |
|
$ |
(2,775,700 |
) |
|
$ |
(2,942,746 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
15,300 |
|
|
|
34,516 |
|
Fixed assets write off |
|
|
8,808 |
|
|
|
- |
|
Inventory reserve |
|
|
142,733 |
|
|
|
- |
|
Stock compensation expense |
|
|
317,497 |
|
|
|
237,279 |
|
Amortization of right of use assets |
|
|
40,376 |
|
|
|
36,526 |
|
Gain on extinguishment of debt |
|
|
- |
|
|
|
- |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Decrease in prepaid expenses |
|
|
42,609 |
|
|
|
132,002 |
|
Increase in inventory |
|
|
(231,791 |
) |
|
|
(90,632 |
) |
Increase in accounts payable and accrued liabilities |
|
|
337,711 |
|
|
|
122,737 |
|
Decrease in lease liability |
|
|
(41,855 |
) |
|
|
(36,529 |
) |
Net cash used in operating activities |
|
|
(2,144,312 |
) |
|
|
(2,506,847 |
) |
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities |
|
|
|
|
|
|
|
|
Purchases of fixed assets |
|
|
(27,000 |
) |
|
|
(27,000 |
) |
Proceeds from sale of fixed assets |
|
|
3,204 |
|
|
|
- |
|
Net cash used in investing activities |
|
|
(23,796 |
) |
|
|
(27,000 |
) |
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities |
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
419,967 |
|
|
|
- |
|
Proceeds from warrant exercise |
|
|
77,419 |
|
|
|
- |
|
Repayment of loan |
|
|
(28,484 |
) |
|
|
- |
|
Net cash provided by financing activities |
|
|
468,902 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Net decrease in cash |
|
|
(1,699,206 |
) |
|
|
(2,533,847 |
) |
|
|
|
|
|
|
|
|
|
Cash, beginning of period |
|
|
2,833,907 |
|
|
|
4,889,098 |
|
|
|
|
|
|
|
|
|
|
Cash, end of period |
|
$ |
1,134,701 |
|
|
$ |
2,355,251 |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash items |
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
8,801 |
|
|
$ |
- |
|
Income tax paid |
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of non-cash items |
|
|
|
|
|
|
|
|
Stock dividend payable |
|
$ |
(4,932 |
) |
|
$ |
(2,381 |
) |
Right of use asset |
|
$ |
313,715 |
|
|
$ |
469,290 |
|
Lease liability |
|
$ |
324,064 |
|
|
$ |
481,618 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240514975110/en/
Company:
Irina Pestrikova
Senior Director, Finance
investors@endrainc.com
www.endrainc.com
Investor Relations:
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
ybriggs@lhai.com
Source: ENDRA Life Sciences Inc.
FAQ
What were ENDRA Life Sciences' financial results for Q1 2024?
How did ENDRA Life Sciences' net loss in Q1 2024 compare to Q1 2023?
What are ENDRA Life Sciences' cash and cash equivalents as of March 31, 2024?
Where was the first TAEUS system installed for clinical evaluation?
What is the objective of the clinical study at King’s College Hospital?
How many patents does ENDRA Life Sciences hold globally as of Q1 2024?
What is the focus of ENDRA Life Sciences' pre-submission meeting with the FDA in Q2 2024?
What are some non-core indications ENDRA Life Sciences is exploring for licensing opportunities?
