Patrys To Present at the 12 th Annual BIO Investor Forum

Transcription

1 ASX & Media Release Patrys T Present at the 12 th Annual BIO Investr Frum Melburne, Australia; 9 Octber, 2013: Patrys Limited (ASX: PAB), a clinical stage bitechnlgy cmpany tday annunced that Dr. Marie Rskrw, MBBS, PhD, Chief Executive Officer, will present at the 12 th Annual BIO Investr Frum n Wednesday 9 th Octber, 2013 at 9:00 a.m. Pacific time at The Palace Htel in San Francisc, CA. The BIO Investr Frum is an internatinal bitech investr cnference fcused n early and established private cmpanies as well as emerging public cmpanies. The event features plenary sessins, business rundtables and therapeutic wrkshps, cmpany presentatins, and One-n-One partnering meetings. This event is ne f the key investment frums in the wrld and prvides a very imprtant platfrm fr Patrys t raise its prfile t a glbal investr audience. Patrys is entering an exciting and pivtal time as ur Phase I/IIa clinical trial fr multiple myelma is recruiting the final chrt, said Patrys CEO and Managing Directr Dr. Marie Rskrw. The presentatin will prvide an verview f Patrys business and prtfli including: PAT-SM6 multiple myelma trial including interim results frm the first nine patients; Grwing bdy f published evidence supprting PAT-SM6 as a ptential cancer treatment fr multiple myelma Cmmercialisatin pathway fr PAT-SM6 explring ptential deal envirnment; and Updates n PAT-SC1 fr the treatment f gastric cancer, the cmpany s mst advanced asset, and pre-clinical asset PAT-LM1 fr slid tumurs. The presentatin is attached. -Ends- Fr further infrmatin, please cntact: Patrys Limited: Patrys IR: Patrys Media: Dr. Marie Rskrw Rebecca Wilsn Shevaun Cper Chief Executive Officer Buchan Cnsulting Buchan Cnsulting P: P: P: inf@patrys.cm rwilsn@buchanwe.cm.au scper@buchanwe.cm.au Abut Patrys Limited: Based in Melburne, Australia, Patrys (ASX: PAB) is fcused n the develpment f natural human antibdies as therapies fr cancer and ther majr diseases. Patrys has a deep pipeline f anti-cancer natural human antibdies that qualify fr bth internal develpment and partnering pprtunities. Mre infrmatin can be fund at Abut The BIO Investr Frum: The 12th Annual BIO Investr Frum is an internatinal investr cnference fcused n private and emerging public bitech cmpanies. Their missin is t supprt industry-wide success, and present a brad and unbiased view f investment pprtunities. In additin, the BIO Investr Frum draws business develpment executives frm leading glbal pharmaceutical and established bitechnlgy cmpanies. 1

2 Investr Presentatin Dr. Marie Rskrw, CEO & Managing Directr Octber 2013 ASX: PAB

3 Safe Harbur Statement The fllwing material is fr general infrmatin purpses nly and is nt t be relied upn fr the making f an investment decisin. Any investment in Patrys Limited ACN (Patrys) is subject t investment risk including the pssibility f lss f capital invested and n return f incme r payment f dividends. Neither Patrys nr any ther entity r persn in r assciated with the Patrys grup f cmpanies guarantees any return (whether capital r incme) r generally the perfrmance f Patrys r the price at which its securities may trade. In particular, this presentatin is nt a recmmendatin, ffer r invitatin t subscribe fr r purchase Patrys securities. It is nt fr general distributin r third party reliance r use. While it has been prepared frm surces Patrys believe t be reliable, Patrys cannt guarantee its accuracy r cmpleteness and undertakes n bligatin t advise f changes r updates t any such materials. These materials are nt exhaustive f all f the infrmatin a ptential investr r their prfessinal adviser wuld require. Nr d these materials take int accunt any specific bjectives, financial situatin r needs f investrs. In additin, the past perfrmance f Patrys cannt be assumed as indicative f the future perfrmance f the cmpany. Fr these and ther reasns, befre making any investment decisin regarding Patrys securities yu are strngly recmmended t btain yur wn up t date independent legal, financial and investment advice thse acting withut such advice d s at their wn risk. Where this presentatin des cntain any frward lking statements, thse statements are nly made as the date f the presentatin and are t be cnsidered at-risk statements nt t be relied upn as they are subject t further research and t knwn and unknwn risks, uncertainties and ther factrs that may lead t actual results differing frm any frward lking statement. This is particularly the case with cmpanies such as Patrys which perate in the field f researching, discvering, develping, and cmmercialising ptential drugs intended fr safe and effective fr human treatments r therapies. 2 Investr Presentatin Octber 2013

4 Human Antibdy Therapeutics Funded in 2007, listed n ASX Current market cap. $14.7 M AU headquarters, R&D in Würzburg, Germany Cre human IgM mnclnal antibdy assets in develpment: PAT-SM6 Phase I/IIa antibdy in multiple myelma with blckbuster ptential PAT-SC1 clinical prduct with 10-year survival data PAT-LM1 preclinical prduct against nvel target >300 clnes available fr target characterisatin wrk In 2012 raised $2.85 millin thrugh Australian private share placement 3 Investr Presentatin Octber 2013

5 Experienced Bard & Management Marie Rskrw, BSc (Hns), MBBS, PhD Managing Directr, CEO University f Lndn, GSF Munich, Lazard Ltd. Rger McPhersn, CPA, GAICD CFO, Cmpany Secretary Cerylid Bisciences Ltd, Amrad Crpratin Ltd Frank Hensel, PhD Vice President R&D OncMab GmbH Jhn Read, BSc (Hns), MBA, FAICD Nn-Executive Chairman Pr-Pac Packing Ltd, Envirn. Gp. Ltd, CVC Private Equity Mike Strk, BBA Nn-Executive Directr Dspfactry Ltd, Unitrn Industries Ltd. Alan Rbertsn, BSc, PhD Nn-Executive Directr Faulding Ltd, Amrad Ltd, Pharmaxis Ltd. Suzy Jnes Nn-Executive Directr Genentech, DNA Ink 4 Investr Presentatin Octber 2013

6 A Diversified Prtfli Patrys strategy is t discver and develp natural human antibdies fr the treatment f cancer with a fcus n partnering prducts at key value pints t maximise sharehlder value IgM antibdies: Bdy s 1st line f defence as part f innate immune respnse Large bilgic structures capable f binding & killing several tumur cells at the same time Each antibdy prduced binds a unique cancer-specific target Strng evidence f safety and tlerability in patients: PAT-SC1 Phase I/IIa trial in stmach cancer PAT-SM6 Phase I trial in melanma & Phase I/IIa in multiple myelma Strng evidence f lng-term effectiveness in patients: 10 yr survival data frm 1st prf-f-cncept clinical trial (PAT-SC1 in stmach cancer) Able t be manufactured t cmmercial scale using PER.C6 cell line Avid large ryalty stack payable n IgG antibdies 5 Investr Presentatin Octber 2013

7 Pipeline Prduct (Target) Discvery Preclinical Phase I Phase 2a PAT-SM6 (GRP78) PAT-SM6 (GRP78) PAT-LM1 (NONO) PAT-SC1 (CD55) PAT-SM3 PAT-NM1 Melanma Multiple Myelma Slid Tumurs Gastric Cancer Phase I Cmpleted Phase I/IIa Cmmenced 4Q2012 Phase I/IIa Cmpleted Out- Licensing Candidate 6 Investr Presentatin Octber 2013

8 PAT-SM6

9 Patrys Lead Antibdy: PAT-SM6 PAT-SM6: IgM istype, λ-light chain Islated frm stmach cancer patient Targets tumur specific epitpe n GRP78 Binds als t xidised LDL and VLDL Mde f Actin: Internalisatin upn binding f xidised LDL & GRP78 PAT-SM6 Internalisatin triggers apptsis In viv & In vitr Reactivity: Effective in multiple xengraft mdels Expressin data shw specific expressin in wide range f tumurs incl. melanma and myelma 8 Investr Presentatin Octber 2013

10 PAT-SM6 Melanma Phase I Trial 9 Patients enrlled at Ryal Adelaide Hspital and Princess Alexandra Hspital, Brisbane: Octber 2010 February 2012 Primary endpint: N adverse events recrded in any patient Secndary endpints: Half-life f 5.7 hurs reprted (pharmackinetics) N evidence f anti-pat-sm6 antibdies (immungenicity) Presence PAT-SM6 detected by IHC in 3 pst-treatment bipsies Cell-death (apptsis) detected in 2 pst-treatment bipsies 9 Investr Presentatin Octber 2013

11 Multiple Myelma - Opprtunity Multiple Myelma Opprtunity A cancer f the plasma cells in bne marrw. These cells grw ut f cntrl and frm tumurs in slid bne, cause damage t ther rgans Estimated t be mre than 220,000 cases wrldwide and incidence increasing 5 year survival f ~30% Market expected t increase frm $6B (2012) t >$10B (2018) Market dminated by 3 prducts: Revlimid (net sales $3.7B in 2012) Velcade (net sales $2B in 2012) Thalidmide (net sales $302M in 2012) Several MAbs currently in clinical develpment but nne apprved t date. Likely t be used in cmbinatin therapies Significant interest in MM frm bth large pharmaceutical and bitechnlgy cmpanies 10 Investr Presentatin Octber 2013

12 Preclinical Data Multiple Myelma Patient tissue surced frm 11 patients at primary diagnsis, 9 with relapsed disease and 4 healthy cntrls MM1 Istype Cntrl CD138 PAT-SM6 IHC staining n bne marrw sectins shw binding f PAT-SM6 in 20/20 MM patients (primary and relapsed disease) MM2 MM3 BM withut infiltratin 11 Investr Presentatin Octber 2013

13 Multiple Myelma - Pathlgy Abnrmal plasma cells (myelma cells) secrete lts f useless antibdies (M prteins) Mnclnal gammpathy detected by electrphresis Myelma cells crwd ut ther bld cells resulting in anaemia, thrmbcytpenia (bleeding) and leucpenia (infectins) Abnrmal prteins (Bence Jnes) detected in urine 12 Investr Presentatin Octber 2013

14 Multiple Myelma Presentatin Bne disease and hypercalcaemia Evidence f bne marrw failure 13 Investr Presentatin Octber 2013

15 Therapies fr Multiple Myelma Prtesme inhibitrs Brtezmib (Velcade) Carfilzmib (Kyprlis) Stem cell transplantatin Autlgus Allgeneic IMIDs Lanalidmid (Revlimid) Pmalyst (Pmalidmide) Thalidmide Clinical studies Small mlecules Antibdies, peptides Chemtherapeutics Melphalan Cisplatin Cyclphsphamide Dxrubicin 14 Investr Presentatin Octber 2013

16 Antibdies in Clinical Trials fr MM Eltuzumab (BSM/Abbtt, Phase III) Daratumumab (Genmab/Janssen Bitech, Phase I/II) MOR 202 (MrphSys/Celgene, Phase I/II) PAT-SM6 (Patrys Limited, Phase I/IIa) GRP78 BHQ880 (Nvartis, Phase II) Antibdies in all stages f clinical develpment CD138 txin- cnjugated (BT062, Bitest AG, Phase I/IIa) 15 Investr Presentatin Octber 2013

17 Multiple Myelma Clinical Trial Phase I/IIa pen-label multidse trial in relapsed and multi-resistant patients (N=12 in 4 escalating dsing grups) 4 chrts ( 0.3mg/kg, 1mg/kg, 3mg/kg, 6mg/kg ) Patients receive 4 dses f PAT-SM6 given i.v. ver 2 weeks Primary endpint = safety and tlerability Secndary endpints include Pk, immungenicity, measures f respnse and Prgressin Free Survival (PFS) Screening Day -14 t -1 Treatment Day 1, 3, 8, 10 with PAT-SM6 Ambulatry visits n Day 15 and 22 After cmpletin f Day 15: DSMB decisin n dse escalatin Serlgical staging Day 29 Day 36 PR* PR* SD r PD Treatment Day 36, 38 Serlgical staging Day 52, 59 Clinical Trial Design Treatment Day 43, 45 Serlgical staging Day 59, 66 EOT Day 63 EOT Day 70 PR = Partial Respnse SD = Stable Disease EOT Day 40 PD = Prgressive Disease EOT = End f Trial Visit 16 Investr Presentatin Octber 2013

18 PAT-SM6 Binds t MM Cells in viv CD138 psitive tumur cells btained frm peripheral bld (Patient ) befre and after treatment with PAT-SM6 anti-id CD138 merge Pre-Treatment Pst-Treatment 17 Investr Presentatin Octber 2013

19 Initial Clinical Data - I T date: 9 patients treated with 4 dses PAT-SM6 in 3 dse chrts (0.3mg/kg, 1mg/kg, and 3mg/kg). 4th chrt (6mg/kg/dse) currently underway PAT-SM6 safe in all patients s far. N dse limiting txicity (DLT), n related serius adverse events (SAE) and n related adverse event grade 4 2 / 9 patients had stable disease (day +35 pst treatment) with a significant reductin in prtein M levels in the peripheral bld Median time t next therapy is 42 days (clinically significant). One patient had stable disease fr 127 days pst treatment 7 / 9 patients respnded very psitively t drugs that they had previusly been resistant t (i.e PAT-SM6 makes cancer cells mre sensitive t ther drugs) 18 Investr Presentatin Octber 2013

20 Initial Clinical Data Initial Clinical Data - II Preliminary Efficacy Changes in M-Prtein frm baseline at D36/EOT 140% 120% 114% 100% 80% 60% 40% 42% Stable disease 54% 36.30% Stable disease 48% 40% 20% 0% -20% -40% 13% 1.40% % 0.3 mg/kg 1.0 mg/kg 3.0 mg/kg 2 patients shwed stable disease accrding t the IMWG criteria 19 Investr Presentatin Octber 2013

21 Initial Clinical Data - III Patient Time t Next Therapy Salvage Regimen Respnse t Salvage days VRCD PR Velcade Nvel Agents Prir t PAT-SM days Benda, Pred, Thal VGPR Revlimid, Brtezmib days Tresulfan SD Revlimid days Benda, Velcade PR Pmalyst, Revlimid days Benda, Velcade, Dex SD Velcade, Thalidmide days Velcade, Melphalan SD Revlimid days Carfilzmib na Brtezmib days Pmalyst, Dex PD Carfilzmib, Revlimid days Carfilzmib, Cycl./Dex PR Revlimid PAT-SM6 shwed a median time t next therapy f 42 days which is a clinical benefit Seven patients respnded t drugs t which they had been refractry befre the trial 20 Investr Presentatin Octber 2013

22 Future Optins fr PAT-SM6 Optin 1: D a deal pst current clinical trial Partners Date Values Amgen & Onyx September 2013 Upfrnt $10.4B Prduct (Type) Kyprlis (2 nd gen. Prteasme inhibitr) Stage f Develpment Marketed MrphSys & Celgene June 2013 Upfrnt $92 M Milestnes $60 M Duble digit ryalties MOR202 (Fully human MAb α CD38) Phase I/IIa fr relapsed / refractry myelma Genmab & J&J Janssn Bitech August 2012 Upfrnt $55M Milestnes $1B Equity $80M Duble digit ryalties Daratumumab (Human MAb α CD38) Phase I/IIa fr relapsed / refractry myelma Optin 2: D a deal pst Phase II trial Raise significant cash and cntinue clinical develpment alne 21 Investr Presentatin Octber 2013

23 PAT-LM1

24 PAT-LM1 Antibdy & Target PAT-LM1: IgM istype, λ-light chain Islated frm a lung cancer patient Targets tumur-specific epitpe f surface-expressed NONO (nn-pou-dmain-cntaining ctmer binding prtein) Mde f Actin: NONO mainly fund in nucleus: invlved in transcriptinal & pst-transcriptinal gene regulatin Unknwn mechanism-f-transprt t cell membrane Crystal structure f NONO with PSPC1 Passn et al PNAS 2012 In Viv & In Vitr Reactivity: Effective in several xengraft mdels Expressin data shw specific expressin in a wide range f tumrs incl. lung, pancreas, cln, leukaemias 23 Investr Presentatin Octber 2013

25 OD655 PAT-LM1 Preclinical Lung Squamus Cell Carcinma + cntrl - cntrl PAT-LM withut C1q cating with 5μ/ml C1q cating 0.3 Cln Adencarcinma Esphagus Squamus Cell Carcinma Breast Ductal Adencarcinma μg 10μg 5μg 1μg 0.5μg IHC staining with PAT-LM1 n varius tumur tissues PAT-LM1 binds C1q, suggestive f CDC LM1 Cntrl Cntrl tumr tumr PAT-LM1 LM-1 treate treate Lung Cancer Animal Mdel (n=10 per grup) Cntrl Cntrl tumr tumr Cytkeratin (n=10 PAT-LM1 per grup) LM-1 treated treated tumr tumr Cytkeratin H&E PAT-LM1 reduced tumur vlume & tumurs shwed areas f apptsis & necrsis H&E (200µg) A) Individual (symbls) and mean Appttic (bar) cells tumr vlume Regressin 24 Necrsis Investr Presentatin A) Individual (symbls) and mean (bar) tumr vlume B) Histlgy n excised tumurs (200µg) Octber 2013 Appttic cells Regressin Necrsis B) Histlgy n excised tumurs

26 PAT-SC1

27 PAT-SC1 (Gastric Cancer) PAT-SC1: Pentameric IgM istype, λ-light chain Islated frm a stmach cancer patient Targets isfrm f CD55 (Decay Accelerating Factr) expressed n surface f multiple types f cancer cells Trial Results: Phase I/IIa pen-label trial cnducted (Germany) Safe in 51 pts receiving single 20 mg dse PAT-SC1 Significant 10 year survival benefit fr 30 pts with minimal residual disease (R0) pstsurgery vs. untreated pts (histric cntrl) Current Stage/Cmpetitin: Currently in ut-licensing prcess N ther knw clinical prducts targeting CD55 26 Investr Presentatin Octber 2013

28 PAT-SC1 Human Trial Open-label Phase I/II study ( ) cnducted at the University f Würzburg, Germany 20 mg PAT-SC1 i.v. 48 hurs prir t gastrectmy 10-Year Survival Data 55% Stmach Cancer 30% 27 Investr Presentatin Octber 2013

29 2013 & 2014 Prjected Milestnes Key Milestne Prjected Timing (CY) PAT-SM6: MM, melanma and GRP78 preclinical data published Orphan drug status btained Cmplete Phase I/IIa multiple myelma (MM) trial enrlment MM data presented at ASH Final results frm MM trial Out-licensing deal PAT-LM1: Prceed with cell line develpment & GMP scale-up Preclinical data published PAT-SC1: Preclinical & clinical trial (gastric cancer) data published Out-licensing deal 1H, H, Q, Q, Q, H, H, H, Other: Cntinue early-stage develpment f PAT-SM3 & PAT-NM Crprate: Ptential fund raising 2H,2013/1H, Investr Presentatin Octber 2013

30 Fr Further Infrmatin Cntact Details: Dr. Marie Rskrw, Chief Executive Officer Mr. Rger McPhersn, Chief Financial Officer Ph: inf@patrys.cm Website: