ENDRA Life Sciences Inc. Q3 FY2023 earnings call

• TAEUS momentum: Includes clinical, regulatory, and commercial progress. Spent time at AASLD liver meeting, interacted with experts, etc.
• FDA de novo submission: Submitted TAEUS de novo request to FDA on August 14, 2023, and it has entered the substantive review period. FDA's goal is to decide on de novo request within 150 review days.
• Clinical data: Second positive clinical data set reviewed and accepted for presentation by EASL, comparing TAEUS liver measurements to MRI in 45 subjects with strong correlation. Participated in multiple clinical conferences in key markets like U.K., Germany, France, U.S.
• IP portfolio: Achieved 70 issued patents, with three additional patents issued in Q3 and three more in Q4 thus far. Actively exploring licensing opportunities in non-core indications.
• Clinical site deployments: Deployed TAEUS FLIP system to a new U.S. clinical collaborator site and scheduling European study site deployment to build clinical evidence.

No detailed product segment breakdown by revenue contribution. The company's focus is on the Thermo Acoustic Enhanced Ultrasound liver system (TAEUS), with progress in clinical, regulatory, and commercial activities related to TAEUS.

• Focus on securing first commercial orders for TAEUS in Europe where CE mark is obtained.
• Support FDA review process to achieve favorable de novo decision for ENDRA.
• Plan to commercialize in U.S. market upon FDA approval, leveraging Vietnam distribution agreement tied to FDA approval.
• Continue to grow and diversify clinical evidence at study partner sites in Europe and U.S. to support commercial adoption.

• General risks related to regulatory approval timelines, as the FDA review process is interactive and uncertain.
• Commercialization challenges in entering new markets like the U.S. after FDA approval.
• Capital raising needs to support future funding requirements for operations and growth.

Q: About the de novo submission timeline, you said 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?

A: It's actually 150 days of review time, including various risk products. It's an interactive process, not a black box, with potential for being around that timeframe but interactive with the FDA.

Q: 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 follow-up questions?

A: No, it's not a binary process. It's quite interactive. We've had interactions with the FDA with questions and have provided rapid turnaround responses, continuing the collaborative process.

Q: As you guys get ready for hopefully a successful approval, would you talk about commercialization plans, specifically in the U.S., can you start now or have to wait until you actually get the final approval to really step on the gas?

A: First focus is Europe due to CE mark. Have a small sales team in France, U.K., Germany. Building clinical sites there. As we get closer to FDA decision, will replicate Europe approach in U.S., leveraging clinical evidence from U.S. sites under IRB protocols, then deploy targeted sales team around reference sites once FDA approved.