mariposa · mariposa health 4 investment summary 1. mariposa health has 2 key projects in mid-phase...
TRANSCRIPT
mariposaHealth
better health, better life
Corporate PresentationAugust 2014
1
ma
ripo
sa
Health
2
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.
ma
ripo
sa
Health
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
ma
ripo
sa
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, 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.
ma
ripo
sa
Health
5
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.
ma
ripo
sa
Health
6
Projects Backed by >$50m in Investments to Date
Stage of Development TA-270 HI-164OV
# Study Invested ($USm) # Study Invested ($USm)
Discovery na >10 na ??
Chemist, Biology & Manufacturing na 6 na 2.5
Pre-clinical R&D 88 14 >40 3.2
Clinical Trials 9 20 4 9.3
Total 50 15
ma
ripo
sa
Health
7
Why COPD & Asthma?Large market, critical gaps in current treatments
Disease Prevalence (m) Patients Treated (m) Market Leaders Market Share (%) Revenue ($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
ma
ripo
sa
Health
8
Tobacco smoke and pollution Driving Market Growth
Source: Nature, Vol. 489, S18-20, Sept. 2012
Experts say it’sbound to get
worse.
ma
ripo
sa
Health
9
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.
ma
ripo
sa
Health
10
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.
11
mariposaHealth
better health, better life
Clinical Trial & Technical
Information
ma
ripo
sa
Health
12
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
ma
ripo
sa
Health
13
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
ma
ripo
sa
Health
14
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
ma
ripo
sa
Health
15
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
ma
ripo
sa
Health
16
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
ma
ripo
sa
Health
A Step Forward to Improve BreathingTA-270
17
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
ma
ripo
sa
Health
18
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
ma
ripo
sa
Health
19
(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
ma
ripo
sa
Health
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.
ma
ripo
sa
Health
Product development timeline
21
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
ma
ripo
sa
Health
22
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
ma
ripo
sa
Health
23
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
ma
ripo
sa
Health
24
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
ma
ripo
sa
Health
25
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 $41,992,821
Funds two projects to be Phase 3 ready, including:
a) Working capital
b) Clinical trials in a Phase 2 program
c) Advance pipeline projects
ma
ripo
sa
Health
26
Shareholding
52.9 million shares on issue
Employees 11%
Directors (past & present) 27%
Early Stage Investors
27%
Phillip Comans 35%
ma
ripo
sa
Health
27
Patent Families
ProductPatent
familyPurpose Status Expiry Expiry after extension
TA-270 1Substance
Certain indicationsGranted 10/2016 10/2021
2 Substance Production Granted 9/2019 9/2024
3 Improved substance Granted 6/2022 6/2027
4 Indication: COPDGranted all
Except pending US7/2024 7/2029
MH-003 5 Indication International phase 10/2029 10/2034
HI-164OV 6 Isolate selection Granted in US, EU 8/2025 8/2030
7 Indication: asthma Pending US, EU 3/2028 3/2033
8 Probiotic additive Granted in US, EU 5/2021 5/2026
9 Commercial isolates Pending US, EU 9/2029 9/2034
ma
ripo
sa
Health
28
MOU with Chinese Pharma
Key Terms
Total value is 120m RMB (~$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
ma
ripo
sa
Health
29
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.
mariposaHealth
better health, better life
30