Benitec Biopharma Ltd (BNTC)

[Blane]

Benitec Info/Due Diligence Consolidated 11-12-2014
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 by various board members. Welcome to Benitec Biopharma Ltd!

Benitec Biopharma is an Australian Biotech Company that is currently developing a platform method of treating diseases. Unlike traditional drugs, Benitec has developed a system of treatment utilizing viral vectors and a patented process known as ddRNAi, or DNA-directed RNA interference. What this means is that when their treatment is delivered, the modified virus takes the treatment into the target cell, and modifies that cell's DNA so that it effectively produces the therapy/cure itself. Benitec is currently utilizing this technology, in its first clinical trial, to target Hepatitic C. Other disease targets in development in-house are Hepatitis B, Non Small Cell Lung Cancer, Cancer Associated Pain, Age Related Macular Degeneration & Oculophayngeal Muscular Dystrophy.

Out-licenced Programs include HIV through Calimmune, Cancer Vaccine through Regen Biopharma, Retinitis Pigmentosa through Genable, Huntington's through uniQure, and Intractable Pain through Circuit Therapeutics.

ddRNAi:

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.
UPDATE: November 9, 2014 – Another article by Pannobhaso on Seeking Alpha seeks to prognosticate the future of Benitec and ddRNAi here: http://seekingalpha.com/instablog/19837781-pannobhaso/3444735-ddrnai-center-of-excellence

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

Hepatitis C:

November 12, 2014 - UPDATE: The second patient has been dosed in the TT-034 Trial for Hepatitis C. While the second patient is solely for safety purposes, this much anticipated dosing moves Benitec closer to reaching therapeutic levels... and hopefully demonstrating efficacy. The announcement regarding this can be seen here: http://blt.live.hqi.com.au/IRM/Company/ShowPage.aspx/PDFs/1454-10000000/SECONDPATIENTDOSEDINTT034TRIAL

Additionally, a third patient has already been identified, as well as a back up in case there is a delay in dosing the first choice for third dosing.

November 9, 2014 Update: A November 3rd Interview regarding the TT-034 Clinical trial for Hepatitis C can be heard here: http://www.brrmedia.com/event/129281. In it, it details why certain people were excluded from the trial. This accounts for the delay in dosing the next patient, but also reveals the confidence in dosing the next patient by the middle of November. It also talks about Benitec’s recent licensee Circuit Therapeutics. Dr. David Suhy, Benitec’s Senior Vice President of Research and Development, released an article this month detailing a comparison between Gilead Sciences recently approved Hepatitis C treatment, Harvoni, and TT-O34. That article can be read here: http://www.benitec.com/documents/1411_Harvoni_Why_Hep_C_Focus_is_a_Plus.pdf

Benitec dosed its first patient with TT-034 for the treatment of Hepatitis C on May 28, 2014. 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 more. The PR release on first dosing, as well as timeline of future dosings, can be seen here:http://www.benitec.com/documents/140529HEPATITISCPATIENTDOSINGCOMMENCEDFINAL.pdf

The first 2 patients are solely for safety, and following patients will be dosed with escalating doses until therapeutic levels are reached, and efficacy is demonstrated. So far, the first patient has demonstrated no adverse effects. As of October 28, 2014, it will have been 5 months since dosing.

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/

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

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

Tribetarna (Lung Cancer):

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:

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

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

Huntington's Disease:

uniQure has licensed out Benitec's technology for Huntington's Disease.

Other Disease Areas to Note:

Alzheimer’s Public Forum – October 31, 2014
http://ausbiotech.org/updates/details.asp?cat=4&id=1164&returnToUrl=%2Fdefault%2Easp

Financials:

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

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

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!

For more information regarding the Australian releases on the ASX, please refer to this link: http://www.benitec.com/investor-centre/asx-announcements

Blane