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Now I will hand the conference over to the speakers. Please go ahead. Good afternoon all, and a warm welcome to Nanoform's Q3 2025 report presentation.

My name is Henry Von Haartman and I'm your Director of Investor Relations. Today our CEO, Edward Hæggström, Chief Quality Officer, Johanna Kause, CFO, Albert Hæggström, Chief Commercial Officer, Christian Jones and Chief Development Officer, Peter Hänninen now present to you. This presentation is webcasted through Investor Column and there's also the possibility to call in and listen by phone.

The slides shown here are also to be found on our webpage in the investor section. After the presentation we will hold a Q&A and it's possible to ask questions by calling in. We will today start with a short introduction, then key business highlights, then financials, then commercial performance and we conclude with our product kernels.

With these words our CEO, founder, Professor Edvard Heegaard, please go ahead. Henry, thank you and welcome also on my behalf. Next slide please.

So what you see here is a commercially licensed manufacturing factory. This is the big thing for today. We got a license to serve European plus other markets with a total headcount of 500 million.

Next slide, please. I here want to repeat a little bit and rehearse our strategy. First of all, all active pharmaceutical ingredients should be stormapped.

This gives a way to look at where we can make a difference. We work with customers and partners to enable novel and existing molecules to become new and improved medicines. In parallel to that, we show a conservative industry the power of nanoforming, and we do that by creating up to a dozen of product kernels.

Today, we are going to talk a lot about Nanoform, we're going to talk a lot about product kernels, and we are also going to talk a little bit about the bio-logic's case of Electrophile. Next slide, please. Here, basically we work with originators, and these customers are global large pharma, mid-sized and specialty pharma, and biotechs.

Together with them, we try to bring Nanoform improved drugs to the market. The product kernels is a API that we have Nanoformed, which allows for a commercial relevant offering. Here we work with development partners, they can be originators or they can be super generic and high value medicine companies.

Then we work with commercial partners, these can be the same as the development partners or different. And here, as soon as possible, we try to get our first nano-improved drug on the market in order to show the power of our tech platforms. Next, please.

We have four different technology platforms: one for small molecules, one for large molecules, one for nanoformulation, and then Starmap for AI. On the small molecule side, improved bioavailability and high drug load are the things that are driving the commercial cases. On the large molecule side, it's the high drug load and long-acting delivery that are driving now the commercial cases.

On the formulation side, it's clear that highly differentiated novel formulations and unique drug delivery opportunities is what drives the commercial opportunities forward. Next slide, please. Nothing has changed in our simplified value chain.

We have our clients, they own the API, usually. We nanoform it, and then we either get paid for showing that it can be done for making material under GMP, or now together with our partners for moving the kernels forward. Next, please.

This is the timeline. Long time ago, we invented and discovered the CESS process. We did in 2020 the first GMP campaign in a clinical setting, and now we finally obtained the authorization to sell Nanoform's API onto the European market.

And of course, now the target is to get as soon as possible the first nanoform medicine onto the European market. Next, please. Here I want to walk you through the key business highlights.

The manufacturing license is apparently and clearly the most important achievement right now. It is not insignificant that Nanoform, as one of the kernels, has now gotten funding and we have signed a licensing and development agreement that was signed with A4R, which is part of Riverside, and together with IMGa. This is a fund and later on you will hear more of the details.

There is also a new kernel which is being introduced now, which is a nano-formulated combination of olaparib, and temozolomide. And this here is now announced in a partnership together with Revio Therapeutics. This is a boutique player with people with a long history in the industry and with serious financial backing.

We also right now are introducing the first target for the 2026. It is to continue our path towards cash flow positivity. The target is a cash burn below 10 million euro.

For 2025, all our near-term targets are on track. And welcome to Helsinki on December 16 for a capital markets day. And here we will show the new 2030 midterm targets and we will also discuss around them.

Next slide, please. This is where I hand over to our quality boss, Chief Quality Officer Johanna Kaus. Please.

Thank you, Edward. Hello, everybody. I need to start this slide off by saying that for me today is a great day and I believe that this is a great day also for European patients and patients across the globe.

We were granted the commercial GMP manufacturing license that we've been working very hard in the past years to achieve. What this means is that we are now authorized to produce and take care of the quality control for nanoformed small molecule APIs. This means that we will be able to manufacture APIs for products with a marketing authorization in Europe.

Focusing on Europe, but also in other geographies across the globe. So this has been a really, really big thing for us and I believe also for in the wider scale because it's not really every day that a new technology gets this far. The next step now that we have achieved this is that we will continue to work on the launch of the NanoEnzalutamide product.

So what we've been doing in parallel with preparing for this commercial license is that we've been creating our first active substance master file. So this is a documentation that will become part of the marketing authorization application for NanoEnzalutamide. The marketing authorization application procedure will of course be handled or managed in collaboration with our partners in the consortium, but we are a vital part of that.

And also meanwhile we are of course working towards ensuring improving security of supply throughout the whole supply chain for Nanoensalutamide. Next slide please. Okay, with this slide, I will hand over to our CFO, Albert Hegstrom.

Thank you, Johanna. If we go to this one, you can see here that on the left-hand side, we have really seen a jump in proposals sent during this year. And there are many reasons for that, but the main reasons are that after four years of really In being in the doldrums of the industry, it's clear that now the investors, but also the generics companies, are starting to move because they see that the technologies we offer can bring something really valuable to the industry.

The signings are still being hampered by the fact that the funding situation for biotechs is not what it used to be, but also because of the fact that large pharma and major pharma are now focusing a lot on cost-cutting and reducing their personnel rather than on the early stage of the pipeline. What is clear is that the early stage of the pipelines in the pharma industry has grown thinner and thinner during the last years because all the focus have been on late stage assets. But we believe that that is now starting to come to an end.

It can't get any darker. So that means that we believe that this is also one of the reasons that we see that the proposal sent is going up. At some point everybody needs to replenish their early stage pipeline and that's what we believe here.

So we look with optimism towards next year. On the right hand side you can see that despite the tough market situation we have been able to maintain or rather a flattish number of projects signed during the last four years and of course proposals that should be indicative of or a leading indicator for what's coming next year. If you look at the revenue and other operating income, you see a similar situation there.

But however, here you can already see that this year has been better. And of course, if you look at the following slide, which is the customer payments versus revenues recognized, you can even see it more clearly. So last year they were going hand in hand, but now it's clear that customer payments have been growing faster than revenues recognized.

And this is because when you sign an agreement, you get the upfront payment and we have also started to get the first small milestone payments. And this then when the work is done later on is recognized as revenue. So even if the top line hasn't shown it yet, the customer payments have been growing very nicely this year.

And this is, of course, very important for cash flow. We are running the company based on cash flow and not based on revenues recognized. And this is where you can see that the quarterly cash burn trend has been and the annualized cash burn trend has continued to go in a very good direction.

And compared, for example, third quarter this year, 3.9 million versus 5.3 last year.

And now we've been at our annualized rate of roughly a minus 15 million Now we come out with the new target for 2026, which is a cash burn of below 10 million for the full year. And this can be compared with the cash we had at hand at the end of third quarter, which was almost 30 million. So we feel we have a strong balance sheet and we feel that the trend is definitely the right one.

Questions related, where will this come? This will come from several different factors, improved top line customer payments, but also we can see that we had been building the factory, we have been doing the big investments, we have done some parts to automation and all these factors will mean that we will also see a continued trend with lower costs going forward. So higher income and lower cost is a good combo to get a much better cash flow. If you then look at the near-term targets, as Edward said, they're all on track for this year.

Some of them we have already achieved and we are very happy with that. And then, as I said, the first business target for 26 has been announced and that is cash burn below 10 million and that can be compared to the 30 million we have in cash at the moment. We will be coming with a few more business targets when we report the full year report.

And with that, I hand over to Christian and Peter from the commercial side. Thank you. Thank you, Albert.

Let's move forward. So the highlights that I'd like to talk to you today are a commercial manufacturing license. What does that mean? It effectively means that we have a very strong trajectory to take our partners' products to the market.

It provides confidence to the innovator pharma companies and biotechs that we serve that we have a clear path to market. And it also enables the product kernels that we're developing to proceed forward with the timelines that we have associated with them. Great progress so far in our product kernels.

In particular, Enzalutamide is moving forward with We're currently in our pivotal bioequivalence study. We're very much looking forward to getting the results soon on that. We have some fantastic news on encorafenib and on a product development with ReVio Therapeutics for glioblastoma.

We'll talk more about that later in the following slides. We've also seen a very strong market pull for our biologics technology. It's been considerable and I think it's partly in due because small molecules have been around for a long time.

There are lots of technologies to try and address the challenges. Whereas biologics is a very new area and there are very few technologies that can really add value into the drug delivery space. Nanoform's technology is being seen as one of those and that can play a key role in driving the biologics market forward.

That's been complemented by the great work that we've done with Takeda and the ability for Takeda and Nanoform to co-present on our results at multiple conferences. And we've been able to cover case studies for high concentration subcutaneous injection. This is a very hot area at the moment, and also the delivery of biologics to the lungs.

An area where we see a lot of advantages for our technology versus other approaches. Up until the end of the third quarter we had 16 customer projects. Looking at previous years, that's no mean feat in what is this year a very tough CDMO market.

We have seen other peers in the CDMO space some of the leading CDMOs in the world who have commented that they have a very dry pipeline in this space for early development assets. We've also, not only have we been growing our customer base in Europe and the US, we've also expanded into Asia as well with great relationships established in both Japan and South Korea. Key markets, but also key markets from an innovation perspective and we look forward to further growing business in that territory.

I'm going to hand over to Peter to talk us through the next couple of slides. Thank you, Christian, and welcome to all on the call on my behalf as well. I want to start again with a reminder on the strategy around our product kernels.

In order for us to further accelerate the adoption of technology offering by the industry, we have initiated this internal development of a number of nanoparticle-enabled reformulations. And this is to show in practice to the industry what our technology can enable for their products across a range of delivery routes and for both small and large molecules. And each of these also with the possibility to become a commercially attractive partnering opportunity for us in itself.

And we are very pleased with how this strategy is playing out now and what we've achieved in a relatively short time period. Importantly, we've also been able to attract experienced partners to support the execution of multiple of these projects already. And the closing of the out-licensing development and commercialization agreement and an investment into Nanoform by A4L and IMGa was a major milestone for the progression of this product, kernel to the clinic.

This investment is expected to be sufficient to finance the clinical development of Nanoform up until the commercialization and a future out-licensing either an attractive patient-centric lifestyle management opportunity or as a value-added generic medicine. And the company that was founded together with IMG for all, BraphMed, will pay Nanoform service fees low single million development milestones and up to mid single digit tiered royalties going forward as well. Nanoform's fully diluted ownership in ImperviMed is expected to be around 40 to 50% whereas today it stands at 71%.

In the quarter we also announced the identity another kernel, the co-development with Regenerative Therapeutics of what we call GLyOra, a locally administered, long-acting, thermoresponsive hydrogel for the treatment of high-grade glioma. GLyOra is a nano-formulated combination of olaparib, which is currently marketed by AstraZeneca, and temosolomide, which is currently marketed as Temodar and was originally developed by Merck and Company. We're very happy to partner with Revio Therapeutics on this project.

They're a boutique of really seasoned industry veterans with their own platform to identify repurposing opportunities and backed by strong private investors. And this provides us with a highly synergistic partner to our enabling formulation technologies. And then this is what we can see already in this first example with this program is expected to be in the clinic by the second half of 2026, and we expect that this could be eligible for orphan designation and accelerated approval and therefore subject to successful co-development and commercialization could be already commercially available by 29.30

timeframe. If we look at the overall pipeline of our kernels, I think we can safely say that we continue to progress these projects across the board. My colleagues on the call already spoke at length on the importance of the commercial manufacturing license generally and specifically as a milestone for launching Nanoform in the future.

And I think this is really something that cannot be underestimated. We're also actively preparing to start manufacturing of the first GMP batches of Nanoform supported by the €5 million R&D loan from Finland and we're also seeing continued and growing interest to partner on that asset as well. We look forward to the opportunity to tell you more of the undisclosed kernels as well in the future of course.

I would say as an overall reflection, being able to attract seasoned specialist healthcare investors to invest in our strategy to use Nanoform's technology to develop this nanoparticle-enabled reformulation is important on many levels. It both helps validate the strategy, but it also amplifies the message around the technology and supports the commercialization of these assets. These partners will also be able to provide experience and expertise in regulatory, clinical and market access questions that will directly support the successful execution of the products.

And finally, I would say it also allows us to continue to cast a wide net and work on a broad range of APIs, delivery routes and therapy areas, underscored the broad applicability of our particle technologies. And I think already touched on the recent industry news around HaloScience's acquisition of Electrify. But a few words on that still from my perspective as well before I turn it over to Christian.

I think subcutaneous delivery will be a big part of the future of products due to the obvious advantages of a higher dose products. The only meaningful technology today to say, Uroni approach, and they've been able to create a highly successful business model around that. And as you know, Nanoform has been one of the few companies globally that has pioneered the development of ultra-high concentration suspensions for subcutaneous delivery together with companies like Electrify.

Hail Science acquisition of Electrify for up to $900 million with 750 million upfront in cash is a strong endorsement for this approach generally. And we believe this will continue to be an extremely interesting space as the first products using this approach and clinic. And then we're confident that our platform that was designed with scalability and robustness and patient-centric administration in mind will be highly competitive as this new market for higher the subcutaneous delivery of biologics is.

Is formed. And with that, I turn it over to Christian for his reflections. Thank you, Peter.

I think just to add to that, we've seen a significantly increased interest around our biologics platform and in particular the high concentration subcutaneous delivery by many major pharma and leading biotechs globally as a function possibly driven by the news around Electrify, but also by the continued presentations that we give publicly around our technology. We have developments ongoing in this space to prove the value of the technology in biology and we look forward to being able to talk about those results in the coming months. This is a platform which When we've had visitors to our manufacturing facility in Helsinki, visitors from the US, from Europe and elsewhere, they have been highly impressed with Nanoform's ability to scale our technology.

This is something which they see as a potential advantage amongst the competition. And the robustness, the high yields that we can get from our technology, and the ability to scale to a commercial manufacturing scale, they've seen what we have with the small molecule technology. They've seen the engineering powerhouse that we have within Nanoform and they've seen our ability already to demonstrate significant scale with this manufacturing technology.

It has provided them with great confidence that Nanoform's technology really stands out within the competitive field in the ability to deliver these drugs potentially in the future to the market. So a super exciting place to be. One that we are highly engaged in and one that we hope to be able to make more announcements shortly on.

If I move forward, news from the farmer market. So we've been very active this year, particularly in the last couple of months. This is the sort of the largest conference season for the farmer industry.

We had presentations at Pod in Boston, where I presented alongside Takeda on our news on two two areas, high concentration bio and lung delivery of biologics. There is a significant interest here, as I've mentioned already. Other news, we were at BioEurope in Vienna and at CPHI in Frankfurt just a couple of weeks ago.

Major CDMO peers, and I mentioned this earlier, have confirmed low project numbers in small molecule early development outsourcing. So it very much aligns with what we're seeing. We have the highest number of proposals ever issued.

On an annual basis, but there are delays in decision making. So we hope that that will come to the fore very soon and some of those proposals will start to land and we'll have a big uptick in the number of projects signed as we move forward in the coming months. But it's, you know, the industry is in flux.

Major pharma, they have a lot of headcount reduction going on at the moment. In addition to that, a lot of the factors that affected the pharmaceutical landscape two to three years ago in terms of VC investors pausing funding on very early stage projects with their biotech companies and focusing on late stage assets. That has created a deficit in the preclinical landscape.

And so I think that's also a contributing factor. But despite that, Nanoform has active conversations with many, many companies and people see a great value in our technology. So we're very much looking forward to this uptick, which we expect to come shortly.

In addition, the biosimilar landscape has seen some changes recently. So just over a month ago, there was a change in the regulatory approval pathway for biosimilars. And this has now increased the interest in the space for biosimilar developers because it is now faster and cheaper to take these products to market.

Previously, it was a huge hurdle to launch a biosimilar. 120 million to 150 million if you had an oncology product are not unusual numbers compared with 5 to 10 million in a small molecule space for generics. Now biosimilars are looking at somewhere between 30 to 50 million in terms of development costs.

So it's brought in a much greater interest into this space. So it would be very interesting to see how that plays out, particularly with technologies that we have in-house and they might be of interest. As I mentioned also on my opening slide, we have expanded our market presence, fantastic relationships established with CBC, a company with over 100 years of history in Japan, one of the leading distributors in Japan.

And we have been able to create a very strong presence in the territory at major pharmaceutical conferences, at very specific formulation events, and we are starting to see the fruits of that labor pay forward with lots of projects and interest coming. And in Korea, we have also seen significant interest. Just last week we had a business meeting in Korea where we visited many companies and it's clear that Korea is a country that is focused on innovation, focused on biologics innovation and also has a strong interest in the product kernel space of which we occupy.

So with that I will now end the commercial session and thank you for your time. Thank you Christian and this is Henry IR speaking. So December the 16th we will help arrange our capital markets day in Helsinki.

Everybody is most welcome there. There's limited seats so tomorrow we will PR the invite and there will be instructions in that PR how to sign up and if you have any questions please wait to reach us and easy way to remember is ir@nanoforum.com. I will now start the Q&A session.

One moment please. If you wish to ask a question, please dial star 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star 5 again on your telephone keypad.

The next question comes from Christopher from SEB. Please go ahead. Hi there, Christopher.

Thank you for taking my questions. So I have two. The first one, I should precede with a congratulations on the GMP license big achievement.

Johanna, what can you tell us about how you are preparing for GMP inspections by FDA? I guess the backdrop being that it seems that in general that they have a little bit of a higher bar than other regulators. We frequently see companies getting rejections because of manufacturing observations that we, you know, despite those drugs being approved in other markets. So what can you say about that? That's my first question.

Thank you. Thank you for the question. So, and thank you also for the congratulations.

Much appreciated. So in parallel with preparing now for the commercial license, we've already for a while now had in place a program to prepare for FDA. We recognize that there is a difference between the EU regulators and FDA, and of course we want to be well prepared.

So what we are looking at is, of course, training of our personnel, making sure that we have the capabilities in place. We run, for example, simulations. We do so-called mock inspections.

Then one of the main or one of the big things that we do in addition to that is that we look at our own supply chain for all the critical materials. Of course, what we call raw material API or bulk API. We do audits of our partners, our service providers.

Generally speaking, make sure that our quality management system takes into account also any FDA requirements that are potentially different or let's say more stringent, more strict than the EU requirements. Our understanding is that we are potentially subject to an FDA inspection at the time when the marketing authorization application has been submitted in the United States. So we're specifically preparing also for a pre-approval inspection from from that perspective.

Thanks very much. My second question, I guess, is probably for Peter. How should we think about the various kernels from a financial modeling perspective? Is it sort of, I mean, are you looking at making deals where it's sort of copy paste on sort of the financial final terms of the kind of aggregate agreements, recognizing obviously that you have this deal mosaic that you have to work out.

Thanks. Albert, can you take first a step at this and then Peter can continue? Yes, so hi Christopher. What we are doing is of course as you know, because we have a technology that is new to, we don't want to add to the potential hurdles by having a different business model.

So we are very business model friendly in that sense that we use the industry norms. And as you know, the industry has very old and very good and very worked out models for biotechs and for service providers and for even for colonels. So we don't create anything new.

When we talk to clients, we talk in a language that they are very familiar with. One other aspect, of course, is there that when the cost of capital for Nanoform was clearly lower than it is today and money was free and so forth by the central banks, our thinking was more that it is okay for us to take the bigger upside a little bit later, meaning after launch and so forth. During the last two years, we have been focusing more on finding partners and choosing business models where we spend less money upfront.

And that is, of course, a very important thing. So we are prepared to, if the clients or the partners fund a lot or even all of the development costs, then we are, of course, giving away a little bit of the upside. And I I think that's only fair.

And that is what you can see now with when you compare the first deals we did compared to the last deals we've done. And also from a, if you're a larger company or if you're even a major pharma, you have clearly lower VAX or capital return requirements than comparing with the smaller ones. So they are also happy with this situation.

That's what I would say. Peter, do you want to add something? No, I think that maybe sort of what's good to keep in mind, of course, is that although we license sort of the product specific by the spin out, the manufacturing still stays with Nanoform. So regardless of what happens to the kernel downstream, the manufacturing is still in our facility and there will be on top of sort of the share we have been in the asset and the royalty and the milestones and the profit shares, there will also manufacturing income coming our way.

And potentially you're going to add there that of course considering that we have not yet shown significant milestone payments or significant top line That does not mean that it's impossible to do it. It only means that the industry works in a way that in the preclinical phase, the sums you get are quite small, but when you get to clinic and when you get closer to market launch, then you get very big upswings in the values distributed and the deals you can sign. And that of course you know what kind of deals can be done in the industry.

And there I want to say an example of, of course, one recent example is the Halo-SAM acquisition of Electrify, who is still in the sort of preclinical phase. Thank you so much. There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.

Thank you, Operator. On behalf of Nanoform, I would like to thank all participants for today. And if you have any more questions, then please do reach out to us.

We wish everybody a great Wednesday afternoon and evening. Thank you and goodbye.