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A researcher into gene silencing as a technology for improving the lives of those suffering from incurable diseases. Benitec Biopharma is my primary investment in this technology as ddRNAi offers one-time treatments for a broad range of these diseases.
  • Under The Radar 7 comments
    Jan 21, 2014 8:30 PM | about stocks: BNIKF

    Anyone following the market would know that companies such as Alnylam (ALNY) and ISIS (ISIS) are leading the way when it comes to moving gene silencing from the laboratory, through clinical trials and on to commercialisation. However, if all one did was follow the market then it is likely that a small, private company based in Texas would slip under the radar. That company is Gradalis®.

    Gradalis has not focused on Orphan Diseases, they have gone for the big one, cancer. In partnership with the Mary Crowley Research Center they have produced outstanding results. The impact of this life changing technology has been reported in the news and the company has made a number of presentations at various conferences.

    In May 2013 the company presented nine abstracts (1,2,3,4,5,6,7,8,9) at the ASGCT and it is understood that they mentioned that they are considering applying to the FDA for a Breakthrough Therapy designation for their treatment for ovarian cancer.

    Gradalis currently has seven clinical trials on foot and two of them are reaching their final data collection points in the next two months. The Pll trial treating ovarian cancer reaches its final data collection point in July this year.

    By any standard Gradalis is a serious player in the field of gene silencing.

    So, what has this got to do with Benitec Biopharma (OTCPK:BNIKF)?

    Well, Benitec is the elephant in the room for Gradalis when it comes to discussions surrounding commercialisation. The technology which Gradalis employs in its treatments uses bi-functional shrna. Benitec believes that its ddRNAi patents cover the pathway by which shrna is expressed in cells. This would cover, at least in part, Gradalis's use of bi-functional shrna, for which Gradalis has its own patents. As Gradalis is yet to take out a licence from Benitec, this represents a commercial risk to the company.

    Benitec has expressed a view that it does not wish to engage in costly court battles to settle patent issues (it had a lengthy dispute with Nucleonics which it eventually won) but if Gradalis was to obtain a Breakthrough Therapy designation from the FDA with a view to commercialisation, then Benitec would have to reconsider the merits of this view. Gradalis would have to consider the implications of a possible legal challenge to its patents.

    Any action in regards to patent disputes would drain both companies of potential research funds and would possibly discourage any new investors that Gradalis may need to launch its treatment commercially. None of these outcomes are particularly desirable.

    Hopefully, the two companies can come to an amicable outcome without the need to engage patent attorneys.

    On the positive side and regardless of any legal wrangling, over the next few months, we can expect to see some good data coming out of the Gradalis trials. This will not only validate Gradalis's outstanding work but it will also validate ddRNAi as a significant technology in the advancement of cancer treatments.

    Disclosure: I am long BNIKF, .

    Stocks: BNIKF
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Comments (7)
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  • ddRNAi works
    , contributor
    Comments (18) | Send Message
    Thank's Pannobhaso for your recent critiques of Benitec. Very interesting company that I agree is way under the radar.
    21 Jan 2014, 11:08 PM Reply Like
  • Greenfire87
    , contributor
    Comments (661) | Send Message
    BNIKF is gaining attention. Becoming hard to acquire shares at reasonable levels as of late. I'll keep adding on pull backs.
    22 Jan 2014, 10:10 AM Reply Like
  • subrkaus3
    , contributor
    Comments (98) | Send Message
    i came across this company only yesterday. how many shares are outstanding today? Also how many ordinary shares is equal to one ADS/ADR?
    1 Feb 2014, 01:10 PM Reply Like
  • Pannobhaso
    , contributor
    Comments (245) | Send Message
    Author’s reply » The company has approx 85.2M shares. I believe ADS/ADR is one for one. Your broker should be able to confirm this.
    1 Feb 2014, 07:42 PM Reply Like
  • subrkaus3
    , contributor
    Comments (98) | Send Message
    Thanks Pannobhaso. I would expect them to do additional capital raise later this year. Also the company should focus more on promoting in US as the money is here. Hopefully they can turnaround this year with their Hep C Phase 1 trial. I like their patents/pipeline and plan to initiate a position.
    2 Feb 2014, 12:39 PM Reply Like
  • SmokeyNYY
    , contributor
    Comments (95) | Send Message
    Any recent news on Gradalis?
    10 Oct 2014, 12:48 AM Reply Like
  • Pannobhaso
    , contributor
    Comments (245) | Send Message
    Author’s reply » Being a private company Gradalis does not have to say much, however, they must be close to running out of capital. If I am right, then I would expect to see an IPO for their off-shoot Strike Bio or Reflex Bioscience in the new year. Strike is already gearing up for increased manufacturing which is a good indication that the company's expansion is going according to plan.


    If an IPO is in the plan, Gradalis may want to settle IP issues with Benitec in order to remove any doubts that investors may have when doing due diligence.
    10 Oct 2014, 10:29 AM Reply Like
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