Mr. Roger DuMoulin-White reports

THERALASE(R) PROVIDES UPDATE ON BLADDER CANCER CLINICAL STUDY

Theralase Technologies Inc. has provided an update to its phase 2 bacillus calmette guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) (with or without resected Ta/T1 papillary disease) clinical study (study 2).

To date, Theralase has enrolled and provided the primary study 2 treatment for 62 patients.

The study 2 end points have been defined as:

• Primary: Efficacy -- defined as complete response (CR) rate at any point in time. CR is defined as at least one of the following:
  • Negative cystoscopy and negative (including atypical) urine cytology;
  • Positive cystoscopy with biopsy -- proven benign or low-grade NMIBC and negative cytology;
  • Negative cystoscopy with malignant urine cytology, if urothelial cancer is suspected in the upper tract or prostatic urethra and random bladder biopsies are negative.
• Secondary: Duration of CR -- defined as 12 months after initial CR assessment.
• Tertiary: Safety -- defined as the incidence and severity of adverse events (AEs), Grade 4 or higher, directly related to the study drug or study device, that do not resolve within 450 days post primary study 2 treatment, whereby: Grade 1 equals mild, Grade 2 equals moderate, Grade 3 equals severe, Grade 4 equals life-threatening or disabling and Grade 5 equals death.

In addition, survival surveillance for all patients who achieve a CR or indeterminate response (IR) (negative cystoscopy and positive urine cytology, without confirmatory negative bladder cancer biopsies) at 450 days and remain in study 2 will be monitored past 450 days.

In performance to the primary, secondary and tertiary end points, refer to the clinical data in the associated table.

The CR, IR and total responders are detailed in the associated table by assessment visit.

On Aug. 1, 2020, the company optimized the study 2 treatment. For patients that received the optimized study 2 treatment the CR, IR and total responders are detailed in the associated table by assessment visit.

Theralase is currently working with its clinical study sites in Canada and the United States to compile information requested by the Food and Drug Administration (FDA for resubmission of a prebreakthrough designation (BTD).

If the pre-BTD submission is successful, this could lead to BTD approval.

Arkady Mandel, MD, PhD, DSc, chief scientific officer of Theralase, stated: "Theralase is delighted in its latest clinical data analysis. The Theralase Ruvidar-based anti-cancer therapy (ACT) has shown remarkable single-agent activity by proving to be safe and effective on a very difficult to treat BCG-unresponsive patient population that has been diagnosed with high-grade NMIBC CIS, with or without resected Ta/T1 papillary tumours. These patients have failed the standard of care, such as BCG therapy, and a large majority of them have failed treatment with various modern immunotherapy drugs. Theralase has been able to demonstrate strong efficacy in the form of a CR or IR, with a well-tolerated safety profile, after predominately one treatment. This ACT technology, pending successful regulatory approval and commercialization, will be very attractive to patients, uro-oncologists and the insurance companies that insure these patients."

Roger DuMoulin-White, BSc, PEng, ProDir, president and chief executive officer of Theralase, stated: "To date, the Theralase study 2 clinical data has demonstrated best-in-class performance for a single agent, providing high efficacy, durable response and a high safety profile, with no serious adverse events directly related to Ruvidar or the TLC-3200 medical laser system. Theralase hopes to complete patient enrolment with accompanying administration of the primary study 2 treatment by year-end 2024. If successful, this will allow the company the ability to complete assessment of the primary, secondary and tertiary end points of these patients by 2026. Based on the clinical data to date, Theralase is investigating potential partnerships for commercialization, financing and distribution of this ACT technology on an international basis. Theralase looks forward to commercializing this world-class technology for the benefit of all shareholders."

About Theralase Technologies Inc.

Theralase, a clinical-stage pharmaceutical company dedicated to the research and development of photo dynamic compounds, in addition to the light and radiation systems that activate them, is focused on the safe and effective destruction of various cancers, bacteria and viruses, when light or radiation activated.

We seek Safe Harbor.