Earnings release
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SPECTRAL Medical Spectral Medical Announces Second Quarter 2026 Financial Results and Provides Corporate Update TORONTO , Aug. 07 , 2026 -- 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 second quarter ended June 30 , 2026 and provided a corporate update . The second quarter of 2026 marked a significant milestone in the Company's evolution as Spectral completed its U.S. Food and Drug Administration ( " FDA " ) Premarket Approval ( " PMA " ) application for PMX , reported positive 12 - month follow - up results from the Tigris trial , and advanced into the FDA's substantive review process following acceptance of the PMA application . During the quarter , the Company also continued to preparations for potential commercialization alongside its exclusive U.S. and Canadian distribution partner , Vantive . " The second quarter represents an important inflection point for Spectral , " said Chris Seto , Chief Executive Officer of Spectral Medical . " With the PMA submission complete and accepted for substantive review by the FDA , we have transitioned from generating clinical evidence to executing the regulatory review process . Our efforts are now focused on supporting the FDA review , preparing for pre - approval inspections with both Spectral and Toray , and ensuring we are operationally prepared for commercialization alongside Vantive should PMX receive approval . " John A. Kellum , Chief Medical Officer of Spectral Medical , added , " The 12 - month follow - up results from the Tigris trial demonstrate that the survival benefit observed at 28 and 90 days persisted through one year . The consistency of benefit across multiple clinically meaningful endpoints further strengthens the totality of evidence supporting PMX as a targeted therapy for patients with endotoxic septic shock . " Corporate Highlights During & Subsequent to the Second Quarter of 2026 Tigris • PMA : • ° On May 28 , 2026 , Spectral submitted its PMA application to the FDA ° The completed application included the final 12 - month follow - up data from the Tigris trial , providing the FDA with the totality of clinical evidence supporting the safety and effectiveness of PMX ⚫ On June 25,2026 , the FDA completed its filing review and formally filed Spectral's PMA application for PMX 。 The Company is actively supporting the FDA review process and preparing for anticipated pre - approval inspections . Tigris 12 - Month Follow Up : ⚫ On June 4 , 2026 , Spectral announced positive 12 - month follow - up results from the Tigris trial with 100 % patient follow - up ° Mortality at 12 months was 52.8 % in PMX treated patients compared to 66.7 % in patients receiving standard of care , representing an absolute mortality reduction of 13.9 % , and a number needed to treat ( NNT ) of 7.2 。 Initial Bayesian analyses based solely on the randomized Tigris trial demonstrated a 95.9 % probability of benefit at 12 months 。 The data demonstrated that the survival benefit observed at 28 and 90 days persisted through one year . PMX Commercialization • Continued commercialization planning activities with Vantive in preparation for potential FDA approval . • 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 . Balance Sheet and Financing • On May 07 , 2026 , the Company entered into a side letter agreement with Vantive US Healthcare LLC in respect of its existing senior secured promissory note . • Under the agreement , Vantive agreed , at its sole discretion , to advance US $ 1.0 million as a partial funding of the US $ 2.0 million Tranche D , notwithstanding that the related milestone ( PMA filing acceptance ) had not yet been satisfied . • On July 28 , 2026 , following the FDA's acceptance for filing of the Company's PMA application on June 25 , 2026 , the Company received the remaining US $ 1.0 million of the Tranche D advance from Vantive , completing the US $ 2.0 million
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Tranche D funding under the senior secured promissory note. The Company has been and continues to actively evaluate financing scenarios with a view to be fully funded beyond PMX commercialization. Financial Review Revenue for the three-months ended June 30, 2026 was $621,000 compared to $813,000 for the same three-month period last year, representing a decrease of $192,000 or 24%. The decrease in revenue was primarily due to lower reagent sale and reduced service revenue following the conclusion of the Vantive PrisMax sub study in May 2026. Revenue for the six-months ended June 30, 2026, was $1,512,000 compared to $1,385,000 for the same period last year, representing an increase of $127,000 or 9%. The Increase was primarily driven by the sale of EAA Instrumentation. Royalty revenue for the six-months ended June 30, 2026 was $136,000 compared to $142,000 for the same six-month period last year. Product Revenue for the three-months ended June 30, 2026 was $381,000 compared to $403,000 for the same three-month period last year, representing a decrease of $22 or 5%. Product revenue for six-month ended June 30, 2026 was $766,000 compared to $580,000 for the same six-month period last year, representing an increase of $186,000 or 32%. The six-month increase in product revenue was primarily driven by sales of EAA Instrumentation. Operating expenses for the three-months ended June 30, 2026, were $ 62,000 compared to $ 2,514,000 for the same period in the preceding year, a decrease of $ 2,452,000 or 98%. The decrease was primarily driven by a fair value adjustment on derivative liabilities (a non-cash item) as well as foreign value adjustments on derivative liabilities and convertible debentures and finance income on promissory note issued May 8, 2026 (a non-cash item). These variances resulted largely from changes in market assumptions and the market price used to calculate the option feature. There has also been a decrease in consulting and professional fees due to clinical site closures and Tigris Trial coming to an end. This was partially offset by an increase in interest expense. Interest expense for the three-months ended June 30, 2026, was $1,730,000 relating to previously issued convertible notes and promissory notes issued in May 2025, August 2025, and May 2026. The aggregate principal amount of the promissory notes issued in 2025 and 2026 was $11,038,000. Operating expenses for the six-months ended June 30, 2026 were $3,695,000 compared to $15,564,000 for the same period in the preceding year, a decrease of $11,869,000 or 76%. The decrease in operating expenses was primarily due to a fair value adjustment on derivative liabilities and decrease in finance income on promissory notes, both of which are non-cash items. This decrease was partially offset by an increase in interest expense relating to previously issued convertible notes and promissory notes issued in May 2025, August 2025, and May 2026. Excluding the derivative adjustment, underlying cash-based operating costs were largely stable period-over-period. Clinical development and regulatory program costs (as disclosed in Note 13 of the condensed interim consolidated financial statements) were $415,000 for the three-months ended June 30, 2026 compared to $1,842,000 for the same period in the prior year representing a decrease of $1,427,000 or 77%. For the six months ended June 30, 2026, clinical development costs were $1,183,000 compared to $3,427,000 for the corresponding period in the prior year, representing a decrease of $2,244,000 or 65%. 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 decrease in clinical costs was due to the winding down of trial activities and site closures. Cumulative trial and regulatory program costs totaled $60,347,000 as of June 30, 2026 Gain for the three-months ended June 30, 2026 was $331,000, $0.00 per share compared to a loss of $1,933,000 or $(0.00) per share for the same period in the prior year. The favorable variance of $2,264,000 was driven by decreased operating expenses, finance income on promissory notes issued in May 2025, August 2025, and May 2026, as well as fair value adjustments on derivative liabilities. Loss for the six-months ended June 30, 2026 was $ 2,607,000, $(0.01) per share, compared to a loss of $14,539,000, $(0.05) per share, for the same period in the prior year. The decrease in loss of $11,932,000 was driven by lower operating expenses, primarily resulting from finance income on promissory notes issued in May 2025, August 2025, and May 2026, as well as fair value adjustments on derivative liabilities 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.
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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. 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. Condensed Interim Consolidated Statements of Financial Position In CAD (000s), except for share and per share data (Unaudited) Notes June 30, December 31, 2026 2025 $ $ Assets Current assets Cash 803 4,071 Trade and other receivables 427 205 Inventories 369 377 Prepayments and other assets 909 640 2,508 5,293 Non-current assets Right-of-use-asset 259 321 Property and equipment 118 153 Intangible asset 305 333 Total assets 3,190 6,100 Liabilities Current liabilities Trade and other payables 3,086 2,484 Current portion of contract liabilities 6 426 693 Current portion of lease liability 140 136 Notes payable 7 18,829 16,435 Derivative Liability 7 39,740 46,520 62,221 66,268 Non-current liability Non-current portion of lease liability 164 235 Non-current portion of contract liabilities 6 4,322 4,564 Non-current portion of promissory note 8 5,597 4,285 Non-current portion of interest accrual promissory note 8 953 470 Total liabilities 73,257 75,822 Shareholders' deficiency 10 Share capital 96,828 95,933 Contributed surplus 10,220 10,220
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Share-based compensation 13,633 12,266 Warrants 390 390 Deficit (191,138) (188,531) Total shareholders' deficiency (70,067) (69,722) Total liabilities and shareholders' deficiency 3,190 6,100 Spectral Medical Inc. Condensed Interim Consolidated Statements of Loss and Comprehensive Loss In CAD (000s), except for share and per share data (Unaudited) Three months ended June 30, 2026 Three months ended June 30, 2025 Six months ended June 30, 2026 Six months ended June 30, 2025 $ $ $ $ Revenue 6 621 813 1,512 1,385 Expenses Cost of goods sold 228 232 421 357 Gross Profit 393 581 1,091 1,028 Raw materials and consumables used 118 59 225 201 Salaries and benefits 14 1,098 1,025 2,066 2,081 Consulting and professional fees 547 1,314 1,406 2,581 Regulatory and investor relations 155 136 360 266 Travel and entertainment 139 98 215 175 Facilities and communication 89 30 188 88 Insurance 101 82 205 183 Depreciation and amortization 41 26 84 67 Interest expense 7,8 1,730 1,175 3,330 2,258 Finance income promissory note 8 (639) (3,137) (639) (3,137) Foreign exchange(gain) loss 1,363 (1,546) 2,646 (1,583) Share-based compensation 10 293 306 1,914 1,567 Other expense 70 57 121 116 Fair value adjustment derivative liabilities7 (5,043) 2,889 (8,426) 10,701 62 2,514 3,695 15,564 Income (loss) and comprehensive loss for the period from continuing operations 331 (1,933) (2,604) (14,536) Loss from discontinued operations 4 - - (3) (3) Income (loss) and comprehensive loss for the period 331 (1,933) (2,607) (14,539) Basic and diluted income (loss)from continuing operations per common share 11 0.00 (0.00) (0.01) (0.05) Basic and diluted income (loss) from discontinued operations per common share 11 0.00 (0.00) (0.00) (0.00) Basic and diluted income (loss) per common share 11 0.00 (0.00) (0.01) (0.05) Weighted average number of common shares outstanding - basic and diluted 11 293,429,976 284,906,444 293,327,875 284,801,035 Spectral Medical Inc. Condensed Interim Consolidated Statements of Changes in Shareholders’ Deficiency In CAD (000s), except for share and per share data (Unaudited) Notes Number of Shares Share Capital Contributed surplus Share-based compensation Warrants Deficit Total Shareholders’ (deficiency) equity $ $ $ $ $ $ Balance
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January 1, 2025 284,316,20790,566 10,149 11,196 1,383 (140,839) (27,545) Warrants exercised 97,341 63 - - (16) - 47 Share Options Exercised 10 831,882 472 - (179) - - 293 RSU released10 574,269 100 - (100) - - - Loss and comprehensive loss for the period - - - - - (14,539) (14,539) Share-based compensation10 - - - 1,567 - - 1,567 Balance June 30, 2025 285,819,69991,201 10,149 12,484 1,367 (155,378) (40,177) Warrants exercised 10 5,300,6343,372 - - (906) - 2,466 Warrants expired10 - - 71 - (71) - - Share Options Exercised 10 979,1681,092 - (502) - - 590 RSU released10 463,412 268 - (268) - - - Loss and comprehensive loss for the period - - - - - (33,153) (33,153) Share-based compensation10 - - - 552 - - 552 Balance December 31, 2025 292,562,91395,933 10,220 12,266 390 (188,531) (69,722) Balance January 1, 2026 292,562,91395,933 10,220 12,266 390 (188,531) (69,722) Share Options Exercised 10 684,531 637 - (289) - - 348 RSU released10 306,530 258 - (258) - - - Loss and comprehensive loss for the period - - - - - (2,607) (2,607) Share-based compensation10 - - - 1,914 - - 1,914 Balance June 30, 2026 293,553,97496,828 10,220 13,633 390 (191,138) (70,067) Spectral Medical Inc. Condensed Interim Consolidated Statements of Cash Flows In CAD (000s), except for share and per share data (Unaudited) Notes Six months ended June 30, 2026 Six months ended June 30, 2025 $ $ Cash flow provided by (used in) Operating activities Loss for the period (2,607) (14,539) Adjustments for: Finance income on Promissory Note (639) (3,137) Depreciation on right-of-use asset 62 62 Depreciation on property and equipment 35 47 Amortization of intangible asset 28 8 Amortization and Derivative related financing fee 7 127 127 Unrealized foreign exchange (gain) and loss 2,646 (1,583)
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Interest expense on lease liability 10 (4) Accreted interest on Notes Payable 7 2,492 2,136 Accreted interest on Promissory Note 8 345 32 Interest expense on Promissory Note 8 483 76 Share-based compensation 10 1,914 1,567 Fair value adjustment derivative liabilities (8,426) 10,701 Changes in items of working capital: Trade and other receivables (221) 145 Inventories 8 (15) Prepayments and other assets (269) (144) Trade and other payables 71 481 Contract liabilities 6 (509) (112) Net cash used in operating activities (4,450) (4,152) Investing activities Purchase of Technology - (167) Net cash used in investing activities - (167) Financing activities Financing charges paid on promissory notes (5) (202) Interest expense paid (453) (1,161) Lease liability payments (77) (60) Share options exercised 10 348 293 Share warrants exercised 10 - 47 Promissory Note 1,369 5,514 Net cash used in financing activities 1,182 4,431 Increase in cash (3,268) 112 Cash, beginning of period 4,071 2,988 Cash, end of period 803 3,100