Tigris Trial Enrollment completedTopline results expected to be released in August 2025Entered into an up to US$10 million Promissory Note with Vantive to Fund Spectral to PMX commercialization

TORONTO, May  09, 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 first quarter and provided a corporate update.

The Company made significant progress throughout the first quarter of 2025, both clinically and operationally. Specifically, regarding its Tigris trial, a Phase III clinical trial evaluating PMX for endotoxic septic shock. The Company recently completed full enrollment of its Tigris trial, and is expected to be in a position to share the topline results in the third quarter of this year and bringing the Company closer to U.S. FDA submission and potential U.S. FDA approval. In parallel to its clinical trial, the Company continues to work closely with its commercialization partner, Vantive US Healthcare LLC (“Vantive”); and most recently the parties collaborated on completing the enrolments for PrisMax sub-study in February 2025.

Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We are grateful for the strong interest in the clinical development of PMX among researchers and clinicians that has helped drive us towards completing full enrollment in the Tigris trial with a total of 157 patients. On behalf of Spectral Medical, I would like to express gratitude to the patients and their families in addition to the dedicated teams at the clinical sites, as well as our clinical and regulatory staff. We remain confident in the potential of PMX, and if ultimately approved, to play a major role in reducing the tragic rates of mortality caused by endotoxic septic shock.”

Corporate Highlights During & Subsequent to the First Quarter of 2025

Tigris

Total enrolled patients:

157 total patients enrolled

151 evaluable patients, 100 treated with PMXRelease of topline results:

Data lock to be completed in approximately 90 days

Expected release of topline results approximately 2 weeks post-data lockPMA 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 2025EDEN Abstract Presentation:

On February 23, 2025, an abstract of the EDEN study was presented by Dr. Mark Tidswell at the 2025 Society of Critical Care Medicine Annual Congress (see abstract: Critical Care Medicine)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 submitted to a medical journal.

PMX Commercialization

On January 31, 2025, Baxter International Inc. (“Baxter”) completed the sale of its Kidney Care business, including Vantive and its affiliated entities throughout the world, to funds affiliated with The Carlyle Group, pursuant to which Spectral Medical’s PMX distribution agreement was assigned to Vantive.Commercialization Activities:

In anticipation of a positive Tigris trial outcome, the Company has been working closely with Vantive on post-approval marketing plans for PMX commercialization.In February 2025, the Vantive PrisMax sub-study was completed

Vantive intends to submit a 510(k) application and obtain clearance for its PrisMax SystemThe PrisMax System, with its leading installed base in ICUs throughout the U.S., is anticipated to be the primary ICU device utilized for PMX treatments on commercial launch

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 millionUnder 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

“Finalizing enrollment represents another key milestone for the Company and brings us a step closer on our regulatory path to potential approval of PMX. Spectral is now heavily focused on the regulatory phase for PMX, in addition to our continued commercialization activities with our distribution partner Vantive,” said Chris Seto, CEO of Spectral. “With enrollment now complete, we expect to be in a position to share topline results in the third quarter of this year. Additionally, the Company recently strengthened its balance sheet as we entered into a promissory note with Vantive. Not only is this a non-dilutive financing, but the promissory note provides a funding path to advance PMX through the regulatory phase and, if ultimately approved, into commercialization.”

Financial Review

Revenue for the three-months ended March 31, 2025 was $572,000 compared to $668,000 for the same three-month period last year, representing a decrease of $96,000, or 14%. Royalty revenue for the three-months ended March 31, 2025 was $142,000 an increase of $7,000 from $135,000 for the same period in the prior year. Product revenue decreased by $174,000 because of timing difference of billings.

Operating expenses for the three-months ended March 31, 2025, were $13,174,000, compared to $4,825,000 for the same period in the preceding year, an increase of $8,349,000, or 173%. The increase in operating expenses were primarily due to increase in fair value adjustment on derivative liabilities which is a non-cash item in March 31, 2025. The increase was primarily due to change in the market assumptions and market price considered for the calculation of the option feature. Also, there was an increase in the interest expense, consulting and professional fees and share-based compensation. Interest expense of $1,076,000 which relates to the three months ended March 31, 2025 in relation to the May 30, 2024 and July 19, 2024 convertible notes previously issued. The principal amount of convertible notes issued in 2024 was $9,880,000.

Clinical development and regulatory program costs (as disclosed in Note 12 of the consolidated financial statements) were $1,585,000 for the three-months ended March 31, 2025 compared to $964,000 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. Increased clinical costs was due to the increase in volume of trial activities. Cumulative trial and regulatory program costs total as of March 31, 2025 was $56,415,000.

Loss for the three-months ended March 31, 2025 was $12,605,000 ($0.04 per share) compared to a loss of $4,160,000 ($0.01 per share) for the same period in the prior year. The increased loss of $8,445,000 was due to increased operating expenses, primarily due to increased fair value adjustment of derivative liability on March 31, 2025. Outside of the increase in the FV adjustment, operating expense were flat period over period.

The Company concluded the first quarter of 2025 with cash of $1,670,000 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 285,117,225 at March 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 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 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 SetoCapital Markets & Investor Relations CEOSpinnaker Capital Markets Inc. Spectral Medical Inc.416-962-3300 [email protected] [email protected]

Spectral Medical Inc.Condensed Interim Consolidated Statements of Financial PositionIn CAD (000s), except for share and per share data(Unaudited) Notes March 31, December 31, 2025 2024 $ $ Assets Current assets Cash 1,670 2,988 Trade and other receivables 310 451 Inventories 201 229 Prepayments and other assets 1,079 790  3,260 4,458 Non-current assets Right-of-use-asset 413 444 Property and equipment 218 243 Intangible asset 171 175 Total assets 4,062 5,320 Liabilities Current liabilities Trade and other payables 4,321 2,769 Current portion of contract liabilities6720 380 Current portion of lease liability 130 129 Notes payable714,815 14,425 Derivative Liability717,546 9,742  37,532 27,445 Non-current liability Lease liability 338 371 Non-current portion of contract liabilities64,928 5,049 Total liabilities 42,798 32,865 Shareholders' (deficiency) equity9 Share capital 90,897 90,566 Contributed surplus 10,149 10,149 Share-based compensation 12,282 11,196 Warrants 1,380 1,383 Deficit (153,444) (140,839) Total shareholders' (deficiency) equity  (38,736) (27,545) Total liabilities and shareholders' (deficiency) equity 4,062 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)  Reclassified
(Refer Note 16)  Notes Three months ended March 31, 2025 Three months ended March 31, 2024  $ $ Revenue11572 668 Expenses Cost of goods sold 125 211 Gross Profit 447 457 Raw materials and consumables used 142 162 Salaries and benefits131,056 976 Consulting and professional fees 1,266 925 Regulatory and investor relations 129 175 Travel and entertainment 77 76 Facilities and communication 58 74 Insurance 101 105 Depreciation and amortization 41 107 Interest expense71,083 540 Foreign exchange (gain) loss (36) 464 Share-based compensation 1,260 177 Other expense (income) 59 (12) Fair value adjustment derivative liabilities77,813 845  13,174 4,825 Loss and comprehensive loss for the period from continuing operations (12,602) (4,157) Loss from discontinued operations4(3) (3) Loss and comprehensive loss for the period (12,605) (4,160) Basic and diluted loss from continuing operations per common share10(0.04) (0.01) Basic and diluted loss from discontinued operations per common share10(0.00) (0.00) Basic and diluted loss per common share10(0.04) (0.01) Weighted average number of common shares outstanding - basic and diluted10284,760,158 279,472,325

Spectral Medical Inc.Condensed Interim Consolidated Statements of Changes in Shareholders’ DeficiencyIn CAD (000s)(Unaudited)  NotesNumber of Shares Share Capital Contributed surplus Share-based compensation Warrants Deficit Total  Shareholders’ (deficiency) equity  $ $ $ $ $ $ Balance January 1, 2024 278,576,261 87,061 8,916 10,385 2,526 (125,437) (16,549) Warrants exercised9750,000 463 - - (90) - 373 Share Options exercised968,167 37 - (15) - - 22 Loss and comprehensive loss for the period - - - - - (4,160) (4,160) Share-based compensation9- - - 177 - - 177 Balance, March 31, 2024279,394,428 87,561 8,916 10,547 2,436 (129,597) (20,137) Warrants exercised 9232,500 155 - - (31) - 124 Warrants issued9- - - - 211 - 211 Warrants expired9- - 1,233 - (1,233) - - Share Options Exercised91,839,444 1,153 - (520) - - 633 RSU released9114,210 50 - (50) - - - Notes Conversion71,879,647 1,368 - - - - 1,368 DSU exercise9855,978 279 - (279) - - - Loss and comprehensive loss for the period - - - - - (11,242) (11,242) Share-based compensation9- - - 1,498 - - 1,498 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 Exercised9431,882 219 - (74) - - 145 RSU released9350,386 100 - (100) - - - Warrants exercised 918,750 12    (3)  9 Loss and comprehensive loss for the period - - - - - (12,605) (12,605) Share-based compensation9- - - 1,260 - - 1,260 Balance March 31, 2025 285,117,225 90,897 10,149 12,282 1,380 (153,444) (38,736)

Spectral Medical Inc.Condensed Interim Consolidated Statements of Cash FlowsIn CAD (000s)(Unaudited)  Notes Three months ended March 31, 2025 Three months ended March 31, 2024  $ $ Cash flow provided by (used in) Operating activities Loss for the period (12,605) (4,160) Adjustments for: Depreciation on right-of-use asset 31 31 Depreciation on property and equipment 25 27 Amortization of intangible asset 4 4  Amortization and Derivative related financing fee 63 69 Unrealized foreign exchange (gain) and loss (26) 464 Interest expense on lease liability 6 9 Accreted Interest on Notes Payable 1,076 531 Share-based compensation 1,260 177 Fair Value adjustment derivative liabilities 7,813 846 Changes in items of working capital: Trade and other receivables 141 (296) Inventories 28 47 Prepayments and other assets (289) (359) Trade and other payables 820 (453) Contract liabilities 219 1,839 Net cash provided by (used in) operating activities 1,434 (1,224) Investing activities Purchase of property and equipment - (16) Net cash used in investing activities - (16) Financing activities Lease liability payments (38) (33) Share options exercised 145 22 Warrants exercised 9 373 Net cash provided by financing activities 116 362 Increase (decrease) in cash (1,318) (878) Cash, beginning of period 2,988 2,952 Cash, end of period 1,670 2,074