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8/26/2026
Welcome to Alligator Bioscience's interim report call for the second quarter of 2026. My name is Greta Hög. I am the IR and Communications Manager at Alligator and I will be introducing today's call. With me today is our CEO Søren Weinholt and our CFO Johan Gillius. They will walk you through the latest developments at the company, after which they will be happy to answer any questions you may have. You may either submit these questions in the Q&A function of this chat, or you may email them to ir.alligatorbioscience.com. As you know, Alligator Bioscience is a publicly listed company, and I would like to note that today's presentation may include forward-looking statements. Please refer to the disclaimer on this side and to the next slide for the whole presentation. And with this, I would like to turn the call over to you, Sara.
Thank you, Greta. And once again, welcome to this Alligator earnings call, Q2 2026. We have some Wi-Fi issues here at the Medican Village in Lund. So I will already now apologize if the line is unstable or there any other sort of technological fallout during today's meeting. With that out of the way, let's go to the next slide, Greta. Thank you. So a couple of key updates from the company. In April, we saw data from Itazelumab Investigate initiated study presented at the Congress of American Association of Cancer Research and at that meeting also our the molecule called HLX22, which is developed by Henleus and partly derived from HLX22 that we'll talk more about later today. Data on that was also presented. Then in May, Henleus reported that HLX22 had announced follow-up data beyond the 39 months in gastric cancer, something that the aggregator also reported. And later in June, the company also reported that all patients or that the first patients had been dosed in all of the phase three regions on the ongoing study with HLA-22 in gastric and gastrointestinal junction cancer, two important milestones for HLX22. Why is that important? A number of significant events reported from alligator after the quarter in in July we reported that we will refocus on our financial interest in HLX22 and that we will discontinue independent development of metersalimab and that the remaining operations of the company will be wound down and we'll of course spend some time on that in today's call with the aim of giving the explanation why we have taken this decision and also convey to you the potential financial upside of our interest in HLX22. Also in July, we announced the rights issue of units to approximately 225 million, with an abridged loan of 19 million to secure the continued operation of the company. And I can tell you, as you probably saw earlier today, that today's extraordinary general meeting approved that that rights issue and at the same time also approved a share capital reduction. So if we take the next slide, we will spend some time on discussing the the pivot in strategy at Alligator, and of course also answer any questions that you may have towards the end of the call. As you are well aware, we have developed Metazalomab in first-line metastatic pancreatic cancer, a disease that currently is being treated with chemotherapies in first line. The development rationale for mitocelumab and OPTIMIZE-1 study that we have been reporting data on and discussed here several times was to combine mitocelumab with chemotherapy in first line. And as you all know, we have shown some pretty encouraging data in that setting. Now, in parallel with Alligator developing mitosalumab, a number of companies have been developing a new frog class of small molecules, or orally available molecules, tablet-based molecules targeting a mutation in pancreatic cancer called KRAS. It's approximately 90% of the patients with KRAS that has this this mutation to drive their disease. We have known that these drugs would come. We have known that they had some level of efficacy in second line. We've also seen glimpse of of data in first line during the year, and the hypothesis has been that even though these drugs are being developed, there would still be a clinical rationale for a combination of mesothelioma and chemotherapy. If we change to the next slide, I think what has happened... Next slide, please. What has happened actually since... The beginning of June and until now is that we have seen the latest data from these molecules. They have been taking the clinical community in this indication by surprise, how efficacious they are and how many patients they actually provide benefits for. If we just focus on the left-hand side of the slide here, First, we saw the paradigm changing phase three data from the molecule that called Direxonazib from Revolution Medicine. We saw them presented at ASCO in the beginning of June in patients in second line, extending their life more than double than what had been seen with chemo alone. Therefore, setting a new regime for KRAS inhibitors in second line. significant medical achievement and significantly good news for patients suffering from pancreatic cancer. What we have then seen since then, latest at ESMO GI, so another medical conference in Munich, early July, was then another set of data from this molecule now in first line, again, blowing chemotherapy almost out of the water. And at the same conference, we also saw data from a more specific molecule from Revolution Medicine called Saldoranosib combined with Folfirinox in first line. And these data showed that these patients, almost 100% of the patients were actually benefiting clinically from this. So what this means for alligator, what it means for patients with pancreatic cancer, is that this new class of drug will drive a paradigm change in the standard of care, both in first line, but initially in second line we expect direct ownership to be approved already this year in the U.S. at least, and then in three to four years, probably a similar change in first line, either to Revolution Medicine's drugs or via those drugs, or via some of the other players that are now starting Phase III studies in first line with KRAS inhibitors. So a significant change expected. in the standard of care in the treatment of metastatic pancreatic cancer, both in first and second line. That, of course, have a number of implications for a company like Alligator or anybody else developing drugs. In the indication, first of all, the industry itself refocuses towards this new drug class and those companies that are partnering in the disease, their focus is of course also changing towards agents that are either KRAS inhibitors or complementary to KRAS inhibitors and away from drugs that primarily have data in the chemo setting. If we then talk specifically what this means for alligator. It's very clear from our dialogues with our key opinion leaders, so leading physicians treating patients with metastatic pancreatic cancer, both in Europe, in US and also in Asia, there is a clear indication or a clear conclusion that standard of care also in first line will change away from the current chemotherapy backbone towards a KRAS inhibitor-based backbone. So, of course, a significant change there. That also means that the commercial rationale for developing metaxalimab in combination with fulferinox as we were preparing to start a phase III for, that commercial rationale do no longer exist. hence the rationale for the registration will start in this population is no longer relevant. We don't want to spend with it. It's not prudent or rational to spend money on developing a drug in a population that will not exist once the drug is ready to get approved. So here the The prudent business decision is, of course, to discontinue registrational development for mitocelumab in combination with chemo. We still believe that a combination of mitocelumab and a KRAS inhibitor remains both scientifically and also most likely clinically relevant. We believe that some of the Some of the longer-term effects we see with mitocelumab will be highly relevant in combination with the KRAS inhibitor, whether in combination with chemotherapy or alone. The fact is that the next step in that development will be potentially a Phase I study followed by a randomized Phase IIb study, i.e. a clinical undertaking on par with what we have done with metacelumab in OPTIMIZE 1. And unfortunately, with our available cash, with our current market cap, we do not see this as an undertaking that Alligator can do without a partner. And as we do not have a partner, and I do believe that it will take some time before the industry has refocused itself toward combination strategies with KRAS inhibitors, we took the decision to discontinue all further independent development of metacetamol, i.e. discontinue the preparation for the Phase III study. We have a number of IITs, Investigator Initiated Trials, so remember these trials that bear no cost for Alligator. We have a couple of those ongoing, plus a randomized Phase II study in the planning. We are reviewing those opportunities and the cost benefit of these programs, but our primary focus, as you can see, the next bullet point here is to preserve the royalty potential of HLX22 within the company and only invest in these all those free opportunities if we have secured a financial cushion allowing us to do that. So we will start winding down remaining operations. We will reduce the organization and the cost base. We have started that already and will continue working that in the coming period. And then we will, of course, continue to seek to divest metazolamab as a broader immune oncology acid within the coming month. And the press release of a couple of weeks ago have already created some incoming interest from companies of metastatic pancreatic cancer. And that is, of course, discussions that we will engage in as we go along. So, external factors has eroded the commercial rationale for continuing to develop metacelumab in combination with funferinox. We have decided that we are not able financially to pursue what needs to be done for development of salimab in combination with the RAS inhibitor. Therefore, we have continued all further independent development. We are reviewing ongoing IITs, refocusing on preserving the royalty potential of HLX22 in the company, and then wind down remaining operations and organizations to reduce the cost base in the company.
Can I have the next slide, please?
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