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Expanded the intellectual property portfolio to 82 issued patents globally. During the third quarter of 2024, ENDRA was issued a new patent in Europe. ENDRA’s broad intellectual property portfolio provides protection for the TAEUS system with its novel thermoacoustic technology and the ability to explore licensing opportunities in areas outside its initial indications of use.
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Significantly reduced operating expenses and improved efficiencies. Management implemented cost-cutting initiatives, as well as refocused resources to its clinical and regulatory activities to support the future submission of the TAEUS De Novo request. As a result of the restructuring, ENDRA realized $3.1 million in annualized savings and reduced year-over-year expenses for the quarter by 54%, primarily coming from general and administrative reductions.
"We are laser focused on securing the clinical data necessary to support a new De Novo regulatory filing with the FDA - above all other initiatives - and are encouraged by the subject recruitment progress at our pilot clinical evaluation sites," said Alexander Tokman, acting Chief Executive Officer of ENDRA. "In parallel, we are making significant progress with our go-to-market strategy for TAEUS to ensure we are prioritizing the most promising verticals, setting our longer-term vision and business strategy, while significantly reducing operating expenses to extend our cash runway."
Third Quarter 2024 Financial Results
Operating expenses in the third quarter of 2024 were down 52% to $1.5 million compared with $3.1 million in the third quarter in 2023, and down 32% compared with the second quarter of 2024. The decrease from prior year was primarily due to a reduction in general and administrative spending. Included in this reduction are bonus adjustments and a decrease in stock-based compensation expense, which were the result of the restructuring. These non-cash items reduced total operating expenses by $410,000 and are not expected to recur.
Net loss in the third quarter of 2024 was $2.4 million, compared with a net loss of $3.1 million in the third quarter of 2023. However, the third quarter 2024 loss included a net non-cash charge of $911,000 related to warrants in the Company’s last financing.
Cash and cash equivalents were $4.7 million as of September 30, 2024.
Future Conference Calls
Going forward, management intends to hold periodic business update calls to discuss recent events with shareholders and answer questions. These calls typically will be catalyzed by major events including regulatory, clinical and commercial developments.
About ENDRA Life Sciences Inc.
ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS?), 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? is initially focused on the measurement of fat in the liver as a means to assess and monitor steatotic liver disease (SLD) and metabolic dysfunction-associated steatohepatitis (MASH), 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 regain 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. Condensed Consolidated Balance Sheets |
| | | |
| | September 30, | December 31, |
| Assets | 2024 | 2023 |
| Current Assets | (Unaudited) | |
| Cash | $ | 4,745,187 | | $ | 2,833,907 | |
| Prepaid expenses | | 217,120 | | | 198,905 | |
| Total Current Assets | | 4,962,307 | | | 3,032,812 | |
| Non-Current Assets | | |
| Inventory | | 2,711,923 | | | 2,622,865 | |
| Fixed assets, net | | 80,281 | | | 111,782 | |
| Right of use assets | | 229,771 | | | 354,091 | |
| Prepaid expenses, long term | | 388,842 | | | 626,610 | |
| Other assets | | 5,986 | | | 5,986 | |
| Total Assets | $ | 8,379,110 | | $ | 6,754,146 | |
| | | |
| Liabilities and Stockholders’ Equity | | |
| Current Liabilities | | |
| Accounts payable and accrued liabilities | $ | 626,706 | | $ | 700,754 | |
| Lease liabilities, current portion | | 187,339 | | | 173,857 | |
| Loans | | - | | | 28,484 | |
| Total Current Liabilities | | 814,045 | | | 903,095 | |
| | | |
| Long Term Debt | | |
| Lease liabilities | | 49,823 | | | 192,062 | |
| Warranty Liability | | 910,556 | | | - | |
| Total Long Term Debt | | 960,379 | | | 192,062 | |
| | | |
| Total Liabilities | | 1,774,424 | | | 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; 522,005 and 5,937 shares issued and outstanding, respectively | | 52 | | | 1 | |
| Additional paid in capital | | 105,893,728 | | | 97,583,906 | |
| Stock payable | | 1 | | | 5,233 | |
| Accumulated deficit | | (99,289,095 | ) | | (91,930,152 | ) |
| Total Stockholders’ Equity | | 6,604,686 | | | 5,658,989 | |
| Total Liabilities and Stockholders’ Equity | $ | 8,379,110 | | $ | 6,754,146 | |
| | | | | |
| ENDRA Life Sciences Inc. Condensed Consolidated Statements of Operations (Unaudited) |
| | | | | |
| | Three Months
Ended | Three Months
Ended | Nine Months
Ended | Nine Months
Ended |
| | September 30, | September 30, | September 30, | September 30, |
| | | 2024 | | | 2023 | | | 2024 | | | 2023 | |
| Operating Expenses | | | | |
| Research and development | $ | 794,444 | | $ | 1,632,849 | | $ | 2,552,336 | | $ | 4,424,345 | |
| Sales and marketing | | 83,157 | | | 243,332 | | | 484,769 | | | 672,721 | |
| General and administrative | | 631,413 | | | 1,252,881 | | | 3,483,303 | | | 3,965,889 | |
| Total operating expenses | | 1,509,014 | | | 3,129,062 | | | 6,520,408 | | | 9,062,955 | |
| | | | | |
| Operating loss | | (1,509,014 | ) | | (3,129,062 | ) | | (6,520,408 | ) | | (9,062,955 | ) |
| | | | | |
| Other Expenses | | | | |
| Other income (expense) | | 65,528 | | | 28,226 | | | 72,069 | | | 462,241 | |
| Warrant expenses | | (7,323,685 | ) | | | (7,323,685 | ) | |
| Changes in fair value of warrant liability | | 6,413,081 | | | | 6,413,081 | | |
| Total other expenses | | (845,076 | ) | | 28,226 | | | (838,535 | ) | | 462,241 | |
| | | | | |
| Loss from operations before income taxes | | (2,354,090 | ) | | (3,100,836 | ) | | (7,538,943 | ) | | (8,600,714 | ) |
| | | | | |
| Provision for income taxes | | - | | | - | | | - | | | - | |
| | | | | |
| Net Loss | $ | (2,354,090 | ) | $ | (3,100,836 | ) | $ | (7,538,943 | ) | $ | (8,600,714 | ) |
| | | | | |
| Net loss per share – basic and diluted | $ | (9.54 | ) | $ | (706.20 | ) | $ | (82.14 | ) | $ | (2,672.98 | ) |
| | | | | |
| Weighted average common shares – basic and diluted | | 246,816 | | | 4,391 | | | 89,592 | | | 3,218 | |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241115971092/en/
Contacts
Company Contact:
Richard Jacroux
Chief Financial Officer
[email protected]
www.endrainc.com
Investor Relations Contact:
Yvonne Briggs
Alliance Advisors IR
(310) 691-7100
[email protected]