Avacta Group Plc (AVCT) Earnings Call Transcript & Summary

Thank you for joining us. Welcome to the Annual General Meeting of Shareholders for Avacta Therapeutics. My name is Christina Coughlin, and I am the CEO of Avacta. This is a recorded presentation of the business update that we gave earlier today at the AGM in the room. As part of this presentation, I will be making forward-looking statements. First, let's look at the highlights and the achievements for the Avacta team. FAP-Dox AVA6000, which is our first clinical program, this one has completed its Phase Ia, meaning its dose escalation enrollment. We have selected the recommended dose for expansion, and that has allowed us to move into, as you can see there, the opening of the Phase Ib expansion cohorts. We disclosed that the expansion cohorts began screening at the end of last year. And we do anticipate two data catalysts coming up. The first is that the initial data in salivary gland cancer will be released in late 2025 and the data in the triple-negative breast cancer will be released in the first half of 2026. Our second program, FAP-EXd or FAP exatecan AVA6103, is in clinical candidate selection, which was completed late last year, which allowed the molecule then to move into the IND-enabling studies, which takes about a year. The IND-enabling part of a clinical stage program such as this one has two main goals. The first is GMP manufacturing. GMP stands for good manufacturing practices. It essentially manufactures the drug for use in humans up to the standards that have been established by multiple health authorities across the globe. The second part of the IND-enabling studies are the toxicology studies. And so this will be taking a very potent drug like exatecan, that is FAP-enabled into multiple different animal types and animal models, allowing us to assess the toxicology. First part of that are what are called dose range finding studies, meaning find the dose that is safe in various animal models. The second are the GLP tox studies, where we take that dose that was deemed as safe in the various models and study it at a deep level. And so we are knee deep in all of these studies. The planned catalyst for this program is that the Phase Ia dose escalation is anticipated to begin in the first quarter of 2026 once the IND is cleared. We have completed our strategic collaboration. This is ongoing. We've completed the first part, and it has delivered on both the overall market opportunity for pre|CISION medicines. And that allows us to understand the breadth of the opportunity -- the commercial market opportunity for our pre|CISION platform. What we have seen from that and disclosed is that among the various diseases that we are planning to go into with both FAP-Dox as well as FAP-EXd, we are looking at the potential reach of about 1 million patients globally. Now there are multiple other disease settings that we can look at with other pre|CISION molecules FAP-enabled that would increase that opportunity. We've looked at the idea of driving smarter clinical trials. And we've added a couple of slides into the deck today and that is a question that continues to come up among shareholders. And so we'll talk a little bit about that coming up soon. We are engaging with third parties across a range of commercial opportunities. This is reflecting the breadth of the pre|CISION platform and progressing these discussions remains a top priority for us. We do have an enviable intellectual property position. We do have another 10 years of exclusivity around the foundational IP of the pre|CISION peptide and our novel IP around the sustained release delivery mechanism. And our management team has been strengthened with the appointment of our Chief Medical Officer and our Business Development Adviser as well. Let's look at those two additions next. Our Chief Medical Officer, David Liebowitz, joined us just very recently and will be taking over the medicine, the leading of the medicine from me. Yulii Bogatyrenko joined us as well as our Business Development Adviser. Both gentlemen are located in the United States and joined the management team at a pivotal time. We announced earlier that there was a second partial response that was noted among patients treated in the expansion cohort in salivary gland. And just a little bit more detail on this particular patient treated in, again, that expansion cohort. So chose the dose and moved up a line. As you can see here, this patient is a 69-year-old gentleman, a recent diagnosis of metastatic salivary gland cancer. Now he was diagnosed with localized disease earlier and his prior therapy for that localized disease with surgery and radiation, standard of care for this particular disease study. And he has had no prior systemic therapy. And his combined tumor diameters, as you can see there, the tumor shrinkage, a 0% shrinkage, so completely stable with his lung lesion and then an 80% shrinkage with his metastatic lesion in the sinuses. And so very excited about this patient. We continue to see -- to observe efficacy in the expansion cohorts, and we do continue to observe that favorable safety profile. Turning again to this idea of driving smarter clinical trials. What you can see here is the second analysis and the second part of the project that we did with Tempus. Along the X-axis in these figures, you can see the FAP expression in these two diseases. And then, along the Y-axis is another biomarker, SLFN11, which has been reported in the literature to predict for those patients who would have a favorable outcome when treated with a Topoisomerase I, of which Exatecan is one of the most potent of the topo I inhibitors. And so this project was designed across the entire database in the Tempus system to take a look at each individual patient's tumor, which each dot represents an individual patient and across all of the disease -- all of the solid tumors. And we asked the AI engine to rank these and tell us exactly which are the diseases that these two biomarkers would predict would have the highest number of patients that would be predicted to be sensitive to this mechanism of AVA6103. And so the next step then is, well, how would we use this? Other than just selecting diseases, how would we use this to drive a smarter clinical trial? And that's on the next slide. So the Phase I enrollment is only gated by cancer indication, but we can measure both FAP and SLFN11, the two biomarkers, one that predicts how well pre|CISION would work, but one that would also predict how well the topo I mechanism would work. We would then take a look and we would measure this continuously and look through each individual patient as they are treated. And the hypothesis is, and this is just a hypothesis that SLFN11 high would have a go, and those would be the patients that would respond and react to this mechanism. And that as we accumulate data and SLFN11 negative that these patients would not respond as well. This biomarker strategy may not work, but it's a key component of the trial to take a look at this. And so, then what would happen is that biomarker-driven strategy could then allow us to then see that the trial could be limited at that point, and we can use that biomarker. That's how we adapt. This is essentially an adaptive design. We will also use smarter statistics, so BOIN design that allows us to drive to that recommended dose for expansion, perhaps even in a quicker manner. So driving smarter clinical trials, biomarker-driven, but also those adaptive design statistics that we'll use in the trial coming up. We've been asked a lot about what else is in the pipeline. What else are we looking at in terms of pre|CISION. We have disclosed that we've pre|CISION-enabled a number of warheads. We have not disclosed what those are. But we see on the right-hand side there, the sort of funnel, and we use computational design of these. So we design them on the computer and make some of them in the chemistry labs to allow us to assess an in vitro, meaning in cells and dishes. And then, in terms of those that we use in animal models, we deepen the funnel even further. So use the computational design, use the in vitro models, use basic tumor to plasma and then finally, the in vivo pharmacology studies. But so the question comes up, why haven't we disclosed what is in all of these pipelines? And it's really because of IP. And you can see here the three foundational IP families that we have in the company. And so anything that falls into these categories can be disclosed publicly. Importantly, this middle one was actually filed early in October of last year. And so we haven't been able to talk about this sustained release mechanism except for the last few months since the IP was filed. And you can imagine there's quite a few aspects of the pipeline that we haven't disclosed yet, and that's because the programs can't be disclosed prior to filing the IP. The company has a number of challenges in front of it, and I'd like to describe probably the two biggest ones that we hear from shareholders frequently. The first here, the Heights Convertible Bond. We have myself and Sean and the Board have inherited this bond. It does have onerous terms. It was raised to fund the purchase of the diagnostic businesses. As you know, we have disclosed that we have divested Launch Diagnostics, and we are nearly there with the Coris business transaction. We have actively looked at numerous options. You can see them there. All of these options were too onerous for existing shareholders who were not possible under the terms of the bond. We do have GBP 25.5 million outstanding, and that will take us the next 2.5 years. The strength of the platform that I've described in the last few slides really does allow us. It's expected to provide optionality here in terms of the repayments of the Heights Convertible Bond. I can tell you that this issue is foremost in front and center for the Board of Directors. It is discussed frequently among us, and we are seeking solutions, as you have seen with a number of the announcements that we have made. In terms of our funding, we are managing our cash to the R&D pipeline. We are building IP and value. We have realized cash from the sale of Launch. The Coris divestment is ongoing and near term. We are supported by a number of brokers. We are broadening our relationships with a wide range of investors, including both U.K. and U.S. specialists. We have widened the BD team with the addition of Yulii Bogatyrenko, who will focus on commercial partnerships, and we do have our data catalysts coming to attract both commercial partnerships and attracting new investors. The next chapter for Avacta. We have upcoming key data catalysts that will be important. We've talked about these with Program 1. You can see there, both salivary gland and triple-negative will readout in due course. Our FAP-EXd key catalyst will be the opening and the treatment of that first patient in the clinical trial in the first quarter of 2026. And we have committed to disclose that next program, Program 3, by the end of 2026. Our key goal is the financing to support this key R&D engine. There are multiple opportunities that are created by these multiple catalysts in the 2025, 2026 time frame. We've demonstrated proof-of-concept of our platform. We have made significant operational progress over the past year. We have a significant reduction in those key toxicities. We will be presenting some of that long-term safety data in the second half of 2025 with the key program AVA6000 FAP-Dox. And the efficacy will be presented in both salivary gland cancer and soft tissue sarcoma a little bit later this year, again, realizing the data in the full Phase Ia program. We do have multiple data catalysts upcoming across both of the programs, FAP-Dox and FAP-EXd. And we have confidence that the pre|CISION platform is increasingly well suited and attractive to partnerships in a range of oncology indications. And we look forward to continuing the dialogue with our shareholders. We thank those that joined us in the room, and we thank those of you joining us online, and we look forward to continuing our conversation with all of you.