VECTUS BIOSYSTEMS LIMITED — AGM Information 2020

Nov 29, 2020

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2020 Annual General Meeting

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Chairman’s Address to 2020 AGM

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ABN 54 117 526 137

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Chairman’s Address to the 2020 Annual General Meeting

The last year has been very productive for Vectus, with the Company’s continued progress towards the Phase I 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 very confident that the toxicology work done to-date gives every indication that there will be a good result from the Phase I trial.

Vectus continues to progress 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 in normal tissue, is the end point of a whole host of diseases from blood pressure, injury, post infections (such as COVID-19) and silicosis. To have a potential drug, 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 and Capital Raising

On 20 November 2020 the Company was very pleased to announce that it received firm commitments from investors to raise $7 million, before costs, through a placement of 7.78 million shares at $0.90 per share. The placement was supported by a number of institutions, together with a range of sophisticated investors, including healthcare industry professional investors. We are grateful for the support of both Gleneagle Securities, the Lead Manager for the placement, and the assistance provided by Morgans’ Scone office, which introduced key cornerstone investors to Vectus.

Shareholders will be asked today at the AGM to approve the proposed issue of placement shares in Resolutions 5 and 6. I am pleased to see the strong support for the Resolutions in the proxies, which you will see shortly. If the placement is approved at the AGM, the funds will be received on 4 December 2020. These funds, together with the cash-at-bank prior to the placement of $1.8 million, will be used to accelerate the Phase I clinical trials for VB0004, to fast-track work on the Company’s additional compounds to get them to lead status and move them towards human trials, for the commercialisation of the Accugen technology and for working capital.

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ABN 54 117 526 137

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Commercialisation Process

Vectus has expanded its dialogue with a cross-section of global and mid-size pharmaceutical companies. Feedback from these industry leaders remains very positive for the potential of a significant transaction upon completion of a successful Phase I human trial for VB0004. The Company is currently in discussions in respect of its clinical programme and commercialisation roadmap in a major international market. If successful, this would have the potential of accelerating additional compounds through the pre-clinical and clinical programme.

Accugen

Vectus continues its development and commercialisation work on its Accugen technology aimed at calibrating qPCR DNA and RNA analysis in samples tested in laboratories. The technology, consisting of AccuCal™ and RealCount™ software, offers a time, cost and accuracy benefit compared with currently-available systems. The Company’s commercialisation programme will be extended to further international reference sites, with the view of establishing the Accugen system in the scientific community worldwide, and potentially eliminate the time-consuming use of housekeeping genes, which can vary in accuracy and in some cases delay the commencement of experiments by weeks, or even months.

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The Vectus Team

I thank the Vectus team, whose work in this field has received wide international recognition. I appreciate the very relevant expertise of the Company’s Board, with the experience of Karen Duggan and Susan Pond in medical research and in large pharmaceutical companies being critical. The commercial skills in the medical field of my fellow Directors Maurie Stang, the Deputy Chairman, and Peter Bush are of great benefit.

Vectus’ achievements continue to receive recognition by pharmaceutical companies, physicians and our peers in the rapidly-expanding search for therapeutics that can have a meaningful impact on not only the disease progression that is associated with fibrosis, but also on improvements in the health and wellbeing of patients with these degenerative illnesses.

Vectus Biosystems Limited

Ron Shnier

Chairman

VECTUS BIOSYSTEMS LIMITED ABN 54 117 526 137

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

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CEO Presentation

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VIP Agonists –VIP Agonists – The Benchmark for The Benchmark for Anti-Fibrotics Anti-Fibrosis

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OVERVIEW

Fibrosis is the replacement of normal tissue (heart, lung, kidney etc) by scar tissue and can lead to organ failure 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)

• Respiratory failure (pulmonary fibrosis)

Fibrotic disease contributes to more than 40% of all deaths worldwide

Fibrosis Reversal, a major unmet need

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PATH TO THE CLINIC – VB0004

Validated Target

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Platform Technology

Transformational Agent

Demonstrated Efficacy in Animal Model Demonstrated Safety – IND toxicology

IP Covers Composition of Matter

Synthesis at Scale

Cost of Good Competitive Sufficient Patent Life Phase I Safety Study Human pD (Efficacy) Data

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TARGET VALIDATION

Normotensive rats on 4.4%

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

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TARGET VALIDATION

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” (see right) https://doi.org/10.1016/j.ejphar.2020.172979

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PATH TO THE CLINIC – VB0004

Pharma criteria	Vectus
Validated Target
Platform Technology
Transformational Agent
Demonstrated Efficacy in Animal Model(s)
Demonstrated Safety – IND toxicology
Synthesis at Scale
Cost of Goods Competitive
IP Covers Composition of Matter
Sufficient Patent Life
Phase I Safety Study
Human pD (Efficacy) Data

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VB0004 & SYSTOLIC BLOOD PRESSURE
25
40 30
VB0004
B
B
20
20 B
30
10
B J
B
15 20 0 BJ
R2=0.9792 B -10 J
10 10 B
R2=0.9813 -20
Enalapril
-30
5 0
0 2 4
1 10 100 1000 10000 0 2 4 6 8 10
VB0004 (pmol/kg/min) Time (weeks) Time (weeks)
Delta SBP (mmHg)
Change in SBP (mmHg)
Decrease in SBP (mmHg)
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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 7mmHg was 705 pmol/kg/min. SBP continued to decrease 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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Treatment with VB0004 at 3 Doses
20
##
VB0004
15

#
10
5
0
Control / 14 weeks 500 / 18 weeks 100 / 18 weeks 10 / 18 weeks Control / 18 weeks
At the highest dose (500pmol/kg/min), VB0004 reversed pre-existing
fibrosis, while a dose response effect on the level of fibrosis is
apparent
Myocardial Fibrosis (% surface area)
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VB0004 & CARDIAC FIBROSIS

VB0004 has been shown to:

• Rescue cardiac tissue damaged by fibrosis

• Repair existing cardiac damage

• i.e. VB0004 is transformational

• Reduce systolic blood pressure

14-Week Control

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

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

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Minimal fibrosis is visible; normal architecture has been restored

Fibrosis visible as blue stained tissue is

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

present throughout the section.

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VB0004 & KIDNEY FIBROSIS

Treatment with VB0004 at 3 Doses

In the kidney VB0004 has been shown to:

• Reverse renal interstitial fibrosis at all doses

• •Restore normal architecture at all doses

• i.e. VB0004 is considered transformational

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35 ##
VB0004
30
25

#
20
##
15
10
5
0
Control 14 weeks 500 / 18 weeks 100 / 18 weeks 10 / 18 weeks Control 18 weeks
Renal Interstitial Fibrosis (% surface area)
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14-Week Control

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

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

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Fibrosis (blue) partially surrounds some but not all tubukes

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Fibrosis has progressed to surround most tubules

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No fibrosis visible

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30
# #
20 *
10
0
Control 16 VB0004 A79 Control 20
Pulmonary Fibrosis (% surface area)
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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

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VB
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16 Week Control

20 Week Control

VB4-A79 at 20 weeks

VB0004 at 20 weeks

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SUMMARY

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VB0004 the first non-peptide, orally dosed VIP mimetic:

• Decreased systolic blood pressure in a dose dependent manner

• Reversed pre-existing cardiac fibrosis and restored normal cardiac architecture

• Reversed pre-existing renal interstitial fibrosis and restored normal renal architecture

• Reversed pre-existing pulmonary fibrosis secondary to bleomycin

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PATH TO THE CLINIC – VB0004

Pharma criteria	Vectus
Validated Target
Platform Technology
Transformational Agent
Demonstrated Efficacy in Animal Model
Demonstrated Safety – IND toxicology
Synthesis at Scale
Cost of Goods Competitive
IP Covers Composition of Matter
Sufficient Patent Life
Phase I Safety Study
Human pD (Efficacy) Data

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DEMONSTRATED SAFETY

• SAD and MAD (2 species)

• S ingle A scending D ose (SAD) to 2,000mg/kg no adverse events

• 7 day M ultiple A scending D ose (MAD) to 2,000mg/kg no adverse events

• 28 day MAD to 500mg/kg no adverse events

• 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

• Mutagenic potential

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

• 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 THE CLINIC –VB0004

Pharma criteria	Vectus
Platform Technology
Validated Target
Transformational Agent
Demonstrated Efficacy in Animal Model
Demonstrated Safety – IND toxicology
Synthesis at Scale
Cost of Goods Competitive
IP Covers Composition of Matter
Sufficient Patent Life
Phase I Safety Study
Human pD (Efficacy) Data

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SYNTHESIS SCALE AND COST

• 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

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

• • Second GMP synthesis Assymchem

• 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 THE CLINIC – VB0004

Pharma criteria	Vectus
Validated Target
Platform Technology
Transformational Agent
Demonstrated Efficacy in Animal Model
Demonstrated Safety – IND toxicology
Synthesis at Scale
Cost of Goods Competitive
IP Covers Composition of Matter
Sufficient Patent Life
Phase I Safety Study
Human pD (Efficacy) Data

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INTELLECTUAL PROPERTY

• VB0004 patent covers

• compositions of matter

• methods of use

• VB0004 Patent granted in all major jurisdictions  USA, Europe, Japan, Peoples Republic of China, Republic of South Korea, Russian Federation

• as well as Australia, Israel, Phillipines, South Africa, Canada,

• ARIPO

• Patent life

• Priority date September 2014

• 14 years (+5 years on licensing)

• • VB0004 Method of synthesis patent at National

• Phase entry stage

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PATH TO THE CLINIC

Pharma criteria	Vectus
Validated Target
Platform Technology
Transformational Agent
Demonstrated Efficacy in Animal Models
Demonstrated Safety – IND toxicology
Synthesis at Scale
Cost of Good Competitive
IP Covers Composition of Matter
Sufficient Patent Life
Phase I Safety Study
Human pD (Efficacy) Data

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PHASE 1

• 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

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Fibrotic Liver Disease VB4-A32

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HEPATIC CIRRHOSIS (LIVER FIBROSIS)

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.

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CURRENT THERAPIES

• vaccination Hep A, Hep B for prevention

• abstinence to prevent further damage (EtOH)

• weight loss

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• 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 – 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

Insulin sensitisers – 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.

THR β agonist 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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SUMMARY – LIVER FIBROSIS

No current approved therapy

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Potential therapies – ineffective and/or high incidence of side effects Liver Fibrosis continues to represent an unmet therapeutic need

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10
8

6
4
2
0
14 W eek Control A32/1000 A32/500 A32/100 20 w eek Control
Hepatic Fibrosis (% surface area)
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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)

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-
20 Week�Control
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A32 20 Weeks
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150
140
130 p<0.05
120
110
100
Control A32
AST (Iu/L)
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Fibrotic Lung Disease VB4-A79

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PULMONARY FIBROSIS

Causes

• Environnemental (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)

• Radiation

• Autoimmune diseases (e.g. sarcoid, SLE, scleroderma, Wegener Granulomatosis)

• Idiopathic (no discernible cause) termed IPF

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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CURRENT THERAPIES

Two current therapies

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Pirfenidone – regulatory approval approximately 5 years ago. Slows lung function (FVC and 6MWD) decline. Approximately 50% discontinued or reduced dose due to side effects.

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

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.

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-interleukin Antibodies – No efficacy

Leukotriene Antagonists – Phase 2, no interim results

Anti-Integrin Antibodies – Phase 2 completed, awaiting data Somogyi etal https://doi.org/10.1183/16000617.0021-2019

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SUMMARY- PULMONARY FIBROSIS

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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SBP
250
DBP
200 p<0.005
p<0.001
150
100
50
0
Control VB0004 A79
Blood Pressure (mmHg)
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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.

31

VB4-A79 PULMONARY FIBROSIS

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30
# #
20

10
0
Control 16 VB0004 A79 Control 20
Pulmonary Fibrosis (% surface area)
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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, 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

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- 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 followed by 4 weeks treatment with 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.

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VECTUS IN SUMMARY

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

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

VB4-A79 – addresses pulmonary fibrosis from all causes except scleroderma where BP lowering probably required, revered existing fibrosis due to bleomycin

Exceptional patent portfolio encompassing a library of > 1,000 compounds

Successful raising of $7 million by Gleneagle and Morgans (Scone)

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USE OF FUNDS

VB0004 – Phase 1

VB4-A32 – undertake GMP synthesis (Assymchem), with IND toxicology studies to follow

Laboratory –

further work on detailed mechanisms of action for VB4-A32, VB4-A79 diversify to encompass other areas of unmet therapeutic need and investigate therapies from Vectus extensive library e.g. develop cellular models for Alzheimer’s disease and investigate efficacy of potential candidates

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WHY ALZHEIMERS

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which Accumulation of B-amyloid in the brain causes formation of plaques, which disrupt neuronal connections and cause accumulation of Tau proteins, are dissociated from microtubules within neurones causing tangle formation, a precursor to neuronal cell death.

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PATENT PORTFOLIO

• 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

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

• VIP fragment patents compositions and methods of use for hypertension, cardiac, renal and aortic fibrosis – granted most jurisdictions

• GMP method of synthesis VB0004 – gran ted USA, Australia, India, accepted Europe, China

• VB0004 compositions and methods of use for –

• hypertension, cardiac and renal fibrosis granted US, Japan, China, South Korea, Europe, Australia, Russian Federation, Israel, Singapore, ARIPO, Canada, Philippines, South Africa, Ukraine, Vietnam, Nigeria, Mexico, accepted in Indonesia

• 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

• VB0004 library of approx. 70 related compounds compositions and methods of use for treatment of hypertension, cardiac and renal fibrosis – granted US, Australia, China, Europe, Japan, Korea, Russia, Ukraine, Hong Kong, Vietnam, Singapore, accepted in • South Africa, ARIPO, Brazil, accepted Mexico

• VB0002, VB0003 and VB0005 and related compounds compositions and use for management of hypertension and fibrotic disease – national phase

• VB4 A32 and library of related compounds compositions and methods of use for treatment of hepatic, cardiac and renal fibrosis – granted US, Europe, Australia, South Africa

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VIP Agonists –VIP Agonists – The Benchmark for The Benchmark for Anti-Fibrotics Anti-Fibrosis

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