Topline Tigris results expected to be released around mid-August 2025 TORONTO, Aug. 08, 2025 (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 and provided a corporate update. The second quarter of 2025 marked significant clinical and operational progress for Spectral. Following the completion of patient enrollment in the Tigris trial in April, the Company remains on track to report topline results in the third quarter. Tigris is a Phase III trial evaluating PMX for the treatment of endotoxic septic shock. The results of this pivotal study are expected to support the Company’s Premarket Approval (“PMA”) submission to the U.S. Food and Drug Administration (“FDA”). Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We are now in the final stages of data analysis following the completion of follow-up for the final patient in Tigris. We continue to believe in the strong clinical potential of PMX to reduce mortality in patients with endotoxic septic shock, and we look forward to sharing topline results soon.” Corporate Highlights During & Subsequent to the Second Quarter of 2025 Tigris Total enrolled patients: 157 total patients enrolled 151 evaluable patients, 100 treated with PMX Release of topline results: Data lock completed at end of July 2025 Expected release of topline results around mid-August 2025 PMA submission: The Company’s Premarket Approval submission (“PMA”) is a modular approach, whereby non-clinical aspects are submitted separately from the clinical dataTo-date the Company has submitted all non-clinical studies and reports to the US Food & Drug Administration (“FDA”) for evaluationOn track to submit the clinical results and reports by end of October 2025 EDEN Abstract Presentation: The Company completed its EDEN study in Q4 2023 with 92 patients enrolled. The ancillary observational study collected data on patients with sepsis even if ineligible for Tigris, and captured much needed data on the full range of septic shock and its relation to organ failure and endotoxin activity.Based on the results of 84 evaluable patients, compared to other patients with septic shock, those with endotoxic septic shock (EAA ≥ 0.6 and SOFA >11) had significantly higher mortality (60% vs 14.1%, p < 0.001).These data will inform subsequent discussions with the FDA on labelling for PMX, as well as to provide the medical community and the Company a better picture of the addressable population in the U.S. for PMX.A manuscript describing the full results of the EDEN study has been accepted for publication in a medical journal and should be available in the next few weeks. PMX Commercialization Ongoing collaboration with Vantive on post-approval commercialization planningVantive intends to submit 510(k) application for its PrisMax system, expected to be the primary ICU platform for PMX treatmentMarket readiness efforts are aligned with potential FDA approval timelines Balance Sheet and Financing Update On May 6, 2025, Spectral entered into a senior secured promissory note (the “Agreement”) with Vantive, in the aggregate principal amount of up to US$10 million Under the terms of the Agreement, Vantive may advance funds to Spectral in up to four separate tranchesFirst tranche of US$4 million payable to Spectral was triggered on May 6, 2025 upon the execution of the AgreementThe primary terms of the Promissory Note are: 4-year maturityPayment-in-Kind (“PIK”) interest at an annual rate of 9%Principal balance and PIK interest to be repaid at maturityThe Promissory Note is not convertible into any securities of the Company On July 4, 2025, Spectral filed a preliminary short form base shelf prospectus Given upcoming milestones and catalysts which may be impactful to the Company, the base shelf prospectus provides maximum flexibility to optimize Spectral’s balance sheet. “The second quarter represented a pivotal period in our path to potential FDA approval, with the finalizing of Tigris enrollment. With data lock now complete and data analysis underway, we are closer than ever to the critical topline readout from Tigris,” said Chris Seto, CEO of Spectral Medical. “In parallel, we were pleased to secure non-dilutive funding from our commercialization partner, Vantive, providing us with the financial flexibility to navigate the regulatory process and plan for launch. The totality of evidence continues to build in support of PMX, and we remain focused on execution across regulatory, clinical, and commercial fronts.” Financial Review Revenue for the three-months ended June 30, 2025 was $813,000 compared to $471,000 for the same three-month period last year, representing an increase of $342,000, or 73%. Revenue for six-months ended June 30, 2025, was $1,385,000 and $1,139,000 for the same period last year, representing an increase of $246,000 or 22%. Royalty revenue for the three-months ended June 30, 2025 was NIL and NIL for the same period prior year. Royalty revenue for the six-months ended June 30, 2025 was $142,000 compared to $135,000 for the same six-month period last year. This is due to an increase in usage of the Company’s IP from one customer. Product Revenue for the three-months ended June 30, 2025 was $403,000 compared to $217,000 for the same three-month period last year, representing an increase of $186,000 or 86% Product revenue for six-month ended June 30, 2025 was $579,000 and $567,000, representing an increase of $12,000 or 2%. Product revenue increased because Vantive purchased PMX for marketing purposes as PMX is not FDA cleared and there is no commercial activity in Canada. Operating expenses for the three-months ended June 30, 2025, were $2,514,000, compared to $4,702,000 for the same period in the preceding year, a decrease of $2,188,000, or 47%. The decrease in operating expenses were primarily due to finance income on promissory note issued May 06, 2025 which is a non-cash item on June 30, 2025. Also, there was an increase in the interest expense and raw material and consumable used. There has been improved customer forecast since 2024 for raw materials and consumables. Interest expense of $1,175,000 which relates to the three months ended June 30, 2025 in relation to the May 30, 2024, July 19, 2024 convertible notes previously issued and May 2025 promissory notes issued. The principal amount of convertible notes issued in 2024 was $9,880,000. The principal amount of promissory note issued in 2025 was $5,154,000. Operating expenses for the six-months ended June 30, 2025 were $14,536,000 compared to $8,559,000 for the same period in the preceding year, an increase of $5,977,000 or 70%. The increase in operating expenses were primarily due to increase in fair value adjustment on derivative liabilities which is a non-cash item on June 30, 2025. Also, there was an increase in the interest expense and raw material and consumable used. Interest expense of $2,258,000 which relates to the six months ended June 30, 2025 in relation to the May 30, 2024 and July 19, 2024 convertible notes previously issued and May 2025 Promissory Notes issued. Clinical development and regulatory program costs (as disclosed in Note 13 of the condensed interim consolidated financial statements) were $1,842,000 for the three-months ended June 30, 2025 compared to $1,413,000 for the same period in the prior year. For the six-months ended June 30, 2025, clinical development costs are $3,427,000 compared to $2,377,000 for the corresponding period in 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. Increased clinical costs was due to the increase in volume of trial activities. Cumulative trial and regulatory program costs total as of June 30, 2025 was $58,257,000. Loss for the three-months ended June 30, 2025 was $1,933,000 $(0.00) per share compared to a loss of $4,402,000, $(0.02) per share for the same period in the prior year. The decreased loss of $2,469,000 was due to decreased operating expenses, primarily due to finance income on Promissory Note issued May 2025. Loss for the six-months ended June 30, 2025 was $ 14,539,000, $(0.05) per share, compared to a loss of $8,562,000 $(0.03) per share, for the same period in the prior year. The increased loss of $5,977,000 was due to operating expenses, primarily due to increased interest expense in relation to May 30, 2024, July 19, 2024 convertible notes previously issued and May 2025 promissory notes issued on May 06, 2025 and fair value adjustment of derivative liability on June 30, 2025. The Company concluded the second quarter of 2025 with cash of $3,100,000 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 285,819,699 at June 30, 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 and has been used safely and effectively over 360,000 times 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 9endotoxic 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 MahdaviChris SetoCapital Markets & Investor RelationsCEOSpinnaker Capital Markets Inc.Spectral Medical Inc.416-962-3300 am@spinnakercmi.comcseto@spectraldx.com Spectral Medical Inc.Condensed Interim Consolidated Statements of Financial PositionIn CAD (000s), except for share and per share data(Unaudited) NotesJune 30, December 31, 2025 2024 $ $ Assets Current assets Cash 3,100 2,988 Trade and other receivables 306 451 Inventories 244 229 Prepayments and other assets 934 790 4,584 4,458 Non-current assets Right-of-use-asset 382 444 Property and equipment 196 243 Intangible asset 334 175 Total assets 5,496 5,320 Liabilities Current liabilities Trade and other payables 3,219 2,769 Current portion of contract liabilities6510 380 Current portion of lease liability 132 129 Notes payable714,901 14,425 Derivative Liability719,540 9,742 38,302 27,445 Non-current liability Lease liability 304 371 Non-current portion of contract liabilities64,807 5,049 Promissory Note82,183 - Non-current interest accrual promissory note 76 - Total liabilities 45,672 32,865 Shareholders' (deficiency) equity10 Share capital 91,201 90,566 Contributed surplus 10,149 10,149 Share-based compensation 12,484 11,196 Warrants 1,368 1,383 Deficit (155,378)(140,839)Total shareholders' (deficiency) equity (40,176)(27,545)Total liabilities and shareholders' (deficiency) equity 5,496 5,320 Spectral Medical Inc.Condensed Interim Consolidated Statements of Loss and Comprehensive Loss In CAD (000s), except for share and per share data(Unaudited) Notes Reclassified Reclassified (Refer Note16) (Refer Note16) Three monthsended June30, 2025 Three monthsended June30, 2024 Six monthsended June30, 2025 Six monthsended June30, 2024 $ $ $ Revenue11813 471 1,385 1,139 Expenses
Cost of goods sold 232 171 357 277 Gross Profit 581 300 1,028 862 Raw materials and consumables used 59 321 201 558 Salaries and benefits141,025 998 2,081 1,981 Consulting and professional fees 1,314 1,445 2,581 2,370 Regulatory and investor relations 136 126 266 301 Travel and entertainment 98 195 175 271 Facilities and communication 30 88 88 176 Insurance 82 105 183 210 Depreciation and amortization 26 525 67 641 Interest expense71,175 668 2,258 1,208 Finance income promissory note8(3,137)- (3,137)- Foreign exchange(gain) loss (1,546)65 (1,583)529 Share-based compensation10306 1,079 1,567 1,256 Other expense 57 - 116 (12)Fair value adjustment derivative liabilities72,889 (913)10,701 (68) 2,514 4,702 15,564 9,421 Loss and comprehensive loss for the period from continuing operations (1,933)(4,402)(14,536)(8,559)Loss from discontinued operations4- - (3)(3)Loss and comprehensive loss for the period (1,933)(4,402)(14,539)(8,562)Basic and diluted loss from continuing operations per common share11(0.00)(0.02)(0.05)(0.03)Basic and diluted loss from discontinued operations per common share11(0.00)0.00 (0.00)0.00 Basic and diluted loss per common share11(0,00)(0.02)(0.05)(0.03)Weighted average number of common shares outstanding - basic and diluted11284,906,444 280,049,434 284,801,035 279,539,697 Spectral Medical Inc.Condensed Interim Consolidated Statements of Changes in Shareholders’ DeficiencyIn CAD (000s) (Unaudited) NotesNumber ofSharesShareCapital ContributedsurplusShare-based compensation Warrants Deficit Total Shareholders’ (deficiency) equity $ $$ $ $ $ Balance January 1, 2024 278,576,26187,061 8,91610,385 2,526 (125,437)(16,549)Warrants exercised10750,000463 -- (90)- 373 Warrants issued10-(212)-- 212 - - Share Options Exercised101,867,6271,163 -(524)- - 639 RSU released1051,65126 -(26)- - - Loss and comprehensive loss for the period -- -- - (8,562)(8,562)Share-based compensation10-- -1,256 - - 1,256 Balance June 30, 2024 281,245,53988,501 8,91611,091 2,648 (133,999)(22,843)Warrants exercised10232,500155 -- (31)- 124 Warrants issued10-212 -- - - 212 Warrants expired10-- 1,233- (1,233)- - Share Options Exercised1039,98427 -(11)- - 16 RSU released1062,55924 -(24)- - - Notes Conversion71,879,6471,368 -- - - 1,368 DSU exercise10855,978279 -(279)- - - Loss and comprehensive loss for the period -- -- - (6,840)(6,840)Share-based compensation10-- -419 - - 419 Balance December 31, 2024 284,316,20790,566 10,14911,196 1,383 (140,839)(27,545)Balance January 1, 2025 284,316,20790,566 10,14911,196 1,383 (140,839)(27,545)Share Options Exercised10831,882472 -(179)- - 293 RSU released10574,269100 -(100)- - - Warrants exercised1097,34163 -- (16)- 47 Loss and comprehensive loss for the period -- -- - (14,539)(14,539)Share-based compensation9-- -1,567 - - 1,567 Balance June 30, 2025 285,819,69991,201 10,14912,484 1,368 (155,378)(40,176) Spectral Medical Inc.Condensed Interim Consolidated Statements of Cash FlowsIn CAD (000s)(Unaudited) Six months endedJune 30, 2025Six months endedJune 30, 2024Cash flow provided by (used in) Operating activities Loss for the period(14,539)(8,562)Adjustments for: Finance income on Promissory Note(3,137)- Depreciation on right-of-use asset62 62 Depreciation on property and equipment47 56 Amortization of intangible asset8 9 Amortization and Derivative related financing fee127 554 Unrealized foreign exchange (gain) and loss(1,583)537 Interest expense on lease liability(4)17 Accreted interest on Notes Payable2,136 1,191 Accreted interest on Promissory Note108 - Share-based compensation expense1,567 1,256 Fair value adjustment derivative liabilities10,701 (68)Changes in items of working capital: Trade and other receivables145 (166)Inventories(15)94 Prepayments and other assets(144)(311)Trade and other payables481 (36)Contract liabilities(112)1,747 Net cash provided by used in operating activities(4,152)(3,620)Investing activities Purchase of property and equipment- (24)Purchase of Technology(167)- Net cash used in investing activities(167)(24)Financing activities Financing charges paid(202)(722)Interest expense paid(1,161)(518)Lease liability payments(60)(76)Share options exercised293 639 Share warrants exercised47 373 9% convertible notes issued- 8,532 Promissory Note5,514 - Net cash provided by financing activities4,431 8,228 Increase in cash112 4,584 Cash, beginning of period2,988 2,952 Cash, end of period3,100 7,536
