Mr. Richard Muruve reports

ARCH BIOPARTNERS TO EXPAND PHASE II CARDIAC SURGERY-ASSOCIATED ACUTE KIDNEY INJURY TRIAL TO THE UNITED STATES

Arch Biopartners Inc. will expand its phase II trial of LSALT peptide targeting cardiac surgery-associated acute kidney injury (CS-AKI) into the United States, following interest from clinicians at five leading U.S. institutions.

The planned U.S. expansion builds on progress at the four Canadian clinical sites currently participating in the trial and patient data collected from the five sites in Turkey that were the first to recruit patients to the study. Patient recruitment has maintained momentum; there have been no adverse events related to the study drug, and AKI has occurred consistently among enrolled patients, validating trial design. These factors support the company's decision to expand the study with additional sites.

Expanding the trial to the U.S. is intended to increase access to eligible patients and support continued recruitment. The company is also continuing to grow the trial in Canada as one additional Canadian site moves through the activation process.

"We are seeing strong interest from American clinicians to join our CS-AKI trial for LSALT peptide to protect patients from cardiac surgery-related acute kidney injury. Establishing a U.S. arm of the study will increase awareness of LSALT peptide and our phase II trial among kidney care specialists, the pharmaceutical industry and potential partners," said Richard Muruve, chief executive officer of Arch Biopartners.

The company expects new U.S. clinical sites to require approximately four to six months to complete site preparation, contracting, regulatory review, training and other start-up activities before dosing their first patients. Timing will vary by institution and is subject to the completion of all applicable approvals.

The company will provide further updates as U.S. clinical sites complete the steps required to join and begin recruiting patients in the trial.

About the CS-AKI phase II trial

Cardiac surgery-associated acute kidney injury is a common complication following on-pump (heart-lung machine) cardiac surgery and can lead to longer hospital stays and worse outcomes. The trial is designed to evaluate whether LSALT peptide can reduce the rate of AKI in this setting.

The CS-AKI phase II trial is a multicentre, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with acute kidney injury within seven days following on-pump cardiac surgery, as defined by the KDIGO (kidney disease: improving global outcomes) criteria.

Details of the phase II trial can be viewed at the U.S. government's clinical trials website, NCT05879432.

About Arch Biopartners Inc.

Arch Biopartners is a therapeutic biotechnology 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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