Kazia Therapeutics Ltd · NASDAQ:KZIA
Kazia Therapeutics — Investor Presentation (April 2021)
34 slides from Kazia Therapeutics's investor presentation, Apr 19, 2021
Slide 1: Kazia Corporate Presentation (ASX Release)
ASX RELEASE 19 April 2021 KAZIA CORPORATE PRESENTATION Sydney, 19 April 2021 – Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to provide its latest corporate presentation, including updates for its newly in-licensed asset, EVT801
Slide 2: A Diversified, Clinical-Stage Oncology Drug Development Company
A Diversified, Clinical-Stage Oncology Drug Development Company Corporate Introduction April 2021 ASX: KZA | NASDAQ: KZIA | Twitter: @KaziaTx
Slide 3: 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 substantial risks and uncertainties, not all of which may be known at the time. All state
Slide 4: Company Overview
Company Overview Diversified, Clinical-Stage Substantial Strong Corporate Oncology Pipeline Commercial Opportunity Fundamentals Paxalisib • Glioblastoma represents ~US$ 1.5 • Listed on ASX (KZA) and on • Brain-penetrant PI3K / mTOR billion commercial market NASDAQ (KZIA) inhibitor • 5x additional cl
Slide 5: Corporate History
Corporate History Kazia has shown remarkable growth in five years October 2016 May 2018 November 2019 January 2021 April 2021 Paxalisib (then Phase II clinical First interim Paxalisib begins EVT801 licensed in known as GDC- study of paxalisib efficacy date from recruitment to GBM from Evotec SE 0084
Slide 6: Pipeline
Pipeline Two world-class assets in clinical trials by end CY2021 licensed from: Paxalisib (GDC-0084) Small molecule, brain-penetrant inhibitor of PI3K / mTOR PRECLIN. PHASE 1 PHASE 2 PHASE 3 MARKET Glioblastoma Most common primary brain cancer DIPG Highly aggressive childhood brain cancer Primary CN
Slide 7: Operating Model
Operating Model Partnering-based approach harnesses the best global research A Proven Strategy Jun 2010 – licensed niraparib from Merck Mar 2017 – Zejula® (niraparib) approved by FDA License under- Develop value Partner for Dec 2018 – Tesaro acquired by GSK valued assets through late-stage from larg
Slide 8: Leadership
Leadership Extensive international drug development experience Board Scientific Advisory Board Iain Ross Professor Sir Murray Brennan Chairman Emeritus Chairman of Cancer Surgery at Memorial Sloan Kettering Executive and Board roles in pharma Hospital, New York and small biotech Bryce Carmine Dr Kar
Slide 9: Financial Metrics
as at 31 MAR 21 Financial Metrics Value-driving news flow for investors 16.00 Share Price (US$) KZIA Market Capitalisation US$ 160M 14.00 Listing ASX (primary) KZA 12.00 NASDAQ (ADSs @ 1:10 ratio) KZIA Shares on Issue 127M 10.00 Balance Sheet US$ 8.00 Cash (at 31 Dec 20) ~$15M Partnering Income (Q1
Slide 10: CY2021 Milestones and Newsflow
CY2021 Milestones and Newsflow Multiple catalysts across two clinical programs Commence of recruitment to GBM AGILE pivotal study for paxalisib January 2021 ✓ Out-license of Cantrixil legacy asset to Oasmia Pharmaceutical March 2021 ✓ Partnership for paxalisib in Greater China with Simcere Pharmaceu
Slide 11: Paxalisib Brain Cancer Phase III
Paxalisib Brain Cancer Phase III 9
Slide 12: Treatment of brain cancer has improved little in recent decades
Treatment of brain cancer has improved little in recent decades, unlike other cancers Lung 1990s 2000s 2010s Cancer Brain Cancer 1990s 2000s 2010s (glioblastoma) 10
Slide 13: Paxalisib designed to overcome key challenges in brain cancer treatment
Paxalisib was designed specifically to overcome key challenges in the treatment of brain cancer Crosses Blood-Brain Barrier Oral Presentation Most anti-cancer drugs are not brain penetrant 15mg capsule, taken once daily; no significant food effect Targets PI3K / mTOR Pathway Strong IP Protection Com
Slide 14: Glioblastoma is the most common and aggressive primary brain cancer
Glioblastoma (GBM) is the most common and most aggressive form of primary brain cancer Lung No clear Any age, No clear but most improvement in cause common in prognosis for Breast or strong risk factors 60s 20 years 14 million cancer cases per annum Colon 3-4 months 12-15 Five-year survival Prostate
Slide 15: Temozolomide is only FDA-approved drug for GBM; ineffective in ~65%
Temozolomide is only FDA-approved drug for GBM; it is ineffective in ~65% of cases Standard of Care Debulking surgery Radiotherapy + Temozolomide (‘Stupp where possible temozolomide maintenance therapy Regimen’) 6 weeks 4w 6 x 28-day cycles ~35% of patients respond Paxalisib is being developed prima
Slide 16: PI3K / Akt / mTOR pathway is a critical signalling mechanism
The PI3K / Akt / mTOR pathway is a critical signalling mechanism for many tumor types Growth factor receptors (e.g. EGFR, HER2) Idealisib (Gilead) PI3K Alpelisib (Novartis) PIP2 PIP3 Paxalisib mTORC2 Akt Everolimus (Novartis) mTORC1 + - + Protein synthesis Cell cycle & Survival & cell growth prolife
Slide 17: Paxalisib is unique among PI3K inhibitors in crossing the blood-brain barrier
The PI3K inhibitor class is well-established, but paxalisib is unique in its ability to cross the blood-brain barrier Zydelig Aliqopa Copiktra Piqray Ukoniq paxalisib (idelalisib) (copanlisib) (duvelisib) (alpelisib) (umbralasib) FDA Approved FDA Approved FDA Approved FDA Approved FDA Approved In pi
Slide 18: Latest phase II data compares well to temozolomide
INTERIM DATA Latest phase II data compares well to historical data for temozolomide (existing standard of care) Progression-Free Survival (PFS) Overall Survival (OS) (n=30) (n=30) Paxalisib 8.4 months Paxalisib 17.5 months Median PFS Median OS Temozolomide 5.3 months Temozolomide 12.7 months (existi
Slide 19: Toxicities are generally mild to moderate and manageable
INTERIM DATA Toxicities are generally mild to moderate, entirely reversible, and manageable with readily-available therapies Number of Patients at 60mg (n=24) Experiencing AEs ‘Possibly’ or ‘Likely’ Related to Paxalisib (affecting ≥2 patients) Term Gr 1 Gr 2 Gr 3 Gr 4 Total (%) Rash 4 6 7 17 (71%) F
Slide 20: Broad-based clinical program across multiple forms of brain cancer
A broad-based clinical program is underway across multiple forms of brain cancer Registration Indication Phase N Status Sponsor Primary Brain Cancer NCT03522298 Glioblastoma II 30 Follow-up Glioblastoma Up to 200 NCT03970447 II / III Recruiting (GBM AGILE) on paxalisib NCT03696355 DIPG and DMGs I 27
Slide 21: GBM AGILE international pivotal study is underway
GBM AGILE international pivotal study is underway, and is expected to provide the basis for regulatory approval Key Points 3 • A ‘platform study’, run Regorafenib Economies of scale independently of individual due to multiple companies, designed to expedite participating drugs allows for large site
Slide 22: Commercial opportunity is substantial, with one partnership in place
Commercial opportunity is substantial, with one commercial partnership already in place Opportunities ‘Blue Sky’ Other Cancers with PI3K Partnership with Simcere Pharmaceutical for Greater Dysregulation China signed in March 2021 (e.g. breast, lung) Simcere will develop and commercialise paxalisib f
Slide 23: Key Points
Key Points • Well-understood mechanism (PI3K inhibition) but unique differentiating feature (brain penetration) • Positive phase II data in glioblastoma, supported by very strong preclinical package • Fully-funded international registration study underway with support of FDA and leading clinicians •
Slide 24: EVT801 Solid Tumors Pre-Phase I
EVT801 Solid Tumors Pre-Phase I 22
Slide 25: Targeting angiogenesis is a well-established approach in cancer treatment
Targeting angiogenesis is a well-established approach in the treatment of cancer Product Company Target Indications Annual Sales (US$)* • Colorectal cancer • Lung cancer VEGF-A • Breast cancer $7 billion • Other cancers VEGFR • Hepatocellular carcinoma PDGFR • Renal call carcinoma $1 billion RAF kin
Slide 26: Angiogenesis inhibitors are limited by several key challenges
Despite their proven efficacy, angiogenesis inhibitors are limited by several key challenges 1 Angiogenesis inhibitors work by reducing Tumor Hypoxia the formation of new blood vessels around the tumor, starving it of vital Sustained tumor hypoxia activates adaptive mechanisms, Limited nutrients nee
Slide 27: EVT801 is a selective VEGFR inhibitor inhibiting lymphangiogenesis
EVT801 is a selective VEGFR inhibitor, primarily inhibiting lymphangiogenesis (formation of new lymphatic vessels) Highly selective for VEGFR3 Oral Presentation Expected to minimise off-target toxicities Administered by mouth once or twice daily Inhibits lymphangiogenesis Strong IP Protection Compos
Slide 28: EVT801 selectively inhibits VEGFR3
EVT801 selectively inhibits VEGFR3 Avastin Lucentis (bevacizumab) (ranibizumab) VEGF-B VEGF-A VEGF-D VEGF-E VEGF-C Sutent EVT801 (sunitinib) VEGFR1 VEGFR2 VEGFR3 Nexavar (sorafenib) Inlyta Cell Survival Signal Modulation Angiogenesis (axitinib) Votrient Lymphangio- Vasculogenesis genesis (panzopanib
Slide 29: EVT801 expected to have three primary mechanisms of action
EVT801 is expected to have three primary mechanisms of action Tumor Killing 1 Direct effect on VEGFR3-expressing tumor cells (typically from endothelial origin, e.g. sarcoma) 3 3 Increase in Anti-Tumor Immune Activity 2 Increased infiltration of effector T-cells, and reduction in immunosuppressive 1
Slide 30: Preclinical data confirms activity of EVT801 (1/2)
Preclinical data confirms activity of EVT801 (1/2) Dramatic single-agent activity in DEN-induced HCC model Tumor Growth Metastasis Experimental Methods Total Tumor Volume Number of Tumors in the Liver • Syngeneic mouse model • Hepatocellular carcinoma chemically 85% reduction 50% reduction induced w
Slide 31: Preclinical data confirms activity of EVT801 (2/2)
Preclinical data confirms activity of EVT801 (2/2) Synergistic activity in combination with anti-CTLA4 mAb Tumor Volume (mm3) Experimental Methods 500 • Orthotopic mouse model Vehicle • 4T1 tumor cells inoculated in BALB/c EVT801 mice (mammary fat pad) 400 anti-CTLA4 • Treatment with EVT801 on D7-D2
Slide 32: Kazia plans to commence a phase I clinical trial in CY2021
Kazia plans to commence a phase I clinical trial in CY2021 Up to 90 patients with advanced Current Status solid tumors, resistant to existing • Investigational product therapies manufactured and ready to ship ✓ Endpoints will include safety and • Draft clinical trial protocol prepared tolerability,
Slide 33: Key Points
Key Points • Well-understood mechanism (anti-angiogenesis) but unique differentiating feature (VEGFR3 selectivity) • Very strong preclinical data package, with evidence of activity in multiple tumors and favourable toxicology • High potential for combination use with immuno- oncology therapies • ‘Cl
Slide 34: www.kaziatherapeutics.com
www.kaziatherapeutics.com 32 [email protected]
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