Avacta Group Plc (AVCT) Earnings Call Transcript & Summary

September 30, 2025

AIM GB Health Care Biotechnology earnings 45 min

Earnings Call Speaker Segments

Operator

operator
#1

Good afternoon, ladies and gentlemen, and welcome to the Avacta Group plc Interim Results Investor Presentation. [Operator Instructions] Due to the significant attendance on today's call, the company will not be in a position to answer every question received during the meeting itself. However, the company can review all questions submitted today, and will publish those responses where it's appropriate to do so. Before we begin, we'd like to submit the following poll. And I'm sure the company will be most grateful for your participation. I'd now like to hand over to the management team, Chris, Brian. Good afternoon.

Christina Coughlin

executive
#2

Good afternoon, Mark. Thank you for having us, and good morning to our colleagues across the pond in states. My name is Christina Coughlin. I am the CEO of Avacta Therapeutics coming to you here from White City, London at our headquarters, and I'm joined by my Chief Financial Officer, Brian Hahn. We look forward to delivering to you today our interim results for the period ending June 30, 2025. As part of our presentation, both Brian and I will be making forward-looking statements. Recent research and development highlights from the company. We are currently enrolling our clinical stage program, faridoxorubicin, happy to bring that name to you for the first time today. It has been issued by the World Health Organization, FAP-Dox or AVA6000. We continue to enroll in the expansion cohorts in this program. Our second clinical program, and I use that term as FAP-exatecan, is quickly approaching the clinic. FAP-exatecan does remain on track to dose its first patient in the first quarter of 2026. As part of today's presentation, I would like to update for you one piece of data, one experiment that is ongoing, and show you the time line for that IND. Our clinical data with faridoxorubicin, FAP-Dox or AVA6000, and our clinical data -- our preclinical data with FAP-exatecan, and translational work in the pre|CISION program, all of these were presented as part of the period under review today. April of 2025, these 3 presentations occurred at the American Association for Cancer Research, the Annual Meeting that occurred earlier this year Those 3 presentations were quite pivotal for the company, in that we showed exactly what faridoxorubicin was able to do. Some very preliminary, but very encouraging data in the lead indication of salivary gland cancers for that particular program. FAP-exatecan, we did show a number of the preclinical studies. Again, with some of those being preliminary at the time, we're happy to update one key study today. And then the translational work, really highlighting some of the power of our Tempus collaboration there at the AACR. Avacta is slated to present the final Phase Ia dose escalation data for our lead program, faridoxorubicin. This will be at ESMO 2025 in Berlin, a little bit later next month in October of 2025. There, we are looking to present our longer-term cardiac safety data as well as updating the efficacy data that we have in that program. As promised, we have an updated data slide for you today. That's similar to how we are collecting longer-term survival data, progression-free survival data and overall survival data with our faridoxorubicin. We continue that with our FAP-exatecan program. And this animal model is what we call patient-derived xenograft, meaning that the tumor cells were taken directly out of the patient and instead of passaging them in a plastic dish, which changes the cells somewhat, these were injected directly into an animal model. And those are passaged that way, meaning that these cells don't see plastic in terms of our ability to keep these cells going. There's 2 important points on this slide. The first is the histology and a small inset there, showing in blue, the tumor cells; and showing in brown, the FAP-positive fibroblasts. This models what we see in the clinic and specifically what we have seen with our salivary gland indication for faridoxorubicin in that the tumor cells are all completely negative for FAP in blue. And the fibroblast, which actually come from the mouse themselves instead of humans, the fibroblast there are staining positive brown for FAP. This is exactly what we expect in most solid tumors, a low level of FAP expression compared with the number of tumor cells. If you let your eyes wander down to the below inset there, there's an important aspect of this animal model that we think critically tells us something important about the FAP-exatecan program. And that is this patient, prior to the biopsy being taken where this model was developed, this patient had been treated with irinotecan, another TOPO1 inhibitor. And what you're seeing in that small graph there, that small inset, is that this animal model is TOPO1 resistant, meaning irinotecan has essentially no activity in this particular animal model. We expect, based on some of the early clinical data with exatecan, that in animal models such as this might be sensitive to exatecan being a much more potent TOPO1 inhibitor. And that's exactly what we find in the animal model. On the left-hand side, you can see the actual tumor growth in 3 different groups in this experiment. The first in gray are the vehicle-treated animals. This is the natural history of this tumor type in this animal model. It grows very rapidly and is very aggressive. In orange, you can see, we delivered 3 doses of conventional exatecan. And what you can see there is after that third dose, which are depicted in the triangles, we start to see the tumors grow in these animal models. In navy blue is the growth pattern that we see with our FAP-enabled FAP-exatecan molecule. Importantly, we see now durable complete responses. Essentially, what you can see on the right-hand side of the waterfall plots is that nearly 4 out of 4 of the animals treated with FAP-exatecan developed complete responses. These are prolonged and sustained, and the durability of these responses despite the animals only receiving 3 doses, is critically important to us. It took us some time to pull these data together, exactly what is happening in the faridoxorubicin trial. It's the survival statistics and observing the patients or the animal model for some time, tells us something very important about the drug. An update now on the time lines for the IND and the dosing -- initiating the dosing in this particular program. In order to bring a program into the clinic, there are 3 activities that we continue to work on through that last year of the IND-enabling studies, and that is the manufacturing for patients, the preclinical program, including the good laboratory practice, toxicology studies that are in progress, and then as well developing the clinical stage program. So developing the clinical protocol for this and also bringing the clinical sites on board, which will lead us then to a first patient in the first quarter of 2026. So not too far off, and we're very excited to get started with this one in the clinic. Brian, let me hand it over to you for our financial update.

Brian Hahn

executive
#3

Thank you, Chris. Cash and cash equivalents at the period end were GBP 12.65 million as compared to GBP 28.56 million for the same period in 2024 and GBP 12.87 million for year-end 2024. It's important to note here that this does not reflect the proceeds from the sale of Coris that we announced in late August of GBP 2.15 million. Cash outflows from operations and working capital movements were GBP 12.14 million for the first half of 2025. This is compared to GBP 12.6 million for the same period in 2024 and GBP 26.05 million for the full year 2024. Cash inflows from investing activities were GBP 8.77 million for the first half of '25. This reflects the proceeds of the sale of Launch Diagnostics. This is compared to cash outflows of just under GBP 1 million for the first half of 2024 and full year outflows of GBP 1.43 million. I'd like to note here that we've renegotiated the terms of the [ Heights ] Convertible Bond. We know this has been an overhang on the company. And we've also raised GBP 6.5 million gross to fund 2 quarterly payments of the cash bond. Year-to-date bond settlement was GBP 5.1 million. Bond balance as of 30th June 2025, was GBP 25.5 million, and it is now reduced down to GBP 22.95 million by the 30th September 2025.

Christina Coughlin

executive
#4

Thanks, Brian. Moving on. Our upcoming key data list, data catalysts for the 2025 and then into 2026. So where are we and where are we going next? So our faridoxorubicin program, FAP-Dox, has advanced to the expansion cohorts, Phase Ib, that is completed. We look forward to updating the data in late 2025 in salivary gland cancer. We are on track for that. That will be a combined update from both the dose escalation portion of the trial as well as the expansion cohort data. We will be updating the Phase Ia, as mentioned, at ESMO, and that will not include any of the expansion cohort data. We are also on track to deliver the initial data in the triple-negative breast cancer cohort. That will be in the first quarter -- or the first half of 2026. For our FAP-exatecan program, Program 2, we are looking forward to dosing the first patient in the Phase I, that is on track for the first quarter of 2026. And then finally, we're excited to note that we are on track for our pipeline program update, and that one will be on track and will occur later in October. And we're excited to bring that one. It is a new way of leveraging our pre|CISION platform and a whole new way of looking at it and using this in the clinic. Very excited to bring that to you later in October. So as you can see from these catalysts, with both ESMO and our pipeline update, we're going to have a very busy October in front of us, a number of key updates from the company coming there. And so that brings me to the strategic opportunities and what is the outlook for the company. I mentioned at the beginning our collaboration with Tempus and how this had delivered in a few different ways. Let me describe some of those. The first is the Tempus collaboration really delivered on the overall market opportunity for our pre|CISION medicines, confirming for us 90% of patients with solid tumors have FAP expression at some level. Important data will be coming at ESMO, looking at the different levels of expression and how we see the platform moving forward. The second is that the Tempus collaboration really is delivering for us a much smarter clinical trial for the FAP-exatecan molecule. And finally, Tempus has even touched our next pipeline update in terms of what are some of the ways that we could be thinking about essentially using the pre|CISION platform moving forward. We very much look forward later in October for that pipeline update. We are engaging with third parties across a range of commercial opportunities. This really reflects the breadth of the pre|CISION platform and where we're going to be able to take the pre|CISION platform now that we've entered the next chapter of a pure-play biotechnology company. We're happy to note that industry interest in our innovative platform continues to increase, and that pipeline update planned for next month really factors into this importantly. We do have a highly enviable intellectual property position. Let me tell you why. For the foundational IP, we have another 10 years of this that is exclusively licensed of the pre|CISION peptide, and this mechanism of action is wholly owned by Avacta. Our sustained release mechanism IP just filed last October is owned by Avacta. It was filed last year, and the full patent life for this one is anticipated to last to 2045. We will implement this sustained release mechanism, this novel IP into our novel pre|CISION medicines and all new pre|CISION molecules coming in the pipeline. We also have a great deal of confidence that the pre|CISION platform is increasingly well suited and very attractive to pharma and biotech partnerships for a range of oncology indications. Back to the first bullet there, the Tempus collaboration really showed us the market opportunity that we have here. And we continue to have that confidence in our platform and excited to very much bring you the updates that we will see in October. Mark, I'll hand it back to you for questions.

Operator

operator
#5

That's great. Chris, Brian, thank you very much indeed for updating investors. Ladies and gentlemen, please do continue to submit your questions. But just want to -- can we take a couple of minutes to review your questions submitted already. I'd just like to remind you that a recording of this presentation, along with a copy of the slides and the published Q&A, can be accessed via your investor meet company dashboard. Firstly, thank you to everybody for your engagement this afternoon and for the questions you sent ahead of today's event. Chris, if I may, I'll start off by reading out some of these questions that hopefully cover a number of the themes. I know we've had a number of questions around funding perhaps. So let's start off there. What are the fundraising priorities for the remainder of 2025? And how do you plan to minimize dilution for existing shareholders, whilst ensuring adequate capital for clinical development?

Christina Coughlin

executive
#6

Thanks, Mark. So as Brian reported, the company currently has a cash runway that extends into the first quarter of 2026. And as you know, we are laser-focused on strategic partnerships, business development. We are prioritizing those strategic collaborations that would provide both funding as well as development expertise with potential partners. Our maturing Phase Ia as well as the Phase Ib trial data are critical to these discussions. The purpose of those equity raises that we've done a bit earlier in 2025 were exclusively to address the need for the quarterly payments of the convertible bond, as Brian mentioned. These have been causing negative pressure on the share price. And we're -- as Brian mentioned as well, we're really happy with the renegotiation of that. As we always have been, we're focused on tight cash control, and we carefully allocate our cash very, very carefully into each of our programs. But in terms of any next steps, we're not giving any time lines. It would be inappropriate for us to state when and how until any deal is really agreed. Brian, do you have anything to add to that reply?

Brian Hahn

executive
#7

What I can add here is the Board is not worried. You're aware, we're working on a number of options to fund our R&D programs. We have a number of levers, including partnerships, JVs, industry investments and/or equity funding. The data from pre|CISION is only improving. As Chris mentioned, we are seeing industry interest in our platform increase, and our business development activities continue.

Christina Coughlin

executive
#8

Yes. Correct. Correct. Agree, Brian. We -- just to add to that, we are discussing both indications of faridox -- we're now using its new name, faridox, with a number of potential partners. There's a lot of interest as well in FAP-exatecan. But the company's strategy on that particular molecule remains -- we want to retain 100% ownership of this one. It's so close to the clinic. It's so close. And until it enters the clinic and delivers, we want to retain that 100%. It's been a decision made with the Board of Directors, and that is on track for the first quarter of 2026. And as you all know, we're quite energetic in our business development discussions. We have a range of potential partners, and it is a key focus of our financial strategy. The maturing data really factor into this, the maturing data in our clinical programs. And as we discussed in that last slide there, we are really approaching some key inflection points for the company coming up soon.

Operator

operator
#9

Great. Well, let's stick to the subject, I guess, how much do you expect Phase II for faridoxorubicin to cost Avacta? How will you fund this if a partnership doesn't materialize?

Christina Coughlin

executive
#10

So we're very confident in the maturing data in the Phase Ib of faridox. And we think that this will support the long-term value of this asset. Salivary gland cancer is high unmet need, and we continue to collect data in the various cohorts. We have committed that we won't start the further development activities in the absence of a partnership. However, as I've said, the maturing data set in Phase Ib is providing us with ample confidence that pre|CISION is working exactly as we designed it to work. The development in the expansion cohort is well underway. We believe the preliminary data here will provide that natural inflection point for the program. It's going to provide also clarity on accelerated approval pathways that we might be able to seek. And also, there's really an opportunity for the overall market to digest essentially the commercial potential for the program and the platform. As I mentioned, we'll have that pipeline update, platform update. And so we're really excited about the fourth quarter for the company.

Operator

operator
#11

I guess we've been discussing imminent license deals and partnerships now for several months, but nothing has materialized. Can you comment on where you are with this?

Christina Coughlin

executive
#12

Sure. It's completely understandable. We know that this is a recurring theme for our shareholders, and we appreciate the comments that we get here. I've already shared a lot as to our expectations here. But let me wax poetic on this a bit. We are in multiple conversations across multiple assets. The data in Phase Ib does continue to mature, which is really strengthening Avacta's position here. On timing, I can't give definitive answers, that wouldn't be appropriate. But what I can tell you though is that the team has a clear plan and we are executing on that plan. We have a number of touch points with a number of potential partners coming up. Our objective is really to exploit the potential of this technology for the benefit of patients and shareholders. And so whilst it may not be reflected in our share price today, these improving data sets, both clinical, but also on the preclinical side of things that we are seeing, these really strengthen the intrinsic value of our technology. We're looking to leverage this value for shareholders, and we will continue to update as we can on this particular topic.

Operator

operator
#13

I guess a question really relevant to all those over 1,000 people that registered for today's call. Around the share price really, why does the share price still not reflect the value in today's pipeline?

Christina Coughlin

executive
#14

Let me let Brian take that one.

Brian Hahn

executive
#15

Biotech really follows a normal path. The only constant is good technology ends up with partnerships under buyouts. Avacta has a clear strategy, which it's executing, and we have shown in the clinic that our tech does what we designed it to do, concentrate the drug in the tumor while sparing healthy tissue from toxicity.

Operator

operator
#16

That's great. Okay. Commercial strategy. I guess you have touched a bit on this throughout your presentation, but I wondered if you could just share a little bit more on your commercial strategy with those on the call.

Christina Coughlin

executive
#17

Sure. So we've chatted before on this. And commercial strategy, to us, really reflects sort of 3 -- I think about it in 3 buckets. The first is our business development strategy, partnering deals, which we have touched on. As you noted, Mark, the long-term funding strategy for the company. And then also, one can think about the game plan for commercializing a drug. We do have the opportunity to commercialize both of our assets that have been disclosed, faridoxorubicin as well as FAP-exatecan. So let's think about each of these. So faridox, our lead program. We've successfully completed the Phase Ia. It has an excellent safety profile, encouraging PFS data in the salivary gland indication. And there's promising early signals in the ongoing Phase Ib that we continue to observe and continue to have those conversations with third parties. The development in the expansion cohorts, this is underway. The preliminary data is expected later this year, and it's going to provide sort of a natural inflection point for the program. It's going to provide clarity on accelerated approval pathways. And there's also an opportunity for the market to look at these carefully. For faridox, we anticipate releasing the initial data in salivary gland cancer late in 2025 and triple-negative cancer in the first half of 2026. Now our second asset, FAP-exatecan, this one is going to advance into clinical testing, and we anticipate initiating that trial in the first quarter of 2026, with the initial data available in late 2026. I have to be honest, I don't think that Avacta is given enough credit for how quickly, and the speed with which we have taken AVA6103 through preclinical testing and advanced straight to IND-enabling studies. I am extremely excited. If you haven't heard, I've nicknamed it the beast. But I'm very excited about seeing this one in humans for the first time. The new data that we shared today, or I should say, the updated experimental data, really speak to what this invention is and what we're seeing here with this particular drug. I'm so excited about this one. This is what my entire career has been about, novel breakthroughs in the fight on cancer. I've shared with many of you in my personal story here and like -- let's call it my personal vendetta against cancer. We've been asked quite a bit about this particular program. How does it work? And what is this new invention that we're talking about? And so I'm happy to tell you that we are bringing you an R&D spotlight tomorrow that will go -- it's a bit of a deeper dive into this particular asset and the sustained release mechanism. Now here in the office at Avacta, I've had the advice to tell everyone to have -- to pour a strong cup of tea. It is 23 minutes of the chemistry. We usually put a leash on our chemists, and they're unleashed in this one. It's not for the faint of heart. But aside from faridoxorubicin and FAP-exatecan in the pipeline, there's also the opportunity for us to develop a partnership with another oncology drug in a potential partner's pipeline. It would be inappropriate for me to say anything more on that at this time, but it is something that our business development team and our R&D team are really laser-focused on. And I will commit to you that we will continue to update shareholders as soon as we are able to do so.

Operator

operator
#18

That's great, Chris. Well, let's switch gears a little bit and talk about R&D, I guess. In the salivary gland cancer data in late 2025, Q1 of 2026, the key inflection point, when will that read out?

Christina Coughlin

executive
#19

So as you have seen, we can make periodic updates prior to the full salivary gland data set. We will reveal the entire data set as we have it in late 2025, late this year. And that data update, this is not the ESMO data. I want to be 100% transparent here. The ESMO data is going to be the dose escalation. That will be an update on the 11 patients that we saw the preliminary data at AACR. Late 2025, we're going to be looking at both the expansion cohorts, which are ongoing, as well as the dose escalation. So think about a larger data set in late 2025. We commit to hosting an investor meet regarding these data, and we will be hosting an investor meet right along with the ESMO data and then later in 2025 with the full data set as we have it, that will be released in the salivary gland cancer indication.

Operator

operator
#20

What encouraging clinical activity has been observed in the AVA6000 Phase Ib trial?

Christina Coughlin

executive
#21

So the initial clinical activity here in Phase Ib is encouraging, it's highly encouraging. It has increased the management team's confidence in the pre|CISION platform, the value, the utility. We look forward to sharing that later this year. But as I'm sure you can appreciate, we're not able to disclose further information at this time. The Phase Ia dose escalation at ESMO, I'll be in Berlin with Dr. Tap, who has been a long-standing supporter of the company and of the program, in October. We will be looking there at the longer-term cardiac safety data. The Phase Ib data, though, in that expansion cohort, will be at the end of 2025. And as well, the triple-negative breast cancer patient data in the first half of 2026.

Operator

operator
#22

Okay. And maybe let's talk about AVA6103. What is the status of the AVA6103? Are you still on track to dose in Q1 of '26?

Christina Coughlin

executive
#23

Yes. So 100%. We're happy to bring you that update today. FAP-exatecan remains on track. First quarter of 2026, it's those 3 areas that we're working on, manufacturing and the nonclinical program and then the clinicians, the clinicians in the company are quite busy. The initial data from FAP-exatecan, we anticipate late 2026 being able to make some early comments on the program. This program, again, I've called it the beast. It builds on the validated pre|CISION technology. It builds on that biopsy data, my favorite slide in the deck, as I always say. It builds on the ability of the pre|CISION platform to really concentrate the drug in the tumor microenvironment. Keep it as best we can out of the bloodstream. And what that does is it minimizes the toxicity, optimizes the efficacy. And we're very encouraged by the initial clinical activity showing how this platform works, and really excited to get the second one into the clinic.

Operator

operator
#24

Great. And let's stick with AVA6103. You mentioned that the data had changed with the animal model of the [ FAPX ]. Since the previous data was released, why is this so important?

Christina Coughlin

executive
#25

Yes, it's a great question. Why rehash this animal model that we already presented at AACR? It's one of the reasons that we do periodic updates on the clinical trial. It takes time for us to see survival durability. All of these endpoints take time to mature. Our animal models work in the exact same way as the patients. We have to continue to observe. And sometimes, it looks a lot better. If anyone wanted to pull up that exact figure from the AACR presentation, you'll see it was cut off with the data that we had at the time. And as we allow that animal model to mature, you can see that some of the lines end, so the vehicle-treated animals end. The exatecan, the conventional exatecan arm, that one ends as well because 3 doses is not enough of conventional exatecan, conventional chemotherapy. But what you can see in that new data is the tremendous durability of the responses with the FAP-exatecan molecule. This is exactly how we designed the sustained release mechanism. At the time that we still have responses in this animal model, we actually can't detect the exatecan anymore. And so it's active even at those really low doses is because it's such a potent drug. It's an important observation. It speaks to, frankly, what we're seeing in the early days of the salivary gland cancers, that we see this durability and sometimes the patients stay in responses even after we remove the drug. What we're pleasantly surprised at in this is that only 3 doses of FAP-exatecan lead to these kinds of responses. Again, I know I've said it before, this is exactly how we designed this drug, long and slow release of the payload, exatecan, which can then lead to these durable complete regressions. I've said it before, I can't wait to get this one into the clinic.

Operator

operator
#26

That's great. Okay. Let's talk about shareholder communications and a number of questions around that. How is Avacta improving its shareholder communications?

Christina Coughlin

executive
#27

Thanks for that one. First, I want to say, once again, Avacta greatly appreciates the support and the engagement of all of our shareholders. And we do take the feedback very seriously. We take it on board and we try and work better with it. Our approach is to really provide, what we think are informative deep dives into our progress, the clinical and the preclinical programs, and we try to do that at regular scheduled points through the calendar year when the need arises. We have investor engagement events such as this one. We have also listened to feedback from investors. So specifically at the AGM -- and we are responding to that. We will schedule investor meet presentations around every data release. And so I can commit to you that we will have an investor meet around the ESMO Congress. We will also have an investor meet later in October around that pipeline update. And then as we go deeper into this year, we will also host an investor meet around the data that will be released from the expansion cohorts. We heard that feedback, and we absolutely take that on. We're also going to commit to organizing live events. Shareholders have the opportunity to meet the management team, the scientists at Avacta, and to ask questions of us. We had a very good interaction at the AGM, and we will continue to build on that. Also, let me also mention that we have our regular R&D spotlight series videos that -- we put those on both the X platform and LinkedIn, and those will start to come through the investor meet as well. So you don't have to go to social media. That's another that we've heard. This is to educate on the pipeline. We have 2 new episodes coming up. The first is tomorrow, again, we're going to release that one with the sustained release mechanism explained. And then a bit later in October, we will have one of the R&D spotlights that really speaks to and speaks -- understanding of this new pipeline update. We're really excited to bring that one to you later in October. But what I also have to mention, though, is outside of these events, we can't respond directly to investor queries about the share price, matters that we can't discuss. These include, for example, our ongoing corporate opportunities, decisions being made, data that hasn't been released, clinical development progress, all of these. We would need to disclose these all transparently to the wider market. But we want everyone to rest assured, we will continue to engage. As part of these shareholder investment forums, we will look forward to R&D spotlight series. Tomorrow's episode is in direct response to a number of questions from shareholders about, can you really explain how this sustained release mechanism works? And so we commit to updating you via our public announcements when we have material news.

Operator

operator
#28

Great. How does Avacta think about competing peptide drug conjugate platforms at Philogen and Bicycle?

Christina Coughlin

executive
#29

Great question. So our pre|CISION platform has a couple of key differences compared to these other peptide drug conjugates. We often get this question from institutional investors. So let me take Bicycle first. The Bicycle peptide drug conjugates don't use a cleavable technology. That's one big difference between the pre|CISION platform and the Bicycle platform. The Bicycle peptide is designed to direct the payload to the tumor. And we think the reason that pre|CISION and this tumor-specific cleavage is so critical, in our mind, it's borne out in the clinic. We see a tenfold great -- back to my favorite slide, but we see a tenfold greater concentration of active payload in our biopsy samples compared with the published data from the Bicycle peptide. So while they see 10x concentration, we're seeing a median of a hundred-fold concentration. It was -- and I've mentioned this before, but it was really during a Board meeting when I saw those data for the first time, that I thought to myself, I'd really like to have a full-time role. I was just a nonexec at that point. But anyway, we also think that these data allow us to leverage much more potent payloads. That's why we can be bold and moved into the exatecan program. And then to take the second part of that one, it's similar, but the Philogen approach also uses a FAP cleavable linker, so much closer to the pre|CISION technology. However, they do substitute out the alanine residue. Remember, ours is an alanine, proline, and it's a post -- FAP is a post-proline cleaving enzymes. And so that substitution actually greatly reduces the specificity for FAP cleavage. So it will be cleavable by other post-proline cleaving enzymes. And so that reduces the specificity of the Philogen approach. And so we would predict that their results would be similar to the Bicycle. Lower specificity would mean lower concentration in the tumor micro environment, but also it could result in higher rates of toxicities because those cleavage points would be -- the cleavage would be not just specific in the tumor, but you could see more of those ADC-like toxicities there.

Operator

operator
#30

There's a couple of questions around tariffs. I don't know how relevant this is, but what will U.S. tariffs on pharmaceuticals impact our clinical trials? Chris, can you hear us then?

Christina Coughlin

executive
#31

Yes, I lost the audio there for a second. I don't know what happened, Mark.

Operator

operator
#32

Sorry. No worries. Just a couple of questions on tariffs. Will U.S. tariffs have an impact on clinical trials?

Christina Coughlin

executive
#33

Interesting question, especially as Brian and I hail from the States. But no, the tariffs are imposed currently on approved marketed drugs and those manufactured outside of the U.S. So since our programs are all pre-approval, the tariffs won't impact us.

Operator

operator
#34

Great. Well, look, I think from a Q&A point of view, I'll submit all the questions to you. And if there's any topics that we haven't covered, Chris, we can always give clarity post today's call. But before I redirect investors to give their feedback. I wondered if you had any further comments before I redirect investors to give you some feedback?

Christina Coughlin

executive
#35

Yes. So thanks for the opportunity. Avacta is in a very strong position. I hope you can hear from myself and Brian, we're super excited about the technology. We are executing on the goals that we've set for ourselves. We are seeing execution in our strategy, and everything is going according to plan. We're very much looking forward to the fourth quarter of this year. We're making great progress, and look forward to our next updates to shareholders, which include those data at ESMO, the pipeline update, which is a whole new way of thinking about the pre|CISION platform and how we can leverage that for the benefit of both patients and shareholders. We're moving our second program forward in the first quarter of next year. I've been quoted in saying programs are not children, so I'm allowed to have a favorite. The exatecan program is just -- it is sort of everything that we thought this platform could be, delivering a highly potent drug directly to the tumor, minimizing a lot of normal tissue exposure. It's exactly how pre|CISION was designed. So very excited for a number of updates that are coming over the next several months. And I'll be honest with you. I think that the future is very bright for this company. It is very bright. I've shared with many of you, as an oncologist, I gave many of these drugs in my clinical practice. I treated many teenagers with soft tissue sarcoma. I gave doxorubicin. What Avacta has been able to accomplish here is truly remarkable. And we are so excited to have a second program moving into the clinic. We're thrilled that the management team can now focus on delivery of pre|CISION as a pure-play biotech oncology company. And I'll say it again, the future is very bright for our company. And we're very grateful for our shareholders who have come along with us. This has been -- a dream of mine is to really impact cancer, and Avacta is doing it. So proud of all the scientists here, grateful to the sites, the clinical trial sites and very grateful, at the end of the day, to the patients who have signed up for our trials. I think we've got a very bright future in front of us.

Operator

operator
#36

Chris, thank you very much indeed. Chris, Brian, thank you very much indeed for updating investors. If I could please ask investors not to close the session. We'll now automatically redirect you to the opportunity to provide your feedback in order that the company can better understand your views and expectations. This may take a couple of moments to complete, but I'm sure it'll be greatly valued by the company. On behalf of the management team of Avacta Group plc, we'd like to thank you for attending today's presentation, and wish you all a good rest.

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