TG Therapeutics, Inc. (TGTX) Earnings Call Transcript & Summary

Hi, everybody. Thank you so much for joining our Virtual London Healthcare Conference this year. My name is Chris Howerton, part of the Jefferies biotechnology research team. Very pleased to be hosting a fireside chat with the next company, TG Therapeutics. And on behalf of the company is CEO Mike Weiss. So thanks for joining us, Mike.

Thanks, Chris. Thanks for having us.

Absolutely. So I think it's been obviously a hell of a year for a variety of reasons, but I think for you guys, it's been coming down to this, this time, right? I mean this is a big period of time for the company. So I think we have obviously a big event in just, what is it, in a couple of weeks at ASH, and then, of course, the big news for the MS program. So maybe why don't we start off with ASH? What is it that we're expecting to learn at ASH on top of what we learned from your KOL then just the other day?

Yes. Not a whole lot more actually. So we've got -- just to level set, we'll have 4 presentations at ASH. We've got the final UNITY-CLL data, the final UNITY-NHL data for the marginal zone and follicular cohorts. We've got about the early Phase I experience with U2 plus venetoclax. And we have the early experience of our BTK inhibitor 1701, also alone and then some patients with the combination of U2 plus 1701. And as you alluded to, we presented the abstracts. Particularly, the abstracts for the pivotal trials were relatively final data sets. So there's obviously more detail that we'll provide, but it's not -- it's incremental information. The guts of what is to be presented has been presented in those abstracts, which is why we held the event coincident with the abstracts, because that was really the heart of the presentation. The Phase I, we'll have some updated information. Those studies continue to enroll. So there'll be some more incremental information there as well.

Got it. Okay. Yes. And I'm sorry, I didn't mean to cut you off there. The -- my -- for those of you out there that are aware of this, that we have a little baby over here at my house. So we had actually -- I had missed the big abstract event, and I apologize about that, Mike. So maybe for myself and for those that were unable to attend in person, what was the -- what was kind of the headlines that we learned from the abstracts at ASH?

Yes. So I'll start with the UNITY-NHL, because that's on file. So UNITY-NGL, more or less across marginal zone, follicular and SLL, the 3 cohorts that were presented. Actually, we don't talk about SLL much, because it's not part of the registration package. But the 3 cohorts basically across the indolent non-Hodgkin's lymphoma, about a 50% response rate, follicular was basically 45%, 49% for marginal zone. And I think it was 50% -- pretty much flat or 51% for SLL. So across the indolent lymphomas, I would say, about a 50% overall response rate. I thought the safety profile looked good. The dropouts due to AEs, which is kind of that stock number we talk about when trying to compare our compounds to prior generations, was also in line, I think, 13%, 14%. So really, exactly what we -- we were guiding to what exactly what we were hoping for. So that, to me, looked right in line. And obviously, the stock price reacted accordingly, which is didn't do all that much, because we had guided, I think, relatively effectively to the data, and that was too big a step. For UNITY-CLL, similarly, really nice data. We presented the PFS curves for -- or the hazard ratio [indiscernible]. The curve is actually for the whole group. The hazard ratio for the total population, which was a little over 0.50, and then for the frontline, it was a little under 0.50. And for the relapsed patients, it was above -- it was actually close to 0.60. So all in a pretty tight range, all within what most analysts were expecting 0.50, give or take a little bit, was the expectation. We landed in a good spot there. And again, safety profile there, clean. And the benefit, as we just described, went from the whole population to frontline and to the relapsed patients. And the safety profile looked very good as well, again, similar. Dropouts due to AEs were about the same as we saw in UNITY-NHL trial. Lots of follow-up. I think we had almost 30-plus, 32 months of follow-up. So really long periods of follow-up. And that's...

Median, yes.

Median follow-up for the studies for that. And the NHL was pretty long too, I can't remember, in the 20s, high 20s, mid-20s. So significantly longer and median follow-ups than I believe ever presented for any of the other PI3Ks. Particularly, the early studies were done -- they didn't have this level of follow-up when they were certainly the label-enabling studies. There may have been some later publications. But in terms of label-enabling trials, this is by far the longest follow-up for these agents. So think the fact that the safety profile held up nicely throughout, feeling good about the whole...

Excellent. Yes. I mean -- and that was -- pardon me, one of the conversation pieces that I had with folks, I think, about the data was, look, the UNITY-CLL trial was going on for a long time. So patients were on drug for a long time. And I think that you're not going to do that if it's not safe and effective, at least to some degree. And so I think that certainly was played out in the data themselves that we saw. So that's fair. So I guess -- go ahead, Mike.

Correct. Yes, that's a point worth highlighting, as you mentioned. So with the prior class of PI3Ks treating frontline patients became dangerous, right? So I go, listen, I had a very bad experience treating frontline patients and the label is updated. So the fact that we treated so many patients for so long that had frontline is -- I think is one of the, I'd say, hallmark, it all says about the ability to treat frontline patients, really the first time ever PI3K has been able to do that. It's the aggregated dropouts due to AEs, and it's the low rates of AEs of special interest, that kind of level and say, yes, this is a different agent, for sure, and I think the doctors we've spoken to and it's a different agent, for sure, from prior...

Yes, totally. And so I guess, maybe just to make a couple of points with respect to UNITY-CLL, so you noted that there was maybe a difference in kind of relative performance for either frontline or relapsed/refractory. Is that -- was that expected to you? And why or why not?

Yes. Not clear, to be honest. Why? Not fully expected. We can't assume both groups would act equally again. They're not powered to see whether relatively they were -- I mean certainly, when you eyeball it, relatively the frontline patients and the relapsed patients, but statistically, I'm not sure that analysis would hold up. But we said that you take the data as it comes in and you work with it. I think no matter what -- the nice part is we do want to be able to treat frontline patients. I think patients who go on this in the frontline are going to have, on average, a very good outcome. And so when there's patients who aren't good candidates for BTK and are sitting in the community and don't want to deal with venetoclax, this should be a very good option for them, right? So that's -- the data supports exactly what we were trying to present for this drug. Where it fits in? Again, this is -- we're targeting the unmet medical needs in CLL. And because of new drugs, they're more limited, but they're not -- they're far from 0. There's unfortunately plenty of patients that fall through the 2 current therapies, whether it's, again, not good candidates or have been on them and didn't tolerate them for a variety of reasons. And so having another really good upfront option that is not chemotherapy, we think, is a win-win.

Yes, absolutely.

And then the relapsed side, the choice is -- the comparator arm is really the alternative in the community, right? It's chemotherapy-based or it's us and still pretty darn good performance over and above what you get with chemotherapy without using chemotherapy. So I think net-net, data fits in exactly the way we would want to come out to support the unmet medical needs.

Yes. Yes, totally. And I -- so I mean, of course, you're very much into the commercialization process. But we would love to have that conversation with Adam at some point too, kind of how he sees those frontline data and what kind of excitement that could potentially generate as a team, I would think.

Yes. I mean not on these fireside chats, where it's hard to get a multiple talking heads in. But...

Yes, totally.

But as you know -- yes, firstly for investors that we chat with in one-on-ones, Adam joins all the meetings and is available to answer analysts' question. And yes, I think he would provide similar information, because there's a lot of the -- getting through him anyway. So yes.

Taught him everything you know.

More like he's taught me everything I know, certainly about commercialization.

Yes. Excellent. Okay. And I guess the other -- one of the things that we've talked about, and I don't know if you want to talk about this in the context of NHL, CLL or both, was that there is this historical feature of PI3K deltas. There's a class that's toxic, but they're effective. And so we're at the point now where you have the opportunity to start shaping that conversation with your own data set. And so I guess -- you've mentioned a couple of things here that there's toxicities of interest and there's overall dropout rates. Talk to us a little bit about those numbers there and how that actually will play out in terms of true differentiation.

Yes. Look, in terms of patients that can stay on the original generation of PI3Ks, I mean, the dropout rates in clinical trials run from 25% to 40-plus percent. So they're hard to stay on, and the physicians know that. So that part is not the educational part, right? The educational part is convincing them that they should try this one and then it's different, right? And so we will have -- we have the data that will support that. But we also have -- we did something different than a lot of other companies, I believe, which is we engaged the community extremely early and had them as a major part of our clinical program. So on the call that you unfortunately missed, we had one of the clinicians, he heads up clinical research for Florida Cancer. Florida Cancer has -- I can't remember the number, 200 -- 150. I mean they have sites all over Florida. They're basically the community oncologist of Florida, which is one of the biggest markets in the country. And they've been a partner with us in developing the drug, I call them a partner, right? They've been involved in our clinical trials. I think they had somewhere between 100 to 150 patients on our clinical trials during the development process. So there's a lot of physicians in that group, certainly not all of them. There's a lot of physicians in the group. But we have a number of them that really used the drug. So there's an internal reference point across -- and that's not just for cancer, that's U.S. oncology, that's Tennessee oncology. They have sites all over the...

There are [indiscernible] in Colorado, the community clinics that I think was familiar with your drug too. So I think all over in the place for sure.

Yes. Rocky Mountains community centers as part of U.S. Oncology, they've been a great partner of ours as well. So we really went out early and engaged the community in the clinical trial process to ensure that there are people out there who could say -- could stand and say, "Look, I used the drug. You've got to try this thing. It's definitely different than the rest." So the data plus a personalized assurance that you should try it. Now having said that, if there's 14% of patients that are going to drop out due to AE, that means 14 out of 100 patients are probably not going to have a great experience, but 86 are, right? And if you line up that against even drugs like acalabrutinib or ibrutinib, it's not that different. They're going to be also -- I mean, acalabrutinib is probably in the 8% to 12% range across different studies. And ibrutinib in real-world practice in the community is almost 40% over 2 years. So -- and those are well -- those are perceived to be well-tolerated drugs, right? So I think we're going to be fit into the category of "well-tolerated drugs." Nothing is perfect. And so within the overall class of drugs that are deemed to be generally well tolerated, I believe this one will fit into that category. And again, part of our mission is to get people to try it. Most people are going to have a good experience with the drug.

Okay. And I think per one of the points that you've impressed upon me, Mike, as well is that I think part of the launch process is to make sure that they have that good experience. And so I think you knowing your own drug and helping them understand what would be the best candidates for the therapy, I think, just sounds like such a great partnership between you and the physicians.

Yes, I think it's a combination of good candidates. And again, most patients, if it's 14 versus 86, right, most patients are going to have a fine course of action and they're going to be without much [indiscernible] still some of those initiatives still requires some management. But the better you know what's coming just -- some patients will get in trouble. If you know in advance what to look for and the patient knows what to look for, all you've got to do for the most part is stop taking the drug for some period of time, usually relatively short, a few days to up to a week or so. But drugs have a nice long half-life. Patients are relatively protected for a while. It's the convenience of once-a-day with the beauty of almost 7 day half-life. So this drug, if you skip it for a little bit, you're probably not losing a whole lot of protection. I don't think we've seen a lot of the patients who've come off even for 7 to 10 days have also lost their responses, right? So the key is try it, because it's different. And -- but don't assume it's benign. It's still a drug. And be mindful that if you see something, say something and deal with it quickly. And then most patients will be really well served.

Absolutely. Okay. Okay. So very good. So we have the NDA package and, I think, completely now for follicular and marginal zone. That's right. Those are both complete, right?

Yes. So the NDAs are complete for marginal zone and follicular. We have PDUFA target dates of February 15 and June 15, respectively. So marginal zone is February 15, and follicular is June 15.

Okay. And there -- I'm baiting the hook here to some degree. But there's a difference between the 2 PDUFA dates. And so any commentary you'd like to make there with respect to the urgency the agency may or may not see between the 2 or any common conspiracy theories you'd like to address?

Well, I don't know what conspiracy theories are out there, but I can give my own personal view.