Clinuvel Pharmaceuticals Limited

Recording in progress.

Hello, everyone. Thank you for joining Clinuvel's investor webinar. I'm Stella of Monsoon Communications. In today's webinar, Clinuvel will share their healthier results and operational highlights for the six months ended on 31st December 2025. I will now hand over to Malcolm Bull, Head of the Australian Operations and Investor Relations to conduct the proceedings.

Thank you, Stella, for the introduction. I'd first like to welcome members of Clinuvel management team to the webinar. Not surprisingly, reflecting the focus of the webinar on the financial results for the half year to December 25, we have Chief Financial Officer Peter Vaughan. We are joined by two executives who are leading the business in key operational areas Director of Clinical Affairs Dr Emily Rottenberger and Director of North American Operations Dr Linda Teng We're also joined by our Managing Director Philippe Walden I'd like to acknowledge there are several analysts on the line who cover Clinuvel and will ask some questions in the webinar It would be remiss of me if I didn't say on behalf of management and the board that we appreciate your work on Clinuvel. Your role in telling our story to a wider audience than we could reach ourselves and your involvement in this webinar. It's pleasing also that there are over 175 participants to the webinar reflecting increasing interest in Clinuvel. So welcome one and all. Before going further, I think it's appropriate to highlight why we have five executives in today's webinar. So you frequently see Philippe, our Chief Operations Officer Lachlan Hay, Peter Vaughan and Investor Relations presenting the company to a range of stakeholders. We have received feedback that it would be good to have greater access and the opportunity to hear from other executives. So for today's webinar, noting this is not the forum for a strategic review, but as a courtesy to you all, we include Dr. Roddenberger and Dr. Teng to answer questions and provide their insights direct to you. Today's webinar will be in two parts. First, a discussion of the half-year results, and second, the analysts online will be called upon to ask questions of the CFO and management. We will be talking today about plans and intended outcomes. So draw your attention to the forward-looking statement or safe harbour statement on screen that identifies a range of risks that can materialise and impact their achievement. So I think 10 seconds to review that is enough and that is on our website and on all of our announcements. I now kindly invite the CFO to summarise the results. Peter.

Thanks Malcolm. Good evening and good morning, everyone, from wherever you're calling in from. It's another set of very consistent results at Clinuvel, I'm pleased to announce, with our revenues up 4% on the prior year, maintaining a steady growth pattern. Our expenses were up 22% for the period, and this really was part of supporting the expansion initiatives that we'd foreshadowed previously that we were going to be undertaking during this period. We continued our strong positive net operating cash flows and this saw our cash reserves over the six months increase by $9 million to $233 million. We're closely monitoring all of our expenditures and any discretionary spending is being scrutinised really closely. and the good news is that our profitability for this period, whilst lower, continues to be maintained despite the increasing level of expenditure during this expansionary phase.

Thanks, Peter. I'll now ask Philippe to comment on the results.

Thanks, Malcolm. Welcome to all the analysts and shareholders. Well, in a nutshell, we follow a plan, a strategy, which is gradual and with purpose and for this strategy to play out we need to manage our finances tightly and in a very controlled manner in the past 12 months we intentionally increased our expenses and therefore naturally one expects to see the net profit decrease these expenses towards R&D the clinical trial and vitiligo and regulatory findings We are very much in line with our own forecast, so we are content with the results and we will proceed on this basis.

and with positive cash flows, we can expand the activities of the company, the group.

We gave expense guidance from 2021 to 2025. And for the financial year, we expect to spend about 55 to 58 million, excluding the capital expenditures. So in summary, the business model we chose is playing out really well.

I agree. So let's delve into the results and call on Peter to look at in-term revenues, expenses, profit and indeed the balance sheet.

Thanks Malcolm. So our revenues for the period continue to grow year on year and this period I'm pleased to say we saw our highest ever sales revenue result. This period marks the 20th consecutive profit for Klingerville since the commencement of our commercial operations. And our expenditure, as I touched on before, whilst increasing, is very focused, controlled and targeted around the specific areas of the business that we're focusing on. Our expansion saw key developments in our R&D activities across our ACTH Nurectel program, our vitiligo study CUV105 and of course our peptide drug platform that we developed at our Singapore Research Development and Innovation Centre that we recently announced we'll be undertaking a large expansion of. Now all of this expenditure and all of this growth has been achieved without sacrificing our overall profitability which is really a fantastic result for the organisation. Only 4% of biotechs deliver a profit, and even fewer are able to sustain a profit for an extended period of time. So where Clinuvel has done this for over a decade, it's truly a remarkable outcome. In turning forward to our revenues specifically, we saw our revenues from sales increase by 4% from the prior period to just under $37 million. As I mentioned before, this is our highest first half year sales results we've ever seen. This reflects the increasing and continued demand for Cines right across our sales regions. In particular, we saw strong growth in volume of sales across Europe. And as we announced in September 2025, The approval by the EMA, lifting the number of maximum implants per year from four to six, has already seen some of the patients take up that extra initiative, and we expect other patients to follow suit as well. In the US, our team, led by Linda, has been able to increase the number of sites to meet the target that we had for December, which was 120 sites across North America. The patient demand has been consistent throughout the period, and our US team operates extremely well, given the evolving US medical reimbursement landscape that is constantly changing at the moment. Passed at this point, Linda, as our Head of Director of North American Operations, I might ask you, could you provide some insight to the people listening in around the US reimbursement process and in particular the prior authorisation scheme that enables us to have such a high success rate of reimbursement?

Linda, we can't hear you well Linda, we can't hear you Can you hear me now? No, it's a bit muffled Go off the headphones if you can Is that better? No

Not really. Better?

Can you hear me now?

Yeah, much better. Okay, let's move on.

Yeah.

Can you not hear me?

Yes. Okay. Yeah.

Can you hear me now?

Yes, please proceed.

Yes. Yes?

Yes.

Okay. So, all right. So, we're going to continue with what Peter said about prior authorization. So, in short, basically, prior authorization is a way for health insurance companies to control their costs by making sure that they are only paying for treatments that are medically necessary for their patients. And so because CNET is the only FDA-approved treatment for EPP, it has a strong and also a long-standing safety record. We haven't seen any prior authorization denials for the EPP patients. And we also have a dedicated in-house team that works very closely with the physicians to really streamline the submissions and also speed up the approvals. And for CNET, Most of our PAs that are already approved, they are only renewed annually. So there really is minimal paperwork for the physicians, and so they don't have to get approval for every single treatment they need. And for those that are familiar with the U.S. healthcare system, you might notice that our approach is very unique. You know, most high-cost drugs, they go through the middleman or the pharmacy benefit managers, or we call them the PBAs. and they usually drive up prices up even more. So we made that deliberate decision to avoid the PBMs. And I think that is moving like a smart move, especially now because the government is increasingly the scrutiny of them. And we sent the 2026 consolidated appropriations act, which has really signed into law a few weeks ago, including the provisions aimed at the PBM industry. And after the patient, the feedback has been consistently positive. And I think the reason for the continued treatment year after year is because they are seeing real clinical benefits. And we even saw some patients are increasing their treatment dose, you know, within the year, you know, because of the clinical benefits. And I do want to be clear that we don't pay physicians or patients for any testimonials. Everything is completely organic. You know, the feedback from the patients are voluntary and genuine, and usually they do share it more with them, either within their patient communities or directly with my team. So I hope this gives you some insight into our prior office process. Peter, I'm back to you.

You're on silent, Peter.

Thank you, Linda. As we look forward to the other areas of revenue for the period, our interest income was up to $5.3 million this period, which was a 14% increase on the prior year. And this was really the result of a larger cash reserves balance that we continued to maintain. We generally take our surplus funds that we have at the time and invest them into term deposits to help to build and grow on that balance. and at the moment we're extending the length of our term deposits to be able to take longer term maturities at higher yields. So we're seeing our average term deposit for about 300 days at the moment and we're receiving an average yield of about 4.5% across the portfolio. Our other income, now this number has swung the other way from the prior period and it's a difference of about $4.6 million. Now, just to explain, this is an unrealised foreign currency translation that occurs each balance date, so each reporting date. It's really a non-cash transaction that's effective at balance date for accounting purposes and it takes the process of taking all of our foreign currency balances and bringing them back to account at balance date into Australian dollars. So it's not a real loss, it's an unrealised loss, just purely to be able to balance the books at balance day. So if we look at our revenues overall, I would mark them as being stable, growing and also consistent. Historically, our second half of our financial period generally tends to be proportionately higher from a revenue perspective. with the EU and US summers coming into effect through that second half of the year. So we're really excited to see how the second half of the year plays out, given we've still got that maintaining growth. Perhaps moving to expenses, Mel, now more specifically.

Mel?

So we saw a 16% increase in our personnel expenditure and I'd just like to provide some context around that for everyone to understand. This is a strategic part of our expansionary team and increase in the in-house capability of Klingerville. It provides greater control and oversight of our activities but at the same time we're upgrading the skill and expertise within our organisation. Now as everyone will know skill and expertise within the life sciences sector is really important and recently we've seen regulatory challenges and hurdles that some other life sciences and biotech companies have faced in just recent times. So this highlights the need to really develop and create the skill and expertise within that team and make sure we've got the right people around the decision making process. Now when we look at Clinuvel, Clinuvel's never had a market authorization knockback in over 20 years of being active in the pharmaceutical sector. Now if that was to occur in some shape or form, a regulatory rejection of some sort can really have a significant effect on an organization. It erodes shareholder and market confidence in the company. It raises doubts around management's decision making and assessment of processes and events. It can push commercialization timeframes back up to three years, as seen in some of our peers, where another study or more data may need to be gathered before a resubmission can take place. and clinical trial designs and endpoints around the quality of data may suit one region which brings in revenue, but not always both regions to bring in revenue across the globe. And this can really affect the total revenue pie that's available from the advancement and the approval. Our people are really critical to the process and in plotting the path forward, we're really confident that they'll be able to obtain the right outcome around our clinical programs. In turning specifically to our clinical and non-clinical expenditure, the expansion of our CUV 105 expenditures was somewhat offset by the orderly wind down of some of our earlier phase programs. We've reallocated and focused our resources towards our later stage and strategically significant programs aimed at achieving the nearest term commercial results and prospects we can. Preparation for CUV107 has already commenced and is well underway, and we'll start to see those expenditures flow through in the second half of the year also. Commercial distribution, if we look at that area, that was up 42%, but this is predominantly off the back of increased volumes of shipments, particularly in Europe, as I touched on before. So it's all increased proportionately. There has been some temporary one off costs that have been associated with some transitions that we've made in our supply chain to some of our warehouse providers to ensure the long term stability of that supply chain, as well as being able to scale with us for the future. The other area that is somewhat affecting the commercial distribution area is also some of our regulatory fees. Previously, we used to sit under an SME discounted scheme in some of those regions for the FDA and EMA annual fees. And now that our revenues have increased to the point that they are, we're no longer eligible for some of those discounts, so we're having to pay full annual service fees now to those organisations, which is also increasing the expenditure in that area. The next area to touch on is really finance, corporate and legal. Now, this did increase proportionately from the prior year to up 47%. And really, this is the direct cost of a lot of it is being our ADR program uplift from Level 1 to Level 2, that I'm sure you're all aware of, as we uplist that program for the US to list on NASDAQ. There's been a substantial amount of work undertaken across that area by the finance team, but also in conjunction with our accountants, auditors and legal firms, both here in Australia and in the US. And this process we had to go through undertook a three-year re-audit of all of our financials into US GAAP, converted into US GAAP financial presentation, and then that was submitted to the SEC for review. Our other expenses, that's up 191%, and it's predominantly driven by the increase in our R&D programs and all the consumable materials that we use within those programs, whether it be ACTH, Pronumbra, or Nurectal, any of those developments. Our non-cash expenditure was down for the period, This is usually a change in our inventories, in our balance sheet differences from period to period. That's really what reflects quite a bit of that expenditure. This period, that's a lower number than it was previously because we've actually increased our manufacturing during the period, so therefore there hasn't been as low a drop in our inventories. It's stayed more on par. Our share-based payments have also been much lower this period than in previous years and we recently changed our share plan at the start of 2025 which meant that the expenditures will now appear differently but also that it's now a one-year plan instead of a three-year plan. Now I've spoken fairly at length around all of the expansionary activities that we're undertaking and some of the critical advancements to our program But this expanding expenditure should really be seen as an investment in the organisation rather than just being pure expenditure. So from a financial perspective, it does take time to build up these resources internally, but it is cheaper than outsourcing to a CRO. CROs can add 25% or more costs to the bottom lines of a clinical trial program. But by having that skill and expertise in-house, it's critically important for us to maintain that control and oversight of the program. We've got Emily Rottenberger on the call, who's our Director of Global Clinical Affairs. Emily, in speaking around our expansionary activities and what's been undertaken, I guess, would you be able to provide some insight into why that was necessary and what are the specific advantages of doing them in-house?

Yes, absolutely, Peter. I can give some additional context to the numbers. So first of all, good morning, good afternoon, good evening, everyone. It's good to be here. In my capacity as Director of Clinical Affairs, I really think more on the deliverable and how to achieve them, but it certainly ultimately impacts the numbers we report. Clinical expansionary activities are to fault its talent growth and building the infrastructure into which the talents operate. As Peter mentioned, the company has taken a conscious decision to build our capabilities in-house, which is not the norm in our industry where most are relying on outsourcing their studies. We have chosen not to rely on these models and not to work with CROs. It increases costs and can result in loss of control and oversight over studies and data. In order to deliver the CV105 study, we had to invest in new talents and these professionals will be retained through the CV107 and beyond. Currently, the clinical affairs department that I lead is the largest department in the company spread across UK and US with a great range of expertise, operations, data science with data management and statistics, medical affairs and clinical quality. In addition to bringing new talents in, we have also trained and upskilled existing talent. building and retaining the expertise in-house. And again, I repeat what Peter said, it's really critical for the health of our business. In terms of infrastructure, it's really the processes and the systems, and we've also been investing in this. This investment will continue further for us to be able to manage a significant data set that are coming from the vitiligo studies and deliver efficiently on a steady. So when we build in-house, we're both supporting the present and investing for the future. I mentioned the talents, the expertise, ownership, processes and systems. They can be seen as a platform asset that is transferable to any studies and programs that we will be conducting in the future. So in a way, we're building a CRO in-house.

Excellent. Thank you, Emily. In turning to our balance sheet, Malcolm, If we look at our balance sheet, it keeps going year by year from strength to strength. As I touched on, our cash reserves increased by $9 million to just under $233 million, and it's the highest cash balance we've had in the company's history. Our net assets have also increased by $8.2 million to just under $250 million, which again is the strongest point in the company's history. and we remain debt-free for the 21st consecutive year with no equity dilution since May, March of 2016. A strong balance sheet with positive net cash flows is really a strategic priority for Clinuvel as it enables us to see clinical programs through to commercialization without any additional funding required. It also provides resilience for any unforeseen events or economic uncertainty, particularly in the current geopolitical times. It provides flexibility to ensure expansionary opportunities, acquisitions or investments that align with our objectives can be taken advantage of, which many peers in the industry aren't able to consider without having to raise additional capital. It also enables strategic objectives to be delivered such as the expansion of our Singapore Research and Development Facility which we've slated for over the next five years to provide vertical integration of ongoing peptide and formula development and innovation. A number of our peers have recently announced capital raisings, some as much as at a 45% discount to market, to fund these sorts of activities that we can take on and that we can develop without having to raise any further capital. Some of these peers are raising for clinical program developments, for raw material supplier scale-up, or for product roll-out into a new jurisdiction. As already touched on CUV is funded for our full clinical trial program for vitiligo.

Thanks Peter. I mean that was a comprehensive overview I must say but I'd like now to move to strategy and mention and share with you that a number of institutions particularly in the US have asked us why Clingerville stands out in its strategy. They even ask, are we a bit dogmatic and a bit rigid in our strategic focus and execution? Philippe, can you comment on this?

Well, I pick up the two words, dogmatic and rigid. The contrary. We've built in the flexibility and optionality in this business model. And that allows us to navigate markets and cycles in pharma. but the objectives are really clear that fivefold. We need to expand the EPP commercial markets, advance the vitiligo programs as a focal point of the company, Advanced New Actel Dossier which is a large opportunity in the use of ACTH in a number of indications. Advanced Photocosmetics and bring in-house the manufacturing of the new and next formulation. So, you know, in any given business model there are a number of options. We can serially raise funds like most of our peers We can change the business strategy altogether, step away from Milan importance and do something totally different. We can self-fund the program, studying regularly as we've done. And the fourth option is you can seize operations and say, listen, ladies and gentlemen, it's too difficult, it's too hard, and let's give the cash back to the shareholders. And we haven't chosen that because we believe that There are a number of opportunities that we worked on for decades that are worthwhile pursuing. And there are a number of underlying assumptions that a board and management take into account that we are privy to and no one else is. And first of all is, are we conducting an honest, genuine business? No one is implicated in fraudulent activities. Do we keep the teams in check? Do we have technologies that are safe and work? And third of all, do the investors have the patience to see out the strategies? But the most important underlying assumption is whether there is perpetual funds available for this company. We've come to the conclusion that this model is very appropriate for the way we need to reach the vitiligo and ACTH markets. So in summary, Malcolm, we needed to accumulate these funds to execute a program which we all believe will lead to a sustainable multi-billion dollar enterprise. But we also need to be conscious of the realistic risks that evolve around clinical, regulatory and execution. And for that you need to have optionality and optionality is cash. And that will eventually lead to a diversified company. So that's how the company stands out.

Thanks Philippe. So moving to another area where we've had numerous questions and this is on the readout of Vitiligo and Emily it's good to have you here and this is where you come in. What can you tell us about the regulatory process and path to market on Vitiligo?

Thank you Malcolm. I will address your question by providing a number of Specific observations that support the regulatory process and pass to market for CNS in vitiligo. Some of these observations are unique to CNS and some you might also be familiar with, but allow me to go through them. The first one is CNS is already on the market for another indication, EPP. It's a product for which we have accumulated two and a half decades of safety data and a safety profile that has been maintained over time. The regulatory agencies know the product well from the annual reports of regulatory and pharmacovigilance teams are and have submitted for one decade now. In regards to vitiligo, vitiligo is a condition with visible symptomatology, and the treatment effect that we desire is visible. So from the cases we receive and cases published by physicians, one can gain much confidence that the effects of the treatment are visible. From an operational point of view, the trials can't be blinded. The drug either works or not. And physicians and patients can see the effects very quickly. The visible efficacy. So what I'm trying to say here is that in vitilego the photographs do not lie. and part of the analysis is to have centrally assessed photographs up to 32 per patient which is up to 6000 assessments. Very importantly as well is the patient experience and how they appreciate the return of their pigments. JAK inhibitors, some currently in phase 3, One recently submitted to the EMA and FDA for marketing approval. They take a long time to work, thereby suppressing the immune system. And last but not least, we are living in a very dynamic regulatory landscape where the concept of generating clinical evidence is evolving. EMA speaks about totality of evidence for drug approval while as I'm sure you've seen the FDA recently announced that single trial will now be the default for drug approval. So what I really wanted to convey by all of this is that these are positive considerations for CNS to come to market for vitiligo as we are continuing on the same trajectory. I can't tell you exactly when, but for sure vitiligo is the natural home for alpha melanotide, a pigment activating peptide, which is an analogue of an hormone that's naturally produced by our own body. Thanks Malcolm.

Thanks Emily. So before we go to analyst questions, all stakeholders want to know what's next. Philippe, can you summarise that for us please?

Sure. So there are a number of catalysts that we're approaching over the next two years. The most immediate ones are the top-line results from Vitiligo CEV105 in the second half of 2026, the start of the Vitiligo CEV107 study, the preclinical results on the peptide formulation in the latter half of this year,

and the listing of the achieving the nearest term commercial results and prospects we can. Preparation for CUV107 has already commenced and is well underway, and we'll start to see those expenditures flow through in the second half of the year also. Commercial distribution, if we look at that area, that was up 42%, but this is predominantly off the back of increased volumes of shipments, particularly in Europe, as I touched on before, So it's all increased proportionately. There has been some temporary one off costs that have been associated with some transitions that we've made in our supply chain to some of our warehouse providers to ensure the long term stability of that supply chain, as well as being able to scale with us for the future. The other area that that is somewhat affecting the commercial distribution area is also some of our regulatory fees. Previously we used to sit under an SME discounted scheme in some of those regions for the FDA and EMA annual fees and now that our revenues have increased to the point that they are, we're no longer eligible for some of those discounts so we're having to pay full annual service fees now to those organisations which is also increasing the expenditure in that area. The next area to touch on is really finance, corporate and legal. Now, this did increase proportionately from the prior year to up 47%. And really, this is the direct cost of a lot of it is being our ADR program uplift from level one to level two that I'm sure you're all aware of as we uplist that program for the US to list on NASDAQ. There's been a substantial amount of work undertaken across that area by the finance team, but also in conjunction with our accountants, auditors, and legal firms, both here in Australia and in the US. And this process we had to go through undertook a three-year re-audit of all of our financials into US GAAP, converted into US GAAP financial presentation, and then that was submitted to the SEC for review. Our other expenses, that's up 191%, and it's predominantly driven by the increase in our R&D programs and all the consumable materials that we use within those programs, whether it be ACTH, Pronumbra, or Nurectal, any of those developments. Our non-cash expenditure was down for the period, This is usually a change in our inventories, in our balance sheet differences from period to period. That's really what reflects quite a bit of that expenditure. This period, that's a lower number than it was previously because we've actually increased our manufacturing during the period, so therefore there hasn't been as low a drop in our inventories. It's stayed more on par. Our share-based payments have also been much lower this period than in previous years and we recently changed our share plan at the start of 2025 which meant that the expenditures will now appear differently but also that it's now a one-year plan instead of a three-year plan. Now spoken fairly at length around all of the expansionary activities that we're undertaking and some of the critical advancements to our program But this expanding expenditure should really be seen as an investment in the organization rather than just being pure expenditure. So from a financial perspective, it does take time to build up these resources internally, but it is cheaper than outsourcing to a CRO. CROs can add 25% or more costs to the bottom lines of the clinical trial program. But by having that skill and expertise in-house, it's critically important for us to maintain that control and oversight of the program. We've got Emily Rottenberger on the call, who's our Director of Global Clinical Affairs. Emily, in speaking around our expansionary activities and what's been undertaken, I guess, would you be able to provide some insight into why that was necessary and what are the specific advantages of doing them in-house?

Yes. Absolutely, Peter. I can give some additional context to the numbers. So first of all, good morning, good afternoon, good evening, everyone. It's good to be here. In my capacity as Director of Clinical Affairs, I really think more on the deliverable and how to achieve them, but it certainly ultimately impacts the numbers we report. So clinical expansionary activities are to fold its talent growth and building the infrastructure into which the talents operate. As Peter mentioned, the company has taken a conscious decision to build our capabilities in-house, which is not the norm in our industry where most are relying on outsourcing their studies. We have chosen not to rely on these models and not to work with CROs. It increases costs and can result in loss of control and oversight over studies and data. In order to deliver the CV105 study, we had to invest in new talents and these professionals will be retained through the CV107 and beyond. Currently, the clinical affairs department that I lead is the largest department in the company spread across UK and US with a great range of expertise, operations, data science with data management and statistics, medical affairs and clinical quality. In addition to bringing new talents in, we have also trained and upskilled existing talents. So building and retaining the expertise in-house. And again, I repeat what Peter said, it's really critical for the health of our business. In terms of infrastructure, it's really the processes and the systems, and we've also been investing in this. This investment will continue further for us to be able to manage a significant data set that are coming from the vitiligo studies and deliver efficiently on a study. So when we build in-house, we both supporting the present and investing for the future. I mentioned the talents, the expertise, ownership, processes and systems. They can be seen as a platform assets that is transferable to any studies and programs that we will be conducting in the future. So in a way, we're building a CRO in-house.

Excellent. Thank you, Emily. In turning to our balance sheet, Malcolm, if we look at our balance sheet, it keeps going year by year from strength to strength. As I touched on, our cash reserves increased by $9 million to just under $233 million, and it's the highest cash balance we've had in the company's history. Our net assets have also increased by 8.2 million to just under 250 million, which again is the strongest point in the company's history. And we remain debt free for the 21st consecutive year with no equity dilution since May, March of 2016. A strong balance sheet with positive net cash flows is really a strategic priority for Clinuvel. as it enables us to see clinical programs through to commercialization without any additional funding required. It also provides resilience for any unforeseen events or economic uncertainty, particularly in the current geopolitical times. that provides flexibility to ensure expansionary opportunities, acquisitions or investments that align with our objectives can be taken advantage of, which many peers in the industry aren't able to consider without having to raise additional capital. It also enables strategic objectives to be delivered such as the expansion of our Singapore Research and Development Facility which we've slated for over the next five years to provide vertical integration of ongoing peptide and formula development and innovation. A number of our peers have recently announced capital raisings some as much as at a 45% discount to market to fund these sorts of activities that we can take on and that we can develop without having to raise any further capital. Some of these peers are raising for clinical program developments, for raw material supplier scale-up, or for product rollout into a new jurisdiction. As I've already touched on, CUV is funded for our full clinical trial program for vitiligo.

Thanks, Peter. I mean, that was a comprehensive overview, I must say, but I'd like now to move to strategy and mention and share with you that a number of institutions, particularly in the US, have asked us why Cliniavel stands out in its strategy. They even ask, are we a bit dogmatic and a bit rigid in our strategic focus and execution? Philippe, can you comment on this?

Well, I pick up the two words, dogmatic and rigid. The contrary. We've built in the flexibility and optionality in this business model. And that allows us to navigate markets and cycles in pharma. But the objectives are really clear, they're fivefold. We need to expand the EPP commercial markets, advance the vitiligo programs as a focal point of the company, advance to the New York TEL dossier, which is a large opportunity in the use of ACTH in a number of indications, advance photocosmetics, and bring in-house the manufacturing of the new and next formulation. So, in any given business model, there are a number of options. We can serially raise funds like most of our peers, We can change the business strategy altogether, step away from midland quarters and do something totally different. We can self-fund the program steadily and gradually as we've done. And the fourth option is you can seize operations and say, ladies and gentlemen, it's too difficult, it's too hard, and let's give the cash back to the shareholders. And we haven't chosen that because we believe that There are a number of opportunities that we worked on for decades that are worthwhile pursuing. And there are a number of underlying assumptions that a board and management take into account that we are privy to and no one else is. And first of all is, are we conducting an honest, genuine business? No one implicated in fraudulent activities. Do we keep the teams in check? Do we have technologies that are safe and work? And third of all, do the investors have the patience to see out the strategies? But the most important underlying assumption is whether there is perpetual funds available for this company. And we've come to the conclusion that this model is very appropriate for the way we need to reach the vitiligo and ACH markets. So in summary, Malcolm, we needed to accumulate these funds to execute a program which we all believe will lead to a sustainable multi-billion dollar enterprise. But we also need to be conscious of the realistic risks that evolve around clinical regulatory and execution and for that you need to have optionality and optionality is cash. And that will eventually lead to a diversified company. So that's how the company stands out.

Thanks Philippe. So moving to another area where we've had numerous questions and this is on the readout of Vitiligo and Emily it's good to have you here and this is where you come in. What can you tell us about the regulatory process and path to market on Vitiligo?

Thank you Malcolm. I will address your question by providing a number of Specific observations that support the regulatory process and path to market for CNS in vitiligo. Some of these observations are unique to CNS and some you might also be familiar with, but allow me to go through them. The first one is CNS is already on the market for another indication, EPP. It's a product for which we have accumulated two and a half decades of safety data and safety profile that has been maintained over time. The regulatory agencies know the product well from the annual reports of regulatory and pharmacovigilance teams are and have submitted for one decade now. In regards to vitiligo, vitiligo is a condition with visible symptomatology. And the treatment effect that we desire, representation, is visible. So from the cases we receive and cases published by physicians, one can gain much confidence. The effects of the treatment are visible. From an operational point of view, the trials can't be blinded. The drug either works or not. And physician and patient can see the effect very quickly. It's a visible efficacy. So what I'm trying to say here is that in vitiligo, the photographs do not lie. And part of the analysis is to have centrally assessed photographs. up to 32 per patient, which is up to 6,000 assessments. Very importantly as well is the patient experience and how they appreciate the return of their pigments. JAK inhibitors, some currently in phase three, one recently submitted to the EMA and FDA for marketing approval. They take a long time to work thereby suppressing the immune system. And last but not least, we are living in a very dynamic regulatory landscape where the concept of generating clinical evidence is evolving. EMA speaks about totality of evidence for drug approval while as I'm sure you've seen the FDA recently announced that single trial will now be the default for drug approval. So what I really wanted to convey by all of this is that these are positive considerations for CNES to come to market for vitiligo as we are continuing on the same trajectory. I can't tell you exactly when, But for sure, vitiligo is the natural home for alpha melanotide, a pigment activating peptide, which is an analogue of an hormone that's naturally produced by our own body. Thanks, Malcolm.

Thanks, Emily. So before we go to analyst questions, all stakeholders want to know what's next. Philippe, can you summarise that for us, please?

Sure. So there are a number of catalysts that we're approaching. over the next two years. The most immediate ones are the top-line results from Vitiligo CEV105 in the second half of 2026, the start of the Vitiligo CEV107 study, the preclinical results on the peptide formulation the latter half of this year, and the listing of the ADRs on Nasdaq that we await the SEC answers from. So the catalyst will naturally change the complexion of the company. And this is exciting. And we've navigated the waters over time to arrive at this point. And so we all need to bear patients and see what the impacts are from these results. So there's much to look forward to. Yeah.

Indeed. Thank you, Philippe. So let's go to analyst questions. But thank you, Peter, Emily, Linda, Philippe for the discussion. Some good insightful comments there. And I hope those on the line also have got some insights and appreciate that. The first analyst to ask a question is Dr. David Stanton of Jefferies. Hello, David. Are you there? I am. Can you hear me? Yes, David. Please go ahead. Thank you. So my question is, do you have to wait until you have the results of CUV 105 and CUV 107 before you file for approval in Vitiligo? And which geography would you file in first and why, please?

I'm going to take this question, Malcolm.

Okay.

It's a good follow-up and... from what I was mentioning a couple of minutes ago. So thank you, Dr. Stanton, for this question, question that's relevant and often asked. Our intention is to complete CV105 and CV107 before going to the EMA and FDA. And the recent announcement on single trial for drug approval from the FDA doesn't change this strategy. So based on the ongoing interactions we have, with both agencies, EMA and FDA, on the specificity of our work that we are conducting. We will need the CV107 study to complete our program. For the second part of the question, we opt to file with the EMA first and then FDA second. And this strategy really much follows the approach we had with EPP back in 2012. Thank you. Now, I want to say more. I think it's important for me when we speak about regulatory agencies, I want to give a bit more color. An agency, as you know, is a conglomerate of thousands of people. So at the EMA in Amsterdam, there are more than 1,000 permanent staff and more than 4,000 part-timers and experts. We are dealing with two European reporters that are representing their national competent authorities, which are Lithuania and Poland, with a scientific advisor representing the Scientific Advice Working Party, a very knowledgeable German physician. At the FDA in Silver Spring, there are more than 8,000 permanent staff and another 6,000 elsewhere consultant part-timers. We interact with the Division of Dermatology and Dentistry, now led by Dr. Jean Lindstrom, in the Center of Drug Evaluation and Research. And we have a new commissioner, as you know, Dr. Marty Makary, who has reshuffled the agency, bringing new procedures and a new approach. In our EMA reporters, we find willing listeners and, may I say, more supportive of our regulatory and market strategy, We are the only company focusing on patients of darker skin color, and this point resonated very well in our recent discussions with the EMA. The approach we have on vitilego is so novel that we deem the European regulators to be the first port of call, and then it will make it easier for the FDA to assess similar data.

Okay, thanks, Emily. The next question is for or from Dr. Melissa Benson of Baron Joey. Hi, Melissa.

Hi, Malcolm. Hi, team. So I had a question in regards to the ACTH program, so Nuractel. Just to help us understand, you've mentioned there later this year you expect to file with EMA. A similar question to the lining of Vitiligo, but understand like how does filing with Europe first and then the FDA, how does that kind of expedite the U.S. opportunity? And then secondly, any color you can kind of provide on the differences, I guess, between the commercial landscape for a product like this in Europe versus the U.S. Because I understand, you know, one market is quite a synthetic peptide base and the other is a natural hormone base. So that would be great. Thanks.

Philippe, for you.

Thanks, Melissa. We talked about this in the past. Nurectil will first be filed in Europe through the route of mutual recognition. And as you know, the analogs of ASTH, in our case, Nurectil, are used by many institutions, both as a therapeutic and as a diagnostic. And so we opted to go to Europe first and US second. Once you're filed through the mutual recognition procedure, you can file shortly in the US after. ACTH products are mostly distributed to specialty centers in Europe. They prescribe an internal specialist, endocrinologist, and we believe that it's possible to make the first inroads directly to these centers in Europe. reimbursement in Europe is albeit lower than in the US. So both markets are sizable and are attractive, but we have experience in leveraging the European regulators and the resonance there is high. So it's a slightly different strategy than most of our competitors. But so far it worked.

Okay. Thanks, Philippe. We've just lost you on camera. So if you can try and get back to us, we'd like to continue to see you. Let's move to Dr. Thomas Schieschel of Parmentier in Germany. Thomas, you're a long way away, but let's hope you're connected. Hello Malcolm. Hi.

Wonderful to hear you. Good morning and good evening everybody on the phone. I would like to ask a question. What does the recent FDA decision on disc medicines by topatin mean for your business and growth outlook, please? Okay, Peter.

Sure. Yep, no problem. I can answer that one. So I guess thank you, Doctor, for your question. From a finance perspective, I'm happy to answer that. So I see it from a way of increasing our monopoly in the market with the other player obviously not being able to enter that market yet as we're really the only approved drug treatment for EPP with a proven safety and efficacy record in the U.S., So it could take them, I would estimate, about one to two years to come back or even longer to enter the European market. So it could be quite an extended period of time that we still maintain a monopoly within that market. So I guess that's how I see it, Doctor.

I'll come back to you, Thomas, to ask another question because we've covered that fairly succinctly. But I'd like Linda to make some comment because some shareholders have asked, what's our reaction to the FDA's decision on DISC? So can you make some comment on that, please, Linda?

Sure. First, can you hear me okay?

Yes.

Okay. Right. So first, you know, I definitely can't comment. However, I do prefer not to comment.