Mr. Richard Muruve reports

ARCH BIOPARTNERS RECEIVES CENTRAL IRB APPROVAL TO SUPPORT U.S. SITES IN PHASE II CARDIAC SURGERY-ASSOCIATED ACUTE KIDNEY INJURY TRIAL OF LSALT PEPTIDE

Arch Biopartners Inc. has received central Institutional Review Board (IRB) approval of the protocol and related study documents for the company's continuing phase II trial of LSALT peptide targeting cardiac surgery-associated acute kidney injury (CS-AKI).

Arch recently announced that the company will expand the study into the United States following interest from clinicians at five leading institutions. The central IRB approval completes an important step toward activating these U.S. sites. It provides an ethical review that participating sites may use instead of their local institutional review board to accelerate the site activation process.

The planned U.S. arm of the study builds on progress achieved at the trial's existing clinical sites in Canada and past sites in Turkey. The expansion into the U.S. is intended to increase the trial's visibility in the global health care sector and broaden patient recruitment. The company is also continuing to grow the trial in Canada as one additional Canadian site moves through the activation process.

"The U.S. expansion is an important part of our development strategy for LSALT peptide and the CS-AKI program," said Richard Muruve, chief executive officer of Arch Biopartners. "For Arch, it is also a strategic step toward establishing a stronger global presence as we advance our clinical-stage kidney programs."

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

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 Clinical Trials website.

About Arch Biopartners Inc.

Arch Biopartners is a therapeutic biotechnology company developing on-target 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 focused on protecting the kidney from common causes of acute and chronic damage. Chronic kidney disease affects more than 800 million people worldwide, while acute kidney injury adds a further significant burden. Together, Arch's programs target unmet needs across both acute and chronic kidney disease. Both phase II programs are currently enrolling patients at Canadian clinical sites, with an additional Canadian site in development and a U.S. expansion of the CS-AKI trial under way.

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