1. Spectral Medical filed a $100M base shelf prospectus on September 26, 2025. 2. This prospectus allows various securities distribution over 25 months. 3. The company revised its AIF for disclosures related to prior bankruptcy issues. 4. Spectral seeks U.S. FDA approval for its endotoxin-removing device, PMX. 5. PMX could transform sepsis treatment, with high patient numbers annually in North America.
The potential for capital raising via the shelf prospectus boosts financial flexibility for R&D outcomes, similar to prior cash infusions seen positively affecting biotech stocks.
The company's steps to ensure funding through a base shelf prospectus and its progress in critical clinical trials significantly enhance its market position and growth potential.
The ongoing clinical trials and potential FDA approvals could take time, affecting long-term market outlook rather than immediate price shifts.
TORONTO, Sept. 29, 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, announced that it has filed a final short form base shelf prospectus (the "Base Shelf Prospectus") with the securities regulatory authorities in each of the provinces of Canada, except Québec (the "Securities Regulators") on September 26, 2025 (the "Effective Date").
The Base Shelf Prospectus allows 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 from the Effective Date. 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.
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.
Spectral has also revised its Annual Information Form ("AIF") for the year ended December 31, 2024, as requested by the Ontario Securities Commission, to disclose a director's prior role as an executive officer and director of a corporation which was involved in bankruptcy proceedings, and further, to incorporate updates regarding the release of topline results from the Tigris clinical trial.
A copy of the Base Shelf Prospectus and revised AIF 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, licensed by Health Canada, and has been used safely and effectively with over 360,000 units sold worldwide 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
