Board Change • Jul 02
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 3 experienced directors. 3 highly experienced directors. Independent Director Cristiano Franzi was the last director to join the board, commencing their role in 2024. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Major Estimate Revision • Jun 26
Consensus EPS estimates fall by 33% The consensus outlook for fiscal year 2026 has been updated. 2026 expected loss increased from -CA$0.03 to -CA$0.04 per share. Revenue forecast of CA$2.81m unchanged since last update. Biotechs industry in Canada expected to see average net income decline 72% next year. Consensus price target of CA$3.15 unchanged from last update. Share price was steady at CA$1.36 over the past week. Announcement • Jun 04
Spectral Medical and Vantive Announce Topline 12 Month Follow-Up Results from Tigris Trial Spectral Medical and Vantive announced topline 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. 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% at 28 days corresponding to a number needed to treat (NNT) to prevent one death of 9.7 and 15.5% at 90 days corresponding to a NNT of 6.5. As a secondary endpoint 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%) in patients treated with PMX compared to 34/51 (66.7%) in patients receiving standard of care alone, representing an absolute risk reduction of 13.9% 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% probability of benefit for PMX at 12 months compared to standard care alone. Additional analyses are ongoing to include the combination of prior EUPHRATES data in Bayesian and non-Bayesian analyses and survival analyses out to one year. 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 submitted the final Premarket Approval (PMA) module (Module 3) for PMX to the FDA 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. The Tigris trial was a U.S.-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 an FDA cleared, semiquantitative diagnostic test for measurement of endotoxin activity, allowing for rapid measurements to obtain results in approximately 30 minutes. PMX is not approved for use in the United States. 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. 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, 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 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. Complete results of the Tigris trial appeared in the May 2026 issue of the Lancet Respiratory Medicine. 
