Welcome to the conference call. For the first part of the conference call, the participants will be in listen only mode. During the questions and answer session, participants are able to ask questions by dialing *5 on their telephone keypad.

Now I will hand the conference over to the speakers. Please go ahead. Thank you very much and welcome to this third quarter call for Orexo.

It has indeed been a transformative quarter in many ways for the company in particular in our R&D departments where we have made very good progress good progress in two projects and I will come back to that a little later. Today I'm Nikolaj Sørensen and I will be joined by Fredrik Järrsten, our CFO and this time also Ed Kim, our Chief Medical Officer, who I believe will be new to many of you but Ed Kim will talk a little more about our OX 390 project and why we think this is an important project both for Orexo but also for the US. We will go through the business update, I will take that As I said, Ed will come in under products under development, focusing on OX-390.

Frederik will take us through the financials before I will close up with the legal update and some approach for expansion for where we think we have some future value drivers. Starting with a brief overview of the quarter, as I said in the introduction here, we have made some great progress in our pipeline, in particular with our GLP-1. This agonist project that we have OX 472, where we showed some very promising in vivo data.

And also we received a BARDA fund, which initially is worth eight million dollars, but could be all the way up to 51 million dollars, where BARDA will finance the majority of our wake 390 project. During the quarter, our work with ICPR, formerly known as 124, has proceeded well and we are now starting the reliability and stability testing that was required by FDA more or less on time. With regard to OX 640, we have during the quarter, we have manufactured the first batches of the amorphous powder with the epinephrine at commercial scale.

We have continued partner discussions, but we've also, as I wrote in the CEO comments, seen some increased uncertainty around the market in the US. We believe that is something that will be solved and I will come back to that a little later. Looking at the revenues, clearly in the Swedish krona, dollar Swedish exchange rate has had a strong headwind during the quarter for the company.

It impacted with nearly 11 million Swedish kronor, which is kind of close to 10%. But we have also seen during the quarter that the wholesale inventory has declined in the US, which explained a lot of the development compared to last year. Then on EBITDA, we have a negative EBITDA, which was not entirely according to our plans, but that is very much associated with the increased value of the share price during the quarter where we are reserving provisions for taxes and particularly around the social securities in Sweden, which is impacting negatively in the quarter, but not from a cash flow perspective, but from a P&L perspective.

Fredrik, we'll come back to that a little later. Looking at the outlook, we reaffirm the 2025 outlook and what's worth noting is that we still believe that it's possible for us to reach our path to EBIT number for the Moving into our US commercial update, we're seeing the buprenorphine/naloxone market is picking up a little pace, getting closer to 5% with 4% growth year over year. And also over the last quarter, we saw a slight increase with 1%.

This is particular now, which is the interesting is behind the scene is that the market has really been driven by the commercial segment, which is now basically on the edge of surpassing Medicaid as the largest segment in the US. That is important for us because of two reasons. First of all, the commercial segment has a lower rebate, so it's more valuable.

Each patient within the commercial segment is worth much more fast than a patient with Medicaid. But also we have, and we maintain into next year, unrestricted access to nearly the entire market with 99% of the volume today sitting with payers where we have no limitations and access for sub-salts. And we have no changes expected for next year.

In the public segment, we have seen Medicaid decline. This quarter, they actually increased a little, but a much slower pace than the commercial segment. And we have seen in both Medicaid and Medicare that our access is nearly unchanged.

There's a small, small plan where we got some restrictions for 2026, but it's not really material for the company. One thing that is interesting in this space is particularly where we see Our largest account is with Humana Medicare and Humana Medicare have for a sub-solid perspective had a significant impact of two reasons. So the one is that we have seen Humana Medicare declining because they had new restrictions for certain part of their patients populations, but also that the rebate increased for that particular account.

So we kind of both at lower prices, but also we saw negative volumes, which have had an impact on the company year over year, which is actually the the main explanation behind the year over year negative development. From a quarter over quarter perspective, we're actually from a pure demand perspective, we have no major changes. We are quite stable in both Medicaid and open and actually grow a little in some of the segments, but we do still have some negative impact from Humana and to less extent of the United Health Group.

For those of you who are new to the companies, these were the formerly exclusive contracts where Orexo had nearly the entire volumes within these accounts, but after the introduction of generics in 2019, we have seen a steady decline in the two accounts. One thing that I have shown before is a little around the inventory and this because we have a strong expectations of a build up here in Q4. And to validate that a little, I just want to show some more interesting data here.

So one is looking at the sales to pharmacies. That means that the wholesaler sales to the pharmacies is down about 1% compared to last year. Some of that is, of course, pricing when you compare to our net sales.

In these numbers, we also have a 4% price increase in the start of the year, but that's also something we anticipate will happen next year. From a gross sales perspective, we are also stable, despite the volatility you can see here on the dark line. And we're down about 1% year to date.

And that is despite the destocking we have seen. And I'm just looking a little closer on the inventory levels at wholesalers. This is a new picture for all of you, I believe.

You can see these two peaks that are in the picture. They're both in the end of the year 2023 and also 2024. And if you look at the level of inventory when we entered 2025, it was 60% above the inventory that we have today in the end of Q3.

But even just looking into the inventory in the end of Q2, it was actually 30% higher than where we are now in the end of Q3. So there has been an inventory decline and it follows the same pattern that we've seen in previous years. So we are now expecting to see the Q4 that there will be some inventory build which help us when we reiterate our guidance for the year that we actually believe we can hit the sales numbers that are in here and also overall the company hit the positive EBITDA number.

Coming in under products and the development, the first area I will go a little into depth with is we did show some promising data in semaglutide where we have done a nasal administration. For most of you should be aware and I'm sure following the pharmaceutical industry that this anti-obesity medications, which kind of a collective name for these GLP-1s, is growing substantially. One is within obesity and diabetes, but also looking forward, there are a lot of expectations in more neurogenerative diseases such as Alzheimer's and Parkinson's.

We also see that there are areas within addiction where these have shown promising data. It's really, in one way, a drug with a very wide range of applications and where we see some of these patient segments would have benefit from a and new administration form. On top of that, we also see with our dry powder formulation, we can add a lot of stability to the products.

So what are some of the reasons why we believe it's of course compared, it's a small needle today that you need to take subcutaneous for most of the GLP-1s. Most of them only have an injectable or losan pipeline. There are a couple who also have an oral formulation, but with very poor performance in terms of bioavailability.

But taking it into the nose, it's quite quite easy to self-administer. It's of course needle-free. It's a non-invasive route of administration.

It will bypass the first past metabolism where you would normally, and that's why we see this low bioavailability of GLP-1 medications when they're taken orally in the GI tract. We don't see any need for refrigeration. We have data for six months of semaglutide in our formulation, and during those six months, in 40 degrees heat, we're basically not seeing any degradation of the active substance.

So we think there are a lot of advantages coming in with the powder formulation both from a patient perspective, from a stability perspective, and we think that can help also with improved adherence for the patients. With the data that we presented, this is a preclinical in vivo study, so I will say this is very early stage. We think semaglutide is the perfect model substance but this could probably be applied to other peptides used for GLP-1.

Semaglutide is a very difficult peptide in the sense it's a very large peptide, but we're still showing this quite impressive uptake when we compare to the oral formulation of semaglutide, but basically up to about seven times higher bioavailability using the nasal route of administration in the studies. As I said before, we have continued to do stability studies and we see minimal degradations after six months. What we're doing now is that based on the learnings from this study, we will continue working on the formulation because the study was in seven milligram.

We know that seven milligram of Repelcis, we know some of the data that we've seen from Novonordisk is about 25 milligram for Repelcis. We probably have to work a little on the formulation to increase the dosing also. The aim is of course to take this into a human trial but we will have to look at the timeline so it's a little early for us to commit to a timeline but this is of course the ambition that we're working towards is to show that we can replicate the data we've seen in dogs also in humans with improved bioavailability over the oral formulation.

Then I will invite Ed into the conference and Ed will talk a little about our OX 390 project and why we think this is so important for the US. So Ed, the word is yours. Okay, thank you very much, Nikolai, and good morning, good afternoon to everybody.

For those of you who may not recall, it was in April of 2023 that the White House declared fentanyl-xylazine mixtures as an emerging public health threat. So that was about two and a half years ago. And in the latest DEA National Drug Threat Assessment, which goes back over the past three years, the prevalence of xylazine in illicit opioid samples that are confiscated by the DEA has increased over four times.

And it's no longer a problem just in the Northeast, but it's spreading. And certainly, if you look at this heat map, it has already reached significant numbers on the West Coast. And it's been identified in all 50 states.

Now, it's not just how common it is now, but what we see here is that the deaths due to xylazine-fentanyl overdoses continue to rise. This is a paper that analyzed CDC data, which currently only goes to 2023. Now, if you recall, 2023 was the first year where the total number of overdose deaths started decreasing.

What you see here, though, is that in 2023, the number of Xylazine-Fentanyl overdose deaths continued to increase. So we're hearing this from market research as well as informal discussions that we have with colleagues and customers in the substance use disorder space that this really is a problem. And in the last two to three years, there's been emerging animal data suggesting that while xylazine is an FDA approved veterinary product that is safe and effective when used appropriately in animals, When xylazine and fentanyl is given to these animals, in this case usually mice or rats, it actually increases and sometimes multiplies the lethality and the opioid-induced respiratory depression.

There is a paper published in 2023. It's the title on the left, which identified it didn't measure respiration, but identified that a moderate dose of xylazine increased the lethality of fentanyl by over 100 times. So it took 1/100th the dose to kill 50% of the animals.

So we believe that this is truly a public health threat and it is growing over time. Now the BARDA partnership that we recently announced is a true partnership with this agency that is part of the Department of Health and Human Services. They're not only contributing a substantial amount of financial support, but BARDA has technical experts in all phases of drug development and public health who are at our disposal to continue to consult with us, advise us, and advocate for the continued development of OX-390.

You heard, Nick, I mentioned that the total value is $51 million. The current base period is going to be dedicated to the IND enabling toxicity studies, formulation development, and in-house manufacturing capabilities. And that total is $8.5

million. Based on achieving certain regulatory, manufacturing, clinical milestones, there are four option periods to continue the development. And these are negotiated with BARDA at each stage so that this is a staged approach to manage the risk of this program.

Because as you know, drug development always carries some degree of technical risk. The goal is to develop an intranasal rescue medication for use by laypersons or first responders in the community where these overdoses are happening. It'll be developed on Orexo's own Amorphox platform that you know so much about, and it will continue to leverage the existing manufacturing supply chain that we've already developed for OX 124 and 640.

Back to you. Thank you very much, Ed. And maybe worth noting also is we received the grant was signed in the last few days of September and that's also the last few days of Q2.

We have not included any effect of this grant into the Q3 numbers. So you will start to see some effect in the Q4 numbers and of course continuing into next year. What it is is it's a cost covering so we would basically for the expenses running the project and then BARDA will cover the majority of the expenses for the project upon invoice and the cost coverage will be recognized as other income by the company.

So going on to ICPR. ICPR is of course intimately connected to the same issue Ed was just talking about. Here we have basically proceeded according to plan with our upscaling of the manufacturing.

We have had some good dialogue with FDA also around the nasal device where we can now use the new new nasal device without any further studies. We would say that looking at the entire market for Naloxone, it's very highly competitive and that's something we're taking into account when we're looking at the launch strategy. So we are reviewing how we can put this to the market with the least amount of financial risk to the company based on a more competitive market in the US and also the need for financing some of these other projects we just talked about.

We do see that the Getting product as such and getting approved is something that's highly valuable for the entire value chain. Every partner we're talking to is talking about the commercialization and for those of you in Sweden have probably seen some of our colleagues in the industry just recently have had issues with manufacturing. Manufacturing is central and I would say the number one cause of delays of many approval processes so that we can have a product that has been approved on and supply chain I think is immensely valuable for other discussions and other projects.

Also some of the exceptions that we unique exceptions we're using for Morphox is something with an approved product that is also supportive evidence for some of the other products that we have in pipeline. So in many ways I think IC3 is paving the way for a lot of other products moving forward. And one of them is of course OX640.

And with OX640 we have continued to do the upscaling. We have manufactured the first batches of powder which are now being analyzed. We have had some partnering discussions but I will say that the data we received from the first launch of a nasal product in the US and even in Europe, that launch have gone somewhat slower than some of our partners had anticipated and that have had a negative impact on these discussions where there's a little more, let's see how the market evolves over the next quarter or two.

But from an Orexo perspective, when we look at this market, we see the first product has come out with a strong growth and we actually see from a financial perspective, some investors are seeing it's performing expectations. But some of the industry players, maybe based on some early expectations from the company launching the product in the US, AOS Pharmaceuticals, they find that this is somewhat slower than what they have seen. And when we are looking into this space, we're seeing it's around physicians' hesitance to prescribe before that they see real world data supporting that the nasal delivery is as effective as an injectable.

We know that patients in the US who have allergies have quite infrequent interactions with healthcare. A lot a lot of them don't see an issue in the daily day. So it's the annual meeting with their allergist, which is the time when you can get a new product.

But also from a more market perspective and something pushback is around the first ANDA that was filed in August by Lupin Pharmaceuticals on this product. So that have created some uncertainty. But if you look at the expectations by the investors, we see that the valuations are still significant.

Our competitor, AstraZeneca, actually according to the Wall Street Journal markets have a buy rating by all analysts. We have some of the largest investors in AstraZeneca, pharmaceuticals have just continued financing with up to $250 million in the launch of Nefi in the US. So for those who are close to the company, there's clearly an expectation that this market will go through.

And from a Rexa perspective, we still believe that Orexo has significant opportunity. Looking at the Naloxone market, which we very well. We saw that it didn't really take off before after 18 months and we saw exactly the same concerns by physicians and patients but today I don't think anyone in the US questioned the benefits of a nasal administration which is probably a lead for some of the decline we've seen the number of people dying from overdose in the US.

And we also believe that coming in with OX 640 we're actually looking competitively we have done some market research we know some of our potential partners have done some market research and all of that and confirms that we have a very competitive product in the US. We still have IP until 2044, but to continue understanding the market and to get more evidence, we have started a market research using some external experts running the study in the US. That will be concluded during Q4 to ensure that we actually focus on the right market differentiating parameters of 6:40 when we proceed and to confirm the attractiveness of the market.

So 6:40, we continue with the development we have seen some, you can say, delay in the partnering discussions. And also there's a concern from Orexo is the attractiveness with the uncertainty of some of these partnering opportunities where if you go a little further, get more certainty around the market, we see that could be a significant value inflection for a potential partnership. Moving into the financial section, I will invite Frederick to talk a little about our financial results.

Thanks, Niklas. So on page 22, looking at revenues, if we start looking on the top part of this page, you can see that our total Q3 revenue for the group was 190 million. And the vast majority of that, 114 million or 96%, came from sub-sol in our US commercial business.

Now, that's down about 17 million SEK year over year. Mainly driven by negative 11 million SEK FX impact. But we also had lower demand in net revenue terms, primarily from the previously exclusive contracts within United Health Group and Aetna.

So that was about a 3% demand reduction year over year. Now partly offsetting this, we had a lower destocking effect versus last year that contributed to a positive 2 million in local currencies subsal revenue declined 4.8% year over year.

Looking at other revenues within HQ and pipeline, Astral royalties were higher but that is largely because Q3 last year included a negative adjustment to historic reported royalties. As well royalties were stable but subsal ex US revenues were lower mainly because that didn't have any tablet sales to a partner called Healthcare this quarter. That's following the one-time inventory build earlier this year ahead of a cord starting manufacturing in Europe.

Now, if we switch to the quarter of a quarter view for subside Revenue, the waterfall chart on the bottom part of the page shows that opposite to the year over year Trend reported net revenues in local increased slightly in Q3 by approximately 2% versus reported Q2 numbers that though include the non-recurring rebate payment we had in Q2, 9 million. In SEAC terms, with the negative FX impact of 1.5 million, quarter-over-quarter net revenue shows only very marginal growth, reflecting a broadly stable demand picture in the quarter as shown in the the first three bars of the chart.

And working against the growth was also sizable negative inventory destocking effect of 6 million during the quarter, as Nikolai previously talked about. Moving on to the next page, the P&L, we already touched on our net revenues total of 990 million. FX effect was a negative 12 million year over year.

But the weakening of the US dollar year over year has of course also had a positive effect on our USD denominated costs, which account for approximately 65% of total expenses. The declining cogs, as you can see this quarter, is driven largely by this favorable FX effect within US commercial, and that was about $6 million TAG. Also, improved production costs for sub-salt.

So as a result, gross margin increased from 85% in Q3 last year to 94% on operating expenses in Q3, which landed at 133 million. We're pleased to see that's down four percent compared to last year, although about 12 million sec is coming from the weaker US dollar. But we also saw lower costs from a performance perspective.

With lower selling expenses in our US operations in relation to staffing, as well as lower marketing related costs for a Cipra. We also had lower admin costs, mainly from reduced legal fees. R&D costs on the other hand though were higher, mostly related to high costs for the upscaling of manufacturing.

And then we have these costs of 13 million for the long-term incentive program. Mainly related to provision for social security fees following the sharp increase in our share price during the quarter. EBITDA was negative for the quarter by minus 9.8

million and that though include this 13 million negative LTI impact. So if you would exclude those costs, EBITDA would be positive 3 million and if you look at the US business specifically, EBIT was an impressive 38 million SEK for the quarter and that's up from 25 million a year ago. So that's an EBIT margin of 34% and an improvement from 19% last year.

Let's go to the next page, cash flow. We reported negative cash flow of 15 negative 15 million SEK for the period. After adjusting for a negative FX effect of 0.8

million, that resulted in a decrease in cash and cash equivalents of 16 million in the quarter. Operating cash flow was negative and that's mainly due to negative operating earnings and interest paid on the bond. Adjustments non-cash item had a positive effect especially from the provisions related to timing of rebates payments and also from adding back these non-cash LTIP related costs we had this quarter.

So by the end of Q3, cash and cash equivalents were approximately 106 million SEK. And just a reminder, at the end of Q3, we still held 20 million our own bond, which could serve as an additional funding going forward. And then we're looking at the next page, our financial outlook for 2025.

These metrics are reaffirmed and specifically EBITDA guidance remains unchanged, driven by expectations of a positive inventory impact for Q4 as well as stable demand. Continued strong cost control is also expected to have positive effect and then we should probably also see positive impact with the Board of Warden and the covering of incurred costs in Q4. However, the EBITDA outlook is related to some increased risk due to impact from non-budgeted one-time items such as the non-recurring rebate payment we had in Q2, 9 million.

Also provisions we talked about associated with LT program and also significant exchange rate fluctuations. With that back to you. Thank you.

Maybe a word also on the badder contract on work 390 is that it's covering also our internal expenses and particularly in the first phases of the project. It's really our existing staff that is working on the project. So we will have covering of salaries that we would otherwise have to finance ourselves, among others, Ed Kim's part of Ed Kim's salary that you listened to him earlier today is also covered partly by this award by So a short legal update.

The one process we still have ongoing, never ending, is the Department of Justice, where we have not really any materialist movement during the quarter. What is worth saying is the US system with US prosecutors, which are the one leading these processes, that's political appointees on the US prosecutors are political appointees. And that process have been going on during the quarter.

And that actually even was a change of the appointed US prosecutor in the district that we worked with. And they really need to be confirmed before we think we can make any movement here. This is of course a process that is taking unnecessary time and also money and it's something we would like to resolve, but we would need to have a US prosecutor in place to have that discussion.

So looking at the future, we can say we have three buckets that we really focus on. One is our commercial assets where of course we have some revenue of royalties generating assets like Abstral, Etirax, which are still there even on a low level, but the most important is Subsalo, where we are continuing to work on how can we optimize the value contribution to Subsalo long term. On top of that, we of course have ICPR, which we're now putting into the semi-commercial space here as we are making good progress towards an approval, where we we will then look at what is the right go-to-market strategy, both looking at the market potential and the amount of expenses needed.

But really value optimizing those are important to enable the next areas, which is running our own projects, which today consists of three projects. One is OX 390 that you heard, one is OX 472 and GLP1s, and the last one is OX 640. On top of that, we have the Morphex technology and how we can apply that to to other in partnerships and to other companies' APIs.

And really with the goal to become the partner of choice in nasal powder delivery technology. We believe today we have the world's leading nasal powder delivery. We think the powder has a lot of advantages over a liquid nasal delivery.

And this is something we are working to apply together on partners, in particular in large molecules, where we think this can move from injectables to nasal delivery, among others. To vaccines, which is in our partnership with Abira, and we also have other non-disclosed partnerships where we're testing on larger molecules using our technology. With that, I will open up for Q&As.

If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. 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 Samir Devani from RX Securities. Please go ahead.

Hi everyone. Thanks for taking my questions. Probably easier if I just give them to you one at a time.

So I can I guess kicking off on a couple of the positive developments that we've seen over the quarter on OX 390, the $8 million initial period. How long will that cover? And can you make any further comment on how 390 will be differentiated from existing rescue medications? I don't think you've disclosed yet the end the active and maybe when we might hear about so I will take the first and then it can answer your second question around the differentiation and difference. So the 8 million dollars is lasting in until the first gateway and that is right now planned to be in the first half of 2025.

So this will cover the expenses on the first half of 2027. And with regards to the differentiation, it could you give a little comment on how this is different than other naloxone and naloxone rescue medications? Sure, thanks, Nikolai. Thanks for the question.

So what the preclinical evidence shows is that Naloxone does not have a beneficial effect on the respiratory depression associated with Xyloazine. So there is nothing else available. This will be specifically targeted to reverse the toxic negative effects of xylazine and drugs like it.

So it'll be a first in class. And when do you think you'll be in a position to tell us what that active is? I'll leave that to Nikolai. I think he's going, we're not prepared certainly today to disclose specifics around the API.

So, yeah, I think we will do that relatively soon, but I would say in the start of next year, it's a little around the supply chain, it's around the IP and others that we want to get control of before we will disclose the details. Okay, that's totally fair enough. And then just maybe moving on to semaglutide.

Obviously, this is a non-core area for you and I'm just again thinking about obviously we've got OX640 on the partnering table, when do you think you'll have enough or what further investment do you need to make before you think you could be in a position to partner this? So I think that OX-4772 or Semaglutide is an interesting one because we see it as a two I can say two legged opportunity. One is of course semaglutide as a product where that one will before you can get to market will be subject to semaglutide API patents which I believe some of the large market is in the early 30s before they go. So there is an opportunity in semaglutide and before you get to a partnering around that I think there could be opportunities short term but really To get through human data, I think will be an important milestone.

To have the first human data showing that it actually works, not only in vivo in animal testing, but also in humans. I think that would be a great value inflection point. And also think the expenses to take us to that level is not that high.

On the other leg, which is more other P1s, where, you know, today Novo Nordisk and H. Lundbeck, they have an oral formulation. There are some of the other, but not a lot.

Who have all formulations, but there are basically a large number of companies who have peptides for GLP-1s which don't have access to an oral or nasal formulation. And that could give an opportunity which is coming much faster to test whether GLP-1, we could have the product tested on that GLP-1, which of course then in that end you will have to decide whether you can run both legs or you will have to decide which one you're going on. But we really think from a partnering in a pharmaceutical company with semaglutide, the real value inflection point is likely to come with the first human study.

The other ones could come earlier than that. Okay, that's great. And then just on my final question, just on Izpree, I just wanted to double check that nothing has changed since we last spoke in terms of the likely timeline for the FDA filing, which you've said is mid-2026.

Just wanted to confirm that's your current expectation. That is still our current expectation. That's great.

Thanks very much. The next question comes from Klaas Palin from DNB Carnegie. Please go ahead.

Yes, hello, and thanks for taking my questions. The first one relates to OREX 390, and I wonder if you are perhaps willing to share some further detail about the clinical program needed to get an approval for this, what you have for kind of discussions with the FDA and the scope of such trials, perhaps? I would refer that to Ed with keeping the communication line as we have discussed that we can't go into too much details but on a high level Ed you can maybe answer this. Sure, thanks Nikolai.

Yeah, good question. We are because OHX-390 is a new chemical entity, we are going through the IND enabling studies currently. So our initial conversations with the FDA are going to be around getting to first in human.

So the clinical program and the pathway to developing this important rescue medication Those conversations need to be had once we're getting closer to our first in human studies. Okay. Okay, thank you.

And yes, to confirm the device that you are intend to use there is this very similar to the one for ICPR? Yes, that's the plan. Okay, perfect. And then let's jump to OREX 640.

You are sort of downplaying the expectations of a near-term partnership, at least what I'm hearing. And just wonder, is the negotiations on pause awaiting this market research analysis or what's going on? So there's a limit to how much I can go into individual discussions, but we still have ongoing discussions with interested parties. I think some of the Some of the opportunities, there's a question mark from us whether the attractiveness of entering a partnership with that market on search is attractive or we would have more value to take this a step further while monitoring the market development.

So there's a little on the value that you can get from the product partnering today, but there is still companies interested in the game. With different setups. So there are still opportunities for partnership in relatively short term, but I think the company needs to decide on what level of risk are we willing to take because we think there could be more value taking this a step further if we believe the market development is in line with some of the valuation indications for Orexo's pharmaceuticals and some of their larger investors believe how this will evolve.

Okay. Great. Then my last question is about Orexo and you talked about perhaps conducting a human trial before partnering.

Is it possible to provide some sort of timeframe when you perhaps could enter clinical trials with this compound? I think here we, so this has gone very, very fast for us. Of course we've been working on the formulation and it has been even in the patents since quite some years back, but the real work started this year. And what we are discussing internally and we are looking into the market opportunities is what is the target profile that we're looking for? For example, is the dosing that you need for obesity is likely to be higher than what you need for some of the other indications, but that also increase the risk in the study.

If you have to go very high in dose then that could lead to more frequent dosing through the nose and that comes with some other potential issues that we don't know. So there's a discussion where we're leading and that comes from two sides. One is to understand the market and this clinical profile that we think is desirable and the other one is purely formulation to say how can we work on excipients and how much can we get into one dose of the nasal spray.

So that is some formulation work that we would like to conduct. Probably followed up with some in vivo study before we move into humans with what you can say a targeted formulation. So we will have to wait a little to see where that is going.

But it is to run this first exploratory clinical study in humans is not a large study and it's not something that's going to be quite very time consuming. So we could make a decision and we could run it relatively fast. As you might know, we have manufacturing capacity for clinical trials internally so we don't have to wait for slot times at a contract manufacturer.

Okay, thank you so much. That was all for me. Thank you and I believe we received some questions on the telephone conference here.

So I will go through those here. So have you applied or intend to apply for these FDA vouchers giving the company much shorter timelines? So one to two months of approval for drugs of importance for the US, for example, OX 390 and OX 124. For 124, we have tested to see if we could get accelerated approval.

We think we came in a little late because there are other alternatives on the market, so we didn't have that pathway available. For 390, that could be a possibility, and that, of course, is something we're exploring. What's worth noting here is that buprenorphine is not only a financing, they are an active part in the development barta is part of the HHS in the US which is under the same department as the FDA.

So I think even here there are opportunities for us to work with barta to find the most optimal pathway to approval in the US. So that is something we expect. Then there's a question whether OREXO 390 will be a single agent product or we could combine it with Naloxone together with an alpha 2 receptor antagonist.

So alpha 2 Orexo is the target for silas and for those of you who don't know that. And the use of a combination product in the US is from FDA perspective, it's a hard sell. It requires quite a lot of data to combine the two products.

Often it will be easier to have some kind of combination package or you will have work with pharmacies to make a combination of the two agents. We will have to see how we would, what is kind of the the emergency steps you would take when you see someone who is potentially overdosed with thalidomide or similar agent, and then decide what is the best distribution way. But to combine it in one nasal spray, we believe will be a very complicated process from an FDA perspective.

Then we have a question here, which is around whether we think inhaled semaglutide would be a better solution than the oral products in clinical trials oil production clinical trials given higher toxicology discontinuation seen in trials such as those led by Viking which is an other company just for those of you who don't know who works with a GLP1. Do you see interest from new investors including international investors given potentially huge market opportunity coming from that product? We think there's a lot of opportunities of advantages of using a nasal delivery of a GLP-1. Working with inhaled could be, but in my and here I'm not a physician.

It is of course, so it maybe I will take it to you later, but I would just say in general I have seen that inhaled products come with more tox stories, at least historically, than what we have seen with others because you get it into the lung and the long term toxicology effect of that is difficult to predict and I at least have been part of withdrawing a product from the market because of late coming toxic indications from real world data. The nasal distribution or nasal at least with our powder formulation with the seven times higher uptake through the nose without the issues that you have with using an oral tablet, what we've seen with ReBelsys is very low bioavailability and also high variability among the individuals who received Repaglinide and taking it through the nose, at least in our in vivo study, we saw much more consistent data from the nasal delivery than the oral delivery. So we think there could be a great advantage, say, from a nasal delivery over the oral on the inhaled.

I'm not that sure. I don't know, Ed, if you have any thinking around inhaled semaglutide Yeah, yeah, Nicola, I think you've stated it all that the inhaled route of administration carries some risks and what we want to focus on is de-risking as much as we can the development of novel formulations. And we believe that the intranasal de-risks it the most.

And then there was a second part of the questions which is around whether we have seen interest from new investors including international investors given potentially huge market What I can see is that our share price have increased even though today it probably came with some disappointment I can understand from the commentaries. A lot of that is related to week 640 where we of course also had hoped and had some qualified expectations that we could have come to an agreement this autumn. But I will say that the quarterly data and also the patent litigation that Orexo ended up with came as a surprise to both us and at least the lead potential partner that we had during the summer.

But looking at what has happened after the GLP-1 announcement and also OX 390, which one of them is driving, it's a little hard, but I actually think they might be very complementary with the GLP-1s having a huge market potential and OX 390 actually give us some financial stability in the company. By supporting a development program with a lot of the staff that we're working with. We're a small company, of course, the same people who have to work on both the GLP ones and also on the WIG 390.

And what we have seen is significantly increased volumes. We have seen more block trades in the stock than we've seen recently. Some of the block trades are managed by international banks or banks which at least a part of the banks not present in Sweden.

And that indicates in my view that it's either some very affluent private individuals or more likely it's an institutional investor that is buying the share. We have not seen that in our statistics and I think that is due to many international investors don't disclose the holdings. So we just see that we have an international custodian bank that hold an additional amount of shares.

Then we normally would see that there are Some of these investors will call us and ask for individual presentations. And I will say that we have had more inbound interest in the company after the GEP1s from international investors than we have seen for quite a while. So that's maybe different indications that the hypothesis presented here in the question that we have new investors and that there has been an interest increased interest is correct.

And then we have another question which is I think came before the conference which is around whether Orexo is involved in a various long-term study for its influenza vaccine. What data was presented quite recently which was quite promising? The short answer is no, we were not a part of this long-term study but I also think looking at how you design these studies it would be natural for Orexo to actually focus on the delivery method with the least noise and that is probably working with an injectable. The way of delivering the product that they have done for most of their studies.

That said, we still have an intimate connection or dialogue with Orexo. We have discussions about future studies that we could conduct together. So this is just supportive of Ivera's vaccine that they have some great data that they could show.

For us, that is very good news because it of course helped us in the discussion with Ivera for where the powder could add value to Ivera's vaccine candidate. But we have not been involved in the study. With that, I believe we have no further questions.

I would thank all of you that you listened in. I hope this is a new partner we work with for the conference call from our side. It seems to have been working very well.

I hope it's the same for you. Thank you so much for your time and you're welcome to reach out to Orexo if you have any further questions. Thank you.