IXC 2.86% 7.2¢ invex therapeutics ltd

Ann: Notice of Investor Call and Presentation, page-33

  1. 395 Posts.
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    Great points @Halo99. There are problems dealing with a larger manufacturer.

    I can also understand the frustration, but I think we brought that upon ourselves by expecting a partnership with a major pharma. They didn't hint at this - we hoped for it.

    If we take a step back and remember where we were on Thursday: we needed to organise a CMO; complete the reformulation and the necessary tolerability/pharmokinetic studies (which will have taken several months and pushed back the Phase 3 trial); and decide on an EMA/FDA strategy. We weren't even expecting to have formed a major collaboration with another biotech.

    In one fell swoop we've organised a CMO and at the same time partnered with a mid-sized firm (Peptron) who are experts in the manufacturing of GMP-grade, sustained-release Exenatide and have the data we need to move straight into the P3 trial. It's not flashy, but it's very efficient and cost-effective. This... " reduces Invex’s development costs and risk and significantly expedites our planned Phase III registration study in IIH.” So, we're now absolutely on track to begin the P3 trial in H1 2022. And we won't have supply issues when we begin the trial. And we now have the money and time to look at another indication, if we so choose.

    At one point the SP was up almost 20%. I suspect it settled at 10% because some impatient shareholders used the opportunity to offload their shares. And we need to remember that a bundle of shares recently came out of escrow.

    IMO, we will not see a major increase in the SP/re-rate until the EMA/FDA strategy is finalised (and a decision is made to conduct one trial to satisfy the EMA). And as I've mentioned before, initiating another study in another indication with a large TAM (e.g., stroke, TBI, COVID, Parkinson's and other causes of dementia) will also help.

    The next few months are going to be huge for IXC. Very excited
 
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