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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) March 31, 2025
ENDRA Life Sciences Inc. |
(Exact name of registrant as specified in its charter) |
Delaware |
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001-37969 |
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26-0579295 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
3600 Green Court, Suite 350 Ann Arbor, MI |
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48105 |
(Address of principal executive offices) |
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(Zip Code) |
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Registrant's telephone number, including area code |
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(734) 335-0468 |
______________________________________________
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common stock, par value $0.0001 per share |
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NDRA |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition
On March 31, 2025, ENDRA Life Sciences Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2024. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item 7.01 Regulation FD Disclosure
Additionally, on March 31, 2025, the Company issued a press release regarding the Company’s business strategy, which is being furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The information in Items 2.02 and 7.01 of this Current Report on Form 8-K and Exhibits 99.1 and 99.2 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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2 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ENDRA Life Sciences Inc. |
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March 31, 2025 |
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By: |
/s/ Richard Jacroux |
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Name: |
Richard Jacroux |
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Title: |
Chief Financial Officer |
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3 |
EXHIBIT 99.1
ENDRA Life Sciences Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides a Business Update
ANN ARBOR, Mich. (March 31, 2025) – ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo-Acoustic Enhanced UltraSound (TAEUS®), 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.
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| · | 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. |
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| · | 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. |
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| · | 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. |
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| · | 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. |
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| · | 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: |
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| o | 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; |
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| o | Defined ENDRA’s new mission, multi-generational product strategy and business model; |
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| o | Defined the new go-to-market strategy for the TAEUS Liver device; |
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| o | Defined and executed a business optimization, which yielded a significant reduction in monthly cash burn; and |
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| o | 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:
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| · | 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 |
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| · | 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®), 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 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 visitwww.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.
Company Contact:
Investor relations
investors@endrainc.com
www.endrainc.com
Investor Relations Contact:
Yvonne Briggs
Alliance Advisors IR
(310) 691-7100
ybriggs@allianceadvisors.com
[Financial Tables Follow]
ENDRA Life Sciences Inc.
Consolidated Balance Sheets
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| December 31, |
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| December 31, |
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| Assets |
| 2024 |
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| 2023 |
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| Current Assets |
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| Cash |
| $ | 3,229,480 |
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| $ | 2,833,907 |
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| Prepaid expenses |
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| 204,185 |
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| 198,905 |
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| Total Current Assets |
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| 3,433,665 |
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| 3,032,812 |
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| Non-Current Assets |
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| Inventory |
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| - |
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| 2,622,865 |
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| Fixed assets, net |
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| 69,281 |
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| 111,782 |
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| Right of use assets |
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| 578,013 |
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| 354,091 |
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| Prepaid expenses, long term |
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| 365,417 |
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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 |
| $ | 4,452,362 |
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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 |
| $ | 508,293 |
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| $ | 700,754 |
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| Lease liabilities, current portion |
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| 96,937 |
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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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| 605,230 |
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| 903,095 |
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| Long Term Debt |
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| Loans, long term |
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| - |
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| - |
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| Lease liabilities |
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| 487,482 |
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| 192,062 |
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| Warrant Liability |
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| 799,284 |
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| - |
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| Total Long Term Debt |
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| 1,286,766 |
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| 192,062 |
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| Total Liabilities |
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| 1,891,996 |
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| 1,095,157 |
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| Stockholders’ Equity |
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| Series A Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized; 17.488 and 141.397 shares issued and outstanding, respectively |
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| - |
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| 1 |
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| Series B Convertible Preferred Stock, $0.0001 par value; 1,000 shares authorized; no shares issued and outstanding |
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| - |
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| - |
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| Series C Convertible Preferred Stock, $0.0001 par value; 100,000 shares authorized; no shares issued and outstanding |
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| - |
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| - |
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| Common stock, $0.0001 par value; 20,000,000 shares authorized; 536,908 and 5,937 Shares issued and outstanding, respectively |
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| 53 |
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| 1 |
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| Additional paid in capital |
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| 105,998,412 |
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| 97,583,906 |
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| Stock payable |
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| - |
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| 5,233 |
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| Accumulated deficit |
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| (103,438,099 | ) |
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| (91,930,152 | ) |
| Total Stockholders’ Equity |
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| 2,560,366 |
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| 5,658,989 |
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| Total Liabilities and Stockholders’ Equity |
| $ | 4,452,362 |
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| $ | 6,754,146 |
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ENDRA Life Sciences Inc.
Consolidated Statements of Operations
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| Year Ended |
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| Year Ended |
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| December 31, |
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| December 31, |
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| 2024 |
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| 2023 |
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| Operating Expenses |
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| Research and development |
| $ | 3,190,293 |
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| $ | 5,003,695 |
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| Sales and marketing |
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| 571,040 |
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| 820,554 |
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| General and administrative |
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| 7,055,814 |
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| 4,696,486 |
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| Total operating expenses |
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| 10,817,147 |
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| 10,520,735 |
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| Operating loss |
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| (10,817,147 | ) |
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| (10,520,735 | ) |
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| Other (expenses) income |
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| Other income |
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| 108,484 |
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| 460,485 |
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| Warrant expense |
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| (7,323,685 | ) |
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| - |
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| Changes in fair value of warrant liability |
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| 3,447,737 |
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| - |
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| Gain on settlement of warrant exercise |
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| 3,076,664 |
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| - |
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| Total other expenses |
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| (690,800 | ) |
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| 460,485 |
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| Loss from operations before income taxes |
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| (11,507,947 | ) |
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| (10,060,250 | ) |
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| Provision for income taxes |
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| - |
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| - |
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| Net Loss |
| $ | (11,507,947 | ) |
| $ | (10,060,250 | ) |
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| Net loss per share – basic and diluted |
| $ | (56.94 | ) |
| $ | (2,766.85 | ) |
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| Weighted average common shares – basic and diluted |
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| 202,106 |
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| 3,636 |
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# # #
EXHIBIT 99.2
ENDRA Life Sciences Announces Enhanced Strategy to Enable the Early
Detection and Management of Metabolic Diseases Facilitated by Emerging
GLP-1 Therapies
Enhanced strategic focus for TAEUS addresses a large, unmet global need for a cost-effective tool for monitoring liver health at the point of patient care
ANN ARBOR, Mich. (March 31, 2025) – ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo-Acoustic Enhanced UltraSound (TAEUS®), today announced a new strategic direction to develop and deploy its TAEUS system 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 and other metabolic dysfunction-associated steatohepatitis (MASH) therapies.
ENDRA’s management has thoroughly evaluated the Company’s technical capabilities and go-to-market strategy for TAEUS Liver and determined that this new target market opportunity is far larger and more viable than its prior focus on hepatology and radiology markets, noting that metabolic diseases are an upstream phenomenon that lead to multiple risk factors including those specific to liver diseases. With this pivot toward metabolic health, ENDRA’s revised mission is to develop and market an accurate, simple-to-use, inexpensive, point-of-care test – essentially a “blood pressure cuff” – for the assessment and management of steatotic liver disease (SLD).
“SLD is on the rise and represents an enormous health burden that affects over two billion people globally and approximately one third of the U.S. population. As GLP-1 therapies continue to be embraced to treat metabolic risk factors such as obesity, type 2 diabetes and cardiovascular disease, there is an unmet need for a cost-effective, simple-to-use and accurate point-of-care test,” said Alexander Tokman, Chief Executive Officer of ENDRA. “We believe our TAEUS technology is uniquely positioned to fill this gap and meet the needs of providers, patients and payers. Our development efforts are now focused on refining TAEUS’ design for this use as we continue to collect crucial clinical data to support our future De Novo regulatory filing with the FDA.”
Highlights of this strategy include new target customer segments, enhanced TAEUS features to improve its adoption and a realignment of the business model, as described below:
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| · | Identified new target customer segments. As part of the revised market strategy, TAEUS Liver will target four markets: |
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| 1. | Pharmaceutical companies and clinical research organizations to assist in the efficient screening and monitoring of subjects for GLP-1 and related clinical trials; |
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| 2. | Concierge medical practices to assist in screening patients for obesity, diabetes, cardiovascular risk factors and liver disease, as well as monitoring responses to lifestyle changes and drug therapies; |
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| 3. | Bariatric and metabolic clinics for managing obesity, detecting metabolic disorders and monitoring responses to therapies; and |
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| 4. | Primary care and internal medicine practices to screen patients for metabolic diseases related to obesity, diabetes and hypertension, as well as cardiovascular risk factors, and to monitor responses to lifestyle changes and drug therapies. |
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| The Company anticipates that patients prescribed GLP-1 therapies will be managed primarily by these providers, rather than hepatologists. |
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| 1 |
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| · | Redefined and redesigning TAEUS Liver device to improve its scalability and adoption into new target markets. In order to meet market requirements as a biomarker solution, ENDRA will further TAEUS’ development to be more accurate, simpler to use and more ergonomic, as well as scalable and more cost effective. As a result, ENDRA’s management has developed a multi-generational product plan to include 1) new artificial intelligence features to improve accuracy, 2) full integration of thermo-acoustic and ultrasound technologies in a single device to simplify clinical workflow and reduce procedural time, and 3) a reduction in the device’s form factor and a decrease in manufacturing cost. All of these changes are deemed necessary for greater adoption of TAEUS Liver in the new target markets, and particularly in the very large primary care market segment. |
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| · | Introducing a subscription-based sales model. Once commercially available, ENDRA expects to offer TAEUS through a monthly subscription-based sales model with no upfront capital expenditures to reduce the barrier to entry and maximize customer uptake. ENDRA intends to deploy a small direct sales force that will leverage TAEUS’ value proposition as evidenced by clinical results from current and additional evaluation sites. |
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| · | Extend TAEUS applicability beyond liver health. To increase the value and versatility of TAEUS’ patented thermoacoustic technology, ENDRA will develop several additional high-value applications, following the development and commercialization of TAEUS for its initial indication to measure liver fat. These expanded applications include temperature monitoring for ablation therapies, vascular and tissue perfusion. |
SLD is often asymptomatic and not easily detectable at the early stages, and represents a global health crisis affecting over two billion people worldwide including more than 100 million in the U.S. Despite its prevalence and severe health implications, there remains a significant gap in dependable, affordable and easily accessible point-of-care tools to accurately detect and monitor liver fat. As the number of people with SLD continues to rise, its impact on public health and healthcare systems is becoming more evident, particularly as it is strongly linked to metabolic syndrome and a range of chronic conditions such as obesity, type 2 diabetes, cardiovascular disease and even liver cancer.
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 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 visitwww.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.
Company Contact:
Investor relations
investors@endrainc.com
www.endrainc.com
Investor Relations Contact:
Yvonne Briggs
Alliance Advisors IR
(310) 691-7100
ybriggs@allianceadvisors.com
# # #
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