Hansa Biopharma AB (publ)

Good day and welcome to the Hands of Biopharma year end and fourth quarter 2024 report. All participants will be in listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touch tone phone. To withdraw your question, please press star and then two. Please note this event is being recorded. I would now like to turn the conference over to Soren Tolstrup, President and CEO. Please go ahead.

Thank you, operator. Good afternoon, good morning, and welcome to the Hensa Biopharma conference call to review the full year and Q4 results for 2024. I'm Soren Tolstrup, President and CEO of Hensa Biopharma. Joining me today is Evan Ballantyne, Chief Financial Officer, and Hito Kaufmann, Chief R&D Officer. Please turn to slide two. Please allow me to draw your attention to the fact that we'll be making forward-looking statements during this presentation, and you should therefore apply appropriate caution. Please turn to slide three and then overview today's agenda. Today, we'll discuss the progress we made during the fourth quarter and review the full year of 2024 performance. The presentation should take roughly 15 to 20 minutes, after which there will be an opportunity to ask questions during a Q&A session. Please turn to slide four and an overview of our Q4 and full-year performance. Let's first begin with full-year performance. Total revenue for 2024 was 220.9 million SEC, and full-year IDFRIC sales totaled 189.7 million SEC, representing an 83% increase over the prior year. This performance excludes the impact of a provision of 49.6 million tech taken in 2024 to reflect discounts and a one-time retroactive rebate linked to successful special early access programs since the launch of ID3 in 2020. Including the impact of the provision, full year 2024, total revenue was 171.3 million tech, representing a 28% increase versus prior year. Additionally, full-year ID4X sales, including the impact of the provision, total 140.1 million tech, representing a 35% increase over the prior year. The solid year-over-year ID4X sales growth reflects continued strong launch execution in Europe, which has resulted in an increase in clinical utilization in key markets and continued advancement of regional and local clinical guidelines on the appropriate use of ID4X in highly sensitized kidney transplant patients. We're especially encouraged not just by the growing number of key clinics with specific itabrix protocols in place, but also the growing number of clinics with repeat itabrix usage following successful outcomes of first transplants, and we see this as a key driver of expected future growth. Please turn to slide five. I'd also like to highlight the trailing 12-month product sales data that shows performance over the previous year. This underscores the continued launch progress and growing market uptake without quarterly volatility due to variations in the flow of organ offers to specific highly sensitized patients waiting for an organ offer. Volatility we expect will continue, albeit with diminishing effect over time as we expand the ongoing usage of IDFRIX and penetrate new markets throughout Europe and beyond. Please turn to slide six. 2024 saw much progress in our pipeline projects, and we're very pleased with the delivery of several key pipeline catalysts and advancement of scientific exchange. Of note, we announced positive results from our Phase II trial in GBS and results of an indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study, or IGUS, demonstrating the potential of imifidase, our first-generation IgG-cleaning molecule, to address a significant unmet need in GBS. Additionally, we completed enrollment in our Phase 3 study in anti-GBM and initiated a Phase 2 trial with our partner, Jonathan, in Crickler-Najjar syndrome. This marked our second gene therapy trial to commence last year. The first trial was a Phase 1B study with our partner, Sarepta, in Duchenne muscular dystrophy. This trial continues to enroll patients. 2024 also marked significant progress with HANSA 5487, our next-generation IgG-cleaning enzyme with redosing potential. In October, we share positive data from our 12-month analysis of the NICE-01 first-in-human study. This analysis demonstrated that HANTSA-5487 can robustly and rapidly reduce ITG levels, has redosing potential, and a favorable safety and tolerability profile. Early in the year, we completed randomization of all patients in the U.S.-confided phase 3 trial in kidney transplantation. The trial is on track for data readout in the second half of 2025, followed by the expected submission of a BLA to the US FDA under the accelerated approval pathway. Lisa will share more details in a few minutes about these trials and our clinical development plans. Before moving to the next slide, I'd like to highlight our successful efforts to communicate the benefits of amlifidase in scientific publications and presentations at leading medical congresses around the world. Please turn to slide seven for an overview of the commercialization of itabrix in Europe. We continue to make solid commercial progress with Idafrix in Europe as a desensitization treatment and kidney transplantation. Due to the continued successful launch efforts in the number of centers gaining clinical experience with Idafrix continues to grow with three additional centers added in Q4 and more than half of all clinics utilizing Idafrix more than once after a positive first clinical experience. Additionally, I'm pleased to share that following the team's successful engagement with key opinion leaders in Europe and medical societies there, there are now two published international consensus documents providing guidance on desensitization in kidney transplantation. The most recent guidance was published in Transplant International, providing specific guidelines on the appropriate use of amlifidase in clinical practice to enable kidney transplants in highly sensitized patients. Finally, Thanks to our continued successful market access efforts, we recently secured reimbursement in three additional European markets. Hansa now has secured reimbursement in 18 markets, including the five largest European markets. We recognize the innate volatility in organ transplantation market due to variations in the flow of organ offers, but are encouraged by the growing number of clinics that are ready to treat with Idafrix and the increase in new and repeat users. providing a solid foundation for expected continued growth and market uptake. I will now turn it over to Hisu for an update on the pipeline and clinical development. Please turn to slide eight.

Thank you, Theron. Please turn to slide nine for an update on the pipeline and clinical development highlights to date. As you can see, we continue to make good progress across the pipeline in all three therapeutic areas, And in the fourth quarter, we shared several updates in both the autoimmune and gene therapy areas. I'll now walk through some of the specific trials and studies we have ongoing and the clinical development plans we have in place. Please move to slide 10. Let me start with the left-hand side of the slide and reiterate the continuous focus of Hamza on advancing science in areas where there remains high unmet medical need. I'm pleased to share But over the course of 2024, we have presented at several leading congresses in autoimmune, gene therapy, and transplantation, and published 10 articles in peer-reviewed journals. These efforts underscore our commitment to advancing the understanding of potential applications for our molecules, as well as the science behind complex conditions with very few treatment options. On the right-hand of the slide, you can see a summary of the progress we have made in 2024, and specifically the clinical development of inlifidase in 15487. In autoimmune, we communicated two key pieces of data in Q4. The first is the positive results of the 15H meditis O9 phase 2 study of inlifidase, an indirect treatment analysis of that data to the International Guillain-Barré Syndrome Outcome Study, or IGOS, in Guillain-Barré Syndrome, also known as GBS. The second is the completed enrollment of GUDIDIS-02 Phase III trial in anti-GBM. The GUDIDIS-02 trial is a Phase III open-label controlled randomized multicenter trial across Europe and the U.S. and is evaluating renal function and the need for dialysis at six months in patients with severe anti-GBM disease. Anti-GBM is a rare severe autoimmune condition affecting around 1.6 people per million annually. Encouraged by our Phase II data, we believe imlifidase has significant potential in improving the outcome of these patients and address the unmet medical needs. Imlifidase has been granted often drug designation for the treatment of anti-GBM disease, by both the U.S. Food and Drug Administration and the European Medicines Agency. Q4 also marks the commencement of our second trial in gene therapy. In December, we announced the initiation of a trial with Genton, one of our gene therapy partners, in Priglin-Major syndrome. The trial, GNT-O18-IDIS, is a Phase II trial in patients with Krasnoyarsk syndrome with pre-existing antibodies against adeno-associated virus vectors, or AAV. The trial will evaluate the efficacy and safety of single intravenous administration of Geniton's gene therapy, GNT-0003, following pretreatment with imbifidase. Antibodies against ACE vectors remain a major challenge, as their presence in patients excludes them from entering clinical studies with potential curative gene therapy treatments and from access to currently marketed and future gene therapies. Kriglin-Major syndrome is a rare genetic liver disease characterized by abnormally high levels of bilirubin in the blood, which leads to irreversible neurological damage manifested as muscle weakness, lethargy, deafness, intellectual disability, and eye movement paralysis. At present, patients must undergo phototherapy for up to 12 hours a day to keep the bilirubin levels below the toxicity threshold. Kregler-Majard syndrome is an ulcerative disease affecting less than one case per one million per year. GNT3003 is currently being evaluated in a pivotal clinical study in France, Italy, and the Netherlands and has received prime status from the European Medicines Agency. Of note, enrollment in SRP 9001-104 Phase 1B trial continues. As a reminder, the trial is evaluating the use of amlifidase as a pretreatment to Siretia Therapeutics' elevated gene therapy in Duchenne muscle dystrophy. In transplantation, we continue to progress enrollment of patients in the Post-Authorization Efficacy and Safety Study, PAES, as part of our obligation to the European Medicines Agency. As mentioned, we are now at 96% enrollment rate, with 48 out of 50 patients enrolled. This study will support the adoption of Idiferix more broadly and allow even more clinics to gain clinical experience. Once completed, centers are expected to commence or increased usage of commercial product. And the confided U.S. pivotal trial 3 in phase 3 was fully randomized in May, and we plan to deliver data in the second half of 2025, followed by a VLA submission to the U.S. FDA. Moving to 154.87, our next-generation IgG-cleaning enzyme, in October of 2024, we announced positive results of the 901st in human trial and findings from a 12-month analysis of that data. The analysis demonstrated that HANSA 5487 can robustly and very rapidly reduce IgG levels, has redosing potential, and a favorable safety and tolerability profile. We believe HANSA 5487 has a highly differentiated profile compared to published data from studies with other IgG-targeted therapies. AMSA 5487 has the potential to address significant unmet need across a spectrum of chronic autoimmune diseases, where IgG plays a role in disease pathology, including autoimmune conditions, and where the need for management of repeat acute immune system attacks is crucial. We will focus initial clinical development in new autoimmune diseases with a well-characterized role of specific autoantibodies in disease pathology, and recurring acute phases, specifically myasthenia gravis, or MGE. A significant number of patients with chronic neurological autoimmune diseases face exacerbations and even severe crisis, leading to hospitalization, demonstrating the high unmet medical need today. In the first half of 2025, we plan to align with regulatory agencies on the clinical development part of HANSA 5487 in myasthenia gravis. Please turn to slide 11 for a summary of the data from 15H metitis study in GBS. I want to spend just a few minutes providing a bit more context on the 15H metitis 09 and the indirect treatment comparison to IGOS. As a reminder, 15H metitis 09 is an open-label, single-arm, multicenter study across the UK, France, and the Netherlands. Patients with severe GBS included all patients with a disability score at and above 3. The study evaluated safety, tolerability, and efficacy of single-dose amlifidase in combination with intravenous hemoglobin or IVIG in 27 adult GBS patients. Data from the study demonstrated that severe GBS patients treated with amlifidase plus IVIG had rapid overall improvement in functional status, including expedited recovery of muscle strength, rapid return to independently walking, and a median time to improve by at least one grade in the GBS study at six days. The key results from the study are one week after treatment, 37% of patients were able to independently walk, and the median improvement in muscle strength was 10.7 points, as assessed by Medical Research Council, or MRC, some score. Additionally, the median time to independently walk for patients treated in the study was 16 days. Finally, at week eight, 67% of patients were able to walk independently, 41% of patients had regained the ability to run, and 37% of patients had improved by at least three points in the GBS disability score. Finally, at six months, 63% of patients were able to run or had no functional disability. Please turn to slide 12. When compared to the IGOS Reward Comparative Group, 754 severe GBS patients treated with IVIG patients in the 15-meta-IDIS study, which included 27 severe GBS patients treated with imlicidase in combination with IVIG, experienced statistically significant improvements across several clinical meaningful measures. The indirect treatment comparison concluded that patients in the 15-H-meta-IDIS-09 study treated with imlicidase plus IVIG returned to independently walking six weeks sooner, when compared to severe GBS patients in the IGOS real-world comparator group treated with IVIG alone. Additionally, patients in the 15 HMED-ISO9 study experienced statistically significant improvement across several clinically meaningful measures at multiple time points. At week one, patients were 6.4 times more likely to walk independently compared to the IGOS real-world comparator group. In GBS, IgG is a key driver of inflammatory attacks on peripheral nerves and has been clinically linked to the severity and progression of the disease. Rapid reduction of IgG levels has the potential to benefit GBS patients by depleting pathological IgG antibodies, thereby halting disease progression, resulting in faster recovery and less severe disease. Improvement in GBS disability score is important because it directly affects the clinical outcomes, recovery, and quality of the life for patients. Better management of disease severity can help reduce the risk of life-threatening complications, shorten recovery time, prevent long-term disability, lower healthcare costs, and improve overall patient well-being. We believe these results demonstrate the significant role that illicit AIDS may play in the treatment of GBS in combination with the standard of care IVIG. Unlike other molecules, illicit AIDS can effectively and very rapidly cleave IgG, potentially halting the progression of nerve damage associated with GBS and stopping the progression of the disease. I will now turn it over to Evan to cover financial performance. Please turn to the slide.