Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — HC Wainwright & Co 22nd Annual Investment Conference (September 2020)
20 slides from Kazia Therapeutics's conference presentation, Sep 15, 2020
Slide 1: Presentation to HC Wainwright 22nd Annual Investment Conference
A company developing innovative, high-impact drugs for cancer Presentation to HC Wainwright & Co 22nd Annual Investment Conference Dr James Garner Chief Executive Officer & Managing Director 15 September 2020
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: Corporate Overview
Corporate Overview Company Description Oncology-focused, mid-clinical-stage, small-molecule biotechnology company, headquartered in Sydney, Australia Pipeline Paxalisib – brain-penetrant PI3K / mTOR inhibitor about to enter phase III for glioblastoma Cantrixil – cancer stem cell-targeting agent in p
Slide 4: Investment Rationale
Investment Rationale Glioblastoma (GBM) is a disease with very high unmet medical need GBM is the most common and most aggressive form of brain cancer Only existing drug, temozolomide, is ineffective in two-thirds of cases Commercial opportunity is ~US$ 1.5 billion per annum Kazia’s paxalisib (GDC-0
Slide 5: Treatment of brain cancer has improved little in recent decades
Treatment of brain cancer has improved little in recent decades, unlike other cancers Lung Cancer Brain Cancer (glioblastoma) 1990s 1990s 2000s 2000s 2010s 2010s
Slide 6: Blood-Brain Barrier
Blood-Brain Barrier Most cancer therapies do not penetrate the BBB Brain-Penetration GDC-0084 is designed to cross the blood-brain barrier Paxalisib was designed specifically to overcome challenges associated with brain cancer treatment Challenge Approach Tumour Heterogeneity Brain tumours exhibit a
Slide 7: Paxalisib is unique among PI3K inhibitors in crossing the blood-brain barrier
PI3K class is well-established, but paxalisib is unique in its ability to cross the blood-brain barrier FDA Approved July 2014 (blood cancers) [accelerated approval] FDA Approved September 2017 (blood cancers) [accelerated approval] FDA Approved October 2018 (blood cancers) [accelerated approval] ü
Slide 8: Glioblastoma is the most common and most aggressive 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 9: Temozolomide is the only FDA-approved drug for GBM; ineffective in ~65% of cases
Temozolomide is only FDA-approved drug for GBM; it is ineffective in ~65% of cases Source: ME Hegi, A-C Diserens, T Gorlia, et al. (2005). N Engl J Med 352:997-1003 Note: Temozolomide is only approved therapy for newly-diagnosed patients; Avastin (bevacizumab) is approved for use in recurrent settin
Slide 10: Current phase II study focuses on newly-diagnosed patients
The current phase II study is designed to focus on newly-diagnosed patients, following radiotherapy Note: timelines are estimated and subject to periodic revision based on recruitment performance and treatment effect Step 1: Dose Optimisation 9 patients September 2018 – May 2019 21 patients June 201
Slide 11: New phase II data compares favourably to temozolomide
New phase II data compares favourably to historical data for temozolomide (existing standard of care) Note: figures for existing therapy are for temozolomide, per Hegi et al. (2005); comparison between different studies is never perfectly like-for-like Progression-Free Survival (PFS) Overall Surviva
Slide 12: A broad-based clinical program across multiple forms of brain cancer
A broad-based clinical program is underway across multiple forms of brain cancer Glioblastoma Most common and most aggressive brain tumour Phase II NCT03522298 Glioblastoma (planned pivotal study for approval [in set-up]) Phase II / III NCT03970447 Brain Metastases Cancer that has spread from any pr
Slide 13: GBM AGILE is the planned pivotal study for paxalisib
GBM AGILE is the planned pivotal study for paxalisib in glioblastoma Stage 1 (Phase II) upto 150 patients 50 patients Stage 2 (Phase III) Primary endpoint of both stages is overall survival (OS); final analysis performed on all patients from both stages, compared to all control patients recruited to
Slide 14: GBM AGILE is an adaptive multi-drug registrational study
GBM AGILE is an adaptive multi-drug registrational study, with strong FDA support Randomization Drug #2 Drug #3, etc… Drug #1 Common Control Arm Comparison against a common control arm reduces overall subject numbers, saving time and cost (no drug vs. drug comparison) Adaptive study design limits nu
Slide 15: Recent regulatory achievements position paxalisib for commercialisation
Recent regulatory achievements position paxalisib well as it moves towards commercialisation Glioblastoma Most common and most aggressive form of brain cancer DIPG Highly aggressive childhood brain cancer Orphan Designation February 2018 August 2020 Rare Pediatric Disease Designation (not applicable
Slide 16: Brain cancer represents a significant commercial opportunity for paxalisib
Brain cancer represents a significant commercial opportunity for paxalisib, with limited competition ~$1.5B+ market opportunity INDICATIVE Glioblastoma 12,500 patients p.a. in the US Brain Metastases (secondary brain cancer) Childhood Brain Cancers Other Adult Primary Brain Cancers Other Cancers wit
Slide 17: Kazia has delivered all milestones to date, with data read-outs expected
Kazia has delivered all milestones to date, with multiple data read-outs expected over 6-12 months H1 H2 H1 H2 2020 2021 Note: forward-looking milestones are forecast and indicative but subject to revision, particularly in light of changing conference schedules 2019 Commence NCI-funded ‘Alliance’ st
Slide 18: Positive newsflow has supported revaluation of Kazia
Positive newsflow has supported revaluation of Kazia as paxalisib moves towards commercialisation Market Capitalisation ~US$ 75 million Listing ASX:KZA NASDAQ: KZIA (1:10 ratio) Share Price (US$) KZIA Shares on Issue ~94 million Balance Sheet (as at 30 Jun 20) Current Assets:US$ 7.7M FY20 Spend:US$
Slide 19: A strong team with international experience in big pharma and 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 20: www.kaziatherapeutics.com
www.kaziatherapeutics.com
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