CureVac N.V.

Greetings, and welcome to the CureVac fourth quarter and full year 2023 financial results and business update conference call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Tara Fahey, where you may begin.

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 Alexander Sender, Chief Executive Officer of CureVac, Miriam Mandela, our Chief Development Officer, and Pierre Quimula, Chief Financial Officer of CureVac. Our Head of Intellectual Property, Marcus Dalton, will be present for the Q&A session. 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, April 24th, 2024. 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 provisions. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected. CureVectors claims 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 Alexander.

Thank you, Sarah. Ladies and gentlemen, good morning, good afternoon to everyone on the webcast. After recently celebrating my first year as CEO of CureVac, I'm thrilled to be speaking to you today as a leader of a company that is dramatically transforming itself. As societies are moving beyond the COVID-19 pandemic, we are embracing a new normal where agility and innovation are more vital than ever. At CureVac, this means we are taking decisive steps in 2020 form to trim unnecessary residual pandemic infrastructure and have started redesign initiatives to increase efficiency, reduce operating costs, and extend our cash run way. These initiatives began in March this year with a voluntary lever program that aims to reduce 150 positions and is intended to align our workforce to our business scope and priorities. At the same time, based on the rapidly changing epidemiological environment following the end of the COVID-19 pandemic, together with our partner GSK, we have made the decision to wind down the pandemic preparedness agreement with the German government signed in April 2022. Based on our solid cash position of 402.5 million euros at the end of 2023, And despite a negative cash impact in 25 related to the wind down of the pandemic preparedness agreement, our efficiency initiatives are expected to result in a net extension of our cash runaway into the fourth quarter of 2025. While we continue to streamline the company and optimize costs, it is essential for us to preserve existing and create new value by maintaining a strong focus on advancing our research and development activities. Accordingly, we have made substantial progress in our clinical trials and are growing our pipeline of development programs in infectious disease and oncology. In infectious diseases, together with GSK, we have initiated a new Phase I-II study in avian flu, which is considered a potential future pandemic threat. It is the latest program progressing to clinical trials under a broad infectious disease collaboration with GSK. Our ongoing programs in seasonal flu and COVID-19 have provided promising phase two entering data confirming that our technology platform generates strong antibody titers at well-tolerated dose levels. In oncology, the dose escalation part A of our phase one study in patient with vasectomy has completed enrollment. Part A successfully progressed to a safety review confirming no dose-limiting toxicity and providing a recommended dose of 100 micrograms for the Part B of the study. This important growth driver, I'm particularly thrilled about our collaboration with Andy Anderson, one of the world's leading cancer centers with whom we are joining forces for the development of normal mRNA cancer vaccines. Further expanding such strategic collaborations will be a key focus for Taminda Ramanayake, a veteran in the biopharma industry who we are delighted to welcome as our new chief business officers as of June 1st this year. Also supporting our oncology strategy is the mRNA printer, CureVac's end-to-end solution for automated manufacturing of GMP-grade RNA vaccines and therapeutics. The printer achieved next important regulatory milestones by obtaining a framework license providing even greater freedom and flexibility to manufacture different mRNA cancer vaccine candidates. Taking a step back and looking at 2023 on slide five, I'm profoundly inspired by the progress that has been achieved by the entire CureVac team. Last year, we made critical advancements in our clinical trials, was notably the positive phase one data in COVID-19 and flu that allowed us to transition into the current phase two programs potentially differentiated vaccine candidates in collaboration with GSK. We started to phase one program in glioblastoma kicking off our strategy for the development of next generation cancer vaccines based on our proprietary second generation mRNA backbone. Our successful capital raise in February 2023 was a word of confidence of investors providing us with the resources to advance multiple programs and research activities. And last but not least, we strengthen our intellectual property position by adding new IP rights to ongoing patent litigation with Pfizer BioNTech, demonstrating that we continue to be at the forefront of mRNA innovation. Building on our achievements in 2023, we are poised to continue in 2024 with a clear focus to make CureVac fit for the future. To this end, we have put strategic emphasis on an organizational redesign which I will describe in more detail on the next slide. In our clinical trial programs, we continue to move forward with GSK, following the promising Phase II interim data in COVID and flu this year, as well as the newly started Phase I-II study in avian flu. In oncology, following the clearance of the Phase I, Part A, glioblastoma safety data, we anticipate advancing to the dose confirmation Part B mid-2024. We expect to report a first data readout in the second half of 2024, most likely at scientific conferences such as ESMO or CITI. Our efforts to build up our manufacturing facility, GMP4, are progressing, and we expect certification of the facility in the second half of 2024, contingent on regulatory approvals. With these catalysts driving our efforts, we are confident in our ability to make meaningful strides in maturing the company and advancing our clinical trial programs in 2024. In slide six, let me provide you with a more detailed overview of our corporate streamline and redesign initiatives in 2024. As already mentioned, the redesign aims to significantly increase efficiencies and performance while maintaining a strong focus on innovation and R&D activities. This encompasses a range of targeted actions to trim unneeded pandemic area infrastructure, reduce operating costs, and become a leaner, more agile, and focused organization. The cornerstones of our efforts include our strategic reorganization, streamlining reporting lines, and digitizing the company. The focus is on an improved interface between our discovery, research, and clinical development areas by bringing them together under the leadership of Miriam as Chief Scientific Officer. A unified leadership will allow for an optimal alignment on strategic goals, improved prioritization, resource allocation, and seamless transition from innovation from discovery to the clinic. Furthermore, we will double down on our company-wide digital and data strategy to enhance the use of data and AI throughout the company and enable accelerated business processes and pipeline innovation. The areas where we are trimming pandemic structures, as mentioned earlier, the targeted resizing via a voluntary leaver program to reduce 150 positions is ongoing. The reduction of workforce will be accompanied by an overall stronger financial discipline. This includes a much leaner budget in 24 compared to 23, which is driven by lower operating costs and lower expenses of raw materials as our commitments for first-generation COVID vaccines are mostly closed. Also, our capex spend will be significantly lower with the completion of our GMT-4 manufacturing plant. While these actions have already been initiated, we will continue to look for more opportunities to improve efficiencies throughout 2024. Pierre will go into more details in the financial update later in this call, and we will continue to inform you on the progress of these initiatives throughout the year. In parallel with our organizational redesign, we have made significant progress in achieving our goals through strategic collaboration, such as the co-development and licensing agreement we recently entered with one of the world's most renowned cancer institutions, the University of Texas MD Anderson Cancer Center. The collaboration focuses on the joint development of differentiated off-the-shelf mRNA-based cancer vaccines in selected hematological and solid tumor indications with higher mathematical needs. It combines CureVac's unique end-to-end mRNA capabilities for cancer antigen discovery, mRNA design, and manufacturing with Andy Anderson's world-class expertise in cancer antigen discovery and validation, translational drug development, and clinical research. This collaboration is more than just a synergy of skills. the shared commitment of CureVac as the pioneer of mRNA, and Andy Anderson as one of the most trusted leaders in cancer care to go further and faster in making a profound impact on the lives of cancer patients. Accordingly, both sites will contribute to the identification of novel cancer antigens based on whole genome sequencing, RNA sequencing, and cutting-edge bioinformatics. Preclinical validation of the highest quality cancer antigens is expected to be followed by Phase 1-2 studies with potential lead candidates conducted by MD Anderson. We are convinced that this collaboration will be instrumental in boosting our oncology strategy. It will be an engine for the development of new cancer vaccines, helping us to deliver novel treatment options faster and more efficiently. In this context, it's with great pleasure that I introduce Taminda Ramanayake as our new Chief of Business Officer. Taminda will join our management team on June 1st at this pivotal moment in our corporate revolution. Taminda joins from Affinity Therapeutics. He brings 15 plus years of international experience in business development and corporate strategy. He has a strong track record of successful clinical collaborations, M&A, licensing, and strategic financing across multiple therapeutic areas. He has previously had positions at Sanofi, Biomerion Pharmaceuticals, and Amgen. His wealth of knowledge is complemented by a strong foundation in science with focus on immunology and oncology. This broad expertise uniquely positions Taminda to build upon our current achievements and drive CureVac's corporate strategy forward. With this, let me hand over the call to Miriam for an update on our clinical development programs.