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

•  Recent financing expected to fund operations through anticipated FDA PMA decision

•  Company to host a Corporate Update call December 10, 2026

TORONTO, Nov. 06, 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 third quarter ended September 30, 2026 and provided a corporate update.

During the third quarter, Spectral advanced the regulatory review process for Toraymyxin™ (“PMX”), including an in-person 100-Day Meeting with the U.S. Food and Drug Administration (“FDA”). Following receipt of the FDA’s deficiency letter, the Company is working to address requests for clarification, additional data analyses and testing. The Company also continues to interact with the FDA regarding inspection activities and other matters associated with the substantive review of its Premarket Approval (“PMA”) application.

“The recent financing is expected to provide the funding needed to advance PMX through the anticipated FDA PMA decision,” said Chris Seto, Chief Executive Officer of Spectral Medical. “With this funding in place, we can focus on addressing the FDA’s feedback, supporting ongoing review and inspection activities, and preparing for potential commercialization with Vantive and Toray.”

John A. Kellum, Chief Medical Officer of Spectral Medical, added, “The Tigris clinical evidence, including follow-up through one year, remains central to our PMA application. Our team is focused on addressing the FDA’s analytical and testing requests and supporting its assessment of the totality of evidence for PMX in patients with endotoxic septic shock.”

Corporate Highlights During & Subsequent to the Third Quarter of 2026

Tigris

• PMA:
  • On September 11, 2026, the Company provided an update on its in-person 100-Day Meeting with the FDA. The FDA’s deficiency letter requested clarification, additional data analyses and testing, but did not request an additional clinical trial.
    • The Company is preparing its response to the deficiency letter and continues to interact with the FDA regarding inspection activities and other aspects of the PMA review. The timing and outcome of the review remain subject to the FDA’s regulatory processes.
  • The Company is actively supporting the FDA review process and inspection activities.

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.
• The Company continues to collaborate with Toray, the manufacturer of PMX, on manufacturing readiness, commercial supply planning and quality system activities in preparation for potential commercialization, subject to regulatory approval.

Balance Sheet and Financing

• On July 28, 2026, the Company received the remaining US$1.0 million of the Tranche D advance from Vantive under its senior secured promissory note, completing the US$2.0 million Tranche D funding.
• On October 30, 2026, the Company closed the first tranche of a C$14.0 million private placement of unsecured convertible notes due November 1, 2031, issuing C$7.7 million aggregate principal amount. The Company expects to issue an additional C$6.3 million aggregate principal amount in a second tranche on or about November 6, 2026, subject to customary closing conditions. The notes are convertible into units at C$1.00 per unit. Each unit consists of one common share and one-half of one common share purchase warrant, with each whole warrant exercisable at C$1.10 until November 1, 2031.
• Proceeds from the offering are intended to support repayment of maturing convertible notes and fund regulatory activities and working capital.
  

Management estimates that the recent convertible note financing provides sufficient funding to support the Company’s operations through the anticipated FDA decision on its PMA application for PMX.

Corporate Update Call

The Company will host a corporate update call on December 10, 2026. The time and participation details will be announced at a later date.

Financial Review

Total Revenue for the three-months ended September 30, 2026, decreased to $275,000 compared to $675,000 for the same period in 2025, representing a decrease of $400,000, or 59%. This decline was primarily due to absence of service revenue, following the conclusion of the Vantive PrisMax sub study in May 2026, as well as timing difference in the product mix. Revenue for the nine months ended September 30, 2026, was $1,787,000 compared to $2,060,000 for the same period in 2025, representing a decrease of $273,000 or 13%. Decrease in total revenue for both the three-and-nine-month periods was primarily driven by the conclusion of the Vantive PrisMax sub study in May 2026, which impacted service revenue. Product revenue for the three months ended September 30, 2026 was $154,000 compared to $446,000 for the same three-month period last year, representing a decrease of $292,000 or 65% primarily due to timing differences. Product revenue for nine-month ended September 30, 2026 was $919,000 compared to $1,025,000 for the same nine-month period last year, representing a decrease of $106,000 or 10% primarily due decrease in sale of biochemicals, EAA kits and sample PMX sales which has been partially offset by increase in instrumentation sale.

Net Operating expenses for the three-months ended September 30, 2026, were $(4,897,000), compared to $30,800,000 for the same period in the prior year, representing a decrease of $35,697,000 or 116%. The decrease was primarily driven by non-cash fair value adjustment 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. Additionally, there was a decrease in consulting and professional fees due to clinical site closures and the conclusion of the Tigris Trial. These reductions were partially offset by an increase in interest expense. Interest expense for the three-months ended September 30, 2026, was $1,948,000, relating to previously issued convertible notes and promissory notes issued in May 2025, August 2025, May 2026 and July 2026. The aggregate principal amount of the promissory notes issued in 2025 and 2026 was $12,448,000.

Net Operating expenses for the nine-months ended September 30, 2026 were $(1,201,000) compared to $46,364,000 for the same period in the prior year, representing a decrease of $47,565,000 or 103%. This decrease was primarily driven by fair value adjustment on derivative liabilities (a non-cash item) and finance income on promissory notes (a non-cash item). These reductions were partially offset by an increase in interest expense relating to previously issued convertible notes and promissory notes issued in May 2025, August 2025, May 2026 and July 2026.

Clinical development and regulatory program costs (as disclosed in Note 13 of the condensed interim consolidated financial statements) were $398,000 for the three-months ended September 30, 2026 compared to $1,055,000 for the same period in the prior year representing a decrease of $657,000, or 62%. For the nine months ended September 30, 2026, clinical development costs were $1,581,000 compared to $4,482,000 for the corresponding period in the prior year, representing a decrease of $2,901,000, or 65%. A significant portion of clinical trial and regulatory costs consist 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 $60,745,000 as of September 30, 2026.

Income for the three-months ended September 30, 2026 was $5,099,000, $0.02 per share compared to a loss of $30,316,000 or $(0.11) per share for the same period in the prior year. The favorable variance of $35,415,000 was driven by decreased operating expenses, primarily resulting from finance income on promissory notes issued in May 2025, August 2025, May 2026 and July 2026, as well as fair value adjustments on derivative liabilities.

Income for the nine-months ended September 30, 2026 was $2,491,000, $0.01 per share, compared to a loss of $44,855,000, $(0.16) per share, for the same period in the prior year. The favorable variance of $47,346,000 was driven by lower operating expenses, primarily resulting from finance income on promissory notes issued in May 2025, August 2025, May 2026 and July 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.

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