AI assistant
BIOTRON LIMITED — Investor Presentation 2015
Aug 19, 2015
64528_rns_2015-08-19_a62e9a8f-c36a-4731-8195-ac121cbcc414.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
20 August 2015
The Manager Companies ASX Limited 20 Bridge Street Sydney NSW 2000
(15 pages by email)
Dear Madam
INVESTOR PRESENTATION
I attach an updated Investor Presentation.
Yours sincerely
==> picture [106 x 68] intentionally omitted <==
Peter J. Nightingale Company Secretary
pjn8207
BIOTRON LIMITED (ASX:BIT)
Mid-Clinical Stage Antiviral Drug Development Company
Investor Update 20 August 2015
Dr Michelle Miller Managing Director +61 412 313329 [email protected] www.biotron.com.au
==> picture [720 x 50] intentionally omitted <==
This presentation may contain forward‐looking statements with respect to the financial condition, results and business achievements/performance of Biotron Limited (ACN 086 399 144) 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 may not prove accurate. There is no guarantee that the 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 [720 x 50] intentionally omitted <==
Key Financial Metrics Ticker Code ASX: BIT Share Price (19 Aug 2015) A $0.10 Market cap A $31.3 million 12 Month Trading Range A $0.0864 – 0.1832 Shares Outstanding 313 million Options (BITO) 50.7 million $0.12 expiry 30/09/16 Cash Position (06/2015) A $6.5 million
Board
Michael Hoy Non-executive Chairman Michelle Miller Managing Director Susan Pond Non-executive Director Rob Thomas Non-executive Director Denis Wade Non-executive Director
==> picture [352 x 298] intentionally omitted <==
----- Start of picture text -----
12 Month Share Price Performance
Ticker Code ASX: BIT
Share Price (15 Sept 2014) A $0.115
Market cap A $26.3 million
12 Month Trading Range A $0.075 – 0.315
Shares Outstanding 228 million
Cash Position (06/14) A $1.76mn
----- End of picture text -----
Slide 1
-
-- First in class drug and new drug target for treatment of HIV and Hepatitis C virus (HCV)Prepared based on above after the August Board meeting
-
e
-
Seven clinical trials completed; anothGuided the wording of the prosp ctus draft and the use of proceedsr is fully recruited
-
- While capital requirements are determined based on proposed plan, the final schedule Demonstrated clinical activity against HCV G1 and G3
==> picture [204 x 46] intentionally omitted <==
-
of work will be largely dictated by available capital ~~Independently shown to have HCV pan-genotype activity~~ ~~in vitro~~
-
Efficiently inhibits HIV replication in monocyte/macrophage reservoir cells in vitro and in vivo
-
Patent position over compound and its uses
-
Compound is relatively easy to make and formulate; very stable at room temperature – important for supply chains
-
Significantly undervalued compared to other HCV drugs = potential for considerable upside
Slide 2
| ACTIVITY STATUS/OUTCOME Phase 2 HIV/HCV co-infected trial 100% SVR12 data reported for HIV/HCV G3 ~~Phase 2a HIV trial~~ ~~Impact on immune activation reported~~ Phase 2, three-month dosing HCV G1 & G3 trial ~~Fully recruited; SVR12 G3 3Q15; SVR12 G1 1Q16~~ ~~Development of BIT225 capsules~~ Improves delivery of BIT225, in a user friendly format suitable for larger scale trials Patent position strengthened Key patents for BIT225 and other compounds issued in the USA and other jurisdictions $8 million raised July 15 – Placement plus SPP raised $4 million; Nov 14 - fully underwritten rights issue closed over-subscribed with no shortfall raising $4 million |
|
|---|---|
Slide 3
==> picture [708 x 305] intentionally omitted <==
----- Start of picture text -----
PIPELINE
Designed library of compounds to Compounds screened in
target viroporins : proprietary assay set up for Leads PRE- PH 1 PH 2 PH 3
CLIN
each virus target e.g. HIV
>250 compounds designed and
synthesised Vpu; HCV p7; Influenza M2; HCV
Dengue M; Coronavirus E. BIT225
HIV/HCV
BIT225
VIROPORINS Hits tested against
- New class of viral proteins virus in cell DENGUE – BIT225HIV
cultures Several
- Key roles in production and
compounds Next gen
release of infectious virus with – HCV
Lead promising BIT314
optimisation antiviral
Dengue
and selection
activity
BIT314 (HCV)
10, 563-574 (2012)
----- End of picture text -----
BIT225 (HIV and HCV)
Slide 4
-
Over 200 patients and healthy volunteers dosed with BIT225 to date
-
Positive data recorded in all trials
-
HCV G1 (BIT225-005) – 100% receiving 400mg (28 days in combination with 48 weeks IFN/RBV) were virus-free at 48 weeks
-
~~Co-infected HIV/HCV GT3 (BIT225-006) – 100% completing course of 300mg (28 days in combination with 48 weeks IFN/RBV) were HCV-free 12 weeks post-treatment (SVR12) i.e.~~ cured of HCV infection
-
BIT225 increases the rate at which HCV is cleared
Slide 5
-
Forecast to grow to over $19bn by 2016
-
180 million infected worldwide (3% world population)
-
~3 to 5 million in US & 30 million in China
-
New drugs have demonstrated significant pricing power
-
Gilead’s Sovaldi (Sofosbuvir) at US$84,000 for a 12 week course
-
Best performing ‘first year’ sales: ~US$10 billion
-
Recent new HCV drug combinations not optimal
-
Lengthy treatment – 12 weeks or more
-
Not pan-genotypic – BIT225 is pan-genotypic in vitro
-
Not as effective against HCV G3 – BIT225 has good activity against HCV G3
-
More treatment failures than anticipated – need for new classes of drugs like BIT225
-
Partnering still active
-
J&J partnered Achillion in US$1.1 bn deal in May ‘15; Merck bought Idenix for US$3.8 bn in June ‘14
Slide 6
==> picture [720 x 160] intentionally omitted <==
----- Start of picture text -----
Placebo + IFN/RBV
n=20 (HCV Genotype 1 or 3) IFN/RBV (G3 – to week 24; G1 – to week 48)
n=20 BIT225 200 mg BID + IFN/RBV IFN/RBV
HCV Genotype 1
BIT225 200 mg BID + IFN/RBV
n=20 IFN/RBV
HCV Genotype 3
Week 12 24 36 48 60
Design: SVR12 FOR G3 SVR12 FOR G1
-
Randomised, placebo-controlled, double-blind trial (n=60) Aims:
----- End of picture text -----
-
Randomised, placebo-controlled, double-blind trial (n=60)
-
Treatment naïve, HCV gen 1 and 3
- Demonstrate safety of BIT225 with 3 months dosing
-
3 months dosing with BIT225 in combination with IFN/RBV
-
Using new capsule formulation
-
1.6 fold higher blood levels than previous formulation
-
Fully recruited
-
SVR12 for G3 due 3Q15; SVR12 for G1 due 1Q16
-
Extend HCV gen 3 efficacy data
-
Provide key data to assist with determining future dosing with BIT225 capsules
-
Generate safety data to support US FDA IND filing for combination trial with other HCV direct-acting antivirals (DAAs)
Slide 7
==> picture [309 x 254] intentionally omitted <==
-
Infection rates in Australia are at 20 year high
-
Over 1.1 million people living with HIV in the USA, with 1 in 6 unaware of diagnosis
-
US$11.9 bn sales in US, Europe and Japan in 2013; expected to grow to US$16.8 bn by 2020
-
HIV patients need to stay on antiretroviral drugs (ART) to keep virus levels under control
-
New mode of actions drugs are needed to eradicate or cure HIV infection
Slide 8
-
BIT225 inhibits assembly and budding of new virus
-
Phase 2a trial (004) showed that BIT225 can reduce HIV levels in macrophage cells in vivo , paralleling in vitro studies
-
Potential benefits on immune aging and HIV-associated dementia
-
Potential for use in future virus eradication treatment
-
Progressing to pivotal Phase 2 HIV trial
==> picture [633 x 189] intentionally omitted <==
----- Start of picture text -----
In vitro Effect on HIV Replication
A B
d14 infection & d21 BIT225 addition
20 0 Placebo
150
100 +BIT225
50
16 17 19 21 22 23 24 25 26 27 28
+HIV-1 Time (days)
(A) Untreated Controls (B) BIT225 treated cells
----- End of picture text -----
Slide 9
-
2.5 billion people (40% world population) live in areas at risk of Dengue
-
~100 million people infected yearly
-
A leading cause of illness and death in tropics and subtropics
-
Transmission is by mosquito; most prevention programs target the vector
-
No approved Dengue-specific therapeutic
-
Vaccine trials have had disappointing results
-
Biotron is targeting Dengue M protein – Similar target to HIV/Vpu and HCV/p7
-
Several compounds with promising activity at early stage of development
==> picture [255 x 125] intentionally omitted <==
==> picture [257 x 143] intentionally omitted <==
----- Start of picture text -----
www.sciencenews.org
----- End of picture text -----
Slide 10
-
HCV and HIV are high growth, multi-billion dollar markets
-
Significant treatment gaps remain
-
BIT225 is a novel approach with demonstrated promising efficacy in Phase 2a/2 clinical trials
-
Represents a new class of direct-acting HCV drugs
-
Potential to fill significant HCV treatment gaps
-
HCV Genotype 3
-
HIV/HCV co-infected patients
-
Cirrhotic patients & treatment failures
-
-
Potential to eradicate important HIV reservoirs, plus may impact on HIV-associated dementia
-
Flexibility to combine with any other HCV and HIV drug combinations
-
Significantly undervalued in comparison with other HCV companies
Slide 11
-
Complete BIT225-008 HCV trial currently in progress
-
SVR12 for G3 due 3Q15 ; SVR12 for G1 due 1Q16
-
Investigational New Drug application (IND)
-
Engaged with FDA - pre-IND consultation HCV combination trial with DAA
-
File HCV IND application late 2015
- Currently completing studies required by FDA
-
Progress protocol and regulatory documentation for key Phase 2 HIV trial
-
Expand earlier stage drug programs e.g. Dengue virus when funding available
-
Continue commercialisation activities aimed at attracting partners
-
Continue to promote company to local and international investment community
Slide 12