Ms. Kristina Hachey reports

THERALASE(R) COMMENCES GLP TOXICOLOGY ANALYSIS OF RUTHERRIN(R)

Theralase Technologies Inc. has started good laboratory practice (GLP) toxicology analysis of intravenously administered Rutherrin.

Rutherrin is formed by combining Theralase's lead small molecule Ruvidar with transferrin (blood plasma protein made by the liver that transports iron throughout the body). Rutherrin has demonstrated preclinically the ability to target cancer cells and after energy-activation destroy the target cancer cell.

The GLP toxicology analysis of Rutherrin represents an important step forward for regulatory submissions in the clinical development of Rutherrin. The program has been designed to generate GLP data of intravenous administration of Rutherrin to determine the optimum dose for first-in-human clinical studies for Glio Blastoma multiforme (GBM) (a deadly form of brain cancer), non-small cell lung cancer (NSCLC) (the second-most common cancer and the leading cause of cancer death globally) and muscle-invasive bladder cancer (MIBC) (25 per cent of all bladder cancer diagnoses). Additional cancers, such as, pancreatic cancer (the third-leading cause of cancer death in North America) and colorectal cancer (the second-leading cause of cancer death worldwide) will be investigated, as the clinical program progresses and the clinical data are analyzed.

Upon receipt of GLP toxicology reports and regulatory approval, the company plans to commence an adaptive clinical development program of intravenous Rutherrin for various life-threatening cancers.

The adaptive clinical development program is designed to evaluate the quantity of Rutherrin localized within various cancerous tumours following a single intravenous administration. If proven successful, multiple intravenous administrations of energy-activated Rutherrin will be evaluated for safety, tolerability and efficacy for various oncological conditions, in combination with (or without) other standards of care.

The GLP toxicology analysis is expected to be completed in 2026, with the results expected to be available in early 2027.

Theralase has previously reported preclinical research supporting the safety and efficacy of energy-activated Rutherrin in multiple life-threatening cancers.

When successfully completed, the GLP toxicology program could lead to a broader clinical development program and create opportunities for future pharmaceutical partnerships, licensing arrangements and combination-treatment studies.

Arkady Mandel, MD, PhD, DSc, chief scientific officer of Theralase, stated: "Our scientific team has generated an extensive body of preclinical research demonstrating Rutherrin's potential across numerous life-threatening cancers. I am delighted that after years of research Theralase is now in the position to commence GLP toxicology analysis for the intravenous administration of Rutherrin. Pending successful completion of this analysis, the company is laser focused on the clinical development of this technology for: GBM, NSCLC, MIBC, and many other deadly and/or hard-to-treat cancers."

About Rutherrin

Rutherrin is Theralase's patented formulation of Ruvidar, which when combined with recombinant human transferrin, can be used for intravenous administration. The transferrin component has been designed to transport the payload Ruvidar and facilitate the preferential uptake and retention of it within cancer cells prior to energy-activation.

About Theralase Technologies Inc.

Theralase is a clinical-stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria, and viruses.

We seek Safe Harbor.