Mr. Chris Seto reports

SPECTRAL MEDICAL AND VANTIVE ANNOUNCE PUBLICATION OF COMPLETE RESULTS FROM SPECTRAL'S TIGRIS TRIAL IN THE LANCET RESPIRATORY MEDICINE

Spectral Medical Inc. and Vantive have published the complete results from the Tigris trial in The Lancet Respiratory Medicine, a leading peer-reviewed journal in critical care medicine. The randomized-controlled trial evaluated the use of Polymyxin B Hemoadsorption (PMX) in adults with endotoxic septic shock, providing a more complete picture of patient outcomes, including survival and safety over time.

• Tigris publication confirms positive results for primary and key secondary end points with 95.3-per-cent and 99.4-per-cent 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 per cent at 28 days and 15.5 per cent at 90 days.
• Safety profile consistent with standard of care with no significant difference in adverse events.
• Tigris trial results to be presented at the Society of Critical Care Medicine (SCCM) in Chicago, Ill., on March 24, 2026.

Each year, approximately five million to seven million cases of endotoxic septic shock, a particularly deadly form of sepsis, occur worldwide. Currently, no specific therapy targeting this patient population is available in the United States. The published Tigris trial results confirm the positive primary and key secondary end points previously reported in August, 2025, and provide additional analyses on longer-term survival, safety and treatment effect. After adjusting for baseline severity, the Tigris trial demonstrated 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 a NNT of 6.5.

"We are pleased that the complete results of our Tigris trial are to be published in The Lancet Respiratory Medicine and will be presented at the Society of Critical Care Medicine (SCCM) Congress," said Dr. John Kellum, chief medical officer of Spectral Medical. "The detailed analysis in the publication shows that the trial not only achieved its prespecified goal of greater than 95 per cent posterior probability of benefit for 28-day mortality using a Bayesian analysis, but also demonstrated robust 90-day results across multiple sensitivity analyses, confirming a lasting survival benefit."

Tigris trial overview

The Tigris trial was a United States-based, multicenter, 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 a Food and Drug Administration-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.

Eligible patients also had to meet additional criteria for ESS including multiple organ dysfunction; a multiple organ dysfunction score (MODS) greater than nine or a Sequential Organ Failure Assessment (SOFA) score of greater than 11. A total of 157 patients were randomized in a 2:1 ratio to receive either PMX plus standard care (n equals 106) or standard care alone (n equals 51).

The prespecified primary analysis used a Bayesian statistical model, which evaluates results in the context of prior data -- in this case a subgroup of the prior Euphrates trial. The Tigris trial's design and analysis plan were aligned with published FDA's Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials.

The Tigris trial publication appears in The Lancet Respiratory Medicine, a leading peer-reviewed journal in respiratory and critical care medicine. The publication includes extensive supplementary analyses, including Kaplan-Meier survival curves, subgroup analyses and Bayesian sensitivity analyses, providing a comprehensive evaluation of treatment effect across multiple statistical assumptions.

Key findings of the Tigris trial

The publication confirms the previously reported positive findings for the primary and key secondary end points announced in August, 2025, while providing additional analyses on survival, safety, secondary and sensitivity analyses.

Primary end point (28-day mortality):

• Intention to treat cohort showed a probability of benefit of 95.3 per cent at 28 days;
• Adjusted odds ratio 0.67 (0.39 to 1.08):
  • Adjusted probability of benefit from PMX at 28 days exceeds the prespecified 95-per-cent target and thus meets the prespecified primary end point;
  • Adjusted absolute risk reduction for mortality was 10.3 per cent (negative 1.7, 22.3) corresponding to a number needed to treat (NNT) to save one life at 28 days of 9.7.

Key secondary end point (90-day mortality):

• The key secondary end point, mortality at 90 days, showed a 99.4-per-cent probability of benefit for patients treated with PMX.
• Adjusted odds ratio 0.54 (0.32 to 0.87):
  • Adjusted absolute risk reduction in mortality was 15.5 per cent (3.6, 27.1) corresponding to a number needed to treat (NNT) to save one life at 90 days of 6.5.
  • Ninety-day results were robust to all sensitivity analyses and show greater than 98-per-cent probability for benefit at 90 days even for Tigris alone (non-informative prior).
  • Survival over 90 days was significantly greater for patients treated with PMX with a posterior hazard ratio: 0.68 (0.47, 0.95); probability of benefit 98.8 per cent.

At day 28, nearly half of surviving patients remained hospitalized (46 per cent) and 16 per cent remained in the ICU, reflecting the continuing clinical instability typical of septic shock patients. By day 90, however, nearly all surviving patients (98 per cent) had been discharged from hospital. Kaplan-Meier survival curves demonstrated continued separation beyond day 28, indicating that the survival benefit observed with PMX was sustained over time.

Safety:

• Adverse events over the treatment period did not differ between PMX and standard of care.
• A serious adverse event (SAE) occurred in 30 subjects (30 per cent) randomized to PMX and in 11 (22 per cent) randomized to SOC, a difference which is not statistically significant.
• Two subjects (2 per cent) experienced a SAE that was classified as possibly, probably or definitely related to the intervention (PMX, catheter or anticoagulation). Neither was permanent and both subjects were discharged from the hospital.

This safety profile for PMX is consistent with other forms of extracorporeal blood purification therapies commonly used in the ICU, including ICU dialysis.

"Publication in The Lancet Respiratory Medicine reflects the scientific rigor of the Tigris trial and the strength of the data supporting these findings," said Dr. Matthieu Legrand, corresponding author of the Tigris manuscript. "The manuscript includes extensive analyses beyond the primary end point, including adjusted models, survival analyses and sensitivity analyses, that consistently support the observed treatment effect. Importantly, the study also illustrates that many patients remain clinically unstable at 28 days -- nearly half of survivors were still hospitalized and a meaningful proportion remained in the ICU. By contrast, by 90 days almost all surviving patients had been discharged, and it appears organ dysfunction had largely resolved. This highlights why longer-term outcomes provide a clearer view of the true impact of therapy in septic shock, a condition where recovery from multiple organ failure often extends well beyond the initial ICU phase."

2026 Critical Care Congress

The Tigris manuscript will be presented during the late-breaking studies affecting patient outcomes session at the Society of Critical Care Medicine (SCCM) Critical Care Congress, one of the most influential scientific forums for intensive care physicians worldwide.

The presentation will take place in Skyline Ballroom, of the McCormick Place convention centre in Chicago, Ill., at 10:20 a.m. local time.

Dr. Javier Neyra, first author of the Tigris publication and who will present the Tigris findings at SCCM, commented: "Endotoxic septic shock remains one of the most challenging syndromes in critical care medicine. Despite decades of research, randomized clinical trials in septic shock have rarely demonstrated improvements in survival. Septic shock remains one of the leading causes of death in intensive care units worldwide, underscoring the need for therapies that address the underlying drivers of organ failure. Presenting the Tigris results at SCCM provides an important opportunity to engage the global critical care community and discuss how precision medicine and blood purification technologies can be applied to help address this major unmet clinical need."

"Publication of the Tigris results represents an important milestone in advancing the clinical evidence supporting endotoxin-targeted therapy in septic shock," said Dr. Peter Rutherford, MB BS, PhD, head of Worldwide Medical at Vantive. "Vantive remains committed to supporting research that advances treatment options for critically ill patients and improves outcomes from these complex conditions. Publication of the Tigris randomized trial results provides important clinical evidence to inform treatment decisions at the bedside and support a broader understanding of endotoxin-guided approaches to care."

"The publication of the Tigris results represents a significant milestone for Spectral as we continue advancing toward our goal of improving outcomes in endotoxic septic shock," said Chris Seto, chief executive officer of Spectral Medical. "When considered alongside prior evidence from the Euphrates trial and global clinical experience, the totality of data supporting PMX continues to strengthen. Importantly, the safety profile observed in Tigris was consistent with PMX's historical use with over 360,000 units sold worldwide. We believe these findings further support our planned FDA PMA submission and our efforts to make this therapy available to the patients who need it most."

Vantive is Spectral's exclusive distributor of PMX in the U.S. and Canada and has non-exclusive rights to distribute EAA globally. Spectral Medical intends to submit the final premarket approval (PMA) module (Module 3) for PMX to the FDA around the end of April to mid-May, 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.

PMX is not approved for use in the United States.

EAA Rx only: For safe and proper use of devices mentioned herein, please refer to user manual.

About Spectral Medical Inc.

Spectral is a phase 3 company seeking United States 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 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 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 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.

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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