Benitec Biopharma Ltd (BNTC)

[Blane]

Benitec Info/Due Diligence Consolidated 8-16-2014

Stock Tickers
US:BNIKF (OTC) & BTEBY (ADR)
Australian: ASX:BLT

If you are new Benitec, this post has the majority of due diligence nuggets dug out for you, so that you don’t have to. Welcome to Benitec Biopharma Ltd!

Hepatitis C

As of May 28, 2014, Benitec commenced its clinical trial of TT-034 for the treatment of Hepatitis C on Their first patient. This treatment is supposed to be pan-genotype, gene-silencing, no-side effect, one-shot cure to cure Hepatitis C in hopefully 10 days, with continuing effects of the treatment for up to 150 days or so. The PR release on first dosing is here:http://www.benitec.com/documents/140529HEPATITISCPATIENTDOSINGCOMMENCEDFINAL.pdf
The above document will detail the timeline of future escalated dosing, in order to determine safety first, and then efficacy.

Clinical Trials on ClinicalTrials.gov can be seen here:http://www.clinicaltrial.gov/ct2/show/NCT01899092?term=tt-034&rank=1

For more information on dosing timlines, please see:http://www.irasia.com/listco/au/benitec/press/p140711.htm

For a more scientific review regarding TT-034 as a recombinant adeno-associated virus serotype 8 (AAV8) agent used in the treatment of diseases (More specifically HCV in this case), can be seen here:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3951910/

As of July 19, Benitec released a presentation for the Bioshare Summit in Australia. It details TT-034 and ddRNAi in comparison to Isys and Alnylam. This presentation can be seen here:

http://present.knowledgevision.com/player/mobile/version/2/0/index.html?config=http://present.knowledgevision.com/account/brr/player/BLT20140718/config/config.xml&kv_id=KnowledgeVisionEmbeddedContentdc93b1db7dfa4120a77642bb03edafa8&kv_presentationId=ODA2OTY%253D&kv_presentationVersion=1.0&kv_duration=907.778&kv_slideCount=29&kv_trackUrl=http%3A//track.presentation-cloud.net/&kv_licenseId=138&kv_subAccountId=-1

Or here:

http://www.brrmedia.com/event/124682/

UPDATE: As of July 20/21 of 2014- Benitec released a PR announcing that the DSMB has approved the continuation of dosing with TT-034 after finding that the first patient had NO adverse side effects AND tests show that TT-034 is transducing into the liver. There will be at least a 28 day delay to dose the next patient, as a transient rise in liver function tests return to acceptable levels in the first patient, and preparation for next dose is made. The PR can be seen here:
http://www.benitec.com/documents/HCVTRIALUPDATE.pdf

Also, an Instablog on Seeking Alpha by Pannobhaso regarding TT-034’s intial positive results can be seen here: http://seekingalpha.com/author/pannobhaso/instablog

In March 2014, Benitec released their Spotlight Presentation in PDF format. That presentation can be seen here:
http://www.asx.com.au/spotlight/london/documents/presentations/Benitec_Biopharma_london.pdf
and it highlights where the company stands in terms of financial snapshot, technology timelines, and information on their flagship treatment, TT-034 for Hepatitis C. They also have potential treatments being developed in-house for Hepatitis B, Non Small Cell Lung Cancer (NSCLC), Cancer Associated Pain, Age-Related Macular Degeneration, and Oculopharangeal Muscular Dystrophy. They have out-licensed their technology to Calimmune for HIV, Regen Biopharma for potential Cancer Vaccine (Regen is currently is spinning off of Bio-Matrix Scientific Group, their majority shareholder) Genable for Retinitis Pigmentosa, and UniQure for Huntington’s Disease.

The VIDEO portion of their latest Spotlight Presentation can be watched here:http://www.finnewsnetwork.com.au/archives/finance_news_network76292.html

Here is the update on the clinical trial on TT-034 as of May 12, 2014.
http://www.asx.com.au/asxpdf/20140512/pdf/42pkng61rx74k0.pdf
as well as the audio presentation with Dr. Peter French that can be heard here:http://www.brr.com.au/event/123347

Numerous articles detailing why Benitec has so much potential for revolutionizing how we treat diseases, and as a company itself, can be seen here:
http://seekingalpha.com/instablog/24166073-24166073/2773743-why-benitec-biopharma-bnikf-has-a-very-bright-future-ahead
It also details insights from the author on what very KEY points were made during the investor Briefing that took place this March as well.

Another article detailing more about Benitec’s patented ddRNAi tech can be read here:
http://seekingalpha.com/instablog/19837781-pannobhaso/2771933-ddrnai-is-in-the-eye-of-the-beholder?source=kizur_seekingalpha

Benitec as a company that has the potential to dramatically change the cost of healthcare can be read here:
http://seekingalpha.com/article/2083973-benitec-the-health-payers-dream-biotech

How Benitec’s method of ddRNAi is distinct from the typical RNAi treatment can be read here:
http://seekingalpha.com/article/2054223-benitec-an-undiscovered-biotechnology-with-a-twist

Benitec’s treatment for lung cancer is another avenue that is currently being worked on, and is detailed in a Youtube video from UNSW Australia… and can be watched here:

If you’re interested in viewing an Australian stock blog like Investorhub, you can view this one:http://www.topstocks.com.au/new_asx_stock_forum.php
as well as this one: http://hotcopper.com.au/search_do.asp?fid=1&symbol=382

HIV and Callimune

Here is a YouTube link regarding Tye Olson, one of the indivuals who is doing the Calimmune HIV trial using altered T-Cells with Benitec’s Tech. His trial is mentioned starting at around 6:20. This video was posted 04/14/2014.

A gene therapy presentation in regards to a cure for HIV can be seen here: www.isheid.com/presentations/mercredi/16-00/hutter/hutter.pdf

On June 25, 2014, a PR was released announcing that Calimmune has been given the green light to treat its second group in the HIV gene therapy trial. That announcement can be seen here:http://www.businesswire.com/news/home/20140625005962/en/Calimmune-Approved-Treat-Group-HIV-Stem-Cell#.U8HG3PldXzc


As of 5-29-2014, Benitec has also announced it has chosen New York Bank of Mellon as its authorized U.S. representative and Depository Bank to establish an ADR (American Depositary Receipt) Facility. The announcement can be seen here:http://www.benitec.com/documents/140530USADRTOBEESTABLISHED.pdf

A recent post on Seeking Alpha with author Pannobhaso has listed Benitec’s ddRNAi technology in the fight against HIV in various ways. This article can be viewed here: http://seekingalpha.com/article/2418705-benitecs-ddrnai-targeting-fight-against-hiv
The 2015 Palm Springs Symposium on HIV Schedule of Events can be viewed here: http://cri.bio.uci.edu/events/2013-palm-springs-symposium-on-hivaids-hiv-infection-towards-a-cure/
As of 08/14/2014, An interesting patent application on HIV resistant stem cells and ddRNAi can be seen here: http://www.freepatentsonline.com/y2014/0227236.html

Other ddRNAi programs are potentially in the works for possibly ALS and can be read in a blog here:http://seekingalpha.com/author/pannobhaso/instablog

I will try to continually update this post when new information comes out. Again, Welcome!

Blane