08:30 AM EST, 11/07/2025 (MT Newswires) -- Spectral Medical ( EDTXF ) , Friday said it is compiling its pre-market approval (PMA) submission package to the Food & Drug Administration for PMX, which is now targeted for completion in the first quarter of next year, from the fourth quarter of 2025.

Topline results from the Tigris trial "reinforce the clinical and statistical robustness of PMX as a life-saving therapy for endotoxic septic shock," the company said. Discussions with the FDA are focussed on non-clinical components of the PMA, which the company is incorporating in its submission.

Spectral Medical ( EDTXF ) also said its third-quarter loss ballooned out to $30.3 million, or $0.11 per share, from a loss of $10 million, $0.04 per share, for the same period last year. The increase was due to higher operating expenses, which were linked to higher fair value adjustments of derivative liabilities.

Total revenue jumped 34% to $675,000, driven by higher product revenue.

The company concluded the third quarter with $6 million cash, compared with $3 million at the end of December last year.

"This was a transformative quarter for Spectral, highlighted by the positive topline results from Tigris," said Chris Seto, chief executive. "The totality of evidence continues to build in support of PMX as the first targeted therapy for endotoxic septic shock. With our PMA submission in sight, we are continuing to work closely with our commercialization partner Vantive."