Q3 2025 Iovance Biotherapeutics Inc Earnings Call
Welcome to the iovance Biotherapeutics, third quarter, and year to date 2025 conference call.
My name is Daniel and I will be your operator for today's call.
At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session.
Please note that this conference call is being recorded. I will now turn the call over to Sarah Pellegrino.
Senior vice president and best relations and corporate Communications at iovance. Sarah, you may begin.
Thank you, operator. Good morning and welcome to the iovance webcast discuss our business pipeline milestones and third quarter 2025 results.
Members of our executive leadership team. Speaking on today's call includes Dr. Fred vote interim, CEO and president.
Corlen row Chief Financial Officer Dan Kirby Chief commercial officer, Dr. Igor bilinsky. Chief Operating Officer and Dr. Frederick sin, chief medical officer during the question and answer.
Session, we will also, welcome Dr. Raj puree. And Mark Surrey from our Regulatory Affairs, executive leadership, team and Dr. Brian gathmann. Executive Vice President of translational medicine and research.
This morning, we issued a press release that is available on our corporate website at iovance.
I would like to remind everyone that this conference call will include forward-looking statements regarding iio Vance's. Goals business, focus, business plans and transactions, revenue, and revenue, guidance commercial activity, clinical trials, and results.
Regulatory approvals and interactions plans and strategies research and preclinical activities potential future applications of our Technologies. Manufacturing capabilities, regulatory feedback, and guidance, pay your interactions, restructuring licenses and collaborations cash position and expense guidance, and future updates.
Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filing.
Our results May differ materially from those projected during today's call.
we undertake no obligation to publicly update, any forward-looking statements,
I will now like to turn the call over to Fred.
Thank you, sir.
I will start by sharing our continued progress to increase revenue and margins Advance our pipeline.
Reduce expenses and improve operational execution.
Third quarter Revenue, grew 13% over the prior quarter and notably gross margin. Improved and was 43% following the initial results of our strategic restructuring and cost optimization.
Ility.
Our highest priority is to accelerate Revenue growth to increase and tag the adoption.
Across our network of academic and Community, authorized treatment centers for atc's.
We've expanded to include new academic atc's and multiple community atc's.
Initial patients are being treated in the community and are generally earlier in their melanoma treatment Journey.
As we educate Community oncologists across our atc's.
Including the major academic centers.
We are seeing earlier more frequent patient, referrals, that drive growth.
Real world data showed response rates of 60% in the second line treatment setting.
Which is provided a strong Foundation to amplify our compelling story to the melanoma Community, for the power of Phil therapy in melanoma.
We are on track to achieve our Revenue, guidance range of 250 to 300 million dollars for the full year of 2025.
With robust current demand. We expect a strong fourth quarter of ram tag be
alongside increasing Pro Lucan sales.
as we saw in late 2024,
we contain a project and tagging Peak sales of more than 1 billion dollars in the US and melanoma.
With larger additional opportunities in international markets.
And in future indications.
for example, our interim, clinical data and previously treated non-squamous non small cell, lung cancer,
Showed a best-in-class.
Excuse me.
for a technical difficulty here, 1 second
To the best. For example, our intra clinical data and previously treated non-slave is naanalle, lung cancer, should a best-in-class profile and unprecedented durability compared to the standard of care in this population.
Including an objective response rate of 26% and a median duration of response, not reached at more than 25 months of follow-up.
There is a significant Market opportunity in this 1, cancer indication.
which is about 7 times greater than our current Advanced melanoma indication
We expect to quickly complete enrollment in our lung 202, registrational trial in 2026 with approximately 80 patients.
the sample size will support an accelerated approval, given, the unmet need in non small cell lung cancer,
Precedent of the antag the approval and 73 million patients.
And recent accelerated approvals based on 70 to 80 patients.
Were defined non small cell lung cancer population.
The US FDA previously provided positive feedback on our trial design.
Which aligns with FDA guidance for single arm trials, the support accelerated approvals for single agents and conditions with unmet medical needs.
We look forward to advancing toward a supplemental biologics, license application and non-squamous non small cell, lung cancer and a potential launch in the second half of 2027.
As we increase revenue and Advance our pipeline, we are laser focused on expense management and profitability.
Following our third quarter rear organization, we are finding our operating plan to ensure we are appropriately investing.
And our commercial launch and high-value programs.
Again, cost of sales and gross margin will improve significantly.
as we transition manufacturing to our internal facility in early 2026,
During this call and our future quarterly updates. We will highlight our ongoing efforts toward further, expense reductions and resource allocation.
Corlene will now highlight our third quarter. Financials in further detail.
Thanks Craig. Good morning everyone. During my first quarter, as Chief Financial Officer. I want to emphasize our focus on driving the company towards sustained profitability. Our strategy includes prioritizing Topline growth.
Significantly improving margin and controlling costs with the disciplined approach.
In the third quarter, our Topline Revenue remains strong total product Revenue increase. Approximately 13% over the prior quarter to about 68 million
This included antibi sales of approximately 58 million dollars and Global Pro Loop and revenue of nearly 10 million dollars.
As expected and consistent with prior quarters overall, gross connect was less than 2% and is expected to remain minimal.
As Fred mentioned, we are on track to achieve our Revenue guidance in the First full calendar year of Integrity sales.
The corporate restructuring and continued cost optimization initiative.
Implemented in the third quarter.
We reduced total costs and expenses by approximately 10% over the prior quarter excluding restructuring charges of approximately 5 million.
We lowered cost of sales by approximately 21% over the prior quarter, resulting in improved gross margin of approximately 43%.
Importantly, costs, associated with patient, drop off in manufacturing results, that continue to decline as our Revenue continues to grow.
Gross margin will improve over time as we acrew benefits from our recent restructuring Implement additional cost savings.
Initiatives and centralized manufacturing at our internal facility.
Our cash position of approximately 307 million.
As of September 30th was bolstered by expense reductions and is expected to fund operations into the second quarter of 2027.
I will now turn the call to Dan Kirby. Our chief commercial officer.
Thanks Caroline.
Our ultimate goal is to establish and tag me as the preferred option for all eligible patients.
Patients deserve a 1-time, cell therapy with Curative intent. And we are steadfast in delivering on that promise.
My conversations with patients and caregivers. Remind us of the commitment to the ivens. Mission pioneering a new treatment Paradigm for patients with solid tumor.
At the recent melanoma Research Foundation gala in Denver Ivan's, received the corporate leadership award in recognition of our efforts to advance care for melanoma patients.
In my first 8 months at IMs, we have made notable progress to lay the foundation for Revenue growth by driving adoption across our atc's.
I'll highlight 3. Key areas of focus.
First.
New atc's are driving growth. In the third quarter, we added Community atc's, alongside new High, Vol academic atc's.
These new atc's contributed to the highest number of patient starts with better capture in the third quarter.
Our first Community, atc's are beginning to treat patients with anti in this setting.
New atc's continue to come online and will drive further growth in the fourth quarter and Beyond.
Second penetrating, the community market is key to unlocking and tag these tremendous potential. As we increase the frequency speed and efficiency of community referrals to atc's.
Healthcare professional and patient focused campaigns are having a positive impact.
Under our Specialty, Pharmacy agreement with biologics by McKesson patients, have broader access to intact.
Hospitals. Now have flexibility to obtain a tagging directly or through a specialty pharmacy, giving their Finance teams confidence to place more orders.
Our third Focus area is to drive earlier treatment within tagging.
This will increase penetration in our academic centers.
We are educating medical oncologists on the advantages of cell treatment.
Within tag me when it has the greatest benefit.
Earlier shifts and referral patterns are supported by our first real world data that shows 60% of patients respond in the second line setting.
In addition, new initiatives in academic atc's will address earlier tissue procurement for patient types, such as braf, mutations, so they can be treated before their health status declines.
Prolook and revenue, also grew in the third quarter.
Our main Revenue channel for proloan is used within tagging.
2 Us wholesalers ordered in the third quarter and all 3 wholesalers are expected to order significant volume in the fourth quarter.
For looking will continue to grow through this main Revenue channel, in addition, to the 2, other Revenue channels for clinical and Manufacturing use.
like other companies we are evaluating our prolook and pricing strategy, out of the United States, based on the current environment, which may help Drive future Revenue growth,
And tag me has the potential to reach more than 30,000 patients with Advanced melanoma and globally.
Canada, became the first New Market to approve it and tag me and approvals are pending in 3 additional markets.
The United Kingdom and Australia in the first half of 2026 and Switzerland in early 2027.
In the European Union, we are confident in our plan strategy. We are seeking scientific advice from the European medicine agency.
And intend to resubmit for regulatory approval shortly thereafter.
our interim data demonstrates that 1-time treatment with Lial represents a true game-changer and potential cure for patients with non-squamous Advanced non small cell lung cancer
With approximately 50,000, addressable patients in the us alone. The market opportunity is about 7 times larger than our current melanoma opportunity.
And represents potential us peek sales of 10 billion dollars.
Us academic and Community practices are enthusiastic about our loan cancer program.
All of our current and future atc's are expected to launch in non small cell. Lung cancer.
A significant portion of them. Already treat patients and are Lund 2022 trial.
The ATC footprint, for lung cancer is essentially the same as our melanoma treatment Network.
Atc's are eager to leverage their current till infrastructure to quickly adopt like lucil in lung cancer, upon approval.
I will now pass the call to Eagle.
Thank you, Jen.
I will provide a brief manufacturing update.
we have streamlined all manufacturing organizations while reducing costs and improving our manufacturing success rate as reflected in our third quarter, growth margin
Importantly, we're finalizing an extension at our internal facility. The higher end, Cell Therapy Center for ICDC, that will enable us to support anticipated demand without the need for a contract manufacturer.
All I'm tagged in clinical. Manufacturing will transition to ICDC in early 2026 to maximize capacity, utilization lower cost of sales and drive, future cross margin growth.
We will complete a key step in this facility extension. During routine, annual maintenance around the end of this year.
During this time, our contract manufacturer will provide continued access for patients to meet demand before we transition for manufacturing to ictc.
We will also boost capacity immediately prior and following the maintenance period to provide additional manufacturing slots for patients allowing smooth Supply. Through the next 2 quarters.
Bringing all manufacturing. Internally will be an important milestone for us as a company.
In addition to the cost benefits, we will maintain uninterrupted Supply during routine maintenance in the future.
Using internal capabilities.
We can also scale up within the existing facility to support future markets globally and indications including banking.
I will now pass the call to British.
Earlier this week, we reported interim data, from our registrational, iov Lund 202, clinical trial of Life, in lusso.
The data demonstrated, a potentially best-in-class clinical profile.
And meaningful improvement over current standard of care in previously. Treated patients with non-claims non small cell lung cancer.
Following 1 time treatment, but life a little monotherapy, the objective response rate was an impressive. 26%.
An objective response was observed in 10 out of 39 patients which included 2 complete responses. The Disease Control rate was 72% showing a meaningful benefit for many patients with stable disease.
Importantly, median. Duration of response was not reached at more than 25 months of follow-up, which is unprecedented durability for a non small cell lung cancer therapy in the post chemo and immune checkpoint inhibitor setting.
Standard of care to the tactile monotherapy. Recently showed an objective response rate of only 13% and a median duration of response of only 5.6 months without any complete responses in the same patient population.
We are on track to quickly. Complete enrollment of approximately 80 patients in 2026.
We have seen a strong increase in enrollment this year, driven by the positive reception of the efficacy data among trial investigators.
In addition to the 39 patients in the data set, a double-edged number of patients are awaiting or have recently received till infusions and more patients have entered the trial as of today.
Of additional patients and longer follow-up.
We also look forward to advancing towards uh supplemental biological license application for like a little in non-. Famous non smaller, lung cancer, and a potential launch in the second half of 2027.
We also continue to make progress across the rest of our pipeline, which I am happy to discuss during the Q&A session.
Thank you.
Thank you.
To ask a question. Please press star 1, 1 on your telephone and wait for your name to be announced to withdraw your question. Please press star 1 1 again.
In the interest of time, we ask that you please limit yourself to one question.
Please stand by while we compile the Q&A roster.
Our first question comes from Andrew Tsai, with Jeffrey's, your line is open.
Hey, uh, good morning. Nice execution. This quarter a great to see various Dynamics improving, uh, good job. So, uh, my question, this quarter is on the lung cancer data update that you had. It's interesting that the signal did not uh necessarily degrade compared to the prior data cut. In fact, maybe the efficacy on Dr. Seem to get better. Um, so for the remaining batch of patients, would you expect the third data cut to be also similar or even better than what we're seeing in this interim that you just had.
Um or would you expect some kind of Ethics efficacy degradation on a larger sample size. Thank you.
Thanks Andrew. I can start now, maybe Frederick can chime in here.
Uh I don't we don't expect any degradation in the Esky signal, we're getting very good within the lung 202 trial at making sure our investigators identify the right patients for the trial.
Uh and we are obviously going to be cutting the data with longer and longer follow-ups and with ongoing responders that you can see in the swimmer's, plot from that data cut, we would expect to see that durability uh, improve even beyond what we have today. Uh, I'll let Frederick comment a little bit on the details of of how we think that study is going to play out. But that's the big picture view.
Yeah, I agree with Fred not much to add there. Um, I think the study now has reached the uh, the that phase where where folks know what they're doing. They are familiar with the therapy, they know how to identify patients. Um we we are able to to communicate best practices. So um I think this is all in a very stable place. What what is noticeable is that we saw a a true uptick in enrollment which is really driven by the positive by the positive data that we were able to share with the investigators lately that's also fairly typical. It's kind of an injection point where then things just take off because folks see and and and and believe in in the therapy and and things are working really well.
Thank you.
Thank you. Our next question comes from Yan Zhu with Wells. Fargo, your line is open.
Great. Uh, thanks for taking our questions and congrats on on the quarter. Um, just, uh, a quick 1 on the lung cancer. Can you talk about the wind? Uh, did you touch base with FDA, uh, regarding the, the path and, uh, pass? Uh, the regular pass and you did mention 80 patients. Uh, I wanted to see, uh, here your confidence that, uh, uh, 80 patient. Patience is enough, uh, for the lung cancer, uh, filing. Um, then I am happy to be in melanoma. Um, can you uh, you know, talk about infusion uh, growth uh, into fourth quarter?
And uh, into 2026.
Um you know your your your your confidence, uh for um inflection points um in the uh patient infused. Um and lastly, sorry if I may uh on the uh improved uh world's margin uh great to see that result, can you comment on how much of it is coming from? Uh uh patient Dropout and Manufacturing success rate improvements uh versus uh how much is coming from uh cost reduction?
Thank you.
Viously engagement with FDA as a continuous process during a trial. As I'm sure investors know, we have to engage frequently and we do engage frequently. A lot of it doesn't get talked about.
So, we'll continue to do that on this trial, but we're very comfortable where we stand right now on the trial design. And on what we need to do, to get us up on the supplemental, bla submitted on time, uh, on the on the sample size for the patient, you know, for the the 80 patients
Uh, we pointed out.
During a lot of our calls earlier this week as well as during our prepared remarks here that we think 80 patients will be sufficient based on the precedent of and tag me with 73 patients.
Uh, which was the approval. It's on label on melanoma, as well. As a lot of recent FDA, meaning the last couple of months, FDA approvals and non small cell lungs, so I'll let Raj and maybe more comment on that.
Uh, on on what they've seen at the FDA and why they think that's reasonable.
And that they sent to us. I said that we can continue as interaction but the FDA the design to apply for many different priorities. Designations such as fast track, the ignition and automatic designation um Etc. Um and I mentioned that uh that 80 basis uh is also based on the 73 mil and all bases, as we got them tagged via approval on and they sent me remarkable. Elaborate further that uh
The FDA has approved about 4 on, on a small cell, lung, cancer files, and based on accelerated approval of patient business. 7280, uh, 88
um, agree with what you had said, Raj, I think, um, the recent president for this number of patients in patients uh with non small cell, lung cancer, and very high unmet medical needs uh, with the response rate and particularly this unprecedented duration of response, you know, we feel uh, based on the Precedence and
Are.
A patient.
And compelling.
All right. So on the uh, inflection question and fourth quarter growth, obviously we feel very confident in having a strong fourth quarter, but I'll let Dan talked about short on the details there. Thank you. And thanks, Fred. Thanks, Hannah for the question first. The answer is yes. We expect continued growth in the fourth quarter and Beyond in the 2026, the reasons behind that are I'm going to separate this from academic and community and the academic setting. We've launched field efforts including a disease awareness campaign in Q3 to educate medical oncologists for earlier referral into those centers. We're seeing some results from that right now that will continue moving forward. We also are launching in the academic, setting initiatives to increase penetration, um, which would have to do with addressing certain patient types, that we haven't been able to capture such as breathe mutations,
Where we have opportunities to get tissue earlier. So we do see growth in the academic setting, moving to community, I mentioned that we're
On boarding now. And we've started to treat at the first community site. We have several large ones that are coming on. In this quarter, that will drive significant growth, um, in Q4 and Beyond at the 2026 and then also set the table for
Months more than let me just focus on on on 2 are I think you mentioned them 1 which is patient drop off and Manufacturing results. So if you think about the dollars that are uh written off from out of spec, since beginning of the year, they have decreased by 40%
They're about 9 million this quarter. Uh and we are now seeing the initial benefit of their structuring that we announced in Q3. So those are 2 key areas that are driving Revenue improvements for margin improvements.
Great, thanks. Thanks for the update and congrats on the all the progress.
Thank you, John.
Thank you. Our next question comes from Saleem saiyad with mizuha, your line is open.
Uh, great thanks so much guys. Uh, congrats on the progress, I guess. 1 for me and the the guidance here, I know you're reiterating the guidance uh, Coraline. I guess is there, is there any scenario here in your mind where you're going to actually hit the closer to the top in here? I'm just curious. Why? Why at this point uh, 2 months left in the year? Why why we haven't narrowed it down the top end of the range to a lower number that seems more reasonable. Thank you.
Yes. So we we reiterated our guidance range of 250 to 300, which is a pretty narrow range to begin with. It's our first full calendar year on the market. As, you know, and we're on track right now towards that guidance.
uh fourth quarter as damage just mentioning a minute ago when we have a large influx of new agents,
Especially based on what quarter last year. You can go back and look at those numbers.
Uh and you know, we have gotten to CTC growth both in the community and in the academic setting. So I think at this point we we're just comfortable with the guy that we put out 250 to 300 and we'll be in that range. And that's that's what we're comfortable saying it right now.
Okay, thank you very much.
Thank you. Our next question comes from Tyler van Burren with TD Cowen. Your line is open.
Great, thanks very much. This is Nick on for Tyler. Um,
Just 1 for me. Can you let us know how many, and type the patients were treated this quarter? And then also, how will the CTC maintenance. Um, this quarter impact, em tag, be infusions and sales. Thanks very much.
Yeah, Nick we're not going to we're not talking about infusions anymore, we're just going to use Revenue going forwards. As you can see, from our press release. We think that's the the ultimate story here and uh, we hope investors appreciate that. We're focusing on the dollars and that's what matters at the end of the day on the ictc maintenance. I'll pay us the eagle or uh, for that question. I think you have covered it as prepared remarks and maybe you can highlight it. You know, have to highlight that again, you are, you know, of course, thanks for the question. So, as I mentioned as part of the routine maintenance this year, we'll complete the extension part of the facility. That's important with centralizing manufacturing at ICDC and also,
Gonna continue providing interrupted capacity from ICDC during future maintenance periods.
And this year we've learned from our experience in q1 2025. So it made several improvements.
Um we will boost manufacturing capacity immediately and prior to the ICDC maintenance that will provide additional manufacturing slots for patients and that will allow essentially smooth Supply through the next 2 quarters.
Thank you very much.
Thank you. Our next question comes from David die. With the UBS, your line is open. Uh, great. Thanks for taking my questions. Um, a couple of questions for me. So, just on the, um, the ATC Ram. We're seeing early Community, uh, initiatives in their, I'm just curious in terms of what are the timeline for the community activation to actually see patients treated. Um, that's the first question and the second question, just around the margin Improvement. Uh, you said you're planning to to have more margin pool of the next few quarters. So I'm just curious, you know, what is sort of like the, the, the of the market we should be expecting over the next quarter's. Uh, you know, uh, essentially, uh, we should be expecting, uh, you know, the the the plateauing of the, the, the margin over time.
So I'll take the ATC 1 first, and look at the RAM for that. So, you mentioned specifically Community, our first community centers are starting to treat now typically with centers, they treat a few patients. They make sure the insurance goes through, they get comfortable.
We start ramping patients.
After that, that is expected to continue with our community ones that are just starting to treat. Now, the newer ones coming on with the volume will start slow in with with a few patients in there for it but then we'll start to ramp
The key with the community is that the referral patterns are already there to get those patients in earlier. So, as we discussed with those larger entities opening them, we also have robust discussions regarding referral patterns and patience lining up so we will see a ramp there. Um, a little faster than you'll see with the academics but um it should be coming over in the next quarter or 2 and then we'll get to fully by mid next year.
Uh, David on the gross margin. Yes, we mentioned, they will continue to improve so that will be further benefit from their structuring, but also a number of initiatives across operational efficiency in the manufacturing plant as well as cost-saving initiatives to run the organization in sufficiently as possible.
And just to finish off, we, we did announce 1 of those things today, David by transitioning. All manufacturing to internal is even more clearly. And others discussed, we expect this to have
additional margin improvements on the back of that. That's not something that's reflected in the 43% that we reported today, correct.
Thank you so much for the color.
Thank you. Our next question comes from calling koozie with beard. Your line is open.
Great. Good morning. Thank you for taking our questions and congrats on the progress on the community atc's that you're seeing, uh, come online. Can you just speak to the capacity that you see at those centers versus what the capacity is that you're seeing at the academic centers?
It's less of a clinical trial allocation and other um competing priorities for those of us. And and more of a priority in the solid tumor space than we see in the academics for it because they do split beds in the academics, with the hematology space, where the cartes are Etc. So we do see an opportunity, uh, to have a larger Capac, larger percent of their capacity in the community setting.
That's helpful. Thank you.
Thank you. And our final question comes from Ronnie Benjamin with citizens. Your line is open.
Hey guys, thanks for taking the questions. I'm sorry. I jumped on the call a little late, um, so you may have answered this already. So just indulge me. I'd like to understand a little bit more about the global expansion that you that you highlighted. Um, you know, how do you, how do you envision this programs or or, you know, the the expansion without a partner, you know, should we really be? Should we be thinking about any sort of a meaningful contribution in terms of revenues, you know, going forward or at least in 2026 or is this something that goes out much further? And just a, a follow-up question. Um, regarding both til Vance and the Lund 202 study.
You know, it it seems like enrollment will slow at least from the the 202 study. Can you just give us a, a better sense as to how enrollment is progressing in in each of those studies? Um, that would be great. Thank you.
Yeah, Randy. So first on the global expansion, we we're not thinking right now really about partnership till technology and
Uh, the science is delivering pills to patients to Medicine behind. It is complicated. We, we're not really sure there's a partner out there that would give us any kind of advantage.
And we're always, um, really cautious about asset solution uh and giving anybody writes to anything that we do because we think that pills are going to be extremely powerful in the future. And we would like to uh, to own all that.
That said, we may work with distributors in certain markets. We may work with people that can help, uh, enter markets for us. We tend to stay after every light and lean in those markets while we wait for Revenue to appear. Um
In 2026. I don't expect the significant amount of revenue from those markets. However, we'll start to see that business grow. And then over time, I think it will become a major component of our business in the future. And since Dan heads those teams, I'll let him give some color and maybe just highlight the markets that we're going to go back into including the UK. And we're going to be entering into the first time in the UK and Australia and other places where there's a significant number of nmo patients in need sure. And so, so, Ronnie, 1 of the things, we've always said about our Global expansion. If you look at the history of self therapies globally, um, this has been more of a long-term strategy to produce Revenue.
27 and Beyond but you needed to get the filing and approvals um in place because reimbursement does take a while in those regions. You want to make sure you do it in the proper.
Season. So where we are right now with it, we are
ramping up in Canada. Uh, with our first ATC, we have pending approvals in UK as well as Australia. Um, we're in discussion right now in the UK about um, getting an HS support on which atc's will go up and running there. So we're getting the process in place as well as uh, within Switzerland and then refiling in the EU. So this has been a long-term strategy with it and something that we will see. If you look at kite, who did a great job with guests Carta globally, it took them several years from the approvals to get Revenue in there. So we followed that.
uh, knowing it would take 2027, uh,
Which would be our first year to have any appreciable revenues. Not saying we won't get any next year, but really appreciable weapons in 2027 from
And then on the enrollment question, I'll focus on long to, to renie because to Vance, we really haven't said anything publicly about the enrollment there beyond that. It's going well, uh, and we think, uh, that that that's on track right now, but along, 202 enrollment is really picked up lately. And if you heard on the calls, earlier this week, you know, we have double digit patience right now waiting for infusions and we have a lot of activity there. I'll let Frederick come in a second here but we we think we can easily hit the timeline that we gave.
for the launch of, uh, like lusol and non small cell lung in the second half of 2027 based on our current enrollment enrollment timings
in the lung to a 2 Trials of that.
Benefit in the patients. And and and they now are are are are enrolling at the speed of what is typical and for trial, that that that has shown data like this. Um, so I'm I'm I I share, uh, Fred's confidence in in, in, uh, in US being being on track here with our
goals, got it. And just just as a quick, follow-up, maybe, um, Fred to your comments about toe Vance, that, you know, enrollments going well and, and things around on, on schedule. Can you just remind me when, when do you think ultimately enrollment would be complete? Or when, you know, you might be following, the, The Da have you provided any of that guidance before?
Not yet. We're still pretty early in this in this trial here. This is a longer term study. We do have the ability to to read at an interim time point.
For or and seek an accelerator approval and first line melanoma in this study, and that's not too far off. Uh, we have not guided anything publicly and there's obviously for 670 patient trial uh, at least 600 patients on the, on the, on the main population. That's that's tough to
Uh, predict accurately right now, but we, we should be in touch pretty soon with some more updates on that, is that starts to crystallize for us.
Last 1. Thanks very much for taking the questions.
This concludes the question and answer session.
Spread vote for closing remarks.
Thank you again for joining the Ivan. Bio Therapeutics third quarter of 2025 conference call.
We look forward to providing future updates on our commercial launch and pipeline.
As well as our cost optimization initiatives to drive towards profitability.
We are motivated by the stories. We continue to hear about the patients, who benefit from Ivan, still cell Therapies.
I'm confident that I have answer will remain the global leader in innovating developing and delivering current and future generations of pill cell Therapies.
For patients with cancer.
As always, we are thankful for our patients, the healthcare and advocacy communities, our partners and our exceptional Advanced team.
I would also like to thank our dedicated shareholders and covering hours for their support.
Thank you.
This concludes today's conference call.
Thank you for participating. You may now. Disconnect