Transgene SA
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Earnings Call Transcript

Earnings Call Transcript
2020-Q4

from 0
Operator

Hello, and welcome to the full year results 2020 business update and update on the clinical development plan of TG4001. My name is Stefano, and I will be your coordinator for today's event. [Operator Instructions]I will now hand over to your host, Lucie Larguier, to begin today's conference. Thank you.

L
Lucie Larguier
Director of Corporate Communications & IR

Thank you, Stefano. So I'm Lucie, in charge of IR at Transgene. Together with me are Hedi Ben Brahim, Chairman and CEO of Transgene; Jean-Philippe Del, Chief Financial Officer; and Maud Brandely-Talbot, Chief Medical Officer, so -- on this call.Before I turn the call over to Hedi, I'd like to remind everyone that today's discussion contains forward-looking statements, which are subject to numerous risks and uncertainties. This presentation and the webcast can be accessed via the Investor page of our website, transgene.fr, and the other press release issued today. [Operator Instructions]With this short introduction, I'll now turn the call over to Hedi Ben Brahim.

H
Hedi Ben Brahim
Chairman & CEO

Thank you, Lucie, and welcome, everyone. I'm very happy to be here today to discuss Transgene business update and provide you some perspective on our future goals. So as you know, I officially joined the company at the beginning of the year, after more than 2 years as a Board member, and have enjoyed a very smooth transition with my predecessor, Philippe Archinard.The last weeks and months have been truly exciting. I've joined really very talented teams within Transgene, and their great efforts have paid off in a very successful 2020 year for the company and prepare a great 2021. In 2020, Transgene has made remarkable progress with our new technology platforms, our clinical pipeline, and at the same time, we have strengthened our financial position. All of these have been achieved despite the challenges that we continue to face as a result of the unprecedented COVID-19 and situation.In January 2021, we have had the first patient in France with TG4050, our individualized cancer vaccine based on our cutting-edge myvac platform. This achievement followed the treatment of our first patient in the U.S. during the fall of last year. The pace of patient recruitment we have seen in this release make us confident that we will be able to share the first data with you from the TG4050 trials before the end of this year.In the fall of 2020, we announced positive results with TG4001, which allowed the start of an expanded randomized Phase II study that Maud will provide details of later in this call.BT-001, the first oncolytic-based on our Invir.IO platform, has recently entered the clinic. And the Phase I trial is currently, including patients in France and in Belgium, and enjoying a very good start.We also obtained first results on TG6002 that provide a highly encouraging data on the 0 backbone that form the basis of our new generation of oncolytic virus based on our exciting Invir.IO platform. And it also shows that these oncolytic viruses could be administered via IV, which would greatly increase their utility.Finally, regarding our finances, we've sold a part of our stake in Tasly BioPharmaceuticals for more than $22 million, which secures our cash horizon until 2022. I'm convinced that our commitment, our focus on novel immunotherapies based on our world-leading technologies and our knowledge in viruses and answering very significant medical needs will allow us to achieve several milestones in the next 18 to 24 months.As you are well aware, our core expertise is based on optimized viruses that have demonstrated their capability to stimulate the patient's immune system. We have evolved this expertise, and we've created 2 edge technology platforms. Based on our deep understanding of the Vaccinia Virus, we can design either therapeutic vaccines or oncolytic viruses. The strains that we used have been used in the past for prophylactic vaccination. So they have demonstrated a very strong safety profile. They also have demonstrated that they can induce a strong and sustained immune response, which is key for the success of candidates in terms of treating cancer.On the top of the slide with therapeutic vaccine, we educate the immune system against a specific tumor characteristic. Myvac is an individualized immunotherapy platform, and the myvac-derived products are designed to target the patient's own cancer-specific genetic mutations. This strategy triggers an optimized immune response that stimulates the patient's immune system through multiple mechanisms.Oncolytic viruses are engineered to replicate within the cancer cells and deliver anti-cancer therapies in the tumor. With our Invir.IO, and our patented virus strains, we have already developed 2 highly innovative candidates, TG6002 and BT-001. So globally, both of our platforms aim to produce multiple candidates, able to trigger tumor cell death and enlarge immune response and repertoire. As a result, we think that we are confident in the potential to effectively target multiple solid tumors.So going to the next slide, we have an overview of our diversified portfolio and the numerous important milestones that are expected in the coming 24 months. I would like to start to discuss, first, our myvac platform, which is able to generate our individualized neoantigens vaccines and take the treatment of each patient's tumor to a new level.I would like really to highlight that the pace at which we have developed this world-leading technology has been very impressive. In less than 3 years, we have found a new, fast and innovative way to vectorize neoantigens and create a personalized therapy. We have set up a GMP production unit, which has been validated by the authorities. We brought in the clearance for 3 -- from 3 major health authorities to launch our clinical trials. We've included and treated the first patients with an individualized treatment in 2 Phase I trials.For the proof of concept for myvac, we are focused on indication with a moderate tumor burden. It is important for 2 reasons. The first one is that there are numerous mutations, which results in neoantigens. So they are ideal to demonstrate the importance of the neoantigens collection systems we are using. The second, is that in these indications, checkpoint blockers have so far demonstrated limited efficacy and TG4050 can thus be administered as a single agent. So we've been very ambitious and we've launched from scratch 2 trials with TG4050. They are co-funded by NEC, our Japanese partner, and also supported by the French authorities, Bpifrance. The first clinical trial is enrolling patients in ovarian cancer. And the TG4001 is administered when the patient is in remission, but still has a very high-risk of relapse. And the first patient has already received the treatment.Our second trial follows the same logic, but it is randomized. It is enrolling patients with head and neck cancers, and that will have first received -- so the first will receive TG4050 or they will be monitored until the relapse, and then they will get the standard of care, which includes checkpoint blockers. So this unique setup of the clinical trials will demonstrate the potential of TG4050 as a single agent.Here again, the first patient received treatments, and we already have many more patients behind. The pace of the patient recruitment in this study is progressing as anticipated. And we expect to communicate the first data in the fourth quarter of the year. This will be a really great milestone for the company, I'm sure.Please note that we've put in place an extensive transactional research program. So we are leveraging the patient genomic data to identify patient characteristics that could better predict the chances of success of our therapy. This novel analysis will be particularly useful to better target our next developments and accelerate the future developments of TG4050. Our goal is to leverage these comprehensive data sets to trigger partnering discussions and out-license our novel immunotherapy, TG4050.I now turn over the call to Maud, who will provide an update on our promising clinical trial that we are launching with TG4001.

M
Maud Brandely-Talbot

Thank you very much, Hedi. So I am going to share with you the promising clinical results we obtained in patients with HPV16-positive cancer, and then to provide you with the details about our plan -- our future plan for a Phase II trial. So TG4001 is a therapeutic vaccine, which encodes E6 and E7 antigens from the HPV16, and indicated in the treatment of patients with HPV16 positive cancer. And we have defined some interesting features to target the best population, which can benefit from this treatment.So on the next slide, you have the main results we obtained by combining TG4001 with avelumab, which is an anti-PD-L1 from Merck and Pfizer. So overall, we treated 34 patients who were heavily pretreated, who had metastatic HPV16 cancer, including oropharyngeal and mostly anogenital cancer. Overall, we got an interesting response rate of 23.5%. And if we focus on the 23 patients who do not -- did not have liver metastasis, we end up with an impressive objective response rate of 34.8% and a median in the progression-free survival of 5.6 months, while in patients with liver met it was only 1.4 months. This include 1 complete response, which is durable and 7 response. And indeed, this compares very favorably, which has been reported with ICI with only a response rate between around 10% to 15% and a median PFS around 2 months. So moving then to the durability of response, which is illustrated here on the spider plot. You can see that the response are there, not only there, but also durable. And we have response not only in patients for more than 3 years, so it's quite impressive. And this is associated with the induction of specific immune response against HPV antigen and also with change in the tumor microenvironment. So we observed a shift from cold to hot tumor with an increase in lymphocytes infiltrate and higher expression of PD-L1, which is the rationale for combining our therapeutic vaccine with an anti-PD-1 or PD-L1. And although the result, I forget to mention, but I'm sure you remember, have been presented by the end of last year at SITC and the ESMO Euro congresses.So moving then to the -- our next trial. So what we decided, and this was strongly supported by our investigator, which, of course, are very enthusiastic about our results. So we decided to expand the trial, to amend the trial so that we focus on patients who got the best response, to patients with anogenital cancer, indeed with record metastatic disease treated in first or second line. So the disease is less advanced than in the first phase of our Phase II, which allowed up to 2 prior line of systemic chemotherapy. No prior exposure to immunotherapy, without liver met. So we have seen the major impact of liver met on the disease outcome, and whatever the level of PD-L1 expression. Meaning that we will characterize the expression, but we are not going to select the patient on the basis of this expression.So then this population of patients with advanced anogenital cancer represents a significant subset of patients, so around 25,000 new patients per year. And -- which are young patients with poor outcome with the current therapy, including mostly radiotherapy combined with chemotherapy. No immune checkpoint inhibitor has been approved so far in first line. The only approval has been pembrolizumab in second-line in cervix cancer but only in the U.S. for the time being. So have huge medical need.So what are we going to do now? So we need a strong demonstration of the benefit of adding TG4001 to avelumab. And for this purpose, we have decided to set up a randomized trial so in the population, which I just described, and we will randomize the patient in a 1:1 ratio to the combination of TG4001 plus avelumab versus avelumab single agent. The primary endpoint will be progression-free survival. And of course, we will look at -- as a secondary endpoint to overall response rate, overall survival and also immunological parameters.So what is -- plan is to perform an interim analysis when an approximate number of 50 patients will be enrolled, and this will provide us the results by the end of 2022. And until then, this trial has been already submitted to health authorities in the form of an amendment in the country where the initial portion of the trial has been conducted, in France and Spain. And we are expecting feedback from both authorities in April. And as a new protocol, because we expand the number of countries involved in the trial to the U.S., and we have already obtained the clearance of the protocol from the FDA. And so that's we -- in turn, we expect and I cross my finger because, of course, you know that COVID is there, but we believe that we will be in a good position to start first actual in May -- this year, 2021.And again, the aim is to have the data from the interim analysis by the end of 2022. And this is, of course, very important because based on the results, we'll be in a good position, if interim analysis is positive, to discuss with health authorities. I would move forward for a registration trial and, of course, to discuss with potential partners.

H
Hedi Ben Brahim
Chairman & CEO

Thank you very much, Maud. We are very excited by this new step for TG4001 that we are opening today. Now if you're okay, let's move to Invir.IO. So you are familiar with our patented virus. The Vaccinia Virus Copenhagen double-deleted, which is the foundation of our Invir.IO oncolytic virus. It has been designed to have multiple mechanism of action. The 3 main ones is the direct lysis of the cancer cell. It's the induction of a durable immune response, and the capacity to deliver a therapeutic payload right into the tumor.One of the major advantage of Vaccinia Viruses is that the can be administered via multiple routes, which overcome the administration limitation of most oncolytic virus.So we'll start with BT-001. BT-001 is the perfect illustration of the potential of our Invir.IO platform, and it has entered the clinic very recently earlier this year. This virus encodes for BioInvent's anti-CTLA-4 antibody and GM-CSF. And it's using, like we said, our Copenhagen double-deleted strain.It's been designed to combine the very powerful activity of the anti-CTLA-4 design by Bioinvent, which depletes the T regs and increase the competence of the tumor with the induction of the immune system. It's -- we expect it to show a better tolerability profile, that regular anti-CTLA-4 administered via system route.We've shown remarkable data at 2 congresses in 2020, AACR and SITC. We are really excited to see a very strong antitumor effect in several models. That really underlines the potential for BT-001 in several solid tumors. We've shown this graph at SITC for the first time. And you see on the top that by injecting the virus in 1 tumor we can induce the shrinking of the injected tumor, the picture on the top right. But also, it can induce the disappearance of a distant tumor, the one on the top left. And that's key to show that our oncolytic virus are able to stimulate the in system globally and induce a selective response against tumor cell in the injected lesion and in distant tumors.Based on these great pre-collected precise data that we've seen, we have initiated a Phase I/II trial in Europe. It has started a few weeks ago, and it is enrolling patients. We will evaluate the intra-tumor injection of BT-001 first as a single agent and then in combination with pembrolizumab. This trial will allow us to identify and rapidly generate data in combination with a checkpoint blocker and identify the most promising indication.Going to the next slide, you can see that the recent progress of TG6002. This candidate targets patients with cancer that are sensitive to the chemotherapy agent, 5-FU. This represents roughly 200,000 patients receiving a second line of treatment for colorectal cancer with liver metastasis.The initial data we obtained last year demonstrate that the oncolytic virus is able to reach the tumor when administered via IV route, and that TG6002 included the productions of 5-FU directly in the tumor as we targeted. So these results, of course, confirm the safety of TG6002 in this setting.We will be presenting the details of the data at the upcoming AACR 2021 Congress. So please watch out for that. We will also communicate data on the other trial evaluating TG6002 when administered via the intrahepatic artery in Q3 this year. All these elements provide really highly encouraging data for TG6002 and for the backbone that form the basis of our novel oncolytic viruses that are developing within our Invir.IO platform.I will now hand over to Jean-Philippe, who will walk us through the financial results.

J
Jean-Philippe Del

Thank you, Hedi, and hello, everyone. Our P&L for 2020 was in line with our expectations, and we'll take as we allocate most of our resources for strategic clinical and pre-clinical operations. Revenue stood at EUR 9.9 million in 2020, with the research tax credit amounting to EUR 6.3 million, and EUR 2.9 million from our collaboration with AstraZeneca.Operating expenses decreased at EUR 33.9 million in 2020, with the reduction of R&D expenses as we were mostly initiating trials and reduce the external expenses related to the manufacturing of clinical batches. The rest of the expenses remain stable.Overall, the net operating loss remain under control at EUR 24 million. The net financial income amounted to EUR 6.8 million in 2020. Thanks to the financial gain related to the partial sale of Tasly shares in July '20. And as a result, our total net loss amounted to EUR 17.2 million in 2020.Let's look at the details of R&D expenses. They decreased to EUR 27.3 million in 2020 compared with EUR 31.4 million in 2019. This decrease is due to lower external expenses on clinical projects in 2020, reduced from EUR 10.9 million in 2019 to EUR 5.4 million in 2020. And this is explained by the clinical state of our product portfolio in 2020 and by the reduction of subcontracting manufacturing of clinical batches.As a result, you can see on this slide that our cash burn over the year was reduced to EUR 70 million in 2020 compared to EUR 20.5 million in 2019. This cash burn includes the net cash inflow of EUR 18.2 million from the sale of Tasly BioPharmaceutical shares in July '20. This transaction enabled the company to early repay the EUR 10 million bank loan from the European Investment Bank, saving approximately EUR 0.6 million in interest.Our cash and cash equivalents at the end of 2020 stood at EUR 26.3 million. And in addition, we still have access to a credit line of EUR 15 million. And still holds Tasly BioPharmaceutical shares valued at EUR 32.3 million at the end of December '20. These figures secure our cash horizon until 2022, and we believe that these financial resources will allow Transgene to clearly demonstrate the power of its novel immunotherapies.With that, let me now turn the call back to Hedi.

H
Hedi Ben Brahim
Chairman & CEO

Thanks, Jean-Philippe, for the financial update. So before the Q&A, let me conclude with our outlook. So today, we've shown you our clear strategy, and we will execute it effectively. I think we have really 2 very exciting years ahead of us. Each of the 4 of our clinical products will have readouts in the coming 2 years. We'll have TG6002 in Q2 and Q3, then at the end of the year, will be TG4050 myvac. Then in early 2022, will be BT-001. And in the second half of the year, will be TG4001, that we are launching right now.So thanks to our funding, covering our plans until next year. And the progress we've seen and the exciting clinical trials we have, we are very confident in Transgene future. We hope that the upcoming trials will allow us to negotiate licensing agreements, reflecting the fair value and the potential of Transgene's portfolio immunotherapies, then generating significant value for our shareholders.Thank you very much for listening to us. Let's now move to the Q&A.

Operator

[Operator Instructions] Our first question comes from the line of Arsene Guekam from Kepler Cheuvreux.

A
Arsene Guekam
Senior Equity Research Analyst

What do you expect in terms of cash burn for 2021? This is my first question, if I may.Second question, more clinical. On TG4001, could you give us more explanation on the macro, why do you choose anogenital cancer? Maybe it was to -- in order to have less competition? This is the first -- the second question.And also one also related to TG4001, is what's the aim of the interim analysis? Is it a futility analysis? And what this kind of results could give you, either for a -- for a partnership or to pursue the clinical trial?And the last one is on BT-001. You start the clinical trial in Europe in solid tumor. Could you give us an update regarding the expansion in the U.S.?

H
Hedi Ben Brahim
Chairman & CEO

Thank you very much for these great questions. So let's have Jean-Philippe answer on the financial, and we'll have Maud to start on the clinical answers.

J
Jean-Philippe Del

Arsene, so regarding the cash burn for 2021, with our basic scenario, we can consider that we will have a cash burn above 2020 cash burn, knowing that we had this exceptional financial gain with the sale of Tasly shares in 2020. So with that, we can consider that would be in the range of EUR 25 million -- or around EUR 25 million to EUR 30 million depending on what could happen in revenue in this year.

A
Arsene Guekam
Senior Equity Research Analyst

Okay.

M
Maud Brandely-Talbot

So regarding TG4001. So indeed, we have selected anogenital cancers because you can see competition, but I will say medical need. Because indeed, for the time being, what is approved for this kind of cancer is only a standard chemotherapy, radiotherapy at an earlier stage. And as I mentioned, only kind of immunotherapy, which was approved and only in cervix cancer is pembrolizumab in the U.S. in the second-line treatment of cervix cancer. And with only in patients with expression, CPS; more than 1% expression of PD-L1; with an objective response rate of 14%.So indeed, there is a major improvement, which are expected in this kind of cancer. So this is really the reason why we select anogenital cancer. And on top of that, as you know, in head and neck, there is much more therapeutic option with the approvals of pembrolizumab in first line. So a patient can now benefit much more immunotherapy than before.Regarding the aim of the interim analysis is not futility analysis. Actually, the Phase II is designed with an adaptive design so that the objective of the interim analysis is to adjust the so called size of patients to be enrolled in the next step according to the result of the interim analysis we can obtain. So on average, we may end up with a total of 140 patients, I would say.

A
Arsene Guekam
Senior Equity Research Analyst

Okay. Just to be sure, could you give me more explanation about the adjustment that you could make based on this interim analysis? I'm not sure to have caught what you have said?

M
Maud Brandely-Talbot

Yes. I would be happy to do so. So I am not going to enter into the details of the statistical design but to make things simple. So we calculate the conditional power based on the difference we will observe between the 2 arms and see if the difference is huge, we can end up with simply saying that we reach the goal, we have observed a statistical significant difference. So that's it.If the difference is less important, we need more patients to reach statistical significance. So it's really the difference we will observe in terms of median PFS which will drive the decision to -- on the number of additional patients to be included in -- after the interim analysis. Is it clear -- is it clear for you?

A
Arsene Guekam
Senior Equity Research Analyst

Yes, yes, yes. If I understood well, it's a step in order to fine-tune the number of patients you will need for this clinical trial, in order -- okay.

M
Maud Brandely-Talbot

To reach statistical...

A
Arsene Guekam
Senior Equity Research Analyst

To reach -- yes -- okay.

M
Maud Brandely-Talbot

That's what the health authorities are expecting next week.And for BT-001, indeed, we are contemplating an expansion to the U.S., and the plan is to file an IND in April this year.

Operator

The next question comes from the line of Sebastiaan van der Schoot from Kempen.

S
Sebastiaan van der Schoot
Analyst

Can you hear me?

M
Maud Brandely-Talbot

Hi, Sebastiaan.

S
Sebastiaan van der Schoot
Analyst

First, I have a couple on the TG4001. The first one is whether the results of the Phase II could be enough for regulatory submission? And then as a follow-up, you also mentioned that you will include all levels of PD-L1 patients in your trial. Will you also stratify these patients so that in both arms there's the same amount of subset of patients with similar PD-L1 levels? And does this also mean that patients without PD-L1 expression will be recruited in the avelumab-only arm?And then another question on TG4001. Did I understand correctly that the interim analysis will be then used on a specific number of patients and not on time? But will you first recruit, let's say, 70 of the patients and then do the interim analysis?And then for my last question is financial. Can you remind us of the Tasly stake situation, what is the remaining value of the Tasly stake? And when will you be able to have access to that?

M
Maud Brandely-Talbot

So I will address the question on TG4001 and then Jean-Philippe will answer regarding Tasly.So our current Phase II data is enough for submission, where there are these issues, but we really need to convince the authority because it's a combination regimen to show that each -- the avelumab user alone is not doing all the job. We have historical data, which shows that, not only from avelumab but also from other ICI, showing that the results are much, much, much lower than what we have observed. But to be on the safe side, we really need this comparison to be convincing enough for registration purpose.Well, to make it clear, we will enroll all patients with any expression of PD-L1. So we are not going to select patients on the level of PD-L1 expression. And indeed, among the responder, we have observed patients -- we have patients who are PD-L1 negative. So we have not observed any correlation between response and the level of expression of PD-L1.Having said that, we will still characterize because this is something we -- you ask and everybody ask when you use an ICI, we will characterize at deadline the level of expression, that's for sure. But the stratification will be performed, but not on PD-L1, on the primary tumor location. So we will stratify because among anogenital cancer, you understood that you have different locations, including anal, cervix, vulvar, vaginal, penile cancer. Meaning that we will stratify the primary location to make sure that there is a right balance between the 2 arms in terms of primary location.Regarding the interim analysis, so it requires indeed an approximate number of 50 patients. Meaning that those patients will be followed for a sufficient period of time to see, one, the progress. Because, as I mentioned, the primary endpoint is progression-free survival. So meaning that we will need an approximate, on average, a follow up of, let's say, 4 months to make sure that we have captured enough events. And the number of events based on our statistical calculation estimate is 37. So actually, the interim analysis will be performed when we will have 37 events, meaning progression among the -- those 7 patients, which will need to be followed enough, and the longer will be the better.

S
Sebastiaan van der Schoot
Analyst

Yes.

J
Jean-Philippe Del

Regarding the -- our Tasly stake. So we still have shares of this company that were booked at the end of December 2020 at EUR 32.3 million. So corresponding to the transaction price of the deal we had in July 2020. Today, we have to wait until the IPO of Tasly before being able to sell those remaining shares. And as you remember, we will have a 12-month lockup between the IPO and the date when we'll be able to sell those shares. So it means that -- well, depending on this timing of the IPO, and it will probably not occur before -- before middle '22.

Operator

The next question comes from the line of Jean-Jacques Le Fur from Bryan Garnier.

J
Jean-Jacques Le Fur

I have 3 actually. So the first one, probably for Maud. Regarding the liver metastasis in this new population you've chosen for the TG4001 Phase II. Could we have a sort of a percentage of liver metastasis because I understood from the call we had during SITC with you that these metastasis were more frequent with anal cancer so I don't know if it's the same for vaginal or cervical cancer. So what could be the percentage of liver metastases with these cancers? The second question is regarding TG4050. Which type of data could we expect in Q4 '21 end of this year?And lastly, for Hedi, it is now a few months or a few weeks you joined Transgene. So it's a sort of classical question. What do you have changed since you arrived? Or what do you want to change on a strategic point of view in the next few weeks, months or years?

M
Maud Brandely-Talbot

So starting with liver met. So actually, the answer is not easy because, indeed, the incidence is greater in anal, but it's not trivial in cervix or vaginal cancer. Having said that, the reason why I am not giving you numbers is because it depends on the time course as the cancer. I mean in the Phase II part where we treated patients who we see were treated in third, even in fourth line. So meaning they have received 2 or 3 prior line of chemotherapy for their metastatic recurrent disease. Of course, the proportion of patients with liver met, you have seen, we have 11 among 44 is in the range of 20%, 25%.But if we now move, and you have seen that we allow now only one line of prior treatment for recurrent metastatic disease, meaning that this incidence of liver met will drop. Because clearly, the evolution of this cancer is to have more and more your organ involved. And indeed, liver met is an issue and is really, where all those patients are usually unfortunately dying. So that's for liver met.Regarding TG4050. So what we will have by the end of this year is for sure and which is pretty important is immunogenicity data. Meaning that what we are looking for because we are, of course, collecting a lot of samples is to determine the induction of CD8 response to each of the new antigen we have selected and injected to the patients. There are the 2 vaccines. We will also have a look to the clinical behavior of patients. So we will have a full set of data on a handful of patients.

H
Hedi Ben Brahim
Chairman & CEO

Thank you. So for my part, I would say my first goal is really that it's well understood inside the company and outside the company of the dramatic change that Transgene has really gone. Invir.IO and myvac, I think we're communicated, but really not fully understood and not yet a reality. But now we have the first patient who have received our -- who are receiving our Invir.IO treatment. Myvac, a year ago were still a dream. Now it's a reality with the first patient treated with several tens of production batches here. So that's really a reality that's pretty recent.And I think I have to repeat that message, and it's getting to be really understood. Of course, we have also big assets of TG4001, which is entering a really exciting and very smart new trial. So these assets are extremely strong. And I think they are better recognized now. So my first goal is really to make that message heard, and I will hammer it.Second, I think we need more exposure in the United States. Of course, we are well-known in Europe. We have a strong knowledge of China, but we must be better known in the U.S. And of course, COVID didn't help last year. But when trouble with begin again, I think we will accelerate on that.I want to accelerate also on the business development side. It's clear that our business model is to sell our products through license at a certain stage. Some of our products we can push them forward quite late, such as TG4001, which is now in randomized Phase II. But some assets, I think we can have -- we can catch a lot of value even if they are very young. And I think that, for example, TG4050 is part of that. So this will happen -- it will not happen by chance, but this will happen with a comprehensive plan, really, to develop these assets, make it known on the market and then out-license it in a way that it would create a lot of value for the shareholder.Also, we are working on the next-generation of products. I think it's -- we have really exciting products in the clinic. We are pushing them. We'll bring value from these products. But we will not stop there. We will come with new products, even if they will be there maybe in 2 years, in 3 years and so on. We are already working on that. So we are revisiting the plan. Of course, it's a more hidden work, but that's still pretty important. So this is really my priorities that I've been focused on, and I will continue in the coming years.

Operator

We have currently no questions from the line. [Operator Instructions] There are no further questions from the line.

H
Hedi Ben Brahim
Chairman & CEO

All right. So thank you much for your time listening to us, and this great conversation, and thanks to your questions. So to conclude, I really want to stress out that we have a great clinical and preclinical portfolio. We will have major milestones. Each of our products will have a clinical outcome in the 18 to 24 months. This is -- I think it will be a key innovator in immuno-oncology. We are confident that we will deliver the strategy, and we will create significant value for -- and improve the options for the patients. So thanks again for your time, and talk to you soon. Bye-bye.

Operator

Thank you for joining today's conference. You may now disconnect.

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