Q2 2024 BioNTech SE Earnings Call

August 5, 2024

Victoria Meissner: Thank you. Good morning and good afternoon. Thank you for joining BioNTech's Second Quarter 2024 Earnings Call. As a reminder, the slides we will be using during this call and the corresponding press release we issued this morning can be found in the Investor Relations section of our website. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this call are subject to significant risks and uncertainties and stick only as of the date of the conference call. We undertake no obligation to update or revise any of these statements. On slide three, you can find the agenda for today. Today, I am joined by the following members of BioNTech's management team: Ugur Sahin, Chief Executive Officer and Co-Founder.

Victoria Meissner: Thank you. Good morning and good afternoon. Thank you for joining BioNTech's Second Quarter 2024 Earnings Call.

Victoria Meissner: As a reminder, the slides we will be using during this call and the corresponding press release we issued this morning can be found in the Investor Relations section of our website. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this call are subject to significant risks and uncertainties and stick only as of the date of the conference call. We undertake no obligation to update or revise any of these statements. On slide three, you can find the agenda for today. Today, I am joined by the following members of BioNTech's management team: Ugur Sahin, Chief Executive Officer and Co-Founder.

Victoria Meissner: As a reminder, the slides we will be using during this call and the corresponding press release we issued this morning can be found in the Investor Relations section of our website. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this call are subject to significant risks and uncertainties and speak only as of the date of the conference call. We undertake no obligation to update or revise any of these statements.

Victoria Meissner: On slide three, you can find the agenda for today. Today, I am joined by the following members of BioNTech's management team: Ugur Sahin, Chief Executive Officer and Co-Founder; Özlem Türeci, Chief Medical Officer and Co-Founder; Jens Holstein, Chief Financial Officer and Ryan Richardson, Chief Strategy Oficer. With this, I would like to hand over to Ugur. Thank you, Victoria. Thank you. A warm welcome to all those joining us today. I will start with an overview of the quarter's highlights, with a focus on communality and our late stage oncology portfolio. Let me then talk about some of our recent oncology pipeline advances in more detail. Jens and Ryan will then provide updates on our financial and corporate progress and the outlook for the remainder of the year.

Victoria Meissner: On slide three, you can find the agenda for today. Today, I am joined by the following members of BioNTech's management team: U?ur ?ahin, Chief Executive Officer and Co-Founder; Özlem Türeci, Chief Medical Officer and Co-Founder; Jens Holstein, Chief Financial Officer and Ryan Richardson, Chief Strategy Oficer. With this, I would like to hand over to U?ur.

Victoria Meissner: On slide three, you can find the agenda for today. Today, I am joined by the following members of BioNTech's management team. Ugur Sahin, Chief Executive Officer and Co-Founder.

Ugur Sahin: Ozlem Tureci, Chief Medical Officer and Co-Founder, Jens Holstein, Chief Financial Officer, and Ryan Richardson, Chief Strategist. With that, I would like to hand over to you, Victoria. Thank you. A warm welcome to all those joining us today. I will start with an overview of the quarter's highlights, with a focus on communality and our late stage oncology portfolio. Let me then talk about some of our recent oncology pipeline advances in more detail. Jens and Ryan will then provide updates on our financial and corporate progress and the outlook for the remainder of the year.

Victoria Meissner: With this, I would like to hand over to Ugur.

Ugur Sahin: Thank you, Victoria. A warm welcome to all those joining us today. I will start with an overview of the quarter's highlights, with a focus on communality and our late-stage oncology portfolio. Let's then talk about some of our recent oncology pipeline advances in more detail. Jens and Ryan will then provide updates on our financial and corporate progress and the outlook for the remainder of the year. Slide five. The second quarter of 2024 was marked by a significant execution across our oncology pipeline and our leading COVID-19 franchise. Our progress in the quarter will set up for an impactful end of 2024 as we continue to progress towards our long-term vision. I would like to highlight achievements in three areas.

Ugur Sahin: Thank you, Victoria. A warm welcome to all those joining us today. I will start with an overview of the quarter's highlights, with a focus on COMIRNATY and our late-stage oncology portfolio. First, I will talk about some of our recent oncology pipeline advancement in more detail. Jens and Ryan will then provide updates on our financial and corporate progress and the outlook for the remainder of the year. Slide five.

Ugur Sahin: The second quarter of 2024 was marked by a significant execution across our oncology pipeline and our leading COVID-19 franchise. Our progress in the quarter will set up for an impactful end of 2024 as we continue to progress towards our long-term vision. I would like to highlight achievements in three areas. First, with regard to our COVID-19 vaccine leadership. On the back of the first regional approvals, we have initiated the launch of our new variant-adaptive vaccine and expect additional approvals in the coming weeks and months. Second, in Oncology, we shared numerous updates at major medical meetings that highlighted our clinical execution and pipeline progress and provided data on several of our assets across modalities. Özlem will discuss some of these updates in more detail but I would like to highlight two of those specifically.

Ugur Sahin: The second quarter of 2024 was marked by significant execution across our oncology pipeline and our leading COVID-19. Our progress in the quarter will set up for an impactful end to 2024 as we continue to progress towards our long-term vision. I would like to highlight achievements in three areas.

Ugur Sahin: First, with regard to our COVID-19 vaccine, on the back of the first regional approvals, we have initiated the launch of our new variant adaptive vaccine and expect additional approvals in the coming weeks and months. Second, in Oncology, we shared numerous updates at major medical meetings that highlighted our clinical execution and pipeline progress and provided data on several of our assets across Medelln. I am going to discuss some of these updates in more detail, but I would like to highlight two of those in particular.

Ugur Sahin: Second, in Oncology, we shared numerous updates at major medical meetings that highlighted our clinical execution and pipeline progress and provided data on several of our assets across modalities. Özlem will discuss some of these updates in more detail but I would like to highlight two of those specifically. Last week, we announced that our off-the-shelf FIXVAC mRNA cancer vaccine for melanoma, BNT111, met the primary endpoint in the ongoing randomized Phase II trial evaluating BNT111 in combination with CEMIPLIMAB in patients with stage 3 and stage 4 proteomic melanoma. This preliminary result is a significant milestone for our company and underscores our belief in the transformative potential of this new class of medicine and of our mRNA vaccine technology, which is a key pillar of oncology strategy.

Ugur Sahin: Last week, we announced that our office share of Tic Tacs and Arnie can protect you from melanoma. BNT-111 met the primary endpoints in the ongoing randomized phase 2 trials evaluating BNT-111 in combination with primitivimab in patients with stage 3 and stage 4 proteomic melanoma. This preliminary result is a significant milestone for our company and underscores our belief in the transformative potential of this new class of medicine and of our mRNA vaccine technology, which is a key pillar of our own project.

Ugur Sahin: This preliminary result is a significant milestone for our company and underscores our belief in the transformative potential of this new class of medicine and of our mRNA vaccine technology, which is a key pillar of oncology strategy. We have exciting news also with regard to another key pillar of our oncology strategy, namely the development of novel IO+ADC combination. This quarter, we started the first of several preparatory trials for our combination therapy strategy. The trial evaluates the combination of our anti-PD-L1 VEGF bispecific antibody BNT327 and our Trop2 ADC BNT325. We look forward to re-initiating additional trials evaluating novel IO+ADC combinations over the next 12 months. The third area in which we made progress is our mission towards the creation of a sustainable and resilient end-to-end vaccine ecosystem in Africa by expanding our partnership with CEPI. CEPI has committed up to $145 million to support us to establish mRNA vaccine clinical and commercial scale manufacturing capabilities at our facility in Kigali, Rwanda. These capabilities will contribute to better prepare for potential future epidemic and pandemic threats in Africa, in alignment with our corporate purpose of ensuring equitable access to our medicines.

Ugur Sahin: We have exciting news also with regard to another key pillar of our oncology strategy, namely the development of novel IO-LDC combinations. This quarter, we started the first of several preparatory trials for our combination carotid. The trial evaluates the combination of our NTi-TGL1 VGS bi-specific antibody BNT327 and our Trop2ABC BNT325. We look forward to initiating additional charts evaluating novel IO-ADC combinations over the next 12 months.

Ugur Sahin: The third area in which we made progress is our mission towards the creation of a sustainable and resilient end-to-end vaccine ecosystem in Africa by expanding our partnership with CEPI. CEPI has committed up to $145 million to support us to establish mRNA vaccine clinical and commercial scale manufacturing capabilities at our facility in Kigali, Rwanda. These capabilities will contribute to better prepare for potential future epidemic and pandemic threats in Africa, in alignment with our corporate purpose of ensuring equitable access to our medicines. Slide six, starting with our COVID-19 franchise. The continued circulation of SARS-CoV-2 leads to the ongoing evolution and emergence of novel variants of the virus, which we continue to monitor and evaluate for their immune-evasive potential and virulence.

Ugur Sahin: The third area in which we make progress is our mission towards the creation of a sustainable and resilient end-to-end vaccine ecosystem in Africa by expanding our partnership with three partners. TP has committed up to $145 million to support us to establish mRNA vaccine clinical and commercial scale manufacturing capabilities at our facility in Kigali 1. These capabilities will contribute to better care for potential future epidemics and pandemic threats in Africa, in alignment with our corporate purpose of ensuring equitable access to our medicines.

Ugur Sahin: Slide six, starting with our COVID-19 franchise. The continued circulation of SARS-CoV-2 leads to the ongoing evolution and emergence of novel variants of the virus, which we continue to monitor and evaluate for their immune-evasive potential and virulence. In September 2022, the XBB lineage gradually emerged, dominated globally throughout 2023 with multiple sub-lineages and was successfully addressed by the XBB.1.5-adapted COVID-19 vaccine, including our own. This year, JN.1 lineage including KP.2 became the predominant variant globally, leading to the current surge in infections in many regions in the northern hemisphere. Shown on the right graph, we use our real-world effectiveness data to demonstrate that the antigen shift and the distance of JN.1 lineages from XBB.1.5 has impacted the vaccine effectiveness of the XBB.1.5-adapted vaccine against the now prevalent JN.1 lineages. Slide seven. Based on this and additional data, regulatory and public health authorities consequently advise vaccine manufacturers to revise the formulation for their authorized COVID-19 vaccine. The WHO and the EMA recommended the use of JN.1 lineage antigen in a monovalent COVID-19 vaccine for the season 2024-2025 and 17 days later, we were able to submit our application to the European regulator. Based on this recommendation and the consequent EMA approval on July 3rd, we have begun rolling out our updated COMIRNATY JN.1 vaccine in Europe.

Ugur Sahin: That's six, starting with our COVID-19 pandemic. The continued circulation of SARS-CoV-2 leads to the ongoing evolution and emergence of novel variants of the virus, which we continue to monitor and evaluate for their immune-invasive potential and near-relationship.

Ugur Sahin: In September 2022, the IFPB lineage gradually emerged, dominated globally throughout 2023 with multiple sub-injects, and was successfully addressed by the IFPB-1 fast-dying adapted COVID-19 vaccine, including our This year, JN1, Linus, including KP2, became the predominant variant globally, leading to the current surge in infections in many regions in the northern hemisphere. Shown in the right graph, real-world effectiveness data demonstrate that the antigen shift and the distance of JN1 lineages from XBB1 path have impacted the vaccine effectiveness of the XBB1 path-adjusted vaccine against the now prevalent JN1 lineage. Slide seven.

Ugur Sahin: Shown on the right graph, we use our real-world effectiveness data to demonstrate that the antigen shift and the distance of JN.1 lineages from XBB.1.5 has impacted the vaccine effectiveness of the XBB.1.5-adapted vaccine against the now prevalent JN.1 lineages. Slide seven. Based on this and additional data, regulatory and public health authorities consequently advise vaccine manufacturers to revise the formulation for their authorized COVID-19 vaccine. The WHO and the EMA recommended the use of JN.1 lineage antigen in a monovalent COVID-19 vaccine for the season 2024-2025 and 17 days later, we were able to submit our application to the European regulator. Based on this recommendation and the consequent EMA approval on July 3rd, we have begun rolling out our updated COMIRNATY JN.1 vaccine in Europe.

Ugur Sahin: Based on this and additional data, regulatory and public health authorities consequently advise vaccine manufacturers to revise the formulation for their authorized COVID-19 vaccine. The WHO and the EMA recommended the use of JN.1 lineage antigen in a monovalent COVID-19 vaccine for the season 2024-2025 and 17 days later, we were able to submit our application to the European regulator. Based on this recommendation and the consequent EMA approval on July 3rd, we have begun rolling out our updated COMIRNATY JN.1 vaccine in Europe. In the United States, the FDA further recommended the use of KP.2 as the preferred JN.1 lineage antigen for the 2024-2025 COVID-19 mRNA vaccines, on June 13th. Less than two weeks later, we initiated our rolling submission with the U.S. FDA. We and our partner, Pfizer, are working hard to enable early availability of variant-adapted vaccines for people around the world with the aim of reducing or preventing severe disease, hospitalizations and COVID-19-related deaths. We expect the FDA approval of our KP.2-adapted vaccine by mid-September and we aim to deliver the first vaccine doses to the people in the United States shortly thereafter. Slide 8. The other area I'm highly excited about is the progress on our oncology pipeline.

Ugur Sahin: In the United States, the FDA further recommended the use of KP.2 as the preferred JN.1 lineage antigen for the 2024-2025 COVID-19 mRNA vaccines, on June 13th. Less than two weeks later, we initiated our rolling submission with the U.S. FDA. We and our partner, Pfizer, are working hard to enable early availability of variant-adapted vaccines for people around the world with the aim of reducing or preventing severe disease, hospitalizations and COVID-19-related deaths. We expect the FDA approval of our KP.2-adapted vaccine by mid-September and we aim to deliver the first vaccine doses to the people in the United States shortly thereafter. Slide 8.

Ugur Sahin: In the United States, the FDA further recommended the use of Kp2 as the preferred K1-lineage antigen for the 2024-2025 COVID-19 mRNA on June 3rd. Less than two weeks later, we initiated our voting submission with the FDA.

Ugur Sahin: We and our partner Pfizer are working hard to enable the early availability of variant-adapted vaccines for people around the world with the aim of reducing or preventing severe disease, hospitalizations, and COVID-19-related deaths. We expect the FDA approval of our TP2-adapted vaccine by mid-September, and we aim to deliver the first vaccine doses to people in the United States shortly thereafter. Flat 8 The other area I'm highly excited about is the progress in our oncology.

Ugur Sahin: The other area I'm highly excited about is the progress on our oncology pipeline. Before I hand over to Özlem to deep dive into the recent achievements, let me remind you of our overarching oncology strategy. mRNA cancer immunotherapies were our starting point when we founded BioNTech and they remain the centerpiece. Ever since, we have been pursuing a technology-agnostic approach by not limiting ourselves to any one technology. Over the past two years, we added platforms to complement the mRNA centerpiece. Today, we have an oncology toolkit featuring multiple modalities, including targeted therapies such as ADCs and immunomodulators IOs, that open up new combination opportunities to synergistic mechanisms of action. Having this diversity of assets in our pipeline enable us to pursue combination approaches that are proprietary and unique. This strategic advantage allows us to evaluate the activity of each individual compound and to determine those patient populations for which monotherapy or synergistic combinations are best suited.

Ugur Sahin: Before I hand over to zlem to deep dive into the recent achievements, let me remind you of our overarching on-call, Imani Kemping-McCarthy, where our starting point can be found... and David Lee May, the Center. Ever since, we have been pursuing a technology agnostic approach by not limiting ourselves to any one technology.

Ugur Sahin: Over the past two years, we added platforms to complement the MRE center. Today, we have an oncology toolkit featuring multiple modalities, including targeted therapies such as ADCs and immunomodulators, IOs, that open up new combination opportunities to synergistic mechanisms of action. Having this diversity of assets in our past enables us to pursue combination approaches that are proprietary and unique. This strategic advantage allows us to evaluate the activity of each individual compound and to determine those patient populations for which monotherapy or synergistic combinations are best suited.

Ugur Sahin: Today, we have an oncology toolkit featuring multiple modalities, including targeted therapies such as ADCs and immunomodulators IOs, that open up new combination opportunities to synergistic mechanisms of action. Having this diversity of assets in our pipeline enable us to pursue combination approaches that are proprietary and unique. This strategic advantage allows us to evaluate the activity of each individual compound and to determine those patient populations for which monotherapy or synergistic combinations are best suited. We believe that our strategy has the potential to address fundamental challenges of cancer and to drive meaningful improvements in the long-term survival rates for patients. And as you will hear from Özlem, the last quarter has been about executing towards this vision.

Ugur Sahin: We believe that our strategy has the potential to address fundamental challenges of cancer and to drive meaningful improvements in the long-term survival rates for patients. And as you will hear from Özlem, the last quarter has been about executing towards this vision. Before I hand over, I would like to thank you all for your ongoing support as we enter this truly exciting period for BioNTech and our progress towards our founding vision. Thank you. Thank you, Ugur.

Ugur Sahin: We believe that our strategy has the potential to address fundamental challenges in cancer and to drive meaningful improvements in long-term survival rates for patients. And as you will hear from Estem, the last quarter has been about executing on decisions.

Ugur Sahin: Before I hand over, I would like to thank you all for your ongoing support as we enter this truly exciting period for BioNTech and our progress towards our founding vision. Thank you.

Ugur Sahin: Before I hand over, I would like to thank you all for your ongoing support as we enter this truly exciting period for BioNTech and our progress towards our founding vision. Thank you. Thank you, Ugur.

Özlem Türeci: Thank you, Ugur. Glad to speak with everyone today. Our multi-platform immuno-oncology clinical pipeline is continuing to grow and to progress and it is a rich resource for the rationally-planned novel-novel combinations that we consider a key pillar of our strategy. As you can see, two of our modalities, namely mRNAs and immunomodular [inaudible] IOs, are dominantly represented in our pipeline and particularly so in advanced clinical stages. Today I want to focus on priority assets within these modalities which have our special attention, our mRNA vaccines and one of our IO compounds, BNT327.

Özlem Türeci: Thank you, Ugur. Glad to speak with everyone today.

Ozlem Tureci: Glad to speak with everyone today. Our multi-platform ophthalmology clinical pipeline is continuing to grow and to progress, and it is a resource for variationally planned novel-novel combinations that we consider a key pillar of our. As you can see, two of our modalities, namely mRNAs and immunomodular beta-iods, are dominantly represented in our pipeline, and particularly so in advanced clinical trials. Today I want to focus on priority assets within these modalities which have our special attention, our mRNA vaccines and one of our I.O. compounds, DNA-Based Antibody.

Özlem Türeci: Our multi-platform immuno-oncology clinical pipeline is continuing to grow and to progress and it is a rich resource for the rationally-planned novel-novel combinations that we consider a key pillar of our strategy. As you can see, two of our modalities, namely mRNAs and immunomodular [inaudible] IOs, are dominantly represented in our pipeline and particularly so in advanced clinical stages. Today I want to focus on priority assets within these modalities which have our special attention, our mRNA vaccines and one of our IO compounds, BNT327. Before I cover these assets, let me just mention that a rich, clinical pipeline and ambitious plans require execution capability, which we are continuously building. As you can see on the slide, we are accelerating the pace of pipeline-wide patient accrual compared to last quarter. Compared to 2022, we and our network of partners are now recruiting six times as many patients per quarter to support enrollment into the clinical trials you saw on the previous slide.

Özlem Türeci: Before I cover these assets, let me just mention that a rich, clinical pipeline and ambitious plans require execution capability, which we are continuously building. As you can see on the slide, we are accelerating the pace of pipeline-wide patient accrual compared to last quarter. Compared to 2022, we and our network of partners are now recruiting six times as many patients per quarter to support enrollment into the clinical trials you saw on the previous slide. This increase is a testament of our drive towards more and larger mid- to late-stage trials as part of our ambition to achieve multiple product launches in oncology by the year 2030. It also underlines the success of our partnership strategy, which not only gives us access to compounds that complement our own pipeline but enables us to leverage additional clinical trial execution capacity and know-how and geographically. Now, to the centerpiece of our oncology portfolio, our mRNA cancer vaccine platforms--iNeST and FIXVAC--which differ in the type of tumor antigen they target. iNeST targets new antigens derived from somatic mutations in cancer cells that are unique to an individual's tumor.

Ozlem Tureci: Before I cover these areas, let me just mention that a rich clinical pipeline and ambitious plans require execution capability, which we are continuously building. As you can see on the slide, we are accelerating the pace of pipeline-wide patient accrual compared to last quarter. Compared to 2022, we and our network of partners are now recruiting six times as many patients per quarter to support enrollment into the clinical trials you saw on the previous slide.

Ozlem Tureci: This increase is testament to our drive towards more and larger mid- to late-stage trials as part of our ambition to achieve multiple product launches in oncology by the year 2030. It also underlines the success of our partnership strategy, which not only gives us access to compounds that complement our own pipeline, but enables us to leverage additional clinical trial execution capacity and know-how and geographically. Now to the centerpiece of our oncology portfolio, our mRNA cancer vaccine platforms, INS and IXVAC, which differ in the type of tumor antigen data. INAS targets new antigens derived from somatic mutations in cancer cells that are unique to an individual's tumor.

Özlem Türeci: This increase is a testament of our drive towards more and larger mid- to late-stage trials as part of our ambition to achieve multiple product launches in oncology by the year 2030. It also underlines the success of our partnership strategy, which not only gives us access to compounds that complement our own pipeline but enables us to leverage additional clinical trial execution capacity and know-how and geographically.

Özlem Türeci: Now, to the centerpiece of our oncology portfolio, our mRNA cancer vaccine platforms--iNeST and FIXVAC--which differ in the type of tumor antigen they target. iNeST targets new antigens derived from somatic mutations in cancer cells that are unique to an individual's tumor. iNeST vaccines are manufactured on-demand and personalized to each individual patient. FIXVAC vaccines target multiple non-mutated antigens shared by a majority of patients with a given tumor type and are off-the-shelf. The computational approaches to discover and select these two different types of target entities are one of our core competencies. iNeST and FIXVAC both use the same technology, namely our proprietary mRNA LPX platform. Today, we have ongoing trials in multiple disease settings and indications across both vaccine platforms. We have reported translational and clinical data over the last couple of years and future data updates from multiple trials shown on this slide are planned. Aggregate data that we have reported in the past across iNeST and FIXVAC trials indicate that uridine mRNA LPX-based vaccines have a manageable and largely mild safety profile as single agents in combination with anti-PD-1/PD-L1 compounds and in combination with chemotherapy.

Ozlem Tureci: INAS vaccines are manufactured on demand and personalized to each individual's needs. Kickback vaccines target micropill non-mutated antigens shared by a majority of patients with a given pneumotype and are also shared. The computational approaches to discover and select these two different types of target entities are one of our core competencies.

Özlem Türeci: iNeST and FIXVAC both use the same technology, namely our proprietary mRNA LPX platform. Today, we have ongoing trials in multiple disease settings and indications across both vaccine platforms. We have reported translational and clinical data over the last couple of years and future data updates from multiple trials shown on this slide are planned. Aggregate data that we have reported in the past across iNeST and FIXVAC trials indicate that uridine mRNA LPX-based vaccines have a manageable and largely mild safety profile as single agents in combination with anti-PD-1/PD-L1 compounds and in combination with chemotherapy. Our data also indicates that our uridine mRNA LPX-based vaccines are proficient in inducing and expanding high-magnitude, functional and long-life T cell responses in a majority of patients, which is the prerequisite of clinical activity. Furthermore, our data from small sample size patient cohorts indicate clinical activity alone and in combination with anti-PD-1/PD-L1 treatment. Several of the now ongoing trials shown on this slide aim to answer the material question of whether our mRNA vaccines are superior to the respective standard of care.

Ozlem Tureci: INAS and SIGCHI both use the same technology, namely our proprietary mRNA-LTX platform. Today, we have ongoing trials in multiple disease settings and indications across both vaccines. We have reported translational and clinical data over the last couple of years, and future data updates from multiple trials shown on this slide are planned. Aggregate data that we have reported in the past across INS and FIXBAC trials indicate that uridine mRNA-LTX-based vaccines have a manageable and largely mild safety profile as single agents in combination with N-type Td1-Tdl1 compounds and in combination with chemotherapy.

Özlem Türeci: Our data also indicates that our uridine mRNA LPX-based vaccines are proficient in inducing and expanding high-magnitude, functional and long-life T cell responses in a majority of patients, which is the prerequisite of clinical activity. Furthermore, our data from small sample size patient cohorts indicate clinical activity alone and in combination with anti-PD-1/PD-L1 treatment. Several of the now ongoing trials shown on this slide aim to answer the material question of whether our mRNA vaccines are superior to the respective standard of care. In our FIXVAC program, here on the right, I would like to highlight three vaccine candidates currently being evaluated in multiple trials in both the metastatic and adjuvant trials. First, BNT113 being well-underway in first-line HPV16+ PD-L1 positive head and neck squamous cell carcinoma in a potentially registrational Phase II randomized trial.

Ozlem Tureci: Our data also indicates that our urogen mRNA-ATX-based vaccines are proficient in inducing and expanding high-magnitude functional and long-life T-cell responses in the majority of patients, which is the prerequisite for clinical activity. Furthermore, our data from small sample size patient cohorts indicate clinical activity alone and in combination with anti-TB1-TBL1. Several of the now ongoing trials shown on this slide aim to answer the material question of whether our mRNA vaccines are superior to the respective standard of care.

Özlem Türeci: In our FIXVAC program, here on the right, I would like to highlight three vaccine candidates currently being evaluated in multiple trials in both the metastatic and adjuvant trials. First, BNT113 being well-underway in first-line HPV16+ PD-L1 positive head and neck squamous cell carcinoma in a potentially registrational Phase II randomized trial. Second, BNT116 being investigated in two trials as a single agent and in various combinations in different non-small cell lung cancer patient populations and treatment lines. And last, but not least, BNT111 being investigated in anti-PD-1 relapsed or refractory melanoma--about which I would like to talk a bit more. BNT111 is a uridine mRNA LPX-based vaccine that encodes four melanoma-associated antigens that collectively cover more than 90% of melanoma patients and are highly immunogenic. In the randomized three-arm Phase II clinical trial conducted in collaboration with our partner Regeneron, we are evaluating BNT111 in combination with Regeneron's anti-PD-1 compound, CEMIPLIMAB and we measure activity of BNT111 alone or CEMIPLIMAB alone in a total of 184 enrolled patients with PD-L1 refractory unresectable stage 3 or stage 4 melanoma.

Ozlem Tureci: In our six-step program, shown on the right, I would like to highlight three vaccine candidates currently being evaluated in multiple trials in both the metastatic and adjuvant trials. Trust BNT-113 being well underway in first-line HBV-16-positive TdL1-positive head-neck-squamous delta phenoma in a potentially registrational state to randomize.

Ozlem Tureci: Second, BNT1-16 is being investigated in two trials as a single agent and in various combinations in different non-small cell lung cancer patient populations and treatment lines. And last but not least, BNT1-11, being investigated in anti-PD-1 relapsed or refractory melanoma, about which I would like to talk a bit more. The NT1-11 is a urine mRNA-LPX-based vaccine that encodes four melanoma-associated antigens that collectively cover more than 90% of melanoma patients and are highly immunogenic. In the randomized pre-RMPS2 clinical trial conducted in collaboration with our partner Regeneron, we are evaluating DNT111 in combination with Regeneron's anti-TD1 compounds, the MIPI-MAP, and measuring activity of DNT111 alone or the MIPI-MAP alone in a total of 184 enrolled patients with TDL1 refractory unreflectible stage 3 or stage 4 melanin.

Özlem Türeci: And last, but not least, BNT111 being investigated in anti-PD-1 relapsed or refractory melanoma--about which I would like to talk a bit more. BNT111 is a uridine mRNA LPX-based vaccine that encodes four melanoma-associated antigens that collectively cover more than 90% of melanoma patients and are highly immunogenic. In the randomized three-arm Phase II clinical trial conducted in collaboration with our partner Regeneron, we are evaluating BNT111 in combination with Regeneron's anti-PD-1 compound, CEMIPLIMAB and we measure activity of BNT111 alone or CEMIPLIMAB alone in a total of 184 enrolled patients with PD-L1 refractory unresectable stage 3 or stage 4 melanoma. As Ugur noted earlier, we very recently announced that the trial, not its primary endpoint, achieved a statistically significant improvement in overall response rate in the BNT1-11-Dimethimab combination arm as compared to a historical control of anti-CD1 monotherapy in relapsed refractory patients. The historic control was based on multiple late-stage clinical trials that established the expected objective response rate for monotherapy checkpoint inhibitors in While the data are further maturing, we do see a trend towards improved overall survival.

Ozlem Tureci: As Ugur noted earlier, we very recently announced that the trial, not its primary endpoint, achieved a statistically significant improvement in overall response rate in the BNT1-11-Dimethimab combination arm as compared to a historical control of anti-CD1 monotherapy in relapsed refractory patients. The historic control was based on multiple late-stage clinical trials that established the expected objective response rate for monotherapy checkpoint inhibitors in While the data are further maturing, we do see a trend towards improved overall survival.

Özlem Türeci: As Ugur noted earlier, we very recently announced that the trial met its primary endpoint, achieving a statistically significant improvement of overall response rate in the BNT111+CEMIPLIMAB combination arm as compared to a historical control of anti-PD-1 monotherapy in relapsed/refractory patients. The historic control was based on multiple late-stage clinical trials that established the expected objective response rate for monotherapy checkpoint inhibitors in this setting for this patient population. While the data are further maturing, we do see a trend towards improved overall survival. The BNT111-01 trial is based on the earlier Lipo-MERIT Phase I/II trial in patients with advanced melanoma who had exhausted treatment options. The trial established the dose and provided initial safety, efficacy and immunogenicity data on BNT111 as single agent and with checkpoint inhibitors approved in this patient population. In that proof of concept study, we observed that treatment with BNT111 alone or in combination with anti-PD-1 could induce strong, high-magnitude T cell responses against at least one targeted tumor-associated antigen in all analyzed patients, most of which were not detectable prior to using the vaccine.

Özlem Türeci: The BNT111-01 trial is based on the earlier Lipo-MERIT Phase I/II trial in patients with advanced melanoma who had exhausted treatment options. The trial established the dose and provided initial safety, efficacy and immunogenicity data on BNT111 as single agent and with checkpoint inhibitors approved in this patient population. In that proof of concept study, we observed that treatment with BNT111 alone or in combination with anti-PD-1 could induce strong, high-magnitude T cell responses against at least one targeted tumor-associated antigen in all analyzed patients, most of which were not detectable prior to using the vaccine. As shown here, objective responses by BNT111 were durable, with some patients followed up for several years. The safety profile was generally mild and in line with expectations for those patients who were co-treated with checkpoint inhibitors. The results we have seen in the Phase II BNT 111-01 study are consistent with Yif's primary analysis. We plan to present the full data from the primary analysis at the Medical Conference in 2025 and are entering into discussions with regulatory authorities regarding our data and the clinical path forward for this talk. Cutaneous melanoma carries a high and continuously increasing incidence and mortality rate.

Ozlem Tureci: The BNT1101 trial is based on the earlier lipomeric case 1-2 trial in patients with advanced melanoma who had exhausted triglycerides. The trial established the dose and provided initial safety, efficacy, and immunogenicity data on DNP111 as single agent and with checkpoint inhibitors approved in this patient. In that proof-of-concept study, we observed that treatment with BND1-11 alone or in combination with anti-PD-1 could induce strong, high-magnitude T-cell responses against at least one targeted tumor-associated antigen in all analyzed patients, most of which were not detectable prior to using the vaccine.

Özlem Türeci: As shown here, objective responses by BNT111 were durable, with some patients followed up for several years. The safety profile was generally mild and in line with expectations for those patients who were co-treated with checkpoint inhibitors. The results we have seen in the Phase II BNT111-01 study are consistent with these prior results. We plan to present the full data from the primary analysis at a medical conference in 2025 and are entering into discussions with regulatory authorities regarding our data and the clinical path forward for this program. Cutaneous melanoma carries a high and continuously increasing incidence and mortality burden.

Ozlem Tureci: As shown here, objective responses by BNT111 were durable, with some patients followed up for several years. The safety profile was generally mild and in line with expectations for those patients who were co-treated with checkpoint inhibitors. The results we have seen in the Phase II BNT 111-01 study are consistent with Yif's primary analysis. We plan to present the full data from the primary analysis at the Medical Conference in 2025 and are entering into discussions with regulatory authorities regarding our data and the clinical path forward for this talk. Cutaneous melanoma carries a high and continuously increasing incidence and mortality rate.

Özlem Türeci: Cutaneous melanoma carries a high and continuously increasing incidence and mortality burden. The introduction of checkpoint inhibitor-directed therapies was a breakthrough for patients that led to significant improvements in survival. Nonetheless, in advanced disease stages, only a third of patients achieved a long-term response and long-term survival. After failure of checkpoint inhibitors, there is no established standard of care, with only limited and short-lived responses to salvage therapy. While a new adapted [inaudible] has recently become available for this patient population, we do not expect that all patients will be eligible, leaving a significant unmet medical need unaddressed. In this context, our BNT111 may be of interest to potentially help treat this high-medical need population. Moreover, the BNT111 data is a proof of concept in three dimensions.

Ozlem Tureci: The introduction of checkpoint inhibitor-directed therapies was a breakthrough for patients that led to significant improvements in survival. Nonetheless, in advanced disease stages, only a third of patients achieve a long-term response and long-term survival. After failure of checkpoint inhibitors, there is no established standard of care with only limited and short-lived responses to pelvic fluidity.

Ozlem Tureci: While a new adoptive therapy has recently become available for this patient population, we do not expect that all patients will be eligible, leaving a significant unmet medical need unaddressed. In this context, our BNT111 may be of interest to potentially help treat the prior medical need population. Moreover, the DLT-111 data is a proof of concept in free data.

Özlem Türeci: While a new adapted [inaudible] has recently become available for this patient population, we do not expect that all patients will be eligible, leaving a significant unmet medical need unaddressed. In this context, our BNT111 may be of interest to potentially help treat this high-medical need population. Moreover, the BNT111 data is a proof of concept in three dimensions. Firstly, a proof of concept for our decade-long, improved mRNA cancer vaccine technology that uses uridine mRNA chemistry, a non-coding backbone that is engineered for optimal translational performance and our proprietary lipoplex formulation for systemic delivery. Second, this is a proof of concept for our computational approaches for selecting suitable tumor antigens and targets for our cancer indication-specific six-leg program candidates. And lastly, it's a proof of concept for our strategy to combine synergistic modalities, in this case BNT111 with an established immune checkpoint inhibitor treatment.

Özlem Türeci: While a new adapted strategy has recently become available for this patient population, we do not expect that all patients will be eligible, leaving a significant unmet medical need unaddressed. In this context, our BNT111 may be of interest to potentially help treat this high-medical need population. Moreover, the BNT111 data is a proof of concept in three dimensions. Firstly, a proof of concept for our decade-long improved mRNA cancer vaccine technology that uses uridine mRNA chemistry, a non-coding backbone that is engineered for optimal translational performance and our proprietary lipoplex formulation for systemic delivery.

Ozlem Tureci: Firstly, a proof-of-concept for our C-TAPE loan-improved mRNA cancer vaccine technology that uses origin mRNA chemistry, a non-coding backbone that is engineered for obsolete translational performance, and our proprietary LIPO-VEX formulation for systemic delivery. Second, this is a proof-of-concept for our computational approaches for selecting suitable tumor antigens and targets for our cancer indication-specific F And lastly, it's a proof-of-concept for our strategy to combine synergistic modalities, in this case BND1-11, with an established immune checkpoint inhibitor.

Özlem Türeci: Second, this is a proof of concept for our computational approaches for selecting suitable tumor antigens and targets for our cancer indication-specific six-leg program candidates. And lastly, it's a proof of concept for our strategy to combine synergistic modalities, in this case BNT111 with an established immune checkpoint inhibitor treatment. All three of these also apply to BNT122, our individualized mRNA cancer immunotherapy based on our iNeST platform and the same delivery technology. We consider individualized cancer vaccines as a medical breakthrough in addressing the high unmet medical needs of resectable cancer and in adjuvant or minimal residual disease treatment settings. And here, I want to highlight ongoing randomized Phase II trials with our individualized vaccines in pancreatic ductal adenocarcinoma and in colorectal cancer. The five-year survival rate in pancreatic ductal adenocarcinoma after resection alone is 10% and up to 75% of patients with pancreatic ductal carcinoma relapse, even though they appear tumor-free within five years after adjuvant treatment.

Özlem Türeci: is a proof-of-concept for our computational approaches for selecting suitable tumor antigens and targets for our cancer indication-specific F And lastly, it's a proof-of-concept for our strategy to combine synergistic modalities, in this case BND1-11, with an established immune checkpoint inhibitor.

Ozlem Tureci: All three of these also apply to BNT1-22, our individualized mRNA cancer immunotherapy based on our iNAS platform and the same delivery test. We consider individualized cancer vaccines as a medical breakthrough in addressing the high unmet medical needs of resectable cancer and in attribute or minimal residual disease treatment. Here I want to highlight ongoing randomized phase 2 trials with our individualized vaccines in pancreatic ductal adenocarcinoma and colorectal cancer. The five-year survival rate for pancreatic ductal adenocarcinoma after resection alone is 10%, and up to 75% of patients with pancreatic ductal carcinoma relapse even though they appear tumor-free within five years after attribution.

Özlem Türeci: We consider individualized cancer vaccines as a medical breakthrough in addressing the high unmet medical needs of resectable cancer and in adjuvant or minimal residual disease treatment settings. And here, I want to highlight ongoing randomized Phase II trials with our individualized vaccines in pancreatic ductal adenocarcinoma and in colorectal cancer. The five-year survival rate in pancreatic ductal adenocarcinoma after resection alone is 10% and up to 75% of patients with pancreatic ductal carcinoma relapse, even though they appear tumor-free within five years after adjuvant treatment. As for high-risk stage 2 or stage 3 colorectal cancer, about 35% of patients relapse within five years after resection and adjuvant therapy. As discussed in the last earnings call, we demonstrated that our individualized vaccine used in patients with adjuvant pancreatic cancer can induce de novo T cell responses that are specific to the individual mutant tumor neoantigens and that the risk of recurrence of cancer for patients with vaccine-induced immune responses was reduced even after a three-year follow-up period.

Özlem Türeci: As for high-risk stage 2 or stage 3 colorectal cancer, about 35% of patients relapse within five years after resection and adjuvant therapy. As discussed in the last earnings call, we demonstrated that our individualized vaccine used in patients with adjuvant pancreatic cancer can induce de novo T cell responses that are specific to the individual mutant tumor neoantigens and that the risk of recurrence of cancer for patients with vaccine-induced immune responses was reduced even after a three-year follow-up period. At the recent ESMO GI conference, we disclosed findings from the biomarker sub-study of our ongoing Phase II iNeST trial, BNT122-01, involving patients with stage 2 high-risk or stage 3 colorectal cancer who remain ctDNA-positive following the surgical excision of their localized cancer. Upon completion of standard of care adjuvant chemotherapy, these patients received BNT122, our individualized vaccine, in contrast to the conventional wait-and-watch approach. In the subset of said patients who were susceptible for immunogenicity analysis, a high-magnitude de novo T cell response against at least one vaccine-encoded neoantigen was observed in all patients.

Ozlem Tureci: As for high-risk stage 2 or stage 3 colorectal cancer, about 35% of patients relapse within 5 years after resection, and at even fewer. As discussed in the last earnings call, we demonstrated that our individualized vaccine used in patients with atrial and pancreatic cancer can induce de novo G-cell responses that are specific to the individual mutant tumor neoantigen and that the risk of recurrence of cancer for patients with vaccine-induced immune responses was reduced even after a three-year follow-up.

Ozlem Tureci: At the recent ESMO-GI conference, we disclosed findings from the biomarker substudy of our ongoing phase 2 INES trial, BNP12201, involving patients with stage 2 high-risk or stage 3 colorectal cancer who remain CCDNA-positive following the surgical excision of their localized cancer. Upon completion of standard-of-care, adjuvant chemotherapy, these patients received BNP12202, our individualized vaccine, in contrast to the conventional wait-and-watch strategy. In the subset of breast patients who were susceptible to immunogenicity analysis, a high-magnitude de novo t-cell response against at least one vaccine-encoded neoantigen was observed in all patients.

Özlem Türeci: At the recent ESMO GI conference, we disclosed findings from the biomarker sub-study of our ongoing Phase II iNeST trial, BNT122-01, involving patients with stage 2 high-risk or stage 3 colorectal cancer who remain ctDNA-positive following the surgical excision of their localized cancer. Upon completion of standard of care adjuvant chemotherapy, these patients received BNT122, our individualized vaccine, in contrast to the conventional wait-and-watch approach. In the subset of said patients who were susceptible for immunogenicity analysis, a high-magnitude de novo T cell response against at least one vaccine-encoded neoantigen was observed in all patients. These T cell responses were amplified with successive vaccination cycles. Notably, in several patients, the T cell responses were sustained even after two years of follow-up. All 12 patients involved in the immunogenicity analysis remained disease-free at the time of data cut-off.

Özlem Türeci: These T cell responses were amplified with successive vaccination cycles. Notably, in several patients, the T cell responses were sustained even after two years of follow-up. All 12 patients involved in the immunogenicity analysis remained disease-free at the time of data cut-off. Enrollment for the main part of the colorectal cancer study is underway to establish the safety and efficacy of BNT122 in patients with ctDNA positive stage 2, stage 3 colorectal cancer as opposed to the standard wait-and-watch strategy. We anticipate presenting the results from this randomized Phase II study by late 2025 or early '26. As multiple Phase II trials are ongoing and our clinical data on mRNA immunotherapies continues to mature, we are scaling up our manufacturing capabilities and capacities for bulk mRNA drug supplies, for off-the-shelf FIXVAC vaccines and also for our individualized vaccine programs.

Ozlem Tureci: These T-cell responses were amplified with successive vaccination cycles. Notably, in several patients, the T-cell responses were sustained even after two years of follow-up. All 12 patients involved in the immunogenicity analysis remained disease-free at the time of data collection.

Ozlem Tureci: Enrollment for the main part of the colorectal cancer study is underway to establish the safety and efficacy of BND1-22 in patients with ctDNA positive stage 2, stage 3 colorectal cancer as opposed to the standard wait and watch strategy. We anticipate presenting the results from this randomized stage 2 study by late 2025 or early 2026. As mild stage 2 trials are ongoing and our clinical data on mRNA immunotherapies continues to mature, we are scaling up our manufacturing capabilities and capacities for bulk mRNA drug supplies, for off-the-shelf vaccines, and also for our individualized vaccine.

Özlem Türeci: We anticipate presenting the results from this randomized Phase II study by late 2025 or early '26. As multiple Phase II trials are ongoing and our clinical data on mRNA immunotherapies continues to mature, we are scaling up our manufacturing capabilities and capacities for bulk mRNA drug supplies, for off-the-shelf FIXVAC vaccines and also for our individualized vaccine programs.

Özlem Türeci: We anticipate presenting the results from this randomized Phase II study by late 2025 or early '26.

Özlem Türeci: As multiple Phase II trials are ongoing and our clinical data on mRNA immunotherapies continues to mature, we are scaling up our manufacturing capabilities and capacities for bulk mRNA drug supplies, for off-the-shelf FIXVAC vaccines and also for our individualized vaccine programs. To build out our manufacturing capacity for personalized mRNA, we are currently building a pilot facility in Mainz, Germany to support our ongoing late-stage trials and potentially, in the future, commercialization. We also continue to leverage InstaDeep, our wholly-owned AI subsidiary company, to work with our teams in improving both the up and downstream processes in personalized mRNA manufacturing. From our mRNA cancer vaccines, I'm now moving to our immunomodulatory IO compounds, specifically BNT327, which we consider as a key immunomodulatory concept and compelling backbone for novel combinations.

Ozlem Tureci: To build out our manufacturing capacity for personalized mRNA, we are currently building a pilot facility in Mainz, Germany, to support our ongoing late-stage trials and, potentially, in the future, commercialize them. We also continue to leverage InstaVie, our wholly owned AI hub security company, to work with our teams to improve both the up- and downstream processes for personalized mRNA manufacturing. From our mRNA cancer vaccines, I'm now moving to our immunomodulatory I.O. compounds, specifically BNT-327, which we consider a key immunomodulatory concept and compelling backbone for novel combinations.

Özlem Türeci: From our mRNA cancer vaccines, I'm now moving to our immunomodulatory IO compounds, specifically BNT327, which we consider as a key immunomodulatory concept and compelling backbone for novel combinations. BNT327 combines two validated mechanisms of action: VEGF-A binding inhibits the VEGF-A with VEGFR access, blocks tumor angiogenesis--which leads to reduced tumor cell proliferation and survival. VEGF-A inhibition also counteracts formation of the immunosuppressive tumor microenvironment as does the PD-L1 arm of this bispecific antibody by reworking PD-L1/PD-1 access-mediated T cell exhaustion. The PD-L1 arm also anchors the bi-specific antibodies to the tumor bed for efficient and localized scavenging of the EGFA, which may contribute to mitigate tumor-on-target side effects. Given that both the NTVE-GSA and the NTiPE-PB1 mechanisms are validated across many tumor types and, in some cases, as a combination, we have a clear roadmap ahead of us to develop the NT Beyond these initial indications, which we may combine with standard-of-care chemotherapy, we plan to evaluate novel BNP327 combinations, the first of which was started recently. These novel DNP-frequent cell recombination may open up new areas of activity for our anti-DGFA and anti-TBI1 organisms.

Ozlem Tureci: DMT-327 combines two validated mechanisms of VEGF-A binding inhibits the VEGF-A/VEGF-R axis, blocks tumor angiogenesis, which leads to reduced tumor cell proliferation, and survives. VETFA inhibition also counteracts formation of the immunosuppressive tumor microenvironment as does the PBI-1 arm of the guide-specific antibody by reworking the PBI-1-PB1 axis mediated to steric source.

Özlem Türeci: The PD-L1 arm also anchors this bispecific antibody to the tumor bed for efficient and localized scavenging of the VEGF-A, which may contribute to mitigate our tumor-on-target side effects. Given that both the anti-VEGF-A and the anti-PD-1 mechanisms are validated across many tumor types and in some cases, as a combination, we have a clear roadmap ahead of us where to develop BNT327. Beyond these initial indications, in which we may combine with standard of care chemotherapy, we plan to evaluate novel BNT327 combinations, the first of which was started recently. These novel BNT327 combinations may open up new areas of activity for our anti-VEGF-A and anti-PD-L1 molecule. We and our partner, Biotheus, have treated over 600 patients across a wide range of clinical indications with BNT327, either as monotherapy or in combination with various standard-of-care protocols. This extensive data collection effort provides a solid foundation for making informed, data-driven decisions on potential indications and patient cohorts for future registration. Notably, the data demonstrate robust single-agent activity of BNTP27 in previously untreated advanced non-small-cell lung cancer and high response rates in combination with standard-of-care chemotherapy in triple-negative breast cancer and small-cell lung cancer. Specifically, in first-line triple-negative breast cancer, we observed an objective response rate approaching 80% with fewer of the responses than when combined with enough hepatitis B.

Ozlem Tureci: The PD-L1 arm also anchors the bi-specific antibodies to the tumor bed for efficient and localized scavenging of the EGFA, which may contribute to mitigate tumor-on-target side effects. Given that both the NTVE-GSA and the NTiPE-PB1 mechanisms are validated across many tumor types and, in some cases, as a combination, we have a clear roadmap ahead of us to develop the NT Beyond these initial indications, which we may combine with standard-of-care chemotherapy, we plan to evaluate novel BNP327 combinations, the first of which was started recently. These novel DNP-frequent cell recombination may open up new areas of activity for our anti-DGFA and anti-TBI1 organisms.

Özlem Türeci: We and our partner, Biotheus, have treated over 600 patients across a wide range of clinical indications with BNT327, either as monotherapy or in combination with various standard of care protocols. This extensive data collection effort provides a solid foundation for making informed, data-driven decisions on potential indications and patient cohorts for future registration studies. Notably, the data demonstrate robust single-agent activity of BNT327 in previously untreated advanced non-small-cell lung cancer and high response rates in combination with standard of care chemotherapy in triple-negative breast cancer and small-cell lung cancer. Specifically, in first-line triple-negative breast cancer, we observed an objective response rate approaching 80%, with durable responses when combined with NAB-PACLITAXEL. The safety profile in these indications was generally well managed and in line with at-work events observed with other therapies targeting CDL1 and appears to be more favorable than those seen with anti-BGF-AH. These data have driven our strategic decision to initiate registration trials in small-cell lung cancer, non-small-cell lung cancer, and triple negative breast cancer this year and next. In small cell lung cancer, therapeutic options for the treatment of metastatic disease remain limited, with few innovative approaches beyond front-line anti-PD-1 checkpoint inhibitors, which only achieve response rates of around 20%.

Ozlem Tureci: We and our partner, BioPhirs, have treated over 600 patients across a wide range of clinical indications with BNQ-327, either as monotherapy or in combination with various standard-of-care protocols. This extensive data collection effort provides a solid foundation for making informed, data-driven decisions on potential indications and patient cohorts for future registration. Notably, the data demonstrate robust single-agent activity of BNTP27 in previously untreated advanced non-small-cell lung cancer and high response rates in combination with standard-of-care chemotherapy in triple-negative breast cancer and small-cell lung cancer. Specifically, in first-line triple-negative breast cancer, we observed an objective response rate approaching 80% with fewer of the responses than when combined with enough hepatitis B.

Özlem Türeci: Specifically, in first-line triple-negative breast cancer, we observed an objective response rate approaching 80%, with durable responses when combined with NAB-PACLITAXEL. The safety profile in these indications was generally well-managed and in line with adverse events observed with other therapies targeting PD-L1 and appears to be more favorable than those seen with anti-VEGF-A agents. These data have driven our strategic decision to initiate registration trials in small-cell lung cancer, non-small-cell lung cancer and in triple-negative breast cancer this year and next year. In small cell lung cancer, therapeutic options for the treatment of metastatic disease remain limited, with few innovative approaches beyond front-line anti-PD-1 checkpoint inhibitors--which only achieve response rates of around 20%. TNBC patients, particularly those with PD-L1-negative tumors, have few treatment options as they are not eligible for current anti-PD-1 therapies. In metastatic non-small cell lung cancer, while anti-PD-1 inhibitors have significantly changed the treatment landscape, nearly half of these patients still do not respond to front-line therapy in combination with chemotherapy.

Ozlem Tureci: The safety profile in these indications was generally well managed and in line with at-work events observed with other therapies targeting CDL1 and appears to be more favorable than those seen with anti-BGF-AH. These data have driven our strategic decision to initiate registration trials in small-cell lung cancer, non-small-cell lung cancer, and triple negative breast cancer this year and next. In small cell lung cancer, therapeutic options for the treatment of metastatic disease remain limited, with few innovative approaches beyond front-line anti-PD-1 checkpoint inhibitors, which only achieve response rates of around 20%.

Özlem Türeci: In small cell lung cancer, therapeutic options for the treatment of metastatic disease remain limited, with few innovative approaches beyond front-line anti-PD-1 checkpoint inhibitors--which only achieve response rates of around 20%. TNBC patients, particularly those with PD-L1-negative tumors, have few treatment options as they are not eligible for current anti-PD-1 therapies. In metastatic non-small cell lung cancer, while anti-PD-1 inhibitors have significantly changed the treatment landscape, nearly half of these patients still do not respond to front-line therapy in combination with chemotherapy. We will soon start two global Phase II dose optimization studies to enable selection of a registrational dose for global registrational trials in these particular indications. At ASCO, we presented updated preliminary efficacy and safety data from an ongoing Phase I/II study in cohorts of advanced cervical cancer, platinum-resistant relapsed ovarian cancer and advanced relapsed non-small cell lung cancer. We will be presenting signal-finding data from additional tumor indications at upcoming conferences.

Ozlem Tureci: CNBC patients, particularly those with TBI1-negative tumors, have few treatment options as they are not eligible for current anti-TB1 treatments. For metastatic non-smothered lung cancer, while anti-TB1 inhibitors have significantly changed the treatment landscape, nearly half of these patients still do not respond to front line therapy in combination with chemotherapy.

Özlem Türeci: We will soon start two global Phase II dose optimization studies to enable selection of a registrational dose for global registrational trials in these particular indications. At ASCO, we presented updated preliminary efficacy and safety data from an ongoing Phase I/II study in cohorts of advanced cervical cancer, platinum-resistant relapsed ovarian cancer and advanced relapsed non-small cell lung cancer. We will be presenting signal-finding data from additional tumor indications at upcoming conferences. This will add to our extensive database and is the basis of our plans for further development in key indications. Most importantly, as Ugur also noted, it is a strategic goal for us to explore BNT327 as part of novel-novel combinations, in particular with our ADC assets and mRNA therapies. We have started to implement this strategy by investigating BNT327 in combination with our TROP2 ADC, BNT25. Further combinations will be announced in the coming months.

Özlem Türeci: We will soon start two global Phase II dose optimization studies to enable selection of a registrational dose for global registrational trials in these particular indications.

Ozlem Tureci: We will soon start two global stake-through dose optimization studies to enable selection of a registrational dose for global registrational trials in these particular indications. At ESCO, we presented updated preliminary efficacy and safety data from an ongoing Phase I-II study in cohorts of advanced cervical cancer, sediment-resistant relapsed ovarian cancer, and advanced relapsed non-small cell lung cancer. We will be presenting signal finding data from additional tumor indications at upcoming conferences.

Özlem Türeci: At ASCO, we presented updated preliminary efficacy and safety data from an ongoing Phase I/II study in cohorts of advanced cervical cancer, platinum-resistant relapsed ovarian cancer and advanced relapsed non-small cell lung cancer. We will be presenting signal-finding data from additional tumor indications at upcoming conferences. This will add to our extensive database and is the basis of our plans for further development in key indications. Most importantly, as Ugur also noted, it is a strategic goal for us to explore BNT327 as part of novel-novel combinations, in particular with our ADC assets and mRNA therapies. We have started to implement this strategy by investigating BNT327 in combination with our TROP2 ADC, BNT25. Further combinations will be announced in the coming months. We are very excited to advance these combination trials with our partners. On my final slide now, I would like to provide an outlook on upcoming congress presentations in September with updates on some of our priority assets. At the annual ESMO Congress in Barcelona, here we will present an update on our two trials evaluating BNT113, FIXVAC. The first update will include patients with anal, head and neck, cervical and other HPV-16-driven carcinomas and will report mainly safety and immunogenicity findings from the Phase I/II trials.

Ozlem Tureci: This will add to our extensive database and is the basis of our plans for further development in key industries. Most importantly, as Ugur also noted, it is a strategic goal for us to explore BNT-327 as part of novel-novel combinations, in particular with our ADC assets and mRNA theory. We have started to implement this strategy by investigating DNP-327 in combination with our top two ABCs, DNP-325. Further combinations will be announced in the coming months.

Özlem Türeci: Most importantly, as Ugur also noted, it is a strategic goal for us to explore BNT327 as part of novel-novel combinations, in particular with our ADC assets and mRNA therapies. We have started to implement this strategy by investigating BNT327 in combination with our TROP2 ADC, BNT25. Further combinations will be announced in the coming months. We are very excited to advance these combination trials with our partners.

Ozlem Tureci: We are very excited to advance these combination trials with our partners. On my final slide now, I would like to provide an outlook on upcoming Congress presentations in September with updates on some of our priorities at the Annual Ethno-Congress in Barcelona. Here we will present an update on our two trials evaluating GND1-136. The first update will include patients with anal, head, and neck cervical cancers and other HPV-16-driven carcinomas and will report mainly safety and immunogenicity findings from the phase 1 test.

Özlem Türeci: On my final slide now, I would like to provide an outlook on upcoming congress presentations in September with updates on some of our priority assets. At the annual ESMO Congress in Barcelona, here we will present an update on our two trials evaluating BNT113, FIXVAC. The first update will include patients with anal, head and neck, cervical and other HPV16-driven carcinomas and will report mainly safety and immunogenicity findings from the Phase I/II trials. The second update from a safety run-in cohort of our ongoing Phase II trials evaluating BNT113 dosed in combination with PEMBROLIZUMAB versus PEMBROLIZUMAB alone will include patients with HPV16+ head-neck squamous cell carcinoma. This update will focus on the safety, immunogenicity and preliminary activity findings of the cohort. We will also present the updated results on BNT327 in patients with TNBC, with EGFR-mutated non-small cell lung cancer and with kidney cancer, together with our partner Biotheus. These updates will contain either initial or follow up data on safety and efficacy of BNT327 as a monotherapy and as a combination with different chemotherapeutic regimens. And finally, we will be presenting updated results from our ongoing Phase I trial evaluating safety and efficacy of our CLAUDIN 6 CAR-T cell in combination with CLAUDIN 6-encoding mRNA vaccine in patients with relapsed refractory CLAUDIN 6 solid tumors. This data will be a follow up from what was presented at last year's ESMO Congress and will include updated safety and efficacy data as well as data on CAR-T cell persistence.

Ozlem Tureci: The second update from a safety-run in-cohort of our ongoing Phase II trials evaluating BMP1-13 dosing in combination with pembrolizumab versus pembrolizumab alone will include patients with HPV-16-positive head-neck-brain-cell carcinoma. This update will focus on safety, immunogenicity, and preliminary activity. We will also present the updated results on DMT-327 in patients with CMDP, with ECFR-mutated non-small cell lung cancer, and kidney disease, together with our plasma biophysicists.

Özlem Türeci: This update will focus on the safety, immunogenicity and preliminary activity findings of the cohort. We will also present the updated results on BNT327 in patients with TNBC, with EGFR-mutated non-small cell lung cancer and with kidney cancer, together with our partner Biotheus. These updates will contain either initial or follow up data on safety and efficacy of BNT327 as a monotherapy and as a combination with different chemotherapeutic regimens. And finally, we will be presenting updated results from our ongoing Phase I trial evaluating safety and efficacy of our CLAUDIN 6 CAR-T cell in combination with CLAUDIN 6-encoding mRNA vaccine in patients with relapsed refractory CLAUDIN 6 solid tumors. This data will be a follow up from what was presented at last year's ESMO Congress and will include updated safety and efficacy data as well as data on CAR-T cell persistence.

Jens Holstein: These updates will contain either initial or follow-up data on safety and efficacy of CNG-327 as a monotherapy and as a combination with different chemotherapeutic risks. And finally, we will be presenting updated results from our ongoing Phase 1 trial evaluating safety and efficacy of our Cloridin 6 CAR-T cells in combination with Cloridin 6 encoding mRNA vaccine in patients with relapsed refractory This data will be a follow-up from what was presented at last year's ESMO congress and will include updated safety and efficacy data as well as data on CAR-T cells.

Özlem Türeci: And finally, we will be presenting updated results from our ongoing Phase I trial evaluating safety and efficacy of our CLAUDIN 6 CAR-T cell in combination with CLAUDIN 6-encoding mRNA vaccine in patients with relapsed refractory CLAUDIN 6 solid tumors. This data will be a follow up from what was presented at last year's ESMO Congress and will include updated safety and efficacy data as well as data on CAR-T cell persistence. We will share additional details on these and further congress publications in the near future. With that, I will now pass the presentation to our CFO, Jens Holstein. Thank you, Özlem and a warm welcome to everyone who has dialed in today. Let me start by reviewing our financial results for the three months ended June 30th. Our total revenues, reported for the second quarter of 2024, reached approximately €129 million, compared with approximately €168 million for the second quarter of 2020.

Jens Holstein: We will share additional details on these and further converse publications in the near future. With that, I will now pass the presentation to our CFO, Jens Holstein. Thank you, Ozlem, and a warm welcome to everyone who has dialed in today. Let me start by reviewing our financial results for the three months ended June 30th. Our total revenues, reported for the second quarter of 2024, reached approximately €129 million, compared with approximately €168 million for the second quarter of 2020.

Özlem Türeci: With that, I will now pass the presentation to our CFO, Jens Holstein. Thank you, Özlem and a warm welcome to everyone who has dialed in today. Let me start by reviewing our financial results for the three months ended June 30th. Our total revenues, reported for the second quarter of 2024, reached approximately €129 million, compared with approximately €168 million for the second quarter of 2020.

Özlem Türeci: With that, I will now pass the presentation to our CFO, Jens Holstein.

Jens Holstein: Thank you, Özlem and a warm welcome to everyone who has dialed in today. Let me start by reviewing our financial results for the three months ended June 30th. Our total revenues, reported for the second quarter of 2024, reached approximately €129 million, compared with approximately €168 million for the second quarter of 2020.

Jens Holstein: Thank you, Özlem and a warm welcome to everyone who has dialed in today's call.

Jens Holstein: Let me start by reviewing our financial results for the three months ended June 30, 2024. Our total revenues, reported for the second quarter of 2024, reached approximately €129 million, compared with approximately €168 million for the second quarter of 2023. Our second quarter revenues reflect the current demand of the seasonal endemic COVID-19 vaccine market and I expect it to be the low point in this year's COVID-19 vaccine uptake. Part of our total revenues are derived from the pandemic preparedness agreement with the German government, which is expected to run until early 2027. Moving to cost of sales.

Jens Holstein: Our second quarter revenues reflect the current demand for the seasonal endemic COVID-19 vaccine market, and I expect it to be the low point in this year's COVID-19 vaccine sales. Part of our total revenues are derived from the pandemic preparedness agreement with the German government, which is expected to run until early 2025. Moving across the cell.

Jens Holstein: Moving to cost of sales. Cost of sales amounted to approximately €60 million for the second quarter of 2024, compared to approximately €163 million for the comparative prior year period. Research and Development expenses were approximately €585 million for the second quarter of 2024, compared to approximately €373 million for the comparative prior year period. Of the total R&D spend in the second quarter, we invested approximately 90% in our non-COVID business, mainly by initiating larger clinical studies for our late-stage oncology candidates and by investing in additional personnel in our R&D departments to run those clinical trials. Sales, general and administrative expenses amounted to approximately €184 million in the second quarter of 2024, compared to about €138 million in the comparative prior year period.

Jens Holstein: Customer sales amounted to approximately €60 million in the second quarter of 2024 compared to approximately €163 million for the comparative price. Research and Development Expenses were approximately €585 million for the second quarter of 2024 compared to approximately €373 million for the comparable prior year. Of the total R&D spend in the second quarter, we invested approximately 90% in our non-COVID business, mainly by initiating larger clinical studies for our late-stage oncology candidates and by investing in additional personnel in our R&D departments to run those trainings. Sales, general, and administrative expenses amounted to approximately €184 million in the second quarter of 2024, compared to about €138 million in the comparative price.

Jens Holstein: Sales, general and administrative expenses amounted to approximately €184 million in the second quarter of 2024, compared to about €138 million in the comparative prior year period. The increase in SG&A was mainly due to the increased expenses for our IT environment, as well as an increase in headcount to support the scaling of our business. Regarding the company's other operating results during the second quarter of 2024, this amounted to approximately €267 million in negative operating results, compared to about €57 million in negative operating results for the comparative prior year period. This change was primarily due to the recording of a provision related to a contractual dispute. Income taxes were accrued with an amount of €2 million of tax expenses for the second quarter of 2024, compared to approximately €222 million of realized tax income for the comparative prior year period. The effective income tax rate for the first half of 2024 was approximately 1.3%. For the second quarter of 2024, we reported a net loss of approximately €808 million compared to a net loss of about €190 million for the comparative prior year period. Our loss per share for the second quarter of 2024 amounted to €3.36 compared to a loss per share of €0.79 for the comparative prior year period.

Jens Holstein: The increase in SG&A was mainly due to increased expenses for our IT environment, as well as an increase in headcount to support the scaling of our business. Regarding the company's other operating results during the second quarter of 2024, this amounted to approximately €267 million in negative operating results compared to about €57 million in negative operating results for the corresponding value. This change was primarily due to the recording of a provision related to a contractual obligation. Income taxes were accrued with an amount of 2 million euros of tax expenses for the second quarter of 2024 compared to approximately 222 million euros of realized tax income for the Comparative SPIE.

Jens Holstein: This change was primarily due to the recording of a provision related to a contractual dispute. Income taxes were accrued with an amount of €2 million of tax expenses for the second quarter of 2024, compared to approximately €222 million of realized tax income for the comparative prior year period. The effective income tax rate for the first half of 2024 was approximately 1.3%. For the second quarter of 2024, we reported a net loss of approximately €808 million compared to a net loss of about €190 million for the comparative prior year period. Our loss per share for the second quarter of 2024 amounted to €3.36 compared to a loss per share of €0.79 for the comparative prior year period.

Jens Holstein: This change was primarily due to the recording of a provision related to a contractual dispute.

Jens Holstein: Income taxes were accrued with an amount of €2 million of tax expenses for the second quarter of 2024, compared to approximately €222 million of realized tax income for the comparative prior year period. The effective income tax rate for the first half of 2024 was approximately 1.3%. For the second quarter of 2024, we reported a net loss of approximately €808 million compared to a net loss of about €190 million for the comparative prior year period. Our loss per share for the second quarter of 2024 amounted to €3.36 compared to a loss per share of €0.79 for the comparative prior year period. As of June 30, 2024, our cash and cash equivalents and security investments reached approximately 18.5%. Our strong balance sheet provides us with the strategic flexibility to invest in our long-term growth. As part of that strategy, we will continue to invest in the development of our individualized therapies and in the build-out of the manufacturing capacities and capabilities to support additional late-stage trials and commercialization. To create long-term value, we aim to advance our clinical programs quickly, yet cost-efficiently, towards potential recognition.

Jens Holstein: The effective income tax rate for the first half of 2024 was approximately 1.4%. For the second quarter of 2024, we reported a net loss of approximately 808 million euros compared to a net loss of about 190 million euros for the competitive price. Our loss per share for the second quarter of 2024 amounted to €3.36 compared to a loss per share of €79.00 for the comparative prior year period.

Jens Holstein: As of June 30, 2024, our cash and cash equivalents and security investments reached approximately 18.5%. Our strong balance sheet provides us with the strategic flexibility to invest in our long-term growth. As part of that strategy, we will continue to invest in the development of our individualized therapies and in the build-out of the manufacturing capacities and capabilities to support additional late-stage trials and commercialization. To create long-term value, we aim to advance our clinical programs quickly, yet cost-efficiently, towards potential recognition.

Jens Holstein: As of June 30, 2024, our cash and cash equivalents and security investments reached approximately €18.5 billion. Our strong balance sheet provides us with the strategic flexibility to invest in our long-term growth strategy. As part of that strategy, we will continue to invest in the development of our individualized therapies and in the build-out of the manufacturing capacities and capabilities to support additional late-stage trials and commercialization. To create long-term value, we aim to advance our clinical programs quickly yet cost-efficiently, towards potential registration. Coming to The Net, Today we are reiterating the company's financial guidance for the current financial crisis, consistent with the expectations of approval of our variant-adapted COVID-19 vaccine in the United States in mid-September. We expect to recognize the vast majority of our four-year revenues, mostly in, independent of the time. And as communicated earlier in the year, we expect to report a loss for the 2024 financial year, while we continue to invest in our proprietary assets. As such, we also reiterate our R&D and ST&A guidance with 2.4 to 2.6 billion euros for R&D and 700 to 800 million euros for ST&A. Those expenses are expected to increase in the second half compared to the first half.

Jens Holstein: Coming to The Net, Today we are reiterating the company's financial guidance for the current financial crisis, consistent with the expectations of approval of our variant-adapted COVID-19 vaccine in the United States in mid-September. We expect to recognize the vast majority of our four-year revenues, mostly in, independent of the time. And as communicated earlier in the year, we expect to report a loss for the 2024 financial year, while we continue to invest in our proprietary assets. As such, we also reiterate our R&D and ST&A guidance with 2.4 to 2.6 billion euros for R&D and 700 to 800 million euros for ST&A. Those expenses are expected to increase in the second half compared to the first half.

Jens Holstein: Turning to the next slide, Today, we are reiterating the company's financial guidance for the current financial year. Consistent with the expectations of approval of our variant-adapted COVID-19 vaccine in the United States in mid-September, we expect to recognize the vast majority of our full year revenues mostly in Q4. Independent of the timing of the revenue generation and as communicated earlier in the year, we expect to report a loss for the 2024 financial year while we continue to invest in our proprietary assets and technologies. As such, we also reiterate our R&D and SG&A guidance with €2.4 to €2.6 billion for R&D and €700 to €800 million for SG&A expenses. Those expenses are expected to increase in the second half compared to the first half of 2024. Please note that this guidance does not include any M&A transactions, payments for collaboration agreements or licensing deals not yet disclosed, nor any potential payments resulting from the outcomes of ongoing and/or future legal disputes or related activities--such as judgment or settlement--which may have a material effect on our results of operations and/or cash flows. In summary, our focus so far has been on executing the company's strategy, highlighted by the progress in our pipeline. We've advanced and started new potentially registrational trials and have shared encouraging data that demonstrates the potential of our pipeline.

Jens Holstein: As such, we also reiterate our R&D and SG&A guidance with €2.4 to €2.6 billion for R&D and €700 to €800 million for SG&A expenses. Those expenses are expected to increase in the second half compared to the first half of 2024. Please note that this guidance does not include any M&A transactions, payments for collaboration agreements or licensing deals not yet disclosed, nor any potential payments resulting from the outcomes of ongoing and/or future legal disputes or related activities--such as judgment or settlement--which may have a material effect on our results of operations and/or cash flows. In summary, our focus so far has been on executing the company's strategy, highlighted by the progress in our pipeline. We've advanced and started new potentially registrational trials and have shared encouraging data that demonstrates the potential of our pipeline.

Jens Holstein: Please note that this guidance does not include any M&A transactions, payments for collaboration agreements, or licensing deals not yet disclosed, nor any potential payments resulting from the outcomes of ongoing and or future legal disputes or related activities, such as judgment or settlement, which may have a material effect on our results of operations and work. In summary, our focus so far has been on executing the company's strategy, highlighted by the progress in our pipeline. We have advanced and started new potential registration of trials and have shared encouraging data that demonstrates the potential of all types.

Jens Holstein: In summary, our focus so far has been on executing the company's strategy, highlighted by the progress in our pipeline. We've advanced and started new potentially registrational trials and have shared encouraging data that demonstrates the potential of our pipeline. Our focus in oncology remains on investing in our innovative technologies that we believe can make a difference, while progressing our late-stage programs towards potential market authorization. Supported by a strong cash position and demonstrated financial discipline, we will continue to invest in our pipeline and focus on generating value for patients and ourselves. With that, I would like to turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our strategic outlook and concluding remarks. Thank you. Thank you, Jens.

Jens Holstein: Our focus in oncology remains on investing in our innovative technologies that we believe can make a difference while progressing our late-stage programs towards potential market authorization. Supported by a strong past position and demonstrated financial discipline, we will continue to invest in our pipeline and focus on generating value for patients and ourselves. With that, I would like to turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our strategic outlook and closing remarks. Thank you. Thank you, Yaron.

Jens Holstein: With that, I would like to turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our strategic outlook and concluding remarks. Thank you. Thank you, Jens.

Jens Holstein: With that, I would like to turn the call over to our Chief Strategy Officer, Ryan Richardson, for an update on our strategic outlook and concluding remarks. Thank you.

Ryan Richardson: Thank you, Jens. Our efforts over the last few months have put us in a strong position to execute our COVID-19 vaccine launches this fall season. In June, the European Medicines Agency recommended marketing authorization for our JN.1-adapted COVID-19 vaccine, followed by European Commission approval on July 3rd. We started distributing vaccine doses to EU member states shortly thereafter. We expect the earlier launch of our updated COVID-19 vaccine in Europe, relative to last year, will allow vaccination campaigns this year to be more closely aligned with seasonal influenza vaccination campaigns. In the United States, the FDA has recommended the use of KP.2 as the preferred strain for the '24/'25 season. We and our partner, Pfizer, have initiated a rolling submission with the FDA for our KP.2-adapted COVID-19 vaccine and expect to be in a position to begin vaccine distribution in the U.S. following regulatory approval, with first shipments expected in September.

Ryan Richardson: Thank you, Jens.

Ryan Richardson: Our efforts over the last few months have put us in a strong position to execute our COVID-19 vaccine launch. In June, the European Medicines Agency recommended marketing authorization for our JN1-adapted COVID-19 vaccine, followed by European Commission approval on July 3rd. We started distributing vaccine doses to EU member states shortly thereafter. We expect that the earlier launch of our updated COVID-19 vaccine in Europe, relative to last year, will allow vaccination campaigns this year to be more closely aligned with seasonal influenza.

Ryan Richardson: Our efforts over the last few months have put us in a strong position to execute our COVID-19 vaccine launches this fall season. In June, the European Medicines Agency recommended marketing authorization for our JN.1-adapted COVID-19 vaccine, followed by European Commission approval on July 3rd. We started distributing vaccine doses to EU member states shortly thereafter. We expect the earlier launch of our updated COVID-19 vaccine in Europe, relative to last year, will allow vaccination campaigns this year to be more closely aligned with seasonal influenza vaccination campaigns. In the United States, the FDA has recommended the use of KP.2 as the preferred strain for the '24/'25 season. We and our partner, Pfizer, have initiated a rolling submission with the FDA for our KP.2-adapted COVID-19 vaccine and expect to be in a position to begin vaccine distribution in the U.S. following regulatory approval, with first shipments expected in September.

Ryan Richardson: In the United States, the FDA has recommended the use of KP.2 as the preferred strain for the '24/'25 season. We and our partner, Pfizer, have initiated a rolling submission with the FDA for our KP.2-adapted COVID-19 vaccine and expect to be in a position to begin vaccine distribution in the U.S. following regulatory approval, with first shipments expected in September. COVID-19 vaccine demand continues to be globally distributed. We and our partner, Pfizer, are preparing to launch our variant-adapted COVID-19 vaccine in over 40 countries and regions worldwide. We expect approximately two-thirds of demand potential to reside outside the United States. While some regions outside the U.S. continue to be served by government contracts, we anticipate several newly-established private markets to open up in regions like the U.K. and Japan.

Ryan Richardson: In the United States, the FDA has recommended the use of Kp2 as the preferred strain for the 24-25. We and our partner, Pfizer, have initiated a rolling submission with the FDA for our KP2-adapted COVID-19 vaccine, and expect to be in a position to begin vaccine distribution in the U.S. following regulatory approval, with first shipments expected in September.

Ryan Richardson: COVID-19 vaccine demand continues to be globally distributed. We and our partner Pfizer are preparing to launch our variant-adapted COVID-19 vaccine in over 40 countries and regions worldwide. We expect approximately two-thirds of demand potential to reside outside the United States. While some regions outside the U.S. continue to be served by government contracts, we anticipate several newly-established private markets to open up in regions like the U.K. and Japan.

Ryan Richardson: We expect approximately two-thirds of demand potential to reside outside the United States. While some regions outside the U.S. continue to be served by government contracts, we anticipate several newly-established private markets to open up in regions like the U.K. and Japan. This could enable broader access to COVID-19 vaccines for individuals who may not qualify under local immunization recommendations, which tend to focus on the higher-risk population segments. In addition, we have increased our supply of pre-filled syringes but we'll continue to offer a mix of pre-filled syringes, single-dose vials and multi-dose vials across regions. We believe the COMIRNATY franchise is well-positioned to maintain its leading position globally in the continued fight against COVID-19. Moving to oncology on the next slide.

Ryan Richardson: We expect approximately two-thirds of demand potential to reside outside the United States.

Ryan Richardson: While some regions outside the U.S. continue to be served by government contracts, we anticipate several newly-established private markets to open up in regions like the U.K. and Japan. This could enable broader access to COVID-19 vaccines for individuals who may not qualify under local immunization recommendations, which tend to focus on the higher-risk population segments. In addition, we have increased our supply of pre-filled syringes but we'll continue to offer a mix of pre-filled syringes, single-dose vials and multi-dose vials across regions. We believe the COMIRNATY franchise is well-positioned to maintain its leading position globally in the continued fight against COVID-19.

Ryan Richardson: This could enable broader access to COVID-19 vaccines for individuals who may not qualify under local immunization recommendations, which tend to focus on higher-risk populations. In addition, we have increased our supply of pre-filled syringes. But we'll continue to offer a mix of pre-filled syringes, single-dose vials, and multi-dose vials across. We believe the Comirnaty franchise is well positioned to maintain its leading position globally in the continued fight against COVID-19. Moving to oncology on the next slide.

Ryan Richardson: Moving to oncology on the next slide. We will continue to invest in our mRNA cancer vaccine platforms based on our belief that personalized mRNA cancer vaccines have the potential to establish a new paradigm in cancer treatment. These vaccines employ cutting-edge mRNA technology, which aims to address the root cause of cancer--genomic mutations or neoantigens that are largely specific to each individual's tumor. Neoantigen selection for each patient is, today, driven by AI algorithms and a fully in silico process. We believe this is fundamentally distinct from other pharmaceutical products and that it will allow for iterative improvement over time, powered by data assets. In addition to their ability to be combined with other therapies with complementary mechanisms of action,

Ryan Richardson: We will continue to invest in our mRNA cancer vaccine platforms based on our belief that personalized mRNA cancer vaccines have the potential to establish a new paradigm in cancer treatment. These vaccines employ cutting-edge mRNA technology, which aims to address the root cause of... Genomic Mutations or NeoAnimals that are largely specific to each individual's tumor. New agent selection for each patient is today driven by AI algorithms and a fully in silico process. We believe this is fundamentally distinct from other pharmaceuticals and that it will allow for iterative improvement over time, powered by data assets, in addition to their ability to be combined with other therapists. Complementary Mechanisms of Action

Ryan Richardson: We believe this is fundamentally distinct from other pharmaceutical products and that it will allow for iterative improvement over time, powered by data assets. In addition to their ability to be combined with other therapies with complementary mechanisms of action, we believe these therapies have potential to extend beyond the product life cycle of a traditional off-the-shelf pharmaceutical product.

Ryan Richardson: In addition to their ability to be combined with other therapies with complementary mechanisms of action, we believe these therapies have potential to extend beyond the product life cycle of a traditional off-the-shelf pharmaceutical product. The next slide highlights the key pipeline milestones to focus on as we look ahead to '24 and '25. We are entering a catalyst-rich period over the next 18 months with data updates and regulatory submissions expected for multiple product candidates This includes, but is not limited to, Phase III COVID-flu combination vaccine top-line data expected this year and data expected in 2025 from both our mRNA cancer vaccine platforms, FIXVAC and iNeST.

Ryan Richardson: We believe these therapies have potential to extend beyond the product life cycle of a traditional off-the-shelf pharmaceutical. The next slide highlights the key pipeline milestones to focus on as we look ahead to 24 and. We are entering a cattle's wish period over the next 18 months. Data Updates and Regulatory Submissions Expected for Multiple Product Candidates This includes, but is not limited to, phase 3 COVID flu combination vaccine top-line data expected this year and data expected in 2025 from both our mRNA cancer vaccine platforms, ZikZak and IMAP.

Ryan Richardson: The next slide highlights the key pipeline milestones to focus on as we look ahead to '24 and '25. We are entering a catalyst-rich period over the next 18 months with data updates and regulatory submissions expected for multiple product candidates This includes, but is not limited to, Phase III COVID-flu combination vaccine top-line data expected this year and data expected in 2025 from both our mRNA cancer vaccine platforms, FIXVAC and iNeST. We also expect data updates for BNT327, our anti-PD-L1, VEG-F bispecific antibody and BNT323, our HER2 ADC in a variety of solid tumor indications. Finally, we plan to initiate multiple combination trials in solid tumor indications over the next 12 months, consistent with our strategy to develop novel combinations which leverage complementary mechanisms of action. Turning to the next slide. We continue to focus on our late-stage oncology portfolio, in line with our near-term goal to have 10 potentially registrational trials active by the end of the year.

Ryan Richardson: The next slide highlights the key pipeline milestones to focus on as we look ahead to '24 and '25. We are entering a catalyst-rich period over the next 18 months with data updates and regulatory submissions expected for multiple product candidates. This includes, but is not limited to, Phase III COVID-flu combination vaccine top-line data expected this year and data expected in 2025 from both our mRNA cancer vaccine platforms, FIXVAC and iNeST. We also expect data updates for BNT327, our anti-PD-L1, VEG-F bispecific antibody and BNT323, our HER2 ADC in a variety of solid tumor indications. Finally, we plan to initiate multiple combination trials in solid tumor indications over the next 12 months, consistent with our strategy to develop novel combinations which leverage complementary mechanisms of action. Turning to the next slide.

Ryan Richardson: We also expect data updates for BNT-327, our anti-PD-L1, VEGF-5-specific antibody, and BMP323 in her 280 cities, and a variety of solid tumor indicators. Finally, we plan to initiate multiple combination trials and solid tumor indications over the next 12 months, consistent with our strategy to develop novel combinations which leverage complementary mechanisms of action. Turning to the next slide, we continue to focus on our late-stage oncology portfolio in line with our near-term goal to have 10 potentially registrational trials active by the end of the year.

We also expect data updates for BNT-327, our anti-PD-L1, VEGF-5-specific antibody, and BMP323 in her 280 cities, and a variety of solid tumor indicators. Finally, we plan to initiate multiple combination trials and solid tumor indications over the next 12 months, consistent with our strategy to develop novel combinations which leverage complementary mechanisms of action. Turning to the next slide, we continue to focus on our late-stage oncology portfolio in line with our near-term goal to have 10 potentially registrational trials active by the end of the year.

Finally, we plan to initiate multiple combination trials and solid tumor indications over the next 12 months, consistent with our strategy to develop novel combinations which leverage complementary mechanisms of action. Turning to the next slide, we continue to focus on our late-stage oncology portfolio in line with our near-term goal to have 10 potentially registrational trials active by the end of the year.

Ryan Richardson: Finally, we plan to initiate multiple combination trials in solid tumor indications over the next 12 months, consistent with our strategy to develop novel combinations which leverage complementary mechanisms of action. Turning to the next slide. We continue to focus on our late-stage oncology portfolio, in line with our near-term goal to have 10 potentially registrational trials active by the end of the year. While still in the early stages, we are making progress in attracting talented professionals to join our commercial organization to support our first wave of anticipated oncology product launches. We believe that focusing execution on our diverse late-stage pipeline will bring significant potential for mid and long-term value creation. On the next slide, I would like to remind everyone that we plan to hold our first Artificial Intelligence Innovation Series event via webcast on October 1st, followed by our annual Innovation Series event on November 14th. Further details will be released soon. We welcome you to join these events for a deeper look at the exciting developments taking place at BioNTech. With that, I would like to open the floor for questions.

Ryan Richardson: Turning to the next slide. We continue to focus on our late-stage oncology portfolio, in line with our near-term goal to have 10 potentially registrational trials active by the end of the year. While still in the early stages, we are making progress in attracting talented professionals to join our commercial organization to support our first wave of anticipated oncology product launches. We believe that focusing execution on our diverse late-stage pipeline will bring significant potential for mid and long-term value creation.

Ryan Richardson: We continue to focus on our late-stage oncology portfolio, in line with our near-term goal to have 10 potentially registrational trials active by the end of the year. While still in the early stages, we are making progress in attracting talented professionals to join our commercial organization to support our first wave of anticipated oncology product launches. We believe that focusing execution on our diverse late-stage pipeline will bring significant potential for mid and long-term value creation. On the next slide, I would like to remind everyone that we plan to hold our first Artificial Intelligence Innovation Series event via webcast on October 1st, followed by our annual Innovation Series event on November 14th. Further details will be released soon. We welcome you to join these events for a deeper look at the exciting developments taking place at BioNTech. With that, I would like to open the floor for questions. Thank you. To ask a question, please press star 1 1 on your telephone and wait for your name to be announced.

Ryan Richardson: While still in the early stages, we are making progress in attracting talented professionals to join our commercial organization to support our first wave of anticipated oncology product launches. We believe that focusing execution on our diverse late-stage pipeline will bring significant potential for mid- and long-term value creation. On the next slide, I would like to remind everyone that we plan to hold our first AI Innovation Series event via webcast on October 1st, followed by our annual Innovation Series event on November 4th.

Ryan Richardson: On the next slide, I would like to remind everyone that we plan to hold our first Artificial Intelligence Innovation Series event via webcast on October 1st, followed by our annual Innovation Series event on November 14th. Further details will be released soon. We welcome you to join these events for a deeper look at the exciting developments taking place at BioNTech. With that, I would like to open the floor for questions.

Ryan Richardson: With that, I would like to open the floor for questions.

Ryan Richardson: Further details will be released soon. We welcome you to join these events for a deeper look at the exciting developments. With that, I would like to open the floor to questions. Thank you. To ask a question, please press star 1 1 on your telephone and wait for your name to be announced.

Ryan Richardson: Thank you. To ask a question, please press star-1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star-1 and 1 again. We kindly ask participants to limit themselves to one question per person. We will now take the first question, from the line of Daina Graybosch from Leerink Partners. Please go ahead. Hi, thank you guys, and thanks for the question. This one is about the law, as early as 2026.

Operator: Thank you. To ask a question, please press star-1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star-1 and 1 again. We kindly ask participants to limit themselves to one question per person. We will now take the first question, from the line of Daina Graybosch from Leerink Partners. Please go ahead.

Operator: To withdraw your question, please press star, 1, and 1 again. We kindly ask participants to limit themselves to one question per person. We will now take the first question, from the land of Daina Graybosch from Liu Wing Partners. Please go ahead. Hi, thank you guys, and thanks for the question. This one is about the law, as early as 2026.

Ryan Richardson: We will now take the first question, from the line of Daina Graybosch from Leerink Partners. Please go ahead.

Operator: We will now take the first question, from the line of Daina Graybosch from Leerink Partners. Please go ahead.

Ryan Richardson: Hi. Thank you guys and thanks for the question. This one is on the laun--[inaudible] early as 2026. I wonder if you could talk about what specific programs and settings, trials you think are most likely to be able to launch in 2026. And if that depends on accelerated approval, what gives you confidence in accelerated approvals by that date? I guess I'm specifically referencing whether any of those are your Phase II vaccine trials. Thank you. Yeah, thank you, Dana.

Daina Graybosch: Hi. Thank you guys and thanks for the question. This one is on the laun--[inaudible] early as 2026. I wonder if you could talk about what specific programs and settings, trials you think are most likely to be able to launch in 2026. And if that depends on accelerated approval, what gives you confidence in accelerated approvals by that date? I guess I'm specifically referencing whether any of those are your Phase II vaccine trials. Thank you.

Daina Graybosch: I wonder if you could talk about what specific programs and settings trials you think are most likely to be able to launch in 2026, and if that depends on accelerated approval, what gives you confidence in accelerated approvals by that date. I guess I'm specifically referencing whether any of those are your Phase 2 vaccine trials. Thank you. Yeah, thank you, Dana.

Ryan Richardson: Yeah. Thank you, Daina. I'll start briefly and my colleagues can jump in. So, I think for 2026, we have a couple of different programs that potentially could launch in that timeframe. And the first of which is BNT323, our HER2 ADC. And we've highlighted the potential for, we think, for an accelerated approval in second and third-line endometrial cancer. So, that would be one asset where we're expecting data next year and if that timeline is confirmed, with further FDA discussions, we think that that could be a '26 launch opportunity. In addition, we've highlighted the potential for an accelerated pathway with our BNT122 iNeST in adjuvant colorectal cancer. We do still have further discussions to take place with the FDA but based on the current study design and the pace of enrollment, we do think that there's the potential--if the data is strong--also for data to be for submission and potentially launched in that sort of timeframe. Most likely towards the end of the year or early '27 but it could fall in '26. Thank you. We will now take the next question. On the line from Yaron Werber from TD Cullen, please go ahead.

Ugur Sahin: I'll start briefly and my colleagues can jump in. So, I think for 2026, we have a couple of different programs that potentially could launch in that time, and the first of which is BNC323, or HER283, and we've highlighted the potential for, we think, for an accelerated approval in second and third line and a neutral campaign. So that would be one asset where we're expecting data next year. And if that timeline is confirmed with further FDA discussions, we think that that could be a 26th launch opportunity. In addition, we've highlighted the potential for an accelerated pathway with our BQ122 INEST and adjuvant colorectal cancer.

Ryan Richardson: In addition, we've highlighted the potential for an accelerated pathway with our BNT122 iNeST in adjuvant colorectal cancer. We do still have further discussions to take place with the FDA but based on the current study design and the pace of enrollment, we do think that there's the potential--if the data is strong--also for data to be for submission and potentially launched in that sort of timeframe. Most likely towards the end of the year or early '27 but it could fall in '26.

Ugur Sahin: We can still have further discussions take place with the FDA, but based on the current study design and the pace of enrollment, we do think that there's the potential, if the data is strong, also for data to be submitted and potentially launched in that sort of timeframe, most likely towards the end of the year or early 27, but it could be. Thank you. We will now take the next question. On the line from Yaron Werber from TD Cullen, please go ahead.

Operator: Thank you. We will now take the next question from the line of Yaron Werber from TD Cowen. Please go ahead.

Yaron Benjamin Werber: Yeah, hi. Thanks for taking my question. Maybe just a quick question. I know you probably can't say a lot but BNT111 FIXVAC--when you're looking at historical controls and you're looking at sort of the overall survival sort of trend, can you give us a sense what--which historical control do you think are most appropriate just to kind of help gauge what the efficacy could be? Thank you.

Ozlem Tureci: Thank you. Yeah, sure. You know, this is a very dire indication, CPI, refractory resistant melanoma, and the controls against which we compare anti-TD1, TDL1 treatments, which have been tested in this indication, and chemotherapies, which have been tested in this indication. And as compared to those, we see a clinically meaningful benefit with regard to objective response rate. There is a trend for overall survival, but it is too early to be more specific about PFS and OS now. The data will mature, and at the time when we present the data next year, we will be able to be more specific. Thank you. We will now take the next question. From the line of Tazeen Ahmad from Bank of America Securities, please go ahead. Hi, good morning.

Özlem Türeci: Yeah, sure. You know, this is a very dire indication, CPI refractory resistant melanoma and the controls against which we compare anti-PD-1, PD-L1 treatments, which have been tested in this indication; chemotherapies, which have been tested in this indication. And as compared to those, we see a clinically meaningful benefit with regard to objective response rate. There is a trend for overall survival but it is too early to be more specific about PFS and OS now. The data will mature and at that time, when we present the data next year, we will be able to be more specific.

Ozlem Tureci: And as compared to those, we see a clinically meaningful benefit with regard to objective response rate. There is a trend for overall survival, but it is too early to be more specific about PFS and OS now. The data will mature, and at the time when we present the data next year, we will be able to be more specific. Thank you. We will now take the next question. From the line of Tazeen Ahmad from Bank of America Securities, please go ahead. Hi, good morning.

Thank you. We will now take the next question. From the line of Tazeen Ahmad from Bank of America Securities, please go ahead. Hi, good morning.

Operator: Thank you. We will now take the next question from the line of Tazeen Ahmad from Bank of America Securities. Please go ahead.

Tazeen Ahmad: Hi, good morning. Thanks for taking my question. Regarding the upcoming Phase III COVID-Flu combo data later this year, can you frame for us what would be good data? And how would you think that would impact the demand for the regular COVID vaccine going forward? And then, also related to that, how long before you think that this product, the combo product, would be able to launch? Thanks. Hi, it's Ugur.

Tazeen Ahmad: Thanks for taking my question. Regarding the upcoming phase three COVID flu combo data later this year, can you frame for us what would be good data? And how would you think that would impact the demand for the regular COVID vaccine going forward? And then also related to that, how long before you think that this product, the combo product, would be able to launch? Thank you. Hi, it's Ugur.

Ugur Sahin: Hi, it's Ugur. Yeah, thanks for the question. So, we are expecting that timeframe with safety, immunogenicity data and efficacy data--end of this year. And based on the results, we have to see whether the data qualify for submission and potential approval for the season 2025/2026. What would you consider good data to be an improvement over the regular public records?

Ugur Sahin: Yeah, thanks for the question. So we are, we are expecting, a shorter timeframe with safety immunogenicity data and efficacy data end of this year. And, and based on the results, we have to see whether the data qualify for submission and potential, potential approvals for CE 2025-2026. What would you consider good data to be an improvement over the regular public records?

Tazeen Ahmad: What would you consider good data though, Ugur, to be an improvement over the regular COVID vaccine?

Ugur Sahin: Can you repeat your question? I didn't catch that. What would you consider to be good data relative to the COVID-only vaccine in order to... I think the data is very clear. It's an efficacy trial. It's about comparable issues with COVID-19 plus efficacy in the two R's, and the additional immunogenicity data is, of course, in the mode of action. Thank you. We will now take the next question. From the line of Etzer Darout from BMO Capital Markets, please go ahead.

Ugur Sahin: Can you repeat your question? I didn't get that.

What would you consider to be good data relative to the COVID-only vaccine in order to... I think the data is very clear. It's an efficacy trial. It's about comparable issues with COVID-19 plus efficacy in the two R's, and the additional immunogenicity data is, of course, in the mode of action. Thank you. We will now take the next question. From the line of Etzer Darout from BMO Capital Markets, please go ahead.

Tazeen Ahmad: What would you consider to be good data relative to the COVID-only vaccine in order to--

I think the data is very clear. It's an efficacy trial. It's about comparable issues with COVID-19 plus efficacy in the two R's, and the additional immunogenicity data is, of course, in the mode of action. Thank you. We will now take the next question. From the line of Etzer Darout from BMO Capital Markets, please go ahead.

Ugur Sahin: I think the data is very clear. It's an efficacy trial. It's about comparable issues with the COVID-19 plus efficacy in the flu arm and additional immunogenicity data [inaudible] in the mode of action of the vaccine.

Operator: Thank you. We will now take the next question from the line of Etzer Darout from BMO Capital Markets. Please go ahead.

Etzer Darout: Hi, thanks for taking the question. Just wondering, sort of in the wake of the ACASUNLIMAB update and your maintenance of R&D guidance, is there a specific internal oncology program that potentially benefits here? In other words, maybe potential of acceleration of investments or broadening out of the program? Just so curious on your thoughts around who may be--what programs may benefit from this internally.

Ryan Richardson: Yeah, thank you for that question. And ultimately, this does come down to portfolio strategy--as I think your question alludes to. And the fact is that we have multiple programs that we think could have potential in non-small cell lung cancer. We've already started the Phase III for BNT316; we've just brought out data at ASCO for BNT327, which all of the earlier reviews we think is quite promising. And we also have a FIXVAC program that's also in NSCLC. So, we've got--already critical mass in our portfolio in the non-small cell lung cancer indication and we are planning a multi-pronged strategy to execute against. So, while we found the data encouraging for ACASUNLIMAB, we decided to prioritize other programs, frankly, over this in the next phase. I think the important takeaway here though, of course, is that if Genmab now takes this program forward into Phase III, we will still retain a economic stake in the program and a stake in its success--the future success of the program--but we won't fund Phase III. And we think that that's the right balance given the many shots on goal and exciting data that we're seeing from the portfolio.

Ryan Richardson: Yeah, thank you for that question. And ultimately, this does come down to portfolio strategy--as I think your question alludes to. And the fact is that, we have multiple programs that we think could have potential in non-small cell lung cancer. We've already started the Phase III for BNT316; we've just brought out data at ASCO for BNT327, which all of the earlier reviews we think is quite promising. And we also have a FIXVAC program that's also in NSCLC. So, we've got--already critical mass in our portfolio in the non-small cell lung cancer indication and we are planning a multi-pronged strategy to execute against.

Ryan Richardson: So we already have a critical map in our portfolio for the non-small cell lung cancer indication, and we are planning a multi-pronged strategy to execute against. So while we found the data encouraging for the single map, we decided to prioritize other programs, frankly, over this in the next phase. I think the important takeaway here, though, of course, is that if GenMap now takes this program forward into phase three, we will still retain an economic stake in the program and a stake in its success, the future success of the program, but we won't fund phase three. And we think that that's the right balance given the many shots on goal and exciting data that we're seeing from it.

Ryan Richardson: So, while we found the data encouraging for ACASUNLIMAB, we decided to prioritize other programs, frankly, over this in the next phase. I think the important takeaway here though, of course, is that if Genmab now takes this program forward into Phase III, we will still retain a economic stake in the program and a stake in its success--the future success of the program--but we won't fund Phase III. And we think that that's the right balance given the many shots on goal and exciting data that we're seeing from the portfolio.

Yifeng Liu: All right. Thank you. Thank you. We will now take the next question. From the line of Yifeng Liu from HCC Bank PLC, please go ahead. Hello.

Etzer Darout: All right. Thank you.

Thank you. We will now take the next question. From the line of Yifeng Liu from HCC Bank PLC, please go ahead. Hello.

Operator: Thank you. We will now take the next question from the line of Yifeng Liu from HSBC Bank plc. Please go ahead.

Hello. Thank you for taking my question. I've got a question on margin progression. So, just how should we think about--as your oncology pipeline progresses and also, in the meantime, you're scaling up manufacturing and potentially investing in R&D and then SG&A--how should we think about that margin progression and especially as you're launching your oncology products in the future? Thanks. Yes, we couldn't hear you very well there, but just want to make sure we got the question right. So your question is about how we see margin progression over the next couple of years, specifically as it relates to oncology. Is that right?

Yifeng Liu: Hello. Thank you for taking my question. I've got a question on margin progression. So, just how should we think about--as your oncology pipeline progresses and also, in the meantime, you're scaling up manufacturing and potentially investing in R&D and then SG&A--how should we think about that margin progression and especially as you're launching your oncology products in the future? Thanks.

Jens Holstein: I've got a question on..., and so it's hard for me to think about. As your oncology pipeline progresses, and also, in the meantime, you've taken out manufacturing and potentially invested in R&D and then SG&A. How should we think about that margin progression, especially as you're launching your oncology for those in the future? Yes, we couldn't hear you very well there, but just want to make sure we got the question right. So your question is about how we see margin progression over the next couple of years, specifically as it relates to oncology. Is that right?

Ryan Richardson: Yeah. We couldn't hear you very well there but just want to make sure we got the question right. So, your question is about how do we see margin progression over the next couple of years, specifically as it relates to oncology? Is that right?

Jens Holstein: Yes, because I think the launches, predominantly, we see sort of in oncology space. And yeah, just the question on margin progression. Thank you. Maybe I'll start, it's also a difficult action project, you're fading away somewhat. But I mean, seeing that, of course, the margin that we have in our partnership with Pfizer is extremely good. I mean, we're close to 100% giving both months in share. But the fact that we have Pfizer, so that's, that's outstanding. And certainly not normal.

Yifeng Liu: Yes, because I think the launches, predominantly, we see sort of in oncology space. And yeah, just the question on margin progression. Thank you.

Jens Holstein: Maybe I'll start. It's awfully difficult, actually, to understand you. You're fading away somewhat. But I mean, we're seeing that, of course, the margin that we have in our partnership with Pfizer is extremely good. I mean, we're close to 100%, given the gross margin share structure that we have with Pfizer. So, that's outstanding and certainly not normal. In terms of oncology, going forward, we would expect that we see similar sorts of margins as you see in--with other companies. I think in looking forward in terms of in-line medicine, I think we've got to wait a little bit on how we can--when we can make some statements in terms of the margin but we're working very hard. I can assure you, we're working very hard to bring the costs down for in-line medicine candidates.

Jens Holstein: In terms of oncology, going forward, you know, we would expect that we see similar sorts of margins. As you see, in, you know, with other companies, I think, in looking forward in terms of invalid medicine, I think we've got to wait a little bit on how we can, when we can make some statements in terms of the margin, but we're working very hard, I can assure you, we're working very hard to bring the costs down for In Life Matters.

Ryan Richardson: Yeah. I would just add one point to that. So, in addition to what Jens just said about oncology, I think we're still expecting, of course, that our COVID business is going to still be--for the next couple of years--still a driver of our overall margins. And I think there we've got--as we've pointed out in the past--a very attractive economic model vis-à-vis our partner, Pfizer, that we think will allow us to keep our overall operating profile quite attractive. Thank you.

Jens Holstein: EW, our partner Pfizer, that we think will allow us to keep our overall operating profile quite attractive. Thank you. We will now take the next question. From the National Agenda, from Jeffrey, please go ahead. Hi, this is actually Akash.

EW, our partner Pfizer, that we think will allow us to keep our overall operating profile quite attractive.

Yifeng Liu: Thank you.

Thank you. We will now take the next question from the line of Manoj Eradath from Jefferies. Please go ahead. Hi, this is actually Akash.

Operator: Thank you. We will now take the next question from the line of Manoj Eradath from Jefferies. Please go ahead.

Akash Tewari: Hi, this is actually Akash. So, you recently top-lined data from your 111 trial in the cutaneous melanoma. Our analysis suggests that combo arm would have a 24% delta versus roughly the 11% historical control rate for if you're PD-1. Is that the ballpark way to think about the ORR delta in this study? And what would you have to see on PFS and OS to justify moving this forward into a Phase III? And maybe just stepping back, what does this trial teach the BioNTech team about the ideal place for a cancer vaccine? I feel like one of the lessons from your early iNeST data was that cancer vaccines were perhaps not well-suited for patients with metastatic late-stage disease and yet these patients were PD-1 refractory. So, how should we interpret that? Thank you.

Akash Tewari: So you recently presented data from your 1.1.1 trial in instantaneous melanoma. Our analysis suggests the combo arm would have a 24% delta versus roughly the 11% historical control rate for if you're PD-1. Is that the ballpark way to think about the ORR delta in this study?

Ozlem Tureci: And what would you have to see on PFS and OS to justify moving this forward into phase three? And maybe just stepping back, what does this trial teach the BioNTech team about the ideal place for a cancer vaccine? I feel like one of the lessons from your early INUS data was that cancer vaccines were perhaps not well-suited for patients with metastatic late-stage disease, and yet these patients were PD-1 refractory. So, you know, how should we interpret that?

Ugur Sahin: Okay, thank you. It's a great question. So, the personalized cancer vaccines have a manufacturing turnaround time in the range of six to eight weeks. And therefore, in the metastatic setting, this type of vaccines are difficult to provide a clinical benefit since these patients rapidly progress. So, the statement refers to the personalized vaccines. With regard to FIXVAC, we have seen that FIXVAC has two activities on the one side--the direct activity due to the adjuvant function, we are seeing a type 1 interferon response and have seen now in a number of indications, not only in melanoma but also in lung cancer, objective responses in patients with advanced cancer. And we expect that the combination, particularly with the treatment that is able to control the disease for a certain time--and we are particularly interested here in our ADC/mRNA vaccine combination, we will see a number of trials coming up in 2025 for this. Would be an exciting opportunity for FIXVAC approach. And maybe for the other part, I'll give it to Özlem.

Ozlem Tureci: So, the personalized cancer vaccines have a manufacturing turnaround time in the range of six to eight weeks. And therefore, in the metastatic setting, this type of vaccines are difficult to provide a clinical benefit since these patients rapidly progress, so the statement refers to the personalized vaccine. With regard to FIXVAC, we have seen that FIXVAC has two activities on the one side, the direct activity due to the affluence function, we are seeing a type 1 intracranial response and have seen now in a number of indications, not only in melanoma, but also in lung cancer, objective responses in patients with advanced cancer and we expect that the combination, particularly with the treatment that is able to control the disease for a certain time and we are particularly interested here in our ABC mRNA vaccine combination, we will see a number of trials coming up in 2025 for this, would be an exciting opportunity for FIXVAC, and maybe for the other part I take it to a stand.

Ugur Sahin: With regard to FIXVAC, we have seen that FIXVAC has two activities on the one side--the direct activity due to the adjuvant function, we are seeing a type 1 interferon response and have seen now in a number of indications, not only in melanoma but also in lung cancer, objective responses in patients with advanced cancer. And we expect that the combination, particularly with the treatment that is able to control the disease for a certain time--and we are particularly interested here in our ADC/mRNA vaccine combination, we will see a number of trials coming up in 2025 for this. Would be an exciting opportunity for FIXVAC approach. And maybe for the other part, I'll give it to Özlem.

Özlem Türeci: Yes. Your question regarding BNT111 was about the clinical benefit which we would like to see as compared to standard of care. I cannot preempt our disclosure, which will come when we have mature data. But what I can say is, as you know, standard of care objective response rate for this patient population is around 10%-ish. So, what we would like to see is something well above that and this is also what our data shows us. We also want to see duration of response and also this looks clinically meaningful in the current data set which we have. And then, it's obviously also about safety and what we see is that BNT111 as a FIXVAC based on RNA lipoplex technology has a very manageable safety profile and in combination with CEMIPLIMAB, we don't see anything which is surprising. So, there is no additive toxicity also, which for us means that the clinical profile looks very promising for this patient population.

Ozlem Tureci: We also want to see duration of response, and this also looks clinically meaningful in the current data set which we have. And then it's obviously also about safety, and what we see is that BNP111 as a six-pack based on RNA lipoplex technology has a very manageable safety profile, and in combination with the senescing map, we don't see anything that is surprising. So there is also no additive toxicity, which for us means that the clinical profile looks very promising for this patient.

Özlem Türeci: We also want to see duration of response and also this looks clinically meaningful in the current data set which we have. And then, it's obviously also about safety and what we see is that BNT111 as a FIXVAC based on RNA lipoplex technology has a very manageable safety profile and in combination with CEMIPLIMAB, we don't see anything which is surprising. So, there is no additive toxicity also, which for us means that the clinical profile looks very promising for this patient population.

Jessica Fye: Thank you. We will now take the next question from the line of Jessica Fye from J.P. Morgan Chase. Please go ahead. Hey guys, good morning.

Operator: Thank you. We will now take the next question from the line of Jessica Fye from J.P. Morgan Chase. Please go ahead.

Hey guys, good morning. Thanks for taking my question. It looks like the BioNTech topline guidance reflects a different expectation for 2024 COMIRNATY sales than what Pfizer's guidance would imply. What gives you confidence in achieving this result? And to the extent that part of the delta is driven by German pandemic preparedness contract, which I believe falls outside the collaboration, can you quantify what that is contributing to the guidance? Thank you. Yeah, let me sort of explain maybe why I want to jump in.

Jessica Fye: Hey guys, good morning. Thanks for taking my question. It looks like the BioNTech topline guidance reflects a different expectation for 2024 COMIRNATY sales than what Pfizer's guidance would imply. What gives you confidence in achieving this result? And to the extent that part of the delta is driven by German pandemic preparedness contract, which I believe falls outside the collaboration, can you quantify what that is contributing to the guidance? Thank you.

Jens Holstein: Thanks for taking my question. It looks like the BioNTech top line guidance reflects a different expectation for 2024 comorbidity sales than what Pfizer's guidance would imply. What gives you confidence in achieving this result? And to the extent that part of the Delta is driven by a German pandemic preparedness contract, which I believe falls outside the collaboration, can you quantify what that is contributing to the guidance? Yeah, let me sort of explain maybe why I want to jump in.

Jens Holstein: Yeah. Let me start and maybe Ryan would want to jump in. So, I think we are very much aligned with Pfizer in terms of COMIRNATY expectations. We should keep in mind that Pfizer has reiterated its guidance, we did the same today. You should be aware that in taking into account that we have a contract together with the European Union, they have approval in the UK. So, I think for Europe, this gives us some comfort in terms of how the full year should look like. Of course, there's always some insecurity in that respect but in that sense, we feel good about it. And in terms of the pandemic preparedness contract, we have confidentiality with the German government so, we're a bit limited in really stating here some numbers. But you should expect that there is a significant amount of money being part of what we have reported in the first half. So, it's reported outside of COMIRNATY if you look into the documents--€120 million. So, a big chunk of that in the first half comes from that pandemic preparedness contract. Thank you.

Jens Holstein: So I think we are very much aligned with Pfizer in terms of, you know, we should keep in mind that Pfizer has reiterated its guidance. We did the same today. You should be aware that, taking into account that we have a contract together with the European Union, they have approval in the UK, so I think for Europe, this gives us some comfort in terms of how the full year should look. Of course, there's always some insecurity in that respect, but, you know, in that sense, we feel good about it.

Jens Holstein: In terms of the pandemic preparedness contract, you know, we have confidentiality with the German government, so we're a bit limited in really stating some numbers here. But, you know, you should expect that there is a significant amount of money being part of what you have reported in the first half. So it's reported outside of Khamenei, and if you look into the documents, 120 million. So a big chunk of that in the first half comes from that pandemic.

Jens Holstein: And in terms of the pandemic preparedness contract, we have confidentiality with the German government so, we're a bit limited in really stating here some numbers. But you should expect that there is a significant amount of money being part of what we have reported in the first half. So, it's reported outside of COMIRNATY if you look into the documents--€120 million. So, a big chunk of that in the first half comes from that pandemic preparedness contract.

Jessica Fye: Thank you.

Operator: Thank you. We will now take the next question from the line from Cory Kasimov from Evercore ISI. Please go ahead.

Cory Kasimov: Hi, thanks for taking the question. So, regarding the upcoming data at ESMO for BNT327 and EGFR-mutated non-small cell lung cancer, there's obviously been a lot of attention of late on the competitive PD-1 VEG-F bispecific that's out there. I'm curious, based on what you know about that compound and the data presented to date, how similar or different do you expect your approach to be and how confident are you in having competitive data in this population? Thank you. Yeah, thank you for the question. I can keep it short.

Ugur Sahin: Yeah, thank you for the question. I can keep it short. I think the data that we are going to present will be competitive. And as you know, the asset BNT327 is now a molecule that is currently in evaluation for multiple indications at BioNTech and our collaboration partner, Biotheus. And we will see additional studies to be announced end of this year, beginning of next year.

Ozlem Tureci: I think the data that we are going to present will be competitive. And as you know, the acid BNT-327 is now a molecule that is currently in evaluation for multiple indications at BioNTech and in our collaboration with BioNTech, and we will see additional studies to be announced at the end of this year. Okay, thank you. Thank you. We will now take the next question. From the line of Chris Shibutani from Goldman Sachs, please go ahead.

I think the data that we are going to present will be competitive. And as you know, the acid BNT-327 is now a molecule that is currently in evaluation for multiple indications at BioNTech and in our collaboration with BioNTech, and we will see additional studies to be announced at the end of this year.

Okay, thank you. Thank you. We will now take the next question. From the line of Chris Shibutani from Goldman Sachs, please go ahead.

Cory Kasimov: Okay, thank you.

Operator: Thank you. We will now take the next question from the line of Chris Shibutani from Goldman Sachs. Please go ahead.

Chris Shibutani: Yes, thank you. If I could just follow up on the BNT327. Noting from slide 10, it appears from the change in your pipeline plan, are some additional trials there--which seems to signal that BioNTech is quite enthusiastic in that regard. I think it would be helpful, the investor community was certainly attentive during ASCO, to understand how your approach may differ from that of a competitor, Summit Therapeutics. And in particular, can I ask you, are you looking to do any head-to-head trial involving KEYTRUDA? How are you thinking about sort of clinical development strategy that we can understand to be differentiated? Thank you.

Ozlem Tureci: How are you thinking about some sort of clinical development strategy that we can understand to be differentiated? Thank you. Thank you for this question, Chris. We cannot comment on the strategy of others, but what we can say is that we think that BNT-327 and this concept are highly compelling and qualify as an I.O. backbone for various combinations.

How are you thinking about some sort of clinical development strategy that we can understand to be differentiated? Thank you.

Özlem Türeci: Thank you for this question, Chris. We cannot comment on the strategy of others but what we can say is that we think that BNT327 and this concept is highly compelling and qualifies as a IO backbone for various combinations. And our approach here is to be broad with regard to the indications, which we will pursue also in potentially registrational trials. We are well-prepared for that because our partner, Biotheus, has already a broad, multi-indication program ongoing with a number of signal-seeking cohorts in various indications with various standards of care regimens. So, that we have a wealth of data already and can pick the indications and expand them as they mature. And another dimension of diversification is that we see BNT327 as a backbone for many of our pipeline assets, our wholly-owned ones, but also those we have partnered because it has such a permissive, synergistic, strong prone mode of action.

Ozlem Tureci: And our approach here is to be broad with regard to the indications, which we will pursue also in potentially registrational trials. We are well-prepared for that because our partner, BioFields, has already begun a multi-indication program ongoing with a number of signal-seeking cohorts in various indications with various standards of care regimens, so that we have a wealth of data already and can pick the indications and expand them as they mature. And another dimension of diversification is that we see BNT-327 as a backbone for many of our pipeline assets, our wholly owned ones, but also those we have partnered with, because it has such a permissive, synergistic, strong mode of access.

Özlem Türeci: We are well-prepared for that because our partner, Biotheus, has already a broad, multi-indication program ongoing with a number of signal-seeking cohorts in various indications with various standards of care regimens. So, that we have a wealth of data already and can pick the indications and expand them as they mature. And another dimension of diversification is that we see BNT327 as a backbone for many of our pipeline assets, our wholly-owned ones, but also those we have partnered because it has such a permissive, synergistic, strong prone mode of action.

Ugur Sahin: Yeah. And regarding PEMBRO--we are seeing, of course, data from now, a number of invitations coming in and continuing to mature. And we have seen for data for which, for example, historical benchmark data are available--for example, for negative breast cancer. And the extent of clinical benefit that we are observing BNT327 is really encouraging. And for any indication in which PEMBRO is approved as a backbone, our plan would be of course, to compare efficacy of BNT327 plus X against the counterpart standard of care PEMBRO, we would compare it against PEMBRO.

Terence Flynn: Thank you. Thank you. We will now take the next question. From the line of Terence Flynn from Morgan Stanley, please go ahead. Hi, thanks for taking our questions. This is Chris on behalf of Terence.

Chris Shibutani: Thank you.

Thank you. We will now take the next question from the line of Terence Flynn from Morgan Stanley. Please go ahead. Hi, thanks for taking our questions. This is Chris on behalf of Terence.

Operator: Thank you. We will now take the next question from the line of Terence Flynn from Morgan Stanley. Please go ahead.

Hi, thanks for taking our questions. This is Chris on behalf of Terence. We have a two-part question on BNT122 in colorectal cancer. You will guide data by the end of 2025 or early 2026. But is there potential for an interim analysis that would allow you to look at the data earlier? And then second, what would you and your partner, Roche, need to see in this trial in order to advance it into phase three? Thank you. Yeah, we have, we have, we have linked it to a potential analysis at the end of 2025.

Unknown: Hi, thanks for taking our questions. This is Chris, on for Terence. We have a two-part question on BNT122 in colorectal cancer. You guided data by the end of 2025 or early 2026 but is there potential for an interim analysis that would allow you to look at the data earlier? And then second, what would you and your partner, Roche, need to see in this trial in order to advance it into Phase III? Thank you.

Ozlem Tureci: We have a two-part question on BNT122 in colorectal cancer. You will guide data by the end of 2025 or early 2026. But is there potential for an interim analysis that would allow you to look at the data earlier? And then second, what would you and your partner, Roche, need to see in this trial in order to advance it into phase three? Thank you. Yeah, we have, we have, we have linked it to a potential analysis at the end of 2025.

Ugur Sahin: Yeah. We have hinted toward a potential analysis at the end of 2025. As you know, the study's endpoint is disease-free survival in this indication. And the general principle that we expect from individual cancer vaccines is that metastatic tumor cells, which are present after surgery, could be removed by inducing a T cell response. The indication that we have chosen is a ctDNA-positive indication--that means based on published data, we know that this patient population who are ctDNA-positive after surgery with a stage 2, stage 3 colorectal cancer have a PFS in the range of 10 to 12 months. And after chemotherapy, the PFS is more around--median PFS is more around six to eight months. So, that means at that time point, we would expect that at least part of the data would be mature. And then, based on the results, we--it will depend how the results are and whether additional studies would be required at that time point or whether the data would be sufficient to continue and request potential regulatory approval steps. Great. Thank you. Thank you. We will now take the next question. On the line from Simon Baker from Redbird Atlantic, please go ahead.

Ozlem Tureci: As you know, the study's endpoint is disease-free survival in this indication. And the general, general principle that we expect from immunized cancer vaccines is that metastatic tumor cells, which are, which are present after surgery, could be removed by, by, by inducing a T-cell. The indication that we have chosen is a ctDNA-positive indication, which means based on published data, we know that this patient population, patient populations who are ctDNA-positive after surgery for 3, 6 weeks, color And after chemotherapy, the median PSS is around 6 to 8 months.

Ugur Sahin: And after chemotherapy, the PFS is more around--median PFS is more around six to eight months. So, that means at that time point, we would expect that at least part of the data would be mature. And then, based on the results, we--it will depend how the results are and whether additional studies would be required at that time point or whether the data would be sufficient to continue and request potential regulatory approval steps.

Ozlem Tureci: So that means at that time point, we would expect that at least part of the data would be mature. And then, based on the results, we can tell how the results are and whether additional studies would be required at that time point, or whether the data would be sufficient to continue and request potential regulatory approval. Great, thank you. Thank you. We will now take the next question. On the line from Simon Baker from Redbird Atlantic, please go ahead.

Ugur Sahin: Great. Thank you. Thank you. We will now take the next question. On the line from Simon Baker from Redbird Atlantic, please go ahead.

Unknown: Great. Thank you.

Operator: Thank you. We will now take the next question from the line of Simon Baker from Redbird Atlantic. Please go ahead.

Simon Baker: Thank you for taking my question. And it's a question on iNeST capacity. I wonder if you could give us an idea of the capacity the <ainz facility will give you in 2027. And also, you mentioned the ability to reduce the bottlenecks in vein-to-vein time. I wonder if you could give us an idea of where they stand and where they could currently go to. And just related to this, based on your comments on 122, is it right to assume that completion of that facility is--rather 122 approval--is not contingent on completion of that facility? Thanks very much.

Simon Baker: And just related to this, based on your comments on 1.22, is it right to assume that completion of that facility, rather than 1.22 being approved, is not contingent on completion of that facility? Thanks very much. Yeah, so at the moment we can't comment on the capacity of the facility that is being built because we are still in the process of further process improvements increasing the overall capacity, so reliable numbers will be available at the end of 2025 for the capacity, but the facility has been built with the idea that it could act as a private facility if one of the personalized vaccine products is approved at that time.

And just related to this, based on your comments on 1.22, is it right to assume that completion of that facility, rather than 1.22 being approved, is not contingent on completion of that facility? Thanks very much.

Ugur Sahin: Yeah. So, at the moment, we can't comment on the capacity of the facility that is being built because we are still in process--further process improvements, increasing the overall capacity so, reliable numbers will be available end of 2025 for the capacity but the facility has been built with the idea that it could act as a private facility if one of the personalized vaccine products is approved at that time. So, this is ongoing work and parallel for building this facility--which is intended to act as a potential private facility--we are expanding currently our clinical trial capacity to ensure that we can start additional trials in 2025 and later on.

Simon Baker: So this is ongoing work and parallel to building this facility, which is intended to act as a potential private facility; we are currently expanding our clinical trial capacity to ensure that we can start additional trials in 2025 and later on. And then, I think it was Simon, you asked about BioNTech in terms of VaynerVaynerCotton. Yes.

So this is ongoing work and parallel to building this facility, which is intended to act as a potential private facility; we are currently expanding our clinical trial capacity to ensure that we can start additional trials in 2025 and later on.

And then, I think as--Simon, you asked about bottleneck in terms of vein-to-vein time. Yes, please.

Ryan Richardson: And then, I think as--Simon, you asked about bottleneck in terms of vein-to-vein time.

Simon Baker: Yes,.

Ugur Sahin: Bottlenecks, yeah. So this is, of course, a completely new process, manufacturing a vaccine in real time. And you can imagine that every step must be validated so this is, we are--we have established personalized manufacturing of mRNA vaccines for the first time in 2014. Since then, we have been through two additional innovation cycles. We have recently implemented additional change in their manufacturing, further reducing turnaround time. But still, manufacturing release of such a vaccine comes with multiple release tests for the individual batches. So, we are working on making this test more robust, reducing the cost and this will become more or less also the value driver of this approach--being able to reduce the cost substantially and thereby allowing that this is an affordable approach, both be available for a large population of patients. Thanks so much. Thank you. We will now take the next question. On the line from Eliana Merle from UBS, please go ahead.

Ugur Sahin: Bottlenecks, yeah. So this is, of course, a completely new process, manufacturing a vaccine in real time. And you can imagine that every step must be validated so this is, we are--we have established personalized manufacturing of mRNA vaccines for the first time in 2014. Since then, we have been through two additional innovation cycles. We have recently implemented additional change in their manufacturing, further reducing turnaround time. But still, manufacturing release of such a vaccine comes with multiple release tests for the individual batches. So, we are working on making this test more robust, reducing the cost and this will become more or less also the value driver of this approach--being able to reduce the cost substantially and thereby, allowing that this is an affordable approach, [inaudible] available for a large population of patients.

Ugur Sahin: We have recently implemented additional change in their manufacturing, further reducing turnaround time. But still, manufacturing release of such a vaccine comes with multiple release tests for the individual batches. So, we are working on making this test more robust, reducing the cost and this will become more or less also the value driver of this approach--being able to reduce the cost substantially and thereby, allowing that this is an affordable approach, [inaudible] available for a large population of patients.

Ugur Sahin: Thanks so much. Thank you. We will now take the next question. On the line from Eliana Merle from UBS, please go ahead.

Simon Baker: Thanks so much.

Operator: Thank you. We will now take the next question from the line of Eliana Merle from UBS. Please go ahead.

Ugur Sahin: We have recently implemented additional changes in their manufacturing so that it will continue to run. But still, manufacturing the use of such a vaccine comes with multiple release tests for the individual vaccine. So we are working on making this test more robust, reducing the cost, and this will become more or less also the value driver of Thank you very much. We will now take the next question. On the line from Eliana Merle from UBS, please go ahead.

Eliana Merle: Hi, guys. Thanks so much for taking the question. Your slides mentioned starting the first novel combo trials in oncology this year--I guess just a strategic question in terms of your oncology combination strategy. Given the breadth of your portfolio, I guess, what are the programs that you are most excited about or prioritizing for a combination? Thanks.

Ozlem Tureci: We are--thank you for the question, Eliana. We are, in principle, very excited about the IO/ADC combination concept because we expect--and also, our preclinical data supports that this is highly synergistic. And as you pointed out, we have started our first trial, which is the first of a series you will see where we use BNT327 as IO backbone--which in the first trial is combined with our top two ADCs from our partnership with Duality in multiple solid cancers. And this will be extended to additional ADCs from our pipeline to be combined with BNT327. We are also very excited about a combination which is ongoing for quite some time, namely one of our priority assets, BNT211--which is our CLAUDIN 6 CAR-T cells--in combination with our vaccine which is designed, in this case, in a way that it specifically acts on the adaptively transferred CAR-T cells. And our data, which shows that the vaccine in fact adds to the persistence and duration of the adaptively transferred CAR-T cells is getting stronger and stronger with data maturing. Thank you. Thank you. We will now take the next question. From the line of John Newman from Kanakor, Generalty, please go ahead.

Özlem Türeci: We are--thank you for the question, Eliana. We are, in principle, very excited about the IO/ADC combination concept because we expect--and also, our preclinical data supports that this is highly synergistic. And as you pointed out, we have started our first trial, which is the first of a series you will see where we use BNT327 as IO backbone--which in the first trial is combined with our top two ADCs from our partnership with Duality in multiple solid cancers. And this will be extended to additional ADCs from our pipeline to be combined with BNT327. We are also very excited about a combination which is ongoing for quite some time, namely one of our priority assets, BNT211--which is our CLAUDIN 6 CAR-T cells--in combination with our vaccine which is designed, in this case, in a way that it specifically acts on the adaptively transferred CAR-T cells. And our data, which shows that the vaccine in fact adds to the persistence and duration of the adaptively transferred CAR-T cells, is getting stronger and stronger with data maturing.

Ozlem Tureci: We are also very excited about a combination which has been ongoing for quite some time, namely one of our priority assets, BNT-211, which is our clotting fixed CAR T cells, in combination with our vaccine, which is designed in this case in a way that it specifically acts on the adoptively transferred CAR T cells, and our data, which shows that the vaccine in fact adds to the persistence and duration of the adoptively transferred CAR T cells Thank you. Thank you. We will now take the next question. From the line of John Newman from Kanakor, Generalty, please go ahead.

Özlem Türeci: We are also very excited about a combination which is ongoing for quite some time, namely one of our priority assets, BNT211--which is our CLAUDIN 6 CAR-T cells--in combination with our vaccine which is designed, in this case, in a way that it specifically acts on the adaptively transferred CAR-T cells. And our data, which shows that the vaccine in fact adds to the persistence and duration of the adaptively transferred CAR-T cells, is getting stronger and stronger with data maturing.

Thank you. Thank you. We will now take the next question. From the line of John Newman from Kanakor, Generalty, please go ahead.

Eliana Merle: Thank you.

Operator: Thank you. We will now take the next question from the line of John Newman from Canaccord Genuity. Please go ahead.

John Newman: Hi there, thanks very much for taking my question. You're obviously in the midst of very active development for BNT327. I'm wondering, specifically for the trials where you're combining with BNT325 your TROP2 ADC, do you see the potential down the road for accelerated approval in some of those indications? Thank you. I think it is too early to say.

Ugur Sahin: I think this is too early to say.

Ozlem Tureci: Okay, thanks. Thank you. We will now take the next question. On the line from Manos Mastarakis from Deutsche Bank, please go ahead. Hello, thank you for taking my question. Again, on BNT, who's concerned? Just wanted to understand how you're thinking about the clinical trial design. Are you hoping or aiming to study, namely PD-L1 positive populations, or for you, gene tools? Keep that open and see what the data looks like after the chart.

John Newman: Okay, thanks.

Thank you. We will now take the next question. On the line from Manos Mastarakis from Deutsche Bank, please go ahead. Hello, thank you for taking my question. Again, on BNT, who's concerned? Just wanted to understand how you're thinking about the clinical trial design. Are you hoping or aiming to study, namely PD-L1 positive populations, or for you, gene tools? Keep that open and see what the data looks like after the chart.

Operator: Thank you. We will now take the next question from the line of Manos Mastorakis from Deutsche Bank. Please go ahead.

Manos Mastorakis: Hello, thank you for taking my question. Again, on BNT327, just wanted to understand how you're thinking about the clinical trial design. Are you hoping or aiming to study, namely, PD-L1 positive populations or are you keen to keep that open and see what the data looks like after the trial? Thank you.

Ozlem Tureci: Thank you. You see, see, this is a great question. Let me share our views. So the introduction of anti-PD treatment, PD-1 treatment, led to the division of patient populations into 3L1 high, 3L1 low, and 3L1 negative, and the exciting observation that we have made now in two indications is that the combination of chemotherapy plus institutional settings appears to be effective, in a highly clinically meaningful manner, also in the PGL-1 negative.

Thank you.

Ugur Sahin: Yes. See, this is a great question. Let me share our view. So, the introduction of anti-PD-1 treatment led to the division of patient populations into PD-L1 high, PD-L1 low and PD-L1 negative population. And the exciting observation that we've made now, in two indications, is that the combination of chemotherapy plus BNT327, appears to be effective in a highly clinically meaningful manner also in the PD-L1 negative population. And this really provides a great opportunity. So, we believe that BNT327 is not only something which could be better than existing PD-1 treatment but you see the chance that we overcome the current classification of the patients into PD-L1 negative and PD-L1 positive patient population. This is exciting. And by this, of course, the patient populations will dramatically increase and clinical trials could be done in a much easier way and standard of care could become easier and manageable based on treatment combinations that are independent of PD-L1 staining.

Manos Mastarakis: And this really provides a great opportunity, so we believe that the Interpreter-7 is not only something which could be better than the existing Van Krippen, but you see the chance that we overcome the current classification of the patients into PBR1 negative and PBR1 positive. Thank you for watching. And by this, of course, patient populations will dramatically increase, and clinical trials could be done in a much easier way, and standard of care could become easier and manageable based on treatment combinations that are independent of PDR-1 stain.

Ugur Sahin: So, we believe that BNT327 is not only something which could be better than existing PD-1 treatment but you see the chance that we overcome the current classification of the patients into PD-L1 negative and PD-L1 positive patient population. This is exciting. And by this, of course, the patient populations will dramatically increase and clinical trials could be done in a much easier way and standard of care could become easier and manageable based on treatment combinations that are independent of PD-L1 staining.

Ugur Sahin: Thank you. If that's all the time we have for questions today, I would like to hand back over to the speaker. Yes, thank you very much for joining us today. This concludes today's conference call. Thank you for participating. You may now disconnect. Go to pamusgab.org and sign up for the account.

Manos Mastorakis: Thank you.

Thank you. This is all the time we have for questions today. I would like to hand back over to the speaker. Yes, thank you very much for joining us today. This concludes today's conference call. Thank you for participating. You may now disconnect. Go to pamusgab.org and sign up for the account.

Operator: Thank you. This is all the time we have for questions today. I would like to hand back over to the speaker.

Yes, thank you very much for joining us today. This concludes today's conference call. Thank you for participating. You may now disconnect.

Ryan Richardson: Yes, thank you very much for joining us today.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

Welcome to biotech second quarter 'twenty to 'twenty four earnings call I would like to hand, the call over to Doctor, Victoria, Meisner, Vice President of strategy and Investor Relations. Please go ahead.

Speaker Change: Thank you good morning, and good afternoon. Thank.

Speaker Change: Thank you for joining <unk> second quarter 2024 earnings call.

As a reminder.

The slides, we will be using during this call and the corresponding press release, we issued this morning.

Can be found in the Investor Relations section of our website.

On the next slide you will see our forward looking statements disclaimer.

Additional information about these statements and other risks are described in our filings with the U S Securities and Exchange Commission.

Forward looking statements in this call are subject to predict or control and uncertainties and speak only as of the date of the conference call.

We undertake no obligation to update or revise any of these statements.

On slide three you can find the agenda for today's call.

Speaker Change: Today I'm joined by the following members of <unk> management team.

Well of course talking.

Executive Officer and co founder.

That's interesting.

Chief Medical Officer and co founder.

Yeah, our Stein Chief Financial Officer.

Speaker Change: And Ryan Richardson Chief strategy Officer.

With that I would like to hand over to her.

Thank you Victoria and bomb that come through our doors joining us today.

I will start with an overview of the quarters highlights.

Focus on <unk>, our late stage oncology portfolio.

They're starting to talk about some of our recent oncology pipeline advancement in more detail.

Yes in line with them to provide an update.

And corporate Okay and the other.

Outlook for the remainder of the year.

Slide five.

Second part of 2024 was marked by significant execution across our oncology pipeline and our.

Speaker Change: Our leading COVID-19 franchise.

Our progress in the quarter that sets up for impactful end of 'twenty 'twenty four as we continue to progress towards our long term vision.

I'd like to highlight achievements.

Yes.

With regards to our COVID-19 vaccine industrial.

On the back of the Cascade unit, two but we have initiated the launch of our new value.

And expect additional improvement in the coming weeks and months.

Second in oncology.

Yep.

Update.

<unk> medical meeting that highlighted our clinical execution and pipeline progress.

Provided data on several of our assets across modalities.

I can't really discuss come off these updates in more detail, but I would like to highlight two of those specifically.

Last week, we announced that our off the shelf kicks back in.

<unk> for melanoma.

BNP band 11 met the primary endpoint in the ongoing randomized phase two trial.

It can be an 11 in combination with <unk>.

Patients with stage, three and page four of the Chinese melanoma.

This preliminary side is a significant milestone for our company.

And thats crossed our belief and the transformative potential new class of medicine.

Our <unk> technology.

He is a key pillar of our oncology strategy.

We have exciting news also with regard to another key pillar of our oncology strategy and you need the development up Noah.

ADC combination.

This quarter, we started the process of some of the prepared to reprice, our combination therapy strategy.

Evaluates the combination of our anti PDL, one VEGF bispecific antibody P&C, two seven and our trop two ADC <unk> two part.

We look forward to the initiating additional trials.

Speaker Change: ADC combination.

Over the next 12 months.

The third area in which we made progress with our ambition to what's the creation of sustainable and resilient.

Speaker Change: <unk> seen ecosystem in Africa by expanding our partnership with Ctrip.

GP is committed up to 145 million U S dollar to support us to establish amounted in clinical and commercial scale manufacturing capabilities.

Speaker Change: Our facility in <unk>.

This capability.

To better payout for potential future.

And then perhaps in Africa in alignment with our corporate Capex ensure equitable access to our medicines.

That six starting with our COVID-19 franchise.

We continue circulation of task of leaks.

At least to the ongoing evolution and emergence of nowhere values of Arris, which we continue to monitor.

That yield a basis potential and be overlap.

In September 2022, the <unk> gradually and that dominated globally throughout 2023 with multiple injuries.

Speaker Change: Access will be address by SBB when price value adaptive COVID-19 vaccine, including our own.

This year, Jan one clinics, including Cambridge, II became the predominant examine globally, leading to the current batch and infections in many regions in the northern hemisphere shown on the right Scott.

Effectiveness data demonstrated the antigenic <expletive>.

Speaker Change: And the distance.

Finally in Egypt.

SBB Eventbrite has impacted the vaccine effectiveness of the X B B, one five adapted vaccine against them now prevalent Jan brand images.

Slide seven.

Speaker Change: Based on these and additional data regulatory and public health authorities', Consequently advice vaccine manufacturer to revise the formulation for their authorized COVID-19 vaccines, the WH or in the EMA recommended the use of J M lineage ambiguous.

Anti vaccine for the Stifel 2020 for 2025.

70, <unk> EBIT.

Vacation to the European regulator.

Just on this recommendation and the perfect for EMA approval on July <unk>.

Speaker Change: We have begun rolling out our updated come Ngati <unk> one vaccine in Europe.

In the United States. The FDA further recommended the use of <unk> as the preferred James bond limits antigen for the 'twenty 'twenty four 'twenty 25, COVID-19 mrna vaccines on June 30.

Speaker Change: Less than two weeks later, we initiated our rolling submission with the U S.

S FDA.

We and our partner Pfizer blocking Hudson.

The inability of very adaptive exits of people have asked about.

Aim of reducing of preventing CMV, ADC hospitalization and COVID-19 related.

We expect the FDA approval of our cubic to adaptive vaccine by mid September and be able to deliver the plastics in order for the people in the United States. Shortly thereafter.

Slide eight.

The other area I'm highly excited about is the progress on our oncology pipeline.

Before I hand over to ask them to deep dive into the recent achievement.

And your overarching oncology strategy.

I'm on a cancer immunotherapy.

Our starting point can be funded by <unk>.

And daily mail, the centerpiece ever since we have been pursuing a technology agnostic approach.

Not limiting our SaaS to any one technology.

Over the past two years, we added tax bonds to compliment them on the centerpiece.

Today, we have been on quantity will kit featuring multiple modalities, including targeted therapies, such as ACC and immuno modulator.

That opened up new combination opportunity.

Synergistic.

Mechanisms of action.

Having this diversity of assets in our pipeline.

EBIT.

Speaker Change: To pursue combination approaches.

Our property, Italy and unique.

This strategic advantage allows us to evaluate the activity of each individual component and to determine dose patient population for which monotherapy or synergistic combination.

Got it.

We believe that our strategy has the potential to address fundamental challenges of cancer and to drive meaningful improvement.

Survival rates for patients.

And as you will hear from the last quarter has been about executing towards this mission.

Before I hand over that to thank you all for your ongoing support.

We entered the truly extract intelligence for biotech and our progress.

Founding vision.

Speaker Change: Thank you we'll go to speaking with everyone.

Our multi protocol geology clinical pipeline is continuing to grow and to progress and it was a rich let's cover a rationally planned novel novel combinations that we constantly are key to our strategy as you can see two off along with other key namely mrna.

Lunar module.

Our dominant theory presented in our pipeline and particularly the Windsor advanced clinical stage.

Today I want to focus on priority assets within these modalities, which has our attention.

Mrna vaccines, one of <unk> TMT frequency.

Before I cover these assets, let me just mention that the rich clinical pipeline and ambitious plan recliner execution capability, which we are continuously.

As you can see on the slide we are accelerating the pace of pipeline wide patient accruals compared to last quarter compared to 2022, we enter a network partner.

Our recruiting six times as many patients per quarter to support enrollment into the clinical trials.

On the previous slide this increase is a testament of our drive towards more and larger mid to late stage trials are part of our ambition to achieve multiple product launches in oncology by the year 2013. It also underlines the success of our partnership.

G, which not only gives us access to compounds, but constantly growing pie.

Klein, but enables us to leverage additional clinical trial execution capacity and Knowhow and geographic reach.

Now to a central piece of our oncology portfolio.

Any cancer vaccine platform.

And hips, Zac, which defines the type of tumor targets.

Target Neo antigens derived from genetic mutations in cancer.

Unique to an individual tumor.

16, a menu.

<unk> and personalized to each individual patient <unk> targets multiple non mutated antigens shared by a majority of patients with a given tumor type and off the shelf.

The computational approaches to discover and connect these two different types of targets and to turn one of our core competency.

Speaker Change: IMAX and <unk>, both use the same technology, namely our proprietary <unk> platform.

Today, we have ongoing trials in multiple disease settings, and indications across both vaccine platforms, we have reported translational and clinical data over the last couple of years and future data updates for much of the trends shown on this slide upfront.

Aggregate data that we have reported in the past across six our clients indicate that uridine mrna based vaccines have a manageable and largely Myers safety profile of <unk>.

In combination with anti PD, one PDL, one compounds and in combination with chemotherapy or data also indicates that our uridine mrna MTX based vaccines are proficient in using index funding.

Jude functional and long lived T cell responses in a majority of patients which is a prerequisite for clinical activity. Furthermore, our data from a small sample size patient cohorts indicates clinical activity alone and in combination with anti PD, one PDL one treatment.

Several of the now ongoing trial shown on this slide aim to answer the material question of what about what mrna vaccines are superior to their respective standard of care.

Except program younger arrived I would like to highlight pre vaccine candidates currently being evaluated in multiple trials.

Speaker Change: The metastatic and adjuvant settings.

First the <unk> team being well on the way interest line HPV 16 positive PDL, one positive head and neck squamous cell carcinoma.

Speaker Change: <unk> Registrational phase two randomized trial second beyond Q1, 16 being investigated in two trials are single agent and in various combinations and different non small cell lung cancer patient populations and treatment times.

And last but not least E&P 111 being investigated in anti PD, one relapsed or refractory melanoma about which I would like to talk a bit more.

PMT 111 is the European mrna RPX based vaccine that encodes for melanoma associated antigen that collectively cover more than 90% of melanoma patients and are highly immunogenic in the randomized phase two clinical trial conducted in collaboration with <unk>.

Speaker Change: Our partner Regeneron, we are evaluating the key 111 in combination with Regeneron anti PD, one components to meet the market and we measure the activity of the anti 111 alone.

Speaker Change: Okay.

In a total of 184 enrolled patients with PD, one refractory unresectable stage III stage.

Stage four melanoma.

Well noted earlier.

Very recently.

That the trial met its primary endpoint, achieving a statistically significant improvement of overall response rate and the P&G won 11 <unk> combination on this call.

Historical controls of anti PD, one monotherapy in relapsed refractory patients with <unk>.

<unk> control was based on multiple late stage clinical trials.

Catalyst.

Objective response rate for immunotherapy checkpoint inhibitor in this setting for this patient population.

Why is the data also the maturing we do see a trend towards improved overall survival.

BMT 111, or one trial. It is based on your early on disciplined Merit phase one two trial in patients with advanced melanoma, who had exhausted treatment options, but trying to establish the dose and provided initial safety efficacy and immunogenicity data on <unk>.

11, a senior agents and with checkpoint inhibitor.

And this patient population.

Proof of concept study, we observed that treatment with <unk> 111 alone or in combination with anti PD, one could induce strong high magnitude T cell responses against at least one time, it's a tumor associated antigen in all analyzed patients most of which were not to text.

Speaker Change: Prior to using the vaccine.

As shown here objective responses by PMT 111, whereas Europe with some patients followed up for several years now.

The safety profile was generally in line with expectations for those patients who were treated with checkpoint inhibitors.

The results we are seeing in the phase two BMT 111, one study are consistent with this program result, we plan to present the full data from the primary analysis at the medical conference in 2025 and entering into discussions with regulatory authority Keith.

Regarding our data and the clinical path forward for this program.

Cutaneous melanoma carries a high and continuously increasing incidence and mortality bird.

Production of checkpoint inhibitor directed therapies was a breakthrough for patients who had led to significant improvements in survival.

Nonetheless in advance disease stages, only a third of patients achieved a longtime response and long term survival. After failure of checkpoint inhibitors. There is no established standard of care with only limited then shortlist responses to salvage therapy.

New adoptive cell therapy has recently become available for this patient population, we do not expect that all patients will be eligible, leaving a significant unmet medical need and addressed.

Addressed in this context, our BMT 111 may be of interest to potentially had reached the high medical need population.

Small OTA the BMT 111 data is a proof of concept in free dimension.

Firstly, a proof of concept for our TK plant improved mrna cancer vaccine technology that uses George and <unk> chemistry.

Non coding backbone that is engineered for optimal translational performance and our proprietary <unk> formulation for systemic delivery.

Second this is a proof of concept for our computational approach towards selecting suitable tumor antigen.

Targets are cancer indication specific six program candidates.

Lastly, it's the proof of concept for our strategy to combine synergistic modalities in this case <unk> 11, with an established immune checkpoint inhibitor treatments.

Oh actually all fees also applies to BMT 122, our individualized mrna cancer immuno therapy based on our <unk> platform and the same delivery technology, we consider individualized cancer vaccines as a medical a breakthrough in addressing the high.

Unmet medical need of Resectable cancer, and an excellent a minimal residual disease treatment settings.

I want to highlight ongoing randomized phase two trials with our individualized vaccine in pancreatic ductal adenocarcinoma and in colorectal cancer.

So its highest survival rate in pancreatic ductal adenocarcinoma after resection.

It's 10% and up to 75% of patients with pancreatic ductal carcinoma, we less even though they appear to more for you within pockets after adjuvant treatment.

Speaker Change: That's a high risk stage, two or stage III colorectal cancer about 35% of patients relapsed within five years after resection and adjuvant therapy.

As discussed in the last earnings call, we demonstrated that our individualized vaccine used in patients with adjuvant pancreatic cancer can induce the novel T cell responses.

Pacific to the individual Newton tumor antigens and the risk of recurrence of cancer for patients with vaccine induced immune responses once reduced even after a three year follow up period.

At the recent ESMO GI conference, we disclosed findings from the biomarker sub study of our.

Our ongoing phase two imus prior BMT 120, 201 involving patients with stage two higher risk of stage III colorectal cancer, who remains Cte DNA positive Halloween the surgical excision of the localized tensor upon completion of standard of care excellence chemotherapy.

These patients received PMT 122, our individualized vaccine in contrast to the conventional wait and watch approach.

The subset of <unk> patients, who were assessable for Immunogenicity analysis, a high magnitude de Novo T cell response against at least one vaccine encode neo antigen was observed in all.

All patients.

T cell responses were amplified with successive explanation cycle, notably in several patients with T cell responses were sustained even after two years of follow all such patients in Boston. The Immunogenicity analysis remain disease free at the time of data cutoff and Roland for the main part.

Of the collector, Kansas study is underway to establish the safety and efficacy of <unk> in patients with <unk> positive stage, two stage III colorectal cancer.

Post to the standard wait and watch.

We anticipate presenting the results from this randomized phase two study by late 2025 26, as Mike's third phase two trials are ongoing and our clinical data on and the R&D immuno therapy continues to mature we are scaling up our manufacturing capabilities.

And capacities for bulk mrna drug supply for off the shelf <unk> vaccines and also fatwa individualized vaccine homeruns two bit out of our manufacturing capacity for personalized mrna. We are currently building a pilot facility in <unk>, Germany to support or <unk>.

Ongoing late stage trials and potentially in the future commercialization. We also continue to leverage in studies all our wholly owned AI subsidiary company to work with our teams and improving both the up and downstream processes in personalized <unk>.

R&D manufacturing.

From our mrna cancer vaccines are now moving to our immuno modular Tony I O compounds.

<unk> hundred 2007, which we consider it as a key immuno modern luxury concept and compelling backbone for novel combination BMT free 27 combines two validated mechanisms of action.

<unk> binding inhibitor of VEGF VEGF R X's blocks tumor angiogenesis, which seeks to reduce tumor proliferation and survival VEGF a inhibition also contract.

Asian after immuno suppressive tumor micro environment asked us for PD, one office by specific anti body by reworking PD, one PD one access mediated T cell exhaustion with PDL, one also and cuts despite specific anti body.

To let you love, it, but efficient and localized scavenging off fee ETF, eight which may contribute to mitigate ask Jamal on targets.

Speaker Change: Sure.

Given that both the MTBE GSA and the anti PD, one mechanisms already data across many tumor types and in some cases as a combination we have a clear roadmap ahead.

We also developed PMT free 2007.

Beyond these initial indications in which we may combine with standard of care chemotherapy, we tend to evaluate another <unk> hundred 27 combinations, the first of which restaurants. It recently.

<unk> hundred 10, seven combinations may open up new areas of activity for our anti VEGF <unk>.

Speaker Change: <unk> PDL one.

We and our partner Biofuels have treated over 600 patients across a wide range of clinical indications with the anti <unk> hundred 27.

Can I ask one of Europe's <unk> in combination with various standard of care protocols. This extensive data collection effort provides a solid foundation for making informed data driven decisions on potential indications and patient cohorts for future registration studies.

Notably the data demonstrates robust single agent activity of <unk> hundred 27 in previously untreated advanced non small cell lung cancer and higher response rates in combination with standard of care chemotherapy in triple negative breast cancer and small cell lung cancer Spa.

Specifically in first line triple negative breast cancer, we observed an objective response rate approaching 80% with durable responses spend combined with Nab paclitaxel.

Safety profile in these indications was generally well managed and in line with adverse events observed with other therapies targeting PD one.

<unk> appears to be more favorable than those seen with anti VEGF agents.

These data have driven our strategic position to initiate registration trials in small cell lung cancer, non small cell lung cancer and triple negative breast cancer. This year and next year in small cell lung cancer therapeutic options for the treatment of metastatic disease remain limited with few innovative.

Purchased Jan frontline anti PD, one checkpoint inhibitor, which only achieve response rates of around 20%.

<unk> patients, particularly those with PDL one negative two months have few treatment options as they are not as introverts will current anti PD one therapy in metastatic non small cell lung cancer, but anti PD, one inhibitors have significantly changed the treatment landscape nearly half of these <unk>.

<unk> still do not respond to frontline therapy in combination with chemotherapy.

We will soon start two global phase two dose optimization studies to EBIT.

Our registrational adults for global Registrational trials in this particular indication.

At school, we presented updated preliminary efficacy and safety data from an ongoing phase one two study in cohorts of advanced cervical cancer. That's in him resistant relapsed ovarian cancer and advanced non small cell lung cancer, we will be presenting signal finding data from additional.

<unk> indications at upcoming conferences. This wet etch to our extensive database and is the basis of our plans for further development in key indications.

Most importantly, as we go also noted it is a strategic goal for us to explore beyond Q3 2007 as part of novel novel combinations in particular with our ADC assets and.

Mrna therapies.

We have started to implement this strategy by investigating BMT free 27 in combination with our trop two ADC <unk> hundred 25.

Combinations wave Eaton loans in the coming months, we are very excited to advance this combination trials with our partner.

On my final slide I would like to provide an outlook on upcoming Congress presentation in September with updates on some of our priorities.

And Youre ESMO Congress in Barcelona, Yeah, we were present, an update on our two trials evaluating <unk> 13 fixed the first update will include patients with AML havent neck cervical and other HPV 16, <unk> carcinoma, and well report mainly safety.

Immunogenicity findings from the case, one to acquire the second update from a safety run in cohort of our ongoing phase two trial evaluating <unk> dosed in combination with comparable needs from a first <unk> half alone will include patients with HPV 16 positive head and neck squamous.

<unk> carcinoma. This update will focus on the safety Immunogenicity and preliminary activity finds himself for cohort. We will also present the updated results on <unk> hundred 27 in patients with T NBC with Egfr mutated non small cell lung cancer.

And with kidney cancer together with our partner Biofuels.

These updates will contain either initial polo update on safety and efficacy of <unk> hundred 27, as a monotherapy and does the combination with different chemotherapy, you'll take correction.

And finally, we will be presenting updated results from our ongoing phase one trial evaluating safety and efficacy of <unk> six car T cells in combination with of coding and coding mrna vaccine in patients with relapsed refractory <unk> six solid tumor these states.

<unk> will be a follow up from what was presented at last year's ESMO Congress and will include updated safety and efficacy data as well as data on car T cell persistence.

We will share additional details on these in Provo Congress complication in the near future.

With that I will now pass the presentation to our CFO and Todd Stein.

Thank you, Tim and a warm welcome to everyone who has dialed in todays call.

Let me start by reviewing our financial results for the three months ended June 32024.

Our total revenues reported for the second quarter of 2024 reached approximately 129 million euros compared with approximately 168 million euros for the second quarter of 2023.

Our second quarter revenues reflect the current demand of seasonal endemic COVID-19 vaccine market and I expect it to be the low point in this year's COVID-19 vaccine uptake.

Part of our total revenues are derived from the pandemic the patents agreement with the German government, which is expected to run until early 2027.

Moving to cost of sales.

Sales amounted to approximately 60 million euros for the second quarter of 2024 compared to approximately 163 million euros for the comparative prior year period.

Research and development expenses were approximately 585 million for the second quarter of 2024.

<unk> to approximately 373 million euros for the comparative prior year period.

Of the total R&D spend in the second quarter, we invested approximately 90% in our non COVID-19 business, mainly by initiating larger clinical studies for our late stage oncology candidates.

And by investing in additional personnel in our R&D departments to run those clinical trials.

Sales general and administrative expenses amounted to approximately 184 million euros in the second quarter of 2024 compared to about 148 million euros in the comparative prior year period the.

The increase in SG&A was mainly due to the increased expenses for our it environment as well as an increase in headcount to support the scaling of our business.

Regarding the company's other operating results during the second quarter of 2024. This amounted to approximately 267 million euros and negative operating result, compared to about 57 million negative operating result for the comparative prior year period.

This change was primarily due to the recording of a provision related to a contractual dispute.

Income taxes were crude with amount of 2 million euros.

<unk> expenses for the second quarter of 2024 compared to approximately 222 million of realized tax income for the comparative prior year period. The effective income tax rate for the first half of 2024 was approximately one 3%.

For the second quarter of 2020, we reported a net loss of approximately 808 million euros compared to a net loss of about 190 million euros for the comparative prior year period.

Our loss per share for the second quarter of 2024 amounted to three euros and 36 <unk> compared to a loss per share of <unk> 79 euros since for the comparative prior year period as of June 32024, our cash and cash equivalents and security investments reached approximately $18 5 billion euros.

Our strong balance sheet provides us with strategic flexibility to invest in our long term growth strategy.

As part of that strategy, we will continue to invest in the development of our individualized therapies into the build out of the manufacturing capacities and capabilities to support additional late stage Scotts and commercialization.

To create long term value, we aim to advance our clinical programs quickly yet cost efficiently towards potential registration.

Turning to the next slide.

Today, we are reiterating the companys financial guidance for the current financial year <unk>.

Distant with the expectations of approval of our very ended up at COVID-19 vaccine in the United States in mid September.

We expect to recognize the vast majority of our full year revenues, mostly in Q4.

Independent of the timing of the revenue generation.

And as communicated earlier in the year, we expect to report a loss for the 2024 financial year, while we continue to invest in our proprietary assets and technologies.

We also reiterate our R&D and SG&A guidance with two four to $2 6 billion euros for R&D and 700 to 800 million euros for SG&A expenses.

Those expenses are expected to increase in the second half compared to the first half of 2024.

Please note that this guidance does not include any M&A transactions payment for collaboration agreements or licensing deals not yet disclosed any potential payments, resulting from the outcomes of ongoing and future legal disputes related activities, such as judgments or settlements.

Which may have a material effect on our results of operations or cash flows.

In summary, our focus so far has been on executing the company's strategy highlighted by the progress in our pipeline.

We've advanced and started new potentially registrational trials and have shed encouraging data that demonstrates the potential of our pipeline.

Our focus in oncology remains on investing in our innovative technologies that we believe can make a difference while progressing our late stage programs towards potential market.

Sure.

Supported by our strong cash position and demonstrated financial discipline, we will continue to invest in our pipeline focus on generating value for patients and our shareholders with.

With that I would like to turn the call over to our Chief strategy Officer, Ryan Richardson for an update on our strategic outlook and concluding remarks. Thank you.

Ryan Richardson: Thank you Dan.

Our efforts over the last few months have put us in a strong position to execute our COVID-19 vaccine launches this fall season.

In June the European Medicines agency recommended marketing authorization for our Jan one adaptive COVID-19 vaccine.

Followed by European Commission approval on July 3rd.

We started distributing vaccine doses to EU member states shortly thereafter.

We expect that the earlier launch of our updated COVID-19 vaccine in Europe relative to last year will allow vaccination campaigns. This year to be more closely align with seasonal influenza vaccination campaigns.

Added states. The FDA has recommended the use of <unk> as the preferred strained for the 'twenty four 'twenty five season.

We and our partner Pfizer have initiated a rolling submission with the FDA for our <unk> adaptive COVID-19 vaccine.

And expect to be in a position to begin vaccine distribution in the U S. Following regulatory approval with first shipments expected in September.

Ryan Richardson: COVID-19 vaccine demand continues to be globally distributed.

We and our partner Pfizer are preparing to launch our varying adaptive COVID-19 vaccine in over 40 countries and regions worldwide. We expect.

Approximately two thirds of demand potential to reside outside the United States.

While some regions outside the U S continue to be served by government contracts, we anticipate several newly established private markets to open up in regions like the UK and Japan.

This could enable broader access to COVID-19 vaccines for individuals who may not qualify under local immunization recommendations, which tend to focus on the higher risk population segments.

In addition, we have increased our supplier pre filled syringes.

But we will continue to offer a mix of Prefilled syringes single dose vials and multi dose files across regions.

We believe the commonality franchise is well positioned to maintain its leading position globally and the continued fight against COVID-19.

Moving to oncology on the next slide.

We will continue to invest in our mrna cancer vaccine platforms based on our belief that personalized mrna cancer vaccines have potential to establish a new paradigm in cancer treatment. These.

These vaccines employee cutting edge mrna technology, which aims to address the root cause of cancer genomic mutations or neo antigens that are largely specific to each individual's tumor.

Neo antigen selection for each patient is today driven by AI algorithms and are fully in silicon process.

We believe this is fundamentally distinct from other pharmaceutical products.

And then it will allow for iterative improvement overtime powered by data assets.

In addition to their ability to be combined with other therapies with complementary mechanisms of action. We believe these therapies have potential to extend beyond the product lifecycle of a traditional off the shelf pharmaceutical product.

Next slide highlights the key pipeline milestones to focus on as we look ahead to 'twenty four 'twenty five.

We are entering a catalyst rich period over the next 18 months with data updates and regulatory submissions expected for multiple product candidates.

This includes but is not limited to phase III Covid flu combination vaccine topline data expected this year.

And data expected in 2025 from both our mrna cancer vaccine platforms fixed back in August.

We also expect data updates for <unk>, seven or anti PD Lone VEGF Bispecific antibody.

And <unk> three are her to ADC.

In a variety of solid tumor indications.

Finally, we plan to initiate multiple combination trials in solid tumor indications over the next 12 months consistent with our strategy to develop novel combinations, which leverage complementary mechanisms of action.

Turning to the next slide we continue to focus on our late stage oncology portfolio in line with our near term goal to have 10 potentially registrational trials active by the end of the year.

We believe that focusing execution on our diverse late stage pipeline will bring significant potential for mid and long term value creation.

On the next slide I would like to remind everyone that we plan to hold our first artificial intelligence innovation series event via webcast on October one.

Led by our annual innovation series event on November 14th further details will be released soon we welcome you to join these events for a deeper look at the exciting developments taking place at biotech with that I would like to open the floor for questions.

Thank you to ask a question. Please press star one one on your telephone and wait for your name to be announced to waste. A question. Please press star one on one again, we currently ask participants to limit themselves to one question per person.

We will now take our first question.

From the line of Dyno, Great Bush from Leerink partners. Please go ahead.

Speaker Change: Hi, Thank you guys and thanks for the question.

First one is on the law.

Early as 2026 I'm wondering if you could talk about what specific programs and settings trials do you think are most likely to be able to launch in 2026, and if that is dependent on accelerated approval, what gives you confidence and accelerated approvals by.

That date I guess it was specifically referencing whether any of those are your phase III vaccine trials. Thank you.

Okay.

Yes. Thank you Dana I'll start briefly in my colleagues can jump in so I think for 2026, we have a couple of different programs that potentially could launch in that timeframe.

And the first of which is being Q3 Q3, our virtual ADC, we highlighted the potential for we think for an accelerated approval.

Second and third line endometrial cancer.

So that would be one one asset where we're expecting data next year and if that timeline is confirmed with further FDA discussions we think that that could be a 26 launch opportunity. In addition, we've highlighted the potential for an accelerated pathway with our <unk> to two <unk> in adjuvant colon rectal cancer.

We still have further discussions to take place with the FDA.

But based on the current study design and the pace of enrollment we do think that there is the potential if the data is strong also or data too.

<unk> supports submission.

And potentially a launch and that sort of timeframe most likely towards the end of the year with 27, but it could it could fall in 2006.

Thank you.

We will now take the next question.

From the line of Yaron Werber from TD Cowen. Please go ahead.

Yeah, Hi, Thanks for taking my question, maybe just a quick question I know you probably can't say a lot but.

<unk> fixed vivek when you're looking at historical controls.

And youre looking at sort of the overall survival. So the trend can you give us a sense what.

Historical control do you think are most appropriate just to kind of help gauge what the <unk> can.

Thank you.

Oh, Yes sure you know this is a very dire indication C. P. I refractories resistant melanoma and other controls against which we compare our anti PD, one PDL, one treatment, which have been tested in this indication.

Chemotherapies, which have been tested in this indication and just compared to both we see it actually.

Actually meaningfully benefit with regard to objective response rate Ah Theres, a trench of overall survival, but it is too early to be more specific about PFS and OS ethanol the data were mature and at the time when we present the data.

Next year, we would be able to be more specific.

Thank you.

We'll now take the next question.

From the line of Joseph <unk> of March from Banc of America Securities. Please go ahead.

Hi, Good morning, Thanks for taking my question regarding the upcoming phase III closed the cold and flu combo data later this year can you frame for us what would be good data and how would you think that would impact the demand for the <unk>.

Our COVID-19 vaccine going forward and then also related to that how long before you think that this product the commvault products would be able to launch.

Okay.

Hi, It's will go up.

Yeah. Thanks for your question, Sylvia, Yes, expecting expecting net tons play timeframe, the safety Immunogenicity data and efficacy data.

End of this year.

And based on the research they have to see.

That is the data qualify for submission and potential <unk>.

<unk> approval for the season attempt to 25% to tenancy.

What would you consider good data that Luca could be in.

<unk> for the regular corporate vaccine.

Okay.

Can you repeat your question I didn't catch that.

What would you consider to be good data relative to the to the Covid only back.

In order to chaos.

I think the data is very clear.

Speaker Change: It doesn't efficacy type yeah.

It's about compatibility.

COVID-19.

Plus if you could see if it could be in the end.

Okay.

Sure.

Uh huh.

Additionally, the Immunogenicity data.

Parking the moat of excellence to victory.

Thank you we will now take the next question.

From the line of.

<unk> from BMO capital markets. Please go ahead.

Hi, Thanks for taking the question just wondering sort of in the wake of some of the map update and maintenance of R&D guidance is there a specific internal oncology program debt.

Actually benefits here in other words, maybe potential of acceleration of investments are broadening out of.

The program just so curious your thoughts around around who's maybe what programs. They may benefit from this internally.

Yeah.

Yes, yes. Thank you for that question I mean, ultimately this does come down to portfolio strategy.

Thank you your question alludes to.

The factors that we have multiple programs that we think could have potential in non small cell lung cancer.

Already started the phase III for being 2316, we've just brought update us Gulf will be in Q3 two seven.

Which, albeit early we think is quite promising and we also have a six pack program. That's also in our CLC. So we've got already critical mass in our portfolio.

In the non small cell lung cancer indication that we are planning a multi pronged.

Our strategy to execute against so what we found the data encouraging brokers in the mab.

Speaker Change: We decided to prioritize other programs frankly over this in the next phase I think the important takeaway here, though of course is that as Genmab now takes this program forward into phase III.

We'll still retain a economic stake in the program in a stake in the success the future success of the program.

We won't fund phase III and.

And we think that that's the right balance given the many shots on goal.

Writing data that we're seeing from the portfolio.

Alright, thank you.

Yeah.

Thank you we will now take the next question.

From the line of <unk> <unk> from HSBC Bank plc. Please go ahead.

Thank you for taking my question.

Quick question on margin per question.

So just how should we think about.

As your oncology pipeline progresses, and also the meantime youth.

Manufacturing and potentially invest in R&D and SG&A, how should we think about that.

Margin progression.

Especially.

As you're launching your oncology products in the future things.

Speaker Change: Yes, yes, we couldnt hear you very well there, but just want to make sure. We get the question right. So your question is about how do we see margin progression over the next couple of years, specifically as it relates to oncology.

Speaker Change: Right.

Yes.

The launches predominantly we see so in closer space and just the question on margin for question. Thank you.

Speaker Change: Maybe I'll start.

It's also a difficult actually to understand you youre fading.

Trading away somewhat.

I mean, you've seen that of course, the margin that we have with our in our partnership with Pfizer is extremely good with us on a percentage given the best margin structure that we have with Pfizer. So that's that's outstanding and certainly not normal in terms of oncology going forward, we would expect that we see similar sort of margins.

SEC.

<unk>.

With other companies I think and looking forward in terms of internalized medicine, I think we got to wait.

A little bit on how we can when we can make some statements in terms of the margin, but we're working very hard I can assure you we're working very hard to bring the cost down for enlist medicine candidates.

Yeah, and I would just I would just add one point to that so in addition to what you just said about oncology I think we're still expecting of course that our cobot business is going to still be for the next couple of years still a driver of our overall margins and I think there we've got as we pointed out in the past the very attractive economic model is Avi our partner Pfizer that we think will allow us to keep our overall.

<unk>.

Operating profile quite attractive.

Alright, thank you.

Thank you.

We will now take the next question.

From the end of mono and that's from Jefferies. Please go ahead.

Hi, This is actually a cost so you recently topline data from your 101 trial in cutaneous melanoma. Our analysis suggest that combo arm would have a 24% delta versus roughly the 11% historical control rate for your PD one is that the ballpark.

Way to think about the Delta in the study and what would you have to see on PFS and OS to justify moving this forward into a phase III and maybe just stepping back what does this trial keeps the biotech team about the ideal place for cancer vaccines. If you like one of the lessons from your early IMS data was that cancer vaccines, where perhaps not well suited for patients with met.

Static late stage disease, and these patients where PD one refractory so.

How should we interpret that thank you.

Okay. Thank you that's a great question.

The personalized cancer vaccines.

However, manufacturing turnaround time, and the range of six six to eight weeks and.

And therefore in the metastatic setting and in this type of vaccines vaccines.

The ticket.

To provide a clinical benefit.

<unk> patients about the poker so to statement of.

Refers to the person that FX seems so if we got to fix that.

Seen that fix that test to activities on the one side the direct activity due to the actuarial function. We are seeing a type one interferon response yet.

And is seen now in a number of indications not only in melanoma, but also also in lung cancer.

Objective responses in patients with advanced cancer.

We expect that the combination, particularly vis a vis.

With a treatment that is able to control the disease for a certain time and MBR, particularly interested team our ADC mrna vaccine combinations, we will see a number of pilots coming up in 2025 for this.

It would be an exciting opportunity for <unk>.

And maybe for the other part I think it's yes. Your question regarding the <unk> 11 loss about all the clinical benefit, which we would like to say as compared to standard to a standard of care.

I cannot preempt or disclose us which will come.

And when we have mature mature data, but what I can say is that as you know our standard of kiosks objective response rates for this patient population is around 10% Tisch. So what we would like to see is something.

Both search and this is also what Oh, our data shows US we also want to see duration of response.

Also oh this looks clinically meaningful at the current data set which we have and then it's obviously also about safety.

And what we see is that DMT 111, as a six Sigma based on RNA Lipo Plex technology is has a very manageable safety profile and in combination with submitting them up we don't see anything which is surprising. So there is no and just additive toxic.

So.

Which for us means that the.

The clinical profile looks very promising for this patient population.

Yeah.

Thank you we will now take the next question.

From the line of Jessica Fye from Jpmorgan Chase. Please go ahead.

Hey, guys. Good morning, Thanks for taking my question it looks like the beyond Tech topline guidance reflects a different expectation for 2024 commodity sales than what pfizer's guidance would imply.

What gives you confidence in achieving this result and to the extent that part of the Delta is driven by German for pandemic preparedness contract, which I believe falls outside the collaboration can you quantify what that is contributing to the guidance. Thank you.

Okay.

Yeah, Let me, let me start and maybe Ron I wanted to jump in.

So I think we are we are very much aligned with Pfizer in terms of coming out of expectations.

Yeah.

We should keep in mind that Pfizer has its rated its guidance you know we did the same today you should be aware of that and take into account that we have a con subtract together with the European Union.

They have.

In the UK, So I think for Europe. This gives us some comfort in terms of how the full year should look like of course, there is always some in security in that respect.

And in that sense, we feel we feel good about it and in terms of the pandemic to patents contract.

We have confidentiality with the German government. So we are a bit limited in really stating here some numbers.

You should expect that there is a significant amount of money.

Part of what we have reported in the first half so they are supported.

Coming out to you if you look into the documents of $120 million. So a big chunk of that in the first half comes from that and then they put that those contracts.

Thank you.

Thank you we will now take the next question.

From the line of Cory <unk> from Evercore ISI. Please go ahead.

Hi, Thanks for taking the question so regarding the upcoming data at ESMO for BMT three to seven in Egfr mutated non.

Non small cell lung cancer, there's obviously been a lot of attention.

Late on the competitive PD, one VEGF bio specifics that's out there.

Curious I kind of based on what you know about that compound in the data presented to date.

How similar or different do you expect your approach to be and how confident are you in having competitive data in this population. Thank you.

Yeah. Thank you for the question I think.

Keep it short I think the data that we're going to present will be competitive.

And.

<unk>.

As you know.

The asset.

<unk> seven is now now a molecule that.

Can be an evaluation in multiple indications.

Biotech and our clinical Asian partner biopsy.

And we will see additional studies to be announced end of this year beginning next year.

Okay. Thank you.

Thank you.

Let's take the next question.

From the line of Chris Sheppard Chandni <unk> from Goldman Sachs. Please go ahead.

Yes. Thank you if I could just follow up on the BMT three to seven noting from slide 10. It appears problem changing your pipeline plans.

Or some additional trials, there which seem to signal that.

Biotech is quite enthusiastic in that regard.

I think it would be helpful. The investor community was certainly attentive during <unk>.

To understand how your approach may differ from that of our competitors summer therapeutics and in particular can I ask you are you looking to do any head to head trial.

Falling crude out.

How are you thinking about clinical development strategy that we can understand to be differentiated. Thank you.

Hum.

Thank you for this question Chris.

We can not to comment on the strategy of of others, but what we can say is that Oh, we think that the <unk> hundred 27, and this concept is highly compelling and qualifies as a I R. A dec Boeing fall various combinations.

And Oh Wow approach here.

To be is to be a broad with regard to the indications, which we were at plus two also in potentially registrational trials.

Well poised for that because a partner by your peers has already brought a mighty indication program ongoing with a number of our signal seeking cohorts in various indicate occasions.

With various standard of care regimen, so that we have a wealth of data already and can pick the indications index bond debt as they mature and Ah. Another dimension of diversification is that we see beyond you've reached 27.

<unk> as a backbone for our many of our pipeline assets, Oh, well wholly owned ones, but also those we have parked not because it has such a a permissive synergistic prone mode of action.

Yes.

Campbell.

So we are seeing of course.

Data from now a number of indications coming in.

And continue to mature.

And we have seen.

For data for example, the historic.

Benchmark data enable both parks like sampling triple negative breast cancer.

Speaker Change: And.

The extent of clinical benefit yeah, seven BMT seven is.

It's really encouraging and and for any indication in which <unk> is approved.

Yeah.

Our plan would be of course of course to compare efficacy of typically two seven X against against the against the counterparty standards.

Speaker Change: Yeah.

Patent royalty was compared to September.

Thank you.

We'll now take the next question.

From the line of Terence Flynn from Morgan Stanley. Please go ahead.

Hi, Thanks for taking our questions. This is Chris on for tariffs, we have a two part question on <unk> in colorectal cancer, you guided data by the end of 2025 or early 2026, but is there a potential for an interim analysis that would allow you to look at the data earlier and then.

Second of all you and your partner Roche and you could see in this trial in order to advance it into phase III.

Yeah.

Yeah, we have.

Do you have hinted towards potentially in additives.

End of 10% to 25 as you know the study study is our endpoint is disease free survival.

In this indication.

The Genova Genoa principle that we expect from Intuit as cancer vaccines.

Is that a metastatic tumor cells.

Rich.

Our present after surgery and it could be removed bye bye bye.

Inducing a T cell response and.

The indication that we have chosen as the <unk>.

<unk> and a positive indication that means that means based on base.

Based on the on that.

Published data.

Note that this patient population the patient population.

<unk> CTD and had positive after sell to EBIT.

Colorectal cancer.

Have a PFS in the range of of.

10, two months.

And after chemotherapy.

PFS more it's more.

Okay.

Median PFS is that right.

Six to eight months, so that means at that time point.

Speaker Change: We would expect that at least part of the data matured.

And then Dennis then based on that on the risk on the sites that Abbvie.

10 out of it.

And.

Additional studies would be required at the time points or better at the data would be sufficient to continue.

Speaker Change: Right.

Potential regulatory steps.

Great. Thank you.

Thank you will.

We will now take our next question.

From the line of time on Baker from Brisbane Atlantic. Please go ahead.

Thank you for taking my question, it's a question on capacity.

Capacity I Wonder if you could give us some idea.

The capacity the mine facility will give you in 2027 and also.

You mentioned the ability to reduce the.

Bottlenecks in trying to frame time, I wonder if you could give us some idea of where they stand and where this could go to and just to relate to you today based on your comments one.

Is it right to assume that.

Completion of that facility.

While the one to two approval is not contingent on the completion of that facility. Thanks very much.

Yeah.

Yes.

Yeah at the moment, you can't comment on the capacity up.

Of the facility that is as it is.

Being built because because we are still in.

Post that's supported improvements increasing the overall capacity.

So reliable number that would be available.

And for the for the <unk>.

Capacity.

Uncertainty has been built.

Had been built with the idea that it could act okay.

As a pilot facility.

It's one of the personalized vaccine products.

Post at the time and so this is just.

This emphasis ongoing book.

And power a parallel for building.

Building this facility, which is intended to.

It is a potential pilot facility via expanding.

Clinical tire capacity.

To ensure that that.

B, we can start additional cost and 10 to 25 and Tomatoes.

And then I think Simon you asked about bottlenecks in terms of vein to vein time.

Yes.

Bottlenecks yeah.

This is of course, a complete new report that manufacturing of executing in real time and you can imagine.

And that every step must be must be validated.

David.

We have established personalized manitex.

And on EBIT for the first time in 2014 since then.

Yes into two additional innovation cycle.

We have recently implemented implemented additional change in their manufacturing further reducing kind of on plan.

But still still.

Manufacturing what is such a vaccine comes with multiple <unk> tests for the individual batches.

I was working on making this step small goalpost, if you will see the cost.

And this will become become.

<unk> become more or less also with that value with Paypal.

This approach being able to reduce the cost.

Essentially and thereby allowing that.

Speaker Change: Photo but approach both the available.

For that population of patients.

Thanks, so much.

Thank you.

We will now take the next question.

From the line of Liana <unk> from UBS. Please go ahead.

Hey, guys. Thanks, so much for taking my question.

Starting the first novel combo trials in oncology that yeah, I guess, just a strategic question in terms of your oncology combination strategy given the breadth of your portfolio I guess what are the programs that you're most excited about are prioritizing for a combination.

Okay.

We are thank your traffic question, Indiana, we are very excited about the I R. A D. C combination concept because we expect and also all our preclinical data supports this that this is highly synergistic.

And as you pointed out we have started Oh, our first trial, which as of the first also serious you will see well we used the mtc 27, as the I O backbone, which in this first trial is combined with our top tool a D C from our.

No shipped with a duality in multiple solid Ken says and and this would be extended to addition.

A D C from our pipeline to be combined with Yankee CD 27. We are also very excited about a combination which is ongoing for quite some time, namely one off all our priority assets beyond <unk> 11, which is our clothing six car T cells.

In combination with a lot of vaccine, which is designed and in this case in a way that it specific.

Perfect.

X on the adoptive transfer a car T cells and Oh what data.

Which shows that the vaccine in insect.

Two the persistence and duration are also adopt to transfer a car T cells.

Getting our strong on strong west data mature.

Great. Thank you.

Thank you we will now take the next question.

Speaker Change: From the line of John Newman from Canaccord Genuity. Please go ahead.

Hi, there thanks very much for taking my question, you're obviously in the midst of a very active development for <unk> hundred two seven.

I'm wondering specifically for the trials, where you're combining with <unk> three to five your trip to ADC do you see the potential down the road for accelerated approval in some of those indications. Thank you.

And because it's just too early to say [laughter] okay. Thanks.

Thank you.

We will now take the next question.

From the line of Manav Must've Rockies from Deutsche Bank. Please go ahead.

Hello. Thank you for taking my question again on BMT 320 soon just wanted to understand how youre thinking about the clinical trial design are you, hoping or aiming to.

Right.

Eddie mainly PD lone positives.

Applications for our U K.

Keep them open.

And see what the data looks like.

Perfect. Thank you.

C C.

It was a big question, but let me share although the U S.

So the introduction of anti PD, one treatments and talk.

Talk to the division of Ah patient population, hopefully everybody hi, PDI rebounded I think they had won a row and forget about negative population.

And the exciting observation that we that the mate now now in two indications is that the combination of chemo therapy.

Plus vantage 0.27.

P S at two two to be effective.

Uh huh.

In a highly clinically.

Meaning for manner authentic PD, one negative population.

And this really provides a great opportunity.

So we believe that being typically to seven.

It is not only something which is it could could be better, but our then existing PD one treatment.

But we see the chance that the overcome the current talent.

Occasionally patients into PD, one negative MPT around positive patient population this is exciting.

And this of course of course, the patient populations with unmet increased and clinical costs could be done in a much easier way and standard of care.

Could become become easier manageable based on.

Uh huh.

Treatment.

Combinations that are independent of PD L. One statement.

Yeah.

Thank you.

Is this all the time, we have for questions today, I would like to hand back over to the speakers.

Yeah.

Yes, thank you very much for joining us today.

This concludes today's conference call. Thank you for participating you may now disconnect.

Okay.

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Yes.

Yeah.

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Okay.

Speaker Change: [music].

Yes.

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Yes.

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Yeah.

Okay.

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