BIOTRON LIMITED — AGM Information 2012

Nov 27, 2012

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Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333 E-mail: pnightingale@biotron.com.au Website: www.biotron.com.au

28 November 2012

The Manager Companies ASX Limited 20 Bridge Street SYDNEY NSW 2000

(28 pages by email)

Dear Madam,

PRESENTATION TO ANNUAL GENERAL MEETING

I attach a Chairman's Address and PowerPoint presentation which are to be delivered to the shareholders present at today’s Annual General Meeting which is convened to be held at 11.30 am.

Yours faithfully

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Peter J. Nightingale Company Secretary

pjn7001

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Level 2, 66 Hunter Street Sydney NSW 2000 Tel: (61-2) 9300 3344 Fax: (61-2) 9221 6333 E-mail: pnightingale@biotron.com.au Website: www.biotron.com.au

28 November 2012

Dear fellow shareholders

CHAIRMAN'S ADDRESS TO THE AGM

Thank you for your attendance at today’s AGM and for your continued support of Biotron.

For Biotron, this has been a year of transformation.

Significant milestones have been achieved in the development of our lead compound, BIT225, each one aimed at providing a constructive stepping-stone towards achieving ultimate commercial success.

A Phase2 HepC clinical trial was completed, culminating in excellent results.

A Phase2 HIV trial was started. This was and is a particularly challenging trial. It has taken longer than planned. Unfortunately that is the nature of the business we are in. Human trials do not and cannot be expected to run to deadlines. We depend on patient availability and our patient requirements are specific to the point of dramatically narrowing the available number even further. Biotron staff have worked closely with the trial site, and clinicians involved, and you can be assured that everything that could possibly be done to complete this trial sooner has been done. The trial is near completion and we expect results to be available during the first quarter of 2013.

A Phase2 clinical trial has recently commenced for patients suffering from the combination of HepC and HIV. There is a significant unmet treatment need for this particular patient population. Biotron is in the enviable position of developing a drug that targets both problems. It is an area that offers significant commercial opportunities for the Company.

Considerable effort has gone into further improving the standing of Biotron’s antiviral program and I am pleased to report excellent progress on the development of our next generation compound, BIT314.

The Company’s CEO, Michelle Miller, will cover in detail each of these steps – and more - during her presentation.

Over the past year the competitive landscape of HepC drug development has undergone several notable changes. Landmark deals have been agreed, valued in the billions of dollars. These have been counterbalanced by the failure of several high profile HepC drug programs. Biotron continuously analyses this high-wire commercial landscape. Our development plans are under constant review. Every milestone achieved, or considered, is a carefully planned, critical step towards successful commercialisation of the Company’s technology.

I am pleased to report that in these uncertain economic times Biotron is on sound financial footing. Eight million dollars was raised during the year from the exercise of options. We are grateful to the shareholders and investors who supported us and we believe the Company is well positioned to meet all immediate expenditure needs.

In line with the stage of development the Company has now achieved, and with an eye to the immediate future, Biotron’s management team has been strengthened. The Board has also been considerably bolstered to provide the necessary range of skills to oversee the Company’s strategy for clinical development and appropriate commercial outcomes. I sincerely welcome all new appointees.

Biotron has a challenging, but exciting, year ahead. Directors believe that the progress achieved during the past year provides cause for optimism for the future. We are a Company to be watched, as we move, with determination, beyond the confines of early stage development.

With this in mind, I thank the management team, and my fellow directors, for their efforts during the past year. I’m confident they will be equally unflagging in their focus on delivering successful outcomes during the next 12 months.

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Michael J. Hoy Chairman pjn6986

2

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ASX:BIT
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AGM 28 November 2012

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• Clinical Programs:

• HCV – Completed Phase 2a trial; positive data recorded

• HIV - Phase 2a trial commenced end 2011; data expected 1Q2013

• HIV/HCV co-infected - Phase 2 trial commenced Oct 2012

• Non-Clinical Programs:

• Progressed development of next-generation HCV inhibitor

  • BIT314 has increased potency; good safety and druggability characteristics in preclinical tests done to date

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• Value-adding, supporting R&D activities:

• Manufactured 10kg GMP BIT225

• Developed a capsule formulation for future trials

• Commenced three-month toxicology/safety studies

• Other:

• Strengthened Biotron’s team – new staff and directors

• Strong financial position after raising $8 million in Dec 2011

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GLOBAL PERSPECTIVE

BIT225 has demonstrated clinical efficacy against HCV

• What does this mean?

• Where does BIT225 fit with other HCV programs?

• Where to next?

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• 180 m people infected worldwide (3% world population); 130 m are chronically infected; 4 m patients in US (2.7 m chronically infected)

• Majority of infected patients remain untreated or untreatable

• Reportedly only 2.6% are treated each year

• Up to 50% patients don’t respond to current treatment

• Standard of care is interferon and ribavirin

• Significant side effect profile – high drop out rate

• Documented need for new, safer, direct-acting antiviral (DAA) drugs

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HCV – Complexity of Disease
Stable chronic vs
rapid progression
Spontaneous
clearing of virus
GENOTYPES HCV Liver failure/ liver
HETEROGENEITY cancer/ death
CO-INFECTIONS
E.G. HIV and HEP B
Viral rebound
following
Null-responders
treatment
to treatment
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• ~~Industry focus is on developing new direct-acting antivirals (DAAs)~~

• Future treatments expected to be cocktails of different classes of DAAs

• Remember HIV (multi-drug resistance; evolution of treatment options)

• Likely to be more than one cocktail to cover the wide spectrum of HCV disease

T here is unlikely to be just one “winner” in the HCV race

CLASSES IN DEVELOPMENT APPROVED Interferon-lambda NS3 (protease) Interferon-alpha inhibitors - NEW NS5B (polymerase) P7 inhibitors Ribavirin inhibitors BIT225 NS5A inhibitors NS4B NS3 (protease) inhibitors

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*BIT225

NS5B (polymerase) NS5A NS4B Entry Inhibitors NS3 (protease)**	p7
Phase 1 5 6 1 1 1	0
Phase 2 11 0 0 0 8	1*
Phase 3 1 1 0 0 3	0
Phase 4 (approved) 0 0 0 0 2	0

Source – clinicaltrials.gov (Nov 2012)

**Over 12 NS5B drugs have failed or been withdrawn since 2007 - including Ph2 BMS/Inhibitex drug bought for $2.5 billion in Jan 2012

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• In the absence of a crystal ball, but based on latest data and key opinions at AASLD:

• Likely to have a NS5B polymerase and a NS3 protease at its core

• Likely to include ribavirin

• At least one, and most likely two, other classes of drugs

  • Ideally, one of these will be BIT225

• There will most likely be a number (maybe 2-4) different combinations to treat the whole spectrum of HCV disease, for example:

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NS5B NS3 NS5B NS3
RBV p7 RBV NS5A
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NS5B NS3
NS4B p7
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Complex disease which will require a range of treatment options, including different combinations of DAAs

• What will determine treatment selection?

• Price

• Side-effect profile

• Interaction with other drugs

• Disease status

• Efficacy (genotype, responder status, etc)

• Evolution of treatment options as new drugs come to market

• Commercial interests

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• Despite recent encouraging data from various trials, significant gaps remain

• Hard-to-treat groups include:

• Genotype 1a

• Null-responders

• Partial responders

• HCV/HIV co-infected population

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BIOTRON’S ANTIVIRAL PROGRAM UPDATE

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 Only one of its class (p7 inhibitor) in clinical trials

 Works at later stage of virus life cycle to other classes of drugs

• Doesn’t readily generate resistance

 Synergistic with HCV polymerase inhibitors in laboratory studies  Active against hard-to-treat genotype 1a

 Potential for use in HCV/HIV co-infected patients

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BIT225
Interferon + Ribavirin
Placebo
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	BIT225 Placebo				Interferon + Ribavirin
0			4		12	48		72 weeks
	End of Treatment				EVR	SVR		Follow up
					12 WEEKS	48 WEEKS
	Treatment
					Early Response*	Sustained Response*
	400 mg BIT225		+	SOC	86%	100%
	200 mg BIT225		+	SOC	88%	88%
	Placebo + SOC				63%	75%

*virus levels below limit of detection i.e. 50 IU/ml

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• Clear demonstration that this first in class, direct-acting antiviral drug has good antiviral activity in treatment-naïve genotype 1 patients

• Includes difficult to treat genotype 1a

• Well tolerated at the doses selected in trial

• Confirmed preclinical findings that BIT225 is synergistic with IFN and ribavirin

• Potential to combine with new classes of DAAs

• Preclinical efficacy studies demonstrated synergism with NS5B polymerase inhibitors

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• Current international focus on strate ies for elimination or cure of HIV g

BIT225 Prevents production of infectious virus in reservoir cells Potential to eliminate this long-lived source of virus in the body

• Commenced a Phase 1b/2a trial in HIV-positive patients in September 2011 • 24 patients, HIV+, treatment-naïve, high viral loads, healthy CD4 counts

• Biotron has a unique position as BIT225 works on both HIV and HCV

• No other drugs target both viruses

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• ~~: • 20 – 40% HIV-infected patients are also infected with HCV in the US~~

• Significantly worse prognosis than mono-infected

• Faster HCV disease progression

*BIT225

• Trials in progress:

NS5B (polymerase) NS5A NS3 (protease)					p7
Phase 1 0 0 0					0
Phase 2 0 0 0					1*
Phase 3	0 1	2 (new) 2 (approved**)			0
Phase 4 (approved)	0 0 0				0
	not HIV/HCV)

**Approved for HCV (not HIV/HCV)

Potential for adverse drug-drug interactions

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BIT225 300mg Interferon + Ribavirin ART
0 1 5 12 48 60 72 weeks
End of
EVR SVR SVR12 Follow up
Treatment
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• 12 patients

• HIV+, on antiretroviral treatment (ART) with stable disease

• HCV+, treatment-naïve

• Genotypes 1, 2 and 3

• Commenced October 2012

• Expected to run through 1H2013

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• ~~Completed manufacture of 10 kg of GMP BIT225~~

• Demonstrated robustness and reproducibility of manufacturing process

• Sufficient for current and anticipated near-future clinical trials

• Completed development of an improved, capsule formulation of BIT225 • Important for ease of use, handling, and patient compliance in future larger scale trials

• Commenced three-month toxicology/safety studies

• Essential for longer-term clinical trials

• These are critical activities in BIT225's development path, and central to achieving a successful commercial outcome for BIT225.

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• Designed as a follow-on from BIT225

• Increased potency against p7

• Favourable safety and druggable characteristics in preclinical testing to date

• Undergoing extensive pharmacological analyses

• Anticipate moving BIT314 to manufacture and formal preclinical tox/safety studies in 1H2013, and into first-in-human studies in the 2H2013

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[STRATEGIC DIRECTION FOR ] BIOTRON’S ANTIVIRAL PROGRAM

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• Hepatitis C

• Part of combination cocktail with polymerase and protease inhibitors

• Unique mode of action

• Good drug-drug interaction profile

• Limited alternative classes for combinations

• HIV

• Add-on to anti-retroviral treatment to clean out underlying reservoirs

• HIV/HCV

• Part of combination cocktail with either IFN/RBV and/or other new DAAs

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• Other DAA HCV trials moving to at least 3 month dosing

• Need 3 month human data with BIT225 before can be considered for combination with other new DAAs

• Require 3 month tox/safety studies for these longer duration human studies

• Proof-of-concept in the clinic against HIV

• Activity against HCV in HIV/HCV co-infected population

• Development of next-generation inhibitors

• Validates Biotron’s ability to design and develop clinically-relevant inhibitors of viroporin proteins found in a range of viruses

Multiple shots on goal driving asset value

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Clinical Activities:

• Complete Ph 2a HIV trial (1Q2013)

• Complete Ph 2 HIV/HCV co-infected trial (1H2013)

• Conduct bioequivalence study in healthy volunteers with new BIT225 capsule formulation (1H2013)

• Commence three-month Phase 2b HCV trial (2H2013)

Non-Clinical Activities:

• Complete the three-month toxicology studies (1H2013)

• Progress BIT314 through process development, scale-up activities, and preclinical toxicology studies (1H2013)

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ASX:BIT

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Dr Michelle Miller Managing Director +61 2 9805 0488 +61 412 313329 mmiller@biotron.com.au www.biotron.com.au

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