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Arch Biopartners and the Fraser Health Authority enter into a Clinical Trial Agreement for the Phase II Cardiac Surgery-Associated AKI Trial

(Neutral)

Arch Biopartners (OTCQB: ACHFF) announced a Clinical Trial Agreement with Fraser Health Authority to prepare Royal Columbian Hospital for recruitment in its Phase II trial of LSALT peptide for prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Royal Columbian Hospital is now the ninth global site activated and the fourth Canadian recruiting site, after Toronto General Hospital, St. Michael’s Hospital, and University of Calgary.

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Positive

  • Royal Columbian Hospital received final Research Ethics Board and operational approvals
  • Royal Columbian Hospital became the 9th global site activated in the Phase II CS-AKI trial
  • 4 Canadian sites are actively recruiting patients (Toronto General, St. Michael’s, Calgary, RCH)

Negative

  • None.

News Market Reaction – ACHFF

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In the Mar 24 session, ACHFF declined 4.90%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

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TORONTO, March 24, 2026 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the Fraser Health Authority has entered into a Clinical Trial Agreement (“CTA”) with Arch to enable the Royal Columbian Hospital (RCH) to begin preparing for the recruitment phase in Arch’s ongoing Phase II trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

With the Clinical Trial Application (CTA) completed, RCH has now received final Research Ethics Board and operational approvals, including the final letter of authorization from Fraser Health. RCH will be the ninth site activated globally in the study and will be the fourth site to recruit patients in Canada.

Toronto General Hospital, part of University Health Network, St. Michael’s Hospital, part of Unity Health Toronto, and the University of Calgary, Cumming School of Medicine, continue to actively enroll new patients into the trial.

The Company is currently progressing feasibility and start-up discussions with additional leading cardiac surgery centres in Canada and the United States.

About Arch Biopartners

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.

Arch’s development pipeline includes:

  • 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.

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 worldwide1. Both lead programs are currently enrolling patients at Canadian clinical sites, with additional North American sites in development.

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

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

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

For more information, please contact:

Aaron Benson
Director of Communications
Arch Biopartners, Inc.
647-428-7031
 
  

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

Forward-Looking Statements

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 (DPEP-1) 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.

References:

  1. 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

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

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.


FAQ

What does the Clinical Trial Agreement with Fraser Health mean for Arch Biopartners (ACHFF)?

It enables Royal Columbian Hospital to prepare for patient recruitment in the Phase II CS-AKI trial. According to the company, RCH now has final Research Ethics Board and operational approvals plus a letter of authorization from Fraser Health, supporting site activation.

How many sites are active in Arch Biopartners' (ACHFF) Phase II LSALT CS-AKI trial after Royal Columbian Hospital activation?

Royal Columbian Hospital is the ninth site activated globally in the study. According to the company, RCH is also the fourth site in Canada to reach activation and prepare for recruitment.

Which Canadian hospitals are currently recruiting for Arch Biopartners' (ACHFF) Phase II CS-AKI trial?

Toronto General Hospital, St. Michael’s Hospital, University of Calgary, and now Royal Columbian Hospital are recruiting. According to the company, those four Canadian centres are actively enrolling new patients into the trial.

What approvals did Royal Columbian Hospital receive to start recruitment for the ACHFF Phase II trial?

RCH received final Research Ethics Board and operational approvals plus a letter of authorization from Fraser Health. According to the company, these approvals complete site readiness for recruitment and study start-up activities.

Will Arch Biopartners (ACHFF) add more sites in Canada and the US for the Phase II CS-AKI trial?

The company is progressing feasibility and start-up discussions with additional cardiac surgery centres in Canada and the United States. According to the company, those discussions aim to expand site activation beyond the current nine global sites.