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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) November 14, 2023
ENDRA LIFE SCIENCES INC. |
(Exact name of registrant as specified in its charter) |
Delaware |
|
001-37969 |
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26-0579295 |
(State or other jurisdiction of incorporation) |
|
(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 |
Trading Symbol(s) |
Name of each exchange on which registered |
Common stock, par value $0.0001 per share |
NDRA |
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 November 14, 2023, ENDRA Life Sciences Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2023. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 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 (the “Securities Act”) 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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November 14, 2023 |
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By: |
/s/ Francois Michelon |
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Name: |
Francois Michelon |
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Title: |
President and Chief Executive Officer |
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3 |
EXHIBIT 99.1
ENDRA Life Sciences Reports Third Quarter 2023 Financial Results and
Provides Business Update
Conference call begins at 4:30 p.m. Eastern time today
ANN ARBOR, Mich. (November 14, 2023) – ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reports financial results for the three and nine months ended September 30, 2023 and provides a business update. Highlights from the third quarter of 2023 and recent weeks include:
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| · | Shared positive TAEUS clinical data at the Steatotic Liver Disease Summit™ 2023 hosted by the European Association for the Study of the Liver. The company shared positive study findings in its second peer-reviewed clinical abstract, titled "Thermoacoustic assessment of fatty liver disease - a clinical feasibility study.” The results included 45 patient scans comparing TAEUS liver fat fraction estimates to MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction), which is the current gold standard for clinical measurement of liver fat fraction. The study data yielded sensitivity of 95%, specificity of 77% and negative predictive value (NPV) of 0.95. TAEUS estimates of liver fat fraction were strongly correlated to MRI-PDFF scores with a Pearson correlation coefficient of r=0.87. |
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| · | Showcased the TAEUS system at major hepatology, endocrinology and radiology clinical conferences in the U.S. and Europe. The ENDRA team met with prospective customers, industry leaders and key partners at five major clinical conferences, including most recently The Liver Meeting by the American 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-Associated Steatotic Liver Disease (MASLD). The commercial team continued to generate awareness for the TAEUS system by participating in eight industry conferences year-to-date. |
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| · | Achieved an intellectual property milestone with 70 issued patents globally. During the third quarter of 2023 and recent weeks, ENDRA was issued six additional patents, including two in the U.S., two in Europe and two in China. The company is actively exploring licensing opportunities in non-core indications to augment the value of its growing intellectual property portfolio. |
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| · | ENDRA's De Novo request advanced to the next stage of review at the U.S. Food and Drug Administration (FDA). On August 14, 2023, ENDRA submitted a De Novo request for its TAEUS liver system to the FDA and two weeks later the FDA informed ENDRA that its submission was entering the substantive review period. The De Novo pathway provides a means to classify novel medical devices for which there is no legally marketed predicate device and if granted, will strengthen TAEUS’ competitive position with its distinctive, patent-protected capabilities as a non-invasive point-of-care tool to aid in the characterization of Non-Alcoholic Fatty Liver Disease (NAFLD). |
"We are confident in the progress of our TAEUS system's De Novo submission, now in substantive review with the FDA. We look forward to ongoing collaboration with the Agency with the goal of achieving a favorable regulatory decision. In Europe, our growing body of clinical data is boosting commercial efforts, and we are on track to secure the first commercial orders for our technology in the near-term,” said Francois Michelon, Chairman and Chief Executive Officer of ENDRA. "As treatments for steatotic liver disease advance toward potential FDA approval in early 2024, the need for and importance of ENDRA’s non-invasive TAEUS system to assess liver fat becomes increasingly clear.”
Third Quarter 2023 Financial Results
Operating expenses in the third quarter of 2023 were $3.1 million, compared with $3.4 million in the third quarter in 2022. The decrease was mainly due to lower research and development and sales and marketing expenses.
Net loss in the third quarter of 2023 was $3.1 million, or $0.40 per share, compared with a net loss of $3.4 million, or $1.09 per share, in the third quarter of 2022.
Cash and cash equivalents were $3.3 million as of September 30, 2023. In the third quarter, the company raised $1.2 million in gross proceeds from the sale of common stock through its at-the-market (ATM) equity facility.
Conference Call and Webcast
Management will host a conference call and webcast today at 4:30 p.m. Eastern time to discuss these results, provide an update on recent corporate developments and answer questions.
Participants are encouraged to pre-register for the conference call using this link. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing (844) 868-8846 (U.S.) or (412) 317-5465 (International). A webcast of the call can also be accessed at ENDRA’s Investor Relations page and here.
A telephone replay will be available until November 21, 2023 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 4969138. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.
About ENDRA Life Sciences Inc.
ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology which characterizes tissue similar to an MRI, but at 1/50th the cost and at the point of patient care. TAEUS® is designed to work in concert with the more than 700,000 ultrasound systems in use globally today. TAEUS® is initially focused on the measurement of fat in the liver as a means to assess and monitor steatotic liver disease (SLD) (formerly known as NAFLD-NASH), a chronic liver disease spectrum that affects over two billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS®, including visualization of tissue temperature during energy-based surgical procedures. 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: estimates of the timing of future events and anticipated results of our development efforts, including the timing of submission for and receipt of required regulatory approvals and product launches; 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; the impact of COVID-19 on ENDRA’s business plans; the ability to find and maintain development partners; 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:
Irina Pestrikova
Senior Director, Finance
investors@endrainc.com
www.endrainc.com
Investor Relations Contact:
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
ybriggs@lhai.com
[Financial Tables Follow]
ENDRA Life Sciences Inc.
Condensed Consolidated Balance Sheets
|
|
| September 30, |
|
| December 31, |
|
||
| Assets |
| 2023 |
|
| 2022 |
|
||
| Current Assets |
| (Unaudited) |
|
|
|
|
||
| Cash |
| $ | 3,334,536 |
|
| $ | 4,889,098 |
|
| Prepaid expenses |
|
| 305,885 |
|
|
| 490,299 |
|
| Inventory |
|
| 2,757,633 |
|
|
| 2,644,717 |
|
| Total Current Assets |
|
| 6,398,054 |
|
|
| 8,024,114 |
|
| Non-Current Assets |
|
|
|
|
|
|
|
|
| Fixed assets, net |
|
| 160,816 |
|
|
| 235,655 |
|
| Right of use assets |
|
| 393,451 |
|
|
| 505,816 |
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| Prepaid expenses, long term |
|
| 644,610 |
|
|
| 502,576 |
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| Other assets |
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| 5,986 |
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|
| 5,986 |
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| Total Assets |
| $ | 7,602,917 |
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| $ | 9,274,147 |
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| Liabilities and Stockholders’ Equity |
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| Current Liabilities |
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| Accounts payable and accrued liabilities |
| $ | 1,972,362 |
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| $ | 1,523,012 |
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| Lease liabilities, current portion |
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| 168,610 |
|
|
| 152,228 |
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| Loans |
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| 28,484 |
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|
| 28,484 |
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| Total Current Liabilities |
|
| 2,169,456 |
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|
| 1,703,724 |
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| Lease liabilities, non-current |
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| 237,163 |
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| 365,919 |
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| Total Long Term Liabilities |
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| 237,163 |
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| 365,919 |
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| Total Liabilities |
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| 2,406,619 |
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| 2,069,643 |
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| Stockholders’ Equity |
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| Series A Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized; 141.397 shares issued and outstanding |
|
| 1 |
|
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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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| Series C Convertible Preferred Stock, $0.0001 par value; 100,000 shares authorized; no shares issued and outstanding |
|
| - |
|
|
| - |
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| Common stock, $0.0001 par value; 80,000,000 shares authorized; 8,411,777 and 3,169,103 shares issued and outstanding, respectively |
|
| 841 |
|
|
| 317 |
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| Additional paid in capital |
|
| 95,664,011 |
|
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| 89,068,015 |
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| Stock payable |
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| 2,061 |
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| 6,073 |
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| Accumulated deficit |
|
| (90,470,616 | ) |
|
| (81,869,902 | ) |
| Total Stockholders’ Equity |
|
| 5,196,298 |
|
|
| 7,204,504 |
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| Total Liabilities and Stockholders’ Equity |
| $ | 7,602,917 |
|
| $ | 9,274,147 |
|
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
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| Three Months Ended |
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| Three Months Ended |
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| Nine Months Ended |
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| Nine Months Ended |
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| September 30, |
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| September 30, |
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| September 30, |
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| September 30, |
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| 2023 |
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| 2022 |
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| 2023 |
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| 2022 |
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| Operating Expenses |
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| Research and development |
| $ | 1,632,849 |
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| $ | 1,830,297 |
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| $ | 4,424,345 |
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| $ | 4,890,879 |
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| Sales and marketing |
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| 243,332 |
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| 420,439 |
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| 672,721 |
|
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| 1,102,381 |
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| General and administrative |
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| 1,252,881 |
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| 1,166,480 |
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| 3,965,889 |
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| 3,850,918 |
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| Total operating expenses |
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| 3,129,062 |
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| 3,417,216 |
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| 9,062,955 |
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| 9,844,178 |
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| Operating loss |
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| (3,129,062 | ) |
|
| (3,417,216 | ) |
|
| (9,062,955 | ) |
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| (9,844,178 | ) |
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| Other Expenses |
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| Other income (expense) |
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| 28,226 |
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| (23,011 | ) |
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| 462,241 |
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| (45,318 | ) |
| Total other expenses |
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| 28,226 |
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|
| (23,011 | ) |
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| 462,241 |
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|
| (45,318 | ) |
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| Loss from operations before income taxes |
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| (3,100,836 | ) |
|
| (3,440,227 | ) |
|
| (8,600,714 | ) |
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| (9,889,496 | ) |
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| Provision for income taxes |
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| - |
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| - |
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| - |
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| - |
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| Net Loss |
| $ | (3,100,836 | ) |
| $ | (3,440,227 | ) |
| $ | (8,600,714 | ) |
| $ | (9,889,496 | ) |
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| Net loss per share – basic and diluted |
| $ | (0.40 | ) |
| $ | (1.09 | ) |
| $ | (1.53 | ) |
| $ | (3.53 | ) |
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| Weighted average common shares – basic and diluted |
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| 7,683,997 |
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| 3,158,723 |
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| 5,630,888 |
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| 2,800,811 |
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ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
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| Nine Months Ended |
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| Nine Months Ended |
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| September 30, |
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| September 30, |
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| 2023 |
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| 2022 |
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| Cash Flows from Operating Activities |
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| Net loss |
| $ | (8,600,714 | ) |
| $ | (9,889,496 | ) |
| Adjustments to reconcile net loss to net cash used in operating activities: |
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| Depreciation and amortization |
|
| 101,839 |
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| 64,532 |
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| Stock compensation expense including common stock issued for RSUs |
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| 745,873 |
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| 909,069 |
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| Amortization of right of use assets |
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| 112,365 |
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| 101,957 |
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| Changes in operating assets and liabilities: |
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| Decrease in prepaid expenses |
|
| 42,380 |
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| 433,742 |
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| Increase in inventory |
|
| (112,916 | ) |
|
| (1,349,499 | ) |
| Increase in accounts payable and accrued liabilities |
|
| 449,350 |
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| 146,660 |
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| Decrease in lease liability |
|
| (112,374 | ) |
|
| (97,647 | ) |
| Net cash used in operating activities |
|
| (7,374,197 | ) |
|
| (9,680,682 | ) |
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| Cash Flows from Investing Activities |
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| Purchases of fixed assets |
|
| (27,000 | ) |
|
| (164,014 | ) |
| Net cash used in investing activities |
|
| (27,000 | ) |
|
| (164,014 | ) |
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| Cash Flows from Financing Activities |
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| Proceeds from issuance of common stock, net |
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| 5,826,582 |
|
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| 8,399,512 |
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| Proceeds from issuance of warrants, net |
|
| 20,053 |
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|
| - |
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| Net cash provided by financing activities |
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| 5,846,635 |
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| 8,399,512 |
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|
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|
|
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| Net decrease in cash |
|
| (1,554,562 | ) |
|
| (1,445,184 | ) |
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| Cash, beginning of period |
|
| 4,889,098 |
|
|
| 9,461,534 |
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| Cash, end of period |
| $ | 3,334,536 |
|
| $ | 8,016,350 |
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| Supplemental disclosures of cash items |
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| Interest paid |
| $ | - |
|
| $ | - |
|
| Income tax paid |
| $ | - |
|
| $ | - |
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|
|
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| Supplemental disclosures of non-cash items |
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| Stock dividend payable |
| $ | (4,012 | ) |
| $ | (5,373 | ) |
| Right of use asset |
| $ | 393,451 |
|
| $ | 541,456 |
|
| Lease liability |
| $ | 405,773 |
|
| $ | 552,830 |
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# # #