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 reported financial results for the three and six months ended June 30, 2023 and provided a business update. Highlights from the second quarter of 2023 and recent weeks include:

  • Submitted a De Novo Request to the U.S. Food and Drug Administration (FDA) for the TAEUS liver system. The TAEUS system is ENDRA’s proprietary device that is intended to offer clinicians a tool for the non-invasive assessment of fatty liver tissue, as an aid in the management of patients with Non-Alcoholic Fatty Liver Disease (NAFLD). The submission included patient scans from established clinical study sites comparing TAEUS liver fat fraction estimates to MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction), which is the gold standard for clinical measurement of liver fat fraction. The study data yielded a sensitivity of 90%. TAEUS estimates of liver fat fraction were strongly correlated to MRI-PDFF scores with a Pearson correlation coefficient of r=0.78.
  • Showcased the TAEUS liver system's capabilities at two European clinical conferences. ENDRA participated in the German Diabetes Association’s 57th DDG Annual Meeting in Berlin, which underscored the role of liver health in managing type 2 diabetes. Additionally, the company shared study findings in a peer-reviewed clinical abstract titled "Thermoacoustic assessment of fatty liver disease - an early clinical feasibility study” at the esteemed European Association for the Study of the Liver (EASL) Congress in Vienna. This presentation served to elevate TAEUS' profile among potential clinical users to support commercial adoption.
  • Continued the expansion of its intellectual property portfolio to 64 issued patents globally. During the second quarter, ENDRA secured four additional patents, including one in the U.S. and three in China. These newly issued patents not only reinforce ENDRA's unique position in assessing liver fat, but also open the doors for other potential applications. The company is actively exploring licensing opportunities in non-core indications to augment the value of its growing IP portfolio.
  • Raised approximately $4.7 million and extended the cash runway. In May, the company raised approximately $4.7 million in net proceeds from the sale of common stock and warrants in a public offering. Management believes ENDRA has sufficient cash to fund operations through several important milestones expected in 2023, including supporting commercial activities in Europe.

"Our De Novo submission for the TAEUS system marks a pivotal milestone for ENDRA. It's the culmination of remarkable commitment by the ENDRA team and our clinical partners to address a significant unmet clinical need by providing a non-invasive tool to assess liver fat, at a fraction of the cost of MRI. We believe the De Novo process holds the potential to set the regulatory bar for an entirely new product classification, showcasing TAEUS' unique and innovative capabilities," said Francois Michelon, Chairman and Chief Executive Officer of ENDRA. "We believe our submission is robust and we look forward to working with the FDA as they proceed with their review.”

Second Quarter 2023 Financial Results

Operating expenses in the second quarter of 2023 were $3.0 million, compared with $3.6 million in the second quarter in 2022. The decrease was mainly due to a decrease in research and development and sales and marketing expenses.

Net loss in the second quarter of 2023 was $2.6 million, or $0.43 per share, compared with a net loss of $3.6 million, or $1.17 per share, in the second quarter of 2022.

Cash and cash equivalents were $4.8 million as of June 30, 2023. In May, the company raised approximately $4.7 million in net proceeds through an underwritten public offering.

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 August 21, 2023 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 3299822. 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 being developed to visualize tissue like 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 Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH), chronic liver conditions that affect over one 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. Consolidated Balance Sheets

   

 

 

June 30,

 

 

December 31,

 

Assets

 

2023

 

 

2022

 

Current Assets

 

(Unaudited)

 

 

 

 

Cash

 

$

4,819,459

 

 

$

4,889,098

 

Prepaid expenses

 

 

506,914

 

 

 

490,299

 

Inventory

 

 

2,757,633

 

 

 

2,644,717

 

Total Current Assets

 

 

8,084,006

 

 

 

8,024,114

 

Non-Current Assets

 

 

 

 

 

 

 

 

Fixed assets, net

 

 

192,874

 

 

 

235,655

 

Right of use assets

 

 

431,842

 

 

 

505,816

 

Prepaid expenses, long term

 

 

530,068

 

 

 

502,576

 

Other assets

 

 

5,986

 

 

 

5,986

 

Total Assets

 

$

9,244,776

 

 

$

9,274,147

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

1,841,562

 

 

$

1,523,012

 

Lease liabilities, current portion

 

 

163,013

 

 

 

152,228

 

Loans

 

 

28,484

 

 

 

28,484

 

Total Current Liabilities

 

 

2,033,059

 

 

 

1,703,724

 

 

 

 

 

 

 

 

 

 

Long Term Debt

 

 

 

 

 

 

 

 

Lease liabilities

 

 

281,154

 

 

 

365,919

 

Total Long Term Debt

 

 

281,154

 

 

 

365,919

 

 

 

 

 

 

 

 

 

 

Total Liabilities

 

 

2,314,213

 

 

 

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; 7,481,603 and 3,169,103 shares issued and outstanding, respectively

 

 

748

 

 

 

317

 

Additional paid in capital

 

 

94,297,167

 

 

 

89,068,015

 

Stock payable

 

 

2,427

 

 

 

6,073

 

Accumulated deficit

 

 

(87,369,780

)

 

 

(81,869,902

)

Total Stockholders’ Equity

 

 

6,930,563

 

 

 

7,204,504

 

Total Liabilities and Stockholders’ Equity

 

$

9,244,776

 

 

$

9,274,147

 

 

ENDRA Life Sciences Inc. Consolidated Statements of Operations (Unaudited)

   

 

 

Three Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

June 30,

 

 

June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

1,400,182

 

 

$

1,847,560

 

 

$

2,791,496

 

 

$

3,060,582

 

Sales and marketing

 

 

247,773

 

 

 

342,039

 

 

 

429,389

 

 

 

681,942

 

General and administrative

 

 

1,346,610

 

 

 

1,382,094

 

 

 

2,713,008

 

 

 

2,684,438

 

Total operating expenses

 

 

2,994,565

 

 

 

3,571,693

 

 

 

5,933,893

 

 

 

6,426,962

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

(2,994,565

)

 

 

(3,571,693

)

 

 

(5,933,893

)

 

 

(6,426,962

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense)

 

 

437,433

 

 

 

(19,374

)

 

 

434,015

 

 

 

(22,307

)

Total other expenses

 

 

437,433

 

 

 

(19,374

)

 

 

434,015

 

 

 

(22,307

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations before income taxes

 

 

(2,557,132

)

 

 

(3,591,067

)

 

 

(5,499,878

)

 

 

(6,449,269

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

$

(2,557,132

)

 

$

(3,591,067

)

 

$

(5,499,878

)

 

$

(6,449,269

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share – basic and diluted

 

$

(0.43

)

 

$

(1.17

)

 

$

(1.20

)

 

$

(2.46

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares – basic and diluted

 

 

5,996,186

 

 

 

3,082,209

 

 

 

4,582,645

 

 

 

2,617,878

 

 

ENDRA Life Sciences Inc. Condensed Consolidated Statements of Cash Flows (Unaudited)

 

 

 

Six Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2023

 

 

2022

 

Cash Flows from Operating Activities

 

 

 

 

 

 

Net loss

 

$

(5,499,878

)

 

$

(6,449,269

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

69,781

 

 

 

40,739

 

Fixed assets write off

 

 

-

 

 

 

599,886

 

Stock compensation expense including common stock issued for RSUs

 

 

493,134

 

 

 

-

 

Amortization of right of use assets

 

 

73,974

 

 

 

67,158

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Increase in prepaid expenses

 

 

(44,107

)

 

 

513,140

 

Increase in inventory

 

 

(112,916

)

 

 

(1,090,150

)

Increase in accounts payable and accrued liabilities

 

 

318,550

 

 

 

(51,072

)

Decrease in lease liability

 

 

(73,980

)

 

 

(64,284

)

Net cash used in operating activities

 

 

(4,775,442

)

 

 

(6,433,852

)

 

 

 

 

 

 

 

 

 

Cash Flows from Investing Activities

 

 

 

 

 

 

 

 

Purchases of fixed assets

 

 

(27,000

)

 

 

(149,153

)

Net cash used in investing activities

 

 

(27,000

)

 

 

(149,153

)

 

 

 

 

 

 

 

 

 

Cash Flows from Financing Activities

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock

 

 

4,712,750

 

 

 

8,399,512

 

Proceeds from issuance of warrants

 

 

20,053

 

 

 

-

 

Net cash provided by financing activities

 

 

4,732,803

 

 

 

8,399,512

 

 

 

 

 

 

 

 

 

 

Net increase (decrease) in cash

 

 

(69,639

)

 

 

1,816,507

 

 

 

 

 

 

 

 

 

 

Cash, beginning of period

 

 

4,889,098

 

 

 

9,461,534

 

 

 

 

 

 

 

 

 

 

Cash, end of period

 

$

4,819,459

 

 

$

11,278,041

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures of cash items

 

 

 

 

 

 

 

 

Interest paid

 

$

-

 

 

$

-

 

Income tax paid

 

$

-

 

 

$

-

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures of non-cash items

 

 

 

 

 

 

 

 

Stock dividend payable

 

$

(3,646

)

 

$

(8,049

)

Right of use asset

 

$

431,842

 

 

$

576,255

 

Lease liability

 

$

444,167

 

 

$

586,193

 

 

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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