Welcome to Xspray press conference August 2026. For the first part of the presentation, participants will be in listen-only mode. During the questions- and- answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. If you are listening to the presentation via webcast, you can ask written questions using the form below. Now, I will hand the conference over to CEO Blake Leitch. Please go ahead. Good morning, investors and media, and thank you for the strong participation this morning. As mentioned, I am Blake Leitch, CEO of Xspray, and I thank Jacob and Sophia for helping to moderate today's call. Today, I am here to provide color to the CRL announced yesterday and help to answer questions you may have. Before I get into that, I just want to pause and step back. 20 years ago this summer, SPRYCEL was approved in America. SPRYCEL and dasatinib helped to turn a once life-changing condition into a manageable near life expectancy. Dasatinib remains today a key treatment option in leukemia. Last year alone, revenues of dasatinib were about $1.9 billion, and yet, the medical need for improved dasatinib after 20 years is clear. Dasynoc has demonstrated bioequivalence at 30% lower dose and is designed to enable concurrent use with acid-reducing medicines. This is an important benefit to certainly patients, nurses, and physicians. Our view of the Dasynoc and dasatinib landscape is unchanged. The CRL does not change our view of the potential of Dasynoc, certainly not of the HyNap platform technology, nor the commercial opportunity ahead. The remaining issue is still centered on the regulatory status at NerPharMa, which has been known to the market and is ultimately in the FDA's hands. But this is not a new fundamental problem. We have previously communicated that the approval of Dasynoc remains dependent on the resolution of the outstanding regulatory requirements related to NerPharMa, and that the timing of FDA processes cannot be controlled or guaranteed by Xspray. Now, in the Q2 report a couple of weeks ago, I outlined that this could be time- sensitive and tight ahead of the August 25th PDUFA date. Because we stated that the FDA could issue a CRL because of the inspection facility had not yet been completed, while a NerPharMa clearance during the autumn would likely be consistent with launch readiness. The additional batch data request that was received within the CRL is absolutely manageable in substance. We already believe that the submitted quality package is strong and within the FDA's expectations. What the FDA is asking for now is more commercial-scale evidence, which just means producing and documenting additional batches that were, in any case, part of our launch preparation. I also want to highlight what was not in the CRL, which is there were no questions that related to bioavailability, bioequivalence, stability, or pertaining to the risk of medication errors, as was evident in previous CRLs, which indicates that we have now resolved these lingering issues. This is not a product quality problem, and it does not change at all our clinical or commercial rationale. The benefits of Dasynoc are very strong, both in bioequivalence and with acid-reducing medicines. Today, we remain focused on the bigger vision, bringing improved PKI treatments to patients while preparing for a rapid launch once the remaining regulatory requirements are resolved. The batch work will be accelerated so that we can ensure that we are able to resubmit in 2026. We are ready to commercialize once we have clearance, and we have EVERSANA already at our side and ready to start our U.S. commercial operations and organizations once that occurs. Thank you. Those are my opening remarks. Sophia and Jacob, I'd like to open up to questions, please. If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Filip Einarsson from Redeye. Please go ahead. Hi, everybody. Thank you for taking a few of my questions. I want to start off on the batch data, and maybe if you could just clarify a little bit further what sort of data is it that has been requested and if it will require several batches? Thank you. What is requested is commercial scale consecutive batch data. As we are preparing for commercial launch, this was obviously within our anticipated development plans this fall. The request is not surprising for us, and whilst we do have plans to provide these commercial batches, we will now evaluate how we can accelerate that together with our partner to ensure that we can develop the resubmission as quickly as possible. Right. A follow-up there would be, do we have any sort of estimate of how long that process would be from where you stand right now to produce these batches that would be required? At the current moment, we are working with our partners at NerPharMa. I can assure you and the market that we have an expedited timeframe already now under development, and we will aim to complete this as soon as possible in the coming weeks. Okay. The next one then, maybe if you could clarify the issues that have been resolved in this CRL compared to the last to be very clear. One of the major questions that was provided in a previous CRL related to the risk of medication error. That has been substantially now addressed through our resubmission in February and does no longer feature in the discussion with the FDA as outlined in this CRL. Okay, good. The last one from me. With this extended timeline, should we expect a down prioritization of XS008 and XS025 to further serve the cash runway? Any comment on that? Well, thank you, and it's a good point. Indeed, yes. I think our resources will be focused to ensure that we realize the launch of our two products that are currently undergoing FDA review, that being Dasynoc and Nilopki. At the same time, we need to balance that with our commercial readiness, and we will continue to be vigilant in our capital expenditure to focus on driving forward the portfolio and ensuring that we are commercially ready so that we are not delayed upon commercial launch. Okay. Thank you. All from me. Thank you. As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. There are no more phone questions at this time, so I hand the conference back to the speakers for any written questions or closing comments. Thank you, Sophia. This is Jacob. I have the written questions in front of me. There are a number of questions, and some of them are quite long and some cover the same topics that we already touched upon. I will try to do my best to extract the parts that we did not already cover. Blake, Tomas Blad has posted a number of questions concerning the batch manufacture, and just to clarify, one of the questions is, did you already manufacture batches, or is this something that we need to do from scratch with NerPharMa? Jacob, thank you. W hes tha e have produced multiple batches through the course of the development of Dasynoc. In fact, we also, as part of our resubmission in February, appended five batches were developed post the implementation of our corrective actions. The development now of new batches or the request for new batches and consecutive commercial scale batches, which is really what the FDA is asking for, is within our operating plan already, and we will continue to accelerate and ensure that we develop these as we move forward quickly. There is also a detailed question here about the timing that might have some value. Were commercial scale batches manufactured after the CAPA activities were completed as part of NerPharMa's remediation plan before the CRL was received? No. The answer to that is no, they were not. No. They have not been. That's why we have that activity already planned for within our commercial scale-up activities. Yeah, I see. Over to NerPharMa. Tomas Blad again has a question whether we anticipate FDA, that they will need to conduct a new inspection, or is it possible that they could resolve it based on the documentation and commercial batch data? He doesn't mention the previous AIFA inspection, but I suppose that is also included in the alternatives. Can you shed some light on what we know about that? Yeah. At this point, we are anticipating a response and still a decision from the FDA as it relates to the OAI status at NerPharMa. That decision is within the FDA's purview to make. As you indicated, AIFA had completed an inspection earlier this year in May, in fact, with an outcome that was positive as our partners at Benta Group and NerPharMa have communicated to us, and I've communicated previously to the market. At this point, we are waiting for the FDA's decision on whether or not they require an additional inspection and/or if they would rely on the information that potentially would be provided from a mutual recognition route, b ut at this point, I don't want to speculate on timing or certainly the FDA's decision that they would make. Yes. I understand. And timing is, of course, an issue that concerns many of the people asking questions. There is one also wanting to specify, assuming the required commercial batches can be manufactured without issues, what is your current realistic timeline for submitting the response to FDA? What do we say about that? Well, I can certainly say that we expect to resolve this batch data question and work stream within the coming weeks, and that we anticipate resubmitting in 2026. Yes. Also, same person asking, he made the observation that the previous CRL for Nilopki also requested additional information from commercial scale manufacturing. How do those two relate to each other, I think is the question. To what extent can those be coordinated or can they even be done simultaneously? It is important to note for all that we have the same factory that underpins both development programs. NerPharMa is our third-party contractor that is helping us to develop both Nilopki and Dasynoc. The opportunity in front of us for Dasynoc and the questions that were raised in the CRL relate to the Dasynoc dossier and are not linked to Nilopki. As you may recall, Nilopki has had different questions that were also, and are being addressed at this moment now. We, again, will be focusing our manufacturing activity in the coming weeks to satisfy our needs for commercial scale manufacturing of both products. Thank you. I think the questions that I have in front of me now are on the same topics. Give me just a brief moment to see time. Yes. We do have some questions from several people about financing. Is the current cash position sufficient to reach approval and launch? More specifically, there is a person asking whether we should anticipate a new share issue ahead of PDUFA dates upcoming for Dasynoc and Nilopki. What is your comment to that, Blake? Well, it is an important question, and I thank the person for submitting it. We have consistently communicated both in our recent quarterly reports and annual reports that our future capital requirements depend on several factors, including obviously our regulatory timelines, the launch timelines, the commercial uptake activities, and the development activities. Our cash position, as stated in the Q2 report, remains unchanged. What we will execute is enhanced and maintain our financial stewardship to balance the development requirements necessary and manufacturing requirements short term with maintaining our operational readiness for launch. We have also communicated that additional financing would be required to support our commercialization and launch planning. We continue to monitor this very closely and evaluate different financing alternatives, including the potential of any capital raise. We are pleased with the strong support that we have received from our major shareholders in previous financing and their ongoing and continuous support to our business and our development pathway. I would like to just add that the CRL today, as it relates to financing, it does not require a new development program. It means producing, testing, and compiling the quality review additional requirements needed in commercial scale batch data. Since these were already part of our launch preparation, the issue is manageable. Thank you, Jacob. Thank you, Blake. A lot of interest, a lot of questions. We have already covered several of them, and I am trying to orientate around this. We do get questions about whether we anticipate Class 1 or Class 2, meaning the timeline from resubmission to PDUFA date from the FDA, whether it will be two or six months. We have those questions. Would you like to respond to that, Blake? Obviously we're extremely keen to ensure that we have the shortest and the fastest route through to an approval for both Dasynoc and Nilopki. For Dasynoc, I don't want to speculate whether it would be a Class 1 or a Class 2 review. Our focus today is making sure that we deliver, analyze, and manufacture these consecutive commercial scale batches, do that quickly in partnership with the new owners at Benta and NerPharMa, and make sure that we are able to satisfy this additional data that the FDA has requested. Right. So, there are actually two questions here that I would have thought were covered, but they're quite important to have clarified. I think we should go over them again. One is that you said you plan to resubmit the NDA as soon as possible. But can you, and will you be able to file it before the status of the NerPharMa facility and the clearance of the GMP issues have been resolved? Maybe you can start by clarifying the answer to that. Do we have to wait for the resolvement of the GMP issues at NerPharMa, or can we resubmit whilst that's still pending? I think the key point here is that the principal bottleneck remains NerPharMa's regulatory status, and we've communicated that before, and that's not directly within control of Xspray. What is in our control and what we will aggressively manage is the manufacturing of these consecutive commercial batches and their data packages that append them a nd that is what we're focusing on today. Yeah. So once that's done, we can resubmit the NDA without waiting for the GMP issues to be resolved. Right? We won't receive an approval until both items are satisfied. No, but the question is whether we can resubmit the application. The application will require both an approval from the FDA on NerPharMa, as well as the acceptance of the data that we're providing related to these additional consecutive commercial scale batches. Yes. Okay. Hunter Capital asks, "Are we looking at additional studies?" That one would be easy, I think. At this point, there is no requirement for any additional studies, as I mentioned on the contents of the CRL, or as it relates to the previous CRLs that we've also addressed. This question for additional studies actually is not something that we're looking at today. Yes. We also have from several angles, is it necessary or possible to change factory for third-party manufacturers? Second source manufacturing has been on our radar, Jacob and team, for quite some time. As you know, we had initiated work in a site in 2020. Every capital decision is measured against one question. Does this bring these two assets closer to approval or not? A new facility takes roughly 18 months or more to become operational. Funding that instead of funding launch readiness would push out a PDUFA date for both products, not in. It doesn't advance it. Our model has consistently sat somewhere between six or 12 months ahead of the next regulatory milestone. W e've been prioritizing appropriately the approval path before a parallel infrastructure development. That said, we do continuously review our supply chain on all aspects to ensure that we have the right operating model, the right redundancy moving forward. It's not an oversight. Right. I thank everyone for posting so many questions. I struggle, I admit a little bit, to make sure that nothing slips by. I think we covered the essence of what's being posted in the chat s o I think we can round up the question part, Blake. Okay. Thank you, Jacob. Thank you, Sophia. I would like to close by just reiterating the main point here, which is that this CRL does not change our view of Dasynoc, about HyNap or the commercial opportunity. Dasatinib is a nearly $2 billion U.S. market today. We are gating items that are in front of us related to NerPharMa's FDA status. The market knew, and we know that that was time- sensitive. The additional batch data request is manageable documentation, and it is a requirement that we expect to address as part of our launch preparation work, which is already underway. Later, in early October, I am pleased to also share with the community that I am planning an investor update presentation at a CML conference, which will be hosted in Gothenburg, the Goldman Conference, October 1st to the 3rd. Dates and details of that will follow as we confirm. In the meantime, I do look forward to your continued support and remain assured that we will continue to advance both Dasynoc and Nilopki in parallel and drive forward to unlock the potential in front of us. Thank you.