Spectral Medical Announces Second Quarter 2026 Financial Results and Provides Corporate Update

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.
    
    
• 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