BLT 0.00% 2.6¢ benitec biopharma limited

san diego - full summation of meeting

  1. 54 Posts.
    Sorry it has taken so long to post but I had to compile a lot of data and think about my response. Some of you will like my perceptions and some of you won't. After this I will go back to HC board sidelines and observe unless I hear something patently false or dead on correct. You all make some very good observations and also some I think are misinformed or are speculative. Since I was not allowed to tape record this info comes from the hurried notes I took and my memory which is pretty dam good. here going forward I don't want to be an intermediary. If you have a question on anything I regurgitate below you'll have to go to the company.

    Here are my company takeaways from the meeting with DRs French, Suhy, and Chiplin. Below that are my TT-034 questions. If this gets cut off due to length I will post again.

    1.Benitec’s core patent family can’t be extended past 2018 as confirmed by many communications with the local and US patent attorneys. However, Benitec’s strategy is to lodge new patent applications for new targets in new programs, and to build a pipeline of several, they believe, valuable programs protected by new IP. There is also the opportunity to gain 5-7 years patent extension on specific biological products.

    2. CSIRO interference proceeding against Fire-Mello is interesting but will not necessarily motivate Benitec to get into legal disputes. They learned their lesson previously. You have to have big muscle on your side and a willingness to spend a long time in court. It is preferable to them to focus on the science and develop new ground- breaking therapies protected by new patents on the targets. Benitec will however support CSIRO’s efforts in this area if necessary.

    3. All parties who have used Benitec patented technology and have not taken a license are notified of their use of ddRNAi/shRNA and will be dealt with as those therapies become introduced/commercialized. Benitec doesn’t have the money or time for legal proceedings now and will pick the best time to address potential offending IP users. All parties known to Benitec have been formally notified of
    Benitec’s position and these notifications will be discovered with due diligence by potential partners.

    4. Benitec believes they have currently and are in good communication with enough loyal shareholders to prevent a possible hostile takeover. Also CSIROs’ partial ownership interest in the core patents makes a takeover less desirable. If someone wants to offer enough money though, nothing’s impossible.

    5. The most likely reaction to a successful trial of TT-034 may be an offer by a larger company to partner. This as was mentioned at the AGM is the most desirable outcome. They want to move on quickly to other therapies and trials.

    6. With a successful HCV trial and funding the focus would move to wet AMD, Lung cancer, and HBV as quickly as possible and in that approximate order but as close to simultaneous as possible.

    7. Calimmune is a very private company and as much as Benitec would like to hear results Calimmune is keeping everything very close to their chest at this point and will release results at their own choosing. Benitec’s ability to require Calimmune to publicly disclose progress is extremely limited, despite Benitec’s requests to do so.

    8. Business development activity and meetings with interested parties has picked up significantly since the RAC meeting and, as the IND progresses, and trials approach. Business development has been and remains a core focus. Most potential partners have asked to see the upcoming clinical trial data.

    9. Pfizer executives and researchers have indicated that they are interested in following the TT-034 trials and their outcome. Also Pfizer as a company was very helpful with the IND data that they needed to provide.

    10. The trials will begin ASAP as soon as Benitec gets the thumbs up on the IND from the FDA. Everything is complete and set to go.

    11. They are very aware of, and share, our concerns about timelines and goals. Don't worry I beat them up on this a bit but I also learned about more then a few hurdles thrown in front of them.

    12. The HotCopper board is now mined weekly for actionable data. Dr. French and the others appreciate the positive contributions and referred to them as "very good Crowd Sourcing Intel". Let’s face it folks, HC could be helping the company significantly including our future share price if you keep finding the companies using their IP and leaving updates and links to new gene silencing IP. Several of the suggestions have either been adopted or have already been considered with action taken. I liked that.

    13.Benitec has submitted applications for grants to combine stem cell therapies with ddRNAi. Everyone was aware of the 8.5 million that Calimmune received for the HIV project. Benitec realizes there are cases to be made in combining stem cells with ddrnai and also helping pharma extend patents on therapies/drugs that are approaching their patent expiration. Also the company is working with CSIRO and Sigma Aldrich to increase flows of funding from additional sources within the constraints of the research tools contract.

    TT-034 takeaways

    1. The likely cost of commercial production of TT-034 has not been determined. Creating the therapeutic in the lab is not the same as using a pharma partner. A larger pharma partner would have the benefit of scale and pricing power.

    2. HIV trials with the City of Hope show that ddRNAi can be expressed at a therapeutic level in cells up to 4 years later.

    3. The current TT-034 formulation is the same as those used in the Pfizer research. That’s what was presented to the FDA and the RAC and so is required.

    4.Benitec is moving, when appropriate, to a license for for AAV8 when and if required.

    5. A therapeutic level or RNAi is sustained in the liver studies shown for 6 months at least in non-human primates.

    6. TT-034 is limited to a single use in that patient.

    7. Benitec will provide trial protocol data after
    publication of results in Journals. This is normal for the industry. In the meantime the protocol can be found in the RAC presentation.

    8. The vectors in TT-034 are not in equal proportion. However, at all therapeutic doses, all shRNAs are expressed in copy numbers in excess of those needed to silence the virus’ replication.

    9. There is a small percentage, less than 7%, of TT-034 vector that effects non-liver cells but it is not expressed in non-liver tissue.

    10. Dr. Suhy recommended that interested parties study the RAC presentation on the Benitec website if they really want to know the TT-034 protocol in depth.

    Benitec is watching the Crispr technology develop, but the actual use of the tech away from a laboratory bench is a long way off. They do not believe that it falls under any of our patents.

    Ok! HotCopper fanatics. I'm burnt. Time for you to fight it out on the data above. The company is chastened on promising deadlines, the participants to the meeting with a lowly shareholder were amped like prize fighters before the big show. They believe this is their prime time. There is no illusion about funding without a partner, or options exercise. They are hoping for a bump in SP from the IND acceptance. Will that beat the deadline. Who knows. Will a smart pharma partner with foresight step forward and jump in before TT-034 results? I would, just for access to the IP, platform, and first mover discount. Again the amount of interest, number of inquiries, and meetings are up significantly. If TT-034 trials are successful the price to play will move up significantly. It's very much about the trials. So you will have to wait on the edge of your seats biting your nails.

    Again many thanks a to those of you who contributed questions. I think you actually made me look good.

    I'm hedged with siRNA plays. I will add under .50 but
    from listening to this board for a long time I believe some of the investors here are very over extended financially and emotionally with Benitec. If it's over 5 to 7 % of your net worth and, you aren't hedged, you are gambling. If this is supposed to be your lifes' financial home run you are a gambler.

    best regards,

    Derek


 
watchlist Created with Sketch. Add BLT (ASX) to my watchlist

Currently unlisted public company.

arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.