ENDRA Life Sciences Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides a Business Update
ANN ARBOR, Mich.--(BUSINESS WIRE)--March 31, 2025--
ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo-Acoustic Enhanced UltraSound (TAEUS$(R)$ ), 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(R) ), 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(R) 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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CONTACT: Company Contact:
Investor relations
investors@endrainc.com
www.endrainc.com
Investor Relations Contact:
Yvonne Briggs
Alliance Advisors IR
(310) 691-7100
ybriggs@allianceadvisors.com
(END) Dow Jones Newswires
March 31, 2025 08:00 ET (12:00 GMT)
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