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
Information in this news release that is not current or historical factual information may constitute forward-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 management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&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 | ||
| am@spinnakercmi.com | cseto@spectraldx.com | |
| 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 | |||
