Release Date: August 22, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Enhanced management team with experienced operators, including a new CFO and Head of Regulatory and Clinical Affairs.
- Significant reduction in operating expenses by approximately 26%, saving over $3 million annually.
- Strong intellectual property portfolio with 81 issued patents globally, including recent additions in Europe and China.
- Clear strategic priorities for the next 9-12 months, focusing on clinical study completion and regulatory submission.
- Successful public offering raising $7.3 million, providing a cash runway into the first half of 2025.
Negative Points
- Reverse stock split did not achieve the intended outcome, with shares trading below $1, risking NASDAQ listing.
- High volume of exercised warrants from the recent $8 million public offering negatively impacted stock price.
- Shift in go-to-market strategy indicates previous misalignment with target markets, causing delays.
- Significant reliance on successful FDA approval and clinical trial outcomes, which are still pending.
- Ongoing financial challenges, with a need for further expense scrutiny and potential additional adjustments.
Q & A Highlights
Q: How quickly do you think you will be able to get your new strategic path fully implemented? Or do you still think it will take time to evaluate the situation?
A: In the next nine to twelve months, we have clear priorities to execute, including completing the clinical study, obtaining necessary data for regulatory submission with the FDA, and generating compelling data for future customers. We will also create a strategic roadmap that includes several growth opportunities, some pursued organically and others potentially licensed to others.
Q: Do you plan to file your FDA application in 2025? Did you give a specific time in 2025?
A: We aim to complete the clinical study this year and initiate a pivotal study early next year, with the goal of submitting the FDA application by mid-2025.
Q: Can you elaborate on the changes in your FDA regulatory strategy?
A: We are switching from using retrospective data to a hypothesis-driven, statistically-powered prospective clinical trial. We are expanding from a single clinical site to a multi-center trial and increasing the number of subjects from 20 to about 250 to achieve acceptable statistical power.
Q: What progress has been made in your clinical and regulatory efforts?
A: We met with the FDA to demonstrate the TAEUS technology and review clinical and statistical plans. We have alignment with the FDA on the final product configuration, clinical study design, and regulatory pathway. We have acquired data on 25 subjects and aim to complete all clinical work and submit the de novo application by mid-2025.
Q: What are the recent changes in your go-to-market strategy for the TAEUS liver device?
A: We are revisiting our strategy and considering primary care as a potential target market instead of hepatology. Over the next six to twelve months, we will pursue regulatory clearance for the TAEUS liver device and assess the best market opportunities.
Q: How has your patent portfolio evolved recently?
A: Our patent portfolio now stands at 81 issued patents globally, with five additional patents issued in the second quarter of 2024. These include three in Europe and two in China, covering various aspects of thermoacoustic technology and its applications.
Q: What financial measures have you taken to improve the company’s performance?
A: We raised $7.3 million in net proceeds from a public offering and had $6.4 million in cash and cash equivalents as of June 30, 2024. We reduced operating expenses by $3 million annually, focusing on clinical data collection and preparation for FDA submission without impacting primary deliverables.
Q: What are the key priorities for ENDRA moving forward?
A: Our key priorities include enhancing our management team, prioritizing critical deliverables, changing our FDA regulatory strategy, revisiting our go-to-market strategy, formalizing our long-term business strategy, and improving financial execution.
Q: How do you plan to add more value to your customers beyond the liver fat test?
A: We aim to become a metabolic disease biomarker company, adding more value to our customers. This will be developed and assessed over the next twelve months as part of our longer-term business strategy.
Q: What is your outlook for ENDRA’s performance after implementing the new initiatives?
A: We expect that after implementing the six initiatives and changes, ENDRA’s performance will improve, reversing the course the company has been on. The team is energized and knows what needs to be accomplished in the next six to twelve months.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
