RE: Interim Results30 Nov 2021 11:23
Elephant in the room is this:
'The data from the extension study and the earlier lower dose cohort will inform the Company as to the preferred dosing based on its efficacy and safety profile, whether sub-retinal delivery provides the optimal efficacy and duration of action and the commercial potential. The data will support the decision whether to move straight into a pivotal trial or whether additional subjects should be treated to garner further sub-retinal data and also whether to investigate further a move into the clinic with an intravitreal dosing regimen.'
Think they must not be getting the improvement in efficacy data they were hoping for from the increased dosage, based on the initial patients treated in the expanded phase 2a study. The data can still be good, but perhaps not to the extent that it outweighs the increased risk of having two subretinal bleb sites.
However, as they have previously stated, they think based on 1 million cell dosage they have an approvable efficacy signal, so not exactly a bad position to be in when designing a pivotal study.
What I think is telling is the Chairman's statement, as follows:
'Despite the breadth of our stem cell based platforms, if we are to succeed, we need to be prepared to make tough decisions and only progress and invest in those programmes whereby true value can be created. Accordingly, where necessary we will look to share the value creating potential of our assets to secure substantive third-party collaborations, thereby increasing significantly the probability of success in terms of product development and value creation. The Board and management team will continue to assess all opportunities to create value through organic growth but also, as appropriate, explore technology licensing and acquisition opportunities to accelerate and enhance the overall value proposition of our Company.'
For me, reading between the lines, I think 'tough decisions' refers to out-licencing hRPC programme once the data is in at Q1 2022. A pivotal study would be expensive, and I think they would now be happy to take a licencing deal with upfront payment and royalties, and let someone else take on the risk and expense of the pivotal study.
The strategy to me now seems clear; put everything behind the exosomes programme in the near term, because the opportunity they have is potentially huge. Talk of potential 'acquisition opportunities' perhaps relates to how they can expand/scale exosome manufacturing, and presumably whether that can be funded by selling the rights to hRPC.
That's my take anyway. See if they put any more detail forward during the presentation later.
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