Spectral Medical Inc. (TSX: EDT), a late-stage theranostic company focused on treatments for sepsis and septic shock, has announced the appointment of MNP LLP as its new auditor, effective immediately. This decision follows the resignation of PricewaterhouseCoopers LLP (PwC). The Finance & Audit Committee and the board of directors approved the change.
Auditor Transition Details
PwC's resignation was not the result of any disagreement with Spectral Medical regarding accounting principles, financial statement disclosures, or auditing scope. According to Spectral, PwC has not expressed any modified opinion in its reports for the company’s two most recently completed financial years. The board confirmed that there were no "reportable events" as defined by Section 4.11 of National Instrument 51-102.
William Stevens, Chair of the Finance and Audit Committee at Spectral, stated, "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."
Chris Seto, Chief Executive Officer of Spectral Medical, added, "I am confident that MNP’s high standards meet our strict requirements for independent auditing."
Focus on Sepsis Treatment
Spectral Medical is currently in Phase 3 clinical trials, seeking U.S. FDA approval for Toraymyxin™ (PMX), a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream, which can cause sepsis. The treatment is guided by the company’s Endotoxin Activity Assay (EAA™), the only FDA-cleared diagnostic for assessing the risk of developing sepsis.
PMX is already approved for therapeutic use in Japan and Europe, where it has been used safely and effectively on over 340,000 patients. In the U.S., Spectral obtained exclusive development and commercial rights for PMX in March 2009. In July 2022, the FDA granted Breakthrough Device Designation for PMX in the treatment of endotoxemic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year.
Tigris Trial
The Tigris Trial is a confirmatory study evaluating PMX in addition to standard care versus standard care alone. The trial employs a 2:1 randomized design with 150 patients, utilizing Bayesian statistics. Endotoxic septic shock is a severe form of sepsis.
