Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — Shareholder Meeting (November 2019)
24 slides from Kazia Therapeutics's shareholder meeting presentation, Nov 13, 2019
Slide 1: Kazia Annual General Meeting Materials (ASX Release)
ASX RELEASE 13 November 2019 KAZIA ANNUAL GENERAL MEETING MATERIALS Sydney, 13 November 2019 – Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to provide the Chairman’s Address and CEO presentation which will be discussed at our A
Slide 2: Chairman's Address
KAZIA ANNUAL GENERAL MEETING 13 NOVEMBER 2019 CHAIRMAN’S ADDRESS Ladies and Gentlemen, It is my pleasure once again to welcome you to the Annual General Meeting for Kazia Therapeutics Limited. This is my third AGM as Chairman of Kazia, and I can say with confidence that 2019 has been one of the most
Slide 3: Chairman's Address (continued)
Also in September, we presented interim data from our ongoing Cantrixil study in ovarian cancer at the prestigious ESMO conference. The data suggested a potential increase in progression-free survival for patients treated with Cantrixil. Given that these are very late stage patients who are very res
Slide 4: Presentation to Annual General Meeting of Shareholders
Presentation to Annual General Meeting of Shareholders Dr James Garner Chief Executive Officer Sydney, NSW 13 November 2019 ASX: KZA | NASDAQ : KZIA
Slide 5: Agenda
Agenda 2019 in Review Looking Forward 1
Slide 6: Six ongoing clinical trials across two assets
Six ongoing clinical trials across two assets, lead program covers full range of brain cancers GDC-0084 Cantrixil Primary Brain Cancer Secondary Brain Cancer Ovarian (brain cancer that begins in the brain) (brain cancer that spreads from elsewhere in the body) Cancer Glioblastoma DIPG Brain Breast B
Slide 7: Phase 2 study in newly-diagnosed GBM is ongoing
Kazia’s phase 2 study in newly-diagnosed GBM is ongoing, with new data coming in November 2019 Step 1: Dose Optimisation Step 2: Expansion Cohort 6 – 24 patients 20 patients • Newly-diagnosed 12 months 6 months patients with the unmethylated MGMT promotor (i.e. resistant Primary objective is to dete
Slide 8: The Alliance study in brain metastases
The Alliance study in brain metastases is a cutting- edge, multi-drug clinical trial 150 patients Funded by abemaciclib US National Cancer Institute Secondary brain cancer Tumour is from any genetically GDC-0084 primary profiled Executed by Alliance for Clinical tumour Trials in Oncology entrectinib
Slide 9: The St Jude study in DIPG
The St Jude study in DIPG has the potential for breakthrough designation and early approval Step 1: Dose Escalation Step 2: Expansion Cohort 6 – 24 patients 12 patients • All patients with DIPG or high-grade gliomas (2 – 22 years of age), following radiotherapy Primary objective is to determine the
Slide 10: Important new preclinical data reported during the year
Important new preclinical data has also been reported during the year DIPG Breast Cancer Brain Metastases References: Duchatel et al. Neuro-Oncology (2019). 21(Suppl. 2):ii68; Ippen et al. Clin Cancer Res. (2019). 25(11):3374-83 6
Slide 11: The PI3K class validated by approval of Piqray
The PI3K class has been further validated by the approval of Novartis’ Piqray (alpelisib) Zydelig (idelalisib) Aliqopa (copanlisib) Copiktra (duvelisib) Piqray (alpelisib) GDC-0084 FDA Approved FDA Approved FDA Approved FDA Approved In phase II human trials July 2014 ✓ September 2017 ✓ October 2018
Slide 12: Our efforts continue to be recognised in the public sphere
Our efforts continue to be recognised in the public sphere 8
Slide 13: A range of content helps investors grasp our story
A range of content, from academic papers to media interviews, helps investors grasp our story 9
Slide 14: Trans-Tasman Innovation and Growth Award
The Trans-Tasman Innovation and Growth Award was a powerful recognition of Kazia’s achievements 10
Slide 15: Milestones achieved with tight operational management and financial economy
These milestones have been achieved with tight operational management and financial economy AU$ million bar totals = net expenditure 12 5.9 10 4.4 6.9 8 5.1 4.5 6 4.1 Expense → 4 2 0 ← Income -2 -4 -6 1H FY2017 2H FY2017 1H FY2018 2H FY2018 1H FY2019 2H FY2019 Income R&D Expense G&A Expense G&A % 44
Slide 16: Agenda
Agenda 2019 in Review Looking Forward 12
Slide 17: GDC-0084 will be known as 'paxalisib'
From 2020 onwards, GDC-0084 will be known as ‘paxalisib’ Internal GDC-0084 compound code Selected by company once drug begins journey to clinical trials The award of an INN is an important milestone in the International Non- development of a drug and proprietary Name (INN) paxalisib provides an indu
Slide 18: Next step for paxalisib is a pivotal study
Next step for paxalisib is a pivotal study for registration 4-7 years 8-10 years Preclinical Phase 1 Phase 2 Phase 3 Market Paxalisib is here • Upcoming SNO data read-out will be a key check-point before committing to phase 3 • Kazia expects to share more detail on phase 3 plans early in CY2020, pen
Slide 19: New data to be presented at the SNO conference
In the meantime, important new data will be presented at the upcoming SNO conference 1 2 Phase II Trial in Glioblastoma Phase I Trial in Advanced Glioma poster presentation oral presentation Lead Author: Lead Author: 2019 Annual Meeting Professor Patrick Wen Professor Ben Ellingson Dana-Farber Cance
Slide 20: Early-stage studies provide less mature efficacy endpoints
Early-stage studies such as the ongoing phase 2 typically provide less mature efficacy endpoints Definitive Efficacy Overall Survival (OS) The ‘gold standard’ for Phase 3 studies typically aim to show product registration an OS or at least a PFS benefit for a new drug, and this level of evidence is
Slide 21: Paxalisib data compared against key benchmarks
Paxalisib data will ultimately be compared against several key benchmarks Genentech Phase I Study Existing Standard of Care GDC-0084 GDC-0084 Temozolomide Temozolomide 26% 40% From 4.4 to 5.3 From 11.8 to 12.7 months months Of patients with a Of patients with stable Improvement in Improvement in ove
Slide 22: The partnering market for new oncology drugs is active
The partnering market for new oncology drugs is active and driven by emerging data Select CY2019 Licensing Transactions Licensee Licensor Stage Asset(s) Deal Value (US$) Discovery Lipid kinase inhibitors $470M Preclinical Anti-CD38 antibody $275M Preclinical RAS-RAF-MAPK inhibitors $207M Clinical ME
Slide 23: The next six months: a crucial inflection point
The next six months will be an exciting period for Kazia, and a crucial inflection point for our programs November 2019 Initial interim data from ongoing phase 2 study of paxalisib in glioblastoma December 2019 Extraordinary General Meeting (EGM) of shareholders February 2020 Half-Year Report 1Q CY2
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