Genmab A/S

Hello and welcome to GENMAB's third quarter 2023 financial results conference call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipates, plans, or expects. Actual results may differ materially, for example, as a result of delayed or unsuccessful development projects. GenMab is not under any obligation to update statements regarding the future, nor to confirm such statements in relation to actual results, unless it is required by law. Please also note that GenMab may hold your personal data as indicated by you as a part of our investor relations outreach activities in order to update you on GenMab coin. Please refer to our website for more information on GenMab and our privacy policy. I would now like to hand the conference over to your first speaker today, Jan van de Winkel. Please go ahead.

Hello and welcome to GenMob's conference call to discuss our financial results for the period ending September 30, 2023. With me today to present these results is our CFO Anthony Pagano, For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky, our Chief Operating Officer, Anthony Mancini, and our Chief Medical Officer, Tai Yamadi. As already said, we will be making forward-looking statements, so please keep that in mind as we go through this call. During today's presentation, we will reference products being developed under some of our strategic collaborations. This slide acknowledges those relationships. Gemma's strong foundation is built on our consistent track record of success. As we near the end of the year, it's a good time to reflect on how far we have come as a company, even in the last 12 months. We continue to expand our pipeline with new INDs and new product candidates in the clinic. We also matured our pipeline with new clinical trials and positive data readouts. And very excitingly, there are now eight approved medicines that are followed by our innovations, half of which were created with our proprietary dual-body technology. Apcoritumab, which we are co-developing with APVI, is also our first medicine to be approved for patients in territories outside the US. These advances are possible because we have a dedicated and unstoppable team at JanMab, an international team that has grown to enable us to continue to evolve into a leading integrated biotech innovation powerhouse. Let's now turn to recent key company events. September was an exciting month for EPCORITOMOB as we and EPCRE received approvals in both Japan as EPCINLY and Europe as TEPCINLY. Like the approval in the US earlier in the year, these approvals were important milestones both for our patients and needs and for GenMob as a company. The approval in Japan is especially significant as we at GenMob are the commercial leads for EPCINLY there. We began growing our presence in Japan in 2019, so we would be ready for just such an opportunity. So we are very pleased to be launching our own product there, especially as Apkinly is the first and only bispecific antibody approved in Japan to treat adults with certain types of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. And we are excited to note that in addition to the US, Japan, and Europe, abcaritumab has now been approved in Canada and the UK. I'm also happy to announce that once again, the broad potential of abcaritumab to become a core therapy for B-cell malignancies will be on display at this year's prestigious ASH conference at the beginning of December. We have had 15 total abstracts accepted for presentation at ASH, two of which are oral presentations. Of the accepted abstracts, four will be initial disclosures of clinical data for abcaritumab, including an oral presentation of data from the APCOR NHL 5 trial of abcaritumab in combination with lenalidomide as treatment for patients with relapsed or refractory diffuse large cell B-cell lymphoma. This data is further support for APCOR's combinability and highlights its potential to move into earlier lines of therapy. Hexabody CD38 will also be recognized at ASH with a poster presentation on preliminary results from the expansion cohort at the recommended Phase 2 dose of the ongoing Phase 1 tooth trial. We are actively enrolling in the head-to-head portion of the trial. We are very encouraged by what we are seeing, and as we said previously, we anticipate the head-to-head data in 2024. If we look beyond our own pipeline and include all abstracts involving products that are powered by GenMox innovations, there are nearly 200 total abstracts accepted for presentation at this year's ASH meeting, 36 of them oral presentations. Now I want to turn to some additional exciting updates on the progress of our maturing proprietary antibody product pipeline. First, GEN1046. It has cleared the high bar that we set. We are very pleased to share that we are now engaging with health authorities to determine next steps. Previously, we shared data from an expansion cohort of patients with non-small cell lung cancer who failed prior checkpoint inhibitors. We saw encouraging single agent activity, but responses were not durable. Based on clinical and strong preclinical data that showed that the combination of GEN1046 plus checkpoint inhibitors resulted in improved efficacy, we embarked on a scientific question. How to most optimally engage 401 activation with checkpoint inhibition? The phase two study of GEN1046 in combination with pembrolizumab in patients with PD-L1 positive non-small cell lung cancer who failed standard of care therapy with an immune checkpoint inhibitor addressed this question. and emerging data from this study has provided a clear answer. So far, the data from this study indicates that we can combine these two mechanisms and that this leads to improved efficacy. Based on this, we believe there is a clear path forward and we are engaging with health authorities to determine next steps. We look forward to sharing the relevant clinical data at a medical conference in the first half of 2024. As a reminder, We are developing GEN1046 with BioNTech. Moving to TIP-DAC. We were very pleased that we, along with our partner C-GEN, presented the late-breaking results from the innovative 301 trial of Tisotamab-Fedotin in recurrent or metastatic cervical cancer during the Presidential Symposium of the ESMO Congress in Madrid in October. This follows the announcement by us and C-GEN in September that the trial met its primary and point of overall survival. As a reminder, the results of this trial are intended to serve as both the pivotal confirmatory trial for TifDoc's accelerated approval in the US, as well as to support global regulatory applications. Likewise, TifDoc has also cleared the high bar that we set. We are optimistic about the data we have seen in head and neck cancer post standard of care. Here we will actively engage with health authorities on next steps in this indication.

Moving to GEN1042.