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Edited Transcript of TRVX.OL earnings conference call or presentation 11-Mar-20 9:00am GMT

Q4 2019 Targovax ASA Earnings Call

Oslo Mar 27, 2020 (Thomson StreetEvents) -- Edited Transcript of Targovax ASA earnings conference call or presentation Wednesday, March 11, 2020 at 9:00:00am GMT

TEXT version of Transcript

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Corporate Participants

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* Magnus Jäderberg

Targovax ASA - Chief Medical Officer

* Øystein Soug

Targovax ASA - CEO

* Torbjørn Furuseth

Targovax ASA - CFO

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Presentation

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Torbjørn Furuseth, Targovax ASA - CFO [1]

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Welcome, everybody. Welcome to the people in the room. Welcome to the people on the web. Welcome to the Fourth Quarter Presentation of Targovax. My name is Øystein Soug, I'm the CEO. And with me today, I have Magnus Jäderberg, who is the Chief Medical Officer; and Torbjørn Furuseth, who is the CFO. I will give you an introduction and some highlights before Magnus will talk more about the trials and the recent data that we have achieved. And towards the end, Torbjørn will wrap up with the news flow and financials.

In cancer treatment, there's a revolution going on. And that revolution is immunotherapy. Within immunotherapies, the checkpoint inhibitors are leading this revolution, having a great impact on the treatment of patients today, even curing some patients and representing a market of $22 billion last year. But even though checkpoint inhibitors work really very well in some patients, they don't work well in all patients. Actually, most patients, they do not respond to checkpoint inhibitors. And in the indications where checkpoint inhibitors work the best, like in melanoma and lung, you usually see typical response rates only up to 40%. And in other indications, it's much lower. And this has created a great medical need in order to find combinations with checkpoint inhibitors in order to make them relevant for more patients.

And this is where Targovax can play a role in immunotherapies going forward because checkpoint inhibitors, they don't kill cancers. It's the T-cells that kill cancers. And when we say that we immune activate patients, we're actually saying that we create the relevant T-cells in the patient's tumor microenvironment to kill cancers. So that's what we're trying to do. That's the reason why we are here. ONCOS-102 is our lead clinical asset. We are currently one of the most developed oncolytic viruses out there. We have 4 ongoing trials, and there is plenty of data coming later in 2020 from these trials.

Behind us, we also have some results that point to the efficacy of ONCOS-102. We have conducted a trial in monotherapy without a combination, where we have shown some interesting indications on immune activations and the clinical effect. Obviously, we don't think that ONCOS-102 is going to be used as a monotherapy in the future. We'd all think it's going to be used in cocktails, primarily in combination with checkpoint inhibitors. But it's important to show that the agent works alone as well. And we have done that. We've also shown efficacy in combination with checkpoint inhibitors and Magnus is going to talk more about that later. And also, in one of our trials, we recently announced data from, we have shown efficacy in combination with chemo.

Now the way ONCOS-102 works is that we inject it into the tumor of the patient. The tumor gets infected, the cell lysis or the cell breaks up and the tumor cell releases antigens. And these antigens, they are, in a way, the bar code of the cancer. They inform the immune system about the nature of the cancer in question. When the antigens are being released, they are being picked up by the immune system and the immune system then starts producing T-cells that patrol the patient, seeking up the cancer cells and killing the cancer. That's the way ONCOS-102 works.

ONCOS-102 is an adenovirus. And adenoviruses have some advantages. One of the advantages is that it's immunogenic. So it creates flu-like symptoms in the patient, which is important in order to sort of kick-start the immune system of the patient. We don't see any safety concerns with adenoviruses. And it provides a backbone on which we can load transgenes, several transgenes in order to enhance the efficacy of the lysis.

Oncolytic viruses have been around for some time. But over the last couple of years, also big pharma has started to recognize the importance of oncolytic viruses. We have a list here on the slide showing some of the major collaborations and acquisitions that have happened over the last few years. I think the most relevant for us is probably Merck's acquisition of Viralytics. Viralytics is a company that is not too dissimilar from Targovax. But to us, this provides a confirmation that we're on the right track. And that oncolytic viruses is something that also big pharma cares about.

Our strategy with the oncolytic virus is, of course, to get to the market. And we think that mesothelioma can provide an interesting avenue for us to get to the market quickly, simply because we have some advantages in terms of being advanced compared to the competition. And there's also very little competition. But the big promise on oncolytic viruses is to combine them with checkpoint inhibitors. And we seek to demonstrate that our oncolytic virus, ONCOS-102, in combination with a checkpoint inhibitor, can reactivate tumors that are refractory to checkpoint inhibitors, but also that we can provide a benefit to patients with cancers that do not respond to checkpoint inhibitors in the first place. In addition to that, we also have a next-generation platform, where we change the transgenes of the virus.

This strategy is being implemented in this trial program. So the light blue boxes. These are programs that are behind us, single agent. And what we do at the moment are the 3 trials, as you can see in the dark blue box on the right. Mesothelioma, in combination with checkpoint inhibitors. Magnus is going to talk more about that later. The next trial that we're planning in this indication is going to be -- so this current trial is in combination with chemo, the next trial is going to be in combination with both chemo and checkpoint inhibitors. We think this is our path to market. The second trial is in checkpoint inhibitor refractory melanoma in combination with checkpoint inhibitor. And the last one in peritoneal malignancies stemming from ovarian cancer and colorectal cancer in combination with a checkpoint inhibitor, these are indications where checkpoint inhibitors don't work, and we want to investigate whether combining with our oncolytic viruses can make checkpoint inhibitors relevant for these patients. Magnus is going to talk more about these trials and the data we have so far later on.

The highlights over the last few months include the first data set from the mesothelioma trial. We reported that data in January, and we're very happy about those results. Magnus will get back to that. We have also completed the recruitment of the melanoma trial. The first part of that trial, we reported last year, and that was reported at SITC, that happened in November. On the mutant RAS platform, we entered into a collaboration or in an option agreement for a license in China, with a company called IOVaxis. Sort of the first sign of us giving legs to the TG platform, taking it forward with partners as we have promised. And on the corporate side, we raised NOK 101 million.

So as promised, I'll give the word to Magnus. He will start off by talking about the mesothelioma trial and the mesothelioma results. Magnus?

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Magnus Jäderberg, Targovax ASA - Chief Medical Officer [2]

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Thank you very much, and good morning, everyone.

So mesothelioma, what is it? Well, it's a highly malignant tumor in the lining of the lung. And it's a very difficult tumor to treat. And if you look here on the upper left-hand quadrant, you'll notice that only a small percentage can actually be surgically resected. And surgical resection is the only curative treatment here. So about 80%, 90% of the patients, unfortunately, can't be operated on. And in that case, there's only 1 standard of care treatment and that is a combination chemotherapy of pemetrexed and cisplatin. But even when you give pemetrexed/cisplatin, you will notice that the median overall survival is pretty poor. It's only about 1 year. And progression-free survival, that means the time from initiation of treatment until death or progression of the tumor, is only about 6 months. So it's a highly challenging cancer patient as a physician to know what to do with, apart from giving 6 cycles of chemotherapy combination. Radiotherapy is sometimes used in a palliative care fashion.

So what about immunotherapy? We are, of course, in immunotherapy. Well, there are some data from checkpoint inhibitors in second line disease, a couple of small trials. Those data actually resulted in NCCN guidelines, these are the U.S. treatment guidelines, changing to suggest that you can give a checkpoint inhibitor to second line patients. But otherwise, there's no immunotherapy recommendations in Europe and no immunotherapy recommendations in first-line disease. So why are we interested in mesothelioma? Well, one reason is, as I just mentioned, there's a huge medical need. Secondly, in our Phase I study that Øystein alluded to earlier on, we actually had 2 mesothelioma patients that responded immunologically, and 1 also responded clinically with a close to 50% reduction of tumor burden just after the patient finish a trial. And another good reason as a small biotech company is that this is an orphan disease. And that means that from a regulatory point of view, the hurdles are lower. It's easier to get this kind of compound through in this disease because it's an orphan disease, and we have orphan status for this compound, for ONCOS-102, in both the U.S. with the FDA and in Europe with EMA.

So the trial that we're running at the moment is one where we look at patients who are naive to treatment. So these are called first-line patients, but also those patients who have had treatment, surgery and/or chemotherapy. Now this is the design. So there was a safety lead-in of 6 patients. And then after that, there was a randomization into patients who either received a standard of care chemotherapy, pemetrexed/cisplatin, 11 patients, and you can see here 14 patients in the randomization part of the trial also received ONCOS-102 on top of chemotherapy. That meant, that in the end, we had 20 patients in the experimental arm and 11 patients in the control arm.

So what were the data that we presented in January that Øystein already mentioned that we are very happy with? Well, I thought before we start to look at the actual data, it might be interesting to see how these 2 groups of patients in the 2 arms actually compared. And it turns out that the patients in the experimental arm had somewhat more severe disease. And that's, I think, an important point to make. It's -- we're talking about small randomized trials, so small changes of individual patients, of course, can change the outcome, but it's important to look at that profile of patients.

Now then moving on to the first-line group of patients, those patients who haven't had treatment before. You will notice here that there is a numerical difference in progression-free survival. In other words, in the time from the patient receiving treatment until either death or progression. So these data are pretty mature still, a large number of patients are being sensed. But as we continue to follow patients, and we're now following the patients every 3 months, and we are going to provide some more information later on this year, we will see as the data matures, how the progression-free survival and overall survival data come through.

If you look at overall response rate, that means how many patients or percentage of patients actually had shrinkage of the tumor or whether tumor disappeared. You can see in first-line disease here that the 2 arms compared very similar, actually, around 30%, 33%. Same thing with DCR and just explain, DCR was lateral. DCR is either patients have stabilized the disease. That means the tumor is no longer growing. And from a clinician's point of view, that's an important clinical position to say to -- to be able to say to the patient, "your tumor is no longer growing.” So DCR means stabilized disease, partial response or complete disappearance of the tumor. And you can see there that in first-line disease, the figures are fairly similar. In second line disease, and here, the numbers become very small, you'll notice that for the control group that there was no progression-free survival. And in terms of overall response rate, that was somewhat of a difference in favor of the control group, but I have to highlight to you that, as you can see here, the control group only had 5 patients in the second line disease. So it's enough for 1 patient to change and you have a 20% shift. So this is one of the downsides with a small randomized trial that changes of individual patients can impact the picture. But nevertheless, I think the important thing is that the first signals we have from this trial in this first interim analysis in January showed that there is a numerical advantage for ONCOS-102 on top of chemotherapy compared to chemotherapy.

Now what do these data look like in the context of previous trials? Well, on this slide, we have plotted on 1 axis, the vertical axis overall response rate. And on the horizontal axis, you will notice that we have progression-free survival. And you can see here the blue dot represented by the ONCOS-102 experimental arm in the trial and another gray dot somewhere in the middle of this chart represented by the control arm. So how have chemotherapy performed and other trials performed in this difficult-to-treat disease. Well, you'll notice on the very left-hand side of the slide, that there's a trial published and led by a physician called Vogelzang in the early 2000. And this was a trial which, when the authors published it, and they compared here, chemotherapy, pemetrexed/cisplatin, they suggested that there was an overall response rate of about just over 40%. But actually, as the FDA subsequently review the data, they publish separately and suggested a response rate of just over 20%. Nevertheless, the FDA and the EMA provided a license to the company for pemetrexed as the only licensed medicine in this indication.

You'll notice 2 other trials. 1 trial by Ceresoli, which is a trial where they've also combined and looked at pemetrexed, but carboplatin, it's a slightly different platin agent, and Zalcman is represented by a trial where they also included Avastin on top of chemotherapy. And as this picture is suggesting, the early data are pretty encouraging actually for us. And that's the reason why we're very much looking forward to follow-ups later on.

Now we're in immunotherapy, what kind of immunotherapy information do we have here in terms of what happens to these patients' immune cells? And what we've done here is we've looked at CD8+ T-cells, so these are the killer T-cells that ONCOS-102 is able to induce. On the vertical axis, you will notice the full change of those important killer T-cells. And then all the patients for whom we had pre-imposed biopsy material. So we have 15 patients in the experimental group and 5 patients in the control group. And you can see here that the blue bars are represented by patients who responded, the red bars by those who progressed. So there is a sort of a, I would say, an association between those patients who had a good fold increase of these important killer cells and who also responded clinically. So that's an incredibly important finding for us. Although these are early data in a fairly small number of patients. But it's a signal that the oncolytic virus, ONCOS-102, is actually doing something immunologically.

And I think it's interesting, if you look at the slide that not just the experimental group of the patients have this sort of association. But if you look at the control arm, you have the same pattern there. And so those patients, of course, didn't get any oncolytic virus, ONCOS-102, but just chemotherapy. You can see the same pattern where if a patient is able to mobilize the right kind of T-cells, then the patient stands a better chance of responding clinically.

So in summary, at this stage of the trial, we saw some good safety data. We have no concerns about that. In terms of the clinical data, it appears as if ONCOS-102 is able to, at least numerically at this stage, provide some benefit over and above chemotherapy. We saw in terms of T-cells, immune cell infiltration, somewhat of an increase. And in association with clinical outcome, we've also seen PD-L1 expression, haven't shown that here, haven't got quite time, but that's also an important marker of a change to the micro tumor environment that is beneficial for subsequent checkpoint inhibitor treatment, something I'm going to come on to in a second.

And finally, so our sort of take-home message from this interim analysis. That first-line disease is really an area that we wish to continue to develop this product in. There's a strong rationale, as I said, for combining with a checkpoint inhibitor. And indeed, we are now talking to large, big pharma with a checkpoint inhibitor for a collaboration. Which we're very excited about. And what we're doing at the moment is to prepare for this trial to start recruiting at the beginning of 2021. So we are writing the protocol. We are signing principal investigators. We -- in fact, we selected our principal investigator at Memorial Sloan Kettering. They're a very high-profile hospital in New York. We have the other European principal investigator in Madrid. We are signing laboratory services and contract research organizations. So all wheels are moving in the right direction for us to be able to start recruit in the new year of 2021. And this is what the trial looks like.

So as I said, we're going to focus on first line patients, those who haven't had treatment before. And after a smaller safety lead-in, where we're combining ONCOS-102 with chemotherapy and the checkpoint inhibitor, so triple therapy, we will go into randomized phase where the experimental arm will have that triple therapy. And the control arm would have chemotherapy plus a checkpoint inhibitor. As you can see here from the slide, we're talking roughly 100 patients to go into this trial. And I should also say that this trial is set up in such a way that if we get good signals during the trial, we're able to escalate the trial into a pivotal program. So clearly, we are now on the path towards the registration program for ONCOS-102 in mesothelioma.

Right. A couple of words about melanoma. Some of you may remember that we released melanoma data from our checkpoint refractory trial in the summer of last year. Just then to remind everyone, we have 2 cohorts. The first cohort where the data came out last summer included 9 patients. And we have 3 of those 9 patients responded with this treatment. In the sense that we have 2 partial responses and 1 complete response. So that ended up with a 33% response rate. In the second cohort that's running now, we have 12 patients, we stopped recruitment. We're very happy with that, and we're now following these patients. And you can see here the difference is that we're giving a lot more ONCOS-102 all the way through the trial in parallel with KEYTRUDA or pembrolizumab. Here, we expect to release data to all of you at the second half of this year.

So the 33% that we have so far, what do those look like in compare to other modalities, where the same disease has been studied. Well, you notice here our figures at the top. In the top part of the slide, we have compared with some other products including toll-like receptor 9 agonist and a few other modalities. You can see that in comparison with those other 3 trials, the figure of 33% is rather encouraging. The middle part of the slide, CAVATAK and the TLR9 agonist as well. The difference there is that those patients were actually -- CTLA-4 is a type of checkpoint inhibitor naive, those agents were actually given -- were given with a CTLA-4 inhibitor. So it's a little bit difficult to interpret those figures, as you would expect that the CTLA-4 inhibitor would, in itself, have an effect of around 20%. And finally, we have CAR T-cell data, which, of course, is a very difficult type of modality and one where you take T-cells, you take blood out of the patients, you manufacture the T-cells and you give those T-cells back to the patients. So it's a rather different kind of approach. But overall, as you can see here, so far, it looks promising.

Okay. So on that, I'd like to hand over to Torbjørn, who's going to talk about finances. Torbjørn?

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Torbjørn Furuseth, Targovax ASA - CFO [3]

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Thank you, Magnus.

So going to the profit and loss for the quarter. Actually, fourth quarter marked a milestone for Targovax as we started to get revenues. This NOK 2 million stems from the option agreement we signed with IOVaxis. I will come back to that a bit more in detail later. When you see on the expenses, we came out on NOK 42 million, which is more or less in line with the previous quarter except the third quarter, that was an outlier with low expenses due to some reversed provisions and also the holiday on the payroll. So for external R&D expenses, they were fairly high. We had more clinical costs due to mostly the melanoma and mesothelioma trial, also some CMC costs. So that bumped a bit up. But as you can see, the external R&D expenses are taking a larger share of our costs, and that's very positive because we have a focus to cut down on payroll due to the change in strategy for TG, so that's now at NOK 11 million, which will be more or less the level going forward. And on the other operating expenses, we are now down -- stabilized at NOK 5 million per quarter.

Also, a bit special for the quarter is the net financial items. This is due to the loan to Business Finland. So this is more an accounting effect because this loan is only going to be paid back in the event the company becomes profitable, but we have to reapply for the extension. So this is only a book or accounting effect. So cash outflow of minus -- or outflow of NOK 34 million, and we ended at NOK 70 million in cash for the quarter.

We also did -- as you probably know, did a raise in January, NOK 101 million gross proceeds. So we are now sufficiently financed beyond the important value inflection points. Maybe I should have said on last page, also, we expect the OpEx to go down somewhat in next quarter and more for the quarters after. What we also did in the last raise was we were able to bring in AP4, a Swedish life science investor fund. So we're really happy about getting them on our shareholder list. Also, as you can see, we have increased the number of shareholders since previous and are now almost 5,000 shareholders. So to the IOVaxis deal, we announced early in January. This is structured as an option agreement. So we have given them an exclusive option for a license to TG in Greater China. And the reason why they wanted this option was that they saw some uncertainties about the regulatory environment in China. The Chinese FDA have steadily been more positive and accepting Western data, but still they were a bit uncomfortable. So they wanted first to have this option. And at the time, they get an IND to do a trial, then that would trigger that they have to decide on their option.

The terms we have communicated also a bit earlier. The option fee is $250 million -- no, sorry, $250,000. And if they exercise the option, there's a exercise fee of $3 million. In addition to that, there are development and commercial milestone summing up to $100 million. Most of these milestones are in the commercial phase. And if they come to commercial, there are also royalties in up to mid-teens.

So what we're doing now? We are negotiating the final licensing agreement. And we are also working on the IND in collaboration with them too, so that we can file for a Chinese IND. So this is the first results from our efforts to continue to develop the TG with the limited financial and human resources from Targovax. We still have other initiatives, and we will see if they materialize. As you know, we signed a collaboration agreement with Parker Institute in the U.S., that dialogue is still ongoing, but the trial itself has been delayed. So there's still contact and discussions. So we'll see what happens. I think we shouldn't put -- it might play out, but shouldn't put too much confidence in that it will happen with TG.

So summing up our news flow with our pipeline slide, the mesothelioma is the first next data point that will come out. I think, overall, when you look at this slide, it's a fairly rich news flow for us in 2020, and that's very important. Mesothelioma, we will have updated clinical and immune data in first half. For the melanoma, we will have the full data on -- yes, we will have data on all 12 patients coming in second half. And we will see if we divide it in clinical data and then immune data because immune data are somewhat delayed compared to the clinical data, but it will be second half. The peritoneal malignancies trial. So this is the collaboration with the CRI, AstraZeneca and Ludwig Institute. So we are not in full control of the trial. We're not the sponsor. But we have announced that the safety lead-in was successfully completed, no concerns. The trial is still recruiting fairly well. And we hope that there will be a update on the clinical data within the next 12 months and hopefully, also within this year. The Prostate trial is not really a strategic priority for us. It's run by SOTIO. And it will, of course, provide some data on ONCOS that could be beneficial. The trial is ongoing. They're only recruiting at 1 site. So therefore, recruitment is fairly slow. But it's still active, and we are shipping products to them these days. For the next-generation viruses, we will come also with updates later this first half. And that will probably be at the AACR conference. So a fairly rich news flow, the next 9 to 12 months.

So coming to the events, the Wainwright Conference in London is the first and then AACR in San Diego, where we will have a poster on the next-generation viruses. And then Annual Cancer Progress Conference where we will be in the panel where -- and then meet here again at first quarter presentation. So also quite a few events that we will participate in. That being said, of course, there are some uncertainty about the coronavirus. We're also supposed to be at Carnegie in Stockholm last week, but that was canceled. So we will, of course, follow the advice from authorities.

So to conclude, we are well positioned in immunotherapy with the growing need of immune activators, where we have one of the furthest developed oncolytic viruses. We have solid data in -- with single-agent and also combination data are very encouraging. We have an innovative pipeline with the new viruses coming out. And in the medium and short term, we also have a rich news flow.

So thanks, everyone, for following us. We will now open up for questions in the audience first, and then from the web.

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Questions and Answers

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Øystein Soug, Targovax ASA - CEO [1]

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So are there any questions in the room?

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Torbjørn Furuseth, Targovax ASA - CFO [2]

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No.

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Øystein Soug, Targovax ASA - CEO [3]

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We'll take some from the net in the meantime.

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Torbjørn Furuseth, Targovax ASA - CFO [4]

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Yes, I think there is 1 on the conferences that I maybe touched a bit on. If medical conferences are canceled in this coronavirus times, will abstracts results intended for those conferences be posted online anyway? Or submitted to conferences at a later date?

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Øystein Soug, Targovax ASA - CEO [5]

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There will probably be online. We're seeing now that some of these conferences, they are not being canceled, but they are just put on the web so that they will take place virtually and consequently, that means that also the publications will be available electronically. Of course, whenever we produce something, we will also post it on our own web page.

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Torbjørn Furuseth, Targovax ASA - CFO [6]

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Yes. And then on oncolytic viruses, there has been several transactions in the market for oncolytic viruses. You have both ONCOS-102 with a significant number of patients with data, most developed according to your own words. And preclinical next-generation ONCOS still without official data. In which stages do you see most interest from big pharma, developed or preclinical? In light of your strong position and big data set, it's not easy to understand why Targovax has not struck any deals yet on the ONCOS platform in form of near-term upfront deals.

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Øystein Soug, Targovax ASA - CEO [7]

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The big advantage of ONCOS-102 as a product is the fact that we have been used in many patients. So we have a pretty strong, as I said, data set in a clinical setting. We certainly see most of the interest in ONCOS-102, the product with the most data. That being said, we also think that the new viruses, with the new transgenes, they provide some interest because some biotechs and some pharma companies, they do also take earlier bets. I think seen from an employee of a big pharma company, it's probably easier to make an early bet because everybody knows that it's risky. When you take bets on assets in the clinical phase, it has to be supported by solid data. And to address the question directly, why haven't we concluded a deal yet? Well, the answer is simply that we are now in a phase when we are reading out the data from ONCOS-102 and over the next 6 to 9 months, there is going to be much, much more data on that asset. And that is probably the time where big pharma is going to seriously consider whether ONCOS-102 is something that they would take a second look at.

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Torbjørn Furuseth, Targovax ASA - CFO [8]

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Good. Yes, there were some comments to comment on the Parker study. I think we did that in my presentation. There's a question, what percentage is mid-teens? So that's in the middle of the teens between 13% and 19%, somewhere in the middle. And again, a question if we're going to press release data that we're planning to present at AACR.

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Øystein Soug, Targovax ASA - CEO [9]

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It will be available on the web page.

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Torbjørn Furuseth, Targovax ASA - CFO [10]

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Yes. Okay, I think that was all the questions. Yes.

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Øystein Soug, Targovax ASA - CEO [11]

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Good. Any questions from the room? If that's not the case, then thank you very much.