MorphoSys AG

Ladies and gentlemen, good afternoon or good morning. My name is Julia Neugebauer, Head of Investor Relations at North Fortis, and it is my pleasure to welcome you to our 2023 Half-Year Financial Results Conference Call. With me on the call today are Jean-Paul Kress, our Chief Executive Officer, Tim Demuth, our Chief Research and Development Officer, and Lucy Crabtree, our new Chief Financial Officer. Before we begin, I'd like to remind you on slide two that some of our statements made during the call today are forward-looking statements, including statements regarding our expectations for the commercialization of our products and our development plans, and expectations for the compounds in our pipeline, as well as the development plans of our collaboration partners. These forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially, including those described in Morphosis 20F, an annual report All for the year ended December 31st, 2022, and from time to time in other SEC documents of morphosis. It is important to keep in mind that our statements on this webcast speak as of today. On slide three, you will find the agenda for today's call. Jean-Paul will begin with an overview and give an outlook. After that, Tim will share an update on our clinical development work, and then Lucy will provide a summary of our first half 2023 financial results. Following our prepared remarks, we will open the call for your questions. With that, I now hand the call over to Jean-Paul.

Thank you, Julia. Good morning and good afternoon, everyone. Thanks for joining us today. We had an extremely productive and strong first half of 2023. We delivered and surpassed expectations on our key priorities, and we will continue to build on this great momentum as we enter an exciting second half of the year. We completed enrollment of two of our pivotal trials ahead of schedule. The Manifest-2 study of Pelabrasib in first-line myelofibrosis and the FrontMind study of Monjuvi in first-line DLBCL. Additionally, our partner Insight completed enrollment for InMind, the Phase III study of Monjuvi in patients with relapsed refractory follicular lymphoma or marginal zone lymphoma. Furthermore, we presented updated results from our tool memetostat phase 1-2 study showcasing the therapies based in class potential in an array of cancer types. We also took steps to further strengthen our financial position. Today, we are well financed to drive forward our promising mid to late stage clinical programs with more than 12 months of cash available following the top line readout of the Manifest 2 study. Also, Lucy Crabtree joined us this month as our new Chief Financial Officer. We are very pleased to officially have her on board. Elabrasib, our investigational bed inhibitor, is a potential best and first-in-class foundational first-line treatment for patients with myelofibrosis. With this therapy, we have the opportunity to substantially improve the standard of care for this debilitating and difficult-to-treat disease. Today, JAK inhibitors, such as roxolitinib, are the standard of care to treat myelofibrosis. These medications can reduce spleen size and relieve symptoms of myelofibrosis, but they do not address its cause. Furthermore, with this treatment strategy, only about 50% of patients achieve initial adequate disease control. And for many, that relief fades with time. The results from our Phase II manifest study suggest that Pelabrasib in combination with Roxolitinib offers prolonged improvement in both spleen size and symptom severity at and beyond 24 weeks. Further to this, in the manifest study, changes in biomarkers correlated with improvements in clinical measures of treatment success, suggesting a potential disease-modifying effect of Pelabrasiv. We believe these data underscore the strength of this combination therapy and its potential to be the future standard of care in myelofibrosis. Based on precedent in first-line myelofibrosis, we believe that the results from Phase II studies are strong indicators of what we can expect to see in Phase III trials. As such, based on our strong Phase II results, we are very optimistic about the performance of the Pelabrasib and Ruxolitinib combination in our pivotal trials. With top-line data from the Manifest II trial now expected by year's end, we are hearing increased excitement from physician and patient communities around Pelabrasib, reflecting the dire need for more effective and well-tolerated therapies to treat myelofibrosis. We will remain laser-focused on Pelabrasib in first-line myelofibrosis, delivering the Phase III manifesto study results and, simultaneously, preparing our regulatory filings in the U.S. and Europe this year. That said, we also see great possibilities for Pelabrasiv beyond myelofibrosis, and we will continue to explore its therapeutic potential in other myeloid diseases, including lower-risk myelodysplastic syndrome, also known as MDS, and essential thrombocytemia, also known as ET. Tim will share more on this shortly. Moving to Monjuvi now. Monjuvi is our CD19 targeting immunotherapy. It continues to be prescribed to certain adult patients with relapsed or refractory DLBCL. In the second quarter, Monjuvi net sales were 23.6 million US dollars. This represents a 14% quarter-over-quarter growth. and is on track with our 2023 guidance. Beyond the currently approved indication, we see the largest potential upside for Monjuvie in the first-line DLBCL setting, which we are investigating in our phase three front-mind study. The trial randomized nearly 900 patients with data projected to be available in the second half of 2025. Also, Monjuvi's use in relapsed refractory follicular lymphoma and marginal zone lymphoma is being explored in the phase 3 in-mind study. This data will be available in 2024. We have a strong U.S. commercial infrastructure in place for Monjuvi. We have encountered a large overlap in treating physicians for DLBCL and myelofibrosis. especially in the community setting, where we have established relationships. This would enable us to launch Pelabrasib smoothly. We've made exceptional progress with our pipeline. As a result, we have a rich set of catalysts from our pivotal studies over the next two years. Additionally, our key partner programs are progressing very well. These programs developed via our legacy antibody technology platform, include Yanalumab, Abelacimab, Sestrusumab, and Bimacrumab. While not a core focus of our business strategy, these programs offer potential upside and provide us with options for non-dilutive financing. I will now turn the call over to Tim to provide a development update. Tim, over to you, please.

Thank you, Chopin. The Phase 3 Manifest-2 study is our number one priority. In this trial, patients naive to JAK inhibitor therapies were randomized one-to-one to Palabrasib in combination with Raxolitinib or placebo plus Raxolitinib. Recall that after we acquired Constellation, we optimized the Manifest-2 study by increasing our target enrollment from 310 to 400 patients. In the end, we randomized 431 patients. The primary endpoint of the study is the proportion of patients who achieve a 35% or greater reduction in spleen volume at week 24, known as SVR35. The key secondary endpoint of the study is a proportion of patients achieving a 50% or greater improvement in total symptom score, known as TSS50. In addition to these two endpoints, we're also measuring the percent change in total symptom score at week 24, progression-free survival, overall survival, duration of splenic and total symptom score response, and improvement in bone marrow fibrosis, among others. We are confident that the comprehensive MANIFEST-II data package will provide meaningful insights into the potential benefits of pilibrasib and ruxolitinib as a first-line combination therapy for patients with myelofibrosis. Our Phase III MANIFEST-II study is supported by our Phase II MANIFEST trial. These studies are very similar in terms of inclusion and exclusion criteria, endpoints, and treatment regimen. Based on this and the overall body of data we have presented thus far, we remain very confident in the collaborative raxolitinib combination and the outcome of the phase 3 manifest 2 trial. We saw strong efficacy and safety results in the phase two manifest trial data that were presented most recently at the 2023 IHA annual meeting in June. At week 24, 68% of JAK inhibitor naive patients treated with a Pelabrasib and Raxolitinib combination achieved at least a 35% reduction in spleen volume from baseline. Furthermore, 56% of patients had at least a 50% reduction in their total symptom score from baseline. These deep and durable responses were maintained at 60 weeks. The most common treatment emergent adverse events were low-grade. This data suggests that Palabrasib and Ruxolitinib is a well-tolerated combination therapy. We compared MANIFEST-ARM3 with three historical JAK inhibitors studied in randomized double-blind Phase III trials using a method called Matching Adjusted Indirect Comparison, or MIC, analysis. MIC is a robust method that ensures fair and reliable comparisons between trials. It does this by making adjustments for differences and select baseline characteristics across the studies. Our analysis showed that Calabrasib in combination with Ruxolitinib offers at least 1.4 times better symptom control compared to Ruxolitinib monotherapy in JAK inhibitor in naive patients. These findings were recently published in Blood Advances. Also, at the 2023 IHA Annual Meeting, we presented new data showing that hemoglobin levels were not only stabilized, but importantly improved over time in JAK inhibitor-naive patients treated with the pilabrasib and ruxolitinib combination. This has not been observed with ruxolitinib monotherapy, as treatment with this therapy has been shown to cause a drop in hemoglobin levels. While our focus in 2023 remains on pilabrasib and first-line myelofibrosis, we see opportunities for pilabrasib beyond this disease. At this year's ASCO and IHA annual meetings, we presented results from arm four of the phase two manifest study. This arm of the study is investigating Pelabrasib as a monotherapy in patients with high-risk ET, who are refractory or intolerant to hydroxyurea, the chemotherapeutic agent most commonly used to treat the disease. The primary endpoint of this arm of the study is confirmed complete hematologic response. The secondary endpoints include confirmed partial hematologic response and symptom improvement. To date, our findings suggest that collaborative monotherapy provides a potential clinical benefit for this ET patient population. 60% of patients treated with palibrasib monotherapy had a confirmed complete or partial hematologic response at any time. At the data cutoff, 14 of 20 patients were still undergoing treatment. Importantly, an early normalization of platelet count was achieved in many patients with white blood cell count and hemoglobin stable throughout treatment. This suggests that Pallabrasib monotherapy can normalize platelet counts without causing anemia or thrombocytopenia. Further, the results show that half of the treated ET patients had a 50% reduction in total symptom score from baseline at any time. These proof of concept results support Pallabrasib's expansion into other myeloid diseases. As such, We will continue our ongoing evaluation of collaborative in ET in the manifest study. We also plan to initiate a phase two study in lower risk MDS in 2024. We will then determine our phase three development strategy following these assessments. Moving on to Tony Medelstad, our investigational next generation dual inhibitor of ECH2 and ECH1. Tomimetastat was designed to improve on first-generation ECH2 inhibitors to increase potency, longer residence time on target, and a longer half-life, offering the potential for enhanced anti-tumor activity. It is currently being evaluated in a phase 1-2 trial for advanced solid tumors or lymphomas. Updated results from the phase 2 portion of the study were presented at ASCO 2023. The data suggests responses or disease stabilization across all solid tumor cohorts, including those with heavily pretreated patients. Notably, complete and partial responses were also observed in the lymphoma cohort. Physicians have expressed great excitement about the deep responses seen in these heavily pretreated patients, the majority of whom currently have limited or no treatment options. These preliminary results are very promising and showcase the therapy's best-in-class potential in an array of cancer types. As we continue to generate data from the dose-finding portion of our Phase 1-2 study, we will continue to evaluate our future development plans for Tomy metastabs. With that, I will now turn the call over to Lucy to review our financials.