Spectral Medical Announces Second Quarter and Provides Corporate Update

Executive Summary

• Spectral Medical Inc. reported its financial results for the second quarter and six months ended June 30, 2025, alongside significant clinical and operational updates regarding its Tigris Phase III trial and regulatory pathway.
• The company secured non-dilutive financing through a senior secured promissory note with commercial partner Vantive, receiving an initial tranche of US$4 million, with up to US$10 million available in total.
• The Tigris trial data lock was completed in late July 2025, with topline results expected around mid-August 2025; the company remains on track to submit clinical data for its Premarket Approval (PMA) to the FDA by the end of October 2025.

Key Details

• Financial Results (Q2 2025):
  • Revenue: $813,000 (up 73% from $471,000 in Q2 2024).
  • Product Revenue: $403,000 (up 86% from $217,000).
  • Royalty Revenue: $0.
  • Operating Expenses: $2,514,000 (down 47% from $4,702,000, primarily due to finance income on the new promissory note).
  • Net Loss: $1,933,000 ($0.00 per share), compared to a loss of $4,402,000 ($0.02 per share) in Q2 2024.
• Financial Results (Six Months Ended June 30, 2025):
  • Revenue: $1,385,000 (up 22% from $1,139,000).
  • Product Revenue: $579,000 (up 2% from $567,000).
  • Royalty Revenue: $142,000 (up from $135,000).
  • Operating Expenses: $14,536,000 (up 70% from $8,559,000, driven by fair value adjustments on derivative liabilities and increased interest expense).
  • Net Loss: $14,539,000 ($0.05 per share), compared to a loss of $8,562,000 ($0.03 per share) in the prior year period.
• Balance Sheet & Cash Position:
  • Cash on hand: $3,100,000 as of June 30, 2025 (up from $2,988,000 at Dec 31, 2024).
  • Total Shareholders' Deficiency: $(40,176,000).
  • Shares Outstanding: 285,819,699 common shares.
• Financing Update:
  • Entered into a senior secured promissory note with Vantive on May 6, 2025, for up to US$10 million.
  • First tranche of US$4 million was triggered upon execution.
  • Terms: 4-year maturity, 9% Payment-in-Kind (PIK) interest, non-convertible.
  • Filed a preliminary short form base shelf prospectus on July 4, 2025, to provide flexibility for future capital needs.
• Clinical & Regulatory Updates (Tigris Trial):
  • Phase III trial evaluating PMX for endotoxic septic shock.
  • Total enrolled: 157 patients (151 evaluable, 100 treated with PMX).
  • Data lock completed end of July 2025.
  • Topline results expected mid-August 2025.
  • PMA Submission Status: Non-clinical aspects already submitted; clinical results and reports expected to be submitted by end of October 2025.
• EDEN Study Data:
  • Ancillary observational study (92 patients enrolled, 84 evaluable).
  • Patients with endotoxic septic shock (EAA ≥ 0.6 and SOFA >11) had significantly higher mortality (60% vs 14.1%, p < 0.001).
  • Manuscript accepted for publication; results to inform FDA labeling discussions.
• Commercialization:
  • Ongoing collaboration with Vantive for post-approval commercialization.
  • Vantive intends to submit a 510(k) application for its PrisMax system (primary ICU platform for PMX).

Notable Quotes

• Dr. John Kellum, Chief Medical Officer: “We are now in the final stages of data analysis following the completion of follow-up for the final patient in Tigris. We continue to believe in the strong clinical potential of PMX to reduce mortality in patients with endotoxic septic shock, and we look forward to sharing topline results soon.”
• Chris Seto, CEO: “The second quarter represented a pivotal period in our path to potential FDA approval, with the finalizing of Tigris enrollment. With data lock now complete and data analysis underway, we are closer than ever to the critical topline readout from Tigris... In parallel, we were pleased to secure non-dilutive funding from our commercialization partner, Vantive, providing us with the financial flexibility to navigate the regulatory process and plan for launch.”