CureVac N.V.

Greetings. Welcome to CureVac fourth quarter and full year 2024 financial results and business update call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Sarah Fahey, Vice President, Corporate Communication and Investor Relations. Thank you, Sarah. 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 Zehnder, Chief Executive Officer of CureVac, Miriam Mandela, our Chief Scientific Officer, and our Chief Financial Officer, Axel Malcomas. Please note that this call has been webcast live and will be archived on the events and presentation section on the investor relations on our website. Before we begin, a few forward-looking statements. The discussion and responses to your questions on this call reflect management's view as of today, Thursday, April 10th, 2025. 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. The directive 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 everybody on the webcast. The fourth quarter of 2024 completed a transformation of the year for CureVac, which was marked by significant strategic shifts and positive financial milestones, positioning the company for future growth in oncology and infectious diseases. In July 2024, we took decisive action to streamline and right-size the company, laying a solid foundation for future success in 2025 and beyond. We have now refocused the company on what we do best, technology innovation, and R&D, and have made substantial progress in expanding and advancing our pipeline of early proprietary clinical development programs. These programs have the potential to address critical unmet medical needs and capitalize on compelling market opportunities. In oncology, we continue to make progress with our lead program in patients with resected glioblastoma. The Phase I study successfully completed enrollment of Part B The speed of the enrollment underscored the urgent need for new treatment options in this aggressive form of brain cancer, and we are encouraged with the rapid progress we are making. Our off-the-shelf precision immunotherapy program in patients with squamous non-small cell lung cancer achieved a significant regulatory milestone with the IND clearance from the U.S. Food and Drug Administration to proceed with Phase I. We anticipate treating the first patient in the second half of 2025. Transitioning to infectious diseases, our new licensing agreement with GSK prophylactic vaccines continues to progress. In November, GSK initiated a combined phase one, two study for seasonal influenza COVID combination vaccine based on our proprietary second generation mRNA backbone, which triggered a 10 million euro milestone. The milestone payment was invoiced in the fourth quarter of 2024 and received in the first quarter of 2025. Additionally, in its full year and fourth quarter earnings report, GSK confirmed that its clinical program for a standalone seasonal influenza vaccine is being prepared for phase three. Transition to phase three will trigger another significant milestone payment by further validating our technology. On the IP front, as you may have seen recently, the European Patent Office, or EPO, upheld the validity of our split bullion JL668 patent in amended form. This outcome is particularly important as it validates our pioneering role in developing foundational mRNA vaccine technology. And finally, thanks to this steady progress across our portfolio and successful execution of our restructuring plan, We closed 2024 with a strong cash position of 482 million euros, reaffirming our expected financial runway into 2028. On slide five, I would like to highlight the key accomplishments in 2024, which has set CureVac on a trajectory for increased performance and innovation. Our previously mentioned licensing agreement with GSK, signed in July 2024, four or five billion Euros per royalties, marked a pivotal moment for CureVac. This agreement provides us with significant capital and leverages GSK's expertise in infectious diseases for successful development and commercialization. Importantly, we then embarked on a strategic corporate restructuring to streamline the company, including a headcount reduction of approximately 30%, which was completed in 2024. The restructuring has positioned us to achieve higher efficiency and agility in executing our pipeline priorities, allowing us to focus on developing potentially transformational mRNA therapeutics in oncology and infectious diseases. Our oncology pipeline of phase one glioblastoma study demonstrated promising dose escalation data last year, confirming acceptable tolerability and antigen majority of valuable patients. We also added a new program for squamous non-small cell lung cancer to our pipeline, featuring a multi-epitope immunotherapy with novel antigens derived from our collaboration with MyNeo. In prophylactic vaccines, we initiated a program against uropathogenic E. coli bacteria, or UPEC, in urinary tract infections, which is one of the most common bacterial infections with higher medical need by promising clinical data. In the GSK license programs in infectious diseases, positive phase two headline data for seasonal influenza was reported in September 2024, confirming strong antibody titers against both influenza A strains and the notoriously challenging influenza B strains. And as I mentioned, starting the phase three trial would trigger another significant milestone payment from GSK. On the management side, we welcome two new members to our leadership team, Taminda Ramanayake as Chief Business Officer and Axel Malcomas as Chief Financial Officer. Both are seasoned industry experts and bring significant expertise and experience to CureVac. Building on our momentum in oncology, infectious diseases, and senior leadership, we further anticipate key catalysts in 2022-105 that will further expand our pipeline and reinforce our R&D priorities. Beginning with oncology, we expect to share data from the fully recruited Phase I Part B glioblastoma study in the second half of 2025. And pending results, we will take a decision to advance to Phase II, which is expected in the second half of 2025. Following the R&D clearance in the U.S., the first patient in our program for squamous non-small cell lung cancer is scheduled to be treated in the second half of this year. The clinical development of our new prophylactic vaccine program for UPAC is underway, and we expect to file an IND submission in the second half of this year for a phase one study to commence in the first half of 2026. Also in the infectious disease area, we expect GSK to enhance programs with current candidates based on licensed CureVac technology. And lastly, in 2025, we will continue to defend our broad and innovative IP portfolio and anticipate further key decisions throughout the year in Europe and the US. Together, these upcoming milestones position CureVac for another year of great momentum, and with a sharpened focus and innovative pipeline, we probably remain a leader of innovation within the RNA tech ecosystem. In March 2025, the decision of the European Patent Office, or EPO, to uphold the validity of our split poly tail 668 patent in amended form represents an important step in our ongoing litigation with Pfizer-BioNTech. This decision supports our pioneering role and significant contributions to mRNA vaccine technology, particularly in the space of COVID-19 vaccines. Please recall that in Europe, each IP right is handled as a separate case for which validity, infringement, and potential damages will be decided separately. Damages will be assessed only when validity and infringement both have been established. On slide six, you can see a schematic of this bifurcated process. On the left side, the infringement proceedings are displayed. For an IP dispute, infringement is decided by the Regional Court Dusseldorf, as well as potential damages related to all six IP rights at issue. On the right side, validity proceedings are displayed. Validity for IP rights is heard by different authorities, depending on the nature of the IP right. Validity of the split polyethyl patents is heard by the EPO. Following the EPO's positive decision on our first split poly-A 668 patent last month, a hearing to rule on infringement is scheduled for July 1st, 2025. And should validity of the second split poly-A patent also be confirmed by the EPO in a hearing which is scheduled for May 13 to 15, 2025, it would also be included in the July infringement hearing. So we remain confident of our position in the upcoming infringement case, and believes that the validated pattern is infringed in its amended form. As the earliest pioneer in mRNA technology, we are determined to have our contributions recognized and compensated. And with this, let me now hand over to Miriam for a review of our pipeline development activities.