Mr. Chris Seto reports

SPECTRAL MEDICAL AND VANTIVE ANNOUNCE TOPLINE 12 MONTH FOLLOW-UP RESULTS FROM SPECTRAL'S TIGRIS TRIAL

Spectral Medical Inc. and Vantive, a vital organ therapy company committed to pursuing novel diagnostic and therapeutic options for organ failure, have released top-line mortality data at 12 months for patients enrolled in the Tigris trial. The randomized-controlled trial evaluated the use of polymyxin B hemoadsorption (PMX) in adults with endotoxic septic shock.

Endotoxic septic shock is a particularly deadly form of sepsis, occurring in approximately five million to million people annually around the world. There is currently no specific therapy targeting this patient population available in the United States. Complete 28-day and 90-day results of the Tigris trial were published in March of this year in The Lancet Respiratory Medicine. The full Bayesian analysis of Tigris revealed an absolute risk reduction for mortality of 10.3 per cent at 28 days corresponding to a number needed to treat (NNT) to prevent one death of 9.7 and 15.5 per cent at 90 days corresponding to an NNT of 6.5.

Initial 12-month follow-up results

As a secondary end point of the trial, preplanned follow-up was conducted on all enrolled Tigris study patients to assess vital status at 12 months. Mortality differences observed earlier in the study persisted through one year, with 12-month mortality of 56/106 (52.8 per cent) in patients treated with PMX compared with 34/51 (66.7 per cent) in patients receiving standard of care alone, representing an absolute risk reduction of 13.9 per cent and a number needed to treat of 7.2. Initial Bayesian statistical analyses based solely on the randomized Tigris trial data, without incorporation of the informative prior from Euphrates, demonstrated a 95.9-per-cent probability of benefit for PMX at 12 months compared with standard care alone.

Additional analyses are continuing to include the combination of prior Euphrates data in Bayesian and non-Bayesian analyses and survival analyses out to one year.

"Durability of benefit over the long term is the ultimate goal of any acute therapy. The results announced today clearly indicate that the benefits of PMX therapy observed in Tigris persisted over the months following hospital discharge," said Dr. John Kellum, chief medical officer of Spectral Medical. "These results provide further evidence of benefit for PMX when used to treat endotoxic septic shock."

"One-year results from the Tigris trial provide continued support for PMX and EAA [endotoxin activity assay] and mark another step forward toward our goal of improving outcomes in endotoxic septic shock," said Chris Seto, chief executive officer of Spectral Medical. "While many therapies for lethal diseases provide only short-term benefit, PMX has demonstrated a sustained effect on mortality in our phase 3 trial."

"Septic shock continues to carry a high risk of death despite advances in supportive care," said Dr. Peter Rutherford, MB, BS, PhD, head of worldwide medical at Vantive. "These findings further support the potential role of an endotoxin-targeted therapy in a well-defined, high-risk patient population and reinforce the importance of continued innovation in this space."

Vantive is Spectral's exclusive distributor of PMX in the United States and Canada and has non-exclusive rights to distribute EAA globally. Spectral Medical submitted the final premarket approval (PMA) module (Module 3) for PMX to the FDA (U.S. Food and Drug Administration) on May 28, 2026. If approved by the FDA, Vantive plans to commercialize both EAA and PMX, beginning in the United States, to support targeted rapid endotoxin adsorption (TREA) Therapy. TREA therapy brings precision medicine to sepsis, delivering rapid, decisive treatment for patients with endotoxic septic shock.

About the Tigris trial

The Tigris trial was a U.S.-based, multicentre, phase 3 study evaluating PMX in adults with endotoxic septic shock (ESS), defined by an endotoxin activity assay (EAA) level between 0.60 and 0.90. EAA is an FDA-cleared, semiquantitative diagnostic test for measurement of endotoxin activity, allowing for rapid measurements to obtain results in approximately 30 minutes. The treating physician can use these results to help inform timely therapeutic decisions.

PMX is not approved for use in the United States.

About Spectral Medical Inc.

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 single-use 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. EAA is also CE (Conformite Europeenne) marked and licensed by Health Canada.

PMX is approved for therapeutic use in Japan and Europe, licensed by Health Canada, with over 360,000 units sold around the world to date. In March, 2009, Spectral obtained the exclusive development and commercial rights in the United States for PMX and, in November, 2010, signed an exclusive distribution agreement for this product in Canada, where PMX is licensed but is not yet commercially available. 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 versus 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.

Complete results of the Tigris trial appeared in the May, 2026, issue of The Lancet Respiratory Medicine. 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.

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