Earnings Call Transcript - NDRA Q1 2023

Operator, Operator

Good day, and welcome to the ENDRA Life Sciences Inc. First Quarter 2023 Financial Results Conference Call. All participants will be in listen-only mode. After today's presentation, there will be an opportunity to ask questions. Please note, this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

Yvonne Briggs, Investor Relations

Thank you, operator. This is Yvonne Briggs with LHA. Good afternoon, and welcome to ENDRA's first quarter 2023 business update and financial results conference call. Earlier today, ENDRA issued a press release on this topic, which is 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 fourth quarter financial results. With that said, I will now turn the call over to Francois Michelon. Francois?

Francois Michelon, CEO

Thank you, Yvonne, and good afternoon, everyone. Thanks for joining us today to discuss ENDRA's first quarter 2023 financial results and business highlights. I'm extremely pleased to report that we've completed the clinical data collection to support our de novo request to the US FDA. Collectively, more than 100 subject scans have been performed with our interactive guidance tool, and we believe these scans will demonstrate the ability of TAEUS to measure liver fat in the earlier stages of Non-Alcoholic Fatty Liver Disease, known as NAFLD, at the point of patient care. We're analyzing the collective data and expect to make our de novo submission to the FDA midyear. We believe this regulatory pathway will assist us in achieving the strongest market potential with TAEUS optimized claims as the de novo process is reserved for novel technologies without equivalents in the market. Mike Thornton will provide more detail on our clinical progress shortly. Thermo Acoustic Enhanced UltraSound, known as TAEUS, is an integral part of ENDRA's vision to provide better healthcare to more people by introducing point-of-care technology that addresses areas of high unmet clinical need. Non-alcoholic fatty liver disease affects over two billion people globally. And there are currently no diagnostic tools that combine accuracy, safety, cost effectiveness and ease of use. MRI is accurate, but it's also expensive and slow. Liver biopsy is painful and can only be performed by someone with surgical training. Traditional ultrasound derivatives can measure liver stiffness but haven't yet demonstrated the necessary sensitivity to stage NAFLD patients in the early phases of the disease when it's most reversible. The annual liver disease diagnostic market opportunity is estimated to be $12.5 billion in size. The advent of the first targeted NAFLD drug therapies intensifies the need for clinicians to identify appropriate patients with practical diagnostic tools and then to monitor the response of those patients on the drugs. TAEUS aims to fill that gap and help clinicians accurately characterize the liver non-invasively, at the point of patient care, and at one-tenth the cost of an MRI. Given these unmet clinical needs and TAEUS' potential to assess liver fat at the point-of-care, we're very excited to have collected the data necessary for our de novo request, as it represents a significant milestone for the company. Turning to intellectual property, we've made some great progress here, too, increasing our patent portfolio with seven newly issued patents so far this year, bringing the total portfolio to 63 issued patents and 31 filed assets. This significant growth in patents, not only protects our technology but also creates opportunities for out-licensing. Finally, subsequent to the close of the quarter, we were able to strengthen the company's balance sheet with an upsized capital raise of $4.5 million in net proceeds despite the challenging capital market conditions. We'd like to thank the participation of long-term investors and company insiders for this capital, which positions ENDRA to achieve key milestones, such as FDA submission and commercial deployment. Okay, over to Mike Thornton for detail on our clinical progress. Mike?

Michael Thornton, CTO

Thank you, Francois. In our most recent Q4 update, we reported that over 100 study participant exams have been obtained at our clinical study sites in 2022. We observed that while some users were able to obtain TAEUS measurements with high repeatability that is commensurate with our TAEUS systems' capabilities to produce highly repeatable measurements, other users had significantly higher variability. With the aim of normalizing user performance across our clinical collaborator study sites, we deployed additional user training and graphical user guidance tools that provide feedback to the operator regarding the efficacy of probe positioning with the aim of producing valid measurements with our fatty liver assessment system. Since February of this year, our clinical collaborators have obtained more than 100 study participant exams with the user guidance tool. The feedback from users at our three clinical sites has been overwhelmingly positive, with users highlighting the reduction in procedure time and improvement in overall usability. These TAEUS exams were typically completed in 10 minutes, including the ultrasound localization procedure that is required for our fatty liver assessment measurement. As for our upcoming FDA submission, we've now completed the necessary exams and are in the process of reviewing the data package prior to submission. We believe that we have a sufficient number of TAEUS exams with sufficient quality and the associated MRI-derived gold standard NAFLD markers, necessary to support our de novo submission. In addition to the data collection for the de novo submission, we'll continue to work with our current and future clinical study partners to add to the clinical evidence for our TAEUS system. We're very fortunate to have existing clinical partners in key global markets that will serve as reference sites to support commercialization. I'm also pleased to announce that a clinical abstract featuring ENDRA's Thermal Acoustic assessment of fatty liver disease has been accepted by the European Association for the Study of the Liver for presentation at the International Liver Congress in June in Vienna. ENDRA's abstract, which will be published in early June, is derived from a cohort of study participant exams obtained at a single US clinical site in early 2022 before the software guidance tool was deployed. While the sample size was small and the scans were performed before we introduced the current guidance tool, the abstract highlights the correlation of TAEUS measurements to MRI-PDFF as well as TAEUS' potential to differentiate mild or moderate severe fatty liver disease. Scientific and Medical Association journals and conference presentations are the primary forums for introducing new procedures and approaches to the management of diseases and in turn, drive the adoption of new technologies. This peer-reviewed abstract is only the first of what we expect to be several conference presentations in 2023 that will publicize ENDRA's technologically innovative work and the initial clinical performance. In addition to the accepted abstract for the European ILC meeting in June, we plan to submit multiple abstracts to the American Association for the Study of Liver Disease meeting and the European NAFLD Summit. Now I'd like to turn the call over to Irina to review the financial results for the first quarter of 2023. Irina

Irina Pestrikova, Senior Director of Finance

Thank you, Mike. For the quarter ended March 31, 2023, our operating expenses were $2.9 million, unchanged from 2022. Increases in research and development and general and administrative expenses were offset by decreases in sales and marketing expenses. Our research and development expense increased year-over-year by approximately $180,000 due to ongoing product development work. Our sales and marketing expenses decreased by approximately $160,000 for the quarter, mainly due to the departure of our Chief Commercial Officer. General and administrative expenses increased by approximately $60,000 due to increased spending on legal fees. Net loss per share in the first quarter of 2023 was $0.93, compared with a net loss of $1.33 per share in the first quarter of 2022. Cash and cash equivalents were $2.4 million as of March 31, 2023. As Francois just mentioned, subsequent to the close of the quarter, the company raised approximately $4.5 million in net proceeds through a registered offering. We believe our current capital position provides runway into the fourth quarter of 2023. We maintain our asset-light operating model with minimal 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.

Francois Michelon, CEO

Thanks very much, Irina, and thank you, Mike. In closing, here are the three key messages I'd like listeners to take away from this call. First, we've completed the collection of our clinical data necessary to support TAEUS de novo request to the FDA, which we expect to submit mid-year. In addition, we'll leverage this clinical data to arm our sales team with strong clinical value propositions to further our commercial efforts in Europe. Second, we're maintaining a steady cadence of marketing activities to expand awareness of our TAEUS technology, with a range of clinical specialties, particularly in Europe, where we have CE regulatory approval. These activities center on participating in key radiology, hepatology, and endocrinology conferences where clinicians go to learn about the latest research and new technologies. We're entering a new level of market awareness with the first TAEUS clinical abstract accepted for presentation at a major European Clinical Society in June, and we'll continue to publicize the clinical performance of our TAEUS system through additional peer-reviewed papers and abstracts. And third, with the recent capital raise, we're in a solid position to fund our achievement of key milestones, including FDA submission and commercial deployment in Europe. So with that overview, I'd love to turn the call over to questions. Operator?

Operator, Operator

We will now begin the question-and-answer session. Our first question comes from Edward Woo with Ascendiant Capital. Please go ahead.

Edward Woo, Analyst

Congratulations on the progress with the FDA's de novo submission. My question is about the marketing in Europe since it has been CE approved for a couple of years. Have you gained any insights that could be beneficial when you receive approval in the US?

Francois Michelon, CEO

Thank you for the question. We've gained a lot of insights. Initially, we thought that our main focus would be on radiology since radiologists currently conduct many ultrasound liver scans for various reasons, including gallbladder issues. We believed that we could simply enhance their capabilities by adding a new method to measure liver fat. However, we've discovered significant interest beyond radiology. At various conferences, we've connected with clinicians, particularly gastrohepatologists. Hepatology, which focuses on liver diseases, is a branch of gastroenterology. With the emergence of targeted therapies for treating NAFLD and NASH, these fields—gastrohepatology and endocrinology—recognize a chance to engage more actively in patient care before conditions become severe. They also aim to address obesity and diabetes, which are major risk factors for liver disease. Thus, one of the key lessons we've learned from our commercial efforts is that the market is broader than we initially thought, extending well beyond just the radiology segment. We see opportunities to tailor our approach for different sectors: enhancing radiology with new imaging techniques, equipping hepatology with advanced liver management tools, and supporting endocrinology in managing obesity and diabetes using liver fat as a significant biomarker. This has been a very encouraging realization as we navigate the field. Mike Thornton, do you have any insights from your experiences that could further inform our listeners?

Michael Thornton, CTO

Yes. And thanks, Francois. I think I'll just add on the drug development side. We've all been waiting for a NASH drug to be approved. But we've seen that semaglutide and other GLP-1 agonist drugs that have come on the market, and they've become very prominent in the fatty liver health space. So, I think we're pretty excited about the impact that these diabetes, weight reduction drugs are having on fatty liver and the interest to monitor fatty liver disease and associated metabolic disorders.

Francois Michelon, CEO

Thanks, Mike. I hope that answers your question.

Edward Woo, Analyst

Yes, you guys are very thorough. So thank you very much, and I wish you guys good luck with your submission. Thank you.

Francois Michelon, CEO

Thank you so much.

Operator, Operator

There are no more questions at this time. This concludes the question-and-answer session. I would like to turn the conference back over to Francois Michelon for closing remarks.

Francois Michelon, CEO

Jordan and our listeners, thank you so much for joining us today. We are very excited about the progress we've made and shared with you today, and we look forward to keeping you updated in the coming months, speaking with you on the next quarterly conference call, and we wish you all a good evening. Thank you.

Operator, Operator

The conference is now concluded.