CureVac N.V.

Thank you. Good morning, good afternoon, and welcome to our conference call. My name is Sarah Farkey, and I'm the Vice President of Corporate Communications and Investor Relations at CureVac. Please let me introduce today's speakers. On the call with me from CureVac are Franz Werner Haas, the Chief Executive Officer, Ulrike Gnad-Vogt, our Interim Chief Development Officer, Ronald Plasterk, our Senior Vice President, Science and Innovation, and Pierre Quémoulin, Chief Financial Officer of CureVac. Please note that this call is being webcast live and will be archived on the events and presentation section under investor relations on our website. Before we begin, a few forward-looking statements. The discussions and responses to your questions on this call reflect management's view as of today, Wednesday, November 16th, 2022. We will be making statements and providing responses to your questions that state our intentions, beliefs, expectations, or predictions of the future. These constitute forward-looking statements for the purpose of the safe harbor provision. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected. CureVac disclaims any intention or obligation to revise any forward-looking statements. For more information, please refer to our filings with the U.S. Securities and Exchange Commission. I will now turn the call over to Franz.

Thank you, Sarah. Ladies and gentlemen, a warm welcome to this conference call from us here at CureVac. 2022 has been a highly productive year for our company. We have significantly grown our operational bandwidth across the organization, and most importantly, our three core competencies, broad technology platform, robust product development pipeline, and large GMP manufacturing capacities. Let me give you a short overview of four key developments in these areas. First, in our prophylactic vaccine product pipeline, we continue to execute on our broad clinical development programs in COVID-19 and flu, which started earlier in 2022 in collaboration with our partner GSK. The ongoing four clinical trials that have successfully extended our broad technology platform into modified as well as multivalent mRNA approaches are on track to deliver meaningful clinical data early next year. Second, beyond our progress in prophylactic vaccines, the next growth driver we are moving forward with maximum speed and focus is oncology. With the acquisition of Frame Cancer Therapeutics and the partnership with MyNeo, we have made an impressive start to the implementation of our expanded oncology strategy. Today, there is an enormous gap between state-of-the-art analytical methods that provide vast amounts of data about a patient's individual cancer and current treatment options. Immuno-oncology is particularly suited to bridge that gap. We intend to access and translate available data into a meaningful pipeline of new mRNA cancer vaccine candidates driven out of the former FRAME cancer therapeutic site in Amsterdam, which we plan to make our cancer antigen discovery hub. Third, we progressed on the development of dedicated oncology enablers, first and foremost the RNA printer, our automated manufacturing solution for GMP-created mRNA vaccines and therapeutics. In October this year, we submitted applications to the regulatory authorities for the first manufacturing licenses to support our oncology roadmap. Furthermore, we are advancing the development of a proprietary lipid nanoparticle or LNP technology that in oncology we expect to provide additional advantages for the delivery of novel mRNA cancer vaccine cannabis. Fourth, we are We also presented data from the phase one expansion study of our non-coding RNA, CV8102, at the meeting of the Society for Immunotherapy of Cancer, CITSE, earlier this month. CV8102 demonstrated a solid safety profile and preliminary efficacy in heavily pretreated patients with advanced melanoma. In addition to those four developments, we closed the third quarter of 2022 with a solid cash position of 540.9 million euros. And Pierre will later talk you through the financial details. On slide five, let me briefly highlight the CureVac pipeline to show you how we are leveraging our strong mRNA expertise across our three therapeutic areas of prophylactic vaccines, oncology, and molecular therapy, addressing diseases with high unmet medical need. Our most advanced area, prophylactic vaccines, is driven by the technological advances of our versatile second-generation mRNA backbone. This backbone broadly spans unmodified and modified mRNA, as well as monovalent and multivalent vaccine formats to diversify and advance our product development pipeline. All these approaches are currently being validated in four Phase I clinical trials in COVID-19 and flu, that we are conducting together with GSK. The clinical insights we expect to gain from these four studies will also accelerate the ongoing expansion of our oncology program. In this area, our strategic priority is the development of a portfolio of novel cancer vaccine candidates that can elicit strong systemic and tumor-directed immune responses based on our second-generation backbone. Through the implementation of synergistic technologies, we established a high-efficient antigen discovery engine. This will allow us to develop product candidates featuring differentiated neoantigens as well as tumor-associated antigens. As already highlighted, our clinical oncology candidate, CV8102, is currently being assessed in a Phase I dose escalation trial in solid tumors and an expansion study in patients with PD-1 refractory melanoma. Ulrike will come back to the data we presented on CB8102 at the CITSE. The third therapeutic area, molecular therapy, we are developing optimized mRNA therapeutics together with several collaboration partners that are intended to address therapeutic proteins to treat rare and metabolic diseases. On slide six, let me briefly touch on a detailed overview of the four key phase one dose escalation trials that we are currently conducting in COVID-19 and flu together with GSK. The studies are driven by a broad technology approach to select the best performing candidates for later stage clinical development. For COVID-19, on the left, the tested candidates include CV0501, a modified candidate encoding the Omicron variant, and CV2-COV, an unmodified candidate encoding the original virus. For flu, on the right, we are testing flu SV mRNA, a monovalent modified candidate, and CVS-QIV, an unmodified quadrivalent candidate. All four candidates are being tested in a one-shot booster setup. Based on our advanced second generation backbone, they will provide an important clinical validation of our technology platform and corresponding product development. Initial external reporting for both indications will be triggered by data that are comprehensive and meaningfully enough to allow selection of the most promising candidates and determine the optimal dose for a subsequent clinical trial. we expect to report on this data in early 2023. Moving on from prophylactic vaccines to oncology, I will now hand over to you, to Ulrike, to walk you through our recent updates and progress in this area.

Thank you, Franz. Before we dive into the details, I would like to briefly draw your attention to our previously reported three pillar strategy in oncology. These pillars illustrate the roadmap for expanding our oncology footprint, the next growth driver we are rapidly advancing beyond our progress in prophylactic vaccines. Over the last several months, we have either started or continued to execute on each of these strategic pillars with a clear focus on the development of a differentiated cancer vaccine pipeline. The technologies of frame cancer therapeutics and MyNeo will enable us to assess novel classes of tumor antigens and identify those with the highest chance of success for potential clinical testing in alignment with the pillars in the middle and on the right. This antigen discovery engine will be supported by the RNA printer. The automated end-to-end manufacturing solution is expected to contribute to the availability of clinical trial material to rapidly screen new mRNA vaccine constructs in early stage clinical studies. As already mentioned by friends, we are currently in regulatory review to obtain the first manufacturing licenses for the RNA printer to support the initial validation of our second generation backbone in oncology. This validation includes testing our second generation backbone with different classes of tumor antigens to assess T-cell mediated immune responses and discovered by the strategic pillar on the left. I will come back to the strategic pillar later in the presentation. First, let us take a closer look at the antigen discovery technologies we are currently establishing and how they integrate with our three core competencies in oncology. On slide eight, you can see an illustration of how the advanced technology and bioinformatics expertise of Frame Cancer Therapeutics and MyNeo complement our core competencies in product development and manufacturing. The synergistic technologies strongly extend our reach to the latest technologies in oncology while being highly compatible with our own mRNA technology. They provide a powerful front end to deliver antigens that can then be developed into a deep pipeline of novel cancer vaccine candidates along our existing expertise. Let me now hand over the call to Ronald, the founder of Frame Cancer Therapeutics, to walk you through the details of Frame's highly sophisticated and differentiated technology.