Spectral Medical Inc., a late-stage theranostic company developing treatments for sepsis and septic shock, announced the filing of a preliminary short form base shelf prospectus with Canadian securities regulatory authorities. The prospectus will enable the company to raise up to $100 million through various securities offerings over a 25-month period once finalized.
The Toronto Stock Exchange-listed company (TSX: EDT) emphasized that the filing represents a strategic move to maintain financial flexibility rather than an immediate capital raise. "Given the upcoming milestones and catalysts which may be impactful to the Company, combined with our ongoing commitment to have maximum flexibility and optimize our balance sheet, we have filed a base shelf prospectus," said Chris Seto, CEO of Spectral Medical. "Our stakeholders should not assume that this filing is a sign that we would be imminently raising capital."
Breakthrough Device for Septic Shock Treatment
Spectral Medical is currently seeking U.S. FDA approval for Toraymyxin (PMX), a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream in patients with septic shock. The device works in conjunction with the company's FDA-cleared Endotoxin Activity Assay (EAA), which serves as the clinically available test for endotoxin in blood.
PMX has demonstrated significant clinical experience, having been used safely and effectively over 360,000 times in Japan and Europe, where it has received regulatory approval for therapeutic use. The U.S. FDA granted Breakthrough Device Designation for PMX in July 2022 specifically for the treatment of endotoxic septic shock, a malignant form of sepsis.
Phase 3 Trial and Market Opportunity
The company is currently conducting the Tigris Trial, a confirmatory Phase 3 study evaluating PMX in addition to standard care versus standard care alone. The trial employs a 2:1 randomized design with 150 patients using Bayesian statistics methodology.
The market opportunity for PMX in North America is substantial, with approximately 330,000 patients diagnosed with septic shock annually. Spectral obtained exclusive development and commercial rights for PMX in the United States in March 2009 and secured an exclusive distribution agreement for Canada in November 2010.
Financial Structure and Flexibility
The base shelf prospectus, when finalized, will allow Spectral to distribute common shares, debt securities, subscription receipts, warrants, and units, or any combination thereof. The specific terms of any future offering will be established through prospectus supplements filed with applicable securities regulators.
The company's forward-looking statements acknowledge various risks and uncertainties, including the ability to raise capital, recruit additional clinical trial sites, maintain patient enrollment rates, complete clinical studies successfully, and secure necessary regulatory approvals. The filing also references ongoing commercialization efforts by Baxter, though specific details of this partnership were not elaborated upon in the announcement.
