Theralase Release's 3Q2023 Interim Financial Statements - Seite 3

Study II Preliminary Clinical Data:

To date, Study II has provided the primary study treatment for 63 patients.

Performance to Primary, Secondary and Tertiary Objectives

Foto: Accesswire

Study II Clinical Data Based on Assessment Visit

Foto: Accesswire

The interim clinical data demonstrates that at the 90 Day Assessment 58% of Evaluable Patients achieved a CR and 65% achieved a Total Response (CR + IR) post primary Study II Treatment and at 450 days 35% achieved a CR and 40% achieved a TR.

Foto: Accesswire

Study II Clinical Data Based on Assessment Visit for Patients Treated with the Optimized Study II Treatment (Post August 1, 2020)

Foto: Accesswire

The interim clinical data demonstrates that at the 90 Day Assessment 64% of Evaluable Patients achieved a CR and 71% achieved a Total Response (CR + IR) post primary Study II Treatment with the Optimized Study II Treatment and at 450 days 36% achieved a CR and 42% achieved a TR.

Foto: Accesswire

Note:

• For patients to be included in the statistical clinical analysis they must be enrolled in Study II, provided the primary Study II Treatment and evaluated by a PI at the 90 day assessment visit (cystoscopy and urine cytology)
• One patient passed away prior to their 90 day assessment and is therefore not included in the statistical analysis; therefore, there are 63 patients that have been statistically analyzed.
• Evaluable Patients are defined as patients who have been evaluated by a PI and thus excludes a patient's clinical data at specific assessment days, if that clinical data is pending.
• Five patients have been enrolled and provided the primary Study II Treatment, but have not been evaluated at their 90 day assessment; therefore, 57 patients are considered Evaluable Patients at 90 days, with 43 patients considered Evaluable Patients at 450 days.
• The data analysis presented above, should be read with caution, as the clinical data is interim in its presentation, as Study II is ongoing and new clinical data collected may or may not continue to support the current trends, with significant data still pending.
• For patients who have been removed from the study by the PI or have elected to discontinue from the clinical study
• their Last Observation Carried Forward ("LOCF") has been used in this statistical analysis.

Patient Response Chart