Mr. Richard Muruve reports

ARCH BIOPARTNERS SUBMITS APPLICATION TO THE TURKISH MINISTRY OF HEALTH TO CONDUCT A PHASE II CARDIAC SURGERY ASSOCIATED-ACUTE KIDNEY INJURY TRIAL FOR LSALT PEPTIDE

Arch Biopartners Inc. has submitted applications to the Ministry of Health (MoH) and local ethics committee in Turkey to obtain permission to proceed with a phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac-surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the company's lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

This application in Turkey follows the company's submission of an investigational new drug application to the U.S. Food and Drug Administration (FDA). The FDA subsequently granted the company permission to proceed with this phase II trial in late June.

The CS-AKI trial plans to recruit up to 240 patients and will be a double-blind, placebo-controlled study conducted in hospital sites in the United States, Turkey and Canada. Of this total, the application to the MoH requests permission to recruit up to 150 patients in Turkey.

Following approvals from the MoH and the ethics committee, patient recruitment is expected to begin as planned in the fall (fourth quarter) of 2023. The trial will begin with patient recruitment at clinical sites in Turkey, followed by eventual onboarding of clinical sites in the United States and Canada.

There will be an independent data safety monitoring board, which will monitor the safety of the patients enrolled in the trial. This study is designed to produce a signal of efficacy that would justify a larger phase III trial.

Richard Muruve, chief executive officer of Arch Biopartners, stated: "We are very happy to be returning to Turkey to begin a phase II human trial targeting CS-AKI, which is a large unmet medical problem. The Arch team and our colleagues in Turkey have been working hard the last couple of months to prepare the regulatory submissions, select clinical sites and mobilize to execute the trial. As a result, Arch is on schedule to dose the first patient in the fourth quarter of 2023."

Cardiac-surgery-associated AKI and LSALT peptide

Cardiac-surgery-associated AKI is often caused by ischemia reperfusion injury (IRI) that reduces blood flow and thus oxygen (ischemia) in the kidney, causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. At present, there are no therapeutic treatments available to prevent or treat CS-AKI or IRI. In the worst cases of AKI, kidneys fail, leading to kidney dialysis or kidney transplant.

LSALT peptide has been shown to prevent ischemia reperfusion injury (IRI) to the kidneys in preclinical models, providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial.

Details of the phase II trial, entitled "Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery," can be viewed on the Clinical Trials website.

The Science Advances publication, titled "Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury," by Lau et al., can be found at the journal's website.

Advisory services and a funding contribution from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) announced by the company in March, 2023, will significantly offset the costs of the CS-AKI phase II trial.

Incidence of cardiac-surgery-associated AKI

Acute kidney injury (AKI) is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries, which increase the risk of AKI. The reported prevalence of cardiac-surgery-associated acute kidney injury (CS-AKI) is up to 30 per cent and is independently associated with an increase in morbidity and mortality.

Cardiopulmonary bypass (CPB) surgery occurs in nearly one million patients per year. Approximately 0.6 per cent to 5 per cent of patients undergoing cardiac surgery will require immediate postoperative dialysis or renal replacement therapy, and these patients have a very high early mortality rate (up to 25 per cent) compared with 1 per cent to 2 per cent in patients who do not require immediate postoperative dialysis (Conlon et al., 1999; Chertow et al., 2005; Zakeri et al., 2005; Ivert et al., 2014; and Harky et al., 2020).

About Arch Biopartners Inc.

Arch Biopartners is a late-stage clinical trial company focused on preventing inflammation and acute organ injury. The company is developing new drug candidates that inhibit inflammation in the lungs, kidneys and liver through the dipeptidase-1 (DPEP-1) pathway and are relevant for common injuries and diseases where organ inflammation is an unmet problem.

The company has 62,598,815 common shares outstanding.

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