Avacta Group Plc ($AVCT)
Earnings Call Transcript · May 19, 2026
Earnings Call Speaker Segments
Operator
OperatorGood afternoon, and welcome to the Avacta Group Plc investor presentation. [Operator Instructions] And I'd now like to hand you over to the management team. Christina, good afternoon.
Christina Coughlin
ExecutivesGood afternoon. Thank you very much coming to you from London, and a very good morning to our colleagues joining from the United States. 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 preCISION 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 preCISION 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, and our goal is to expand the reach of many of the highly potent anticancer 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 preCISION peptide drug conjugate platform. Let me start with our exciting new clinical program, our GEN2 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 6 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 2 successful antibody drug conjugates in HER2 and Dapraib. We'll take a look at the data, just a couple of slides from Science Day, my 2 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-1 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 '26 in the Phase Ib portion of the trial to assess the efficacy of AVA6000 in those more homogeneous and defined patient populations, the 3 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 third generation AVA6207, which is our recently developed our dual payload technology. This incorporates the sustained release mechanism that is part of our Gen 2 platform, but also with multiple combinations of payloads. We did show updated in vivo data at the AACR Annual Congress in San Diego, again in April of this year. And then finally, we do continue to grow our IP estate around the P ECISION 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.
Brian Hahn
ExecutivesThank you, Chris. Our top priority is to establish Avacta sustainable long-term financing strategy in order to realize the tremendous opportunity that this platform could provide. We invested $18.8 million in 2025 in research and development expenses. Those were in line with expectations. That's up from $14.3 million last year, the same period related to both preCISION therapeutic programs. Administrative expenses have decreased during the year down to about roughly $10 million, down from $12 million in the previous year. Net operating cash outflows from continuing operations was $22.64 million as compared to $24.94 million in 2024. It's important to note that we've raised $32.5 million over the last 18 months to help support these R&D programs and cash as of the end of April was $16.4 million following the oversubscribed placing the subscription of $10 million. This will extend the cash runway into early Q1 2027.
Christina Coughlin
ExecutivesThanks, Brian. As I mentioned, I'd like to cover today, look at today, 2 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 preCISION mechanism requires 2 amino acids in the preCISION 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. So 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. PreCISION peptide is only 2 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 2 different drug classes work. Our translational medicine and our discovery colleagues here compared our kinetic data delivering preCISION through preCISION and compared it to 2 of the ADCs, very successful ADCs out there in HER2 and DARA. And what we found 3 key messages. The first is we see rapid tumor penetration with a preCISION molecule versus an ADC. And 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 preCISION, meaning that our drug begins to release as soon as it sees the CAF. So the CAFs essentially are part of the mechanism of action of preCISION. 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, so hit the tumor right away with a high level of the drug right there within the tumor. It's up to 40x higher when we release exatecan from AVA6103 than daruxtecan when it is released from ADCs. And then 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. And so this is a simple mathematical -- it's a ratio of the area under the curve or the exposure in the tumor versus the plasma. And when we create that ratio for either an ADC or the preCISION, we see that with preCISION, we have nearly 3x higher selectivity in the delivery of that released payload. So 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. And 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. So things that we have achieved have that checkmark next to that. 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. And 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 2 AACR updates that occurred in San Diego at the end of last month. Those boxes here that do not have check box in them are those that we are looking forward to updating on. We will be presenting data from the Phase Ib completed data and joined-up data in the Phase Ib cohorts, and that will be the first half of 2026. We are going to 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. So 2 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. So I 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. And then that will lead us right into the candidate selection. So 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. So 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. And that brings me to what's 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 to 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 AVA-6103 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 compromises quite a bit of our novel IP, the sustained release mechanism, things that our scientists have been working on for quite some time now. It's going to 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 a 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 Ia and Phase Ib cohorts, and those will be presented in the first half of 2026. As I mentioned, at ASCO and also at Bio International in 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. So we look forward to updating on all of these data at those 2 different meetings. Third, our payload selection and our clinical candidate selection in the Gen 3 preCISION dual payload program, AVA6207. These are expected both during the second half of 2026. We will be announcing the payload selection first. And 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. And then finally, we are continuing discussions with multiple parties on the potential partnering of those assets that I described above, our first, our second and our third-generation assets. And this concludes our formal presentation. Thank you very much again for joining us. We appreciate you taking the time to be with us today.
Operator
OperatorThat'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. So 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?
Christina Coughlin
ExecutivesSo I'm very pleased with the progress of this study. We have -- 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 are going to 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. And so 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.
Operator
OperatorThat's great. And just turning to the next question. What was the initial AVA6103 Phase Ia dose?
Christina Coughlin
ExecutivesSo we have disclosed the doses in the program. What I can say now is that this -- because the IND is cleared, this initial starting dose was agreed with the FDA. And the doses that are being tested will be part of that data release that will occur in the late part of 2026.
Operator
OperatorPerfect. Will any U.K. centers be used for the AVA6103 Phase I trial?
Christina Coughlin
ExecutivesA 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 Ia dose escalation within a number of centers, probably on the order of 7 to 9 in the United States. This is a decision that 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 2 different health authorities. The speed with which the 2 health authorities work is different. And that misalignment has been a bit of a challenge. So 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, 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. And 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.
Operator
OperatorPerfect. Thank you. Next, we have some questions on the GEM-1 program, AVA6000. When will we know about if and when Phase II for AVA6000 will begin?
Christina Coughlin
ExecutivesSo 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 2 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. So 2 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 2 presentations coming up. These are both significant conferences in the industry, as you can imagine. And 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. So we have to wait for that time. So progression-free survival, we have to wait for that progression event that occurs through scans. Overall survival, we wait for death essentially. And it takes time to collect these survival endpoints. And so when we receive the new data cut, we'll be making some decisions on which pieces of data we will include in those 2 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 could feel very frustrating. And 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. And 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. And so some will be at ASCO, some will be at Bio International. And we've committed to both potential partners and investors that we will release the data, 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 the biopsy data in patients is really some of what led to our ability to develop that sustained release mechanism. So a number of important data outputs that are coming and quite a few conversations that are ongoing right now. But we have committed that we will not start that trial until there is a partner on board.
Operator
OperatorThat's great. 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 indications specific depending on prior anthracycline exposure and tolerability?
Christina Coughlin
ExecutivesSo I think these quotes from me, if I'm recalling back, are probably around ESMO. And we did disclose quite a bit of safety data at ESMO in late in 2025. We are going to be providing further updates as we move towards 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 milligrams per meter square. We did see some challenges with the 385 cohort. We tried to implement 385 in 2 different ways as a straight 385, but also using an option, which you've seen this cohort in our various presentations, 385/200, which is we attempted a loading dose cohort. In discussions with the health authority, we also added another cohort at 250 milligrams per meter square. It's important at this point, there's an initiative called Project Optimus, where we really want to get the dose right as we move forward. And so 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 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. So you can imagine if a patient has had already half of their lifetime maximum, which is what we see with many of breast cancer patients, -- this would impact ultimately the amount of drug if we had that maximum. And so this is -- 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, this is a good recollection, but it really was before lifting the lifetime maximum. And so this is -- this was an important event for AVA6000. But 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 going to 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 going to be disclosing data at the 310 mgs per meter squared at both ASCO and at Bio coming up again in a few weeks. And just to reiterate, the reason to add that second -- there's going to be quite a bit of data upcoming, as you can hear in the response to this question.
Operator
OperatorPerfect. Just turning to the next question. Has an expedited pathway for the FDA been applied for?
Christina Coughlin
ExecutivesGreat question. As you may have seen some in the room saw and the videos have been posted at our Science Day, our regulatory affairs head, this was the sixth talk, so the last talk of the day. He talked about the different pathways to approval. And he gave a little bit of color on the sorts of discussions that companies like ours have with FDA. There are multiple different expedited pathways that are offered by the various regulators, not just FDA, but across the globe. And these are generally granted based on favorable early data in the program. And when I say favorable early data, it's not just safety, but it's efficacy as well. You can imagine that this -- the health authority is going to take on a bit more work. And so 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. So 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 essentially decisions are final. And 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. And 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 there are a number of patients in the salivary gland cancer indication who come off drug for that lifetime maximum. So 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 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.
Operator
OperatorThat's great. Just turning to the next question. When would you envisage AVA6000 replacing the standard doxorubicin treatment? So...
Christina Coughlin
ExecutivesWe've been asked as well, have we applied essentially for accelerated approval. This is -- 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 there's every reason to expect that oncologists would want to use our medicine rather than the original doxorubicin. But there are a few caveats here. Okay. Let me explain this one. So first, we are currently some way from completing the clinical development of AVA6000, and that goes back to that regulatory affairs talk from Science Day. The next step is really the pivotal study. And 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. But given that, I can't speculate now when that would commence exactly. We're still collecting the data. The survival is longer. And so we're quite happy about that. So I can't also speculate as to when AVA6000 may displace doxorubicin in some of those clinical practice. And as we -- as 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 -- if the current plan holds, it would be salivary gland cancer would be that first approval. So 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 gained a drug approval. This doesn't mean that AVA6000 can be freely used, for example, in breast cancer or soft tissue sarcoma, 2 of the other tumor types with activity of doxorubicin, the use of this medicine and the reimbursement is dependent on the label, and that is agreed based on that pivotal trial that was conducted. And so it's more of an indication specific. And we're hoping with that potential partner that there will be not just that salivary gland indication, but that it could be available to patients with other tumor types as well. And I very much look forward to that day. I could quote it as saying that AVA6000 could actually make a real dent in some other tumor types. And so we very much look forward to that.
Operator
OperatorThat's great. What is the AVA6000 Phase Ib dose? What does the 385/200 of RDE mean?
Christina Coughlin
ExecutivesYes, we've gotten this one. So the Phase Ib dose, as I mentioned, we've used 310. We've also been requested to study dose level lower, which was 250. And we did have 2 different cohorts in the Phase Ia portion of the trial, looking at dose above, which is that 385 and the 385/200. So 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. But with those sort of 3 dose levels now studied, we will be looking at those data together and selecting that dose to take forward into a potential pivotal trial.
Operator
OperatorPerfect. Could you please provide an update for the AVA7100 program, which has missed candidate selection in H2 2025 and therefore, delayed IND in 2H 2026. If these major pipeline delays are because of new plan for Affimers, please provide details.
Christina Coughlin
ExecutivesGreat question. So our work looking at Affimers, AVA70100. This is, again, a further answer to the ADC drug class. And 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 in our IHC data that we've published where we break down FAP expression into that really low level of 1 plus and then compared that to the higher levels of 2+ 3 plus. And so we have essentially held that program for 2 main reasons. One is the clinical data and they're good reasons, but the clinical data with AVA6000, and we started to present that at ESMO last year, we'll be updating again. PRECISION alone works very well even at the lowest levels of expression. We did show some IHC back, and it was patients with very low expression in salivary gland cancer. And so you'll recall that first program looking at an Affimer drug conjugate was utilizing an Affimer, and it was really designed to go after those FAP low tumor types. And we're thrilled that this is no longer needed because preCISION works across the various levels of expression. The second reason is also a really good one in that our preCISION 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 preECISION alone. So we don't need half-life extension. We don't need all of the benefits, the potential benefits that we thought the aim could provide. And so 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 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 use of it as an Affimer drug conjugate. You'll recall with our joint venture with DUAficel that they are looking at Affimers in cell therapy. And so it's not my place to update on Apiicceel and their business, but that continues.
Operator
OperatorThat's great. Just moving on here. What is the plan date for the first drug to market in clinical trial conclusion?
Christina Coughlin
ExecutivesAnd 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 IIIs have progression endpoints like a PFS. And so ultimately, the decisions on indications, designs, endpoints will be made with the partner and the health authorities. And so 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.
Operator
OperatorThat's great. Chris mentioned in the March 2025 panel 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 AVA-6207 made it more likely that these agents would instead be incorporated into dual payload approach?
Christina Coughlin
ExecutivesSo another good one. So as you've seen both 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. So anything that we can do on a dual payload, we can also do as a single agent. Our first disclosures in the dual payload we were with the first couple of pathway inhibitors that we've looked at. These are both the ATR and the PARP inhibitors. And we've disclosed that both of these 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. So we're really excited to move our Gen 3 assets forward. And the chemistry of Gen 2 is really what enables us to be able to put so many different payload options there. And we'll update again once there's more information.
Operator
OperatorPerfect. 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?
Christina Coughlin
ExecutivesGenerally, no. So 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 ACA, 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. And we work with each individual site in terms of the paying of the bills and what goes to insurance and what the sponsor will cover. So that's a big effort in our clinical operations group.
Operator
OperatorPerfect. That's great. That actually rounds up our questions on the Avacta pipeline. So we'll now move on to some of the financial questions. Perhaps, Brian, these ones for you. What is the current cash balance post raise? And what's the expected monthly burn?
Brian Hahn
ExecutivesFor 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.
Operator
OperatorPerfect. That's great. Does the runway into early Q1 2027 assume no partnering income?
Brian Hahn
ExecutivesThat's correct. The cash runway projection does not include any potential income from partnering.
Operator
OperatorThat's great. And just a question around the convertible bond. What conditions trigger more conversations? And is there a planned strategy to reduce the bond overhang?
Brian Hahn
ExecutivesThe way the bond works is that the conversion decision is for the bondholder to make. So really, we aren't in a position to explain these decisions or to speculate. Really, you have to speak to them for more insight on this.
Operator
OperatorPerfect. When will investors see Avactor in profit?
Brian Hahn
ExecutivesAs a clinical stage biotech company, we do not yet generate revenues. Time scales 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. So 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.
Operator
OperatorThat's great. Has there been any progress towards listing shares in the U.S.A.? Also, are there plans to list in the U.S.? Can we have an update on that?
Brian Hahn
ExecutivesAs we've said, we have begun some work on the dual listing on NASDAQ. We have spoken and continue to speak with U.S. institutional investors to ensure that they know about us, and we'll 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. But as these things are ongoing discussions, there's not much we can say about this right now.
Operator
OperatorThank you. Is there a provision to reward the small team of staff with shares?
Brian Hahn
ExecutivesWe 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.
Operator
OperatorPerfect. Thank you, Pam, for giving us an update on the financial position. We have a few more questions. I'm just looking at the strategy and the business development opportunities. So perhaps, Chris, these ones might be for you. How far advanced are the partnerships licensing deals and discussions?
Christina Coughlin
ExecutivesGreat question. The data in AVA6000, the Phase Ib continues to mature. And importantly, our second asset, AVA6103, is now in the clinic. So we have a number of conversations ongoing. Our position -- so 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 sort of ["eXDC"] companies that have a dual payload approach, a highly controlled dual payload approach. And so 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, but it's also important to note that we do also have substantive conversations with a number of partners that are under confidential nondisclosure agreements across different assets. These discussions, I would describe them as constructive. They are progressing. But 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 great scientists good at these, great clinicians and also our business development consultant is working directly with us on these. So we're executing against our plan here.
Operator
OperatorPerfect. Thank you. Just turning to the next questions we've got here. Is the P recISisionON going to be licensed out for other companies to develop anti-inflammatory therapeutics, -- similarly for antifibrotics. Although CC has already said that indication is not such a good target, could PreCISION be licensed out to diagnostic companies to develop diagnostics?
Christina Coughlin
ExecutivesSo let me take the first one. PreCISION is really now demonstrating its value in the clinic. I think that the the biopsy data, the efficacy data, there's tremendous learnings that we have from AVA6000. And that value is just going to continue to increase as we generate more data, learning how the sustained release mechanism works. I'm not sure that I ever said that, that wouldn't work. There could be potential in anti-inflammatory in diagnostics. But 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 precision in the oncology settings and continue to certainly pursue other opportunities for licensing 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 PRECISION platform. And 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.
Operator
OperatorThat's great. What's the current Board view on how to create optimum shareholder value going forward?
Christina Coughlin
ExecutivesGood question. You'll see in our preliminary results, RNS today, our Chairman, Mr. Sean Schulten, and our entire Board really clearly support the strategy. So multiple oncology assets going into the clinic. As I mentioned, one of the biggest expenses that we have is our clinical trials. So we think very carefully about each asset that we take into the clinic, generating robust data packages, really innovating around our platform, new IP, new IP. And then importantly, exploring multiple partnering opportunities with potential strategic partners, which, as I mentioned, we continue to work through some of those opportunities. And we think that, that sort of 3-part strategy really is going to create optimal value for our shareholders. The Board shares and supports us, helps management with each of these. And then 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 support us through this oncology focus, assets in the clinic, robust data packages, IP, IP and then our various potential strategic partners. So Board has been very supportive and management team continues to have that deep focus and execute on those 3 really important pillars for us.
Operator
OperatorThat's great. And 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 Afficel Therapeutics?
Christina Coughlin
ExecutivesSo this is really a topic for Affimer. I'm sure that you can appreciate that we can't comment on those kinds of strategies for other companies. Our relationship with Afficel continues and their corporate moves are their decisions. So I won't comment on this one.
Operator
OperatorThat's great. How secure are Avacta is into [indiscernible]
Christina Coughlin
ExecutivesSo we have a security provider. We do have -- it ensures our web presence. It ensures our e-mail 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. And we do have a very good partner out there that works on this with us.
Operator
OperatorThat's great. And just coming up to the final question we've got here. Is CC's kitchen Avacta's U.S. headquarters?
Christina Coughlin
ExecutivesAs you know, our headquarters are here, White City in London. I do spend quite a lot of time traveling on planes. And one can say, yes, in Philadelphia, our headquarters is somewhat movable. Beyond the cost that we have with our clinical trials, the other big expense that we have is people and adding bricks and mortar costs more money. As you know, we spend every dollar, every pound as if it is ours. But 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. And yes, that is where you can see me when I'm in Philadelphia. But yes, coming to you today from White City, though.
Operator
OperatorThat's great. And Chris, Brian, thank you for taking the time to address all those questions. That does conclude the Q&A. But just before I redirect investors for their feedback, Chris, would you like to sum up on where Avacta is and what's next?
Christina Coughlin
ExecutivesSure. I 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 preCISION 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 2 programs now in clinical development. We have multiple upcoming milestones. And I really do believe the next 9 to 12 months is just going to 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 2 critical areas that we focus on. And you know what, let me conclude, the future is so bright as we enter this transformative period of the next 9 to 12 months, and we really look forward to so many of those updates that we will be giving. And we look forward -- it's only a few weeks away that we'll be talking again. So thank you for the time. Much appreciated, and we look forward to talking again soon.
Operator
OperatorThat'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 will 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.
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