TORONTO, March 27, 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 fourth quarter and for the year ended December 31, 2024 and provided a corporate update.
The Company made significant progress throughout 2024, both clinically and operationally. Specifically, regarding its Tigris trial, a Phase III clinical trial evaluating PMX for endotoxic septic shock. The Company has successfully enrolled 154 patients to date and is focused on the final push to fully enroll and finish the Tigris trial. The Company believes that the continued onboarding of new Tigris sites since the fourth quarter of 2023 could further accelerate enrollment experienced to date and allow Spectral to rapidly reach the 150 evaluable patient target, bringing the Company closer to FDA submission and potential 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 PrisMax sub-study in February 2025.
Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, "We are very much in the final stretch of enrollment into Tigris, and we look forward to finalizing enrollment in the next few weeks. We are committed to advancing Tigris and believe PMX, if ultimately approved, will play a major role in reducing the tragic rates of mortality caused by sepsis."
Corporate Highlights During & Subsequent to the Fourth Quarter and Fiscal Year Ended December 31, 2024
Tigris:
- Total of 154 patients randomized to date in the Tigris trial.
- Despite enrollment headwinds experienced in the fourth quarter of 2024, due to the impact of Hurricane Helene on the medical supply chain, Tigris 2024 enrollment was incredibly robust
- 59 patients enrolled in 2024 vs. 31 patients enrolled in 2023
- Strong start to 2025 enrollment
- 14 patients enrolled 2025 year-to-date
- Despite enrollment headwinds experienced in the fourth quarter of 2024, due to the impact of Hurricane Helene on the medical supply chain, Tigris 2024 enrollment was incredibly robust
- Timing
- Closing in on the full enrollment of 150 evaluable patients:
- Estimate a further two to four patients (given the randomization scheme) to reach 150 evaluable patients
- Addresses the six patients randomized into the PMX arm who did not receive the treatment
- Enrollment of 100 patients in the PMX arm and 50 patients in the standard-of-care arm who received the assigned treatment is important for PMX regulatory review with respect to safety analysis and secondary analyses
- Based on current rate of enrollment, management believes full Tigris enrollment is impending - and should be completed in the next few weeks.
- Closing in on the full enrollment of 150 evaluable patients:
- 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 is in preparation and will be submitted to a medical journal in the next few weeks.
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
"We are on the cusp of full Tigris enrollment, which marks a major clinical milestone for Spectral. Completion of the Tigris study represents a big step forward in the potential of bringing the PMX therapy to market, and we look forward to our continued partnership with Vantive, and the development of a robust commercialization strategy," said Chris Seto, CEO of Spectral. "Spectral is now entering a heavily-focused regulatory phase for PMX. The Company will be providing a more comprehensive view on Spectral's regulatory pathway in the coming weeks."
Balance Sheet and Financing Update
The Company has been and continues to actively evaluate financing scenarios with a view to be fully funded to PMX commercialization. Management anticipates having a fulsome update on its funding solution in the coming weeks, which will be followed by a corporate update conference call shortly thereafter.
Financial Review
Revenue for the three-months ended December 31, 2024 was $645,000 compared to $365,000 for the same three-month period last year. Total revenue for the year ended December 31, 2024 was $2,286,000 compared to $1,598,000 for prior year, representing an increase of $688,000, or 43%. Increase in revenue was primarily driven by a new customer who increased order volumes in 2024.
For the quarter ended December 31, 2024, the Company reported operating expense (income) of $(2,513,000) compared to $6,813,000 for the same period in 2023. When excluding the impact of the $Nil (2023 - $193,000 loss) on investment in iDialco and $Nil (2023 - $600,000) impairment loss on investment as an associate, operating expenses (income) for the quarter ended December 31, 2024 were $(2,513,000) compared to $6,020,000 for the same period in the prior year. The decrease of $8,533,000 was due to decreased fair value adjustment on derivative liability.
For the year ended December 31, 2024, operating costs were $17,681,000 compared to $17,105,000 for the same period in 2023, an increase of $576,000. When excluding the impact of the $Nil (2023 - $398,000 loss) on investment in iDialco, and $Nil (2023 - $600,000) impairment loss on investment as an associate, operating expenses for the year ended December 31, 2024 was $17,681,000 compared to $16,107,000 for the same period in the prior year. The increase of $1,574,000 was due to primarily increased interest expenses on financing and increased foreign exchange loss.
Clinical development and regulatory program costs (as disclosed in Note 22 of the consolidated financial statements) were $3,973,000 for the year ended December 31, 2024 compared to $4,676,000 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. The decrease in costs reflects decreased activity with respect to the initialization of clinical sites and no CRO onboarding fees which were experienced in 2023 as the trial is projected to be completed in first quarter of 2025. Cumulative trial and regulatory program costs total $54,829,000 as of December 31, 2024.
For the quarter ended December 31, 2024, the Company reported a Loss (profit) from continuing operations of $(3,158,000) compared to $6,448,000 for the corresponding period in 2023. When excluding the impact of the $Nil loss (2023 - $193,000 loss) on investment in iDialco and $Nil (2023 - $600,000) impairment loss on investment as an associate, operating loss (profit) from continuing operations for the quarter ended December 31, 2024 was $(3,158,000) compared to $5,655,000 for the same period in the prior year.
For the year ended December 31, 2024, the Company reported a Loss from continuing operations of $15,395,000 compared to $15,507,000 for the corresponding period in 2023. When excluding the impact of the $Nil (2023 - $398,000 loss) on investment in iDialco and $Nil (2023 - $600,000) impairment loss on investment as an associate, operating loss from continuing operations for the year ended December 31, 2024 was $15,395,000 compared to $14,509,000 for the same period in the prior year.
The Company concluded the year end 2024 with cash of $2,988,000 compared to $2,952,000 of cash on hand as of December 31, 2023.
The total number of common shares outstanding for the Company was 284,316,207 at December 31, 2024
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.
For further information, please contact:
| Ali Mahdavi | Chris Seto | |
| Capital Markets & Investor Relations | CEO | |
| Spinnaker Capital Markets Inc. | Spectral Medical Inc. | |
| 416-962-3300 | ||
| am@spinnakercmi.com | cseto@spectraldx.com |
| Spectral Medical Inc. Consolidated Statements of Financial Position In CAD (000s), except for share and per share data | ||||
| Notes | December 31, 2024 | December 31, 2023 (Refer Note 3) | January 1, 2023 (Refer Note 3) | |
| $ | $ | $ | ||
| Assets | ||||
| Current assets | ||||
| Cash | 6 | 2,988 | 2,952 | 8,414 |
| Trade and other receivables | 7 | 451 | 186 | 1,056 |
| Inventories | 8 | 229 | 366 | 340 |
| Prepayments and other assets | 9 | 790 | 621 | 276 |
| 4,458 | 4,125 | 10,086 | ||
| Non-current assets | ||||
| Right-of-use-asset | 10 | 444 | 567 | 464 |
| Property and equipment | 11 | 243 | 326 | 237 |
| Intangible asset | 12 | 175 | 193 | 211 |
| Investment in iDialco | 13 | - | - | 998 |
| Total assets | 5,320 | 5,211 | 11,996 | |
| Liabilities | ||||
| Current liabilities | ||||
| Trade and other payables | 14 | 2,769 | 2,820 | 3,087 |
| Current portion of contract liabilities | 15 | 380 | 727 | 696 |
| Current portion of lease liability | 10 | 129 | 121 | 96 |
| Notes Payable | 16 | 14,425 | 7,940 | 3,566 |
| Derivative Liability | 16 | 9,742 | 6,310 | 2,674 |
| 27,445 | 17,918 | 10,119 | ||
| Non-current liability | ||||
| Lease liability | 10 | 371 | 500 | 420 |
| Non-current portion of contract liabilities | 15 | 5,049 | 3,342 | 4,011 |
| Total liabilities | 32,865 | 21,760 | 14,550 | |
| Shareholders' (deficiency) equity | 18 | |||
| Share capital | 90,566 | 87,061 | 87,050 | |
| Contributed surplus | 10,149 | 8,916 | 8,773 | |
| Share-based compensation | 11,196 | 10,385 | 8,908 | |
| Warrants | 1,383 | 2,526 | 2,490 | |
| Deficit | (140,839) | (125,437) | (109,775) | |
| Total shareholders' (deficiency) equity | (27,545) | (16,549) | (2,554) | |
| Total liabilities and shareholders' (deficiency) equity | 5,320 | 5,211 | 11,996 | |
| Spectral Medical Inc. Consolidated Statements of Loss and Comprehensive Loss In CAD (000s), except for share and per share data | |||
| Notes | 2024 | 2023 | |
| $ | $ | ||
| Revenue | 21 | 2,286 | 1,598 |
| Expenses | |||
| Raw materials and consumables used | 1,268 | 936 | |
| Salaries and benefits | 23 | 4,122 | 3,857 |
| Consulting and professional fees | 4,937 | 4,825 | |
| Regulatory and investor relations | 666 | 581 | |
| Travel and entertainment | 483 | 297 | |
| Facilities and communication | 461 | 414 | |
| Insurance | 420 | 411 | |
| Depreciation and amortization | 251 | 210 | |
| Interest expense | 10,16 | 3,177 | 1,334 |
| Foreign exchange (gain) and loss | 1,933 | (126) | |
| Share-based compensation | 18 | 1,675 | 1,488 |
| Other expense | 744 | 315 | |
| Net (gain) loss on investment in an associate | 13 | - | 398 |
| Impairment loss on investment in an associate | 13 | - | 600 |
| Fair Value Adjustment Derivative Liabilities | (2,456) | 1,565 | |
| 17,681 | 17,105 | ||
| Loss and comprehensive loss for the year from continuing operations | (15,395) | (15,507) | |
| Loss from discontinued operations | 5 | (7) | (155) |
| Loss and comprehensive loss for the year | (15,402) | (15,662) | |
| Basic and diluted loss from continuing operations per common share | 19 | (0.05) | (0.06) |
| Basic and diluted loss from discontinued operations per common share | 19 | (0.00) | (0.00) |
| Basic and diluted loss per common share | 19 | (0.05) | (0.06) |
| Weighted average number of common shares outstanding - basic and diluted | 19 | 281,080,174 | 278,563,241 |
| Spectral Medical Inc. Consolidated Statements of Changes in Shareholders' Deficiency In CAD (000s) | |||||||||||
| Notes | Issued capital | Contributed surplus | Share-based compensation | Warrants | Deficit | Total Shareholders' (deficiency) equity | |||||
| Number | $ | $ | $ | $ | $ | $ | |||||
| Balance January 1, 2023 | 278,547,804 | 87,050 | 8,773 | 8,908 | 2,490 | (109,775) | (2,554) | ||||
| RSU released | 28,457 | 11 | - | (11) | - | - | |||||
| Warrants expired | - | - | 143 | - | (143) | - | - | ||||
| Warrants issued | - | - | - | - | 179 | - | 179 | ||||
| Loss and comprehensive loss for the year | - | - | - | - | - | (15,662) | (15,662) | ||||
| Share-based compensation | 18 | - | - | - | 1,488 | - | - | 1,488 | |||
| Balance December 31, 2023 | 278,576,261 | 87,061 | 8,916 | 10,385 | 2,526 | (125,437) | (16,549) | ||||
| Balance January 1, 2024 | 278,576,261 | 87,061 | 8,916 | 10,385 | 2,526 | (125,437) | (16,549) | ||||
| Warrants exercised | 982,500 | 618 | - | - | (121) | - | 497 | ||||
| Warrants issued | - | - | - | - | 211 | - | 211 | ||||
| Warrants expired | - | - | 1,233 | - | (1,233) | - | - | ||||
| Share Options Exercised | 1,907,611 | 1,190 | - | (535) | - | - | 655 | ||||
| RSU released | 114,210 | 50 | - | (50) | - | - | - | ||||
| Notes Conversion | 16 | 1,879,647 | 1,368 | - | - | - | - | 1,368 | |||
| DSU exercise | 855,978 | 279 | - | (279) | - | - | - | ||||
| Loss and comprehensive loss for the year | - | - | - | - | - | (15,402) | (15,402) | ||||
| Share-based compensation | 18 | - | - | - | 1,675 | - | - | 1,675 | |||
| Balance December 31, 2024 | 284,316,207 | 90,566 | 10,149 | 11,196 | 1,383 | (140,839) | (27,545) | ||||
| Spectral Medical Inc. Consolidated Statements of Cash Flows In CAD (000s) | |||
| Notes | 2024 | 2023 | |
| $ | $ | ||
| Cash flow provided by (used in) | |||
| Operating activities | |||
| Loss for the year | (15,402) | (15,662) | |
| Adjustments for: | |||
| Depreciation on right-of-use asset | 10 | 123 | 104 |
| Depreciation on property and equipment | 11 | 110 | 96 |
| Amortization of intangible asset | 12 | 18 | 18 |
| Amortization and Derivative related financing fees | 823 | 446 | |
| Unrealized foreign exchange (gain) and loss | 2,102 | (228) | |
| Interest expense on lease liability | 10 | 32 | 25 |
| Accreted Interest on Notes Payable | 3,145 | 835 | |
| Share-based compensation | 18 | 1,675 | 1,488 |
| Net (gain) loss on investment in an associate | 13 | - | 398 |
| Impairment loss on investment in an associate | 13 | - | 600 |
| Fair Value Adjustment derivative liabilities | (2,456) | 1,565 | |
| Changes in items of working capital: | |||
| Trade and other receivables | (265) | 870 | |
| Inventories | 137 | (26) | |
| Prepayments and other assets | (169) | (345) | |
| Trade and other payables | (51) | (267) | |
| Contract liabilities | 1,360 | (638) | |
| Net cash used in operating activities | (8,818) | (10,721) | |
| Investing activities | |||
| Purchases of property and equipment | 11 | (27) | (185) |
| Net cash used in investing activities | (27) | (185) | |
| Financing activities | |||
| Financing charges paid | 16, 24 | (766) | (641) |
| Note payable | 16 | 9,897 | 4,058 |
| Lease liability payments | (153) | (127) | |
| Share options exercised | 655 | - | |
| Derivative liabilities | 16 | - | 2,154 |
| Warrants exercised | 497 | - | |
| Interest paid | (1,249) | - | |
| Net cash provided by financing activities | 8,881 | 5,444 | |
| Increase (decrease) in cash | 36 | (5,462) | |
| Cash, beginning of year | 2,952 | 8,414 | |
| Cash, end of year | 2,988 | 2,952 | |
