Announcement • Aug 13
Arch Biopartners Expands Phase II Cardiac Surgery-Associated Acute Kidney Injury Trial to the United States Arch Biopartners announced that the Company will expand its ongoing 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. 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. 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 multi-center, 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 ClinicalTrials.gov: NCT05879432. 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 different causes of 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 underway. Announcement • Jul 17
Arch Biopartners Inc Engages U.S.-Based Laboratory to Accelerate Il-32 Chronic Kidney Disease Program Arch Biopartners Inc. announced that it has engaged a U.S.-based laboratory specializing in bioengineering to accelerate the Company’s pre-IND IL-32 chronic kidney disease program. The U.S.-based lab was selected for its core competencies in the areas required to support the IL-32 program. It will perform studies on behalf of Arch to generate proprietary data and support the Company’s patent portfolio covering its IL-32 drug candidates and related method-of-use claims. These studies represent the next stage of drug development following the identification of IL-32 as a potential therapeutic target in diabetic kidney disease. Announcement • May 02
Arch Biopartners Inc Begins Patient Recruitment In Phase II Trial Of LSALT Peptide Targeting Cardiac Surgery-Associated Acute Kidney Injury Arch Biopartners Inc. announced that Royal Columbian Hospital (RCH) has begun patient recruitment in the Company’s ongoing Phase II trial evaluating LSALT peptide as a new drug to prevent acute kidney injury in patients undergoing on-pump cardiac surgery. Royal Columbian Hospital, located in New Westminster and part of Fraser Health, is the ninth site to be activated globally for the study and the fourth site to recruit patients in Canada. Patient recruitment into the trial is ongoing at 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. Arch continues to evaluate additional sites to support enrollment in the CS-AKI Phase II trial. The Company is in feasibility discussions with cardiac surgery centres in Canada and the United States, including three prospective sites in the United States and one additional site in Ontario (through Clinical Trials Ontario). 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 an international, multi-center, 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 (AKI) in each treatment group within seven days following on-pump cardiac surgery, as defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. The Company has also announced that its Board of Directors has granted a total of 150,000 stock options to a new director pursuant to the Company’s stock option plan and the requirements of the TSX Venture Exchange (TSXV). Each of these stock options is exercisable into one common share of the Company at a price of $1.05 per share for a period of 10 years, effective April 29, 2026, and will be subject to all necessary regulatory approvals. 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 unmet needs in kidney care across both chronic and acute indications, affecting more than 800 million people worldwide. Both lead programs are currently enrolling patients at Canadian clinical sites, with additional North American sites in development. 
