Tg Therapeutics, Inc. Q1 FY2024 Earnings Call

Greetings, and welcome to the TG Therapeutics Conference Call and Webcast. As a reminder, this conference is being recorded.

Thank you. Welcome, everyone, and thanks for joining us this morning. I'm Jenna Bosco, and with me today to discuss the first quarter 2024 financial results are Michael Weiss, 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 recent corporate development, Adam will share an update on our commercialization efforts, and Sean will give an overview of our financial results before turning the call over to the operator to begin the Q&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. These forward-looking statements include statements about our anticipated future operating and financial performance, including sales performance, projected regulatory or clinical milestones, revenue guidance, development plans and expectations for our marketed products. 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. This conference call is being recorded for audio rebroadcast on TG's website, www.tgtherapeutics.com, where it will be available for the next 30 days. With that, I'd like to turn the call over to Mike Weiss, our CEO.

Great. Thanks, Jenna, and good morning, everyone, and thanks for joining us on today's call. 2024 is off to an exciting start, and I'm incredibly proud of the accomplishments already achieved this year. Company-wide, it feels like we are firing on all cylinders. A prime example was the recent announcement of the award of the VA contract for Briumvi as the preferred anti-CD20 for the VA system. We could not be more excited to support our veterans with multiple sclerosis by offering Briumvi at a deep discount. We see this as a great way to serve our veterans, introduce Briumvi to additional healthcare providers, many of whom split their time between the VA and their academic appointments and, of course, generate incremental revenue. As for the first quarter, the demand for Briumvi was extremely strong, and I'm pleased to report that the U.S. Briumvi revenue was in excess of $50 million, and total revenues for the quarter were over $63 million, which includes milestone payments received from our ex-U.S. partner. By any measure, it was a robust revenue quarter for TG. As mentioned previously, starting in late 2023 and continuing, we have significantly increased our investment in patient awareness activities and strategically increased the size of our commercial team. I believe these investments contributed to the strong first quarter results. More broadly, our team continues to be focused on our long-term goal of becoming the number one prescribed anti-CD20 from a dynamic market share perspective. The feedback from physicians, patients, nurses and infusion centers continues to drive our confidence that this is achievable. We believe that Briumvi has a best-in-class profile that should help us get there. Briumvi is the only anti-CD20 monoclonal antibody that can be given as a 1-hour infusion every 6 months following the starting dose and is the only anti-CD20 monoclonal antibody in Phase III trials to achieve an annualized relapse rate of less than 0.10. Also in Phase III trials, the Briumvi 1-hour infusion was generally well tolerated with 95% of the 1-hour infusions being delivered on time. Beyond the clinical data, Briumvi is also differentiated by design, having been glycoengineered for enhanced immune effector cell engagement and efficient B-cell depletion. As previously presented, preclinical data demonstrates that compared to other anti-CD20s approved or used to treat MS, Briumvi has the highest binding affinity to CD20, the target found on B cells and, through its glycoengineering, has the ability to induce the highest level of antibody-dependent cellular cytotoxicity. We look forward to evaluating these preclinical differences further to assess what, if any, contribution they have to Briumvi's differentiated clinical profile, and we will seek to show these data when available. We're also excited to share that during the quarter, three newly issued patents from the U.S. Patent and Trademark Office extended patent protection for Briumvi through 2042. With the extended runway, our development team is focused on potential expansion opportunities for Briumvi, both within MS as well as in other autoimmune diseases. We are focused on three Briumvi-related initiatives this year, which we believe could drive significant future value. The first is further improving the convenient dosing of IV Briumvi. In March, at the ACTRIMS conference, we presented updated data from the ENHANCE trial, evaluating the safety and efficacy of eliminating the 4-hour Briumvi 150 milligram starting dose for patients who switch from a prior anti-CD20. Data presented suggests that Briumvi was well tolerated for patients that skipped the starting dose and went straight to the first full 450-milligram dose given as a 1-hour infusion. These early results are encouraging, and we look forward to continuing to present additional efficacy, safety and tolerability data from this study throughout the year. The second is the development of subcutaneous Briumvi. We believe the subcutaneous CD20 market is distinct from the IV market and could represent a significant additional opportunity for Briumvi. We are preparing to enter human bioequivalence studies this year and look forward to providing additional updates as we have them throughout the year. The third is evaluating Briumvi in other autoimmune indications. The goal is to launch our first autoimmune trial evaluating Briumvi outside of multiple sclerosis later this year. We believe the expansion of Briumvi represents a significant opportunity and look forward to providing updates throughout the year. The future of TG also lies in the expansion of our portfolio. We recently entered into a partnership with Precision BioSciences to acquire a worldwide license to Precision's azer-cel, an allogeneic CD19 CAR T cell therapy for autoimmune diseases and all other non-oncology indications. We believe azer-cel has the potential to be a first-in-class, best-in-class treatment for certain autoimmune diseases, and we look forward to commencing a clinical trial this year. I also want to congratulate our partners at Neuraxpharm on their launch of Briumvi in Europe, which also occurred in the first quarter, with the first commercial sale in Germany. Transitioning the program to enable their timely launch took significant effort from our team, and I'm proud of how everyone worked closely together to make it happen. The Neuraxpharm team is experienced, motivated and focused, and we look forward to hearing more from them as the launch progresses to multiple countries across Europe and then around the globe. Finally, I want to thank and acknowledge the entire TG team. It's amazing to see the focused attention and care that TG-ers take to ensure the best possible experience for patients with MS. While we spent a lot of time on these calls talking about numbers, the most gratifying part of my day is hearing firsthand from patients taking Briumvi and the positive experiences as well as healthcare providers' anecdotes about their patients' treatment successes with Briumvi. With that, let me hand the call over to Adam Waldman, our Chief Commercialization Officer, to provide a detailed update on the Briumvi U.S. commercial launch. Adam, go ahead.

Thank you, Mike, and good morning, everybody. I'm excited to provide insights into our continued commercial progress in the first quarter. This was another very strong quarter of performance, exceeding our revenue guidance in all key performance metrics. Our focus on delivering Briumvi to patients remains unwavering, and I'm pleased to share our progress with you today. In the first quarter of 2024, we continue to see strong uptake of Briumvi in the market. As reported in our press release, first quarter net sales in the U.S. for Briumvi were $50.5 million, representing 25% growth quarter-over-quarter. The first-quarter number exceeded our original guidance of $41 million to $46 million provided in early January as well as our updated guidance in late February. The trends we saw early in the quarter continued throughout the quarter, reflecting strong and growing demand for Briumvi. This growth is particularly impressive given the challenges associated with beginning of the year payer dynamics. In fact, we were the only CD20 in MS to see revenue growth quarter-over-quarter in the U.S. market during this time frame. Equally impressive is that we also saw enrollments grow by approximately 25%, with over 1,250 new patient scripts received by the TG hub in the quarter. I want to congratulate our team on doing an exceptional job preparing for the inherent insurance-related challenges and mitigating the potential impact. Since launch, we've implemented a comprehensive commercial strategy that encompasses targeted educational initiatives; engaging healthcare providers, both virtually and in person; and leveraging digital marketing channels to reach a broader patient audience. Our efforts have resulted in increasing uptake of Briumvi, with healthcare providers recognizing the value that Briumvi brings to patients. Ensuring patient access to Briumvi remains a top priority for us. We continue to receive exceptional feedback on the comprehensive patient support programs we have introduced to assist patients in navigating reimbursement challenges and accessing the treatment they need. We also continue to make significant strides in expanding our market presence. Through targeted marketing initiatives and effective sales force deployment, we successfully penetrated new accounts and prescribers, driving sustained growth. We saw both an increasing number of repeat prescribers and impressive gains in new prescribers, with approximately 160 new prescribers in the first quarter, the majority of which were from academic centers. We also continued to convert new centers, adding 65 new accounts in the quarter. To date, we have seen broad adoption of Briumvi across the U.S. with new prescriptions coming from over 450 centers and over 800 unique prescribers. Encouragingly, we also continue to see a diverse mix of patient types, including those that are naive to all treatments and those that were previously treated and switched from both non-CD20 and CD20 agents. This mix of patient types continues to be fairly consistent quarter-to-quarter, with the largest group consisting of patients that were previously treated but naive to anti-CD20 therapy. 2024 is off to a really strong start. We achieved record Briumvi new patient enrollments into our hub in the first quarter and far exceeded our first-quarter revenue guidance while continuing to show strong quarter-to-quarter growth despite the first-quarter insurance headwinds. We continue to see momentum building into the second quarter, and based on the information we have available, we are targeting Briumvi net revenue of approximately $65 million for the second quarter. In terms of the full year, we continue to feel confident about the Briumvi trajectory. Based on current trends, we believe we are tracking above the top end of our original guidance of $220 million to $260 million and are therefore raising our full-year guidance to $270 million to $290 million. Looking ahead, we see promising opportunities for further growth and expansion. We believe we are poised to broaden our reach and make an even greater impact on the MS patient community. We continue to believe Briumvi's profile remains very compelling and will eventually be the IV therapy of choice in the relapsing MS market. In conclusion, I want to thank our team for their dedication and hard work. They have executed the launch plan with precision, driving awareness and adoption among our targeted healthcare providers, and we believe their outstanding efforts are contributing to the positive experience with Briumvi and confidence in our organization. I also want to thank the healthcare providers and their patients for their trust in TG Therapeutics. Together, we will continue to improve outcomes for those in need, and we certainly have more work to do, but we are focused and extremely motivated to continue to work every day to bring Briumvi to those living with MS and their families. With that, I'll turn the call over to Sean Power, our CFO. Sean?

Thank you, Adam, and thanks, everyone, for joining us. Earlier this morning, we reported our detailed first quarter 2024 financial results, which can be viewed on the Investors & Media section of our website. This morning, I'll start with a discussion of our revenue. We are pleased to report total revenue of approximately $63.5 million during the first quarter of 2024, which, as previously mentioned, includes $50.5 million of U.S. Briumvi net product revenue. Also included in our Q1 '24 revenue total is approximately $13 million of license milestones, royalty and other revenue, which consists primarily of the $12.5 million milestone we received from our ex-U.S. partner for the first commercial launch of Briumvi in the EU. Our OpEx during the first quarter of '24, despite some one-time charges, has remained well controlled and in line with previously discussed ranges. For the first quarter of '24, our operating expenses were approximately $58 million, which includes one-time charges to research and development expenses of approximately $8.8 million related to our agreement with Precision BioSciences for the in-licensed azer-cel program. During the first quarter of '24, we also saw a modest increase in R&D expenses, driven by manufacturing and development costs associated with our ublituximab subcutaneous development work. On the back of the reported revenues and well-controlled OpEx, during the first quarter of '24, we reported a modest net loss of approximately $10.7 million or $0.07 per share compared to a net loss of approximately $39.2 million or $0.28 per share during the comparable quarter in 2023. From a cash standpoint, we ended the first quarter with $209.8 million in cash, cash equivalents, and investment securities, down less than $10 million from Q4 of '23. We believe our current cash position, coupled with our previously guided revenue and expense guidance, provides us with sufficient capital to fund our operations to cash flow positivity.

Our first question comes from Michael DiFiore with Evercore.

And congrats on all the great projects this quarter. A couple for me. Regarding sales in EU, I know it's very early, but when could we expect Neuraxpharm to begin offering details? And I have two follow-ups.

Yes. So in terms of Neuraxpharm providing public details, I think we're a long way off. They are a private company, private equity backed, so I don't anticipate they'll be providing any public guidance or information to my knowledge. Adam, anything different from your side?

No, nothing to add there.

Okay, fair enough. And my other two questions are, how much of Briumvi's fiscal year '24 guidance raise was due to the recently announced VA contract? And any color that you could provide on pricing or increased rebating in this segment? I know you said it's heavily discounted.

Yes. Adam, go ahead.

The revenue increase was not significantly influenced by the VA contract for a couple of reasons. Firstly, it won't take effect until June. Secondly, the rise will be gradual as new patients begin treatment. This year, patients will only really have the chance to receive two infusions at most. Therefore, it was not a major consideration in how we adjusted our guidance, which was primarily based on the demand trends we're observing. Regarding pricing, we have publicly stated that we are offering approximately a 72% discount, which is around $2,900 per vial.

Okay, great. And my last question is this. In the most recent cut of the enhanced data presented at ACTRIMS, three patients in Cohort 2 had to have their infusion slowed down or interrupted. Any color on these patients? How long would these infusions slowed down to or interrupted for? And were there any unique clinical features of these patients that could explain this?

So no, I don't think there was anything particular about the patients, but the infusions were pretty modest. And I think all we've done remotely close to the 1-hour anyway. So no, I think it was just basic stuff that is typical of infusions. But I don't think there's anything to be worried about there. It was well tolerated overall, and those patients did well.

Our next question comes from the line of Ed White with H.C. Wainwright.

Congratulations on the results. So just to clarify what you just said on the VA contract, Adam. Was it a 72% discount?

Yes.

Okay. This has been mentioned before, but I wanted to bring it up again. Considering the potential opportunity in the so-called 'crap-gap' with OCREVUS, is this something you think you'll be able to gather data on or address with your sales team?

Yes, we are working to collect as much data as possible through the ENHANCE study regarding the crap gap. Approximately 50 to 60 percent, or maybe about two-thirds, report experiencing the crap gap when they enter the ENHANCE trial. We aim to gather some information on this in the future, and we hope to have at least some anecdotal evidence from patients about their experiences with the crap gap. Measuring the crap gap objectively is challenging, but we will do our best within the ENHANCE study. In any studies we conduct, we will certainly try to analyze the impact and whether we have affected patients in this regard.

Okay. When considering other potential indications, how do you prioritize them outside of multiple sclerosis? I know there are various factors involved, but how does time to potential approval or the size of the potential market factor into your ranking?

Yes. I mean, I think, look, we are probably focused on things like RA and lupus for Briumvi outside of MS, sort of larger indications. And as we've said previously, in some more niche indications, we would be looking at azer-cel.

Our next question comes from the line of Roger Song with Jefferies.

Congrats to the 1Q results. And then a couple of questions from us. One is understanding your hub is capturing most of the new patients and, given you have quite a few quarters since launch, how would you characterize the repeat infusion rate you have been seeing?

Yes. Adam, do you want to go ahead on that one?

Yes, just to reconfirm, the patient hub numbers we are providing are for new patients only. Regarding persistence, we believe we are still early in analyzing our data, but we continue to see that the 24-week persistence is in line with or slightly better than our expectation of approximately 85% at week 24. We feel optimistic about this, and while the data is still early, we will keep monitoring it. Currently, it is meeting or possibly exceeding our expectations.

Excellent. 85% is good. And then you have now 800 healthcare providers and around 450 centers. When you planned to launch, you were targeting top 50 accounts covering 70% to 80% of MS patients. Just curious, is that still the goal for the provider or the center outreach? And if that is still the case, then when do you expect you will achieve that $550 million from $450 million?

Yes, yes. So I think if I understand the question, it's what's our goal in terms of new accounts and new prescribers? I’ll just say that I think we've done really good. We've got broad adoption right now, but we certainly see opportunity for more adoption with even more prescribers and deepening the use with our current prescribers. The good news in the quarter is we saw increases in both repeat prescribers and adding new prescribers at a pretty good clip and new accounts at a pretty good clip. So we feel good about it. We're continuing to make progress every day and certainly have opportunity, but feel good about where we're at right now.

Okay. One last question related to the financials. Earlier this year, you guided the OpEx as $250 million for the year. Just want to confirm, is that still the guidance for now? And then also curious about the expenses for the coming years given you continue to launch and expand your pipeline.

Yes, I'll start and Sean can add in. We are on track with our guidance of approximately $250 million in operating expenses, which provides some flexibility. In the first quarter, we reported around $58 million, but with an $8 million one-time expense related to Precision, our base operating expenses were about $50 million for the quarter. If you project that over the year, we remain well below the $250 million target. This allows us room for growth, and we are experiencing growth. As I mentioned earlier, we are strategically expanding our team and investing in patient awareness programs. Overall, I believe we are in a strong position. Sean, do you have any additional details?

No. I think you've covered it pretty well, Mike.

Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann.

Congrats on the quarter. So maybe for Adam. In terms of new patient starts, can you give us a little bit more detail in terms of where they're coming from in terms of naive, switch and the background that you're getting these new patients from?

Thank you, Matt. We haven't provided specific percentages regarding the patient demographics or their breakdown. What we can share is that the largest group consists of patients transitioning from non-CD20 treatments. Additionally, we have a solid representation from treatment-naive patients and those switching from CD20 therapies such as OCREVUS or KESIMPTA. Encouragingly, we believe we are attracting a diverse group of patients while maintaining consistency from quarter to quarter. We haven't observed any significant spikes from a particular patient group that diluted over time, and we are seeing stable representation across all three groups.

Okay. That's helpful. And then, I guess, in terms of the subcutaneous opportunity for the Briumvi formulation. I guess, in a recent call, a competitor said they see the subcutaneous opportunity as more than $2 billion. I guess, the question is with your potential differentiated profile, what's your assessment of the subcutaneous opportunity?

Yes. I'll speak broadly, and I'll let Adam chime in. I mean, look, the folks at Novartis have done a really nice job of carving out a subcut market. They've created it. And I think, as Roche probably mentioned, Novartis is probably over $2 billion and growing today. So there's a nice market there. And yes, I mean, our goal is to come into that market with a very competitive profile product. As we've said previously, we understand the parameters. We've got, on the one hand, a relatively elegant auto-injector once a month, and we've got a relatively bulky product every 6 months. Somewhere in the middle, we think it'll be an optimal product design, and we're going to try to get there. So from just where we sit today, we're seeing opportunity, and we're going to take our best crack at it.

Nothing else to really add there, Mike.

Our next question comes from the line of Mayank Mamtani with B. Riley Securities.

Congrats on a strong quarter. Sorry, Adam, if I missed this. Did you say the revenue split up between new patient starts and maintenance patients? And I was also curious to hear from you how you think that stacking up effect in second half, how we should expect that revenue split to be. And if you can comment on some other metrics you've provided before, free drug percentage, gross to net. Anything on that would be helpful as we think about the full year modeling. And then I have a couple of follow-ups.

We did not provide details on the revenue split between new and ongoing patients. However, we believe that the duration of treatment significantly impacts revenue, and we expect a stacking effect over time as patients typically stay on the drug for around five years. Regarding free drug rates, we anticipated they would decrease, and we are observing that trend. Currently, in the first quarter, our rate is about 12%, down from approximately 20% earlier in 2023. Additionally, our gross to net ratio is around 75%, which may fluctuate quarterly, but using 75% is advisable for the remainder of 2024.

That's helpful. And then in your updated guidance for the full year, I was just curious to learn how you are thinking about that year-end exit market share. Again, I don't know if you think of the market as total NRx percentage, which, Mike, I think you provided. You're tracking at that 10%. But obviously curious to hear how you think about that market share in terms of either total RMS patients or within the anti-CD20 drug class patient. Could you just give us some color on how what that $280 million midpoint assumes in terms of market share?

Yes. Mayank, I'm not going to provide specific details. Our goal is to enhance both the depth and breadth of usage and to attract more prescribers. We see significant growth opportunities and are confident in our progress. We recognize strong demand trends and will continue to focus on increasing the use of Briumvi in the market, and we're performing well. Based on our guidance, we are very confident in our continued growth moving forward.

Yes. I'm just going to chime in on the first question you asked about the revenue split, new versus old. I know we're not providing actual numbers, but I think it's worth mentioning that in the early years, we're going to be driven by new starts. In the later years, we will be driven by the ongoing or stacking patients. So if you look at probably our competitive IV CD20s that have been on the market for a long time, the vast majority of their sales are going to be based on continuing patients, not on new patients in any particular quarter, whereas I'd say, we're probably the opposite still, right? We're still reliant on our new starts. But over time, the continuing patients sort of take the commanding role in how the revenue stacks up.

Yes. And that bodes well for that size of that pancake downstream. Yes. I guess, last question on the subcu target product profile, Mike. Just would be helpful to understand how you and even some of the KOL feedback, now that we know what the subcu profile for OCREVUS would look like at launch. Now that all the data is out there, was just curious, Mike, as you design the human bioequivalent study, what differentiating attributes are in mind as we think about that product profile?

Yes. Look, the OCREVUS subcu is not a true patient-administered at home product today. That is yet to be created or not created, but to be available or even studied as far as my knowledge. Our goal is to have something that is patient-administered, patient-friendly, again, more along the lines of what was done with ofatumumab. So I don't know how much market they are in. We think there's a lot of room to thread the needle here and come up with a product profile that accomplishes the goals of being both convenient and easy to use.

Our next question comes from the line of Prakhar Agrawal with Cantor Fitzgerald.

And congrats on the quarter. So just following up on the subcu Briumvi question. I'm trying to understand, what's your base case assumption on where the dosing frequency could land for subcu Briumvi? I guess, the reason I'm asking is if it ends up being once a month, would you still go ahead with the subcu development? And I have one more.

Yes. I mean, I think the bottom line is we probably would, but I don't think that's going to be necessary. So I don't know that, that's a scenario that is likely. But yes, I mean, it's early to tell. And again, I think if we feel like we've got something that has a good opportunity to make a dent in the market, we'll go forward. And certainly, once a month could be an important impact in the market. Obviously, it probably has less impact than something that has a less frequency, and we'll do the math on that in that concentration and less frequency. But I'm not so concerned that that's an issue here.

And when do you expect patients to be dosed for subcu Briumvi?

We would hope to have the first patients dosed within the first half of this year. So hopefully, in the next few months here.

Got it. And lastly from my side, we're seeing a lot of data on CD19 antibodies and other autoimmune indications. What's your view on CD19 versus CD20? And obviously, there is a theory that targeting CD19 could achieve broader coverage of the B-cell compartment compared to, let's say, a CD20. So just wanted to get your perspective there. And do you have a CD19 in your early-stage pipeline?

Yes. I mean, we do have a CD19. It's our azer-cel CAR T therapy. It is a CD19. So we think CD19 is a great target. We think it's hard to know if the broader coverage is a positive in all settings. There are some diseases characterized by plasma cells that may be impacted by CD19 or may be expressed in CD19 or that may be helpful. NMO is one that folks talk about quite frequently as more potentially CD19 driven. So we think there are areas where CD19 may be helpful. But overall, we think the overall opportunity in CD20 and CD19 is going to be hard to distinguish in most diseases. And the CD19, when they hit pre-B-cell in addition to B cells, CD21 hits matured B cells. So in terms of recovery, you may see a difference there. There are a lot of things to balance when you think about CD19 versus CD20. But from an activity standpoint, in most diseases, I don't know if you're going to see a material difference.

Yes. I guess, my one clarification. I was asking about the CD19 antibody, not the CAR T. Do you have a CD19 antibody in early stage, even preclinical?

We don't. I don't find that to be a product of interest to us at this time.

Our next question comes from the line of Eric Joseph with JPMorgan.

This is Noah on for Eric. We were just wondering if there were other exclusive procurement opportunities similar to the contract that you just secured with the VA?

Adam?

Not sure I understand the question. Could you clarify?

Yes. We're just wondering if there are other opportunities for exclusive access contracts with other providers going forward?

Okay, I understand. I don't have any updates at this time on that question.

And our next question comes from the line of Corinne Jenkins with Goldman Sachs.

So maybe a couple of questions from us. One, you've stated that you guys are probably close to reaching profitability in the next quarter or two given the revenue guidance versus the OpEx guidance. How are you thinking through profitability versus ramping or extending your R&D or SG&A spend to support future development? And then from a technical perspective on the subcutaneous formulation areas, what else is left to do before you're able to enter the clinic?

Sure. Regarding profitability, I believe the points you've raised are not mutually exclusive. We will keep investing in the Briumvi launch and have adjusted our operational budget to around $250 million for the year, allowing for potential growth. We are also focused on expanding the Briumvi and azer-cel opportunities and are open to seeking additional external opportunities. While we are aware of the interest in earnings per share, we are not solely focused on specific profitability figures. We intend to enhance our Briumvi initiatives and our team, along with our research and development platform. Overall, our cost structure is relatively modest compared to many other companies, and we maintain a lean operation, which suggests we might achieve profitability sooner than most others under similar circumstances. On the technical side, we have overcome most of the hurdles before entering the clinic and expect to start clinical trials within the next couple of months. We continue to work on improvements that will contribute to the clinical program, and currently, we do not foresee any technical obstacles.

We have reached the end of our question-and-answer session. And with that, I would like to turn the floor back over to Mike Weiss for any closing comments.

Great. Thank you, everybody. Well, okay, so I just want to thank everyone for joining us today. Hopefully, everyone has been able to see the excitement and enthusiasm that we have here at TG and what's going on with the company. The first quarter was quite good, in our opinion. We think everything went extremely well. We look forward to continuing to push forward and achieve even more as we move forward into the remainder of the year. Again, we thank everyone for their support. Most importantly, we want to thank the clinicians and patients who definitely put their trust into TG. The whole team does appreciate it. With that, I'd like to thank everyone for joining us, and have a great day.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.