ENDRA Life Sciences(NDRA) - 2024 Q4 - Annual Results

ENDRA Life Sciences 2024 Q4 and Full-Year Financial Report Business Update In late 2024, ENDRA Life Sciences significantly advanced its TAEUS® Liver device's FDA regulatory path, accelerated clinical data collection, revised its strategy, and implemented substantial cost reductions FDA Regulatory Process and Product Refinement In Q4 2024, the company refocused resources to advance the TAEUS® Liver device's FDA regulatory path, gathering data to optimize design and prepare for a pivotal De Novo trial - ENDRA is prioritizing the advancement of its TAEUS Liver device on its FDA regulatory path, focusing on data collection to optimize design and prepare for a pivotal clinical trial necessary for a De Novo submission[2] - The TAEUS device is undergoing continuous development, with enhancements to its hardware and software to improve both accuracy and usability[2] Acceleration of Clinical Data Collection Two new clinical sites activated in October 2024 have scanned over 110 subjects, providing crucial data across diverse liver disease states for product optimization and De Novo submission - Two new clinical sites have acquired TAEUS scan data from over 110 subjects, which is being assessed against the gold standard MRI-PDFF test[2] - The new data covers a wider range of liver disease states, with about 20% of subjects having moderate and severe steatosis (S2 and S3), which is foundational for regulatory, clinical, and commercial success[2] Revised Regulatory Strategy ENDRA revised its TAEUS Liver device regulatory strategy to a prospective, multicenter clinical trial with approximately 250 subjects, planning pre-submission FDA engagement for alignment - The company will conduct a prospective, multicenter pivotal trial with approximately 250 subjects for its De Novo submission, a change from previous plans to use retrospective data[2] - ENDRA plans a pre-submission engagement with the FDA to align on study design, sample size, hypothesis, and statistical analyses before initiating the trial[2] Cost Reduction Initiatives Significant cost reductions in H2 2024 lowered average monthly cash burn from $0.8 million in 2023 to $0.5 million in Q4 2024, with further reductions expected Reduction in Monthly Cash Used for Operations | Period | Average Monthly Cash Used | | :--- | :--- | | Full Year 2023 | $0.8 million | | Q4 2024 | $0.5 million | | Q2 & Q3 2025 (Expected) | $0.35 million | New Operating Team Achievements Since late Q3 2024, ENDRA's new operating team has focused the business on the De Novo submission, defined a new strategy, and significantly reduced cash burn - The new operating team has achieved several key objectives since Q3 2024: - Focused the business on the new multicenter clinical study for the De Novo submission[2] - Defined a new mission, product strategy, and business model[2] - Executed a business optimization that significantly reduced monthly cash burn[2] - Implemented a more cohesive FDA De Novo strategy[2] Financial Results ENDRA significantly reduced cash used in operations in 2024, though net loss increased due to $3.1 million in one-time non-cash charges, indicating underlying operational improvement Fourth Quarter 2024 Financial Results In Q4 2024, cash used in operations decreased to $1.5 million, but net loss increased to $4.2 million primarily due to $3.3 million in one-time non-cash items Q4 Financial Performance Comparison | Metric | Q4 2024 | Q4 2023 | Change | | :--- | :--- | :--- | :--- | | Cash Used in Operations | $1.5 million | $2.2 million | ($0.7 million) | | Operating Expenses | $4.3 million | $1.5 million | +$2.8 million | | Net Loss | $4.2 million | $1.5 million | +$2.7 million | - The increase in Q4 2024 net loss was primarily due to a $3.3 million swing from one-time non-cash items, including a $2.3 million inventory charge in 2024 and a $1.0 million gain from reversing bonuses in 2023[5][11] Full-Year 2024 Financial Results Full-year 2024 cash used in operations decreased to $7.4 million, while net loss increased to $11.5 million primarily due to $3.1 million in non-cash charges Full-Year Financial Performance Comparison | Metric | FY 2024 | FY 2023 | Change | | :--- | :--- | :--- | :--- | | Cash Used in Operations | $7.4 million | $9.5 million | ($2.1 million) | | Total Operating Expenses | $10.8 million | $10.5 million | +$0.3 million | | Net Loss | $11.5 million | $10.1 million | +$1.4 million | - Excluding $3.1 million in one-time, non-cash items (inventory and warrant charges), the company's financial performance showed notable improvement in 2024[7] Financial Position As of the end of the fiscal year 2024, ENDRA Life Sciences held $3.2 million in cash and cash equivalents on its balance sheet - As of December 31, 2024, the Company had $3.2 million in cash and cash equivalents[8] Financial Statements The consolidated financial statements for 2024 detail a decrease in total assets to $4.5 million, an increase in liabilities, and a net loss of $11.5 million Consolidated Balance Sheets As of December 31, 2024, the balance sheet shows total assets decreased to $4.5 million, total liabilities increased to $1.9 million, and stockholders' equity decreased to $2.6 million Consolidated Balance Sheet Summary (as of Dec 31) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Cash | $3,229,480 | $2,833,907 | | Total Assets | $4,452,362 | $6,754,146 | | Total Liabilities | $1,891,996 | $1,095,157 | | Total Stockholders' Equity | $2,560,366 | $5,658,989 | Consolidated Statements of Operations For 2024, total operating expenses were $10.8 million, resulting in a net loss of $11.5 million or ($56.94) per share, reflecting increased shares outstanding Consolidated Statement of Operations Summary (Year Ended Dec 31) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Total operating expenses | $10,817,147 | $10,520,735 | | Operating loss | ($10,817,147) | ($10,520,735) | | Net Loss | ($11,507,947) | ($10,060,250) | | Net loss per share | ($56.94) | ($2,766.85) | | Weighted average common shares | 202,106 | 3,636 | About ENDRA Life Sciences & Forward-Looking Statements ENDRA Life Sciences develops TAEUS® technology for steatotic liver disease, with the report containing forward-looking statements subject to inherent risks and uncertainties - ENDRA's core focus is the development of its TAEUS® technology for measuring liver fat to assess and monitor steatotic liver disease, a condition affecting over two billion people globally[9] - The report contains forward-looking statements regarding future plans, including FDA submissions, product launches, and financial projections, which are subject to inherent risks and uncertainties[10]