Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — Investor Presentation (November 2024)
37 slides from Kazia Therapeutics's investor presentation, Nov 4, 2024
Slide 1: Kazia Corporate Overview November 2024
Exhibit 99.2 A Diversified Oncology Drug Development Company Kazia Corporate Overview November 2024 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 Genentech (Paxalisib) and Sanofi / Brain-penetrant pan-PI3K / mTOR inhibitor Selec
Slide 4: Pipeline – Two Differentiated Assets
Pipeline – Two Differentiated Assets CY2024 positive clinical data updates driving strong interest in oncology community licensed from: Paxalisib Investigational, small molecule, potent, brain-penetrant inhibitor of PI3K / mTOR Preclinical PHASE 1 PHASE 2 PHASE 3 MARKET Anticipated Collaborators / S
Slide 5: Mechanism of Action
Paxalisib Mechanism of Action Only brain-penetrant drug in development within the PI3K inhibitor class Paxalisib is the only brain-penetrant 1 2 3 The PI3K pathway is activated in Five PI3K inhibitors have already PI3K inhibitor in development been approved by FDA many forms of cancer • Chronic lymp
Slide 6: Paxalisib Development History
Paxalisib – Development History Growing Body of Clinical Evidence Demonstrating Activity in GBM 2012-2015 February 2018 August 2019 7 January 2021 1 August 2022 GDC-0084 becomes GBM AGILE Kazia provides progress Genentech Phase I clinical GDC-0084 awarded ‘paxalisib’ with the granting pivotal study
Slide 7: Glioblastoma Background & Market potential
Glioblastoma Background & Market potential 6
Slide 8: Glioblastoma Overview
Glioblastoma Overview The most aggressive malignant brain cancer Lung Any age, No clear No clear but most improvement in cause common in prognosis for Breast or strong risk 60s 20 years factors 14 million cancer cases per annum Colon Five-year 3-4 months survival Prostate Stomach 3 – 5% Survival, (b
Slide 9: Primary Market Research Outcomes
Primary Market Research Outcomes Physicians indicated a 2-month minimum and 12-month optimum increase in efficacy for newly diagnosed unmethylated GBM treatments, but adoption would be high regardless Key Takeaway • Due to the high unmet need for a more efficacious therapy for Newly Diagnosed Unmeth
Slide 10: GBM AGILE study data – Primary and secondary analysis
GBM AGILE study data – Primary and secondary analysis 9
Slide 11: Paxalisib and GBM-Agile
Paxalisib and GBM-Agile International, multi-center, adaptive, phase 2/3 study evaluating promising therapeutics in patients with glioblastoma Completed Key Points Regorafenib Negative outcome Bayer (Sep 2022) • A ‘platform study’, sponsored by GCAR run independently of Final Top Line 3 Paxalisib in
Slide 12: GBM-Agile Study schema
Paxalisib & GBM-Agile Study schema; Paxalisib arm (n=154) enrolled Newly Diagnosed Unmethylated GBM patients (NDU) and Recurrent GBM patients Paxalisib Paxalisib stage 1 stage 2 Evaluate for graduation Evaluate for futility Study completed Paxalisib 12 months after enrolment stops last patient enrol
Slide 13: Paxalisib and GBM-Agile NDU median overall survival analyses
Paxalisib and GBM-Agile Newly Diagnosed Unmethylated GBM patients (NDU) Primary endpoint: median Overall Survival analyses (ITT) Bayesian Primary Analysis: Prespecified Secondary Analysis: Paxalisib (n=54) vs Standard of Care Paxalisib (n=54) vs Standard of Care 1 2 (n=77) (n=46) 14.77 months vs 13.
Slide 14: Recap and next steps for Paxalisib in glioblastoma
Recap and next steps for Paxalisib in glioblastoma 13
Slide 15: Paxalisib in Glioblastoma Phase II: median OS
Paxalisib in Glioblastoma Phase II Clinical Study Encouraging median OS (mOS) in Newly Diagnosed Unmethylated GBM patients Overall Survival (OS) (n=30) Median OS: 15.7 months (11.1-19.1) Historical mOS for existing therapy: 12.7 months (Hegi et al. 2005) Note: Figures for existing therapy are for te
Slide 16: Paxalisib in Glioblastoma Phase II: safety profile
Paxalisib in Glioblastoma Phase II Clinical Study Encouraging safety profile Number of Patients at Any Dose (n=30) Experiencing AEs ‘Possibly’ or ‘Likely’ Related to Paxalisib (affecting ≥10% of patients) Term Gr 1 Gr 2 Gr 3 Gr 4 Total (%) Fatigue 3 13 2 18 (60%) Stomatitis 4 7 3 14 (47%) Decreased
Slide 17: Consistent median Overall Survival data in two NDU glioblastoma studies
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 18: Paxalisib glioblastoma program highlights
Paxalisib glioblastoma program highlights Significant body of clinical evidence from two clinical trials supporting paxalisib’s activity in newly diagnosed GBM ✓ GBM AGILE Phase II/III trial data showed improvement in a prespecified secondary analysis for overall survival (15.5 months) in paxalisib-
Slide 19: Childhood Brain Cancers
Childhood Brain Cancers 18
Slide 20: Paxalisib in Childhood Brain Cancer
Paxalisib in Childhood Brain Cancer High unmet need especially in patients with diffuse midline gliomas (DMGs) Brain cancer is the most common Brain cancer represents about one Prognosis of childhood brain 1 2 3 malignancy of childhood third of childhood cancer deaths cancer, especially DMGs, has im
Slide 21: Summary of Paxalisib in Childhood Brain Cancer
Summary of Paxalisib in Childhood Brain Cancer Kazia is actively pursuing three forms of childhood brain cancer Advanced Childhood Cancer Diffuse Midline Gliomas Atypical Teratoid / (PI3K/mTOR activated) (DMG, DIPG) Rhabdoid Tumors (AT/RT) Positive preclinical data as Positive preclinical data in Re
Slide 22: Paxalisib in Diffuse Midline Gliomas
Paxalisib in Diffuse Midline Gliomas Follow-up Phase II data presented at ISPNO 2024 Annual Meeting In spite of research that has helped improve treatment for DIPG patients, the prognosis 1 remains poor–with the median survival range being from 8-11 months • 68 patients with biopsy-proven DMG were e
Slide 23: Brain Metastases
Brain Metastases 22
Slide 24: Paxalisib in Brain Metastasis
Paxalisib in Brain Metastasis MSKCC-sponsored Phase I 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 25: Paxalisib in Brain Metastasis: 2024 ASTRO interim analysis
Paxalisib in Brain Metastasis MSKCC-sponsored Phase I trial’s interim analysis presented at 2024 ASTRO* meeting showed encouraging clinical activity of paxalisib in combination with radiation therapy (NCT04192981) Robust response signal seen for concurrent paxalisib Overall Summary and brain RT • Pr
Slide 26: Other Solid Tumors
Other Solid Tumors 25
Slide 27: 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 1 model, TNBC ) has shown encouraging results in inhibiting both the primary tumor burden and metastasis by reinvigorating the
Slide 28: Triple Negative Breast Cancer Treatment Landscape
Triple Negative Breast Cancer Treatment Landscape Projected TNBC market to exceed $1.5 Billion by 2030 1 American Triple negative 2.3 million Cancer Society breast cancer 2 TNBC market growth forecast Cases / year says nearly TNBC Breast cancer USD $1.5b 300,000 most commonly most aggressive diagnos
Slide 29: EVT801
EVT801 28
Slide 30: 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 Oral Presentation Expected to minimise off-target toxicities Administered by mouth once or twice daily Strong IP Protection Inhibits lymphangiogenesi
Slide 31: EVT801 Mechanism of Action
EVT801 Mechanism of Action pos By targeting VEGFR3 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 Tumor metastasis EVT801 activity on tumor microenvironment Normalization of t
Slide 32: EVT801 Phase 1 dose-finding trial
o n f i d e n t i a l EVT801: Phase 1 dose-finding trial; KZA 0801-101 (NCT05114668) Staged development in patients with advanced cancer 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
Slide 33: EVT801 Key Points
EVT801 Key Points Well-understood mechanism (anti-angiogenesis) with unique differentiating feature (high 1 VEGFR3 selectivity) 2 Strong preclinical data package, with observed activity in multiple tumours and favourable toxicology 3 Potential for combination use with immuno-oncology therapies Phase
Slide 34: 2024
2024 Corporate Update 33
Slide 35: 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 Cutting edge preclinical program to evaluate To develop and Paxalisib as a potential Paxalisib in combinat
Slide 36: 2024-2025 Corporate Focus
Kazia Therapeutics: 2024-2025 Corporate Focus Objectives for value creation • Compile data from all clinical trials Progress paxalisib • FDA granted Type C meeting with Kazia in December 2024 glioblastoma program • Propose potential pathways to registration • PNOC team to complete PK/biomarker data
Slide 37: Contact
www.kaziatherapeutics.com info@kaziatherapeutics.com
Kazia Therapeutics — Investor Presentation (November 2024) on 6ix