VECTUS BIOSYSTEMS (ASX:VBS)

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CORPORATE SNAPSHOT

KEY METRICS

ASX	VBS
Shares on issue	31.87m
Market Capitalisation	$52.59m
Share Price (8/11/21)	$1.65
52-week trading range	$0.88- $2.20

BOARD OF DIRECTORS

Dr Ronald Shnier

Non-Executive Director and Chairman

Mr Maurie Stang

Non-Executive Director and Deputy Chairman

SHAREHOLDER BREAKDOWN

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19.04% Board of Directors
39.94% Top20
41.23% Other
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Dr Karen Duggan Executive Director and Chief Executive Officer

Mr Peter Bush Non-Executive Director

Dr Susan Pond

Non-Executive Director

INVESTMENT HIGHLIGHTS

3 FIRST IN CLASS ASSETS ADDRESSING MAJOR UNMET THERAPEUTIC NEEDS

VB0004 – In Phase1, addressing Systolic Hypertension, cardiac, renal and pulmonary fibrosis, possible orphan indication for scleroderma

VB4-A32 – Addresses liver fibrosis, restored normal liver architecture in NASH/ASH models

EXCEPTIONAL PATENT PORTFOLIO ENCOMPASSING A LIBRARY OF > 1,000 COMPOUNDS

VB0004 Patent granted in all major jurisdictions including USA, Europe, Japan, Peoples Republic of China, Republic of South Korea, Russian Federation, as well as Australia, Israel, Philippines, South Africa, Canada, ARIPO

SUCCESSFUL CAPITAL RAISE OF $7 MILLION COMPLETED IN NOVEMBER 2020

HIGHLY EXPERIENCED BOARD AND MANAGEMENT TEAM

Strongly positioning the Company With a proven track record in to accelerate the development of developing and commercialising VB004 biotechnology

VB4-A79 – Addresses pulmonary fibrosis from all causes except scleroderma where BP lowering probably required, revered

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A SIGNIFICANT MARKET

Fibrosis is the thickening and scarring of connective tissue, usually as a result of injury, and is the pathology which underlies:

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HEART FAILURE (largest single item on US health care budget $US32b in 2013)

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LIVER FAILURE (40% of population of China, India and South East Asia are affected)

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KIDNEY FAILURE (Dialysis and renal transplant costs in the US reached $49.2b in 2011)

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RESPIRATORY FAILURE (pulmonary fibrosis)

2022 CATALYSTS

	• Complete Phase 1 of Human Safety Trials
	• Complete Phase 1B Human Trials
VB0004	• Initiate engagement with global pharmaceutical companies
	• Initiate specific programs to encompass other areas of significant unmet
	therapeutic needs (e.g. post Covid fibrosis)*ZQ
VB4-A32	undertake GMP synthesis (Assymchem), with IND toxicology studies to follow
NEW EMERGING LEADS	further work on detailed mechanisms of action for VB4-A32, VB4-A79
EXPAND	facilities and resources to undertake a broader drug development program
	candidates from Vectus’ extensive patented library for roles in other fibrotic /
INVESTIGATE	protein accumulative diseases such as osteoarthritis, retinal fibrosis, Alzheimer’s
	disease
DEVELOPMENT	Broaden Accugen commercial roll out with latest release of the AccuCal software platform

– PATH TO CLINIC VB0004

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Validated Platform TransformDemonstrated Demonstrated Synthesis Cost of IP Covers Sufficient Phase I Human pD Target Technology ational Efficacy in Safety – IND at Scale Goods Composition Patent Life Safety (Efficacy) Agent Animal toxicology Competitive of Matter Study data Model COMPLETED In Progress Pharma Criteria

TARGET VALIDATION

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”

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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 pressure independent mechanism in the rat”

– PATH TO CLINIC VB0004

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VB0004 & SYSTOLIC BLOOD

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Left: Decrease in SBP from controls in 18 week old SHR treated with VB0004 at 10, 100, 500, 1,000 and 2,500 pmol/kg/min for 4 weeks. Enalapril dose to achieve a reduction of 7mmHg was 705 pmol/kg/min. SBP decreased with increasing dose to 2,500 pmol/ kg/min.

Middle: Difference in SBP from control for SHR treated with VB0004 at 2,500 pmol/kg/min at 1, 2, 4, 6 and 8 weeks. The maximal effect of VB0004 in lowering SBP was not reached after 8 weeks treatment

Right: Change in SBP from levels at the commencement of the experiment in Vehicle control for 4 weeks (solid line) SHR treated with VB0004 2,500pmol/ kg/min for 2 weeks then vehicle for 2 weeks (dotted line) SBP in increased in parallel with vehicle control after cessation of VB0004

VB0004 & CARDIAC FIBROSIS

VB0004 has been shown to:

14-Week Control

Rescue cardiac tissue damaged by fibrosis
Repair existing cardiac damage

Fibrous tissue (blue staining) is visible around blood vessels and extending between muscle fibres

i.e. VB0004 is transformational

Treatment with VB0004 at 3 Doses

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At the highest dose (500pmol/kg/min), VB0004 reversed pre-existing fibrosis, while a dose response effect on the level of fibrosis is apparent

5% Ethanol 18-Week Control (Vehicle Control For VB0004)

Fibrosis visible as blue stained tissue is present throughout the section

Heart At 18 Weeks After 4-week Treatment with VB0004 (500 Pmol/Kg/Min)

Minimal fibrosis is visible; normal architecture has been restored

VB0004 & KIDNEY FIBROSIS

In the kidney VB0004 has been shown to:

Reverse renal interstitial fibrosis at all doses

14-Week Control

Fibrosis (blue) partially surrounds some but not all tubukes

Restore normal architecture at all doses
(i.e. VB0004 is considered transformational)

5% Ethanol 18-Week Control (Vehicle Control For VB0004)

Treatment with VB0004 at 3 Doses

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Fibrosis has progressed to surround most tubules Kidney At 18 Weeks After 4-week Treatment with VB0004 (500 Pmol/Kg/Min) No fibrosis visible

VB0004 & PULMONARY FIBROSIS

In the lung:

VB0004 reversed fibrosis present 2 weeks after treatment with bleomycin (an anticancer drug)
(i.e. VB0004 also transformational in the lung)

Treatment with VB0004 and VB4-A79

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14-Week Control 20-Week Control VB4-A79 at 20 weeks VB0004 at 20 weeks

– PATH TO CLINIC VB0004

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DEMONSTRATED SAFETY

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SAD AND MAD (2 SPECIES)

Single Ascending Dose (SAD) to 2,000mg/kg no adverse events
7 day Multiple Ascending Dose (MAD) to 2,000mg/kg no adverse events

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CARDIOVASCULAR SAFETY

hERG studies - low arrhythmia potential
Dog cardiovascular safety – No effects on cardiovascular function at maximum dose of 10 grams

RESPIRATORY SAFETY

• Rat study no adverse events

28 day MAD to 500mg/kg no adverse

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MUTAGENIC POTENTIAL

• In vivo and in vitro tests low to no mutagenic potential

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METABOLISM

• Metabolites are the same in human, rat and dog

DRUG

INTERACTIONS

• No Inhibition of major drug metabolising enzymes (drug interactions less likely)

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– PATH TO CLINIC VB0004

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SYNTHESIS AT SCALE & COST

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FIRST GMP SYNTHESIS BY GLYCOSYN

• Yield increased as scale increased

VB0004 manufactured to 5kg scale
Cost efficient at 5kg scale < $(US)
0.05 per mg

• Estimated dose 1-5mg

Stability studies – stable at 2 yrs (long shelf-life)

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SECOND GMP SYNTHESEIS ASSYCHEM

• Campaign planned to provide 3 validation batches

Confirm consistency of the synthesis process

• Samples of all 3 will undergo 2 yr stability testing

• Meets FDA requirements for GMP manufacture for Phase 1 and 2 clinical trials

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– PATH TO CLINIC VB0004

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COMPLETED

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In Progress

Pharma Criteria

INTELLECTUAL PROPERTY

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VB0004 PATENT COVERS

• Compositions of matter

• Methods of use

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VB0004 PATENT GRANTED IN ALL MAJOR JURISDICTIONS

• USA, Europe, Japan, Peoples Republic of China, Republic of South Korea, Russian Federation

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PATENT LIFE

• Priority date September 2014

• 13 years (+5 years on licensing)

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VB0004 METHOD OF SYNTHESIS PATENT AT NATIONAL PHASE ENTRY STAGE

• As well as Australia, Israel, Philippines, South Africa, Canada, ARIPO

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– PATH TO CLINIC VB0004

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Validated Platform TransformDemonstrated Demonstrated Synthesis Cost of IP Covers Sufficient Target Technology ational Efficacy in Safety – IND at Scale Goods Composition Patent Life Agent Animal toxicology Competitive of Matter Model

Phase I Human pD Safety (Efficacy) Study data

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COMPLETED

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In Progress

Pharma Criteria

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

Affected individuals 2 groups 28 days 2 doses

Biomarkers identified

Includes pharmacokinetic and pharmacodynamic studies

Expected outcomes – maximum tolerated dose, dose limiting toxicity (if present), pharmacokinetic data and pharmacodynamic data

First 2 cohorts of SAD completed no significant adverse events, cohort 3 in progress

COMPARABLE TRANSACTIONS

Successful Phase 1/1b would place Vectus at the point where many transactions have been completed

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Fibrotic Liver Disease VB4-A32

HEPATIC CIRRHOSIS (LIVER FIBROSIS)

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CAUSES

• Genetic

• Infectious (Hep A, B, C)

Alcohol related

• Diabetic

• Due to obesity

• Cryptogenic (no discernible cause)

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PREVALENCE

• Varies to >40% of the population in countries such as India, Cambodia, Vietnam and China due to endemic

Hep B & C.

CURRENT THERAPIES

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 prevent progression of the established fibrosis for which lifetime monitoring is required)

• Transplantation

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POTENTIAL THERAPIES

FXR agonists

Insulin sensitisers

THR β agonist

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/δ agonists

Phase 2 decrease in fat and no progression in 19% at 6 months but a reversible loss in renal function. Phase 3 no progression in 20% at 12 months

Phase 2b no effect on liver disease, but improved insulin sensitivity.

FGF19 analogues

decrease in liver fat in 74-79% at 12 weeks. High incidence of side effects (93%) including injection site reaction, abdominal pain, diarrhoea, nausea

PPAR α & γ agonists

Phase 2 decrease in ALT at 16 weeks and reduced fat at the highest dose vs placebo. Well tolerated.

Phase 2 decreased ALT, AST and liver fat vs placebo at 12 weeks. SCDI inhibitor- Phase 2b no effect at 12 weeks

ASK1 antagonists

Phase 2 open label decreased fibrosis at 6 months. Phase 3 discontinued as no decrease in fibrosis without worsening NASH at 12 months

Cardoso etal https://doi.org/10.1111/liv.14354

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No current approved Potential therapies – ineffective Liver Fibrosis continues to
therapy and/or high incidence of side represent an unmet therapeutic
effects need
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VB4-A32 & HEPATIC CIRRHOSIS

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

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A32 20 Weeks

Fibrotic Lung Disease VB4-A79

PULMONARY FIBROSIS

Causes

Current therapies

Environmental (e.g. air pollution, diesel particles)
Occupational (e.g. dusts such as silica, coal, asbestos, cotton dust)
Infections (e.g. TB, psittacosis, Spanish flu, COVID-19)
Drugs (e.g. bleomycin, methotrexate)

Current therapies:

Regulatory approval approximately 5 years ago
Slows lung function (FVC and 6MWD) decline
Approximately 50% discontinued or reduced dose due to side effects
Radiation
Autoimmune diseases (e.g. sarcoid, SLE, scleroderma, Wegener Granulomatosis)

Nintedanib

Regulatory approval approximately 5 years ago also slows rate of lung function decline.
High discontinuation rate due to side effects

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Essentially, a triggering factor such as coal or silica dust accumulates in the lung which initiates a scarring (fibrotic) reaction to wall off the
irritant. However, instead of then turning off once this is achieved the process becomes autonomous and continues to damage the lung even
in the absence of continuing exposure.
This results in a reduction in the area available for oxygen to exchange across the lungs and manifests as increasing breathlessness.
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POTENTIAL THERAPIES

Pentraxin 2 analogue

Phase 2 showed significant slowing of the decline in FVC and stabilisation of 6MWD at 6 months

Anti-CTGF antibodies

Medium Chain Fatty Acid Analogue (PBI4050)

Phase 2 PBI4050, alone or combined with Nintedanib slowed decline or stabilised FVC at 12 weeks. However, in combination with Pirfenidone the rate of decline increased.

Anti-interleukin Antibodies

No efficacy

Leukotriene Antagonists

Phase 2, no interim results

Phase 2 slowed decline in FVC and 6MWD (awaiting review)

Autoxin-LPA Inhibitors

Phase 2a ? Halted FVC decline at 12 weeks. Phase 3 underway

Anti-LOXL.2 Antibodies

No beneficial effect at Phase 2

Anti-Integrin Antibodies

Phase 2 completed, awaiting data

Somogyi etal https://doi.org/10.1183/16000617.0021-2019

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Current therapies – slow the decline in lung function compared with placebo, but have a high incidence of unacceptable side effects
Potential therapies – slow decline or at best stabilise lung function
Pulmonary Fibrosis continues to represent an unmet therapeutic need
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VB4-A79: BLOOD PRESSURE

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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-A79 had no effect.

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VB4-A79: PULMONARY FIBROSIS

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Pulmonary fibrosis in 16-week controls (two weeks after Bleomycin administration) and at 20 weeks after 4 weeks treatment in VB0004, VB4-A79 and vehicle control rats. VB0004 and VB4-A79 were administered at 500pmol/kg/min in the drinking solution (5% ethanol) vehicle control is drinking solution alone.

*** p<0.001 vs 20 week control, # p<0.01 vs 16-week control.**

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VB4-A79 HISTOLOGY

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 4 weeks treatment with VB4-A79 or VB0004 (500pmolkg/min).

Scar or fibrous tissue appears blue / cyano in these sections. In the controls 2 weeks after bleomycin administration fibrous tissue has thickened many alveoli (air sac) walls but not yet obliterated small blood vessels (capillaries), which appear as red dots which are individual red blood cells.

By 6 weeks in the control rats fibrous tissue is evident causing thickening of all of the alveoli walls and replacing many of the thin walled blood vessels (capillaries) which would normally surround the alveoli allowing gas exchange. In VB4-A79 treated rats alveoli walls are thinner and capillaries are more numerous.

14-Week Control 20-Week Control VB4-A79 at 20 weeks

VB0004 at 20 weeks

PATENT PORFOLIO

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VIP patents for heart, kidney and aortic fibrosis – granted all jurisdictions

VB0004 library of approx. 70 related compounds compositions and methods of use for treatment of hypertension, cardiac and renal fibrosis

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VIP fragment patents compositions and methods of use for hypertension, cardiac, renal and aortic fibrosis

– granted US, Australia, China, Europe, Japan, Korea, Russia, Ukraine, Hong Kong, Vietnam, Singapore, accepted in South Africa, ARIPO, Brazil, accepted Mexico

– granted most jurisdictions

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VB4-A32 and library of related compounds compositions and methods of use for treatment of hepatic, cardiac and renal fibrosis

VB0004 compositions and methods of use for hypertension, cardiac and renal fibrosis

– granted Russian Federation, Israel, Singapore, ARIPO, Canada, Philippines, South Africa, Ukraine, Vietnam, Nigeria, Mexico, accepted in Indonesia

– granted US, Europe, Australia, South Africa

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VB4-P5 and library of related compounds compositions and methods of use for treatment of renal cell death, renal fibrosis and hepatic fibrosis

– granted US, China, Australia, South Africa, accepted Europe, Japan, Russia, Israel

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GMP method of synthesis VB0004

– granted USA, Australia, India, accepted Europe, China

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VB4-A79 and related compounds compositions and use for treatment of pulmonary fibrosis – granted Australia, China, accepted USA, Europe, Mexico

VB0001 and related

compounds compositions and use for management of hypertension and fibrotic disease

– PCT application

VB0002, VB0003 and VB0005 and related compounds compositions and use for management of hypertension and fibrotic disease

– national phase

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COVID AND FIBROSIS

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Sars-Cov2 + ACE2 → ↑Ang II
Cytokine Storm ↑ Agt
↓ ↓
ARDS ↑Ang II
↓ ↙ Fibrosis
ICU + Ventillation ↑TNFα → ↑AT1a
↓ ↓
Fibrosis Fibrosis
Ang II = Angiotensin II ARDS = Acute Respiratory Distress Syndrome
Agt = Angiotensinogen, the Ang II precursor TNFα= Tumour Necrosis Factor alpha
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VIP, VB0004 AND POST COVID FIBROSIS

VIP and VB0004 downregulate expression of: Agt (and therefore Ang II) TNFα AT1a

Possible role in treating post Covid Fibrosis

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WHY ALZHEIMERS

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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.
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CONTACT

MAURIE STANG Non-Executive Director & Deputy Chairman [email protected]

KAREN DUGGAN Executive Director & CEO [email protected]

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AI assistant

VECTUS BIOSYSTEMS LIMITED — Investor Presentation 2021

65993_rns_2021-11-07_c67658e4-6821-452e-859d-2b96c2e9e9f2.pdf

VECTUS BIOSYSTEMS (ASX:VBS)

CORPORATE SNAPSHOT

KEY METRICS

BOARD OF DIRECTORS

Dr Ronald Shnier

Mr Maurie Stang

SHAREHOLDER BREAKDOWN

Dr Susan Pond

INVESTMENT HIGHLIGHTS

A SIGNIFICANT MARKET

2022 CATALYSTS

– PATH TO CLINIC VB0004

TARGET VALIDATION

– PATH TO CLINIC VB0004

VB0004 & SYSTOLIC BLOOD

VB0004 & CARDIAC FIBROSIS

VB0004 has been shown to:

14-Week Control

Treatment with VB0004 at 3 Doses

VB0004 & KIDNEY FIBROSIS

In the kidney VB0004 has been shown to:

14-Week Control

Treatment with VB0004 at 3 Doses

VB0004 & PULMONARY FIBROSIS

In the lung:

– PATH TO CLINIC VB0004

DEMONSTRATED SAFETY

– PATH TO CLINIC VB0004

SYNTHESIS AT SCALE & COST

– PATH TO CLINIC VB0004

INTELLECTUAL PROPERTY

– PATH TO CLINIC VB0004

COMPARABLE TRANSACTIONS

Fibrotic Liver Disease VB4-A32

HEPATIC CIRRHOSIS (LIVER FIBROSIS)

CAUSES

POTENTIAL THERAPIES

FXR agonists

Insulin sensitisers

THR β agonist

PPAR-α/δ agonists

FGF19 analogues

PPAR α & γ agonists

ASK1 antagonists

VB4-A32 & HEPATIC CIRRHOSIS

VB4-A32 demonstrated ability to:

Fibrotic Lung Disease VB4-A79

PULMONARY FIBROSIS

Causes

Current therapies

Current therapies:

Nintedanib

POTENTIAL THERAPIES

Pentraxin 2 analogue

Anti-CTGF antibodies

Anti-interleukin Antibodies

Leukotriene Antagonists

Autoxin-LPA Inhibitors

Anti-LOXL.2 Antibodies

Anti-Integrin Antibodies

VB4-A79: BLOOD PRESSURE

VB4-A79: PULMONARY FIBROSIS

VB4-A79 HISTOLOGY

PATENT PORFOLIO

COVID AND FIBROSIS

VIP, VB0004 AND POST COVID FIBROSIS

WHY ALZHEIMERS

CONTACT

More from VECTUS BIOSYSTEMS LIMITED

VECTUS BIOSYSTEMS LIMITED Investor Presentation 2021