Good day, and welcome to the ENDRA Life Sciences Second Quarter 2023 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded.

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

Thank you, operator. This is Yvonne Briggs with LHA. Good afternoon, and welcome to ENDRA's second quarter 2023 business update and financial results conference call. Earlier today, ENDRA issued a press release on this topic and also issued a news release announcing the submission of de novo request for its TAEUS system to the U.S.

FDA, both of which are available in 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 2022 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, Francois Michelon, Chairman and Chief Executive Officer will begin the prepared remarks; followed by Michael Thornton, ENDRA’s Chief Technology Officer. Mr. Thornton will be followed by Irina Pestrikova, Senior Director of Finance to review the second quarter financial results.

With that said, I will now turn the call over to Francois Michelon.

Francois?.

Thank you, Yvonne, and good afternoon, everyone and thanks for joining us today to discuss ENDRA's second quarter 2023 financial results and business highlights. As we announced earlier today, I'm extremely pleased that ENDRA submitted its de novo request to the U.S. FDA for the Thermo Acoustic Enhanced UltraSound Liver System known as TAEUS.

Our de novo submission is a pivotal milestone for ENDRA, highlighting our team's commitment alongside our clinical partners to offer a non-invasive and cost-effective solution for measuring liver fat, which is the root cause of a disease affecting over 1 billion people worldwide.

We see that de novo process as a gateway to establish a new regulatory standard highlighting TAEUS' groundbreaking capabilities, and we look forward to collaborating with the FDA during the review process.

Gathering and analyzing the scan data along with assembling the submission itself was an enormous task, especially for a company the size of ENDRA. The process has taken a bit longer than we originally expected, but we're delighted to have made what we consider to be a first rate submission to the FDA.

Mike Thornton will provide more detail on our clinical and regulatory progress shortly. But before turning over to Mike, I'd like to mention a few other highlights from the second quarter. We showcase the TAEUS liver system at two major 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 two 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 Congress in Vienna, commonly known as EASL.

This presentation served to elevate TAEUS' profile amongst potential clinical users to support commercial adoption.

At both conferences, in light of approaching commercial drug therapies targeting liver disease, we heard a lot of discussions about the clinical need for a safe and cost-effective way to a suitably identify and monitor patients for their drug response, and this is where ENDRA intends to lead.

In the second quarter, we also expanded our 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 of our thermo acoustic technology. The company is actively exploring licensing opportunities in non-core indications to augment the value of our growing IP portfolio.

Finally, in May of this year, we raised approximately $4.7 million through an underwritten public offering. Management believes that ENDRA's sufficient cash to fund operations through several important milestones expected in 2023, including supporting commercial activities in Europe. Okay.

Over to Mike Thornton for more detail on our clinical and regulatory progress.

Mike?.

Thank you, Francois. We're extremely pleased to have submitted our de novo request to the U.S. FDA for the Thermo Acoustic Enhanced UltraSound Liver System known as TAEUS.

The clinical data submitted as part of our de novo application compared TAEUS estimates of liver fat fraction in 24 subjects to MRI liver fat fraction scores, also known as MRI-PDFF scores in those same subjects.

The study data submitted was consistent with our study design and only included study participants where the TAEUS, UltraSound and MRI data was obtained successfully. The data was collected at a U.S. site and involved volunteers with liver fat fraction ranging from healthy, normal to severe fatty liver disease.

The BMI of the subjects range from 24, which is normal to 42, which is severely obese. It is significant to note that no subjects were excluded because of high BMI or liver fibrosis. TAEUS estimates of liver fat fraction were highly correlated to MRI-PDFF scores of liver fat fraction with an R-value of 0.78.

The sensitivity of the TAEUS flip system in detecting fatty liver disease was 90% with specificity of 71%. To provide some reference of performance, the sensitivity X-ray mammography in detecting breast cancer is approximately 87% with a specificity of 88%.

The negative predictive value, which is the probability of a negative test being correct, was 91%.

Negative predictive value is an important measure of test performance because in a low cost, in a cost constrained healthcare environment, it's often as important to correctly identify healthy subjects as it is to correctly identify those with the disease. We believe the submitted data with 24 subjects sufficiently supports our de novo application.

In an additional submitted study of intra and intra operator variability, no statistical significant differences were found between operators in estimating liver fat fraction with the TAEUS flip system for either an individual with normal liver fat fraction, or an individual with moderate fatty liver disease.

All operators demonstrated a highly statistically significant difference in comparing a healthy individual to an individual with moderate fatty liver disease using the TAEUS flip system. This is extremely encouraging and we're very happy to submit this data. This is an incredibly important technology milestone for ENDRA.

There's a growing interest in point-of-care quantitative measures of liver fat fraction among clinicians. Quantitative attenuation and back scatter applications for estimating fat fraction are now available from several vendors of premium diagnostic ultrasound system.

Although, their use is largely limited to liver imaging in radiology, the interest in these quantitative measures goes far beyond radiology.

ENDRA's thermoacoustic based approach to estimating liver fat leverages unique capabilities that potentially provide four significant advantages when compared to conventional ultrasound based point-of-care approaches for assessing liver fat fracture. The first of these advantages is molecular signal contrast.

Unlike ultrasound approaches that are sensitive to structural changes in tissue, both TAEUS and MRI are sensitive to chemistry when differentiating fat from lean tissue, that means that thermoacoustic signal is directly related to the accumulation of fat molecules in liver cells that underlies the progression of fatty liver disease.

The second advantage of our approach is its insensitivity to fibrosis. Fibrosis is an excessive accumulation of extracellular proteins that is a common comorbidity of fatty liver disease. Fibrosis is a significant confounding factor for ultrasound based techniques and hinders their ability to estimate fat fraction accurately.

In contrast, thermoacoustic signal generation is relatively insensitive to the addition of extracellular proteins to lean tissue, and thus the presence of fibrosis is largely inconsequential for thermoacoustic. In our clinical studies, we did not exclude any TAEUS exams with fibrosis. The third advantage of TAEUS is tissue depth penetration.

The loss of signal in obese patients is significantly lower for thermoacoustic signals than that of conventional ultrasound for two reasons. First, the distance thermoacoustic signals travel is half the distance of that, that conventional ultrasound pulse travels.

And secondly, thermoacoustic signals detected with the TAEUS flip system are much lower in frequency than the standardized three and a half megahertz transmit receive signal in conventional ultrasound approaches to estimating liver fat fraction.

Thus, the difficulty to image patients large or obese patients conventional signal attenuation in ultrasound can be many orders of magnitude greater than thermoacoustic. As a result, thermoacoustic methods are potentially more effective than ultrasound based approaches to quantifying fat fraction in high BMI subjects.

We excluded no subjects from our FDA submission for reasons of high BMI. And the fourth advantage of TAEUS is within image calibration. ENDRA's TAEUS approach to estimating liver fat fraction is unique in that each measurement has its own integral calibration data derived from the individual's own fat and muscle that is contained in each measure.

That ensures measurement uniformity across individuals and across devices. Several other point-of-care devices in the market require periodic calibration and have varying efficacy across patient size that should not be present with the TAEUS device.

In terms of next steps and timeframes for the FDA review process going forward, there are a number of elements that should be considered.

First, ENDRA submitted its de novo request via the FDA's electronic submission template and resource tool known as the eSTAR, which guides applicants through the submission process with a standardized online format, ensuring the submission is complete and structured in a way that facilitates efficient review by the FDA.

Second, we can expect back and forth dialogue with the FDA. The FDA's published goal is to make a decision within 150 days of submission. Investors should remember that the FDA routinely engages in interactive discussions with companies in seeking additional information or clarification.

One factor that may benefit ENDRA during the review process is the FDA's familiarity with our previous 510(k) submission and our interactions in that review process that detailed our technology's principle of operation and safety profile. Naturally, ENDRA will keep investors informed of material updates as we advance through the FDA process.

Now, I'd like to turn the call over to Irina to review the financial results for the second quarter of 2023.

Irina?.

Thank you, Mike. For the quarter ended June 30th, 2023, our operating expenses decreased to $3 million from $3.6 million for the same period in 2022. The decrease was mainly due to a decrease in research and development, and sales and marketing expenses.

Our research and development expenses decreased year-over-year by approximately $450,000 as we completed the development of our initial at TAEUS product. Our sales and marketing expenses decreased by approximately $95,000 for the quarter, mainly due to the departure of our Chief Commercial Officer.

General and administrative expenses decreased by approximately $35,000 due to decreased spending on professional fees. Net loss per share in the second quarter of 2023 was $0.43 per share compared with a net loss of $1.17 per share in the second quarter of 2022. Cash and cash equivalents were $4.8 million as of June 30th, 2023.

During the second quarter of 2023, the company raised approximately $4.7 million in net proceeds through an underwritten public offering. We believe our current capital position provides a runway into the fourth quarter of 2023.

We maintain our asset-light operating model with pretty hires in our operations and commercial team in anticipation of future growth. As we execute our regulatory and commercial strategy for TAEUS, we plan to adjust our expense structure accordingly in support of these activities. Now, I'll turn the call back to Francois..

Thanks very much Irina and Mike. In closing, during the second quarter and subsequent weeks, ENDRA has made a great amount of important progress. I couldn't be more proud of the business. As we've discussed, we submitted our FDA de novo request for the TAEUS liver application with confidence that our work will set a benchmark for a new product class.

We had our first TAEUS liver clinical abstract published by the leading European Association for the study of the Liver. And third, we raise capital with long-term investors to support key milestones throughout the second half of 2023.

Mike spoke about the next steps in timetable between ENDRA and the FDA, and I remind listeners that although there are various due dates in place for regulatory reviews and processes, we don't control the FDA process. However, I can assure you we'll do everything necessary to keep things moving along quickly and productively.

And we, obviously, commit to keeping shareholders apprised of developments with the agency during our quarterly conference calls and to make public announcements when their material developments to report. In closing, I couldn't be more excited about the future of TAEUS and the future of ENDRA. The U.S.

represents the largest market opportunity for TAEUS and we're confident that our technology's various advantages along with a price that's 150th the cost of MRI will secure a place for TAEUS in the hands of clinicians. So, with that overview, I'd like to turn the call over for questions.

Operator?.

Thank you. We will now begin the question-and-answer session. [Operator Instructions] Our first question comes from Ed Woo with Ascendiant Capital. Please go ahead..

Yeah. First off, I wanted to say congratulations for the submission today. It was very good news and wish you guys all the best in getting a quick approval. My question is, you previously had a distribution agreement in Vietnam. Is that still in place? And will you -- I think previously it was -- you'll recognize revenue as soon as you get U.S.

FDA approval, is that correct?.

Good question. Yeah. So, the exclusive distribution agreement with a distributor in Vietnam is in place and it takes effect and is activated by the approval -- by the FDA of our application in the U.S. That will kick off a three-year process with a commitment of 40 systems at an agreed upfront transfer price.

So that is a good example of -- an important, but secondary market opportunity that is going to be directly revenue generating in addition to Europe where we're currently focused than the U.S. and then as you point out, other opportunities like Vietnam through partners..

Great. And then, my next question is how much commercialization efforts -- or can you do now in the U.S.

before you get approval? Are you able to really get things up and running, or do you still have to kind of wait until you get the formal approval to do that?.

Yeah. Good question. If I might, I'll sort of put it under the broader umbrella of commercialization and we expect to record our first sales in Europe before the end of the year.

But it's important to understand as you're asking, that we've been putting in place a number of key elements to support a successful commercial ramp both in international markets as well as the U.S. pending the FDA clearance.

First, I'd say we've been building our basic clinical market awareness by participating in key medical conferences and by hosting people in our exhibit and our booth.

So, as a case in point, although we've been at EASL and focusing on Europe, we're attending and we'll have a booth at the American Association for a study of liver disease, which is the Preeminent Liver Society in the U.S. in November, being held in Boston.

And second, we were delighted to have the EASL peer reviewed abstract publication and building now on our submission with the FDA, we're going to continue to build our base of clinical evidence and sharing it broadly as it comes in. So, that applies and is interesting to clinicians all over the world.

We've had the abstract from EASL already translated into multiple languages and it's something that we're sharing that's on our website for U.S. customers along with everyone else.

The third, and I'd say final thing is you've heard a lot this year about how we've been gaining real-world clinical user feedback and improving our system through user training, the development of active software guidance.

And these are key considerations we're putting in place that are global in nature and that'll benefit customers globally, because learning how they use the product, how we should train them, how we should help them perform their job more effectively and giving them a good experience is really the bedrock of our system.

If our system works only in the hands of experts that are highly supervised, that's going to be tough to kind of scale the business. And we feel like these improvements, the clinical data we've supported and built this year is going to be global -- globally valuable. So, for Europe and the U.S. as you were asking. I hope that's helpful..

Yes. That's very helpful. Thank you for the answering my questions and I wish you guys good luck. Thank you..

Thank you again, Ed..

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

End of Q&A:.

Great. Well, at this point, I just want to thank everyone for joining us today. A lot of work, a lot of accomplishments in the quarter through today with the FDA announcement. We look forward to keeping everyone updated on our progress and to speaking with you again on our next quarterly conference call. Have a nice evening..

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