KINTARA
Therapeutics
Developing Advanced Oncology Therapies for Rare Unmet Medical Needs
Corporate Presentation
August 2023
Copyright © 2022 Kintara Therapeutics, Ir
EG
Robert Hoffman CEO
Late-stage Oncology Company with Two De-Risked Product Candidates
VAL-083: A first-in-class small molecule with unique MOA (MW = 146)
• Pivotal, pre-eminent GBM AGILE International registrational study for three GBM patient subtypes initiated January 2021. A total of 45 sites across US, Canada and Europe.
• ~$1B' market opportunity in lead program: Glioblastoma Multiforme (GBM)
- Multiple shots on goal via parallel enrollment of three GBM patient subtypes
- Over 1,200 patient safety database via ~40 prior studies
REM-001: 2nd generation photodynamic therapy platform
• National Institutes of Health grant awarded June 2023
• 15-patient confirmatory study to start this quarter (3Q 2023)
• ~$500M-market in lead program: Cutaneous Metastatic Breast Cancer
- Extensive Phase 2/Phase 3 efficacy data (80% complete responses across four trials)
- Over 1,100 patient safety database
Multiple follow-on indications with existing orphan designations and/or approved INDs
*Charles River Associates April 2018
EG
Robert Hoffman CEO
Photodynamic Therapy Mechanisms of Action
Light
Energy Source
Necrosis
+
+
10,
Photosensitizen
Catalyst to Activate, Absorb &
Transfer Energy to Oxygen in Cells
Oxygen in Cell
Converted to ROS by Energy Transfer
Reactive 02 (ROS)
Created by
Energy Transfer
PDT induces elimination of diseased cells by
immune response, apoptosis, antiangiogenesis and necrosis
Apoptosis
Antiangiogenic / Anti-vascular
Vascularized,
POT Impairs Vessel
Anglogenic Tumor Function to Cut Off
Blood Supply
Tumor Shrinks
T - Cell Response
Local POT
Tumor
Diseased Cell Death
ROS Provides
Mechanism of Action
Antigen
Metastic
marin
Enzymatic Digestion and
Phagocytosis of Apoptotic
EG
Robert Hoffman CEO
Complete Response Rate of Evaluable Lesions
100
80
60
40
20
71%
CA008
REM-001: High Response Rates in CMBC
97%
86%
80%
54%
• REM-001
= Control
????
Combined
Prior Clinical Trials
Second Generation Photodynamic Therapy
• Light activated cancer therapy
Extensive data from prior Phase 2/Phase 3 clinical trials
• 149 patients treated in 4 trials
- 80% complete response rate in 674
evaluable lesions
Localized Outpatient Treatment
• IV drug infusion accumulates in tumors
• Activated by simple red light
Safety database ~1,100 patients
Previous trial experience used to optimize current trial design
EG
Robert Hoffman CEO
REM-001: CMBC Development Plan
Development plan optimized for success while minimizing cost
• Phase 3 ready
• Initial open-label, 15-patient study to confirm lower dose and optimize trial design
• Leverages prior data indicating lower dose can improve outcome
- Faster healing
- Less photosensitivity
• De-risks full Phase 3 study
IND reactivated August 2022
Fast Track designation received from the FDA in November 2022
National Institutes of Health Grant awarded June 2023
BG
Bullish
