ABN 54 117 526 137

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Vectus Biosystems Limited

Chairman’s Address to the 25 January 2022 Annual General Meeting

The 2021 year was very productive for Vectus as it continued with progress in its the Phase I human trial of its proprietary VB0004 that addresses a significant unmet need for anti-fibrotic agents for patients with cardiovascular and/or kidney disease. We are pleased that the toxicology work done to-date gives every indication that there will be a good result from the Phase I trial. Whilst there have challenges recruiting patients for the phase I trial due to COVID, we have made significant progression.

Vectus continues to advance work on its library of over 1,000 compounds, derived from the platform underpinning VB0004. These emerging lead compounds address some of the most significant unmet needs in medicine today and include:

VB4-A32 (liver fibrosis, including NASH and ASH);
VB4-A79 (pulmonary fibrosis, including idiopathic fibrosis, asbestosis and coal dust pneumoconiosis (Black Lung Disease)); and
VB4-P5 (renal tubular cell death consequent on cytotoxic therapy).

As a Radiologist and Clinical Physician, I emphasise the real need for this new class of drugs, providing significant social, patient and health economic outcomes. Fibrosis, or scar tissue, is the end point of a whole host of diseases including high blood pressure, injury, post infections (such as COVID-19), radiotherapy and silicosis. To have potential drugs, like those in the Company’s stable, that can not only stop the growth of scar tissue, but also reverse the fibrosis, is a major development in medicine. To take the drug orally, in tablet form, also decreases the cost of production and, more importantly, increases the ease of use by patients. The use of Vectus’ compounds to reduce blood pressure is also very significant.

Finance

The $7 million raised in the December 2020 placement of 7.78 million shares at $0.90 per share are being used to fund the human Phase I clinical trials for VB0004, and to fast-track work on the Company’s additional compounds towards lead status and human trials, for the commercialisation of the Accugen technology, and for working capital.

It was pleasing to note that the shareholder value has progressed during the last year marked by Vectus’ increased market capitalisation. The strong share price has encouraged several convertible note holders to convert at the conversion share price of $0.50.

Commercialisation Process

Vectus continues its dialogue with a cross-section of some of the world’s leading pharmaceutical companies and regional mid-sized firms and feedback from these industry leaders remains very positive. The Company’s objective is to partner with one or more companies via a licencing programme focusing initially on VB0004 as it completes its current trials. The additional compounds also present an attractive commercial opportunity for Vectus, and clinical success in any one of the Company’s compounds is likely to generate increased interest by pharmaceutical companies with particular interest in the franchises and disease states that Vectus addresses.

Accugen

During the year Vectus has worked to enhance its technology aimed at improving the speed and accuracy of measuring the amount of DNA and RNA in samples tested in laboratories. The technology, consisting of AccuCal™ and RealCount™ software, offers a time, cost and accuracy benefit compared

VECTUS BIOSYSTEMS LIMITED ABN 54 117 526 137

3-11 Primrose Avenue, Rosebery, NSW 2018 Telephone: +61 2 9662 4144 Facsimile: +61 2 9697 0933 Website: www.vectusbiosystems.com.au

ABN 54 117 526 137

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with currently available systems. Recent activities in the commercialisation programme, which comprises a combination of direct sales, distribution partnerships and licensing opportunities, have broadened the potential market for the Accugen product. Opportunities are being worked on for applications related to food safety, which is a large and growing market. The Accugen reagent (AccuCal-D™) and software evaluation continue by internationally renowned research groups for possible utility in diagnostic tests.

The Vectus Team

I thank the Vectus team, led by Dr Karen Duggan, for the success in getting VB0004 well into the important Phase I stage during a time of unprecedented challenges. I appreciate the very relevant expertise of the Company’s Board, with the experience of Susan Pond in medical research and in large pharmaceutical companies being critical and the strong commercial skills in the medical field of my fellow Directors Maurie Stang, the Deputy Chairman, and Peter Bush.

I thank Vectus’ shareholders for their very active support during this exciting phase of the Company’s development. We look forward to progressing our activities and growth with the objective of contributing in a meaningful way to society, patients, our stakeholders, and the delivery of improved healthcare worldwide.

Vectus Biosystems Limited

Ron Shnier

Chairman

Annual General Meeting

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VIP AGONISTS - The benchmark for Anti-fibrotics

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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)

VB0004 - Heart, lung and kidney fibrosis

– 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

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COMPLETED
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In Progress

Potential Therapeutic Criteria

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TARGET VALIDATION

Treatment with VIP reversed pre-existing 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”

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– PATH TO CLINIC VB0004

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COMPLETED

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In Progress

Potential Therapeutic Criteria

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VB0004 & SYSTOLIC BLOOD PRESSURE

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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

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VB0004 & CARDIAC FIBROSIS

VB0004 has been shown to:

Rescue cardiac tissue damaged by fibrosis
Repair existing cardiac damage

14-Week Control

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

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VB0004 & KIDNEY FIBROSIS

In the kidney VB0004 has been shown to:

Reverse renal interstitial fibrosis at all doses
Restore normal architecture at all doses

14-Week Control

Fibrosis (blue) partially surrounds some but not all tubukes

(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

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VB0004 & PULMONARY FIBROSIS

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)

Treatment with VB0004 and VB4-A79

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20-Week Control

VB4-A79 at 20 weeks

VB0004 at 20 weeks

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– PATH TO CLINIC VB0004

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COMPLETED

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In Progress

Potential Therapeutic Criteria

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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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COMPLETED

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In Progress

Potential Therapeutic Criteria

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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

Potential Therapeutic Criteria

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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

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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

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SAD – doses to 30mg completed no adverse events
100mg dose in progress
PK – Tmax 6-8 hrs
elimination half life 9.5-10hrs
0.8
0.6
0.4
0.2
0.0
0 10 20 30 40 50
Time (hrs)
Plasma VB0004 (ng/ml)
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Comparable Transactions

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1 0 0 ,0 0 0
1 0 ,0 0 0 InterM une
G a lap ago s (P F )
G alapagos P F
T obira
G a la p a g o s (R A & C )
P rom edior
1 ,0 0 0 N im bus A pollo
R eata
P ha rm axis
T obira
P h enex N im bus A pollo G a le cto
A m ira L e x ic o n G a la p a g o s (R A & C )
A rre s to Inve ntiva A chillion Innate L G L ife S c ie n c e s
P rom edior
1 0 0
F ibrotek
B ioN T ech
A kam a
P ha rm axis
H alozym e L G L ife S c ie n c e s
1 0
P re c lin ic a l In P h a s e 1 C o m p le te d P h a s e 2 M ile s to n e s
P h a s e 1 / M a rk e t Va lu e
D e v e lo p m e n t P h a s e
V a lu a tio n ($ U S m illio n )
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Successful Phase 1/1b would place Vectus at the point where many transactions have been completed

Fibrotic Liver Disease VB4-A32

HEPATIC CIRRHOSIS (LIVER FIBROSIS)

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CAUSES

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PREVALENCE

CURRENT THERAPIES

Genetic
Infectious (Hep A, B, C)
Alcohol related
Diabetic
Due to obesity
Cryptogenic (no discernible cause)

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

Hep B & C.

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
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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)

Pirfenidone

Regulatory approval approximately 5 years ago
Slows lung function (FVC and 6MWD) decline
Infections (e.g. TB, psittacosis, Spanish flu, COVID-19)
Drugs (e.g. bleomycin, methotrexate)
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).

16-Week Control

20-Week Control

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.

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VB4-A79 at 20 weeks
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VB0004 at 20 weeks
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PATENT PORFOLIO

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VIP patents for heart, kidney and aortic fibrosis

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

– granted all jurisdictions

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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 ↑TNF α → ↑AT1a ↓ ↓ Fibrosis Fibrosis

Ang II = Angiotensin II Agt = Angiotensinogen, the Ang II precursor

ARDS = Acute Respiratory Distress Syndrome TNF α = Tumour Necrosis Factor alpha

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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VIP AGONISTS - the anti-fibrotic benchmark and a brighter therapeutic future

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AI assistant

VECTUS BIOSYSTEMS LIMITED — AGM Information 2022

65993_rns_2022-01-24_e89b6f94-c70b-46bb-8f6b-4fdc706a903e.pdf

Vectus Biosystems Limited

Chairman’s Address to the 25 January 2022 Annual General Meeting

Finance

Commercialisation Process

Accugen

The Vectus Team

Vectus Biosystems Limited

Ron Shnier

Annual General Meeting

VIP AGONISTS - The benchmark for Anti-fibrotics

A SIGNIFICANT MARKET

HEART FAILURE

LIVER FAILURE

VB0004 - Heart, lung and kidney fibrosis

– PATH TO CLINIC VB0004

TARGET VALIDATION

– PATH TO CLINIC VB0004

VB0004 & SYSTOLIC BLOOD PRESSURE

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

CARDIOVASCULAR SAFETY

METABOLISM

DRUG

– PATH TO CLINIC VB0004

SYNTHESIS AT SCALE & COST

FIRST GMP SYNTHESIS BY GLYCOSYN

SECOND GMP SYNTHESEIS ASSYCHEM

process

– PATH TO CLINIC VB0004

INTELLECTUAL PROPERTY

– PATH TO CLINIC VB0004

Comparable Transactions

Fibrotic Liver Disease VB4-A32

HEPATIC CIRRHOSIS (LIVER FIBROSIS)

CAUSES

PREVALENCE

CURRENT THERAPIES

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:

20-Week Control

Fibrotic Lung Disease VB4-A79

PULMONARY FIBROSIS

Causes

Current therapies

Pirfenidone

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

VECTUS BIOSYSTEMS LIMITED AGM Information 2022