TORONTO, July 04, 2025 (GLOBE NEWSWIRE) — Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced that it has filed a preliminary short form base shelf prospectus with the securities regulatory authorities in each of the provinces of Canada, except Québec (the “Securities Regulators”).
The base shelf prospectus, when made final, will allow Spectral to qualify the distribution by way of a prospectus of up to $100 million of common shares, debt securities, subscription receipts, warrants and units, or any combination thereof, from time to time, during the 25-month period that the final short form base shelf prospectus (the “Base Shelf Prospectus”) is effective. The specific terms of any offering under the Base Shelf Prospectus will be established in a prospectus supplement, which will be filed with the applicable Securities Regulators in connection with any such offering.
“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.”
No securities may be sold nor may offers to buy be accepted prior to the time at which a receipt for the Base Shelf Prospectus is obtained from the Securities Regulators. This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
A copy of the preliminary short form base shelf prospectus can be found under the Company’s profile on SEDAR+ at www.sedarplus.ca.
About Spectral
Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a 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 and has been used safely and effectively over 360,000 times 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. 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 https://www.youtube.com/watch?v=6RANrHHi9L8.
The trial methods are detailed in “Bayesian methods: a potential path forward for sepsis trials”.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information, please visit www.spectraldx.com.
Forward-looking statement
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral’s senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the company’s ability to raise capital and the availability of funds and resources to pursue R&D projects, the recruitment of additional clinical trial sites, the rate of patient enrollment, the successful and timely completion of clinical studies, the success of Baxter’s commercialization efforts, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
For further information, please contact:
Ali Mahdavi
Capital Markets & Investor Relations
Spinnaker Capital Markets Inc.
416-962-3300
am@spinnakercmi.com