Spectral Medical Announces Fourth Quarter and Fiscal 2025 Results and Provides Corporate Update

TORONTO, March 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 announced its financial results for the fourth quarter and for the year ended December 31, 2025 and provided a corporate update. The past year marked a significant milestone in Spectral’s clinical and regulatory progression, highlighted by the completion of enrollment of the Tigris trial, the release of positive topline Tigris results and the advancement of PMX into the final stages of regulatory readiness. During the fourth quarter and subsequent to year end, the Company achieved additional key milestones supporting the clinical and scientific strength of PMX, including the publication of the Tigris manuscript in The Lancet Respiratory Medicine and its selection for presentation at the Society of Critical Care Medicine (“SCCM”) Annual Congress. Together, these milestones further strengthen the overall body of evidence supporting PMX and position the Company as it advances toward its planned FDA Premarket Approval (“PMA”) submission. “Our focus in the second quarter is on completing a high-quality PMA submission and continuing to build the clinical and commercial foundation necessary to support the adoption of PMX,” said Chris Seto, Chief Executive Officer of Spectral Medical. “We believe the growing body of evidence, including publication in The Lancet Respiratory Medicine and presentation at SCCM, further supports the strength and consistency of the Tigris results and advances our efforts to bring this therapy to patients in the United States.” Dr. John Kellum, Chief Medical Officer of Spectral Medical, added, “Publication of the Tigris results in a leading peer-reviewed journal, alongside the presentation of these results at a major international congress, represents an important step in translating these findings to clinical practice. The consistency of benefit observed across endpoints, including longer-term outcomes, suggests that the treatment effect becomes more apparent as patients recover beyond the acute phase of septic shock, supporting the role of endotoxin-guided therapy in this setting.” Corporate Highlights During & Subsequent to the Fourth Quarter and Fiscal Year Ended December 31, 2025 Tigris Tigris manuscript published on March 23, 2026: The Tigris manuscript was published in The Lancet Respiratory Medicine, one of the world’s leading peer-reviewed journals in critical care and respiratory medicine. The publication confirms the previously reported positive findings for the primary and key secondary endpoints announced in August 2025, while providing additional analyses on survival, safety, secondary and sensitivity analyses: Confirms positive results for primary and key secondary endpoints with 95.3% and 99.4% probability of benefit for PMX at 28-day and 90-day mortality After adjusting for baseline severity, absolute risk reduction for mortality of 10.3% at 28-days and 15.5% at 90-days Kaplan-Meier survival curves demonstrated continued separation beyond day 28, indicating that the survival benefit observed with PMX was sustained over time. Safety profile consistent with standard of care with no significant difference in adverse events The findings further suggest that treatment effects observed at earlier timepoints are sustained and may become more apparent over longer-term follow-up, consistent with the recovery trajectory of critically ill septic shock patients. Society of Critical Care Medicine (“SCCM”) Critical Care Congress, Chicago March 24, 2026: Results from the Tigris study presented on March 24, 2026 at the SCCM Annual Congress in the Late-Breaking Studies Affecting Patient Outcomes session Presented by Dr. Javier Neyra, first author of the Tigris paper PMA Submission: Following recent interaction with the FDA, the Company now expects to submit its PMA around the end of April to mid-May 2026, compared to its previously disclosed target of Q1 2026. The updated timing reflects ongoing FDA feedback to incorporate complete 12-month mortality data from the Tigris study into the PMA submission, as well as the completion of certain non-clinical module items, including human factors engineering testing, to support a complete and compliant submission. The Company believes the inclusion of complete 12-month mortality outcomes will further inform the FDA’s review and contribute to the totality of clinical evidence supporting PMX for the treatment of endotoxic septic shock. Spectral currently anticipates being in a position to report topline 12-month mortality and other outcome data in late May or early June 2026, subject to the completion of additional data analysis. PMX Commercialization Ongoing collaboration with Vantive on commercialization planning. Vantive intends to submit 510(k) application for its PrisMax system, expected to be the primary ICU platform for PMX treatment. Market readiness efforts are aligned with potential FDA approval timelines. Financial Review Revenue for the three-months ended December 31, 2025 was $382,000 compared to $645,000 for the same three-month period last year. Total revenue for the year ended December 31, 2025 was $2,442,000 compared to $2,286,000 for prior year, representing an increase of $156,000, or 7%. Increase in revenue was primarily driven by higher product revenue, reflecting the timing of EAA diagnostic order fulfillment, expanded EAA commercialization activities, and increased PMX pre-commercialization launch activities in collaboration with Vantive. For the quarter ended December 31, 2025, the Company reported operating expense (income) of $3,030,000 compared to $(2,513,000) for the same period in 2024.The increase of $5,543,000 was due to fair value adjustment on derivative liability, a non-cash item. The change in fair value reflects the appreciation of Spectral’s share price from approximately $0.50 at December 31, 2024, to $1.44 at December 31, 2025. This price appreciation increased the theoretical value of conversion features embedded in the Company’s outstanding convertible notes. As the Company’s market capitalization rises, these conversion options become more valuable to noteholders, resulting in a higher fair value liability and a corresponding non-cash loss recognized in the income statement. For the year ended December 31, 2025, operating costs were $49,394,000 compared to $16,862,000 for the same period in 2024, an increase of $32,532,000. The increase was primarily driven by the non-cash fair-value adjustment of derivative liabilities, which rose significantly alongside the Company’s share price. Additionally, interest expense increased due to the full-year impact of convertible notes issued in May and July 2024, as well as the Tranche 1 and Tranche 2 drawdowns of the Vantive promissory note in May and August 2025. Interest expense for the year ended December 31, 2025 was $5,164 compared to $3,177 for the year ended December 31, 2024. Interest expense for convertible notes in 2025 was $4,422, compared to $3,145 in 2024, reflecting higher outstanding debt. Interest expense for the promissory note was $470 for 2025, compared to nil in 2024. Clinical development and regulatory program costs (as disclosed in Note 23 of the condensed financial statements) were $4,334,000 for the year ended December 31, 2025 compared to $3,973,000 for the same period in the prior year. A significant portion of clinical trial and regulatory costs consists of consulting and professional fees paid to contract research organizations, clinical sites, and other clinical and regulatory consultants. The increase in program management costs was primarily due to frequent site visits for site closures, statistical planning and analysis and data transfer. Clinical site costs decreased because of reduced patient enrollment and site closures Cumulative trial and regulatory program costs total as of December 31, 2025 was $59,164. For the quarter ended December 31, 2025, the Company reported a Loss (profit) from continuing operations of $2,838,000 compared to $(3,158,000) for the corresponding period in 2024.The increased loss of $5,996,000 was due to increased operating expenses, primarily due to increase in fair value adjustments of derivative liabilities. For the year ended December 31, 2025, the Company reported a Loss from continuing operations of $47,689,000 compared to $15,395,000 for the corresponding period in 2024. The increased loss of $32,294,000 was primarily attributable to the non-cash fair value adjustment of derivative liabilities as of December 31, 2025. In addition, interest expense rose compared to the prior year, reflecting the full-period impact of the convertible notes issued in May and July 2024, as well as interest accrued on drawdowns under the Vantive promissory note facility, including the first tranche advanced in May 2025 and the second tranche advanced in August 2025. The Company concluded the year end 2025 with cash of $4,071,000 compared to $2,988,000 of cash on hand as of December 31, 2024. The total number of common shares outstanding for the Company was 292,562,913 at December 31, 2025 About Spectral  Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s FDA cleared Endotoxin Activity Assay (EAA™), the clinically available test for endotoxin in blood. PMX is approved for therapeutic use in Japan and Europe, licensed by Health Canada, and has been used safely and effectively with over 360,000 units sold worldwide to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year. The Tigris Trial is a confirmatory study of PMX in addition to standard care vs standard care alone and is designed as a 2:1 randomized trial of 150 patients using Bayesian statistics. Endotoxic septic shock is a malignant form of sepsis https://www.youtube.com/watch?v=6RANrHHi9L8. The trial methods are detailed in “Bayesian methods: a potential path forward for sepsis trials”. Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com. Forward-looking statement Informationinthisnewsreleasethatisnotcurrentorhistoricalfactualinformationmayconstituteforward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior managementaswellasinformationcurrentlyavailabletoit.Whiletheseassumptionswereconsideredreasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results aresubjecttoanumberofrisksanduncertainties,includingtheavailabilityoffundsandresourcestopursueR&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected. The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement. For further information, please contact: Ali Mahdavi   Chris Seto Capital Markets & Investor Relations   CEO Spinnaker Capital Markets Inc.   Spectral Medical Inc. 416-962-3300     [email protected]   [email protected]       Spectral Medical Inc. Consolidated Statements of Financial Position In thousands of Canadian dollars, except for share and per share data                 Notes December 31, 2025   December 31, 2024     $   $   Assets       Current assets       Cash 6 4,071   2,988   Trade and other receivables 7 205   451   Inventories 8 377   229   Prepayments and other assets 9 640   790       5,293   4,458   Non-current assets       Right-of-use-asset 10 321   444   Property and equipment 11 153   243   Intangible asset 12 333   175   Total assets   6,100   5,320   Liabilities       Current liabilities       Trade and other payables 14 2,484   2,769   Current portion of contract liabilities 15 693   380   Current portion of lease liability 10 136   129   Notes payable 16 16,435   14,425   Derivative liability 16 46,520   9,742       66,268   27,445   Non-current liability       Non-current portion of lease liability 10 235   371   Non-current portion of contract liabilities 15 4,564   5,049   Non-current portion of promissory notes 17 4,285   -   Non-current portion of interest accrual promissory note 17 470   -   Total liabilities   75,822   32,865   Shareholders' (deficiency) equity 19     Share capital   95,933   90,566   Contributed surplus   10,220   10,149   Share-based compensation   12,266   11,196   Warrants   390   1,383   Deficit   (188,531 ) (140,839 ) Total shareholders' (deficiency) equity   (69,722 ) (27,545 ) Total liabilities and shareholders' (deficiency) equity   6,100   5,320               Spectral Medical Inc.           Consolidated Statements of Loss and Comprehensive Loss In thousands of Canadian dollars, except for share and per share data   Notes 2025   2024       $   $   Revenue 22, 15, 26 2,442   2,286   Expenses       Cost of goods sold 26,8 737   819   Gross Profit   1,705   1,467   Raw materials and consumables used   379   754   Salaries and benefits 24 4,185   4,049   Consulting and professional fees   4,767   4,937   Regulatory and investor relations   779   666   Travel and entertainment   325   483   Facilities and communication   275   302   Insurance   383   420   Depreciation and amortization   178   178   Interest expense 10,16 5,164   3,177   Finance income promissory note 17 (5,389 ) -   Foreign exchange (gain) and loss   (2,056 ) 1,933   Share-based compensation 19 2,119   1,675   Other expense   269   744   Fair value adjustment derivative liabilities 16 38,016   (2,456 )     49,394   16,862   Loss and comprehensive loss for the year from continuing operations   (47,689 ) (15,395 ) Loss from discontinued operations 5 (3 ) (7 ) Loss and comprehensive loss for the year   (47,692 ) (15,402 ) Basic and diluted loss from continuing operations per common share 20 (0.16 ) (0.05 ) Basic and diluted loss from discontinued operations per common share 20 (0.00 ) (0.00 ) Basic and diluted loss per common share 20 (0.16 ) (0.05 ) Weighted average number of common shares outstanding - basic and diluted 20 287,205,257   281,080,174               Spectral Medical Inc. Consolidated Statements of Changes in Shareholders’ (Deficiency) Equity In thousands of Canadian dollars, except for share and per share data     Notes Issued capital Contributed surplus Share-based compensation   Warrants   Deficit Total Shareholders’ (deficiency) equity     Number $ $ $   $   $   $   Balance December 31, 2023   278,576,261 87,061 8,916 10,385   2,526   (125,437 ) (16,549 ) Balance January 1, 2024   278,576,261 87,061 8,916 10,385   2,526   (125,437 ) (16,549 ) Warrants exercised   982,500 618 - -   (121 ) -   497   Warrants issued   - - - -   211   -   211   Warrants expired   - - 1,233 -   (1,233 ) -   -   Share options exercised   1,907,611 1,190 - (535 ) -   -   655   RSU released   114,210 50 - (50 ) -   -   -   Notes conversion 16 1,879,647 1,368 - -   -   -   1,368   DSU exercise   855,978 279 - (279 ) -   -   -   Loss and comprehensive loss for the year   - - - -   -   (15,402 ) (15,402 ) Share-based compensation 19 - - - 1,675   -   -   1,675   Balance December 31, 2024   284,316,207 90,566 10,149 11,196   1,383   (140,839 ) (27,545 ) Balance January 1, 2025   284,316,207 90,566 10,149 11,196   1,383   (140,839 ) (27,545 ) Share options exercised   1,811,050 1,564 - (681 ) -   -   883   RSU released   1,037,681 368 - (368 ) -   -   -   Warrants exercised   5,397,975 3,435 - -   (922 ) -   2,513   Warrants expired   - - 71 -   (71 ) -   -   Loss and comprehensive loss for the year   - - - -   -   (47,692 ) (47,692 ) Share-based compensation 19 - - - 2,119   -   -   2,119   Balance December 31, 2025   292,562,913 95,933 10,220 12,266   390   (188,531 ) (69,722 )                           Spectral Medical Inc. Notes to the Consolidated Statements of Cash Flows In thousands of Canadian dollars, except for share and per share data     Notes 2025 2024 $ $ Cash flow provided by (used in)       Operating activities       Loss for the year   (47,692 ) (15,402 ) Adjustments for:       Finance income on promissory note 17 (5,389 )   Depreciation on right-of-use asset 10 123   123   Depreciation on property and equipment 11 90   110   Amortization of intangible asset 12 37   18   Amortization and derivative related financing fees 16 254   823   Unrealized foreign exchange (gain) and loss   (2,056 ) 2,102   Interest expense on lease liability 10 26   32   Accreted Interest on notes payable 16 4,422   3,145   Accreted interest on promissory notes 17 245   -   Interest expense on promissory notes 17 470   -   Share-based compensation 19 2,119   1,675   Fair value adjustment derivative liabilities 16 38,016   (2,456 ) Changes in items of working capital:       Trade and other receivables 7 246   (265 ) Inventories 8 (148 ) 137   Prepayments and other assets 9 150   (169 ) Trade and other payables 14 (265 ) (51 ) Contract liabilities 15 (172 ) 1,360   Net cash used in operating activities   (9,524 ) (8,818 ) Investing activities       Purchases of property and equipment 11 -   (27 ) Purchase of technology 12 (195 ) -   Net cash used in investing activities   (195 ) (27 ) Financing activities       Financing charges paid 17 (207 ) (766 ) 9% Convertible notes issued 16 -   9,897   Lease liability payments 10 (155 ) (153 ) Share options exercised 19 883   655   Share warrants exercised 19 2,513   497   Interest expense paid 19 (1,901 ) (1,249 ) Promissory notes issued 17 9,669   -   Net cash provided by financing activities   10,802   8,881   Increase (decrease) in cash   1,083   36   Cash, beginning of year   2,988   2,952   Cash, end of year   4,071   2,988