ENDRA Life Sciences Inc. Q2 FY2023 earnings call

• Submitted de novo request to U.S. FDA for TAEUS system, with clinical data showing TAEUS estimates of liver fat fraction highly correlated to MRI-PDFF scores.
• Showcased TAEUS at German Diabetes Association's 57th DDG Annual Meeting and European Association for the Study of the Liver Congress.
• Shared peer-reviewed clinical abstract on Thermoacoustic Assessment of Fatty Liver Disease.
• Expanded intellectual property portfolio to 64 issued patents globally, securing 4 additional patents including one in U.S. and three in China.
• Raised approximately $4.7 million through underwritten public offering in May 2023.
• Advantages of TAEUS over conventional ultrasound: molecular signal contrast, insensitivity to fibrosis, tissue depth penetration, and within image calibration.

No detailed breakdown of product segments with revenue contribution percentages provided. Overall, operating expenses decreased to $3 million from $3.6 million in 2022, net loss per share improved to $0.43 from $1.17 in 2022, and cash and cash equivalents were $4.8 million as of June 30, 2023, with $4.7 million raised via public offering during Q2 2023.

• Current cash position provides runway into fourth quarter of 2023.
• Plan to adjust expense structure in support of regulatory and commercial strategy for TAEUS.
• Expect to record first sales in Europe before end of 2023.

• Uncertainty regarding the FDA review process timeline and outcome for the TAEUS de novo request.
• Dependence on regulatory clearance from the FDA for full commercialization of TAEUS.

Q: Previously had a distribution agreement in Vietnam, still in place? And recognition of revenue on U.S. FDA approval?

A: The exclusive distribution agreement with a distributor in Vietnam is in place and activated by the FDA approval of the TAEUS application, with a three-year process and commitment of 40 systems at an agreed upfront transfer price.

Q: Can commercialization efforts proceed in U.S. before FDA approval?

A: Building clinical market awareness through attending key medical conferences, having peer-reviewed abstract published, and gaining user feedback and improving the system globally, which benefits both Europe and the U.S. pending FDA clearance.