Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — Investor Presentation (July 2018)
35 slides from Kazia Therapeutics's investor presentation, Jul 16, 2018
Slide 1: Kazia Shareholder Presentation
ASX RELEASE 16 July 2018 KAZIA SHAREHOLDER PRESENTATION Sydney, 16 July 2018 – Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to share the slides to be presented to shareholders this evening and on Wednesday at our upcoming share
Slide 2: Lead programs: GDC-0084 and Cantrixil
Our lead program is GDC-0084, a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma multiforme, the most common and most aggressive form of primary brain cancer. Licensed from Genentech in late 2016, GDC-0084 entered a phase II clinical trial in
Slide 3: Cancer-focused biotech with two clinical-stage programs
Cancer-focused biotech with two clinical-stage programs Shareholder Information Sessions Melbourne, VIC 16 July 2018 Sydney, NSW 18 July 2018 ASX: KZA | NASDAQ: KZIA | Twitter: @KaziaTx
Slide 4: 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 5: Investment Highlights
Investment Highlights Cancer drug developer with two distinct therapies in clinical trials 1 - GDC-0084 currently in phase II trial for brain cancer - Cantrixil currently in phase I trial for ovarian cancer Well-differentiated assets, with lead program licensed from Genentech 2 - GDC-0084: targets a
Slide 6: Kazia Corporate Update
Kazia Corporate Update 3
Slide 7: Strategy of developing high-quality assets from external sources
Kazia has implemented a strategy of developing high-quality assets from external sources Identify Value Build Value Realise Value • Conduct focused clinical trials • Bring in under- • Identify optimal • Partner with big valued assets patient groups pharma for late- from other • Understand safety sta
Slide 8: Other companies have built businesses around in-licensed products
Other companies have built successful businesses around in-licensed products (NASDAQ: TSRO) (NASDAQ: PBYI) (NASDAQ: CLVS) US$ billion US$ billion US$ billion 3 $2.4 3 3 $2.5 $2.2 billion billion billion 2 2 2 $360 $440 $291 1 1 1 million million million 0 0 0 IPO (2012) Current IPO (2012) Current IP
Slide 9: GDC-0084 license has built a mid-stage clinical pipeline
Our license of GDC-0084 from Genentech has helped us build a promising mid-stage clinical pipeline Preclinical Phase I Phase II Phase III Glioblastoma Multiforme (GBM) (Kazia-sponsored) GDC-0084 PI3K / mTOR Inhibitor Potential future studies and collaborations TBD Licensed from Genentech in October
Slide 10: Kazia has divested non-core intellectual property
In addition, Kazia has divested non-core intellectual property, providing near-term and long-term value November 2017 December 2017 July 2018 Trilexium & early Early stage discovery ‘Next generation’ anti- benzyopyran research research tropomyosin project TroBio Therapeutics 10% equity interest in 5
Slide 11: Kazia has achieved much in the last three years
Kazia has achieved much in the last three years Key achievements Placements in 2H FY2015 raised • Successful licensing of GDC-0084 from Genentech net proceeds of ~$47 million • Achievement of Orphan Designation for GDC-0084 • Design and implementation of international phase II study for GDC-0084 in
Slide 12: Current funds support work into 2019
Current funds support work into 2019 Current Assets 16 “Whilst the Noxopharm settlement has strengthened our balance Millions $14.8M sheet significantly, we continue to explore grant funding, licensing 14 Prepay opportunities, and equity investment opportunities in the Company. ments Your Board reco
Slide 13: Kazia will lodge an F-3 registration with SEC
In the near term, Kazia will lodge an F-3 registration with SEC – a common tool for NASDAQ companies Company ASX Ticker Date of Amount Amount F-3 Filing Registered (US$) Raised (US$) PBT 2014 $50 million $6 million 2017 $50 million (none yet) NRT 2015 $12.5 million $12.5 million IMM 2016 $60 million
Slide 14: GDC-0084 Program Phase II Glioblastoma Multiforme
GDC-0084 Program Phase II Glioblastoma Multiforme 11
Slide 15: Orphan designation validated 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 16: Glioblastoma is the most common and aggressive primary brain cancer
Glioblastoma (GBM) is the most common and most aggressive form of primary brain cancer Lung No clear 3-4 months 12-15 cause untreated months Breast or strong risk survival average 14 million factors survival with cancer cases treatment per annum Colon Any age, Five-year Prostate but most survival co
Slide 17: Increasing recognition of need for GBM treatment options
There is increasing recognition of the need to find treatment options for patients diagnosed with GBM Growing public attention for brain cancer highlights need for new treatment options • Senator John McCain’s diagnosis in July 2017 highlighted glioblastoma and focused attention on the need for new
Slide 18: Standard of care ineffective in approximately 65% of GBM cases
Current standard of care is essentially ineffective in approximately 65% of GBM cases Standard of Care Debulking surgery Radiotherapy + Temozolomide (‘Stupp where possible temozolomide maintenance therapy Regimen’) 6 weeks 4w 6 x 28-day cycles ~35% of patients respond to temozolomide GDC-0084 is bei
Slide 19: GDC-0084 phase II study design simplified
GDC-0084 phase II study design has been simplified to accelerate data readouts ‘Phase 2a’ Component ‘Phase 2b’ Component Dose Optimisation Expansion Cohort Randomised Controlled Trial March 1H 2H TBD 2H 2018 2019 2019 2021 Dosing and safety data Preliminary efficacy One or more potential in newly-di
Slide 20: Phase 2b randomised controlled trial design
The ‘phase 2b component’ (randomised controlled trial) is based on clinician and regulatory feedback Maintenance Regulatory Strategy n = 114 temozolomide Debulking • Designed to provide robust Radiotherapy + surgery prior to R evidence of clinical efficacy, temozolomide study entry using an endpoint
Slide 21: Exploring collaborations for GDC-0084 in other disease areas
Kazia is exploring potential collaborations to investigate GDC-0084 in other disease areas Potential Collab- Laboratory-based Potential collaborations with orations Collab- researchers may help us to orations identify additional diseases areas for GDC-0084 Phase II GBM study remains the heart of the
Slide 22: PI3K class validated by approval of a new therapy
The PI3K class has been validated by approval of a new therapy in September 2017 PI3K class further validated by approval of Bayer’s AliqopaTM (copanlisib) for lymphoma in Sept 2017 • Two PI3K inhibitors now successfully brought to market – Zydelig (idelalisib) [Gilead] – Aliqopa (copanlisib) [Bayer
Slide 23: PI3K-focused companies 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$ 130 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$ 1.2 billion two in animal testing Market
Slide 24: Cantrixil Program Phase I Ovarian Cancer
Cantrixil Program Phase I Ovarian Cancer 21
Slide 25: Cantrixil targets cancer stem cells
Cantrixil has been developed to target ‘cancer stem cells’ which are often resistant to chemotherapy TRXE-002-1 is active against Ovarian cancer tumours both regular cancer cells and Tumor contain a mixture of cancer stem cells, and may different cell types therefore help to prevent recurrence cance
Slide 26: Cantrixil ongoing phase I dose escalation study
Cantrixil is currently in an ongoing phase I ‘dose escalation’ study • Single patient recruited at each dose level 0.12 mg/kg until toxicity encountered • Thereafter, 3 – 6 patients recruited at a given 0.24 mg/kg dose level • Dose where at least one third of patients 0.6 mg/kg experience toxicity i
Slide 27: Interim phase I results show encouraging signals
Interim results from 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 to give the
Slide 28: Cantrixil Phase I Study – partial response (1/2)
Cantrixil Phase I Study – partial response (1/2) October 2017 (baseline) January 2018 Source: images courtesy of Professor Jim Coward, Icon Cancer Centre 25
Slide 29: Cantrixil Phase I Study – partial response (2/2)
Cantrixil Phase I Study – partial response (2/2) May 2018 (end of study participation) July 2018 Source: images courtesy of Professor Jim Coward, Icon Cancer Centre 26
Slide 30: Recruitment in line with expectations and benchmarks
Recruitment in the study has been in line with expectations and industry benchmarks Indicative Recruitment Metrics for Phase I Studies in Ovarian Cancer Agent Perifosine AGS-84M Farletuzumab BIBF 1120 VS-6063 OMP-54F28 LDE225 TRX-E-002-1 Trial ID NCT02903771 NCT00431054 NCT00816764 NCT01004380 NCT01
Slide 31: Next steps: completion of Part A, progression to Part B
Next steps for Cantrixil are completion of Part A, and progression to Part B Part A: Dose Escalation Part B: Dose Expansion • 3 to 42 patients in up to 8 • 12 patients at MTD cohorts • Seeks to provide potential • Seeks to establish maximum efficacy signals tolerated dose and understand safety profi
Slide 32: Summary
Summary 29
Slide 33: Two clinical programs with value-driving inflection points in 2018
Two clinical programs, with value-driving inflection points providing impactful newsflow during 2018 ✓ ✓ (early calendar 2019) GDC-0084 Brain-penetrant Read-out Receipt of PI3K inhibitor, Start of phase from dose Orphan Drug developed to II study in optimisation Designation Glioblastoma completion o
Slide 34: Investment Highlights
Investment Highlights Cancer drug developer with two distinct therapies in clinical trials 1 - GDC-0084 currently in phase II trial for brain cancer - Cantrixil currently in phase I trial for ovarian cancer Well-differentiated assets, with lead program licensed from Genentech 2 - GDC-0084: targets a
Slide 35: www.kaziatherapeutics.com
www.kaziatherapeutics.com info@kaziatherapeutics.com
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