Spectral Medical Announces Third Quarter 2025 Financial Results and Provides Corporate Update

Core Insights - Spectral Medical Inc. reported significant progress in its Tigris trial, achieving positive topline results for its PMX treatment for endotoxic septic shock, with a 95.3% posterior probability of benefit for 28-day all-cause mortality and a 17.4% absolute mortality reduction for 90-day mortality [2][4][7] - The company is targeting a Premarket Approval (PMA) submission for Q1 2026, following ongoing discussions with the FDA to ensure a comprehensive submission [4][6][9] - Financial results for Q3 2025 showed a 34% increase in total revenue year-over-year, driven by higher product revenue, while operating expenses rose significantly due to non-cash adjustments related to derivative liabilities [9][11][15] Tigris Trial Results - The Tigris trial met its primary endpoint with a 95.3% posterior probability of benefit for 28-day all-cause mortality, and a >99% probability for 90-day mortality, indicating a clinically meaningful survival benefit [2][3][7] - The trial utilized Bayesian statistical methods, reinforcing the robustness of PMX as a life-saving therapy [3][4] Regulatory and Corporate Updates - The PMA submission is now targeted for Q1 2026, reflecting ongoing feedback from the FDA regarding non-clinical components [4][6][9] - The company is in discussions with the FDA to finalize the regulatory submission package, ensuring a high-quality and efficient review process [4][6] Financial Performance - Total revenue for Q3 2025 was $675,000, up from $502,000 in Q3 2024, marking a 34% increase [9][10] - For the nine months ended September 30, 2025, total revenue reached $2,060,000, a 26% increase from $1,641,000 in the same period of 2024 [9][10] - Operating expenses for Q3 2025 were $30.8 million, a 196% increase from $10.4 million in Q3 2024, primarily due to non-cash fair value adjustments [11][15][17] Cash Position and Financing - The company ended Q3 2025 with cash of $5.892 million, an increase from $2.988 million at the end of 2024 [19] - The balance sheet was strengthened by proceeds from warrant exercises and advances from Vantive, providing additional flexibility for regulatory and commercialization efforts [11][12][19] Market and Product Development - PMX is positioned as the first targeted therapy for endotoxic septic shock, with ongoing commercialization efforts in collaboration with Vantive [9][10][23] - The company aims to align its market readiness efforts with potential FDA approval timelines, enhancing its commercialization strategy [12][23]