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BIOTRON LIMITED AGM Information 2017

Nov 19, 2017

64528_rns_2017-11-19_ed3d3de3-40df-4d47-b4b8-74d0c2892548.pdf

AGM Information

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

20 Novem b er 2017

The Mana g er Compa n ies ASX Limi t ed 20 Bridge S treet SYDNEY NSW 200 0

(19 p ages by e m ail)

Dear Mad a m,

PRESENTATION TO ANNUAL GENERAL MEETING

I attach a n address b y the Chai r man and a PowerPoi n t presenta t ion which are to be d elivered t o the shareholde r s present a t today’s A n nual Gene r al Meeting which is c o nvened to b e held at 11.30 am.

Yours fait h fully

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Peter J. Ni g htingale Company S ecretary

pjn9169

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

20 Novem b er 2017

My Fello w Sharehold e rs

CHAIRMAN’S ADDRESS TO THE AGM

In recent w eeks, Biotr o n has take n a giant st e p towards d emonstrati n g that era d ication of H IV is poss i ble. The 36[th] a nd final p a tient in t h e Compan y 's Phase 2 HIV trial completed treatment. The trial w as designed t o demonstr a te the Co m pany's le a d compou n d, BIT225 , benefits patients abo v e and beyond current an t i-HIV trea t ments. An a lysis of tri a l data is, b y necessit y , frustratin g ly slow s o we have l i ttle choice but to impatie n tly await final results. Neverthel e ss, we re m ain confident. For the many mill i ons of patients destined t o live with t h is disease, there is h o pe, and for the thousa n ds of shar e holders of this Company m aybe, just maybe, the r e is light a t the end of a very long tunnel.

This is the 9[th] clinical trial conducted by Bi o tron. The p revious ei g ht trials s u ccessfully p rovided sound stepping s t ones alon g the clini c al develop m ent path w ay for BI T 225. Th e latest tri a l caps off our determinat i on to de m onstrate s o und scien c e and pro v en results add cred e nce to ou r belief in the significance of the C o mpany's p l atform. T h e only w a y to achie v e the com m ercial outcomes that are desired by shareholde r s is by pati e ntly deliv e ring qualit y data from c linical tria l s and supp o rting studi e s.

Much has b een achieved during t h e past 12 m onths, as w ill be outli n ed in the C EO’s prese n tation.

Looking a h ead, we h a ve every reason to be o ptimistic. Close focu s on our co r e assets is p resenting n ew opportunit i es. Biotro n should n o t be viewed as a sing l e asset co m pany. O u r diversity offers a st r ong portfolio o f possibiliti e s capable o f deliverin g sustainable shareholder value.

Importantl y , BIT225 i s only one of hundred s of Biotro n compoun d s. A subs t antial volu m e of evid e nce now supp o rts the beli e f that man y opportun i ties reside i n the Com p any's com p ound libr a ry, likely t o be beneficial a gainst add i tional viral targets.

A discipli n ed and foc u sed appro a ch to capi t al manage m ent is em b edded in o ur operati n g model. O ur priority is t o retain fl e xibility in t he develop m ent of gr o wth oppor t unities alig n ed, of cou r se, to our l ead product.

I would li k e to take t h is opportu n ity to tha n k our sma l l but dedic a ted staff f o r their det e rmination and productive efforts du r ing the pa s t12 month s . I would also like t o thank my fellow dir e ctors for t h eir equally de d icated part i cipation a n d support.

In particular, I should single out Denis Wade for his enduring contribution and dedication to the Company since he joined the Board in 2010.

For personal reasons, Denis steps down from the Board today. Denis' advice and insight have been of enormous value to me personally and to the entire Board. He departs with a mix of our regret and gratitude. I am relieved to report he won't be going far. Denis will retain an ongoing advisory role with the Company.

I would now like to invite our CEO, Michelle Miller, to address the meeting.

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Michael J. Hoy Chairman

Slide 'tle

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Forward Looking Statements

and business achievements/performance of Biotron Limited (ACN 086 399 144) and certain of the plans and objec'ves of its management. These statements are statements that are not historical facts. Words such as “should”, “expects”, “an'cipates”, “es'mates”, “believes” or similar expressions, as they relate to Biotron Limited, are intended to iden'fy forward looking statements. By their nature, forward looking statements involve risk and uncertainty because they reflect Biotron’s current expecta'ons and assump'ons as to future events and circumstances that may not prove accurate. There is no guarantee that the expected events, trends or results will actually occur. Any changes in such assump'ons or expecta'ons could cause actual results to differ materially from current expecta'ons.

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Investment Highlights

  • Biotron is designing, developing and commercialising a plaUorm of an'viral drugs with a novel mode of ac'on – able to target a wide variety of viral infec'ons

  • Pipeline of programs in high value, high need markets

  • Progress in clinical lead program (BIT225) provides strong valida'on for en're plaUorm

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Biotron Limited – Snap Shot

BROAD PLATFORM WITH NEW CLASS OF ANTIVIRAL DRUGS

BROAD PLATFORM WITH NEW CLASS OF ANTIVIRAL DRUGS BROAD PLATFORM WITH NEW CLASS OF ANTIVIRAL DRUGS BROAD PLATFORM WITH NEW CLASS OF ANTIVIRAL DRUGS BROAD PLATFORM WITH NEW CLASS OF ANTIVIRAL DRUGS BROAD PLATFORM WITH NEW CLASS OF ANTIVIRAL DRUGS
HIV-1 ERADICATION HEPATITIS C VIRUS (HCV) HBV & EARLY STAGE PROGRAMS
-
Targe'ng HIV-1 in long-lived
reservoirs
-
Phase 2 trial in progress
during 2017; dosing
complete
-
New class of HCV drug
-
Phase 2 completed
-
Seeking partnerships in
China
-
Pipeline of early stage
programs, including:
-
Hepa''s B virus
-
Respiratory viruses
-
Flaviviruses (e.g. Dengue)
ROBUST CLINICA VALIDATION – COMPLETED 8 CLINICAL TRIALS WITH

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Key Achievements FY 2017

  • Commenced Phase 2 clinical trial of BIT225 and Combina'on An'retroviral Therapy (cART) in Feb’17

  • Fully recruited in July ‘17; Dosing with BIT225/placebo completed; data pending

  • humanised mouse study in Feb ‘17

  • Independent Nature publica'on validated Biotron’s approach of targe'ng HIV-1 in macrophages as a key step in HIV-1 eradica'on in May ’17

  • Appointed Lynx Financial as Corporate Advisor for China – assis'ng with execu'ng HCV regional partnering strategy in June ‘17

  • Raised $1.56 million via rights issue in June ‘17

  • Received $1.6 million R&D tax refund in Nov ‘17 (post-end of FY)

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CommercialisaUon – Key Focus

  • Three tac'cal priori'es:

  • Partnering lead clinical program - BIT225 for HIV-1 eradica'on

  • Partnering one or more preclinical programs – e.g. HBV

  • Execute a regional licensing deal in China - HCV program remains a great opportunity

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HIV-1 EradicaUon

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Current drugs do not eradicate HIV-1 virus

  • HIV-1 remains hidden in reservoirs, leading to chronic, life-long infec'on • Invisible to body’s immune defenses

  • Not sensi've to an'-HIV-1 drugs

  • New mode of ac'ons drugs are needed to eradicate or cure HIV-1 infec'on

Why is HIV-1 eradicaUon necessary?

  • Long-term health implica'ons e.g. HAND, immune ac'va'on, etc

  • Cost of treatment

  • ~ $20 billion p.a. world wide

  • Major burden on healthcare systems

BIT225 has potenUal to be used in combinaUon with other drugs to eradicate HIV-1 reservoirs

Mario Stevenson Scien.fic American 299 , 78 - 83 (2008)

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HIV-1 EradicaUon: BIT225-009 Trial

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----- Start of picture text -----

BIT225 or placebo
added to ART
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  • 36 HIV-1[+ve] , treatment-naïve subjects commencing ART

  • Randomised 2:1 (drug:placebo)

  • Read-out

  • Impact on virus levels; reduc'on of immune ac'va'on markers

  • Fully recruited; completed dosing with BIT225/placebo; in follow-up period (ART alone)

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HIV-1 EradicaUon: BIT225-009 Trial

  • Fully recruited July; last pa'ent, last dose in mid-October

  • Three month follow-up period post-dosing with BIT225/placebo

  • Addi'onal samples collected from pa'ents throughout this next 3 month period

  • Post-trial laboratory analyses on samples from treatment period are in progress:

  • Virological Outcomes

  • Immunological Outcomes

  • Post-dosing sample data also required to complete the analyses

  • E.g. Any rebound or change in parameters once drug ceased?

  • All data is necessary to determine outcome of the trial

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CommercialisaUon: BIT225 HIV-1 EradicaUon

  • Several pharmaceu'cal companies have ac've HIV-1 “Cure” Programs

  • Posi've outcomes – BIT225 clinical trial - key to progressing commercialisa'on discussions

  • Communica'ng trial data as soon as available

  • Follow up mee'ngs with poten'al partners con'nue

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CommercialisaUon: Preclinical Programs – HBV

  • companies

  • Biotron’s HBV program is elici'ng early interest from poten'al partners

  • In vitro data on several candidate compounds includes evidence of reduc'on of industry recognised markers

  • Novel mechanism is very asrac've in combina'on approaches to treatment of HBV

  • Expands Biotron’s partnering opportuni'es – poten'al for early stage co-development / collabora'on agreement

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CommercialisaUon: Regional Licensing – China, HCV Program

  • The new HCV drugs (e.g. Solvadi) may cause reac'va'on of HBV in HCV/HBV coinfected pa'ents

  • Resulted in US FDA “Black Box” Warning on new HCV drugs

  • 30 million HCV-infected people in China, compared to 3-5 million in USA

  • 93 million chronically infected with HBV in China, compared to 2.2 million in USA

  • High HCV/HBV co-infec'on rate in China (es'mated to be 10 million)

  • Reac'va'on of HBV in people undergoing HCV treatment with these new HCV drugs has poten'al to be a major health & economic issue in China

  • in combina'on with Interferon & Ribavirin (IFN/RBV)

  • IFN/RBV have several poten'al advantages over new HCV drugs in some sevngs

  • HBV reac'va'on is less common and less severe in HCV/HBV co-infected pa'ents with IFN/RBV

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CommercialisaUon: Regional Licensing – China, HCV Program

  • Seeking partnerships for commercialisa'on of BIT225 for the treatment of HCV in China

  • Appointed a Shanghai-based corporate advisor with extensive experience in cross-border

  • transac'ons in the healthcare space

  • launch of BIT225 in China

  • Discussions are on-going

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Unlocking Value for Other Virus Targets

Library of compounds designed to target viroporins found in some viruses:

Ini'ally >250 compounds designed and synthesised; library now ~350

OTHER “HITS” IN LIBRARY include :

  • Hepa''s B virus (HBV)

  • Coronaviruses (Including SARS)

  • Epstein-Barr virus (EBV)

  • • Zika virus

  • others

X-axis: compound ID Y-axis: virus Z-axis: strength of hit

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Unlocking Value for Other Virus Targets

Biotron’s Viroporin approach enables the targe'ng of a wide range of viral diseases; examples include:

  • “common cold”)

  • Flaviviruses such as Zika Virus and Dengue

  • Transplant viruses such as BK virus

  • Epstein Barr virus (EBV) - par'cular interest in Asia where it is causa've agent of Nasopharyngeal Carcinoma

Biotron’s Viroporin placorm has the potenUal to become an important tool in the development of anUviral therapies

PotenUal for establishing early stage collaboraUons with pharmaceuUcal companies uUlising Biotron’s approach

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Summary

  • HIV EradicaUon

  • Engaged with the right poten'al partners

  • Wai'ng for data from trial but con'nue to engage with pharma

  • Preclinical Programs

  • HBV has promise as a preclinical candidate for joint development. HBV therapeu'c space is very hot.

  • BIT225 results validate the plaUorm; poten'al to facilitate funded developments by partners for “other” viral diseases

  • Regional Licensing

  • with the high rate of co-infec'on HCV & HBV requires different approach than used in the USA

Success in any or all of these strategies will be a “company maker” increasing the value for Biotron stakeholders

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