Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — Novogen — Investor Presentation (September 2017)
24 slides from Kazia Therapeutics's investor presentation, Sep 11, 2017
Slide 1: An emerging oncology drug developer with two clinical-stage programs
An emerging oncology drug developer with two clinical-stage programs Novogen Limited September 2017 NRT NVGN
Slide 2: Forward-Looking Statements
Forward-Looking Statements 1 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: Executive Summary
Executive Summary •Novogen is an oncology-focused biotechnology company, listed on ASX and NASDAQ •Lead asset is GDC-0084 for GBM, an orally-administered small molecule PI3K inhibitor licensed from Genentech –PI3K class is well-validated, with one commercial product on market: Zydelig (idelalisib) f
Slide 4: Agenda
Agenda •Corporate Overview •GDC-0084 •Cantrixil •Investment Hypothesis 3
Slide 5: Well-diversified portfolio of assets from preclinical to mid-stage clinical
Novogen has a well-diversified portfolio of assets, stretching from preclinical to mid-stage clinical 4 Lead Optimisation Preclinical Proof-of-Concept IND-Enabling Tox & CMC Phase I Clinical Trials Phase II Clinical Trials Patent Expiry SBP TRXE-002-1 Cantrixil 2035 SBP TRXE-009 Trilexium 2035 PI3K
Slide 6: A strong team brings international experience in big pharma and biotech
A strong team brings international experience in big pharma and biotech 5 Board Management Team Scientific Advisory Board Board & Management Dr James Garner Chief Executive Officer & Executive Director Physician / MBA; Extensive drug development experience Dr Gordon Hirsch Chief Medical Officer Phys
Slide 7: Agenda
Agenda •Corporate Overview •GDC-0084 •Cantrixil •Investment Hypothesis 6
Slide 8: Glioblastoma Multiforme is the most common form of primary brain cancer
Glioblastoma Multiforme (GBM) is the most common form of primary brain cancer 7 GDC-0084 Lung 14 million cancer cases per annum Breast Colon Prostate Stomach No clear cause or strong risk factors 3-4 months untreated survival 12-15 months average survival with treatment Any age, but most common in 6
Slide 9: Current GBM standard of care is ineffective in ~65% of patients
Current GBM standard of care is ineffective in ~65% of patients 8 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 weeks 4w 6 x 28-day c
Slide 10: The PI3K pathway is highly relevant to GBM; GDC-0084 is differentiated within the class
The PI3K pathway is highly relevant to GBM; GDC-0084 is differentiated within the class 9 1CW Brennan et al, Cell (2013), 155(2):462-477; 2Y Suzuki, et al. J Radiat Res (2010), 51(3):343 PI3K Activation in GBM PI3K Inhibitor Class is Diverse GDC-0084 PI3K dysregulation is associated with a worse pro
Slide 11: Previous GBM failures are understood and can inform development of new therapies
Previous GBM failures are understood and can inform development of new therapies 10 GDC-0084 Pharmacokinetic Failure •Many small-molecule kinase inhibitors are not well brain-penetrant, and so reach insufficient concentration at the tumour Tumour Genetics & Heterogeneity •Many driver mutations for G
Slide 12: Genentech's phase I study established a dose of 45mg and demonstrated acceptable safety
Genentech’s phase I study established a dose of 45mg and demonstrated acceptable safety 11 GDC-0084 Efficacy Signals Safety •Phase I safety trial conducted by Genentech •47 patients enrolled with advanced glioma (grade 3/4) •Most common adverse events were oral mucositis and hyperglycemia (common ef
Slide 13: 40% of patients achieved stable disease, with response increasing in higher doses
40% of patients achieved stable disease, with response increasing in higher doses 12 Best % change from baseline of target lesions CR / PR: 0 SD: 19 (40%) PD: 26 (55%) GDC-0084 Disease stabilisation is consistent with a primarily cytostatic mechanism, and highly relevant for use in post-resection se
Slide 14: First-line phase II study design supported by preclinical data and KOL consultation
First-line phase II study design is supported by preclinical data and KOL consultation 13 GDC-0084 Debulking surgery prior to study entry Radiotherapy + temozolomide Maintenance temozolomide Maintenance GDC-0084 R Approximately 60 sites in 5-6 countries Will target patients who are resistant to temo
Slide 15: Brain metastases from non-CNS tumors represent long-term upside potential
Brain metastases from non-CNS tumors represent long-term upside potential 14 Source: E Lim & N Lim (2012). Oncology. 26(7):652-9; PK Brastianos, SL Carter, S Santagata, et al. (2015). Discovery 5:1164 •Estimated 100,000—200,000 cases/year in US •~10-25% adult cancer patients develop symptomatic brai
Slide 16: Agenda
Agenda •Corporate Overview •GDC-0084 •Cantrixil •Investment Hypothesis 15
Slide 17: Ovarian cancer remains a disease of high unmet medical need
Ovarian cancer remains a disease of high unmet medical need 16 Source: GLOBOCAN; Holschneider & Berek (2000), Sem Surg Onc 19(1):3-10; Decision Resources Cantrixil Cause of death for 1 in 100 women 10% of cases are primarily genetic in origin Lung 14 million cancer cases per annum Breast Colon Prost
Slide 18: Cantrixil is a novel small molecule optimized to kill tumor-initiating cells
Cantrixil (TRX-E-002-1) is a novel small molecule optimized to kill tumor-initiating cells 17 First-in-class agent that kills the ‘tumor-initiating cells’ thought to be responsible for tumor recurrence and metastasis Prevents recurrence post-chemotherapy Combination treatment of TRX-E-002- 1 and pac
Slide 19: Phase I study designed to establish safety and tolerability, and explore efficacy
Phase I study is designed to establish safety and tolerability, and explore potential efficacy 18 Trial Sites •~6 hospitals in United States and Australia •Investigators are generally specialist gynaecological oncologists with clinical trial experience Patient Population •Women with confirmed ovaria
Slide 20: Agenda
Agenda •Corporate Overview •GDC-0084 •Cantrixil •Investment Hypothesis 19
Slide 21: Milestones and Newsflow
20 2017 2018 2019 2020 GDC-0084 Other Programs 2H Phase I study publication 2H FDA meeting re: GBM phase II program 2H Initiation of GBM study 2H Maximum Tolerated Dose (MTD) from TRXE-002-1 phase I study in ovarian cancer 1H Planned FDA ODD approval 1H Potential exploratory clinical studies with pa
Slide 22: Financial Overview
Financial Overview 21 * Adjusted for change in ASX / NASDAQ consolidation ratio on 14 July 2017 Market Capitalisation 0.00 1.00 2.00 3.00 4.00 5.00 6.00 7.00 8.00 Mar-17 May-17 Jul-17 Sep-17 NVGN US$ 16.2 million Shares on Issue 483 million (35% US, 65% Australia) Cash at Bank ~US$ 11.1 million List
Slide 23: Investment Summary
•Multiple value-driving catalysts between now and 2Q 2019 •Two active clinical programs providing diversification •Board and management brings international big pharma experience •Ambition to source additional assets and to aggressively seek partnering opportunities with big pharma •Lead asset in-li
Slide 24: NOVOGEN
NOVOGEN