ENDRA Life Sciences Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
Conference call begins at
Highlights from the fourth quarter of 2023 and recent weeks include:
-
Installed first
TAEUS system in theUK at King’sCollege 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'sTAEUS 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 theTAEUS 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 theU.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 theAmerican 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 theU.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 theTAEUS 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
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
Participants are encouraged to pre-register for the conference call using this link. Callers
A telephone replay will be available until
About
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
[Financial Tables Follow]
|
||||||||
|
|
|
|
|
||||
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 |
|
|
|
|
|
|
||||
Stockholders’ Equity |
|
|
|
|
||||
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 |
|
|
||||||||
|
|
Year Ended |
|
Year Ended |
||||
|
|
|
|
|
||||
|
|
|
2023 |
|
|
|
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 |
) |
|
|
|
|
|
||||
Net loss per share – basic and diluted |
|
$ |
(1.58 |
) |
|
$ |
(4.56 |
) |
|
|
|
|
|
||||
Weighted average common shares – basic and diluted |
|
|
6,363,759 |
|
|
|
2,891,292 |
|
|
||||||||
|
|
Year Ended |
|
Year Ended |
||||
|
|
|
|
|
||||
|
|
|
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 |
) |
|
|
|
|
|
||||
Cash Flows from Investing Activities |
|
|
|
|
||||
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 |
) |
|
|
|
|
|
||||
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:
LHA Investor Relations
(310) 691-7100
ybriggs@lhai.com
Source: