ENDRA Life Sciences Inc. Q4 FY2023 earnings call

• Advancing mission to revolutionize metabolic health through five areas: activating clinical partner sites, FDA De Novo application, strengthening commercial position, leveraging industry building blocks, and IP licensing.
• Installed TAEUS system at King's College Hospital in London for a clinical study comparing TAEUS's liver fat assessment to MRI. Study to include ~75 subjects and findings to be published.
• Active and pending clinical sites crucial for generating clinical evidence, supporting regulatory filings, commercial traction, and technology enhancement.
• Engaged closely with FDA, received AI request, granted in-person pre-sub meeting in Q2 2024 to discuss product and clinical data.
• Strengthening commercial position through clinical relationships and awareness activities, attending major conferences.
• Leveraging market developments in liver disease detection/treatment, including updated screening guidelines, new ICD-10 code for fatty liver, and FDA approval of Rezdiffra.
• Actively exploring IP licensing and expansion beyond current markets, with 75 issued patents worldwide.

For the year ended December 31, 2023, operating expenses decreased to $10.5 million from $13.2 million in 2022. Research and development expenses decreased by ~$1.6 million as initial TAEUS product development was completed. Sales and marketing expenses decreased by ~$609,000 due to departure of Chief Commercial Officer. General and administrative expenses decreased by ~$478,000. Net loss in 2023 was $10.1 million or $1.58 per share, compared to $13.2 million or $4.50 per share in 2022. Cash and cash equivalents were $2.8 million as of December 31, 2023. In Q4, raised $677,000 from common stock sale and $1.1 million from warrant exercises.

• FDA meeting scheduled for Q2 2024 to advance regulatory submission; confident in positive outcome based on clinical data and FDA interactions, but no specific decision timeline provided as not entirely in control.
• Continuing to engage closely with FDA to move forward with U.S. regulatory submission.

• Regulatory risks associated with FDA approval process, as timelines and outcomes are not entirely within company control.
• Uncertainties related to successfully obtaining regulatory clearances and achieving commercialization goals as per forward-looking statements.

Q: Edward Woo asks about the FDA decision timeframe and when a decision may be made.

A: Francois Michelon states they are in close communication with FDA, granted a meeting to advance discussion, confident in positive outcome but can't give specific timeline as not entirely in control. Michael Thornton adds they are discussing clinical study design with FDA in the upcoming Q2 meeting.

Q: Edward Woo asks about differences in EU approval vs FDA requirements.

A: Francois Michelon and Michael Thornton explain CE mark enables EU sales but FDA has higher bar, focusing more on efficacy including clinical efficacy, whereas CE clearance is more on safety and processes, with De Novo pathway for FDA requiring clinical data unlike 510(k) process.