Thank you for coming over and giving us the opportunity to discuss CYP on our thread. I also don't think that people on here mind a comparison between the two, unlike over on the MSB thread. I wonder why...
First of all you asked @Sector if he was at that Proactive Investor Presentation that @cosair has mentioned on your thread and is therefore able to comment on that post.
As far as I remember he wasn't, but I was:
https://hotcopper.com.au/threads/ann-msb-draws-us-15-million-from-existing-facility.4602853/page-100?post_id=37118149
And let me tell you, that is not what happened, hence I have reported the post. Enough said.
You mentioned in that statement above "MSB is pre commercial" - how so?
Production wise? Better tell Lonza that.
From a financial point of view? From my understanding J.C.R. started paying royalties from 2016 onwards. Unless the financials are incorrect and SMH got it wrong too.
disallowed/business/drug-maker-mesoblast-to-go-commercial-after-japanese-approval-for-treatment-20150920-gjqmej.html
You also gave us the opportunity to reply to @Lopez question:
"Quick question if I may,
Why are CYP proceeding with GVHD with MSB soon commercialising their own product.
You would have to think they will be 3 years behind with a product that is similar in effect,
Am i missing something."
To make it short:
MSB children
CYP adults + children
I suspect that you will now tell me the standard reply over there, which is "label extension".
What I don't understand though and from what I have read over on your thread, it doesn't seem to be a big deal.
If that is the case, why is MSB listing it as the furthest Long-Term target (30/11/2018)? They even used a much smaller font to highlight that it is far away...
https://www.asx.com.au/asxpdf/20181130/pdf/440v6055fdvb12.pdf
Doesn't exactly come across as a "walk in the park" to get that label extension.
Somewhere you made a comment that GvHD may have not been the ideal target for our clinical trial, a Phase 1 I may add.
Again, to make it short:
"At 28 days post-injection, if the patients are sitting up in bed or walking around, the product will have worked. I say that because death is the only alternative."
- Steward Washer
https://www.streetwisereports.com/article/2016/02/03/advanced-stem-cell-manufacture-saves-lives-and-prints-money-stewart-washer-of-cynata-therapeutics.html
I think we can confidently tick that box and the fact that comparisons are beeing made also by third non-HC parties (as well as us over here on our thread, including me) between CYP and MSB, despite only using 1/8 of MSB's dosage in cohort A and 1/4 in cohort B - I'd call that "exceeding expectations". But as you said, most likely scenario is FujiFilm walking away and selling 1 mio shares on market...
I mentioned the dosing difference here:
https://hotcopper.com.au/threads/msb-trading.4042474/page-3306?post_id=36942867
I also drew a comparison there, not with your trial in children, but with J.C.R.'s trial in adults, which was sufficient to gain market approval in Japan. Lets hope your prediction doesn't come true and Fuji is crazy enough to take up their GvHD option, the Japanese market would be the perfect target for them, using our "safety exercise product CYP-001", for obvious reasons (conditional market approval after a successful P2).
Sure, for a cash hungry monster like yours, $60 mio in potential payments plus double digit royalties may not mean much, but for a company with a MC of $130 mio, it is transformational. And as @elvisj mentioned yesterday, Fuji to (un ) likely fund the whole lot going forward.
You mentioned 16 patients treated, on your thread I read 17.
Fact is, 16 have been recruited but only 15 patients received treatment as 1 patient was unable to be treated.
Know your competition and don't tell me you don't want to waste you time - because clearly you do by posting here.
That leads me to comments about the overall number of patients treated.
Yes, overall only a small number of patients have been treated using our cells, but lets put that into perspective -
Last time I checked (mid November last year), a total of 22 patients have been treated world-wide using iPS technology, out of that
- 15 patients (68%) got treated by a public company - Cynata
- 15 patients (68%) got treated outside Japan - Cynata
Consensus on the MSB thread is that it is still very risky and much of a gamble at this stage.
I take it that funding funding one of the world's largest MSC clinical trials to-date (not to mentioned THE largest iPS trial) world-wide, involving 448 patients with Osteoarthritis (knee, to be specific - I will come back to that in a minute) is completely out of the question then... hang on... it is not:
https://globenewswire.com/news-release/2018/12/13/1666610/0/en/NHMRC-to-Fund-Major-Phase-2-Clinical-Trial-of-Cynata-s-Cymerus-MSCs-in-Patients-with-Osteoarthritis.html
I take it that you are not aware where the NHMRC gets the funding from for their grants - taxpayers.
https://www.grants.gov.au/?event=public.FO.downloadDocument&objectUUID=0CB063BA-F77C-06CE-26914DC7D4F65728&fileName=Guide%20to%20NHMRC%20Peer%20Review%202018%2Epdf&documentType=FO
That means if your income is above the tax free threshold, I have to say thank you for your contribution in funding our upcoming Phase 2 trial! Much appreciated!
A working product in that disease target (OA knee) is a very lucrative one. Don't take my word for it, ask Genzyme:
"Chondrogen for osteoarthritis of the knee"
"Success-based fees for Chrondogen could total $500 million if Genzyme opts in on development after Phase II/III data come out. Development and regulatory milestones could total $100 million, and sales-related achievements could trigger up to $400 million. If Genzymes elects to not develop Chrondogen, all rights will revert to Osiris with no further obligation by either company.
https://www.genengnews.com/news/genzyme-to-pay-130m-upfront-for-rights-to-osiris-adult-stem-cell-products-outside-the-u-s-and-canada/
That was back in 2008, ex US and Canada as far as I understand it. There was also an upfront payment of in total $130 mio, but that covered also Prochymal (sound familiar - the very same that got sold off for up to $100 mio, despite having seen a deal that could have been worth up to $1.25 billion for these "forever late stage" products).
Anyways, our phase 2 is fully funded (again, thank you).
However, we have to wait and see if we are still around by them as an independent company, and if we are, what the interim results are. It is however important to remember our current MC of around $130 mio.
There is finally a positive vibe again over here and rightly so in my opinion. See it as hype if you like, but I think given the above, your risk vs reward methodology highlights the massive upside that could be on the cards for Cynata. Yes, "potential" as otherwise our MC wouldn't be $130 mio.