Avacta Group (LSE:AVCT) — Preliminary Results

0:00 Good morning, and welcome to the AVACTA GROUP PLC investor presentation. Throughout the quarter presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time by the q and a tab situated in the right hand corner of your screen. Simply type in your questions and press send. Due to the high attendance on today's call, the company may not be in a position to answer every question it receives in the meeting itself. However, the company can review all the questions submitted today and publish responses where it's appropriate to do so. Before we begin, I'd like to submit the following poll. I'd now like to hand you over to CEO, Christina Coughlin. Good morning.

0:33 Good morning, and thank you for having us. I'm joined today by our chief financial officer, Brian Hahn, and we will be presenting the fiscal year twenty twenty four preliminary results for AVACTA Therapeutics. Let's jump in. We will be making forward looking statements, and our disclaimer is noted here on the second slide.

0:58 Let me start with a few of the highlights for AVACTA. The company has essentially, over the last year, undergone a complete transformation, and we are now positioned as a pure play oncology biopharmaceutical company. When we joined you last year, this was a joined up diagnostics and therapeutics company. And over the course of this last year, with the divestment of one of the aspects of the diagnostics company with the second one coming, we are now focused on our proprietary precision peptide drug conjugate platform within the company and are poised to move this into the next stage.

1:50 Let me tell you a little bit about that and and how we are accomplishing that. Our first entry into the clinic, and really the program that created all the buzz and all the excitement around precision, is FAP docs. This is a FAP enabled doxorubicin. It is the first precision program. There are two highlights for this one. The first is that we completed the phase one a, the dose escalation portion of the clinical trial, and multiple presentations have been made in peer reviewed settings with those data. We opened the phase one b expansion cohorts. We will show you a bit more on the design of these today, and we anticipate releasing the initial data in salivary gland cancer in late twenty twenty five.

2:43 We have also, over the course of this year, moved our exothecam, our topo one, our second program. That one has moved into the IND enabling status. What that means is that we have selected the clinical candidate late last year and have begun GMP or good manufacturing practice, manufacturing of this drug for use in patients. And we anticipate filing this IND and getting this clinical trial started early in 2026. Importantly, we entered into a strategic collaboration with Tempus. This has been leveraging AI to capture the full market opportunity, but also to drive smarter trials.

3:33 I'll describe during the presentation of exactly how we're going to use these Tempest data, both capturing the market opportunity, but also that concept of driving a smarter trial with the FAP exitecan program. You'll see there our cash at December 31, 12,900,000. And as of 04/30/2025 this year, 17,300,000. This was following the divestment of the diagnostics cash runway into the first quarter of twenty twenty six. We have strengthened our leadership of the company. We have our new chief financial officer here with me today, Brian Hahn. We have added our chief scientific officer, Michelle Morrow, and we have also appointed very recently two nonexecutive directors that will help direct the company into the next stage.

4:34 Let's dive in a little bit further. Our two new additions to the leadership team, Brian Hahn, joined us after a long successful successful career with a NASDAQ listed biotechnology company, GlycoMimetics. And Michelle Morrow joins us as our chief scientific officer last year after coming to us from F Star that was acquired by InVox. Both of them have had very successful careers and join AVACTA and will help take us to the next stage of the company. Let's dive into our research and development highlights and show you a bit of the pipeline progress that we are making.

5:23 Just to reset the stage here, the PRECISION platform is a peptide drug conjugate that leverages the enzymatic activity of a protein that is expressed specifically in the tumor microenvironment known as fibroblast activation protein or FAP. While the peptide does bind to FAP, the important part or the important aspect of our platform is the ability of FAP to then cleave the drug and remove that peptide from the drug releasing essentially that free payload into the tumor microenvironment. This happens extracellularly, so outside of the cell.

6:12 Importantly then, the released payload is able to leverage the bystander effect, meaning it can now move into a FAP negative tumor cell, a FAP positive calf. That released drug now able to move into and kill those local tumor cells.

6:34 And so our highlights now of the PRECISION platform. First, our TEMPUS collaboration really allowed us to define the addressable population for the PRECISION platform. And it also allowed us in the second part of that collaboration to really refine indication selection for our FAP exotecan pro program, essentially leveraging AI to drive these smarter clinical trials. Describing that a little bit further, it allows us to now walk into the trial with exothecam knowing what are those tumor types where we really expect that greater activity. The intellectual property for the Precision platform saw a big boost in that we developed and invented a sustained release mechanism. We were able to take that foundational IP and move it now into a whole new realm where we can now dial in the exact kinetics that we want of that release mechanism.

7:42 That IP was filed in September and now essentially creates a reset for the company in terms of our intellectual property. The first program that will come out with that new IP is the FAP exitecan program. Our two programs that we'll talk about today, FAP doxorubicin, AVACTA six thousand, we have advanced into the expansion cohorts for this one. We we have achieved a safety proof of concept. We have essentially eliminated the cardiac toxicity. This was a main goal as we were walking into this clinical trial. And one of the reasons that doxorubicin was selected is it is one of those therapeutics with a a really problematic toxicity, the cardiac tox.

8:32 We felt at the time of moving PRECISION into the clinic for the first time that if we were able to eliminate that cardiac toxicity, this would be a big gain and essentially show the proof of mechanism, of the Precision platform being able to reduce the toxicity. The clinical development path for AVACTA six thousand has been defined with both salivary gland cancer and triple negative breast cancer, and we are in the planning stages towards the phase two trial. And that phase two planning is as well subject to funding. The FAP EXD highlights, this one has moved now into, IND enabling status.

9:20 The clinical candidate has been selected. It is in manufacturing. And so the manufacturing process is being defined and and worked on for that drug to be moved into clinical trials. The IND is anticipated late this year with the clinical trial of this one beginning in the first quarter of twenty twenty six. I like to think of our IP and our pipeline almost like an iceberg. And so what we can see out there are two of the medicines that have been invented by AVACTA, FAPdocs and FAPEXD.

10:07 These are the two that we have shown the preclinical work. We have shown now multiple times the clinical work, with FAPdocs. FAPEXD will go to the clinic in months. And this is what we can see. But what we can't see is the rest of that iceberg. And so we do have a confidential pipeline, and we have a number of aspects of this. We held onto and did not disclose our FAP EXD program until we had filed that important new foundational IP for the platform, that sustained release mechanism. That sustained release mechanism is almost a plug and play. The cap and the linker can be adjusted, and we can dial in the exact kinetics that we want of different therapeutic classes.

11:05 And so what we can see now, that tip of the iceberg, we have two cytotoxic cytotoxic drugs. What we now have in the pipeline are multiple therapeutic classes. This isn't just a delivery mechanism for cytotoxics. We can deliver targeted therapies as well. Our TEMPUS collaboration was started to really allow us to understand the addressable market, the patient populations that we can help with this pipeline. And so turning then to our Tempest collaboration to understand the full scope here, We then started this collaboration with our first question to Tempest, which is where are we seeing the fat positive cancer types?

11:59 How can we understand the exact patient populations that we can address? And so we developed two what we call cut points. This is RNA seq data, and we have essentially taken our immunohistochemistry protein data and layered it now to understand using AI where are the fat positive cancers? It turns out that it's essentially all of them. Solid tumors express a tremendous degree of fat, which allows us now to essentially understand that FAP positive disease setting. With that tip of the iceberg, our two first programs, FAP docs and FAP EXD, let me call out for you now. Here are the disease settings that we will be going into.

12:56 Think triple negative breast cancer and salivary gland cancer. Then let's look at some of the the top indications that we are thinking about in for FAP EXD, pancreatic cancer, gastric cancer, small cell lung cancer. These aren't the only ones that we will be taking forward. But if you just add up there the FAP positive disease settings, we will be impacting with just these two drugs over a million lives a year. Now to address the other diseases that you can see here, it will require additional precision medicines. And that's where this reset that we did with the intellectual property is so important because we now understand to a much greater degree how to deliver individual medicines with the exact kinetics that we want in the tumor and the plasma.

13:56 We can dial in exactly what we want with that new foundational IP that was filed in September 2024 just a few months ago for the company. A big important, development for us was that sustained release mechanism. We'll talk a little bit about that later. First, let's do a little bit of a dive into docs and where we are with this program. We've seen this slide before. This is the design of the completed dose escalation trial that happened with with FAP docs in the clinic. We will be showing you the updated data that was just published in April of this year, in the salivary gland indication.

14:43 And you can see there the number of cohorts that have been enrolled and the recommended dose for expansion, the RDE, has been identified. We will be looking at these doses and these cohorts that have been analyzed for efficacy. It's important to note in a phase one trial such as what was conducted for FAP docs, that there is a heterogeneous patient population. Multiple disease settings were enrolled in this particular trial. And we will now analyze the efficacy based on those indications that we will be taking forward. And you can see now we are enrolling the expansion cohorts in triple negative breast cancer, high grade soft tissue sarcoma, and salivary gland cancer. We'll take you through the design of these cohorts as well moving forward in the presentation.

15:42 As I mentioned earlier, we have achieved a safety proof of concept with precision. Walking into the clinic with this first drug program, FAPDOX, we took doxorubicin forward as the first entry into the clinic for a number of reasons, one of which is depicted on this slide. We knew that there was a key toxicity with doxorubicin that if we could eliminate it, it would essentially show proof of mechanism, proof of concept of the precision platform, and it was the cardiac toxicity. Now there were a few steps that we had to take to get to this conclusion. The first is entering the clinic and going through the dose escalation where we achieved nearly four times the dose level of this extremely toxic drug in the clinic

16:40 and extending beyond the key lifetime maximum that we usually use, we in oncology, with doxorubicin. Doxorubicin is usually halted at a lifetime maximum of four hundred and fifty milligrams per meter squared. But because of the cardiac safety that we were observing through the course of the trial, we have been able to extend that to the lifetime maximum of five hundred and fifty milligrams per meter squared. In the doxorubicin label there, noted by the aster or the arrow, is that the cardiac toxicity would be observed in six to twenty percent of patients treated at that lifetime maximum.

17:29 If we compare that with the other arrow, it is zero with AVACTAL thousand, and we call that proof of concepts of precision in terms of eliminating toxicities. We also see a dramatic reduction in the bone marrow toxicities. We see a dramatic reduction in alopecia or hair loss, and there are zero, no reports of ADC linked toxicities. Probably the most important one being the pneumonitis or the lung toxicity that is seen with pretty much all of the ADCs, and that is because of nonspecific release.

18:11 The key difference with precision is our release mechanism based on FAP is gonna be highly tumor specific, and so we do not see release of the active free payload in organs such as the lung to create that lung toxicity. So several important safety conclusions for FAPTOX. Importantly, we also want to see that this impacts efficacy. And here, we need to look at specific indications, and that allows us to make predictions of what will happen when we move into expansion cohort phase two. And so what we see here in an indication salivary gland cancer that is known to be highly chemorefactory, we see patients with multiple minor responses, one patient with a deep durable partial response, and a disease control rate of over ninety percent.

19:17 These data are very exciting to our investigators, very exciting to our team at AVACTA, mainly because the unmet need here is so high. There is really no standard of care here other than androgen deprivation therapy, and most of these patients on this slide have received that. And so you can note the asterisks, which are indicating patients who are still ongoing, their bars can only get better, and the patients with the diamonds where we are still observing them for PFS. Progression free survival. How much time will patients get out of this drug?

20:03 How long will these responses last? Is important for us. Patients generally don't ask how much did my tumor shrink doc. They usually ask how much time do I have? And that's where progression free survival as an endpoint is so important. And so we have not reached the median PFS in this cohort of patients being observed. But it is at least five point nine months, which compares very favorably and is almost doubling the benchmark three point five months that was published by the EORTC last year in a large cohort of 54 patients at ESMO. We're very excited about these data and look forward to moving into the expansion cohort data, which will be later this year. We will also continue to update on these patients as we have not reached median PFS.

21:04 Let's now move to this is my favorite slide in the deck. Second favorite, as I noted, is that Tempest slide at the beginning. But this one is my favorite. Why?

21:15 It shows proof of mechanism. This is exactly how we designed the precision platform to work in the clinic. On the left hand side, what we see are the tumor biopsy data. Now these biopsies were taken across the phase one and so across different doses. And the biopsies were taken. They were optional for patients, and they were taken twenty four hours after the first dose. So only a single dose of drug was administered in these patients. And we asked the question, are we seeing concentration of the released pre payload or doxorubicin in the tumor versus plasma?

22:02 And the answer was a resounding yes.

22:05 The animals would have predicted a 10 to 20 x, and what we see is a median of 100 fold concentration of doxorubicin in the tumor microenvironment. Why was this so exciting? Well, we knew that conventional doxorubicin in red here was going to produce about a one to one ratio. That's what we expect with cytotoxic. There's no concentration mechanism. It is with the precision peptide attached, that micropeptide, two amino acids, that we now see this concentration of the warhead in the tumor microenvironment. Now this is twenty four hours later. We didn't need a sustained release mechanism because the half life of doxorubicin alone is so long.

22:58 It's a full thirty five hours. Why is that important, and why did we now have to develop and invent? Why did we go after that sustained release mechanism?

23:10 Why did we develop all of that new IP? It was to be able to take payloads that have a a half life mechanism, that have a pharmacokinetic problem, and be able to take those forward. And that's exactly what has happened with our next drug. Let's look now, FAPdocs. How are we gonna take this one forward? So here's our projected timelines. We are now in 2025 enrolling the phase one expansion cohort in salivary gland cancer, and that is to set us up for that next trial that you can see there as we move towards a phase two, three. The idea here in a rare disease such as salivary gland cancer, cancer, being able to go forward in a pivotal trial, this one would be designed as a phase two, three. The two endpoints would be progression free survival and overall survival.

24:13 And as we project it now, we could be in an NDA in 2028 with launching then in 2029. That would be based on something called an accelerated approval strategy. Again, all of these conversations will have to be had with health authorities.

24:33 What will happen then, and the second part, would be the triple negative, and we are enrolling that expansion cohort currently, looking at a potential setting of a a nonregistrational phase two trial that would set up then that phase three. This development scheme is based on exactly how Trodelvy just moved into that first line setting, opening up a very nice market opportunity in the second line setting. We have been clear that we are looking for and having many conversations around a potential partnership around this FAP docs program. Our phase one b expansion cohorts are enrolling now. A little bit more about the design here.

25:26 They are designed to provide us additional clinical data that will allow us to better understand and better plan those next trials. So additional patients understanding exactly what is the progression free survival we would be seeing, how many responses are we seeing. All of these data will then be used to plan the statistics around the next trial. All of the expansion cohorts are using the same dose. The recommended dose for expansion that was selected is three hundred and ten milligrams per meter squared, and it is being dosed every three weeks in three different expansion cohorts.

26:07 The first one being triple negative breast cancer, up to thirty patients will be treated here, and patients are being treated in the first to the third line setting, so up to two prior lines of therapy. The second and the third cohort are high grade soft tissue sarcoma, again, up to thirty patients, UPS or undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma. Patients are treated here in the first and the second line setting, so zero or one prior lines of therapy. And salivary gland cancer up to thirty patients. Any histologic subtype. Important to note that this is somewhat of a heterogeneous disease setting. One of the key questions we have here is do we need to limit those histologic subtypes, or can we treat every patient with salivary gland cancer? So some important questions that will be answered in the expansion cohorts, allowing us to then essentially plan out and understand better, be able to risk manage those next trials that we will move towards.

27:18 We are knee deep in our ongoing commercial analysis of the FATDOCS program. There's a couple of key highlights here. We intend to seek an initial approval in a small population. This is a rare cancer, salivary gland cancer. Rare cancers can often garner a high price point that will then move into the triple negative breast cancer in an approval that is slated now based on data that were released at ASCO just a couple weeks ago in terms of the second line setting. In terms of the price point, the advantages of that first indication, rare cancers often get orphan pricing. It could potentially avoid the IRA, and we are unlikely to see diminution of that price given the high price point that we see in triple negative breast cancer with that ADC Trodelvy there.

28:16 We are currently ongoing and working on label expansion opportunities for AVACTA an important analysis for us to be doing now as we move through the expansion cohorts.

28:32 That's our update on FAP docs, our first program. Let's talk about a little bit around our second program. I mentioned earlier that given some of the data with FAP docs, we were going to be able to take now much more potent payloads into the clinic with our precision mechanism. Exitcan is an ideal payload for us to move forward for three key reasons. The first is it was tested. It was never approved, but it was tested in many patients. Many phase two trials were run. A single phase three trial, was enrolled in pancreatic cancer, and so we see single agent activity of this drug. It is the most most potent topo one inhibitor out there.

29:22 But you may ask why topo one? Well, we know that topo one is a very active ADC payload. It is on multiple ADCs that has been that have been very successful in the clinic. That gives us, you know, a leg up. Duroctacan, very similar to exatecan in terms of their potency and their molecular structure. So we have evidence that diruxtacan works in a couple of disease settings, gastric and breast cancer. And that is an important piece of evidence for us taking this one forward. But finally, are the the the inventions made over the course of 2023 and 2024 that form the basis of that new IP.

30:12 We're now able to take a drug with a very limited therapeutic index and significant PK issues because we have that new sustained release mechanism that could now be implemented in the clinic to take a drug with a significant half life liability into precision and completely transform it in the clinic. What do I mean by that? This is a key figure, and this is a key experiment that was run. These are modeled data based on animal studies that have been conducted. And I choose this one because it is a low dose experiment. We are taking fifteen mgs per kg forward when we can dose up to forty in patients with this program.

31:02 We know that the half life there that we depict in the concentration time plot is only nine hours of exotecan. And so what the new invention does is depicted right here. We take the precision mechanism, which includes high tumor concentration, low plasma concentration, which you can see comparing the blue and the red lines concentration time plot. And what's important is that we now extend the half life from only nine hours out to over sixty hours in the tumor. And so we take it from only hours to days with this sustained release mechanism.

31:49 We didn't talk about this until we first published it in October of last year, and that was because the IP was filed in September. This IP now forms almost a reset for the company in terms of the intellectual position. What this allows us to do is to implement this new IP across all of the programs going forward. This was a very exciting figure. I can still remember the day that these data came in showing that the sustained release mechanism works. Looking at the timeline for the FAP EXD program, we will be moving into the GMP. We're moving through the GMP manufacturing over the course of 2025, toxicology studies. All of these form the basis of the IND enabling studies.

32:43 As well, the clinical trial is being written, conversations had with health authorities, which we expect then the IND to be filed late this year with a phase one start in the first quarter of next year. This trial is gonna be driven by another part of our TEMPUS collaboration looking at what are those sensitive tumor types for us to move into. And that converts the, essentially, empiric nature that we used of the FAP docs trial of looking for those indications, those sensitive indications, allowing us to understand payload sensitivity

33:29 using AI, and that allows us to walk right into a clinical trial limited to those disease settings where we anticipate seeing activity. We expect to have the initial data from the phase one trial at the end of next year and potentially be moving in the first quarter of twenty seven to the expansion cohorts for this one.

33:56 I mentioned we have an enviable IP position in the company. Let me explain why. There are three main IP families that we talk about. Our foundational IP, which formed the basis of the therapeutics company as it was started, was licensed from Bach Bio, which grew out of Tufts University. And this is the foundational IP. This is the IP around the peptide drug conjugate,

34:25 which has now hit a reset button with the filing made in September. This is the sustained release mechanism where we implemented the cap and the linker, allowing us to essentially design and to dial in the exact kinetics that we want of the PRECISION program. It opens up a number of different therapeutic opportunities, not only cytotoxic, but as I mentioned, targeted therapies. Multiple other types of therapies can now be used because we can implement multiple different linkers, multiple different capping groups, and dial in those exact kinetics that we would like. So this IP is not just FAP EXD.

35:10 It's now gonna go across the entire pipeline.

35:14 The third patent family that we have is the biologic drug conjugate IP. And what that allows us to do, think of this linker. Think of precision as being a linker in an ADC like mechanism, and that is deep in the research. That's part of that part of the iceberg that that isn't necessarily always seen. But deep and enviable IP position for the company moving forward. And I'm going to turn it over now to Brian for our financial highlights. Brian, the floor is yours. Thank you, Chris. Can you so top priority is to establish, AVACTA's sustainable long term financing strategy in order to realize tremendous opportunity going forward, which requires additional funding.

36:13 So we've invested 14,270,000. In 2023, it was 13,110,000 restated and researched in line with expectations relating to the precision Aframer therapeutic programs.

36:26 Admin expenses increased to 12,050,000 compared to 7,890,000 in 2023, primarily related to executive management changes and professional expenses related to shift toward a pure play biotech company. Overall loss from continuing operations was 28,980,000 compared to a loss in '23 of 29,150,000.

36:50 Operating cash outflows from continuing operations was 24,500,000 compared to 14,870,000 in 2023. This reflects elevated r and d expenditures and one off costs associated with organizational realignment that occurred during the year. Net cash inflow from continuing financing activities of twenty six point one million compared to 1,300,000 in 2023. This was primarily from proceeds of issue of share capital of 31,100,000 compared to nil in 2023 plus repayment of convertible bonds of 3,100,000 in July 2024. Cash and cash equivalents was 12,870,000 at 12/31/2024 compared to 16,630,000 as of 12/31/2023.

37:37 Cash as of April 2025 was 17,300,000 following the divestment of the LaunchDiagnostics business, which extends the cash runway into the first quarter of twenty twenty six. Oh, no. Back to you, Chris. Hi, Chris. We can't currently hear you. I don't know if you've put yourself on mute there. Apologies.

38:24 Perfect. Thank you. There we go. So AVACTA has now moved into, a significant progress, and we have multiple catalysts to deliver on. We've transformed the company into a dedicated oncology biotechnology company. We are developing our proprietary precision technology for the treatment of multiple solid tumor indications. We've made significant operational progress over the over the past year, essentially transforming the company again into that dedicated biotech. We are basing this on the tremendous data that have been generated with the precision platform both in the clinic with FAP docs, but as well in the preclinical setting with multiple programs in the pipeline and FAP exotecan moving quickly, the beast, towards the clinic.

39:16 There are multiple data catalysts upcoming with the two programs for FAPdocs and FAPEXD. We have multiple goals for the company moving forward. We have established our enviable intellectual property position. I described our proprietary sustained release mechanism that was invented in the company over the course of 2023 and and 2024. That IP was filed in September. We do have another ten years of exclusivity of our foundational IP. And, essentially, what we are seeing with the sustained release mechanism is a reset button there. A novel IP there taking that peptide drug conjugate into an entirely new, mechanism of the sustained release.

40:08 Cash management for us is critical. We tightly manage the cash burn. We look at at every pound that we spend, and our long term strategy is really the key focus in order for us to move this exciting pipeline forward. We do have upcoming key data catalysts in 2025 and and in 2026. Our first program, FAPdocs, is moving through its expansion cohorts. We expect to have updated data in late twenty twenty five in salivary gland cancer and the initial data in triple negative breast cancer in, the first half of twenty twenty six. Those will those datasets will allow us then to move forward into that next stage of trials.

40:56 FAPAXUTICAM, our program two, will move to IND, and we anticipate opening that phase one trial in the first quarter of twenty twenty six. And our third program, which we have not disclosed yet part of that iceberg, we expect to be able to advance the candidate selection later this year with a goal of an IND in late twenty twenty six. And that concludes our presentation. Alessandro, we will hand it back over to you. That's great. Well, thank you very much for your presentation. And as mentioned at the beginning, we have received a number of questions both pre submitted and a number throughout today's presentation. So thank you to all the investors for submitting those.

41:47 Let's start the q and a session with the first question here, which reads as follows. You spoke about the commercial side of AVACTA GROUP potential deals. Can you describe the commercial strategy for the company and why it's taking so long to accomplish anything? So we have talked about this one before. It's a it's a very good question. It's a very important aspect of the company. There there's two elements. I break it down to understand the commercial strategy. The first is, you know, what is the long term game plan for commercializing an individual program such as AVACTALLS that gets approved after, you know, that that pivotal trial is successful. But the second part, as mentioned there, is our business development strategy and and the partnering deals on on the assets themselves. So let me mention the first one first. So AVACTA six thousand, this is our lead program. We have successfully completed phase one a, the dose escalation. We have an excellent tolerability profile. The the progression free survival is very encouraging in that first indication salivary gland cancer.

42:54 No cases of severe cardiac toxicity, as I mentioned, proof of mechanism at the at the safety level. So this drug has extraordinary potential. It is the TOPO two mechanism, though, is limited to breast cancer, salivary gland cancer, and and soft tissue sarcoma. These are the three expansion cohorts. They're underway. The data are expected later this year, early next, that will allow us to have a little bit more clarity on what is the exact, you know, strategy to get this one on the market and and, essentially, essentially to to to commercialize this drug. We have been clear that we are seeking a partnership around that one, and and there are multiple conversations going on. People are waiting to see that next set of data coming forward.

43:49 We because of the activity of a topo two inhibitor, it is limited to a few of those disease settings, makes that kind of deal a little bit easier because we know the exact diseases that that we would be, you know, essentially partnering on. But as I mentioned in that TEMPUS collaboration earlier, there's a number of tumor types that we could be looking at. Now a topo one mechanism like exothecan is a much broader mechanism in in terms of the solid tumor population and the addressable population. So there is that second opportunity, business development, to partner other assets such as AVACTA GAN program.

44:37 Recall that iceberg analogy. There are multiple programs. We are able to FAP enable, other mechanisms, not just cytotoxics. But there are complexities here. With AVACTA six one zero three, the activity of the topo one inhibitor is so broad that there's, you know, any partner there would be looking to license and and, you know, essentially gain exclusivity in a number of the disease settings. So doing a preclinical deal with that one because it forms such a big opportunity for us. While we are having conversations, we prefer to get that one into the clinic and and see what we can actually deliver there by the end of of next year.

45:23 Based on what we observe, it'll become much more evident what the game plan is for that asset going forward. And so we keep all options on the table with that one. But if we think about more short term option, the the opportunity there is to collaborate on the development of another precision medicine, and this would be with a potential partner. And so this means then, you know, potentially licensing the technology to a partner, working together, collaborating on the development of a new medicine. It would be based on a partner's proprietary payload and our precision technology. More to come here in the the not too distant future. Now a key aspect of the question was really why is this taking so long? Well, the key IP that we have, and I talk about this as an enviable IP position, it's important to note that that IP was not filed until September.

46:24 And so conversations couldn't start until October with that one. And so the conversations that we're having with potential partners here haven't been going on for very long. You know, it's it's it's only been months. And these kinds of deals often start with a collaboration, preclinical. Think back to that iceberg analogy. There there's a lot going on. I I call it sort of under the surface that that we we can't disclose. But, you know, we we will disclose as as soon as we can when when we have an announcement there. And so, you know, just to summarize, having conversations around both of the assets that we have disclosed, FAP docs and FAPEXD, the timing of those were really gonna be driven by the clinical development of each and then the the potential for a a platform deal.

47:31 Perfect, Christina. Thanks very much. We we do have another question here, perhaps it's one for you, Brian. What is the strategy for the Heights convertible bond going forward? Listen. We understand that the Heights Capital Bond is a source of ongoing frustration for shareholders. Importantly, at this critical stage in our development with the transition to a phase two trial on the horizon, strategically managing our cash runway to fund r and d pipeline advancement is a primary focus for the company. The board does make quarterly decisions on whether to repay the convertible bond in cash or through share issuance based on a number of factors, principally the need to maintain adequate working capital for operations. The board is committed to actively managing the legacy HCB balancing the needs of all stakeholders.

48:18 That's great. Thank you very much, Brian. Turning to the next question here. The AVACTA GROUP trial started in 2021 and has taken four years. Why was this trial so long, and why would we think there will be any results in the AVACTA six one zero zero three in less than one year? So it it is very it is very true, and and we take that criticism. The the AVA 6,000 trial did start in in 2021. It it has taken quite some time. It's important to note that this was the first trial of a brand new platform, a brand new mechanism. Peptide drug conjugates really weren't around yet in 2021.

49:03 They are all the rage now. There's a number of companies. And and it was a whole new mechanism to leverage an enzyme. The trial started with a low dose. It escalated to standard dose doxorubicin. With that new technology, low starting dose, it's sometimes hard to recruit that first group of patients. We definitely saw that. I was not even on the board yet at this point. I joined the board in in 2022. And as we reported in April of last year at AACR, there was a single dose limiting toxicity in that next cohort after standard dose doxorubicin, and that did slow things down a bit. But once we hit those higher dose cohorts, the enrollment started to become a little bit more smooth. As as I've mentioned, it was an empiric search for what are the disease settings where we were going to see activity of AVACTA 6,000 of of fat docs. Essentially, you know, as we were moving through the cohorts, we weren't enrolling those I'll call them diseases where we were going to see that activity. When we started to enroll soft tissue sarcoma and even salivary gland, I can still remember that first patient with salivary gland cancer.

50:23 And now with breast cancer, these are diseases where we expect nice activity of doxorubicin. It taught us a really important lesson in that trial that we then implemented in our Tempest collaboration. And so I take on that question. You know, why would we think that we could get a SAP EXD data in in a little under a year? Well, it's because we're gonna we know what are those disease settings that we should be going into. We know where the topo one mechanism is active, we expect to see activity in in those cohorts. So instead of an empiric search for what are the disease settings, we've leveraged AI and used AI to drive much smarter trials.

51:16 Now there is a lot of buzz, and we have a number of sites that are quite excited about FAP docs. And they're all asking for the FAP exotecan program, to be at their clinical trial sites. And so, you know, we also aren't going to have to have that sort of, you know, convincing investigators. And so we are we're excited about moving this one forward. And so I think, you know, it it we are making a bold prediction that we are going to be able to get this trial moving very quickly. And it's it's really leveraging AI, but also leveraging those key relationships that we have, with a number of of, you know, really great medical centers.

52:10 We have opened MD Anderson, in The US as our third site here. We have Memorial Sloan Kettering, the you know, we just have fantastic clinical trial sites, and all of them have asked to be able to participate in the FAB exotecan. So it's both AI, but also leveraging those those relationships that we have. That's great. Thank you very much, Christina. The next question we have here, what will it take to sell FAP docs? If we have fixed the toxicity of doxorubicin, what has this drug not started to be sold on the market? What is the accelerated approval, and can we use it, or do we need that?

52:57 Yep. Good question. This one this one comes up frequently. In order to sell a drug on the market, we we can't just prove that it is safer than the existing drug. Because we've attached the peptide, it is what is called a a new molecular entity. And so it needs to be approved first by the health authority of the country where those sales will happen. Think in the US FDA. Think in The UK, the MHRA, you know, the the regulatory strategy or approval in in Europe sort of goes across. But as you saw in the development slide with FAPTAX with AVACTALZ, we are looking at the earliest, absolute earliest approval being late twenty twenty eight. We would be developing that we call it an NDA or a new drug application in in in 2028, launch the drug after that, and that's when we would be able to start selling it on the market and and booking revenues. And this is assuming this concept of an accelerated approval in The US. This is where we can use essentially an an an expedited program to seek approval based on an earlier event.

54:17 That's the whole idea of accelerated approval. Essentially, we're looking at a possible approval based on an earlier endpoint, progression free survival, and then needing to bring back that overall survival. So so both of those endpoints will work together to form an accelerated and then, you know, a a final approval. Accelerated approval is is usually only available in The US, so so that's one of the reasons that we break down the commercial analysis into US revenue versus when we go more global with this. Once we have the expansion cohort data and once we get closer to moving into, you know, those potential pivotal trials, and and we have, you know, said subject to funding, subject to partnerships, and and whatnot.

55:14 But we wouldn't disclose our regulatory interactions with any health authorities. It isn't something, that is is disclosed publicly. It's it's part of that iceberg, that's beneath the surface. But I I can, tell you that that those plan you know, the planning and and the the conversations are are very much ongoing even if they can't be publicly disclosed. Thanks very much, Christina. Changing gears slightly and maybe back to you to you, Brian. All of the science is going to require a large amount of funding. What's the strategy for the long term financing for the company? The management team and board recognizes this is a source of frustration for our shareholders.

55:59 Given the global market complexity and the stage of our business now, we are managing cash tightly in the company. Like any biotech, we will need to raise additional money to fund the programs. We think about managing this in three different ways. First, the cash runway. So the company's cash position enhanced by careful resource allocation and divestment of non core operations now extends into 2026. To support the continued development across the company, we will need to to secure additional funds in due course. Secondly, capital market strategy. So AVACTA continues to explore potential dual listing on NASDAQ to broaden its investor base, access deeper pools of specialist biotech capital, and fund its growing pipeline beyond the capacity of the of the AIM market. So short term AIM market and longer term moving to the Nasdaq to access the pools of capital needed to sustain the company.

56:49 And lastly, partnerships. Throughout the year, we've been actively engaging with interested industry parties who have the potential to bring complementary expertise and resources to the table. These discussions have focused on identifying collaborative opportunities to accelerate the development and commercialization of our precision platform assets. Recall, however, that we would surrender valuable piece of the IP with any partnership we sign, and thus, we must be highly selective as we proceed forward. We continue to be pursue this option in parallel, but, again, as mentioned, these deals do take time to come together. It is important to note that preclinical partnership will not have a significant upfront cash associated with it, so will not impact the runway tremendously. These are usually drawn up with shared risk and later milestone payments versus a large cash upfront payment.

57:38 Understood. Thank you, Brian. The next question is really around share price and ask why the share price is not improving. Yes. We we do get asked this one. We AVACTA is operating right now as every biotech and and pharma in a challenging and, you know, really a a volatile environment. The biotech indices are are down significantly. The XBI on Nasdaq over the last period is down more than 9%. AVACTA is down 15%, you know, year to date. This is due to macroeconomic. There's policy pressures around the world. We we are not the only ones whose shares have been impacted here, but but we hear this, and and we know that this is another source of frustration for our shareholders.

58:36 Over time, though, the way for AVACTA to deliver long term value for shareholders is through the value in the pipeline. It will be incremental. We are building on the positive data that we are generating. I I think that the iceberg analogy here is really important. The data that we published at AACR this year, there were three important presentations. But for our first program in the clinic, we feel that we've achieved proof of concept with this one. Have a disease control rate of over ninety percent in patients with salivary gland cancers, a marked improvement in the safety profile. We've eliminated the cardiac toxicity. We have, you know, nearly doubled the PFS, and we haven't even reached median PFS there. So we're very excited about that first indication.

59:31 We're dosing at nearly four times the dose of conventional DOCS, but the exposure in plasma and normal tissue is is still consistently lower. And so that demonstrates proof of concept, proof of mechanism of the platform. And so the value in this pipeline is gonna become much clearer the longer that we continue to to generate both the data with FAP docs, the data with FAP exotecan, but then the data with the programs that are beneath the surface, you know, the next ones coming forward. Given the data presented at AACR, you know, our most recent clinical data, the data with that that formed the basis of that new IP, We are very confident that this platform can generate significant value over the long term, and we are fully focused on on executing on this. It's one of the reasons that the board made the bold decision to take this to a pure play biotechnology company.

1:00:37 Day to day share price movements don't reflect necessarily the overall value in the company, and so it will take some time. It will take some time. Biotech across the board is is having the same struggles. And, you know, while we know that this answer is frustrating, biotech is a biotech is a marathon and and not a sprint. And and we are incredibly excited about this platform and just the sheer breadth of the the potential here. Thank you very much for that, Christina. Moving on to the next question. Why was the presentation moved twice? Is there a problem in the accounts?

1:01:25 Yeah. The audit of the financials for the calendar year 2024 was was very complex. It it included two discontinued operations, launch in Chorus, the valuation of the bond. As Brian mentioned, there were, you know, management change shifts. And so you can understand there was a lot of work to do with our auditors to complete the audit, and we underestimated the amount of time that was required to get it exactly right. And and, no, there's no impact to the financial statements. No additional issues over over what we have discussed here. It was it was an underestimate of the of the amount of time that it was gonna take for this really complicated audit. I've been in pharma for nineteen years. Brian's been here for way more than that. And for both of us, this was the most complicated, audit that we've ever gone through.

1:02:27 K. Thank you clarifying for that, Christina. We do have another question. Last year, we heard about specific goals for the company. Can you please highlight what are the goals this year and how we should measure you against these? Yes. And this one of the last slides in the deck. But but let me expand on this just a little bit. First, we have the data with AVA 6,000, the expansion data with salivary gland, and and that is gonna be a a patient population that will include both the 11 that we've already been talking about and then, the the expansion cohort. And that'll be you know, the initial data book there will be, late in 2025. First half of twenty twenty six will be the triple negative breast cancer data there.

1:03:17 These these data outputs are really important as they're gonna drive the strategy for the next set of trials. FAP exothecan, IND filed and trial opening, then in the first quarter of twenty twenty six. We do hope to have that initial data late next year. Let's get into that trial, but we have very excited, sites, ready to rock and roll with that one. In addition, we also are setting ourselves the goal of of business development, a deal, and and then, you know, the the long term financing of the company, all of which, are coming together in the background right now. That's great.

1:04:02 The next question really around communication. Why are communications with shareholders so poor? So let me say first to the to the shareholders, AVACTA greatly appreciates the support and the engagement. We know that there are frustrations. We hear directly from many of you. We take the feedback very seriously. The company does have a large percentage of private rather than institutional shareholders, but we take the feedback from from all of our shareholders. We've entered a period now, where there are not frequent updates from the FAP docs trial.

1:04:51 In the case of expansion cohorts, we wouldn't be announcing enrollment figures, just our guidance as to when we would expect to have the data ready to publish. We did see a hiccup with enrollment with, you know, the macroeconomic problems that we've had in in The US. We've even seen that, you know, if we go back just days, the ASCO conference, that was held in Chicago, that's held in Chicago every year, it was just decimated by, some of the macroeconomic. The travel bans have been put in place in a number of of institutions to try and deal with the loss of funding.

1:05:37 But with this stage of the AV 6,000 trial, there won't be regular cohort updates. It's it's just not standard practice. It's more standard in a phase one trial even to not publicly declare every cohort that clears. And so even as we approach the AVACTA six one zero three, you know, the FAPEXD phase one, we will move to more standard communications. And so our approach has really been to provide informative deep dives into our progress, with both the clinical and the preclinical programs. We will have regular scheduled points throughout the calendar year, investor engagement events. The AGM coming up is is an important one.

1:06:23 We will then be hosting our science day again, and so that provides then many months later sort of a a deeper dive into the the preclinical programs as well. And in addition, we've also developed our our spotlight series, and those videos come to both LinkedIn and and Twitter or X. It's called X now. And that allows us to educate on on pipeline developments. That's the first place that we disclosed the sustained release mechanism and and the exotecan program. In addition to that, we have now transitioned. We are going to have a roughly quarterly schedule of of market update. So there will be a regular scheduled RNS market update that comes every quarter. The next one will be right around the the AGM.

1:07:13 But outside of these events, I I hope you can understand, we can't communicate directly with individual shareholders. We we can't discuss strategy, ongoing corporate activities, or even progress in clinical development when people ask, you know, how is the enrollment going. We provide as much detail as we can in the shareholder investment forums, and and we do commit to being transparent. That quarterly update, we will disclose, you know, as as much as we can on on decisions, on strategy, which impact your investment. But we really do have to ask that you bear with us. We can't selectively disclose company information, and and some of our progress for a number of reasons must remain confidential.

1:08:03 Let me give you an example. Any progress that would feed into a patent application, it must be kept confidential until that application is is final and submitted. Our conversations with health authorities, are ongoing on on the programs, those have to remain confidential. And I do say I I did intentionally say programs because those conversations are happening with both SAP docs as well as SAP EXD. And so, you know, we commit to transparency, you know, as as far as we can and and very regular communications, with our shareholders. Thank you for that. We have had a number of questions on AVACTA six one zero three.

1:08:56 So perhaps let let's take this one here. The new drug that you refer to as VAPEXT, can you explain why you're so bullish on this drug and when will you monetize it? Why are you not doing a deal around this asset right now? Yes. We are all excited about this program. I've nicknamed it the beast. There's three reasons why we're so excited about this one. So first is really the new IT, and the new intellectual property here really creates a a reset button almost for Precision, the platform. We've invented an entirely new delivery mechanism for Precision. This has been development a development that's been happening in the labs over 2023 and 2024. We couldn't talk about it because it it fed into that patent application filed in September last year. We had to secure the IP.

1:09:47 This IP we knew that this IP, as we were developing it, was absolutely critical because it's gonna essentially impact every part of the pipeline other than FAP docs. And we do think of it as that that sort of reset button. So it's a very broadly applicable patent. The second part of this one is that it's a topo one. And why is that so different? Well, doxorubicin is a topo two inhibitor. These are two different enzymes in the process of of replicating DNA. And the TOPO one mechanism of exotecan is much more broadly applicable than the TOPO two mechanism of doxorubicin. And so just the sheer number of disease settings that we can take a TOPO one into, it it's huge. Just looking let's just look at lung cancer alone. We could take this into non small cell, small cell.

1:10:42 You know? And both of those disease settings have very high think back to Tempus, very high FAP expression. And so the addressable market for FAP exotecan is much bigger, than we see with FAP doxorubicin. The third reason that we're excited about it, again, think back to that TEMPUS collaboration and some of the data. It it didn't actually make it into today's presentation, but some of the data that we presented at at AACR, how we leveraged the TEMPUS collaboration to predict disease settings for us and really those optimal indications, we can run a faster, smarter trial, but it really allows us to understand the addressable market opportunity for exoteca.

1:11:35 And and what are those exact cancers that we should be targeting? Again, it was an empiric discovery of that within AVACTA six thousand, and it did take quite a bit of time. But we're gonna walk right in leveraging AI. So using AI to drive those smarter trials, walk right into the clinic knowing what are the disease settings, being able to answer that question very quickly. What are the disease settings that we expect activity of this one? And so the second part of that question is really important. Why not do a deal? Why not do a deal right now? So there's two reasons. One is a program with clinical proof of concept is so much more valuable than a preclinical program.

1:12:23 And and so just by getting to the we're so close to the IND. We're in manufacturing right now. We're watching the data come out manufacturing. We are so close to getting this into patients. And so the real catalyst for this one is not the filing of the IND. Some people think of that well, our scientists often think of that as as sort of the the endgame. It's not. That's the beginning. And that's where the value in this asset really gets unlocked. When we can show that we can dose it, we get the tumor to plasma, you know, all of those data that we'll be generating over the course of 2026 dramatically increase the value of this one.

1:13:11 And so that's that's the first reason. And the second, the the potential partner, just thinking about that broad addressable patient population, think about it as a double edged sword. The the the a potential partner will not wanna compete with anyone in some of those disease settings. And so the the deal becomes much more challenging because HOPO one is such a broadly applicable mechanism. And so the best thing for the company right now is to get that one into the clinic and then start to think about, what that deal is. Now with publishing that those data at AACR, we we actually disclosed on both Twitter or X and LinkedIn that, you know, the the crowds were five deep looking at that, and it wasn't just academic.

1:14:03 There were multiple companies looking at it. And so we are having conversations, and there are companies thinking about, you know, what what but but for us, the value really gets unlocked, with, with patients being treated. So we're gonna be very deliberate, in any partnership on this one. And, yes, we are very bullish on this program. That's great. Thank you very much. This question has also kinda come in via a few angles, so I've just summarized it. What steps is AVACTA taking to position its therapeutics or the platform for commercialization, particularly in terms of engaging with global congresses or key stakeholders to attract commercial partners?

1:14:50 So there's three key activities, and and we continue to pursue these as as an active biotech. The first is presentations of data. And so think back just back to April. We had three presentations at at AACR platform, SAP Docs, and and SAP EXD. And so peer reviewed presentation of our data at these congresses is is really important to engage with investigators as well as potential partners and all of the the stakeholders there. In addition to that, there are congresses that are focused primarily on business development opportunities.

1:15:45 Probably the best known one is is the bio series, and we are at almost every one of those. Those focus really you know, there aren't presentations of data that there there are truly they are designed for BD folks and R and D folks to sit down together, and and we do attend these on on both sides of the Atlantic Ocean. The next one is coming up in Boston in in just a few days. And and so those two actually work very well together in that we do have a number of conversations that are ongoing. And if you think about it, some of these leading settings, so one was just held at at ASCO, you know, a partnership forum. Well, that was really a a forum for introductions.

1:16:38 And we have, you know, a a large number of of conversations that are ongoing, a number of potential partners looking at our data as it comes out. As you can imagine, these are ongoing but really couldn't start on the sustained release mechanism on before October of last year. And so there haven't been very many bios since then, let's let's say. But we do it it does take a number of meetings for a a potential partner to become comfortable with the platform, understand that that we are a company that does what we say we're gonna do. And if if we can't reach those goals that we stated for ourselves that that we specifically communicate exactly why. And so it takes some time for a partner to become comfortable with a biotech.

1:17:36 And so, yes, we continue to progress that, at the same time as as we continue, to progress our pipeline. Thank you. The next question here, is the CORA still going to go through to make us a pure play by attack? I'll turn that one over to Brian. Yeah. The deal is, progressing well, and it's anticipated to close, soon. But it is it's underway. Thank you very much, Brian. Next question we have here Horton Suites. Exactly. The next question we have here, the strategy for fat docs appears to be changing. We don't hear updates on the sarcoma arm anymore.

1:18:24 Is this changing, why? So we have placed, three bets on the table, with our expansion cohorts, as we, you know, described their design and and the dose in the presentation. Those three bets are salivary gland cancer, triple negative breast cancer, and soft tissue sarcoma. There are two things that happened late in 2024 outside of AVACTA and inside of AVACTA that essentially defined the strategy. Now we have to be very in tune to anything that happens out there in in the public domain in oncology and how it impacts our programs. And that's the first thing that I'll describe is the the indication of soft tissue sarcoma did take, I'll call it, a little bit of a a regulatory influence that happened in that there was a dataset that was published late twenty twenty four with the Boehringer Ingelheim MDM two inhibitor in dedifferentiated liposarcoma.

1:19:39 It was a randomized phase three trial that failed to meet its primary endpoint. And the comparator arm in that trial, important to note, was monotherapy doxorubicin, and the progression free survival there was over eight months. It's that that is an important development because it is much better than anyone anticipated. And so, excuse me, the regulatory bar then in that indication, is is elevated, and our probability of regulatory success drops when we see because that will be the comparator for AVACTA six thousand for FAPdocs. Now at the same time, we started to see some really nice activity in a rare tumor type salivary gland cancer.

1:20:39 And our investigators that were working with us on that continued to, I'll call it, beat the drum or tell us, like, this drug seems to really be working in this rare tumor type, and the unmet need here is huge. I've mentioned before that if you open up the NCCN guidelines, which drive the the therapies that are administered in a given setting in The United States, the preferred regimen for this tumor type is none. There there isn't one. And that's regulatory speak kind of for you know, we would then be able to use something called an investigator choice arm. We wouldn't have to necessarily compare to doxorubicin alone. Doxorubicin alone isn't isn't actually used.

1:21:26 And so it's both of those sort of an an external factor with the data in doc in doxorubicin and soft tissue sarcoma, but also our own data in salivary gland cancer that, yes, we will we will always we will always adapt to to both external data, but also things that we are are seeing. And so our probability of success, we think, with salivary gland cancer is is just much higher based on both of those factors that I mentioned. And so the the expansion cohorts are ongoing, and we look forward to those data really helping us to drive the next step.

1:22:12 Okay. Thanks very much, Christina. We have nearly run for an hour and a half now. We have had over 1,000 investors kind of register for this meeting. So potentially just one final question here. You've mentioned the potential for a NASDAQ dual listing. Is this primarily to unlock valuation upside in a more biotech savvy market, or is it tied to strategic capital and partner access? I'll ask Brian to to take that one. Biotech, like AVACTA, will grow its cash requirements as we get to produce, I'm sorry, pursue additional programs in the clinic and additional As many are aware, the cost of running the company increases the more success we see.

1:22:58 Actively pursuing global specialist biotech investors and exploring the potential NASDAQ delisting helps us access deeper capital, the capital markets, the broader investor base. So you do know, as Chris said earlier, this is a marathon, and drug development is is very expensive. And the wider net we can cast it to more more capital, the more successful we can make the company. That's great. Brian and Christina, thank you very much for answering all of those questions from investors. Of course, company can review all the questions submitted today, we will publish responses on the investor me company platform. But just before redirecting investors, provide you their feedback, and it's particularly important to you both at the company, Christina, could I just ask you for a few closing comments? Absolutely.

1:23:46 We are very grateful to our shareholders who have provided an incredible amount of support for the company. We understand the frustrations among our shareholders. We understand that the company is in a position, however, to deliver on incredible long term value. I like the analogy of the iceberg. FAP docs and FAP EXD are only the tip of the iceberg in what we can achieve with the precision platform. We are excited about the opportunity.

1:24:33 We are excited about what we can deliver for patients. And when we deliver for our patients, we will be delivering that long term value for our shareholders where everyone wins. We understand the frustration. We understand the time that it takes. Biotech and drug development absolutely is a marathon. We're grateful for the support of the shareholders, and we wake up every morning knowing that this company has the opportunity to do something very, very important for patients with cancer, which is what I've spent my entire life on. And I am so excited about the next chapter for AVACTA, and we're grateful for all of you, coming with us on that journey.

1:25:27 That's great. Well, Christine and Brian, just like to thank you once again for updating investors today. Can I please ask investors not to close the session as you now be automatically redirected to provide your feedback and all the management team can better understand your views and expectations? On behalf of the management team of AVACTA GROUP PLC, we'd like to thank you for attending today's presentation, and good afternoon to you all.