Press release

Guard Therapeutics to present at upcoming investor conferences

Guard Therapeutics (publ) today announced that the company will present at the following investor conferences ahead of the upcoming readout of the Phase 2b POINTER study:

DNB Carnegie Small Cap Day
Monday, September 1, 2025, 14:30–14:55, Stockholm
The presentation will be broadcast live.
Link to the webcast: https://qcnl.tv/p/1eyViEyIJ9YxwDzeBfTWWQ

Pareto Healthcare Conference
Tuesday, September 16, 2025, 10:05–10:25, Stockholm
Attendance by special invitation only.

Redeye Investor Forum – Gothenburg
Thursday, October 9, 2025, 18:00–20:00, Gothenburg
The presentation will be broadcast live.
Link to the webcast: https://www.redeye.se/events/1109642/investor-forum-goteborg-15
The exact time of the presentation will be published on the company’s website approximately three weeks prior to the event.

About RMC-035

The company’s lead candidate RMC-035 represents a completely new class of drugs (first-in-class) and consists of a recombinant and modified variant of the endogenous protein alpha-1-microglobulin. The investigational drug has the ability to protect cells and their mitochondria from damage caused by oxygen deprivation and elevated levels of the oxygen-binding and toxic protein heme. Favorable treatment effects of RMC-035 have been observed in several preclinical disease models. RMC-035 has a natural affinity for the kidneys and is primarily being developed as an intravenous kidney protective treatment for patients at high risk of developing acute kidney injury (AKI).

RMC-035 has obtained an Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for administration to patients in clinical studies. Additionally, RMC-035 has been granted Fast Track Designation by the FDA to reduce the risk of irreversible loss of kidney function, the need for dialysis treatment, or death after open-heart surgery in patients at elevated risk of AKI.

Results from the Phase 2 AKITA study, which enrolled 177 patients, demonstrated a statistically significant and clinically relevant beneficial effect of RMC-035 compared with placebo on long-term kidney outcomes in this patient population. Based on these results, a subsequent Phase 2b study, POINTER, was initiated. In addition to its evaluation in open-heart surgery, RMC-035 has also been assessed in a Phase 1b clinical study in patients undergoing kidney transplantation.

About the POINTER study

The POINTER study is a randomized, double-blind and placebo-controlled phase 2b study of RMC-035 with the main objective of establishing an optimal dosing regimen and exact target patient population for a future pivotal phase 3 study.

The study includes a total of 170 patients who have been randomized into two dose groups of RMC-035 (60 mg and 30 mg) and a control group (placebo) in a 2:2:3 ratio. Renal function prior to surgery was used as a stratification factor to ensure that patients with and without chronic kidney disease were evenly distributed across all treatment arms. The study's primary endpoint is change in eGFR from study entry to 90 days post-surgery, which corresponds to the study's follow-up period. Major Adverse Kidney Events (MAKE) at 90 days post-surgery is a secondary endpoint consisting of either death, dialysis treatment, or ≥ 25% loss of eGFR compared to pre-surgery. Data from the two dose arms with RMC-035 will be pooled and compared against placebo in the primary efficacy analyses.

Patient recruitment for the study was completed during the second quarter of 2025, and the overall study results are expected to be available in the fourth quarter.