Good afternoon, everyone, and welcome to this second quarter interim report presentation from me, Nikolaj Sørensen, the CEO of Orexo, and Fredrik Järrsten, who is the CFO of the company. For those of you who've been following the day, you understand that this quarter, this second quarter of this year, we have continued to clean up the company and go going through the transformation after the sale of of Zubsolv in the end of last year.

This have had some impact both in terms of operational expenses where we have resolved disputes and discussions with suppliers, which have, we've taken a one-time cost on some of these contracts to exit some of some of those contracts. We have also continued to phase out employees from the US and also reduced the staff in in Sweden during the quarter.

All in all, we have in this quarter, we have an inflated both cash flow position and OPEX position, which is driven by this transformation that we're going through, but we feel it's important right now for the company to to come through with a clean slate and and be as transparent as possible of where we stand at the moment. Where are we right now?

I think in in parallel with with working through all of these different operational items to to prepare the company for for the new future, we're of course continue to work in our R&D programs, which is really where we're building value long-term. If we look at what we have accomplished during the quarter, our 390 project, we have gone through in in vivo study which has positive results.

OX124, we are well on track to file in Q3 in September. OX640, we're on track to start the clinical trial that we are are scheduled in for Q4 this year.

We are also during the quarter, we've started what we can call an early-stage scientific collaboration with an external pharmaceutical company to basically work out with the AmorphOX application to GLP-1 agonist. That is an early stage, but it's it's a a good access for the company to really understand how we can optimize this program to create interest from pharmaceutical companies.

I'll come back to that a little later. We also strengthened our business development.

We have recruited a new head of business development, Rahila Nassaji, this is really to leverage the interest that we've seen, growing interest in our AmorphOX platform from different companies. We have intensified our discussions with the Department of Justice.

This has been something that has been following us more or less to the date. I think it was the 14th of July that we started in six years ago, it's a little more than six years now, and and we really would like to put this behind us.

It's a difficult process. It involves more than Orexo.

It's also some of the employees in the US, this is a complex process to coordinate, but we are making progress. We look to be transparent from where we are right now.

We are are have opened the process to to look at what are the financing opportunities looking forward, and this is in terms of our strengthening our position in our business development discussions long-term, to show that we have alternatives and and we are well-financed to complete the programs together with a partner, but also of course to ensure that we we can continue with high pace even if we should reach a settlement with Department of Justice. I'll come back to some of the details around that a little later.

As you saw in the report, we have a cash position 233 million. It was relatively significant cash going out this quarter.

A lot of that is associated to to rebate payments and others from Zubsolv sales that was before we we exited Zubsolv business in the US, and Fredrik will comment on that a little later. Little more into the details.

Where are we? We have as we're working with you can say three segments of of explore, develop, and and partnering.

If you look at the programs that that we're running right now is is all of them are built on the AmorphOX platform. While it could look like we are quite differentiated and work with a lot of different programs, actually what we do as a company is very focused around the AmorphOX technology, and our involvement in the explore space in GLP-1, in infectious disease is limited to for us to do the AmorphOX powder.

If it's a nasal delivery, we can also support in the next steps, but we really look at partners who should take the heavy lifting of of driving the programs forward rather than Orexo, for example, becoming an a vaccine company. We do see that the the technology is very valuable or could be very valuable for vaccine companies.

Where we do have more efforts is in our develop segment where we're working with anaphylaxis, alpha-2 agonist intoxication, and opioid overdose. These programs are those who have been running for a while, and as as a couple of them are now approaching their final stages, it's kind of a a legacy for working with this.

I don't see that Orexo should become a vaccine company moving forward, but there we will rather work with companies who are active in that space. In a little more detail, in GLP-1 agonist, we are working towards an in vivo study this quarter to start that in oral formulation for GLP-1.

We quite pleased to have established a what I will call a scientific collaboration, don't confuse this with a partnership, but it give us access to quite high-quality input in terms of methods for study design. It's about how to do the analyst analytical methods in the in vivo study.

It's about access to some excipients that we're working with. This is an an important for Orexo as we have not worked with GLP-1 before to have access to that kind of competence.

Of course, it gives us a foot if the results are good, because the partner is of course doing this with an expectation to look at those scientific results and see if this is applicable to their portfolio. We are, as said, ready to start an in vivo study with an oral formulation in Q3, but we also continue to work with the with the nasal formulation, and and also there we would be looking for partners to support the company moving forward in in nasal formulations.

Infectious diseases or vaccines, it's quite interesting to see what's happening in the vaccine world. I see more and more recognition of the value of a nasal formulation, and this is exactly the sweet spot for for AmorphOX.

Here, I'm quite pleased with my experience of going to US BIO in in San Diego a few weeks back where we met several vaccine companies and and actually gained some good traction and interest of testing our technology to vaccines that could be taken nasally or even for some companies, existing vaccines that could eliminate their need for cold chain. This is something that we really see as a big opportunity for AmorphOX, but again, we don't do this with anticipation that Orexo should suddenly become an vaccine company.

It is basically to to allow the technology to flourish with with other companies and enable their vaccines to be delivered nasally and/or avoiding a cold chain and thereby having much longer stability and much easier distribution to the end user. For our anaphylaxis study, OX640, we are well on track to start our nasal allergy challenge study in Q4.

What's needed for that is is to upscale the manufacturing to what we call commercial scale. That means that the testing needs to be done on the final commercial product.

Here, we're fortunate that we have the entire manufacturing chain set up for OX124, we can basically use the setup with the reliability data, with the FDA inspected process for OX124, we can use on OX640, taking away an immense amount of work and risk from the OX640 project. It's a very large market, and I see more and more recognitions, even scientifically, for the need for a more convenient formulation like a nasal nasal formulation.

There are some some momentum building in the market in the US, and even though it's it's still small, it's interesting to see that they have after one year they have surpassed the size in sales than what we had with Zubsolv when we were at peak level and continue to show quite good year-over-year growth. Alpha-2 agonist intoxication, that's our OX390 project.

I I would say a real, the active substance that we're working with, atipamezole, is is used daily by veterinaries, clinic, all over the world under the brand name Antisedan. The big test here is it nasally absorbed in a way that is meeting the need for bioavailability to have a nasal formulation.

Because this is really what we see as the opportunity here is not to develop a new injectable, but to have a nasal formulation that can be widely distributed to first responders, community workers, and maybe even patients. Here, to see that we have successful gone through this in vivo study, and with all of our experience of running in vivo studies on other formulations, we're quite certain that the data we see in in vivo studies in animals is is applicable to humans as we come further along.

Although Antisedan, atipamezole, is available for animals, it is in the eyes of the regulatory agencies, it is an NCE project. That means that we actually have to do a lot of of toxicology testing and what you call preclinical testing before we're ready to go into the clinic.

As this project is to the vast majority financed by the American authority, BARDA. Opioid overdose, our OX124 or before OX124, we are well on track to file the product in September.

We expect to have the filing in September, and that would mean the expected review time from FDA is six months. That takes us into the end of of Q1 when we should have approval in the US.

For both the 640 and the the opioid overdose project programs, we are starting and in, or we're intensifying a partnering process where we are looking to, for OX640, to have a partner who can take the commercialization, or partners, because this could very well be different partners for different regions in the world. This is clearly a global product.

We will have partners who can support both the final development and also the commercialization. We expect from Orexo, we have the funds and are expecting to drive the study through the nasal allergy challenge study, but would then look for a partner to take the program over the last last regulatory studies and and also start the commercial manufacturing.

In opioid overdose, we also see a major milestone is the is the submission to FDA. When we reach that, that's also a very good trigger of really intensifying the partnering efforts for the US market.

Where, and just to give an overview of of our future, where we're putting most of our money right now and and are expecting to to have most of the investments moving forward is the 640 program. This is a program where you we're addressing anaphylaxis, for so for those of you new to the company, anaphylaxis is when you get an allergic shock and you need epinephrine to basically reverse the allergic shock.

Today, this market is to 99% dominated by auto-injectors on a global scale. There is a a nasal formulation that's come into the US and have been started to launch in some markets in Europe also.

It is interesting real-life data that comes out of those, both from Europe and also from the US, where we start to see scientific evidence and value of having a more convenient administration than the auto-injectors. There was a recent study sponsored by the Danish company, ALK-Abelló, who's launching a nasal spray in in Europe where nearly 40% said they didn't carry their anaphylaxis products regularly, which is a big risk because you rarely you get the anaphylactic shock when you're at home.

You often get it in a place where you can't control how the food has been treated or or what is happening around you. We we see here that having smaller and more convenient, more stable formulations would have a major meaning for patients, and and we believe this is going to drive continuous growth in the segment.

One of the hurdles, we saw that with the naloxone when that was launched back in 2015 in the US, nasal naloxone products, it took some time before people got got convinced that a nasal formulation has the same effect as an injectable. It took basically I think two years before we really saw the market starting to pick up in the US with na- with nasal naloxone, and today that is completely dominating the market.

Should that happen in the epinephrine market, we're looking at a market that is worth more than than $3 billion on a global scale today. For Orexo, we have somewhat around 200 million left in external expenses.

Then we also have an internal team working with this, of course, and the majority of this is expected from the second half and into the first half of 2028 where we then expect during the summer to have the filing ready if everything goes according to plan. We will seek a partner to to run this.

Why do we think this is an important project? It's basically because we just looking at the the product profile of OX640 compared to the competitors, we see a product that is more stable, we see rapid onset, we see that we have an extensive absorption of of the product and even after an extended period, we don't see a drop in the amount of epinephrine, we basically see that we continue to have an extended absorption even under nasal allergy challenge in the first study we have, and that is something that is differentiating us from the competitor in the market today.

We see an opportunity to have a long shelf life. We have an incredibly stable product.

We don't see any degradation, which you actually see on both the nasal liquid in the market today and also in the auto-injectors. Then on top of that, we have IP exclusivity to at least 2044.

It's a long runway from where we are today with OX640. Even smaller parts of a billion-dollar market is highly valuable for Orexo and of course for partners who are willing to pick up the product.

What are we trying to do apart from our projects? We and I will just say with with AmorphOX, this is really part of what we're trying to build on right now is when we look at the global market for pharmaceuticals, we see some growing issues where we believe AmorphOX can be a solution.

It's around stability of biomolecules. We see a lot of the vaccines and and biologics require cold chains to remain stable, and even under cold chain, they have short shelf lives.

Cold chain is a bottleneck and a growing bottleneck in both in the pharmaceutical manufacturing, but also when you come out in the distribution of the product to the end end user. This is something that we can address.

There are limited biomolecules today are by far, the majority are are delivered to injection. We think that there could be opportunities for more to to be delivered to nasal, and and we have seen, as you saw, our first nasal study on the GLP-1 agonist semaglutide through the nose showed a much higher bioavailability compared to the reference product.

We see an an increasing patient interaction model that is changing, in particular in the US where patients are more and more relying on virtual interactions or video interactions with their physician and then home delivery of their product. You basically, instead of going to the pharmacy, and this have cost an immense amount of closure of pharmacies in the US the last the last years, we see that patients are expecting to get the products sent home.

Of course, that is an that is an obstacle if you have an injectable and also something that requires a a cold chain. Finally, most if you're just doing a normal injectable, you will have little IP associated with the formulation, and we have today a long IP, and the more APIs we're putting into AmorphOX, the longer IP we expect to have.

We even have for for GLP-1 agonist, our IP is expected to go into 20 20 2047, so that's actually 21 years from where we are right now. We can with AmorphOX offer a significant extension of IP for for many products in development.

If you look at vaccines, this is where we really see a big value because we see that most of the vaccines are very, very sensitive, and we can provide something with more stability. One thing I will highlight here is actually just a very recent Swedish study that was talking about how you need mucosal immunity for for to avoid the the full effect of of influenza and others.

You can maybe be injected and have a systemic immunity, but if you don't have the local immunity, you will still get sick, maybe not as serious, but being sick also means that you can spread the virus. By having something that we creates a local immunity, you will actually have a much better, bigger opportunity to to stop the virus from spreading and avoid disease at all.

This is an area, and it was interesting to see this Swedish study done at the Swedish hospital, Danderyd Hospital, to see how they came to the conclusion that we need to deliver flu vaccines through the nose to ensure full immunity in a vaccination. We I think we are quite spot on to one of the real hot topics in the vaccine space at the moment.

Then our model, again, the risk, of course, by working with so many different molecules is that you are getting too fragmented and and spread your your resources across many different areas. What we are basically doing is that we're offering companies with— Sorry, I I believe I got disconnected here, I I hope that it didn't disturb you too much and the sound quality is still good.

What we're trying to do is basically with the AmorphOX platform is offering a way to create, we do the powder, and then our custom- our partners will basically have to lead the clinical development and the development and supportive data for the API. We can then, of course, based on all of our experience from having taken products to the market, offer support throughout the entire development process all the way up to manufacturing, to do some of the clinical testing.

Of course, broad clinical trials, we would need to rely on the partner to do this. Really the work that we are offering is focused around creating a powder where we encapsulate the API and make it bioavailable either through the nose or through reconstitution where you can then avoid cold chain, cold chain and also increase the stability and shelf life of the product.

We're taking this to customers through our business development group where we've just recruited Rahila Nassaji, who's a long experience from business development, have worked with both large and and small pharma companies, most recently the CEO of a small vaccine company. With Rahila, we are basically working to leverage the increased interest we've seen in AmorphOX and to create new collaborations.

Building on the early-stage scientific collaboration, looking for other partners in the GLP-1 space. We see high interest from the US authorities in thermostability in vaccines, again, going with other companies and might maybe build on our experience from BARDA to seek financing together with other companies to test these nasal formulations should be feasible.

We have right now several ongoing discussions with Swedish and international vaccine companies where they are what we're discussing, how can we best assess the value we can bring to their vaccines. The focus areas in business development right now is in the AmorphOX platform, it is finding a commercial partner for OX124 ahead of approval in Q1 next year, and also to work to find a diff- one or more partners for the OX640 project where we see this project could be purely a global or have global opportunities, where OX124 is more US, we think OX640 is something that deserves to have a global market.

To round round off, why do we think that we are at an interesting time right now? I I think Orexo, we have several products that are right now approaching approval or very close in their final stages.

We have OX124 that we are expecting to file just within a few months. We have 640, which we could file also in 2028 with approval either late that year or first approval late that year or early the year after.

We have an OX390 project which is maybe a little longer ahead, but the risk in the project, both from a development perspective, but in particular also from from a finance perspective, is relatively low because Orexo is only covering a fraction of the expenses. We're doing this based on our differentiated AmorphOX platform.

I think we again and again, we see that we can do stuff with APIs that no other company can do. We have our high-value, late-stage pipeline.

We have experience. We have taken four products to the market, we know what it takes to get a product approved.

We see that we have multiple quite interesting inflection points coming up relatively soon in the company, such as the OX124 submission, OX640 commercial scale manufacturing, NAC study results, new partnerships and collaborations around the AmorphOX platform. With that, I will open up for Fredrik to take us through some of the financial numbers.

Fredrik, please.

Thank you, Nikolaj. Starting with the P&L for continued operations, which we, as after the divestment of Zubsolv US, no longer follow up on a segment basis.

Now, divested Zubsolv US business is presented as discontinued operations in note 10 in the report and will be presented that way for the remaining part of 2026. On net revenues of 3.5 million for the quarter, Abstral royalties were low, reflecting ongoing trend of individual country royalty agreements expiring.

In addition, royalties were also negatively affected by the turmoil in the Middle East. Edluar royalties were also lower following launch of generic products in Canada.

Zubsolv ex-US royalties, on the other hand, were higher, explained by positive true-up of Q1 royalties, where we hope to start seeing the effect of Accord's increased market efforts when finalizing their Zubsolv manufacturing setup in Europe. OPEX, so that amounted to 107 million for the quarter, which is up from Q1 last year, but the absolute majority of that difference comes from a settlement with GAIA, as Nikolaj talked about, terminating the collaboration in relation to digital mental health products.

That increased admin expenses by approximately 20 million. Selling expenses were lower than last year, mainly due to lower marketing-related costs for OX124 and lower digital mental health product activities.

Admin were higher, mainly as I mentioned, from the settlements with GAIA, but also from increased legal fees seeking a settlement in the DOJ investigation. R&D costs were also higher following higher costs for the development of OX640 and OX390, which, on the other hand, also meant higher BARDA reimbursement of OX390 related costs of in total 4.5 million, that being the main reason for a total positive contribution from other operating income and expenses of 5 million.

Another comment on OPEX, and the total this quarter of 107 million, and we look at what that would be without nonrecurring items, such as the settlement with GAIA, and normalized with no transition-related expenses or legal costs in relation to the DOJ investigation, we would for the quarter instead look at OPEX of some approximately 60 million, excluding depreciation, or annualized about 240 million SEK. We are also continuously looking at how to become more and more cost-efficient going forward.

We have, for instance, reduced the Swedish workforce with approximately 10% after the transaction. Net financial items nowadays, after the redemption of the bond, give a positive contribution.

It was 1 million for this quarter, mainly explained by higher interest income from bank accounts. Net profit then for continuing operations, minus 102.5 million SEK, and for discontinued operations, plus 2.1 million.

There, the restructuring costs post transaction starting to phase out, although will remain in some degree until the transition period has ended, likely end September. Next page, cash flow.

We reported total negative cash flow in Q2 for continued operations of minus 98 million, where we had a negative contribution from operating activities of 93 million, primarily impacted by negative operating earnings, a negative adjustment for noncash items, where the major part was payment of provisions for outstanding rebates related to Zubsolv sales in 2024, '25, sorry, that is before the transaction with Dexa. These rebates will decrease significantly going forward, are expecting to be fully phased out by year-end.

We have 3 million left to be paid of our provisions for rebates the last two quarters this year. Furthermore, we had positive changes in working capital, mostly related to an increase in accounts payable from our own operations.

Then under the transition services agreement following the divestment to Dexa, Orexo also continues to collect Zubsolv revenues on behalf of Dexa during the first nine months of the year, which also had an effect on working capital through both accounts receivables and accounts payables. Now, this setup with Dexa, though, is just a pass-through exercise with a net-zero effect on cash flow over time, but 44 million of our cash in the balance sheet end of this quarter is payable to Dexa.

Cash flow from continuing operations was a negative 98 million, as I said, cash flow from discontinued operations was a negative 14 million, and this is mainly from payment of severance and other post-transaction-related restructuring costs. The total negative cash flow for the quarter is then 112 million.

After adjusting for positive FX effect of 2.6 million, that meant a decrease of our cash from end of Q1 of 109 million to 277 million, after which then 44 million belongs to Dexa. Our own cash is 233 million end of Q2.

With that, back to you, Nikolaj.

Thank you, Fredrik. As you can understand, this is a relatively complex exercise, in particular given the US setup where you have returns, you have rebate payments, and some of those returns and rebate payments are coming in quite late, and can be associated with the Orexo sale of Zubsolv prior to the transition to Dexa.

This has been a period of transformation and also where we have to work with parallel, both continued and discontinued operations, which of course is clouding the picture a little about the financial performance. I can promise you, we are working intensively to bring down our spend and to really focus our resources where we see most value, and to avoid future expenses associated with the US legacy operations, that means the commercial operation.

To the legal update, and we did mention that we've intensified the discussions with the DOJ. When we look at the structure that we expect, it would be a settlement where the payment will be over several years, so that would not be one big payment coming when you have reached the settlement.

It's something where I think there's a very constructive dialogue with the DOJ for what is feasible for Orexo to ensure that we can continue our operations looking into the financial situation of Orexo, which is some of the stuff we have done during the spring is basically to show forecast and also give the DOJ a full insight into our ability to pay in such a settlement, which of course is relatively limited given where we are at the moment. We also expect that parts of this will be covered by insurance, and as I said before, the settlement will cover not only Orexo, but also some individuals who have been working in leading positions in the US.

For those individuals, that we have a D&O insurance, which should cover their exposure, which should take a decent amount of the total settlement, and the amount should be covered then by insurance. However, the discussions are ongoing.

It's not been closed. It's a slow-moving process, it's something that we have been spending, as Fredrik said before, a decent amount of legal fees during the quarter and historically, quite a lot of legal fees.

I do see that we have made some progress during the quarter, which give us some confidence that we can approach a final resolution, even though I'm also fully aware that the details in the settlement agreement is still to be worked out. Our position remains that we have been compliant.

We have used external legal advisors, regulatory advisors to review our commercial material and training material and others, and we get the word from our lawyers that we've been compliant. However, given where we are, this has been going on for six years, we would really like to put this behind us and also to avoid the cost of a potential legal proceeding in court in the US, and also the continuous expenses that we have right now to manage this process.

Final slide. We have shown this before.

Zubsolv EU, we haven't seen an effect of the EU sales yet. I will say right now what we have in our account is actually based on projections and not the final sales report, but we do know that the Zubsolv EU material was released in the end of the quarter, we expect relatively soon that the material from Accord will reach the market and be the basis for their future commercialization in Europe, which should give them a much more competitive cost of goods in a European market, which in its turn should also have a positive impact on the Orexo royalties.

390 in vivo study, as you understand, is important, and in just a few months, we will hopefully put another box next to the Q3 filing of OX124, and then trial start of OX640 will come shortly thereafter, plus the in vivo study in GLP-1 agonist, which is scheduled for this quarter also. We're looking quite well to basically put a tick in the box between each of these milestones in the short term.

We are working now with a much stronger business development setup after Rahila have joined us to increase the number of partnerships and get more companies to test and work with our AmorphOX platform. With that, I'll just remind you about our financial calendar.

Next report is coming October 22nd, and this is just small subsection of some of the activities where we are with business development. Again, with Rahila joining us, this is an area where we expect to increase activity levels quite substantially during the next half year.

With that, I will open up for Q&A.

Thank you for taking my questions. My first question is about this DOJ process that you're sounding a little bit more optimistic that you're making progress.

Is it possible to share any further details what has happened in this process during the past month?

Thank you, Klas. The DOJ, what we're working with is a slightly moving target because there have been some reorganizations at the DOJ.

We're working on several different lanes to try to resolve this, talking to different people within the Department of Justice, but the main constituents are of course is the Western District of Virginia, as one prosecutor office who initiated this investigation. What I can say because we can't disclose any details, but I will repeat what I have said previously is if you look at the size of the case, the claims, and also the number of involved parties, meaning both Orexo and some individuals, the total expense to run such a process, it's likely to be north of $10 million.

The logic, the rational decision if you see that threat is to look for a settlement when you're in that neighborhood if you can get to a reasonable financial terms. That goes not only for Orexo, but it also goes for our insurance companies, and we are here in the discussions, we are expecting to see insurance coverage for a decent amount of this.

I can't disclose any more details as we are in negotiations at the moment, but this is some of the logic that we're looking at is we really would like to close this. Of course, what we would like to avoid, even though we believe we have a strong case, is to enter into a court process where it would be very difficult to get back some of the legal fees, and of course it's always a risk when you go to court that there will be parts of the decision which is not positive for the companies or the individuals involved in the process.

You have a clear counterpart at the authority to discuss these issues with today?

There's no permanent prosecutor assigned to the Western District of Virginia. As Todd Blanche, I believe, was confirmed yesterday as a new Attorney General for the US, and I think that's been a little of a delay in that process.

There is an interim head of the district, and that's the person that our legal team is speaking to.

Okay. Thank you.

Then another question then. You have done a lot of cleaning of your business this year, and if we exclude the DOJ process, are you done now, or is there any more cleaning to do?

I would say right now we are at the position where we have one person who still works on a temporary contract in the US. In Sweden, we have also one person who's also working with a final end date in the quarter.

I don't see any other supplier contracts that we would need to review as it looks like right now. Yes, we are done in that line.

What I will also remind is in Sweden, we actually moving out of our existing offices, and we're moving to a smaller and more space-efficient office closer to Uppsala University, and in the new office, we expect to see nearly half of the expenses for office. That of course is not directly associated with the US transaction, but it's something that will have full effect from next year.

Great. Just my last question then is related to OX390.

I guess you have had a meeting with FDA now, and were you satisfied what came out of this meeting?

This was about our preclinical work, and we got full support from FDA on the plan. As always, there are some suggestions for things that we could add on further details, and we are working together with BARDA to discuss those activities and of course expecting to continue with the same setup with BARDA where the majority of those expenses will be covered by BARDA.

That was good. FDA also basically wanted to start a process discussing the clinical program, they accelerate in that process ahead of the IND.

I think that is quite positive also because the clinical program is the little more complex setup because you can't go out and test the product on the end users because they are basically people who are suffering from an overdose with different kind of adulterated opioids on the street. To have that dialogue early with FDA, I think is quite beneficial for the company.

I would say 390 is creating a lot of interest, not only from BARDA, but also from other authorities and all the way up to the White House in the US. They are desperately looking for solutions to this zombie drug that's called tranq, or xylazine, medetomidine overdose combined with fentanyl.

This is something that is gaining a lot of traction on a political level on both sides of the aisle in the US. I think this is an interesting project because we're really in the center of US politics with this project, and we're the only one working with an overdose treatment that we are aware of for tranq.

Sounds good. That was all from me, and I wish you a happy summer.

Thank you.

Thank you, Klas.

Hi, guys. Thanks for taking my questions.

Let me kick off with the DOJ, just a further clarification on the DOJ, because there's clearly been some movement this quarter. I just wanted to check, has the DOJ sent you a settlement term sheet?

Not in a sense that we have a written term sheet, but there has been very concrete discussions about a concrete term sheet with the DOJ.

In terms of the financing going forward, I'm just trying to put this in some perspective. I'm assuming you'll have to have the DOJ resolved before you can raise further equity capital.

Is that a fair assumption?

I think we would need to have more clarity around the DOJs before we can do that. Because I know that the process in the US is a bureaucratic process, it can take time to get all paperwork in place.

If we reach a term sheet agreement that we can share, I think that is the trigger, or that's taking away the uncertainty around the process.

Okay. Then just moving on to OX640, and you've helpfully given a figure to do the pivotal trial.

I was just wondering if you could give us a little bit more on the structure of that pivotal trial, and whether there is anything built into it to help you differentiate from neffy?

I would say in the expenses, actually the majority of the expenses is not associated with the trial. It is for doing the stability and reliability testing, manufacturing the batches needed for both the pivotal trial, but in particular to ensure that you have gone through all of the quality stuff, because we need to meet this 99.999% reliability.

A lot of these expenses are actually not clinical trial associated. I would say it's less than half.

We're looking at two studies right now and potentially a third plus a pediatric study. The first one we're running is nasal allergy challenge, and I think this is a quite important from that differentiation perspective, because if you look at the data from neffy, the effect that they get under nasal allergy challenge is relatively short.

What you basically see is a relatively rapid peak, but then it will turn off and it will drop down after about 20 minutes. What we saw in our first nasal allergy challenge study, we saw that we continued up to much higher levels following the profile of EpiPen, and we also had a much more extended profile.

I think this is one of the areas that created a lot of discussions around the advisory board, and there was a need, I believe, for ARS Pharma to do a repeat dosing study for neffy to show that if you have taken it once and you don't get the full effect or there's a secondary allergic shock, then you can give another dose. We believe that with our product, that should not be necessary because we have a much more extended profile when we look at our first study, and we also see that we continue upwards much beyond the level of bioavailability that neffy has reported in their studies.

We do not intend to do a head-to-head study in this round, but I think the data will most likely look different than what you have seen from neffy. This has been one of the discussions and the reason for them in the first round that they didn't get the first approval, that they need to complement their file, which they admittedly did relatively fast.

That's the first study, nasal allergy challenge study. It is in people with allergy against pollen, you need to do this during the winter season in the Northern Hemisphere.

We're basically talking from October into February, that's when you can run the studies, otherwise people would be affected by pollen in the air. That's the first study.

The next study would be a self-administration study, healthy volunteers who basically administer the nasal spray directly in themselves, but that will not be under allergy challenge, so that is more focused on the bioavailability in healthy volunteers plus that they can administer the product easily using the nasal spray. The one that will be depending on whether the data we receive from the nasal allergy challenge study is whether we need a repeat dosing study, and that of course depends on whether we see this extended profile that we saw in our first study or we see a dropping off where there could be a risk that you need to have a second dose of OX640.

The two key studies is the nasal allergy study and it's also the self-administration study that we have left as it looks like, but we're also looking to develop a pediatric dose which would then need to be studied, but for approval, it's those two other studies that are key.

Nik, just so that I'm completely 100% understanding this, when you put in your slide the 200 million for OX640 from H2 '27 to H1 '28, is that including some of these pivotal studies, or is it simply for the stability and manufacturing work still? No,

that number is from today. It is from today until filing.

Some of those expenses will be during this third and fourth quarter and first half of next year. A significant amount of the expenses will come starting when you come into the real final manufacturing, which is going into second half of next year and into early 2028.

We will use some of the 200 million even in this quarter and also in next quarter.

That's great. Thanks very much.

I believe we received some written questions, Fredrik, if you can summarize.

There's some questions again on the DOJ. I think you answered everything on the DOJ, I'll move on.

His third question is GLP-1, regarding the industry collaboration supporting the upcoming semaglutide AmorphOX in vivo study, can you clarify how involved the industry partner is in the program and whether positive results could trigger discussions about expanding collaboration into formal development or licensing agreements?

What I said before is we have an industrial partner who is providing under confidentiality, otherwise I could of course talk about who it is, but this is all done under what you call a material transfer agreement. We do have a written agreement where they provide us with ways of setting up the in vivo study, what kind of measures are we going to look for, what are the methods used that could provide the most reliable data that they see based on their knowledge of running in vivo studies in GLP-1 agonist, and also they provide some material that we use for the in vivo studies.

We have a partner who's involved mostly through their time and expertise, partly through their supply of some of the material that we use for this study. Orexo is the one running the study, we are doing the development and we're taking the expenses for that.

That's the level of involvement. Of course, you don't get anything for free, and of course the reason why we have such a collaboration and discussion is a curiosity about what we can accomplish.

Some of the structures that we can look at for AmorphOX for both oral and potentially also nasal administration is something that could be relevant, if not for existing commercial products, then for pipeline projects that are running at the moment. This is to really understand how our technology could help.

I would say it's not a straight line to a partnership because this is really driven by R&D, but it is a ticket to go into more concrete discussions around where our technology could work. It's definitely not a partnership just of goodwill.

It's something that the partner is doing to basically look at opportunities for future collaboration. Great.

Then on capital allocation/partnering, given important value inflection points expected over the next nine to six months for OX124, 640, and AmorphOX, how do you balance the need to strengthen the balance sheet against the risk of raising equity at current valuation ahead of these milestones?

I think it's always a balancing act. It's also balancing act around communication and there are many, many parameters that are in play.

This has been a thorough discussion both in our board of directors and also with our advisors. We have everything from the DOJ to some internal issues, and also discussions with shareholders where we think by going public that we initiate the process right now is opening up for reviewing different pathways, and there can be different paths to raising additional capital.

Of course, our current valuation is not optimal, but at the same time, we also know that partners will be looking at security. They want a partner who's able to run the projects going forward so that you have a strong balance sheet.

I think that's part of what we're weighing in right now is to be successful in the partnering discussions, both for AmorphOX, for people who are using that time and basically allow us to test their API, but also for partners for 640 and OX124, to know that they have a stable partner who can continue to support the program is important, and that's the reason for us to start the process right now. We think, of course, we see how the market have reacted today, and you could say that it would be optimal to wait.

I think it's also optimal, it's a little around the partnering discussions. Could we partner the program?

I would say and I've said that before that there have been opportunities to partner the 640 program, but that would be to partners who would not have a global perspective. It would be regional and where the amount of payment would not cover our expenses moving forward.

I think here the nasal allergy challenge study is a very important trigger, but to get into that process and not losing time, we need to start the process more or less immediately, and in that process, it will be valuable to show that we have a strong financial capacity from the company.

The final question is on the expenses for OX640, with the majority occurring in H2 2027 and H1 2028, while you also intend to seek a development and commercial partner, how much of these costs is Orexo expected to finance itself before a potential partnership?

I think this is very much up to the partnership discussions where we end up. As some of we have been in partnering discussions previously where the partner did take the vast majority of those expenses.

We would expect to have a partner, in particular for the US market, which is by far the most attractive, that would take the majority of the expenses that's moving forward, in particular external expenses, so that means the expenses they are right now. Whether that is structured as a pass-through expenses, through milestones during development, upfront payments, all of that is depending on the partnering.

My expectations is that a deal would in its full structure cover a large of these expenses, if not more than that.

That's it.

Thank you so much for taking the time out from a beautiful summer day, I believe in Sweden. Fredrik and I, we have been sitting indoor in a relatively nicely air-conditioned room, we haven't been outside the door, but I hope the rest of you have been able to enjoy the summer, and I wish all of you a great summer and thank you for listening to this presentation.

Goodbye.