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Committed to the research, development and Committed to the - - PowerPoint PPT Presentation

Feb 01, 2024 364 likes •638 views

ABN 75 082 811 630 Committed to the research, development and Committed to the research, development and commercialisation of human therapeutic products for commercialisation of human therapeutic products for chronic respiratory and autoimmune

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ABN 75 082 811 630

Committed to the research, development and Committed to the research, development and commercialisation of human therapeutic products for commercialisation of human therapeutic products for chronic respiratory and autoimmune diseases chronic respiratory and autoimmune diseases

February 2004 February 2004

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Overview Overview

Our Objective Our Objective

  • to build a valuable business, recognised internationally for its

to build a valuable business, recognised internationally for its approach to therapeutic discovery, development and approach to therapeutic discovery, development and commercialisation in the fields of respiratory and autoimmune commercialisation in the fields of respiratory and autoimmune diseases diseases

Our Strategy Our Strategy

  • attractive product opportunities

attractive product opportunities

  • engage in the complete product value chain

engage in the complete product value chain

  • focus on products

focus on products

  • focus on core therapeutic markets

focus on core therapeutic markets

  • maintain and build a diversified product pipeline

maintain and build a diversified product pipeline

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Company History Company History

1999 1999 GBS Venture Partners invests $2M to develop GBS Venture Partners invests $2M to develop autoimmune disease research (ANU) autoimmune disease research (ANU) 2001 2001 Licence from Royal Prince Alfred Hospital for Licence from Royal Prince Alfred Hospital for treatment of respiratory disease treatment of respiratory disease 2002 2002 Second round funding of $9.6 Second round funding of $9.6 – – GBS Venture GBS Venture Partners, CM Capital, CIBC Australia, ANU and Partners, CM Capital, CIBC Australia, ANU and Mooroolbark Technology Mooroolbark Technology 2002 2002 Consolidation of operations at Consolidation of operations at Frenchs Frenchs Forest Forest 2003 2003 $3 million grant to develop cystic fibrosis treatment $3 million grant to develop cystic fibrosis treatment

  • secured R&D grants totalling

secured R&D grants totalling ≈ ≈ $5 million $5 million 2003 2003 $25 million raised at IPO $25 million raised at IPO

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TGA approved facilities TGA approved facilities

Frenchs Frenchs Forest NSW Forest NSW

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Products Products

Aridol Aridol

TM TM

lung function test lung function test asthma/COPD asthma/COPD Bronchitol Bronchitol

TM TM

therapeutic therapeutic chronic bronchitis chronic bronchitis bronchiectasis bronchiectasis cystic fibrosis cystic fibrosis PXS25 PXS25 therapeutic therapeutic multiple sclerosis multiple sclerosis rheumatoid arthritis rheumatoid arthritis PXS2000 PXS2000 therapeutic therapeutic rheumatoid arthritis rheumatoid arthritis

  • ther
  • ther

Name Category Indication

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Diversified Product Portfolio Diversified Product Portfolio

3-5 years 15 months 15 months 18 months 18 months indicative time to complete 12 months

  • --------------Clinical Trials-----------------

research preclinical phase I phase II phase III registration

Respiratory diseases

Bronchitol

TM - cystic fibrosis

Bronchitol

TM - bronchiectasis

Bronchitol

TM - chronic bronchitis

Aridol

TM – airway function

Autoimmune diseases

PXS25 - multiple sclerosis PXS25 - rheumatoid arthritis PXS2000 – multiple sclerosis

in progress in progress in progress in progress in progress

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Clinical Trials in Progress Clinical Trials in Progress

approvals dosing/recruitment (600 patients) Report

Q3 2004

approvals dosing/recruitment (60 patients) Report approvals dosing/recruitment (60 patients) Report

Aridol

TM (Phase III)

Bronchitol

TM for cystic fibrosis (Phase IIa)

Bronchitol for bronchiectasis (Phase IIb)

CTM manufacture CTM manufacture CTM manufacture

19 Nov 03 Nov 03 Sep 03 Jun 04 Jun 04 June 04 125 1

Q3 2004 Q3 2004

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Bronchitol Bronchitol

TM TM -

  • bronchiectasis

bronchiectasis

Phase Phase IIb IIb, pilot chronic study , pilot chronic study

  • 4 sites

4 sites 60 subjects 60 subjects

  • Start:

Start: Oct 2003 Oct 2003

  • Finish:

Finish: June 2004 June 2004

  • Primary end point:

Primary end point: quality of life quality of life

  • Secondary end point:

Secondary end point: lung function, sputum properties lung function, sputum properties

  • Outcome:

Outcome: proof of principle for long term efficacy of proof of principle for long term efficacy of Bronchitol Bronchitol

TM TM

  • Status:

Status: Interim analysis (19 subjects) completed Interim analysis (19 subjects) completed

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Trial Design Trial Design

Design Design

  • Randomised

Randomised

  • Placebo controlled

Placebo controlled

  • Blinded

Blinded

  • Crossover

Crossover

Objective Objective

  • Effect of twice daily

Effect of twice daily Bronchitol Bronchitol

TM TM on disability (symptoms) and handicap

  • n disability (symptoms) and handicap

(sleep quality, fatigue, and QOL) (sleep quality, fatigue, and QOL)

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Positive Interim Results Positive Interim Results

Quality of Life (St George Questionnaire) Quality of Life (St George Questionnaire)

  • Trend versus placebo

Trend versus placebo

  • significant versus control

significant versus control

Symptoms Symptoms

  • Trend versus placebo

Trend versus placebo

  • Trend versus control

Trend versus control

Activity (disturbances to patients physical activity) Activity (disturbances to patients physical activity)

  • Trend versus placebo

Trend versus placebo

  • Trend versus control

Trend versus control

Impact (disturbances of psycho Impact (disturbances of psycho-

  • social function)

social function)

  • Significant versus placebo

Significant versus placebo

  • Highly significant versus control

Highly significant versus control

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Next Steps Next Steps……… ………

Complete remainder of study Complete remainder of study Complete preclinical safety program Complete preclinical safety program Prepare for Phase III study Prepare for Phase III study

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Trial Participants Trial Participants

“ “It has been some weeks since my part of the trial It has been some weeks since my part of the trial finished and to be honest I have not felt as well as when finished and to be honest I have not felt as well as when I was on the I was on the Bronchitol Bronchitol. .” ”

Trial participant 1 Trial participant 1

“ “Thank you for any help that you can give and I wish you Thank you for any help that you can give and I wish you well with the well with the Bronchitol Bronchitol project as it has made such a project as it has made such a difference to my health. difference to my health.” ”

Trial participant 2 Trial participant 2

“ “This patient has been on the Phase II clinical trial of This patient has been on the Phase II clinical trial of Bronchitol Bronchitol for for bronchiectasis

  • bronchiectasis. This has

. This has revolutionised revolutionised her her life, she would benefit and would be greatly relieved of life, she would benefit and would be greatly relieved of her daily symptoms if she could continue this treatment. her daily symptoms if she could continue this treatment.” ”

Physician Physician

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Lung defence (normal) Lung defence (normal)

Mucus Mucus Airway Surface Airway Surface Liquid Liquid Submucosal glands Submucosal glands Cilia Cilia

Respiratory diseases Respiratory diseases

(Chronic obstructive lung diseases) (Chronic obstructive lung diseases)

Goblet Cell Ciliated Cell

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Lung defence (compromised) Lung defence (compromised)

Ciliated Cell Goblet Cell

Mucus Mucus

Airway Surface Airway Surface Liquid (thin/viscous) Liquid (thin/viscous)

Submucosal glands Submucosal glands Cilia Cilia

Respiratory diseases Respiratory diseases

(Chronic obstructive lung diseases) (Chronic obstructive lung diseases)

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Lung defence (after Lung defence (after Bronchitol Bronchitol) )

Mucus Mucus Airway Surface Airway Surface Liquid Liquid Submucosal glands Submucosal glands Cilia Cilia

Respiratory diseases Respiratory diseases

(Chronic obstructive lung diseases) (Chronic obstructive lung diseases)

H2O H2O H2O H2O H2O Goblet Cell Ciliated Cell

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Chronic bronchitis Chronic bronchitis

without without Bronchitol Bronchitol

TM TM

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Chronic bronchitis Chronic bronchitis

with with Bronchitol Bronchitol

TM TM (400mg)

(400mg)

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Bronchitol Bronchitol

TM TM

for Chronic Obstructive Lung Diseases for Chronic Obstructive Lung Diseases

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Aridol Aridol

TM TM

100 200 300 400 500 600

Severe Moderate Mild Normal

Aridol

Dose required to cause 15% fall in lung function

Asthma severity

Steroid use

Current With Aridol monitoring

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Aridol AridolTM

TM for asthma management for asthma management

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Respiratory disease markets Respiratory disease markets

Data not Data not available available 2

2

30,000,000 30,000,000 2

2

Aridol Aridol TM

TM

3,840m 3,840m 30,000,000 30,000,000 Bronchitol Bronchitol Included in CB Included in CB 58 580,000 0,000 Bronchitol Bronchitol 575m 575m 75,000 75,000 Bronchitol Bronchitol Existing Market Existing Market Size Size1

1 (A$)

(A$) Patient Population Patient Population1

1

Product Product Target Application Target Application Cystic Fibrosis Cystic Fibrosis COPD COPD -

  • Bronchiectasis

Bronchiectasis COPD COPD -

  • Chronic Bronchitis

Chronic Bronchitis Lung function test Lung function test

1 Worldwide 2 Estimate - there are currently no reliable figures available as to the potential patient size and

existing market size for a lung function test [estimate of 106,000 tests in Australia for fiscal 2003 (cost to govt - $10.5 million). Cost to PBS of ICS = $210 million]

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PX PXS S25 25

Treatment of autoimmune disease Treatment of autoimmune disease

  • multiple sclerosis

multiple sclerosis

  • rheumatoid arthritis

rheumatoid arthritis

Selective inhibitor of T cell migration Selective inhibitor of T cell migration Effective in models of multiple sclerosis and rheumatoid Effective in models of multiple sclerosis and rheumatoid arthritis arthritis Early preclinical safety testing Early preclinical safety testing

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PXS200 PXS2000

Treatment of autoimmune disease Treatment of autoimmune disease

  • multiple sclerosis

multiple sclerosis

  • rheumatoid arthritis

rheumatoid arthritis

Selective activator of peripheral Selective activator of peripheral cannabinoid cannabinoid receptors receptors Effective in models of multiple sclerosis Effective in models of multiple sclerosis Late stage research Late stage research

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Autoimmune disease markets Autoimmune disease markets

1 Worldwide

4,174m 4,174m 5 5, ,5 500,000 00,000 PXS25 PXS25 3,533m 3,533m 1,100,000 1,100,000 PXS2000 PXS2000 3,533m 3,533m 1,100,000 1,100,000 PXS25 PXS25 Existing Market Existing Market Size Size1

1 (A$)

(A$) Patient Population Patient Population1

1

Product Product Target Application Target Application Multiple Sclerosis Multiple Sclerosis Multiple Sclerosis Multiple Sclerosis Rheumatoid Arthritis Rheumatoid Arthritis

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Senior Management Senior Management

Alan Robertson Alan Robertson BSc BSc, PhD , PhD Chief Executive Chief Executive Wellcome/Faulding/amrad Wellcome/Faulding/amrad Brett Charlton MBBS, PhD Brett Charlton MBBS, PhD Medical Director Medical Director Baxter/Stanford/ANU Baxter/Stanford/ANU William Cowden William Cowden BSc BSc, PhD , PhD Chief Scientist Chief Scientist Progen/Peptech/ANU Progen/Peptech/ANU David McGarvey BA, CA David McGarvey BA, CA Finance Finance PWC/ PWC/Memtec Memtec/US Filter /US Filter John Crapper BAS, MBA John Crapper BAS, MBA Operations Operations Syntex/Memtec/US Syntex/Memtec/US Filter Filter Gary Phillips Gary Phillips BPharm BPharm, MBA , MBA Commercial Commercial Novartis Novartis Staff 25 Staff 25

Internationally experienced and capable team with track record

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Financial Highlights Financial Highlights

Half Year Ended 31 December 2003 2002 $ $ Financial Performance Revenue – other 975,219 344,562 Expenses Research and Development (2,186,062) (753,706) Administration (851,743) (312,069) Net loss before and after tax (2,062,586) (721,213) 31 Dec 03 30 Jun 03 $ $ Key Balance Sheet Items Cash and bank accepted commercial bills 27,726,394 7,383,923 Plant and equipment 1,479,577 1,515,016 Intangible assets 1,191,613 1,205,000 Total assets 31,188,195 10,494,556 Total liabilities 466,437 604,495 Total shareholders’ equity 30,721,758 9,890,061

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Summary Summary

Near term value enhancing corporate milestones Near term value enhancing corporate milestones Fully integrated business model Fully integrated business model Effective board & experienced management Effective board & experienced management TGA approved facilities TGA approved facilities Products from leading Australian science Products from leading Australian science Clinical validation for inhalation products Clinical validation for inhalation products Attractive markets Attractive markets Product focused Product focused