Here is a post from RSTICKLE on Hotcopper. VERY INFORMATIVE.
"In my capacity as a significant Benitec investor, I had the opportunity to attend a private investor session with the Benitec management team late last week, and I took some real confidence away from the discussions. In attendance were all key management - plus David Schaffer - from 4D Molecular Therapeutics - Benitec's highly credentialed collaborator for AAV vector development.
Please note there were no disclosures made in the session that have not already been provided to the market, however, I personally gained confidence from the discussions across the following key areas:
1. TT-O34 Timeline: In relation to TT-034 it is intended that commencement of the 3rd cohort will occur as planned within 6-7 weeks post DSMB review. That means within 3 months the first 3 patients of cohort 3 will have been dosed, and if impact on viral load is achieved, this will result in a significant milestone, from which I interpreted any such outcome would require disclosure. Additional key milestones for the company are thought to be the reporting of Cohort 3 safety and efficacy at completion, and the reporting of Cohort 4 safety and efficacy at completion (towards year end).
2. Clinical trial sites: Regarding the addition of trial sites it seems the company has now created relationships with some highly renowned clinical trial facilities. The company's third clinical trial site – the Texas Liver Institute means there will now be genuine parallel recruitment of clinical trial activities. It is notable that TLI is widely thought to be one of the premier clinical research facilities in the world and is the largest in the United States. It seems we are now in bed with the key players in HCV clinical research. I'm betting any mistakes of the past will not be repeated.
3. HBV Program: David Suhy describes the HBV program as a"mirror" of the HCV program, and believes that if TT-034 progresses as hoped, there will be strong interest from big pharma around our HBV program. Because there is nothing dramatically different required in approach for HBV, the focus can be applied to dose related intelligence and monitoring long term expression of shRNAi expression. This is interesting, as my interpretation is that big pharma may perceive the TT-034 clinical trial results as something of a 'tipping point' for Benitec. If good in vivo / clinical data does bring big pharma interest, it will also bring with it company making outcomes. If so, it also means that while our 'one shot' model is different from competitor approaches, it is not a dissuasion to big pharma - albeit related business models may require further definition. My guess is interest from big pharma may already be quite real.
4. US Market: I am convinced that the company understands the need for building a direct exposure to the US market (e.g. through a US listing of the company or its subsidiary Tacere). While Peter French was unable to comment in any detail, I believe the Board and the management are well aware of investors desires for this issue to be addressed. I have no doubt our patience will eventually be rewarded in this regard.
5. 4D Molecular: David Schaffer is an extremely impressive individual. 4D are in partnership with just a handful of companies (Benitec included). David's presentation covered 4D, the science of vector development, the work 4D are doing for Benitec in developing a new next generation of ocular AAV vectors for Benitec (by Q4 2015). This tells me the AMD program is also progressing with real purpose - and based on my assessment, we have the A-team on the job.
6. Lessons learned: David Suhy spoke about the lessons learned over the past 2 years. In particular, he mentioned the benefit of TT-034 in validating Benitec's wider technology platform. If TT-034 progresses as we all hope it will, there will be strong attraction to our HBV program, as all the 'heavy lifting' will have been done. David also noted that from an IP viewpoint the company is thinking about 'platforms within platforms ', and noted they now see each of the company's programs as a 'gateway' to a range of potential solutions. Suhy also mentioned that while the Graham Patent expires in 2019, it is very general in nature, and the company is planning myriad patents focussed upon molecular targets with particular sequences. This gives me a great deal of comfort around our ability to defend our IP going forward.
7. Value Maximisation: Carl Stubbings spoke of the process for identifying optimal inflection points for each of the company's programs in terms of "when best to let them go". The company seems well aware of the likelihood that earlier stage successes may require a greater focus upon immediate proceeds, whereas later stage deals may exhibit a greater focus upon deferred proceeds. The company is also well aware of the opportunity to 'slice and dice' licensing opportunities with appropriately qualified partners (e.g. based on geographic or market segmentation).
I left the session realising that in the context of our company's journey, we are deep in the end game. If things progress as hoped, Benitec may be a very different company in just a few short months - both in terms of market capitalisation and future potential. Aside from the substantial economic gains a successful TT-034 trial outcome will bring investors, the real prize remains the opportunity to be part of a company that has the potential to rewrite the rulebook for the delivery of transformative outcomes for critically ill patients across a range of orphan diseases.
The above observations reflect my personal opinions, and I would encourage you to do your own research, but despite trial delays, and some recent wavering of shareholder patience, my money remains firmly on this team to deliver the outcome we have all been hoping for. Fingers crossed."
-RS
AI
