ENDRA Life Sciences Inc. (NDRA) Q1 2024 Earnings Report, Transcript and Summary

Good day, and welcome to the ENDRA Life Sciences First Quarter 2024 Financial Results Conference Call. [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 Life Sciences' First Quarter 2024 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, are forward-looking statements. These include 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. 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, 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 first quarter financial results, and then we'll take your questions. I'll now turn the call over to Francois Michelon. Francois?

Thank you, Yvonne, and thanks for joining us today to review ENDRA's first quarter 2024 financial results and key business developments. We're advancing on our mission to revolutionize metabolic health through the practical detection and monitoring of liver disease, and we've made good progress in the following areas: first, activating new clinical research sites in target markets to build our body of clinical evidence at the local level across a range of sites, users and patient types. This clinical data is a foundational element to achieving commercial success in the future. Second, working closely with the FDA to align on clinical requirements for our TAEUS system's de novo application. A pre-submission meeting is scheduled with the FDA in suburban Washington, D.C. this quarter. Third, leveraging the accelerating market developments in the detection and treatment of liver disease to strengthen ENDRA's position. And fourth, looking beyond our current markets and technology to new opportunities to license our intellectual property. I'll elaborate on each of these elements. In the first quarter, we achieved a milestone in one of our target markets by installing the first TAEUS system in the United Kingdom. King's College Hospital in London, a prestigious National Health Service institution, is leading the introduction of ENDRA's liver system in the U.K. market. This partnership entails a clinical study comparing TAEUS' liver fat assessment accuracy versus MRI, the recognized research standard. The U.K., along with other active clinical study sites in the U.S., are crucial for generating the body of clinical data needed to support the commercial adoption of our technology across radiology, hepatology and endocrinology in global markets. The clinical abstracts we presented last year at the European Association for the Study of the Liver were a great start, highlighting the impressive clinical performance of our technology compared to the MRI gold standard. But we need to continue to expand this pool of real-world evidence to demonstrate our clinical and economic value to potential users in our target markets at the local level. In addition to the foundational work of building our clinical evidence, ENDRA is working closely with the FDA to achieve alignment on clinical requirements for our TAEUS system's de novo application. ENDRA has had several interactions with the agency since Q4 of 2023, and we've provided additional information about our technology and historical clinical testing. To advance a review process and further align expectations with the aim of ultimately achieving a successful regulatory outcome, ENDRA has scheduled an in-person pre-submission meeting with the FDA this quarter, focusing on clinical requirements. Mike will elaborate on this in a minute. On a broader market basis, key building blocks for diagnosing, treating and managing liver disease are rapidly advancing, providing hope for the millions who are affected and opportunities for companies like ENDRA. Leading clinical societies such as the American Diabetes Association and the American Association of Clinical Endocrinology have updated their guidelines and now recommends screening for fatty liver disease for prediabetic, diabetic and obese patients. That's over 100 million people in the U.S. alone who need to be evaluated, and MRI is not a practical solution for a population this large. A second building block relates to the FDA's recent approval of Rezdiffra, Madrigal Pharmaceuticals' pioneering drug therapy for NAFLD/NASH, marking the beginning of a new chapter in liver disease management. This therapy, along with other emerging targeted treatments for liver disease, will significantly impact health care providers, insurers and patients. Major insurers like Blue Cross are requiring adherence to 9 specific prescribing authorization criteria for Rezdiffra, including an MRI-PDFF liver fat quantification exam, which can only be performed by the most advanced subset of the world's MRIs. This underscores the complexity of managing this disease and highlights the need for precision in diagnosis and treatment. Rezdiffra and future drugs will consequently drive demand, we believe, for more accessible point-of-care diagnostic tools like ENDRA's TAEUS that are capable of facilitating the assessment and monitoring of liver disease affecting over 2 billion people globally. Finally, we're actively exploring collaborations and strategic pathways to expand the applications of our TAEUS platform beyond the liver. By leveraging our intellectual property and engaging in strategic partnerships and out-licensing initiatives, we aim to capitalize on the potential of our TAEUS platform in new therapeutic areas. We've engaged PatentVest, a leading intellectual property advisory firm, to spearhead ENDRA's IP valuation, competitive landscape analysis and licensing efforts. To that end, we're aggressively expanding our global intellectual property portfolio with the issuance of 8 new patents so far this year. With these additions, ENDRA's patent status reached an impressive 80 issued patents worldwide. These patents safeguard key innovations that are integral to the TAEUS system and reinforce our competitive edge in the marketplace. I'll now turn the call over to Mike Thornton for an overview of our clinical and regulatory advancements. Mike?

Thanks, Francois. Today, I'll provide an update on regulatory developments for ENDRA's TAEUS system. ENDRA has secured a valuable opportunity for an in-person pre-submission meeting in the second quarter with the FDA at their Maryland facility to prepare and submit a new de novo application. The focus of this meeting will be clinical trial design that is crucial for obtaining alignment with the FDA on our study design. We'll discuss key aspects, including the study design, study hypothesis and the statistical analysis plan. Further, we provided the FDA with a detailed description of the device and a master protocol that outlines a clinical study across multiple sites. This proposed study will cover a range of liver fat percentages mirroring the prevalence of steatotic liver disease in the U.S. population. And this pre-submission team for the upcoming meeting includes key technical staff and an experienced regulatory lead with over 20 years of first-of-a-kind medical device experience, a senior biostatistician that is familiar to the FDA and several radiology clinical experts. Why is ENDRA's approach different this time? Reflecting on our past regulatory strategies and the fast-evolving medical imaging regulatory landscape, it's clear that ENDRA's historical reliance on clinical data derived from multiple feasibility studies was insufficient for FDA's current standards. The current approach is to work hand-in-hand with the FDA through its pre-submission process to develop a prospective, statistically powered pivotal trial, whose data will be acceptable to FDA for our de novo grant. We look forward to updating you on the outcomes of our FDA meeting and the next steps in our regulatory process. With that, I'll turn it over to Irina Pestrikova for our financial update. Irina?

Thank you, Mike. Turning now to a review of our recent financial performance. For the quarter ended March 31, 2024, our operating expenses decreased to $2.8 million from $2.9 million for the same period in 2023. The decrease was mainly due to lower research and development expenses. Our research and development expenses decreased year-over-year by approximately $350,000 as we completed the development of our initial TAEUS product. Our sales and marketing expenses increased by approximately $57,000, mainly due to higher consulting fees. General and administrative expenses increased by approximately $134,000, mainly due to higher professional fees. Our net loss in the first quarter of 2024 was $2.8 million or $0.26 per share. This compares with a net loss of $2.9 million or $0.93 per share in the first quarter of 2023. Cash and cash equivalents were $1.1 million as of March 31, 2024. In the first quarter, the company raised $420,000 in gross proceeds from the sale of common stock through at the market equity facility and $77,000 from the exercise of warrants. We're focused on managing our current resources and financing opportunities to maintain the capital necessary to progress our operating plan. Now I'll turn the call back to Francois.

Thanks, Irina and Mike. In summary, we remain committed to driving innovation and our market presence through the following 4 levers: number one, leveraging clinical partner sites in Europe and the U.S. to build our base of clinical evidence and achieve successful adoption of our technology; number two, engaging closely with the FDA to advance our regulatory submission in the U.S.; number three, leveraging the accelerating market developments in the detection and treatment of liver disease to strengthen ENDRA's position; and fourth, leveraging our intellectual property to grow beyond our current markets and clinical focus. On behalf of the entire ENDRA team, once again, I extend my thanks to the shareholders for their continued support of ENDRA. And now, operator, we're ready to open the call to questions.

[Operator Instructions] The first question comes from Edward Woo from Ascendiant Capital.

My question is on Asia. I know you have the distribution in Vietnam that will go live as soon as you get FDA approval. Is there any other parts of Asia that you're possibly thinking to go into?

Thanks, Ed. Yes, great question. I think to put it in context, before I get to any specifics on Asia, as a small company, we have to focus our resources. Obviously, we're starting strongly in Europe with the CE mark. The U.K. clinical site is our anchor there. And as we've announced, we plan to carefully add more sites in our target markets, resources permitting; and then, concurrently, managed the FDA process and the 3 active sites we have in the U.S. on a pre-FDA basis to prepare the U.S. market. You're absolutely right, we've disclosed that we do have a distribution agreement in Vietnam, which is a surprisingly high-growth and high-populated market, and we're happy for that. That would go into effect upon FDA approval. And we also previously announced years ago or rather a couple of years ago, the agreement we signed with Shanghai General Hospital as a clinical study site in the PRC. So we're definitely looking at Asia. We have a few anchor points through those 2 mechanisms. Asia, obviously, is a large market where liver disease is quite prevalent. But I would say that I'd like investors to hear, first and foremost, disciplined and focus on being successful first in Europe, then in the U.S. and leveraging then carefully with all that knowledge and the base of clinical evidence that I've mentioned, which would be foundational for it all to then go to Asia. So I hope that helps answer your question.

Yes, it does. I wish you good luck with the FDA meeting. And thank you, and I wish you guys good luck.

Operator, if we don't have any other questions, I think we can wrap up the call then.

Thank you. This concludes the conference. Thank you for attending today's presentation. You may now disconnect.

Thank you, everyone.