Thanks for that "update" or reminder, Hottod. I'm sure other...

Thanks for that "update" or reminder, Hottod.

I'm sure other posters are going to think I am crazy for even attempting to take a crack at addressing the scenario but I am going to anyway.

Whilst it is fair to acknowledge that Steven flagged the shift of focus from OmniCAR to PTX-100 earlier in the year, we are now in August and progress will have been made across all our programs. We know that both OmniCAR and CellPryme underwent very valuable optimisation... which, would have been necessary regardless of when OmniCAR trials commence.

The following snippet from the latest article of StHd:-

Current work is focused on methodically exploring variables such as the number of cells to administer, the doses of binders to administer and the dosing schedule, against a dynamic background of varying cell numbers that expand in vivo. These demonstrate the control and flexibility features of the platform, and will be used to prepare a robust pre-clinical data set to inform clinical studies.

The majority of our pre-clinical optimisation of OmniCAR has involved HER2 and EGFRvii, so the company has been focused on our solid tumour programs. Clinical success for OmniCAR will likely have more impact if achieved with solid tumours anyway, as DerrickJ stated. And, it sounds like AML would be far better served in the real world setting using allogeneic (donor) cells in conjuction with a whole host of off-the-shelf binders... so another reason not to be too phased about the MDA collab outcome.

What we do know about AML is that for Car-T therapy it is a very challenging blood cancer and probably because of the multitude of antigens it expresses. A great candidate to showcase OmniCAR at a later stage when technologies emerge such as allo in more approvals. But PTX-200 along with a lot of other targeted therapies are achieving great results. Steven has also flagged that fact, and because of the crowded clinical space for AML, we will be shelving PTX-200. That is not a biggie and the market has probably already priced that in. The positive is that the cost of continuing the trial is saving us valuable dollars.

I understand that Steve wouldn't want to be highlighting the status of either AML program and direct attention to PTX-100, CellPryme and, to a lesser extent, OmniCAR. However, if there are mitigating circumstances and upsides to both current outcomes, then put it out there, IMO. The way I see it, PTX-200 garnered the outcome sought in terms of safety and efficacy and still may suit a farmout of sorts... and perhaps Steven should highlight how it served its purpose in the development of CellPryme and provide the final readout.

I know that I am comforted in the knowledge that we are deriving meaningful use and value from all programs (because they cost valuable money) even if the core drug is shelved. I'd appreciate to have my curiosity satiated instead of having the feeling that the market feels that its had the wool pulled over its eyes. Transparency is not as bad as I'm sure some CEOs obviously believe and take the disclosure game to the extremes by trying to sweep things under the carpet.

The only matter which I think could be questioned is why getting one OmniCAR trial into the clinic is cost-prohbiitve? Steve had stated on a few occasions that per patient the cost is $330k If we were looking at a total of 12 patients to begin with in a HER2 basket study then the cost is just under $4m. Why is that so unaffordable at this time when we have $20m. Now I don't know if that figure per patient applies to OmniCAR clinical studies or a targeted therapy like PTX-100. The latter I should imagine would be less expensive than OmniCAR. And, yes, PTX-100 is going require a lot more being a much bigger 70-patient Phase 2 trial. But the govt pays tax rebates of nearly 50% for trials conducted here. We also wouldn't need to fund the trials in total all up front. Sure, the FDA want to know that the trials can be funded and need to see the evidence up front, I guess.

The other thing that has me thinking that it is not just cost but the fact that the trial designs require time to nail (as evidenced by the latest optimisation work). Our in-house Car-T program for solid tumours is likely to more time to design. Or are we buying time to await other technological advances to emerage (perhaps even our own... aka gene editing) before commiting any prgram to the clinic? Or are we awaiting for the Govt grants to get cranking into the biotech sector?

I don't know about anyone else... but... I would have thought that whilst finance is tight out there, that it would make for the ideal time to to start proving up OmniCAR in the clinic sooner rather than later. It takes time for data to avail itself afterall... and at least we would be ahead of increasing liquidity back into the sector... unless of course our team believes that our pre-clinical data is enough to sell the story to prospective clients when they have the funds to commit to any licensing deals?

I'd like for Steven to be upfront and indicate how our trial designs in OmniCAR are looking and where we are at with PTX-100 and CellPryme. Will we have news to share from our collab with Thermo Fisher too? The fact that we haven't been able to even discuss that collab is frustrating, so lets hope that it wraps up soon so Steve can talk freely about it.

Anyway, Hottod, thanks for your post. You are right too about the most recent timeline graph having been turned upside down... literally! LOL