ENDRA Life Sciences Inc. Q4 FY2022 earnings call

Francois Michelon:

• Top priority is completing TAEUS scans for de novo submission to FDA; scanned over 100 subjects in 2022, deployed interactive software guidance tool to global study sites.
• Maintaining marketing activities, including participating in 11 clinical conferences in Europe and US, built sales leads.
• Renewed partnership with GE HealthCare for two additional years.
• Strengthened IP portfolio: 19 patents issued in 2022, total 56 globally issued patents, zero in-licensing dependencies, average remaining patent life over 16 years.

Michael Thornton:

• In 2022, clinical study sites obtained over 100 exams; addressed user variability by deploying training and software guidance tools, saw 3x improvement in intra-operator performance, procedure time reduced to less than 10 minutes.

Irina Pestrikova:

• Discussed unaudited financial results, operating expenses, net loss per share, and asset-light operating model; mentioned cash deposits at multiple banks to mitigate liquidity risk.

For the quarter ended December 31, 2022, operating expenses increased to $3.3 million from $3.1 million in the same period of 2021, primarily due to ongoing product development. Net loss per share in Q4 2022 was $1.04 compared to $1.48 in Q4 2021. For the year ended December 31, 2022, operating expenses were $13.2 million, up from $11.5 million in 2021, driven by product development, sales and marketing, and general and administrative expenses. Research and development expense increased by ~$1 million, sales and marketing by ~$350,000, and general and administrative by ~$230,000. Net loss per share for 2022 was $4.56 compared to $5.55 in 2021. As of December 31, 2022, cash and cash equivalents were $4.9 million.

• Primary focus on collecting clinical data with software guidance for successful US regulatory submission and global commercialization.
• Maintaining marketing cadence in Europe, leading commercial activities personally until replacement found.
• Renewed partnership with GE HealthCare viewed as indicative of GE’s interest in liver disease space and emerging tech.

• Forward-looking statements included; refer to Form 10-K for risks related to forward-looking statements.
• Liquidity concerns due to Silicon Valley Bank closure, but ENDRA maintains cash deposits at multiple banks to mitigate risk.

Q: Feedback on interactive guidance tool and data for de novo submission?

A: Francois and Mike responded that the tool provides real-time guidance, data from software-guided procedures using TAEUS system on subjects scanned within weeks on MRI (gold standard) will be submitted for de novo. Procedure time reduced to less than 10 minutes with improved intra-operator performance.

Q: Thoughts on procedure time improvement and GE partnership renewal?

A: Francois and Mike noted procedure time includes ultrasound exam steps, users performing well; renewal of GE partnership has long history, GE helped with engineering and market access, ENDRA aims to leverage GE in radiology and expand into other specialties like hepatology and endocrinology.