Kirax Corp.

Tigris Trial Enrollment Reaches 106 Patients Bought Deal Financing Expected to Fund Completion of Tigris Trial Enrollment TORONTO, May 13, 2024 (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 ended March 31, 2024, and provided a corporate update. Spectral has continued its significant progress throughout the first quarter of 2024 both clinically and operationally and year-to-date enrolled 25 patients for a total of 106 patients out of the 150 total patients target. The Company is focused on the final push to fully enroll and finish the Tigris trial and believes that the continued onboarding of new Tigris sites since the fourth quarter of 2023 could further accelerate enrollment and allow Spectral to rapidly reach the 150-patients 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, Baxter. In Q1 2024, Baxter exercised its right to maintain its exclusive distribution for PMX products in the U.S. and Canada and paid Spectral a non-dilutive milestone payment. Additionally, Spectral and Baxter mutually agreed to amend the initial term of their commercial partnership to ten years post-FDA approval of PMX. The Company believes this amendment provides a mutually beneficial runway for the parties to maximize PMX commercial economics, while providing motivation for continued support and allocation of resources to the PMX partnership. Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We continue to witness robust enrollment activity in 2024, with record enrollment rates since the beginning of the year. As we enter the final push to finish Tigris, our clinical team is focused on trial site support with activities such as site visits, refresher training, and clinical communications, and workshops. We are also activating our last group of sites. Ultimately, we want to ensure that our Tigris sites have the support and resources to enroll patients as efficiently as possible. We are committed alongside our trial sites to advancing Tigris and believe PMX, if ultimately approved, will play a major role in reducing the tragic rates of mortality caused by sepsis.” “I am pleased with the increased level of activity across the Company and its impact on establishing robust trial sites, thus resulting in a significant ramp up of patient enrollment. The recent pace of enrollment, combined with the quality and focus of the current and planned trial sites provide us with confidence in continued robust enrollment activity. The potential to sustain our current pace of enrollment could see us rapidly advance the trial towards completion in the late 2024 to early 2025 timeframe,” said Chris Seto, CEO of Spectral. “Additionally, with our recently announced financing, we have secured funding to finalize Tigris enrollment.” Corporate Highlights Tigris: Total of 106 patients randomized to date out of the 150 total patients to be enrolled in the Tigris trial. accelerated enrollment experienced in 2024 to date, with 25 patients enrolled so far – represents the most robust enrollment rates since the start of the Tigris trial. Currently 22 Tigris sites onboarded addition of three new trial sites in the first quarter – the University of Texas Health Sciences Center at Houston, The Institute for Extracorporeal Life Support (San Antonio, TX), and UCLA.subsequent to the first quarter, the Company added one new site – University of Virginia Health Sciences. Investigator Meeting held March 12th and 13th The Company held a Tigris trial Investigator Meeting in conjunction with the 29th International Conference on Advances in Critical Care Nephrology in San Diego.In-person meeting well-attended with multiple stakeholders present, including principal investigators and clinical research coordinators from existing and new trial sites, CRO, Beaufort, and representatives from the Spectral’s strategic partner Baxter.Focus of the meeting was on the practical aspects of diagnosing endotoxic septic shock and treating with PMX, as well as featuring several talks from trial sites on how EAA and PMX could be implemented into routine clinical practice after potential regulatory approval of PMX. PMX Commercialization: 90 patient enrollment interim milestone achieved On February 15, 2024, Spectral announced that it had reached the 90-patient enrollment threshold and provided written notification to Baxter of this achievement. Subsequently, Baxter exercised its option to maintain exclusive distribution rights and paid Spectral an ~C$2 million non-dilutive payment.Since inception of partnership, funding support from Baxter has amounted to ~C$15 million – comprised of non-dilutive payments and convertible notes subscriptions. Amendment of Initial Term of Exclusive Distribution Agreement In February 2024, the Company and Baxter mutually agreed to amend the initial term of the exclusive distribution agreement to 10 years post-FDA approval; the Company believes the 10-year term provides mutually beneficial runway to maximize PMX commercial economics. Commercialization Activities In anticipation of a positive Tigris trial outcome, the Company has been working closely with Baxter on post-approval marketing plans for PMX commercialization. This includes developing product branding, pricing and roll-out plans with numerous Baxter departments, including marketing, regulatory, clinical and reimbursement. Baxter has communicated its intention to undertake a broad marketing campaign on day one of FDA approval for PMX.The Company is also working with Baxter on a sub-study to obtain FDA clearance for hemoperfusion for Baxter’s Prismax device. The Prismax, 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. Funding: On May 9, 2024, Spectral announced a bought deal private placement of convertible notes for gross proceeds of $8,500,000. Based on recent enrollment rates, provides funding beyond full Tigris enrollment of 150 patients. Financial Review Revenue for the three-months ended March 31, 2024 was $668,000 compared to $530,000 for the same three-month period last year, representing an increase of $138,000, or 26%. Royalty revenue for the three-months ended March 31, 2024 was $135,000 an increase of $9,000 from $126,000 for the same period in the prior year. This is due to an increase in usage of the Company’s IP from one customer. Product revenue increased by $113,000. Operating expenses for the three-months ended March 31, 2024, were $4,825,000, compared to $1,625,000 for the same period in the preceding year, an increase of $3,200,000, or 197%. The increase in operating expenses were primarily due to off-setting income booked for fair value adjustment of derivative liabilities in the first quarter of 2023 and an expense booked on the same during the period ended March 31, 2024 with a net impact of $1,591,000. Results were also affected by an increase in the raw material and consumables used, Consulting and Professional fees and foreign exchange loss. Clinical development and regulatory program costs were $964,000 for the three-months ended March 31, 2024 compared to $431,000 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 increase in costs reflects increased activity with respect to the initialization of clinical sites and the randomization of patients into the Tigris clinical trial. Loss for the three-months ended March 31, 2024 was $4,160,000 ($0.01 per share) compared to a loss of $1,138,000 ($0.01 per share) for the same period in the prior year. The increased loss of $3,067,000 was due to increased operating expenses, partially offset by a reduction in loss from discontinued operations of $40,000 related to the reduction in Dialco operating expenses. The Company concluded the first quarter of 2024 with cash of $2,074,000 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 279,394,428 at March 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 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 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 SetoCapital Markets & Investor Relations CEOSpinnaker Capital Markets Inc. Spectral Medical Inc.416-962-3300 am@spinnakercmi.com cseto@spectraldx.com Spectral Medical Inc.Condensed Interim Consolidated Statements of Financial PositionIn CAD (000s), except for share and per share data(Unaudited) NotesMarch 31,December 31, 20242023$$Assets Current assets Cash 2,0742,952Trade and other receivables 482186Inventories 319366Prepayments and other assets 980621 3,8554,125Non-current assets Right-of-use-asset 536567Property and equipment 314326Intangible asset 189193Investment in iDialco5--Total assets 4,8945,211Liabilities Current liabilities Trade and other payables 2,6112,820Current portion of contract liabilities6496727Current portion of lease liability 123121Notes payable7278264Derivative Liability77,2506,310 10,75810,242Non-current liability Lease liability 468500Non-current portion of contract liabilities65,4123,342Notes payable78,3937,676Total liabilities 25,03121,760Shareholders' (deficiency) equity9 Share capital 87,56187,061Contributed surplus 8,9168,916Share-based compensation 10,54710,385Warrants 2,4362,526Deficit (129,597)(125,437)Total shareholders' (deficiency) equity (20,137)(16,549)Total liabilities and shareholders' (deficiency) equity 4,8945,211 Spectral Medical Inc.Condensed Interim Consolidated Statements of Loss and Comprehensive Loss In CAD (000s), except for share and per share data(Unaudited) NotesThree months ended March 31, 2024Revised (Refer Note 15)Three months ended March 31, 2023 $$Revenue 668 530 Expenses Raw materials and consumables used 279 137 Salaries and benefits131,000 956 Consulting and professional fees 925 628 Regulatory and investor relations 175 108 Travel and entertainment 76 84 Facilities and communication 120 83 Insurance 105 87 Depreciation and amortization 131 61 Interest expense7540 247 Foreign exchange loss 464 (51)Share-based compensation 177 (26)Other expense (12)(28)Net loss on joint arrangement5- 85 Fair value adjustment derivative liabilities7845 (746) 4,825 1,625 Loss and comprehensive loss for the period from continuing operations (4,157)(1,095)Loss from discontinued operations5(3)(43)Loss and comprehensive loss for the period (4,160)(1,138)Basic and diluted loss from continuing operations per common share9(0.01)(0.01)Basic and diluted loss from discontinued operations per common share90.00 0.00 Basic and diluted loss per common share9(0.01)(0.01)Weighted average number of common shares outstanding - basic and diluted9279,472,325 278,547,804 Spectral Medical Inc.Condensed Interim Consolidated Statements of Changes in Shareholders’ DeficiencyIn CAD (000s)(Unaudited) Notes Number of Shares Share Capital Contributed surplus Share-based compensation Warrants Deficit Total Shareholders’ (deficiency) equity $ $ $ $ $ $ Balance January 1, 2023 278,547,804 87,050 8,773 8,908 2,490 (109,744)(2,523)Loss and comprehensive loss for the year - - - - (1,138)(1,138)Share-based compensation9 - - (26)- - (26)Revised (Refer note 15)Balance, March 31, 2023 278,547,804 87,050 8,773 8,882 2,490 (110,882)(3,687)RSU released 28,457 11 (11) - - Warrants issued 179 179 Warrants expired - - 143 - (143)- - Loss and comprehensive loss for the period - - - - - (14,555)(14,555)Share-based compensation - - - 1,514 - - 1,514 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 750,000 463 - - (90)- 373 Share options exercised 68,167 37 - (15)- - 22 Loss and comprehensive loss for the period - - - - - (4,160)(4,160)Share-based compensation9 - - - 177 - - 177 Balance March 31, 2024 279,394,428 87,561 8,916 10,547 2,436 (129,597)(20,137) Spectral Medical Inc.Condensed Interim Consolidated Statements of Cash FlowsIn CAD (000s)(Unaudited) NotesThree months ended March 31, 2024Revised(Refer note 15) Three months ended March 31, 2023$$Cash flow provided by (used in) Operating activities Loss for the period (4,160)(1,138)Adjustments for: Depreciation on right-of-use asset 31 24 Depreciation on property and equipment 27 24 Amortization of intangible asset 4 11 Amortization of deferred financing fee 69 24 Unrealized foreign exchange gain/loss 464 (24)Interest expense on lease liability 9 10 Accreted interest on notes payable 531 238 Share-based compensation (reversal) 177 (26)Net loss on joint venture arrangement - 85 Fair value adjustment derivative liabilities 846 (746)Changes in items of working capital: Trade and other receivables (296)174 Inventories 47 (9)Prepayments and other assets (359)(577)Trade and other payables (453)(1,371)Contract liabilities 1,839 (194)Net cash used in operating activities (1,224)(3,495)Investing activities Purchase of property and equipment (16)- Net cash used in investing activities (16)- Financing activities Lease liability payments (33)(33)Proceeds from share options exercised 22 - Proceeds from warrants exercised 373 - Net cash provided by financing activities 362 (33)Change in cash (878)(3,528)Cash, beginning of period 2,952 8,414 Cash, end of period 2,074 4,886

Tigris Trial Enrollment Reaches 106 Patients Bought Deal Financing Expected to Fund Completion of Tigris Trial Enrollment TORONTO, May 13, 2024 (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 ended March 31, 2024, and provided a corporate update. Spectral has continued its significant progress throughout the first quarter of 2024 both clinically and operationally and year-to-date enrolled 25 patients for a total of 106 patients out of the 150 total patients target. The Company is focused on the final push to fully enroll and finish the Tigris trial and believes that the continued onboarding of new Tigris sites since the fourth quarter of 2023 could further accelerate enrollment and allow Spectral to rapidly reach the 150-patients 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, Baxter. In Q1 2024, Baxter exercised its right to maintain its exclusive distribution for PMX products in the U.S. and Canada and paid Spectral a non-dilutive milestone payment. Additionally, Spectral and Baxter mutually agreed to amend the initial term of their commercial partnership to ten years post-FDA approval of PMX. The Company believes this amendment provides a mutually beneficial runway for the parties to maximize PMX commercial economics, while providing motivation for continued support and allocation of resources to the PMX partnership. Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We continue to witness robust enrollment activity in 2024, with record enrollment rates since the beginning of the year. As we enter the final push to finish Tigris, our clinical team is focused on trial site support with activities such as site visits, refresher training, and clinical communications, and workshops. We are also activating our last group of sites. Ultimately, we want to ensure that our Tigris sites have the support and resources to enroll patients as efficiently as possible. We are committed alongside our trial sites to advancing Tigris and believe PMX, if ultimately approved, will play a major role in reducing the tragic rates of mortality caused by sepsis.” “I am pleased with the increased level of activity across the Company and its impact on establishing robust trial sites, thus resulting in a significant ramp up of patient enrollment. The recent pace of enrollment, combined with the quality and focus of the current and planned trial sites provide us with confidence in continued robust enrollment activity. The potential to sustain our current pace of enrollment could see us rapidly advance the trial towards completion in the late 2024 to early 2025 timeframe,” said Chris Seto, CEO of Spectral. “Additionally, with our recently announced financing, we have secured funding to finalize Tigris enrollment.” Corporate Highlights Tigris: Total of 106 patients randomized to date out of the 150 total patients to be enrolled in the Tigris trial. accelerated enrollment experienced in 2024 to date, with 25 patients enrolled so far – represents the most robust enrollment rates since the start of the Tigris trial. Currently 22 Tigris sites onboarded addition of three new trial sites in the first quarter – the University of Texas Health Sciences Center at Houston, The Institute for Extracorporeal Life Support (San Antonio, TX), and UCLA. subsequent to the first quarter, the Company added one new site – University of Virginia Health Sciences. Investigator Meeting held March 12th and 13th The Company held a Tigris trial Investigator Meeting in conjunction with the 29th International Conference on Advances in Critical Care Nephrology in San Diego. In-person meeting well-attended with multiple stakeholders present, including principal investigators and clinical research coordinators from existing and new trial sites, CRO, Beaufort, and representatives from the Spectral’s strategic partner Baxter. Focus of the meeting was on the practical aspects of diagnosing endotoxic septic shock and treating with PMX, as well as featuring several talks from trial sites on how EAA and PMX could be implemented into routine clinical practice after potential regulatory approval of PMX. PMX Commercialization: 90 patient enrollment interim milestone achieved On February 15, 2024, Spectral announced that it had reached the 90-patient enrollment threshold and provided written notification to Baxter of this achievement. Subsequently, Baxter exercised its option to maintain exclusive distribution rights and paid Spectral an ~C$2 million non-dilutive payment. Since inception of partnership, funding support from Baxter has amounted to ~C$15 million – comprised of non-dilutive payments and convertible notes subscriptions. Amendment of Initial Term of Exclusive Distribution Agreement In February 2024, the Company and Baxter mutually agreed to amend the initial term of the exclusive distribution agreement to 10 years post-FDA approval; the Company believes the 10-year term provides mutually beneficial runway to maximize PMX commercial economics. Commercialization Activities In anticipation of a positive Tigris trial outcome, the Company has been working closely with Baxter on post-approval marketing plans for PMX commercialization. This includes developing product branding, pricing and roll-out plans with numerous Baxter departments, including marketing, regulatory, clinical and reimbursement. Baxter has communicated its intention to undertake a broad marketing campaign on day one of FDA approval for PMX. The Company is also working with Baxter on a sub-study to obtain FDA clearance for hemoperfusion for Baxter’s Prismax device. The Prismax, 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. Funding: On May 9, 2024, Spectral announced a bought deal private placement of convertible notes for gross proceeds of $8,500,000. Based on recent enrollment rates, provides funding beyond full Tigris enrollment of 150 patients. Financial Review Revenue for the three-months ended March 31, 2024 was $668,000 compared to $530,000 for the same three-month period last year, representing an increase of $138,000, or 26%. Royalty revenue for the three-months ended March 31, 2024 was $135,000 an increase of $9,000 from $126,000 for the same period in the prior year. This is due to an increase in usage of the Company’s IP from one customer. Product revenue increased by $113,000. Operating expenses for the three-months ended March 31, 2024, were $4,825,000, compared to $1,625,000 for the same period in the preceding year, an increase of $3,200,000, or 197%. The increase in operating expenses were primarily due to off-setting income booked for fair value adjustment of derivative liabilities in the first quarter of 2023 and an expense booked on the same during the period ended March 31, 2024 with a net impact of $1,591,000. Results were also affected by an increase in the raw material and consumables used, Consulting and Professional fees and foreign exchange loss. Clinical development and regulatory program costs were $964,000 for the three-months ended March 31, 2024 compared to $431,000 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 increase in costs reflects increased activity with respect to the initialization of clinical sites and the randomization of patients into the Tigris clinical trial. Loss for the three-months ended March 31, 2024 was $4,160,000 ($0.01 per share) compared to a loss of $1,138,000 ($0.01 per share) for the same period in the prior year. The increased loss of $3,067,000 was due to increased operating expenses, partially offset by a reduction in loss from discontinued operations of $40,000 related to the reduction in Dialco operating expenses. The Company concluded the first quarter of 2024 with cash of $2,074,000 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 279,394,428 at March 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 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 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 . 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 . Forward-looking statement Informationinthisnewsreleasethatisnotcurrentorhistoricalfactualinformationmayconstituteforward-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 managementaswellasinformationcurrentlyavailabletoit.Whiletheseassumptionswereconsideredreasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results aresubjecttoanumberofrisksanduncertainties,includingtheavailabilityoffundsandresourcestopursueR&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. Condensed Interim Consolidated Statements of Financial Position In CAD (000s), except for share and per share data (Unaudited) Notes March 31, December 31, 2024 2023 $ $ Assets Current assets Cash 2,074 2,952 Trade and other receivables 482 186 Inventories 319 366 Prepayments and other assets 980 621 3,855 4,125 Non-current assets Right-of-use-asset 536 567 Property and equipment 314 326 Intangible asset 189 193 Investment in iDialco 5 - - Total assets 4,894 5,211 Liabilities Current liabilities Trade and other payables 2,611 2,820 Current portion of contract liabilities 6 496 727 Current portion of lease liability 123 121 Notes payable 7 278 264 Derivative Liability 7 7,250 6,310 10,758 10,242 Non-current liability Lease liability 468 500 Non-current portion of contract liabilities 6 5,412 3,342 Notes payable 7 8,393 7,676 Total liabilities 25,031 21,760 Shareholders' (deficiency) equity 9 Share capital 87,561 87,061 Contributed surplus 8,916 8,916 Share-based compensation 10,547 10,385 Warrants 2,436 2,526 Deficit (129,597) (125,437) Total shareholders' (deficiency) equity (20,137) (16,549) Total liabilities and shareholders' (deficiency) equity 4,894 5,211 Spectral Medical Inc. Condensed Interim Consolidated Statements of Loss and Comprehensive Loss In CAD (000s), except for share and per share data (Unaudited) Notes Three months ended March 31, 2024 Revised (Refer Note 15) Three months ended March 31, 2023 $ $ Revenue 668 530 Expenses Raw materials and consumables used 279 137 Salaries and benefits 13 1,000 956 Consulting and professional fees 925 628 Regulatory and investor relations 175 108 Travel and entertainment 76 84 Facilities and communication 120 83 Insurance 105 87 Depreciation and amortization 131 61 Interest expense 7 540 247 Foreign exchange loss 464 (51 ) Share-based compensation 177 (26 ) Other expense (12 ) (28 ) Net loss on joint arrangement 5 - 85 Fair value adjustment derivative liabilities 7 845 (746 ) 4,825 1,625 Loss and comprehensive loss for the period from continuing operations (4,157 ) (1,095 ) Loss from discontinued operations 5 (3 ) (43 ) Loss and comprehensive loss for the period (4,160 ) (1,138 ) Basic and diluted loss from continuing operations per common share 9 (0.01 ) (0.01 ) Basic and diluted loss from discontinued operations per common share 9 0.00 0.00 Basic and diluted loss per common share 9 (0.01 ) (0.01 ) Weighted average number of common shares outstanding - basic and diluted 9 279,472,325 278,547,804 Spectral Medical Inc. Condensed Interim Consolidated Statements of Changes in Shareholders’ Deficiency In CAD (000s) (Unaudited) Notes Number of Shares Share Capital Contributed surplus Share-based compensation Warrants Deficit Total Shareholders’ (deficiency) equity $ $ $ $ $ $ Balance January 1, 2023 278,547,804 87,050 8,773 8,908 2,490 (109,744 ) (2,523 ) Loss and comprehensive loss for the year - - - - (1,138 ) (1,138 ) Share-based compensation 9 - - (26 ) - - (26 ) Revised (Refer note 15) Balance, March 31, 2023 278,547,804 87,050 8,773 8,882 2,490 (110,882 ) (3,687 ) RSU released 28,457 11 (11 ) - - Warrants issued 179 179 Warrants expired - - 143 - (143 ) - - Loss and comprehensive loss for the period - - - - - (14,555 ) (14,555 ) Share-based compensation - - - 1,514 - - 1,514 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 750,000 463 - - (90 ) - 373 Share options exercised 68,167 37 - (15 ) - - 22 Loss and comprehensive loss for the period - - - - - (4,160 ) (4,160 ) Share-based compensation 9 - - - 177 - - 177 Balance March 31, 2024 279,394,428 87,561 8,916 10,547 2,436 (129,597 ) (20,137 ) Spectral Medical Inc. Condensed Interim Consolidated Statements of Cash Flows In CAD (000s) (Unaudited) Notes Three months ended March 31, 2024 Revised (Refer note 15) Three months ended March 31, 2023 $ $ Cash flow provided by (used in) Operating activities Loss for the period (4,160 ) (1,138 ) Adjustments for: Depreciation on right-of-use asset 31 24 Depreciation on property and equipment 27 24 Amortization of intangible asset 4 11 Amortization of deferred financing fee 69 24 Unrealized foreign exchange gain/loss 464 (24 ) Interest expense on lease liability 9 10 Accreted interest on notes payable 531 238 Share-based compensation (reversal) 177 (26 ) Net loss on joint venture arrangement - 85 Fair value adjustment derivative liabilities 846 (746 ) Changes in items of working capital: Trade and other receivables (296 ) 174 Inventories 47 (9 ) Prepayments and other assets (359 ) (577 ) Trade and other payables (453 ) (1,371 ) Contract liabilities 1,839 (194 ) Net cash used in operating activities (1,224 ) (3,495 ) Investing activities Purchase of property and equipment (16 ) - Net cash used in investing activities (16 ) - Financing activities Lease liability payments (33 ) (33 ) Proceeds from share options exercised 22 - Proceeds from warrants exercised 373 - Net cash provided by financing activities 362 (33 ) Change in cash (878 ) (3,528 ) Cash, beginning of period 2,952 8,414 Cash, end of period 2,074 4,886

TORONTO, March 28, 2024 (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, 2023 and provided a corporate update. The Company made significant progress throughout 2023, 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 97 patients to date, out of the 150 total patients to be enrolled, and 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-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, Baxter. Recently, Baxter exercised its right to maintain its exclusive distribution rights for PMX products in the U.S. and Canada and paid Spectral a non-dilutive milestone payment. Additionally, the Company and Baxter mutually agreed to amend the initial term of their commercial partnership to ten years post-FDA approval of PMX. The Company believes this amendment provides a mutually beneficial runway for the parties to maximize PMX commercial economics, while providing motivation for continued support and allocation of resources to the PMX partnership. Dr. John Kellum, Chief Medical Officer of Spectral Medical, stated, “We have witnessed robust enrollment activity to start 2024. This pace of enrollment continues the momentum since we communicated our enhanced recruitment initiatives last April, and it’s fair to say that our steady enrollment over the last twelve months is a culmination of many of these initiatives, which the Company implemented throughout 2023. As we enter the final push to fully enroll and finish Tigris, our clinical team is focused on trial site management activities such as site visits, refresher training, and clinical communications, workshops, and roundtables. Ultimately, we want to ensure that our Tigris sites have the support and resources to enroll patients as efficiently as possible. 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, 2023 Tigris: Total of 97 patients randomized to date out of the 150 total patients to be enrolled in the Tigris trial. accelerated enrollment experienced in 2024 to date, with 16 patients enrolled so far – represents the most robust enrollment rates since the start of the Tigris trial. Currently 22 Tigris sites onboarded addition of two new trial sites in the fourth quarter – the Mayo Clinic and Emory Healthcare. subsequent to the fourth quarter, the Company added three new sites – University of Texas Health Sciences Center at Houston, The Institute for Extracorporeal Life Support (San Antonio, TX), and UCLA, with two additional sites in the pipeline. Investigator Meeting held March 12th and 13th The Company held a Tigris trial Investigator Meeting in conjunction with the 29th International Conference on Advances in Critical Care Nephrology in San Diego. In-person meeting well attended with multiple stakeholders present, including: principal investigators and clinical research coordinators from existing and new trial sites; CRO, Beaufort; and representatives from the Company’s strategic partner Baxter. Focus of the meeting was on the practical aspects of diagnosing endotoxic septic shock and treating with PMX, as well as featuring several talks from trial sites on how EAA and PMX could be implemented into routine clinical practice after potential regulatory approval of PMX. Completion of EDEN Observational Study The Company completed its EDEN study in the fourth quarter 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. 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. The Company expects final analysis of the data in mid-2024. PMX Commercialization: 90 patient enrollment interim milestone achieved On February 15, 2024, Spectral announced that it had reached the 90-patient enrollment threshold and provided written notification to Baxter of this achievement. Subsequently, Baxter exercised its option to maintain exclusive distribution rights and paid Spectral an ~C$2 million non-dilutive payment. Since inception of partnership, funding support from Baxter has amounted to ~C$15 million – comprised of non-dilutive payments and convertible notes subscriptions. Amendment of Initial Term of Exclusive Distribution Agreement In February 2024, the Company and Baxter mutually agreed to amend the initial term of the exclusive distribution agreement to 10 years post-FDA approval; the Company believes the 10-year term provides mutually beneficial runway to maximize PMX commercial economics. Commercialization Activities In anticipation of a positive Tigris trial outcome, the Company has been working closely with Baxter on post-approval marketing plans for PMX commercialization. This includes developing product branding, pricing and roll-out plans with numerous Baxter departments, including marketing, regulatory, clinical and reimbursement. Baxter has communicated its intention to undertake a broad marketing campaign on day one of FDA approval for PMX. The Company is also working with Baxter on a sub-study to obtain FDA clearance for hemoperfusion for Baxter’s Prismax device. The Prismax, 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. i-Dialco Inc.: Throughout 2023, the Company became aware of significant changes in the iDialco business plan that impacted the ability of the Company to forecast the recoverability of the investment. Accordingly, the net investment was assessed for a non-cash impairment loss. As part of this assessment the Company noted significant changes from the initial business plan at inception, including the identification that the period of negative cash flows for the entity increased substantially as a result of shift in both the regulatory and commercialization timelines mainly due to further device developments and improvements required for clinical adoption of the SAMI and DIMI devices. The Company maintains a 30% ownership and voting rights within iDialco, and will continue to track any future losses or gains booked by iDialco. “I am pleased with the increased level of activity across the Company and its impact on establishing robust trial sites, thus resulting in a significant ramp up of patient enrollment. The recent pace of enrollment, combined with the quality and focus of the current and planned trial sites provide us with confidence in continued robust enrollment activity. The potential to sustain our current pace of enrollment could see us rapidly advance the trial towards completion in the late 2024 to early 2025 timeframe,” said Chris Seto, CEO of Spectral. “During the quarter we took a non-cash impairment charge relating to our investment in iDialco. Consistent with our assessment at the time of spinning-off this business, iDialco has proven to be more challenged with delivering on its business plan based on what was initially envisioned.” Financial Review Revenue for the three-months ended December 31, 2023 was $365,000 compared to $553,000 for the same three-month period last year. Total revenue for the year ended December 31, 2023 was $1,598,000 compared to $1,667,000 for prior year, representing a decrease of $69,000, or 4%. The decrease in product revenue was mainly due to the timing of orders in addition to certain supply chain constraints. For the quarter ended December 31, 2023, the Company reported operating expenses of $6,813,000 compared to $1,767,000 for the same period in 2022. When excluding the impact of the $193,000 loss (2022 - $998,000 gain) on investment in iDialco and $600,000 impairment loss on Joint venture arrangement, operating expenses for the quarter ended December 31, 2023 were $6,020,000 compared to $ 2,766,000 for the same period in the prior year. The increase of $ 3,254,000 (excluding investment loss and impairment) was due primarily to increased consulting and professional services majorly due to increased site and patient fees related to the Tigris trial and Eden observational study; and a non-cash expense attributed to a Fair Value adjustment on Derivative Liabilities (the increase was primarily due to change in the market assumptions and market price considered for the calculation of the option feature). Loss for the three-months ended December 31, 2023 was $6,479,000, or $0.02 per share, compared to a loss of $2,537,000, or $0.01 per share, for the same quarter last year. The loss for the year ended December 31, 2023 was $15,662,000, or $0.06 per share, compared to a loss of $11,281,000 or $0.04 per share, for 2022. The Company concluded the 2023 year with cash of $2,952,000 compared to $8,414,000 cash on hand as of December 31, 2022. The total number of common shares outstanding for the Company was 278,576,261 at December 31, 2023. 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 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 . 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 . Forward-looking statement Informationinthisnewsreleasethatisnotcurrentorhistoricalfactualinformationmayconstituteforward-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 managementaswellasinformationcurrentlyavailabletoit.Whiletheseassumptionswereconsideredreasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results aresubjecttoanumberofrisksanduncertainties,includingtheavailabilityoffundsandresourcestopursueR&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 thousands of Canadian dollars) Notes Dec-31 Revised (Refer note 15) Dec-31 2023 2022 $ $ Assets Current assets Cash 5 2,952 8,414 Trade and other receivables 6 186 1,056 Inventories 7 366 340 Prepayments and other assets 8 621 276 4,125 10,086 Non-current assets Right-of-use-asset 9 567 464 Property and equipment 10 326 237 Intangible asset 11 193 211 Investment in iDialco 12 - 998 Total assets 5,211 11,996 Liabilities Current liabilities Trade and other payables 13 2,820 3,087 Current portion of contract liabilities 14 727 696 Current portion of lease liability 9 121 96 Notes Payable 15 264 79 Derivative Liabilities 15 6,310 2,674 10,242 6,632 Non-current liability Lease liability 9 500 420 Non-current portion of contract liabilities 14 3,342 4,011 Notes payable 15 7,676 3,487 Total liabilities 21,760 14,550 Shareholders' (deficiency) equity 17 Share capital 87,061 87,050 Contributed surplus 8,916 8,773 Share-based compensation 10,385 8,908 Warrants 2,526 2,490 Deficit (125,437 ) (109,775 ) Total shareholders' (deficiency) equity (16,549 ) (2,554 ) Total liabilities and shareholders' (deficiency) equity 5,211 11,996 Spectral Medical Inc. Consolidated Statements of Loss and Comprehensive Loss For the years ended December 31, 2023 and 2022 (in thousands of Canadian dollars, except for share and per share data) Notes 2023 Revised (Refer note 15) 2022 $ $ Revenue 20 1,598 1,667 Expenses Raw materials and consumables used 936 684 Salaries and benefits 22 3,857 3,767 Consulting and professional fees 4,825 2,653 Regulatory and investor relations 581 567 Travel and entertainment 297 247 Facilities and communication 414 297 Insurance 411 477 Depreciation and amortization 210 225 Interest expense 9,15 1,334 176 Foreign exchange (gain) and loss (126 ) 39 Share-based compensation 17 1,488 1,197 Other expense 315 290 Net (gain) loss on joint venture arrangement 12 398 (998 ) Impairment loss on joint venture arrangement 12 600 - Fair Value Adjustment Derivative Liabilities 1,565 (326 ) 17,105 9,295 Loss and comprehensive loss for the year from continuing operations (15,507 ) (7,628 ) Loss from discontinued operations 4 (155 ) (3,653 ) Loss and comprehensive loss for the year (15,662 ) (11,281 ) Basic and diluted loss from continuing operations per common share 18 (0.06 ) (0.03 ) Basic and diluted loss from discontinued operations per common share 18 0.00 (0.01 ) Basic and diluted loss per common share 18 (0.06 ) (0.04 ) Weighted average number of common shares outstanding - basic and diluted 18 278,563,241 269,843,447 Spectral Medical Inc. Consolidated Statements of Changes in Shareholders’ (Deficiency) Equity For the years ended December 31, 2023 and 2022 (in thousands of Canadian dollars) Notes Issued capital Contributed surplus Share-based compensation Warrants Deficit Total Shareholders’ (deficiency) equity Number $ $ $ $ $ $ Balance, December 31, 2021 267,886,408 84,357 7,985 7,984 2,251 (98,494 ) 4,083 Bought deal offering 21 10,061,250 2,313 - - 1,027 - 3,340 Share options exercised 15 268,797 157 (69 ) - - 88 RSU released 331,349 223 - (204 ) - - 19 Warrants expired - - 788 - (788 ) - - Loss and comprehensive loss for the year - - - - - (11,281 ) (11,281 ) Share-based compensation 15 - - - 1,197 - - 1,197 Revised (Refer note 15) Balance, December 31, 2022 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 15 - - - 1,488 - - 1,488 Balance December 31, 2023 278,576,261 87,061 8,916 10,385 2,526 (125,437 ) (16,549 ) Spectral Medical Inc. Consolidated Statements of Cash Flows For the years ended December 31, 2023 and 2022 (in thousands of Canadian dollars) Notes 2023 Revised (Refer note 15) 2022 $ $ Cash flow provided by (used in) Operating activities Loss for the year (15,662 ) (11,281 ) Adjustments for: Depreciation on right-of-use asset 9 104 94 Depreciation on property and equipment 10 96 161 Amortization of intangible asset 11 18 17 Amortization and Derivative related financing fees 446 324 Unrealized foreign exchange (gain) and loss (228 ) (10 ) Interest expense on lease liability 9 25 25 Accreted Interest on Notes Payable 835 151 Share-based compensation 17 1,488 1,197 Disposal of property and equipment - 167 Net (gain) loss on joint venture arrangement 12 398 (998 ) Impairment loss on joint venture arrangement 12 600 Fair Value Adjustment derivative liabilities 1,565 (326 ) Changes in items of working capital: Trade and other receivables 870 (851 ) Inventories (26 ) (47 ) Prepayments and other assets (345 ) 599 Right-of-use-asset - (26 ) Trade and other payables (267 ) 1,565 Contract liabilities (638 ) (661 ) Net cash used in operating activities (10,721 ) (9,900 ) Investing activities Purchases of property and equipment 10 (185 ) (33 ) Net cash used in investing activities (185 ) (33 ) Financing activities Proceeds from bought deal offering 23 - 4,025 Financing charges paid 15,23 (641 ) (1,363 ) Note payable 15 4,058 3,802 Lease liability payments (127 ) (91 ) Share options exercised - 88 Derivative liabilities 15 2,154 2,996 Net cash provided by financing activities 5,444 9,457 Increase (decrease) in cash (5,462 ) (476 ) Cash, beginning of year 8,414 8,890 Cash, end of year 2,952 8,414