I'm here today together with a large part of my team who are seated in the front and who all of you will be able to meet and discuss with in the interval. Hamlet BioPharma is a company that takes scientific discoveries through to the clinic. We have built a platform that makes this possible in-house, and I'm very proud to show you the results of these efforts. Our participation here is very timely, and I can assure you that we are passionate, we're high value, and we are very unique, thinking of the partnering discussions we just listened to. Last Monday, we released this press release stating that Hamlet BioPharma receives FDA pivotal study feedback for novel neoadjuvant therapy in non-muscle invasive bladder cancer. Hamlet BioPharma announced it has received written feedback from the FDA supporting a pivotal development path for Alpha1H, first-in-class neoadjuvant for patients with low-risk non-muscle invasive bladder cancer. Alpha1 has so far shown little toxicity in the clinic and offers these patients disease and currently have no therapeutic options. Helpfully advancing Hamlet's marketing objectives for Alpha1H, the FDA comments focus on a pivotal clinical design. Some highlights. The written feedback, as I said, supported the overall pivotal design, which of course is the last step before a marketing application. The agency provided guidance on primary and secondary endpoints, which of course is valuable for us to finalize the clinical protocol. Also aligned Hamlet's plan to utilize central pathology review, a lot of technical details that are essential for the final protocol as well. We intend to incorporate the agency's recommendations and initiate enrollment in the next stage of the clinical program. Pending completion, and this is outlined as well in the next milestones, finalize the protocol, and we anticipate to engage first study sites early next year and to start the enrollment. Complete CMC readiness package is something that we have been dealing with over the past year, and we have produced the phase III quality material that is ready for release from international production plants. We are also evaluating the potential of expedited program designations with the FDA. Of course, for a small company who has discovered the molecule of Hamlet, now Alpha1H, taken this through preclinical and clinical phase II trials to actually be in a situation when we are in a dialogue with the FDA and are advised to do a pivotal trial is a very big and very emotional advance. I hope you can share that moment with us. Also, this was a comment that was attributed to me in the press release, but I would like to highlight the, what you say, the atmosphere, the helpfulness, the collaboration on part of the FDA. We were there in the summer for an in-person meeting over midsummer, by the way, 40 degrees Centigrade. We were, of course, impressed with all the competence and also all the competence that is put towards our program, helping us to advance. Hamlet BioPharma has not only this cancer program, we have finished two additional phase II trials, one in recurrent urinary tract infection, where we have made a controlled trial comparing the antibiotic of choice in this patient group, which is nitrofurantoin to anakinra, our immune inhibitor that actually targets the host response rather than the bacteria. The results show non-inferiority of our approach compared to the antibiotic. This is a conceptual advance because there are no clinical trials out there that have been controlled and where a non-antibiotic approach has been compared to an immunological approach to treat bacterial infections. We are also conducting a trial of immune inhibition in patients with what's called the bladder pain syndrome, which is a chronic syndrome with no really functional treatment options. The phase II data is very good as well. Three positive clinical trials and one on the way into a pivotal phase III. We also have a rich pipeline and our current patent portfolio, I think, has about 150 cases and some pending. We are a very active discovery machine, our lab is, thanks to all the people who are doing fantastic work. In addition to the study that we have completed, the phase II and found non-inferiority, we have three additional approaches to treating the patient's disease rather than the bacteria, a non-antibiotic approach to infection. These all work in animal models. They work against antibiotic sensitive, of course, organisms as expected, but they also work against antibiotic resistant bacteria. I would like to highlight that because I think, again, this is a conceptual advance that we have been part of. In terms of our pipeline for cancer therapies, Alpha1H is one in a member of the Hamlet family of molecules that kill cancer cells broadly. They remove tumor tissue in animal models and patients. They can be used for many cancer types in addition to bladder cancer, which is our primary goal. They also have very low toxicity. You can see the cell here that is starting to die. It's losing its grip. The cells are shed from the treated tumors in patients and in animals. Examples of future indications that we would like to explore is, of course, bladder cancer more widely than neoadjuvant, colon cancer, skin tumors, and brain tumors. There is animal data for all of those indications. I would like to end by, that's the passion. This is the pipeline for additional cancer indications where we have data for colon cancers, skin tumors, and brain tumors. We look forward to having an organization with enough muscle to use the Hamlet molecules also in those indications in human trials. Finally, our experienced team, our organization is a bit virtual, but we do have experts on our side in terms of legal and finance. We have national experts in partnering and many ongoing dialogues, large-scale production, as I said, and CMC regulatory patterns and investor relations that are working very well. The platform that we have built to develop our discoveries all the way from discoveries to the clinic is illustrated here. Key opinion leaders with clinical working with us in these different trials and the team. Thank you very much. Thank you, Catharina. We do have some questions here. We have some almost breaking news about changes to your management where you will be stepping, I do not want to say down because I do not think you are a person who steps down, Catharina, stepping aside maybe as the CEO. Can you comment on this? First of all, we are happy to welcome a new board member. This will be decided at the General Assembly in the beginning of December. This is a press release today with a proposal for a decision to be taken in December. Henrik Sundin, who is a very experienced person in the financial market and also a big shareholder in Hamlet BioPharma, will join us. He will, I think, support our business development and commercialization side and also partnering discussions. I don't know if I'm stepping anywhere. I think the chairman of the board position is a worthy position. It doesn't matter what you call me. I do what I do. I think it's very important to welcome Jakob Testad, who has been our financial coordinator for many years and who is a key person for the function of the company. To actually see that he takes on the role as CEO, which, how to say, it's what he has done together with me for a long time. This describes who we are and we welcome a new member to the board. That's really nice. Returning to the FDA feedback, I've got a couple of questions here. First of all, you described the FDA's feedback as both specific and enthusiastic. What does this response mean for the continued development? It means that Alpha1H as a treatment of bladder cancer is taken very seriously, I think. It means that all of the data we have generated, there was an emphasis on science in the previous panel. There is a lot of science there. There's a lot to relate to. There are lots of new endpoints that are not normally used, molecular endpoints, omics endpoints, things that we have sort of introduced in our clinical trials that put the data at the state-of-the-art level. There is also the convention of how you treat bladder cancer and what you look for. Do you look for the tumor? Do you add the molecular markers? What is the optimal way of defining these patients? I mean, what it really means is that we are progressing to a phase III trial with everything that's needed for a future marketing application. As a final question then, could you just kind of summarize how you see Hamlet standing out from your competitors or similar companies? That's a great question. I mean, Hamlet is a very different molecule in the sense that it's almost prophylactic. Of course, it's therapeutic if you give it to an animal or a patient with a tumor, but it also has long-term preventative effects in our hands and it has very low toxicity. Where do you position it? Our approach has been to position it in the very early tumors where currently there actually is no treatment. This is first. The neoadjuvant approach is to treat the patient with a newly diagnosed tumor before other treatments come in and then to see if eventually Alpha1 can also proceed to become, for example, a co-treatment partner for conventional therapies or a later disease standalone treatment. Start with a neoadjuvant, no risk for the patient, low side effects. We like that. Thank you so much, Catharina. Thank you. Thank you.
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