Alligator Bioscience AB (publ)

Hello and welcome to Alligator Biosciences second quarter 2024 interim report call. My name is Greta Eklund. I'm the Investor Relations and Communications Manager at Alligator and I will be introducing today's call. With me are our CEO Søren Weyenholt, our CFO Marie Svemsson and our CMO Sumitam Barkhane. They will walk you through the latest developments from Q2 2024 and the upcoming news flow, after which they will be happy to answer any questions you may have. Now, before we begin, I would like to share a quick reminder that during today's call, management may make forward looking statements that involve known and unknown risks, uncertainties and other important factors beyond the company's control. that could cause the company's actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those contained in the forward-looking statements. Actual results and the timing of certain events may differ materially from the results or timing predicted or implied by such forward-looking statements, and reported results should not be considered as an indication of future performance. Please note that these forward-looking statements made during this call speak only as of today's date, and the company undertakes no obligation to update them to reflect subsequent events or circumstances other than to the extent required by law. This call is being webcast and will also be made available through the investor relations section of our website. With the formalities out of the way, I would now like to turn the call over to Søren.

Thank you, Greta. I'm Søren Breinholt. I'm the CEO of Alligator Bioscience. Welcome to our second quarterly earnings report of 2024. And if we go to the next slide, I'm pleased to go over some of the main achievements that Alligator has seen in the second quarter. First of all, the mitosalumab phase two data in first-line pancreatic cancer continues to deliver new data. And we recently announced outstanding 18 months follow-up data for mitosalumab. Not only did the median overall survival increase to 14.9 months, which is substantially better than the 11.1 months reported for Folfarinox monotherapy, but importantly, we also reached 36% 18-month survival rate, meaning that 36% of the patients were alive at this important time point. This rate is almost double that of data reported for Folfarinox monotherapy, and Sumit, our CMO, will comment on the result in greater detail shortly. The top-line data from this Phase II study was published in The Lancet Oncology, the world's leading journal on clinical oncology. And this publication naturally validates the significance and the importance of the data. And the entire Alligator team and our investigators are very proud to have been selected by this world-leading clinical oncology research journal to present our groundbreaking data. In addition to the Lancet oncology, we also presented at several key conferences this quarter, AACR in April, ASCO in June, as well as the European Society for Medical Oncology on their GI-related gastrointestinal cancer conference earlier, or late June this year, all highlighting the further validation of mitosalumab phase 2 data. Based on these phase 2 data, Alligator has received a surge in the demand from physicians who want to conduct trials on mitosalumab in their own centers across a number of relevant indications. Recently, one such trial was initiated at the prestigious Moore Cancer Center in San Diego. This phase one study in locally advanced pancreatic cancer is financed by the U.S. National Cancer Institute. We believe that these investigated initiated trials are a great way to generate additional data for mitocelumab at limited or no cost for alligator and to raise the profile of mitocelumab and alligator internationally. And we will continue to evaluate and engage in these trials as appropriate for the development of mitocelumab. On the repartnering front, Alligator announced that Orion Corporation, now a long-term partner for Alligator, had selected the lead bispecific antibodies from the company's second development program, and that Orion was exercising its option to develop these molecules under the existing 2021 research collaboration and research agreement. The exercise of this development option is of course an important validation of alligators' technology and our approach to generate biospecific antibodies and also trigger the milestone payment to alligators. Further on financing, we conducted a capital raise of 80 million Swedish kronor, which extended our cash run way well into Q1 2024, allowing us to continue our investments in key strategic areas and enhancing our manoeuvrability in negotiating the best possible licensing deal for Mitter-Salomon. Marie will go into the details later in today's call. And last but not least, we're also looking forward to welcoming Johan Gileus, who will join as Chief Finance Officer starting August 12th this year. Johan brings valuable experience in leading financing strategy and operations across a number of companies, including overseeing a last phase three clinical trial and out licensing in Japan on the same molecule. continue to bring energy and strong knowledge and experience to the company. So those were the highlights for the second quarter. Next slide, please. So partnering our phase three ready as admitted our key priority, we are pursuing our partnering activities and discussions to find the optimal global partner. And I'm happy to announce that these Dialogues with the global pharmaceutical companies are progressing very well. We are continuing to prepare metacelumab for phase three. And we stay laser focused on advancing metacelumab to patients with pancreatic cancer as soon as possible. With that, I would now like to hand over to our Chief Medical Officer, Sumit, for some more details around OptimizeONE. Sumit, over to you.

Thank you. Thanks, Sorin. Next slide, please. Right. So most of you may be familiar with our ongoing OPTIMIZE-1 study and the impressive tumor shrinkage we have reported in the trial with the metazolamab plus modified folfirinox combination, which is exactly what we see in this waterfall plot. This is basically an indicator of how much was the reduction in the tumor for the individual patient during their trial treatment. Particularly important to note is the vast majority of the patients that benefited from this treatment, that their tumors shrunk, and also the number of patients who had an objective response, either a partial or a complete response seen in the green shades on this chart, as well as the three last patients where there was 100% disappearance of all of their tumor target lesions. This is really an impressive outcome for this very difficult to treat patient population and in a disease so aggressive as pancreatic cancer. Next slide. So, I mean, I hope you have noted the most recent data that we released from the OPTIMIZE-1 study at the end of June, only a few days ago, that demonstrated substantial overall survival benefit and a truly unprecedented duration of response with metazolamab and modified Folfirinox combination as a first-line treatment for metastatic pancreatic cancer. These latest data are summarized on this slide, also in the context with the standard of care therapies, such as gemcitabine plus albumin-bound placlitaxel, folfirinox, as well as nalurifox, the most recently approved treatment. And clearly, the results from the OPTIMIZE-1 study appear favorable compared to any of these other therapies. not just in terms of the objective response, but importantly, in terms of the substantially longer duration of response and its extension into overall survival, particularly notable at the 18-month time point where we see that the percentage of surviving patients was doubled in the OPTIMIZE-1 study compared to the historically reported data from the FOLFIRINOX trial. This is an important point to note because the 18-month time point is unfortunately not the one which most of the patients with pancreatic cancer see. And therefore, this doubling of survival rate at this landmark is really an impressive outcome. These are also very mature data with the 18-month overall follow-up duration across the efficacy population. And they also provide an additional validation of the potential that mitazolamab has in this very aggressive disease. And of course, they also form the basis for our planning for the randomized phase three study. Next slide. So here we have an overview of how our fully owned programs are progressing. uh this gives a very good sense of our robust immuno-oncology pipeline with substantial clinical as well as commercial potential our next generation mono as well as bispecific antibodies address key immune activation pathways such as cd40 and 41bb and they're designed with features that make them complementary to existing anti-cancer treatments we believe that this puts our antibodies in a unique position as a part of the combination therapies for future that can help patients with hard to treat cancers. If you look at the pipeline, there are several infection points coming up. As already mentioned by Soren, we are stepping up our efforts to enter into an agreement with an optimum by a pharmaceutical partner that is best suited to take metazolamab through its confirmatory development and then onto the market as soon as possible. So we are foreseeing that the phase three trial will start in the first half of 2025. Next is our NeuX Prime first-in-class bispecific CD40 agonistic antibody, which we call ATOR4066. This is a very exciting molecule that continues to demonstrate significant potential during its current preclinical phase of development. And that further supports Alligator's commitment to continue advancing this molecule towards the clinic. It also demonstrates that Alligator's pipeline and the CD40 program extends well beyond metazolamab. So something really to look forward to. And last but not least, from our pipeline point of view, are our programs targeting 4-1-BB? We are assessing options for taking the monospecific 4-1-BB molecule 8 or 1017 to phase 2 development as a combination treatment. And we are also expecting for the other program, ALGA-PV527, which is a bispecific 4-1-BB antibody, that the phase one study will be completed in the coming months. This is a program that we are co-developing with our partner company, Aptivo Therapeutics, and we are hoping that the data will be available in the second half of this year. So with that, let's turn to Marie Svensson to review our financial results for the quarter. Marie, over to you.