TORONTO, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the timing of its Premarket Approval (“PMA”) submission to the U.S. Food and Drug Administration (“FDA”) for its hemoadsorption device to treat endotoxic septic shock. Following recent interaction with the FDA, the Company now expects to submit its PMA around the end of April to mid-M ...

PresentationI will now turn the conference over to Ali Mahdavi, Capital Markets and Investor Relations. Thank you. You may begin.Ali MahdaviSpinnaker Capital Markets Inc. Thank you, Sherry. Good morning, everyone, and thanks for joining us for today's year-end corporate update call. Joining me this morning are Chris Seto, Chief Executive Officer of Spectral Medical; and Dr. John Kellum, Spectral's Chief Medical Officer. Following remarks from Chris and John, we will open the call for a Q&A session. Before ...

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]

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 Insights - A new study identifies endotoxic septic shock (ESS) as a distinct and high-risk form of septic shock, with a significantly higher mortality rate compared to other septic shock patients [1][2][4] - The study found that patients with ESS had a 28-day mortality rate of 57.1%, more than three times the 15.9% rate observed in other septic shock patients [2] - The findings support Spectral Medical's precision medicine approach, which combines the Endotoxin Activity Assay (EAA) diagnostic with the PMX hemoadsorption device to target high-risk patients [3][4] Company Overview - Spectral Medical Inc. is a late-stage theranostic company focused on developing therapeutic options for sepsis and septic shock, currently seeking FDA approval for its PMX device [1][6] - PMX is a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream and has been approved for use in Japan and Europe, with over 360,000 units sold globally [7] - The company has received Breakthrough Device Designation from the FDA for PMX in treating endotoxic septic shock, with approximately 330,000 patients diagnosed with septic shock annually in North America [7] Clinical Study Insights - The study titled "Organ Failure, Endotoxin Activity, and Mortality in Septic Shock" involved a multicenter observational analysis of 90 patients, establishing criteria for identifying ESS [2][5] - The criteria for ESS included an endotoxin activity assay (EAA) score of ≥ 0.6 combined with a Multiple Organ Dysfunction Score (MODS) > 9 or a Sequential Organ Failure Assessment (SOFA) > 11 [2] - The results align with the enrollment parameters of Spectral's recently completed Tigris trial, which tested PMX therapy in patients with high endotoxin levels and significant organ dysfunction [3][4][8]

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. 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]