TG Therapeutics Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
March 3, 2025

There are 10 speakers on the call.

Operator

Greetings, and welcome to the TT Therapeutics Fourth Quarter and Full Year Conference Call and Webcast. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded.

Operator

It's now my pleasure to turn the call over to Chief Communications Officer, Jenna Bosco. Please go ahead.

Speaker 1

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the fourth quarter and full year twenty twenty four financial results are Michael Wyeth, our Chairman and Chief Executive Officer Adam Waldman, our Chief Commercialization Officer and Sean Power, our Chief Financial Officer. Following our Safe Harbor statement, Mike will provide an overview of our corporate developments, Adam will share an update on our commercialization efforts, and Sean will give a summary of our financial results before turning the call over to the operator to begin the Q and A session. Before we begin, I'd like to remind everyone that we will be making forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Speaker 1

These forward looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected milestones, revenue guidance, development plans and expectations for our marketed product. TG cautions that these forward looking statements are subject to risks that may cause our actual results to differ materially from those indicated. Factors that may affect TG Therapeutics' operations include various risk factors that can be found in our SEC filings. In addition, any forward looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any later date. We specifically disclaim any obligation to update or revise any forward looking statements.

Speaker 1

This conference call is being recorded for audio rebroadcast on TG's website, www.tgsherapeutics.com, where we'll be available for the next thirty days. Now, I'd like to turn the call over to Mike Weiss, our CEO.

Speaker 2

Great, Anna. Thanks, Jenna, and thanks, everyone, for joining us this morning. I'm really excited to be able to host this call just following the ACTRIMS conference that was held last week. These meetings are really so energizing for me. They're great venues, not only to present and review data, but to interact with so many healthcare providers all in one place.

Speaker 2

And I have to say by and large the feedback on Briohnvy and the TG team was overwhelmingly positive. You don't know how gratifying it is to hear how our team can make a real impact on the patient experience. And even more gratifying is to hear the stories from healthcare providers of how BIOMV is impacting their patients, especially challenging ones. The anecdotes about patients who have challenging times on prior therapies and then followed by a positive experience on Briohnvy is really why we do I myself and everyone at TG do what we do every day. So with that, I thought I'd turn to the business of today.

Speaker 2

2024 was an exciting year for TG, marked by outperformance and growth across various aspects of our business. As noted at the JPMorgan Conference, our full year twenty twenty four U. S. Revenues of $310,000,000 far exceeded our target guidance heading into the year, which we believe is reflective of the value Brianna brings to those living with MS. The team made significant progress also during the year launching and enrolling clinical trials to improve the patient experience on Briamri, which led to the presentation of several meaningful datasets during the course of 2024.

Speaker 2

And most recently we updated our ENHANZE study at the ACTRUM conference. You may recall in 2024 we presented the first data emerging from the ENHANZE trial where we demonstrated the preliminary safety of a thirty minute maintenance infusion as well as the feasibility of switching individuals from another anti CD20 to Briumvie without the need for the four hour introductory dose. At Acterms, we updated the thirty minute cohort showing a consistent safety and tolerability profile as previously presented, now with over 80 patients treated with a thirty minute infusion. In addition to our company sponsored studies presented at ACTRIMS, Doctor. John Foley from the Rocky Mountain Multiple Sclerosis Clinic presented the first ever real world experience data from his practice from over 160 individuals with MS treated with Briohnvy.

Speaker 2

The results seem to be consistent with the overall safety and tolerability of Briohnvy as seen in our ULTIMATE 102 clinical trials. And interestingly, in a subset of patients previously treated with the Ocrevus who experienced a wearing off effect between their Ocrevus infusions did not report this effect while on Briamvie. And that subset there were nineteen patients and sixteen of which, so eighty five percent did not experience the wearing off effect after switching to Briamvie. Since this is an independent presentation of externally generated data, it is not included in our publications library, but I would encourage those who are interested to access the data through the Actrims website. Also during 2024, at the ACTRIMS conference in September, the ACTRIMS conference, so very distinguishable, one is the European that starts with the E and the ACTRIMS which was last week starts with an A.

Speaker 2

We presented the long term follow-up data from the open label extension study of the ULTIMATE one and two Phase three trials. The data showed after five years of BrionV treatment, ninety two percent of patients were free from disability progression and in the fifth year of treatment, an annualized relapse rate of zero point zero two was observed. This is equivalent to one relapse occurring every fifty years of treatment. Additionally, the overall safety profile remained consistent over five years of continuous Briohnvy treatment with no new safety signals emerging with prolonged usage. With Briohnvy being the newest entrant into the CD20 landscape, we believe this data was important to many HCPs and individuals with MS.

Speaker 2

I also wanted to share some clinical progress which we made during the year as well. Some of this for these studies, we haven't yet presented the data. Late in 2024, we started a new cohort to an enhanced study that combined the starting dose, which is one hundred and fifty milligrams given over four hours, and the first maintenance dose, which is four fifty milligrams given in one hour two weeks later and we combine that into one single six hundred milligram infusion which effectively eliminates the need to get two infusions in the first two weeks of starting Briantvie. While we haven't presented data from this cohort yet, from the data we have seen in over 50 patients, we feel confident that this approach is achievable in a four hour infusion, which is the same timeframe as our currently approved starting dose. We look forward to launching one or more pivotal trials this year with the goal of potentially incorporating all or some of the updates exploring the HANDS study into the IV Briampi label as soon as possible.

Speaker 2

Another key effort for us is developing and commercializing a subcutaneous formulation of Briampi. As we've discussed in the past, currently the majority of MS patients starting on ANTHYS CD20 will choose an IV delivered every six months. And the remainder, nearly forty percent are now choosing to self administer a subcu at home. With almost forty percent of new starts going on a self administered subcu, we believe subcu Briumvii would represent a meaningful expansion opportunity for TG. And most recently at the JPMorgan conference, we were pleased to share that we believe the preliminary data from our bioavailability studies support at least every other month dosing for subcu Briampi.

Speaker 2

The currently self administered subcu is taken once per month. So, if we are successful, we could cut the number of injections per year in half. This is an exciting development for us and we look forward to commencing a pivotal trial around the middle of the year and providing additional information on this program later this year. Beyond BRIONV and MS, I'm pleased to announce that we've started treating individuals with myasthenia gravis or MG in the exploratory study. We think MG is a good place for us to begin to explore BRYOMEI outside of MS and look forward to hopefully sharing some data later this year.

Speaker 2

We also plan to continue to evaluate other areas outside of MS where we believe BRIONV may offer a meaningful treatment option for patients. And beyond BRIONV altogether, on the pipeline front, we were pleased to have announced in 2024 that we entered into a partnership with Precision Biosciences to acquire a worldwide license to develop AzerCell for autoimmune diseases. As an allogeneic, which means basically can be given off the shelf CD19 CAR T cell therapy, we believe AzerCell has the potential to be first in class, best in class treatment for certain autoimmune diseases. Having said that, we believe there will be multiple winners in what we see as an extremely large market addressing a significant number of autoimmune diseases with CAR Ts. We are pleased to receive IND clearance for a Phase one study evaluating AzerCell and progressive forms of multiple sclerosis and we look forward to enrolling our first patients into this Phase one study hopefully very soon.

Speaker 2

As you can see, we made a lot of progress on all fronts in 2024 and we plan to carry that momentum into 2025. One last but very important item I wanted to note. During 2024, we were incredibly pleased to have three new patents issued by the U. S. Patent and Trademark Office providing patent protection for Brionvi through 02/1942, which included a composition of matter covering the glyco engineered attributes of Briohnvy.

Speaker 2

In summary, 2024 was a year of continued strong execution by the TG team, including above expectations revenues for Briohnvy, expansion of the Briumvie patent portfolio with composition of matter patent protection now through 02/1942, the launch of Briumvie outside The U. S. With our partners, NeuroaxxPharm, the presentation of important data, including five year follow-up data from the ULTIMATE one and two trials and data from the ENHANZE trial, which we plan to use to support the launch of additional pivotal trials in 2025 And we also made significant progress with our clinical programs, including preliminary bioavailability of subcutaneous Briam V. We treated individuals with MG with Briam V and we opened our Phase one evaluating azurecell in progressive forms of MS. With that, let me hand the call over to Adam Waldman to write a more detailed review of the Briumvie U.

Speaker 2

S. Launch in 2024, our early performance in 'twenty five and our plans for the rest of the year. Adam?

Speaker 3

Thanks, Mike, and good morning, everyone. We are pleased to report another quarter of strong commercial performance, marking continued momentum as we closed out 2024. Despite a new competitive entrant, we delivered significant quarter over quarter growth, reinforcing our confidence in Briampi's positioning and long term potential in the relapsing MS market. As reported at the JPMorgan conference in January, fourth quarter U. S.

Speaker 3

Net sales for Briombee were $103,600,000 representing 24% growth quarter over quarter and 160% growth versus same quarter last year. That brought our full year 2024 revenues to $310,000,000 approximately 250% growth versus 2023. The fourth quarter numbers and full year numbers exceeded our guidance and reflect the growing demand we are seeing for Briombee. Briombee is also gaining momentum internationally. As many of you know, we partnered ex North America commercialization rights to Neurax Farm, who launched Briombe in Germany in February of twenty twenty four.

Speaker 3

Since then, they have launched in a number of EU countries and The UK. And overall, the feedback from the EU has been positive and we look forward to them continuing to expand the geographical reach of BRIANBI in the future. Our differentiation strategy remains strong. The confidence that physicians have demonstrated in continuing to prescribe BRIANBI underscores its importance in the adult RMS treatment paradigm. Our recent five year data and real world experience continue to reinforce the unique value proposition of Breombee, an efficient infusion combined with a proven efficacy and a consistent safety profile.

Speaker 3

The quarter over quarter growth we achieved validates the increasing confidence among prescribers and patients in Briohnvy as a leading anti CD20 option in RMS. Our dynamic market share in the physician administered anti CD20 segment is increasing, and we anticipate continued growth as physician experience and comfort with Briohn B increases. Additionally, our field teams have been highly effective in educating prescribers on the attributes of Briohn B, with increasing adoption among high volume infusion centers and academic neurologists. We remain committed to expanding patient education efforts and optimizing the overall treatment experience. The foundational work we have done throughout 2024, coupled with the strong adoption trends we're seeing today, set the stage for continued growth in 2025.

Speaker 3

We will maintain our focus on driving deeper penetration in the RMS market, ensuring that Breombee reaches as many eligible patients as possible. Looking ahead to 2025, we expect multiple drivers to continue fueling our growth, including expansion into additional infusion centers, academic and community practices, direct to patient engagement efforts, increased real world evidence supporting Breanvie's efficacy, safety and tolerability, and strengthening perceptions around payer coverage and access. We are off to a strong start in 2025. Despite the typical challenges inherent in Q1, enrollments and overall demand have been robust, with January and February being our highest month of total new patients into our hub since launch. We feel confident in how the year has started and are now estimating $115,000,000 in U.

Speaker 3

S. BrionV net revenue in Q1 and believe we are on track to meet or exceed our full year U. S. Guidance of $525,000,000 In closing, I want to thank our dedicated team for the relentless efforts in bringing Breombee to people with RMS. Over the past two years, we have built a strong foundational commercial infrastructure that has delivered exceptional results, exceeding all expectations for the launch.

Speaker 3

This success now provides a solid platform for which to build potential blockbuster products in MS and capitalize on other autoimmune disease opportunities going forward. We have the team, we have the capabilities and the leverage to drive future growth, including the opportunity to further strengthen our position in the RMS market with enhanced IV administration options and the development of a patient administered subcutaneous formulation of Briohnbee. We believe this new option has the potential to significantly expand our market opportunity, allowing us to compete more broadly across the RMS space with potentially best in class products in both the IV and subcutaneous markets. These advancements will help drive sustained growth for years to come. We remain very excited about the future and look forward to updating you on the progress in the quarters ahead.

Speaker 3

With that, I'll turn it over to Sean to discuss our financials. Thank you.

Speaker 4

Thank you, Adam, and thanks everyone for joining us. Earlier this morning, we reported our detailed fourth quarter and full year '20 '20 '4 financial results in a press release, which is available on the Investors and Media section of our website. This morning, I'll start with a discussion of our revenue for the fourth quarter and full year 2024, which Adam had briefly touched on. We are pleased to report U. S.

Speaker 4

Briohn V net product revenue of $103,600,000 during the fourth quarter. Our total net product revenue for the fourth quarter was $107,300,000 and in addition to U. S. Net revenue includes approximately $3,700,000 of revenue for products sold to NeuroXPharm in support of the ex U. S.

Speaker 4

Commercial launch. For the full year, we reported total global revenue of approximately $329,000,000 which is predominantly comprised of $310,000,000 in U. S. Briohn B net product sales and a $12,500,000 milestone from our partner for the ex U. S.

Speaker 4

Commercial launch of Briohn B. As mentioned a moment ago, during the quarter, we recognized revenue for products sold to our partner, NeuroXfang. It is worth noting that when looking at our COGS margin in the fourth quarter, it includes the cost of goods sold to our partner, which are of course sold at a margin significantly less than what we see commercially here in The U. S, thereby giving the appearance of having an unfavorable impact on our gross margin. Absent this infrequent occurrence, when we recognize revenue related to the sale of goods to our partner, our gross margin has and should remain relatively consistent.

Speaker 4

On the expense side of the ledger, we commenced the year with 2024 OpEx guidance excluding non cash items of approximately $250,000,000 and we're pleased to report that during the quarter and full year 2024, our operating expenses have remained well controlled and below our guided ranges. For the fourth quarter and full year 2024, our OpEx was approximately $51,000,000 and $2.00 $6,000,000 respectively. Earlier this year at the JPMorgan conference, we guided that we expect our operating expenses to be approximately $300,000,000 for the full year 2025. As a result of the continued strong Breombee launch and a strategic and disciplined approach to spending, we are pleased to report GAAP net income of approximately $23,000,000 dollars or $0.15 per diluted share in both the three and twelve month periods ending 12/31/2024. And last but not least, I'll close by touching on our cash position.

Speaker 4

We ended the fourth quarter with approximately $311,000,000 in cash, cash equivalents and investment securities. When excluding investments in inventory and share repurchases, we generated cash flow from operations in 2024, a trend which we expect to continue in 2025. We believe our existing cash provides us with a strong financial position to continue to support the Briandique commercialization and invest in our research and development efforts and our business operations for the foreseeable future. With that, I will now turn the call back over to the conference operator to begin the Q and A.

Operator

Thank you. We'll now be conducting a question and answer session. You. Our first question is coming from Bakkar Agarwal from Cantor Fitzgerald. Your line is now live.

Speaker 5

Hi, good morning and thank you for taking my questions and congrats on all the progress. So maybe firstly, you mentioned about January and February being strong growth and 2025 guide to meaningfully exceed the $5,250,000 that you gave. So maybe just give more color around that, what you're seeing, what are the biggest segments of growth as you look towards the rest of the year? And secondly, Okros has a high dose readout this year. Maybe if you can talk about where you see that product playing a role in the market, that would be super helpful.

Speaker 5

Thank you.

Speaker 3

Mike, you want me to take that?

Operator

Parag, the phone is on mute.

Speaker 2

Yes. Sorry about that. Yes, go ahead, Adam. Why don't you go ahead?

Speaker 3

Yes, Prakar, thanks for the question. Our growth let's talk to the first question about the growth. Our growth comes from it's coming from a broad set of customers with enrollment so far in both the academic and private clinic setting, a little bit more in academic now. As I mentioned, I think in previous calls, academic hospitals now account for the majority of where we're seeing growth in our overall enrollments. I think that's being driven by a lot of things.

Speaker 3

So the number of things that we talked about in the call, the five year data, the real world experience, our expansion strategy, of course, with more people in the field versus we did a pretty significant expansion in 2024. So all those things are driving our growth that we're seeing. And as I said, January and February were our best months in terms of new enrollments into our hub. And then for the high dose, I'll start and I'll hand it over to Mike. It really depends on the profile.

Speaker 3

I mean, we haven't seen much in terms of what the profile looks like, what the safety profile will look like, what the infusion experience. So really hard to comment until we know more.

Speaker 2

Yes. I'll just add to that. I think that's a fair point. We have very little to go on for the moment. We imagine it will be a relatively long infusion.

Speaker 2

I assume they'll figure out they'll try to put into some sort of subcu to try to limit the timeframe, but the volume will be pretty dramatic. So, yes, until we know more, I think we just have to wait and see.

Operator

Thank you. Next question today is coming from Michael DiFiore from Evercore ISI. Your line is now live.

Speaker 6

Hi guys. Thanks for taking my call and congrats on all the progress. Two for me. Obviously, it seems like the pivotal Phase III subcutaneous trial for BIOMBI may come around the middle of the year. To the extent that you can, I mean, has the subQ trial design been finalized?

Speaker 6

And can you confirm whether Q2 months or Q3 months remains the target regimen? And finally, just a follow-up, expectations on gross to net for the balance of the year? Thank you.

Speaker 2

Adam, why don't you go ahead and do the gross to net and I'll come back and do the sub Q.

Speaker 3

Yes. Mike, we expect gross to net in the 70% to 75% range with some fluctuations quarter to quarter, but that's what we're expecting.

Operator

Okay.

Speaker 2

And the sub Q, yes. So the target is to get this going hopefully by middle of the year. In terms of the exact design, it has not been finalized. We're still gathering more we're still looking at the study design. And in terms of whether it's going to be every two months or every three months, I think that's still yet to be determined and it is plausible that we could end up with potentially studying two doses in the Phase three.

Speaker 6

Got it. Thanks so much.

Speaker 2

You got it.

Operator

Thank you. Next question is coming from Ed White from H. C. Wainwright. Your line is now live.

Speaker 7

Great. Thanks for taking my questions. So just a follow-up question on the subcu potential. How are you thinking about the size of that trial and the timing for enrollment seeing is that it's a competitive market that's already penetrated?

Speaker 2

Yes. Thanks, Ed, for the question. So the size of the trial is most likely going to be similar to the studies that OCREVUS did for their subQ. I think we're talking about somewhere around 200 per arm, probably a little bit less, trying to remember exactly what they were, maybe they were like 150 per arm. So it's not an incredibly large study, it's not a small study either.

Speaker 2

But in terms of enrollment, I mean, we enrolled in the pivotal studies for BRIONVIA one thousand patients in twelve months or so. So I don't know that enrollment is going to be the challenge here. I just think we just got to get ourselves in a position to get it going. But yes, we're projecting about a twelve month enrollment period.

Speaker 3

Okay. Thank you. It could be

Speaker 2

a little longer, it could be a little shorter, but give or take, about a year. Yes, you got it.

Speaker 7

Okay. Thanks. And then just, I appreciate the OpEx guidance. How should we be thinking about that regarding SG and A versus R and D? The question on SG and A is just is the sales force right size now or you continue to add there and are there any marketing schemes going forward that might lead to increased SG and A costs?

Speaker 2

Adam, you want to go ahead?

Speaker 3

Yes, sure. Thanks, Ed. So, on the sales force, I think we'll look to strategically continue to add people slowly over time where we see opportunity. So I think there could be but I don't think those would be material expansions to the SG and A. And then we do expect to do some patient as we said in the past, we are we and we said this morning, we'll be doing some things on the patient side, but I'll let Sean or Mike comment to the materiality of that.

Speaker 2

Yes. I don't have any further comments, Sean, do you, on that?

Speaker 4

No. Nothing further, not at this time.

Speaker 2

Okay. Ed, just a quick, my crack staff was ready to go with a better answer than mine. So I will tell you that we're probably looking at somewhere about 125 to 150 per arm, which is in line with the OPREVUS subcu study for the subcu arms.

Speaker 7

Okay, great. Thanks, Mike. Thanks for taking my questions.

Speaker 2

Yes. Thank you.

Operator

Thank you. Next question is coming from Eric Joseph from JPMorgan. Your line is now live.

Speaker 8

Hi, good morning. Thanks for taking the questions. Just on your feedback at Actrims, I'm wondering what the reception has been like to the ENHANZE trial data to the extent docs are apt to modify use today based on the data that you're seeing so far? And how much more would a formal label expansion drive utilization based on the feedback you're getting so far? And then I guess looking to that end, I guess when all said and done, would you expect to file an SBLA for a consolidated shortened enhanced infusion

Speaker 3

regimen with BMD?

Speaker 2

Yes, sure. Thanks. Thanks, Eric. Yes, so we actually did do some polling while we were there, asked a number of folks about that. What's interesting is, if you recall, when we started the ENHANZE study for the Ocrevus switches, we did it because in large part, because we had seen in the market that people were already taking folks on another CD20 and switching them to the to Biryani without going through the introductory dose.

Speaker 2

And to be honest, we had no experience with that whatsoever and we really wanted to make sure there was safety information around that in case we needed to give any further guidance to folks. So we got that going rather quickly and we're able to enroll obviously significant number of patients and what we've seen is that switching the patients without the one hundred and fifty milligram dose doesn't appear to cause any safety concerns. So that was our biggest worry was safety of folks that were already in the field doing it. We did ask people about that and most people that we had spoken to are already switching without using the first introductory dose again. So that's out of our hands.

Speaker 2

Obviously, we don't we certainly don't talk about that in terms of commercially talking about it, but we did ask that question. So that one seems to be something that the community seems very comfortable with. I'd say the other stuff that we're working on, including thirty minute infusion, less likely that people will use a thirty minute infusion until there's proper instructions in the label. So that's something we'll be working on as well. And then in terms of the front end consolidating the two doses into one dose that we give on day one and we avoid having to come back, that's something I think we can get started on rather quickly.

Speaker 2

We hope to have a BLA potentially a PDUFA date for something like that by mid-twenty seven. So we'll keep you posted. But yes, I think that's probably the one that could happen the fastest, second would be the thirty minute. And we've stated previously that a full efficacy trial would be required to remove that switch dose. But for the moment, I think we feel comfortable we're providing safety information through medical, but I don't know that that's going to go into a pivotal trial at this time.

Speaker 8

Okay, great. Maybe one follow-up if I could. Just thinking about the myasthenia gravis expansion opportunity. I guess when you talk to neurologists,

Operator

how

Speaker 8

are they thinking about sort of how broadly an anti CD20 approach might be adopted, particularly in relation to the anti C5 and FcRn blockers?

Speaker 2

Yes. I mean, like I said previously, I mean, we are exploring MG. It was one that we've had on our list for a while. It's not as underserved as it used to be. But we do think there's room potentially for a highly active, convenient, safe treatment option that could be potentially provided in a cost effective way.

Speaker 2

I mean, right now, the treatments for MG are all on the highest scale of expenses. And we know Briohnvy is quite cost effective in how we've priced it. So I think there is room in MG. Again, we've said previously, we're not yet ready to plant the flag and say MG is our next development program. But we do think it's interesting and we're just we're doing a lot more work on it and we'll be doing so all across this year.

Speaker 2

As we look for other opportunities, we do think there's we do think the CD19CD20 opportunity across autoimmune diseases is large and whether it's with something like Briombee or there's some opportunity, of course, with CAR T across multiple different autoimmune diseases. So I think there's general enthusiasm. I think there's general belief that these work. I mean, they're all between won't speak much to the complement side of it, but certainly between the CD19, CD20 landscape and the FcRn, I mean, you are working along a certain part of the continuum of B cell to plasma to antibody to pursue some strategies. So they're all similarly aligned in ways and just where in that cascade you think you're going to have the best effect and the best long lasting effect.

Speaker 2

Great.

Speaker 8

Thanks for taking the questions.

Speaker 2

You got it.

Operator

Thank you. Next question is coming from Mayank Mamtami from B. Riley Securities. Your line is now live.

Speaker 9

Yes, good morning team. Thanks for taking our questions and congrats on a great start to 2025. Are you able to share the revenue split of new to Bionv versus maintenance patient segment? And just wondering, looking forward, has there been a change to an internal assumption when maintenance segment revenues exceed to that of new patients? And just a two part question here.

Speaker 9

On a dynamic market share basis, are you able to comment on what where you stand based on how you look at switch from another DMT or CD20 therapy?

Speaker 2

Adam, you want to go ahead and give a crack and if I can add on top if necessary?

Speaker 3

Yes, sure. Thanks for the question, Mike. As far as the revenue splits, I don't have that for you. I think what I've said in the past is that early in 2025, we will start to see repeat prescriptions be the majority of the prescriptions that is forecasted to happen in the early part of twenty twenty five. That's our expectation.

Speaker 3

I can provide more detail on that in the future. And then as far as the dynamic market share, I think we said this at JPMorgan, we're getting about one in four patients on IV CD20 today, which represents about sixty percent of the market. But that number is increasing and certainly we expect that to increase throughout the year.

Speaker 9

Great. And just on the pipeline front, if you're able to give us some color on the size of the allogeneic CD20 study that you're starting enrollment shortly here and kind of what should be the timelines and maybe study objectives. I understand this would be dose finding initially, but any pharmacodynamic data that we could expect would be helpful to get some color, Mike? Thanks for taking the question.

Speaker 2

Yes, sure. So that study is ready to launch. We're ready to receive patients. This study is not yet enrolled its first patient. So I'd like to say we're going to have lots and lots of patients, Mayank, but so far a bit of a slow start out of the gate here.

Speaker 2

The goal, as you mentioned, is dose finding. So first step is finding the right dose, finding the right conditioning regimen that makes the most sense in these patients and in this setting. So we've got a little bit of work to do there. And in terms of outcomes for patients with progressive forms of MS, I mean, the ultimate goal is you slower stop the progression. Unfortunately, that's not something that you will be able to see easily with a handful of patients.

Speaker 2

So I don't think we're in this for some sort of miracle data that we give it we give the CAR T to a person with aggressive forms of MS and all of a sudden you can see some dramatic effect. Hopefully, we will be able to slow or stop that progression, which would be fantastic. There are biomarkers that could be looked at. There's some CNS biomarkers, all the clonal bands would be interesting. Certainly, we'll look at B cell depletion and repletion.

Speaker 2

So it's some of these biomarkers are out there, we can look at those. But I think at some point, we'd have to just get enough conviction to move forward with a randomized, which is the only way for primary forms of progressive forms of MS. Having said that, we're also looking to expand into other disease states, which I'd call adjacent or ancillary to MS and things we think we could do well to get started. And then we can think about further expansion of that opportunity. But I'd prefer probably at this point to start slow and let's do some dose finding and let's make sure we can have a safe product that at least depletes B cells effectively in folks with autoimmune diseases.

Operator

We've reached the end of our question and answer session. I'd like to turn the floor back over to Mike for any further or closing comments.

Speaker 2

Great. Thank you. And thanks again everyone for joining today's call. We've been incredibly pleased with the progress made in 'twenty four and of course looking forward to an exciting 'twenty five. I think you heard some really exciting developments, both on the commercial front and the early enrollments that we're seeing have given us a really nice feel for the year.

Speaker 2

Just to restate some primary goals, for us commencing pivotal program for subcu BRYAN V, commencing one or more pivotal studies to enhance the overall patient experience with BRYAN V, enrolling participants into the ongoing trials for BRYAN V and myasthenia gravis, enrolling hopefully as we discussed in this last question our first patients into the Phase one ASR cell study and we'll continue to make presentations during the course of the year and as Adam described in great detail really continue to push hard to bring Breonvie as far and as wide as we can into the patient community in The U. S. And our partners ex U. S. So with that, again, I'll just thank everyone for joining us and have a great day.

Operator

Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.

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TG Therapeutics Q4 2024
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