Spectral Medical Inc. Announces Change to Auditor

TORONTO, July 11, 2024 (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 MNP LLP (“MNP”) have today been appointed as the auditors of the Company following the decision by PricewaterhouseCoopers LLP (“PwC”) to resign as the auditor of Spectral (the “Effective Date”). The resignation of PwC as the auditor of Spectral and the appointment of MNP as auditor of Spectral were considered and approved by the Finance & Audit Committee and the board of directors.

PwC's resignation was not the result of any disagreement between the Company and PwC on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure. PwC has not expressed any modified opinion in its reports for Spectral’s two most recently completed financial years and ending on the Effective Date. The board of directors is of the opinion that there were no “reportable events” as defined by Section 4.11 of National Instrument 51-102 – Continuous Disclosure Obligations.

“We would like to thank PwC for their professionalism and quality of service rendered to the Company over the past years. We look forward to working with MNP as the Company’s new independent auditor. MNP submitted the most attractive offer in a comprehensive bidding procedure – with a combination of professionalism, specialist and industry knowledge, an impressive track record in taking on new audit mandates, as well as an appropriate fee proposal for a Company of Spectral’s nature of operations and size,” said William Stevens, Chair of the Finance and Audit Committee at Spectral. Chris Seto, Chief Executive Officer of Spectral Medical, added: “I am confident that MNP’s high standards meet our strict requirements for independent auditing.”

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 Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.

PMX is approved for therapeutic use in Japan and Europe and has been used safely and effectively on more than 340,000 patients 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 endotoxemic 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 availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, 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.