BioNTech SE

Welcome to BioNTech's third quarter 2024 earnings call. I would like to hand the call over to Michael Horowitz, Director, Investor Relations. Please go ahead.

Thank you. Good morning and good afternoon. Thank you for joining BioNTech's third quarter 2024 earnings call. As a reminder, the slide we will be using during this call and the corresponding press release we issued this morning can be found in the investor relations sections of our website. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this call are subject to significant risks and uncertainties and speak only as of the date of this conference call. We undertake no obligation to update or revise any of these statements. On slide three, you can find the agenda for today's call. Today, I am joined by the following members of BioNTech's management team. Chief Executive Officer and Co-Founder, Özlem Tefeci, Chief Medical Officer and Co-Founder, Jens Holstein, Chief Financial Officer, and Ryan Richardson, Chief Strategy Officer. With this, I would like to hand over to Ugar.

Thank you, Michael. Welcome to all those joining us today. I will be keeping my introduction very brief today. We made significant achievements during the third quarter, including advancements across our oncology pipeline and a strong start to the season for our COVID-19 vaccine franchise. Our focus in this quarter is on what has already been an impactful year. I would like to highlight achievements in three areas. First, with regard to our COVID-19 vaccine leadership, we have successfully launched updated vaccines targeting the latest variants, distribution now underway in multiple regions globally. In Oncology, they have presented our progress in two strategic priority areas, namely our bi-specific immunomodulator BNT327, partnered with BioPhilis, and our mRNA cancer vaccine portfolio. As part of our pipeline progress, We shared numerous clinical updates across our oncology pipeline at the ESMO Congress. We and our partner, BioFeos, have kicked off the board global development of BNT327, our bispecific antibody targeting PD-L1 and VGFA. The data sets presented at ESMO and at conferences earlier this year support the pan-cancer potential of this priority asset and support our clinical development plans that we will touch on today and discuss in greater detail at our innovation series next week. We took significant steps forward in the execution of our clinical development plan this quarter and dosed the first patients in two optimizations studies in small cell lung cancer and triple negative breast cancer to inform the pivotal studies found in both indications. With regard to our mRNA vaccine portfolio, we announced earlier in the quarter that our off-the-shelf six mRNA cancer vaccine candidate, BNT111, met the primary endpoint in the ongoing randomized two-trial evaluating BNT 111 in combination with Regeneron's anti-PD1 agent Simiprimab in patients with stage 3 and stage 4 cutaneous melanoma. This preliminary result underscores our belief in the transformative potential of our proprietary mRNA vaccine technology, which is a key pillar of our oncology strategy. Moreover, we have taken another step to broaden our personalized mRNA cancer vaccine development program. We and our partner, Genentech, have initiated a new randomized controlled phase 2 clinical trial, evaluating our personalized cancer vaccine candidate in patients with bladder cancer in the adjuvant setting in combination with immune checkpoint inhibition. Our personalized vaccine program now includes four ongoing phase 2 clinical trials. In addition, during Q3, we had our inaugural AI Day where we highlighted our in-house AI company InstaDeep and provided an overview of BioNTech's collective AI capabilities. This was an exciting event where we showcased our commitment to building state-of-the-art AI. Before turning over to Ersan for more detailed coverage of these achievements, let me remind you our overarching strategy for oncology. BioNTech was established with the ambition to revolutionize cancer treatment through the development of mRNA-based immunotherapies, particularly to personalize cancer vaccines. This approach remains at the forefront of our efforts to pioneer the next wave of cancer treatment aiming to tailor therapies to the individual genetic makeup of each patient's tumor. Building on this foundation, we have systematically assessed next-generation immune modulators with a focus on bispecific molecules that can engage more than one target. BNC327, our bispecific antibody targeting PD-L1 and VGF-A, has emerged as a key molecule in our pipeline. We believe that BNT327 has the potential to serve as a foundational component in the treatment regimens from multiple cancer types, enhancing the effectiveness of our therapeutic mRNA cancer vaccines and other therapies to its dual targeting mechanism. Complementing these mechanisms of action, we have recently expanded our portfolio to include targets immunotherapies such as antibody drug conjugates and CAR T-cell therapies. These modalities offer precise mechanisms for attacking cancers, providing new avenues for combination therapies, particularly for fighting large metastatic tumors. Our integrated long-term approach will combine these synergistic therapeutic platforms to optimize cancer treatment. Our strategy aims not only to address the existing challenges in cancer care, but also to significantly improve long-term survival rates, even in patients with advanced disease states. By continually evaluating the effectiveness of individual compounds and innovative combinations, we can better identify the most promising treatment strategies for specific patient populations. Today, I will discuss in more detail our progress on BMP3-27 and our expanding efforts on our therapeutic mRNA cancer vaccine fund, two key pillars of our strategy. Before handing over, I would like to thank you all for your ongoing support as we enter this truly exciting period for BioNTech and progress towards our founding vision. Thank you.