Workflow
Spectral Medical Announces First Quarter and Provides Corporate Update
GlobeNewswire·2025-05-09 11:30

Core Insights - Spectral Medical Inc. has completed enrollment for its Tigris trial, a Phase III clinical trial evaluating PMX for endotoxic septic shock, with topline results expected in August 2025 [1][2][3] - The company has entered into a promissory note agreement with Vantive for up to US10milliontosupportPMXcommercialization[1][9]ClinicalDevelopment−TheTigristrialhasenrolledatotalof157patients,with151evaluablepatientsand100treatedwithPMX[6]−Thedatalockforthetrialisexpectedtobecompletedinapproximately90days,withtoplineresultsanticipatedtwoweekspost−datalock[6]−ThecompanyisontracktosubmitclinicalresultstotheFDAbytheendofOctober2025[6]FinancialPerformance−RevenueforQ12025was10 million to support PMX commercialization [1][9] Clinical Development - The Tigris trial has enrolled a total of 157 patients, with 151 evaluable patients and 100 treated with PMX [6] - The data lock for the trial is expected to be completed in approximately 90 days, with topline results anticipated two weeks post-data lock [6] - The company is on track to submit clinical results to the FDA by the end of October 2025 [6] Financial Performance - Revenue for Q1 2025 was 572,000, a decrease of 14% from 668,000inQ12024[10]−Operatingexpensesincreasedsignificantlyto668,000 in Q1 2024 [10] - Operating expenses increased significantly to 13,174,000, up 173% from 4,825,000intheprioryear,primarilyduetonon−cashfairvalueadjustments[11]−Thecompanyreportedalossof4,825,000 in the prior year, primarily due to non-cash fair value adjustments [11] - The company reported a loss of 12,605,000 for Q1 2025, compared to a loss of 4,160,000inQ12024[13]BalanceSheetandFinancing−AsofMarch31,2025,thecompanyhadcashof4,160,000 in Q1 2024 [13] Balance Sheet and Financing - As of March 31, 2025, the company had cash of 1,670,000, down from $2,988,000 at the end of 2024 [14] - The promissory note with Vantive includes a four-year maturity and a payment-in-kind interest rate of 9% [15] Commercialization Activities - The company is collaborating with Vantive on post-approval marketing plans for PMX commercialization [15] - Vantive intends to submit a 510(k) application for its PrisMax System, which is expected to be the primary device used for PMX treatments upon commercial launch [15] Regulatory and Clinical Study Insights - The EDEN study, completed in Q4 2023, showed that patients with endotoxic septic shock had a significantly higher mortality rate of 60% compared to 14.1% for other septic shock patients [6] - The results from the EDEN study will inform discussions with the FDA regarding PMX labeling and the addressable population in the U.S. [6]