Nanobiotix SA
PAR:NANO

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PAR:NANO
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Earnings Call Analysis

Summary
Q3-2023

Promising Treatment Data and Extended Cash Runway

Nanobiotix has reported notable results in a trial treating locally advanced head and neck cancer patients. The data showed a median progression-free survival (PFS) of 16.9 months and an overall survival (OS) of 23.1 months, significantly exceeding historical data of 9 months PFS and 12 months OS. Furthermore, in patients who responded to treatment, the median OS reached an exceptional 42.8 months. The company anticipates a possibility for accelerated approval by mid-2025 and has secured a cash runway that extends to Q2 2025, enhanced by a recent financing of EUR 50.9 million and a partnership with Johnson & Johnson.

Earnings Call Transcript

Earnings Call Transcript
2023-Q3

from 0
Operator

Good day, and thank you for standing by. Welcome to the Nanobiotix Business Update and Third Quarter 2023 Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentations, there will be a question-and-answer session. Please be advised that today's conference is being recorded.

At this point, I will turn the call over to Craig West, Senior Vice President of Investor Relations of Nanobiotix.

C
Craig West
executive

Thank you, operator. Good afternoon and good morning, and welcome to the Nanobiotix Conference Call to discuss our third quarter 2023 financial and operating results and the clinical data presented at this year's ESMO conference. Joining me on the call today are Laurent Levy, Co-Founder and Chief Executive Officer; and Bart Van Rhijn, Chief Financial Officer.

As a reminder, today's call is being webcast and will be available on our website for replay. Moving on to Slide #2. I would like to remind you that this call will include forward-looking statements which may include statements regarding the progress, success and timing of our ongoing and planned clinical trials, collaborations, regulatory filings, dates of presentation and future research and development efforts, among other things.

These forward-looking statements are based on current information, assumptions and expectations that are subject to change. They are subject to significant risks and uncertainties that could cause the company's actual results to differ materially from our current expectations. Accordingly, you are cautioned not to place undue reliance on forward-looking statements.

Please review the full description of risk factors that can be found in the documents we filed with the AMF in France and the SEC in the United States, which are available in the Investor Relations section of our website, along with the press release issued yesterday highlighting our corporate and financial results for the period.

In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, Nanobiotix undertakes no obligation to update them to reflect subsequent events or future circumstances.

With that said, I'd like to turn the call over to Laurent. Please go ahead.

L
Laurent Levy
executive

Thank you, Craig. I will propose to start with Slide #3. As you may have seen our press release, you could see that we have had a very productive and busy quarter that we think is going to drive Nanobiotix into a great future. We've started this quarter by signing this $2.5 billion collaboration with Johnson & Johnson and gave a number of updates, including final data of our head and neck Phase I trial plus some explore data through ESMO and ASTRO that give us some strength and some confidence about the potential outcome on the ongoing global Phase III.

On the top of that, our partner, MD Anderson has been publishing data on pancreatic cancer showing a good feasibility and safety of this treatment for those specific patients, but also starting to see some strong signal of efficacy. As you will see, our recently completed financing round, we really strengthened our financial position, and Bart will give you an update on that, and we will finish this call by a Q&A session.

Let's go now to Slide 4. Just to remind, for the new shareholder and the new people in this call, what is our first-in-class radioenhancer. Our product, NBTXR3, is here to combine with radiation therapy. And as a reminder, 60% of all cancer patients we get radiation therapy during the course of their treatment.

How this product works? It has been designed to be a onetime injection directly into the tumor in order to maximize the concentration and the efficacy in the tumor and minimize systemic exposure for the patient. And this product is made of crystalline inorganic particle of a very particular material, hafnium oxide.

HFO2 is, first of all, a very stable inert material, which is good in terms of safety, but also provide a very unique property being a very strong X-ray absorber, because of the nature of the materials and the high atomic number and density of electron that compose it. So this is not a new product because we've been able to demonstrate in hundreds of patients, safety and first sign of efficacy, including a strong proof of concept in soft tissue sarcoma where in a randomized trial, we've been able to show the superiority of our treatment versus the standard of care. And this product being a physical universal mode of action, we think that this could be applicable across oncology for many, many patients.

That's why if you move to Slide 5, you'll see the breadth and the size of our pipeline. Had a company being focused on head and neck, but also have been showing in many different clinical situation, the potential or the feasibility and safety of this product. What we need now to develop that broadly is not only a strong development capabilities, but also commercial capabilities.

As you know, the ongoing Phase III in head and neck cancer should have an important readout mid-25. That's why we have been signing recently a partnership, and that's on Slide 6, with Janssen to make sure that we have enough of muscles, brain to develop this product potentially in many indications, but also to start and preparing a global commercialization of that.

So as I mentioned, it has been an overall deal of $2.5 billion. That included some upfront and in-time support and a good number of development and regulatory milestones for the existing program ongoing, and that includes also sales milestone up to $1.8 billion.

There are additional regulatory and development milestone for new indication that Janssen may develop over time, up to $650 million. And on the other side, for any new indication that Nanobiotix will develop and will bring into market, there will be an additional of $220 million per new indication. It is going with also tiered royalties that go to low teens to low 20s. But today, we're here to give you an update on what happened during the quarter, but also what has been published by our partner, MD Anderson, or the final data of the head and neck cancer trial.

So going to Slide 7, and Slide 8. As you may have seen, we've been publishing the first set of data coming from the pancreatic cancer trial done by MD Anderson. If you go to Slide 9, here, we're looking at a very specific population of pancreatic cancer. We're looking at locally advanced pancreatic cancer or borderline resectable pancreatic cancer.

For those patients that have those [indiscernible] and then cannot go to surgery, radiation therapy with chemo is a very important treatment in order to try to either control the tumor or up fully for the borderline resectable pancreatic cancer to get to a surgery.

So when you look at the historical outcome for these patients, variation plus chemo or chemo alone did not provide something big enough to help these patients to go -- to get to a potential cure. So in the trial, we are talking about here, the first part that was an escalation part only included locally advanced pancreatic cancer, so excluding the borderline resectable.

So moving to Slide 10, you see a summary of the design of this trial. So we've been treating so far, 17 patients, where the patient got an injection chemotherapy, and if no systemic progression got our treatment, which is radiation plus NBTXR3. We have a chance here is that MD Anderson, they have been also treating a number of those patients previously. That's why we've been able to make not a direct control, but an internal historical control done with the same center on 243 patients that received a follow-on treatment, chemo, then if no systemic progression, they got either radiation plus chemo or chemo alone.

So it's important to notice that when you look at the 144 patients, that receive the radio plus chemo in the previously treated patients at MD Anderson, they got 1 chemo more than what we have been doing in our trial, as our patient post chemo induction, just get radiation plus NBTXR3.

Moving to Slide 11. So what's the trial status? So as of September, 17 locally advanced patients have been treated with our product and with a median age of 60 years old. RP2D has been established with no DLT related to NBTXR3, our product. Just one, Level 2, DLT-linked radiation therapy has been observed to the patient.

Moving to Slide 12. One of the first things that has been observed, which is interesting, is that you may know that CA19 is a biomarker in pancreatic cancer that is interesting because in certain conditions, may be a surrogate or may be important to follow a potential response for the patients and the potential outcome in internal survival.

So if you look at the previously treated patients at MD Anderson, you had a number of patients having elevated CA19 at baseline and 17% of them have been normalized post all course of treatment. In our trial, what we have been observing, it's 42% of the patients have been normalized CA19 post all course of treatment. So more than double what has been observed previously. And let's not forget that we have less -- one less chemo versus most of the patients that have been treated previously.

So that's for our first biomarker, which is very interesting, but does not completely reflect the expected outcome for the patient. What is important is looking at Slide 13. So at the later scale update, what we have seen on the first 15 subjects evaluated is a median overall survival of 20 months post diagnosis, which is, if you look at what has been done previously at MD Anderson, slightly better, and we should say even better.

If you look at Slide 14, you see that patients that previously received a chemo injection followed by radiation plus chemo, got to 19.2 months median overall survival. In our case, with one less chemo, but our product NBTXR3 in combination with radiation, we got to 23 months, which shows a potential improvement for those patients. And obviously, when you remove 1 chemo in combination with radiation, you should expect or could expect less toxicity and less combined toxicity.

So in a nutshell, moving to Slide 15. So we've been able to successfully administer this product into patients with a good safety profile. We start getting a good potential signal of efficacy for the 23 months median overall survival, and what we see is when we look at the comparative data that have been previously obtained by MD Anderson, same center, same patient. We think versus this historical control, it does show a good potential for our product.

So now we're going to discuss, obviously, those data with our partner, MD Anderson, LianBio, Johnson & Johnson to start assessing what could be the next step for pancreatic cancer patients.

Let's move now to Slide 16. So as I remind in the introduction, we have an ongoing Phase III global trial in head and neck, locally advanced cancer patients and those patients being ineligible for cisplatin. I think the 2 pieces of data that have been lately shown by Nanobiotix are very important. There have been 2 different times, one at ASTRO, followed by the ESMO.

First of all, let's go back to the design of this trial. So that's Slide 17. Total, the Study 102 has been enrolling 75 patients. Part of this patient being in the escalation and 56 patients being in the expansion part. The latest data that have been shown, both ASTRO and ESMO have been extracted from the final data coming from the expansion phase. So in this trial, we take locally advanced head and neck cancer patients that are frail, elderly and that are not eligible for cisplatin.

So the only option -- the therapeutic option they have is radiation alone, and we've been able to add our product. Obviously, a big part of this trial was about safety and feasibility, but we also started to look at overall response rate, complete response, PFS and OS.

So in the conclusion of the ASTRO presentation that you can see on Slide 18, first of all, we have seen that this product has been able to be administered safely in all the patients, confirming in the expansion phase, what we have been already showing in the escalation part.

Importantly, on the top of safety, we've been showing a very high response rate, 79% of our response rate. And we've seen a median duration of response, which is really high, especially in the tumor that has been treated with our product and irradiated.

Two very important endpoints where median PFS and median OS because they are the one that's going to be used for the Phase III as a primary endpoint. So medium PFS in the evaluable population has been 16.9 months and the median OS, 23.1. Just as a reminder, this should be compared, if you want to, versus historical data, where median PFS in similar population, but better has been 9 months, and the median OS has been 12 months.

So all those data and final data of this Phase I/II gives us a lot of confidence to the management and to our investigator about the potential success of the ongoing Phase III.

Moving to Slide 19. Those are the latest exploratory data we've been publishing at ESMO. And looking a bit more precisely of what's happening in terms of correlation. We know here, we're looking at locally advanced cancer patients. So what is important is to see, can you get response because we know that getting a good response will provide a good PFS and a good PFS will provide a good OS.

So we just wanted to make sure that this is happening because given the high rate of response we have seen, around 80%, we want to make this correlation. Just as a reminder, in this Phase I, we've been having patients that have a primary tumor and a good number of them having surrounding lymph node involved with cancer cell. So both of those will be irradiated with the same dose of radiation, 70 grades. Nevertheless, in the Phase I part, we've been injecting only the primary tumor, not the surrounding lymph node.

So if you move to Slide 20, it is very interesting to see that we find a high correlation between PFS, duration of response and overall survival. And we find an even stronger correlation when you look at the local, meaning the tumor that have been injected and irradiated with our product. But you find a very strong and stronger correlation with PFS and OS.

So all this is just confirming that our product does provide a good impact in terms of response that induce an improved PFS and potentially improved OS too.

Moving to Slide 21 is just a recall of one of the slides that have been shown at ASTRO. Here, we see all the response the patients got. As you can see, there is a very large number of complete response and a large number of response. We get to 81% of response of -- 79% of response for the overall response rate. Why this is important? If you look at literature, you can look at what radiation plus chemo does in better population that are less frail. And you can see what kind of rate of response they obtain and what kind of survival is bringing to those patients.

Here, again, we have just radiation on nano particles and that's it. The patient will not get further treatment. So what we did obtain out of the 80% of response is a very big survival. When you move to Slide 22, you see the different survival curve, the blue one is the overall survival for all treated population on left and evaluable population on the right.

What is very important is the green curve. Here, we have taken patients that got either CR or PR for the responder, and for those patients, we found a median OS of 42.8 months. And that's very important. Let's remind ourselves that this is a very frail population where radiation therapy is not really curative for a large number of patients.

And what we can see, usually in head and neck with locally advanced, when you go beyond the 24 months, then you start getting to a good position for the patient not to be cured yet, but we're getting closer to that point. And the fact that we have been observing this high rate of response, 80% or more.

And this is linked to a very strong survival with the median survival of 42.8 months really let us think that we may be on our way to change the outcome for this patient population. And obviously, it does give us a lot of confidence on what's coming, which is presented on Slide 23, and that's the design of the ongoing global Phase III, which is made for registration of our product in locally advanced head and neck cancer.

So I will not go over the detail here. But what's important to know is this trial is ongoing, as we did mention during our last communications, we expect to have an interim analysis after reaching 283 events on the primary endpoint, which is PFS, and this should occur by mid-25. And that's a very important endpoint and a very important time for the company and this trial because assuming that this is positive, we should be or could be eligible for an accelerated approval. And therefore, this could be the first indication that our partner, LianBio and Janssen may start commercializing across the globe.

If you move to Slide 24, I think there are a few things that make us really confident in the potential outcome of the Phase III. First of all, what we've been observing in the Phase I with a good median PFS and a good overall survival when you look at the population we are treating. And in the Phase III, there are 2 differences that we think would be again an improvement versus what we have seen in the Phase I.

First of all, we will have or may have a much broader population than the one in the Phase I with overall less comorbidity to make sure that we have time for the product to give some benefit to the patient. And in any case, because we know how comorbidity to this population is important, we've been using ACCI as a stratification factor.

So that's to be on the safe side, let's say. Plus on the top of injecting the primary lesion as we have done in the Phase I, in the Phase III, we allow not only to inject the primary tumor but also the lymph node. So that potential will give an additional efficacy versus what we have been seeing in the Phase I.

But let's be clear, if we just reach the data we've been showing in the Phase I, then this trial will be positive. So all this have been very important to us and to our investigator to give us a lot of confidence about what's coming for the Phase III.

Now thank you very much for your attention, and I will give the mic to Bart to update you on the cash runway and the financial update.

B
Bart Van Rhijn
executive

Thank you, Laurent. Good morning, and good afternoon, everyone. Nanobiotix has had an extremely productive quarter, and we believe that the company's position has been completely transformed into one where we set the stage to allow us to deliver on the potential of NBTXR3, a pipeline in the products.

There's a lot of work left to do, but the company is on a substantially firmer ground than when we began this quarter. More specifically, we started the quarter with the [ balance ] we began our collaboration with Johnson & Johnson through which we are working to bring NBTXR3 to the millions of patients that suffer from solid tumor malignancies that are amenable to treatment with radiotherapy.

The first 2 indications targeted for development are planned to be head and neck cancers and lung cancers. But it is far from the full potential we see possible with the solid tumor and combination agnostic product like NBTXR3. And as you've just heard Laurent discuss, additional indications such as pancreatic cancer can, we believe, benefit from adding our potentially first-in-class radioenhancer to the treatment armamentaria.

We believe the quarter has also seen the company address in a significant manner, the financial overhang that has been an understandable concern of capital market participants. As of September 30, 2023, Nanobiotix had EUR 37.8 million in cash and cash equivalents compared to EUR 41.4 million as of December 31, 2022. For clarity, this cash balance does not take into account the EUR 50.9 million financing the company just completed.

We are grateful for the continued support we are receiving from existing shareholders and are pleased to welcome new shareholders to the journey.

As previously discussed, the European Investment Bank, or EIB, has agreed to the removal of the minimum cash and cash equivalent covenants from the company's EIB loan, effective October 13, 2023. As a result of the terms of this new agreement, the company will pay EIB approximately EUR 0.5 million, which is 1% of the EUR 50.9 million gross proceeds.

Based on the current operating plan and financial projections, we anticipate that the cash and cash equivalents of EUR 37.8 million as of September 30, 2023 in conjunction with the EUR 50.9 million on the recently completed financing, combined with the derisked milestone related to our NBTXR3 collaboration with Johnson & Johnson, results in a cash runway that extends into the second quarter of 2025.

I would note that due to regulatory requirements, Johnson & Johnson's initial subscription to the second equity tranche was approximately EUR 19.1 million. This amount is expected to be increased to the full EUR 23.7 million or $25 million, following approval from the French Ministry of Economy to do so.

If we include this last amount in our cash and cash equivalents, projections, we expect that the cash runway extends to the end of Q2 2025. This run rate gets us into the time frame in which we expect to potentially report the NANORAY-312 study interim efficacy results.

And now I will turn the call back to Laurent. Laurent?

L
Laurent Levy
executive

Thank you, Bart. As you can see, we have had a very busy quarter that we think is going to help us to pivot Nanobiotix into a great future. With that, I will now ask the operator to begin our Q&A session. Operator?

Operator

[Operator Instructions]

Our first question comes from the line of Swayampakula Ramakanth of HC Wainwright.

S
Swayampakula Ramakanth
analyst

My first question is on the pancreatic cancer indication. So certainly, it's interesting data that MD Anderson put out at ESMO. So what do you think is the appetite for J&J to take this and go forward? And if they decide to do this, how soon do you think that those studies will get started?

L
Laurent Levy
executive

Thanks RK for the question. So we concur, I think what MD Anderson has provided as the first data in pancreatic cancer are very encouraging and interesting.

As you know, that's an indication where it's very hard to provide something suitable for the patient.

So first of all, we think we should complete this trial, and the expansion phase is we're cooking really well, and we should be able to finish that soon and to be able to report the final data on that.

Now as far as the next step concern, I think there's a need for discussion, not only with J&J but also MD Anderson and LianBio to see, not only of pancreatic cancer should continue, but more broadly, how shall we expand the development of NBTXR3.

For now our focus is really on moving forward the head and neck program, but also starting the lung program that J&J wants to begin with. And as a follow-up and subsequent step, we will notify the market but the more global development plan about NBTXR3. Finally, let's continue to push while it's on the table and promise in due time, will tell you about pancreatic cancer.

S
Swayampakula Ramakanth
analyst

And then MD Anderson is also conducting a few additional -- I mean, evaluating a few additional indications. Do you have an idea of the cadence of data that's expected from them?

L
Laurent Levy
executive

Sure. So you're right. MD Anderson is running different clinical trial, and we can name on the top of pancreatic cancer trial, the esophageal cancer trial or lung cancer. And as we also inform in one of the previous PR, they are preparing another big trial that hopefully will start soon, and we will tell you about it much more in the near future.

As far as the new data are concerned, we expect to reach the RP2D in lung cancer soon and also all next year to start providing additional data on panc, on esophageal and on lung cancer too. So we will -- we think across '24 and '25, keep informing you about how the progress are made with MD Anderson and give more data on all this. And as I mentioned in the previous question also, what are the potential subsequent step for a successful trial like pancreatic cancer.

Operator

Our next question comes from the line of Colin Bristow at UBS.

Y
Yihan Li
analyst

This is Yihan Li for Colin. Congrats on the quarter. So I guess I have 2 questions. So the first one is just about NANORAY-312, statistical assumption. So you expected the median PFS in the control arm will be around 6 months, and the median OS will be around 12 months. Also, we think it is definitely like reasonable assumptions, but also note, the patients enrolled in this NANORAY-312 have a lower comorbidity burden versus the Study 102. So just wondering if the control arm may perform relatively better versus the historical data? And what is your view on this?

And the second question is about your run rate -- cash run rate. So currently, you're assuming to second quarter 2025, assuming a development milestone. And you mentioned in your prepared remarks that it is derisked. So I'm just like assuming there's no risk for this milestone. And just wondering if you think it is -- this will be sufficient to support the NANORAY-312 interim in mid-2025?

L
Laurent Levy
executive

Thanks for the question. So in terms of hypothesis for the 312, I think the hypothesis that we have been taking are based on literature and what we've been observing in the recent trial treating elderly patients with radiation alone. And the hypothesis, as you mentioned, will be 9 months for the PFS in the control arm in 12 months. And so how do we read that versus the 1 or 2?

First of all, the 312 will be positive if we get the tested arm with our product plus radiation to 13 months as the PFS instead of 9 and 15 months for the OS, which is a lower burden than what we've been observing in the available population in the 102. So I think where we get some confidence is when you look at the real population, we've been treating in the 102. As we mentioned in the past, you have 2/3 of the patient in this population that have had high comorbidity. Whereas in general, you get more 20% to 30% max of the patient having this high comorbidity.

So being able to see such an improvement of such a PFS and OS in a population with such a high comorbidity for us, is a very good sign of the efficacy of our product. Our hypothesis is if you get less patient with high comorbidity, meaning more patients that will have time to get the benefit of the treatment, we should be able to see even bigger or better results in the Phase III.

So those are part of the hypothesis. And if we think that in overall, a larger population will perform better than the 9 and 12 months, then our product should also perform better in a better population. So that's why we think we have a good room to play in that regard for success of the 312 trial.

Now just to answer the other question you have, maybe about this, what we call the secured milestone or the risk milestone, that's a very short-term milestone. We expect from this collaboration, which is due to the progress in recruitment in all Phase III head and neck cancer. And I will let Bart to comment on the cash runway versus the readout of the interim readout in the 312.

B
Bart Van Rhijn
executive

Thank you, Laurent, and thank you for the question. We're pleased to share with you that we removed the finance overhang that we did away with the EIB cash covenants and extended our runway into mid-25. That includes that derisk milestone as Laurent indicated, that will be announced in the not-too-distant future. It's primarily function of the timing at this stage.

And as we shared in the press release, the execution of the last part of the second equity tranche that is subject to the French Ministry of Economic Affairs. So we're excited about being able to focus on sharing updates with you in the markets with regards to what is coming over the next 12 months, and we're very pleased to be in this position.

Operator

[Operator Instructions]

And we've had 1 further question come through. That's from the line of Clément Bassat at Stifel.

C
Clément Bassat
analyst

I had one for the pancreatic cancer study. How comparable are the baseline characteristics of the patients into previous MD studies? And the patients in the ongoing Phase I, for instance, in terms of level of CA19-9 at diagnosis? And could you give us the amplitude of reduction of that biomarker levels observed in your study?

And my second question was on the EIB. If you could just give an update because you reimburse the payment and can you pay EUR 0.5 million? In the old terms, it was either before June 2029 or [ 3.7 ] after commercialization. Now you have this new mechanism of royalties per amount of financing kind of, is it the only way you're going to reimburse the amount?

L
Laurent Levy
executive

Thank you for the question. So about the MD Anderson trial in pancreatic cancer, so obviously, the baseline of the patients are both in all trial and the previously treated patients at MD Anderson, all locally advanced pancreatic cancer, so nonoperable patient. So it's not a real comparator, right? It's not a randomized trial. So that's why we've been taking every patient that have been locally advanced pancreatic cancer as a historical control versus the patient we've been treating.

What is clear and interesting is what you mentioned about the CA19 comparison. So in general, in this patient population, when you got high CA19 at baseline, it's a very bad prognosis. And there is a small amount of this patient at MD Anderson, for example, it was 17% of those patients that would have a normalization. And when you go for a patient getting normalization of CA19, usually have better outcome than the one that don't have this normalization. And in our case, with the 17 patients we've been treating so far, we got 42%.

So I think this is a very good first step to see that we have more patients getting to normalized CA19 with a good amplitude plus the OS that we start to see in this ongoing trial of 23 months. So those 2 together are very good surrogate for us of efficacy of our product, plus the fact and that in the comparator or the historical comparator data, most of the patients, they got radiation plus chemo versus what we got in our patient was radiation plus all products.

So there was less chemo or replaced by our product. So we think altogether, that's a very good deadline to define what would be the next step in pancreatic cancer. And we're working on it right now, and we will inform you in a short -- in the near future about what we intend and plan to do in that regard. And maybe I'm going to give the mic to Bart about the EIB.

B
Bart Van Rhijn
executive

Thank you for your question, Clément. So with the EIB, you may remember that in 2022, we restructured the loan that introduced the milestone concept of EUR 20 million. That would be repayable at the start of commercialization but has a long stop date in mid of 2029. And what we shared with you today is that as part of the removal of the cash covenants, we included an ability for the EIB to get access to that EUR 20 million milestone sooner.

So if there is a qualified fundraising, there is a tiered structure that allows them to get access to that. And based on the amounts we raised, that is 1% that resulted in that payable.

But the overall loan restructuring that we did in 2022 really allowed us to essentially renew the loan at that stage to give the company a much more flexibility from a funding perspective, given the capital market dynamics we have been facing for the past 3 years in Nanobiotix. So hopefully, that addresses your question.

C
Clément Bassat
analyst

Yes, very clear. If I just may quote details, I see that the RP2D in lung cancer of the MD study, there was interest supposed to be in H2 2023 has been moved to 2024. Why is the site delayed? Is there some enrollment decrease rate?

B
Bart Van Rhijn
executive

Just to be on the safe side, in this trial, as you know, when we recruit patient, there is a 3 to 4-month delta between the injection of the patient and the potential readout of the end of safety study period to declare the RP2D.

So the enrollment continues to be good in this trial. It's just slightly delayed versus what was initially planned. But all the trial, and media understand, globally are accelerating. The pancreatic is running well, esophageal too, and they are preparing full speed this new trial that we will discuss soon with you.

Operator

And as there are currently no further questions in the queue at this time, I'll hand the floor back to our speakers for the closing comments.

L
Laurent Levy
executive

So thank you very much, and thank you again to be so numerous in this quarterly call. We'll be happy to continue to report progresses of the company and a different program we have and hope to see you soon in person. On that note, I wish you a great day and great rest of the week. Thank you very much.

Operator

Thank you. This now concludes the conference. Thank you all very much for attending. You may now disconnect your lines.

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