CYP (ASX) Ann: Cynata Commences DFU Clinical Trial

Originally posted by pfeifer1982: ↑

"id be interested to get ur view on timelines going forward of various projects.i see DFU as next revenue potential..as well as..fuji cdmo and aGVHD partner as wake ups."
Sure, but bear in mind that you are asking the guy that predicted back in early 2018 that we could see royalties by 2019 and believed the statement that the FujiFilm P2 GvHD trial will commence before the end of 2020 based on FF reporting.

For that reason, I have asked my personal financial/investment advisor to check every single statement this time around. I will also limit my sarcasm to a minimum, to ensure that my predictions are perceived as intended.

Let me start with a disclaimer that should be added to our financial statements:
"Past performance is no guarantee of future results".
Not as a warning, more so as a promise... #straightface

Next revenue potential:

In my opinion (also expressed here), DFU is still a bit off from generating revenue. Although the trial is estimated to complete recruitment by December 2022 given that, it is a P1 trial.
Unless you are looking at it from a licensing point of view, in which case - if the P1 data confirms the pre-clinical data - that is definitely a possibility given that the data will be based on a randomised, controlled trial with the final product to be much cheaper given the low number of cells used per patch (using a patent as indicator).

Quickly passing on that question to my financial/investment advisor -
"Will we see a licensing deal for DFU within the next 12 months?"

I am also still placing hopes on a licensing deal for an indication that was meant to be our priority target prior to the COVID-19 outbreak: CLI.
With the trial approved in the UK and AU, now also adding our US IND for GvHD, which lowered the hurdle for a trial to also take place in the US (same CMC plus compelling pre-clinical data), I consider this to be a potential revenue generating asset in the short/mid-term.

Quickly passing on that question to my financial/investment advisor -
"Will we see a licensing deal for CLI within the next 12 months?"

(hmm... maybe my financial/investment advisor is broken... I asked the same question 3 times and got the same answer 3 times)

Timelines

P2 GvHD trial to commence in December 2022 with the first patient enrolled in January 2023

"Will the P2 GvHD trial commence in December 2022?"

"Can we expect for the first patient to be enrolled by January 2023?"

P1 DFU trial to complete enrolment by end of March 2023, with data published in May 2023

"Will the P1 DFU trial complete enrolment by March 2023?"

P3 knee-OA trial to complete enrolment by end of June 2023

"Are we on track with the P3 knee OA trial to complete recruitment by end of this year?"

"Is it feasible to assume that the trial will finish recruitment by end of June 2023?"

Given that my advisor seems to look at Cynata rather favourable (by disregarding past performance of course), I thought I might as well get an opinion on the SP by year's end:
"Will the CYP shareprice still be below AUD1 by the end of this year?"

Well, you get what you pay for.

Expand

Dr Ross Macdonald, Cynata's Chief Executive Officer, said:
"A cleared IND represents a very significant achievement for any pharmaceutical or biotech company and underpins a major valuation catalyst; I would like to thank our shareholders for their patience during this process. We are delighted to have crossed this threshold and will continue to leverage the momentum in our negotiations with study centres with an expectation to commence a US trial in aGvHD by the end of the year."
The proposed Phase 2 clinical trial will seek to recruit approximately 60 patients with high risk aGvHD, at clinical centres in a number of countries, including the US and Australia. Participants will be randomised to receive either CYP-001 or placebo, in addition to corticosteroids. The primary objective of the trial is to assess efficacy of CYP-001 in subjects with high risk aGvHD by Overall Response Rate (ORR) at Day 28. The trial is expected to commence enrolment by later this year, with results of the primary evaluation expected in early 2024.

This doesn’t match your crystal ball…..
Timelines

P2 GvHD trial to commence in December 2022 with the first patient enrolled in January 2023

"Will the P2 GvHD trial commence in December 2022?"

"Can we expect for the first patient to be enrolled by January 2023?"

P1 DFU trial to complete enrolment by end of March 2023, with data published in May 2023

You should research before investing. Is that you, Ross? Or is it a possible typo?