Earnings call transcript: Alligator Bioscience's Q3 2025 sees stock drop 46%

Alligator Bioscience (ATORX) reported its Q3 2025 earnings on October 23, revealing significant financial and operational updates. The company's stock plummeted by 46.36% following the announcement, closing at 2.7 SEK. This dramatic decline comes amid a strategic rights issue and pivotal developments in its cancer treatment pipeline. According to InvestingPro data, the company's financial health score is rated as WEAK, with an EBITDA of -20.04M USD for the last twelve months. The company reported operating costs of 17 million SEK for the quarter, with plans to manage expenses between 15 to 20 million SEK going forward.

Key Takeaways

• Alligator Bioscience's stock fell by 46.36% post-earnings announcement.
• The company has secured 65% of its 120 million SEK rights issue.
• Mitazalimab shows promising 30-month survival data in pancreatic cancer.
• Plans for multiple phase II investigator-initiated studies in Q4 2025.

Company Performance

Alligator Bioscience is navigating a challenging market environment with a strategic focus on its oncology pipeline. The company highlighted key developments in its flagship drug, mitazalimab, which demonstrated a unique mechanism of action and promising survival data in pancreatic cancer. Despite these advancements, the financial strain is evident with a significant rights issue aimed at extending its financial runway into 2026.

Financial Highlights

• Operating costs for Q3 2025 were 17 million SEK.
• Projected quarterly costs are between 15 to 20 million SEK.
• Rights issue targeting 120 million SEK, with 65% already secured.

Market Reaction

Following the earnings call, Alligator Bioscience's stock price fell sharply by 46.36%, settling at 2.7 SEK. This decline reflects investor concerns over the company's financial health and the dilution effect of the rights issue. The stock's movement is significant, considering its 52-week high of 7.4 SEK and low of 0.0066 SEK, indicating heightened volatility.

Outlook & Guidance

Alligator Bioscience is focusing on advancing its clinical pipeline with several planned studies, including phase II investigator-initiated trials in Q4 2025 and a biliary tract cancer study in Q2 2026. The company is also in discussions with potential partners to further develop mitazalimab, which could provide additional financial and strategic support.

Executive Commentary

CEO Søren Bregenholt emphasized the significance of mitazalimab's survival data, stating, "We have one-fifth of the patients still being alive at 30 months. That is a set of unprecedented data." He also expressed optimism about ongoing partnership discussions, noting, "We are discussing with seriously interested parties, and we remain optimistic."

Risks and Challenges

• Financial sustainability with a limited runway and reliance on rights issues.
• Potential dilution of shareholder value due to the rights issue.
• Competitive pressures in the oncology market.
• Execution risks associated with clinical trials and regulatory approvals.

Q&A

During the earnings call, analysts inquired about the company's burn rate, which Alligator Bioscience confirmed would decrease. There were also questions regarding partnerships, with the company indicating ongoing discussions with potential collaborators. The development of ATOR-4066 is contingent on securing a partnership for mitazalimab, highlighting the strategic importance of these discussions.

Alligator Bioscience's Q3 2025 earnings call underscores the company's strategic focus on its oncology pipeline amidst financial challenges and market volatility.

Full transcript - Alligator Bioscience AB (ATORX) Q3 2025:

Greta Höög, IR and Communications Manager, Alligator Bioscience: Hello everybody, and welcome to the Alligator Bioscience interim report call for the third quarter of 2025. My name is Greta Höög. I am the IR and Communications Manager at Alligator, and I will be introducing today's call. With me are our CEO, Søren Bregenholt, and our CFO, Johan Giléus. 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 emailed to ir@alligatorbioscience.com. 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 side, which applies to the full presentation. With that, over to you, Søren.

Søren Bregenholt, CEO, Alligator Bioscience: 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. 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. 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. We published those data in a renowned journal called Cell Reports Medicine a couple of weeks ago.

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%. I think just to make it absolutely clear that those 65% will allow us another six to nine 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 six to nine 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 TO13 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. In connection with that, we strengthened our near-term liquidity and also renegotiated the loan agreement that we have with Fenja Capital. 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. 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. Finally, our Chinese partner, Shanghai Henlius Biotech Inc., 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 midterm. 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. We are continuing to work on that. 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.

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, a cancer very similar to pancreatic cancer. 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. We have two 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.

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, 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 ATOR-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. If we do one more click on the mouse cursor, you can see that we have a number of partner programs.

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. 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. 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 four 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. We previously reported the 18 and 24 months survival rates.

What we reported early in the quarter was that at 30 months, that means two and a half years, we have one-fifth of the patients still being alive. That is a set of unprecedented data. 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 three or four 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. 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? 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. As you may recall, the drug has three main mechanisms. First of all, it softens up the tumor when it's given before chemotherapy. It decreases the amount of fibrosis in the tumor or connective tissue.

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. You can see that those patients that have this specific signature are doing significantly better when you look at their survival versus those patients in the study that do not have this signature. 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. 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. 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. 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. All this data, of course, provides mechanistic insight to the drug, but also allows us to more rationally design our future studies with mitazalimab.

Let's take the next slide. 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. 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, the non-clinical program, is adequate for both phase III study and subsequent marketing authorization.

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. As one of the only drugs in mid and late-stage development, mitazalimab is being combined with FOLFIRINOX. If we just take a step back and remind ourselves how the treatment landscape in first-line metastatic pancreatic cancer looks, there are basically three to four 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 three years with the drug. How does this chemo backbone look like? What we really see, and our discussions with U.S. clinicians confirm, is that there is an increasing use of FOLFIRINOX in the U.S. It's outcompeting gemcitabine. It's completely outcompeting the onivite compound from Ipsen. This means that the choice of FOLFIRINOX is the right one as chemo backbone. The current market trend, 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 safety profile that makes it a prime combination partner with FOLFIRINOX. In addition to that, we are starting phase II investigator-initiated phase I and II studies that are aimed at expanding the mitazalimab into the maintenance setting in these patients, thereby adding further patient reach and commercial potential to the drug. All in all, we have been clever and also lucky in choosing the chemo backbone here with FOLFIRINOX. 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. We are pretty optimistic here at Alligator. 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 HLX22 in HER2-positive gastric cancers.

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 ATOR-4066, we published a very deep and intense dataset in a journal called Cancer Immunology Research in September, which sees ATOR-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. This was further supported by the U.S. patent grant that we announced as late as yesterday. Not formally part of the Q3, but I just thought of it. Finally, RUBY bispecific antibody platform, as I said, we entered into an evaluation and option agreement with a biotech company focused on viral disease. This bispecific antibody format in itself has its own merit as a standalone platform.

That is something that we're discussing with a number of other potential partners. 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?

Johan Giléus, CFO, Alligator Bioscience: Thank you, Søren. Please, can we, yeah, exactly. Thank you. We have now reported our Q3 results. As you can see from the blue-colored column, 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 respect to the phase II closure procedures, and the IMP that is now in final stages. We will continue to see some of these costs, but not in the region that we have seen before. The SEK 17 million is a good proxy for the cost going forward. 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 TO12 and TO13, 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. The others are, of course, purely cash-out effects, including interest and other things. All in all, there are quite a lot of costs in the quarter, and also in the previous quarters and around the financing of the company. There are details in the Q3 report if you want to dig in deeper to that. Can we have the next slide, please? As you can see, we have the lowering of the operating costs from going back two years and then into this quarter. We continue to lower these costs. I'm predicting that we will come into SEK 15 million up to maximum SEK 20 million in certain quarters where it spiked and in the following quarters.

SEK 15 million, SEK 16 million, SEK 17 million is a good proxy for the quarter cost. That's also going back to how we estimate the runway that we have announced in connection with the rights issue. 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, we have a runway for six months in 2026. On top of that, we do have the TO14. 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. Let me come back on that. Of course, as Søren mentioned, we're looking to a different way of financing companies through licensing agreements and other kinds of agreements like the RUBY agreement that we made.

There are other means that we're looking into in parallel to the rights issue. Next slide, please. 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. We have then secured 65% of that through commitments, both securing commitments, but also a guarantee consortium. Would we then, as Søren mentioned, 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 mitazalimab 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 EGM.

That will be on the 25th of November. 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. Each shareholder will then, if they subscribe, get two ordinary shares and one warrant TO14, and the TO14 will be able to be listed and tradable. We have also summoned to an EGM, and that is to approve this rights issue. The following week, we will then start the subscription period and launch the prospectus, etc. We expect that around the 22nd of December, we can then announce the outcome of the rights issue. Together with that, there is some trading of these paid but not issued shares. Beyond the 13th of January, you will have the ordinary shares on your account. That was in short around the rights issue.

We will come back to that a number of times, including at EGM and the prospectus, etc. 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, Søren, to take this one.

Søren Bregenholt, CEO, Alligator Bioscience: Yeah, absolutely. Thank you, Johan. 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. I'll not talk about that unless in a couple of minutes. 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. We have the phase II IIT in biliary tract cancer that is scheduled to start in the second quarter next year.

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. 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. Right now, this is where we are, finalizing the phase II study with mitazalimab in first-line metastatic 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. Getting ready to start the biliary tract phase II in the second quarter next year. That concludes the presentation.

There are a lot of questions I can see. I will do it as we 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 Red Eye. Richard asks, "If a fully subscribed rights issue provides a runway for nine months next year, does that mean that the burn rate will increase?" 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 nine-month runway next year. The burn rate will not increase. It will decrease. I can reiterate the 15 to 18, maybe in one quarter, 20 million SEK in burn rate. Is that correct, Johan?

Johan Giléus, CFO, Alligator Bioscience: That's correct, yeah.

Søren Bregenholt, CEO, Alligator Bioscience: Yeah. 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 of cost. 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. Shifting a little bit of 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. We have not sort of laid out the final dates or the final schedule for data readouts together with the investigator. That remains to be seen. I'll come back on that. "When could the RUBY option and infection deal be converted into a deal to a real option?" 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. Approximately 18 to 24 months is a reasonable timeframe there. We have a number of questions around the mitazalimab deal, and they 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 we more optimistic than we were six 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 six 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 were 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. We are discussing with seriously interested parties, and we remain optimistic and more optimistic than we have been before. 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. 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. 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 warrant 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 a mitazalimab arm and a mitazalimab or a chemo arm and a mitazalimab plus chemo arm.

That sort of basic design remains the same. 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?" 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. We have had a number of patients that have been for more than a year, some almost two years, have been completely off the chemotherapy. They have gotten chemotherapy in the beginning of the study, of course, as part of the treatment regime. They have had the tumor under control together with mitazalimab.

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 two 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. That's one of the four drugs in the FOLFIRINOX combination. They've been on only one of the chemotherapies together with mitazalimab. This, of course, means two things. It means that it's fantastic to see that mitazalimab can sustain an immune response to the tumor on an ongoing basis. 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.

Let me just see what one final question here, also from Kempen. "What are the next steps for ATOR-4066 following the recent preclinical data, and are there any ongoing partnership discussions around the molecule?" ATOR-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 ATOR-4066 is manufacturing development. That's quite costly. For us to be able to start this work and be able to finish it, we need to get mitazalimab partnered before that. Yes, we are discussing with various companies in relation to a license for ATOR-4066.

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. It does not seem like we have more constructive questions for today's call. 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. Thank you for listening, and thank you for your support.

Johan Giléus, CFO, Alligator Bioscience: Thank you all.

Greta Höög, IR and Communications Manager, Alligator Bioscience: Thank you.

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