Transcript Mariposa Corporate Presentation February 2016

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Corporate Presentation
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February 2016
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Forward Looking Statements
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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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.
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Introduction
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1) oral bacterial vaccine, 2) anti-inflammatory/anti-oxidant

Both are complementary to current treatments
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Out-licensed for development & marketing in China
Target on-sale or out-license to larger pharma by end 2018
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Our market focus is COPD, the 3 leading cause of death in the US
2 products in Phase 2 clinical trials:
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Company Information
 Shareholders:
65
 Shares on issue: 9,881,211
 Warrants exercisable at listing: 438,789
 SEC filings: Forms 10K, 10Q
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 Fully diluted share structure: 10,320,000
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 Mariposa Health Inc was formed merger of Mariposa Health Ltd
(Australia) and a US shell
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Board & Management
Margaret Bridges
Yasuo Aoki
Margaret Dunkley
TA-270 Project Specialist
BSc. PhD. Pharmacologist, Dainippon Ink & Chemical (Japan),
Activus Pharma (Japan)
HI-164 Project Specialist
BSc, PhD MBA. Immunologist, University of Newcastle, Hunter
Immunology
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Kevin Lynn
Chairman & CEO
BSc, PhD, MBA. Pharmaceutical development & marketing (CibaGeigy, Novartis).
Director, CFO
CA, FFIN, FICD. Past CFO & Director Australian listed small & midcap companies
Non-executive Director
B.Eng. Strategy consultant including Pharmaceutical & medical
services, Asia area
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Phillip Comans
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Chronic Obstructive Pulmonary Disease (COPD)
leading cause of death in the United States.
12.7 million people have been diagnosed with COPD, up to 24
million have the disease without being aware. .
COPD causes serious long-term disability and early death.
Source: American Lung Association, 2016 http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd/learn-about-copd/howserious-is-copd.html
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 At this time there is no cure, and the number of people dying
from COPD is growing.
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COPD: We address a major market
$6billion (US)
 Disease costs:
$30-40billion annual (US)
 Drug sales:
$6billion (US)
 Major drugs:
Spiriva (BII), Advair (GSK)
Source: American Lung Association, 2016 http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd/learn-about-copd/howserious-is-copd.html
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Our drugs are complementary to existing treatments
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 Hospital costs:
Market dynamics
 Generics bring low pricing
Aim: Unique benefits, Higher prices & Large market
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 Introduction of numerous similar (bronchodilator +
steroid)
 Gaps in existing treatment: Much room to reduce
“Medical interventions”
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 Market leaders coming off patent
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COPD: A complex disease
Faulty immune activity
Host factors, exogenous
oxidative stress and amplifying
mechanisms
Recurring bacterial
infections
Lung
Inflammation
Oxidative Stress
Repair
Mechanisms
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COPD
Pathology
Proteases
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Cigarette Smoke
Biomass particles and particulates
From Global Guideline for COPD : GOLD
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Two drugs: Place in treatment
Host factors, exogenous oxidative
stress and amplifying mechanisms
Faulty immune activity
TA-270: Anti-inflammatory
Lung
Inflammation
TA-270: Anti-oxidant
HI-164: Bacterial vaccine
Oxidative Stress
Proteases
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COPD
Pathology
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Cigarette Smoke
Biomass particles and particulates
Repair
Mechanisms
From Global Guideline for COPD : GOLD
TA-270: Inhibits 5-lipoxygenase and peroxynitrite
HI-164: Non-typeable H. influenzae
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HI-164
One Phase 1 study
Two Phase 2 studies of 6 & 9
months duration
21 hospital centers
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Oral, mucosal vaccine to Nontypeable H. influenza
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HI-164-OV: Reduction in exacerbations of COPD
Phase 2 studies in COPD patients (post-hoc analysis: Studies H-002/4, HI-005)
Exacerbations (n)
p = 0.0009
p = 0.002
p = 0.01
Study designs
COPD patients, m or f
Randomised, db, pc
HI002/4, n=140; HI-005, n= 90
Treatment with oral HI-164 tablets or
placebo once daily for 3 days, repeated
after 4 & 8 weeks
Duration of study: HI002/4 6 months; HI005 9 months
Patients <65 years
All p-values: Statistical differences, active vs placebo (N= HI-002/004, A 68, P 72; HI-005, A 34, P 56)
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All ages
HI-164OV
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Placebo (existing
treatment)
Definition of a moderate to severe exacerbation includes:
+ Patient is admitted to hospital or prescribed corticosteroid or antibiotic to treat the exacerbation
++ Patient is admitted to hospital or prescribed corticosteroid to treat the exacerbation
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Increased time to first episode of COPD
(Post hoc analysis, Patients aged <65years, Study HI-005; n= a34, p56)
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1.00
Log-rank test, p<0.01
Survival distribution
p = 0.02
HI-164OV
Placebo
0.75
0.50
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0.25
0.0
50
150
250
Days to first exacerbation
350
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HI-164OV: Effects on hospital admissions
Placebo
(n= 56)
P-value
0.3
0.7
0.028
1.63
4.02
0.032
0.2
0.4
0.086
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Hospital admission rate per patient
(mean)
Duration of hospitalization (mean,
days)
Admission rate for acute
exacerbations (mean)
Active
(n= 35)
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(Post hoc analysis, Patients aged <65years, Study HI-005)
Reduction in exacerbations and hospital admissions was also observed in Study HI-002/004
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Next trial
Study in patients aged 65 years or less with COPD (chronic bronchitis)
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Phase 2 clinical trial under IND
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TA-270
Five Phase 1 studies
Four Phase 2 studies of 1-4 weeks
duration
Studies in Japan, EU and UK
Improve lung epithelium, oxygenation
of RBC
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Improve chronic lung capacity
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Oral, inhibitor of 5-lipoxygenase (5-LO)
and peroxynitrite (ONOO-)
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TA-270: Dual Mode of Action, More Potent Effects
2. Superior Inhibition of leukotriene pathway
Inhibition of 5-LO (%)
Inhibition of peroxynitrite (%)
100
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1. Superior free radical scavenging
TA-270
Inhibition of LTB4 (%)
TA-270
TA-270
80
60
40
20
0
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
1.00E-09
1.00E-08
Concentration (mol/L)
TA-270
N-Acetylcysteine
Tyrosine
Zileuton
1.00E-07
1.00E-06
1.00E-05
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Superior free-radical scavenging to N’acetylcysteine
- More potent 5-LO and LTB4 inhibition than Zileuton
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TA-270: Complementary improvements in breathing
(Exploratory Phase 2; Moderate to severe COPD)
Increase in FEV1 from
Baseline (mL)
Patients in Study TA-007 may have been taking Spiriva, Advair or a similar product
Study TA-007, Open label Phase 2, n=13
Source: TA-270 data on file, FDA approved information, publications; TA-270 shows change vs Baseline, others
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change vs. placebo
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•
•
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Current medications
Path forward
Preliminary, inhaled dose form
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Reformulation of oral form: patent life to 2036
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Path to Value II
H-164
COPD (Chronic bronchitis)
Manufacturing & regulatory
Clinical Phase 2
TA-270/271
COPD (oral, SR)
Manufacturing & regulatory
Clinical Phase 1
Clinical Phase 2
COPD asthma (inhaled)
Pre-clinical
Manufacturing & regulatory
Clinical Phase 1
Q2.16
Q3.16
Q4.16
Q1.17
Q2.17
Q3.17
Q4.17
Q1.18
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TA-276
Q1.16
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Product Indication
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License agreement for HI-164 in China
 Conditions:
Exclusive license for the territories
Up-front payment, milestones & royalties (all non-dilutionary)
Chinese partner pays full cost of development in the territories
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 Shanxi Kangbao Biological Products Company
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Patent Families
TA-270
Patent family
Purpose
Status
Substance certain indications
Granted
10/2016
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Substance production
Granted
9/2019
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Improved substance
Granted
6/2022
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Indication: COPD
Granted
(except pending EU)
7/2025
MH-003
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Reduce snoring
International phase
10/2029
HI-164OV
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Isolate selection
Granted
8/2025
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Probiotic additive
Granted
5/2021
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Indication: asthma
Pending US, EU
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Commercial isolates
Pending US, EU
3/2028
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Product
Expiry
before extensions
9/2029
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Budget
2017
2018
Total
Corporate & admin.
$2,121,364
$2,266,643
$5,777,898
$3,286,985
$4,950,701
$3,702,458
$11,940,145
$1,495,790
$5,052,310
$2,111,527
$8,659,627
$401,708
$415,411
$415,411
$1,232,531
$6,574,374
$12,539,786
$8,496,039
$27,610,201
R&D TA-270
R&D HI-164
Patents
Total expenses
Funds two projects to be in a high value saleable form, including:
a) IND preparations
b) Clinical trials
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$1,389,891
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2016
c) Patent and brand build
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Share ownership
% of total
WT Trust
16.00%
PT Soho Industri Pharmasi
Piccadilly Portfolio Pty Ltd
7.21%
7.85%
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Shareholder
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License agreement for HI-164 in China
 Conditions:
Exclusive license for the territories
Up-front payment, milestones & royalties (all non-dilutionary)
Chinese partner pays full cost of development in the territories
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 Shanxi Kangbao Biological Products Company
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High Return Potential
 An investment is an opportunity for significant growth while addressing
a significant need
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 Out-license provides non-dilutive access to an emerging market
 Corporate filings are in an advanced stage to listing
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Health
better health, better life
For More Information Please Contact:
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Philip Comans, CEO
Email: [email protected]
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