By the end of the first quarter of 2020, we'll get the headline results of this Phase 2 study looking into 16 patients. If it shows significant results, then it requires further liaising with the US and UK Drug Administrators on what their requirements would be in a subsequent Phase 2B study to register the drug for an orphan drug designation.
One would expect that the second study would need to be powered in the hundreds of patients and a reasonable estimate is that this study will take at least 1-2 years to complete from start to finish. They'd also need to raise additional funds. So the fact that they're issuing options to a "sophisticated investor" suggests to me, that they recognise the need to raise additional funds in the coming years to fund the additional Phase 2B study, that their current cash reserves of $10m may not be sufficient to fund this study.
Invex is, therefore, in my mind is a 3-5 year play for which we're in Year 2. I think this year is very much a key inflexion point with the initial Phase 2 study and the possible approval of US/UK patents. If successful in the initial Phase 2 study, the next big catalyst will be the readout of the larger Phase 2B study which will likely happen post-2020.
IXC Price at posting:
$1.07 Sentiment: Buy Disclosure: Held
This video from Invex gives a clear roadmap forward -
