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SYNTARA LIMITED — AGM Information 2005
Nov 14, 2005
65830_rns_2005-11-14_2c489be5-e868-463a-a00d-bef141f64963.pdf
AGM Information
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pharmaxis
Pharmaxis Ltd. 2005 Annual General Meeting Chairman's Address
My fellow shareholders, 2005 has again been a year of great achievement for Pharmaxis.
As I reported in last years address the risk reward equation for you as our shareholders in this early stage of your company's development is directly proportional to the reduction of the risks associated with commercialising our inventions.
ARIDOL
With Aridol we have completed our clinical registration study and filed for approval to market in Europe and Australia to identify and help manage Asthma. Thus the risk for this product only remains with registration and marketing. Technical risk has been removed.
An additional Aridol study for the US market is now planned and expected to begin this year. Your company is confident of success with this study, as it relates more to clinical practice in the USA than it does the ability of Aridol to do what it has proven to do in many previous studies.
We have also commenced phase 2 studies to demonstrate that with Aridol it is possible to identify which patients with COPD (a large 30 million potential patient base) would benefit from inhaled steroids. Indications that this can be achieved have come from independent third party medical studies in Europe and so again your company has high expectations that the clinical work will be successful for this new and large purpose.
BRONCHITOL
Last year your company conducted a successful Phase 2 clinical trial for our second product, Bronchitol.
This trial prepared the way for a global Phase 3 clinical trial, which is designed to lead to registration of this compound for clinical use in the treatment of bronchiectasis on a world wide basis.
This year, we have followed this up with a successful Phase 2 clinical trial demonstrating that Bronchitol is beneficial to patients with Cystic Fibrosis. This work has paved the way for a global Phase 3 clinical trial designed to lead to the registration of Bronchitol for Cystic Fibrosis on a world wide basis.
From the work your company has completed on both of these classes of patients, I believe that eventually Bronchitol will be shown to be beneficial for most patients with bronchial congestion which would potentially see 30 million patients benefit from the product.
2006 should see our first approvals to market Aridol.
In general then we have come a long way in reducing the technical risks associated with our lead products, Aridol and Bronchitol and our share price movements have reflected our achievements. There still remains the business risk associated with the marketing of the product. This will determine how much value your company can return to you, its investors, for their investment but - there will no longer be any risk that the product is of no value.
To fund this new projected clinical work, your company has just completed successfully a global capital raising involving a public issue in the United States and a placement of shares with Australian institutional shareholders.
This global capital raising funds the required clinical work that I have described before. In that sense it takes away another level of risk. We now have the resources to complete our clinical work.
We have now come a long way from our early research beginnings. We have excellent people with a track record of delivery. We have excellent products that change peoples lives and we have the financial resource to progress our work.
I am personally confident that our company will continue to achieve its milestones and so help many patients whose quality of life is not what it might be. At the same time I am also confident that this good work will deliver appreciating value to you our investors.
I believe we have the potential to be a truly significant Pharmaceutical business.
Your Managing Director, Dr Alan Robertson in his presentation will be providing a brief review of where we find ourselves at this point in time and some insight into the scope of the opportunity in front of us.
Your CFO, Mr. David McGarvey will give an overview of the company's financial position.
On your behalf, I want to thank your Board for their oversight and strategic Direction of our company. Also on your behalf, I would also like to thank your Management and staff for delivering the success we are enjoying.
Denis M Hanley
15 November, 2005

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Atitorininini disers:

Mamireiudng
- Bronchitol: Entering Phase III
- Successiul Phase II trial in cysito florosis ľ
- Successiul Phase II trial in prononcerasis e.
- Orphan drug designation Europe and USA e
- J Aridol: Management of airway inflammation
- European Phase III completed (asthma) .
- US Phase III to start late 2005 (asthma)
- Market authorization filed in EU, Australia (target 2006 launch) Œ
- COPD clinical study commenced
- European Phase III completed (asthma) .
- a Relatioed marketing rights for all programs
- Experienced management Ø.
- Extensive patent portfolio Į.
- e Near term value enhancing milestones
Pipeline Pulmonary and Autoimmune Focus
Respratory diseases
Bronchio – orononicorasis
Bronchilol - cystic floresis
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40
Manadement

- O Alan Robertson PhD Wellcome (GSK); Faulding; Amrad; Inventor of Zomig
- J David McGarvey CA CFO, Memiec (NYSE); CFO, US Filter Filtration Group
- G BIGHChEINDIN PHD Stanford: ANU
- O GEINY PHILLIPS, MBA GEO Novaris Australia
- o John Grapper, MBA Managing Director, Memcor; Syntex (Roche)
- e William Cowden, PhD ANU: Co-inventor of TNF mAb's
- Gin MeDonale, PhD VP Discovery, SIBIA (Merck), VP Discovery, SGX
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a Belokground
- Genetic disorder affecting 30,000 in U.S. r
- Poorly hydrated, tenacious, thick mucus Ŧ
- Current life expectancy is 31 years Z
- D Current treatments: rhDNase and tobramycin
- Delivered by nebulizer (preparation, sterilization) Ő
- rhDNase (pulmozyme): $265mm @ ~30% penetration E
Bronchiol Phase II CF trial

- O Crossover 8 stie study in 39 GF carents
- Q Randomised two week treatment periods
- O Double-blind, placebo controlled
- O Primery Enclooint:
- Orelalgia FEV
- O Secondary Englopinis:
- Eifect on other lung function measures
- Effect on symptoms/signs
- Eifect on OoL
- Safety (including microbiology)

Bronchiol
CF Phase II Results: Change in Lung Function
| Bronghtor | oontola | O Value | |
|---|---|---|---|
| Grande in FEVA | $\mathcal{L} = 2$ | $0 = 2%$ | OXOIOEE |
| Citange in F_{25/5} | TOROLOGYA | $0.6 - 5%$ | EXECUTE |
Mincludes patients being treated with pulmozyme
(FEF25-75 or MMEF is considered a measure of small airway function)
Bronchitol CF Phase II Results: FEV, Change

Bronchito! CF Phase II Results: FEF25-75 Change

Bronchitol

cystic fibrosis registration strategy

O Phase II trial (EU & Aus):
- Dosing to be finalized based on ongoing dose-ranging study W.
- General Caller F2006

- Principy Sacopolate Caragge in HEVA
- Placebo-controlled, 6 month dosing, finalising design with EMEA

- Phase II trial (US) to connience 2006
- Similar size, design to EU/Aus trial
Orphan chug designation - EU and USA
Bronchitol
bronchiediasis



U Background
- Abnormal, irreversible dilation of the lower airways ť.
- Daily mucus production, constant coughing, breathlessness: A major quality of life impact
- Normal lung clearance impaired Z.
- 100,000 affected in the U.S. W
- a Current treatments: bronchodilators, antibiotics
- No drugs effective to clear mucus X
ra je p
Bronchiol
bronchiectasis
O Phase II Trial results
- 60 patient, double blind, crossover, plateebo-controlled e e
- Promising results in QoL, symptom scores (p<0.05 versus placebo) Ő
- For all patients 4.5 unit improvement in St. George's impact score es.
- For the 75% of patients with unclear chests 6.9 unit improvement in St. Ő. George's Impact score
- Well tolerated, no adverse events 8
O Phase II Trais
- Plantio commande 4005/1006 in Australia, EU T.
- Finalising protocol following FDA meeting J.
- Initiate US pivotal trial mid-2006
- O Supplied on compassionate-use basis in Australia
Bronchitol
chronic bronchitis
ŋ
Ő
Ä
X
O Belokground


a Acute pilot studies completed
No therapy halts disease progression
J Phase II dinical protocol in development
p
Chronic cough, breathlessness, tenacious soutum
30 million people affected in 7 major pharma markets
Current treatments almed at symptom relief / bronchodilation
- Quality of Life en.K
- Reduction in exercerbation period
- Sittely to commence 2006

Artelor

A repid and simple test for airways inilammation that facilitates diagnosis and management of asthma and COPD patients.
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Asthma and COPD Opportunity
Q Astrine
- 51 mm patients in 7 major markets E.
- No simple test, many not diagnosed nasLiid
- $-34%$ of people diagnosed with asthma do not have the disease r
- Ongoing pattent management difficult M
O (OPD)
- 30 million people affecied in 7 major pharmaceutical markets
- Cost to US healthcare US$30 billion pa Œ
- 20-25% respond to inhaled steroids but no test to identify them m
Ariclol
quantitation of airway hyperresponsiveness

Address CUrrent status
O Phase III results (646 pattent study)
- Good agreement with hypertonic saline $($ p<0.01) e e de la construcción de la construcción de la construcción de la construcción de la construcción de la constrCasa de la construcción de la construcción de la construcción de la construcción de la construcción de la cons
- Effective at identifying clinical mis-diagnosis (7%) E.
- 20% of subjects over treated and over diagnosed e de
- 25% of subjects not well controlled
- European and Australian marketing authorization submitted
- Potential 2006 launch
- O US Phase II trial to commence Q42005
- Scheduled completion H2 2006
Aridol
addressable market

- Multiple trials in progress with key US/EU opinion leaders
- Reimbursable under existing codes in US. J.
- Marketing partner for GP audience en de la porta de la porta de la porta de la porta de la porta de la porta de la porta de la porta de la portaDel porta de la porta de la porta de la porta de la porta de la porta de la porta de la porta de la porta de l
- Publication of clinical results for ICH ageacence
- First revenue 2006 (subject to approval) t.

Autoimmune diseases
multiple sclerosis meumatoid arthritis
Autoimining Disease
Initemnetion the laukocyte activation cascace

Autoimmune Disease PXS64
- a Selective inhibitor of T cell migration
- a Novel mechanism
- a Effective in animal models of multiple scierosis
- O Oral proditug of PXS25, both discovered by Pharmaxis
- Current status: preclinical development, start human Phase I cinical trials 1-06

Financial Overview
NO TA $\mathcal{L}$
| YEELERGE EGOLOGIE | ||||
|---|---|---|---|---|
| 2003 | 2007. | 2003 | PLOTOPA | |
| Reference | MODES | Matolog | Signed | |
| Firanca Faromanca | ||||
| Revenic | ||||
| Inclesiacce von | Engel | ESTE | 26 | |
| ECHO IONE IONE | 1997 - Johann Stoff, Amerikaansk konge | Miti | OYAC | ol (a) |
| OINER | Z. | T. | ||
| en va | DI LA | ING COL | st. | |
| Research & clavelopment | CARTIST | COLLEG | KEZCO) | a Mi |
| edinierali | K.Z. | |||
| Actions tender | Card | PACE | CGLA | ezi |
| TO CALLER CO | KEWICH | (SPPA) | e al lin | GRADE |
| Net loss before and after tax | KIDZZZA | COL | CHACO | KOLLAND |
| Depredetion & amonisation | oya o | 7. | KI | |
| MENTOA | GENGROSS | ICLE COL | KELON | I. |
| CESTIFICWS | ||||
| Cash flows from operating activities | (CR27/4) | II. Maro | GAGE | Ciato |
| Cash flows from investing activities | CICLES | Kigen | Killer Britanni | G. |
| Cash flows from financing activities | ISOZ | 22 T. | EL SE | |
| Net increase (decrease) in cash held | . | MACK | organ | r Co |
| KORTO I | |||
|---|---|---|---|
| 2010. | PIBILE | ||
| SIOOO | MOTOTO | ||
| HITCH CHE ROSTITOR | |||
| Oash and bank addepied commercial bills | 831639 | 25, 24 M | |
| Plant & Gourbardin | 2440 | TALL | |
| Intendiolexasers | Explore | IN 32 | |
| , ko le del con | 8743874 | 23261 | |
| IKOTE NE PILITES | 246189 | TAN | |
| Total shareholders' equity | CORO 30 | 267630 |
NY TA

Total Capital Raised to 30 June 2005 A$53.3m

Cash 333.4m
Global Captial Raising
Clobal Captial Raising
aCoordinated bookbuild in Australia and USA
aOne of largest Australian biotech capital raisings - $86.7 million
Common pricing of A$2.20
-0.5% discount to 30 day VWAP at announcement
10% discount to 5 day WWAP at closing
| Australia (ASX) | ETWAIC ORGANISM OF 1919 MILLON Shares.60% Institutions (>20) |
|---|---|
| LUSAN (NESSEG) | Public critering of 19.5 million shares/1.3million $ADS, >90%$ institutions $(~10)$ |
| TOFII | 39.4 million shares: 6% +/- US to Australia |
| ESTERS REGIONS TO | 174.398.092 |
k y
Cash of AS110 million(1) - positioned to:
- Complete clinical development of Bronchitol for cystic florosts
- O Complete cinical development of Bronchitol for pronchiectasis
- . Complete US clinical development of Aridol
- e International launch of Artdol
- International launch of Bronchitol for cystic fibrosis and OKOROJ REGESIST
- Q Broaden the commercial opportunity for Aridol
- o Additional clinical opportunities for Bronchitol eg chronic bronchitis
- Excansion of manufacturing/company facilities
- Further development of preclinical pipeline O.

Recent Milestones
TELEVISION CONTRACTOR
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- Completed Phase III Artdol trial in asthma m
- Filed for Aridol approval in Australia, EU ã
- o Bronentol
- Positive Prase II OF results ang.K
- Positive Preset Foronchiecters results X.
- Orphan Drug designation for CF, bronchiectasis (U.S.) W
- Orphan Drug designation for CF (Europe) Ĩ.
- Discovered PXS64 for MS improved oral form of PXS25 e de
- Tripled manufacturing capacity I.
- A$6 million Aus P3 government grant awarded S.
- Global Capital raising completed $87 million X.
Upcoming Milestones
1999 - Johann Barbara, martxa amerikan da
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- Potential Aridol approval in Australia & EU: ALL (0) e
- Data from Phase I COPD inst. 24
o Bronchtol
- Initials prononlagests plyotal trial Œ
- Initiate US brononiectasis pivotal trials: A
- Initiale CF pivotal trials: Ó
- Data from CF dosing study Ü
o Pioeline
- US IND for PXS64 for multiple scierosis: ALLIOCI ene.A
- Nominate IND candidate for PXS2076 for RAT 2006 Ã
4005/1006 Innie 2016) $2006$ ALLIOT
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