PYC, page-49

Quick update - PYC delivered on that promised milestone this week!

FDA has “concurred” (I take that as agree/approve?) with PYC VP-001 approach and we are on track to be a clinical stage company!

Given we are pretty unique on the ASX; we are fast catching up to US listed RNA therapeutic Stoke who’s also tackling CNS and ocular; roughly same same in tackling the ADOA target.

They are 4.2x bigger than us in terms of market cap, but more importantly they’re out of the biotech lows and back to where they are 6 months ago; if we do an ape like translation PYC should be back to the 14c where we were 6 months ago and who knows; we might be the same market cap as Stoke by the end of 2022 with Clinical ocular and CNS preclinical work up if we keep the current progress milestones

Anyway, back to reality; In summary this week, we have the below ASX progress updates:

1) commenced Good Laboratory Practice toxicology studies to support this IND submission.

2) PYC has also now completed its first pre-IND engagement with the FDA for VP-001. (The purpose of the engagement was to seek alignment from the Agency on early clinical development including the study design for the FIH evaluation and for the non-clinical studies required to support these clinical efforts.)

3) The FDA concurred with PYC’s plans for both non-clinical and early clinical evaluation of the investigational candidate, VP-001.

4) PYC plans to submit the IND filing in the second half of this year.

5) The Company anticipates progressing VP-001 into a two-part phase 1/2 clinical trial conducted in patients with RP11

A close PYC competitor which I think we can catch up to by year end: