ENDRA Life Sciences Inc.

Good day and welcome to the NDRA Life Sciences third quarter 2023 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 star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touch tone phone. To withdraw your question, please press star then two. 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 NDRA's third quarter 2023 Business Update and Financial Results Conference Call. Earlier today, NDRA issued a press release on this topic, which is available in the Investors section of NDRA'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 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, NDRA's Chief Technology Officer. Mr. Thornton will be followed by Irina Pestrikova, Senior Director of Finance, to review the third quarter financial results. With that said, I'll now turn the call over to Francois Michelin. Francois?

Thank you Yvonne and good afternoon everyone and thanks for joining us today to discuss Endra's third quarter 2023 financial results and business highlights. I'm delighted by the momentum that's building for our thermoacoustic enhanced ultrasound liver system known as PEAS. This momentum checks a number of boxes including clinical, regulatory, and commercial along with a convergence of a number of factors that put NDRA in the right place at the right time. We spent the last few days of the liver meeting held by the American Association for the Study of Liver Diseases where we interacted with experts in the field, clinical users, prospective customers, and partners. Steatotic liver disease, known as SLD, is the umbrella term for a multifaceted metabolic disorder resulting in too much fat in the liver. Anything over 5% liver fat is of clinical significance, and this fat can irritate and inflame the liver, then scar it, and ultimately lead to irreversible end-stage liver disease. Steatotic liver disease is estimated to affect more than 2 billion people worldwide, and it's predicted to become the leading root cause of liver transplants in the U.S. by 2030. The American Association of Clinical Endocrinology and the American Diabetes Association have updated their guidelines over the past 18 months to include the screening for fatty liver in adults with obesity, prediabetes, and type 2 diabetes. The good news is that the new GLP-1 obesity drugs have demonstrated clinically significant reductions in liver fat, and a rich pipeline of targeted therapies to treat SLD in both obese and non-obese patients is approaching commercialization, with the first drug approvals expected in early 2024. This intersection of variables, a heavy public health burden, a lack of practical diagnostic tools and the near-term availability of the first treatments creates an opportunity to address the large unmet clinical need for a noninvasive, cost-effective tool to assist in identifying and monitoring patients. That's where NDRA intends to lead. As discussed on our last conference call, we submitted the TEIS de novo request to the FDA on August 14th of this year. And since then, the submission has entered the substantive review period. The de novo submission was a significant milestone for NDRA as this regulatory pathway should strengthen our competitive position with distinctive patent protected capabilities as a noninvasive point of care tool to aid in the characterization of liver fat. We look forward to working with the FDA during the review process. And the FDA's published goal is to make a decision on a de novo request within 150 review days. Since our FDA submission, we've had our second positive clinical dataset reviewed and accepted for presentation by the European Association for Study of the Liver. These clinical abstracts are available on ENDRA's website under the tab Research and Media. The most recent abstract includes 45 subjects comparing ENDRA's TEIS liver measurements to MRI, and we're very pleased with the results. We believe the data in these published abstracts and related presentations are crucial to building awareness of the TAIS system and its capabilities with clinical users and to supporting commercial adoption of our new technology. The clinical data is the most critical element for getting commercial traction with clinical customers. Mike Thornton will provide more detail on our clinical data in a moment. In terms of commercial activities, We've been actively showcasing our TEIS liver system at the key clinical conferences in hepatology, endocrinology, and radiology in our target markets of the UK, Germany, France, and the US. We've participated in eight clinical conferences this year, including five since September, namely, The British Association for Study of the Liver, European Association for the Study of Diabetes, French Society for Hepatology, Drei Lander Treffen, which is the annual meeting of the ultrasound societies in Germany, Austria, and Switzerland. And I've just returned with Mike Thornton from the American Association for the Study of Liver Diseases in Boston, which is the preeminent liver meeting in the US. We also sponsored a great multidisciplinary panel discussion on liver disease while at ASLD from the perspective of a hepatologist, the liver experts, an endocrinologist, the metabolic obesity and diabetes experts, and a radiologist, the imaging experts. Steatotic liver disease resonates with each of these specialties, and there's a growing interest in the primary care arena as well. Turning to intellectual property, we continued to bolster our portfolio and recently achieved a great new milestone of 70 issued patents, with three additional patents issued during the third quarter and three more patents issued in Q4 thus far. A portfolio with 70 issued patents and no in-licensing dependencies is a remarkable achievement for a company of our size and a testament to the innovation of Endra and the proprietary nature of our technology. These newly issued patents protect and further differentiate Endra's thermal acoustic systems in areas of high unmet clinical need, such as the early detection of steatotic liver disease. The company is also actively exploring licensing opportunities in non-core indications with outside partners to augment the value of our growing intellectual property portfolio. With that update, I'll turn the call over to Mike Thornton for more details on our clinical and regulatory progress. Michael?

Thank you, Francois. We're very pleased to have submitted a de novo request to the FDA for our TAIS system in August and to report that our file has advanced to the substantive review stage. At this point, We're engaged with the FDA in addressing their questions in a timely and complete manner to keep advancing the process. As we noted earlier, if there are any significant updates, we'll share those with shareholders as we've always done. As Francois mentioned, our clinical study activities support both our regulatory and early commercialization efforts. Our second presentation of clinical data was presented at the recent European Association for the study of liver diseases, steatotic liver disease summit in September. The clinical study that was presented included 45 study participant exams comparing KS estimates of liver fat fraction to the established gold standard MRI measurements of liver fat fraction. The study cohort included a wide range of body size with body mass index ranging from 24, that is normal, to 45, which is classified as Class III obesity. The cohort included four study participants with confirmed fibrosis. No study subjects were excluded due to high body mass index or liver fibrosis. This is a key point. Conventional quantitative ultrasound methods are not able to accurately estimate the liver fat fraction in individuals with high body mass index and often overestimate liver fat fraction in subjects with confirmed liver fibrosis. In other words, conventional tools for the assessment of steatotic liver disease are not capable of accurately assessing the wide range of possible patient body size and medical conditions, which creates an urgent market need for a device like TEAS. The TEAS system estimates of liver fat fraction in this study were highly correlated to MRI PDFS scores of liver fat fraction with a correlation coefficient R-value of 0.87. In biology and medicine, two variables are considered to be strongly correlated if the Pearson correlation coefficient is greater than 0.8 and that a large part of the measurement variation in the gold standard measurement can be explained by the new measurement method. The sensitivity of TEIS in detecting fatty liver disease was 95%, with a specificity of 77%. The negative predictive value, which is the probability that a negative test result is correct, was 95%. Negative predictive value is an important measure of test performance because in a cost-constrained healthcare environment, it is often important to correctly identify healthy subjects and preclude additional costs. as it is to identify those individuals with the disease. We're excited by the performance of the system, and our aim is to continue to expand the collection of clinical data and to publish results from our clinical collaborations. In support of this effort, we have recently deployed a KS flip system to a new US clinical collaborator site and are scheduling a European study site deployment in the next few weeks. These new clinical study sites along with the authorization for new studies at past clinical collaborator sites, will drive our goal of obtaining several hundreds of study participant exams with our approach to estimating liver fat fraction. As Francois mentioned, we recently participated in the American Association for the Study of Liver Disease annual meeting in Boston, where we showcased the TEAS system and highlighted its capabilities. Our system generated a great deal of interest from both healthcare providers and industry attendees. During the conference, we also hosted a panel discussion of multidisciplinary experts in the fields of hepatology, endocrinology, and radiology, in a discussion of the multidisciplinary nature of the diagnosis, treatment, and management of metabolic-associated steatotic liver disease. The discussion highlighted the importance of liver fat fraction as a biomarker of diseases that expand beyond the liver, namely hypertension, diabetes, cardiovascular disease, and the increased risk of cancer that will drive interest in our technology beyond hepatology. To further emphasize the relationship between steatotic liver disease and the complex of diseases that make up metabolic syndrome, recent GLP-1 obesity drug studies have illustrated the relationship between weight loss a reduction in liver fat fraction, and cardiovascular disease risk. Overall, the discussion with clinicians and the focus on issues directly addressed by TEIS during the panel discussion demonstrates not only a clear market need for our system, but also an awareness and urgency from practitioners, which we are hopeful will soon translate into our first sales. Now I'd like to turn the call over to Arena to review our financial results for the third quarter of 2023. Arena?

Thank you, Mike. For the quarter ended September 30, 2023, our operating expenses decreased to $3.1 million from $3.4 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 $197,000 as we completed the development of our initial TS product. Our sales and marketing expenses decreased by approximately $177,000 mainly due to the departure of our chief commercial officer. General administrative expenses increased by approximately $86,000 due to higher spending on professional fees. Net loss in the third quarter of 2023 was $3.1 million or 40 cents per share. And this compares with the 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, We raised a total of $1.2 million in gross proceeds from the sale of common stock through our ATM facility. We believe our current capital position provides a runway into the first quarter of 2024, and we are currently evaluating alternatives to raise capital to provide for our future funding needs. We maintain our asset-light operating model with spreading hires in our operations and commercial team in anticipation of future growth. As we execute our regulatory and commercial strategy for TAIS, 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, We remain very excited about the value proposition for TEAS as a non-invasive, cost-effective tool to assess liver fat, especially as the clinical community prepares for the near-term arrival of the first treatments targeting the disease, which affects 2 billion people worldwide. Endra's near-term focus is on the following four value-added catalysts. Number one, securing the first commercial orders for Arteus technology in Europe where we have the CE mark. Second, supporting the FDA through their review process with the goal of achieving a favorable de novo decision for Andra. Third, commercializing in the U.S. market upon FDA approval along with our Vietnam distribution agreement that is tied to the FDA approval. And fourth, continuing to grow and diversify our base of clinical evidence at clinical study partner sites in our target markets in Europe and the U.S. to support commercial adoption of our technology. With that overview of our business and recent financial performance, I'd like to now open the call for questions. Operator?

Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Edward Wu with Ascendian Capital. Please go ahead.

Yeah, congratulations on the progress. I had a question about the de novo submission. You said that it was a target of 180 days. Does the FDA typically keep it at 180, or is there a possibility that it could be quicker depending on the review?

Yeah, it's actually, I don't know if I misspoke or my voice wasn't clear, it's 150 days of review time. And, you know, that includes everything from invasive higher risk products to lower risk products. It's a bell curve. I don't want to get any more specific than that, but obviously there is a possibility of, you know, being somewhere around that. I just wanted to give what's the official sort of target coming from the FDA. And I hope now that we're past the COVID distraction that burdened the FDA for quite a lot of time in 2021 and 22, that the agency will return to its norms in terms of review cycles. So thanks for that question. Anything else on your mind?

Yeah, then a follow-up. Is it a binary process where you submit the application and then you just get a response after 150 days? Or is there a back and forth that they have

No, no, great question. And I may ask Mike to jump in here a little bit. But no, thankfully, it's not a black box. It is quite interactive, and because it is a new technology and we're in this de novo category, there are a number of anticipated questions that we've been engaging on with the FDA, and it's quite collaborative so far in tone and cadence. Mike, I don't know if you have other ways you might want to characterize our interaction with the FDA thus far.

Yeah, we've had a number of interactions with them with some questions that came from the FDA, including two cycles of rapid turnaround responses within a matter of days. So we're continuing that process.

Yeah. Sorry, go ahead.

So it's typically an iterative process until the end.

Yeah, correct. And I think along the way, both parties kind of understand where they're going, address any issues, resolve any questions that may be open. But hopefully it's not a surprise at the end since you've been engaged along the path. So to be clear, it's not submit it and wait 150 days and get a yes, no. It's submit it, engage, address questions as we've been doing quickly and effectively. and collaborate with the agency to bring this to market.

Yeah, that sounds good. And, you know, congratulations. Good job. And my last question is just on, you know, as you guys get ready for hopefully a successful, you know, approval, what do you talk about? Can you talk a little bit about the commercialization plans that you guys are having set up in the U.S.? Can you start now or do you have to wait until you actually get the final approval to really step on the gas?

So a couple of things. One, our focus right now is Europe because we obviously have regulatory approval there. We have a small, cost-effective sales team in France, UK, and Germany. And we're building our clinical study sites in those regions in each country, not only to build the base of clinical evidence, as Mike referred, but also to become reference sites in each of those target markets. So our first focus, and we think our first opportunity, is clearly commercially in Europe. And those are very large markets. You know, Germany, France, and the UK are the largest healthcare markets. They have a mix of public and private structures, but there's plenty of opportunity for ENDRA there. And I would say as we get closer to an FDA decision, we would replicate some of that approach and certainly leverage anything we've learned in Europe in terms of clinical and economic value propositions that support the product. But also, I think we'll be a little bit ahead, because as Mike said, we have sites in the US that are currently scanning patients under what is called a IRB, or Institutional Review Board, protocol, which is a pre-FDA approval to use this study, or use the TEIS technology on subjects and patients. And so we're going to be building our basic clinical evidence in the US ahead of getting the FDA approval, which will help us once we have the FDA approval, and then we'll carefully deploy a targeted sales team, probably around the reference sites that I mentioned, the clinical sites where we can use and leverage those partnerships to be references for the next wave of adopters. But clearly, the goal is to stay focused on Europe first, get the FDA approval, open up that market, leverage the clinical evidence that's being built around, and then pursue opportunities in Asia. But, you know, we have to be as focused and effective and cost-effective as possible as well. Hope that's helpful.

Yes, that was very helpful. Thank you, and I wish you guys good luck. Thank you.

Thank you, Ed, very much. Operator, yeah, I don't see any other questions. Thank you, operator, for facilitating that. And I very much want to thank our listeners, our investors today for joining our call. We look forward to keeping you informed of our accomplishments and to speaking with you again when we report our fourth quarter and full year financial results. And I wish you all a good evening.

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