Arch Biopartners Announces St. Michael’s Hospital Commences Patient Dosing in the Phase II CS-AKI Trial of LSALT Peptide

4 hours ago 2

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With no approved pharmacologic therapies indicated for prevention of CS-AKI or drug-induced AKI, these conditions remain areas of significant unmet medical need. LSALT peptide is being evaluated as a potential first-in-class therapeutic approach to prevent inflammation-related injury in patients at high risk of developing AKI, and cilastatin is being evaluated in the investigator-led PONTiAK Phase II trial for nephrotoxin-induced AKI.

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About Arch Biopartners

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Arch Biopartners Inc. is a therapeutic biotech company developing novel drugs for acute kidney injury (AKI) and chronic kidney disease (CKD). The Company is advancing an integrated program that includes new treatments targeting inflammation- and toxin-related kidney injury.

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Arch’s development pipeline includes:

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  • LSALT peptide: in a Phase II trial targeting cardiac surgery-associated AKI.
  • Cilastatin: a repurposed drug in a Phase II trial targeting toxin-induced AKI.
  • CKD Platform: next-generation therapeutics targeting chronic kidney disease.

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These assets represent distinct, mechanism-based approaches to treating and preventing common causes of kidney damage. Together, they target serious unmet needs in kidney care across both chronic and acute indications, affecting more than 800 million people worldwide6. Both lead programs are currently enrolling patients at Canadian clinical sites, with additional North American sites in development.

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For more details about the Company’s science and ongoing clinical trials, please visit: www.archbiopartners.com/our-science

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Follow Arch on LinkedIn, Bluesky, and X (formerly Twitter) for scientific insights and industry news.

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The Company has 66,933,289 common shares outstanding.

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Send a message or subscribe for trial updates and company news at www.archbiopartners.com/contact-us

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Forward-Looking Statements

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This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of the Company’s future performance, liquidity, and capital resources, as well as the ongoing development of its drug candidates targeting chronic kidney disease and the dipeptidase-1 (DPEP1) pathway, including the outcome of its clinical trials relating to LSALT peptide (Metablok) or cilastatin, the successful commercialization and marketing of its drug candidates, whether the Company will receive, and the timing and costs of obtaining, regulatory approvals in Canada, the United States, Europe, and other countries, its ability to raise capital to fund its business plans, the efficacy of its drug candidates compared to the drug candidates developed by competitors, its ability to retain and attract key management personnel, and the breadth of, and its ability to protect, its intellectual property portfolio. These statements are based on management’s current expectations and beliefs, including certain factors and assumptions, as described in the Company’s most recent annual audited financial statements and related management discussion and analysis under the heading “Business Risks and Uncertainties”. As a result of these risks and uncertainties, or other unknown risks and uncertainties, the actual results may differ materially from those contained in any forward-looking statements. The words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company undertakes no obligation to update forward-looking statements, except as required by law. Additional information relating to Arch Biopartners Inc., including the Company’s most recent annual audited financial statements, is available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (“SEDAR”) website at www.sedarplus.ca.

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References:

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  1. Nadim, M., et al. “Cardiac and Vascular Surgery–Associated Acute Kidney Injury: The 20th International Consensus Conference of the ADQI (Acute Disease Quality Initiative) Group”, Journal of the American Heart Association, 2018, 7(11). https://doi.org/10.1161/JAHA.118.008834
  2. Scurt, F. G., et al. “Cardiac Surgery–Associated Acute Kidney Injury”, Kidney360 5(6):p 909-926, June 2024. https://doi.org/10.34067/KID.0000000000000466
  3. Vervoort, D., et al. “Global Cardiac Surgical Volume and Gaps: Trends, Targets, and Way Forward.” Annals of Thoracic Surgery Short Reports, 2024, 2:320–324. https://doi.org/10.1016/j.atssr.2023.11.019
  4. Perazella M., et al. “Drug-Induced Acute Kidney Injury.” Clinical Journal of the American Society of Nephrology (CJASN). 2022;17:1220–1233. https://doi.org/10.2215/CJN.11290821
  5. Acharya D., et al. “Nephroprotective Effects of Cilastatin in People at Risk of Acute Kidney Injury: A Systematic Review and Meta-analysis.” Kidney Medicine, 2024;6:100913. https://doi.org/10.1016/j.xkme.2024.100913
  6. Mark, Patrick B et al. Global, regional, and national burden of chronic kidney disease in adults, 1990–2023, and its attributable risk factors: a systematic analysis for the Global Burden of Disease Study 2023. The Lancet, 2025;406(10518), 2461 – 2482. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01853-7/fulltext

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The scientific and medical content of this release has been reviewed and approved by the Company’s Chief Science Officer.

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Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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For more information, please contact: Aaron Benson Director of Communications Arch Biopartners, Inc. 647-428-7031

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