AI assistant
BIOTRON LIMITED — Investor Presentation 2011
Jun 30, 2011
64528_rns_2011-06-30_14fadae9-8527-4707-a078-24fd71773ec6.pdf
Investor Presentation
Open in viewerOpens in your device viewer
==> picture [227 x 36] intentionally omitted <==
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
1 July 2011
The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000
(17 pages by email)
Dear Madam
CEO PRESENTATION AT BIO2011 IN WASHINGTON DC
Biotron Limited's Managing Director, Dr Michelle Miller, has presented the attached update of the Company's activities to an international audience at the annual international biotechnology industry convention, BIO2011, in Washington DC.
The BIO International Convention is the largest global event for the biotechnology industry and attracts the biggest names in biotech, offers key networking and partnering opportunities. A key feature of BIO is the Business Forum offers which provides a unique platform for biotechnology and pharmaceutical companies, academic research institutions, and investors from around the world to gather and discuss strategic opportunities in one-on-one meetings and company presentations.
In addition, Dr Miller has given briefings to US institutional investors and pharmaceutical company representatives as part of activities surrounding BIO2011, including presenting at the Australian Life Sciences Investment Showcase in New York.
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 influenza, Dengue and Hepatitis B.
For further information please contact Dr Michelle Miller, Managing Director, on (61-2) 9805 0488.
Yours sincerely
==> picture [105 x 67] intentionally omitted <==
Peter J. Nightingale Company Secretary
pjn6096
==> picture [721 x 136] intentionally omitted <==
BIOTRON LIMITED ASX:BIT
BIO2011
Michelle Miller CEO & Managing Director
==> picture [721 x 69] intentionally omitted <==
==> picture [721 x 68] intentionally omitted <==
==> picture [721 x 69] intentionally omitted <==
‐ This presentation may contain forward looking statements with respect to the financial condition, results and business achievements/performance of Biotron Limited and certain of the plans and objectives of its management. These statements are statements that are not historical facts. Words such as “should”, “expects”, “anticipates”, “estimates”, “believes” or similar expressions, as they ‐ relate to Biotron Limited, are intended to identify forward looking statements. By ‐ their nature, forward looking statements involve risk and uncertainty because they reflect Biotron ’ s current expectations and assumptions as to future events and circumstances that not accurate. There is no that the may prove guarantee expected events, trends or results will actually occur. Any changes in such assumptions or expectations could cause actual results to differ materially from current expectations.
==> picture [721 x 69] intentionally omitted <==
==> picture [721 x 68] intentionally omitted <==
==> picture [721 x 69] intentionally omitted <==
-
Established in 1999 as a spin-out from the Australian National University, Canberra; Currently based in Sydney, Australia
-
IPO on ASX in Jan 2001 (ASX:BIT)
-
Focus on developing novel small molecule antiviral drugs
-
Hep C, HIV, Dengue and others
-
Key highlights
-
Successful implementation of clinical trials for the Hep C and HIV programs
-
Successful capital raisings in challenging market conditions
-
A$2.7m in 2010; A$2.4m in 1Q2011
-
A$23m since foundation
-
==> picture [721 x 68] intentionally omitted <==
----- Start of picture text -----
Ca ital Structure & Financials
p
----- End of picture text -----
==> picture [721 x 69] intentionally omitted <==
Shares on issue 148 m Listed options 108 m (exp Dec 2011)
Current S/P A$0.10 52 wk high/ low A$0.15/ 0.051 Market cap A$15 m Cash at 31 March 11 A$1.3m*
- excludes proceeds of share placement in April 2011, raising A$1.7m
Biotron Limited
==> picture [721 x 68] intentionally omitted <==
-
Identification of new class of viral proteins called viroporins
-
Small hydrophobic proteins with ion channel activity
-
Key roles in production and release of infectious virus
-
Present in influenza (M2), HIV (Vpu), Hep C (p7), Dengue (M) , SARS (E) and others
-
Ongoing need for new drugs to overcome viral resistance; patients are treated with cocktails of antiviral drugs
-
Designed library of new drugs to target these viral targets
-
350 compounds designed , synthesised and screened
-
Developed proprietary bacterial screening assays for HIV-1 Vpu, HCV p7, Coronavirus E, Influenza M2, and Dengue M protein.
-
Generating first-in-class drugs to treat these diseases
-
Initial focus on HIV and Hep C
==> picture [721 x 68] intentionally omitted <==
==> picture [721 x 69] intentionally omitted <==
• Two clinical phase programs:
– Hepatitis C virus (BIT225) and HIV
• Current status of pipeline:
Clinical Trials Project Target Discovery Preclinical Phase I Ph Ib/IIa Ph II P o C Hep C p7 HIV Vpu Dengue M protein + other targets
==> picture [721 x 69] intentionally omitted <==
==> picture [721 x 68] intentionally omitted <==
----- Start of picture text -----
– The Silent Killer
----- End of picture text -----
-
. 7m
-
170 m people infected worldwide; 4 m patients in US (2 chronic infection)
-
Majority remain asymptomatic for decades before developing cirrhosis or liver cancer
-
US sur eon eneral considers he atitis C is one of the most g g p
-
significant public health threats facing US.
-
40 – 50% of liver transplants are due to HCV
-
Standard of care is interferon and ribavirin
-
not direct acting on virus
-
Up to 50% patients don’t respond to current treatment
-
Significant side effect profile
-
Documented need for new, safer drugs
==> picture [721 x 68] intentionally omitted <==
----- Start of picture text -----
He C – An Ex andin Market
----- End of picture text -----
==> picture [721 x 69] intentionally omitted <==
Worldwide market ~US$2.8 billion; predicted to expand to >US$10 billion as new, safer drugs enter the market. O l ll t tl i n y sma percen age curren y rece ve treatment.
USA and Europe represent major markets but other, larger markets are emer g in g .
==> picture [721 x 68] intentionally omitted <==
Smith Nature Reviews Drug Discovery 5, 715–716 (September 2006)
==> picture [721 x 68] intentionally omitted <==
----- Start of picture text -----
C Lead Product – BIT225
----- End of picture text -----
==> picture [721 x 69] intentionally omitted <==
-
BIT225 i s a new i nves ti ga ti ona l ora l sma ll mo ecu e l l d rug i n d eve opmen l t for treating Hep C infection
-
Completed two clinical trials:
-
–
-
Phase Ia 48 patient, single dose safety study in healthy volunteers; Status - com leted p
-
-
-
Phase Ib 18 patient, 7-day multiple dose study in patients with Hepatitis C Virus infection; Status - completed
-
–
-
Phase IIa 24 patient, 28-day multiple dose study in patients with Hepatitis C infection (genotype 1)
-
Combination with pegylated Interferon and Ribavirin.
- Status trial commenced Sept 2010 and due to complete recruitment mid 2011.
==> picture [721 x 68] intentionally omitted <==
----- Start of picture text -----
BIT225 Clinical Information
----- End of picture text -----
==> picture [721 x 69] intentionally omitted <==
• p7 critical role in production of infectious HCV in infected cells
• Ph ase a resu I lt s emons ra e d t t d BIT225 we ll - o era e t l t d a t d oses up o t 600mg with no dose-limiting toxicities
-
Ph ase Ib resu lt s emons ra e d t t d 200 mg BIT225 s gn i ifi can tl y re d uce d HCV levels compared to placebo (p=0.0002) – 3 of the 6 subjects receiving 200 mg of BIT225 had significant re d uct ons n v ra i i i l l oa d s.
-
• Phase IIa – 24 subjects (HCV+, genotype 1) commencing standard of care (SOC) to receive 200 or 400 mg BIT225 (or placebo) twice daily for 28 days
==> picture [721 x 69] intentionally omitted <==
==> picture [721 x 68] intentionally omitted <==
==> picture [721 x 69] intentionally omitted <==
-
Future Hep C therapies expected to be a cocktail of drugs
-
In short-term new drugs to be used with current approved drugs inter eron f ( IFN ) and ribavirin
-
Industry focus on developing new, specific direct-acting antiviral dru s to use in combination g
-
P7-inhibitors e.g. BIT225 are potential new additions to this mix
-
Biotron is well positioned to partner with either current OR future therapies as synergistic with BOTH
-
BIT225 expected to have significantly higher potency in combination with interferon and ribavirin on basis of preclinical data
-
Phase II trial is a combination study of BIT225 with interferon and ribavirin
==> picture [721 x 69] intentionally omitted <==
==> picture [721 x 68] intentionally omitted <==
----- Start of picture text -----
He C Phase II Combination Trial
----- End of picture text -----
==> picture [721 x 69] intentionally omitted <==
| Ph II Trial Period | Ph II Trial Period | Trial design | |||
|---|---|---|---|---|---|
| 8 | pts | 0 2 BIT225 (400mg) + IFN/rib Placebo |
4 | Weeks 44 wks Interferon + Ribavirin |
|
| 8 | pts | BIT225 (200 + IFN/rib |
mg) | Interferon + Ribavirin | |
| 8 | pts | BIT225 (400 + IFN/rib |
) mg |
I t f Rib i i n er eron + av r n |
-
Pts randomly assigned to receive either placebo or BIT225 twice daily for 28 days commencement of standard combination therapy for Hep C (IFN/ribavirin)
-
Patients continue after 28 days just on IFN/ribavirin as part of their standard treatment (external to Phase II trial)
-
24 patients, genotype 1
-
Trial commenced Sept 2010 in Thailand
-
Expect to complete recruitment mid 2011
==> picture [721 x 68] intentionally omitted <==
----- Start of picture text -----
Biotron ’
----- End of picture text -----
-
First-in-class new anti-HIV dru tar etin HIV-V u rotein g g g p p
-
New mode of action – inhibits budding of virus from infected cells
-
Targets HIV in viral reservoirs in vivo
-
Reservoirs are last of the holy grail in HIV
-
No existing drugs target this source of HIV in the body “ ”
-
• Eradicat on oi f reservo rs s essent ai i i l for cure of HIV
-
-
Completed Phase I safety trial in healthy volunteers
-
• Phase Ib – 24 sub j ect randomized trial in HIV+ p atients anticipated to commence in 3Q2011
-
Trial designed to demonstrate proof-of-concept
- i.e. can reduce HIV loads in HIV-infected reservoir cells
==> picture [721 x 68] intentionally omitted <==
----- Start of picture text -----
Human Reservoirs cells infected with HIV –
Untreated (A) and Treated with BIT225 (B)
----- End of picture text -----
==> picture [721 x 474] intentionally omitted <==
----- Start of picture text -----
A B
Damaged, non-
Healthy HIV
infectious HIV
----- End of picture text -----
==> picture [721 x 68] intentionally omitted <==
-
Developing first-in-class antiviral drugs
-
Successfully completed two human trials of BIT225
-
Good safety and promising efficacy results
-
Pivotal Phase IIa Hep C trial results anticipated early 3Q 2011
-
Potential to combine BIT225 with current or next generation Hep C drugs
-
Biotron has back-up drugs and proprietary assays to facilitate development of 2[nd] generation drugs
-
Novel approach to treating HIV reservoirs anticipated to commence Phase Ib in 3Q 2011
-
Additi l l t d di t f D d o th ers ona ear y s age rug scovery pro ec s or engue an j
-
Strong patent protection – 5 patent families filed worldwide
-
Seeking w/w partnership for further development
==> picture [721 x 203] intentionally omitted <==
Michelle Miller M anag ng i Di rec or t +61 2 9805 0488 + 61 412 313329 [email protected] www . biotron . com . au
==> picture [721 x 136] intentionally omitted <==
----- Start of picture text -----
. . .
----- End of picture text -----