Ultimovacs Asa

Good afternoon, everybody, and welcome to UltimoVAG's second quarter of 2024 business update and financial results. As usual, I have with me our chief medical officer, Jens Björheim, and our chief financial officer, Hans Vassgaard-Heidt. We will go through the main news from this quarter, and as usual, if you have any questions, please use the system to send it to us, and we'll try to answer as many as possible at the end of this presentation. If we can move to the next slide, I have to show you a disclaimer. And if we move to the next slide, I will give a brief introduction. Jens will cover then the clinical update on UV1. I will have a slide on our novel drug conjugation platform. Hans will cover the financial update, and then I will cover the news flow and the meeting before Q&A. Okay, so let's proceed and move to the next slide. Again, you know, this quarter was mainly impacted by the results of initial in focus. Of course, despite these disappointing results and that, you know, we are, sorry for patience, we are still committed as a company and as a team to bringing UV1 across the next important data point. That is the Duvac readout. These top line results, as you know, the focus, the more recent one now in August, showed that we didn't meet a primary endpoint of improved progression-free survival. And there was also no improvement in overall survival. As Jens will cover, you know, these results are still very important and will be submitted for publication in a peer-reviewed medical journal. NIPO, as you know, we had encouraging results showing a clinical benefit, you know, presented last year. Also, publication giving a little bit more details on the specific group of patients that responded better. You know, this was in the spring. But there will be an update by the investigators that post the presentation during ESMO now next month of September. DUVAC continues to have a good inclusion of patients. Top line readout expected first half of 2025. Of course, you know, this quarter is impacted because we look at mid-May to mid-August in terms of the number of inclusion of patients is impacted by the vacation period in the Nordics and all over Europe. But we expect this will pick up and there are several patients also in screening. You are all familiar that we implemented the cash preservation initiatives with a very important goal to expand the financial runway to the fourth quarter of 2025. And this is important because then takes us over the anticipated top line readouts for the Dufac trial. We also have an ongoing development of a novel drug conjugation technology platform. And I will cover that topic in more detail during the presentation. So if we move to the next slide. I give the world to Jens. Jens, please.

Thank you so much, Carlos. Good afternoon, everybody. I will go through the clinical program. On the next slide, just as a recap for us, the background for the phase two program we are running. So going back a few years, we had phase one trials that showed good and lasting immune responses after the UB1 vaccine. It appeared to be a good synergy between checkpoint inhibitors and the vaccine in different patient populations. And it was a good and beneficial safety profile for the UB1 vaccine. So the ambition with the phase two program was to combine the vaccine with different immune therapy and in different indications to find a good home for UV1 moving forward. Therefore, we had a few things that needed to be in place. The indications we are working in need to express telomerase, as that is what we are vaccinating towards. And also, immune therapy should be approved in that indication. On the next slide, you can see the phase two program that we initiated. First, our sponsored own indication, malignant melanoma with the initial trial, as Carlos reported. Then we are also participating in four other trials in mesothelioma that reported at ESMO last year, and we'll have an update at ESMO this year in September. It was also presented in a journal during the spring this year, this study. For the head and neck cancer study back in August, earlier in August, we presented top line data from this trial. Unfortunately, this trial proved to be a negative one. Still, there are two trials ongoing within recruitment in the DOLBAC trial. As of now, 120 patients are recruited in this trial. And in the LUNBAC trial, 31 patients are recruited. Moving on to the next slide, just a small background on the head and neck cancer group. So this is the seventh most common cancer globally. So it's a large indication. Telomerase is highly expressed in these patients. Pembrolizumab is considered a standard of care for first-line treatment of patients with PD-L1-positive head and neck cancer. Also, a few comments on the trial as such. On the next slide, it was a randomized trial. one arm, 50 patients with the vaccine on top of pembrolizumab and a control arm with 25 patients. The primary endpoint was progression-free survival at six months. All patients were followed up to 12 months in this trial before the database was closed and they had a readout of the results. On the next slide, you can see the results from this study. Adding the vaccine on top of pembrolizumab did not meet primary or secondary endpoints in patients with metastatic or recurrent head and neck cancer. UV-1 continues to show a positive safety profile in line with the other studies with similar events observed in the control arm and a good tolerability. So this was disappointing, but it's the top line results from the FOCUS trial. And the data from this trial will be published in a journal in the near future. Moving on to the next slide, we now look towards ovarian cancer. So ovarian cancer is also quite large indication. It's the 18th most common cancer overall. Standard treatment for these patients include surgery, chemotherapy, PARP inhibitors, and Bevacizumab. Several studies have shown that if you combine PARP inhibitor with a checkpoint inhibitor, you have better efficacy for patients. Also in this indication, telomerase is highly expressed, which is important for the UB1 vaccine. If you take a... Look at the trial as such on the next slide. This is a large trial. 184 patients will be included in this study. It is a maintenance trial, meaning that patients are treated with chemotherapy. If they respond to that chemotherapy with a partial or complete response, they can be included in this trial. There are three arms, one Olaparib arm, which is a standard of care for this patient population. Then there is an in-between arm, Olaparib, Durvalumab, which is there to get a numeric understanding of the efficacy from Durvalumab only. And then there is the third arm with the vaccine, UV-1, Olaparib and Durvalumab. The statistics in this study is between the triple combination arm and the Olaparib arm. Also in this trial, progression-free survival is the primary endpoint with the secondary endpoints for overall survival response rate and safety. The top line results for this trial is expected first half of next year. Moving on to the next slide. Just also to update on this, so the LANGMAG trial is a trial in patients with non-small cell lung cancer that don't have the mutations in EGFR and ALK and others. In this study, 138 patients are planned to be included. Two arms here, one with PD-1 semiplimob and one with UV-1 semiplimob. Primary endpoint in this trial is also progression-free survival and secondary endpoints, other efficacy endpoints and safety. The top line results are expected in first half of 2036 for this trial. And as we have done earlier, we will update on the top line results in the Q4 presentation later. Moving on to the next slide, I give the word back to Carlos to present the novel drug congregation platform.

Thank you. So if we move to the next slide, why are we talking about a novel drug conjugation platform? As you know, we have been spending a lot of time in the team in developing a new technology for cancer vaccines, with one example being the TET vaccine that we tested clinically in prostate cancer. In order to optimize that formulation of that vaccine, we had to develop a novel conjugation technology that, as I mentioned, was initially formed to optimize the expansion of our vaccine pipeline. So this novel conjugation technology is really the result of several years of work by our research and CMC teams. The key benefits is that this is a very flexible conjugation technology. and has the potential to be broadly applicable to a variety of therapeutic modalities, particularly in the creation of innovative drug conjugates with favorable pharmacological properties. This means that, you know, in addition to the space of oncology, this can be used potentially in other therapeutic areas. What is, of course, very exciting. We are currently conducting preclinical proof of concept research And we'll seek external validation of this novel drug conjugation platform by talking, discussing with experts in this area. We see a significant value proposition within this technology, representing a major opportunity for UltimaVox for future pipeline growth and expansion of potential collaborations. We are currently going through several of these projects tests and we will provide expect to provide an update to the market before the end of 2024. OK, so if we move to the next slide, we move into the financial area and I give the word to Hans.