Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — Biotech Showcase 2019
25 slides from Kazia Therapeutics's conference presentation, Jan 7, 2019
Slide 1: A clinical-stage oncology company with two novel agents in development
A clinical-stage oncology company with two novel agents in development Presentation to Biotech Showcase #BTS19 San Francisco, CA 8 January 2019
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 four ongoing clinical trials across two novel programs
Kazia has four ongoing clinical trials across two novel programs Note: All studies performed substantially in US under IND Preclinical Phase I Phase II Phase III GDC-0084 PI3K / mTOR Inhibitor Licensed from Genentech in October 2016 Potential future collaborations Diffuse Intrinsic Pontine Glioma (D
Slide 4: 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 5: GDC-0084 Phase II Glioblastoma Multiforme
GDC-0084 Phase II Glioblastoma Multiforme
Slide 6: Glioblastoma (GBM) is the most common and most aggressive form of primary brain cancer
Glioblastoma (GBM) is the most common and most aggressive form of primary brain cancer 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 60s
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 GDC-0084 phase 1, patients showed a metabolic partial response on FDG-PET
In GDC-0084 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, 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: GDC-0084 is currently in a phase 2a study in GBM, with multiple data-readouts during 2019
GDC-0084 is currently in a phase 2a study in GBM, with multiple data-readouts during 2019 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 Trial ‘Phase 2a’
Slide 11: Brain metastases represent a significant expansion to the commercial opportunity for GDC-0084
Brain metastases represent a significant expansion to the commercial opportunity for GDC-0084 Glioblastoma HER2+ Breast Cancer Approximately 130,000 patients per annum worldwide Approximately 340,000 patients per annum worldwide $2.3 billion estimated market opportunity in 2024 [Transparency Researc
Slide 12: GDC-0084 analogue has shown good preclinical evidence of activity in breast cancer brain mets
GDC-0084 analogue has shown good preclinical evidence of activity in breast cancer brain mets Source: Breast Cancer Res Treat. (2017):164(3):581-591
Slide 13: Recent data from Novartis at ESMO showed impressive results for PI3K inhibitor in breast cancer
Recent data from Novartis at ESMO showed impressive results for PI3K inhibitor in breast cancer Source: Novartis company presentation Alpelisib (BYL719) is a PI3K inhibitor being developed for breast cancer Alpelisib only inhibits the alpha form of PI3K, and was not developed to cross the blood-brai
Slide 14: GDC-0084 value proposition is considerable
GDC-0084 value proposition is considerable Currently in Phase II clinical trials, under IND with US FDA, at leading US centers for brain cancer Clear Phase I data, with favourable safety profile and indications of efficacy in late-stage GBM patients Clear unmet medial need, with only existing therap
Slide 15: Cantrixil Phase I Ovarian Cancer
Cantrixil Phase I Ovarian Cancer
Slide 16: Cantrixil phase study has now progressed into Part B, and data is expected in calendar 2019
Cantrixil phase 1 study has now progressed into Part B, and data is expected in calendar 2019 Part A: Dose Escalation 3 to 42 patients in up to 8 cohorts Seeks to establish maximum tolerated dose and understand safety profile Part B: Dose Expansion 12 patients, all at 5 mg/kg Seeks to provide potent
Slide 17: Part A has already shown evidence of activity with one partial responder to date
Part A has already shown evidence of activity with one partial responder to date Source: images courtesy of Professor Jim Coward, Icon Cancer Centre October 2017 (baseline) January 2018
Slide 18: Corporate Summary
Corporate Summary
Slide 19: Kazia is NASDAQ & ASX listed
Kazia is NASDAQ & ASX listed Market Capitalisation US$ 17 million Shares on Issue 62 million (25% US, 75% Australia) Current Assets (Jun 18) US$ 6.9 million Listing NASDAQ: KZIA (1:10 ratio) ASX: KZA Share Price (US$) Outstanding Options / Warrants ~6 million Average Daily Volume NASDAQ: 0.4% /day A
Slide 20: Other companies have built successful businesses around in-licensed products
Other companies have built successful businesses around in-licensed products Source: Bloomberg; Company SEC Filings; Crunchbase (NASDAQ: CLVS) (NASDAQ: PBYI) (NASDAQ: TSRO) US$ billion $360 million $2.4 billion Dec 2010 Licenses rolapitant from Schering-Plough Jun 2012 Licenses niraparib from Merck
Slide 21: Other companies focused on the PI3K pathway have been highly-valued in the market
Single asset company with one PI3K inhibitor in phase I human trials US$ 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 Cap One PI3K inhibitor in phase II human trials Acquired by big pharma in 2011 fo
Slide 22: 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 23: A strong team brings international experience in big pharma and early-stage biotech
A strong team brings international experience in big pharma and early-stage biotech Board Scientific Advisory Board Iain Ross Chairman Executive and Board roles in pharma and small biotech Bryce Carmine Deputy Chairman 36 years executive experience in Eli Lilly Steven Coffey Non-Executive Director C
Slide 24: 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 25: www.kaziatherapeutics.com
www.kaziatherapeutics.com