Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — Investor Presentation (August 2025)
40 slides from Kazia Therapeutics's investor presentation, August 2025
Slide 1: A Diversified Oncology Drug Development Company
A Diversified Oncology Drug Development Company Kazia Corporate Overview August 2025 NASDAQ: KZIA | X: @KaziaTx
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward -looking statements, which can generally be identified as such by the use of words such as “may,” “will,” “estimate,” “future,” “forward,” “anticipate,” “plan,” “expect,” “explore,” “potential” or other similar words. Any statement descri
Slide 3: Company Overview
Company Overview A late-clinical-stage oncology drug development company Corporate Highlights Licensing-driven business model Paxalisib EVT801 focused on high quality, differentiated clinical-stage assets sourced from Advanced breast cancer trial launched 1Q CY2025 Phase 1 final data anticipated CY2
Slide 4: Pipeline – Two Differentiated Assets
Pipeline – Two Differentiated Assets Clinical progress in rare, resistant and relapsing cancers Paxalisib licensed from: Investigational, small molecule, potential best-in-class, brain-penetrant inhibitor of PI3K / mTOR Preclinical PHASE 1 PHASE 2 PHASE 3 MARKET Collaborators / Sponsors Anticipated
Slide 5: Paxalisib Mechanism of Action
Paxalisib Mechanism of Action A brain-penetrant PI3K pathway inhibitor with modest mTOR activity, by design 1 2 Five PI3K inhibitors have already 3 Paxalisib – Unlocking the full potential The PI3K pathway is activated in been approved by FDA of PI3K pathway inhibition many forms of cancer • Chronic
Slide 6: Paxalisib – Development History
Paxalisib – Development History Expanding the clinical footprint of paxalisib into solid tumors beyond CNS 2012-2015 July 2023 August 2019 January2025 Genentech Phase 1 clinical Paxalisib received Fast GDC-0084 becomes study in 47 patients with February 2018 7 January 2021 Track Designation by the K
Slide 7: Advanced Breast Cancer
Advanced Breast Cancer 6
Slide 8: Invasive breast cancer - unmet need
Invasive breast cancer - unmet need Most worldwide common cancer among women 2.3 million1 ~1 in 8 Cases / year Women in the US Breast cancer will be diagnosed most commonly with invasive diagnosed cancer breast cancer American Cancer Incidence Society says Increased over >300,000 the last decade by
Slide 9: Advanced breast cancer treatment landscape
Advanced breast cancer treatment landscape Modest results for HER2- subtypes, despite checkpoint and PARP inhibitors 10%1 70% 4% 9% Subtypes HR-/HER2- HR+/HER2- HR-/HER2+ HR+/HER2+ (TNBC) 62% 38%3 PD-L1 PD-L1 Stratification CPS <10 CPS >10 80% 20%4 BRCA wt BRCA m Aromatase inhibitor + Pertuzumab + t
Slide 10: Resistance, recurrence and metastatic spread
Resistance, recurrence and metastatic spread Cancer Stem Cells and a functioning immune system play a critical role in recurrence and metastatic spread of cancers Loss of neoantigens E.g. Low tumor mutational burden and neoantigen load are associated with poor antigen-specific T cell response Immuno
Slide 11: PI3K-mTOR inhibition may overcome metastasis and immunotherapy drug resistance
PI3K-mTOR inhibition may overcome metastasis and immunotherapy drug resistance PI3K-mTOR inhibition + PI3K-mTOR inhibition Immunotherapy ↓ Metastasis-initiating cells & EMT ↓ Highly aggressive CD44high/CD24low cancer stem cell phenotype ↓ Persister cancer cell phenotype (p65, FOXQ1, NRF2, and NNMT)
Slide 12: Paxalisib (GDC-0084)
Paxalisib (GDC-0084) Designed to be best in class PI3K pathway inhibitor with modest mTOR activity Paxalisib Relevant marketed or active clinical PI3K inhibitor programmes • Potent, selective, oral, once a day Paxalisib Alpelisib Gedatolisib WXFL- dosing, no unexpected toxicities 10030390 (Kazia) (N
Slide 13: Pre-clinical studies combining Paxalisib with checkpoint or PARP inhibitor
Pre-clinical studies combining Paxalisib with either checkpoint inhibitor or PARP inhibitor resulted in highly consistent and statistically significant signals of efficacy 4T1 mouse model: • Standard model for TNBC • Immunotherapy resistant model • Highly tumorigenic and invasive Checkpoint Inhibito
Slide 14: Kazia-sponsored clinical study overview
Kazia-sponsored clinical study overview PAX-ABC STUDY: KZA-0084-ABC001 Phase 1b, multi-center, open-label, randomized study to evaluate the safety, tolerability, and clinical activity of combining paxalisib with olaparib or pembrolizumab/chemotherapy in approximately 24 patients with advanced breast
Slide 15: Kazia-sponsored clinical study overview
Kazia-sponsored clinical study overview KZA-0084-ABC001 Arm A: Arm B: Paxalisib plus Olaparib Paxalisib plus Pembrolizumab/chemotherapy 28 Day Cycle 21 Day Cycle 1 Participant disease characteristics: Participant disease characteristics: • HER2-negative stage IV (metastatic) breast • Recurrent, unre
Slide 16: Early efficacy data from first TNBC patient in Phase 1b trial
Early efficacy data from first TNBC patient in Phase 1b trial Combination regimen results in >50% reduction in circulating tumor cells (CTCs) Background Results Results at at Day Day 21 21 (End-of-Cycle (end-of-cycle 1) Patient profile • >50% reduction in total circulating • 61-year-old woman with m
Slide 17: Development plan & timeline
Development plan & timeline 2025 2026 2027 2028 2029 2030 2031 Lead indication Milestones Phase 1b Readout H1 2027 Phase 2 Start H2 2027 TNBC (Stage IV) Interim ORR/PFS readout / BTD request H2 2029 Combination with pembrolizumab 1st / 2nd line Phase 3 Start H1 2030 Submit NDA if threshold PFS/OS me
Slide 18: Triple negative breast cancer market
Triple negative breast cancer market Projected TNBC market to exceed $1.5 Billion by 2030 TNBC market growth forecast2 USD $1.5b Triple negative TNBC market breast cancer 15-20% valued at USD $953.8m USD $953.8m in Of all breast TNBC 2022. Predicted cancers most aggressive to grow to USD attributed
Slide 19: Intellectual property: QIMR Berghofer Collaboration
Intellectual property QIMR Berghofer Collaboration • Kazia has obtained an exclusive, worldwide, sub-licenseable, royalty-bearing license to the relevant patents from QIMR • Patent Overview (WO2024/108256A1) – PI3K inhibitors in combination with immunotherapy (including PARP inhibitors) for treating
Slide 20: Paxalisib in triple negative breast cancer
Paxalisib in triple negative breast cancer QIMR Berghofer Medical Institute collaboration “In treatment-resistant pre-clinical models of breast cancer, paxalisib (4T1 mouse model, TNBC1) has shown encouraging results in inhibiting both the primary tumor burden and metastasis by reinvigorating the im
Slide 21: Glioblastoma
Glioblastoma 20
Slide 22: Glioblastoma Overview
Glioblastoma Overview The most aggressive malignant brain cancer Lung No clear Any age, No clear but most improvement in cause common in prognosis for Breast or strong risk factors 60s 20 years 14 million cancer cases per annum Colon 3-4 months Five-year survival Prostate Stomach Survival, 3 – 5% if
Slide 23: Paxalisib in Glioblastoma
Paxalisib in Glioblastoma Consistent median Overall Survival data in two studies of NDU glioblastoma patients Standard of Care data GBM AGILE study (left) Compelling Paxalisib data in NDU patients and STUPP historical controls (right) in NDU when compared to SOC patients Paxalisib in Paxalisib in Co
Slide 24: Paxalisib in Newly Diagnosed Unmethylated GBM Next Steps
Paxalisib in Newly Diagnosed Unmethylated GBM Next Steps FDA Type C meeting was held in December 2024 to discuss next steps with key highlights of the discussion below: • The FDA's current position is that data on Overall Survival would generally not be appropriate for accelerated approval but could
Slide 25: Childhood Brain Cancers
Childhood Brain Cancers 24
Slide 26: Paxalisib in Childhood Brain Cancer
Paxalisib in Childhood Brain Cancer High unmet need especially in patients with diffuse midline gliomas (DMGs) 1 Brain cancer is the most common 2 Brain cancer represents about one 3 Prognosis of childhood brain malignancy of childhood third of childhood cancer deaths cancer, especially DMGs, has im
Slide 27: Summary of Paxalisib in Childhood Brain Cancer
Summary of Paxalisib in Childhood Brain Cancer Kazia is actively pursuing three forms of childhood brain cancer Diffuse Midline Gliomas Atypical Teratoid / Advanced Childhood Cancer (DMG, DIPG) Rhabdoid Tumors (AT/RT) (PI3K/mTOR activated) Positive preclinical data as Preclinical Positive preclinica
Slide 28: Paxalisib in Diffuse Midline Gliomas
Paxalisib in Diffuse Midline Gliomas Follow-up Phase 2 data presented at ISPNO 2024 Annual Meeting In spite of research that has helped improve treatment for DIPG patients, the prognosis remains poor–with the median survival range being from 8-11 months1 • 68 patients with biopsy-proven DMG were enr
Slide 29: Brain Metastases
Brain Metastases 28
Slide 30: Paxalisib in Brain Metastasis
Paxalisib in Brain Metastasis MSKCC-sponsored Phase 1 trial’s interim analysis showed encouraging clinical activity of paxalisib in combination with radiation therapy (NCT04192981) 12-13 August 2022 July 2023 February 2024 Data from first stage presented at Fast Track Designation granted by Announce
Slide 31: Paxalisib in Brain Metastasis: 2024 ASTRO & SNO interim analysis
Paxalisib in Brain Metastasis MSKCC-sponsored Phase 1 trial’s interim analysis presented at 2024 ASTRO* & Society of Neuro-oncology meetings showed encouraging clinical activity of paxalisib in combination with radiation therapy (NCT04192981) Robust response signal seen for concurrent Overall Summar
Slide 32: EVT801
EVT801 31
Slide 33: EVT801 is a highly selective VEGFR3 inhibitor
EVT801 is a highly selective VEGFR3 inhibitor, primarily inhibiting lymphangiogenesis (formation of new lymphatic vessels) Highly selective for VEGFR3 Expected to minimise off-target toxicities Oral Presentation Administered by mouth once or twice daily Strong IP Protection Inhibits lymphangiogenesi
Slide 34: EVT801 Mechanism of Action
EVT801 Mechanism of Action By targeting VEGFR3pos tumor blood vessels, EVT801 may induce tumor blood vessel normalization, reduce hypoxia, and improve CD8 T-cells infiltration Schematic overview based on pre-clinical data EVT801 activity on tumor microenvironment Tumor metastasis Normalization of tu
Slide 35: EVT801: Phase 1 dose-finding trial
EVT801: Phase 1 dose-finding trial; KZA 0801-101 (NCT05114668) Staged development in patients with advanced cancer l a i t n e d i f n Phase 1 study in advanced cancer patients completed STAGE 1 • Primary objective of stage one of the study was successfully Monotherapy dose escalation met: n<48 o MT
Slide 36: EVT801 Key Points
EVT801 Key Points 1 Well-understood mechanism (anti-angiogenesis) with unique differentiating feature (high VEGFR3 selectivity) 2 Strong preclinical data package, with observed activity in multiple tumors and favourable toxicology 3 Potential for combination use with immuno-oncology therapies 4 Phas
Slide 37: 2025 Corporate Update
2025 Corporate Update 36
Slide 38: Paxalisib Licensing and Collaborations
Paxalisib Licensing and Collaborations Opportunistic partnering and strategic collaborations continue to add value Licensing Key Collaborations Summary To develop, manufacture and commercialize To develop and Paxalisib as a potential Cutting edge preclinical program to evaluate Territories and comme
Slide 39: Kazia Therapeutics: 2025 Corporate Focus
Kazia Therapeutics: 2025 Corporate Focus Objectives for value creation Progress paxalisib in • Launch Kazia-sponsored phase 1b clinical study in advanced breast cancer patients advanced breast • Provide additional preclinical data and updates from the QIMR collaboration throughout the cancer year •
Slide 40: www.kaziatherapeutics.com
www.kaziatherapeutics.com info@kaziatherapeutics.com
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