Perspective, having some great conversations across the board because of azer-cel's data strength, our off-the-shelf positioning, make-to-stock, and our regulatory readiness that we'll talk more about. So our FDA Type C meeting confirmed all these major elements required to move toward a pivotal program. This includes acceptance of third- line and later DLBCL, alignment on overall response rate with durability for accelerated approval, and PFS or progression-free survival for full approval. We're now preparing for a registrational study initiation in 2026. The strategic appeal of azer-cel. azer-cel really delivers what the field needs. It's got strong efficacy. It has clean safety, as you heard Leslie talk about, and it's got off-the-shelf scalability. And importantly, compared to autologous cell therapies, our allogeneic cell therapy, azer-cel, has lower cost of goods. That, when you really think about that commercial model, it pays dividends. It has the potential to expand CAR-T access to many more treatment centers and to patients who really can't access autologous products today. That makes azer-cel Imugene's product highly attractive from both a clinical and commercial perspective. Next slide. I'll just close here and say thanks for your time today. We're continuing to progress along this clear regulatory and commercial path supported by strong and durable clinical data. At this point, I'll turn it back over to Sally. Thank you, Brad. Now, before we dive into more details and we've got some questions coming from shareholders, can you briefly, Leslie, please summarize what this FDA guidance means for shareholders? Great. T hank you, Sally. T his is obviously a significant milestone in Imugene's history. The FDA has provided guidance and support of our pivotal strategy, our phase III study design. T hat means we can skip phase II. We can go right into phase III from a phase IB to phase III. So that's quite significant. We have a targeted patient population currently with the third-line plus patients in diffuse large B-cell lymphoma. We received confirmation that with only one study, we could possibly receive an accelerated approval with overall response rate and durability, and then a full approval with progression-free survival, all in just one study. This eliminates the biggest risk in biotech development, really, in that regulatory uncertainty. We have absolute certainty now, and we have a clear pathway to bring azer-cel to market. Thanks, Leslie. Brad, can you add to Leslie's comments? Sure. t he level of FDA endorsement we received is, from my perspective, exceptionally rare in biotechnology. The minutes from the meeting were really overwhelmingly positive and validated every critical component from our dosing regimen to patient population endpoints and manufacturing readiness. This moves Imugene from, I would say, from promising science to really laying out a clear commercial pathway down the road. This is good news for science and good news for shareholders, and importantly, good news for patients. Thank you, Brad. Now, Leslie, can you explain a little bit more for us what makes this FDA guidance so directional compared to other or typical regulatory interactions? I can tell you from my personal experience having had FDA meetings Type Bs and Type Cs prior to Imugene, and it speaks to the strength of Imugene's team. They have put a beautiful briefing document together so that they basically made the job of FDA quite easy. So the data was there that they generated. The experience of the team really shined through. And getting an FDA guidance this clear and this easy is quite unusual. I've not had it until we've had this meeting with Imugene. So it's really, I just want to congratulate my team, the ability to author the briefing document, the ability to generate the data, and their preparation really shined through. So I think it is important to get FDA guidance all the way. They're the major agency of the land. So, getting their approval, getting that interaction is quite. It makes going to a pivotal study seamless, and so I think it's quite important for any company to get FDA guidance, especially about a pivotal registrational strategy. Thanks, Leslie. Brad, would you like to add to that? T hat's well said, Leslie. And I think that a lot of companies, unfortunately, walk into FDA meetings finding out something they didn't know. And the FDA lets them know, "Didn't you read our guidance, our published guidance, our draft guidance, our recommendation?" S o then there's a dialogue about how long is it going to take to get the data? Do we have the data? I think this is an example where the leadership at Imugene, the awareness of FDA expectations, where we really measure twice to cut once. W e walked into the meeting having submitted a briefing book that had spot-on questions. We got responses, and then the team really delivered. And it's not just the questions that we asked. I n the briefing book, when they had questions, we had data sets prepared to really address that. I think that just, as Leslie mentioned, shows the experience of the team in really being ready and prepared. Thank you, Brad. On that note, after this meeting, Brad, can you explain a little bit more about how our clinical results support the regulatory pathway moving forward? Our clinical data really does provide a compelling validation of the FDA's confidence in us. I mean, we're seeing 82% overall response rates in DLBCL in these patients where all other treatments, unfortunately, have failed them, including autologous CAR-T therapies. For example, the first patient that we dosed in 2024 remains cancer-free after 19 months. These results in end-stage patients demonstrate azer-cel's potential to address the highest unmet medical need. Thank you, Brad. And I think we saw in Leslie's slides there how powerful that information was. Leslie, can you explain to us what this means then for azer-cel's commercial potential? Sure. W e're now positioned to capture significant market share in that multi-billion dollar CAR-T space. There are no current allogeneic CAR-Ts approved, so that's well positioned as well. Our target population currently is third-line plus DLBCL patients, which represents a massive unmet need with limited treatment options. As Brad mentioned, we have patients who have failed off of all prior therapies prior to coming on to our study and seeing a level of response rate. The FDA's validation of our off-the-shelf first-in-class allogeneic approach addresses every major limitation of current autologous CAR-Ts in terms of location, time it takes to manufacture. So this could potentially deliver better efficacy and better time and better location. So I'm thrilled. Thanks, Leslie. Brad, the FDA also validated your manufacturing program. So what does this mean operationally? T his is a crucial validation that we can, from their perspective, we can reliably produce azer-cel at commercial scale. The FDA confirmed that our Chemistry, Manufacturing and Controls, or CMC program, is registration-ready with only a few late-stage refinements needed. A lot of times companies walk in and CMC is always an Achilles heel. Not in this case. I think that just reflects the strength of our CMC team. That's a really good update, Brad. So Leslie, how does this change the drug development and regulatory risk profile? It's quite clear. We've moved from just promising science now to a clear path to market, which makes us very attractive in so many different ways. The biggest uncertainty in biotech drug development is the ambiguity of what the agency may or may not say. Now we have lessened that risk. This is dramatically reduced with our Type C meeting. We have now two pathways to approval: the accelerated approval for faster market entry, as well as the full approval for long-term commercial success. Thank you, Leslie. I'll move now on to talk about this commercial readiness. We've got lots of questions coming through on the Q&A around this commercial readiness. So Brad, the guidance represents a fundamental shift, as Leslie said, from promising science to a clear path to market. So fundamental shift from clinical stage to near commercial readiness. How should shareholders think about the valuation implications of this regulatory de-risking, a nd what does this mean for Imugene's positioning relative to other CAR-T companies in the market? That's a long question. All right. Sorry, Brad. That's no problem. I think this FDA validation, I mean, fundamentally changes, from my perspective, the risk-reward profile, and it should be reflected in how the market values Imugene. W e've moved from, say, more of an early-stage clinical biotech with regulatory uncertainty to now a company with a product that's matriculating through the pipeline and through the regulatory gates, with the FDA endorsing the strategy and the execution, so when you compare our valuation to other CAR-T companies that have achieved similar regulatory clarity, I think there's, in my opinion, there's a significant opportunity for a re-rating. I think from just the BD perspective, we've seen companies reaching out to learn more, big companies, mid-sized companies, to learn more about azer-cel. And especially with the ASH data that was just presented, I've been getting texts from friends in other areas, chief medical officers and strategy folks saying, "Wow, your data looked really good." So it's really validating what we're seeing. I t's not just us thinking that we've got a great product. It's being validated externally, not just by other colleagues in the industry, but by the FDA with respect to the readiness. I'd say the commercial comparables are compelling. Companies with similar regulatory positioning and clinical data trade at significantly higher valuations. Our 82% response rate in CAR-T relapse patients combined with the FDA validation of our strategy really uniquely positions us in our place. And I'd say from my perspective, what we've done in previous announcements is we've refined our portfolio. We are a cell therapy company focusing on clinical execution of azer-cel. Our CMC is ticked and tied, and we're really moving forward. W e've not only de-risked azer-cel as an asset, I think we've de-risked Imugene as an investment prospect for the industry. So it's very exciting times. Hope that answered your long question. Thank you, Brad. It does, and really positive outcomes out of the ASH as well. So Brad, you mentioned moving forward, and there are a lot of questions in the Q&A about next steps. So thank you, Brad. And now Leslie, if you can take this question for me, what are the next immediate steps following the FDA guidance? I think the team is executing, and that's what our goal is to just keep on executing, so we need to integrate the FDA guidance into a study protocol. There's various different operational plans that we need to integrate their feedback and our comments and conversation with them about, but it's really focused on initiating activities for that registrational study, and we hope to provide updates as we progress and continue to build on our clinical momentum. Thank you, Leslie. We've got quite a few questions now that we'll move into. I think one that keeps coming up when we talk about next stages is if Imugene plans to bring the drug to market by ourselves, or what is the process around partnerships moving forward? This has come up time and time again in the Q&A. Well, we at Imugene really focus on executing the data so that we are attractive to pharmaceutical companies and other collaborators, partnership, etc. W e entertain them all. T here's several different paths to market, including partnership or collaboration. Thank you, Leslie. N ow we've got some questions around the studies and around the phases. C an you clarify for us what a single randomized study means in practical terms? It's exactly as it's stated, a single study. Usually, the FDA prefers one study to be for accelerated approval, all the while another confirmation study to be already started and well enrolled and have some level of data ready. They usually ask for two separate studies. In this case, we're looking at only one, a single study with an accelerated endpoint, which is a wonderful thing because you can get the initial approval and then worry about getting the final approval later. Thank you. And can you let us know what type of control arm is the FDA expecting? This is around standard of care, investigator's choice, or is it another option? We're still discussing that. It's likely going to be what's called an investigator's choice, which is an advantage to us as we think we have the technical advantage, right? Because our current phase Ib study is treated after CAR-T failure. So we've already got the results and data across that. So if that's looking promising and if we're going into third line without autologous CAR-T failures, likely we could potentially do better. So we think an investigator's choice is an advantage. Thank you, Leslie. Thanks for explaining that. A nother question was, is there any flexibility in the randomization ratio? Absolutely. It really depends on our data and our statistical analysis plan that we will be discussing with the FDA. Thank you. And for accelerated approval, what durability window did the FDA consider clinically meaningful? Look, the FDA generally considers six months as a gold standard rule. However, this is a third- line plus, so we will need to further discuss and review with the FDA. As an example, Cargo achieved 18% CR with only three months durability. W e'll continue to discuss what our drug is doing and how we could better some of that standard. Excellent. Thank you. D id the FDA provide guidance on the expected sample size for the pivotal study? We will continue to discuss that as we put all the operational and protocols together with the FDA. Thank you. And is the low-dose IL-2 permitted within the pivotal study design, or is it to remain exploratory only? Absolutely included. O ne of the beautiful nature of this particular meeting was that they not only approved or confirmed our lymphodepletion conditioning regimen, such as chemo to sort of dampen down your T cells so that you can receive a T- cell therapy. They also approved our dosing regimen, which includes azer-cel plus our low-dose IL-2. So yes, that was approved. Thank you. D id the FDA in this meeting offer any feedback regarding the parallel development in niche lymphoma indications such as PCNSL, WM, or CCL/SSL? At the time of the briefing document, which is September, we didn't have a lot of data across that. We have mentioned this, and they know this is coming. W e do plan to discuss this with the FDA when data is much more mature. Thank you. W ere there any CMC or manufacturing-related requirements from the FDA that could impact timelines or trial readiness? We've said that the pivotal start could be and often is 12-18 months. With the FDA minutes in hand, what are these milestones, and is there anything that could impact the timelines? Yeah. I mean. I think this one's for Brad. Oh, you're going to? All right. I'll let you—you want me to answer? I'll take it. That's you, Brad. All right. Thanks. There's no indication that CMC is a bottleneck for azer-cel right where we are right now. The 12 to 18 months, yes, that can happen a lot of times if the FDA comes back with guidance, and you've got to go back and develop an assay. You've got to generate comparability or something. In this case, we have nicely parallel ongoing activities, both in the clinical execution and readiness for dosing in the pivotal and the CMC readiness. So I think the two shall meet at the perfect location, and I don't think there'll be any bottlenecks. So it's really a nice feathering these together. Thank you, Brad. T hat's a good outcome from the meeting. D id the FDA indicate whether crossover will be allowed in the pivotal study design? That's an interesting question. A s most of these doses with CAR-Ts are single dose, it would be hard to consider a crossover of patients. I f the patients were on autologous CAR-T, they usually don't go on to another autologous CAR-T. A lso, it would corrupt the data. However, as I said, azer-cel technically outperforms as our current study is with CAR-T failures, s o the FDA may allow that, and it's all really according to the data. Thank you. B ased on the feedback from the meeting with the FDA, what do you consider a realistic regulatory timeline to that commercialization? I think this continues to evolve as we continue to strategize with the FDA on how to bring azer-cel to commercialization for patients as fast as we can. Excellent. Thank you. Now, I'm just going through the other questions. Given the 82% response rate in the post-autologous CAR-T patients, is Breakthrough or RMAT designation on the table for accelerated approval? W hat has to be demonstrated for this to be considered? Data is always king, especially with the Breakthrough or RMAT designation. We will seek those as data comes through, especially in the CAR-T naive cohort. Thank you, and we've got a lot of questions in the Q&A about the estimate of total cost of the pivotal program. How is it going to be funded? We've spoken about partnerships. What would a good partnership look like in broad terms? I know they're very early conversations to have, but it is something that's coming up through the Q&As. Partnership is always great when, much like when you go out to eat with somebody, they pay. So yes, that would look great. But really, a partnership where the pharmaceutical company has the wherewithal to develop this in full because they have the machine to be able to do that. We will design the study as lean as possible with all the data points and checking all the boxes ticked and tied, as Brad already had said. T hese are things that we're looking for and looking at within the company to ensure that we have well enough funding so that we could either go it alone, but a partnership would be greatly advantageous to us. Back on that de-risking, when big companies come and look at potential deals, they want to say, "Have you de-risked some of the uncertainties?" W e really have with azer-cel regulatory risk, clinical risk. We're still, of course, enrolling more patients and increasing our data set. But when it comes to commercialization, it's a scaling. S o there are plenty of big companies out there that have the infrastructure in place globally, and they can lift and shift. I think we're continuing doing our job with clinical execution and taking some meetings to discuss potential partnerships, as most companies do. But we're optimistic with what we see with azer-cel. Excellent. Thank you, Brad. Now, with that in mind, we've gone through the questions of an overall very positive meeting. Have you, Brad or Leslie, got any further comments for our shareholders today? Brad, do you want to go first? Of course. I think we possess every element needed for success. We have exceptional clinical data, validated manufacturing, clear regulatory pathway. We have lean operations, a focused pipeline. We've announced deals just like the one we did recently with collaborations for oncolytic virus, maximizing value creation. T hen we have a massive market opportunity. We're executing really with determination to deliver on what we see as a historic opportunity. Thank you, Brad. Leslie? I think this represents a real key pivotal moment, not just for Imugene, but for thousands of patients worldwide who have exhausted all other treatment options. The FDA has given us the clearest possible pathway to bring life-saving azer-cel treatment to market. So I'm really happy. We just will continue to execute. Thank you, Leslie, and I want to extend my thanks to the shareholders present with us today. There's some very powerful messages in here today. Thank you for joining us.