Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — Novogen — Shareholder Meeting (November 2016)
21 slides from Kazia Therapeutics's shareholder meeting presentation, Nov 16, 2016
Slide 1: Presentation to Annual General Meeting of Shareholders
Novogen Limited Presentation to Annual General Meeting of Shareholders Dr James Garner Chief Executive Officer Sydney, NSW 16 November 2016
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 actua
Slide 3: Novogen is a biotech company dedicated to driving sustainable, long-term growth in shareholder value
Novogen is a biotech company dedicated to driving sustainable, long-term growth in shareholder value Focus on unmet medical need Financially sound Pipeline of novel therapies, targeting Listed on ASX and NASDAQ, with oncology patients poorly served by ample cash runway to drive forward existing trea
Slide 4: 2016 has been a transformative year for Novogen
2016 has been a transformative year for Novogen 3Q 2016 Submission of Cantrixil 2Q 2016 IND 4Q 2016 1Q 2016 Appointment of Scientific Granting of patent for ATM Advisory Board Licensing of GDC-0084 Appointment of CEO technology from Genentech Granting of patent for SBP Conclusion of CanTx joint Recr
Slide 5: Novogen is financially efficient, with increasing expenditure reflecting progression of the pipeline
Novogen is financially efficient, with increasing expenditure reflecting progression of the pipeline Revenue Operating Expenditure G&A / Total Expenditure Revenue (AU$, M) Expenditure (AU$, M) G&A / Total Expenditure (% ) 5 20 50% ?43% 4.1 15.7 39% ‘ 60% 4 40% 37% 15 2.8 3 9.8 30% 10 2 20% 5 1 10% 0
Slide 6: Stock price performance, while disappointing, has been consistent with other companies in the biotech sector
Stock price performance, while disappointing, has been consistent with other companies in the biotech sector Share Price (AU$) 0.16 0.14 Novogen NASDAQ Biotech Index 0.12 0.10 0.08 Volume 0.06 5,000,000 4,000,000 0.04 3,000,000 0.02 2,000,000 1,000,000 0.00 0 Jan-16 Mar-16 May-16 Jul-16 Sep-16 Nov-1
Slide 7: Novogen has focused on oncology, with a clear strategy for building and managing a high-value portfolio
Novogen has focused on oncology, with a clear strategy for building and managing a high-value portfolio Assets from internal discovery engines Molecules partnered with Programs taken through preclinical and clinical pharma / large biotech for development, generally to phase III development completio
Slide 8: Novogen has built a strong management team with international experience in big pharma
Novogen has built a strong management team with international experience in big pharma Dr James Garner Chief Executive Officer & Managing Director Physician / MBA; Extensive pharma drug development experience Dr David Brown Chief Scientific Officer Twenty years of drug discovery and development expe
Slide 9: Our newly-appointed Scientific Advisory Board brings global expertise and experience to Novogen
Our newly-appointed Scientific Advisory Board brings global expertise and experience to Novogen Professor Sir Dr Karen Professor Professor Murray Brennan Ferrante Peter Gunning Alex Matter 8
Slide 10: Novogen now has a well-diversified portfolio of assets, stretching from preclinical to mid-stage clinical
Novogen now has a well-diversified portfolio of assets, stretching from preclinical to mid-stage clinical Lead Preclinical IND-Enabling Phase I Phase II Patent Optimisation Proof-of-Concept Tox & CMC Clinical Trials Clinical Trials Expiry Phase I I PI 3K GDC-0084 Glioblastoma 2032 2017 TRXE-002-1 Ph
Slide 11: GDC-0084: Glioblastoma Multiforme (GBM) is the most common form of primary brain cancer
GDC-0084 Glioblastoma Multiforme (GBM) is the most common form of primary brain cancer Presentation Epidemiology Prognosis Usually presents with non- Approximately 12,500 incident Median survival following specific symptoms (e.g. cases per annum in United diagnosis = 12-15 months with headaches, nau
Slide 12: GDC-0084: Current GBM standard of care is ineffective in ~65% of patients
GDC-0084 Current GBM standard of care is ineffective in ~65% of patients Standard of Care Debulking surgery Radiotherapy + Temozolomide (‘Stupp where possible temozolomide maintenance therapy Regimen’) 6 weeks 4w 6 x 28-day cycles Temozolomide is clearly efficacious… …but only in ~35% of patients wh
Slide 13: GDC-0084: PI3K inhibitors are well-validated, with one marketed product and extensive clinical data
GDC-0084 PI 3K inhibitors are well-validated, with one marketed product and extensive clinical data Zydelig (idelalisib) on market Other PI3K inhibitors in clinical trials GDC-0084 differentiated from other PI 3K inhibitors by:- Ability to cross blood-brain barrier Optimised balance of PI 3K and mTO
Slide 14: GDC-0084 has successfully completed a phase I study which established dose and safety profile
GDC-0084 GDC-0084 has successfully completed a phase I study which established dose and safety profile Phase I Study 47 patients enrolled at 4 centres 45mg established as Maximally (MD Anderson, UCLA, Dana- Tolerated Dose (MTD) for phase II Farber, and Vall d’Hebron) study Patients were grade 3 or 4
Slide 15: GDC-0084 has shown promising efficacy signals on FDG-PET in phase I study population
GDC-0084 GDC-0084 has shown promising efficacy signals on FDG-PET in phase I study population mean in Lesion Response Enhancing in Overallmax Best SUV FDG-PET is an experimental imaging technology that shows the metabolic activity of a tumour 7 / 27 patients (26%) had a metabolic partial response 14
Slide 16: Cantrixil: Ovarian cancer remains a disease of high unmet medical need
Cantrixil Ovarian cancer remains a disease of high unmet medical need High I ncidence Poor Prognosis with Existing Therapies Growing and Evolving Market Five-Year Survival Market Size (US$ ,000) Lung 1,500 0% 50% 100% Ovarian Cancer 17th most common $1,100M Breast Stage 1 tumour worldwide 7th most c
Slide 17: Cantrixil: Phase I study is designed to establish safety and tolerability, and explore potential efficacy
Cantrixil Phase I study is designed to establish safety and tolerability, and explore potential efficacy Trial Sites Patient Population Study Design Completion ~6 hospitals in Women with Standard dose Forecast 18 month United States and confirmed ovarian escalation to study duration Australia cancer
Slide 18: Work continues at full pace with Anisina and Trilexium
Anisina Work continues at full pace with Anisina and Trilexium Trilexium Anisina (ATM-3507) Trilexium (TRXE-009-1) Current Status Current Status IND-enabling activities (CMC, toxicology, Preclinical development ongoing regulatory) well underway Broad activity against multiple cancer types Final prec
Slide 19: 2017 will be an important year for Novogen, with a rich series of value-driving events
2017 will be an important year for Novogen, with a rich series of value-driving events Key Milestones for 2017 IND submission and approval for Anisina Initiation of Anisina phase I study Initiation of GDC-0084 phase II study Full recruitment of Cantrixil phase I study Initiation of IND-enabling acti
Slide 20: Novogen now has a diversified portfolio and is positioned for growth
Novogen now has a diversified portfolio and is positioned for growth Focus on unmet need: pipeline of novel therapies, targeting oncology patients, poorly served by existing treatment options Building a sustainable model: leveraging oncology expertise, developing commercially attractive, in- house a
Slide 21: @8@ NOVOGEN
® @8@ NOVOGEN