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) August 22, 2024

______________________________________________

(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:

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 August 22, 2024, ENDRA Life Sciences Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 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

On August 22, 2024, the Company held a conference call to discuss its financial results for the three months ending June 30, 2024. The Company has prepared a transcript of that conference call, a copy of which is being furnished as Exhibit 99.2 to this Current Report on Form 8-K.

The information furnished under Items 2.02 and 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, 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

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.

EXHIBIT 99.1

ENDRA Life Sciences Reports Second Quarter 2024 Financial Results and Provides a Business Update

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

ANN ARBOR, Mich. (August 22, 2024) – ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), reports financial results for the three and six months ended June 30, 2024, as filed in a Form 10-Q on August 14, 2024, and provides the following business update:

New executive team

Focus on clinical and regulatory activities

Raised capital and significantly reduced operating expenses

“In the near-term, the company is prioritizing securing the clinical data to support a new De Novo regulatory filing with the FDA above all other goals,” said Alexander Tokman, acting Chief Executive Officer.  “In parallel, we are revisiting our go-to-market strategy for TAEUS to ensure we are prioritizing the most promising vertical markets while formalizing our longer-term business strategy and crystalizing our vision for ENDRA.  All of this is being done with careful attention to operating expenses, which we recently reduced by 26% on an annualized basis without impacting any of our primary deliverables.”

Second Quarter 2024 Financial Results

Operating expenses in the second quarter of 2024 were $2.2 million, compared with $3.0 million in the second quarter in 2023. The decrease was mainly due to lower research and development expenses as we shift resources and spending from development to clinical activities and product optimization.

Cash and cash equivalents were $6.4 million as of June 30, 2024. In June 2024, the Company raised approximately $7.3 million in net proceeds through a public offering.

Conference Call and Webcast

Management will host a conference call and webcast beginning at 4:30 p.m. Eastern time today, 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 start of the call. 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 29, 2024 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 5567407. 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 that characterizes tissue similar to an MRI, but at 1/40^th the cost and at the point of patient care. TAEUS^® is initially focused on the non-invasive assessment of fatty tissue in the liver. Steatotic liver disease (SLD, formerly known as NAFLD-NASH) is 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 non-invasive 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: 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 regain 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:

Richard Jacroux

Chief Financial Officer

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

ENDRA Life Sciences Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

EXHIBIT 99.2

PRESENTATION

Operator

Good afternoon, and welcome to the ENDRA Life Sciences Second Quarter 2024 Financial Results Conference Call.  All participants will be in a listen-only mode.  Should you need assistance, please signal a conference specialist by pressing the "*" followed by "0."  After today's presentation, there will be an opportunity to ask questions.  To ask a question, you may press "*" then "1" on your telephone keypad, to withdraw your question, please press "*" then "2." Please note, this event is being recorded.

I would now like to turn the call over to Yvonne Briggs.  Please go ahead.

Yvonne Briggs

Thank you, operator.  This is Yvonne Briggs with LHA.  Good afternoon, and welcome to ENDRA Life Sciences second quarter 2024 business update and financial results conference call.  Earlier today, ENDRA issued a press release on this topic, which is available on the investors section of ENDRA's website.

Before we begin, please note that today's discussion will include forward-looking statements.  All statements by management other than statements of historical facts, including statements regarding the company's strategies, financial condition, operations, costs, plans and objectives as well as anticipated results of development and commercialization efforts, the timing of clinical studies, potential partnership opportunities and expectations regarding regulatory processes, receipt of required regulatory clearances and product launches are forward-looking statements.

Except as required by Federal Securities Laws, the company disclaims any obligation to update or revise any forward-looking statements.  Please refer to the company's Form 10-K for the 2023 fiscal year and subsequent SEC filings for more information about risks and uncertainties related to forward-looking statements.

In terms of the structure of today's call, Alexander Tokman, acting Chief Executive Officer, will begin the prepared remarks; followed by Ziad Rouag, new Head of Regulatory and Clinical Affairs, and then Michael Thornton, ENDRA's Chief Technology Officer.  They will be followed by Richard Jacroux, ENDRA's new CFO, to review the second quarter financial results.

With that said, I will now turn it over to Alex.  Alex.

Alexander Tokman

Thank you, Yvonne.  Good afternoon, and thank you for joining us today to discuss ENDRA's second quarter 2024 financial results and business highlights.  Before we proceed to the business update, let me address the reverse stock split and the subsequent trading of our common stock.  As you know, after receiving shareholder approval earlier this month, the company authorized 1 for 50 reverse stock split which we announced last Friday and was effective past Tuesday…this past Tuesday.

The primary goal was to keep our share price above $1, and in turn, maintain the NASDAQ listing.  This plan was derailed because of an extremely high volume of exercise warrants, which were issued as a part of the $8 million public offering that was completed in June.  This public offering was necessary in order to keep the company operational and not to lose all the progress ENDRA made over the years.

ENDRA Life Sciences Inc.

Thursday, August 22, 2024, 4:30 PM Eastern

We strongly believe that the sharp decline in our stock over the past few days is completely unrelated to ENDRA business prospects [indiscernible] have the intended outcome, as we are trading below $1 right now. We recognize the seriousness of the situation on the company and our investors, and we will keep you apprised of our actions as we move forward.

Now let's turn our attention to the second quarter results and recent changes. I would like to start by reviewing with you six specific items we intend to do differently moving forward to become more actionable and predictable as we bring ENDRA's differentiating thermoacoustic technology to market. The six changes include stronger operating team, relentless prioritization of our activities, new approach with FDA, enhanced go-to-market strategy for TAEUS liver device, crystallization of our ENDRA vision, and finally, improved financial execution.

Let me elaborate on each. First, we enhanced our management team by adding two experienced operators who have proven track record of success in transforming new technology companies. Richard Jacroux is a seasoned CFO with public and private company experience, and he well understands lean operations and restructuring. He is already working very closely with Irina, formerly Senior Director of Finance, to ensure a smooth transition of daily finance operations. Irina will remain as an adviser to the company moving forward.

Ziad Rouag has joined us as the Head of Clinical and Regulatory Affairs. Ziad has successfully led a number of emerging medical device technology companies through regulatory process and early commercialization, and he already made a huge impact on our most recent strategy and interactions with FDA. I anticipate that both Richard and Ziad's experiences will greatly benefit ENDRA as we move forward through this critical phase for the company. Mike Thornton, our CTO, will continue to focus on product delivery as well as enhancing ENDRA's technology road map and intellectual property.

Second change, after reviewing after all the priorities that we are facing, we as the new operating team are unanimous in our relentless prioritization and laser-focus on the most critical deliverable for the company and is executing as statistically powered multi-center prospective clinical trial to obtain the necessary data that will allow us to successfully move forward. This clinical data is a foundational element for both regulatory and commercial success. It offers three important benefits. It allows for optimization of product design for maximum user utilization; it is a necessary piece of successful de novo application, and finally, it answers the big why, as in why, I as a clinician or pharmaceutical user should utilize this technology.

The third change we are implementing as we will fundamentally change our FDA regulatory strategy under Ziad's leadership. We are switching from the use of retrospective data to a hypothesis-driven, statistically-powered prospective clinical trial, which is pre-vetted through FDA.

We are, therefore, expanding from a single clinical site to a multi-center trial, and we're increasing the number of subjects by an order of magnitude from 20 to about 250, which is necessary to achieve acceptable statistical power. We are now fully engaged with the FDA on establishing the consensus and trial design prior to data collection. Later in this call, Ziad will elaborate further on these changes.

Fourth, we are revisiting our go-to-market strategy for the TAEUS liver device. We have more and more evidence that hepatology may not be the beachhead market we should pursue. [Indiscernible] primary care and [indiscernible] segment, and believe then over the next 6 to 12 months as we pursue the regulatory clearance for the TAEUS liver device. Hepatology will likely to remain a market for us, but perhaps not the primary target.

ENDRA Life Sciences Inc.

Thursday, August 22, 2024, 4:30 PM Eastern

Fifth, or…the change in our initiative number five, we are preparing changes related to ENDRA's strategic direction. We will formalize our longer-term business strategy and crystallize our vision, as in what's next after we commercialize our TAEUS liver device. How do we have to…we have to answer questions such as how do we add more value to our customers beyond the liver fat test and become a metabolic disease biomarker company, which could be a lot more valuable. All of this is expected to be developed and assessed over the next 12 months.

Lastly, we are focusing on improved financial stewardship. Our goal is to scrutinize every dollar we spend, and as a result, we recently conduct significant reduction of our operating expenses, and we were able to reduce them by $3 million plus, which represents approximately 26% reduction on annualized basis, all of it without impacting the primary deliverable, which is clinical data collection in preparation for our FDA submission. Richard will elaborate on this further during the financial update.

Now that I outlined what we will do differently moving forward, Ziad, Mike and Richard will now highlight for you the progress we made since Q1 conference call in three areas: clinical and regulatory, technology and IP, and financial. Ziad.

Ziad Rouag

Thank you, Alex. In May of this year, we met with the FDA at the headquarters in Maryland to demonstrate live the TAEUS technology and review the clinical and statistical plans for the proposal...proposed pivotal study. The meeting minutes from the FDA meeting confirmed alignment between ENDRA and the FDA on the final product configuration, clinical study design and regulatory pathway of a successful outcome.

As part of our refocused clinical program, we are limiting initial data collection to three pilot sites, 2 US and 1 EU. These pilot trial sites were selected based on their ability to recruit patients. We have already acquired data on 25 subjects through these efforts.

In terms of time [indiscernible], these will be...there will be sequential studies, meaning the results of the pilot study will inform the design of the pivotal study. Our goal is to have all clinical work completed and the data incorporated into our de novo submission targeted for mid-2025. I've handled similar opportunities during the course of my career with complex trials and devices, including imaging studies, and I'm highly optimistic about the regulatory path we have set for the TAEUS liver device. Mike.

Michael Thornton

Thank you, Ziad. Our patent portfolio now stands at 81 issued patents globally. During the second quarter of 2024, ENDRA has issued five additional patents, three in Europe and two in China.

The issued patent portfolio consists of 42 thermoacoustic device and foundational enabling technology patents, 22 patents related to estimating fat fraction, and 17 patents covering other thermoacoustic applications and non-thermoacoustic technologies. Our broad intellectual property portfolio provides protection for the TAEUS system with its novel thermoacoustic technology and the opportunity to explore licensing opportunities beyond our core focus.

I'll turn the call over now to Richard.

ENDRA Life Sciences Inc.

Thursday, August 22, 2024, 4:30 PM Eastern

Richard Jacroux

Thank you, Mike. And it's a pleasure to be speaking with our investors in my first quarterly conference call as ENDRA's CFO. During the quarter, we raised $7.3 million in net proceeds from the sale of common stock and warrants in a public offering. As of June 30^th, 2024, we had cash and cash equivalents of $6.4 million, based on our current projections, our cash runway funds the company into the first half of 2025.

Turning now to review of our financial results. For the quarter ended June 30^th, 2024, our total operating expenses decreased to $2.2 million from $3 million for the same period in 2023. The decrease was mainly due to declines in research and development and sales and marketing expenses. Year-over-year, R&D expenses decreased $684,000 or 49% as we shift our resources and spending from development to clinical activities.

In sales and marketing, cost decreased $85,000 or 34%, as we restructured our European operations to support the company's near-term clinical study goals.

General and administrative expenses increased $5,000 overall, due to the administrative cost of the fundraising, which offset decreases elsewhere. We continue to scrutinize our spending and will likely make further adjustments to our expense structure to focus on achieving our priorities as we reset our strategy.

Now, I'll turn the call to the operator for questions. Operator.

QUESTION AND ANSWER

Operator

We will now begin the question and answer session. To ask a question, you may press "*" then "1" on your telephone keypad. If you are using a speakerphone, please pick-up your handset before pressing the keys. To withdraw your question, please press "*" then "2." At this time, we will pause momentarily to assemble our roster.

Our first question today is from Edward Woo with Ascendiant Capital. Please go ahead.

Edward Woo

Yes. Nice to meet you, Alexander and Richard. My question is more on, as you guys are hitting the ground running. How quickly do you think you guys will be able to get your new strategic path fully implemented or do you still think it needs time to kind of evaluate the situation?

Alexander Tokman

Thank you for the question Ed. In terms of the next 9 months to 12 months, we have a clear priorities described that we're going to execute. So, this would involve completing the clinical study, obtaining all the necessary data to prepare for regulatory submission with FDA, as well as generating enough compelling data to use for promoting this technology to future customers. So, in terms of…again, this priority has been agreed upon and articulated to every employee within the company.

In terms of longer vision, what happened following the introduction of TAEUS liver device, we give a sharpened pencils over the next six months to nine months, look at all the opportunities that our IP offers and determine the path going forward. One thing I can tell you for sure is that we are going to create a strategic road map that will include several critical…several growth opportunities, some of which we will pursue organically, and some of it could be licensed to others. More on this later.

ENDRA Life Sciences Inc.

Thursday, August 22, 2024, 4:30 PM Eastern

Edward Woo

Great. And then just a final clarifying question. I wasn't sure if I heard right. Do you say that in 2025, you plan to file your FDA application? Did you give a specific time in 2025?

Alexander Tokman

We haven't provided the specific guidance, I don't believe. But what I can tell you is that our goal is to complete the clinical study this year and initiate a pivotal study early next year, with the goal of submitting sometime by mid of 2025.

Edward Woo

Great. Well, thank you and I wish you guys good luck.

Alexander Tokman

Thank you.

Operator

This concludes our question and answer session. I would like to turn the conference back over to Alex Tokman for any closing remarks.

CONCLUSION

Alexander Tokman

Thank you. Given…I would like to wrap this call by telling you that given that everybody feels, the board and the operating team are bullish in ENDRA's technology and market opportunity. We expect that after implementing the six initiatives and changes I described earlier in this call, ENDRA's performance will improve, and we will reverse the course that the company has settled for in the past. I'm confident personally about this because I have led several successful turnarounds of medical device and emerging technology companies for both Fortune 100 and micro caps, and I think we can do this again here. I believe the team is energized. We know what we need to accomplish in the next 6 months, 9 months and 12 months, and you'll see hopefully, different output from this team moving forward. Thank you.

Thank you for joining us today, and we look forward to keeping you updated on our progress.

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

ENDRA Life Sciences Inc.

Thursday, August 22, 2024, 4:30 PM Eastern