Earnings call transcript: Nykode Therapeutics Q2 2025 shows revenue fall, profit rise

Nykode Therapeutics reported its Q2 2025 earnings, revealing a significant drop in revenue but a swing to profitability. The company posted a total revenue of $200,000, a steep decline from $600,000 in the same quarter last year. However, it achieved a net profit of $900,000, contrasting with a net loss of $7.3 million in Q2 2024. The stock price fell by 7.11%, closing at $1.61, reflecting investor concerns over the revenue decrease. According to InvestingPro analysis, the stock is currently trading near its 52-week low of $0.15, with a market capitalization of $55.37 million.

Key Takeaways

• Revenue decreased by 66.7% year-over-year.
• Achieved net profit of $900,000 compared to a loss last year.
• Stock price dropped by 7.11% post-earnings announcement.
• Cash position strong at $70 million.
• Approved a cash dividend of NOK1 per share.

Company Performance

Nykode Therapeutics demonstrated resilience by turning a profit despite a substantial revenue drop. This shift was primarily due to a significant reduction in operating expenses, which were halved from $12.4 million to $6 million. The company is strategically focusing on its lead asset, Abisuga, for head and neck cancer, alongside other key programs.

Financial Highlights

• Revenue: $200,000, down 66.7% YoY.
• Net Profit: $900,000, compared to a loss of $7.3 million last year.
• Cash Position: $70 million at the end of the quarter.
• Operating Expenses: $6 million, down from $12.4 million.

Outlook & Guidance

Nykode has extended its cash runway to 2028, with potential to reach 2029 pending a tax case outcome. The company remains focused on three primary programs: Abisuga for head and neck cancer, VB-ten neo for neoantigen therapy, and a tolerance platform for autoimmune diseases.

Executive Commentary

CEO Michael Linsig emphasized the potential of VB-ten sixteen, now Abisuga, stating, "We do consider VB-ten sixteen our lead asset, with the potential to deliver meaningful clinical data within twenty-four months." He also highlighted the strategic position of their technology as an attractive unencumbered asset.

Risks and Challenges

• Revenue decline may impact investor confidence.
• Dependency on successful clinical trials for future growth.
• Competitive pressures in the individualized neoantigen therapy market.
• Regulatory challenges in expanding clinical trials across Europe.
• Potential financial impact from unresolved tax cases.

Nykode’s Q2 results highlight its strategic shift towards profitability through cost management and a focus on promising clinical assets, though revenue challenges and market reactions underscore the risks ahead. For deeper insights into Nykode’s financial health and future prospects, including 8 additional exclusive ProTips and comprehensive valuation metrics, visit InvestingPro to access the detailed Pro Research Report, part of our coverage of over 1,400 US equities.

Full transcript - Nykode Therapeutics ASA (NYKD) Q2 2025:

Kevin, Conference Moderator: Greetings and welcome to the Nikko Therapeutics Second Quarter twenty twenty five Strategy Update and Results Webcast. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It’s now my pleasure to turn the call over to CEO, Michael Linsig.

Please go ahead, Michael.

Michael Linsig, CEO, Nikko Therapeutics: Thank you very much, Kevin. And also from my side, a very warm welcome to everybody to this Q2 webcast and not least our long anticipated strategy update from Nicode. Before moving on, just want to remind everyone of you of our forward looking statements. We assume you are familiar with those. And on that basis, I’ll quickly move on.

As usual, I am very pleased to have with me here today, Anders Fredriksen, our Co Founder and CSO and Al Gurwin, our CFO. Before moving into the strategy update, which I believe you’ve all been waiting for at this time from here, we’ll just very quickly or briefly review the key highlights from our Q2 report, which was also announced or issued this morning here. And because we are focusing most of this call today on the strategy, we’ll be reviewing the Q2 a little bit briefer than usual. Still, we did have a couple of very important events during the quarter from the VBD neo program. We did announce the key data from our NO2 trial at ASCO in 2025 in Chicago.

And these data once again highlights our VB-ten neo program’s ability to induce a robust and durable immune responses across multiple tumor types in a heavily pretreated patient population. And just to remind you here that the number of biotech companies that do have an established manufacturing platform and epitope selection algorithm and actually clinical data to boot is very small. So we’ll be reviewing more on that one later today. For our VB-ten 16 program, we are conducting the Part one of the CO3 trial, which is in essence a dose escalation program. We have enrolled all the patients there, so 13 patients spread along three different dose levels.

So one patient in three milligrams, six patients in six milligrams and six patients in nine milligram doses. And during the quarter, the so called Trial Safety Group did what we call a safety clear all of the doses for that program, which again underlines VB-sixteen’s very favorable safety profile. Nyco has entered discussions with Regeneron regarding the future of the collaboration programs and these programs are no longer included in NYcho’s updated strategy or our financial forecasts. And finally from my side, Susanne Staphos was also elected as Chair of the Board at the Extraordinary General Assembly on the April 23. I’m going to hand over to Har for a quick review of the Q2 financials.

Harald, CFO, Nikko Therapeutics: Thank you, Michael. Looking at the key financials for the second quarter. Total revenue and other income came in at $200,000 compared to $600,000 in the 2024, which was driven by less revenue from Genentech and Regeneron. Total operating expenses five reduced from $12,400,000

Kevin, Conference Moderator: in the 2024 to 6,000,000

Harald, CFO, Nikko Therapeutics: reflecting the reduced organization following the organizational streamlining finalized in the 2025 and with full effect expected in the third quarter and also reduced clinical activities. We recorded a net profit of $900,000 in the 2025 compared to a net loss of $7,300,000 in the 2024, mainly due to reduced operating expenses and also unrealized currency gains relating to our cash held in Norwegian krone and the noncurrent receivable relating to the tax gains denominated in the same. A cash dividend of NOK1 per share was approved at the Annual General Meeting held on 05/26/2025, and the dividend totaling $32,300,000 was paid on December. We are still well capitalized with a cash position of $70,000,000 at the end of the second quarter. And with that, I will give the word back to Mikael, who will take you through the updated strategy.

Michael Linsig, CEO, Nikko Therapeutics: Thank you very much. And that concludes the Q2 part of this webcast. We’ll then move into the updated strategy part, which no secret, it’s we’ve been really looking forward to take you through these thinking here. It’s no secret also that it has been tough last twelve months for the Nicode for the Nicode Company and the team. On the one hand, we were left with great technology, good data and a strong cash position.

On the other hand, we had a disconnect between plans, inflection points and our cash runway. The first thing we did in that light was to bring down or bring control of our cash burn through a series of significant restructurings and prioritization efforts. This was a very painful, but necessary process and I cannot emphasize enough how grateful I am to the employees and all the shareholders who stuck with us through those times. Secondly, and in particular since April, since the April events, we have together with the new Board carefully assessed the strategy and the options in front of us. And as I mentioned before, the management team is really looking forward to take you through what we think is a very exciting new strategy for the company.

We looked at how we could most optimally deploy our capital on our pipeline to achieve meaningful debt inflection points within our cash runway, while building as much value for patients and shareholders possible. And that plan, which we will present today, includes a robust Phase II randomized clinical trial for VB-ten sixteen first line head and neck, which we expect to lead to significant data within our cash runway. Furthermore, we have also, we think compelling strategies for VB-ten neo and VB-ten our tolerance program. We’ll just quickly take you through the key highlights here. No surprise for you that we do consider VB-ten sixteen our lead assets, with the potential to deliver meaningful clinical data within twenty four months.

We have very strong confidence in this program supported by data from two completed and one ongoing clinical trial. And therefore, the key activity for us is to initiate a Phase II randomized clinical trial aimed at demonstrating proof of concept in first line head and neck cancer. VB-ten neo is our individualized neoantigen therapy. And that field or the concept of INTs are looking at very exciting peer readouts over the next eighteen months, which we think can increase the conviction in the concept of individualized neoantigen therapies. Our job, meanwhile, is to strengthen our position as the most attractive unencumbered IMT asset for a selected range of activities, which we’ll review with you in a minute.

Tolerance platform, the concept of tolerance induction could transform autoimmune disease treatments in the future. And we continue to see data generated in our laboratories, which supports the versatility of our platform and the differentiated perspective. And we will continue to invest in really pursuing a best in class tolerance induction platform with our technology. All this we’ll be doing while keeping a very diligent cost discipline, which on the top of our well capitalized position allows us to reach key inflection points within our cash runway. We have streamlined our cost base through a series of restructuring and prioritization efforts.

And the current plans that we have in front of us do not foresee any significant growth in the organization or in the underlying cost base. We’ll do a bit of double click on each of the program to take you through the rationale and the plans before we open up for questions in the end. So VB-ten 16 does represent our lead assets, as we said. And that is based on the number of clinical data that we have previously reported from the two trials, CO1 and CO2, which if we just highlight the key conclusions from that did show that our objective response rate in the PD L1 positive patient populations of patients pretreated patients with advanced cervical cancer came out double what you would see with the historical trials for checkpoint inhibitor monotherapy. We saw more or less the same effect on medium over all survival, so a doubling of what you typically see with checkpoint inhibitor monotherapies from historical trials.

We have also with VB-ten sixteen shown a monotherapy effect in the premalignant setting in the CO1. And what we consider extremely important, we have shown that the clinical effects we observe in both the CO1 and CO2 is associated with an antigen specific immune response. And we do consider that a very important part of any cancer vaccines combined or collected clinical data setting. In addition to the data we have published, we have also been looking into the ongoing CO3 trial. And I remind you all, this is a very limited number of patients, but the preliminary data that we see from the CO3 does support our investments into this program in the first line head and neck setting.

So based on our conclusion that this is our lead asset where we’ll be able to drive majority the of shareholder value in the near term. Our next step was to design a randomized Phase II trial, which will show VIVITEN16’s contribution on top of the current standard of care, which in this case is KEYTRUDA monotherapy in a head to head comparison, which will have the ability to generate clinical data within the next twenty four months. We chose the indication first line head and neck based on both the unmet need in this market, the combined market potential, and of course, also again with the ability to have readouts within our cash runway. In addition to generating very important proof of principle or proof of concept data within the program, we also do believe that this activity will be derisking the entire, NICo platform as randomized clinical data will have a validating spillover effect on all other APC driven cancer vaccines we may deliver in the future, including Evogene neo. And as a very natural step for the development stage, which VB-ten sixteen is, we have also now had approval or acceptance for our INN name for VB-ten sixteen, which is avipabagine supraplasmib or short short is Apisuga.

And henceforward, we will be calling VB-ten sixteen abysuga in our continued communication. So first line head and neck or head and neck in total does represent a significant market potential for arbezuga. The total estimated market size for HPV16 driven cancer types cancer in head and neck is estimated to be US1.1 billion dollars with a predicted CAGR of 9.2%. Patients the HPV16 driven head and neck patients are younger than the rest of head and neck patients and therefore does call for more unmet need and stronger investments into this segment. We do see a remaining unmet need since the current standard of care does leave room for improvement and the majority of other head and neck focused development programs seem to be focusing mainly on HPV negative patient populations.

When we look at the direct competitors in the HPV16 specific treatments, we do find strength in comparing our data to what has been reported to our competitors, which again gives us conviction that abyssurva has a role to play in this segment here. Quick look at the trial, which we will be calling ABILITY. It is going to be a randomized controlled trial enrolling up to 800 patients, randomized one to one into two arms. One arm will combine Abilsuva with pembrolizumab. The other one will be giving pembrolizumab alone.

We will, of course, be enrolling HPV16 positive head and neck patients first line PD L1 positive. And we will be analyzing the usual battery of endpoints with ORR and PFS and of course also medium survival as some of the key ones to look at for this trial here. We will be planning a series of interim analysis and very importantly, the first interim analysis, which will encompass approximately one third of the patients, is expected during 2027, which is within our estimated cash runway. So in summary, we consider ABIZUVA our key assets and key value driver. We do see a large remaining unmet need, which needs to be addressed.

We have high conviction in our program based on two finalized and one ongoing trial, showing strong and durable efficacy, efficacy correlated with immune response, a very favorable safety profile. We’ve shown this both in advanced cancer and in pre malignant setting. And as I said, in addition to the two finalized trials, the preliminary data from the ongoing trial also does indicate support and does indicate the same level of benefit on top of the standard of care, which gives us the conviction to move forward with this plan here. Our strategic approach is to start randomized clinical trial and is designed both to show effect on top of standard of care and to deliver the first interim analysis well within our cash runway. I’m going to hand over the mic to Auneeti, who will take us through the program for Vipizen neo.

Anders Fredriksen, Co-Founder and CSO, Nikko Therapeutics: Thank you, Michael. So there is no doubt that we are entering a defining period for individualized neoantigen therapies. We know that this space has a huge market potential. It’s possible to treat basically all tumor types with an individualized neoantigen therapy. These days, we’re actually looking at an ongoing Phase two and Phase three randomized clinical trials using this concept from our peers.

And there’s a strong focus these days on doing these trials in adjuvant setting, meaning in patients that’s gone through a definitive treatment where the tumor mass is low and where these therapies are now actively being pursued. We’ve never seen higher investments in this space before than what we see now. And these readouts e readouts from these peers are expected within the next eighteen months. So what we consider shortly. It’s an emerging phase.

We see a huge potential market. And there are currently, as Michael alluded to, few players that are in position to move into this market. There is also definitely room for technologies with improved efficiency, also with improved cost of goods and turnaround time, which is essential for succeeding with individualized services. We do believe Nickel is now well positioned as the most attractive unencumbered individualized neoantigen therapy. We intend to further strengthen this position as the most attractive unencumbered IMT through selected activities ready then to leverage peer readout.

So going through some of the key data points that we feel is putting us in a good space in this field. We have our own in house proprietary AI algorithm able to select individualized neoantigens from each patient based on their biopsies and identification of tumor specific mutations. We have even seen that within the 20 neoantigens that we select per patient, our algorithm is ranking the top 10 higher than the top 20 or the 10 to 20 in the epitopes. So there is even a correlation between the epitopes that we select to be predicted to be high risk immunogenic and those that are actually proven to be immunogenic in our patients so far. In general, we can say that we have seen strong immune responses in our clinical trials and clinical data showing that these selected neoantigenes able to elicit immune responses in patients.

These are even in heavily pretreated late stage patients. Some of these, particularly in NO2, received few vaccinations, which increases our confidence in the platform’s ability to induce immune responses. And we’d expect to see this even further strengthened if we, in the future, will move into adjuvant setting. We see the majority of the patients having epitopes are able to induce de novo responses, meaning eliciting an immune response to epitopes that were not able to see an immune response before vaccinations, up to one hundred percent of the patients do see an immune response to the vaccine induced neoantigens. So we are in good space here.

Importantly, and more importantly than off the shelf vaccines, our manufacturing is essential to succeed in this space. We do have a robust supply chain. We have, over time, significantly improved the turnaround time, as you can see here. Today, the current setup allows us a robust seven week turnaround time in clinical setting, And we do also look into potential for further improvements that are tangible within a short time frame. We have an established supply chain with all vendors involved in the full turnaround time here, and we do have a clear path to also competitive cost of goods.

If you can go to next. So in summary, Vipizen neo is well positioned as best unencumbered individualized therapy. There’s a huge unmet medical need. We know we can potentially treat all tumor types with this treatment, so there will be space for multiple players. We do see a readout from these multiple large randomized trials from peers expected in the next eighteen months that will be definitive early impacting the interest in the field of individualized therapies and also have spillover effect for off the shelf T cell therapy.

We do have competitive strengths, both we have clinical data strong in intensity in heavily pretreated patients. We do have proprietary algorithm proven to identify the most immunogenic epitopes. The fact that we are focusing on a plasmid DNA technology is providing us with a competitive manufacturing time as well as cost of goods, which will be essential in the future. And our robust manufacturing process is able to take proven to be able to go through this entire process from tumor samples to drug manufacturing in a robust manner. Our strategic approach now is to further strengthen this position with timely and streamlined investments aimed further improve our competitive advantage and follow the field tightly as we move forward.

We go to the next, our tolerance program. First of all, little background on the antigen specific immune tolerance. To do what we’re aiming for here is really a new way of thinking about autoimmune disease treatments. The current problem is that the treatments are available for patients today, even the latest advancements, they still focus on treating the symptoms. They do not address the underlying root cause of the disease.

That also means that there are side effects that are frequently impairing the quality or life of these patients, and it’s not offering a potential cure. We have one out of ten in the global population is actually affected by autoimmune diseases, meaning that the market size is huge and there’s a huge need and a huge potential for novel treatments in this space. The future, we believe and the field believe can be antigen specific immune tolerance, which is a new way of addressing these diseases, addressing really the underlying cause of the autoimmune disease, which can offer the prospects of a cure. And that will obviously increase the number of patients that can get a meaningful treatment and significantly improve the quality of life. We go to the next.

The approach that we are taking here is to induce fully antigen specific immune tolerance and that’s by targeting these epitopes that are causing the disease. We do that by using our technology and making sure that these disease causing epitopes are presented to the immune system through our ATP targeted technology in a manner that can lead to the upregulation of regulatory T cells that are focusing on down regulating this antigen specific disease causing effector T cells and effector B cells. If you go to the next. This field is new. We are still looking for a potential

So any therapies in this space, we have we are seeing quite a few Phase one trials, but it’s still new and holds a lot of promise. What we consider the best approach here is to aim for generating the best in class antigen specific immune tolerance platform. The ideal platform in this space should aim at generating long lasting efficacy, ideally at the late onset in that disease course by therapy and we can see that we need this in preclinical models and it should be with convenient dosing. So far, we have also recently presented long lasting efficacy in the late onset model in this MS model that we are working with, with only two doses long term efficacy. This is something we are now focusing on expanding and looking into a range of disease models to support this strong ability to change the course of the disease.

Another important criteria is to generate specific regulation of not only one of the disease causing immune cells, but all major also active disease causing cells. We have actually in the last year demonstrated regulation of all major auto reactive cells. That means we have seen down regulation of auto reactive T cells that are secreting auto reactive antibodies as well as down regulating of disease causing affected T cells and upregulation of regulatory T cells. This provides us with a unique ability to further look into the versatility of our technology. We are the only company harboring a technology that can really fine tune these immune responses by working with our APC targeted technology and really understand what would be the optimal way of generating the perfect immune response that is leading to the most effective therapy for range of autoimmune disease.

Another aspect in this field is that we are still working on what will be the optimal antigens across multiple of these diseases. The ability to incorporate multiple antigens into one like vaccine module and also using AI solutions in order to identify and select and combine these antigens is going to be a huge benefit for the field. We have recently shown that we can use our AI powered vaccine design to generate these multi antigen vaccines. And we have validated these leads into vaccine constructs that are functional in vitro. And we are now looking into demonstrating their in vivo translatability.

We will continue to invest to demonstrate best in class technology and substantial Michael’s position in this novel therapeutic area in the next period. So to summarize, we are increasing our investment based on the latest achievements in order to develop the best in class antigen specific immune There’s a huge unmet need. As I said, the current treatments are not optimal for the patients. And if we succeed with this field, this can be considered the holy grail of treatment in autoimmune disease therapies.

We do have a range of competitive strengths in this field. Our promising data in the preclinical models do show this long lasting efficacy also in late stage disease. We have the potential of providing the unique best in class modulation of the immune responses through our APC targeting technology that we don’t see with any other players in the field. So our strategic approach is to focus now really on substantiating and increasing the confidence in the platform’s ability to be best in class ready to then enter into drug development in the future with or without partners and establish this disease specific immune tolerance across a range of disease. And I think we’ll hand over to Harald again.

Harald, CFO, Nikko Therapeutics: Thank you, Haralda. We are well positioned to execute our business strategy with a cash position of SEK70 million at the end of the second quarter. With disciplined execution and strong financial focus, we will reach key inflection points within the estimated cash runway into 2028. This does not include the pending tax case, where we have booked a non current receivable amounting to SEK32.2 million at the end of the second quarter as per described in the quarterly report. As communicated in the first quarter, we have received a letter from the tax authorities that we can expect a draft of the recommendation from the sectariat in the 2020.

Michael is confident that we will receive a positive ruling in the tax case, also based on advice from third party tax experts. A positive outcome would push the cash runway even further into 2029. And with that, I will give the word back to Mikael for some closing remarks.

Michael Linsig, CEO, Nikko Therapeutics: Thank you very much. And I’ll just close this down before we open up for questions. I really hope you can all sense our excitement and enthusiasm with this new strategy for Nicode. For Ubuntu 16, we will be initiating the randomized clinical trial, controlled trial, which we think this platform needs now. We’ll be doing it in a large patient population with a very sizable market opportunity.

And we’ll be doing it with a time line that allows us to reach meaningful interim analysis within our cash runway. For Vipetin neo, our individualized neoantigen therapy, we continue to see that market as an extremely interesting concept with several key peer readouts within the next eighteen months, some of them could come very soon. We believe our technology is very well positioned to be one of the most attractive unencumbered assets at this time point, and we want to be in a position to leverage any shifts in deal activity should that come. For Tolerance, we continue to believe we have potential best in class and we’ll invest to strengthen that position. And all of this, we’ll be doing on the best platform of being very well capitalized and a cost discipline that will allow us to reach several meaningful inflection points within our cash runway.

I think at this time point, Kevin, we are ready to close down and open up for questions from the audience.

Kevin, Conference Moderator: Certainly. We’ll now be conducting a question and answer session. Our first questions today are coming from Guy Holm from D. N. B.

Carnegie. The first one is, I understand that the details of the trial design have not yet been finalized, but in important terms, how would you define a successful outcome for this study?

Michael Linsig, CEO, Nikko Therapeutics: Thank you very much, Gaye, for these questions. And as all with all trials in our field, it is going to be a little bit of a collection of endpoints that we will be looking at. As you know with this trial, the first data point that we can read out is typical objective response rate. And we do see from the CO2 trial, as long as the preliminary insights we have to the ongoing CO3 trial that VB-ten sixteen or abisuva does tend to lift the ORR compared to the standard of care alone. So that’s going to be a meaningful parameter to look at.

But as we have reported earlier, we are at least as excited, if not more excited by the durability parameters that we see from the CO2 trial. So we will, of course, also be looking forward to see how Abiskuva on top of pembrolizumab lifts both the progression free survival, the duration of response and the medium overall survival. And of course, the benchmark that we will need to beat in this case here is the respective data points from KEYTRUDA alone since that’s what we will be comparing with.

Kevin, Conference Moderator: Thank you. A follow-up from Geir Hallum from D. A. Carnegie. Could you please elaborate on your considerations for selecting the geographic territory or territories in which to pursue the trial, example Europe and The U.

S? And what key steps remain before initiation?

Michael Linsig, CEO, Nikko Therapeutics: Yes. Also very good question, Gaye. So we are still in the phase of planning the operational execution of Biswonia. So we do have some optionality in terms of selecting the regions. I would advise everybody to consider Europe a key region for us to run this trial in.

And that’s not least based on the very good experience we have from the ongoing CO3 trial, which is in the same indication first line head and neck patients. So here we’ve had very good experience with several of the sites across a number of countries in Australia and it is natural to expect that we’ll continue leveraging that relationships and those experiences here. We may decide to add further countries and are in the process of deciding that analyzing and deciding that right now, and we’ll be able to give you more insight to that as we take those decisions over the course of the next couple of months. You also asked what the next key steps in the initiation is. So first of all, we have now finalized the design of the trial here.

We are discussing that with our potential partners MSD and have of course had a very good discussion with them also had very, very good input to the design from MSD. Next step is to submit the protocol along with supportive documentation to the authorities in Europe as well as additional regions we might want to include into the study. We expect to be doing that over the course of the coming months through the rest of 2025. And as long as we haven’t had feedback to that process, we can’t give you a very precise timing for when we expect to see the first patient in. But I would again here advise you to think in terms of mid next year.

Kevin, Conference Moderator: Thank you. Our next question is a follow-up from Geir. Could you also share your perspective on the competitive landscape within the relevant patient population as well as your assessment of potentially competitive I’m sorry competing assets currently in clinical development?

Michael Linsig, CEO, Nikko Therapeutics: Yes. So I would divide those that question into two different types of competing assets. There are other assets in development for head and neck, including some that actually has been showing encouraging data. Our assessment and the assessments we also get from the external advisers we talk to is those assets will mainly be focusing on the HPV negative head and neck segment for very natural reasons when you consider their mechanisms of action. So we do not see those assets as the key competitors or the direct competitors in the field of HPV16 driven head and neck cancer.

If you look at the field of direct competitors, so that means HPV16 specific therapies, over the last couple of years, we have seen the number of competitors decrease significantly with several of the assets failing their clinical trials and some of the companies actually no longer in operations. We do see a few competitors that we consider our main competitors in the field here. When we compare to the data the sparse data that have been reported from those competitors, we do think our immune responses comes out on top of that one. We think we have an edge, a competitive edge in the dose regimens when comparing to what the competitors is seeing. And there’s so far been no data that gives us any indication that we would be coming out with inferior data neither on immune responses, objective responses or durability responses.

Kevin, Conference Moderator: Thank you. Our next question today is coming from Elvin Haugen from Abraxas. With the current leadership in the U. S. Health department that has put it carefully very anti modern vaccine technology, are you looking to run future trials in Europe instead of The U.

S?

Michael Linsig, CEO, Nikko Therapeutics: Yes. Thank you very much, Ivan, for that question. I am and this obviously is on my own account. I would encourage everybody to be a little bit careful putting an equal between the messages you’ve seen towards prophylactic vaccines directed to infectious diseases in The U. S, where I do agree there’s been some very strong messages coming out from the administration On the one hand and on the other hand, immune therapies directed towards treating advanced or locally advanced cancer types like Nykod is doing.

I have not sensed the same level of messages from the administration direct towards immunotherapies that Nikko is engaged in. So I do feel that level of concern. Still, as I mentioned before to the other question, our plan right now is to conduct the next Phase II trial with Europe as the core area. We’re not taking a firm decision not to include U. S.

At this time point here. But as I said, based on our very good experience conducting the trial in Europe, you should see Europe as the core area for the ABILITY trial with abisuga.

Kevin, Conference Moderator: Thank you. Our next question today is coming from Gyorgyztynologbe Birke from ABGSC. Thank you for taking our questions. May I say, can you provide any further flavor when you expect to initiate the new randomized PHQ trial? We’ll stop there.

And there’s two follow ups.

Michael Linsig, CEO, Nikko Therapeutics: Yes. So I think, we covered some of those aspects in the questions from Gaia. Right now, the next step in front of us is to finalize the so called submission package to the authorities in the countries where we want to run the trial. This is ongoing, we expect to continue that process and submit the packages over the course of 2025 with an estimated first patient first dose around mid-twenty twenty six. These timelines may change both forward and backward depending the feedback we have from the authorities, but I think that’s a good estimate to be counting with at this time point given the information we have at hand.

Kevin, Conference Moderator: And a follow-up from Georg. You elaborated on the positive on pursuing head and neck, but can you please also give some insight to potential negatives that you have within cervical cancer that may have influenced your decision?

Michael Linsig, CEO, Nikko Therapeutics: Yes, very good question. And I want to really make sure nobody misunderstands this. We have not had any potential feedback or input regarding pursuing further development in cervical cancer. But we have had both a long strategic process and of course also a lot of interaction with external advisers and potential future partners regarding the future development program for AbiSuga. And I think the combined impression that we have is that in the area or in the indication of cervical cancer, we have already very strong data from the CO2 trial, which provides very strong support and indication of effects and very meaningful effect on top of standard of care in that patient segment.

On top of that, we have very strong indications from the CU-one trial in the pre malignant setting also as monotherapy. So the gaps we had for the development programs for iprintsuva was to basically show effect in the head and neck segment, which is a larger segment when you look at the number of patients both in advanced as well as in the locally advanced. And the other gap we clearly had was randomized controlled data. And that’s why we with this new Phase two trial ABILITY, we closed those two remaining gaps. We provide randomized clinical data showing the effect of abysuga on top of standard of care in a direct head to head comparison against standard of care.

And we do it in head and neck, which is the largest segment or the largest potential for this treatment of this therapy here for abyssuba. So that’s why we’ve chosen this indication. It’s not because we do not consider cervical cancer as an important indication going forward. We just feel we have provided enough data there, and it’s more important for us to close the gap on the head and neck.

Kevin, Conference Moderator: And a further follow-up from Bjork from ABGSC. Can you give any insight into which commitments remain and what kind of decisions you’re currently having with Regeneron in relation to the termination discussions, I apologize, you are currently having with Regeneron in relation to the termination of the collaboration?

Michael Linsig, CEO, Nikko Therapeutics: Thank you very much, Geoffrey. I’m going to hand over to Ami for answering that question.

Anders Fredriksen, Co-Founder and CSO, Nikko Therapeutics: Yes. So at the current stage, we can’t say much more than that we have entered the discussions with Regeneron and advise to take it off the balance sheet of Michael. It is not terminated. So that’s important today. We are in discussions with the general about the future of the program.

Kevin, Conference Moderator: And a further follow-up, how do you assess VB-ten neo in the individualized cancer therapy landscape?

Anders Fredriksen, Co-Founder and CSO, Nikko Therapeutics: Yes. So that’s a good question. Try to be brief. It’s the field is today dominated by a couple of players, which are the two companies that have received a high cash income during the COVID period with the sales of prophylactic COVID vaccines. And they have moved forward they’re both partnered and they have moved forward with great confidence investing in multiple large Phase two and Phase three trials.

Actually on the back of quite limited data as of today, Moderna have presented a randomized Phase II trial in melanoma in adjuvant setting that is promising. And BioNTech basically based their future investments on a small investor data initiated trial in PDAC with 16 patients. So the upcoming period is going to be extremely interesting to see if those early signs will pan out and we will see readout from so many big randomized trials. So this will give us a proof on whether the concept works, but importantly also whether the concept works with mRNA based vaccines and two different kinds of mRNA based vaccines. They are quite different in their mode of action, Moderna and BioNTech.

When it comes to our position compared to those, these vaccines have also been tested in later stage advanced disease without being convincing clinical improvement and have moved to adjuvant setting. So that is one important aspect. Another aspect is the importance of the turnaround time and the cost of goods, where plasmid DNA based vaccines per definition has a quite strong edge compared to mRNA based vaccines. There are also a few other players with us as we’ve also seen in the HPV field, there’s in the number of players that are active in the field of individualized cancer vaccines as well over the last few years. We have also seen these companies focusing on viral vectors, including Wisdom are no longer in operation.

So we do believe we have a nice edge here. Very few companies have their own proprietary algorithm to select the antigens as well as a proven supply chain with the already proven effective turnaround time and with the prospects of being very competitive on cost of goods. In addition to have clinical data. And even in the advanced setting NO2, you may have seen at a medium line of prior therapy of five. So it’s a very other range of the disease progression compared to adjuvant setting where they focus on treating patients after basically having reduced the tumor mass to close to nothing.

So we believe we are one of very few players that will be there and based on historically how the pharma world operates. If we see positive outcome from the readouts that will come in the next few months, we would expect increased interest in alternative players with improved technologies and improved cost and COGS from other potential pharma partners out there. So we hope we’re in good shape depending on the outcome of the peer readout.

Kevin, Conference Moderator: Thank you. Our next question is coming from Alexandra Ekkelsen from Superstar AS and they would like an update on Genentech.

Anders Fredriksen, Co-Founder and CSO, Nikko Therapeutics: Yes. So Genentech, her definition is no longer a collaboration partner of us. They have basically reduced their investments in cancer immunotherapy, dramatically of theirs as you’ve seen also closed down other collaborations. We do, as you saw also in June, have a still a good collaboration with the Genentech team. And we have now presented the key data from the N02 trial that we did in collaboration with Genentech, which was very important for us.

And we don’t foresee any future payments in any directions from Genentech and Michael. So you can basically see that you can consider this as a more or less finalized breakup where we have the right to the product and we have been able to release the core data of importance for us.

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

Michael Linsig, CEO, Nikko Therapeutics: Thank you very much, Givin, and thank you very much for listening in, and thank you for the questions. Once again, we’re very happy to announce this strategy today, which we believe is a very exciting new path forward for the company, and we look forward to get to work, start executing and also reengage with all of you over the coming period. Wish you all a good day. 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.

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