Vectus Biosystems Limited · ASX:VBS
Vectus Biosystems — Shareholder Meeting (November 2023)
29 slides from Vectus Biosystems's shareholder meeting presentation, Nov 22, 2023
Slide 1: Chairman's Address to the 22 November 2023 Annual General Meeting
ABN 54 117 526 137 Vectus Biosystems Limited Chairman’s Address to the 22 November 2023 Annual General Meeting The 2023 year was very productive and Vectus achieved a significant number of milestones, commencing with the September 2022 finalisation of the Phase Ia human safety clinical trial in coll
Slide 2: Finance, Commercialisation Process and Accugen
ABN 54 117 526 137 Finance The funds expended by the Company during the last year were largely in connection with the finalisation of the Phase Ia and the Phase Ib human clinical trials for VB0004. Cash-on-hand at 30 September 2023 was $1,769,000. In addition, Vectus received a $1,226,161 R&D refund
Slide 3: AGM 2023: Solutions for unmet medical needs
For personal use only AGM 2023 Solutions for unmet medical needs 1
Slide 4: Protein Deposition Diseases
Protein Deposition Diseases Three groups: For personal use only • Fibrosis related diseases Accumulated proteins collagen and fibronectin Common diseases, major unmet needs, fibrosis is the pathology underlying Heart failure Removal of Kidney failure Liver cirrhosis and failure deposited, disease Pu
Slide 5: VB0004 & Cardiac Fibrosis
VB0004 & CARDIAC FIBROSIS For personal use only VB0004 has been shown to: 14‐Week Control • Rescue cardiac tissue damaged by fibrosis Fibrous tissue (blue staining) is visible around blood vessels and extending • Repair existing cardiac damage between muscle fibres • i.e. VB0004 is transformational
Slide 6: VB0004 & Kidney Fibrosis
VB0004 & KIDNEY FIBROSIS For personal use only In the kidney VB0004 has been shown to: 14‐Week Control • Reverse renal interstitial fibrosis at all doses Fibrosis (blue) partially surrounds • Restore normal architecture at all doses some but not all tubukes (i.e. VB0004 is considered transformationa
Slide 7: Benchmarks
Benchmarks For personal use only 15 25 25 D e lta C a rd ia c F ib ro s is (% s u rfa c e a re a ) D e lta R e n a l F ib ro s is (% s u rfa c e a re a ) 20 V B 0 0 0 4 V I P 20 J F V B 0 0 0 4 D e lta S B P (m m H g ) J 10 V B 0 0 0 4 15 V I P 15 F J R2=0.9896 R 2 = 0 . 9 6 8 2 E n a l a p r i l 10
Slide 8: VB0004 – Fibrotic Mediators & CK Activity
VB0004 – Fibrotic Mediators & CK Activity For personal use only Agt Expression (Replicates/ng RNA) 2500 100 B VB0004 reduced P la sm a C rea tin e K in as e (u/L) 2000 80 B VB0004 treatment reduced: 1500 B plasma CK activity in a 60 1000 40 p<0.0005 dose related manner Ang II synthesis 500 20 R = 0
Slide 9: VB0004 & Pulmonary Fibrosis
VB0004 & PULMONARY FIBROSIS For personal use only In the lung: • VB0004 reversed fibrosis present 2 weeks after treatment with bleomycin (an anticancer drug) 16‐Week Control (i.e. VB0004 also transformational in the lung) Increased fibrosis (cyano), reduced capillaries (red dots) Treatment with VB00
Slide 10: Summary of treatment with VB0004
For personal use only Treatment with VB0004 • Reduced profibrotic mediator expression • Reduced Ang II synthesis • Reduced CK activity (potential biomarker) • Reduced SBP • Removed accumulated protein in heart, lung Summary and kidney (i.e. reversed established fibrosis) 8
Slide 11: Removal of established accumulated proteins
For personal use only Removal of established accumulated proteins Mechanism(s) can be accomplished by for • Activating macrophages which then remove the protein Removal • Making protein fibrils more susceptible to of protease digestion Accumulated Proteins 9
Slide 12: Removal of Accumulated Proteins
Removal of Accumulated Proteins For personal use only 25 0 Baseline Normalised Cell Index Fibrosis (% surface area) 20 J -0.1 * 15 J B J -0.2 B 10 * B 5 -0.3 VB0004 -0.2 -0.1 0 Baseline Normalised Cell Index Reversal of fibrosis in heart and kidney Relationship between cellular implies VB0004 stimul
Slide 13: Intellectual Property
INTELLECTUAL PROPERTY For personal use only VB0004 PATENT COVERS VB0004 AND LUNG FIBROSIS • Compositions of matter • Methods of use • Methods of use • Priority date July 2017 • Priority date September 2014 • Expiry 2037 (+5 years on FDA/EMA approval) • Expiry 2034 (+5 years on FDA/EMA approval) VB00
Slide 14: Towards the Clinic
For personal use only the Clinic Towards 12
Slide 15: Synthesis at Scale & Cost
SYNTHESIS AT SCALE & COST For personal use only FIRST GMP SYNTHESIS BY SECOND GMP SYNTHESEIS GLYCOSYN ASSYCHEM • Yield increased as scale increased • Campaign planned to provide 3 • VB0004 manufactured to 5kg scale validation batches • Cost efficient at 5kg scale < $(US)0.05 • Confirm consistency of
Slide 16: Demonstrated Safety
DEMONSTRATED SAFETY (extensive IND Toxicology) For personal use only SAD AND MAD CARDIOVASCULAR RESPIRATORY (2 SPECIES) SAFETY 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
Slide 17: Phase 1a
For personal use only PHASE 1a 5 15
Slide 18: Phase 1a Outcomes
Outcomes SAD All planned doses were completed For personal use only No VB0004 related AE’s Maximum tolerated dose 300mg Metabolised to VB4‐glucuronide undergoes enterohepatic circulation Tmax occurred between 6 and 8 hrs post dose T1/2 between 10 and 15 hrs Plasma concentration decreased by food , T
Slide 19: Phase 1a Outcomes – PK Profile
For personal use only PHASE 1a Plasma VB0004 (ng/ml) Outcomes – PK Profile 17
Slide 20: Phase 1b
For personal use only PHASE 1b 8 18
Slide 21: Phase 1b Aims – Possible Outcomes
Aims – Possible Outcomes For personal use only demonstrate clinical efficacy of VB0004 (↓BP) demonstrate via selected bio‐markers anti‐fibrotic actions of VB0004 on - heart and/or PHASE 1b - kidney correlate ↓BP with VB0004 plasma concentra ons correlate changes in selected bio‐markers with plasma V
Slide 22: VB0004 In Summary
• Fist in class therapeutic For personal use only VIP agonist • Transformational agent reverses existing disease effective removal of deposited proteins restores normal tissue architecture effective in multiple organs • Side effects none discernible in animals or humans even at very high dose VB0004
Slide 23: Austrade BIO23 Advance Australia Delegation
For personal use only Austrade BIO23 Advance Australia Delegation 21
Slide 24: Pharma engagement process
Presentation from Merck (US) outlining their format for engagement. Initial meeting – if interested pharma will ask for non‐confidential deck. For personal use only Review non‐confidential deck – questions and responses. If wanting to proceed the next steps are for pharma to ask for CDA then a confi
Slide 25: Indicative upfront and near term milestones
For personal use only Indicative Upfront and near term milestones $100m Deal Milestones to licensing $1.2bn 23
Slide 26: Regulatory Environment
For personal use only Regulatory Addition of fast‐track category Alzheimer’s disease, Environment heart failure kidney failure 24
Slide 27: Regulatory Environment (cont)
For personal use only Orphan/fast track status from FDA/ EMA Phase 2a for either Open label Regulatory Approx 30 subjects Environment Followed by Phase 2b with 300‐400 subjects (cont) Apply for FDA/EMA approval 25
Slide 28: Patent Portfolio
For personal use only PATENT PORFOLIO VIP patents for heart, VB0004 library of approx. VB4-P5 and library of VB0001 and related kidney and aortic fibrosis 70 related compounds related compounds compounds compositions – granted all jurisdictions compositions and methods compositions and methods and u
Slide 29: Contact
For personal use only CONTACT KAREN DUGGAN MD FRACP Chief Executive Officer kduggan@vectusbiosystems.com.au 27
Vectus Biosystems — Shareholder Meeting (November 2023) on 6ix