PTX released an announcement detailing a significant issue with their OMNICAR platform and its resolution through a collaboration with CSIRO and the Peter Mac Cancer Centre in Melbourne. I follow PTX and hadn't realised they were having (announced) issues with OMNICAR before now although I had noted the very significant pivot towards PTX-100 as the primary focus.

In simple terms, the 'unarmed' T-Cells which should be harmless were exhibiting cytotoxic (killing cells) effects when they should not have been. This calls into question the fundamental principles which underlie the idea of modular CAR-T (the principle being that the T cells can be armed and re-armed targeting cells with paricular antigens). Apparenty they have now demonstrated modifications which have resolved the issue, it the T Cells kill when they're supposed to and chill when they're not...

On the face of it, the announcement is very positive. Even as a medical doctor (non oncologist/haematologist), however, I find it impossible to predict the possible evolution of this platform. Huge potential but on what timeline and how will it perform compared with alternative approaches... At the current share price and market cap I think PTX100 alone in CTCL is probably a reasonable investment where the whole area of CAR-T is a free swing and could be a home run...

Held in a very small weighting.

Gaz

PTX-OmnicarAnnoucement23rdJan2025.pdf

One step closer to commercialisation… Given the current standard of care for CTCL is so ineffective you’d think this has a reasonable chance of approval/success which would really give Prescient the breakthrough it needs (not to mention hope for a really unfortunate group of patients)

The last CEO was highly promotional but also a good steward of capital. The incoming CEO looks to have expertise and experience in haematological malignancy which has become an area of increasing focus with the positive response PTX has seen to PTX-100.

Im not sure how to judge the new CEO at this point but I can’t help but compare his remuneration to that at PAR also pre revenue (essentially) biopharma. The new CEO will be on a little less than 400k /year at PTX as opposed to the million dollar salaries for multiple execs at PAR. Fits with relative number of cap raises also…

bottom line is that a highly speculative microcap in the oncology research basket. Better capital managers than others and right now you can take a share of a business with some near term possibilities of commercialisation and a market cap of 39 mil with 21 mil in cash on the balance sheet. Hold IRL and buyer at 4.5 cents

nice little nod to the possibility of commercialisation in the next 2 - 3 years for PTX. They’ve been pretty gentle in capital but I suppose it will cost a bit to run the phase 2 trial of PTX-100 in T cell lymphoma… but probably a lot less than a phase 3 trial

https://smallcaps.com.au/prescient-therapeutics-pivotal-year-ptx-100-development-treat-t-cell-lymphomas/

This straw is mostly to help me keep track of what's happening.

Today's announcement is a follow up to the one in July last year.

Essentially, the latest announcement is that the FDA has broadened the scope of Prescient's orphan drug designation for their drug PTX-100 from just peripheral T-cell lymphomas to all T-cell lymphomas.

The drug is not actually finished trials yet though. They say they expect to share updates on the trial shortly.

(Disc: held)

Nothing really new added in this 4C.

• Continued work on clinical trials and new OmniCAR system.
• Net cash outflow $323,000. Although this would have been $1.96M outflow if not for a government grant.
• Cash balance of $21M after raising about $10.5M during the quarter.
• This gives them a couple of years of funding without any new grants.

But the main thing I was looking for was anything about their CellPryme-M and CellPryme-A technologies. They've strongly hinted that they can licence this for money to other companies working on CAR-T therapies:

``Prescient believes the CellPryme platforms can open the door to potential licensing and commercial collaborations.''

But the current status is only:

``...management continues to raise awareness of these programs among the global medical community, the biotechnology industry and investors.''

Which sounds to me like any actual cash transactions for the technology will be at least a couple of years away. On the issue of timing they say:

``Such arrangements are always challenging to achieve and take time, but interactions so far have been encouraging.''

So I don't yet know what to think of how CellPryme should figure in the thesis, if at all. Thoughts welcome!

(Disc: held in RL and SM.)

I always enjoy listening to Steve Yatomi-Clarke discuss PTX's progress and plans when I tune in. However, as a long term shareholder (IRL) I'm developing a touch of scepticism based on the regularity of presentations and IR exercises...

Steve presents weekly sometimes more than once in a week and whilst I understand they're a pre-revenue biotech and therefore communication and IR relations are pretty important. BUT... Does anyone worry that this is just a way to string the market along and continue to milk the market for cap raises? I don't feel this way with PTX, I feel they've been decent stewards of shareholder capital but I have some doubts just based on the extreme number of presentations...

Does anyone else have a view on this for PTX or more generally?

As I mentioned in the straw about the CellPryme-M platform, I'm looking to see if this new program is causing an increase in costs like @GazD suggested.

Their most recent 4C actually had a pretty big decrease in operating cash flow: -$1,167,000 (June) vs -$1,633,000 (March), which is largely driven by a reduction in R&D costs: $493,000 (June) vs $1,072,000 (March). Their prior 4C (December 2021) had R&D in the middle $827,000, and September 2021 was roughly the same.

In the most recent 4C, on the topic of CellPryme-M they say that ``This program has been in development for some time in stealth mode whilst data was generated and patents filed.'' and so maybe the higher R&D spends in the previous quarters accounted for that.

The takeaway: so far it looks like the CellPryme-M platform isn't leading to increased costs. Of course, a significant reduction in R&D spending by a biotech is an interesting fact by itself, since that's basically their entire business. So I'll be watching to see what happens there.

(Disc: held)

[Edited to add disclaimer]

I dug into some of the details of the announcement in @GazD's straw. So the company is saying that one of the main problems with Car-T therapies is that the production process produces too many of the wrong kind of T-cell. But they've developed a pre-treating process that takes only 24 hours, after which you then take the cells and stick them into your standard production process for whatever treatment you're producing. This then results in more of the right kinds of cell after the full production is completed. In particular, the cells will last longer and be better able to locate the tumors that they're trying to attack.

They're saying that they can use these to improve their own products, but I suspect that probably the most important thing about the announcement is that they're aiming to make this available to other companies to licence for their own drug development. They claim it's ready now, so if this turns out to be true, and they can get other companies interested, then I think the company could really be in good shape, and importantly, can start getting earning some cash before they run out --- their March 4C estimated 2 years of remaining cash. The other important implication of the announcement, as @GazD suggests, is this new program might increase expenses and force them to pass the hat around much sooner.

So, what I'm watching: can they get any traction on this CellPryme-M platform by the end of CY2022? How much are expenses increasing in their next 2 quarterly updates?

(Disc: held)

Not much to report, but I finally got around to following up wtih Rebecca Lim (Prescient's Director of Scientific Affairs) about their IP and the announcement about the expansion of their PTX-100 trial. In retrospect, I should have been more specific with my questions, so I didn't get a particularly informative response. At any rate, here's the questions that I asked:

• From what I understand from the [journal article that Rebecca sent me previously], the Omnicar system is a development of the Spytag/spycatcher system. Is this correct?
• If so, can you give an outline of what's unique about Omnicar? Does Prescient own all the IP for this system?
• I saw the ASX announcement on 27th July about the successful phase 1b trial of PTX-100, and the results sound really encouraging. Was this result published somewhere, and if so, can you please point me to the reference?"

Here's Rebecca's response:
"To answer your questions: we’ve licensed the IP for the OmniCAR system which comprises of the SC/ST system from Oxford University and the SC/ST application for cell therapies which is from U Penn. OmniCAR is unique amongst universal immune receptor systems due to its covalent binding system and rapid binding. This addresses challenges in the field as unbound binders can negatively impact targeting of the tumour cells and/or safety concerns associated with unbound binders in circulation.

The PTX-100 trial outcomes are yet unpublished as we are moving onto an expansion trial now. You might have seen on the same ASX announcement, we have seen some encouraging results with relapsed/refractory PTCL patients and will be expanding into a cohort focusing on this patient group."

So it's still not clear to me exactly what differentiates the Omnicar system from other Spytag/Spycatcher systems, but her brief mention about covalent binding matches what is described in this paper [Minutolo et al. (2020), J.Am.Chem.Soc. 142], so I'm assuming that this is the same thing. None of the authors on that paper are listed on Prescient's website, although in their latest investor presentation (ASX announcement 4/8/21) the two authors who declared patents in the paper are both mentioned, so presumably they have some relationship with the company.

(Disc: held)