ENDRA Life Sciences Reports Fourth Quarter And Full Year 2022 Financial Results And Provides Business Update

Today's conference call begins at 4:30 pm ET

ANN ARBOR, MI, March 14, 2023 –(BUSINESS WIRE)–Indra Life Sciences Inc. (NASDAQ: NDRA), a leader in thermoacoustic enhanced ultrasound ( ^TAEUS® ), today announced three-month financial results and announced the fiscal year ended December 31, 2022 and provided business information. Highlights include:

• More than 100 TAEUS scans were performed in 2022 at clinical assessment centers around the world using the new interactive guidance tool. To increase the effectiveness of the TAEUS system among clinical users, ENDRA introduced a pilot tool in early 2023 to assist operators at clinical evaluation sites. With greater reliability and greater repeatability. ENDRA will use the data from these reviews to submit a de novo submission to the US Food and Drug Administration (FDA) to support the commercialization of the TAEUS liver device in Europe and, following FDA approval, in the United States.

• Concentrated efforts to complete and submit the de novo application to the FDA. In the US, ENDRA implements a de novo TAEUS regulatory hepatobiliary pathway designed to characterize fatty liver tissue as a non-invasive method to assess and monitor nonalcoholic fatty liver disease (NAFLD). ENDRA plans to submit the application once it receives TAEUS and MRI scan data confirming the scan with the new interactive reference tool. The de novo track dedicated to new technologies is intended to help ENDRA achieve the strongest position in the market with optimized TAEUS requirements.

• The partnership agreement with GE HealthCare has been extended for two more years until 2024. December. GE HealthCare continues to support ENDRA, including facilitating implementation for GE HealthCare clinical ultrasound customers around the world.

• Increase clinical awareness of the Liver TAEUS system through demonstrations at clinical conferences in hepatology and radiology. In 2022, the ENDRA team will meet with potential clients and key partners at 11 clinical conferences in the US and Europe. The sales team is continuing its market research activities and intends to attend nine clinical conferences in 2023.

• Global intellectual property portfolio expanded to 56 patents issued worldwide. In 2022, ENDRA received 19 patents, including two US patents announced in the fourth quarter. These patents support ENDRA's strategy to protect the TAEUS primary signaling system for measuring liver fat, as well as other potential applications, such as tissue temperature monitoring during surgical procedures.

the story goes on

“We are working closely with our global clinical assessment partners to obtain the most reliable data for our de novo survey. We're excited to launch our interactive advice tool to make it easier for clinicians to use. We are seeing improvements as a result of operator performance and the reliability of TAEUS measurements François Michelon, President and CEO of ENDRA, said: "This data is critical to ensuring successful regulation in the US and to supporting enforcement efforts. Marketing in Europe". unmet clinical need for cost-effective diagnostic tools to identify and monitor patients with liver disease at the point of care We strongly believe that the TAEUS system can measure liver fat in the early stages of NAFLD when it is still reversible and can improve the health of millions of people".

Unaudited Financial Results for the Fourth Quarter of 2022

• Operating expenses increased to $3.3 million in the fourth quarter of 2022 from $3.1 million in the same period of 2021. The growth is primarily due to continued product development.

• Net loss for the fourth quarter of 2022 was $3.3 million, or $1.04 per share, compared to a net loss of $3.1 million, or $1.48 per share, for the fourth quarter of 2021.

Financial results for the full year 2022 have not been audited

• Operating expenses increased from $11.5 million in 2021 to $13.2 million in 2022. The increase was primarily due to higher costs associated with bringing the TAEUS system to market in Europe and continued product development.

• Net loss for 2022 was $13.2 million, or $4.56 per share, compared to a net loss of $11.2 million, or $5.55 per share, for 2021.

• Cash and cash equivalents as of December 31, 2022 were $4.9 million.

Due to liquidity problems in the banking system as a result of the closure of Silicon Valley Bank and the appointment of the Federal Deposit Insurance Corporation as receiver, the company maintains cash on deposit at various banks to reduce the risk associated with the failure of a particular bank. .

Conference call and webcast

Management will host a conference call and webcast today at 4:30 pm ET to discuss these results, present company updates and answer questions.

Attendees are encouraged to pre-register for the conference call through this link. Pre-registered subscribers receive a unique PIN code for instant call access and operator referral. Participants can record at any time, including before and after the call start time. Those unable to pre-register can call (844) 868-8846 (US) or (412) 317-5465 (International). You can also view the webcast of the conference call on ENDRA's Investor Relations page and here.

Telephone transcripts are available through March 21, 2023 by calling (877) 344-7529 (US) or (412) 317-0088 (International) and entering area code 2113040. Webcast replays are available about an hour after launch. Live conference call here.

Information about ENDRA Life Sciences Inc

ENDRA Life Sciences pioneered Thermoacoustic Enhanced Ultrasound ( ^TAEUS® ), an advanced technology being developed to create tissue images similar to MRI, but at ^1/50 the cost and right at the patient's point of care. ^TAEUS® was designed to work with more than 700,000 ultrasound systems in use around the world today. ^TAEUS® initially focused on measuring lipids in the liver as a means of evaluating and managing nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), chronic liver diseases that affect more than two billion people. Worldwide. There are no practical diagnostic tools. In addition to the liver, ENDRA is exploring other clinical applications ^{of TAEUS®} , including visualization of tissue temperature during energy-based surgical procedures. Visit www.endrainc.com for more information.

forward-looking statements

All statements in this press release that are not historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. Plans, strategies and expectations based in certain assumptions and our Describing the future, usually characterized by terms such as "estimate", "anticipate", "experience", "believe", "may", "estimate", "anticipate", "future", "goal", "hope", "intend", "could", "plan", "might", "possibility", "project", "aim", "must", "will" or other similar terms (including the negative of the foregoing ), although certain forward-looking statements are expressed differently. Examples of forward-looking statements made by ENDRA include, but are not limited to: statements regarding future financial conditions and projected costs and revenues; Forecast of ENDRA's business strategy. and data on ENDRA's ability to find and retain development partners. Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from forward-looking statements due to various factors including, among others; ; the ability to sell ENDRA's medical devices in a timely manner, or at all, in certain markets required regulatory approvals; your ability to develop commercially viable technology and your reliance on third parties to develop and manufacture your products; Impact of COVID-19 on ENDRA's action plans. ability to find and retain development partners; market acceptance of ENDRA's technology and the level and nature of competition in the industry; ENDRA's ability to protect its intellectual property; and other risks and uncertainties described in the Discussion and Analysis of Financial Condition and Results of Operations sections of the Company's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the Securities . and exchange commission. Forward-looking statements should not be construed as predictions of future events. Forward-looking statements contained in this press release speak only as of the date of this release, and ENDRA does not undertake any obligation to update these forward-looking statements to reflect actual results or changes in expectations, except as required by law.

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See original on businesswire.com: https://www.businesswire.com/news/home/20230314005919/en/

contacts:

Company contact:
Irina Pestrykova
senior financial director
[email protected]
www.endrainc.com

Connect with investors.
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
[email protected]

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