Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — Shareholder Meeting (November 2018)
22 slides from Kazia Therapeutics's shareholder meeting presentation, Nov 8, 2018
Slide 1: Presentation to Annual General Meeting of Shareholders
Presentation to Annual General Meeting of Shareholders Dr James Garner Chief Executive Officer 8 November 2018
Slide 2: 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 3: 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 Glioblastoma Multiforme (GBM) Cantrixil Ovarian Cancer Preliminary data from phase 1 study in ovarian cancer Completion of Part A of phase 1 study (safety and dosing)* *Full publication plans to be
Slide 4: GDC-0084 Phase II Glioblastoma Multiforme
GDC-0084 Phase II Glioblastoma Multiforme
Slide 5: 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 Source: FDA; BIO; KL Miller (2017). Orphanet Journal of Rare Diseases. 12:114 FDA Orphan Designation recognises diseases affecting <200,000 Americans pa Orphan Designation provides benefits to companies througho
Slide 6: The phase 2a study of GDC-0084 in glioblastoma is well underway, with the first cohort fully recruited
The phase 2a study of GDC-0084 in glioblastoma is well underway, with the first cohort fully recruited Note: timelines are estimated and subject to periodic revision based on recruitment performance and treatment effect Step 1 Dose Optimisation Step 2 Expansion Cohort Step 3 Planned Registration Tri
Slide 7: 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 Source: ME Hegi, A-C Diserens, T Gorlia, et al. (2005). N Engl J Med 352:997-1003 Standard of Care (‘Stupp Regimen’) Debulking surgery where possible Radiotherapy + temozolomide Temozolomide maintenance therapy 6 w
Slide 8: In phase 1, patients (26%) showed a 'metabolic partial response' on FDG-PET
In phase 1, 7 / 27 patients (26%) showed a ‘metabolic partial response’ on FDG-PET Analysis courtesy of Professor Ben Ellingson, UCLA Brain Tumor Imaging Laboratory Pre-Dosing On GDC-0084 Pre-Dosing On GDC-0084
Slide 9: 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 FDA Approved July 2014 (blood cancers) [accelerated approval] FDA Approved September 2017 (blood cancers) [accelerated approval] FDA Approved October 2018 (blood cancers) [accelerated approval] In phase I
Slide 10: 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 Source: Novartis company presentation 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-brai
Slide 11: There are now three ongoing human trials with GDC-0084, each in different forms of brain cancer
There are now three ongoing human trials with GDC-0084, each in different forms of brain cancer Preclinical Phase I Phase II Phase III GDC-0084 PI3K / mTOR Inhibitor Licensed from Genentech in October 2016 Diffuse Intrinsic Pontine Glioma (DIPG) (collaboration with St Jude Children’s Research Hospit
Slide 12: Cantrixil Phase I Ovarian Cancer
Cantrixil Phase I Ovarian Cancer
Slide 13: 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 3 to 42 patients in up to 8 cohorts Seeks to establish maximum tolerated dose and understand safety profile Part B: Dose Expansion 12 patients, all at 5 mg/kg Seeks to provide potential efficacy s
Slide 14: Interim results from Part A of phase I study provide encouraging signals for potential safety and efficacy
Interim results from Part A of phase I study provide encouraging signals for potential safety and efficacy Complete Response CR Complete disappearance of target lesion on MRI / CT Partial Response PR At least 30% decrease in size of target lesion on MRI / CT Stable Disease SD Between 20% increase an
Slide 15: Part A has already shown evidence of activity with one partial responder to date
Part A has already shown evidence of activity with one partial responder to date Source: images courtesy of Professor Jim Coward, Icon Cancer Centre October 2017 (baseline) January 2018
Slide 16: Kazia is working closely with IQVIA on leading-edge data analytics to identify potential trial patients
Kazia is working closely with IQVIA on leading-edge data analytics to identify potential trial patients Site 004 HIGH ovarian cancer pts (30+) LOW drug use (>39 units) Site 003 HIGH ovarian cancer pts (30+) HIGH drug use (100+ units) Site 001 HIGH ovarian cancer pts (30+) LOW drug use (>39 units)
Slide 17: Company Summary
Company Summary
Slide 18: 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 Note: R&D – research and development; G&A – general and administrative Largely constant R&D investment… …against significant reduction in G&A costs Expenditure (AU$, millions) $11.1M $9.8M ò 12% Expenditure (AU$, millions)
Slide 19: 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 *NOX shares valued as at October 2018 $9.3M Current assets as at 30 June 2018 ~$3.5M* Shares in Noxopharm (ASX:NOX) $3.4M Proceeds (pre-costs) from institutional placement in Oct 18 Current funding allows:- Com
Slide 20: Other companies focused on the PI3K pathway have been highly-valued in the market
Other companies focused on the PI3K pathway have been highly-valued in the market Single asset company with one PI3K inhibitor in phase I human trials US$ 140 million Market Cap One PI3K inhibitor in phase II human trials, one other drug in phase III, and two in animal testing US$ 430 million Market
Slide 21: Kazia has become a compelling investment proposition
Kazia has become a compelling investment proposition Lead program, GDC-0084, sourced from Genentech, the world’s most successful cancer drug developer Class of drugs, PI3K inhibitors, is well-validated and resurgent, but GDC-0084 is uniquely differentiated by ability to cross the blood-brain barrier
Slide 22: Kazia Therapeutics
KAZIA THERAPEUTICS www.kaziatherapeutics.com info@kaziatherapeutics.com
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