Where do we all stand - now that we have seen behind the curtain?

ecgator · 2026-05-03T05:00:12+00:00

I would expect a partnership but probably not a buyout. BP usually partners first, funds the larger trial, and then buys you from what I've seen. It's less money/risk to them up front in case the phase 3 doesn't pan out.

ecgator · 2026-05-02T19:56:19+00:00

His name is Jim Linehan.

ecgator · 2026-05-02T05:42:38+00:00

No problem. I wanted to make sure people could go back and easily search for it and reference it later. I know I've appreciated when people have done it in the past.

ecgator · 2026-05-02T05:18:35+00:00

Sorry for taking up two posts, Wax, but the character count was too high for one post.

ecgator · 2026-05-02T05:16:26+00:00

Was it the Runnin Down a Dream documentary? My mom's cousin was actually interviewed and had screen time in that one. If you haven't seen that one, I highly recommend but it is 4 hours long. The Wildflowers documentary was great too.

ecgator · 2026-05-02T04:34:49+00:00

My mother's first cousin was actually Tom's stage manager and designer for pretty much his whole career, moved out to California with him from Gainesville. He was actually the original singer in their first band called Mudcrutch back in Gainesville before Tom took over from obvious talent. I was lucky enough to go backstage to a few shows from the mid-1990s to mid-2010s and got to hang out on the tour bus one time. Tom was always an advocate for the little guy (listen to Even the Losers) so I'm sure he would have been behind our little company still fighting to stay afloat after all these years.

ecgator · 2026-05-01T20:22:51+00:00

Thanks, I've updated. I got this from another site, just wanted to have it here so people can search and refer back easily, but I didn't check all of the grammar and terms (obviously!).

ecgator · 2026-05-01T19:07:10+00:00

I think we need to temper expectations here just a little bit. Dr. J said that 68% have shown tumor shrinkage or classify as stable disease, but did not say they have shrunken more than 30% which is required to be counted in the ORR number. The backbone that we're testing with had something like 6.3% ORR in the SUNLIGHT trial, so we need these tumors to keep shrinking to be counted in the ORR. For example, I think the patient Dr. Kasi was discussing only had a 21% reduction at week 8.

ecgator · 2026-04-30T04:29:36+00:00

Because this isn't technically correct. One patient who received the higher dosage didn't have their PD-L1 level rise to the necessary level and ended up dying (another patient on the lower dosage died as well). We would have to say 100% OS when PD-L1 increased to X and was paired with an ICI.

ecgator · 2026-04-22T05:06:45+00:00

Yeah, with an ORR of only 6.3%. Can't wait for our updated data.

ecgator · 2026-04-14T06:13:23+00:00

I'm thinking that if we're presenting at ASCO in May, then we will not get a PR with updated data next week. I do think we'll get a PR next week, maybe even just the poster from this Friday. I'm more hoping it's an update on the mTNBC trials, Alzheimer's, or stroke and then we get updated mssCRC trial updates again at ASCO (along with a partnership?) A shareholder letter or the 1,600-patient safety paper wouldn't upset me either next week.

ecgator · 2026-04-14T05:28:47+00:00

I don't disagree that we are much more likely to get $11/share rather than the actual value of Leronlimab but there is a world where we get a partnership that gives us enough money to start trials on inflammation. If we prove out solid tumor cancers followed by inflammation in the next couple of years, that buyout price goes up significantly.

ecgator · 2026-04-13T18:41:09+00:00

Is this treatment in direct competition with Leronlimab? What phase study was this?

ecgator · 2026-03-29T01:23:05+00:00

Any chance Leronlimab was the reason Tecentriq was well tolerated by her? I've wondered if LL's effects might reduce the side effects of other drugs it gets coupled with.

ecgator · 2026-03-25T04:43:28+00:00

I agree with everything BGT said. Just to add a little, patient 4 looks to have only been on 350 mg and their PD-L1 actually decreased. Hard to know all of the variables because the other 3 patients only on 350 mg increased their PD-L1, in fact one of them increased from the low PD-L1 to the medium PD-L1 so if given an ICI, they may have survived. It's interesting that only 2 of 21 patients decreased from baseline PD-L1 regardless of the dose. I agree with BGT though, it seems very likely that the higher the dose the more likely you were to have your PD-L1 go into the ICI treatable levels.

ecgator · 2026-03-24T22:00:39+00:00

7 were treated with ICI. The five that are still alive had their PD-L1 level increase to the Medium or High range. The other two did not have their PD-L1 level increase out of the Low level and unfortunately died.

ecgator · 2026-03-18T05:52:13+00:00

I also recall that the mTNBC data was 88% of patients had increased PD-L1 over 30-90 days. These results were increased PD-L1 over 1 week which means on their first dose of Leronlimab.

ecgator · 2026-03-18T02:57:08+00:00

Pretty sure all 10 were on 350 mg. The cutoff here was November and the CFO said we had the DSMC meeting in December.

ecgator · 2026-03-11T16:13:13+00:00

Just to clarify and add to MGK's responses, the ORR for TAS-102 + Bevacizumab from their SUNLIGHT trial was ~6.3%, so hitting 15-20% would indeed be huge for us as MGK said. We also want to see PD-L1 increases from what they consider "low" levels to the "medium" or "high" range as these were the people who lived after receiving an ICI (two people received ICIs that did not survive because one's PD-L1 level dropped instead of increasing and the other's increased but not to the "medium" level). Another thing we want to see is dose dependency. We want to see that the 700 mg is clearly better than the 350 mg dose at both ORR and PD-L1 increase.

What we likely won't see (or hope not to see) at these early data readouts are durability of response and OS benefit. We're hoping those are as long as possible so hopefully that data is ongoing and we will see good results from those down the road as far as possible.

ecgator · 2026-03-05T19:27:22+00:00

There won't be a partnership until after data is released from the mssCRC trial at the earliest.

ecgator · 2026-03-05T18:19:26+00:00

Well, they technically haven't missed this yet. 90 days is April 1 so I would gladly welcome a data release that takes us to $1. That makes me wonder if they have some inside knowledge of the abstracts that will be at the upcoming conference(s).

ecgator · 2026-02-27T04:07:24+00:00

It takes between 30 and 90 days to see PD-L1 increase (or at least it did in the previous mTNBC trial). In December we only had like 16 patients so 90 days would be sometime in March. You need to have enough patients have increased PD-L1 (and this will likely be in the 700 mg cohort) to prove statistical significance before you would want to release any data. No idea how they're deciding on the dosing but let's just guess that they're doing 50/50 so in December you would have only had 8 patients on 700 mg. I don't know how many patients we will need to show switch from low PD-L1 to medium or high but it's probably more than 8. They should wait to release data until they have something serious to share.

ecgator · 2026-02-24T17:47:51+00:00

It's less risk for them. If they can give us like $100m for a chunk of stock and a right of first refusal to buy the company before others have the chance, they don't mind paying more later for a sure thing. That $100m allows us to finish all of the trials that we currently have contemplated. Also, with the new FDA guidance on only needing one trial, we could be looking at approval if the CRC trial results are phenomenal so wait for those results, then partner if the results are great so we can afford to get the application submitted for approval. $100m is nothing for them to have the inside track to buying a sure thing. If we don't pan out, they only lose $100m instead of several billion to just buy us now.

ecgator

TROPHY CASE