Ann: PTX invited to present at international lymphoma forum, page-20

I think it's fair to say that all eyes will be on the potential of PTX-100 to offer a viable treatment for PTCL. The weight of the efficacy results derived from the Phase 1b study is due to the number of evaluable patients with CTCL.

Sure, it appears that we are focusing on one drug and one indication only, but T-cell Lymphoma comprises many indications and is therefore difficult to treat broadly. The FDA is keen to advance treatments in the immuno-oncology space that have the potential for broad application.

The difficulty is likely in finding the sweet spot in dose levels and dosage regimes that suit both CTCL and PTCL which could also provide promise across the broader TCL basket of diseases. The industry is clearly struggling to find the best treatment for PTCL which is an aggressive disease compared to CTCL, and if PTX-100 can build on the data derived in our Phase 1b study (early in a Ph2 study) to substantiate its applicability for PTCL patients, then it could open the doors in many ways.

As for a CR later in the year... quite possibly. Targeted therapy trials cost a lot less than CarT trials. According to what Steven has stated in the past, the cost is around $70k per patient (which is substantially less than that for CarT). The latest figure on the size of the upcoming trial is approx 120 (considerably higher than previously guided). Based on those numbers, one would expect that a CR would be prudent, albeit not necessarily "needed" upfront or even this year. It would be better to seize an opportunity to raise if it presents (at a higher SP).

I'm not so sure that newsflow will be limited given that PTX-100 has the potential for broader interest beyond TCL, for one, and that cell therapy is somehow out of vogue. For cost reasons, OmniCAR has been put on the back-burner, but there is nothing to indicate that newsflow won't come from CellPryme. Testing of CellPryme-M in other cell types to bolster IP position is ongoing according to the timeline guided by the company. And, regulatory packages for CP-M are in progress. CP-A as a neoadjuvant is undergoing pre-clinical testing at this moment. So there appears to be plenty of potential from CellPryme for newsflow.

In addition to CellPryme, there could be news on the patent front given that patents in the biotech space are lent the privilege of expiry extensions. So, PTX-100 and/or our biomarker p27 could provide news on that front. Eventhough, PTX is focusing on the inhibition of RhoA downstream pathways and the unmet needs of TCL, the company would have its sights on other cancer types driven by KRAS mutations.

Here is an example of the value bestowed on KRAS technologies:-

https://endpts.com/after-approvals-for-one-of-cancers-undruggable-targets-research-into-new-kras-therapies-booms-aacr24/

The broader the applicability, the better... as far as both the FDA and the industry go. Lets not dismiss what PTX is trying to do here... and that is get the ball rolling with the least amount of funds possible. Focus on the orphan indications and leverage that towards collaborative deals in more common indications.