BioNTech SE

Welcome to the BioNTech first quarter 2023 update call. I would like to hand the call over to Dr. Victoria Meissner, Vice President of Strategy and Investor Relations. Please go ahead.

Good morning and afternoon. My name is Victoria Meissner and I'm the new Head of Investor Relations at BioNTech. I'm a medical doctor by training and have recently joined BioNTech from Healthcare Investment Banking at Jefferies. I look forward to working with you on the corporate side. Thank you for joining us today for BioNTech's first quarter 2023 earnings call. As a brief reminder, the slides that accompany this call and the first quarter 2023 press release that was issued this morning can be found in an investor section of our own website. As outlined on slide two, you can see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings made with U.S. Securities and Exchange Commission. Forward-looking statements on the call are subject to substantial risks and uncertainties. Speak only as of called original date, and we undertake no obligation to update or revise any of the statements. On slides three and four, you can see detailed safety information regarding our COVID-19 vaccine. On slide five, you can find the agenda for today's call. Today, I am joined by the following members of BioNTech's management team. Our CEO and co-founder, Ugr Zahin. Özlem Türeci, our chief medical officer and co-founder. Jens Holstein, our chief financial officer. And Ryan Richardson, our chief strategy officer. I would like to turn the call over to Ugr Zahin.

Thank you, Victoria. Good morning and good afternoon and warm welcome to all the call participants. We appreciate your continued support. Today I will summarize our first quarter 2023 highlights and priorities before I pass the call over to my team to provide further details. Let me reiterate our strategic goals for 2023 and highlight our first quarter and recent achievements. to expand and sustain our leadership in COVID-19 with Pfizer by advancing our next generation vaccine candidates, developing combination vaccines, and advancing key Cominati features. This quarter, we maintained our strong COVID-19 vaccine market position, supported by key label expansions in regions around the world. We published preclinical data in the journal Cell on our next generation T-Side spring vaccine component in combination with Cominati. Our second goal is to accelerate our oncology pipeline and initiate multiple potentially registrational trials. Our new collaborations with Duality Bio and Oncoseed4 complement our pipeline. with multiple mid- to late-stage clinical programs that will help us to achieve this goal in the near term. Our third and final strategic goal is to initiate and accelerate clinical programs with high unmet medical need in infectious diseases. In the first quarter, we initiated new clinical vaccine programs, namely for shingles and tuberculosis. The first quarter was a strong start to 2023. We plan to continue execution against these strategic goals to continue our development into a fully integrated global multi-product biotechnology company addressing medical needs worldwide. Cancer remains one of the key unmet medical needs. Our long-term oncology strategy is to expand the treatment options available for cancer patients and become a multi-product company in the next year. In order to best serve the needs of tumor patients, we aim to address the full continuum of cancer treatment, bring novel therapies to market for patients with adjuvant and late-stage cancer, and combining our platforms and programs to translate our science into survival. Key elements in our oncology pipeline are mRNA cancer vaccines, steric therapies, next generation checkpoint immune modulators, and antibody drug conjugates. We believe that these drug classes have the potential to drive improved outcomes for solid tumor patients across multiple lines of treatment and tumor types. Our most advanced oncology assets are currently in development for a range of solid tumors at all stages of treatment. We believe that these assets have first-in-class or best-in-class potential and they enable us to drive meaningful change in the treatment of many cancers. How are we planning to achieve this? Our technology agnostic innovation engine leverages modular technology platforms, both developed internally and accessed via collaboration partnerships to produce novel product candidates. In the first quarter, we announced two new collaborations to give us access to assets and platforms that we believe may be important in how solid tumors are treated in the future. One of those, which I'm particularly excited about, is the new collaboration with Duality Biologics The company focused on the discovery and development of next-generation antibody drug conjugates. In the last few years, advancements in ADC technology have resulted in its potent use for the treatment of solid tumors. We believe that ADCs have the potential to replace highly toxic chemotherapy regimens as a cytotoxic backbone to cancer treatment. ADCs consist of three main components, antibody, linker, and payload. Each of these components has an impact on ADCs pharmacological and clinical properties. ADCs are precision medicine allowing for targeted drug delivery, particularly to tumor cells with high specificity and potently induced cell death with the benefit of reduced off-target events. When the monoclonal antibody binds to the target antigen specifically expressed on the tumor cell, the ADC is internalized, allowing for the release of the cytotoxins, which leads to cell death. Slide 11. Under the terms of the exclusive worldwide licensing collaboration agreement with Duality Bio, excluding mainland China, Hong Kong region, and Macau region, we will gain access to two programs. DB1303 targeting HER2, and DB1311. Driven by Duality's DITAC platform and novel cleavable link and payload technologies, this third-generation ADCs have demonstrated pharmacokinetic properties that may contribute to an increased therapeutic window compared to other ADC platforms. ADCs offer a broad combination potential, especially with various A Phase 1-2 clinical trial for DB1303 is ongoing, which we plan to expand into further tumor indications, and we aim to rapidly advance clinical development of this program. Slide 12. I want to end where I started, our vision. With our new collaboration, we now have 27 programs. We plan to start multiple potentially registrational trials in the coming years. Within the next years, we aim to become a multi-product global biotechnology leader aiming to contribute and address the world's most pressing health challenges with pioneering disruptive technologies delivered at scale. With that, I would like to thank you all for your confidence in our success and your continued support. I will now turn the call over to Esnet.