Alligator Bioscience AB (publ) (ATORX) Earnings Call Transcript & Summary

So hello, everybody, and welcome to the Alligator Bioscience Interim Report Call for the third quarter of 2025. My name is Greta Hoog. I am the IR and Communications Manager at Alligator, and I will be introducing today's call. With me are our CEO, Soren Bregenholt; and our CFO, Johan Gileus, and they will walk you through the latest developments in the company from this quarter and the upcoming news flow, after which they will be happy to take any questions that you may have. These can be submitted to the Q&A function of this webinar or e-mailed to [email protected]. Now as you all know, Alligator is a publicly listed company, and I'd like to note that today's presentation may include such things as forward-looking statements. Please refer to the disclaimer on this slide, which applies to the full presentation. And with that, over to you, Soren.

Thank you, Greta. And once again, welcome to Alligator's Q3 call 2025. It's a pleasure having so many of you following us at the webinar. With that said, let's have the first slide, Greta. So it has been an eventful quarter for Alligator again. If we start looking at the mitazalimab, we were able to announce the 30-month follow-up data from the Phase II study in first-line metastatic pancreatic cancer, data that confirms the long-term survival benefit of mitazalimab in combination with chemotherapy. And we will talk more about those data in a few minutes. From that study, we also have reported so-called biomarkers giving us further insights into mitazalimab's mode of action and its direct effect on the survival rate in responding patients. And we published those data in a renowned journal called Cell Reports Medicine a couple of weeks ago. And then we, as we'll also discuss in a second, are going to initiate a number of externally funded Phase II studies to expand the development option of mitazalimab. On the business side of things, you probably all saw that we, this morning, or actually very late yesterday evening, announced a SEK 120 million rights issue, with a secured level of 65%. And I think just to make it absolutely clear that those 65% will allow us another 6 to 9 months of runway in 2026, i.e. to the end of potentially end of Q3. If the rights issue becomes subscribed above the 65%, that will of course allow us to extend our runway or initiate value-creating activities that are currently on hold. We have chosen to do it this way. We think that is most prudent to secure the rights issue to give us 6 to 9 months of runway, giving security to investors, and then allow for the opportunity to extend runway, as I just said. Earlier in the quarter, we successfully executed the TO 13 program in connection with the previous rights issue and raised approximately SEK 28 million gross, corresponding to almost a 92% exercise rate in this unsecured TO program. And in connection with that, we strengthened our near-term liquidity and also renegotiated the loan agreement that we have with Fenja. So all good on a financial perspective. We're continuing our partnering discussions with mitazalimab, with global pharma and biotech, and I'm pretty sure that there will be a number of questions to that process. So I'll not comment any further on that at this point in time. Those of you who follow the company closely will also see that we signed an agreement on our antibody technology called RUBY, a so-called evaluation and option agreement with a company working within the field of biology. This demonstrates the facility of the platform, and as I said before, Alligator has an ambition to also continue to monetize our various technology platforms. And then finally, our Chinese partner, Henlius dosed the first U.S. patient in the global Phase III study with HLX22 in gastric cancers. As we've discussed several times, Alligator's royalty stake in this program may generate both milestones and royalty revenues in the near to mid-term. So that's the overview. If we go to the next slide, we have the company's pipeline here. Everybody, of course, is aware that mitazalimab is our lead asset, and we believe that the drug is ready to enter a registrational or Phase III study, if you will. And we are continuing to working on that. And in addition to that, we have initiated a number of so-called investigator-initiated studies. These are either Phase I or Phase II studies where mitazalimab is either being used in pancreatic cancer or being explored in other indications. Just to run through them very briefly, we are running a study at the University of California in San Diego in pancreatic cancer together with Dr. [ White's ] lab, that I would call an exploratory Phase I study. We are getting ready to dose the first patient in a study in Italy in oral premalignancies, so that's lesions in the oral cavity that will be injected with mitazalimab to prevent their transformation into tumors. Then as we also announced in the quarter, there is a French group led by Professor Cindy Neuzillet, who has been granted a big grant to start and conduct a randomized Phase II study with mitazalimab in combination with chemotherapy in an indication called biliary tract cancer, so a cancer very similar to pancreatic cancer. A this is a study that will, if positive, lead to a Phase III study and therefore a very good option to expand the clinical footprint of mitazalimab. And then we have 2 studies in the U.S. that we have not announced yet, both with mitazalimab and various other immune activators. I cannot reveal the exact location, just say that it's Ivy League universities. Some of it is in pancreatic cancer in a so-called maintenance setting, and the other study is in another solid tumor in combination with standard of care. So this is just to illustrate that even though mitazalimab is the lead value generator in our pipeline and pancreatic cancer is the lead indication, we are working continuously to, in a very cost-efficient way, to expand the clinical footprint of mitazalimab to, of course, maximize the potential commercial value and the patient benefit for Alligator and a potential partner. If we just flip once, you all know that we have 4066, an interesting next-generation CD40 molecule. The entire team here is eager to start development, but you also know, as you follow the company, that we have focused our efforts and our funds on advancing mitazalimab's Phase II study. And if we do one more click on the mouse cursor, you can see that we have a number of partner programs, and I just want to once again focus your attention on HLX22, which is in a Phase III study in gastric cancers and in a global Phase II study also in breast cancer. And I think there is a fair chance that Henlius would expand the late-stage clinical program of HLX22 in the years and months to come. So all in all, a diversified immuno-oncology pipeline. If we take the next slide, just to reemphasize that we have now reached the final data point of the Phase II study with mitazalimab in pancreatic cancer. We've reported many of the data points earlier, including the 4 months difference in median overall survival, the very long and extended median duration of response, i.e. how long the patients have the tumor under control. And we previously reported the 18 and 24 months survival rates. What we reported early in the quarter was that at 30 months, that means 2-1/2 years, we have one-fifth of the patients still being alive. That is a set of unprecedented data. So not only do we increase the probability of survival for the entire population, but we have a profound effect on a number of patients that are extending their life well beyond what can be expected with chemotherapy alone. The OPTIMIZE-1 trial has successfully fulfilled its purpose. We are now winding it down. We are closing sites without patients, and the cost associated with this trial is really being brought down significantly and fast, leading to a significantly reduced burn rate as we go into 2026. I'd also want to just mention that mitazalimab will continue to be provided to that number. I think it's around 3 or 4 patients that are still on treatment. Even though we're closing down the trial, these patients will, of course, still be supplied with mitazalimab as it is a lifesaving medication for these patients. Let's go to the next slide. Not to make this overly scientific, but the basis of everything we do here is, of course, science. And it's important that when you have strong clinical data, can you then explain why you have these data and can you make any forward-going predictions based on the data that you have? And I just want to mention to you that the data that we published a couple of weeks ago in Cell Reports Medicine strongly underpins and validates the mechanism of action of mitazalimab. And as you may recall, the drug has 3 main mechanisms. First of all, it soften up the tumor when it's given before chemotherapy. It decreases the amount of fibrosis in the tumor or connective tissue. And what you can see on the left-hand side here is that we have identified -- that's the patients in the green line on the left-hand side of your screen. And you can see that those patients that have this specific signature is doing significantly better when you look at their survival versus those patients in the study that do not have this signature. And this is something that we believe in the future can be used as the foundation of a patient selection or patient stratification strategy. The second part of the mechanism of mitazalimab is, of course, its ability to activate the immune system, the so-called dendritic cells, to make them activate, educate, and attract T-cells to the tumor, and then also diminish the so-called immune suppressive mechanisms in the tumor, giving a much more strong T-cell-mediated immunity. And do we have evidence for this? Yes, we do. If we look on the side of the slide here, what we've done is that we have taken the patients 24 hours after they've received the first dose of mitazalimab. Then we have looked at those patients that have a strong response in terms of so-called activated T-cells versus those patients that have a less strong response. And what you can see again is that the green line, the patients on the right-hand side here, in the green line, almost live twice as long as those patients that don't have a strong response to mitazalimab. So this puts a very, very clear connection between how the drug was designed, how it works in the patients, and the clinical benefit that the patients have. And all this data, of course, provides mechanistic insight to the drug, but also allow us to more rationally design our future studies with mitazalimab. Let's take the next slide. So a little bit of forward-looking statements here on how the drug will be developed and how the current treatment landscape is looking and developing. We are just back from the big European conference of medical oncology, which was held in Berlin this weekend. So if we just look initially at the study, we have previously announced that the study design has been endorsed both by the U.S. and the European authorities, and that there is alignment that the 900 microgram is the right Phase III dose, and that the clinical program and the non-clinical program is adequate for both Phase III study and subsequent marketing authorization. And also let me just mention that we have successfully developed the commercial manufacturing process that has been established, which is also something that now means that we are on the backside of a significant investment, which again will take down the cost and the burn rate in the company as we go into 2025. But as one of the only drugs in mid and late-stage development, mitazalimab is being combined with FOLFIRINOX. And if we just take a step back and remind ourselves how the treatment landscape in first-line metastatic pancreatic cancer looks, there are basically 3 to 4 options. There are the gemcitabine-based drugs or chemotherapies. These are the most gentle, but also the very least efficacious. Most of our peers are combining with that. I would suspect that is based on safety considerations. As we have talked about repeatedly, mitazalimab has a very, very benign safety profile, which makes it more appropriate maybe to combine with FOLFIRINOX, something that we've confirmed in the Phase II study, both with the specific safety data, but also with the fact that we are treating patients for up to 3 years with the drug. So how does this chemo backbone look like? What we really see, and our discussions with U.S. clinicians confirm that there is an increasing use of FOLFIRINOX in the U.S. It's outcompeting gemcitabine. It's completely outcompeting the Onivyde compound from Ipsen, and this means that the choice of FOLFIRINOX is the right one as chemo backbone and the current market trends, of course, expands mitazalimab's patient footprint and also commercial opportunity in the metastatic pancreatic cancer market. In addition, it's also clear that there is a consensus among clinicians that you need an immune activator like mitazalimab to get these sustained long-term benefits that we've just discussed with mitazalimab, i.e., we have a drug here with an increasing market potential and a mechanism that makes it a -- and safety profile that makes it a prime combination partner with FOLFIRINOX. And then as I said, in addition to that, we are starting Phase II IITs that are aimed at expanding mitazalimab into the maintenance setting in these patients, thereby adding further patient reach and commercial potential to the drug. So all in all, we have been clever and also lucky in choosing the chemo backbone here with FOLFIRINOX. And if we go to the next slide here, if we can go one back, Greta, just to finalize that. We are continuing our dialogues with potential partners. We are moving closer than we have been before, meaning we are moving longer in the process with a select number of partners. And we are pretty optimistic here at Alligator. And it's clear that these trends of increased FOLFIRINOX use, the 30 months data that we've demonstrated, and the consensus that mitazalimab is needed to see these data in pancreatic cancer is, of course, something that resonates well in our dialogue with partners. Now, Greta, we can go to the next and, I guess, final slide in this part of the presentation. Just once again, to repeat that the first patient was dosed in the global Phase III study, and the first U.S. patient was dosed in this Phase III trial evaluating HLX in HER2-positive gastric cancers. And just once again, reiterate that Alligator is following this program, but that we are not privy to any other information than what is shared in the public domain by Henlius. On 4066, we published a very deep and intense dataset in a journal called Cancer Immunology Research in September, which sees 4066 as a next-generation and follow-on molecule to mitazalimab. Pancreatic cancer not being the primary indication there, that would probably be gastric cancer or colorectal cancer. The drug has a very strong profile and this was further supported by the U.S. patent grant that we announced as late as yesterday. So not formally part of the Q3, but I just thought of it, yes. And then finally, RUBY, as I said, we entered into an evaluation and option agreement with a biotech company focused on viral disease and that is of course demonstrates this bispecific antibody format in itself has its own merit as a standalone platform and that is something that we're discussing with a number of other potential partners. So with these words, I will hand over to Johan, who will take you a little bit more into the numbers and some of the details of the recently announced rights issue. Johan?

Thank you, Soren. Please, can we, yes, second. Thank you. We have now reported our Q3 results. And as you can see them from the blue-colored column, that we are getting to lower and lower costs this quarter. We reported SEK 17 million in cost. That, of course, is cost for the operation of the organization, but also costs incurred with in respect to the Phase II closure procedures, but also then the IMP that is now in final stages. We will see, continue some of these costs, but not in the region that we have seen before. So the SEK 17 million is a good proxy for the cost going forward. And I'll come back to that on the following page. On top of that, we have had the cost related to the financing of the company, both on the TO 12 and TO 13, and also the loan with Fenja Capital. All in all, some of these effects are related to how you have to treat things under IFRS and the others are, of course, then purely cash-out effects, including like interest and other things. But all in all, there are quite a lot of costs in the quarter, but also in the previous quarters and around the financing of the company. And there are details in the Q3 report if you want to dig in deeper to that. Can we have the next slide, please? And as you can see, we have the lowering of the operating costs from going back 2 years and then into this quarter, and then we continue to lower these costs. So I'm predicting that we will come into 15, up to maximum 20 in certain quarters where it spiked and in the following quarters, but 15, 16, 17 is a good proxy for the quarter cost. And that's also going back to how we estimate the runway that we then have announced in connection with the rights issue because if we take in the secured level of around SEK 78 million, deduct the costs and some of the repayments that need to be made, then we have a runway for 6 months then in 2026. On top of that, we do have the TO 14. I will come back to that on the following slide. That could extend the runway even more than at the secured level for the time being. But let me come back on that. Of course, as Soren mentioned, we're looking to a different way of financing companies through licensing agreements and other kind of agreements like the RUBY agreement that we made. So there are other means that we're looking into in parallel to the rights issue. Next slide, please. So the rights issue in 2025, we have done this before, unfortunately, but that's part of the biotech industry. We are targeting proceeds of SEK 120 million to the gross amount. And we have then secured 65% of that through commitments, both securing commitments, but also a guarantee consortium. Would we then, as Soren mentioned, would we then get proceeds above the 65%? We will, of course, then extend the runway and also with a mix of introducing very carefully some of the activities that we may not have on the critical line, but that are on the drug development line for mita and that we can then have the financing to initiate them. The subscription price mechanism will be further detailed when we come to that period, which will be in the week before the AGM. That will be on the 25th of November, but of course, there is a way or mechanism of doing the subscription price and it is very carefully described in the press release, but also in the prospectus that will come. And each shareholder will then, if they subscribe, will get 2 ordinary shares and 1 warrant TO 14, and the TO 14 will be able to -- will be listed and tradable. We have also summoned to an AGM, and that is to approve this rights issue then. And then there will be, the following week, we will then start the subscription period and launch the prospectus, et cetera. And we expect that around the 22nd of December, we can then announce the outcome of the rights issue. And together with that, there are some trading of these paid but not issued shares. And beyond 13th of January, you will have the ordinary shares on your account. So that was in short around the rights issue. We will come back to that a number of times, including at the AGM and the prospectus, et cetera, but these are the snapshots of the rights issue that comes up in a couple of weeks' time. Next slide, please. I think I hand over to you, Soren, to take this one.

Yes, absolutely. Thank you, Johan. And, yes, so just to sum up, I think we have during the year met quite a lot of, if not all of the milestones that we have set out to do, including both 24-month follow-up data, and even though it's not here on the slide, 30-month data and sort of trial closeout mitazalimab in Q3. What can we expect to happen in the rest of 2025? You have a lot of questions, I can see on a potential deal. So I'll not talk about that until in a couple of minutes. But what we know will happen definitely is that we will start Phase II IITs. We already talked about some of them. Several of them are scheduled to start in the fourth quarter here. And then we have the Phase II IIT in biliary tract cancer that is scheduled to start in the second quarter next year. And that is how close we can get to that date at this point in time. These are the things that are planned and in the budget. And as Johan and I alluded to, there might be other value-generating things that we may initiate and which may lead to additional milestones going forward if the current or the coming rights issue subscription level allows for that. But right now, this is where we are, finalizing the Phase II study with mitazalimab in first-line pancreatic cancer, continuing the outstanding Phase III preparations, continuing our partnering discussions at full speed, getting these IITs initiated in Q4, also working on new IIT options to continue to expand the mitazalimab universe. There is a lot of external interest in the drug across a number of indications. And then getting ready to start the biliary tract Phase II in the second quarter next year. So that concludes the presentation.

And there is a lot of questions I can see. And I will do it as we're used to. I will read them out, and then Johan and I will try to answer them as good as we can. I think we'll start with a couple of questions here from Richard at Redeye. And Richard asks, if a fully subscribed rights issue provides a runway for 9 months, next year does that mean that the burn rate will increase? And first of all, it's Alligator who has not been ultra-sharp in our communication. It's the current subscription level, as I think I said at least once, and also Johan, that will give us a 9-month runway next year. So the burn rate will not increase. It will decrease. I can reiterate the 15 to 18, maybe in 1 quarter, SEK 20 million in burn rate. Is that correct, Johan?

That's correct, yes.

Yes. And Richard also asks, could you specify the use of cash on the rights issue proceeds? I think we have touched on that. We can do that. The primary case is to be able to continue our BD activities, cover some of the tail-off costs that nevertheless exist in the Phase II study, in the manufacturing. Even though these programs are winding down, there's still a tail-off cost. And if the rights issue is fully subscribed, we may start a few other activities that are on hold, value-generating activities, but right now, they're not in the budget. Then shifting a little bit gears, when do you expect the first, and this is also from Richard, when do you expect the first readout from the biliary tract trial? I think that's a very good question that I'm unfortunately not able to answer at this point in time. We know the trial will start in the second quarter next year. And we have not sort of laid out the final dates or the final schedule for data readouts together with the investigator. So that remains to be seen. And I'll come back on that. When could the RUBY option and option and infection deal be converted into a deal to a real option? Yes, there is a period of 18 to 24 months for evaluation. I think that's a fair time to construct antibodies and get them into animal studies and other things. So approximately 18 to 24 months is a reasonable timeframe there. Then we have a number of questions around the mitazalimab deal, and they go -- have a little bit of different flavors. I'll try to sum them up here. Who are you speaking to? Are you talking to more than one? Are you -- are we more optimistic than we were 6 months ago? What partners are we looking for? And what type of deals are we discussing? Yes, we are progressing. I would say we are further than we were definitely 6 months ago. It's clear that when you're getting closer to the end point, you are discussing with fewer potential partners than you are when you are early on. I think we are at a time in some of these discussions where I will be a little bit careful about how I comment this. But we are discussing with seriously interested parties, and we remain optimistic and more optimistic than we have been before. But I actually refrain from commenting too much about structures and type of partners. I hope that is well perceived. I think, of course, when you look at a potential partner for mitazalimab, it's clear for everybody that you have to have an interest in pancreatic cancer. That is the lead indication. And then as we have discussed several times, we believe that there is significant potential of the drug outside of pancreatic cancer, which is also reflected in the number of IITs that we have started. And of course, it would be fantastic to see a partner that had development capabilities beyond pancreatic cancer in order to maximize the commercial and clinical potential of the drug. We have a couple of questions here. We have one question from [ Mirth ] from Kempen. How do the final 30-month OPTIMIZE-1 result influence the design and expectation for the Phase III study? The short of the long is that they don't really influence the design of the trial. That's a study that is based on median overall survival and the overall design with the mitazalimab arm and the mitazalimab or chemo arm and then mitazalimab plus chemo arm. That sort of the basic design remains the same. But it's clear that we have now gotten confirmation that we have this long-term effect of mitazalimab, which again reinforces our belief in the clinical relevance of mitazalimab. Are any of the long-term survivors still in OPTIMIZE-1, given mitazalimab as monotherapy?. Yes, that's a very good question. Actually I have to answer the question a little bit differently. I don't know if any of the current survivors in the trial are on mitazalimab alone. But we have had a number of patients that have been for more than a year, some almost 2 years, have been completely off the chemotherapy. So they've gotten chemotherapy in the beginning of the study, of course, as part of the treatment regime. And they have had the tumor under control together with mitazalimab. And then they have cycled out of chemotherapy and been in a mitazalimab maintenance therapy for some of them more than a year, some of them more than a year-and-a-half, nearly 2 years. In addition to that, we've also had a number of patients who have not been completely out of chemotherapy, but have been at only 5-FU. So that's one of the 4 drugs in the FOLFIRINOX combination. So they've been on only one of the chemotherapies together with mitazalimab. And this, of course, means 2 things. It means that it's fantastic to see that mitazalimab can sustain an immune response to the tumor on an ongoing basis. But for the patients not being either on chemotherapy or being on a very reduced chemotherapy, it means that the quality of life is, of course, significantly better than when you are on the full chemotherapy regimen. And let me just see what one final question here, also from Kempen. What are the next steps from 4066 following the recent preclinical data? And are there any ongoing partnership discussions around the molecule? 4066 is at a stage where we have a very, very strong translational package. We know how the drug works. We are very convinced by the ex vivo human data that we've generated that this drug will be great, either in combination with chemo or with checkpoint inhibitors like PD-1s. The next investment in 4066 is manufacturing development. That's quite costly. So for us to be able to start this work and be able to finish it, we need to get mitazalimab partnered before that. And yes, we are discussing with various companies in relation to a license for 4066. And I think it's funny to see, or not funny, but it's encouraging to see that now there are a couple of additional CD40 bispecifics, not with this mechanism, but other preclinical and early clinical CD40 bispecifics, meaning that the industry's belief in CD40 as a drug target has reoccurred. And it does not seem like we have more constructive questions for today's call. So with those words, I'll once again thank you for participating. Thank you to you, Johan, for taking us through the finances and the upcoming rights issue. And thank you for listening, and thank you for your support. Thank you.

Thank you, all.