Mr. David Regan reports

SONA NANOTECH CLINICAL CANCER STUDY TISSUE ANALYSIS CONFIRMS TUMOR PRIMING AND SUGGESTS POTENTIAL IMMUNOTHERAPY SYNERGIES

Sona Nanotech Inc. is providing a follow-up histology tissue analysis data from its first-in-human early feasibility study of its Targeted Hyperthermia Therapy (THT) in late-stage melanoma patients who had failed on standard immunotherapy protocols. An extensive multiplex histological tissue analysis conducted at Dalhousie University of representative tissues from study patients showed extensive natural killer cell infiltration in tumour tissues biopsied after treatment with THT indicative of innate immune activation. Also, analysis of samples from study patients who only partially responded to the THT treatment showed a significant increase in T-regulatory cells and strong PD-L1 expression suggesting that these tumours may benefit from adding PD-1 immunotherapy in combination with Sona's THT treatment.

Dr. Carman Giacomantonio, Sona's chief medical officer (CMO), commented: "We are very proud and excited to report that the detailed histological tissue analysis from representative patient samples validates our preclinical findings. Our analysis confirms that patients responding to Sona's THT treatment experienced a strong immunogenic response characterized by extensive innate immune activation with abundant macrophage infiltration and a robust natural killer cell infiltration. Notably, in partially responding patients, we observed a significant increase in T-regulatory cells and strong expression of PD-L1. The significance of this in response is these patients would be predicted to respond to PD-1 and CTLA-4 immunotherapy, particularly if administered in timely combination with our THT."

These results, together with our preclinical modelling studies, give us great confidence that immunotherapy response rates, which are typically below 20 per cent for colorectal cancer, can be increased by first priming tumours with Sona's THT therapy before administering immunotherapy, giving hope to the four out of five colorectal cancer sufferers for whom no treatment tends to work."

This histology tissue analysis, together with the study's protocol and other findings are now being prepared for submission to a scientific journal for peer review and publication.

In the study, 10 advanced-stage melanoma patients, all of whom were failing to respond to standard immunotherapy treatment, were recruited into this early feasibility study. Under the study protocol, patients had up to four tumours treated with Sona's THT on days one and eight of the study. By day 15, eight out of 10 patients experienced a clinical response to the THT treatment with a majority (six out of eight) showing no detectable residual melanoma in representative, biopsied tumours, with two patients showing no response.

About Sona Nanotech Inc.

Sona Nanotech is developing Targeted Hyperthermia, a photothermal cancer therapy, which uses therapeutic heat to treat solid cancer tumours. The heat is delivered to tumours by infrared light that is absorbed by Sona's gold nanorods in the tumour and re-emitted as heat. Therapeutic heat (42 C to 48 C) stimulates the immune system, shrinks tumours, inactivates cancer stem cells and increases tumour perfusion, thus enabling drugs to reach all tumour compartments more effectively. Targeted Hyperthermia promises to be safe, effective, minimally invasive, competitive in cost and a valuable adjunct to drug therapy and other cancer treatments.

We seek Safe Harbor.