Hansa Biopharma AB (publ)

Good morning and welcome to the HANSA Biopharma Interim Report for January to September 2024 conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Soren Tolstrup, President and CEO of Hansa Biopharma. Please go ahead.

Thank you, operator. Good afternoon, good morning, and welcome to the Hansa Biopharma conference call to review the Q3 results for 2024. I'm Soren Tolstrup, President and CEO of Hansa 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. Now, please turn to slide three and an overview of today's agenda. Today, we'll discuss the progress we made during the third quarter 2024 and review our near-term priorities. 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 Q3 performance. The third quarter, 2024, marks the company's highest ever quarterly in-market Ida Creek sales and fourth consecutive quarter of solid sales performance with total revenue of $78.4 million six. Of this, 69.5 million SEC can be attributed to ID4X sales. Year-to-date sales for ID4X total 164.2 million SEC. The continued strong ID4X sales performance can be attributed to an increase in clinical utilization in key EU markets, including Italy, Germany, France, Spain, and the UK. Additionally, we're seeing more repeat utilization of Idafrix in clinics across major European markets following cost of outcomes of first transplants. Of note, the provision of 29.7 million sec was recorded in the third quarter. This reflects a revised estimate of the one-time retroactive adjustment of cumulative sales since launch in 2020 based on recent advancement of near final pricing negotiations in one key market where IDFRIX has benefited from early access under a special program prior to the conclusion of pricing and reimbursement negotiations. We expect to achieve a successful conversion of this program into full reimbursement in Q4. With the provision, only 4.9 million SEC relates to sales in the third quarter of 2024. Evan will cover this in more detail later in today's call. 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. Please turn to slide five for an overview of Q3 highlights. Throughout 2024, we made significant scientific advancement. In May of this year, we announced the completed randomization of all patients in the U.S. Confidus Phase III trial in kidney transplantation. The trial is on track for data readout in second half 2025, followed by the expected submission of a BLA to the U.S. FDA under the accelerated approval pathway. As a reminder, a total of 23 sites were involved in the trial, and consented over 140 patients. The sites in the trial represent about 20% of the total transplantation volumes in the U.S. The third quarter also marked steady progress in additional studies, including the post-authorization efficacy and safety study, or PIE study, in kidney transplantation, and the GUT-ITIS-02 phase three trial in the autoimmune disease anti-GBM. The PIE study in Europe is 78% involved, with 39 out of 50 patients in the trial. The study is progressing in parallel with the continued commercialization of Idiferix and is part of our obligation to the European Medicines Agency. We believe that the data generated by this study will support the adoption of Idiferix more broadly and allow even more clinics to gain clinical experience. The GUDIDIS-02 Phase III trial in anti-GBM disease also continues to progress with 86% of patients involved in the trial. Condition of enrollment and data readout is expected in 2025 as previously guided. Anti-GBM is a rare, severe autoimmune condition affecting around 1.6 people per million annually. Mifidase has been granted orphan drug designation for the treatment of anti-GBM disease by both the U.S. FDA and the European Medicines Agency. We also continue to progress scientific exchange through data presentations at key medical congresses and publications in peer-reviewed journals. This underscores our commitment to advancing the science related to IDFRX. Of note, as mentioned last quarter, a real-world evidence study was initiated in France to evaluate outcomes in nine inlifidase-treated patients. The study was presented at the AST meeting in June and published in Kidney International Reports in July. Through the follow-up period, there was no graft failure and no deaths. These real-life data demonstrate that the use of hemiphidase to desensitize highly sensitized patients can have an acceptable short-term efficacy and safety profile in selected patients in a real-world setting. Peter will provide a more comprehensive update on the pipeline and clinical development progress later in the presentation. Now, please turn to slide six for an update on the ID4X launch in Europe. We continue to make solid progress with the launch of ID4X in Europe. To date, this marks the fourth consecutive quarter of strong commercial sales. As of today, we have reimbursement in 15 European markets, including the top five markets, representing approximately 75% of the European transplant market. In the third quarter, we saw a 10% increase in the number of clinics who gained clinical experience with Idifrix. This represents 32 clinics in 11 markets. Of these, 62% have used Idifrix more than once. This reflects clinicians' growing confidence in ID4X and willingness to identify ID4X-appropriate patients. We also saw an increase in utilization in markets within the uro-transplant program. In total, 53 patients have been identified as ID4X-appropriate patients in markets in the uro-transplant program. Uro-transplant is an international allocation system responsible for the allocation of donor organs across eight countries, including Austria, Belgium, Croatia, Germany, Hungary, Luxembourg, the Netherlands, and Slovenia. This reflects the adoption of IDFRX in local and international organ allocation systems and underscores an increased demand for IDFRX-designated organs. We recognize the innate volatility in the transplantation market as it relates to organ allocations. We're encouraged by the growing number of clinics that are IDFRX-ready to treat and the increase in new and repeat users as we continue to build out opportunities to ensure ongoing expansion of IDFRX, including extensive engagements with KOLs and clinics in key markets. I will now turn over the call to Hitzu for an update on the pipeline and clinical development. Hitzu, please.

Please turn to slide seven. Thank you, Cern. Please turn to slide eight for an update on the pipeline and clinical development highlights to date. We continue to make good progress across the pipeline, inclusive of studies in various stages in autoimmune gene therapy and transplant. We continue to believe that imifidate and HANSA-5487, or next-generation IgG cleaving molecules, have the potential to address significant unmet need across the spectrum of diseases where IgG plays a role in disease pathology. During the second quarter, we have made solid progress across our three key therapy areas and with all trials. Please turn to slide nine. As Sirin mentioned, we have advanced several key clinical trials over the course of the third quarter and 2024. To date, Hunter has seven ongoing clinical trials, three phase three trials, two phase two trials, and two phase one trials. We are excited about the imminent commencement of a second phase one trial in gene therapy, broadening our clinical program with regard to vector use and target tissue. In transplantation, we continue to advance enrollment in the post-authorization efficacy and safety study as part of our obligation to the European Medicines Agency. The CONFIDAS US Pivotal Phase III trial was fully randomized in May, as previously mentioned, and we plan to deliver data in the second half of 2025, followed by BLA submission to the US FDA. As mentioned last quarter, pooled five-year data, including data from The 17 MED-IDIS-14 and 4 Phase II trials have been submitted to a peer-reviewed journal for publication. 70H MED-IDIS-14 is a prospective observational long-term follow-up study of patients treated with emicidase prior to kidney transplantation to measure long-term graft survival in patients who have undergone kidney transplantation after emicidase administration. Patient survival was 90% death-centered, And graft survival was 82% and in line with standard of care outcomes seen at three years post-transplant. This data is an important part of the broader clinical evidence supporting the use of imifidase as desensitization therapy for highly sensitized kidney transplant patients. In autumn, we have also made good progress across all trials. The Good Ideas 02 trial in anti-GBM continues to enroll. Currently, the trial is 86% enrolled, which means 43 out of 50 patients are in the study. We look forward to sharing data in 2025. As a reminder, Good Ideas 02 trial is a Phase III open-label controlled, randomized, multicenter trial across Europe and the U.S., and it's evaluating renal function and the need for dialysis at six months in patients with severe anti-GBM disease. We believe amlifidase has significant potential in improving the outcome of these patients and address the unmet medical need. Further, I'm pleased to share that the 15-age metitis O9 phase 2 trial in Guillain-Barré syndrome remains on track. We plan to share contextualized efficacy data this year based on the comparison between the data of the study and a matched cohort from the International Guillain-Barré Syndrome Outcome Study called IGOS. IGOS is a large-scale global research initiative that collects extensive clinical and biological data from GBS patients to enhance understanding and treatment of this potentially life-threatening disease. GBS is an acute, rare, paralyzing, inflammatory disease of the peripheral nervous system, usually preceded by an infection or other immune stimulation. Two-thirds of patients have severe symptoms resulting in the inability to walk unaided. Data from the 16 MED-IDIS 12 Phase 2 trial was published in Clinical Transplantation in July. Moving on to gene therapy. Enrollment in the Sarepta 9001-104 Phase 1B trial continues. As a reminder, the trial is evaluating the use of imbitidase as a pretreatment to Sarepta Therapeutics' Alevitis gene therapy in Duchenne muscle dystrophy. We expect to share preliminary data from the trial in 2025. With both Aspio and Genitome, we continue to progress preclinical efforts. As previously shared, we have plans to commence a study this year with Genitome evaluating imlifidase as pre-treatment to its GNT0003 for patients with Kregler-Majard syndrome. GNT0003 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. And finally, just a week ago, we announced positive results for the NICE-01 trial and a 12-month follow-up analysis of HANZA5487, the company's next-generation IgG-cleaning molecule. This analysis demonstrates that HANZA5487 can robustly and very rapidly reduce IgG levels, has redosing potential and a favorable safety and tolerability profile. 154.87 has a highly differentiated profile compared to published data from studies with other IgG targeted therapies. 154.87 has transformational potential to address significant unmet need across the 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. The company will focus initial clinical development on HANZA5487 in neuro-autoimmune disease with well-characterized role of specific autoantibodies in disease pathology and acute phases. Initial clinical development of HANZA5487 will focus on neuromyelitis optica, NMO, myelin oligodendrocyte glycoprotein antibody disease, MOGARD, and myasthenia gravis. 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. It's also important to note that we are advancing the science of imifidase through medical congress presentations and publications in peer-reviewed journals. To date, in 2024, we have published in seven peer-reviewed journals, and there have been eight presentations of data at key medical congresses. I will now turn it over to Evan to cover financial performance.