Spectral Medical Provides Update on Tigris Clinical Trial and Other Business Developments

50 Patients Randomized to Date out of the 150 Total Target to be Enrolled

Reports Significant Uptick in Screening and Enrollment Activities

TORONTO, Jan. 12, 2023 (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 provided a business update focusing on Tigris, the Company’s follow-on study designed to build on knowledge gained from the earlier EUPHRATES trial, which evaluated the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock. The Tigris trial end point is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge versus standard of care.

Chris Seto, Chief Executive Officer of Spectral Medical, commented, “We continue to aggressively advance our Tigris trial with 50 of the 150 total patients now enrolled and randomized in the study. Importantly, preliminary mortality data continues to exceed our expectations and supports our confidence in a positive trial outcome and potential FDA approval. Additionally, we are working closely with Baxter on pre-launch commercialization activities that we believe will allow us to quickly penetrate the market assuming FDA approval.”

Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We are making steady progress and although hospitals are still encountering staffing shortages, we are witnessing a significant increase in enrollment activities. In particular, patient enrolment ramped up during late Q3 and for most of Q4, leading up to the holiday season when ICUs typically see lower activity in patient enrolments. As a result, we added approximately 30% of our total enrollment target in the second half of 2022 alone. Given our progress, we are nearing our interim enrollment target of 90 patients. Moreover, we have seen a 30-40% increase in sepsis cases at our trial sites compared to last summer. Flu season is upon us and as influenza cases rise, we believe sepsis cases will concurrently increase, as the flu is often a precursor to sepsis. According to the CDC, so far this season, there have been at least 13 million illnesses, 120,000 hospitalizations, and 7,300 deaths from the flu. This rate of hospitalizations is greater than every previous flu season since 2010-2011. Looking ahead, we anticipate the pace and cadence of patient enrolment to increase meaningfully based on current feedback from our active trial sites.

In addition, we are increasing our trial sites for 2023. Since the FDA approved the expansion of clinical trial sites to a total of 25, we are now actively onboarding additional sites, while removing sites that have underperformed, in order to focus our resources. As a result, we anticipate 18-20 sites to be onboarded and actively enrolling patients by the end of the first quarter of 2023. In turn, we believe this will enable us to accelerate patient enrollment and more rapidly reach our 150-patient target.”

Mr. Seto, added, “On a final note, I’d like to highlight that we have also funded an observational research study using EAA-guided PMX in Italy. This research study is now complete, and we have had the opportunity to review the top-line results. These top-line results are highly encouraging and strongly support the preliminary data received from our Tigris trial. We anticipate publication of the research study results in early 2023. Given all of these positive developments, we remain highly optimistic about the outlook for the Tigris trial, which we expect to complete in 2023, and remain steadfast in achieving our goal of obtaining FDA approval.”

Corporate Highlights

Tigris Trial

  • Patient Enrollment
    Total of 50 patients randomized to-date out of the 150 total to be enrolled in Tigris, with preliminary topline data continuing to exceed expectations.
    • Specifically, we added approximately 30% of our total enrollment target in the second half of 2022 alone;
    • We are also nearing our interim enrollment target of 90 patients (“Interim Enrollment”); at Interim Enrollment, Baxter has the right to view the trial data, and subsequently the option to make the second milestone payment to Spectral to maintain its exclusive distribution rights.
  • Tigris Clinical Trial Sites
    There are currently 15 Tigris sites onboarded and actively enrolling patients. We have actively removed underperforming sites while aggressively pursuing the onboarding process of additional sites.
    • January 11, 2023, onboarded the Medical University of South Carolina and is open for enrollment;
    • Anticipate Tigris site no.16, a premier northern California health science center, to be onboarded in the next 1-2 weeks;
    • There are 6 potential Tigris trial sites that are at various stages of our clinical team’s vetting process; and
    • We expect to have 18-20 clinical trial sites onboarded by the end of the first quarter of 2023.
  • Timing
    We continue to focus on finalizing the Tigris trial within the reasonably shortest timelines. To meet final trial enrollment in 2023, we estimate the need for approximately 20 productive trial sites.

Observational Studies

  • EUPHAS-2 is a Spectral-sponsored observational study in Italy using EAA-guided PMX, which is now complete We have reviewed the topline results, which strongly support the preliminary data received from the Tigris trial. These data strengthen our confidence in our ability to achieve a successful trial outcome as well as potential FDA approval.
  • EDEN is the Company’s ancillary observational study, in which data is collected on patients with sepsis even if ineligible for Tigris. EDEN will capture much needed data on the full range of septic shock and its relation to organ failure and endotoxin activity. These data will inform subsequent discussions with the FDA on labelling for PMX, and provide important data on potential expanded indications for PMX.

    The Company has onboarded 5 EDEN sites and enrolled 30 patients into the observational study.

PMX Commercialization

  • In anticipation of a positive Tigris trial outcome, the Company has been working closely over the last eight months with Baxter, the Company’s strategic commercial partner, on post-approval marketing plans for PMX commercialization. This includes developing product branding, pricing and roll-out plans with numerous Baxter departments, including marketing, government/regulatory, clinical and reimbursement. Baxter has communicated its intention to undertake a broad marketing campaign on day 1 of FDA approval for PMX
    • The Company is working with Baxter on a sub-study to obtain FDA approval for hemoperfusion for Baxter’s Prismax device; the Prismax, with its leading installed base, is anticipated to be the primary device utilized for PMX treatments on commercial launch.
    • January 6, 2023, Baxter announced a corporate re-organization, in which it will spin-off its Renal and Acute Therapies business, into an independent, publicly traded entity (“KidneyCo”) in the next 12-18 months. With respect to our partnership with Baxter, the Company has been dealing with the Acute Therapies business unit; as such, we anticipate our exclusive distribution agreement will be transferred to KidneyCo at the time of the spin-off.

      For information on Baxter’s spin-off, please visit:
      Baxter Announces Strategic Actions to Enhance Operational Effectiveness, Accelerate Innovation for Patients and Drive Value for Shareholders | Baxter

      Renal Investor Presentation (q4cdn.com)

i-Dialco

As previously announced, we entered into a strategic joint venture with Infomed SA, a Swiss company dedicated to the development and manufacturing of blood purification devices. The new joint venture company, i-Dialco Inc., will be exclusively focused on advancing commercialization of the SAMI and DIMI dialysis devices in the North American markets. This strategic joint venture allows Spectral to increase its operating and capital allocation focus on PMX for the treatment of patients with septic shock while reducing its operating costs by over $3 million annually.

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.

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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