Okay. Thanks so much for the introduction. And I would like to welcome you all to this conference call, which will focus on our year end report. Let's move to next slide, Slide 2. This is just to confirm, as usual, the presentation does include some forward looking statement.
With that, we go to the next slide, Slide 3. So let's start with the agenda. I and Marie will present the Q4 year end results 2020. We will also give a short pipeline update and some outlooks for 2021. So the presentation will then be ended with a Q and A session.
And with that, we can move to Slide 4. This is a summary of the key highlights in 2020. During the year, alligators increased our focus on clinical development and to reach major clinical inflection points with selective programs. Our focus programs are EPR1017 and mitasalimab. The decision to focus on EBITDA, 1017 and Mitte is based on their strong positioning.
The positive data that supports a very competitive profile for the respective programs versus competitors, but also on the fact that both programs are moving now into clinical Phase 2 this year. Phase 3 is, of course, critical in the sense that a positive study greatly increases the chance to reach the market and overall is associated with Significantly increased valuation, usually in the range of 5x. So to start with ADER1017. 10/17 has raised through clinical Phase 1 development despite the challenging patient recruitment environment during the pandemic. We have released interim data demonstrating good safety profile at therapeutic range dose level sessions, which is very promising considering the toxicities associated with the 1st generation competitor products.
We'll come back to this shortly. Mittasalimab then or Nika has completed Phase 1. A recent data analysis was performed on patient gene special material and that confirms proof of mechanism in these patients. Or let's just put this in a simpler way, META activate premium system just the way it was designed to do. A thorough benchmark assessment has been performed versus key competitors, And Midas stands out with potential for superior clinical activity.
Based on this, we took the decision to advance Midas to clinical Phase to impact ready to answer. This is a disease where CD4 has been clinically validated. And We have submitted CTA for starting clinical Phase II end of last year with potential of start dosing in Q2. Then last, MiRx Prime. This is a novel drug concept for more patient specific immunotherapy.
It builds on our leadership within dendritic cell therapies and our proprietary bispecific format, Ruvi. The antibody identifies patient specific cancer mutations, which is proteins that are generated only in that tumor, so called neoantigen, and allows those new antigens to be selectively presented to the immune system. This It's hoped for greatly increased response rate in cancer treatment. And I'll go through that briefly during the presentation as well. So let's move to Slide 5, next slide.
This summarizes our key press releases during the Q4 2020. Apart from what I just mentioned for ETR-ten seventeen and MITA, we also initiated preparations for bringing ALGA PD-five twenty seven to clinical clinical phase together with our co development partner, Aptivo Therapeutics. And this was on the back of positive clinical data from Aptivo's first program using the same bispecific platform. Apart from our clinical programs, we launched a novel antibody, alligator fan, and this is developed to act in concert with our internal bi specific pharma, Ruvi. With that, our bi specific Antibody platform is complete and provides a very efficient discovery engine that can continue to build on our track record on drilling, bringing novel products from ID to clinical phase.
So let's move to our clinical candidates, our focus programs and start with ATR1017, where we have ongoing Phase 1 study. Next slide, Slide 6. ATR1017C is a leading 2nd generation immune oncology antibody designed for optimal efficacy. Performance gives us the potential for strong and tumor selective immune activation. The objective here is to increase response rates, basically to have more patients benefiting from immunotherapy.
And there is a strong rationale for combining ATR1017 with our other T cell activating products, such as PD-one or other checkpoint inhibitors. So while PD-one releases the brakes on T cells. ADOR1017 pushes the gas. And it's adjustable for car. It's much more likely that you get Up to full speed, if both are active at the same time, you need to release the brakes and push it again.
ADO1017 It's currently in late Phase 1, and we are planning for presentation of clinical study data before the summer. So move to next slide, Slide 7. The ongoing Phase 1 study then, it's a dose escalation trial in metastatic cancer patients, terminal metastatic cancer patients. And safety is the primary endpoint, but also selected dose for clinical Phase II. In Q4, we cleared 100 milligram or 1.5 mg per kg, which is expected to be in the therapeutic range.
We are currently evaluating higher doses, And so far, it looks very promising, few drug related side effects and mainly low grade toxicity of those effects. This is important since the target has been associated with quite significant toxicity, and this is based on 1st generation products, including liver toxicity, which has been one of the major concerns. ADERS-ten seventeen is a leading 2nd generation product within 4 MBD space and is designed for a more tumor selective activity to overcome just those issues. So far, It looks like we might be onto something important here. The data looks really promising with a few significant side effects.
We plan to present the Phase 1 data at a conference before the summer. And the data set will include safety, tolerability, pharmacokinetics and potential signs efficacy as well as a recommended Phase II dose. Now with that, I will move on to mitafalimab or META, Slide 8, next slide. Based on promising data from the Phase 1 trial win, we will summarize to the left. A CTA for starting a clinical Phase II trial was submitted by the end of the last year.
This is a study in pancreatic cancer And the first patient is expected to be recruited within a few months in Q2. We expect to be able to report initial data from the first handful of patients by the end of the year and then to present a larger set of data at the end of 2022. But let's take a closer look on the strategy side, and this is in the next slide, Slide 9. Pancreatic cancer, this is a challenging indication. But given the clinical precedent for the target in pancreatic cancer, We believe that there is a good probability of seeing a response with metafellamal.
The study is designed to build on the mechanism of action of CD40, and this is illustrated on the right hand side. Patients will receive Modified FOLFIRONOX, a chemotherapy cocktail every 2 weeks. And this is a chemo that will damage tumor cells and release tumor antigens. These tumor antigens will then be taken up by dendritic cell, and these are subsequently stimulated with Emita to induce an immune response to these tumor antigens. This sequence of events is then repeated for every administration cycle of the chemotherapy.
The selection of Volfirnox as a combination partner, this reflects The best in class properties of META. META is again a tumor selected CD40 agonist antibody. And the tumor selectiveness allows for strong activation and better tolerability. We have, in fact, confirmed that While meta induces at least equal effects at the same dose level as competitors, we have an advantage in that we can dose much higher. This has also been confirmed in our Phase I trial.
While our key competitors have been forced to Select potentially sub therapeutic doses due to toxicity, Mitta can be dosed at the expected therapeutic dose range. And this provides an opportunity, of course, for superior activity and importantly, also allows for combination with more advanced and effective chemotherapy combinations like modified false309. With that, we move on to Slide 10. Far from our clinical focus programs, I would like to bring up another drug development concept, Neo X Prime. This is a platform of bispecific antibodies that have potential to solve one of the great obstacles of immunotherapy today.
And that obstacle is a fact that only that 4 out of 5 patients are resistant to current immunotherapies. The low response rate is largely due to poor T cell priming. In other words, The immune system has difficulties in educating its effector parts, the T cells, to selectively attack tumor antigen. These tumor antigens are unique for each patient, and that makes it extremely challenging. MiWayx Prime solves this problem by binding to tumor material that's continuously being shed from the tumors of each patient, And this is shown in the lower left graph of this slide.
And then Nirexplam physically brings that tumor material to the antigen presenting cells for selective presentation and then activation of tumor specific T cells. This concept holds the potential to induce strong immune responses even in patients with very few tumor mutations. That is patients that otherwise would not be eligible for immunotherapy. So it's Interesting from a theoretical point of view, but the main reason why we are so enthusiastic about the concept is that it outperforms anything we have previously tested in our models. And as an example to the right, we have a combination of 2 antibodies compared to the same antibodies incorporated into the nevex prime prototype.
And the effect, as you can see, is amazing. We are currently in discussions with partner on potential co development of Nurex Prime, and the ambition is to be able to develop our concept to the clinic with a partner, And that is to reduce our internal costs and to allow us to focus our internal resources on our 2 clinical focused programs, EIDR1017 and Mika Selenor. So with that, I will leave it to Marie to walk you through our Q4 results and the recent share issues.
Thank you, Per. So then we move to Slide 11. In 2020, the group's net sales amounted to 4,400,000, which pertain to the 2nd license installment from the agreement with Bayer Studios. As Per touched on earlier, Alligator took a Strategic decision during the spring to focus the company's resources on the projects that have the prospect of most rapidly generating the greatest value, the clinical program. As a result of this, the company's operating expenses during 2020 decreased by 60 €9,000,000 versus 2019, corresponding to the reduction of more than 30%.
The reduction in the company's expenses is mainly due to fewer employees in the company. That certain research project has been suspended in favor of the clinical program and the conclusion of manufacturing of clinical Starting material. Expenses during the year were mainly related to the ongoing Phase 1 clinical studies with AC1015 and 1017 and preparations for the clinical Phase 2 study with mitasalimab. Finally, operating loss for the quarter amounted to SEK 34,000,000 and SEK 140 SEK 4,000,000 for the year. During the Q1, the holdings in corporate bonds and interest funds were Divested, which had a positive effect on the cash flow that you can see here in the page.
Next slide,
12.
The reduction in cost came into full effect in the Q3 2020, which is Again, the diagram to the left. At the end of 2020, Alligator's cash amounted to 103,300,000. In order to continue pursuing our focus projects, Mittalema and I8 to turn 17, We carried out a write issue in January 2021 that generated proceeds of SEK 86,000,000 before transactions cost. Our assessment is that the financial resources are sufficient for planned activities until Q2 'twenty two. With that, I hand over back to Per.
Okay. Thank you, Marie. And let's move on then to Slide 13. Team. This is the last slide.
I would like to finish off with a summary of next important events. Eirik 10 17 We'll continue dose evaluation during the spring, and that's in the ongoing Phase 1 trial. And we plan to present the study data before the summer. And then we will proceed towards a Phase II trial, which will be taking place in gastric sorry, in gastric cancer patients during the autumn. We will submit the CTA during the autumn and start of trial a few months later.
Mirasalimab is under CPA revision for starting a clinical Phase II trial in pancreatic cancer, And we expect to be able to start dosing patients in the Q2 this year, that is within a few months. I will then conclude that we are advancing our clinical pipeline with 2 products entering a efficacy assessment in clinical Phase 2 during the course of the year. And with that, we are approaching important value inflection points for both these programs. So with that, I would like to open up for questions. Thank you so much.
Thank
And so far, we have one question in the queue, and that's from Ingrid Gafoniel of Kempen.
I have 2, if I may. So I just wanted to confirm, the data that we are expecting now for the Phase 1 with 8 or 10, 17, Are you planning to just issue a PR? Or should we expect to see something at a scientific conference?
Yes. So that is both is correct, actually. We are planning to present it at a conference, and Hopefully, that will be at ASCO in early June. And we have submitted and we hope to get it approved for And we will also submit a press release while we before the abstract when the abstract is to become published.
All right. That's very clear. And a second question, I just wanted to confirm, in the Phase 2 trials with dosed It will be those IV, correct?
Yes, that is correct.
Okay. All right. No, that's very clear. Thank you very much.
Thank you.
Thank you. Once again, if there are any further questions, And we had one further question come through. That's from the line of Nicholas Elpamer of Redeye.
Okay. Thank you, and good afternoon. Curious about Mitra Salle, but what are your plans for evaluating In combination with CDWANs, I guess that would be very natural at some point. Yes, that is absolutely true. And We have a lot of the plans for Pillar 1.
The reason why we start without PD-one is basically that we want to make sure that we have activity by Mirasaliman without PD-one basically. And that is to say that every combination with PD-one, there is always the suspicion that PD-one is the major contributor to the effect. So once we have shown that mitaxalumab has an effect by itself, even if it's a combination with chemo. But the fact is with chemo, we know very well the expected response rate. So we can see an effect on top of that.
Then we plan to add on PD-one. But we hope to be able to do that rather soon. So It's in the plans, but not while the study starts now in Q2. Okay. Thank you.
That's helpful. And looking at 10/17, So perhaps you could allude to what would design for the next clinical trial look like provided you The ongoing trial is successful. Yeah. That is an important question. And I have many answers to that question.
So actually, I would like to wait until we have decided upon the final design. We are Looking at both first line and second line possibilities, and that, of course, leads to different combination regimens. But until we have a final decision on the selected design, I would like to wait and go after that at one time. Okay. That's understandable.
And do you have any comments on the clinical benefits you have seen so far in the ongoing trial? On 10/17? Yeah, yeah, 10/17. Yes. So What the data that has been presenting so far, we have patients with quite long standing stable disease, And that looks promising.
But we don't have any firm or confirmed responses in that the release data yet. Hopefully, we can present something towards June, but that is too early to say anything about. Okay. Thank you. And then finally, regarding 10,015, If there are any activities going on there or any resources that you plan to use there?
Well, we have reduced resources quite a lot in that program. There is still some patients on, but it is A lot activity has been reduced quite a lot. And as we have communicated during the autumn, we have run into some challenges with anti drug antibodies, and that has also been associated with immune reactions. And we are looking at ways to proceed despite those obstacles. And it's something that is not the priority for us right now, because we have Quite limited resources.
I think we have 2 programs moving into Phase 2 with Midtown17, which has Because of these challenges, we have elected or decided to focus on those 2 programs, which are much more straightforward at the moment. But still, we hope to find a partner that would help us and to be able to invest in further study for that program. But right now, we are not investing ourselves. Okay. Thank you.
I'll move back into the queue. Thank you, Marcon. Thanks so much.
Thank you. Okay. Currently, there seems to be any further questions coming through on the phones at this point.
Okay. Then I would like to thank everyone for joining this conference call and hope to meet soon again in the future.