BioNTech SE

Thank you for standing by and welcome to the BioNTech first quarter 2020 operational progress and financial results conference call. At this time all participants are in listen only mode. There will be a presentation followed by a question and answer session at which time if you wish to ask a question you will need to press star 1 on your telephone keypad and wait for your name to be announced. I must advise you the conference is being recorded today Tuesday the 12th of May 2020. I would now like to hand the call over to the Vice President, Investor Relations and Business Strategy, Silke Maas. Please go ahead.

Thank you for joining us today for BioNTech's first quarter 2020 update call. Before we start, we encourage you to view the slides for this webcast, as well as the financial results press release issued this morning, both of which are accessible on our website in the investor section. As shown on slide 2 during today's presentation, we will be making several forward-looking statements. These forward-looking statements include, but are not limited to, the timing for enrollment and completion and reporting of data from our clinical trials and the potentially registration nature of certain of our clinical trials and the impact of the COVID pandemic on our business and our financial outlook. Actual results could differ from those we currently anticipate. We will therefore caution not to place undue reliance on any forward-looking statements which speak only as of the date of this conference call and webcast. Speaking and available for questions today will be Ugur Sahin, Chief Executive Officer, Ozlem Tureci, Chief Medical Officer, and Sierk Pötting, Chief Financial and Operating Officer. Ryan Richardson, Chief Strategy Officer, is available for the Q&A session. I'll now hand the call over to Ugur Sahin, BioNTech's CEO.

Thank you, Silke. It's a pleasure to welcome you to our first 2020 conference call. I will start with a few introductory remarks about our quarterly and recent highlights. I will then provide an update on our COVID-19 program. Ozlem Tureci will provide a brief pipeline update before handing the call over to Sierk Pötting who will review our financial results and provide an update on our manufacturing scale activities. I will then make a few closing remarks on the outlook for 2020 before opening up the call for your questions. I wanted to start by quickly highlighting the significant progress we have made since the beginning of the year despite the ongoing COVID-19 pandemic. Slide 3 illustrates our vision of building a global next generation immunotherapy company. Our strategy is to utilize our suite of novel therapeutic platforms to fully explore the potential of the immune system. We are advancing a pipeline of potentially first-in-class immunotherapies for the treatment of cancer and infectious diseases. The most recent coronavirus vaccine program, which we named Project Lightspeed, shows the speed and versatility of our mRNA vaccine technology. We have invested significantly in our manufacturing capabilities in the mRNA and cell therapy areas, which is a key pillar of our long-term strategy. I am incredibly proud that we have been able to quickly generate GMP-grade clinical drug supply for multiple vaccine candidates for our ongoing COVID-19 vaccine trials. Finally, As we outlined in our last call, we quickly implemented a three-point plan to manage the impact of the COVID-19 pandemic on our clinical programs. To date, that plan has been successful and expectations for clinical trial timelines have not changed substantially since our last update. This week, we achieved an important milestone with the close of the acquisition of Neon Therapeutics. Neon offices in Cambridge, Massachusetts, will now serve as our U.S. headquarters and the hub for the U.S. research and development effort. This has provided an immediate R&D footprint in the U.S. As we have highlighted previously, the acquisition brings novel neoantigen-based T cell therapies and deep expertise in the development of neoantigen therapies with both vaccine and as well as T cell capabilities. We are pleased to report that NEON recently received a clinical trial authorization from the Dutch Health Authority for NEON PTCO1, which we have now named BNT221. The drug candidate is a personalized neuroantigen-targeted T-cell therapy derived from patients' peripheral blood mononuclear cells, or PBMCs, consisting of multiple T-cell populations targeting the most therapeutically relevant neuroantigen from each patient's tumor. The initial phase 1 clinical trial of BNT221 will be in patients with metastatic melanoma who are not responsive to checkpoint inhibitors. We will focus on the integration effort in the coming months and look forward to providing additional detail in the coming quarters. Now, let's move to slide four. I'm proud of our progress towards developing a vaccine to prevent COVID-19 infection to combat the pandemic threat. Since the beginning of the project Lightspeed in late January, we have selected four vaccine candidates and initiated clinical trials in the US and in Europe, following a fast and rigorous preclinical testing program that included a number of studies in animal models as well as many, many in vitro assays. The first cohorts in both US and Europe have now been dosed, and we expect first clinical data in late June and July timeframe, assuming that our trial will progress as planned. The clinical trial material for this trial have been manufactured at our state-of-the-art GMP-certified mRNA manufacturing facilities in Europe. In parallel, we are working closely with Pfizer to scale up manufacturing for global supply capacity at risk to provide a worldwide supply. Our goal is to be in a position to produce hundreds of millions of doses in beginning 2021 along with Pfizer if our vaccine program is successful in Thais. Slide five. I want to provide a quick overview on the mRNA technologies being utilized for BNT162. On April 23rd, we hosted a webcast that provided a detailed overview of the science behind our program. A replay of that event is available on our website in the investor relations section for those that missed it and would like to know additional details. Our mRNA vaccine for COVID-19 exploits a highly potent liquid nanoparticle, or LNP, mRNA vaccine product. We believe that mRNA vaccines are highly suited for this challenge because, first, mRNA vaccines have been shown to be highly immunogenic and induce neutralizing antibodies as well as T cell responses. Messenger RNA is a naturally occurring molecule with a very characterized safety properties as well as defined by our pharmaceuticals with a high purity and are animal free. We believe that our vaccines may offer several advantage over traditional vaccine approaches, including the ability to precisely design and manufacture them rapidly and in large quality. We believe that our vaccine program is differentiated in a number of key aspects. The first is that our program utilizes multiple mRNA formants. Two of our four vaccine candidates include a nucleoside modified mRNA backbone, one includes a uridine containing messenger RNA, and the fourth vaccine candidate utilizes a self-amplifying mRNA. We expect that these different mRNA formants to produce different immunogenicity profiles which could be relevant in determining the dose and dosing frequency ultimately required to generate immunity. Self-amplifying messenger RNA in particular has the advantage that it may allow for greater potency and potentially enable a single administration at a very low dose. Our program is differentiated in that we are bringing vaccines against two distinct targets into clinical testing. One is the full-length spike protein of the virus, and the other is the much smaller optimized receptor binding domain, or RBD, from the spike protein. To our knowledge, we are the only company currently in clinical testing with a vaccine targeting the RBD domain. Ultimately, we will need to wait for clinical data before we can draw firm conclusions whether this domain has advantage as compared to the full-length antigen. I will now turn to slide 6. I will provide an update on our ongoing global development program for BMP162. As stated before, we have completed dosing for the first cohorts in both Our US as well as in our European Phase 1-2 trials. In both cases BioNTech is the sponsor of these trials. The dose escalation portion of Phase 1-2 trials will include about 200 healthy subjects in Europe as well as 360 healthy subjects in the US. In both trials the objective is to determine the safety Immunogenicity and the optimal dose levels for our four messenger RNA vaccine candidates and is evaluated in a single continuous study. The design of the US study has the advantage that it could allow us to move seamlessly into phase two testing if the phase one results are successful and allow us immunization of several thousands of subjects. Both trials are currently enrolling healthy subjects between the ages of 18 to 55 and will target a dose range of at least 1 microgram to 100 micrograms. The study will assess the effects of repeated vaccination following a prime injection for the three vaccine candidates that utilize uridine-containing messenger RNA or nucleoside-modified mRNA The fourth vaccine candidate, which contains self-amplifying mRNA, will be evaluated after a single dose as well as a prime boost vaccine. Older adults will only be immunized with a given dose level of a vaccine candidate once the testing of that candidate and the dose level in younger adults has provided initial evidence of safety and immunogenicity. We have a number of key objectives in our trial design. First, it is designed to accelerate the clinical development path to approval. Another objective is to get insights into the immunogenicity of our vaccine candidates in different subject groups across multiple regions. The ultimate goal is to quickly identify a safe vaccine candidate that can prevent COVID-19. I will now hand over to Ozlem to discuss key updates in our development program.