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SYNTARA LIMITED Investor Presentation 2021

Apr 13, 2021

65830_rns_2021-04-13_69759e84-5d66-4302-bf7d-d5d6a8eff17e.pdf

Investor Presentation

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Investor Presentation | 14 April 2021
Gary Phillips CEO

developing breakthrough treatments for fibrosis and inflammation

Forward looking statement

This document contains forward-looking statements, including statements concerning Pharmaxis’ future financial position, plans, and the potential of its products and product candidates, which are based on information and assumptions available to Pharmaxis as of the date of this document. Actual results, performance or achievements could be significantly different from those expressed in, or implied by, these forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements.

These forward-looking statements are not guarantees or predictions of future results, levels of performance, and involve known and unknown risks, uncertainties and other factors, many of which are beyond our control, and which may cause actual results to differ materially from those expressed in the statements contained in this document. For example, despite our efforts there is no certainty that we will be successful in developing or partnering any of the products in our pipeline on commercially acceptable terms, in a timely fashion or at all. Except as required by law we undertake no obligation to update these forwardlooking statements as a result of new information, future events or otherwise.

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Capital Raising Overview

Pharmaxis is raising ~A$4.4m at A$0.08 per share via a Private Placement

 Private Placement to institutional investors

  • A$4.4m under existing placement capacity pursuant to ASX Listing Rule 7.1

  • A$0.08 issue price represents a 1.3% premium to the last closing price of A$0.079 on 12 April 2021

 Use of funds

  • Strengthen balance sheet. A$20m pro-forma cash balance (31 March 2021 post raising)

  • Support the Company’s clinical program for myelofibrosis (PXS5505) and skin scarring (PXS-6302)

  • General working capital and capital raising costs

 Strong support from new and existing substantial shareholders

  • Karst Peak Capital Limited:

  • Asia/Australian healthcare investor with a contrarian, fundamental, long term oriented investment approach

  • committing A$3.2m to take a 8.9% stake post capital raising

  • BVF Partners LP committing A$0.8m to maintain their 19.5% shareholding of Company post capital raising

 Indicative timetable*

  • Trading halt

Tuesday 13 April 2021

  • Placement announced and Company resumes trading Wednesday 14 April 2021

  • Settlement of issue of Placement Shares Tuesday, 20 April 2021

  • Allotment of issue of Placement Shares Wednesday, 21 April 2021

*The timetable above is indicative only and may be varied subject to the ASX Listing Rules

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Executive Summary

  • Pharmaxis is a clinical stage drug development company targeting fibrosis and cancer

  • Lead asset PXS-5505 is in phase 1c /2a trial – a breakthrough clinical program with disease modifying potential in Myelofibrosis

  • PXS-5505 has further potential in oncology as an adjunct to standard of care

  • Additional asset PXS-6302 is an anti-skin scarring drug in phase 1a/1c trial in 2021 – PXS-6302 to enter patient studies in commercially important dermatology indications with potential to improve function and appearance

  • Specific corporate strategy to deliver non-dilutive cash and cost savings from other parts of our business

  • Distribution license fees from currently un-partnered mannitol territories

  • Simplification and rationalisation across business

  • Post capital raising Pharmaxis is in a strong position to fund its focused clinical program

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Clinical stage
medicines
Targeting fibrosis
and cancer
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Cash and capital structure

Extended cash runway

Cash

  • Cash at March A$16m

  • • Proceeds of placement A$4m

  • • Proforma cash balance as at March A$20m

Mannitol business forecast to go from cash burn (FY 20: EBITDA (A$4m)) to cash flow positive from FY 21 onwards (FY 26: EBITDA A$10m+)

Sale of Russian Bronchitol distribution rights effective 1 May

  • €1.25m (~A$2m)** – 70% payable now, 30% in twelve months

  • Cost reductions of ~A$1m per annum

Further opportunities to extend cash runway

  • Potential cost savings from rationalization across business

Share capital

  • Current shares on issue 397.5m

  • • Placement shares 54.6m • Shares on issue on completion of placement 452.1m

  • Enterprise value • Market capitalisation at $0.08 per share $36.2m

  • • Less: proforma net cash ($20.0m)

  • • Enterprise value $16.2m

  • Lead institutional shareholders • BVF Partners LP 19.5% • Karst Peak Capital Limited 8.9%

Enterprise value

Lead institutional shareholders

  • Distribution license fees from currently un-partnered Aridol and Bronchitol territories

  • Pipeline supported by grants and R&D tax credit (~A$5m 2020)

  • Partnering deals with pipeline assets

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Mannitol segment EBITDA only not included in proforma cash balance as at March 5
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Multiple potential value inflection points over next two years

Pipeline creates multiple opportunities

Target timelines

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Product Candidate 2021 2022 2023
Myelofibrosis Phase 1c Myelofibrosis Phase 2
PXS-5505
MDS pre-clinical MDS Phase 2
LOX Oncology
Hepatocellular Carcinoma Phase 2
Phase 1 Established scars Phase 1c
PXS-6302
LOX topical scarring
Post burns scarring Phase 1c
PXS-4699 preclinical
Preclinical compound assessment by DMD TACT
committee
Phase 2 ready programs
Evaluating grant and partnering
PXS-4728: SSAO
options
PXS-5382: LOXL2
Potential value inflection point Additional programs under evaluation
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DMD: Duchenne Muscular Dystrophy

MDS: Myelodysplastic Syndrome

Anticipated news flow: 2021 – 2022

Multiple anticipated value inflection points over next two years

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H1 2021

  • Feb 22: Breakthrough drug PXS-5505 phase 1c/2a myelofibrosis study commenced recruitment

  • Mar 19: Chiesi pays US$3m milestone on Pharmaxis shipment of US launch

  • Mar 31: LOX topical drug PXS-6302 commenced independent investigator studies - safety

  • April 14: Sale of Russian Bronchitol distribution rights

  • Mannitol business simplification – realising annual cost savings

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H2 2021

CY 2022

  • PXS-5505 phase 2a myelofibrosis study dose expansion stage commence

  • PXS-5505 phase 2a myelofibrosis study safety and efficacy data

  • First collaborations to progress PXS-5505 into clinical trials in other cancer indications

  • LOX topical drug phase 1c studies burns and established scars safety and efficacy data

  • Ongoing cash receipts from supply of Bronchitol for US sales

  • LOX topical drug PXS-6302 progresses into independent investigator patient studies - burns and established scars

  • Feedback from global advisory committee (TACT) on development fast tracking for Duchenne muscular dystrophy clinical trials.

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Pipeline opportunities
in fibrosis and inflammation

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PXS-5505 Breakthrough clinical program in
myelofibrosis prioritised into phase 1c/2

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First in class PXS-5505 IND approved and in the clinic

Novel anti fibrotic approach with broad applications in difficult to treat cancers

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Myelofibrosis: Orphan Disease with high unmet need forecast to exceed US$1b

  • Drug with disease modifying potential patent application filed 2018

  • Six month tox and Phase 1 studies completed 1H 2020

  • FDA orphan status granted July 2020

  • IND approved August 2020

  • Phase 1/2a proof of concept myelofibrosis study commenced recruitment Q1 21

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Adjunct to best standard of care in multiple cancers

  • LOX inhibition synergistic with current standard of care and potentially pharma development pipeline in many stromal cancers

  • Academic and clinical interest in additional indications including; o Myelodysplastic syndrome ( MDS) ; liver carcinoma (Hepatocellular carcinoma); pancreatic cancer; glioblastoma

  • International studies facilitated by IND approval and availability of drug product

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Myelofibrosis background

A rare type of bone marrow cancer that disrupts your body's normal production of blood cells

KEY FACTS

Primary Myelofibrosis is caused by a build up of scar tissue (fibrosis) in bone marrow reducing the production of blood cells:

  • Driven by clonal mutations of a hematopoietic stem cell (JAK, MPL, CALR genes)

Affects 15 in 1m people worldwide

  • Reduced red blood cells can cause extreme tiredness (fatigue) or shortness of breath

  • Reduced white blood cells can lead to an increased number of infections

  • 5 Years Median survival

  • Reduced platelets can promote bleeding and/or bruising

  • Spleen increases blood cell production and becomes enlarged

Age of onset 50 – 80

  • Other common symptoms include fever, night sweats, and bone pain

Standard of Care; JAK inhibition

11% transformation to leukemia

  • Symptomatic relief plus some limited survival improvement. 75% discontinuation at 5 years

  • Median overall survival is 14 – 16 months after discontinuation

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Mode of action in myelofibrosis Disease modifying potential as monotherapy and on top of standard of care

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Unique mechanism of action
targeting the extracellular matrix
Disease modifying
potential
Designed to provided efficacy on top of
existing standard of care
AND potentially pipeline drugs
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“Specific targeting of ECM dysregulation to prevent and diminish MF may prove the frontline of research and therapy development in PMF with the greatest promise of relieving symptoms and extending life expectancy of patients” Blood Cancer Journal (2017) 7, e525; doi:10.1038/bcj.2017.6

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PXS-5505; LOX inhibitor with promising profile Pre clinical and clinical studies strongly support entry into patient studies

PXS-5505 attenuates hallmarks of primary myelofibrosis in mice.

PXS-5505 – Phase 1 SAD

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Treatment with
PXS-5505
significantly
reduced reticulin
fibrosis
( = p<0.001)
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“JAK inhibition alone is insufficient in the treatment of patients with myelofibrosis; it is not associated with changes in underlying disease biology and it can worsen blood counts, leading to high drug discontinuation rates over time. The trial utilizing PX-5505 is supported by a sound scientific rationale, based on pre-clinical work demonstrating the importance of lysyl oxidase in the development of myelofibrosis. PXS-5505 has a unique mechanism of action that has the potential for disease modification. I am looking forward to seeing the effect of this drug in clinical trials.”[1]

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  • Good safety profile with 6 month tox studies complete

  • Dose dependant 24 hour inhibition of LOX enzymes from single once a day dose in humans

  • No safety signal seen in phase 1 trials

  • 2018 patent application filing date

Ref Graph1: Leiva et al. Intl J Hemat 2019. https://doi.org/10.1007/s12185-019-02751-6

PXS-5505 Phase 1/2a Trial in myelofibrosis

6 month monotherapy study with meaningful safety and efficacy endpoints

STUDY POPULATION

DESIGN

JAK-inhibitor unsuitable* Phase 1/2a open primary MF or post-ET/PV label study to MF patients with: evaluate safety, PK/PD, and efficacy

  • INT-2 or High risk MF requiring therapy

  • Symptomatic

  • BMF Grade 2 or greater

TREATMENT COHORT

ENDPOINTS

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Primary: Safety TEAEs

Dose escalation: PXS-5505 3 ascending doses, 4 weeks (n = 3 to 6 subjects/dose)

3 ascending doses, 4 weeks Secondary: (n = 3 to 6 subjects/dose) PK/PD BMF Grade IWG Response SVR Cohort expansion: Haematology PXS-5505 (n = 24 subjects) 26 weeks Symptom score

FDA granted orphan drug designation July 20 and IND approved August 2020

Multiple sites across 3 countries to enhance trial recruitment (USA, Korea, Australia)

Study budget (~US$5m)

Study recruitment commenced Q1 2021, study targeted to conclude H2 2022

*Unsuitable = ineligible for JAKi treatment, intolerant of JAKi treatment, relapsed during JAKi treatment, or refractory to JAKi treatment. JAKi – Janus Kinase inhibitor, MF myelofibrosis, ET Essential Thrombocythaemia, PV polycythaemia vera, INT intermediate,

BMF bone marrow fibrosis, RP2D recommended phase 2 dose, TEAE treatment emergent adverse event, PK pharmacokinetics, PD pharmacodynamics, SVR spleen volume response, IWG International Working Group Myeloproliferative Neoplasms

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Myelofibrosis – examples of other programs

PXS-5505 unique mechanism of action designed for disease modification and good tolerability

Company Market cap(1) Bourse Asset Description Clinical phase
$1.2bn Nasdaq KER-050 TGF-β ligand trap Phase 2
$1.1bn Nasdaq CPI-0610 BET inhibitor Phase 3
$0.7bn(2) n.a. – private KRT-232 MDM2 antagonist Phase 3
$0.5bn Nasdaq Imetelstat Telomerase inhibitor Phase 3
$24m (A$31m) ASX PXS-5505 LOX inhibitor Phase 1c/2
commenced

PXS-5505 unique mechanism of action expected to deliver additional efficacy on top of existing standard of care and/or known pipeline drugs without adding to tolerability issues

Notes: (1) Approximate market cap as at 22 March 2021

Pipeline opportunities
in fibrosis and inflammation

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PXS-5505 Significant opportunity in other cancers;
-
 Myelodysplastic Syndrome
-
 Hepatocellular Carcinoma

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PXS-5505: Significant opportunity in other cancers

Global academic and clinical interest in LOX inhibition drives development plan

Normal tissue

Pharmaxis Research Collaborations

Myelodysplastic syndrome

Germany

Liver Cancer

Rochester (NY)

Pancreatic Cancer

Sydney, Rochester (NY)

Melanoma and glioblastoma Houston

Head and Neck Cancer

Boston, (MA)

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Collagen
Tumour with fibrotic tissue has
• increased tissue stiffness
• Increased interstitial pressure
Increased Increased
EMT angiogenesis
Increased Decreased
Increased
Invasion drug perfusion
tumour growth
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Multiple expected benefits from inhibition of LOX enzymes

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EMT: epithelial to mesenchymal transition 16
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Myelodysplastic Syndrome (MDS)

A group of bone marrow cancers that disrupt normal production of blood cells

KEY FACTS

  • A group of malignant hematopoietic neoplasms characterized by Bone marrow failure with resultant cytopenia and related complications

 Current standard of care

Affects ~40 in 100,000 people > 70 years

  • Allogeneic stem cell transplantation

  • Immunomodulatory drug lenalidomide,

  • Advanced disease: DNA hypomethylating agents (HMA), azacitidine (AZA), and decitabine

50% to 60% of the patients will die from complications of the disease

New US diagnoses per annum ~50,000

 Pre clinical evidence

  • Unpublished data from Pharmaxis scientific collaboration demonstrating strong proof of concept

 Proposed clinical strategy

30% transformation to Acute Myeloid Leukemia

  • Build on myelofibrosis strategy in hematological diseases

  • 6 month proof of concept study on top of standard of care

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Hepatocellular Carcinoma (HCC)

4th leading cause of cancer-related mortality worldwide with a 19.6% 5-year relative survival

 Primary liver malignancies have doubled in incidence over the last two decades.

 HCC is a stromal (fibrotic) tumour

  • Accumulation of collagen crosslinks increases stromal stiffening and interstitial fluid pressure (IFP) reducing delivery of chemotherapy and immunotherapy.

 Etiology

  • Extrinsic factors e.g. Virus infections

  • Intrinsic factors e.g. auto immune diseases, fatty infiltration, genetics

 Current standard of care

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 Pre-clinical data

  • High LOX expression associated with reduced survival

  • LOX is up-stream regulator of VEGF expression and inhibition of this enzyme could potentiate the intratumoral effects of anti-VEGF therapy

  • Combination anti-PD-1 therapy with LOX inhibition has demonstrated synergistic decrease in tumor growth

 Proposed clinical strategy

Enhance the intratumoral response to standard of care through the addition of LOX inhibition in human HCC

  • 6 month study combination PXS-5505 on top of standard of care in newly diagnosed unresectable or metastatic hepatocellular carcinoma

  • Tyrosine kinase inhibitors

  • PD-L1 inhibitors + anti-VEGF

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Pipeline opportunities
in fibrosis and inflammation
PXS-6302 Topical LOX inhibition for
scarring

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Hypertrophic and keloid scarring

Cutaneous scarring following skin trauma or a wound is a major cause of morbidity and disfigurement

KEY FACTS

Collagen turnover in keloid

  • Mechanisms underlying scar formation are not well established; prophylactic and treatment strategies remain unsatisfactory

  • Current standard of care includes:

100m patients develop scars in the developed world alone each year as a result of elective operations and operations after trauma

Hypertrophic scars and keloids are fibroproliferative disorders that may arise after any deep cutaneous injury caused by trauma, burns, surgery, etc.

Hypertrophic scars and keloids are cosmetically and functionally problematic significantly affecting patients’ quality of life

The increase in extracellular matrix is a key factor and this depends on collagen and elastin cross-linking to make them less degradable.

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  • Corticosteroids

  • Surgical revision

  • Cryotherapy

  • Laser therapy

  • 5-fluorouracil

  • Pre clinical evidence

  • Unpublished data from Pharmaxis scientific collaboration demonstrating strong proof of concept

  • Treatment with PXS-6302 monotherapy demonstrates cosmetic and functional improvements to the scar

 Clinical strategy

  • 3 month placebo controlled study in patients versus current standard of care

  • Initial patient groups will include those with established scars and those with scarring subsequent to burn injury

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Further non core pipeline opportunities in fibrosis and inflammation Leveraging global leadership position in amine oxidase enzymes to deliver targeted drugs for fibrosis and inflammation

Product Candidate
Indications
Pre-
clinical
Product Candidate
Indications
Pre-
clinical
Product Candidate
Indications
Pre-
clinical
Phase 1 Phase 2
Next Steps
Phase 2
Next Steps
SSAO; PXS-4728 Repurposing for neuro
inflammatory disease

Partnering discussions; phase 2
protocol and funding discussions with
independent investigators
LOXL2; PXS-5382 Chronic fibrotic disease
e.g. chronic kidney disease,
idiopathic pulmonary fibrosis

Partnering discussions; phase 2
protocol and funding discussions with
independent investigators
SSAO/MAOB; PXS-4699 Anti inflammatory
Muscular Dystrophy

$1m matched funding grant

DMD TACT committee Q2 2021

Explore funding opportunities to
advance to the clinic H1 2022
SSAO/MPO; PXS-5370 Anti inflammatory
Multiple indications

Investigating funding opportunities
including grants

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Mannitol respiratory business

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Mannitol respiratory business (Bronchitol® and Aridol®)

Transformational impact of FDA Bronchitol approval (Oct 2020) – business segment cash flow positive from FY 2021 onwards

Sales

  • Mannitol respiratory sales forecast to double by FY 2022 with Bronchitol > 75% of sales

  • Strong longer term growth contribution from US

  • Growth in Ex-US markets including Russia

Expenses

  • Relatively fixed production cost base

  • Potential for simplified business model to reduce costs

Segment EBITDA

  • Forecast positive EBITDA from FY 2021 onwards (before potential cost savings).

  • US volumes contribute to mannitol segment generating profit

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Bronchitol in US

  • US CF market >65% of global market in value

US market doubles global cystic fibrosis patient opportunity with attractive pricing

  • Chiesi approval /launch milestone payments US$10m received FY 2021

  • US sales commenced in Q2 CY 2021

  • High teens % of Chiesi sales + supply contract - ~20% of Chiesi US Bronchitol net sales flow directly to the Pharmaxis bottom line

  • Three sales milestones totaling US$15m payable on achieving annual sales thresholds

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Appendices

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Novel, small molecule medicines focused on inflammation, fibrotic diseases and cancer

In house discovery and development capability

Experienced team delivering stream of novel drugs to the clinic

Platform technology drives pipeline of clinical assets

Multiple opportunities from global leadership in amine oxidase enzymes

Cash flow positive manufacturing business

FDA approval for Cystic Fibrosis drug transformative with Pharmaxis manufacturing business now cash flow positive

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Clinical stage
medicines
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Targeting Fibrosis and Cancer

Lead asset PXS-5505 in phase 1c/2a trial

Breakthrough clinical program with disease modifying potential in Myelofibrosis

Broad potential for PXS-5505 in oncology

Global scientific and clinical collaborations to extend value of PXS5505 in further oncology indications

Anti skin scarring drug in phase 1a/1c trial in 2021

PXS-6302 to enter patient studies in commercially important dermatology indications

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Experienced Scientific Leadership Team

Significant global experience in drug development, commercialisation and partnering

In senior management

On the board

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Wolfgang Jarolimek – Drug Discovery

  • more than 20 years’ experience in pharmaceutical drug discovery and published more than 30 peer reviewed articles

  • previously Director of Assay Development and Compound Profiling at the GlaxoSmithKline Centre of Excellence in Drug Discovery in Verona, Italy

  • spent 8 years as post-doc at the Max-Plank Institute in Munich, Germany; Baylor College of Medicine, Houston, Texas; Rammelkamp Centre, Cleveland Ohio; and University of Heidelberg, Germany

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Gary Phillips – CEO and Managing Director

more than 30 years of operational management experience in the pharmaceutical and healthcare industry in Europe, Asia and Australia joined Pharmaxis in 2003 and was appointed Chief Executive Officer in March 2013 at which time he was Chief Operating Officer

previously held country and regional management roles at Novartis – Hungary, Asia Pacific and Australia

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Dieter Hamprecht – Head of Chemistry

  • more than 20 years experience with small molecule and peptide drug discovery, contributed to greater than 10 drug candidates brought to development and co-inventor of 50 patent families, co-author of 30+ scientific publications

 previously Managing Director – Boehringer Ingelheim’s research group in Milan

  • senior medicinal chemistry positions at GSK

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Kathleen Metters – Non Executive Director

former Senior Vice President and Head of Worldwide Basic Research for Merck & Co. with oversight of all the company’s global research projects. in a subsequent role at Merck &Co she led work on External Discovery and Preclinical Sciences

former CEO of biopharmaceutical company Lycera Corp

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Brett Charlton - Medical

 more than 25 years experience in clinical trial design and management  author of more than 80 scientific papers  founding Medical Director of the National Health Sciences Centre  previously held various positions with the Australian National University, Stanford University, the Baxter Centre for Medical Research, Royal Melbourne Hospital, and the Walter and Eliza Hall Institute

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Neil Graham – Non Executive Director

  • former VP of immunology and inflammation responsible for strategic program direction overseeing pipeline development and clinical programs at Regeneron (REGN:US)

  • former SVP program and portfolio management at Vertex Pharmaceuticals

  • former Chief Medical Officer at Trimeris Inc and Tibotec Pharmaceuticals

Read more on the Pharmaxis website

Board

Significant international pharmaceutical experience

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Malcolm McComas – Chair

  • former investment banker and commercial lawyer

  • former MD Citi Group

  • has worked with many high growth companies across various industry sectors and has experience in equity and debt finance, acquisitions and divestments and privatisations.

  • joined Pharmaxis Board in 2003

  • chair since 2012

Will Delaat – Non-Executive Director

  • more than 35 years’ experience in the global pharmaceutical industry

  • former CEO of Merck Australia

  • former chair of Medicines Australia and Pharmaceuticals Industry Council

  • joined Pharmaxis Board in 2008

Dr Kathleen Metters – Non-Executive Director

  • former Senior Vice President and Head of Worldwide Basic Research for Merck & Co. with oversight of all the company’s global research projects.

  • in a subsequent role at Merck &Co she led work on External Discovery and Preclinical Sciences

  • former CEO of biopharmaceutical company Lycera Corp

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Gary Phillips – Chief Executive Officer

  • more than 30 years of operational management experience in the pharmaceutical and healthcare industry in Europe, Asia and Australia joined Pharmaxis in 2003 and was appointed Chief Executive Officer in March 2013 at which time he was Chief Operating Officer

previously held country and regional management roles at Novartis – Hungary, Asia Pacific and Australia

Dr Neil Graham – Non-Executive Director

former VP of immunology and inflammation responsible for strategic program direction overseeing pipeline development and clinical programs at Regeneron (REGN:US)

former SVP program and portfolio management at Vertex Pharmaceuticals former Chief Medical Officer at Trimeris Inc and Tibotec Pharmaceuticals

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Read more on the Pharmaxis website

Drug development capability

Established team in Drug Discovery and Clinical Trials with broad experience across multiple regulatory agencies

2015-2021

Organisation

  • Leadership with extensive drug discovery/development experience from big pharma and biotech

  • Extensive in house capabilities o On site laboratories

  • Leveraged with international network of external contract organisations

  • Numerous collaborations with leading academic institutions in Australia and world-wide in pharmacology and medicinal chemistry

  • High scientific reputation through peer-reviewed publications

  • Direct management of regulatory interaction with FDA, EMA, etc.

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7 Drugs
entered
pre-clinical
12
testing
publications
4 Drugs
entered
phase 1
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3 Drugs cleared phase 1 / IND ready

Strategy

  • Focus on inflammation and fibrosis/cancer driven diseases with high unmet medical need

  • Leverage global leading position in amine oxidase chemistry and biology

  • Create first or best in class small molecule inhibitors with biomarker assays for early validation of clinical hypothesis in phase 1 trials

  • Protect intellectual property by focused chemical matter, use and biomarker patents

  • Capture advantages of Australian location:

  • Accelerated (and lower cost) Phase 1 entry

  • Australian Government R&D tax credit system

2 Drugs in phase 2

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Financials

Cash

Periods ended (A$’000) Dec 2020
HY
Dec 2019
HY
Jun 2020
FY
Jun 2019
FY
Proforma cash
Cashperiod end 18,249 25,864 14,764 31,124
R&D tax credit - - 5,048 6,221
Chiesi US FDA milestonepayments ~4,0001 - ~14,000 -
~$22,249 $25,864 ~$33,812 $37,345
Cash Flow Statement Highlights
Operations
Receipts from customers 3,602 3,973 7,775 6,893
R&D tax incentive 5,099 6,221 6,271 -
Chiesi milestone 9,949 - - -
Payments to suppliers,employees etc (13,602) (13,886) (27,330) (26,691)
Total operations 5,048 (3,692) (13,284) (19,798)
Investing (capex) (281) (328) (574) (981)
Finance leasepayments2 (1,147) (1,111) (2,232) (1,593)
Financingagreementpayments3 (135) (129) (270) (254)
Share issue - net - - - 22,677
Net increase(decrease)in cash $3,485 ($5,260) ($16,360) $51
  1. US$3m milestone earned February 2021 2. Lease over 20 Rodborough Rd (to 2024) – total liability at 31 December 2020: $7.1 million

  2. NovaQuest financing – not repayable other than as % of US & EU Bronchitol revenue – up to 7 years

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Refer to Quarterly Shareholder Updates, 2020 Annual Report and December 2020 Half Year Report for complete financial information 29
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Financials

Income statement highlights

Periods ended (A$’000) Dec 2020
HY
Dec 2019
HY
Jun 2020
FY
Jun 2019
FY
Segment Financials
New drug development
Oral LOX (external costs) (1,323) (1,400) (3,124) (3,833)
Otherprogram external costs(net ofgrants) (775) (1,078) (3,315) (5,108)
Employee costs (1,799) (1,529) (3,373) (2,837)
Overhead (238) (281) (460) (606)
R&Dtax credit 148 259 5,159 5,962
EBITDA (3,987) (4,029) (5,113) (6,764)
Mannitol respiratory business
Sales 3,086 3,259 7,027 5,676
Other revenue and income 10,098 10 20 27
13,184 3,269 7,047 5,703
Expenses – employee costs (2,912) (3,037) (5,855) (6,083)
Expenses–manufacturing purchases (1,172) (746) (1,456) (1,689)
Expenses–other (2,376) (1,755) (3,713) (2,944)
EBITDA 6,724 (2,269) (3,977) (5,013)
Corporate– EBITDA (2,024) (1,701) (2,990) (3,874)
Total Adjusted EBITDA 713 (7,999) (12,080) (15,651)
Net profit (loss) $46 ($10,319) ($13,943) ($20,058)

Important Notice and Disclaimer

The following notice and disclaimer applies to this investor presentation (Presentation) and you are therefore advised to read this carefully before making any other use of this Presentation or any information contained in this Presentation. By accepting this Presentation you agree to be bound by the limitations, contained within it.

This Presentation has been prepared by Pharmaxis Ltd (ACN 082 811 630) (Company) in connection with the Company’s proposed placement to institution and professional investors (Placement) of new fully paid ordinary shares (New Shares).

Important Notice and Disclaimer

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PAST PERFORMANCE

Past performance and pro forma historical financial information in this Presentation is given for illustrative purposes only and is not an indication of future performance, including future share price information. FINANCIAL DATA

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Investors should also be aware that certain financial data included in this Presentation may be ‘non-IFRS financial information’ under Regulatory Guide 230 Disclosing non-IFRS financial information published by the Australian Securities and Investments Commission or ‘non-GAAP financial measures’ under Regulation G of the US Securities Exchange Act of 1934. The non-IFRS financial information and these non-GAAP financial measures do not have a standardised meaning prescribed by AIFRS and, therefore, may not be comparable to similarly titled measures presented by other entities, nor should they be construed as an alternative to other financial measures determined in accordance with AIFRS. Investors are cautioned, therefore, not to place undue reliance on any non-IFRS financial measures included in this Presentation.

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• exclude and disclaim all liability (including, without limitation, any liability arising from fault, negligence or negligent misstatement) for any direct or indirect expenses, losses, damages or costs incurred as a result of participation in the Placement or the information in this Presentation being inaccurate or incomplete in any way for any reason;

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• make no representation or warranty, express or implied, as to the currency, accuracy, reliability or completeness of information in this Presentation and take no responsibility for any part of this Presentation or that this Presentation contains all material information about the Company or that a prospective investor or purchaser may require in evaluating a possible investment in the Company or acquisition of shares in the Company, or likelihood of fulfilment of any forward-looking statement or any event or results expressed or implied in any forward-looking statement.

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The New Shares have not been, and will not be, registered under the U.S. Securities Act or the securities laws of any state or other jurisdiction of the United States. Accordingly, the New Shares may not be offered or sold directly or indirectly in the United States, unless they have been registered under the U.S. Securities Act (which the Company has no obligation to do or procure) or they are offered and sold in a transaction exempt from, or not subject to, the registration requirements of the U.S. Securities Act and any other applicable U.S. state securities law.

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developing breakthrough treatments for fibrosis and inflammation Pharmaxis Ltd ABN 75 082 811 630 www.pharmaxis.com.au

Contacts
Gary Phillips
Chief Executive Officer
[email protected]
David McGarvey
Chief Financial Officer
[email protected]