ENDRA Life Sciences Reports Second Quarter 2024 Financial Results and Provides a Business Update
Conference call begins at
New executive team
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Subsequent to quarter-end, ENDRA announced leadership changes. Board member
Alexander Tokman was appointed as acting CEO, bringing 24+ years of global commercial leadership experience. Additionally, two industry veterans joined in key roles including regulatory and clinical affairs, and finance.Richard Jacroux , new Chief Financial Officer, has over 20 years of experience in financial management and accounting and has held the role of CFO at several technology companies.Ziad Rouag , Head of Regulatory and Clinical Affairs, brings to ENDRA more than two decades of experience in the medical device industry as a leader of clinical operations and regulatory affairs for emerging startups and high-growth businesses.
Focus on clinical and regulatory activities
-
Advanced the
U.S. regulatory process. ENDRA met with theU.S. Food and Drug Administration (FDA) at their headquarters inMaryland to demonstrate theTAEUS technology and review the clinical and statistical plans. The meeting minutes confirmed alignment on the topics discussed and the steps required for a successful regulatory outcome. To drive the process forward, ENDRA has hiredMr. Rouag , an experienced regulatory and clinical leader. -
Started new pilot clinical trials. New pilot trials were initiated at two clinical sites in
North America and one is expected to commence inEurope to generate data that supportTAEUS' value to clinical users. ENDRA will use the data from these sites to demonstrate theTAEUS system’s performance to the FDA before initiating the De Novo pivotal study. -
Expanded the intellectual property portfolio, now with 81 issued patents globally. During the second quarter of 2024, ENDRA was issued five additional patents, including three in
Europe and two inChina . ENDRA’s broad intellectual property portfolio provides protection for theTAEUS system with its novel thermoacoustic technology and the opportunity to explore licensing opportunities for indications beyond its core focus.
Raised capital and significantly reduced operating expenses
-
Raised
$8.0 million in a public offering. The company raised approximately$8.0 million in gross proceeds from the sale of common stock and warrants in a public offering. -
Significantly reduced operating expenses. As part of focusing resources on clinical and regulatory activities, ENDRA restructured operations, reducing annualized expenses by
$3.1 million compared with the prior-year second quarter.
“In the near-term, the company is prioritizing securing the clinical data to support a new De Novo regulatory filing with the FDA above all other goals,” said
Second Quarter 2024 Financial Results
Operating expenses in the second quarter of 2024 were
Cash and cash equivalents were
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About
Forward-Looking Statements
All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of terms such as “approximate,” "anticipate," “attempt,” "believe," "could," "estimate," "expect," “forecast,” “future,” "goal," “hope,” "intend," "may," "plan," “possible,” “potential,” “project,” "seek," "should," "will," “would,” or other comparable terms (including the negative of any of the foregoing), although some forward-looking statements are expressed differently. Examples of forward-looking statements for ENDRA include, among others: expectations with respect to FDA requirements regarding its clinical trials and de novo submission for its
[Financial Tables Follow]
Condensed Consolidated Balance Sheets |
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Assets |
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2024 |
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2023 |
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Current Assets |
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(Unaudited) |
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Cash |
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$ |
6,400,732 |
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$ |
2,833,907 |
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Prepaid expenses |
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|
312,742 |
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|
198,905 |
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Total Current Assets |
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6,713,474 |
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3,032,812 |
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Non-Current Assets |
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Inventory |
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2,711,923 |
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2,622,865 |
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Fixed assets, net |
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91,777 |
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|
111,782 |
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Right of use assets |
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|
272,284 |
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|
354,091 |
|
Prepaid expenses, long term |
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|
647,085 |
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|
|
626,610 |
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Other assets |
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|
5,986 |
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|
|
5,986 |
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Total Assets |
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$ |
10,442,529 |
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$ |
6,754,146 |
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Liabilities and Stockholders’ Equity |
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Current Liabilities |
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Accounts payable and accrued liabilities |
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$ |
1,167,434 |
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$ |
700,754 |
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Lease liabilities, current portion |
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|
182,733 |
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173,857 |
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Loans |
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- |
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28,484 |
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Total Current Liabilities |
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1,350,167 |
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903,095 |
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Long Term Debt |
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Lease liabilities |
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98,421 |
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192,062 |
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Total Long Term Debt |
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98,421 |
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192,062 |
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Total Liabilities |
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1,448,588 |
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1,095,157 |
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Stockholders’ Equity |
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Series A Convertible Preferred Stock, |
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- |
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1 |
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Series B Convertible Preferred Stock, |
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- |
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- |
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Series C Convertible Preferred Stock, |
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|
- |
|
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- |
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Common stock, |
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7,244 |
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|
|
1,039 |
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Additional paid in capital |
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|
105,921,675 |
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|
97,582,868 |
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Stock payable |
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|
27 |
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5,233 |
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Accumulated deficit |
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|
(96,935,005 |
) |
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(91,930,152 |
) |
Total Stockholders’ Equity |
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8,993,941 |
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5,658,989 |
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Total Liabilities and Stockholders’ Equity |
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$ |
10,442,529 |
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$ |
6,754,146 |
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Condensed Consolidated Statements of Operations (Unaudited) |
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Three Months Ended |
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Three Months Ended |
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Six Months Ended |
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Six Months Ended |
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2024 |
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2023 |
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|
2024 |
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2023 |
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Operating Expenses |
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Research and development |
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$ |
716,366 |
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$ |
1,400,182 |
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$ |
1,757,892 |
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$ |
2,791,496 |
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Sales and marketing |
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|
162,952 |
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|
247,773 |
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401,612 |
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|
429,389 |
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General and administrative |
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1,351,535 |
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1,346,610 |
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2,851,890 |
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2,713,008 |
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Total operating expenses |
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2,230,853 |
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2,994,565 |
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5,011,394 |
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5,933,893 |
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Operating loss |
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(2,230,853 |
) |
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|
(2,994,565 |
) |
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|
(5,011,394 |
) |
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|
(5,933,893 |
) |
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Other Income |
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Other income |
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1,700 |
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|
437,433 |
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|
6,541 |
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|
434,015 |
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Total other income |
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|
1,700 |
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|
437,433 |
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|
6,541 |
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|
434,015 |
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Loss from operations before income taxes |
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(2,229,153 |
) |
|
|
(2,557,132 |
) |
|
|
(5,004,853 |
) |
|
|
(5,499,878 |
) |
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Provision for income taxes |
|
|
- |
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- |
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- |
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- |
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Net Loss |
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$ |
(2,229,153 |
) |
|
$ |
(2,557,132 |
) |
|
$ |
(5,004,853 |
) |
|
$ |
(5,499,878 |
) |
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Net loss per share – basic and diluted |
|
$ |
(0.08 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.26 |
) |
|
$ |
(1.20 |
) |
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Weighted average common shares – basic and diluted |
|
|
27,283,009 |
|
|
|
5,996,186 |
|
|
|
18,998,902 |
|
|
|
4,582,645 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240822003939/en/
Company:
Chief Financial Officer
investors@endrainc.com
www.endrainc.com
Investor Relations:
LHA Investor Relations
(310) 691-7100
ybriggs@lhai.com
Source: