This press release is provided by GlobeNewswire and is published as received.
TORONTO, May 08, 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 first quarter ended March 31, 2026 and provided a corporate update.
The first quarter of 2026 marked continued progress across regulatory, clinical and commercial readiness initiatives as the Company advances toward submission of its U.S. Food and Drug Administration (“FDA”) Premarket Approval (“PMA”) application for Toraymyxin™ (“PMX”). During the quarter and subsequent to quarter-end, Spectral further strengthened the clinical and scientific foundation supporting PMX, highlighted by the publication of the Tigris trial in The Lancet Respiratory Medicine and presentation at the Society of Critical Care Medicine Annual Congress in Chicago
The Company is targeting a PMA submission date of May 29, 2026, a timeline established in coordination with the FDA to support both submission readiness and efficient allocation of review resources. The timing reflects incorporation of complete 12-month mortality data from the Tigris study, as well as completion of key non-clinical modules, including human factors engineering testing, to support a complete and compliant submission.
“Our focus remains on executing a high-quality and comprehensive PMA submission while advancing commercialization readiness alongside our partner Vantive,” said Chris Seto, Chief Executive Officer of Spectral Medical. “We are encouraged by the continued support from Vantive, including their decision to provide additional funding ahead of the PMA acceptance milestone. We believe this reflects a shared commitment to the PMX program and provides additional flexibility as we execute against this important regulatory step. The progress achieved during the quarter reinforces the strength of the Tigris data and the totality of evidence supporting PMX as we move toward submission and, ultimately, potential approval in the United States.”
John A. Kellum, Chief Medical Officer of Spectral Medical, added, “The consistency of benefit observed across endpoints, particularly at later timepoints, supports the concept that treatment effects become more apparent as patients recover beyond the acute phase of septic shock.”
Corporate Highlights During & Subsequent to the First Quarter of 2026
Tigris
PMX Commercialization
Financing
Financial Review
Revenue for the three-months ended March 31, 2026 was $891,000 compared to $572,000 for the same three-month period last year, representing an increase of $319,000, or 56%. The increase was primarily driven by higher Product revenue, including proprietary biochemical sales, instrumentation sales, and PMX pre-commercialization activities, partially offset by a decrease in Royalty revenue and EAA diagnostic sales mix. Product revenue increased to $386,000 from $176,000 in the prior-year period.
Operating expenses for the three-months ended March 31, 2026, were $3,633,000 compared to $13,049,000 for the same period in the preceding year, a decrease of $9,416,000 or 72 %. The decrease was primarily driven by a lower fair value adjustments on derivative liabilities (a non-cash item), as well as foreign exchange adjustments on derivative liabilities and convertible debentures. These variances resulted largely from changes in market assumptions and the market price used to calculate the option feature. Excluding the derivative fair value adjustment and foreign exchange adjustments on derivative liabilities and convertible debentures, expenses increased period-over-period, primarily due to higher interest expense, regulatory and investor relations costs, facilities costs and share-based compensation. Increase in interest expense reflects higher outstanding debt related to the Company’s convertible notes and the Vantive promissory note, including a full-quarter accrual of paid-in-kind (PIK) interest. Interest expense of $1,600,000 which relates to the three months ended March 31, 2026 in relation to convertible notes previously issued and May 2025 and August 2025 promissory notes issued.
Clinical development and regulatory program costs (as disclosed in Note 13 of the consolidated financial statements) were $768,000 for the three-months ended March 31, 2026 compared to $1,585,000 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 decrease in clinical costs reflects the completion of Tigris enrollment in April 2025 and reduced clinical site activity, partially offset by an increase in activities related to the Company’s ongoing FDA PMA submission, including regulatory consulting, data analysis, and other submission-readiness work. Cumulative trial and regulatory program costs total as of March 31, 2026 was $59,932,000.
Loss for the three-months ended March 31, 2026 was $2,938,000 ($0.01 per share) compared to a loss of $12,605,000 ($0.04 per share) for the same period in the prior year. The decreased loss of $9,667,000 was due to decreased operating expenses, primarily due to decreased fair value adjustment of derivative liability on March 31, 2026.
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.
Spectral Medical Inc.
Condensed Interim Consolidated Statements of Financial Position
In CAD (000s), except for share and per share data
(Unaudited)
Spectral Medical Inc.
Condensed Interim Consolidated Statements of Loss and Comprehensive Loss
In CAD (000s), except for share and per share data
(Unaudited)
Spectral Medical Inc.
Condensed Interim Consolidated Statements of Changes in Shareholders’ Deficiency
In CAD (000s), except for share and per share data
(Unaudited)
Spectral Medical Inc.
Condensed Interim Consolidated Statements of Cash Flows
In CAD (000s), except for share and per share data
(Unaudited)
NEWS RELEASE TRANSMITTED BY Globe Newswire
Globenewswire
