Core Insights - Spectral Medical Inc. has filed a final short form base shelf prospectus allowing the company to distribute up to $100 million in various securities over a 25-month period [1][2] - The company is advancing therapeutic options for sepsis and septic shock, with a focus on its product Toraymyxin™ (PMX) [6][7] - The Tigris clinical trial is a key study for PMX, designed to confirm its efficacy in treating endotoxic septic shock [8] Company Overview - Spectral is a late-stage theranostic company seeking U.S. FDA approval for PMX, a therapeutic hemoperfusion device that removes endotoxin from the bloodstream [6] - PMX has been approved for therapeutic use in Japan and Europe, and has sold over 360,000 units worldwide [7] - The company has exclusive rights for PMX development and commercialization in the U.S. and Canada [7] Financial and Regulatory Developments - The base shelf prospectus enables the company to raise capital through common shares, debt securities, and other financial instruments [2] - The Ontario Securities Commission requested revisions to the Annual Information Form, which now includes disclosures about a director's prior involvement in bankruptcy proceedings [4]

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. and Vantive announced topline results from the Tigris trial, a Phase 3 study evaluating Polymyxin B Hemoadsorption (PMX) for treating endotoxic septic shock [1][2] Group 1: Trial Overview - The Tigris trial is a multicenter, randomized, controlled Phase 3 study conducted in the U.S. with 157 patients, comparing PMX plus standard care to standard care alone [2][3] - The primary endpoint was 28-day all-cause mortality, evaluated using a Bayesian statistical model that incorporated data from the previous EUPHRATES trial [3][4] Group 2: Key Findings - The trial exceeded the prespecified primary endpoint with a 95% posterior probability of benefit for PMX on 28-day mortality, showing an absolute risk reduction of 8.3% and a relative risk reduction of 18% [6][7] - The observed 28-day mortality was 38.7% for PMX compared to 45.1% for standard care, indicating a 6.4% absolute difference [7] - For the key secondary endpoint of 90-day mortality, PMX showed a 17.4% lower mortality rate with a >99% posterior probability of benefit [12] Group 3: Expert Commentary - Dr. John Kellum, Chief Medical Officer of Spectral, expressed satisfaction with the results, noting that the observed 6.4% difference exceeded the threshold established in prior simulations [9] - Professor Claudio Ronco highlighted the consistency of the Tigris results with earlier trials, emphasizing the effectiveness of PMX in selected patient populations [9] Group 4: Future Plans - Spectral Medical plans to submit the final Premarket Approval (PMA) module for PMX to the FDA by the end of October 2025, aiming to commercialize PMX and the Endotoxin Activity Assay (EAA) in the U.S. [9][10] - Vantive, as the exclusive distributor of PMX in the U.S. and Canada, is committed to advancing therapy innovation for critically ill patients [9][19]

Core Insights - Spectral Medical Inc. reported significant clinical and operational progress in Q2 2025, particularly with the Tigris trial, which is pivotal for the PMA submission to the FDA [3][4][7] - The company achieved a revenue increase of 73% year-over-year for Q2 2025, driven by product sales and non-dilutive funding from Vantive [8][12] - Operating expenses decreased by 47% in Q2 2025 compared to the previous year, contributing to a reduced loss for the quarter [9][13] Clinical Development - The Tigris trial, a Phase III study evaluating PMX for endotoxic septic shock, completed patient enrollment in April 2025 and is on track to report topline results by mid-August 2025 [3][6] - The company has submitted all non-clinical studies to the FDA and plans to submit clinical results by the end of October 2025 [6][8] - The EDEN study, completed in Q4 2023, provided critical data on septic shock, indicating a significantly higher mortality rate for patients with endotoxic septic shock [6][11] Financial Performance - Revenue for Q2 2025 was $813,000, up from $471,000 in Q2 2024, marking a 73% increase [8] - Product revenue for Q2 2025 reached $403,000, an 86% increase from $217,000 in the same period last year [8] - Operating expenses for Q2 2025 were $2,514,000, down from $4,702,000 in Q2 2024, primarily due to finance income from a promissory note [9][10] Balance Sheet and Funding - The company ended Q2 2025 with cash of $3,100,000, a slight increase from $2,988,000 at the end of 2024 [15] - Spectral entered into a promissory note agreement with Vantive for up to $10 million, providing financial flexibility for regulatory processes and commercialization planning [5][12] - Total liabilities increased to $45,672,000 as of June 30, 2025, compared to $32,865,000 at the end of 2024 [21] Market Position and Product Development - PMX, the company's therapeutic hemoperfusion device, is already approved for use in Japan and Europe and has been used over 360,000 times [17] - The Tigris trial is designed as a 2:1 randomized study of 150 patients, utilizing Bayesian statistics to evaluate PMX's effectiveness [18] - The company is collaborating with Vantive on post-approval commercialization planning, aligning efforts with potential FDA approval timelines [6][12]

Core Points - Spectral Medical Inc. held its Annual Meeting of shareholders on June 5, 2025, where all resolutions in the Management Information Circular were approved [1][2] Group 1: Election of Directors - Seven director nominees were elected with high approval rates, including Jan D'Alvise (99.78%), Jun Hayakawa (99.79%), and David W. Feigal, Jr. (99.67%) [3] Group 2: Appointment of Auditors - MNP LLP was re-appointed as the auditor of Spectral with 99.95% votes in favor [4] Group 3: Company Overview - Spectral is a Phase 3 company seeking U.S. FDA approval for its product Toraymyxin™ (PMX), a therapeutic hemoperfusion device for treating septic shock [4][5] - PMX has been approved for use in Japan and Europe, with over 360,000 applications to date [5] - The U.S. FDA granted Breakthrough Device Designation for PMX in July 2022 for endotoxic septic shock treatment [5] Group 4: Clinical Trials - 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 of 150 patients [6]

Company Overview - Spectral Medical Inc. is a late-stage theranostic company focused on advancing therapeutic options for sepsis and septic shock [1] - The company is seeking U.S. FDA approval for its product Toraymyxin™ (PMX), a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream [4][5] - PMX has been approved for therapeutic use in Japan and Europe, with over 360,000 applications to date [5] Clinical Trials and Regulatory Status - The Tigris Trial is a confirmatory study comparing PMX in addition to standard care versus standard care alone, involving 150 patients in a 2:1 randomized trial [6] - The U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock in July 2022 [5] Upcoming Events - Management will participate in a fireside chat at the 3rd Annual H.C. Wainwright BioConnect Investor Conference on May 20, 2025, at Nasdaq headquarters in New York City [1][3] - Investors interested in meeting with the management team can contact their H.C. Wainwright representative [2]

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].

Core Insights - Spectral Medical Inc. is advancing its Tigris trial, a Phase 3 study evaluating Polymyxin B Hemoperfusion (PMX) for treating endotoxemia and septic shock [2][4] - The company aims to finalize full enrollment of 150 evaluable patients by the end of March 2025, with 152 patients already enrolled [8] Enrollment Update - As of now, 152 patients have been enrolled in the Tigris trial, with six patients enrolled in February [8] - The trial is designed to randomize 150 patients in a 2:1 ratio, with 100 patients receiving PMX and 50 receiving standard care [6][8] - The company estimates that an additional four to seven patients are needed to reach the target of 150 evaluable patients [8] Product and Market Context - PMX is already approved for therapeutic use in Japan and Europe, having been safely used on over 340,000 patients [5] - Approximately 330,000 patients are diagnosed with septic shock annually in North America, highlighting the market potential for PMX [5]