Core Viewpoint - Spectral Medical Inc. has secured a US$3 million Tranche B advance from Vantive US Healthcare LLC, enhancing its financial position to support regulatory and commercialization efforts for its product PMX [1][2][3] Financial Position - The Tranche B advance strengthens Spectral's balance sheet and will be utilized for regulatory preparations, commercialization, and general working capital [2] - The company does not foresee the need for additional funding beyond the current promissory note to achieve key milestones, including U.S. FDA submission and PMX commercialization [2] Funding Details - Under the promissory note, Vantive can provide up to US$10 million in four tranches, with the current cumulative draw being US$7 million after the Tranche B advance and the initial US$4 million Tranche A advance [3] Product Overview - Spectral is focused on obtaining U.S. FDA approval for PMX, a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream, which is critical in treating septic shock [5][6] - PMX has been approved for use in Japan and Europe, with over 360,000 units sold globally [6] Clinical Trials - The Tigris Trial is a confirmatory study comparing PMX in addition to standard care against standard care alone, involving 150 patients and utilizing Bayesian statistics [7]

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 US$10 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 $668,000 in Q1 2024 [10] - Operating expenses increased significantly to $13,174,000, up 173% from $4,825,000 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 $4,160,000 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]

Core Viewpoint - Spectral Medical Inc. has secured a non-dilutive financing agreement with Vantive US Healthcare LLC for up to US$10 million to support the commercialization of its blood filtration therapy, Toraymyxin™ (PMX) [2][4][5]. Financing Details - The financing consists of a senior secured promissory note with a total principal amount of up to US$10 million, which can be drawn in up to four tranches [2][3]. - The first tranche of US$4 million was triggered on May 6, 2025, upon the execution of the agreement [4]. - The remaining tranches are contingent upon specific milestones outlined in the agreement [4]. Company Strategy and Milestones - The funds will support Spectral's evidence generation strategy and the path to commercialization of PMX, which is designed to remove endotoxin from the bloodstream in patients with sepsis [3][4]. - The company does not anticipate needing additional funding to meet key upcoming milestones, including the release of topline results and U.S. FDA submission [4]. Management Commentary - The CEO of Spectral expressed gratitude for the partnership with Vantive, emphasizing the non-dilutive nature of the funding and the alignment between the two companies [5]. Product Overview - PMX is a therapeutic hemoperfusion device that has been approved for use in Japan and Europe and has been utilized over 360,000 times [11]. - The device is currently seeking U.S. FDA approval and has received Breakthrough Device Designation for the treatment of endotoxic septic shock [11]. Clinical Trial Information - The Tigris Trial is a confirmatory study comparing PMX in addition to standard care versus standard care alone, designed as a 2:1 randomized trial involving 150 patients [12].