Theralase(R) Release's 4Q2023 Interim Financial Statements - Seite 3

To date, Study II has provided the primary study treatment for 63 patients, with new patients being enrolled in 2Q2024.

An advisory board meeting is scheduled to take place on April 12, 2024 during the Canadian Urologic Association ("CUA") Bladder Cancer Forum 2024 located in Toronto, Ontario to provide an update to all Canadian Principal Investigators ("PIs") of the Study II interim clinical data and to discuss opportunities for patient enrollment.

An advisory board meeting is scheduled to take place on May 4^th , 2024 during the 2024 American Urology Association ("AUA") meeting in San Antonio, Texas to provide an update to all Canadian and US-based PIs of the Study II interim clinical data and to discuss opportunities for patient enrollment.

Break Through Designation Update

The Company submitted a pre-Break Through Designation ("BTD") submission to the FDA in July 2023 and based on the FDA's feedback, the Company is currently working with the Clinical Study Sites ("CSSs"), a biostatistics organization and a regulatory organization to update the pre-BTD with clinical data clarifications identified by the FDA. The Company plans to resubmit the pre-BTD submission to the FDA in 2Q2024 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company will compile a BTD submission for review by the FDA in support of the grant of a BTD approval.

Study II Preliminary Clinical Data :

Performance to Primary, Secondary and Tertiary Objectives

Foto: Accesswire

The Study II interim clinical data is demonstrating the following data:

For the primary objective, 64% of patients provided the Study Procedure (Study Drug activated by the Study Device) demonstrated a Complete Response ("CR") (negative cystoscopy and negative urine cytology). Including patients, who demonstrated an Indeterminate Response (" IR") (negative cystoscopy and positive or suspicious urine cytology), the Total Response ("TR") increases to 75%. This represents that 3 out of 4 Bacillus Calmette Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") patients treated with Theralase's unique Study Procedure are demonstrating complete destruction of their CIS bladder cancer within their bladders.