Vectus Biosystems Limited · ASX:VBS
Vectus Biosystems — Investor Presentation (August 2021)
39 slides from Vectus Biosystems's investor presentation, Aug 30, 2021
Slide 1: CEO Presentation
For personal use only CEO PRESENTATION www.vectusbiosystems.com.au
Slide 2: Overview
OVERVIEW For personal use only Fibrosis is the replacement of normal tissue (heart, lung, kidney etc) by scar tissue and can lead to organ failure Fibrosis Reversal, Fibrosis is the pathology which underlies: a MAJOR unmet need HEART FAILURE LIVER FAILURE (largest single item on US health (liver cir
Slide 3: Pharma Criteria: Path to the Clinic – VB0004
For personal use only PHARMA CRITERIA VECTUS Validated Target Platform Technology Transformational Agent PATH TO THE Demonstrated Efficacy in Animal Model Demonstrated Safety – IND toxicology CLINIC – VB0004 IP Covers Composition of Matter Synthesis at Scale Cost of Good Competitive Sufficient Paten
Slide 4: Target Validation
TARGET VALIDATION For personal use only Treatment with VIP reversed cardiac fibrosis in multiple animal models data from one was published in the paper entitled “Vasoactive intestinal peptide reverses existing myocardial fibrosis in the rat” (see right) https://doi.org/10.1016/j.ejphar.2019.172629 w
Slide 5: Target Validation
TARGET VALIDATION For personal use only Treatment with VIP was also found to reverse interstitial fibrosis in the kidney in multiple animal models data from one was published in the paper entitled “Vasoactive intestinal peptide infusion reverses existing renal interstitial fibrosis via a blood press
Slide 6: Pharma Criteria: Path to the Clinic – VB0004
For personal use only PHARMA CRITERIA VECTUS Validated Target Platform Technology Transformational Agent PATH TO THE Demonstrated Efficacy in Animal Model(s) Demonstrated Safety – IND toxicology CLINIC – VB0004 IP Covers Composition of Matter Synthesis at Scale Cost of Good Competitive IP Covers Com
Slide 7: VB0004 & Systolic Blood Pressure
VB0004 & SYSTOLIC BLOOD PRESSURE For personal use only Left: Decrease in SBP from controls in 18 week old Middle: Difference in SBP from control for SHR Right: Change in SBP from levels at the SHR treated with VB0004 at 10, 100, 500, 1,000 treated with VB0004 at 2,500 pmol/kg/min at 1, 2, commenceme
Slide 8: VB0004 & Cardiac Fibrosis
VB0004 & CARDIAC FIBROSIS For personal use only VB0004 has been shown to: 14-Week Control Fibrous tissue (blue staining) is visible around blood vessels and extending • Rescue cardiac tissue damaged by fibrosis between muscle fibres • Repair existing cardiac damage • i.e. VB0004 is transformational
Slide 9: VB0004 & Kidney Fibrosis
VB0004 & KIDNEY FIBROSIS For personal use only In the kidney VB0004 has been shown to: 14-Week Control Fibrosis (blue) partially surrounds some but not all tubules • Reverse renal interstitial fibrosis at all doses • Restore normal architecture at all doses (i.e. VB0004 is considered transformationa
Slide 10: VB0004 & Pulmonary Fibrosis
VB0004 & PULMONARY FIBROSIS For personal use only 16-Week Control In the lung: • VB0004 reversed fibrosis present 2 weeks after treatment with bleomycin (an anticancer drug) • i.e. VB0004 also transformational in the lung 20-Week Control Treatment with VB0004 at 3 Doses VB4-A79 at 20 weeks VB0004 at
Slide 11: Summary: First Non-Peptide, Orally Dosed VIP Mimetic
For personal use only VB0004 THE FIRST NON-PEPTIDE, ORALLY DOSED VIP MIMETIC: • Decreased systolic blood pressure in a dose dependent manner SUMMARY • Reversed pre-existing cardiac fibrosis and restored normal cardiac architecture • Reversed pre-existing renal interstitial fibrosis and restored norm
Slide 12: Pharma Criteria: Path to the Clinic – VB0004
For personal use only PHARMA CRITERIA VECTUS Validated Target Platform Technology Transformational Agent PATH TO THE Demonstrated Efficacy in Animal Model(s) Demonstrated Safety – IND toxicology CLINIC – VB0004 IP Covers Composition of Matter Synthesis at Scale Cost of Good Competitive IP Covers Com
Slide 13: Demonstrated Safety
DEMONSTRATED SAFETY For personal use only Sad And Mad (2 Species) Cardiovascular Safety Respiratory Safety • Single Ascending Dose (SAD) to • hERG studies - low arrhythmia • rat study no adverse events 2,000mg/kg no adverse events potential • 7 day Multiple Ascending Dose (MAD) to • Dog cardiovascul
Slide 14: Pharma Criteria: Path to the Clinic – VB0004
For personal use only PHARMA CRITERIA VECTUS Validated Target Platform Technology Transformational Agent PATH TO THE Demonstrated Efficacy in Animal Model(s) Demonstrated Safety – IND toxicology CLINIC – VB0004 Synthesis at Scale Cost of Good Competitive IP Covers Composition of Matter Sufficient Pa
Slide 15: Synthesis Scale and Cost
FIRST GMP SYNTHESIS BY GLYCOSYN • Yield increased as scale increased For personal use only • VB0004 manufactured to 5kg scale • Cost efficient at 5kg scale < $(US) 0.05 per mg • Estimated dose 1-5mg SYNTHESIS • Stability studies – stable at 2 yrs (long shelf-life) SCALE AND Second GMP synthesis Assy
Slide 16: Pharma Criteria: Path to the Clinic – VB0004
For personal use only PHARMA CRITERIA VECTUS Validated Target Platform Technology Transformational Agent PATH TO THE Demonstrated Efficacy in Animal Model(s) Demonstrated Safety – IND toxicology CLINIC – VB0004 IP Covers Composition of Matter Synthesis at Scale Cost of Good Competitive IP Covers Com
Slide 17: Intellectual Property
VB0004 patent covers • Compositions of matter For personal use only • Methods of use VB0004 Patent granted in all major jurisdictions • USA, Europe, Japan, Peoples Republic of China, Republic of South Korea, Russian Federation INTELLECTUAL • as well as Australia, Israel, Phillipines, South Africa, C
Slide 18: Pharma Criteria: Path to the Clinic – VB0004
For personal use only PHARMA CRITERIA VECTUS Validated Target Platform Technology Transformational Agent PATH TO THE Demonstrated Efficacy in Animal Model(s) Demonstrated Safety – IND toxicology CLINIC – VB0004 IP Covers Composition of Matter Synthesis at Scale Cost of Good Competitive IP Covers Com
Slide 19: Phase 1
For personal use only • Syneos Health (Nasdaq SYNH) retained to write Investigator Brochure (IB), trial protocol and monitor Phase 1 trial • Trial design conventional Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) • Healthy subjects 14 day MAD PHASE 1 • Affected individuals 2 groups 2
Slide 20: Fibrotic Liver Disease VB4-A32
For personal use only Fibrotic Liver Disease VB4-A32 www.vectusbiosystems.com.au 20
Slide 21: Hepatic Cirrhosis (Liver Fibrosis)
For personal use only Causes Prevalence HEPATIC • genetic • varies to >40% of the CIRRHOSIS population in countries such • infectious (Hep A, B, C) as India, Cambodia, Vietnam • alcohol related and China due to endemic (LIVER Hep B & C. • Diabetic FIBROSIS) • due to obesity • cryptogenic (no discern
Slide 22: Current Therapies
For personal use only • Vaccination Hep A, Hep B for prevention • Abstinence to prevent further damage (EtOH) weight loss • Diabetes management CURRENT • Symptom relief (albumin infusion, ascites THERAPIES removal) • Sofosbuvir and related agents for Hep C (note this treats the infection but does no
Slide 23: Potential Therapies
POTENTIAL THERAPIES For personal use only • FXR agonists – Phase 2 reduced liver fat at 6 months, Phase 3 no change in liver fat, decreased fibrosis at 18 months in 18-23% of patients, none achieved resolution of fibrosis. Side effects - itching moderate to severe in intensity in up to 50% • PPAR-α/
Slide 24: Summary – Liver Fibrosis
For personal use only • No current approved therapy SUMMARY – • Potential therapies – ineffective and/or high LIVER FIBROSIS incidence of side effects • Liver Fibrosis continues to represent an unmet therapeutic need www.vectusbiosystems.com.au 24
Slide 25: VB4-A32 & Hepatic Cirrhosis
VB4-A32 & HEPATIC CIRRHOSIS For personal use only VB4-A32 demonstrated ability to: • reduce peri-portal fibrosis in the liver in a dose dependent manner (right and below) • Improve liver function tests (below right) 20-Week Control A32 20 Weeks www.vectusbiosystems.com.au 25
Slide 26: Fibrotic Lung Disease VB4-A79
For personal use only Fibrotic Lung Disease VB4-A79 www.vectusbiosystems.com.au 26
Slide 27: Pulmonary Fibrosis
PULMONARY FIBROSIS For personal use only Causes Essentially, a triggering factor such as coal or • Environmental (e.g. air pollution, diesel silica dust accumulates in the lung which particles) initiates a scarring (fibrotic) reaction to wall • Occupational (e.g. dusts such as silica, off the irrita
Slide 28: Current Therapies
For personal use only Two current therapies: Pirfenidone regulatory approval approximately 5 years ago. CURRENT Slows lung function (FVC and 6MWD) decline. Approximately 50% discontinued or reduced dose THERAPIES due to side effects. Nintedanib regulatory approval approximately 5 years ago also slow
Slide 29: Potential Therapies
• Pentraxin 2 analogue – Phase 2 showed significant slowing of the decline in FVC and stabilisation of 6MWD at 6 For personal use only months • Anti-CTGF antibodies – Phase 2 slowed decline in FVC and 6MWD (awaiting review) • Medium Chain Fatty Acid Analogue (PBI4050) – Phase 2 PBI4050, alone or com
Slide 30: VB4-A79: Blood Pressure
For personal use only Current therapies – slow the decline in lung function compared with placebo, but have a high incidence of unacceptable side effects VB4-A79: BLOOD Potential therapies – slow decline or at best stabilise lung function PRESSURE Pulmonary Fibrosis continues to represent an unmet t
Slide 31: VB4-A79: Blood Pressure
VB4-A79: BLOOD PRESSURE For personal use only Systolic and diastolic blood pressure in 20- week SHR following treatment with bleomycin at 14 weeks and randomisation to control, VB0004 or VB4-A79 at 16 weeks. As previously VB0004 significantly decreases both systolic and diastolic pressure while VB4-
Slide 32: VB4-A79 Pulmonary Fibrosis
VB4-A79 PULMONARY FIBROSIS For personal use only 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. VB0004 and VB4-A79 were administered at 500pmol/kg/min in the drinking solution (5% etha
Slide 33: VB4-A79 Histology
VB4-A79 HISTOLOGY For personal use only 16-Week Control 20-Week Control VB4-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
Slide 34: Vectus in Summary
For personal use only • 3 first in class assets addressing major unmet therapeutic needs • VB0004 – entering Phase1, addressing Systolic Hypertension, cardiac, renal and pulmonary fibrosis, possible orphan indication for scleroderma VECTUS IN • VB4-A32 – addresses liver fibrosis, restored normal liv
Slide 35: Use of Funds
For personal use only • VB0004 – Phase 1 • VB4-A32 – undertake GMP synthesis (Assymchem), with IND toxicology studies to USE OF FUNDS follow • Laboratory – further work on detailed mechanisms of action for VB4-A32, VB4-A79 • Diversify to encompass other areas of unmet therapeutic need and investigat
Slide 36: Why Alzheimers
WHY ALZHEIMERS For personal use only Accumulation of B-amyloid in the brain causes formation of plaques, which disrupt neuronal connections and cause accumulation of Tau proteins, which are dissociated from microtubules within neurones causing tangle formation, a precursor to neuronal cell death. ww
Slide 37: Patent Portfolio
PATENT PORTFOLIO For personal use only • VIP patents for heart, kidney and aortic fibrosis – granted all • VB4-P5 and library of related compounds compositions jurisdictions and methods of use for treatment of renal cell death, • VIP fragment patents compositions and methods of use for renal fibrosi
Slide 38: Comparable Transactions
Comparable Transactions For personal use only 1 0 0 ,0 0 0 1 0 ,0 0 0 In te rM u n e V a lu a tio n ($ U S m illio n ) G a la p a g o s (P F ) G a la p a g o s P F T o b ira • Successful Phase 1/1b would place Vectus at the G a la p a g o s (R A & C ) P ro m e d io r 1 ,0 0 0 N im b u s A p o llo R
Slide 39: VIP Agonists – The Benchmark for Anti-Fibrotics
For personal use only VIP AGONISTS – TH BENCHMARK FOR ANTI-FIBROTICS www.vectusbiosystems.com.au 39
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