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Agenix Limitedg

Next Generation Drugs and DiagnosticsNext Generation Drugs and Diagnostics

Nicholas Weston Chairman & CEONicholas Weston, Chairman & CEO

BioKorea 201129 September 201129 September 2011Seoul, Korea

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Agenix company overviewAgenix company overview

Objective Next Generation drugs and diagnostics with a focus on China

Lead products

ThromboView® Location of live blood clots (PE + DVT) by radio-tagged mAb + SPECTCompleted two FDA Phase II trialsIn partnering discussions

AGX-1009 Tenofovir prodrug for chronic hepatitis BPreclinical trials in progress

Leadership St b d d t ith bilit t t i ChiLeadership Strong board and management with proven ability to operate in China

Listing ASX: AGX (1987), NASDAQ OTC: AGXLY

Locations Melbourne, Australia and Shanghai, China

Cash A$1.8M (30 June 2011)

Value Inflection

Partnering / Sale of ThromboView® State Food & Drug Administration CTA filing for AGX 1009 on track for 2012

points

Structure 747,331,576 shares outstanding, 18,691,312 options outstanding, Market cap ~A$11.2m

Next Generation Rx and Dx2

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OperationsOperations

Melbourne AustraliaMelbourne, Australia

Shanghai, China g


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Recent accomplishmentsRecent accomplishments

Technical • ThromboView® clot imaging agent peer reviewed publications in

Heart Lung and Circulation– Heart Lung and Circulation– American Journal of Respiratory and Critical Care Medicine

• AGX-1009 (tenofovir prodrug) demonstrated manufacturing in pre-clinical batches to 99.63% purityp y

Pre-clinical • AGX-1009 toxicology contracts signed with Institute of Radiation Medicine of the

Chinese Academy of Military Medicine SciencesChinese Academy of Military Medicine Sciences

Commercial • AGX-1009 compound patent transferred to Agenix from IMB and PCT manufacturing p p g g

patent filed• ThromboView® potential partners are conducting due diligence


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International experienced management teamInternational experienced management team

• Our people are Agenix’s core asset andOur people are Agenix s core asset and strength

• Agenix today is a well managed company

• Proven technical and China skills of directors, management and team aredirectors, management and team are driving our business forward to create long term shareholder value.


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Strategy to create long term valueStrategy to create long term value

1. Complete transformation to a company based on capital:• human capital (experience, creativity, networks, core competencies)• relationship capital (ASX listed since 1987 partners consultants suppliers• relationship capital (ASX listed since 1987, partners, consultants, suppliers,

customers, hospitals, universities, alumni, scientific advisory board, goodwill)• intellectual capital (patents, copyright, trade marks, licensing)• organisational capital (research methodologies, reference material, research g p ( g

results)• monetary capital (raisings, recoveries)

2 Partnering our capital with China infrastructure and technical skills2. Partnering our capital with China infrastructure and technical skills

3. Driving business by reference to technical, clinical and commercial value inflection points and realistic milestonesp

4. Competent execution of basics like good corporate governance, mitigating risk and communicating milestones and results.


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Effective working partnerships in ChinaEffective working partnerships in China

• Our partners include experienced State Food and Drug Administration (SFDA) hands and Hepatitis B experts:

• (acquisition of AGX-1009 patents) Institute of Medicinal Biotechnology (IMB), Chinese Academy of Medical ( ), ySciences (CAMS), Beijing

• (pre-clinical partner) Institute of Pharmacology and Toxicology (IPT), Chinese Academy of Military MedicalChinese Academy of Military Medical Sciences (AMMS), Beijing

• (pre-clinical partner) Institute of Radiation Medicine (IRM), AMMS, Beijing( ) j g

• (drug manufacturing partner) Beijing Honghui Meditech

• (clinical trials, ThromboView®) University of California San Diego USA


of California, San Diego, USA

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Current lead drug and diagnostic programsD-dimer

Current lead drug and diagnostic programs

ThromboView® diagnosticThromboView® diagnostic• Uniquely, images blood clots based on

molecular structure • Radiolabelled Fab’ fragment of

DD-3B6

ghumanised 3B6 epitope binds to clots then SPECT

• 3B6 epitope has >250 referenced publications since 1982publications since 1982

Hepatitis B anti-viral drug• Proprietary AGX-1009 compound is a

China’s State Intellectual Property Office (SIPO) approved the patent

tenofovir prodrug with the same active compound as Gilead’s FDA-approved Viread but with a different ‘sidechain’

• As a pro drug of a marketed product

approved the patent application of AGX-1009 after it authorized five tenofovir related patents to Gilead, which• As a pro-drug of a marketed product,

AGX-1009 has relatively low risk compared to a typical new chemical entity

to Gilead, which indicates that Gilead’s patents have little impact on AGX-1009 at compound level.


compound level.

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A successful history of commercialisationA successful history of commercialisationSince 1987 Agenix has taken ~ 20 animal and human products and 4 technology platforms to s ccessf l commercialisation and/or strategic sale and e it

®

Products commercialised

platforms to successful commercialisation and/or strategic sale and exit

Pre-clinical Phase I Phase IIIPhase II Marketing / sales

DIMERTEST® Latex, Auto DIMERTEST®

D-dimer detection (IVD)

VetRED® CHW, FIV;WITNESS® CHW FHW FeLV FIV CPV

Sold to American Diagnostica 2005

WITNESS® CHW, FHW, FeLV, FIV, CPV Veterinary infectious diseases (IVD)

SimpliRED® D-dimer; Simplify® D-dimer

)Sold to BBI UK 2007

Sold to Idexx Labs 2006

VTE Exclusion (IVD)

ThromboView P l E b li

Current businesses Divestment / partner discussions underwayPulmonary Embolism

AGX-1009Hepatitis B

discussions underway


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AGX 1009 proof of conceptAGX-1009 – proof of conceptAGX-1009 is a patented tenofovir ‘prodrug’ with the same active compound as Gilead’s FDA-approved Viread but activated by a different molecular sidechain.

Tenofovir (Viread) is FDA approved in USA for HIV (2001) and HBV (2008) . It is not approved in China.

REVEAL Study：The Relationship Between Virus Number And Hepatocirrhosis/Hepatocellular Carcinoma

4006 Study：antiviral therapy could slow down the development of chronic hepatitisＢ

1992 1998 2002 2005 2007 20082004 2006

Interferon was approved for chronic hepatitis B Lamivudine

PegIFN

Adefovir Entecavir Telbivu-dine Tenofovir


PegIFN

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ThromboView® safe and effectiveThromboView® – safe and effective

Relatively low radiation exposurey p

Avoids exposure to nephrotoxic contrast dye

Sensitivity and specificity comparable to CTPA

11

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ThromboView® Strategy to create valueThromboView® – Strategy to create value

• Strategic transaction discussions underway

• Follows appointment of Partner International working from offices in Canada USA• Follows appointment of Partner International working from offices in Canada, USA and Switzerland

• The strategic transaction objective is for eitherg j

• divestment of the ThromboView® technology• partnering fully funded ThromboView® Phase III trials• sale of Agen Limited (subsidiary holding IP)• sale of Agen Limited (subsidiary holding IP)

• We anticipate current discussions will continue into early 2012.


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ThromboView® Market opportunitiesThromboView® – Market opportunities

Market

Pulmonary Embolus (PE)• 600 000 clinically recognised

Opportunities

ThromboView® and PE• first occurrence600,000 clinically recognised

incidences of thromboembolism in the US alone annually

• Real figure may be 3 – 10 X. Why?

first occurrence• even in small vessels• diseased lungs with altered

perfusion• In 20.5% of fatal PE, the PE was

suspected but not followed up due to renal failure (ie patient cannot have contrast agent) or patient unstable

• recurrence (vs scarring)• renal insufficiency• young women• repeat testingcontrast agent), or patient unstable

• 47.5% of fatal PE is unsuspected pre-mortem

• CTA inconclusive rate around 5% in d PE

repeat testingThromboView® and co-existing Deep Vein Thrombosis• legs and upper extremities: first

suspected PE occurrence • legs and UEVTE: recurrence• other large veins• radiation dose with CTPA a


radiation dose with CTPA a growing issue

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Hepatitis B Market opportunity in ChinaHepatitis B Market opportunity in China

China Population (1.335 billion)Over 10 million HBV patients and carrierswho receive treatment withtreatment with Lamivudine, Adefovir, Entecavir and Interferon.

HBV Carrier Prevalence 7.2%1

2HBV China market worth A$460 million in 2009 and will triple by

HBV Patient transformation rate ~20%2

2019 (IMS Health) HBV Patients in Treatment ~50%3

Lamivudine Adefovir Entecavir Interferon

1 MOH Statistics 2008

AGX-1009Tenofovir-DF


1 MOH Statistics, 20082 Ibid3 IMS Health

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Hepatitis B Current market in ChinaHepatitis B Current market in China

2 800 4602 745

Million , RMB

2,600

2,800

2 200

2,400

460

280220

200

2,745

651

1 600

1,800

2,000

2,200 180

160

140

120521

2,097

518

1,606

1 000

1,200

1,400

1,600

80

60

40

100

515421

398

377

948 ENTECAVIRLAMIVUDINEADEFOVIR DIPIVOXIL

600

800

1,000

-40

-20

20

0

400317

389

286

255

383

235

243

398948

63

316

197631

280

35 TELBIVUDINEINTERFERON ALFA-2BPEGINTERFERON ALFA-2A

PEGINTERFERON ALFA-2B

-80

-60

-100

400

200

0

2009

36102

216

2008

31 74128

286

2007

32 51 34236

2006

49 13197

11363

2005

63 419356

INTERFERON ALFACON-1INTERFERON ALFA-N1INTERFERON ALFA-2A


SOURCE: IMS HEALTH

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Intellectual Property protectionIntellectual Property protection

ThromboView® blood clot diagnostic

• Patents registered in USA EU Singapore Australia New Zealand to 2022• Patents registered in USA, EU, Singapore, Australia, New Zealand to 2022• Patent application under examination in China• Data protection as a biologic 10 years EU and 12 years USA from date of regulatory

approvalpp

AGX-1009 anti hepatitis B compound

• Patent registered in China for AGX 1009 small molecule compound after Gilead• Patent registered in China for AGX-1009 small molecule compound after Gilead patents indicating third party patents will have little impact on AGX-1009 molecule protection

• PCT applications for synthesis methods and drug fixed-combination formulationspp y g


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Capital and shareholder overviewCapital and shareholder overview Capital Structure• Shares on Issue: 747,331,576 Share price chart, ,• Share Price @ 9 Sep 2011: $0.015• Market Cap: $11.2m

Listed Options ($0.06)expiry June 2012 6,444,998Unlisted Options ($0.017) expiry Jan. 2012 10,700,000

• Cash (30 June 2011) $1.8m• First Listed 1987

Shareholding StructureTop 20 Shareholders 68.88%

• Annmac 18.19%• Tang Wen Sen 12.06%

TickerASX: AGX

NASDAQ OTC AGXLYg

• OKS AGX Inc 5.57%• Pacific Super 4.77%• Sino Sky Holdings 4.02%

Di t /M t 15 13 %

NASDAQ OTC: AGXLY


• Directors/Management 15.13 %

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A strategic approach to reduce our risksA strategic approach to reduce our risks

Issue StrategyIssue Strategy Clinical results

• AGX-1009 based on an established and proven existing compound • Significantly lower risk profile to a new drug compound • ThromboView® successfully completed Phase I and Phase II• ThromboView® successfully completed Phase I and Phase II

Clinical recruitment

• Working with strategic partners who are the experts in China • Minimum errors in data and regulatory submissions in China• Government priority to expedite new drugs like AGX-1009Government priority to expedite new drugs like AGX 1009

Intellectual property

• AGX-1009 protected by broad patents in all key global markets• ThromboView protected by broad patents until 2022• Continue to build and will aggressively defendgg y

Capital needs

• Continue to develop strong supportive shareholder base• Close control of costs and programs to reduced our burn rate

Sentiment • Lead drug candidate contains successful proven compoundSentiment Lead drug candidate contains successful proven compound • Proven strategic partners in China (CAMS, AMMS)• Positioned to benefit from significant unmet needs in China• Well managed company with strong management team

18 Next Generation Rx and Dx

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Value inflection points near termValue inflection points – near term

ThromboView® • Potential partners currently conducting due diligence may conclude a deal in 2011/2012 including access to technology fees, milestone payments, royalties

• Potential Phase III start• Progress of patent applications• Progress of patent applications• Key publication expected

AGX-1009 • Data available from pre-clinical studies of tenofovir prodrug AGX-1009• Announcements regarding proof of confidenceAnnouncements regarding proof of confidence• SFDA CTA filing expected mid-2012 • Announcements regarding distribution and clinical partnerships• Potential licensing deals in key geographies

Potential clinical trial approval in 2012/3• Potential clinical trial approval in 2012/3• Potential commencement of combination trials• Progress of patent applications

Pipeline • Announcements concerning steps to resolve ‘in principal’ rights to other pipelinePipeline Announcements concerning steps to resolve in principal rights to other pipeline candidates

• Announcements regarding technical, clinical and commercial opportunities to build a late stage pipeline or assets that are accretive in the near term


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Next generation Rx and DxNext generation Rx and Dx

Next Generation Rx and Dx symbolises

• transformation of our business

• new era of growth in next generation therapeutics and diagnostics

• Agenix history and culture

• A focused approach to creating a path to profitibility and shareholder returns

• Commitment to meeting large unmet medical needs with innovative new products that transform the way common diseases are treated y

• Improve the quality of life for millions of people.


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Thank youa you

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ContactContact

Nicholas WestonChairman & CEO+61 3 8616 0379+61 3 8616 0379

Agenix Limited156 Collins Street156 Collins StreetMelbourne Victoria 3000Australia

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AddendumAddendum

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ThromboView® Safety and EfficacyThromboView® – Safety and Efficacy

• Well-tolerated in all patient cohorts

• No symtomatic adverse effectsy

• Majority of the adverse effect mild in severity and resolved without intervention

• Most frequently occurred adverse event of• Most frequently occurred adverse event of abnormal liver function tests thought to be related to concomitant therapy with concomitant therapy.py

• Sensitivity and specificity warrant further clinical testing

• Received FDA endorsement on phase III• Received FDA endorsement on phase III trial design to ‘gold standard’ using PIOPED II truth standard rather than CTPA


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ThromboView® Completed StudiesThromboView® - Completed Studies

Study Subjects Design ObjectivesPhase Ia 32, healthy

volunteersSingle center, 4 ascending doses

To test safety, pharmacokinetic and dosimetry profile

Phase Ib 26 patients diagnosed with

Multi-center, 3 ascending doses

To test safety, pharmacokinetic and

DVT dosimetry profile in patientsPhase Ib 15 patients

diagnosed with PE b CTPA

Multi-center, single dose (0.5mg)

To assess safety and tolerabilityP f f tPE by CTPA Proof of concept

Phase II 82 patients with confirmed DVT by venography

11 sites in the US and Canada, single dose

To assess sensitivity and specificity

by venographyPhase II 52 patients with

high to moderate probability of PE

7 sites in the US and Canada, single dose

To assess sensitivity and specificity


probability of PE

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ThromboView® pharmacokineticsThromboView® – pharmacokinetics

A large and growing body of independent clinical evidence confirms ThromboView® is safe and well tolerated in a range of patients

Bl d ClBlood Clearance

0.05

0.06

0.03

0.04

% ID

/g

0.01

0.02

%

0

0 2 4 6 8H


Hours

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CT False Positives in PIOPED 2

Stein, et al. Multidetector computed tomography for acute pulmonary embolism. N Engl J Med 2006; 354:2317-2327

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Agenix glossaryAgenix glossary

Antibodies - unique proteins produced by the immune system when a specific type of harmful substance, called an antigen, is detected

AGX-1009 - A patented ‘prodrug’ of tenofovir owned by AgenixAGX 1009 A patented prodrug of tenofovir owned by Agenix

Assay - a procedure for measuring the biochemical or immunological activity of a sample

HBV – Hepatitis B virus

Prodrug - the pharmacologically inactive derivative of an active drug,Prodrug the pharmacologically inactive derivative of an active drug, designed to maximise the amount of active drug that reaches its site of action by adding a molecular side chain to the active compound.

Tenofovir – the active drug substance in both AGX-1009 and Viread

Viread: the market name of a ‘prodrug’ of tenofovir owned by Gilead


Viread: the market name of a prodrug of tenofovir owned by Gilead Sciences Inc

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For personal use only - Australian Securities Exchange · SimpliRED® D-dimer; Simplify® D-dimer )...

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