Patrys Limited · ASX:PAB
Patrys — Non-Deal Roadshow (April 2012)
47 slides from Patrys's roadshow presentation, Apr 12, 2012
Slide 1: ASX & Media Release: Patrys Non-Deal U.S. Roadshow
ASX & Media Release Patrys Non-Deal U.S. Roadshow For personal use only Melbourne, Australia; 12 April, 2012: Patrys Limited (ASX: PAB; “the Company”), a clinical stage biopharmaceutical company, has commenced a non-deal road show in the United States. The purpose of the road show is to introduce Pa
Slide 2: Investor Presentation - Patrys Management Team
For personal use only Investor Presentation Patrys Management Team April 2012 Confidential
Slide 3: Safe Harbour Statement
Safe Harbour Statement For personal use only The following material is for general information purposes only and is not to be relied upon for the making of an investment decision. Any investment in Patrys Limited ACN 123 055 363 (Patrys) is subject to investment risk including the possibility of los
Slide 4: Presentation Overview
Presentation Overview For personal use only I. Company Overview and Key Investment Highlights 4 II. Technology and IgMs 7 III. Manufacturing IgMs 13 IV. Lead Programmes 15 PAT-SM6 17 PAT-LM1 30 PAT-SC1 33 V. Intellectual Property 35 VI. Financials 38 VII. Summary 40 VIII. Appendix 43 Confidential 3
Slide 5: Key Investment Highlights
Key Investment Highlights For personal use only Patrys is an ASX listed, Australian-based international biotechnology company focused on the discovery and development of natural human antibody therapeutics for the treatment of cancer Pipeline of potential blockbuster drugs for cancer, currently in
Slide 6: Corporate Overview
Corporate Overview For personal use only KEY STATISTICS – 31 MARCH 2012 (AUD$) CURRENT FINANCIAL YEAR SHARE PERFORMANCE $0.1 ASX Code PAB $0.09 Current share price $0.034 $0.08 Share Price A$ 52 Week High $0.16 $0.07 52 Week Low $0.031 $0.06 Shares on Issue 363,612,177 $0.05 Market Capitalisation $1
Slide 7: Presentation Overview
Presentation Overview For personal use only I. Company Overview and Key Investment Highlights 4 II. Technology and IgMs 7 III. Manufacturing IgMs 13 IV. Lead Programmes 15 PAT-SM6 17 PAT-LM1 30 PAT-SC1 33 V. Intellectual Property 35 VI. Financials 38 VII. Summary 40 VIII. Appendix 43 Confidential 6
Slide 8: Technology Overview - I
Technology Overview - I For personal use only Spleen / lymph nodes Proprietary antibody isolated from multiple capture technology patients 40,000 MAbs Captured 27% IgG IgM » clear choice of immune system 61% 12% IgM for fighting cancer IgA 0.10% IgG 14 products 99.90% evaluated to IgM Screening Test
Slide 9: Technology Overview - II
Technology Overview - II For personal use only Precancerous cells Human Ab-producing cells Lead Abs selected on basis generated constantly by have short life and no of absolute specificity for normal cell division division ex vivo cancer cells These cells express unique Patrys produced uni
Slide 10: Characteristics of IgMs
Characteristics of IgMs For personal use only Body’s 1st line of defence as part of innate immune response Shown anti-tumour activity in mice and humans and exhibit therapeutic promise Excellent safety profile in humans – e.g. Patrys’ PAT-SM6 melanoma trial Specificity may result in reduced
Slide 11: IgM versus IgG
IgM versus IgG For personal use only Feature IgM IgG Main type of Ab made when exposed for the Human production 1st Ab made by B cells when stimulated by Ag 2nd time to Ag Distribution Account for 10% of total immunoglobulins Major circulating antibody Half-life ~ 10 days ~ 20 days Larger size appro
Slide 12: Natural Human Antibody Space
Natural Human Antibody Space For personal use only Disease Company Product Class Target Stage Indication Stimulates Acorda hIgM22 IgM Preclinical CNS oligodendrocytes Kenta Biotech Panobacumab IgM P. aeruginosa 011 Phase IIa Pneumonia Chugai L612 IgM Ganglioside GM3 Phase I/IIa Melanoma Phase I Mela
Slide 13: Presentation Overview
Presentation Overview For personal use only I. Company Overview and Key Investment Highlights 4 II. Technology and IgMs 7 III. Manufacturing IgMs 13 IV. Lead Programmes 15 PAT-SM6 17 PAT-LM1 30 PAT-SC1 33 V. Intellectual Property 35 VI. Financials 38 VII. Summary 40 VIII. Appendix 43 Confidential 12
Slide 14: Manufacturing Cell Line PER.C6
Manufacturing Cell Line PER.C6® For personal use only PER.C6® cell line: Generated from retina-derived primary human cells Tested negative for presence of endogenous and adventitious agents Biologics Master File filed with FDA 1999; yearly updates To date >400 pts treated with PER.C6® derive
Slide 15: Presentation Overview
Presentation Overview For personal use only I. Company Overview and Key Investment Highlights 4 II. Technology and IgMs 7 III. Manufacturing IgMs 13 IV. Lead Programmes 15 PAT-SM6 17 PAT-LM1 30 PAT-SC1 33 V. Intellectual Property 35 VI. Financials 38 VII. Summary 40 VIII. Appendix 43 Confidential 14
Slide 16: Pipeline
Pipeline For personal use only Product Discovery Preclinical Phase I Phase 2a Phase I Completed PAT-SM6 Melanoma Phase I/IIa to PAT-SM6 Multiple Myeloma Commence 2012 PAT-LM1 Solid Tumours Phase I/IIa PAT-SC1 Gastric Cancer Completed Out- Licensing Candidate PAT-SM1 SM4 SM5 NM3 Confidential 15
Slide 17: Presentation Overview
Presentation Overview For personal use only I. Company Overview and Key Investment Highlights 4 II. Technology and IgMs 7 III. Manufacturing IgMs 13 IV. Lead Programmes 15 PAT-SM6 17 PAT-LM1 30 PAT-SC1 33 V. Intellectual Property 35 VI. Financial 38 VII. Summary 40 VIII. Appendix 43 Confidential 16
Slide 18: PAT-SM6 Antibody & Target
PAT-SM6 Antibody & Target For personal use only PAT-SM6: IgM isotype, λ-light chain Isolated from stomach cancer patient Recombinantly expressed in PER.C6® Targets tumor specific epitope on GRP78 Binds also to oxidized LDL and VLDL Mode of Action: Internalisation upon binding of oxidized
Slide 19: GRP78 (Glucose-regulated protein 78kDa)
GRP78 (Glucose-regulated protein 78kDa) For personal use only Major ER (endoplasmic reticulum) chaperone, facilitating protein folding & assembly, protein quality control, Ca2+ binding and regulating ER stress signalling in normal cells Can also exist on surface of cancer cells in vivo hence pro
Slide 20: PAT-SM6 Preclinical Data
PAT-SM6 Preclinical Data 2 hrs 24 hrs 48 hrs For personal use only Control PAT-SM6 Magnification x 3,800 PAT-SM6 Representative IHC staining of PAT-SM6 on Scanning EM on effect of PAT-SM6 on stomach various tumour tissues carcinoma cell line 23132/87 1,4 ) 415 -A 490 1,2 Cell death ELISA of Bx
Slide 21: PAT-SM6 Toxicology Studies
PAT-SM6 Toxicology Studies For personal use only Route of Study Type & Duration Species Administration Normal human tissues Tissue cross-reactivity studies - Cynomolgus monkey Single-dose: Received 10, 30 or 50mg/kg/dose Intravenous BALB/c mouse 1-week study with 14-day recovery Single-dose: Receive
Slide 22: PAT-SM6 Melanoma Phase I Trial Design
PAT-SM6 Melanoma Phase I Trial Design For personal use only Study Design: Single low-dose study in pts with recurrent in-transit cutaneous melanoma: 0.15, 0.3 and 0.6mg/kg 3 pts per cohort, with surgery/biopsy 48-72 hours post dose Primary endpoint: Investigate the safety & tolerability of PAT
Slide 23: PAT-SM6 Melanoma Phase I Trial Results
PAT-SM6 Melanoma Phase I Trial Results For personal use only Patients enrolled at Royal Adelaide Hospital and Princess Alexandra Hospital, Brisbane: October 2010 – February 2012 Primary endpoint: No adverse events recorded in any patient Secondary endpoints: Half-life of 5.7 hours reported (
Slide 24: PAT-SM6 Melanoma Trial IHC/Apoptosis
PAT-SM6 Melanoma Trial IHC/Apoptosis Pre-treatment biopsy Post-treatment biopsy For personal use only Patient 1 Patient 2 Tumour biopsies were collected pre and post treatment with PAT-SM6, fixed in formalin and embedded in paraffin. An antibody specific for PAT-SM6 (PAT-SM6 anti Idiotype antibody)
Slide 25: Multiple Myeloma Opportunity
Multiple Myeloma Opportunity B-cell malignancy characterized by abnormal proliferation of plasma cells able to For personal use only produce a monoclonal immunoglobulin (M protein) Estimated to be approx. 100,000 new cases/yr WW and 72,000 deaths/yr. Incidence increasing 5 year survival ≈40% (
Slide 26: Preclinical Data I – Multiple Myeloma
Preclinical Data I – Multiple Myeloma For personal use only Patient tissue sourced Isotype Control CD138 PAT-SM6 from 11 patients at primary diagnosis, 9 with MM1 relapsed disease and 4 healthy controls IHC staining on bone marrow sections show MM2 binding of PAT-SM6 in 20/20 MM patients (primar
Slide 27: Preclinical Data II – Multiple Myeloma
Preclinical Data II – Multiple Myeloma For personal use only PAT-SM6 mediates cytotoxicity to patient MM cells and MM cell lines by induction of apoptosis A 80 ** ** ** ** B 100 ** PI/LDS positive cells (%) PI/LDS positive cells (%) U266 INA-6 80 60 OPM-1 MM1S 60 40 40 ns 20 20 0 0 PAT-SM-6 [µg/ml
Slide 28: Preclinical Data III – Multiple Myeloma
Preclinical Data III – Multiple Myeloma For personal use only PAT-SM6 binds C1q and mediates complement deposition and activation on both cell lines and patient cells A B 1.5 PAT-SM6 Binding C1q Deposition Rituximab PAT-SM6 1.0 Control Anti-C1q without PAT-SM6 OD 450nm Isotype PAT-SM6 Anti-C1q wit
Slide 29: Multiple Myeloma Trial Design
Multiple Myeloma Trial Design For personal use only Phase I/IIa open-label multi-dose trial in relapsed and multi-resistant patients (N=12 in 4 escalating dosing groups) Primary endpoint = safety and tolerability Secondary endpoints include Pk, immunogenicity, measures of response and Progress
Slide 30: Presentation Overview
Presentation Overview For personal use only I. Company Overview and Key Investment Highlights 4 II. Technology and IgMs 7 III. Manufacturing IgMs 13 IV. Lead Programmes 15 PAT-SM6 17 PAT-LM1 30 PAT-SC1 33 V. Intellectual Property 35 VI. Financial 38 VII. Summary 40 VIII. Appendix 43 Confidential 29
Slide 31: PAT-LM1 Antibody & Target
PAT-LM1 Antibody & Target For personal use only PAT-LM1: IgM isotype, λ-light chain Isolated from a lung cancer patient Recombinantly expressed in PER.C6® Targets tumour-specific epitope of surface-expressed NONO (non-POU-domain-containing octomer binding protein) Mode of Action: NONO main
Slide 32: PAT-LM1 Preclinical Data
PAT-LM1 Preclinical Data + control - control PAT-LM1 0.4 For personal use only Lung Squamous without C1q coating Cell Carcinoma 0.35 with 5μ/ml C1q coating 0.3 Colon 0.25 Adenocarcinoma 0.2 OD655 0.15 Esophagus Squamous Cell Carcinoma 0.1 0.05 Breast Ductal Adenocarcinoma 0 20μg 10μg 5μg 1μg 0.5μg L
Slide 33: Presentation Overview
Presentation Overview For personal use only I. Company Overview and Key Investment Highlights 4 II. Technology and IgMs 7 III. Manufacturing IgMs 13 IV. Lead Programmes 15 PAT-SM6 17 PAT-LM1 30 PAT-SC1 33 V. Intellectual Property 35 VI. Financials 38 VII. Summary 40 VIII. Appendix 43 Confidential 32
Slide 34: PAT-SC1 (Gastric Cancer)
PAT-SC1 (Gastric Cancer) For personal use only Pentameric IgM antibody Overview First Patrys Ab evaluated in clinical trial Target: Binds to isoform of CD55 (Decay Accelerating Factor) expressed on CD55 surface of multiple types of cancer cells Phase I/IIa open-label trial conducted 1997-200
Slide 35: Presentation Overview
Presentation Overview For personal use only I. Company Overview and Key Investment Highlights 4 II. Technology and IgMs 7 III. Manufacturing IgMs 13 IV. Lead Programmes 15 PAT-SM6 17 PAT-LM1 28 PAT-SC1 33 V. Intellectual Property 35 VI. Financials 38 VII. Summary 40 VIII. Appendix 43 Confidential 34
Slide 36: Patent Portfolio – PAT-SM6
Patent Portfolio – PAT-SM6 For personal use only SAM-6 SAM-6 LDL SAM-6 Target SAM-6 Variant & Priority Date 14 Nov Priority Date 14 Nov Priority Date 27 Nov Target 2003 2003 2006 Priority Date 9 Feb AU Granted 2009 US Granted US Abandoned EP Granted US Under Exam US Cont. Waiting Exam US Cont. Filed
Slide 37: Patent Portfolio – PAT-LM1
Patent Portfolio – PAT-LM1 For personal use only LM-1 LM-1 Target, Variants and LM-1 Epitopes and Priority Date 14 March Metastasis Methods 2003 Priority Date 16 Jun 2008 Priority Date 28 Oct 2011 EP Under Exam US Under Exam US Filed EP Div. Under Exam EP Under Exam Registered; AU Filed US Expires 1
Slide 38: Presentation Overview
Presentation Overview For personal use only I. Company Overview and Key Investment Highlights 4 II. Technology and IgMs 7 III. Manufacturing IgMs 13 IV. Lead Programmes 15 PAT-SM6 17 PAT-LM1 30 PAT-SC1 33 V. Intellectual Property 35 VI. Financials 38 VII. Summary 40 VIII. Appendix 43 Confidential 37
Slide 39: Financials
Financials For personal use only Listing Details Listed on ASX (Australian Securities Exchange) ASX Code: PAB IPO: 13 July 2007 Cash @ 31 March 2012 AUD - $5.3 million Burn Rate Cash to April 2013 Jul-07 IPO @ $0.40 $25m Total Funding Since Dec-08 Acceptys Transaction @$0.274 $3m Listing:
Slide 40: Presentation Overview
Presentation Overview For personal use only I. Company Overview and Key Investment Highlights 4 II. Technology and IgMs 7 III. Manufacturing IgMs 13 IV. Lead Programmes 15 PAT-SM6 17 PAT-LM1 30 PAT-SC1 33 V. Intellectual Property 35 VI. Financials 38 VII. Summary 40 VIII. Appendix 43 Confidential 39
Slide 41: Plans For 2012
Plans For 2012 For personal use only Complete PAT-SM6 melanoma trial and release full data (1Q12) Finalise preclinical work to support a PAT-SM6 multiple myeloma trial Commence PAT-SM6 Phase I/IIa open label multi-dose multiple myeloma clinical trial Out-license PAT-SC1 Further prepare PAT
Slide 42: For Further Information
For Further Information For personal use only Contact Details Dr. Marie Roskrow, Chief Executive Officer Roger McPherson, Chief Financial Officer Dr. Deanne Greenwood, Senior Director Business Development Ph: +61 3 9670 3273 Email: info@patrys.com Website: www.patrys.com Confidential 41
Slide 43: Presentation Overview
Presentation Overview For personal use only I. Company Overview and Key Investment Highlights 4 II. Technology and IgMs 7 III. Manufacturing IgMs 13 IV. Lead Programmes 15 PAT-SM6 17 PAT-LM1 30 PAT-SC1 33 V. Intellectual Property 35 VI. Financials 38 VII. Summary 40 VIII. Appendix 43 Confidential 42
Slide 44: PAT-SC1 Target = CD55
PAT-SC1 Target = CD55 For personal use only Decay-accelerating factor (DAF) or CD55 = member of a family of proteins involved in complement pathway PAT-SC1 target/antigen is isoform of the membrane-bound CD55 (DAF-B) (“wildtype-CD55”) that has a molecular weight of 82 kDa CD55PAT-SC1 is over-e
Slide 45: PAT-SC1 Human Trial - Overview
PAT-SC1 Human Trial - Overview For personal use only Open-label, randomized investigator lead Phase I/II study between 1997 and 2001 conducted at the University of Würzburg, Germany using PAT-SC1 Stomach hybridoma material Cancer CD55SC-1 positive patients given 20 mg PAT-SC1 i.v. of PAT-SC1 ove
Slide 46: PAT-SC1 Human Trial – Survival Data
PAT-SC1 Human Trial – Survival Data For personal use only 10-Year Survival Data Survival of treated patients (Group 3; CD55 positive and PAT-SC1 treated) patients followed over time and compared to historic control patients (Group 1; CD55 positive) with R0 stage gastric cancer who did not receive
Slide 47: PAT-SC1 Human Trial – IHC Results
PAT-SC1 Human Trial – IHC Results PAT-SC1 reactivity & apoptosis: Lymph node metastasis of stomach cancer For personal use only IgM Post-surgical exam of H&E primary gastric tumors Control demonstrated that PAT-SC1 induced apoptosis in 80% of resected tumors 47% of these tumors had Keratin PAT-S