BioInvent International AB (publ) (STO:BINV)
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Earnings Call: Q4 2020
Feb 23, 2021
Yes. Thank you very much for the introduction, and welcome, everybody, to our audio cast for the Q4 2020. The next slide, please. On the next slide, you see our forward looking statements since we are listed in Stockholm. And then on Slide number 3, you will see a very brief snapshot of the company.
So just to remind everybody, so we are an antibody discovery and target discovery company, and we think clearly on cancer immunotherapy. And there specifically, we are focusing on overcoming tumor resistance. We have a lead program, BI-two forty six. This is currently in a Phase III clinical trial for non Hodgkin lymphoma and also in the Phase 1, 2, 5 of solid tumors, and I'll come back to that later in a little bit more detail. And then we have 2 additional programs.
So currently, we have 4 programs in the clinic for proprietary. And I will come back to that in more detail when I discuss with you our current portfolio. All those programs are based on our in house discovery. So we have a discovery engine that has been validated through a number of collaborations such as Daiichi Mitsubishi Takeda and most recently with Pfizer. Pfizer selected in 2019 targets And then by the end of 2020, antibodies that they are now moving into their development pipeline.
On the last bullet on Slide 3, you see a brief summary, and Stefan will come back to that a little bit later. Obviously, we had big news today in the morning announcing a very good and high quality financing. So we have now new shareholders that I would like to welcome, Redmile and then also the Current shareholders such as VanHag, Omega, HBM, Zeb Bank, Revuor, 84 and Invus, of course. And from the current shareholders, I want to mention Van Herk HPM, who were at before INROS. They also participated in this financing that we just implemented during the night and announced this morning.
And we'll come back to that later in more detail. I'm sure there will be a lot of questions around it, and we will try to keep the presentation rather short such that we have sufficient time for Q and A. So on Slide 4, just to remind you quickly about the very unique discovery platform that we have, so this is a phenotypic functional driven discovery platform. And I'm not explaining that to you in detail, just highlighting the USPs. So first of all, I mentioned it's patient centric, which means we are starting from new intronic tissue that we receive freshly from the local clinic in Lund, and we have a very good collaboration with them such that we get high quality material several times a week.
Once we have done our QAQC, this goes into the screening process and we screen our human encoderfetch display library that has been validated now a number of external collaborations, as I already mentioned. And once we have identified specific binders, Then before we even check what those antibodies are binding to, we do phenotypic screening, which means we check those antibodies for therapeutic effects in a number of animal models, and then we only focus on those who have shown strong therapeutic effects. And then for those, we also identify the target. So basically, this is a machine which spits out clinically or preclinically validated targets and targets in antibodies. And obviously, this is of clinical relevance.
That was what I wanted to say before. So with that platform, we have served collaborators, and we might also come back to that in our Q and A session. But most importantly, we have built, and this is summarized on Slide 5, a very interesting portfolio with multiple value drivers. And it's quite focused, even though it's a number of programs. So currently, 4 that are in the clinic.
By the end of the year, we will have 5 programs in the clinic, but they are all around targets and cells which play a role in tumor resistance in various liquid as well as solid cancers. So the main focus is on solid cancers. So we have 1 program in Dona and Hodgkin lymphoma, which is a liquid cancer, obviously. And I go briefly from the top to the bottom. So we have 2 antibodies targeting a structure called SEGAM R2D.
And our lead there is BI-two fifty six. As I already mentioned, this is in the clinic for non Hodgkin lymphoma but also for solid tumors. Just to highlight here, so this program has been partnered for China with CAR T Pharmaceuticals. And in the SOLIDCancer trial, we have a clinical supply in collaboration with Merck, but Merck doesn't any right to BI-six thousand and six. I'll come back to those 2 programs later in more detail.
Then we have a second antibody called BI-sixteen oh seven, and this is actually scheduled to go into the clinic during the second half of this year. And once we do that, we will also announce a little bit more around the mode of action, etcetera, etcetera. So this is news to come basically. Then we had a very broad approach and still have an ongoing approach actually screening on the regulatory cells, specifically in the tumor microenvironment. And there, I want to highlight 3 programs.
First of all, our collaboration with Transgene, which is a fifty-fifty collaboration. And that program is called BT-one, which is a combination of our proprietary the L4 and the oncolytic device platform from Transgene. And there, we just got approval for several clinical trial applications. And this program is ready to move ahead, and we are expecting to enclose to enroll patient at any time point soon. That program, and I will also highlight a little bit more, has been published quite significantly the preclinical data, I mean, during last year and also a lot of promise.
And it's basically a fast follow-up of the replanium program. They also have combined their own colluding virus platform with an anti CKD4 antibody, which is the one which is currently used in the clinic. Then we have quite some activity around TNF receptor 2, which also recently was highlighted in an endpoint article. BeiGene, who have licensed their anti PD-one to Novartis, just recently brought antibodies against TNF receptor 2 into their hands for China. Not only for China, I think for Asia, New Zealand and Australia, option license deal.
And obviously, acknowledging that TNF-two, the pathway of TNF-two plays a big role in the PD-one based therapies. And in that article, it was also mentioned that's by invent, is actually quite ahead of the crowd since we have BI-eighteen oh eight, which is now in the clinic, And we have enrolled the 1st patient, and we have mentioned that already. And then we have a second program, BI 1910, which is basically the preclinical. But we are very much ahead of everybody at the moment, and we are planning to keep that advantage. Then the last column here in a way or the last bucket or category is our collaboration with Pfizer.
And they are maybe just to mention, so they have selected targets that were expressed on tumor associated myeloid cells in 2019. And now in 2020, end of 2020, I've selected also antibodies, which are now moving into their development. Coming then to Slide 6, where I provide a quick product overview for BI-two fifty six. So I mentioned already that it blocks as the gamma R2B and has application potential in both in liquid cancers as well as in solid cancers and also in autoimmune disease. We're going to come back to that later in a minute.
The lead program is clearly in the multiple lymphoma, which is an interesting market and also a very interesting introduction point of the antibody. And as I said, it has the potential also in solid tumors, and I'll come back to that also in a minute. So probably going directly to Slide 7. So in the non Hodgkin lymphoma trial, there we're exploiting hexagonard treatment stress on the tumor B cells. And there, we're focusing currently on 3 areas, which are mentioned on the right, multicellular lymphoma, follicular lymphoma and marginal insomnia lymphoma.
For multicellular lymphoma, we have orphan fracture technician. And The trial design is basically described on Slide 8. So it's an open label study. We're currently and consists out of 2 parts, Part A and Part B. Part A is the dose escalation and Part B, the dose expansion.
We're currently at Part A, and I will summarize the data on the next slide, but not quite yet, just to mention a little bit on the study here. So as I said, so Part A is almost done. We're at the end of dose escalation and we are soon moving into dose expansion. We're basically focusing on patients who have relapsed or are refractory of those 3 different monosomal lymphoma types, monoclonal lymphoma, follicular lymphoma and marginal zone lymphoma. So going to Slide 9, which basically gives a quick update that we already provided to the market at the end of January.
So to date, 15 patients are enrolled in Part A. 9 can be evaluated at the moment and to our serum treatment and out of those 9. We have 2 complete responses, and those complete responses are still continuing as of today. One is more than a year and the other one is more than 2 years, which I think is a very strong value indicator because Those patients that we're treating, normally, if you can get a response again, we'd not respond for that long. And then we have 4 partial responses.
So I think still early days, but 6 out of 9 is a good start as a next step. So we still have to get the read off from 2 patients at the 100 mix, which should come in at any time soon. And then, of course, we'll continue to recruit and then hopefully determine to the recommended Phase II dose. And then we'll start Part B. When we do that, we will obviously mention that also to the market and provide an update.
On Slide 10, you basically see the potential for TROPOL 6. So when we start at the center, with indolent monocular lymphoma. This can be expanded into monocular lymphoma, and we are also looking into solid cancers. And to that study, I will come in a minute. There, we're focusing at the moment on metastatic melanoma and non small lung lung cancer, but We also look into other solid tumors.
And then we also have the possibility to go into autoimmune diseases. But within BioEnvent who clearly focus on the cancer indication and beyond autoimmune disease we try to explore in academic collaborations. And I would be interested to establish at least the proof of concept preclinically and then see how we take it from there, but our focus is clearly within cancer. Then moving to Slide 11. So this is the ongoing solid cancer study that runs under a clinical by and trial collaboration with Merck.
We are currently in Part A. It is also a dose escalation then followed by a dose extension. We're focusing on patients with solid tumors who have relapsed or are refractory to anti PD-one or anti PD L1. And the current plan is to update the market throughout the end of the year about the status and data that we have accumulated so far in that study. So far, the trial is running well and it's enrolled in patients.
So then on Slide 12, a quick introduction to the T Regulatory Cell Program. This is The antibody that I already mentioned, the i8m0a, this is in the clinic for TNF receptor 2. And on Slide 13. You see the clinical trial design. And as I mentioned, so the study has started.
And what we're doing here is basically testing both. So we're looking first for simulation activity. There we are looking in particular for 3 indications, non small cell lung cancer, ovarian cancer, which is quite interesting. Then a lot of material that we use for screening came from ovarian cancer patients. But then we also look at DTE CL, which is the very rare T cell lymphoma, which is also quite interesting since tNF receptor 2 as a target needs to play a role there.
Then in addition, we'll look for combination and for synergies with anti PD-one. There, we also look for non small cell lung cancer as well as ovarian cancer. And I think ovarian cancer is also very interesting And this is an indication where checkpoint inhibitors did not have a strong footprint yet. So as I said, so the study has started. We have enrolled the first patient.
And I think it's quite interesting and We are allowed to start at a relatively high dose such that we might be able to see already glimpse of data during this year. So then going to Slide 15, which is our program that we run-in collaboration with Transgene, BT-one. And so Transgene has a very interesting oncology virus platform based on vaccinia. And that virus can incorporate large payloads such as a full length antibody. And we have identified our screening on 2 regulatory cells, our own proprietary anti PD LIFO, which is nicely differentiated from the one which is currently used in the clinic.
In that way, it has similar inhibition or blocking profile of CTLA-four, but it has much stronger T. Rec depletion activity. And what we could see preclinically and that has been published over the last year significantly that we have a very nice enriched expression of anti CDLFO only in the solid tumor environment after intertumoral infection and a very strong antitumor activity. And that is quite encouraging, and I mentioned already at my introductory part that Reptimmune has a similar program, which already has generated some clinical data, such that our hopes are quite high that we will have at least the same quality of data, if maybe not even better since we have a more potent anti CTLA-four. I should also mention briefly that the anti TNF receptor program, BR-eighteen oh eight, but also BR-nineteen ten also has been published last year at AACR and SITC.
And especially for BI-eight thousand and eight, we had very encouraging preclinical data where we could show that it works as a single agent, but also very well has a combination in synergy in combination with and the PD-one. And that's basically also what we're testing, as I already have mentioned. So I think I stop here. Such as Stefan can give the financial overview and also talk about the most recent fundraising a little bit more detail. And then I have a slide at the end, Slide 18, that basically also highlights the milestones that we have achieved, but also what we are doing going forward, especially also with the new fund coming in.
So Stefan, maybe take it, please, on Slide 16.
Thanks. Please turn to Page 16. I will present the financial overview for Q4 and the 12th March period, January to December. All amounts are in SEK 1,000,000 unless I say something else. Net sales were €98,700,000 in Q4 2020 compared to €25,400,000 in Q4 2019.
That's an increase of SEK 73,000,000. And net sales for January December 2020 was SEK 147 point €4,000,000 and for the same period in 2019, net sales were €93,700,000 and that's an increase of €54,000,000 The Increase is mainly related to that net sales in 2020. It was including we had an upfront payment of $5,000,000 from when we licensed BR-twenty six, the Cassey Pharmaceuticals for the China region. We also had a $3,000,000 milestone from Pfizer, which was triggered by the selection of antibodies under our collaboration. And we had a €2,000,000 milestone under our collaboration with H.
C. Sankyo when they started their Phase 1 study. These prepayments, they correspond to approximately SEK91 1,000,000. In 2020, revenues from production of antibodies was €9,000,000 lower than in 2019 and also €9,000,000 lower for Research Fund. When it comes to operating costs, In Q4, operating costs increased from €65,800,000 in Q4 2019 to €69,300,000 in Q4 2020.
We had higher cost in BI-eight zero eight, 1206 and the TAM program and also lower cost for production of antibodies for customers. For January December, the decrease of operating cost was €9,000,000 from €231,600,000 in 2019 to 222.8 in 2020. We had low cost in BA126, 1607 and the Treg program and also a little bit lower cost for production antibodies for customers. Same time, we had higher cost in BA8 and the TAM program. We also in 2019, we also had some year round.
The profit for Q4 2020 was €28,500,000 and the loss January December 2020 was minus SEK76,300,000. And liquid funds end of December 2020 was SEK729,000,000. When it comes to share issues, the share issues completed in August 2020 amounted to $625,000,000 before issue expenses. And the Kasey Pharmaceuticals. They made a $7,000,000 investment in shares in Q4 2020, and that corresponds approximately €61,000,000 Please turn to Page 17.
I would just summarize the directed share issue that was announced this morning. It's a directed share issue of 96 €2,000,000 that corresponds to $116,000,000 before transaction costs. And the investors, it's a range of international Swedish institution investors, including Redmile, Invus, HBM, AP4, Swedbank RoboFonder and Van Herck Investments. This capital injection enabled us to accelerate and broaden our clinical development. The proceeds that we have got will fund the continued transformation of BioNVent, the expansion of our programs.
And assuming continued generation of positive data, we plan to, in particular, use the fund to prepare a pivotal clinical trial for Biotrila-six with the aim of and that's for NHF, with the aim of receiving an accelerated regulatory pathway. But also to expand the clinical programs of BI 1206 in combination with KEYTRUDA in solid cancer and also BI 888 in solid cancer. The subscription price for new shares was SEK50.36 and that corresponds to a 5 day volume weighted share price we won. 2,800,000 new shares are issued based on authorization granted by the EGN in November, and 16,300,000 new shares are issued subject to approval of an EGM on the 23rd March this year. That was my summary for Perret.
Over to Martin.
Yes. Thanks very much, Stefan. So please, if we could go to Slide 18. Because what I would like to do is to give you a quick summary, and I will not bore you with details there on what we have achieved during 2020. So basically, as you can see that the upper part of the slide, we had quite a number of important clinical and preclinical development milestones and that's, of course, also a reflection that we are pushing ahead with the portfolio.
This is clearly our strategy. So we are not focusing on one program, but on several programs because we feel the best risk diversification that we can do as a company in order to increase the chances of success to generate significant value. Then we also had and still have quite some focus on business development and partnering activities. So we mentioned a number of time already that we have our deal with BI 1246 and Kafi Pharmaceuticals. They got an exclusive license for the Greater China region, which which includes Macau, Hong Kong and Taiwan.
We talked already about the commercial numbers there, But I can say this is really a very active collaboration. You could also see that we had Wei Wu, the Chairman and CEO, participating and our webcast. And we're pleased with Kafi Pharmaceuticals, and we feel that they add also significant value to the program. Stefan mentioned already the milestones that we received from Pfizer and Daiichi. And then of course, We also have in house manufacturing capabilities, which is the number one priority, of course, to support manufacturing for our programs, which also enables us to be very quick.
So just to give you an idea, In August 2018, we had 1 clinical program. By the end of this year, we will have 5 clinical programs and that is only possible with having our own cell and generation and manufacturing capabilities in house. But in case we have in our available spot center. We do also manufacturing for external parties and we signed and this will impact the deal with Cantavia at the end of 2020. Then looking now a little bit detailed at 2021, and I touched basically on the main milestone already.
So obviously, we have started a number of studies. We also presented our early data in Donut and Hodgkin lymphoma. And as Stefan already mentioned, the financing that we just implemented successfully during tonight and announced this morning would allow us really to prepare for potential accelerated approval. Obviously, this whole thing will be data driven, but currently, the data that we see is actually quite encouraging. And if that should hold up during the dose expansion phase, then that's something that we will be prepared for on CMC side, but also with all the clinical development steps that needs to be implemented in order to be able to do that.
Then obviously, we want to push our 2nd program, 1607, into the clinic during the second half of this year, and that will be also exciting, and I think it will be also interesting for the market because then once we do this, we will also give a little bit more granularity regarding the mode of action of this antibody. We have been quite secretive about it, and that's for the reason to give the competitive advantage. And then we have those 2 programs that I already mentioned, 1808 and the other one that hopefully will give us first glimpse of data during this year already, but definitely here. And we will remain active regarding business development and potential additional partnering. You can see that with all our programs, We are actually in quite interesting areas where there's a lot of demand and unmet need.
And then last but not least, so at the end of this year, we will present our second clinical program with BI-twelve oh six with pembrolizumab in solid tumors. So that will be happening at the end of the second half of this year. I think I will stop here such that we have still some time for questions. Thank you very much for your attention.
Thank Our first question comes from Sebastien van der Schu from Kempen. Please go ahead.
Hi, Martin and Stefan. Can you hear me?
Yes. Yes. Hi, Sebastien. Yes.
Great, great, great. Congratulations on the rates of this morning. Can you maybe expand on how the rate has expanded your current cash rate? And does the current cash position also allow you to approach business development in a different from different angle? And can you also give a bit of guidance on what we can expect for R and D and SG and A expenditure in 2021?
Yes, absolutely. Happy to do so. The financials will be covered by Stefan. I can make a quick comment around the partnering with the activities. So obviously, we can be very selective, and we will be.
That doesn't mean that we will not do deals, but we will only do very selective deals, provide the right partner and the right commercial structure. And Already last year, our collaboration with Kafi was actually under that premise. So we want to find the right parties, getting the right commercial structure in place and also keep enough update for ourselves. So Basically, selectivity, that's the catchword there. Stefan, do you want to address the financial points that Sebastian has.
Yes. The cost, of course, that will increase over the years now. We see we had a little bit over €200,000,000 this year or 2020, and that will increase, Yes, quite. We don't really give forecast, but we could say for the cash run is that we foresee with the use of proceeds that we have presented, The expansion of the studies, the pivotal study, we would have money until, yes, end of 2024 and yes, early 2025. It depends a little bit of our plans, of course.
Okay, great. Thank you. And then if I may, regarding epsilon receptor 2b in Hodgkin's lymphoma. You previously mentioned that you would enrich for multiple cell lymphoma patients, which also were refractory to BTK inhibitors. Is this still a goal of the study given that you experienced some difficulty in recruiting these type of patients in so far?
Or will you focus now more on the flicking pulp?
That's still thank you for the question. So that's still the goal, absolutely. But we will also include or we'll look closer also at follicular lymphoma as well because based on the data that we have seen. But we still want to explore and we will try to push for more monthly selling implementations during the dose expansion.
And then regarding the dose escalation, can you give some insight on how it is progressing? Do you expect that the 100 milligram cohort will be the final cohort? Or do we expect more? And then also Regarding the 2 patients you already mentioned in the monomericline cohort, will you PR that separately? Or will you PR that when you have determined recommended Phase 2 dose.
Yes. So starting with your last point, So obviously, what we're trying to do is not to report every patient or every second patient. So what we will do, we will always try to make Just so what I currently can foresee that is, 1, we have the Part 2 dose that we then at that time point do an update. And I can't tell you right now whether the 100 mb will be the final. So what I remember that we might try one dose higher, But I can't tell you at the moment exactly so because we're still waiting for the data to come in.
And then my final question For FG Garners and it could be in solid tumors. We have seen for the other programs that you have generated a lot of preclinical data that Actually supports the rationale, but for acetaminophenol, Septinib and Solutonic, we have Not seen that yet. Can we expect more preclinical or clinical data for Fc telerceptus to be in solid tumors and then especially for 1206 at conferences or in the form of a publication of some sort.
Yes, so what I can tell you, and of course, it's always difficult to promise when it comes in, but we're trying to make a very nice high impact publication around the mode of action of Telpukin in solid tumors. In any case, we will have an update at the end of the year regarding the clinical program and then we might include there also some updates around the mode of action. So the only thing that I can tell you at the moment is that obviously we got Merck on board. They have seen for the data. So that, of course, doesn't help you much because I know everybody is keen.
But we decided basically to keep the data such that we can do an high impact publication. And that, of course, did not stop us to go ahead with the clinical trial in any way. So yes, in summary, so hopefully we'll have some publication around the mode of action soon. That's the piece we're trying to get into place. And in any way, there will be an update at the end of this year around the clinical trial.
And then depending on what has happened in between, we also give some more ideas around the war of action at that time point. So probably might do something similar what we have done for the multi lymphoma study.
Okay, great. Thank you very much, guys.
Thank you. Our next question comes from Dan Achiuti from Pareto Securities. Please go ahead.
Hi. Can you hear me?
Yes, we can then. Hello?
Perfect. Just regarding the increase in Interest from specialist investors that we have seen since last year and now this year, could you maybe shed some light on what they Specifically or what they like the most about the buy and rent and also what are they bringing to the company besides capital?
Yes. Okay. I'm happy to do that. So obviously, what they see is a very interesting package. So I think All of them are not only interested specifically in one program, but they can clearly see that we're building a portfolio, which I think is good for the reason that I already have mentioned.
And then, of course, they can see that we have a fully integrated discovery engine, which spit out those clinical development opportunities. And I think combined with the manufacturing capabilities that we have to become a powerhouse of generating new treatment modalities and testing them in the clinic. So I think that's probably what triggered the interest. And then basically all the programs that we have, they are based on high class forefront science. So for all the programs that we have, We are 1st and best in class, which of course also has a certain risk profile, but since we have then those multiple shots on growth, I think it's nicely balanced.
And I think it is this package which triggers the interest of those specialist investors because they know as good as we know and everybody in the field that good preclinical data and good science is a good starting point, but there's no guarantee for good clinical data. So therefore, we need multiple shots on both. And obviously, what we have Been striving for is not only the money but also high quality investors who can basically support us regarding the further development of the company because that will be the next step to get it in more professional, not only to accelerate and to push and deliver, but also to ensure that we basically really deliver the highest quality. And then, of course, they also provide the network and have also very deep insight into the science. They would know exactly what is going on in completing programs.
And that is, of course, also quite helpful to get their perspective on that as well.
Makes sense. Thank you very much. Another question is on now you have a bit more funds than before, and you also mentioned that you would like Some of the programs in light of personalized medicine, do you consider combinations of Similar maybe as with the Transgene collaboration where you also include the TNFR2 antibody, for instance, for a specific indication. Are you looking Into such kind of expansions of your portfolio?
Yes. So basically, what we are basically ensuring is that, First of all, that since we already have a broad portfolio, that we ensure that we move that ahead as diligent and as quickly as possible, but also with a clear focus on quality because it's not only speed, but also the quality of the data that you deliver. And in that sense, we now can do things, as Stephan mentioned, for the enrollment of monoclonal lymphoma getting prepared for potential pivotal study, which obviously will be a data dependent decision. But then also in the other studies, we might include additional cohorts in other interesting indications or in order to ensure that we move quickly. And then in some cases, we do things sequentially that we now can do a little more in parallel.
And then and that is basically all in order to ensure that the current portfolio, as I presented it today, will move ahead as good as possible. And then on top of that, exactly what you say, and that's something that we already have initiated actually before we even implemented the financing. We're always in the lookout for combinations. And I think a good example for that is the oncolysis virus program that we run-in collaboration with Transgene. And we're looking into other possibilities in order to make sure that and especially on glutivar.
It's actually quite interesting what you can do there if you have the right platform because you can incorporate quite interesting antibodies. And we are currently, as we are speaking, evaluating other combinations as well. Absolutely.
Okay. Thank you. And now with all the capital and the clinical trials and expansion of those trials, I guess we can expect that the clinical team will be increased and also maybe the amount of centers, If you identified other high quality centers around the world to kind of accelerate the trials?
So that's what I call with making the company more professional. So that process already has started. So obviously, we need more heads, more hands, and that is already in process and was already started before we even thought about this new fundraising that we just implemented during tonight. And then clinical centers, yes, that's always something that you look at. But again, also it has to be done very selective.
So it's not that you just say, okay, now I have a lot of money and I get a lot of other clinical dentists on board that doesn't help either. So it will be a very selective case by case process. But now we have the flexibility to add on where it makes sense to add on, absolutely. Okay. Thank
you. Just another question On the 2 additional patients, you mentioned that it could come within the next week with the 100 milligram dose. Can we expect the press release there within the coming weeks, Dennis.
Yes. So basically, as I said to Sebastian, so we don't want to become a company where we basically press release. Every patient or maybe if it's just 2 patients, though, we'd rather put, like we have done already for the last year, well, a more meaningful package together. So I think without committing, but I think what would make sense, once We know the Phase II dose, the recommended Phase II dose, but at that time point, we update the market and then also maybe give another where we are with data. So that's kind of what I have in mind.
And yes, that's probably the next news that you will hear from that program.
Okay. Thank you. And a last question on the PAMs with Pfizer. Do you have any insight into the time lines of Pfizer? Are they initiating a preclinical development this year?
Can we Then expect maybe Phase I trials next year or
I don't have the agreement in front of me. I think probably have some diligence milestones in there. But at the end, of course, as you know, with those pharma collaborations, not only with Pfizer, also the collaboration that we have with Daiichi, Mitsubishi, etcetera. They do it at their pace. And there's not so much from our side to control.
I think nevertheless, It's interesting because if you would put the programs together in a diagram as have done our internal portfolio. We would get an as impressive portfolio, which is kind of a secondary portfolio, but obviously not under our control. But as you could see, so last year, we received a couple of milestones, the year before we did. So those programs are moving quite nicely. And going forward, we will have every year probably 1 or the other milestone coming in as long as those programs are performing.
And from my perspective, so that's nice, but it's obviously nothing that we control. And the most important thing for BioNvent as we did the validation that we get through this because that means that not only we use our platform to generate therapeutic agents. It's also done by a handful of other companies, which are among the high quality and large pharma companies of this world. And I think that's probably the most important message for the shareholders from those collaborations. And eventually, there will be 1 or the other jackpot And then that might hit some later stage milestones where it really becomes interesting.
But we don't control it. No, we don't.
Okay. Thank you very much and all the best in this exciting year.
Thank you, Dan.
Thank you. Our next question comes from Nicholas Aujhammer from Redeye. Please go ahead.
Yes. Thank you. Hello and good afternoon. Just one follow-up regarding the Fire City. If you just could clarify, are you done with Pfizer in terms of screening and selecting targets and antibodies?
Yes, so we did not disclose that specifically publicly. And of course, I have to be careful since it's not only BioEnvent, it's also Pfizer. But the way I would describe it is that Pfizer is moving now into the development phase, which, of course, gives an indication where we are with that collaboration. So we have an ongoing collaboration, which now has moved in its development phase.
Okay. Could you, If possible, comment on the potential value here for those antibodies and programs.
Yes, I think we had some disclosures around that. Stephan, can you maybe make a quick comment here, what we have disclosed publicly?
Sorry, I didn't hear the question.
Can you please repeat? Yes, yes. Regarding Besides the collaboration, how it looks right now, what is the potential value in terms of milestone payments now?
I think it's if you have an antibody that goes all the way to the market, it's $100,000,000 in milestone payments. And then on top of that, you have royalties.
Okay. But there's still several antibodies or how would you describe it?
Yes, basically, as I said, so they have selected targets and now they have selected antibodies. And obviously, you will understand, Mikaelas, so since this is always very coordinated, the communication that we have to do with Pfizer, But we can't say anything in addition that has already been announced in the context of the Pfizer collaboration.
Okay. Understandable. Thank you.
You're welcome.
Thank you. Our next question comes from Sebastian Van Der Schuy from Kempen. Please go ahead.
Hi, guys. I just have Few more questions. And that's mostly regarding the time lines. Regarding Sigmarsson to be in On Auspension Pharma, when do you expect to actually have the recommended Phase II dose? Is that still in H1 twenty 'twenty one.
How do you expect it to be in H2?
That could be still in H1. But of course, this is always difficult to forecast. So the current forecast that we have, it should be during H1. And then, of course, this is driven by the recruitment, etcetera, and maybe COVID. So far, we can probably still maintain that expectation.
So we would actually, as I said, in the next couple of weeks, maybe months, then we would like to know the recommended Phase II dose such that we can move into dose expansion.
And then for the TENAR42 program, you mentioned that you Before that, you already start at clinical meaningful doses or can Actually escalate faster than with the TNFR2. Do you expect still that you would have data or some sort of data in 2021?
Yes, that could happen actually. And of course, again, to be also very careful here and to manage expectations very clearly. So the driver here is really that the study is going well and that we are at this high dose, which also has a relatively high receptor occupancy. And then basically, the expectation that we are currently having is based on the preclinical data set that we also published last year at AACR in Sydney, where we basically and that is, of course, all animal studies and you cannot extrapolate that 1 to 1 into human. But based on that and the high dose that we already are providing to patients, We have some expectation or let's put it that way, we have hope that we might see something at the end of data during this year.
Yes. Okay.
And then one final question is regarding the effect of We're starting actually commercial with the P in solid tumors. In non Hodgkin, Srivarma, you are also seeing depletion of B cells. Is it something that you would also see in the solodimera setting?
Yes. You would get the same effect Obviously, so the main difference really, if you think about in the context of mode of action is, as I briefly mentioned in my part of the presentation. So when we are in the monocular lymphoma setting, then we're targeting epsigamR2b on the tumor B cell. And it looks also, especially in those indications that we have selected as well as there's a clear correlation also with the outcome of our resistance to rituximab with the expression of Fc gamma RGB. So of course, the expression rate plays a role.
But in the solid tumor setting, obviously, the FDM R2b is not expressed by the solid tumor cells there. We're targeting really the innate immune Cells in the tumor microenvironment, which are, by the way, also overexpressing epigramargine and there's also a nice correlation with resistance or non responsiveness to anti PD-one and anti PD L1. But you could see certain spillover effects there to the NGL, obviously. Yes.
Okay.
Thank you very much.
You're welcome.
Thank you. There appears to be no further questions registered. So I will hand back to the speakers for any other remarks.
Yes, I think this as we already have summarized, this is really very, very exciting times head, I think we have now a very stable financial position, which gives us the power and strength to really execute as good as we can on our portfolio. And since we now have a number of programs in the race. I think there will be ample of data points coming along during this year and next year. So that will be exciting to see. And as I mentioned, so we still have also we'll have all the activities on the BD partnering side, but we will be very selective that we know can be with the good financial position that we're having.
So that will be my final words. I don't know, Stefan, whether you have any concluding remarks from the financial perspective.
No, I think you have no additional. You summarized it very well. So thanks everybody for your attention today.
Absolutely. Thank you very