Earnings call transcript: Nykode Therapeutics Q4 2024 revenue jumps, stock up

Published 26/02/2025, 14:18
 Earnings call transcript: Nykode Therapeutics Q4 2024 revenue jumps, stock up

Nykode Therapeutics ASA (NASDAQ: NYKD), with a current market capitalization of $74.88 million, reported a significant increase in revenue for the fourth quarter of 2024, reaching $6.9 million, up from $2.3 million in the same period the previous year. Despite a net loss of $6.8 million, the company’s stock rose by 5.72% to $2.55, reflecting investor optimism. According to InvestingPro analysis, the company holds more cash than debt on its balance sheet and maintains liquid assets exceeding short-term obligations, supporting its strategic initiatives in cancer vaccine development.

Key Takeaways

  • Nykode Therapeutics’ revenue increased significantly year-over-year.
  • The company’s stock rose by 5.72% following the earnings announcement.
  • Strategic focus on cancer vaccine programs and partnership opportunities.
  • Strong cash position supports ongoing and future initiatives.

Company Performance

Nykode Therapeutics demonstrated strong performance in the fourth quarter of 2024, with revenue tripling from the previous year. The increase was primarily driven by research and development activities with major partners such as Genentech and Regeneron (NASDAQ:REGN). Despite the net loss, the company maintains a robust cash position, which is crucial for its strategic refocus and cost management efforts.

Financial Highlights

  • Revenue: $6.9 million in Q4 2024, up from $2.3 million in Q4 2023
  • Net Loss: $6.8 million in Q4 2024, compared to $5.3 million in Q4 2023
  • Cash Position: SEK 150.4 million

Outlook & Guidance

Nykode Therapeutics is extending its cash runway into February 2030, focusing on partnerships and the development of its VB1016 and VB10 Neo programs. The company anticipates the readout of the CO3 trial later in 2025. Future earnings projections indicate a slight improvement, with EPS forecasted at -0.08 USD for FY2025, compared to -0.15 USD for FY2024.

Executive Commentary

CEO Michael Enzig stated, "We are aiming for a cost base of approximately US$20 million dollars per year," highlighting the company’s commitment to financial discipline. Enzig also noted the growing interest from pharmaceutical companies in Nykode’s field of individualized immunotherapy.

Risks and Challenges

  • Potential delays in clinical trial results could impact timelines.
  • Dependence on partnerships for revenue generation poses risks.
  • Market competition in cancer vaccines is intensifying.
  • Regulatory challenges in individualized immunotherapy could arise.

Q&A

During the earnings call, analysts inquired about potential partnerships and the company’s differentiation in immune tolerance technology. Executives emphasized ongoing discussions with multiple pharmaceutical companies and the promising data generated in their programs.

Nykode Therapeutics’ strategic initiatives and promising trial results have positioned the company favorably in the growing field of cancer vaccines and immunotherapy. While the recent stock movement has been positive, investors should note that according to InvestingPro data, the company faces challenges with rapid cash burn and analysts anticipate a sales decline in the current year. For deeper insights into Nykode’s financial health and growth prospects, access the comprehensive Pro Research Report, which provides detailed analysis of over 1,400 US equities.

Full transcript - Nykode Therapeutics ASA (NYKD) Q4 2024:

Kevin, Conference Moderator: As a reminder, this conference is being recorded. It’s now my pleasure to turn the call over to your CEO, Michael Enzig. Please go ahead.

Michael Enzig, CEO, NiCod: Thank you very much, Kevin. And also from my side, a warm welcome to all the participants for this NIcod’s fourth quarter webcast. Just a quick reminder of our forward looking statement. We assume you’re all familiar with those. On that note, we’ll move forward.

I am very pleased to, as usual, have Agneth Frederiksen, Chief Scientific Officer, Head of Business Development and Co Founder with me together with Harald Gourvin, Chief Financial Officer. And together, we’ll take you through the key highlights of fourth quarter as well as, of course, the financial numbers. So it’s been an eventful fourth quarter for us, although obviously there are parts of this we are not looking forward to see any time through. It has been a tough period with a number of layoffs and people leaving the organization because we have announced the strategic refocus to align our activities and our organization and our cash balance with our cash runway. And we are good through these processes right now.

The intent is, of course, to align the activities with the cash runway and to extend the cash runway into 02/1930. We’ll achieve that by reaching an annual cost base of approximately $20,000,000 going forward. We are reporting today strong cash position of more than $150,000,000 which is, I think in these days in this industry, a uniquely strong position to be in. Also on the very positive side, we did publish the final data set from our Phase II trial, the CO2 trial in the peer reviewed Jitsi journal, once again confirming what we saw in the interim data, a prolonged benefit, definitive vaccination effect in the patients with advanced cervical cancer. We regained ownership, including the IP rights to our VB10eo program from our partner Genentech and are now looking into the optimal path for that program going forward.

We did announce a small set of data from the NO2 trial that does confirm what we’ve seen earlier in the N01 trial, a comparative immune response. I will take you a little bit through these data again later in this call here. But just to say that we remain very confident in the VB10 Neo program compared to the industry or other programs in the same field. Then we presented new data on both our cancer vaccine, the mRNA modality, and we’ll spend a little bit of time for that later in this call here and of course, on our very exciting APC targeted immune tolerance program. And we’ll also be spending some time on this later in this call here.

We’ve been through this before, but just want to recap for everybody. The purpose of our refocused strategy is to create a company, which is obviously lean and research focused, focused on discovering novel assets, which we in turn think will create very exciting investment opportunities through targeted development activities, including also clinical trials. And everything we do will be geared and aimed towards generating early partnerships. We do believe that is the best way to create value for a company like NiCode with a very strong technology platform, but also with our strongest competencies in the product discovery and early development area. So expect to see us continue to generate exciting new assets from our research engine at a very cost conscious way also take decisions on targeting cost efficient development activities to create shareholder value and pave the way for early partnerships.

Our lead program, BP1016, is still in progress and also here reminding you that we are addressing a patient population with a huge unmet need. And perhaps surprising to some still remain with high and growing incidences. It’s been a notion that some of the prophylactic vaccines would change the market opportunity for this patient population going forward. That does does not seem to be the case. First of all, because of a lack of uptake of prophylactic vaccines around the world, which means there will be a continued use of or need for therapeutic vaccines in the APV16 driven cancer fields in the future.

We have now reported very strong data for VB1016 combined with atezolizumab in the CO2 trial together with also a favorable safety profile. We see an even stronger effect in the PD L1 positive patients and again, even stronger effect in the PD L1 positive patients with only one trial line of systemic treatment. Again, reminding you that we have also in our very first trial with VB1016 in H2O patients, seen very encouraging effects with VB1016 as a monotherapy in an area that is also gaining increasing attention from industry players around the world. We have an ongoing trial, CO3, where we are looking for the immune responses and safety in patients with first line patients with head and neck in combination with pembrolizumab. We did announce or publish the data in the from CO2 trial, and we’re not going to take you through all the data.

The publication is available also through a link on the homepage. But just want to remind you what gives us a very high level of confidence and conviction in VB1016. What you show here is the key data from the patient population with high PD L1 expression. And we show you here the overall response rate, the PFS and the median overall survival compared to three different historical trials that were assessing checkpoint inhibitor. Monotherapy in a very similar patient population also PL1 positive.

And you see that the CO2 trial basically observed an ORR of twenty nine percent compared to from sixteen percent to eighteen percent seen with checkpoint inhibitor monotherapy. We saw PFS of six point three months compared to one point nine to three months for the checkpoint inhibitor monotherapies. And very impressively, we saw the median role survival land at twenty four point seven months compared to overall survivals ranging from approximately ten point six to thirteen point nine months observed with checkpoint inhibitors on monotherapy. These data obviously gives us, as I said before, very high level of conviction and confidence in the effects of VB10 sixteen and give us every reason to continue developing VB10 sixteen and look for partners. Next (LON:NXT) slide just shows you what we’ve seen in the patient population that are PD L1 positive and have only received one prior line of systemic therapy.

If you go to the far right of this graph, our table here, you see the aura climbing from twenty nine percent up to forty percent, the PFS from six point three to fifteen point eight months. And for this patient population, we did not reach the median overall survival. So this also gives us conviction that the earlier stage we go into, the higher the efficacy we will observe for VB1016. With those words, I’m going to hand over to Alneida, our Chief Scientific Officer, Head of Business Development to take us through the updates on VB10 Neo and our immune tolerance program. So please, Anil?

Agneth Frederiksen, Chief Scientific Officer, Head of Business Development, Co-Founder, NiCod: Yes. Thank you, Michael. So moving into Vibetenia, that’s our fully individualized neoantigen based cancer vaccine. This has really the potential to address a broad set of indications as we do make one vaccine per patient that could be explicable for basically all tumor types. We do see a strategic focus in large investments these days in individualized cancer vaccines in late stage trials by our peers focusing then importantly on the adjuvant setting and expecting data readout from these trials from our peers in 2020 and ’25 some and 2026, ’20 ’20 ’7.

So as you may all be aware of, there has been limited transactions in the field of cancer vaccines since Michael was very active in the space in 2020 and 2021. We now see that that is changing in the landscape, being very aware of what’s happening in the field of cancer vaccines in early stage. So that’s positive for NIcod and also regaining the rights from VB10E. We do have, as you all should be aware of, proven to generate broad and long lasting T cell responses across two clinical trials. And importantly, this has not been in adjuvant setting.

This has been in heavily pretreated patients with recurrent metastatic solid tumors. We have successfully established in house proprietary neoantigen selection algorithm that we call NeoSelect. And we work with plasmid DNA that for individualized cancer vaccines do have a very competitive turnaround time and cost of goods reaching the market. We have strong patent protection. If you remember, we got a patent approved earlier this year for our VB10 Neo.

And as we recorded in Q3, preliminary immunogenicity data from the NO2 trial aligns and confirms the final positive data from the NO1 trial. Even though these patients are with even a broader set of indications and later stage patients. Final analysis is currently ongoing as we are regaining also all the rights from Genentech for this program. Looking forward to finalize all the analysis. As we also showed in Q3, preclinical data supports the opportunity for strong and durable responses.

We’re using our technology across modalities, important to hear with mRNA, which I’ll show you in the next slides. So just to remind you, we have done some preliminary analysis from VB NO2 that we reported in Q3, where we see comparing to what was presented in NO1 that we generate the same amount or even slightly higher percentage of immunogenic neoantigen patients with at least one immunogenic or de novo induced vaccine response and those do have response to any neoapitope. Additionally, where we haven’t shown you really the data yet, we are looking forward to do that in the future. We do see a persistent expansion of T cell clones in the majority of eligible patients measured also by the alternative method TCR sequencing with the persistently expanded clones emerging already as early as after two to four vaccinations and also durable in frequencies. And the adoption of this persistent T cell response has been confirmed by IBS Allispot, which means we can identify that some of these clones are truly generated by the vaccine.

So we continue to be very confident in Vipitinio’s potential and happy to see that there is an increased interest in cancer vaccines by the environment. MRNA. Go to the next. These are data that we’ve generated to also investigate our technology across modalities. So this generated by mRNA LNP and we looked into durability.

As Michael mentioned, we have very strong convincing durability of VB1016 in the CO2 trial leading to prolonged median overall survival. We wanted to see if that holds true when we also use the mRNA format. Here we have vaccinated in preclinical models two times early and looked that we can actually still identify neoantigen specific T cell responses at day one hundred and thirty three after two initial vaccinations, but also importantly, when we boost this with a third vaccination at day one hundred and thirty two, we are able to really boost the T cell responses to be up to 35,000 spots there in this particular experiment, which can mimic either that you do see the antigen coming naturally by the disease or with the third vaccination. So very promising data. We also see very strong increase in this in the number of the epitopes that are boosted after this long term in this long term assay.

If you go to the next, we also looked whether these T cell responses were able to come for tumor protection at this later time point. So here vaccinating either day zero or two times day zero and day twenty one and doing a tumor trial and as late as day ninety, we see that with one vaccination, we generate seventy five percent tumor protection. But with two vaccinations, we’ve been able to fully protect the mice at this later time point of tumor challenge. So able to prove that the T cell responses that’s generated are efficacious also long term. And then as Michael mentioned, the immune tolerance field is a very interesting field these days in the industry.

We see a lot of activities in immune tolerance. We also see a lot of activities and interest into this field that we are working with, which is truly antigen specific immune tolerance. The field and such has huge opportunities both within a range of autoimmune diseases, but also allergies and organ transplant rejection. So basically those indications where we see an unwanted antigen specific immune response that we can then modulate with the treatment. The antigen specific immune tolerance field is unique and still new with the few players, but a lot of activities.

Also, we see transactions in the field. There’s a lot of unmet medical need and we know that up to one in ten people are actually affected by autoimmune disorders and then you can add allergies to organ transplant rejection. So this has a huge focus for NIICO these days. That is obviously supported by the preclinical proof of concept data that we’ve generated in the most common autoimmune disease models that is being used by the field, we show potent therapeutic advantage to our APC targeting technology that is significantly better than other technologies operating in the space that do not have our APC targeting platform. Patents obviously submitted and we are moving very rapidly forward now establishing several tolerance relevant methods and assays that will be extremely important in order to both identify the most optimal version of the, and I call it, tolerance vaccine, but also to really understand our opportunity to specifically modulate the immune system in different directions also within autoimmune diseases.

Go to the next. So these are data shown in Q3 where we Q4, sorry, with the comparison of two different versions of our technology where we have kept everything identical except the two targeting units. So we have a range of different targeting units that we can use that we believe can turn immune response into tolerance. You see they are both very effective in preventing disease in this EAE model, which is the model that most of the players in our field are using really to understand the efficacy and the model action of antigen specific tolerance. If you go to the next, when we look into that in particular with different dose levels as well as comparing with constructs that do not have any relevant targeting units of the non targeted vaccine, which is then shown in black in the figures, you really see that adding a functional targeting unit provides a very strong increase in the ability to alleviate disease in this model.

And this was done with the first targeting unit that we did show earlier this year. And then if you go to the next, we mimic this with the second targeting unit and confirm that this also works and potentially works as good or even slightly better with this targeting unit here. And then if you go to the next version, we have also now successfully set up a very interesting alternative model, which is a relapsing remitting EAE model, which means that we have generated data with another construct that holds the different relevant antigen PLP compared to MOG antigen that we used before. We also see that this provides efficacy in a relapsing remitting model. And all of these data now allows us to move more rapidly forward from where we stand today to really dig into the variety of our different constructs, which ones provide the optimal activity and modulates which arms to the immune system.

Should we go to the next? We are currently in Boston and looking forward to present new data from our antigen specific human tolerance efforts at this highly relevant conference, Antigen Specific Immune Tolerance Summit, going on this week. And we will present a lot of interesting data tomorrow. Then by those words, I will transfer to you, Hayab, for going through the financial results.

Harald Gourvin, Chief Financial Officer, NiCod: Thank you, Ravenetto. Looking at the income statement, we reported total revenue of $6,900,000 in the fourth quarter, up from $2,300,000 for the same period in 2023. ’6 point ’8 million dollars of the revenues related to R and D activities delivered under agreements with Genentech and Regeneron and the remaining relates to government grants. The increase in the quarter is mainly due to the cancellation of the contract with Genentech. Part of the $245,000,000 in upfront term item payments received under the contract were taken to income over time as the R and D services under contract were delivered.

Following the cancellation of the contract in the fourth quarter, the outstanding balance of $6,800,000 was taken to income in full. Employee benefit expenses were $8,300,000 in the fourth quarter, down from $8,900,000 for the same period in 2023, reflecting the first part of the organizational changes executed during the second half of twenty twenty four. The main part of the reorganization was executed in January and is expected to be finalized in the first half of twenty twenty five, which will significantly reduce the employee benefit expenses going forward. Other operating expenses were 4,100,000 down from $10,000,000 in the same period for 2023, mainly reflecting reduced R and D services to Genentech and reduced clinical activity. Finance income and costs were net $1,100,000 negative in the fourth quarter, which mainly relates to interest income and unrealized currency movements on the Wiedenkraut exposure.

So overall, we reported a net loss of $6,800,000 for the fourth quarter compared to a net loss of $5,300,000 for the same period in 2023. Next slide please. Then moving on to the balance sheet, we had a strong cash position of SEK 150,400,000.0 at year end, which based on the reorganization will give us a runway into 02/1930. As previously communicated, we received a decision from the Norwegian tax authorities on October 2023 relating to the tax agreement of the upfront payment received under a license agreement entered into 2020, which generated a payable of approximately US30 million dollars to the tax authorities in the fourth quarter of twenty twenty three. Nycore is confident that upfront payment has been treated correctly, a view which has also been confirmed by third party experts.

NACO appealed the decision in the first quarter of twenty twenty four and the payment has been booked as a receivable via a rate outcome of the appeal. The receivable is in Norwegian kronor and the dollar amount in our account will fluctuate with movements in the exchange rate, which also explains the large unrealized movements in finance income and costs in the income statement between the quarters. In February, we received a letter from the tax authority that we can expect a draft of the recommendation from the Secretariat in the first quarter of twenty twenty six. Next please. Moving on to equity and liabilities.

We had total equity of SEK106.2 million at year end, which represents a strong equity ratio of 89%. And with that, I will give the word back to Michael.

Michael Enzig, CEO, NiCod: Thank you very much, Ralf. And we’ll finish off with an outlook on our priorities for 2025 before we open up for a few questions. So we are obviously having a high focus right now from the management side on continuing the implementation of our refocused strategy and organizational adaptations, aligning our financial resources and cash runway with the new organizational priorities. As we said, we are aiming for a cost base of approximately US20 million dollars per year, which will in turn extend the cash runway into 02/1930. We also continue to be convinced and progress our pipeline.

We are currently executing the CO3 trial in the VB1016 program in first line head and neck patients where we are assessing VB1016 in combination with pembrolizumab. This trial is expected to read out later this year here, and we’ll mainly be looking for the ability of VB1016 to generate immune responses in these patient populations and of course, assess the safety in this particular patient population. We’ll also be assessing the or discussing the optimal path forward for VB10 neo, aiming at positioning VB10 neo for future partnerships. And for the immune tolerance program, we are working hard to retain our leadership in this field here and really position NIco’s immune tolerance platform as the best in class antigen specific tolerance treatment and will of course also be on the outlook for partnerships in that field. And with those words, I think we’ve come to the end of formal presentation on our rig to take some questions.

Kevin?

Kevin, Conference Moderator: Thank you. Our first question is coming from Geyer Hallum from DNB Markets. It’s in two parts. Part one, what are the most important events for value creation in the coming years as you see them? And part two is, you aim to reach a cost base of approximately US20 million dollars per annum.

How fast can you get down to that level and what cost level could we expect?

Michael Enzig, CEO, NiCod: Thank you very much, Gaia (NASDAQ:GAIA), for your questions. I think I will address point question number one and then I’ll hand over to Johan for addressing question number two. So the most important event for us in the coming years, not just 2025, is obviously to see progress on our most important assets and our assets. I would say I would divide into the three. Probably obvious one for everybody, VB1016, VB10 neo and our immune tolerance platform.

So for VB1016, we did just report very exciting final data from the CO2 trial in patients with advanced cervical cancer. And we will be seeing the results of the CO3 trial this year. As I said before, the CO3 trial is mainly designed to give us a feeling for the immune response levels and the safety in this patient population, which is the first time we test U1016 in first line head and neck. So that will also be important. And I think together, all these data will inform us on the next best step for VB1016.

So we will, of course, on the back of that trial, be coming out and giving some guidance on where we see the next step for VB1016 as a sense of priority. For the VB10 neo program, we remain, as I said a couple of times during this call here, convinced about the uniqueness of the program and the ability to generate a broad and deep immune response. We see the levels that Alnida went through earlier on a very competitive level compared to what we see with peer reported data. So our conviction in VB10eo is despite the development partnership front, actually unchanged. We also sense that the excitement around individualized immune therapies these years here are higher than ever.

They are being put more money into clinical development of individualized immunotherapies across the industry than we’ve seen any earlier year with several pivotal programs going on and also a range of randomized Phase II programs going on from peers. And as always in this field here, we do expect to see a lot of spillover effect should those programs come out positive, which we, of course, hope they will. And we sense that also from discussions with the pharma industry. We do see an increasing pickup on the number of pharma companies that wants to get an update in this field here. So I think our job for the VB10 Neo is to really figure out how we position ourselves best as the most attractive unencumbered individualized immune therapy, aiming obviously at entering a future partnership.

And how we do that exactly? We’ve indicated earlier, we will need a little bit more time. I think we’ve indicated we’d be coming back in the first half of twenty twenty five with further guidance on how we see the best path for VB10neo going forward. And then of course, the whole field of immune tolerance, which is an extremely exciting field these days, generating a lot of interests from potential pharma partners here. We will continue to strengthen the underlying base for the APC targeted technology platform and continue to demonstrate that our approach is really unique and best in class.

We will be on the lookout for various constructions of collaborations with partners that could potentially accelerate both our both programs and of course contribute critical know how and muscles to the programs. So that’s basically how we approach that. And as Omidi indicated in her slide, we will be presenting what we actually consider to be exciting preclinical data at the conference in Boston tomorrow, which we think further establishes the APC target technology platform that we have as one of the best in class, if not the best in class. I think I’m going to leave it to you, Hart, to talk about the second question.

Harald Gourvin, Chief Financial Officer, NiCod: Yes. Thank you. We are, of course, constantly working to prioritize costs where they’re being the most value. If you look at the 2025, there will, of course, be both restructuring costs. The main part of the reorganization was executed in January.

And there will also be ongoing costs related to the CO3 trial and finalization of the NO2 trial. So the cost level for 2025 will be higher than the 20,000,000 long term cost base we are aiming at, exactly how we will come back to once we have more clarity. But if you look at when we aim to reach the new long term cost base based on the current plans, we should already next year be able to reach that $20,000,000 cost level.

Kevin, Conference Moderator: Thank you. Our next question is coming from Sean Hama from Jefferies. In your discussions with potential partners, has anyone said whether they await further data from VB10.16 before signing an agreement such as immunogenicity data from VBCO3? When can we expect this data?

Michael Enzig, CEO, NiCod: Yes. Thank you very much. And of course, I fully do appreciate the question, but it does to some extent suddenly become a gross simplification of, I think, partnership dialogue in general when you try to boil it down to so singular questions. So when we talk to partners about any programs, it’s an ongoing dialogue that stretches over long periods, where you try to keep people engaged in the program and tell them about the progress and the data coming out. And the responses comes in, in a broad range or a longer spectrum from there will be people who are not even focused on these strategic areas.

There will be people who are on the lookout and trying to stay updated. And there will be people who are interested, but will be looking for something more. So it is a correct implication that some companies need to see more data. Some companies even say they want to see randomized data before going into new modalities. And therefore, there will be companies who have said we’ll be looking for more data in the areas Where the CO3 is bringing those data, we will have to see whether that will be enough.

It depends both on the outcome of the data and the way I think some of the parameters that we are not emphasizing here pans out when you dig down into patient cases. So we’ll have to see, but we are definitely not ruling it out.

Kevin, Conference Moderator: Thank you. Next question is a follow-up from Sean Hama from Jefferies. What have you gathered from FDA regarding the feasibility of running later stage trials for personalized cancer vaccines and the scope for commerciality?

Michael Enzig, CEO, NiCod: Yes. Thank you. Also a good question. And I think this whole field is in a flux these years. And I say that in a positive sense, although I realize it can be perceived as something that is risky.

I always felt that or we always felt that in particular the FDA have had a very old mind to these new technologies and the prospect of using AI driven algorithms to design individualized therapies. So I think FDA is one of the more forward looking agencies you’ll find together with perhaps the German authorities, PIE. We don’t sense that there’s any hesitancy from FDA towards a particular patient population. But we do agree with the majority of parties in the industry right now that the sweet spot for the current individualized immunotherapy platforms, including probably our own, lies towards the more early stage cancer tumor type. So in the adjuvant setting, the local advanced or respectable settings, where we’ve seen actually quite encouraging data coming out.

We never ruled out late stage cancer, but I think just to repeat myself here, we do agree that it is probably in the early stage. We will see the first breakthroughs for individualized immunotherapies like ours and our peers. And also expect that is where we will be focusing our own thoughts as we map out our plans.

Kevin, Conference Moderator: Thank you. Next question is coming from Cara Monterone from Van Der Schlot Kempen. What kind of partnership are you looking for or are you looking for?

Agneth Frederiksen, Chief Scientific Officer, Head of Business Development, Co-Founder, NiCod: Thank you. As you know, partnerships come in all shapes and forms and we are in general very open for exploring multiple partnerships, particularly at this stage of the company. I think if you look at our three main priorities programs at the moment, VB1016 is an asset that we find to be very mature as it is, generated very promising data across cervical cancer and we’re now waiting for the first data in head and neck cancer. So that is more likely to be a traditional partnership with pharma that we will prioritize. Although there are also other innovative therapies moving forward towards approval that can be interesting to explore in combination of it also VB1016.

When it comes to VB10 Neo, we have a very broad opportunity space for partnerships. We have currently generated promising data from everything from feasibility, turnaround time, cost of goods and immunogenicity as a science of clinical efficacy in very late stage cancer patients across multiple different indications with the plasmid DNA format in combination with checkpoint inhibitors. We do see that the field is moving forward, really focusing on very similar setups, but in adjuvant setting. So still here, really open for standard collaborations moving the asset forward into adjuvant setting. But we also importantly here as you see the results have the opportunity to explore partnerships on the back of other modalities like RNA.

We also have the opportunity to explore partnerships in combination with other therapies that are moving forward. We’ve seen approvals recently with cell therapies in the space and there are multiple cancer immunotherapies that we now see are reaching a stage where they are looking for combinations that can further increase the potency of their therapies and cancer vaccines, both off the shelf and individualized cancer vaccines falls in that space. So I would say there is a broad opportunity space for potential partnership structures that we can explore, particularly for where we have Vipitenia at the moment. Then for immune tolerance, that feel is currently very different from cancer immunotherapy. There has been multiple years now where you need late stage clinical trials in order to see transactions in cancer immunotherapy or there’s basically not been very much activity on the transaction sites in cancer immunotherapy.

While in the field of immunotolerance and also specifically in the field of antigen specific immune tolerance, we see a very active space with multiple pharma companies saying that’s really false within their strategy and we see also transactions on a preclinical stage. And if you look at our data and we’ll also see multiple data tomorrow, what we have here with our platform is really differentiating from the other technologies being explored in the field. And we are getting closer and closer to be in a position to continue to support the differentiation and the ability we have when we are changing our Hc targeting units and modulating in response to different directions. So we are focusing really here on the preclinical path to be able to support those partnership discussions that we are currently seeing. So what really differentiates our platform compared to others.

And there are certainly opportunities that we will explore to also pursue early stage partnerships even at the preclinical stage, which is obviously of importance for us because there could be more near term than clinical partnerships based on clinical data. I think that answers the question. Go to next.

Kevin, Conference Moderator: Our next question comes from Arvind (NSE:ARVN) Desender from Carnegie. It’s in two parts. I’ll ask part one first. What is the current development stage of your most advanced immune tolerance project? And when do you anticipate entering the clinic?

Agneth Frederiksen, Chief Scientific Officer, Head of Business Development, Co-Founder, NiCod: Yes. Thank you, Avid. I think I touched upon that also in answer for the previous question. And the antigen specific immune tolerance space is newer. There are fewer players.

There are fewer players that have moved into the clinic. There are few players now that also are not in dialogue or already in a partnership with pharma companies. What we are focusing on the moment, which is based on tight interactions with the range of potential future partners, is to really show and understand the differentiation of broader our technology compared to technologies that are not using APC targeting, but also the opportunity to investigate different APC targeting units and whether we can see a differentiated modulation of the immune response which can be indications within autoimmunity, allergy, organ transplant rejections. Currently, we don’t see any other companies out there that do have a technology that has the same potential as we have, which is where we really truly differentiate and that’s where we focus on before we choose the optimal path forward to move into the clinic either alone or in collaboration with a partner per indication.

Kevin, Conference Moderator: Thank you. Thank you. Thank you. A follow-up from Marvin Ascenta from Carnegie is with your strategy now more focused on asset generation and early stage development, do you approach pipeline expansion in terms of therapeutic focus and breadth?

Agneth Frederiksen, Chief Scientific Officer, Head of Business Development, Co-Founder, NiCod: Yes. So I will continue with the tolerance part here. I think the breadth of the pipeline and tolerance can obviously be further expanded by first focusing on the platform and the uniqueness of the platform and the potential across different APC targeting unit, different antigens and models and allow us to broaden the pipeline also in collaboration with partners with which are indication specific. So that obviously has a strong potential to broaden the pipeline within tolerance in the future years to come. We do focus our cancer immunotherapy pipeline on further advancing the assets that is already passed already provided clinical benefit, which is including BB10 sixteen and BB10 Neo and making sure that we move those forward in the most cost effective manner and that can lead to partnership discussion and further support the platform so we can continue to expand the pipeline in the future also here.

Kevin, Conference Moderator: Thank you. We’ve reached the end of our question and answer session. I’d like to turn the floor back over for any further or closing comments.

Michael Enzig, CEO, NiCod: Thank you very much, Kevin. Thank you very much to all the participants joining in for the questions that we covered today. Stay tuned. We are looking forward to keep you updated on progress, both on our immune tolerance platform, but also as we’ll be giving further guidance on the next step for VIVICIAN NEO and of course for Vibeten sixteen once we’ve seen the readout from the CO3. So with those words, we wish you all a continued good day and look forward to keep you updated.

Bye.

Kevin, Conference Moderator: Thank you. That does conclude today’s webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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