Vectus Biosystems Limited · ASX:VBS
Vectus Biosystems — Shareholder Meeting (November 2016)
47 slides from Vectus Biosystems's shareholder meeting presentation, Nov 17, 2016
Slide 1: Chairman's Address to 17 November 2016 AGM
ABN 54 117 526 137 For personal use only Vectus Biosystems Limited Chairman’s Address to 17 November 2016 Annual General Meeting The 2015-16 financial year has seen a continued series of milestones achieved by the Company, together with the successful Initial Public Offering (IPO) of Vectus in Febru
Slide 2: Chairman's Address (continued)
The size of the Company’s Board was expanded during the last financial year, with Dr Ron Shnier, an eminent Radiologist with an enviable track record in both the clinical and research arenas, becoming a Director in September 2015, and Dr Susan Pond becoming a Director in May 2016, bringing with her
Slide 3: Annual General Meeting 2016
For personal use only Annual General Meeting 2016
Slide 4: Achievements 2016
Achievements 2016 For personal use only • Successful IPO • ASX listing Feb 2016 • GMP synthesis almost complete (edd Dec 2016) • Toxicology commenced (2 species) • Major expansion in IP Granting US patent for VB0004 (compositions and methods of use) PCT applications for A32 and P5 libraries (com
Slide 5: Oral VIP Agonists: Transformational Platform for Fibrotic Disease
For personal use only Oral Vasoactive Intestinal Peptide (VIP) Agonists The Transformational Platform To Manage Fibrotic Disease
Slide 6: Why Fibrosis?
Why Fibrosis? For personal use only Fibrosis is the pathology which underlies Heart failure (largest single item on US health care budget ($US32b in 2013) Kidney failure (Dialysis and renal transplant costs in the US reached $49.2b in 2011) Liver failure (also precursor to liver cancer) Re
Slide 7: Why VIP?
Why VIP? For personal use only VIP reversed fibrosis in multiple models Myocardial Fibrosis (% surface area) 30 a p<0.05 p<0.0005 a normotensive rats on 4.4% salt diet treated with VIP (5pmol/kg/min) or control vehicle infusion for 4 weeks 20 b rats on 4.4% salt diet plus L-NAME (10mg/kg/day)
Slide 8: Hypertension, Cardiovascular and Renal Disease
For personal use only HYPERTENSION, CARDIOVASCULAR AND RENAL DISEASE
Slide 9: Why Include Hypertension?
Why Include Hypertension? For personal use only Hypertension affects 40% of the adult population worldwide (exceeding the predicted 30% in 2025) less than 25% of patients achieve target blood pressure it is the major risk factor for heart failure kidney failure stroke dementia No cur
Slide 10: Systolic Blood Pressure
Systolic Blood Pressure For personal use only 30 50 30 VIPAG 1b Change in SBP (mmHg) Decrease in SBP (mmHg) B B Decrease in SBP (mmHg) 20 40 20 10 30 B B J 0J B B 20 B 10 -10 J enalapril 10 B -20 R2=0.9553 2 R =0.9347 0 0 -30 1 10 100 1000 10000 0 2 4 0 2 4 6 8 10 D ose (pm ol/kg/m in) Time (weeks)
Slide 11: Myocardial Fibrosis
Myocardial Fibrosis For personal use only 25 Upper Panel: Myocardial fibrosis after 4 weeks treatment with VIP (5pmol/kg/min) or enalapril (dose adjusted to maintain the same BP reduction as VIP average dose 705 Myocardial Fibrosis (% surface area) # 20 pmol/kg/min). * p<0.005, ** p<0.001, *** p<0
Slide 12: Cardiac Histology
Cardiac Histology For personal use only Control 14 weeks Control 18 Weeks 18 Weeks 5% EtOH Heart sections stained with Masson trichrome, fibrous tissue appears blue- cyano in colour Upper Panels: 14 week control fibrosis is predominantly around blood vessels with some interstitial extension 18 week
Slide 13: Renal Fibrosis
Renal Fibrosis For personal use only In humans increasing interstitial fibrosis in the kidney parallels the decline in renal function leading to 30 # Renal Interstitial Fibrosis (% surface area) p<0.0005 dialysis 20 Upper panel shows results from 14 week old SHR on ## 2.2% salt diet which were r
Slide 14: Renal Histology
Renal Histology For personal use only Kidney sections stained with Masson trichrome, fibrous tissue appears blue in colour Control 14 weeks Control 18 Weeks 18 Weeks 5% EtOH Upper Panels: 14 week control: fibrosis surrounds some but not all tubules 18 week vehicle control: marked increase in interst
Slide 15: Market Metrics
Market Metrics For personal use only • Fibrotec – Shire FT011 Phase I renal only $75m upfront up to $600m milestone payments • Reata – Abbott bardoxolone renal only $850m plus royalties
Slide 16: Current Status
Current Status For personal use only • GMP synthesis almost complete 1kg engineering batch manufactured main 5kg batch edd Dec 2016 • toxicology and pharmacokinetic studies have commenced • tendering process for Phase1 underway • engagement with most of the major pharmaceutical firms with an int
Slide 17: Fibrotic Lung Disease
For personal use only Fibrotic Lung Disease
Slide 18: Pulmonary Fibrosis
Pulmonary Fibrosis For personal use only Causes • Environmental (e.g. air pollution, diesel particles) • Occupational (e.g. dusts such as silica, coal, asbestos, cotton dust) • Infections (e.g. TB, psittacosis) • Drugs (e.g. bleomycin, methotrexate), • Radiation • Autoimmune diseases (e.g. sarcoid,
Slide 19: Aims
Aims For personal use only The aim was to evaluate VB0004 as a treatment for conditions such as scleroderma where severe hypertension and pulmonary fibrosis co-exist. Cardiac and renal fibrosis may also be present in this disease. A second aim was to develop a non-blood pressure lowering analogue of
Slide 20: Why Scleroderma and IPF?
Why Scleroderma and IPF? For personal use only • Scleroderma and IPF have been declared orphan diseases by the FDA • Affect <200,000 people or if >200,000 no prospect of recovery in US <1 in 2,000 people in Europe no current therapy • Grants available for clinical trials in US • Restricted marke
Slide 21: Blood Pressure
Blood Pressure For personal use only 250 SBP DBP 200 p<0.005 Blood Pressure (mmHg) p<0.001 150 100 50 0 Control VB0004 A79 Systolic and diastolic blood pressure in 20 week SHR following treatment with bleomycin at 14 weeks and randomisation to control, VB0004 or A79 at 16 weeks. As previously VB0004
Slide 22: Pulmonary Fibrosis
Pulmonary Fibrosis For personal use only 30 Pulmonary Fibrosis (% surface area) # 20 ## ## * * 10 0 Control 16 VB0004 A79 Control 20 Pulmonary fibrosis in 16 week controls (two weeks after Bleomycin administration) and at 20 weeks after 4 weeks treatment in VB0004, A79 and vehicle control rats. VB00
Slide 23: Histology
Histology For personal use only 16 Week Control 20 Week Control A79 at 20 Weeks VB0004 at 20 Weeks Lung sections in bleomycin treated rats after 2 weeks of control drinking solution (left), after 6 weeks of control drinking solution (centre) and after 2 weeks of control drinking solution followed by
Slide 24: Summary
Summary For personal use only VB0004 reverses fibrosis in lung as well as in heart and kidney in addition to lowering BP making it a suitable agent for treatment of scleroderma A79 reverses pulmonary fibrosis but does not affect blood pressure making it suitable for treatment of other causes of pulm
Slide 25: Market Metrics
Market Metrics For personal use only • InterMune – Roche Pirfenidone IPF FDA approved $8.3bn acquisition • Promedior – BMS PRM-151 Phase IIA IPF $125m plus $1.1bn milestones • Inventiva – Boerhinger Ingelheim IVA-337 Phase I IPF & scleroderma €170m plus royalties • Galecto –
Slide 26: Fibrotic Liver Disease
For personal use only Fibrotic Liver Disease
Slide 27: Hepatic Cirrhosis (Liver Fibrosis)
Hepatic Cirrhosis (Liver Fibrosis) For personal use only Causes genetic, infectious (Hep A, B, C) alcohol related, diabetic due to obesity cryptogenic (no discernible cause) Prevalence varies to >40% of the population in countries such as India, Cambodia, Vietnam and China due to endemic Hep B & C.
Slide 28: Current Therapies
Current Therapies For personal use only •vaccination Hep A, Hep B for prevention •abstinence to prevent further damage (EtOH) •weight loss, •diabetes management, •symptom relief (albumin infusion, ascites removal) •sofosbuvir and related agents for Hep C (note this treats the infection but does not
Slide 29: NASH Video
For personal use only NASH Video
Slide 30: A32 – Liver
A32 – Liver For personal use only 20 Week Control A32 20 Weeks 150 140 AST (Iu/L) 130 p<0.05 120 110 100 Control A32 10 Liver p<0.005 8 Hepatic Fibrosis (% surface area) Treatment with A32 for 6 weeks in a rat model 6 of liver cirrhosis resulted in significant 4 improvement in liver function (above
Slide 31: Market Metrics
Market Metrics For personal use only Nimbus Apollo – Gilead NDI-010976 NASH $400m upfront & $800m milestones Pharmaxis – Boerhinger Ingelheim PXS4728A NASH $39m upfront & $711 milestones Tobira – Allergan DPP-4 NASH $615m upfront & $1.08bn milestones
Slide 32: Market Metrics Summary
Market Metrics Summary For personal use only
Slide 33: External Recognition
External Recognition For personal use only AusBiotech Updates Australian biotech wins technology award for global potential 8 November 2016: Australian biotechnology company Vectus Biosystems has won the 'Medtech & Pharma' category in the Australian Technologies Competition (ATC), which was announce
Slide 34: Patent Portfolio
Patent Portfolio For personal use only VIP patents for heart, kidney and aortic fibrosis - granted most jurisdictions VIP fragment patents compositions and methods of use for hypertension, cardiac, renal and aortic fibrosis – granted most jurisdictions VB0004 compositions and methods of use for hype
Slide 35: Patent Portfolio (cont)
Patent Portfolio (cont) For personal use only P5 and library of related compounds compositions and methods of use for treatment of renal cell death, renal fibrosis and heptic fibrosis - PCT application GMP method of synthesis VB0004 - PCT application A79 and related compounds compositions and use fo
Slide 36: Advantages
For personal use only Advantages •Transformational technology – Reverses fibrotic disease Unique selling point Large market(s) – unmet need Strong argument for re-imbursement •Strategic area(s) of interest: Pfizer, GSK, Roche, Merck, Sanofi, Novartis, BMS, Boehringer Ingelheim •Validated global p
Slide 37: VIP Agonists: the benchmark for anti-fibrotics
For personal use only VIP Agonists: the benchmark for anti-fibrotics
Slide 38: AccuCal and RealCount: a new standard in qPCR
For personal use only AccuCal™ and RealCount™: a new standard in qPCR Vectus Biosystems Limited - Annual General Meeting November 17, 2016
Slide 39: What is qPCR?
What is qPCR? For personal use only • Quantitative real-time polymerase chain reaction. • Gene expression analysis, genotyping, pathogen detection, food safety and drug target validation. • Research, pharmaceutical development, clinical diagnostics.
Slide 40: The problem
The problem: For personal use only • Relative quantification: requires reference (or “housekeeping”) genes – sometimes these just don’t exist. • Absolute quantification: requires construction of a standard curve – time-consuming, expensive, only valid for a single gene.
Slide 41: The solution
The solution: For personal use only • Patented method (AU 2009904258) • AccuCal™ - a consumable DNA calibrator. • RealCount™ - a software package that processes raw qPCR data and performs the quantitation calculation.
Slide 42: The solution
The solution: For personal use only • Reference genes no longer needed – opens up new experimental possibilities. • Accuracy of standard curve method – applicable to all genes. • Fast, simple, cheap, universally applicable.
Slide 43: The solution
The solution: For personal use only • Reference genes no longer needed – opens up new experimental possibilities. • Accuracy of standard curve method – applicable to all genes. • Fast, simple, cheap, universally applicable. AccuCal™ and RealCount™: a new standard in qPCR
Slide 44: Market potential
Market potential For personal use only • Worldwide qPCR market: US$500 million by 2018 - no market leader • 35% instrumentation, 65% consumables (master mix: premade reagent mix for performing qPCR) • Accugen total addressable market: -Australia: ~$6 million -World: ~$100 million
Slide 45: Commercialisation
Commercialisation For personal use only • Ongoing: product trial in labs across Sydney. • Market research survey pre and post-use: usability and pricing information. • Publication of paper in BMC Biotechnology has generated international interest.
Slide 46: Commercialisation
Commercialisation For personal use only • Business model: licensing deal with an established, multinational molecular biology consumables supplier. • With no market leader, a licensing partner gets increased market share. • Leverages established sales team, contacts and infrastructure.
Slide 47: Summary
Summary For personal use only • Accugen solves a recognised problem in a sizable market. • Using AccuCal™ and RealCount™ can save the user time and money and deliver increased confidence in the accuracy of results. • We have identified a business model that can provide a revenue stream to your compa
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