BIOTRON LIMITED — Investor Presentation 2012

Nov 15, 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

16 November 2012

The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000

(3 pages by email)

Dear Madam

PRESENTATION OF BIT225 HEPATITIS C VIRUS 48-WEEK DATA AT AASLD CONFERENCE, BOSTON MA

- 100% SVR in patients receiving 400mg BIT225 in combination with standard of care - No detectable antiviral resistant variants generated during treatment

Sydney, Australia: 16 November, 2012: Australian drug development company Biotron Limited (ASX:BIT) has presented the latest data from its Phase 2a trial of BIT225 in patients infected with hepatitis C virus (HCV) in a presentation at the American Association for the Study of Liver Diseases (AASLD) 2012 annual conference that took place this week in Boston MA, USA.

The poster entitled "High sustained viral response with a HCV p7 inhibitor, BIT225: Antiviral activity and tolerability of BIT225 plus pegylated interferon alfa 2b and weight-based ribavirin for 28 days in HCV treatment-naïve patients" is attached in the Appendix that follows. It was presented in a late-breaking poster session at The Liver Meeting® 2012, the 63rd annual meeting of the AASLD.

The new data shows that 100% of patients who were treated with 400mg BIT225 in combination with the current approved anti-HCV treatment had no detectable virus at the 48-week time point. This compares to 75% of patients who only received the approved treatment, and demonstrates that in this trial BIT225 improved the outcome in patients infected with hard-to-treat genotype 1 HCV infection.

Analysis of blood samples taken from the patients after dosing with BIT225 indicated that the drug did not induce antiviral resistance.

The 48-week data extends the previous three-month data, and demonstrates that BIT225 appeared to continue to provide additional benefit to patients after the conclusion of dosing.

"The data from this trial are very encouraging - to see no detectable virus at the 48 week follow-up is a good outcome for the patients, who are infected with the hard-to-treat genotype 1 version of the virus," reported Michelle Miller, Managing Director of Biotron. "During preclinical development of BIT225, laboratory studies indicated that BIT225 could potentially improve the activity of interferon and ribavirin, and this trial has confirmed that this has translated into benefit for the patients. In addition, the drug does not appear to readily generate resistance, which can be a problem with some of the other new classes of anti-HCV drugs in development."

Biotron’s BIT225 targets the HCV viral protein p7, which has crucial roles in virus replication and reproduction. It is a new target, and BIT225 is a first-in-class direct acting antiviral for the treatment of HCV.

BIT225 is also in development for treatment of HIV, with a Phase 1b/2a trial currently in progress. BIT225 offers a unique opportunity for potential use in the HIV/HCV co-infected population. A phase 2 trial in this patient population is current recruiting.

Enquiries Dr Michelle Miller Rudi Michelson Managing Director Monsoon Communications Biotron Limited +61-3 9620 3333 +61-(0)412 313 329 mmiller@biotron.com.au

Yours sincerely

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Peter J. Nightingale Company Secretary

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About Biotron

Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need, with a major focus on HIV and HCV. The Company has BIT225 in clinical development for both HIV and HCV, and also has several earlier stage preclinical and research programs for several other viral infections including Dengue.

About BIT225 and HCV

BIT225 represents a first-in-class drug for treatment of HCV, targeting the p7 protein of HCV. It is estimated that in the USA alone, some 4 million people have been infected with Hepatitis C with 2.7 million suffering from chronic infection. Worldwide, 170 million people are infected. HCV causes inflammation of the liver, which may lead to fibrosis and cirrhosis, liver cancer and, ultimately, liver failure. Existing drugs for HCV have limited effectiveness and toxicity issues, leaving a significant need for new therapies. The worldwide market is currently almost US$3.3 billion, but is estimated that this market will expand to over US$10.0 billion as safe, effective therapies enter the market.

Monotherapy with interferon-α and combination therapy with interferon-α and the ribonucleoside analog ribavirin are the two different regimens currently approved as therapy for chronic hepatitis C. Treatment with interferon-α alone, or in combination with ribavirin, has limited effectiveness. The use of interferon based therapy for the treatment of HCV can be further limited by frequent side effects, injectable administration and poor patient tolerance and adherence. Many patients receiving interferon can experience influenza like symptoms, fatigue and depression. Ribavirin can be problematic for patients with preexisting anemia, kidney problems or heart disease.

BIT225 has been shown to be synergistic with interferon and ribavirin, the current approved drugs for HCV treatment, as well as with NS5B inhibitors which are a new class in development. The use of BIT225 in combination with either the current standard of care treatment, or NS5B inhibitors, holds exciting potential therapeutic treatment of human HCV infections.

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O NH High sustained viral response with a HCV p7 inhibitor, BIT225: Antiviral activity and tolerability of BIT225 plus N NH2 H pegylated interferon alfa 2b and weight-based ribavirin for 28 days in HCV treatment-naïve patients. N N T Tanwandee[1] , C Luscombe[2] , G Ewart[2] , J Wilkinson[2] , M Miller[2] , M Peters[3] , and R Murphy[4 ] 1 Siriraj Hospital, Thailand; 2 Biotron Limited, Australia; 3 University of California-San Francisco, USA; and 4 NorthWestern University USA Introduction Adverse Events BIT225-005 Study Design The development of new classes of compounds with different modes of action •Genotype 1, chronic HCV infection, treatment naïve Viral Load will be essential for future therapy options to combat the disease and provide patients between 18-55 yrs of age efficacy against the genetic diversity of hepatitis C virus (HCV). BIT225 is a •24 patients, randomized 8:8:8 (200mg BIT225: 400 mg Cohort RVR cEVR pEVR nonEVR SVR % SVR novel, first in class, HCV p7 inhibitor. p7 is involved in the release of viral BIT225: placebo) enrolled from a single clinical site, were (week 4) (week 12) (week 12) (week 12) (week 48) particles from the cell and is essential for viral replication. BIT225 is an administered BIT225 (200 and 400 mg) or placebo orally Placebo 2/8 3/8 2/8 1/8 6/8 75 investigational, orally-administered, novel antiviral compound in development twice a day for 28 days in combination with pegylated 200mg 2/8 5/8 0 1/8 7/8 88 by Biotron Limited (ASX: BIT). BIT225 was previously studied in a phase 1b interferon and ribavirin, remaining on SOC and monitored 400m 2/7 4/7 1/7 0 7/7 100 g trial for 7 days at doses up to 200 mg in HCV genotype 1, 2 and 3 subjects. for an additional 44 weeks. RVR = Rapid Virological Response: HCV RNA < LLQ at week 4 BIIT225 was found to reduce viral load over 7 days and was well tolerated. •Safety , pharmacokinetic, virologic response, IL28 SNP cEVR = complete Early Virological Response: HCV RNA < LLQ at week 12 genotyping and genomic sequencing parameters were pEVR = partial Early Virological Response: Change in HCV RNA > 2 log units at week 12 examined. SVR = Sustained Virological Response: HCV RNA < LLQ at week 48 to reduce viral load a 4 weeks of BIT225, IFN and RBV • BIT225-005: A Phase IIa, Placebo-Controlled, The week 48 sustained viral response (SVR) rates were Randomized Study of the Safety, Pharmacokinetics 7/7, 7/8 and 6/8 subjects for 400 mg, 200 mg and •4 interrupted BIT225 dosing (2-5 Days) placebo groups respectively. • Vomiting/ Nausea (400mg, 400mg, 200mg); Vertigo (400mg) and Antiviral Activity of BIT225 in Combination with • All recommenced dosing and completed trial Pegylated Interferon and Ribavirin in Patients with Results to Week 4 – (RVR) •5 Severe Adverse Events • Hepatitis C Virus Infection. Vomiting (400mg, 200mg); 400mg cohort: Two out of seven (2/7) subjects had viral • Horizontal diplopia (400mg)- withdrew Day 10 The trial design was to examine the safety and efficacy of two doses of loads ≤ LLQ by week 4. 5/7 subjects experienced a viral • Vertigo (400mg) BIT225 (200 and 400 mg) delivered orally twice a day for 28 days compared Results load reduction > 2 logs. Median viral load reduction = - • Syncope (200mg) to placebo with standard of care (SOC). Twenty-four subjects were enrolled 3.771 log units. •All other AEs mild to moderate intensity from a single clinical site. The subjects were genotype 1 that had not 200mg cohort: 2/8 subjects achieved RVR by week 4. 48 weeks of treatment previously received antiviral therapy. After the 28 day treatment phase all 6/8 subjects experienced a viral load reduction > 2 logs. Conclusions subjects remained on SOC and were followed for an additional 44 weeks. Median viral load reduction = -3.871 log units. Placebo cohort: 2/8 subjects achieved RVR by week 4. • First in class, novel p7 inhibitor BIT225 demonstrates clear antiviral activity in Study Objectives addition to IFN/RBV among treatment-naïve, genotype 1 patients. The week 48 6/8 subjects experienced a viral load reduction > 2 logs. Primary objective : sustained viral response (SVR) rates were 7/7, 7/8 and 6/8 subjects for 400 mg, Median viral load reduction = -3.013 log units •to evaluate the safety and tolerability of 200 and 400 mg of BIT225 twice 200 mg and placebo groups respectively. daily compared with placebo in combination with PEG-IFN and RBV in •There were no detectable antiviral resistant variants generated during treatment Regression analysis shows 400mg and 200mg cohorts patients with chronic HCV infection that are treatment-naïve to antiviral (4 week analysis). treatment with ribavirin and/or interferon. have significantly faster median rates of decrease of HCV RNA than placebo over the first 35 Days (P<0.05). •The drug was well tolerated at the doses selected Secondary objectives : •Potential to combine with current or next generation DAAs drugs Results to Week 48 – (SVR) •to evaluate the pharmacokinetics of 200 and 400 mg of BIT225 administered •Formulation development to optimize tolerability in progress daily on Day 0 and Day 28 and twice daily on Days 1 - 27 for 28 consecutive 400mg cohort: All subjects in the 400mg cohort had viral •Potential for use with HCV and HIV co-infected patients days in combination with PEG-IFN and RBV in patients with chronic HCV infection. loads ≤ LLQ by week 48 (this is defined as achieving •BIT225 is currently being evaluated in a phase 1b study in HIV infected “Sustained Virological Response” (SVR). This subjects. corresponds to a 100% rate of SVR. (Median viral load •to evaluate the antiviral activity of BIT225 administered for 28 consecutive •BIT225 will be evaluated in a phase II study in HIV and HCV co-infected reduction = -5.189 log units.) days in combination with PEG-IFN and RBV in patients with chronic HCV subjects in 4Q of 2012. infection that are treatment-naïve to antiviral treatment with ribavirin and/or 200mg cohort: 7/8 subjects achieved SVR by week 48. interferon. This corresponds to a 87.5% rate of SVR. (Median viral load reduction = -5.271 log units.) Test formulation: BIT225 powder mixed with 25 mL OraSweetSF[TM] Placebo cohort: 6/8 subjects achieved SVR by week 48. Acknowledgements This corresponds to a 75% rate of SVR. (Median viral Placebo formulation: Lactose mixed with 25 mL OraSweetSF[TM ] load reduction = --4.998 log units.) ACLIRES and Siriraj Hosiptal clinical sites Thailand, SOC: Peg-interferon alfa-2b (PEG-IFN) at doses of 80, 100, or 120 mcg Southern Research Institute for sequencing analysis weekly and ribavirin (RBV) 400 or 500 mg BID based on weight . Jacob George and Reynold Leung at Westmead Millenium Institute • 24 patients were enrolled into the study. 50% of patients were E2-P7-NS2 Sequencing analysis Sydney NSW Australia for IL28 genotyping genotype 1a. 23 patients completed study therapy; 1 discontinued in the first week for intolerance (400 mg). • The day -14 (pretreatment) and day 28 plasma samples were analyzed by population sequencing and Pharmacokinetic data suggested adequate BIT225 levels in the For further information compared to the consensus sequences of HCV genotype 1a and 1b. The viral genes E2, P7 and NS2 blood were detected for antiviral efficacy. were sequenced to determine if there were any alterations to the HCV population during antiviral Please contact or cluscombe@biotron.com.au mmiller@biotron.com.au IL28 SNP genotyping therapy with IFN/RBV and BIT225 during the first 4 weeks of treatment. Several changes were More information on this and related projects can be obtained at • The IL28B genotypes for 21 of 23 subjects were homozygous CC identified but there were no unique mutations selected in the BIT225 treatment cohorts compared to www.biotron.com.au at rs12979860 and homozygous TT at rs8099917. One subject placebo that would suggest the differences were significant over that of the usual HCV quasispecies. from each of the 400 mg BIT225 and placebo groups were heterozygous for both alleles. Annual meeting of AASLD, 2012, Boston

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