Nykode Therapeutics As

Greetings, and welcome to the NICO Therapeutics Q2 2024 Financial Results Presentation. At this time, all participants are in listen-only mode. There'll be a question and answer session following the formal presentation. You may ask a question anytime by typing it into the Ask a Question feature on your screen. As a reminder, this conference is being recorded. It's now my pleasure to introduce your host, CEO Michael Ensig. Please go ahead, sir.

Thank you very much, Kevin. And also from our side, a very warm welcome to all participants at this webcast to go through the second quarter of NYCODE's results. With me today, I'm pleased to have Arne Frederiksen, Chief Scientific Officer and Head of Business Development, Harald Govind, our Chief Financial Officer, and Claus Edwardsen, Head of Research and Development. We assume you're all familiar with our forward-looking statement, so on that note, we'll just quickly skip forward. So, test quarter has been another eventful quarter, and in addition to that, we have this morning also announced a strategic repositioning, which will take you further through I'm going to give you a brief rundown of the key highlights and then I'm going to hand over the words to Klaus to take us into the rational and thinking behind our repositioning. Then I'm going to hand over the word to our leader to take you through some of the exciting updates we have from our technology platform. And finally, Ahal will take us through the financial highlights. This morning, we announced a strategic repositioning of our BB1016 development plan. to refocus the program on two key indications, locally advanced cervical cancer and recurrent metastatic head and neck cancer. And this decision comes on the back of very positive feedback from our key opinion leaders as well as potential future partners regarding these two indications. These two indications have been chosen by us because they do represent areas where we see a large unmet medical need as well as a significant commercial potential. We have consequently decided to discontinue the CO4 trial and that decision comes on the back of changes in the dynamics related to the standard of care which was impacting the timing of the trial which in the end put some challenges to the whole strategic rationale of our faster market strategy for VP1016 in the recurrent metastatic circuit cancer and we therefore decided to allocate the funding to the locally advanced circuit cancer at the metastatic head and neck cancer because we think they represent more valuable areas for the company. We have also To further emphasize the positive sentiment around the locally advanced cervical cancer area announced during the second quarter, the agreement with MSD to supply Keytruda for our CO5 trial, which will be our first trial into the locally advanced cervical cancer treatment. And we'll have Klaus tell us more about the background and the rationale and our enthusiasm for that trial when I hand over the word to him. Further along the decisions to reevaluate our allocation of funding, we have decided also to discontinue further activities on the NIC11 preclinical program, and that also comes as a consequence of our focus to really concentrate our both capital and human resources within the oncology segment on our partners and programs and our clinical assets. We had a key patent issued in the U.S. around our individualized neoantigen-based vaccines. Anita will tell us more about that patent when we hand over the word to her. We presented very exciting data from our ABC-targeted neoantigen vaccines in the mRNA format, which shows again its superiority over antigen-alone vaccines formulated by mRNA. We've presented advancements in the inverse vaccine platform, which is our use of the technology within the autoimmune disease area, which highlights the versatility and effectiveness of NYFO's ABC-Targon technology in this area. And we have revealed plans to form a new subsidiary focused on advancing our immune tolerance platform further. Again, a quick look at the pipeline, which have been modified to reflect today's refocusing. So again, you want to emphasize or bring the attention to BB1016, our lead assets. Again, I want to emphasize we continue to have a very high level of conviction in BB1016 to benefit patients. across a range of diseases. We're now focusing on head and neck and locally advanced. And we'll, as I said before, update you a little bit more on the programs as they are running when we hand over the word to Klaus. Also seeing exciting development on our other programs, not least the Regeneron programs that are still moving forward, as well as our partnership with Genentech. With those words, I'll hand over to you, Klaus, to take us through the strategic repositioning of BB 1016.

Thank you, Michael. Klaus here. Good afternoon. Good morning to everyone. Obviously, the IMD update today will focus primarily on the announcement that was made this morning to discontinue the BB CO4 trial. Let me just state upfront that this decision is not based on any data that is indicating that we should lose faith in VP1016, nor any safety data. It is a strategic decision that is purely made for feasibility reasons. And let me try to give you a bit of context for what those feasibility situation is. We have every confidence that we would have been capable of recruiting this trial to completion, but we have to accept that we will be faced with significant delays and therefore have made the strategic decision that those delays are not acceptable for a strategy that was set out as the fastest to market authorization possibility. And therefore, we decided to stop at this stage and reallocate resources, as Michael mentioned, to the locally advanced cervical cancer as well as the recurrent metastatic head and neck cancer. But let me just stay honest to the slide and say that what we have been faced with that has been taking us with a bit of surprise is that the recruitment numbers of this stage are not where they need to be. And that is primarily based on a reason that we are seeing that the consequences of a full approval of TIFTAC, obviously a compound that we were fully aware was present, has not changed the number of prescriptions necessarily filled for TIFTAC, but changed the dynamic of the patient flow. Understood in that fashion that patients with recurrent metastatic cervical cancers is very often entering into the healthcare system in community hospitals and then used to be referred to tertiary cancer centers that are obviously GOG centers and different centers where our partners would see the patients. What seems to have happened now with an element of misjudgment, obviously, from our side, is that that referral is not happening to the degree that we would have expected it to happen. And that's obviously a dynamic of patient flow that NICODE and, for that matter, GOG would have difficulty in changing. And therefore, we came up with the strategic reposition of the program because the fast of the fastest-to-market strategy has somewhat disappeared. If I can have the next slide. I just want to remind everyone that we have always been guiding the market to say that obviously we build a strategy with a fast-to-market strategy. That's the CO4 strategy that I just described. But very intimately linked into that strategy was also to capture a patient population with an equally high on the locally advanced cervical cancer. which is a patient population that is larger than the recurrent metastatic. And if we really look at the data that we have available from the CO2 trial, that we have shared interim data with you and also guided you that when the final results from that trial was read out, that we closely mirrored the interim data but decided not to give you any numbers from the actual trial. I will, although for this call, allude to why the CO2 results were not only important for CO4, but actually more important in reality for the strategy in locally advanced. If you look at the very simple data set, or maybe not that simple because it is a spider plot or a spaghetti plot, if you like. It is, in essence, showing in color blue patients that did not have what's called an objective response, meaning they would have had a tumor reduction of at least 25%. On the other side of the cartoon, it's shown in red, patients that actually did have an objective response in the CO2 trial, meaning that they would have had a reduction of their original tumor size of more than 25%. What you also would see on this slide is that obviously the reds are having a much deeper fall down of the curve. That's because of the response on the tumor. On the blue, you would not see as deep reduction of the tumor, but you would, in essence, for a majority of patients, see a flat curve, meaning that adding the vaccine to standard of care in that experiment led to a maintaining of to feel whether that clinical effect was a response or a stabilization. If you think about locally advanced disease in an adjuvant setting, There you, in essence, treat patients with a definitive treatment, and then you have preselected patients for effects, and then you vaccinate them, if I can use that terminology. And therefore, the CO2 data very, very nicely support that we would go into the CO5 trial with an expectation that the vaccine will add a significant more effect than we would have obtained by standard of care. Next slide, please. So as Michael alluded to and I also alluded to, we will stop CO4 with the aim of focusing on primarily locally advanced cervical cancer. We have already communicated to the market that this is not something that we are in the early planning stages of. We have announced that we did sign a supply agreement with our clinical partner, Merck MSD, and we are imminently ready to release the final design of that locally advanced C05 trial. and would obviously advance that through the fastest possible degree based on the decision of not continuing CO4. And by that, I hand it over to Agneta.