Conference call begins at 4:30 p.m. Eastern time today

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:

  • 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.
  • 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.
  • 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.
  • 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.

[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

 

Prepaid expenses, long term

 

 

644,610

 

 

 

502,576

 

Other assets

 

 

5,986

 

 

 

5,986

 

Total Assets

 

$

7,602,917

 

 

$

9,274,147

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

1,972,362

 

 

$

1,523,012

 

Lease liabilities, current portion

 

 

168,610

 

 

 

152,228

 

Loans

 

 

28,484

 

 

 

28,484

 

Total Current Liabilities

 

 

2,169,456

 

 

 

1,703,724

 

 

 

 

 

 

 

 

 

 

Lease liabilities, non-current

 

 

237,163

 

 

 

365,919

 

Total Long Term Liabilities

 

 

237,163

 

 

 

365,919

 

 

 

 

 

 

 

 

 

 

Total Liabilities

 

 

2,406,619

 

 

 

2,069,643

 

 

 

 

 

 

 

 

 

 

Stockholders’ Equity

 

 

 

 

 

 

 

 

Series A Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized; 141.397 shares issued and outstanding

 

 

1

 

 

 

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; 80,000,000 shares authorized; 8,411,777 and 3,169,103 shares issued and outstanding, respectively

 

 

841

 

 

 

317

 

Additional paid in capital

 

 

95,664,011

 

 

 

89,068,015

 

Stock payable

 

 

2,061

 

 

 

6,073

 

Accumulated deficit

 

 

(90,470,616

)

 

 

(81,869,902

)

Total Stockholders’ Equity

 

 

5,196,298

 

 

 

7,204,504

 

Total Liabilities and Stockholders’ Equity

 

$

7,602,917

 

 

$

9,274,147

 

 

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,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

1,632,849

 

 

$

1,830,297

 

 

$

4,424,345

 

 

$

4,890,879

 

Sales and marketing

 

 

243,332

 

 

 

420,439

 

 

 

672,721

 

 

 

1,102,381

 

General and administrative

 

 

1,252,881

 

 

 

1,166,480

 

 

 

3,965,889

 

 

 

3,850,918

 

Total operating expenses

 

 

3,129,062

 

 

 

3,417,216

 

 

 

9,062,955

 

 

 

9,844,178

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

(3,129,062

)

 

 

(3,417,216

)

 

 

(9,062,955

)

 

 

(9,844,178

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense)

 

 

28,226

 

 

 

(23,011

)

 

 

462,241

 

 

 

(45,318

)

Total other expenses

 

 

28,226

 

 

 

(23,011

)

 

 

462,241

 

 

 

(45,318

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations before income taxes

 

 

(3,100,836

)

 

 

(3,440,227

)

 

 

(8,600,714

)

 

 

(9,889,496

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

$

(3,100,836

)

 

$

(3,440,227

)

 

$

(8,600,714

)

 

$

(9,889,496

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share – basic and diluted

 

$

(0.40

)

 

$

(1.09

)

 

$

(1.53

)

 

$

(3.53

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares – basic and diluted

 

 

7,683,997

 

 

 

3,158,723

 

 

 

5,630,888

 

 

 

2,800,811

 

 

ENDRA Life Sciences Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

 

 

Nine Months

Ended

 

 

Nine Months

Ended

 

 

 

September 30,

 

 

September 30,

 

 

 

2023

 

 

2022

 

Cash Flows from Operating Activities

 

 

 

 

 

 

Net loss

 

$

(8,600,714

)

 

$

(9,889,496

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

101,839

 

 

 

64,532

 

Stock compensation expense including common stock issued for RSUs

 

 

745,873

 

 

 

909,069

 

Amortization of right of use assets

 

 

112,365

 

 

 

101,957

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Decrease in prepaid expenses

 

 

42,380

 

 

 

433,742

 

Increase in inventory

 

 

(112,916

)

 

 

(1,349,499

)

Increase in accounts payable and accrued liabilities

 

 

449,350

 

 

 

146,660

 

Decrease in lease liability

 

 

(112,374

)

 

 

(97,647

)

Net cash used in operating activities

 

 

(7,374,197

)

 

 

(9,680,682

)

 

 

 

 

 

 

 

 

 

Cash Flows from Investing Activities

 

 

 

 

 

 

 

 

Purchases of fixed assets

 

 

(27,000

)

 

 

(164,014

)

Net cash used in investing activities

 

 

(27,000

)

 

 

(164,014

)

 

 

 

 

 

 

 

 

 

Cash Flows from Financing Activities

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock, net

 

 

5,826,582

 

 

 

8,399,512

 

Proceeds from issuance of warrants, net

 

 

20,053

 

 

 

-

 

Net cash provided by financing activities

 

 

5,846,635

 

 

 

8,399,512

 

 

 

 

 

 

 

 

 

 

Net decrease in cash

 

 

(1,554,562

)

 

 

(1,445,184

)

 

 

 

 

 

 

 

 

 

Cash, beginning of period

 

 

4,889,098

 

 

 

9,461,534

 

 

 

 

 

 

 

 

 

 

Cash, end of period

 

$

3,334,536

 

 

$

8,016,350

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures of cash items

 

 

 

 

 

 

 

 

Interest paid

 

$

-

 

 

$

-

 

Income tax paid

 

$

-

 

 

$

-

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures of non-cash items

 

 

 

 

 

 

 

 

Stock dividend payable

 

$

(4,012

)

 

$

(5,373

)

Right of use asset

 

$

393,451

 

 

$

541,456

 

Lease liability

 

$

405,773

 

 

$

552,830

 

 

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

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