Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — Novogen — 9th Annual Biotech Showcase Conference 2017
25 slides from Kazia Therapeutics's conference presentation, Jan 10, 2017
Slide 1: Novogen Limited Presentation to 9th Annual Biotech Showcase Conference
9th ANNUAL CONFERENCE BIOTECH SHOWCASE TM NOVOGEN Novogen Limited Presentation to 9th Annual Biotech Showcase Conference Dr James Garner San Francisco, CA Chief Executive Officer 9 January 2017 [email protected] Version 1.2
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: 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 Robust pipeline of novel therapies, targeting oncology patients poorly served by existing treatment options Financially sound Listed on ASX and NASDAQ, with cash runway fo
Slide 4: 2016 has been a transformative year for Novogen
2016 has been a transformative year for Novogen 1Q 2016 Appointment of CEO Granting of patent for SBP technology 2Q 2016 Granting of patent for ATM technology Conclusion of CanTx joint venture 3Q 2016 Submission of Cantrixil IND Appointment of Scientific Advisory Board Recruitment of senior manageme
Slide 5: Novogen is listed on ASX and NASDAQ, and is well-funded
Novogen is listed on ASX and NASDAQ, and is well-funded Share Price (US$) 3.00 Cash at Bank* Debt NVGN US$ 25 million Nil NASDAQ Biotech Index 2.50 2.00 Market Capitalisation US$ 33 million 1.50 Listing ASX: NRT NASDAQ: NVGN (1:25 ratio) 1.00 ASX: ~570,000 /day Average Daily Volume NASDAQ: ~50,000 /
Slide 6: 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 Assets in-licensed from external partners Programs taken through preclinical and clinical development, generally to completion of phase II Molecules partnere
Slide 7: 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 8: 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 Murray Brennan Dr Karen Ferrante Professor Peter Gunning Professor Alex Matter Memorial Sloan Kettering Cancer Center Takeda MILLENNIUM THE TAKEDA ONCOLOGY COMPANY UNSW AUSTRALIA NOVARTIS PH
Slide 9: 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 Optimisation Preclinical Proof-of-Concept IND-Enabling Tox & CMC Phase I Clinical Trials Phase II Clinical Trials Patent Expiry PI3K SBP ATM SBP GDC-0084 TRXE-002-1 Cantrixil ATM-3507 Anisi
Slide 10: 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 Usually presents with non-specific symptoms (e.g. headaches, nausea) Rapid clinical progression to permanent neurological defect and coma Epidemiology Approximately 12,500 incident cases per annum in
Slide 11: 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 (‘Stupp Regimen’) Debulking surgery where possible Radiotherapy + temozolomide Temozolomide maintenance therapy 6 weeks 4w 6 x 28-day cycles Probability of Progression-free Survival (%) Temozolomide is clearly
Slide 12: The PI3K / Akt / mTOR pathway is activated in 80% of GBM cases
GDC-0084 The PI3K / Akt / mTOR pathway is activated in 80% of GBM cases Canonical Oncogenic Pathway for GBM Worse Prognosis 50% 90% overall EGFR 57% PDGFRA 10% MET 1.6% FGFR 3.2% amplication or mutation 66% combined 2-Year Survival Rate 0% PTIN 41% PIK(3)K 25% RAS 1% NF1 10% 30% deletion or mutation
Slide 13: PI3K inhibitors are well-validated, with one marketed product and extensive clinical data
PI3K inhibitors are well-validated, with one GDC-0084 marketed product and extensive clinical data Zydelig (idelalisib) on market Other PI3K inhibitors in clinical trials Review Nature Reviews Clinical Oncology 10, 143-153 (March 2013) | doi:10.1038/ Development of PI3K inhibitors: lessons learned f
Slide 14: GDC-0084 is among the most advanced PI3K inhibitors in active development for GBM
GDC-0084 is among the most advanced PI3K GDC-0084 inhibitors in active development for GBM 212 173 40 100% Completed P1 in Non-GBM (n=47) Oncology GDC-0084 (39) Discontinued 80% / No Development P1/2a in GBM due (79) to complete in Oct buparlisib 2016 60% Other Oncology Indications Single-site P2 in
Slide 15: GDC-0084 shows single-agent activity in preclinical models of glioblastoma
GDC-0084 GDC-0084 shows single-agent activity in preclinical models of glioblastoma Illustrative Dose-Dependent Activity in U87 Model General Findings Tumor Volume (mm3) Widespread activity in a range of PDX Vehicle models; appears unaffected by MGMT 0.03 mg/kg promotor status 0.45 mg/kg 2.2 mg/kg 4
Slide 16: 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 (MD Anderson, UCLA, Dana-Farber, and Vall d’Hebron) Patients were grade 3 or 4 gliomas with at least one (and in most cases, several) lines of prior
Slide 17: Time on study exceeded historical controls for the majority of patients
GDC-0084 Time on study exceeded historical controls for the majority of patients EGFR PIK3R2 AKT1 PIK3CA PTEN PTEN IHC Patient Glioma Grade WT WT WT WT WT WT 108 Gr 3 WT WT WT MUT MUT LOW 217 Gr 4 ND ND ND ND ND LOW 414 Gr 4 WT WT MUT WT AT LOW 109 Gr 3 WT MUT WT WT WT WT 218 Gr 4 WT MUT WT WT WT FA
Slide 18: 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 Best Overall Response in mean SUVmax in Enhancing Lesion 50 40 30 20 10 0 -10 -20 -30 -40 65 mg 45 mg 30 mg 15 mg 8 mg 4 mg 2 mg FDG-PET is an experimental imaging technology that shows the metabolic activi
Slide 19: Brain metastases from non-CNS tumors represent long-term upside potential
GDC-0084 Brain metastases from non-CNS tumors represent long-term upside potential Overview Estimated 100,000 - 200,000 cases/year in US ~10-25% adult cancer patients develop symptomatic brain mets Lung, breast and melanoma represent the majority of brain mets Frequency of brain mets increasing with
Slide 20: Cantrixil: Ovarian cancer remains a disease of high unmet medical need
Cantrixil Ovarian cancer remains a disease of high unmet medical need High Incidence 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 tumour worldwide Breast Stage 1 $1,100M 7th most co
Slide 21: 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 ~6 hospitals in United States and Australia Investigators are generally specialist gynaecological oncologists with clinical trial experience Patient Population Women with confirmed ov
Slide 22: Work continues at full pace with Anisina and Trilexium
Anisina Work continues at full pace with Anisina and Trilexium Trilexium Anisina (ATM-3507) Current Status IND-enabling activities (CMC, toxicology, regulatory) well underway Final preclinical studies underway to optimise phase I clinical trial design Initiating GMP manufacture Plans for 2017 Submis
Slide 23: 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 24: 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 an
Slide 25: NOVOGEN
NOVOGEN
Novogen — 9th Annual Biotech Showcase Conference 2017 on 6ix