Spectral Medical Announces Fourth Quarter and Fiscal 2025 Results and Provides Corporate Update

Executive Summary

• Spectral Medical reported a fiscal‑year loss of C$47.7 M, widening from the prior year’s C$15.4 M loss, driven largely by non‑cash fair‑value adjustments to derivative liabilities.
• Positive clinical milestones were announced: publication of Tigris trial results in The Lancet Respiratory Medicine, presentation at the SCCM Annual Congress, and an updated FDA PMA submission timeline (now end‑April to mid‑May 2026).
• Cash increased to C$4.07 M year‑end 2025; revenue grew modestly to C$2.44 M (+7% YoY), while operating expenses rose sharply to C$49.4 M.

Key Details

• Financial Results – Q4 2025
• Revenue: C$382 k (down from C$645 k YoY).
• Operating loss: C$3.03 M vs. operating income of $(2.51) M in Q4 2024.

• Loss from continuing operations: C$2.84 M (vs. $(3.16) M prior year).

• Financial Results – FY 2025

• Total revenue: C$2.44 M vs. C$2.29 M in 2024 (+7%).
• Operating expenses: C$49.39 M vs. C$16.86 M in 2024; increase of C$32.53 M.
• Loss from continuing operations: C$47.69 M vs. C$15.40 M loss in 2024 (Material‑Negative).

• Cash at year‑end: C$4.07 M (up from C$2.99 M).

• Key Drivers of Expense Increase

• Fair‑value adjustment to derivative liability: C$38.0 M (vs. a gain of $(2.5) M in 2024).

• Interest expense: C$5.16 M (up from C$3.18 M), reflecting full‑year impact of convertible notes and promissory note drawdowns.

• Clinical & Regulatory Milestones

• Tigris Trial: Manuscript published March 23, 2026 in The Lancet Respiratory Medicine.
  • Primary endpoint (28‑day mortality) – 95.3% probability of benefit; absolute risk reduction 10.3%.
  • Key secondary endpoint (90‑day mortality) – 99.4% probability of benefit; absolute risk reduction 15.5%.
  • Safety profile comparable to standard care.
• SCCM Congress: Late‑Breaking presentation of Tigris results on March 24, 2026 in Chicago.

• FDA PMA Submission: Expected submission window shifted to end‑April – mid‑May 2026 to incorporate complete 12‑month mortality data and final non‑clinical modules (human factors testing).

• Commercialization Update

• Ongoing collaboration with Vantive; Vantive to file a 510(k) for its PrisMax ICU platform, intended as the primary delivery system for PMX upon FDA approval.

• Equity & Capital Structure

• Shares outstanding (Dec 31 2025): 292,562,913.
• Convertible notes (9% interest) issued in 2024 remain outstanding; fair‑value adjustments increased derivative liability to C$46.52 M.

• Promissory note facility with Vantive: two tranches drawn (May 2025 & Aug 2025), total principal C$9.67 M issued in 2025.

• Cash Flow Summary

• Net cash used in operating activities: C$(9.52) M (vs. C$(8.82) M prior year).
• Net cash provided by financing activities: C$10.80 M (primarily from share‑based exercises, warrant exercises, and promissory note issuance).

Notable Quotes

• Chris Seto, CEO: “Our focus in the second quarter is on completing a high‑quality PMA submission and continuing to build the clinical and commercial foundation necessary to support the adoption of PMX.”
• Dr. John Kellum, CMO: “Publication of the Tigris results … represents an important step in translating these findings to clinical practice… the consistency of benefit observed across endpoints suggests that the treatment effect becomes more apparent as patients recover beyond the acute phase of septic shock.”