Good afternoon and welcome to the Avacta Group PLC Investor Presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and could be submitted at any time via the Q&A tab situated on the right-hand corner of your screen. Simply type in your questions and press Send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company can review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, I'd like to submit the following poll, and then I'd like to hand you over to the management team. Christina, good afternoon.
Good afternoon. Thank you very much. Coming to you from London. A very good morning, to our colleagues, joining from the U.S. We're thrilled today to bring you, our fiscal year 2025, preliminary results, and a short business update. Let me start first on the research and development side, for our company. The Avacta vision and our strategy. Our vision is to conquer cancer with existing therapies while preserving patient vitality and improve healing. You've heard us say that in a world where effective cancer therapy often means a difficult trade-off between efficacy and safety, our pre|CISION platform has the potential to offer something very different. Hope without compromise.
The strategy for Avacta is to develop and ultimately to commercialize a broad portfolio of drugs, given that importantly, FAP or the enzyme that our platform is based on, is expressed in 90% of solid tumors, which represents a very large market opportunity for our pre|CISION technology. Our technology is capable of repurposing a range of oncology drugs to significantly reduce toxicity by concentrating the drug directly in the tumor. With these, we are challenging the current drug delivery methods. Our goal is to expand the reach of many of the highly potent anti-cancer therapies that we have seen in the field of oncology. Let me turn to our fiscal year 2025 highlights. First, on the research and development on the R&D side. Over the course of 2025, we've increased our momentum and strengthened our position as a pure-play oncology biopharma.
We're focusing now entirely on the company's unique proprietary pre|CISION peptide drug conjugate platform. Let me start with our exciting new clinical program, our Gen Two AVA6103. Our first patient received treatment in FOCUS-01, which is a multicenter open label phase I trial of AVA6103 right on time in March of 2026. The work behind this occurred all through the course of our fiscal year 2025. The FOCUS-01 trial is enrolling patients with six advanced cancers. These were selected by leveraging our strategic collaboration with Tempus AI. We've presented highly favorable data from multiple preclinical studies in multiple meetings, and importantly, we have compared our delivery kinetics to two successful antibody drug conjugates Enhertu and Datroway. We'll take a look at these data. Just a couple of slides from Science Day. My two favorite slides from that meeting.
We also updated our preclinical and our translational data at the American Association for Cancer Research, AACR, very recently in April of this year. As we look at our Gen One AVA6000, this was our first clinical program. We've reported highly encouraging preliminary efficacy and safety data from patients with our lead indication of salivary gland cancer. The program has continued to enroll patients throughout the course of fiscal year 2025 and into 2026 in the phase I-B portion of the trial to assess the efficacy of AVA6000 in those more homogeneous and defined patient populations, the three cohorts. We've also reported positive health authority interactions.
Two outcomes of this were, first, the lifting of the lifetime maximum dose, that it was due to highly favorable cardiac safety data, and we also have gained an agreement on the pathway to our dose selection for the pivotal trials. Our 3rd generation, AVA6207, which is our recently developed our dual payload technology. This incorporates the sustained release mechanism that is part of our Gen Two platform, but also with multiple combinations of payloads. We did show updated in vivo data at the AACR Annual Meeting in San Diego, again in April of this year. Finally, we do continue to grow our IP estate around the pre|CISION platform, filing and protecting both the sustained release mechanism and our dual payload technologies. Let me turn over to our Chief Financial Officer. I'm joined today by Mr. Brian Hahn. Brian, over to you.
Thank you, Chris. Our top priority is to establish Avacta's sustainable long-term financing strategy in order to realize the tremendous opportunity that this platform could provide. We invested GBP 18.8 million in 2025 in research and development expenses. Those were in line with expectations. That's up from GBP 14.3 million last year, the same period, relating to both pre|CISION and our therapeutic programs. Administrative expenses have decreased during the year down to about roughly GBP 10 million, down from GBP 12 million the previous year. Net operating cash outflows from continued operations was GBP 22.64 million as compared to GBP 24.94 million in 2024.
It's important to note that we've raised GBP 32 .5 million over the last 18 months to help support these R&D programs, and cash as of the end of April was GBP 16.4 million following the oversubscribed placing and subscription of GBP 10 million. This will extend the cash runway into early Q1 2027.
Thanks, Brian. As I mentioned, I'd like to cover today and look at today, two of my favorite slides from our recent Science Day. This is a new slide that describes essentially the difference between our peptide drug conjugate and an antibody drug conjugate, with ADCs representing probably one of the most active areas in clinical oncology right now. Let's call it a really hot area. On the left-hand side of this slide, you can see that the payload delivery via the pre|CISION mechanism requires two amino acids in the pre|CISION peptide, and you can see there in blue the cap and the payload itself, which is represented in red.
What happens when the payload encounters the cancer-associated fibroblasts, which express FAP on their cell surface, is immediate cleavage, and that released payload is now capable of migrating into the tumor that is surrounded by the CAF. The PDC, the joined-up drug encounters that FAP-positive CAF. It's cleaved, and the payload moves immediately into the tumor. It's different than an ADC. The first big difference is the size. A pre|CISION peptide is only two amino acids, making it a small molecule drug versus a monoclonal antibody, which is 1,300 to 1,400 amino acids, a very large biomolecule that requires different manufacturing. ADCs then have to penetrate through that CAF layer to move into the tumor.
It's then taken up into the tumor cells, cleaved in the lysosome, and the bystander effect would tell you that the drug then moves out of dying cells and can then move into an antigen negative. Let's look at a little bit of the differences in the kinetics of how these two different drug classes work. Our translational medicine and our discovery colleagues here compared our kinetic data delivering pre|CISION through pre|CISION, and compared it to two of the ADCs, very successful ADCs out there in HER2 and Datroway. What we found, three key messages.
The first is we see rapid tumor penetration with a pre|CISION molecule versus an ADC, that's because the cancer-associated fibroblasts, which are often thought of as almost a resistance mechanism, a way to keep large biomolecules like an ADC out, they're part of the mechanism of action of pre|CISION, meaning that our drug begins to release as soon as it sees the CAF. The CAFs essentially are part of the mechanism of action of pre|CISION. The second is that we see a much higher maximal concentration of free payload in the tumor. We designed our molecules around this idea, ideally, that we would see a very high Cmax, hit the tumor right away, with a high level of the drug right there within the tumor.
It's up to 40 times higher when we release exatecan from AVA6103 than deruxtecan when it is released from ADCs. Finally, the tumor selectivity index. This is a way for us to consider and look at how selective is the mechanism of action with delivering that released payload in the tumor versus the plasma. This is a simple mathematical, it's a ratio of the area under the curve or the exposure in the tumor versus the plasma. When we create that ratio for either an ADC or the pre|CISION, we see that with pre|CISION, we have nearly three times higher selectivity in the delivery of that released payload. We think that these advantages may translate in the clinic.
We have shown in the preclinical setting, and I hope you'll enjoy, our scientists going through some of that in the Science Day, videos that have been posted. We now look forward in the clinical trial to understanding if these, now pan out in terms of the activity. Let's take a look next at, both, the data catalysts that are coming and our outlook, for the rest of 2026. Things that we have achieved, have that check mark next to them. We strive as a management team and a board to be the kind of company that does what it says it's going to do and does it on time.
I'm happy to report that all of the goals that we put in front of ourselves we have achieved on time, most recently with our first patient, treated on our AVA6103 phase I trial by the end of the first quarter of this year, and also our two AACR updates that occurred at San Diego at the end of last month. Those boxes here that do not have check marks in them are those that we are looking forward to updating on. We will be presenting data from the phase I-B, completed data and joined up data. in the phase I-B cohorts, and that will be the first half of 2026. We are gonna be looking at a couple of different options there. We will be presenting at ASCO.
We will also be attending BIO International, which will be at the end of June, with ASCO beginning at the end of May. Two presentations coming up towards the end of the first half of 2026. In our exatecan program, AVA6103, we have achieved the first patient in. We've achieved the AACR update, and we will be looking forward to the initial phase I data, which we have committed will be released by the end of 2026. Think late fourth quarter for that data to be released. In our third program, in our dual payload, we will be looking at disclosing those first payloads that we will be working towards and that will be at some point in the not-too-distant future.
We're hoping that that is in the third quarter of this year. That will lead us right into the candidate selection. Selecting that clinical candidate really then launches us into those IND-enabling studies and what we think about in Avacta being that last year before a program, a molecule, will be moving towards the clinic. We have achieved a number of our goals that we set for ourselves in 2026, and we have a number of goals still to come. That brings me to what is the outlook for the rest of 2026?
One thing that to mention there as part of my quote in this morning's announcement is that the next period, and we've talked about the next 9- 12 months, this really promises to be a transformative period for Avacta, our shareholders, and our patients. What's important is by the end of that period, we will be seeing the initial clinical data in the AVA6103 program by the end of 2026. Why are these data important? This clinical data really is going to show us in the second program, which really comprises quite a bit of our novel IP, the sustained release mechanism, you know, things that our scientists have been working on for quite some time now.
It's gonna show us in the clinic, does this program behave the way that we anticipate it will behave based on all of the preclinical data that we've worked on for this one? Can we convert a drug like exatecan with a very short half-life and a highly potent and toxic molecule in the clinic? Can we convert it using our pre|CISION platform into a medicine that can be used for a number of malignancies, a number of different indications, as you've seen from the design of our clinical trial?
Second, AVA6000, our first clinical program, will have the clinical data from both the phase I-A and phase I-B cohorts, and those will be presented in the first half of 2026, as I mentioned, at ASCO and also at BIO International, and ASCO being at the end of May and BIO being at the end of June. We will include updated efficacy data, the lead indication of salivary gland cancer. We will have our cardiac safety data that resulted in the removal of the lifetime maximum dose limit, which was really a pivotal time, a pivotal decision made for this particular program. We look forward to updating on all of these data at those two different meetings.
Third, our payload selection and our clinical candidate selection in the Gen 3 pre|CISION dual payload program, AVA6207, these are expected both during the second half of 2026. We will be announcing the payload selection first. Then as we move towards the end of the year, we will also be updating on the clinical candidate selection. We're very excited to move this one into the clinic as fast as we can. Finally, we are continuing discussions with multiple parties on the potential partnering of those assets that I described above, our 1st, our 2nd, and our 3rd-generation assets. This concludes our formal presentation. Thank you very much again for joining us. We appreciate you taking the time to be with us today.
That's great. Chris, Brian, thank you for the overview of your preliminary financial results. Now, if we may just turn to the questions which have been sent in for the management team. We have had a strong response, and thank you to everyone who has submitted. The questions are divided into thematic areas. We'll start with clinical and then turn to financial, business development, and others. First up, we have had some questions on the Gen 2 program. If I may just start off with the first question here, which reads as follows: how many sites are open now, and what's the enrollment pace, patients treated to date?
I'm very pleased with the progress of this study. We've delivered on that commitment that we made to dose the first patient on the FOCUS-01 trial in the first quarter of this year. Recruitment is going well. We are opening further sites. We won't be essentially updating on a cohort-by-cohort basis. We're gonna provide updates at significant points related to data generation. We have committed that the data in this particular trial will be released by the end of this year publicly. Rather than sort of a running commentary on the status of enrollment, that provides very limited insight. We will be releasing all of the data together.
We expect to share data on the safety, on the PK that we're seeing in this trial late Q4 this year as we've previously communicated. We do know that this is different from the communications within the AVA6000 program. However, our approach here is really a standard release of information. We will not surprise with data. We will always give guidance as to when the clinical data will be available and when there will be releases of that data.
That's great, thank you. Just turning to the next question. What was the initial AVA6103 phase I-A dose?
We have disclosed the doses in the program. What I can say now is that this as because the IND is cleared, this initial starting dose was agreed with the FDA. The doses that are being tested will be part of that data release that will occur in the late part of 2026.
Perfect, thank you. Will any U.K. centers be used for the AVA6103 phase I trial?
A very good question, and one that we have had pretty frequently. Let me explain first that the current plan does not envisage the opening of U.K. centers in the AVA6103 phase I clinical trial. The clinical trial will be conducted, at least the phase I-A dose escalation, within a number of centers, probably on the order of 7-9, in the U.S. This is a decision that it was not made lightly, made by the company management team and our board of directors. We considered for this decision, the speed, the cost, and then the challenges that occur when you're aligning a study across two different health authorities. The speed with which the two health authorities work is different.
That misalignment has been a bit of a challenge. Let me also say that although U.S. sites can be a bit more expensive for the company, not for the patients, the benefits of the U.S. FDA and as the health authority, you know, as a single health authority, overseeing the trial and the ability of the FDA to work quickly and the fact that their review groups will work in parallel, is really critical for the ability of the company to move quickly. We have heard from a number of our colleagues in the U.K. at our U.K. sites that this continues to be a conversation. We've been asked about this pretty frequently.
Just to reiterate, this was a decision made by management team and with the support of our board, considering speed, cost, but the alignment really needed to go as quickly as possible.
Perfect, thank you. Next, we have some questions on the Gen-1 program, AVA6000. When will we know about if and when phase II for AVA6000 will begin?
Another really good question. We're very pleased with the data that we've generated thus far with AVA6000. We're very excited about this program, and we look forward, as I mentioned, to presenting more at those two upcoming conferences. We will both be at ASCO beginning at the end of May, but also BIO International in San Diego, which is in the latter part of June. two upcoming conferences. Since we have such a great deal of data that will be coming for the trial to present, it's important for us to have those two presentations coming up. These are both significant conferences in the industry, as you can imagine. We do anticipate having some good conversations there.
You can imagine the addition of the BIO International event as part of the data release that allows us to collect even further scans beyond the data cut that we will present at ASCO. I can confirm that we are still scanning patients in the trial. As you know, as we've disclosed, many of the patients in the trial were enrolled more recently, and that does present a challenge for the concept of, and we've talked about this before, a time to event analysis. The survival analyses are that time to event. We have to wait for that time. Progression-free survival, we have to wait for that progression event that occurs through scans. Overall survival, we wait for death, essentially. It takes time to collect these survival endpoints.
When we receive the new data cut, we'll be making some decisions on which pieces of data we will include in those two different presentations. It's a bit of a conundrum. It's important to note that if it takes longer for us, and you guys have watched this with us, if it takes longer, to see the event mature in the clinic, it actually is very good because the survival is longer. We know, however, it can feel very frustrating. We're trying to go as fast as possible, but it's important to remember that this is good news.
We have committed that we will not start that pivotal trial that phase II or phase III trial that would be designed for an approval until we have a partner on board. What you can imagine is that there are a number of conversations that are ongoing and we will pick those up as well at both of those meetings. Some will be at ASCO some will be at BIO International. You know we've committed to both potential partners and investors that you know we will release the data that are mature.
We have committed that with that decision that was made with the health authority that we will be releasing all of the cardiac safety, which is important for the platform, and then the mature efficacy that is coming from the trial. We will also include some of the biopsy data. We have discussed previously that, you know, the biopsy data in patients is really some of what led to our ability to develop that sustained release mechanism. A number of important data outputs that are coming and quite a few conversations that are ongoing right now. We have committed that we will not start that trial until there is a partner on board.
That's great. Thank you. Chris mentioned that the higher 385 mg dose showed some tolerability challenges and described the TNBC cohort as a bit of a challenge because many patients have prior anthracycline exposure. Does Avacta now see AVA6000 dosing as potentially indication-specific depending on prior anthracycline exposure and tolerability?
I think these quotes from me, if I'm recalling back, are probably around ESMO. We did disclose quite a bit of safety data at ESMO in late in 2025. We're going to be providing further updates as we move toward the end of May at ASCO and later in June in BIO, as I mentioned. The recommended dose for expansion or the RDE, as we call it, for further development was defined as 310 mg/m2 . We did see some challenges with the 385 cohort.
We tried to implement 385, in two different ways, as a straight 385, but also using an option which you've seen this cohort in our various presentations, 385 slash 200, which is we attempted a loading dose cohort. In discussions with the health authority, we also added another cohort at 250 mg/m2 . It's important at this point there's an initiative called Project Optimus where we really wanna get the dose right as we move forward. The added cohort was requested essentially to better judge the appropriateness of our selected 310 dose moving forward.
We're testing these multiple doses, and we anticipate, you know, sort of that final selection to take forward. We don't anticipate, although it's a good question. We don't anticipate indication-specific dosing. It really does add a level of complexity to the development. And so it's only something that we would take forward if there was really a justification from a clinical standpoint. The important change between ESMO and now, and the reason that I can feel so confident to say that, is it's the lifting of the lifetime maximum. You can imagine if a patient has had already half of their lifetime maximum, which is what we see with many of the breast cancer patients, this would impact ultimately the amount of drug if we had that maximum.
This is a, this change meaning that patients are dosing either to progression or unacceptable toxicity. The lifetime maximum was a challenge in breast cancer and the investor asking this question is a good recollection, but it really was before lifting the lifetime maximum. This was an important event for AVA6000. I'm being a little bit long-winded here, but with all that being said, we can't determine the final dose that we'll take forward into those the pivotal study yet.
What I can tell you is that we're gonna have a good deal of data from both the dose escalation trying 385 twice, the 310 that has been used across the expansion cohorts, and then the additional cohort just requested again by the health, so that we get that decision 100% right. I can tell you as well that we are gonna be disclosing data at the 310 migs per meter squared at both ASCO and at BIO again in a few weeks. You know, just to reiterate, the reason to add that second there's gonna be quite a bit of data upcoming as you can hear in the response to this question.
Perfect, thank you. Just turning to the next question. Has an expedited pathway for the FDA been applied for?
Great question. As you may have seen, some in the room saw, and then the videos have been posted, at our Science Day, our regulatory affairs head, this was the 6th talk, so the last talk of the day, he talked about the different pathways to approval. He gave a little bit of color on the sorts of discussions that companies, like ours have, with FDA. There are, you know, multiple different, expedited pathways that are offered, by the various regulators, not just FDA, but across the globe. These are generally granted based on favorable early data in the program. When I say favorable early data, it's not just safety, but it's efficacy as well.
You can imagine that this, you know, the health authority is going to take on a bit more work. What I can tell you is similar to our discussions with pharma partners, the discussions with the health authorities are conducted under the understanding of confidentiality. We don't disclose the status. We can't disclose the status at this point. Any material information which is meaningful to the program that is discussed with health authorities is disclosed once, you know, once essentially decisions are final. I can give you a good example of this is that lifting of the cumulative lifetime maximum of doxorubicin exposure in the AVA6000 program.
This was important for us to announce because it does change the thesis for any individual patient, especially those who have received prior anthracycline. It also may change the likelihood that a given patient would be a responder with longer therapy. As you saw in our ESMO data, we have disclosed that, you know, there are a number of patients in the salivary gland cancer indication who come off a drug for that lifetime maximum. What I can tell you here is that if a decision is made on an expedited program or data review, if one of those was granted, we would of course disclose that just as we would disclose, you know, final agreed trial designs.
The material information here is the granting of any application, and this would be agreed with that regulator or the health authority.
That's great. Just turning to the next question. When would you envisage AVA6000 replacing the standard doxorubicin treatment?
We've been asked as well if we've applied essentially for accelerated approval? The short answer is no. We've not sought any kind of approval for AVA6000. If the profile of AVA6000 continues to develop essentially the way that we hope and expect it to, then, you know, there's every reason to expect that oncologists would want to use our medicine rather than the original doxorubicin. There are a few caveats here. Okay, let me explain this one. First, we are currently some way from completing the clinical development of AVA6000, and that goes back to that regulatory affairs talk six from Science Day. The next step is really the pivotal study.
As I've mentioned, that's only going to commence once we have a partner on board. We'll not take this one on alone. Given that, I can't speculate now when that would commence exactly. We're still collecting the data. The survival is longer. We're quite happy about that. I can't also speculate as to when AVA6000 may displace doxorubicin in some of those clinical practice. As we discussed in that regulatory presentation, a medicine like AVA6000 would seek an approval in a specific indication or a specific tumor type. Conventional doxorubicin, if you look at the label, it's used in a number of different tumor types, but not every one of these would be approved at the outset.
In fact, it would probably be in if the current plan holds, it would be salivary gland cancer would be that first approval. You know, as an example, if we were to run that proposed trial with AVA6000 in patients with salivary gland cancer and it was successful and we gain a drug approval, this doesn't mean that AVA6000 can be freely used, for example, in breast cancer or soft tissue sarcoma, two of the other tumor types with activity of doxorubicin. The use of this medicine and you know, the reimbursement is dependent on the label, and that is agreed based on that pivotal trial that was conducted. It's more of an indication specific.
And it, you know, we're hoping with that, with that potential partner that there would be, you know, not just that salivary gland indication, but that it could be available to patients with other tumor types as well. I very much look forward to that day. I've been quoted as saying that, you know, AVA6000 could actually make a real dent in some other tumor types. We very much look forward to that.
That's great. What is the AVA6000 phase I-B dose? What does the 385/200 of RDE mean?
Yeah, we've gotten this one. The phase I-B dose, as I mentioned, we've used 310. We've also been requested to study 1 dose level lower, which was 250. We did have two different cohorts in the phase I-A portion of the trial looking at 1 dose above, which is that 385, and the 385/200. Those were 2 385 dose cohorts. one was straight 385. It did have some tolerability issues. Many of the patients went through a dose reduction, and that's why we tried essentially the loading dose cohort.
With those, sort of three dose levels now studied, we will be looking at those data together and selecting that dose to take forward into a potential pivotal trial.
Perfect. Thank you. Could you please provide an update for the AVA7100 program, which has missed candidate selection in H2 2025 and therefore delayed IND into H 2026? If these major pipeline delays are because of new plan for Affimers, please provide details.
Great question. Our work looking at Affimers, AVA7100, this was again a further answer to the ADC drug class. Specifically, we were looking at how to target those tumor types with low FAP expression. You've seen our Tempus data where we break down, and our IHC data that we've published, where we break down FAP expression into that really low level of 1 plus, and then it, you know, compared that to the higher levels of 2 +, 3 +. We have essentially held that program for two main reasons. One is the clinical data, and they're good reasons. The clinical data with AVA6000, and we started to present that at ESMO last year, we'll be updating again.
pre|CISION alone works very well, even at the lowest levels of expression. We did show some IHC back, and it was a patient with very low expression in salivary gland cancer. You'll recall that first program looking at an Affimer drug conjugate was utilizing a FAP Affimer, and it was really designed to go after those FAP low tumor types. We're thrilled that this is no longer needed because pre|CISION works across the various levels of expression. The second reason is also a really good one in that our pre|CISION technology appears to deliver payloads. Our sustained release mechanism is important here. It has, we think, even a better kinetic profile than an ADC. And that's just using pre|CISION alone. We don't need half-life extension.
We don't need all of the benefits, the potential benefits that we thought the Affimers could provide. We don't think that there is the need for a larger biologic agent to facilitate that sustained release. It was really the development of AVA6103 that provided that that sort of half-life. That sustained release is essentially as good as a half-life extension. It's also important for me to note that the Affimer franchise itself is not discontinued, just our, you know, use of it as a Affimer drug conjugate. You'll recall with our joint venture with Daewoong AffyXell that they are looking at Affimers in cell therapy. You know, it's not my place to update on AffyXell and their business, but that continues.
That's great. Just moving on here. What is the plan date for the first drug to market and clinical trial conclusion?
This is going to really relate back to something that we've talked about, which is our partnering discussions, which I know we'll be discussing, you mentioned as there are questions on this topic. We talked about this a bit on at Science Day. Clinical trials can be quite a long process. The more effective a drug turns out to be, especially with those time to event, the longer the trials can take. Oftentimes, those later stage, phase II, phase III's have progression endpoints like a PFS. Ultimately, the decisions on indications, designs, endpoints will be made with a partner and the health authorities. As soon as decisions are made and as soon as we can update, we will bring you all of these news when there's more information to share on that topic.
That's great. Chris mentioned in the March 2025 Panmure podcast that pathway inhibitors was something the company had hoped to see coming soon to the clinic. Is this still an area of interest for the platform, or has the development of AVA6207 made it more likely that these agents would instead be incorporated into dual payload approach?
Yeah, another good one. As you've seen both, you know, as we've talked about today, but also at our Science Day, our novel chemistry in AVA6103 really facilitates this. It's really propelled the company forward. It allows us to consider multiple different, a whole range of payloads that we can implement both as single agents, but also as dual payload delivery. Anything that we can do on a dual payload, we can also do as a single agent. Our first disclosures in the dual payload were with the first couple of pathway inhibitors that we've looked at. These are both the ATR and the PARP inhibitors.
We've disclosed that the both of these, you know, relatively limited activity on their own, but looking quite good in both late last year, but also at AACR just about a month ago, in terms of the dual payload delivery. We actually think we are the only drug conjugate company that can produce a non-ADC dual payload drug. We're really excited to move our Gen 3 assets forward. You know, the chemistry of Gen 2 is really what enables us to be able to put so many different payload options there. We'll update again, once there's more information.
Perfect. That's great. Do patients have to pay anything to be on the trials at the U.S. centers? For example, hospital stays, procedures, et cetera, who pays for that?
Generally, no. Patients enrolled in a clinical trial, they receive their treatment at the expense of the trial sponsor, but also using their health insurance. This is one of the reasons why it's an expensive business running clinical trials, and we think very carefully about designs and how to maximize data collection. We believe that this is a very worthwhile investment for both the patients, the broader population of Avacta, our shareholders. I should probably also add to this that patients may be receiving other therapies. Parts of the trial are actually covered by the insurers. We work with each individual site in terms of, you know, the paying of the bills and what goes to insurance and what the sponsor will cover. That's a big effort in our clinical operations group.
Perfect. That's great. That actually rounds off our questions on the Avacta pipeline. We'll now move on to some of the financial questions. Perhaps, Brian. These ones are for you. What is the current cash balance post-raise, and what's the expected monthly burn?
Per the announcement today, our net cash at the end of April 2026 was GBP 16.4 million. We don't disclose a specific figure on expected monthly cash burn.
Perfect. That's great. Does the runway into early Q1 2027 assume no partnering income?
That's correct. The cash runway projection does not include any potential income from partnering.
That's great. Just a question around the convertible bond. What conditions trigger more conversations? Is there a planned strategy to reduce the bond overhang?
The way the bond works is that the conversion decision is for the bondholder to make. Really, we aren't in a position to explain these decisions or to speculate. Really, you'd have to speak to them for more insight on this.
Perfect. Thank you. When will investors see Avacta in profit?
As a clinical stage biotech company, we do not yet generate revenues. timescales are quite long in R&D and clinical development, and so it's usual for companies like us not to be generating a profit for some time, at least until a drug from our pipeline is on the market. This is linked to the partnering question earlier, and the onward clinical development and regulatory filings of our assets with a partner in the future.
That's great. Has there been any progress towards listing shares in the USA.? Are there plans to list in the U.S.? Can we have an update on that?
As we've said, we have begun some work on a dual listing on Nasdaq. We have spoken and continue to speak with U.S. institutional investors to ensure that they know about us and will be interested to own the stock when we do list. Our presentation and participation at the Cowen conference in March was very much part of this work. When the time is right, we will have a lot more to say on this. As these things are ongoing discussions, there's not much we can say about this right now.
Thank you. Is there a provision to reward the small team of staff with shares?
We are in the process of implementing a long-term incentive program for Avacta staff, which will provide employees the opportunity to become shareholders of the company.
Perfect. Thank you, Brian, for giving us an update on the financial position. We have a few more questions, just looking at the strategy and the business development opportunities. If perhaps, Chris, these ones might be for you. How far advanced are the partnerships licensing deals, discussions?
A great question. The data in AVA6000, the phase I-B, continues to mature and, importantly, our second asset, AVA6103, is now in the clinic. We have a number of conversations ongoing. Really moving AVA6103 into the clinic was a big deal for us because our position in these partnering discussions is only getting stronger. Even the dual payload is quite interesting as well. As I mentioned, we think that we're the only of these, you know, sort of quote, unquote, "XDC companies", that have a dual payload approach, a highly controlled, dual payload approach. What this means though is many of the potential partners that we are talking to are awaiting some of those data in order to make decisions.
We do continue to update the wider market on the frequency that we have confirmed. It's also important to note that we do also have substantive conversations with a number of partners that are under confidential, you know, or non-disclosure agreements across different assets. These discussions, I would describe them as constructive. They are progressing. Given the NDAs that are in place, it wouldn't be appropriate for me to speculate on any kind of status beyond saying that we do have a clear business development plan that we are executing. We have, you know, great scientists good at these, great clinicians, and also our business development consultant is working directly with us on these. We're executing against our plan here.
Perfect. Thank you. Just turning to the next questions we've got here. Is the pre|CISION going to be licensed out for other companies to develop anti-inflammatory therapeutics similarly for anti-fibrotics, although CC has already said that indication is not such a good target? Could pre|CISION be licensed out to diagnostic companies to develop diagnostics?
Let me take the first one. Precision is really now demonstrating its value in the clinic. I think that the biopsy data, the efficacy data, you know, there's tremendous learnings that we have from AVA6000. That value is just gonna continue to increase as we generate more data, learning how the sustained release mechanism works and whatnot. I'm not sure that I ever said that that wouldn't work. There could be potential in anti-inflammatory, in diagnostics. As yet there's not sufficient evidence to take that forward.
What I can tell you is, while there is the potential there, our company, Avacta, we remain focused on developing pre|CISION in the oncology settings, and continue to certainly pursue other opportunities for licensing. You know, conversations that are ongoing right now on that specific topic are somewhat earlier than our oncology pipeline as you can imagine. It would have to be on the right terms and reflect the full value. We retain the full IP rights to the pre|CISION platform, and, you know, I'll close this one by saying it's interesting. I think it's very important for us as a management team, as our scientific team to focus, against the goals, that we've put in front of us, and that really includes our oncology settings right now.
That's great. What's the current board view on how to create optimum shareholder value going forward?
Good question. You'll see in our preliminary results RNS today, our Chairman, Shaun Chilton, and our entire board really clearly support the strategy. Multiple oncology assets going into the clinic. As I mentioned, you know, one of the biggest expenses that we have is our clinical trials. We think very carefully about each asset that we take into the clinic. Generating robust data packages, really innovating around our platform, new IP. Importantly, exploring multiple partnering opportunities with potential strategic partners, which as I mentioned, we continue to work through some of those opportunities. We think that, you know, sort of three-part strategy really is gonna create optimal value for our shareholders.
The board shares and supports us, helps management with each of these. We as a management team, we have a very strong and a very constructive relationship with our board. I'm very pleased to have their support. They continue to, you know, support us through this oncology focus, assets in the clinic, robust data packages, IP, and our, you know, our various potential strategic partners. Board has been very supportive, management team continues to have that deep focus and execute on those three, you know, really important pillars for us.
That's great. Thank you, Chris, for answering all of those questions. We have had a couple of further questions coming in now, and then that should probably take us up to time. Can you update investors on the potential IPO of AffyXell Therapeutics?
This is really a topic for AffyXell. I'm sure that you can appreciate that, we can't comment on those kinds of strategies for other companies. Our relationship with AffyXell continues. Their corporate moves are their decision, so I won't comment on this one.
That's great. How secure are Avacta's intersite comms?
We have a security provider. We do have you know, it ensures our web presence. It ensures our email traffic, and all of our communications methods, SharePoint, all of that is well locked down. Any of our sensitive information is always stored and communicated in a very secure manner. We do have a very good partner out there that works on this with us.
That's great. Just coming up to the final question we've got here. Is CC's Kitchen Avacta's U.S. headquarters?
As you know, our headquarters are here, White City, in London. I do spend quite a lot of time traveling on planes. One can say, yes, in Philadelphia, our headquarters is somewhat movable. You know, beyond the costs that we have with our clinical trials, the other big expense that we have is people. Adding bricks and mortar costs more money. As you know, we spend every dollar, every pound, as if it is ours. Even though I do spend a lot of time on the road and think of London as my other home, I do often work from home when I am in Philadelphia, and I have joked that I like to work in the kitchen.
It's right in the middle of the house. Yes, that is where you can see me, when I'm in Philadelphia. Yeah, coming to you today from White City, though.
That's great. Chris, Brian, thank you for taking the time to address all those questions. That does conclude the Q&A. Just before I redirect investors for their feedback, Chris, would you like to sum up on where Avacta is and what's next?
Sure. Really appreciate the time that everyone has taken today. Thank you. I know that time is really one of our most precious resources as people. Thank you for your continued interest and your continued support of Avacta. We're very grateful. I wanted to start today with our strategy and our vision. I think that the mission that we have of really trying to make a dent in cancer is so critically important. This is really an exciting time for the company. We have made huge progress. We've strengthened our position as a pure play oncology therapeutics company. We are centered on our unique pre|CISION XDC technology. We are well-positioned. We have a solid financial basis. We have incredible support from our shareholders.
We, our whole team here was so happy to meet with so many at Science Day. That was a really great interaction. As we've highlighted, we have two programs now in clinical development. We have multiple upcoming milestones, I really do believe the next 9 - 12 months is just gonna be transformative for this company. We are looking to deliver value for shareholders and patients alike. When we deliver for our patients, we will be delivering for our shareholders. We've made excellent progress in our pipeline. We have done what we said we were going to do. We've progressed the pipeline. We've progressed our IP. These are two critical areas that we focus on. You know what?
Let me conclude the future is so bright, as we enter this transformative period of the next 9 -12 months, and we really look forward to so many of those updates that we will be giving. We look forward. You know, it's only a few weeks away that we'll be talking again. Thank you for the time. Much appreciated, and we look forward to talking again soon.
That's great. Chris, Brian, thank you for updating investors today. Can I please ask investors not to close this session, as you'll now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations. This may only take a few moments to complete, and I'm sure will be greatly valued by the company. On behalf of the management team, we'd like to thank you for attending today's presentation, and good afternoon to you all.