Nykode Therapeutics

For those not familiar with Nykode Therapeutics, could you briefly describe the company and your focus within cancer immunotherapy?

Nykode is a clinical-stage immunotherapy company focused on oncology and autoimmune diseases. What we do differently, in one sentence, is that we target antigens to the right antigen-presenting cells. In oncology, that translates into an antigen-specific immune response against tumour antigens, and in autoimmune diseases we use the same core technology to dampen an antigen-specific immune response and thereby address the underlying disease.

We currently have three assets. Our most advanced is Abi-suva (prev. VB10.16), a therapeutic cancer vaccine targeting HPV16-driven cancers, most notably head and neck cancer and cervical cancer. It is now in early enrolment in a randomised Phase 2 trial in first-line head and neck cancer (Abili-T trial). Our second oncology asset is VB10.NEO, our fully individualised neoantigen cancer vaccine, where we identify each patient’s unique tumour mutations, use AI to select the most suitable ones, and build a fully personalised vaccine – one patient, one vaccine. In addition, we have our tolerance platform for autoimmune diseases, currently in preclinical development, where we will announce our updated strategy in the second half of this year.

We are listed on the Oslo Stock Exchange and headquartered in Norway, where the bulk of our approximately 60 people sit, with a smaller Danish contingent of around 12 people in our Copenhagen office.

What do you see as the most important strategic steps for the remainder of 2026, and where does Nykode stand strongest right now?

The most important news ever for the entire cancer vaccine field came last week when Moderna announced positive phase 3 data from their individualised cancer vaccine programme. Their market cap increased by around USD 45 billion on the news, and Nykode’s share price increased by more than 30 percent in the days that followed. After many years where cancer vaccines struggled to reach the market, we are now potentially looking at the first cancer vaccine approval ever, which fundamentally changes the outlook for everyone working in the field.

Additional readouts are expected over the coming months, including the full Moderna–Merck individualised cancer vaccine data at ESMO in October, as well as BioNTech’s Phase 3 readout for their off-the-shelf HPV cancer vaccine. These months will be transformative for the cancer vaccine space, and we now benefit from having endured what has been a very difficult period for biotech. We have been extremely disciplined on cost and are one of the few players that has persevered through this period with a technology backed by clinical proof from multiple prior studies.

Beyond executing on the Abili-T trial and driving Abi-suba forward, we are also waiting for a ruling from the Norwegian tax authorities that could result in a refund of around USD 30 million, which is particularly meaningful in the current market backdrop. We also plan to progress the ASIT platform towards first clinical development program, giving that platform a much more defined identity. All in all, we are more enthusiastic today than we have been for many years.

Moderna’s individualised cancer vaccine data last week has been described as a watershed moment for the field. How does that news specifically strengthen Nykode’s position?

It is a huge validation of the concept of individualised cancer vaccines. Moderna is one of very few companies operating in this space, and until now the technology has still been perceived by many as unproven at scale. What last week’s data did was give the entire field a clear roadmap – it demonstrates that individualised cancer vaccines can work, and it opens the door for the next wave of programmes to follow.

For Nykode specifically, we are among the very small group of companies that has been in the clinic with individualised cancer vaccines. We dosed our first patients back in 2018, and our VB10.NEO programme is today one of the most attractive unencumbered individualised cancer vaccine assets in the field. That combination of clinical experience, a proven manufacturing setup, and freedom to partner is exactly what makes the current momentum so relevant for us.

At the same time, we will now see a broader debate around where individualised vaccines are the right choice and where off-the-shelf products fit best. That plays directly into our strategy, because we have both angles covered – VB10.NEO on the individualised side and VB10.16 on the off-the-shelf side – which we believe positions us uniquely as this space matures.

You have positive data from three earlier trials with Abi-suba, and the Abili-T trial is now advancing – could you describe what these results mean and what investors should focus on going forward?

We have positive data from three different trials with Abi-suba across three different tumour types, from precancerous settings to later lines of treatment. Most recently, the C-03 trial evaluated Abi-suba in combination with checkpoint inhibitors in first-line head and neck cancer, which is the largest patient group among the HPV16-driven cancer types. From the 13 patients included in that dose-escalation trial, we saw an objective response rate of 38.5 percent, which compares to around 19 percent typically seen with checkpoint inhibitors alone – effectively twice as high. We also saw strong immune responses and a very good safety profile.

That dataset gave us the confidence to move forward with the Abili-T trial, our randomised Phase 2 trial of up to 100 patients in first-line head and neck cancer. The trial has two arms – Abi-suba on top of pembrolizumab, a checkpoint inhibitor from Merck, versus pembrolizumab alone. This is the first time we are taking Abi-suba into a randomised trial, and it will be pivotal for us, for investors and, most importantly, for future patients.

We have started up in eight European countries and will expand to around ten countries in total. The first patient was dosed in May 2026, and we have planned three interim analyses in the trial, with the first one on track for 2027. Right now, this trial is what I sometimes call all hands on deck for the company, and it is the clinical data that everyone – including investors – will be focused on in the period ahead.

You just announced a new U.S. patent strengthening the IP protection around VB10.NEO. How does this fit into your broader strategy for the programme?

It is a coincidence that this patent comes at exactly the same time as we see this extreme validation of individualised cancer vaccines from Moderna. The patent protects the very concept of what we do in VB10.NEO. Because these are products we make uniquely per patient, patenting is complex – it is more about protecting the process than a single product. Getting the first patent was already very important, and this new patent expands on the original, giving us the ability to make future modifications and improvements to the product while still remaining within a protected space. It also keeps competitors that try to closely mimic our approach away, which becomes more and more important as the field heats up.

It also builds on another patent we received late last year that protects our use of AI and machine learning in designing individualised vaccines. Because every vaccine is unique to the patient, we rely on an antigen selection algorithm to identify and prioritise which mutations are most likely to trigger a productive immune response. Since we entered clinic with individualised cancer vaccines already in 2018 – before the big AI wave – we had to develop our own AI and ML capabilities early on, and today we are one of the few biotechs that has both the platform and the data behind it.

The strategic significance is therefore twofold. It strengthens the uniqueness and defensibility of VB10.NEO ahead of what we expect to be increasing partner and investor interest, and it also broadens our technology moat, since the same AI and process work can be applied across other programmes, including our off-the-shelf cancer vaccines and our tolerance platform.

Where do you see Nykode Therapeutics one year from now?

The most significant thing from a capital markets perspective is that we will be close to the first interim data from Abili-T, which is what has everyone’s attention right now. In parallel, following last week’s Moderna announcement, we expect a lot more interest in personalised cancer vaccines a year from now, and we would like to see the field having moved substantially by then. That naturally means we will also be actively exploring partner opportunities for VB10.NEO.

In addition, we have said we want to move our tolerance platform forward towards a defined indication – in other words, we plan to advance towards clinical development. I strongly anticipate we will have communicated that by then, so that a year from now the tolerance asset will have a much clearer face in terms of a therapeutic area as well.

Could you give three reasons why Nykode Therapeutics is an interesting investment today?

First, cancer vaccines have never been more exciting than they are right now. We are looking at what could be the first-ever cancer vaccine approval, coming on the back of positive data rather than years of failures. That gives every other cancer vaccine developer a validated roadmap. Nykode sits right inside that setup with an individualised programme with real clinical experience behind it and with one of the few unencumbered assets in the space, which we believe is commercially more attractive than RNA-based alternatives.

Second, we are running Abili-T, our randomised cancer vaccine trial with Abi-suva on the back of three previously positive datasets, and we are capitalised to reach the first interim readout in 2027. That gives us a well-defined value inflection point on an asset that has already produced encouraging results across multiple settings. And on top of that, our technology is a platform that can be employed in multiple additional products.

Third, our tolerance platform potentially addresses a huge market. Just as we have now seen proof that you can manipulate T-cell responses in the cancer setting, we believe our platform has the potential to manipulate T-cell responses in the opposite direction to address autoimmune diseases, allergies and transplantation. That could turn into a whole new business leg for Nykode – potentially as large as the oncology franchise itself.