ENDRA Life Sciences Inc. Q2 FY2024 earnings call

• Reverse stock split: Authorized 1-for-50 reverse stock split to maintain NASDAQ listing, affected by high warrant exercises. - Strengthened management team: Richard Jacroux as CFO with lean ops experience, Ziad Rouag as Head of Regulatory and Clinical Affairs with regulatory success, Mike Thornton focusing on product delivery and IP. - Relentless prioritization: Laser focus on statistically powered multi-center clinical trial for regulatory and commercial success. - FDA regulatory strategy shift: From retrospective to hypothesis-driven prospective trial, expanding from single site to multi-center with 250 subjects, engaged with FDA on trial design. - Go-to-market strategy revisited: Reassessing hepatology as beachhead market, considering primary care and other segments. - IP and technology: Patent portfolio at 81 issued patents, 5 additional patents in Q2 2024. - Financial: Raised $7.3M net proceeds from public offering, cash and cash equivalents at $6.4M as of June 30, 2024, cash runway into first half of 2025.

For the quarter ended June 30, 2024, total operating expenses decreased to $2.2 million from $3 million in the same period of 2023. Research and development expenses decreased $684,000 (49%) year-over-year as resources shifted from development to clinical activities. Sales and marketing expenses decreased $85,000 (34%) due to restructuring European operations. General and administrative expenses increased $5,000 overall due to fundraising administrative costs, but overall operating expenses decreased.

• Goal to complete clinical study this year, initiate pivotal study early next year, target mid-2025 for de novo submission to FDA. - Within 6-9 months, sharpen pencils to determine longer-term strategic vision post-TAEUS liver device launch, including organic growth and potential licensing opportunities.

• Stock price decline due to high volume warrant exercises, unrelated to business prospects. - Need to refer to company's Form 10-K for 2023 fiscal year and subsequent SEC filings for risks related to forward-looking statements.

Q: How quickly will you fully implement the new strategic path?

A: Next 9-12 months focus on completing clinical study, preparing regulatory submission, and generating data for customer promotion. Longer vision to be determined in 6-9 months.

Q: Plan to file FDA application in 2025?

A: Goal to complete clinical study this year, initiate pivotal study early next year, target mid-2025 for submission.