Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — Shareholder Meeting (November 2018)
25 slides from Kazia Therapeutics's shareholder meeting presentation, Nov 8, 2018
Slide 1: Kazia Annual General Meeting Materials (ASX Release)
ASX RELEASE 8 November 2018 KAZIA ANNUAL GENERAL MEETING MATERIALS Sydney, 8 November 2018 – 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 Ann
Slide 2: Chairman's Address
KAZIA ANNUAL GENERAL MEETING 8 NOVEMBER 2018 CHAIRMAN’S ADDRESS Ladies and Gentlemen, It is my great pleasure to welcome you to the 2018 Annual General Meeting for Kazia Therapeutics Limited. When I spoke at last year’s AGM, I referred on several occasions to the enormous potential that all of us on
Slide 3: Chairman's Address (continued)
between now and the end of calendar 2019. However, no less important is the validation that this investment represents. The fact that high calibre healthcare professional investors see the company as an attractive investment opportunity is definitive evidence that we are on the right track. The Boar
Slide 4: Presentation to Annual General Meeting of Shareholders
Presentation to Annual General Meeting of Shareholders Dr James Garner Chief Executive Officer 8 November 2018 ASX: KZA | NASDAQ: KZIA | Twitter: @KaziaTx
Slide 5: Forward-Looking Statements
Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of the “safe- harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual
Slide 6: Kazia has delivered all milestones for 2018, with high-value data read-outs expected in 2019
Kazia has delivered all milestones for 2018, with high-value data read-outs expected in 2019 ✓ ✓ ✓ GDC-0084 Commence Commence Data read-out Data read-out Receipt of Start of phase potential other from phase 2a from phase 2a Orphan Drug 2a study in collaborations potential study (safety study Designa
Slide 7: GDC-0084 Phase II Glioblastoma Multiforme
GDC-0084 Phase II Glioblastoma Multiforme 3
Slide 8: Orphan designation in February 2018 was an important validation for the GDC-0084 program
Orphan designation in February 2018 was an important validation for the GDC-0084 program FDA Orphan Designation Orphan Designation provides Orphan Designation is recognises diseases affecting benefits to companies usually recognised by <200,000 Americans pa throughout a drug’s lifecycle investors as
Slide 9: The phase 2a study of GDC-0084 in glioblastoma is well underway
The phase 2a study of GDC-0084 in glioblastoma is well underway, with the first cohort fully recruited ‘Phase 2a’ Component Step 1 Step 2 Step 3 Dose Optimisation Expansion Cohort Planned Registration Trial 6 – 24 patients 20 patients 12 months 6 months March 1H 2H (potentially) 2018 2019 2019 2023
Slide 10: Current standard of care is essentially ineffective in approximately 65% of GBM cases
Current standard of care is essentially ineffective in approximately 65% of GBM cases Standard Debulking surgery Radiotherapy + Temozolomide of Care where possible temozolomide maintenance therapy (‘Stupp Regimen’) 6 weeks 4w 6 x 28-day cycles ~35% of patients respond to temozolomide GDC-0084 is bei
Slide 11: In phase 1, 7/27 patients showed a metabolic partial response on FDG-PET
In phase 1, 7 / 27 patients (26%) showed a ‘metabolic partial response’ on FDG-PET Pre-Dosing On GDC-0084 Pre-Dosing On GDC-0084 Analysis courtesy of Professor Ben Ellingson, UCLA Brain Tumor Imaging Laboratory 7
Slide 12: The PI3K class has been further validated with a third approved therapy, but GDC-0084 is unique
The PI3K class has been further validated with a third approved therapy, but GDC-0084 is unique Zydelig (idelalisib) Aliqopa (copanlisib) Copiktra (duvelisib) GDC-0084 FDA Approved FDA Approved FDA Approved In phase II human trials July 2014 ✓ September 2017 ✓ October 2018 ✓ under US FDA oversight (
Slide 13: Recent data from Novartis at ESMO showed impressive results for PI3K inhibitor in breast cancer
Recent data from Novartis at ESMO showed impressive results for PI3K inhibitor in breast cancer • Alpelisib (BYL719) is a PI3K inhibitor being developed for breast cancer • Alpelisib only inhibits the alpha form of PI3K, and was not developed to cross the blood-brain barrier; GDC-0084 inhibits all f
Slide 14: There are now three ongoing human trials with GDC-0084
There are now three ongoing human trials with GDC-0084, each in different forms of brain cancer Preclinical Phase I Phase II Phase III Glioblastoma Multiforme (GBM) (Kazia-sponsored) Breast Cancer Brain GDC-0084 Metastases (BCBM) (collaboration with Dana- PI3K / mTOR Farber Cancer Institute) Inhibit
Slide 15: Cantrixil Phase I Ovarian Cancer
Cantrixil Phase I Ovarian Cancer 11
Slide 16: Cantrixil has now progressed into Part B, and data is expected in calendar 2019
Cantrixil has now progressed into Part B, and data is expected in calendar 2019 Part A: Dose Escalation ✓ Part B: Dose Expansion • 3 to 42 patients in up to 8 • 12 patients, all at 5 mg/kg cohorts • Seeks to provide potential • Seeks to establish maximum efficacy signals tolerated dose and understan
Slide 17: Interim results from Part A of phase I study provide encouraging signals
Interim results from Part A of phase I study provide encouraging signals for potential safety and efficacy Key findings from June 2018 RECIST Criteria for early-phase interim analysis oncology studies 1 Complete disappearance Study has progressed Suggests we will be able Complete through most dose t
Slide 18: Part A has already shown evidence of activity with one partial responder
Part A has already shown evidence of activity with one partial responder to date October 2017 (baseline) January 2018 Source: images courtesy of Professor Jim Coward, Icon Cancer Centre 14
Slide 19: Kazia is working closely with IQVIA on data analytics to identify potential trial patients
Kazia is working closely with IQVIA on leading-edge data analytics to identify potential trial patients Site 003 HIGH ovarian cancer pts (30+) HIGH drug use (100+ units) Site 001 HIGH ovarian cancer pts (30+) LOW drug use (>39 units) Site 004 HIGH ovarian cancer pts (30+) LOW drug use (>39 units) 15
Slide 20: Company Summary
Company Summary 16
Slide 21: Kazia is running efficiently, with majority of funds applied directly to R&D
Kazia is running efficiently, with majority of funds applied directly to R&D Largely constant R&D investment… …against significant reduction in G&A costs Expenditure (AU$, millions) Expenditure (AU$, millions) 8 8 12% 34% 7 7 $11.1M $9.8M $8.5M $5.6M 6 6 5 5 4 4 3 3 2 2 1 1 0 0 1H FY2017 2H FY20
Slide 22: Kazia is now well-funded to see both programs through key data read-outs in calendar 2019
Kazia is now well-funded to see both programs through key data read-outs in calendar 2019 Current funding allows:- $9.3M ~$3.5M* $3.4M • Completion of phase IIa Current assets as at Shares in Noxopharm Proceeds (pre-costs) GDC-0084 trial 30 June 2018 (ASX:NOX) from institutional placement in Oct 18
Slide 23: Other companies focused on the PI3K pathway have been highly-valued in the market
Other companies focused on the PI3K pathway have been highly-valued in the market Single asset company with one PI3K US$ 140 million inhibitor in phase I human trials Market Cap One PI3K inhibitor in phase II human trials, one other drug in phase III, and US$ 430 million two in animal testing Market
Slide 24: Kazia has become a compelling investment proposition
Kazia has become a compelling investment proposition 1• Lead program, GDC-0084, sourced from Genentech, the world’s most successful cancer drug developer 2• Class of drugs, PI3K inhibitors, is well-validated and resurgent, but GDC-0084 is uniquely differentiated by ability to cross the blood-brain b
Slide 25: www.kaziatherapeutics.com
www.kaziatherapeutics.com info@kaziatherapeutics.com
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