TORONTO, Aug. 07, 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 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.
- On May 28, 2026, Spectral submitted its PMA application to the FDA
- 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 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.
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 | |||
| 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 liabilities | 7 | (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 January 1, 2025 | 284,316,207 | 90,566 | 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 released | 10 | 574,269 | 100 | - | (100 | - | - | - | - | |||
| Loss and comprehensive loss for the period | - | - | - | - | - | (14,539 | - | (14,539 | - | |||
| Share-based compensation | 10 | - | - | - | 1,567 | - | - | 1,567 | ||||
| Balance June 30, 2025 | 285,819,699 | 91,201 | 10,149 | 12,484 | 1,367 | (155,378 | - | (40,177 | - | |||
| Warrants exercised | 10 | 5,300,634 | 3,372 | - | - | (906 | - | - | 2,466 | |||
| Warrants expired | 10 | - | - | 71 | - | (71 | - | - | - | |||
| Share Options Exercised | 10 | 979,168 | 1,092 | - | (502 | - | - | - | 590 | |||
| RSU released | 10 | 463,412 | 268 | - | (268 | - | - | - | - | |||
| Loss and comprehensive loss for the period | - | - | - | - | - | (33,153 | - | (33,153 | - | |||
| Share-based compensation | 10 | - | - | - | 552 | - | - | 552 | ||||
| Balance December 31, 2025 | 292,562,913 | 95,933 | 10,220 | 12,266 | 390 | (188,531 | - | (69,722 | - | |||
| Balance January 1, 2026 | 292,562,913 | 95,933 | 10,220 | 12,266 | 390 | (188,531 | - | (69,722 | - | |||
| Share Options Exercised | 10 | 684,531 | 637 | - | (289 | - | - | - | 348 | |||
| RSU released | 10 | 306,530 | 258 | - | (258 | - | - | - | - | |||
| Loss and comprehensive loss for the period | - | - | - | - | - | (2,607 | - | (2,607 | - | |||
| Share-based compensation | 10 | - | - | - | 1,914 | - | - | 1,914 | ||||
| Balance June 30, 2026 | 293,553,974 | 96,828 | 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 | - | ||
| 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 | |||
