Prescient Therapeutics Limited · ASX:PTX
Prescient Therapeutics — Investor Presentation (November 2015)
47 slides from Prescient Therapeutics's investor presentation, Nov 4, 2015
Slide 1: The best value healthcare stock on ASX?
For personal use only The best value healthcare stock on ASX? » Breast cancer » Ovarian cancer » …and soon AML November 2015
Slide 2: Disclaimer and Safe Harbor
Disclaimer and Safe Harbor For personal use only Certain statements made in this presentation are forward-looking statements within the meaning of the safe harbour provisions of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements are not historical fa
Slide 3: Investment Highlights
Investment Highlights For personal use only One of Deepest Clinical 3 clinical trials: 2 underway and 1 on track to initiate 1H 2016 Pipelines on ASX Two Clinical Stage 2 drug candidates targeting key cancer pathways Oncology Drugs » AKT (PTX-200) and Ras (PTX-100) Distinguished Scientific Compellin
Slide 4: Deep, Clinical Stage Product Pipeline
Deep, Clinical Stage Product Pipeline For personal use only PTX has one of the deepest and most mature product pipelines on ASX Discovery Screening Preclinical Phase I Phase Ib Phase II Phase III PTX-200 Breast Cancer Underway PTX-200 Ovarian Cancer Underway PTX-200 AML In preparation PTX-100 Breast
Slide 5: Corporate Snapshot
Corporate Snapshot For personal use only Key Metrics Shareholder Base ASX Ticker PTX Total Issued Capital 57.2 M shares Board & 4.3 M Management: 18% Options (ex A$0.10; exp 12 Oct 2017) Share Price1 A$0.06 Market Capitalisation1 A$3.3 M Cash Position2 A$1.0 M Top 20 Own 33% 6 month turnover1 21.4 M
Slide 6: Let's Explore Value vs. Valuation
For personal use only LET’S EXPLORE VALUE VS. VALUATION 6
Slide 7: PTX's valuation obviously doesn't weigh up!
PTX’s valuation obviously doesn’t weigh up! For personal use only >$20 M Prestigious already Two novel invested Technology technology founders platforms targeting AKT and Ras/Rho Two INDs inhibition Mechanism open in breast & of Action well ovarian cancer understood Phase 1b ovarian trial recruiting
Slide 8: Valuation anomaly against ASX peers
Forget about the US – there’s a pronounced valuation anomaly against ASX peers! For personal use only Company Mkt Cap Multiple Clinical Trials to FDA Phase 1 Phase 2 ($AUD) Technologies trials? standard? Trials Trials PTX $3 M Imminent! Starpharma $190 M Bionomics $171 M
Slide 9: PTX Ahead of the Pack
PTX Ahead of the Pack The time, money and risk facing many of our peers is already behind us For personal use only Investment required $ M • >$20 M spent to date • $3 M market cap Phase 2 Trials Phase 1 Trials Clinical Trial Site Selection IND from FDA Manufacturing Preclinical Studies Discovery Yea
Slide 10: PTX's clinical maturity substantially de-risks its assets
PTX’s clinical maturity substantially de-risks its assets Operationally speaking, we share a healthy ASX peer group For personal use only Probability of Success • Multiple clinical trials • Two drugs Phase 2 Phase 1 Pre-Clinical Screening Discovery Stage of Development 10
Slide 11: Potential explanations for the valuation anomaly
Potential explanations for the valuation anomaly For personal use only • A victim of our own success? Too much too soon? • Was the pipeline too full for the market to digest all at once? » 2 drugs; 5 trials; overlap in breast cancer » Stem cell application » Personsalised medicine – p27 biomarker »
Slide 12: What will we do to bridge the valuation gap?
What will we do to bridge the valuation gap? For personal use only • Narrow the focus on priority programs » Breast cancer » Ovarian cancer » Already in the clinic. Will produce data the soonest. » There is already more here than most companies have! • Renewed focus on AML. Why? » This indication cl
Slide 13: PTX Overview
13 For personal use only PTX OVERVIEW
Slide 14: How Our Drugs Work: Molecular Switches
How Our Drugs Work: “Molecular Switches” For personal use only AKT & Ras are growth factors PTX’s drugs block the AKT & found in cancer cells – Ras growth signals, when they are turned on, switching the growth signals they send a signal to the off and causing the cancer cancer cell to grow cell to d
Slide 15: What is Chemoresistance?
What is Chemoresistance? For personal use only • Despite the many advances in cancer treatment over many decades, 90% of advanced cancer patients become resistant to chemotherapy • Resistance comes about when some of the cells that are not killed by the chemotherapy mutate (change) and become resist
Slide 16: Making big market opportunities bigger
Making big market opportunities bigger For personal use only • PTX’s drugs are used in combination with existing chemo drugs (e.g. Velcade, below) to make these drugs effective once again. • PTX’s drugs therefore provide lucrative opportunities for Big Pharma to extend patents on blockbuster drugs o
Slide 17: World Class Centres & Collaborations
World Class Centres & Collaborations For personal use only New York Florida Previous clinical trials conducted at: 17
Slide 18: Introducing the Moffitt Cancer Center
Introducing the Moffitt Cancer Center • H. Lee Moffitt Cancer Center & For personal use only Research Institute, established in 1986 in Tampa, Florida • 3rd largest cancer centre in the US • On one side of the campus is a world- leading “comprehensive cancer clinic” » offering patients medical oncol
Slide 19: Working with the Moffitt Cancer Center
Working with the Moffitt Cancer Center For personal use only • The perfect environment to conduct clinical trials: Treatment Research » Collaboration and synergy between researchers and clinicians » Currently over 350 clinical trials » Huge influx of patients for trial recruitment » Bird’s eye view
Slide 20: Board of Directors & Scientific Advisory Board
Board of Directors & Scientific Advisory Board For personal use only Steve Engle • Former Chairman and CEO of US-listed XOMA (NASDAQ:XOMA) and La Jolla Non-Executive Pharmaceuticals (NASDAQ: LJPC) Chairman • Currently CEO of Averigon Consulting, an advisory firm to life science industry Paul Hopper
Slide 21: Drugs Don't Develop Themselves!
Drugs Don’t Develop Themselves! For personal use only Said Sebti, PhD Terry Chew, M.D. Chief Scientific Officer Chief Medical Officer • Professor and Chair, Department of Drug Discovery - • Hematologist/oncologist with 20 years experience in biotech & Moffitt Cancer Center pharma • Co-Program Leader
Slide 22: Clinical Advocates Driving Our Programs
Clinical Advocates Driving Our Programs For personal use only Acute Myeloid Breast Cancer Ovarian Cancer Leukemia Joseph Sparano, M.D. Heather Han, M.D. Robert Wenham, M.D. Jeff Lancet, M.D. • Prof. of Medicine & • Assistant Prof. of • Section Head, • Prof. of Oncologic Obstetrics, Gynecology, Medic
Slide 23: Breast Cancer Market Overview
Breast Cancer Market Overview For personal use only • Breast cancer market currently US$10 B; due to double by 2023 • Most breast cancer drug sales are for HER2+ cancers, but this only represents ̴20% of all breast cancers • By contrast, PTX is targeting “HER2 negative” (HER2-) breast cancer • HER2-
Slide 24: Trial #1: Breast Cancer Already Underway
Trial #1: Breast Cancer Already Underway For personal use only • PTX-200 plus Taxol in patients with metastatic and locally advanced breast cancer » Phase 1b trial currently underway » Recruiting at Albert Einstein College of Medicine Montefiore Medical Center Joseph Sparano, M.D. » Funded by Nation
Slide 25: Ovarian Cancer Market Overview
Ovarian Cancer Market Overview For personal use only • One of the most common cancers in women • Increasing with an ageing population • Due to reach US$1.7 B by 2019 » Market size currently constrained by old generic drugs that just aren’t good enough • Standard of care is “platinum based” drugs (of
Slide 26: Trial #2: Ovarian Cancer Already Underway
Trial #2: Ovarian Cancer Already Underway For personal use only • PTX-200 plus Carboplatin in platinum resistant ovarian cancer • Significant need for new products to treat platinum-resistant ovarian cancer • Phase 1b already underway Robert Wenham, M.D. Principal Investigator • IND transferred to P
Slide 27: Acute Myeloid Leukemia Market Overview
Acute Myeloid Leukemia Market Overview • AML is a type of cancer that affects the blood and bone marrow. For personal use only » Patient cannot produce normal blood cells » Blood cells cannot function properly nor fight disease • 5-year survival is a dismal 25% • Progresses very quickly • More commo
Slide 28: Planned Trial #3: Acute Myeloid Leukemia
Planned Trial #3: Acute Myeloid Leukemia For personal use only . • PTX-200 plus cytarabine in refractory or relapsed acute leukemia • Phase 1 results very encouraging » Undertaken at MD Anderson and Moffitt » 17 out of 32 patients had stable disease after one cycle of treatment » 3 patients with AML
Slide 29: What To Watch Out For
What To Watch Out For For personal use only 2014 2015 1H 2016 2H 2016 Transfer Breast Cancer IND Breast Complete Phase 1b cancer Initiate Phase 2 Initiate Phase 1b Ovarian Transfer Ovarian Cancer IND cancer Dose escalation and interim analysis Complete Phase 1b IND allowed by US FDA Acute Myeloi
Slide 30: Investment Summary
Investment Summary For personal use only • Two clinical stage cancer drugs from top US institutions (Yale and Moffitt) • Two clinical trials currently underway: » Breast cancer » Ovarian cancer • 3rd trial starting early 2016 in Acute Myeloid Leukaemia » A massive unmet market » Intense market inter
Slide 31: Appendices
For personal use only Appendices
Slide 32: Robust Intellectual Property Portfolio
Robust Intellectual Property Portfolio For personal use only PTX-200 PTX-100 • IP estate anchored by “foundational” • Strong Composition of Matter patent patent issued in January 2013 covering “Piperazinone compounds as • Established PTX-200 as a targeted anti-tumor and anti-cancer agents & therapy
Slide 33: PTX-100
33 For personal use only PTX-100
Slide 34: PTX-100: Profile
PTX-100: Profile For personal use only • PTX-100 is a 1st in class: 1st in man small molecule inhibitor PTX-100 (GGTI) of Ras signaling pathway • Ras is faulty in 30% of all human cancers and known to mediate chemoresistance • Geranylgeranyl transferase (GGT) enzyme is a key “on switch” in the pathw
Slide 35: PTX-100: Mechanism of Action
PTX-100: Mechanism of Action Ras and Ral are ON/OFF switches that control normal cell division For personal use only Resting/non-dividing Cell Dividing Cell GGT-1 adds GG to Ral. GG and Ral go from OFF to F F ON which contributes to Receptor Receptor cell division GGT-1 Ras Ras GGT-1 GG GG GDP GTP R
Slide 36: PTX-100: Mechanism of Action
PTX-100: Mechanism of Action Ral requires geranylgeranylation (GG) to cause cancer For personal use only Untreated Cancer Cell PTX-100 Treated Cell Some cancer cells contain Ras PTX-1– Binds to GGT-1 and and Ral that are always in the prevents GGT-1 from adding ON GTP position GG to Ral, blocking it
Slide 37: PTX-100: Completed Phase in Advanced Solid Tumors
PTX-100: Completed Phase 1 in Advanced Solid Tumors For personal use only Patients 13 Trial Centers Indiana University, University of Pennsylvania Patient Advanced solid tumors for which standard treatments Inclusion failed – “refractory” PTX-100 as a 30-minute IV infusion on Days 1-5 every 21 Metho
Slide 38: PTX-100: Cancer Stem Cell Opportunity
PTX-100: Cancer Stem Cell Opportunity For personal use only • PTX-100 reduces breast cancer stem cells from patient derived tumors by more than 70% • Cancer stem cells (CSCs) are resistant to conventional therapies causing relapse and metastasis by giving rise to new tumors • Therapies that target C
Slide 39: PTX-200
39 For personal use only PTX-200
Slide 40: PTX-200: Profile
PTX-200: Profile For personal use only • Small molecule inhibitor of the AKT signaling pathway the most commonly altered pathway in cancer PTX-200 (TCN-P) • Activated AKT plays key role in many cancers including breast, ovarian (40-70%), colorectal, prostate (55%), pancreatic (70%) and hematologic c
Slide 41: PTX-200: Mechanism of Action
PTX-200: Mechanism of Action AKT is an ON/OFF switch that controls normal cell division AKT is ON when phosphorylated and OFF when not For personal use only Resting/non-dividing Cell Dividing Cell Akt moves to cell membrane where it gets phosphorylated P and activated to stimulate cell division Rece
Slide 42: PTX-200: Mechanism of Action
PTX-200: Mechanism of Action Some cancer cells contain Akt that is always phosphorylated* stimulating cells to divide forever Akt is ON when phosphorylated and OFF when not For personal use only Untreated Cancer Cell PTX-200 Treated Cell Akt is stuck in PTX-200 prevents AKT the ON position membrane
Slide 43: PTX-200: Completed Phase in Solid Tumors
PTX-200: Completed Phase 1 in Solid Tumors For personal use only Patients 13 Trial Center Moffitt Patients whose tumors displayed evidence of Patient increased AKT phosphorylation as measured by Inclusion immunohistochemical analysis Administration over 30 minutes on days 1, 8, & 15 of a Methods 28-
Slide 44: Acute Myeloid Leukemia
For personal use only ACUTE MYELOID LEUKEMIA 44
Slide 45: PTX-200: Completed Phase in AML
PTX-200: Completed Phase 1 in AML For personal use only Patients 32 Trial Centers MD Anderson & Moffitt Patient Advanced hematologic malignancies (mainly AML) Inclusion Administration 1 hour IV infusion on days 1, 8, and 15. Methods Cycles repeated every 21 days. Study To establish dosing regime and
Slide 46: PTX-200: Proposed Phase 1b/2 in AML – early 2016
PTX-200: Proposed Phase 1b/2 in AML – early 2016 For personal use only 6 x 6 x 6 with refractory or relapsed acute leukemia in Patients combination with cytarabine chemo Trial Center H. Lee Moffitt Cancer Centre Florida, USA Dr Jeffrey Lancet Investigator Department of Hematologic Malignancies, Moff
Slide 47: Contact
For personal use only Contact Paul Hopper Executive Director Prescient Therapeutics Limited M: +61 406 671 515 E: receptogen@earthlink.net prescienttherapeutics.com
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