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spk03: Greetings and welcome to the NICO Therapeutics Third Quarter 2022 Financial Results Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the call over to Chief Executive Officer Michael Ensign. Thank you. You may begin.
spk04: Thank you very much. And also from our side, a warm welcome to all participants joining here, both from Europe and the early birds from the U.S. Start out with a quick note on the forward-looking statement. We assume you're all familiar with that. So on that note, we'll move forward. With me today here at this third quarter call, I'm very pleased to have Arne Fredriksen, our co-founder and chief business officer, as well as Arne Grovin, our chief financial officer, and Michael Ingsie. CEO of Nycode. A quick introduction to those of you who are new to Nycode. Nycode is a Norwegian-based immunotherapy company. We're entirely focused to building the leading immunotherapy company, and we're focused on a dual strategy, advancing our portfolio, which consists of a good mix of in-house programs and partner programs through development stages towards the market, while at the same time investing in broadening out the application and the potential of our platform. We have also focused on validating and de-risking the company through clinical data, partnerships, a broad application, as I mentioned, and a solid cash position. So we have taken four different compounds all based on our core platform into clinical development. We have consistently shown, through these clinical trials, the ability to raise a strong T cell response, and in particular, a strong broad CD8 kilo T cell response. We have also consistently shown that the technology is well-tolerated and safe for the patient, both as a monotherapy and in combination with various other anti-cancer drugs. We entered three partnerships with top-tier US-based biopharmaceutical companies, built the organization to scale. We're now more than 150 employees in the company or offices in Oslo and Copenhagen and Denmark and we've also focused on internalizing core competencies in the early research and in your monitoring area. As I mentioned, the platform's potential is already now used across a number of different tumor types, both in oncology, and we've also taken it into infectious diseases, and we've announced that we see a potential to move this into autoimmune diseases also. We just today reported a strong cash position, $212 million at the end of third quarter, and the company is listed on the Oslo Stock Exchange. So it's been another busy quarter and this one in terms of clinical trials. So we started out by reporting the exciting interim results from our T-cell focused Cov2 vaccine that was followed by the positive immunogenicity results from our phase one trial with Levitoneo, our individualized cancer therapy that we are developing together with Genentech. And finally, we reported the additional efficacy analysis from our Phase II trial with BP1016, which is right now investigated in patients with advanced cervical cancer. And our data fraction will take us into a deep dive on these data in a few minutes. On the finance side, as we mentioned, we continue to have a very strong cash position of $212 million U.S. dollars. And we were recently included in two of the important indexes on the Oslo Stock Exchange. We've grown the company now up to 153 employees as of today. And with those words, I'm going to hand over to Auneide.
spk00: Thank you, Michael. Yes, so you have to change the slides. Yes.
spk02: Yeah, so first, briefly going through the data that we were very happy to announce this quarter. This is COVID-19. So the data we announced now was the VB102210, which is a vaccine against COVID-19 that is focused on eliciting very broad T cell response. So this vaccine induces T cell responses both against spike and against additional antigens from COVID-19. So that means we included seven antigens in addition to COVID-19 in the antigenic unit of the vaccine, which allows us to induce a broad response against antigens that are also conserved across different variants that arises as this virus continues to mutate. So next slide, Michael. So we've performed the first in human trial investigating VB102210 as a booster vaccine to people that's been previously vaccinated with an mRNA-based vaccine that includes the spike antigen. And this study has been performed in two sites here in Norway with the primary objective to look into safety, reactivity, cellular immunogenicity as the secondary objective. For this, the data that we were happy to announce, we can see that maybe 10, 22, 10, it's the novelties or responses to all non-spike and concern across.
spk00: So let's go to Ryan.
spk02: We also could see that the vaccine was able to elicit a very broad response, so against all the different antigens that we could see. We could see that we could elicit a response to most patients to more than one of the antigens of the peptides that we included from each antigen in each patient's vaccine. This confirms the induction of broad responses to the vaccine antigens that we include in our vaccine and that we see across different studies with different antigens, both within infectious diseases as well as oncology. So when we also looked into the different types of immune responses, we know that this vaccine has the intention of inducing T cell responses, which can include both CD4 T cell responses and CD8 T cell responses. and also knowing that the CD8 T cell responses have been shown to be relevant for elimination of disease in an early time point and reduction of severity of the disease. We have evaluated the CD4-CD8 distribution in five patients where we do see a dominant CD8 response in all patients tested so far, which again confirms the mechanism of action and the unique ability to generate this strong and broad CD8 T cell responses. So we feel this data continues to confirm the unique mechanism of action and the broad CD8 T cell responses we see. We have by this data successfully proved that our technology with the APC targeted vaccine body technology, unique T cell responses can be used together with adaptive biotechnologies method of selecting immunogenic T cell epitopes that we can incorporate into our vaccine. And it confirms, again, the ability of our platform to induce broad CD8-dominated T cell responses that can recognize viral peptides on the cell surface, and this has the potential to eliminate infected cells. And it also suspends just the favorable safety profile we have with our platform, continue to demonstrate that it's well-tolerated across studies. We also said that we will continue to guide on further development strategies for our COVID vaccines first half of next year. This has been a busy quarter, so also recently we have had the opportunity to announce immunogenicity data from our VB-N01 study, which is our study with our fully individualized cancioneantigen-based vaccine. So this vaccine is based on the same platform as the COVID vaccine. It has the same targeting unit with the chemokine, and then in the antigenic unit, we identify patient-specific mutations for each individual patient, and we manufacture one vaccine per patient that includes this most immunogenic and selected cancer neoantigens in the antigenic unit for each patient. And we continue to see a 100% manufacturing success rate with this vaccine. And we have previously announced positive immunogenicity data and clinical data from the first 14 patients. And now, as of 2020, we entered an exclusive out-licensing deal with Russian Genentech for this program. Then we were very happy to be able to update on the safety and immunogenicity data from this program with more patients, so this includes 41 patients, originally and then immunogenicity data in a subset of these patients. So this is a study where all patients have had prior chemo, prior checkpoint inhibitor therapy with an anti-PD1 or anti-PAL1 and 80% of these patients are continuing on the checkpoint inhibitor and then we add the vaccine on top. And when we look into the immune responses against the antigens that we select per patient, we have up to 20 neoapitopes selected per patient that we identify in each patient's tumor. And we can see that all patients across all five different indications show the response to at least one neoapitope, which we're very happy to see. And then on average, 53% of the new-resulted new epitopes were immunogenic. That ranged from anything from 3 to 20 new epitopes and gives us comfort in the ability of this vaccine to induce a broad response. Looking more in detail, we can see the majority of these epitopes are the lower responses, but importantly, we also see amplification of pre-existing responses. This is something we see that is induced by the vaccine in 95% of the patients. When we are here again, I wanted to look into and characterize the immune responses in more detail. We've been able to do this thoroughly in six patients so far across three different indications. And looking into the distribution of CD4 versus CD8 responses in these patients, you can see many of these patients do have a dominating CD8 T cell response. And we can see when we look in detail, we can actually see that anything between 53% and 100% of the epitopes were able to induce a CD8 response, which we again feel is really comforting for our technology and its ability to induce these CD8 T cell responses. We also characterized them in even more detail, knowing that the T cells that can secrete multiple cytokines are most effective when it comes to being able to have induce a clinical response, and we see polyfunctional CD8 and CD4 T cell responses. In summary, we can see that the data in this indication as well indicates that it's very safe and well-tolerated in all these patients with different solid tumors, with different background therapies. We see a broad T cell response and we see these T cell responses also remain for many weeks after the last vaccination and these are polyfunctional. So just another data set that we have released now across three different programs that indicates that we are able to induce the same kind of T cell responses independent of the antigens that we include. With VB1016, we looked a bit more in detail on the data that we released earlier in May. So we looked in more detail into these patients that we have in an ongoing cervical cancer study. In this study, we've shown before that we have included heavily pretreated cervical cancer patients, meaning we included patients that had failed prior systemic treatment lines, anything between one and five prior systemic treatment lines. And we also highlighted that 30% of the patients actually had failed three or more prior lines of treatment. We also have highlighted that these patients have been heavily burdened by metastases, with 90% of the patients having extra pelvic metastases, and many with liver, lung, or both metastases. And this is something that we wanted to look into in more detail. The data we released before showed, in totality, in this interim analysis, an objective response rate of 21%, and disease control rate of 64%. Importantly, these are interim data, so we are looking forward to release full-year data after one year of treatment later. In this interim data, they were being treated anything between three and 20 months. And earlier this month, we were able to look a bit more into detail on the effects in the different treatment lines. And we can see that if we had only included patients that have been treated with one or two prior lines of treatment, this is really where we see the responder is when it comes to objective response rates. And that would have led to a 30% objective response rate. which gives us the opportunity to compare a bit more in detail to other competitors that have more patients in these patient groups. We importantly do see disease control also in patients with at least up to five prior treatment lines, which we think is very encouraging as well. And again, we do see a nice correlation between the T cell responses and the clinical responses. We basically see the same picture when we look into the number of extra pelvic metastases, which is another way of looking into the severity of the disease. And we see a nice objective response rates up to at least five extra pelvic metastases. And then we see the response rate reduces with these patients that have many metastases. And we also see this reduction on the disease control rate. Again, we do see a very nice correlation with the immune responses and clinical responses. So in totality, we continue to be enthusiastic about the data we generated with EB1016 in this trial and look forward to
spk04: um the full year data that we are able to be analyzing in the first half of 2023. then my thought i give back to you thank you very much it's a quick look at the organization as we already mentioned we are continuing to wrap up and by the mid november now 153 employees in the organization. We continue to focus on building up mainly in research and development. So more than 50% of the organization is now actually engaged in the early stage research and 33% in the development activities. Probably we'll see a slight ramp up in the development part of the organization over the coming 12 months as we engage in the further development of the VB1016 And with those words, I'll hand over to Juha to take us through the financials.
spk05: Thank you, Michael. Nycode is financially well positioned to grow and execute the company's strategy over the next years with a cash position of 212 million a quarter. We're also very pleased with a successful uplift to the main list of the Oslo Stock Exchange in the second quarter and the subsequent inclusion in the Oslo Burst Benchmark Index and Oslo Burst Mutual Fund Index in the third quarter. As previously stated, we continue to explore a potential listing on the Nasdaq global market in the U.S. We can unfortunately not give any guidance on timing, which will depend on amongst other market conditions. Looking at the income statement, we reported revenues of $650,000 in the third quarter and $4.5 million for the first nine months relating to the R&D activities under the agreements with Genentech and Regeneron. Our other income represents government grants from Skattebyn and the Research Council of Norway, where we have a total of four projects running. Moving on to the employee benefit expenses and other operating expenses, we have, as Michael said, been ramping up the organization and our research and development activities over the last years, resulting in increased expenses. Other operating expenses of US$14.8 million in the third quarter, include a non-recurring cost of 6.3 million relating to the R&D services provided over time under the Genentech agreement. The non-recurring cost represents an increase in the total cost estimate for these activities, and under RFRS, such increase needs to be booked when identified. So overall, we recorded a net loss of 14.9 million for the third quarter and 30.5 million for the first nine months of 2022. Then moving on to the balance sheet, as mentioned, we had a strong cash position of 212 million at the end of the quarter. And looking at trade receivables, these are the amounts invoiced under the Genentech and Regeneron agreement. The reduction of trade receivables for the period is due to a true 20 million milestone from Genentech, which was invoiced in the fourth quarter of 2021 and received in the first quarter of 2022. And then finally, moving on to equity and liabilities, we had a total equity of 167 million at quarter end, which represents a strong equity ratio of 73%. And with that, I will give the word back to Michael.
spk04: Thank you very much. Just a final slide here, a quick look at the upcoming catalysts in front of us. So we are looking forward to an exciting period ahead of us. We will be coming back with an update on where we see the opportunities and which of these opportunities we'll prioritize within the EB1016 program, and we'll do that during the course of December this year. Then we, of course, also very much look forward to coming back with the interim analysis following the first year of treatment, as Anita said, during the first half of next year for the CO2 trial. And we are focused on initiating the trial that we've already discussed in the head and neck segment. It will be a phase one trial where we will test different doses of VB1016. Then we are also looking forward to the progress on the autoimmune disease in the early stage program. This is still at the preclinic stage, and we will be coming back to the market within the course of the first nine months of 2023 to provide further guidance on where we see this franchise or business area moving for NYCODE. And with those words, I'd like to thank the participants for listening in, and we're open for questions.
spk03: Thank you. We will now be conducting a question-and-answer session. If you'd like to ask a question, please refer to the Ask a Question area of the webcast player screen. Please type in your question and then click send.
spk01: One moment, please, while we poll for your questions. Okay, our first question here is a two-part question.
spk03: It says somipilimab was recently approved by the European Commission as the first immunotherapy in second-line recurrent or metastatic cervical cancer irrespective of PD-L1 expression level or tumor histology? A, how do you compare these results with NICODE's interim data? And B, does this approval in any way affect your strategy within cervical cancer?
spk02: Yeah, thanks for the question, and congratulations to Regeneron for the approval. and we are club partners with Regeneron, so we're happy to see that they have success here in Europe today. The data generated so far by Simicnoa, we haven't had the opportunity to talk to them today about how they have received their approval, but the data that they've generated is of interest, and it gives basically my coaches more opportunities to continue development in cervical cancer, as you are all aware of. Our BB1016 is intended to be given together with a checkpoint inhibitor and we see that more of these checkpoint inhibitors being approved in the indication with quite similar results. They will always have different patients with different number of lines of prior therapy and also different effects in in different patients with different levels of PD-L1. And I think this is, for us, a positive direction that continues to prove that immunotherapy can be approved and have effects in the patient population. I'm still confident to see the addition of VP1016, as we have shown in detail before with the interim data, and look forward to see in the full year data.
spk01: Thank you.
spk03: And as a reminder, if you would like to ask a question, please refer to the ask a question area of your webcast player screen.
spk01: Simply type in the question and click send on your keyboard. I'm not showing any further questions at this time.
spk03: I'd like to hand the call back over to you for any closing comments.
spk04: Thank you very much, and thanks again for everybody listening in, and thanks, Gaia, for your questions. And we wish you all a continued good day and good holidays in the U.S. for those listening in from there.
spk03: Thank you. This does conclude today's teleconference. You may disconnect at this time. Thank you for your participation, and enjoy the rest of your day.
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