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mariposa Health better health, better life Corporate Presentation August 2014 1

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Page 1: mariposa · mariposa Health 4 Investment Summary 1. Mariposa Health has 2 key projects in mid-Phase 2 clinical trials for COPD 2. Large, growing market. The market for COPD is large,

mariposaHealth

better health, better life

Corporate PresentationAugust 2014

1

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Disclaimer

This presentation contains certain statements which may constitute "forward-looking statements.” Such statements are only predictions

and are subject to inherent risks and uncertainties which could cause actual values, results, performance or achievements to differ

materially from those expressed, implied or projected in any forward-looking statements. No representation or warranty, express or

implied, is made by Mariposa Health that the material contained in this presentation will be achieved or prove to be correct.

Except for statutory liability which cannot be excluded, each of Mariposa Health, its officers, employees and advisers expressly disclaims

any responsibility for the accuracy or completeness of the material contained in this presentation and excludes all liability whatsoever

(including in negligence) for any loss or damage which may be suffered by any person as a consequence of any information in this

presentation or any error or omission there from.

Mariposa Health accepts no responsibility to update any person regarding any inaccuracy, omission or change in information in this

presentation or any other information made available to a person nor any obligation to furnish the person with any further information.

Investment in Mariposa Health should be considered speculative.

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Mariposa Health

Presenting today

3

Executive Chair & CEO

Dr Phillip Comans

• Over 25 years experience in international Pharma & biotech

• BSc, PhD, MBA

• Experience: International medical advisor based in Switzerland, responsible for drugs

in the cardiovascular & smoking cessation fields; taken 2 drugs through FDA & EU

approvals; Market positioning, health economics & reimbursement; Founder Mariposa

Health, Hunter Immunology

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Investment Summary

1. Mariposa Health has 2 key projects in mid-Phase 2 clinical trials for COPD

2. Large, growing market. The market for COPD is large, growing and has significant gaps with

existing treatments

3. Strong IP. The lead projects are covered by 8 patent families

4. MOU for out-license . Completed an MOU for out-licensing of one or more projects with the PR

China

5. Mariposa’s capital needs are well understood and its pricing for APO offers considerable upside.

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Investment Summary

Two key projects in mid-Phase 2 clinical trials for COPD (Chronic Obstructive Pulmonary Disease)

and Asthma.

The market for COPD is large and expanding, with significant gaps in existing treatments.

The lead projects are covered by eight patent families granted in all major territories

(including US, EU, PR China, Japan).

Interest in both projects from major pharma.

Key Management and Research team experienced in bringing compounds to market.

MOU signed for out-licensing of projects for PR China & Taiwan.

Mariposa’s capital needs are well understood and its pricing for APO offers considerable upside.

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Projects Backed by >$50m in Investments to Date

Stage of Development TA-270 HI-164OV

# Study Invested ($USm) # Study Invested ($USm)

Discovery na >10 na ??

Chemist, Biology & Manufacturing na 6 na 2.5

Pre-clinical R&D 88 14 >40 3.2

Clinical Trials 9 20 4 9.3

Total 50 15

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Why COPD & Asthma?Large market, critical gaps in current treatments

Disease Prevalence (m) Patients Treated (m) Market Leaders Market Share (%) Revenue ($USbn)

COPD 111 14 Spiriva (BI) 41% 3.5

Advair (GSK) 22% 1.9

Asthma na 56 Advair (GSK) 32% 4.6

Symbicort (AZ) 20% 2.8

Despite the large revenues, there are severe therapeutic gaps with existing treatments

- Modest effects in reducing COPD exacerbations

- Poor impact on inflammation, an under-lying feature of COPD

- Up to 25% of hospital admissions each winter due to COPD

- Minimal impact on disease progression

Current leaders coming off patent

Our trial compounds are designed to be supportive for current therapy regimes

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Tobacco smoke and pollution Driving Market Growth

Source: Nature, Vol. 489, S18-20, Sept. 2012

Experts say it’sbound to get

worse.

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Our Products Fit the Market Needs

TA-270

Therapeutic target: Moderate to severe COPD (other

conditions such as severe asthma, cystic fibrosis)

Mechanism: Oral, anti-inflammatory and anti-oxidant

drug designed to improve airflow

Studies completed: Five Phase 1 and four Phase 2

studies completed (400 subjects treated)

Competitive advantages:

Complementary or alternative to current treatments

Mucolytic, anti-inflammatory, bronchodilator

Potential to reduce disease progression.

HI-164OV

Therapeutic target: Vaccine, taken each year to

reduce exacerbations of COPD

Mechanism: Oral, bacterial vaccine to reduce

exacerbations of COPD

Studies completed: One Phase 1 and three Phase 2

clinical trials completed (300 subjects treated)

Competitive advantages:

Reduce infectious exacerbations due to H.

influenzae & other bacteria (e.g. Ps. Aeruginosa,

S. pneumoniae, M. Cattarhalis)

Reduces exacerbations either alone or in

combination with other medication+

* The observation that gender and age are important to the effects of vaccines has only recently come to light. Study HI-005 provided information in the clinical setting, supporting recent

pre-clinical and clinical immunology and vaccine publications. Gender effect is in females of any age and males aged 65 years or less.

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Board & Management

Dr Phillip Comans

Chairman & MD International pharmaceutical development and marketing; Founder, Mariposa Health, Hunter Immunology.

Kevin Lynn

Director Finance & accounting, Director & CFO Australian listed small-mid-cap companies.

Margaret Bridges

Director Corporate strategy, Asian pharmaceutical businesses.

Dr Yasuo Aoki

Head, TA-270 projectPharmacologist, product developer. Based in Tokyo. Formerly with Dainippon Ink & Chemical Co. (Japan),

Activus Pharma (Japan).

Dr Margaret Dunkley

Technical Manager,

HI-164OV projectImmunologist. Pre-clinical and CMC specialist. Formerly with Hunter Immunology (Australia)

and University of Newcastle.

tba

Physical chemist. Experienced in medicinal chemistry, biological products, formulation development

including tablet and inhaled dose forms.

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mariposaHealth

better health, better life

Clinical Trial & Technical

Information

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Cigarette Smoke

Biomass particles and particulates Host factors, exogenous oxidative

stress and amplifying mechanisms

Lung

Inflammation

Anti-oxidants Anti-proteases

Anti-inflammatory agents

Oxidative Stress Proteases

COPD

Pathology

Repair

Mechanisms

Faulty immune

response causes

recurring infections

From Global Guideline for COPD : GOLD

Pathogenesis of COPD

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Cigarette Smoke

Biomass particles and particulates Host factors, exogenous oxidative

stress and amplifying mechanisms

Lung

Inflammation

Anti-oxidants Anti-proteases

Anti-inflammatory agents

Oxidative Stress Proteases

COPD

Pathology

Repair

Mechanisms

Faulty immune

response causes

recurring infections

From Global Guideline for COPD : GOLD

Unique Combination Action: TA-270

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TA-270 - Superior free-radical scavenging to N’acetylcysteine

- More potent 5-LO and LTB4 inhibition than Zileuton

TA-270 N-Acetylcysteine Tyrosine Zileuton

2. Superior Inhibition of leukotriene pathway

100

80

60

40

20

0

-20

Inhibition of peroxynitrite (%)

1.0E-08 1.0E-07 1.0E-06 1.0E-05 1.0E-04 1.00E-09 1.00E-08 1.00E-07 1.00E-06 1.00E-05

Inhibition of 5-LO (%)

1.00E-09 1.00E-08 1.00E-07 1.00E-06 1.00E-05

Inhibition of LTB4 (%)

Concentration (mol/L)

1. Superior dose dependent free radical scavenging

TA-270 TA-270 TA-270

Dual Mode of Action, More Potent Effects

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COPD: The Place of TA-270

TA-270 breaks the cycle

Air pollutantsCigarette smoke

Free radical stimulation(ONOO-:

Peroxynitrite)

Immunologic cascade

Damage to epithelial cells & surfactant proteins (↓Antiproteases)

Activation of NFkBand AP-1

Inactivation of HDAC2Biosynthesis of LTs(5-

lipoxyoxygenase, 5-LO)

Decrease:Relaxing factor releaseEpithelial protective function

Increase:EmphysemaFibrosis

Enhance cytokine and chemokine activation Steroid insensitivity

BronchoconstrictionInflu

x of inflammatory

cells (congestion)

Break viscous cycle Reduced inflammation: COPD & severe asthma

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Improved Lung Function Associated with Biomarker Effects

TA-270

Regulators, such as FDA, demand to see evidence of how the drug works in the clinical setting correlated with the

therapeutic effects. The above observations are a critical breakthrough in the development of TA-270.p

= difference to Baseline ↓ 8-isoprostane: Measure of reduced oxidative damage ↓ LTB-4: Measure of reduced local inflammation

Increase in FEV1 (mL)Day 15 Day 29

p = 0.12

p = 0.052

p = 0.036p = 0.024

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A Step Forward to Improve BreathingTA-270

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Incre

ase in F

EV

1 f

rom

Base

line

(mL

)

Current medications

• Benefit of TA-270 is in addition to any increase in FEV1 observed with existing medication.

• Note in some instances, patients in Study TA-007 may have been taking Spiriva as an alternate to Advair or similar.

Source: TA-270 data on file, FDA approved information, publications; TA-270 shows change vs Baseline, others

change vs. placebo

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COPD: The place of HI-164OV

Healthy COPD

Bacteria, e.g. H. influenzae; scanning

electron micrograph

‣ Increased doctor visits

‣ Systemic corticosteroids, antibiotics

‣ Hospital admissions

‣ 4th major cause of death

Flare-ups

✘Prevents Flare-ups HI-164OV, mucosal bacterial vaccine:

✓Boosts underlying poor

inflammatory response to

infectious bacteria

✓Reduce recurring infections

MHC2

T helper cell

T helper cell

B cells

Killer T cells

CD4+

CD4+

CD4+ Antibodies

macrophanges

T helper cell

Antigen

APC

HI-164OV delivery

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(a) Exacerbation is associated with hospital admission or either corticosteroid or antibiotic use

(b) Exacerbation is associated with either hospital admission or increased corticosteroid use

All p-values: Statistical difference, active vs placebo + In Study H=005, benefit was over background LABA and/or ICS

Reduction in COPD Exacerbations

(post-hoc analysis, Studies H-002/4, H-005)

Number of ExacerbationsPlacebo HI-164OV

p = 0.004

p = 0.02

p = 0.02

Patients with moderate to severe COPD,

excluding males over 65 yearsPatients with COPD,

excluding males over 65 years

HI-164OV

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HI-164OV: Progressive Benefit on Reducing ExacerbationsNational health priorities

20

Redu

ctio

n in

exa

ce

rba

tio

ns

Current medications

Fewer exacerbations means fewer doctor visits, less drug use, fewer hospital admissions.

Major cost savings for health authorities and insurance companies

Advair+ indicates exacerbations defined by use of corticosteroids or hospital admission, the same definition as used for Study HI-005.

Data for Advair is FDA approved Product information. Data for Spiriva, Barr et al 2006.

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Product development timeline

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2014 2015 2016 2017

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

TA-270

Supply

Regulatory

Ph 2 Clinical trial

HI- 164

Toxicology

Supply

Regulatory

Ph 2 Clinical trial

TA-270, 2nd generation

Inhaled dose ,

development

NCE discovery

Licensing

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Clinical Trial Program

Protocol:

Purpose:

Design:

No. of subjects:

Patient selection:

Background Rx:

Study duration :

Sites:

PI:

TA-008

Find the optimal therapeutic dose

Double blind, placebo controlled, dose ranging study

120

Moderate to severe COPD

Patients will be taking LABA & ICS or tiotropium

2 months per patient

Multicentre study

tbd

TA-270 Study design

Envisaged program:

1. Study TA-008 2. Phase 2b clinical trial with the primary dose

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Protocol:

Purpose:

Design:

No. of subjects:

Patient selection:

Background Rx:

Study duration :

Sites:

PI:

MH-007

Efficacy, safety & dose comparison in patients with Chronic or recurring

bronchitis (COPD)

Randomised, double blind, placebo controlled study

180

Chronic bronchitis or recurring episodes of acute bronchitis Female subjects,

Males aged less than 65 years.

Patients may be taking LABA & ICS or tiotropium

12 months per patient

UK

tbd

Clinical Trial Program

HI-164OV Study design

Patients treated

for COPD

according to

gender & age

(m)

Males < 65 years

1.3

Male ≥65 years

1.4

Female < 65 years

1.1

Female ≥65 years

1.1

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Pipeline Projects

TA-270 Brandextensions

HI-164OV Brandextensions

MH 103

Inhaled dose formNew indications: asthma, allergic rhinitis

New indications:asthma, chronic sinusitis

Oral preventative to Staph aureusIndication: snoring andrespiratory sleep disturbances

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Financing Requirement

Use of funds 2014 2015 2016 2017 Total

Corporate/Admin $1,400,563 $2,009,224 $2,520,720 $2,410,380 $8,340,886

TA-270 R&D $826,478 $4,926,481 $3,593,016 $5,979,392 $15,325,367

HI-164 R&D $875,734 $3,666,944 $7,500,278 $3,922,500 $15,965,456

Other R&D $254,630 $833,333 $648,148 $625,000 $2,361,111

Total $3,357,405 $11,435,983 $14,262,162 $12,937,271 $41,992,821

Funds two projects to be Phase 3 ready, including:

a) Working capital

b) Clinical trials in a Phase 2 program

c) Advance pipeline projects

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Shareholding

52.9 million shares on issue

Employees 11%

Directors (past & present) 27%

Early Stage Investors

27%

Phillip Comans 35%

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Patent Families

ProductPatent

familyPurpose Status Expiry Expiry after extension

TA-270 1Substance

Certain indicationsGranted 10/2016 10/2021

2 Substance Production Granted 9/2019 9/2024

3 Improved substance Granted 6/2022 6/2027

4 Indication: COPDGranted all

Except pending US7/2024 7/2029

MH-003 5 Indication International phase 10/2029 10/2034

HI-164OV 6 Isolate selection Granted in US, EU 8/2025 8/2030

7 Indication: asthma Pending US, EU 3/2028 3/2033

8 Probiotic additive Granted in US, EU 5/2021 5/2026

9 Commercial isolates Pending US, EU 9/2029 9/2034

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MOU with Chinese Pharma

Key Terms

Total value is 120m RMB (~$US23m) in cash payments plus royalties

- Up-front payment upon signing the formal contract

- Milestone payments during product development until product registration

in PR China

- Royalties on sales

Costs of development & marketing for PR China is the responsibility

of the Chinese pharma

Share information: Mariposa Health will have access to any data

developed for use outside China

- Payments are cash revenue to Mariposa Health for license rights within

the defined territories

- Lays the foundation for future collaboration

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Investment Summary

1. Mariposa Health has 2 key projects in mid-Phase 2 clinical trials for COPD

2. Large, growing market. The market for COPD is large, growing and has significant gaps with

existing treatments

3. Strong IP. The lead projects are covered by 8 patent families

4. MOU for out-license . Completed an MOU for out-licensing of one or more projects with the PR

China

5. Mariposa’s capital needs are well understood and its pricing for APO offers considerable upside.

Page 30: mariposa · mariposa Health 4 Investment Summary 1. Mariposa Health has 2 key projects in mid-Phase 2 clinical trials for COPD 2. Large, growing market. The market for COPD is large,

mariposaHealth

better health, better life

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