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Edited Transcript of TRVX.OL earnings conference call or presentation 7-May-20 8:00am GMT

Q1 2020 Targovax ASA Earnings Call

OSLO May 29, 2020 (Thomson StreetEvents) -- Edited Transcript of Targovax ASA earnings conference call or presentation Thursday, May 7, 2020 at 8:00:00am GMT

TEXT version of Transcript

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Corporate Participants

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* Øystein Soug

Targovax ASA - CEO

* Torbjørn Furuseth

Targovax ASA - CFO

* Victor Levitsky

Targovax ASA - Chief Scientific Officer

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Presentation

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Torbjørn Furuseth, Targovax ASA - CFO [1]

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Good morning, everyone, and welcome to Targovax' First Quarter Virtual Quarterly Presentation. I am Torbjørn Furuseth, I'm the Chief Financial Officer of Targovax. And today, I also have with me is Øystein Soug, our Chief Executive Officer; and our new Scientific Officer, Victor Levitsky.

This is the first time we're doing a virtual quarterly presentation, so let's hope the technology is on our side today. 2020 has been a very exciting year for us so far with a lot of events. And we will take you through that. The program today, first, we will give an introduction to Targovax and our activities, then go to the highlights, before we introduce Victor, the new Chief Scientific Officer. And then we will talk a little bit about some new pipeline initiatives, before I round up with financials and the news flow.

At Targovax, we strongly believe in the importance of activating the patient's immune system. And we also clearly see that there's a growing need now in the market and in the treatment of patients for immune activators. And cancer treatment is now really being revolutionized by the introduction of checkpoint inhibitors and immunotherapy. And checkpoint inhibitors were introduced in the market 5, 6 years ago and have already become a $22 billion market, and several patients have been helped by this treatment. Almost 40% of cancer patients are eligible for a checkpoint inhibitor treatment.

However, they're still -- not sufficient to treat only with checkpoint inhibitors because only 10% to 40% of the patients actually do respond to a checkpoint inhibitor. And the reason for that is that the immune system is very tightly regulated to avoid reactions against self. So there are a lot of inhibitory factors. And also, one important factor is that you need to have the right T cells that can kill the cancer. And that leads to a very strong need for checkpoint inhibitors -- sorry, for immune activators. And that's where we, in Targovax, and our technologies come in.

Our lead assets is ONCOS-102. It's an adenovirus platform targeting hard-to-treat solid tumors. It is one of the furthest developed oncolytic viruses, and we have soon 200 patients treated with ONCOS-102. Currently, there are 4 ongoing trials, and there is, therefore, a rich news flow coming out from our programs.

So far, we have strong data. We have a 33% ORR in refractory melanoma in combination with KEYTRUDA. We also have shown strong single-agent data, which is important to show and getting even more challenging these days with all the immune therapies and combinations being introduced. And also this year, we have shown encouraging data in mesothelioma.

So how does our ONCOS-102 work and why is it an ideal partner for -- a combination partner for checkpoint inhibitor? So what we do, we inject the virus locally and either directly into the tumor, intratumoral, or into the peritoneal cavity, intraperitoneally, and virus then infects the cancer cells because it has a higher affinity for cancer cells. What happens then, the virus replicates and prescribe -- and transcribes also the GM-CSF, the transgene. There is a lysis of the tumor cell, which creates a strong immune activation and the unique tumor antigens for the patient is released.

Then the immune cells come in. They take up the antigens and bring them to the lymph node, where T cells are activated, specifically targeting the patient's tumor. And then the T cells infiltrate the tumor and attacks the cancer cells, and this is where the synergy with the checkpoint inhibitor is really important. Since the checkpoint inhibitors is now allowing the T-cells to kill the cancer.

And we are not the only ones that believe in oncolytic viruses as one of the key modalities to improve the cancer treatment. Over the last couple of year, there has been several large deal done by big pharma. And the last one was Takeda when they made a strategic collaboration with Turnstone in a deal that totals up to $1 billion, if successful. But also, quite rich on near term with $120 million.

Viralytics is also a significant deal, that's 2 years ago when Merck acquired the Australian company. That's a company fairly similar to Targovax. They were in Phase II when they were acquired for $400 million. And then there are also several more preclinical deals and collaborations. So with that background, I will give the word over to Øystein, that will go a bit more into our strategy and our program and the highlights for the quarter. Øystein, are you with us?

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Øystein Soug, Targovax ASA - CEO [2]

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Yes. Hello, everybody. Thank you, Torbjørn, for this introduction.

We're now on Slide 9, which is the ONCOS development strategy. And the strategy for the ONCOS platform is fourfold, and one of the strategies that we're following is, of course, [gets] as quickly as support to the market. And today, the way (inaudible) this mesothelioma is our -- is the path to market. (inaudible) it's a fairly small indication with limited competition, several reasons why (inaudible) in this indication.

So this is where (inaudible) we also know, there is a (inaudible) where we start (inaudible) next state to -- with a (inaudible) combination of (inaudible). And in terms of (inaudible) something which I (inaudible). One is to activate refractory tumors (inaudible). But I think immune activators start production of the relevant T cell [once again], so (inaudible) [challenge checkpoint inhibitors], the patient will (inaudible).

The second area is (inaudible)…

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Torbjørn Furuseth, Targovax ASA - CFO [3]

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Øystein? It sounds like the line is quite bad. So I suggest that I just step in and take over that because of this bad line.

So just on the development strategy. First, we want to establish a path to market, which is the mesothelioma indication. It's a fairly small indication, but we have orphan drug designation. And we have a potential to also become a first-line treatment with a limited competition compared to other indications.

Secondly, we also want to activate the refractory tumors to really generate and restart the immune attack on the cancer, and that's what we're doing in the melanoma indication. And this is really a benchmarking arena for checkpoint inhibitors as well.

Secondly (sic) [Thirdly], we also want to expand the checkpoint inhibitors because they do not work in all indications. So if we're able to open up new indications where checkpoints in combination with ONCOS-102 can help patients, that also is a big potential. So that's the peritoneal trial we're doing together with AstraZeneca. And these are patients with ovarian or colorectal cancers that has spread to the peritoneum, and treatment alternatives are few and bad for those patients.

Secondly (sic) [Fourthly], we also want to expand our pipeline with the next-generation viruses where we have inserted double transgenes with unique and novel mode of actions.

So this then translates into our development program. We started out with a compassionate use program and entered into all-comers solid tumors trial with 12 patients, where we saw very interesting immune responses and improved survival. And now we have the 3 dark blue trials ongoing.

The mesothelioma is a randomized trial in combination with standard of care chemotherapy. And we have released the first set of data, and we're now following the patients. So 9-month data, we just issued a short press release, and 12 months data will come later this second quarter.

In the anti-PD-1 refractory melanoma, this is the combination with KEYTRUDA. It's led out of Memorial Sloan Kettering in New York. Part 1 we completed with a 33% ORR, and the Part 2 is ongoing.

The peritoneal malignancies trial is the combination with Imfinzi. It's a PD-L1 antagonist. This is an intraperitoneal administration, as mentioned, and a strong collaboration with AstraZeneca, Cancer Research Institute and Ludwig Institute. We'll also come back and talk a bit more about that trial later.

So to the highlights. For ONCOS, we have announced encouraging 6 months data and the follow-up on the 9 months, that the data are in line with what we've seen so far. We did complete the recruitment in melanoma trial. And that is -- that was important in itself, but also in the light of the COVID-19 outbreak, it was also very important that we were able to fully recruit the trial prior to the outbreak.

And also, yesterday, we announced that the abstract on the interim Phase I data from the peritoneal trial is accepted at ASCO. We'll also talk a little bit more about that.

For the mutant RAS platform, we announced early in the year the option agreement we made with the Chinese company, IOVaxis Therapeutics. So they have an option to take a license on TG in China -- in Greater China. We'll also come back a bit more on that later.

We also entered into a collaboration to develop the mutant RAS neoantigen coating of our ONCOS-102. So this is really merging the 2 platforms we have into one, and delivering the peptides in a different way that we hope can give a stronger and better immune activation.

And finally, we did a raise in January, where we raised NOK 101 million in gross proceeds. That was also good timing, we believe, based -- since the COVID-19 created some uncertainties later.

And then on the Annual General Meeting, Damian Marron was elected as the new Chairman. We're very happy about that. So a very strong, strong profile, and I think that will be very helpful for the company going forward. That also goes with Victor Levitsky that you will meet later today if the line works for Victor.

So a little bit more on mesothelioma. As you remember, this is a patient population quite mixed with both first line and second and later lines. And first, we had the nonrandomized phase, where we treated 6 patients. And then we went into a randomized phase with 14 in total in the experimental group and 11 in the control group. This was a randomization. So in total, 20 patients were treated with ONCOS-102 plus standard of care chemo, which is pemetrexed and cisplatin.

The 6 months data set were released in detail, the 9 months data set were much in line with those data. And we will come with a 12-month update later this quarter or in the second quarter.

So what we saw, no safety concerns from the combination, and that's important. We saw a PFS of 8.9 months in the first line. And this first line is what is clearly most interesting and important for us, so that's what we will be pursuing going forward. And the data compares favorably to the historical controls we have seen. We also saw immune activation in T-cell infiltration and in PD-L1 expression. So those are also important measures that we got out from the trial and could compare also with control group. So all in all, we see a robust immune activation that is associated with a clinical benefit.

So next steps will be the 12 months data. First line is now identified as the target population. And we see a strong rationale for a combination with an anti-PD-1 or PD-L1 checkpoint inhibitors. As we said also earlier, there is discussions with a pharma partner to provide the checkpoint inhibitors for us. And that's the deal we envision that we will get free supply. And now there has been some questions to that, whether it will be milestone payments or licensing rights, but that's not included in this discussion. And we are now also collaborating with a partner on the trial design and the study protocol.

So a few words on COVID-19 and the impact for Targovax. What we see is that, in the data collection, there are some changes. Some hospitals has -- have closed their labs. So some of the samples we plan to take from the patients will not be taken, unfortunately, but it won't sort of have a huge or a significant impact overall on the trial, we believe. For some sites, they have also closed external access. So the monitoring of the trials are stopped at some hospitals. So the readout time lines will be somewhat delayed, but we still believe that the guiding holds true.

So the recruitment in mesothelioma was completed in '19, so that's not affected. Melanoma was also fully recruited. The peritoneal trial is still recruiting, but we have seen, as a consequence of COVID, that recruitment rate has been reduced somewhat, so probably some extended time lines before we can have final data from Part 1.

On the logistics side, with production of the virus and also with distributing the virus, we have seen no interruptions, and the treatment itself of the patients also is going as planned.

So with that, let's see if we can connect Victor. We are very happy and proud that we were able to recruit Victor to our team. He has a very strong background, and he's a great person to work with. So I hope you can meet him now virtually.

Victor, can you hear us?

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Victor Levitsky, Targovax ASA - Chief Scientific Officer [4]

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Yes, Torbjørn. Thank you. I hope that the line works for me and I can start talking. So I'm very pleased, first of all, to become a member of the Targovax team, which is composed of very dedicated to qualified people. And what I will try to do now is to summarize my qualification and experiences, which I could add that will generate a favorable (inaudible).

As you can probably see it on the slide, which is on your screen now, I am trained as a medical doctor. And after my graduation from the medical school, completed my PhD in virology [formally]. But already, at that time, I started learning immunology as my work has focused on generation and characterization of monoclonal antibodies for viral diagnostics.

In the early '90s, I was invited to the Karolinska Institute for 3 months and I stayed there for 15 years, progressing to the ranks of associate professor and independent principal investigator having my only laboratory which was funded by (inaudible) funding [solution] agencies. And as my work was primarily focused on immunology of (inaudible) virus, which (inaudible) tumor-associated viruses, I will always operate as a scientist on the junction of virology and immunology (inaudible). And this culminated at some point in the first clinical trial, which I (inaudible) hospitals. Although, on cell therapy or [worked mainly on] single virus associated with (inaudible).

[For giving], my academic career entrance and training a number of (inaudible) scientists, where I'm now holding independent academic position for work (inaudible) companies (inaudible). In 2005, I joined -- I left Sweden and joined Johns Hopkins University, which is the #1 medical school in the United States and (inaudible) center. And even if it's (inaudible) office organization, at least (inaudible). And Johns Hopkins, I spent approximately 5 years as a (inaudible) chair at oncology department and worked alongside with the most [prominent] onco-immunologist in the center, who (inaudible) to, a large extent, shaped the (inaudible) of immunology.

In 2011, I decided to move back to Europe and at that -- joined the industry, starting a position at Roche as a senior principal scientist and tumor immunology leader in one of the major R&D oncology -- immuno-oncology centers of the company located in Zurich, and where I build essentially from scratch a new department of human immunology and contributed significantly into the shaping of the portfolio of the company in this field. And now several compounds which have invented and developed have been prioritized for a clinical development approach.

So after 5 years in -- I left Roche and joined Molecular Partners, which is a biotech located also in Zurich as the head of oncology research of that company with a mandate field and develop onco-immunology portfolio. Now for this (inaudible) before (inaudible) development. And I think (inaudible) fully accomplished this mandate, which can be just exemplified by (inaudible) with the company's (inaudible) for [$30 million] in double-digit royalties, development of just one of the assets(inaudible).

And now at this point, I feel that I can (inaudible) make an oncology (inaudible) deliver on the promise that has been (inaudible) quite some time already. And I think we have got (inaudible) incremental progress on the -- and are ready to lead through with the disposition and make it (inaudible) indications for patients with oncolytic viruses platform (inaudible).

So if we move to the next slide, then this slide summarizes really how I see my short-term and mid-term goals at the company. First of all, of course, it would be very important to support design, collection and analysis of scientific data and the interpretations of this data, and make sure that we will learn as much as possible (inaudible) antibodies that Torbjørn has described in his presentation.

And then generate and continue to (inaudible) the full potential available ONCOS-200 series of compounds on which the company has been investing for quite a while. And then, of course, we also initiate external collaborations and support for development of both ONCOS and TG platforms.

If we can proceed to the next slide, if you follow the progress of the company, you probably know already that the company had investment in generation of several viral vectors, which shall [improve the proteins] for potential (inaudible) activities. I will not discuss this in detail today. I think (inaudible) that these viruses have been primarily characterized both in vitro and in vivo and do not show any unexpected issues which would prevent further development.

And now it is our task to design and generate the clinical (inaudible) which will reveal the most optimal way potential of this new construct. And this will open very significant important new development and business development opportunities for Targovax.

I am also strongly convinced that we continue to invest into the expansion of the (inaudible) program by developing additional viral constructs with immunomodulatory functions. And this can be done in collaboration with external industrial and academic partners, and some (inaudible) cooperations that we have on the radar. [But in the end] (inaudible) and the new one should be initiated following the (inaudible) important potential investments which are [initiated].

In the next slide, you can see that the company is always thinking of developing the ONCOS platform in some kind of merger with the RAS-mutated peptides, the TG (inaudible). The company has recently announced its collaboration with Valo Therapeutic, which developed novel technology allowing to coat viruses with its particles with peptides, and we are considering the possibility of using TG peptides in the system, which together with immunomodulatory properties of onco-viruses, will help boost immune responses (inaudible) neoantigens, which are (inaudible). And I hope that we will be able to share more details on these collaborations and including the ones that I have not mentioned today in our quarterly presentations.

And maybe the last statement before I conclude and pass to Torbjørn the deck, when it comes to the long-term vision, my long-term vision for the company is (inaudible) we're able to (inaudible) just the best in oncolytic viruses in this particular space, and generate a lot of new value for patients and for the market.

So thank you very much for your attention. And then I give the [floor to Torbjørn].

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Torbjørn Furuseth, Targovax ASA - CFO [5]

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Yes. And thank you, Victor, and I look forward to join you to achieving what you just said.

So over to the financials. As I mentioned, we did a raise back in January. So that's now -- that was an important raise for us because now we are sufficiently funded to advance the program beyond the important readouts and value inflection points.

At the end of the first quarter, we had NOK 135 million in the accounts. The net cash flow was positive due to the raise of NOK 65 million. And the market cap is now trending around NOK 690 million.

We have the same coverage as previously with DNB, Wainwright, Arctic, ABG, Redeye and Edison. The shareholders list is also given here with HealthCap and RadForsk still the 2 largest owners. We see fourth AP-Fonden from Sweden that came in, in the last capital raise. That's a strong fund, and they have increased their holdings since the share issue. We now have still around 5,000 shareholders.

So going a bit more in detail on the OpEx. The total OpEx for the quarter was NOK 30 million. So that's fairly much in line with the third quarter of '19 with the fourth quarter in between that had an increase again in -- especially in the external R&D. But we see now that we're now coming more to this level going forward. And as you can see also, the operating expenses have now stabilized lower than they were due to focus on costs.

As you also may remember, we had a resizing of the organization back in May last year. So payroll is also reduced from previous years and are now stabilized. And yes, as I said, the cash end of the quarter was NOK 135 million.

So to the news flow, this is our pipeline overview. The mesothelioma combination trial, we are still generating data and the important 12 months data will come later in this second quarter. Melanoma, we are guiding for second half with clinical and immune data.

The peritoneal malignancies, we released the press release last -- yesterday, telling that we are accepted for ASCO as an abstract. So that is -- we're very happy for that. And our principal investigator of the trial will be presenting the poster.

For prostate, that's not an important trial for the company. It's still ongoing. But due to COVID, the recruitment has stopped. So we will await when the recruitment will restart.

And yes, the next-generation viruses, we will have updates on upcoming conferences. And also, we have now added the novel mutant-RAS concept. So this is something we have been working on for a while, and we have some dialogues or NIDs or other approaches as well. Of course, we cannot say more about it before we can say about it, and we'll press release it. But it's -- we're happy to see the collaboration with Valo, where we can really merge our 2 technologies, ONCOS, oncolytic virus, and the mutant-RAS peptides.

The next events, ASGCT, where we will present the next-generation viruses, that's in a few days next week. ABG has a conference in -- it was planned for Stockholm, but has now gone virtual. We will participate there. ASCO also has become virtual, and the peritoneal trial will be there with an abstract presentation. And also, AACR, we will present the next-generation viruses.

So -- and then we're also invited to present at the IO Summit in Boston and the RAS-targeted drug discovery summit also in Boston in the fall. And as of now, they are still planned to be face-to-face and not virtual. So that's what we're preparing for. But we can, of course, also change to virtual if that's required.

The next upcoming milestones, the most important ones, are the 12 months data from mesothelioma and then the melanoma data from Part 2.

So to round up Targovax, activating the patients' immune system to fight cancer, that's really important now in the combination with the checkpoint inhibitors. Our ONCOS program is clinically proven. It's one of the furthest developed viruses. We have strong single-agent data, and we also have activation of anti-PD-1 refractory tumors.

Our pipeline is innovative. We have next-generation viruses with novel transgenes and double transgenes. And we have now also started to explore novel mutant RAS concepts, building on our expertise and technology platform.

And also importantly, 2020 is a year with rich news flow. So clinical and immune activation data from mesothelioma and melanoma will come out. And also, there will be data from the peritoneal trial we now know.

So with that, I thank you all for following. This is -- this was the presentation we wanted to give you. And we have received some questions. Since Øystein was on a bad line, I suggest I'll just go through it.

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Questions and Answers

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Torbjørn Furuseth, Targovax ASA - CFO [1]

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And yes, it's about the mesothelioma trial and the undisclosed big pharma partner, and if we could expect some shared costs or milestones.

I think I've touched upon it in the presentation that what we're discussing now is free supply of checkpoint inhibitor and also collaborating on the trial design and protocol. And yes, so that's the involvement from the big pharma partner. But that's also important actually to have their input on clinical development of a compound.

And there's a question, after we released the mesothelioma in January, if we have noticed increased interest from academic centers and/or commercial partners to participate.

And yes, we have experienced an increased interest from both commercial and academic centers to participate.

And then there's a question on the ipilimumab and nivolumab trial from BMS.

And there was a press release on the BMS trial, I think, around a month ago, where they said that they had met primary endpoint. They did not disclose any data, so it's difficult for us to interpret sort of the impact of the trial and how strong the data are. But certainly, we -- and there's a question also if we're able to change design. Yes, we're still in a phase where we can change design if we see that is beneficial.

But I think still a lot of -- I think the combination with the chemotherapy is also perceived to be important to debulk the tumor in the early stage. If you only do immune therapy, you might sort of lose the train the patient progresses too much before the immune therapy really starts working. So I think our belief, that also goes with several clinicians, is that chemotherapy should be part of the therapy.

And then there is also a question about the cost of the mesothelioma trial.

We are now in a phase where we are negotiating with CROs, imaging, labs and everything. So the final costing is not clear. But -- it's a 100-patient trial. So I would say, plus -- or at least NOK 200 million is what we foresee so far.

For the melanoma, there's a question if there will be interim results before the summer or if we will only communicate the whole data set in the autumn.

So our guiding is still the second half. As you saw, that there's some issues on the monitoring of the sites. So there might be -- we are sort of considering whether we wait or we do an earlier release as well. So that's not finally decided. But for now, we still keep the guiding of second half.

For TG, if you could describe a bit more where we are in the process with IOVaxis and the work there.

So what we're doing now, we are collaborating on the IND filing. There is communication with the Chinese FDA and [NDA]. And we are also negotiating the final collaboration and licensing agreements. So that's ongoing.

Yes. Is there a milestone payment from IOVaxis both at the exercise option and with the start of Phase II?

So there is an exercise fee. So if they decide to execute or exercise their option, then there is payment to Targovax. And also, if their Phase I trial is completed, there is the payment to Targovax, but not at the start of the Phase I trial. So I guess that's -- and then, yes, a bit more on the deal structure. So I think in all these types of collaborations, where you sort of -- that you need to still develop the compound, it's fairly back-loaded deal, so to make sure that the company has funds available to really develop the compound.

Is there currently any ongoing dialogue or interest from potential commercial partners or academic partners to bring TG into clinical trials in Europe and the U.S.?

And yes, we have discussions. We don't want to sort of speculate too much, but there are both discussions with academic and commercial partners for TG in Europe and the U.S.

So for the new next-generation viruses, there's a question whether we will present data at AACR, the virtual rescheduled conference. And that's -- we will do that.

And there's also a question of -- since the majority of the oncolytic virus deals are done in the preclinical stage, what can we expect from ONCOS-200 series near term? And what is the development strategy for these assets?

So I would say that we are still developing the viruses. It's still early also in terms of preclinical work. So our assumption is that we will develop those viruses a bit further before they become attractive to potential partners.

For the peritoneal trial, there's a question on what will be presented at ASCO if the disease control rate and the predefined targets are set and met in the 2 indications. Is there any plan on what will happen after completion of Part 2?

I would say that -- so the ASCO poster is focused on the safety lead-in. So the data and presentation will be available from the safety lead-in only. Part 1 is ongoing. And depending on the recruitment, we hope we might see it this year, whether the endpoints are met to move into part 2, but it might also be into next year. So I think plans for what happens after Part 2, we haven't discussed so far.

Yes. And if we have moved into Phase II. So phase or Part 1 is now recruiting. So that's what's ongoing. And we will announce if and when Part 2 is initiated.

And then there is a question whether we have been picked out for the poster discussion sessions at ASCO.

And we didn't specify that in the press release. It's not entirely decided yet, but it is our understanding. So I think we will announce that specifically later if that materializes.

On the financing, there's a question if we have estimated -- or what is the estimated burn rate for the next quarters since the clinical activity in the company is -- or sponsored by the company is being reduced.

So as you -- as I also indicated when I presented the OpEx data, we see that the third quarter in '19 and the first quarter of '20, there was a significant lower OpEx than the other quarters. So we expect that total cost will be more in line with those quarters than the other quarters going forward. And I think the payroll will be fairly stable. The other operating expenses will be fairly stable. So it's the external R&D that is the variable going forward.

Are there any more questions that came in? This one?

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Unidentified Company Representative, [2]

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Yes. And I guess...

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Torbjørn Furuseth, Targovax ASA - CFO [3]

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Yes. But -- okay. So presuming that 12 months mesothelioma data will be in line with the 6 and 9 months' results, will that be sufficient for you to confirm further development plans?

Yes. I think, so far, it looks encouraging. And I mean it will be a total assessment of all factors and alternatives. But so far, so good, and that's what we foresee.

And the new preclinical data with the next-generation viruses this year, that might be -- I wouldn't be too firm on that, and I will -- I think what we have been thinking is that when we now manage to recruit Victor, it would make sense for him to get an overview of what we have and what we've done and also make up his mind on what we should do going forward.

And -- yes. So for new viruses, it's -- the next-generation of viruses' posters, 2 different studies. So they are -- yes, I believe they are different, the 2 different posters for each individual, the 2 different viruses.

So I think, with that, we conclude this first Targovax' virtual quarterly presentation. I hope you were able to understand our messages. I'm sorry the line was bad, especially for Øystein. So if you have any further questions to us, feel free to shoot us an e-mail, and we will come back to you.

Thank you very much.