Spectral Medical Announces Fourth Quarter and Fiscal 2025 Results and Provides Corporate Update

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

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