ENDRA Life Sciences Inc. Q1 FY2024 earnings call

• Activating new clinical research sites in target markets to build clinical evidence. - Working closely with the FDA on TAEUS system's de novo application, with a pre-submission meeting scheduled. - Leveraging market developments in liver disease detection/treatment, including clinical society guidelines updates and FDA approval of Rezdiffra. - Actively exploring collaborations and strategic pathways to expand TAEUS platform applications beyond liver, including engaging PatentVest for IP efforts and having 8 new patents issued, bringing total issued patents to 80. - Michael Thornton provided update on regulatory developments, including in-person pre-submission meeting with FDA on clinical trial design.

For the quarter ended March 31, 2024, operating expenses decreased to $2.8 million from $2.9 million in the same period of 2023. Research and development expenses decreased by approximately $350,000 as the initial TAEUS product development was completed. Sales and marketing expenses increased by approximately $57,000 due to higher consulting fees. General and administrative expenses increased by approximately $134,000 due to higher professional fees. Net loss in Q1 2024 was $2.8 million or $0.26 per share, compared to a net loss of $2.9 million or $0.93 per share in Q1 2023. Cash and cash equivalents were $1.1 million as of March 31, 2024. 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.

• Continue leveraging clinical partner sites in Europe and US to build clinical evidence. - Continue engaging closely with FDA to advance regulatory submission in US. - Leverage accelerating market developments in liver disease detection/treatment. - Leverage intellectual property to grow beyond current markets and clinical focus.

Q: 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?

A: 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.