• Tigris Trial Enrollment completed
• Topline results expected to be released in August 2025
• Entered into an up to US$10 million Promissory Note with Vantive to Fund Spectral to PMX commercialization
  
  

TORONTO, May 09, 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 its financial results for the first quarter and provided a corporate update.

The Company made significant progress throughout the first quarter of 2025, both clinically and operationally. Specifically, regarding its Tigris trial, a Phase III clinical trial evaluating PMX for endotoxic septic shock. The Company recently completed full enrollment of its Tigris trial, and is expected to be in a position to share the topline results in the third quarter of this year and bringing the Company closer to U.S. FDA submission and potential U.S. FDA approval. In parallel to its clinical trial, the Company continues to work closely with its commercialization partner, Vantive US Healthcare LLC (“Vantive”); and most recently the parties collaborated on completing the enrolments for PrisMax sub-study in February 2025.

Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We are grateful for the strong interest in the clinical development of PMX among researchers and clinicians that has helped drive us towards completing full enrollment in the Tigris trial with a total of 157 patients. On behalf of Spectral Medical, I would like to express gratitude to the patients and their families in addition to the dedicated teams at the clinical sites, as well as our clinical and regulatory staff. We remain confident in the potential of PMX, and if ultimately approved, to play a major role in reducing the tragic rates of mortality caused by endotoxic septic shock.”

Corporate Highlights During & Subsequent to the First Quarter of 2025

Tigris

• Total enrolled patients:
  • 157 total patients enrolled
    • 151 evaluable patients, 100 treated with PMX
• Release of topline results:
  • Data lock to be completed in approximately 90 days
    • Expected release of topline results approximately 2 weeks post-data lock
• PMA submission:
  • The Company’s Premarket Approval submission (“PMA”) is a modular approach, whereby non-clinical aspects are submitted separately from the clinical data
  • To-date the Company has submitted all non-clinical studies and reports to the US Food & Drug Administration (“FDA”) for evaluation
  • On track to submit the clinical results and reports by end of October 2025
• EDEN Abstract Presentation:
  • On February 23, 2025, an abstract of the EDEN study was presented by Dr. Mark Tidswell at the 2025 Society of Critical Care Medicine Annual Congress (see abstract: Critical Care Medicine )
  • The Company completed its EDEN study in Q4 2023 with 92 patients enrolled. The ancillary observational study collected data on patients with sepsis even if ineligible for Tigris, and captured much needed data on the full range of septic shock and its relation to organ failure and endotoxin activity.
  • Based on the results of 84 evaluable patients, compared to other patients with septic shock, those with endotoxic septic shock (EAA ≥ 0.6 and SOFA >11) had significantly higher mortality (60% vs 14.1%, p < 0.001).
  • These data will inform subsequent discussions with the FDA on labelling for PMX, as well as to provide the medical community and the Company a better picture of the addressable population in the U.S. for PMX.
  • A manuscript describing the full results of the EDEN study has been submitted to a medical journal.

PMX Commercialization

• On January 31, 2025, Baxter International Inc. (“Baxter”) completed the sale of its Kidney Care business, including Vantive and its affiliated entities throughout the world, to funds affiliated with The Carlyle Group, pursuant to which Spectral Medical’s PMX distribution agreement was assigned to Vantive.
• Commercialization Activities:
  • In anticipation of a positive Tigris trial outcome, the Company has been working closely with Vantive on post-approval marketing plans for PMX commercialization.
  • In February 2025, the Vantive PrisMax sub-study was completed
    • Vantive intends to submit a 510(k) application and obtain clearance for its PrisMax System
    • The PrisMax System, with its leading installed base in ICUs throughout the U.S., is anticipated to be the primary ICU device utilized for PMX treatments on commercial launch

Balance Sheet and Financing Update

• On May 6, 2025, Spectral entered into a senior secured promissory note (the “ Agreement ”) with Vantive, in the aggregate principal amount of up to US$10 million
• Under the terms of the Agreement, Vantive may advance funds to Spectral in up to four separate tranches
• First tranche of US$4 million payable to Spectral was triggered on May 6, 2025 upon the execution of the Agreement
• The primary terms of the Promissory Note are:
  • 4-year maturity
  • Payment-in-Kind (“ PIK ”) interest at an annual rate of 9%
  • Principal balance and PIK interest to be repaid at maturity
  • The Promissory Note is not convertible into any securities of the Company

“Finalizing enrollment represents another key milestone for the Company and brings us a step closer on our regulatory path to potential approval of PMX. Spectral is now heavily focused on the regulatory phase for PMX, in addition to our continued commercialization activities with our distribution partner Vantive,” said Chris Seto, CEO of Spectral. “With enrollment now complete, we expect to be in a position to share topline results in the third quarter of this year. Additionally, the Company recently strengthened its balance sheet as we entered into a promissory note with Vantive. Not only is this a non-dilutive financing, but the promissory note provides a funding path to advance PMX through the regulatory phase and, if ultimately approved, into commercialization.”

Financial Review

Revenue for the three-months ended March 31, 2025 was $572,000 compared to $668,000 for the same three-month period last year, representing a decrease of $96,000, or 14%. Royalty revenue for the three-months ended March 31, 2025 was $142,000 an increase of $7,000 from $135,000 for the same period in the prior year. Product revenue decreased by $174,000 because of timing difference of billings.

Operating expenses for the three-months ended March 31, 2025, were $13,174,000, compared to $4,825,000 for the same period in the preceding year, an increase of $8,349,000, or 173%. The increase in operating expenses were primarily due to increase in fair value adjustment on derivative liabilities which is a non-cash item in March 31, 2025. The increase was primarily due to change in the market assumptions and market price considered for the calculation of the option feature. Also, there was an increase in the interest expense, consulting and professional fees and share-based compensation. Interest expense of $1,076,000 which relates to the three months ended March 31, 2025 in relation to the May 30, 2024 and July 19, 2024 convertible notes previously issued. The principal amount of convertible notes issued in 2024 was $9,880,000.

Clinical development and regulatory program costs (as disclosed in Note 12 of the consolidated financial statements) were $1,585,000 for the three-months ended March 31, 2025 compared to $964,000 for the same period in the prior year. A significant portion of clinical trial and regulatory costs consists of consulting and professional fees paid to contract research organizations, clinical sites, and other clinical and regulatory consultants. Increased clinical costs was due to the increase in volume of trial activities. Cumulative trial and regulatory program costs total as of March 31, 2025 was $56,415,000.

Loss for the three-months ended March 31, 2025 was $12,605,000 ($0.04 per share) compared to a loss of $4,160,000 ($0.01 per share) for the same period in the prior year. The increased loss of $8,445,000 was due to increased operating expenses, primarily due to increased fair value adjustment of derivative liability on March 31, 2025. Outside of the increase in the FV adjustment, operating expense were flat period over period.

The Company concluded the first quarter of 2025 with cash of $1,670,000 compared to $2,988,000 of cash on hand as of December 31, 2024.

The total number of common shares outstanding for the Company was 285,117,225 at March 31, 2025.

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 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.

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