• Topline Tigris results expected to be released around mid-August 2025

TORONTO, Aug. 08, 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 second quarter and provided a corporate update.

The second quarter of 2025 marked significant clinical and operational progress for Spectral. Following the completion of patient enrollment in the Tigris trial in April, the Company remains on track to report topline results in the third quarter. Tigris is a Phase III trial evaluating PMX for the treatment of endotoxic septic shock. The results of this pivotal study are expected to support the Company’s Premarket Approval (“PMA”) submission to the U.S. Food and Drug Administration (“FDA”).

Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We are now in the final stages of data analysis following the completion of follow-up for the final patient in Tigris. We continue to believe in the strong clinical potential of PMX to reduce mortality in patients with endotoxic septic shock, and we look forward to sharing topline results soon.”

Corporate Highlights During & Subsequent to the Second Quarter of 2025

Tigris

• Total enrolled patients:
  • 157 total patients enrolled
    • 151 evaluable patients, 100 treated with PMX
• Release of topline results:
  • Data lock completed at end of July 2025
    • Expected release of topline results around mid-August 2025
• 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:
  • 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 accepted for publication in a medical journal and should be available in the next few weeks.

PMX Commercialization

• Ongoing collaboration with Vantive on post-approval commercialization planning
• Vantive intends to submit 510(k) application for its PrisMax system, expected to be the primary ICU platform for PMX treatment
• Market readiness efforts are aligned with potential FDA approval timelines

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
• On July 4, 2025, Spectral filed a preliminary short form base shelf prospectus
  • Given upcoming milestones and catalysts which may be impactful to the Company, the base shelf prospectus provides maximum flexibility to optimize Spectral’s balance sheet.

“The second quarter represented a pivotal period in our path to potential FDA approval, with the finalizing of Tigris enrollment. With data lock now complete and data analysis underway, we are closer than ever to the critical topline readout from Tigris,” said Chris Seto, CEO of Spectral Medical. “In parallel, we were pleased to secure non-dilutive funding from our commercialization partner, Vantive, providing us with the financial flexibility to navigate the regulatory process and plan for launch. The totality of evidence continues to build in support of PMX, and we remain focused on execution across regulatory, clinical, and commercial fronts.”

Financial Review

Revenue for the three-months ended June 30, 2025 was $813,000 compared to $471,000 for the same three-month period last year, representing an increase of $342,000, or 73%. Revenue for six-months ended June 30, 2025, was $1,385,000 and $1,139,000 for the same period last year, representing an increase of $246,000 or 22%. Royalty revenue for the three-months ended June 30, 2025 was NIL and NIL for the same period prior year. Royalty revenue for the six-months ended June 30, 2025 was $142,000 compared to $135,000 for the same six-month period last year. This is due to an increase in usage of the Company’s IP from one customer. Product Revenue for the three-months ended June 30, 2025 was $403,000 compared to $217,000 for the same three-month period last year, representing an increase of $186,000 or 86% Product revenue for six-month ended June 30, 2025 was $579,000 and $567,000, representing an increase of $12,000 or 2%. Product revenue increased because Vantive purchased PMX for marketing purposes as PMX is not FDA cleared and there is no commercial activity in Canada.

Operating expenses for the three-months ended June 30, 2025, were $2,514,000, compared to $4,702,000 for the same period in the preceding year, a decrease of $2,188,000, or 47%. The decrease in operating expenses were primarily due to finance income on promissory note issued May 06, 2025 which is a non-cash item on June 30, 2025. Also, there was an increase in the interest expense and raw material and consumable used. There has been improved customer forecast since 2024 for raw materials and consumables. Interest expense of $1,175,000 which relates to the three months ended June 30, 2025 in relation to the May 30, 2024, July 19, 2024 convertible notes previously issued and May 2025 promissory notes issued. The principal amount of convertible notes issued in 2024 was $9,880,000. The principal amount of promissory note issued in 2025 was $5,154,000.

Operating expenses for the six-months ended June 30, 2025 were $14,536,000 compared to $8,559,000 for the same period in the preceding year, an increase of $5,977,000 or 70%. The increase in operating expenses were primarily due to increase in fair value adjustment on derivative liabilities which is a non-cash item on June 30, 2025. Also, there was an increase in the interest expense and raw material and consumable used. Interest expense of $2,258,000 which relates to the six months ended June 30, 2025 in relation to the May 30, 2024 and July 19, 2024 convertible notes previously issued and May 2025 Promissory Notes issued.

Clinical development and regulatory program costs (as disclosed in Note 13 of the condensed interim consolidated financial statements) were $1,842,000 for the three-months ended June 30, 2025 compared to $1,413,000 for the same period in the prior year. For the six-months ended June 30, 2025, clinical development costs are $3,427,000 compared to $2,377,000 for the corresponding period in 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 June 30, 2025 was $58,257,000.

Loss for the three-months ended June 30, 2025 was $1,933,000 $(0.00) per share compared to a loss of $4,402,000, $(0.02) per share for the same period in the prior year. The decreased loss of $2,469,000 was due to decreased operating expenses, primarily due to finance income on Promissory Note issued May 2025.

Loss for the six-months ended June 30, 2025 was $ 14,539,000, $(0.05) per share, compared to a loss of $8,562,000 $(0.03) per share, for the same period in the prior year. The increased loss of $5,977,000 was due to operating expenses, primarily due to increased interest expense in relation to May 30, 2024, July 19, 2024 convertible notes previously issued and May 2025 promissory notes issued on May 06, 2025 and fair value adjustment of derivative liability on June 30, 2025.

The Company concluded the second quarter of 2025 with cash of $3,100,000 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 285,819,699 at June 30, 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 9endotoxic 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.

For further information, please contact: