AGM Q&A
• Partnering/Corporate engagement
As previously noted, we have received inbound interest from pharmaceutical companies and potential strategic investors in the Company and its
programs.To date our approach has been to engage with these groups to explore such interest. It is important to note that such parties can often seek to undertake comprehensive due diligence ahead of any capital injection and/or collaborative commitment. Such processes can take many months to complete with no guarantee of a deal emerging from such efforts. As the Company begins to gain better definition around its clinical program in DMD following feedback from, and alignment with, expert groups including regulatory bodies, it anticipates this inbound interest to grow. The Company is well positioned and suitably experienced to manage and potentially extract value from such corporate interactions. The Company would advise the market should these interactions lead to a material transaction. Future human resourcing plans, as touched on below, will look to increase our bandwidth in managing and executing on such corporate/business development opportunities as they emerge.
==> In my view, "its program" can be anything beyond DMD... it could be other types of muscular dystrophies (from other indications) or inflammatory diseases...Remember, we have not heard anything from Dr. Gittleson so far...anything can happen behind the scene... I think soon or later she will come into the picture and we will hear a lot more from her..
==> from Morgan Report: "Management has stated its intention to pursue licensing arrangements for a number of other indications in order to extend its cash runway for its core applications in DMD and MS."
Phase IIb timelines/funding
As per our disclosures we are looking to submit our PIP application early next calendar year and based on initial feedback on the Phase IIb component of the PIP, look to finalise and submit our trial application for approval to conduct the study, all going well, anticipated mid-2021. The study is proposed as a 12 month dosing trial with an open label extension phase. The company expects to be able to outline additional trial details once the company has received PIP feedback and has submitted its trial protocol. The costs associated with conducting the trial will depend on the final approved design, so again the Company will be better positioned to outline these costs upon trial application submission. As reported, the recent financing has provided capital to support the preparatory work for the trial up to trial initiation, therefore the major costs associated with the conduct of the trial are not anticipated to come through until later in 2021. In the interim, the company will look at funding options for the trial while continuing with its planned corporate engagement which may present as part of the financing option.
===> "late in 2021" , so we still have plenty of time to get our funding in place..it could be out-licencing deal? upfront payment...and milestone payment -> Back to Partnering/Corporate engagement
Just my thought...
Chart, page-3522
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