Q2 2026 BioNTech SE Earnings Call

August 4, 2026

Operator: Welcome to BioNTech’s Q2 2026 Earnings Call. I will hand the call over to Doug Maffei, Vice President of Strategy and Investor Relations. Please go ahead.

Speaker #2: Thank you, Operator. Good morning and good afternoon. Thank you for joining BioNTech's Q2 2026 earnings call. As a reminder, the slides we will be using during this call and the corresponding press release can be found in the Investor section of our website.

Doug Maffei: Thank you, operator. Good morning and good afternoon. Thank you for joining BioNTech’s Q2 2026 earnings call. As a reminder, the slides we will be using during this call and the corresponding press release can be found in the investor 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 US Securities and Exchange Commission, or SEC. Forward-looking statements on this call are subject to significant risks and uncertainties and speak only as of the date of this conference call. We undertake no obligation to update or revise any of these statements. On slide three, you can see the agenda for today’s call.

Speaker #2: 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.

Speaker #2: Securities and Exchange Commission, or SEC. Forward-looking statements on this call are subject to significant risks and uncertainties, and speak only as of the date of this conference call.

Speaker #2: We undertake no obligation to update or revise any of these statements. On slide 3, you can see the agenda for today's call. I'm joined by the following members of BioNTech's management team.

Doug Maffei: 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, and Ramón Zapata, Chief Financial Officer. Also available for the Q&A portion of the call is Annemarie Hanneken, Chief Commercial Officer. Related to yesterday’s Chief Executive Officer announcement, we will also be joined today by Helmut Jeggle, Chairman of BioNTech Supervisory Board. With this, I will hand the call over to Helmut.

Speaker #2: Ugo Şahin, Chief Executive Officer and Co-Founder; Ozlem Tureci, Chief Medical Officer and Co-Founder; and Ramon Zapata, Chief Financial Officer. Also available for the Q&A portion of the call is Anne-Marie Hannekamp, Chief Commercial Officer.

Speaker #2: Related to yesterday's Chief Executive Officer announcement, we will also be joined today by Helmut Jegle, Chairman of BioNTech Supervisory Board. With this, I will hand the call over to Helmut.

Speaker #3: Thank you, Doug, and good morning, everyone. Before we begin with a business update from the management board, I would like to provide further color on the appointment of BioNTech's next Chief Executive Officer.

Helmut Jeggle: Thank you, Doug, and good morning, everyone. Before we begin with a business update from the management board, I would like to provide further color on the appointment of BioNTech's next Chief Executive Officer. As announced yesterday, Guido Oelkers will take office as CEO as of 1 February at the latest. From the outset, the BioNTech Supervisory Board's CEO search was guided by three clear priorities: proven strategic leadership, the ability to scale a global biopharmaceutical business, and a strong track record of building and growing innovation-driven, science-based organizations. Guido is an excellent fit on all three dimensions. Most recently, as CEO of Sobi, he more than quadrupled the company's revenues over 9 years by strengthening its global capabilities and maximizing the value of its late-stage pipeline.

Speaker #3: As announced yesterday, Gide Ölköz will take office as CEO as of February 1 at the latest. From the outset, the supervisory board's CEO search was guided by three clear priorities: proven strategic leadership, the ability to scale a strong track record of building and growing innovation-driven science-based organizations.

Speaker #3: Gide is an excellent fit on all three dimensions, most recently as CEO of Soby, he more than caught up with the company's revenues over nine years by strengthening its global capabilities and maximizing the value of his late-stage pipeline.

Helmut Jeggle: He brings deep expertise in launching and commercializing innovative products with a focus on the US market, as well as extensive leadership experience across Europe and Asia Pacific. The BioNTech Supervisory Board believes that Guido is the right leader for BioNTech's next phase. His expertise in scaling innovative organizations in a focused and capital-efficient manner, combined with his deep knowledge of the markets most relevant to BioNTech, will position the company well to deliver on its key objectives, evolve into a multi-product biopharmaceutical company, and continue its remarkable success story. With that, I would like to hand over to Ugur and will be available for questions during the Q&A at the end of the call.

Speaker #3: He brings deep expertise in launching and commercializing innovative products, with a focus on the U.S. market, as well as extensive leadership experience across Europe, Asia, and the Pacific.

Speaker #3: The supervisory leader for BioNTech's next phase. His expertise in scaling innovative organizations in a focused and capital-efficient manner, combined with his deep knowledge of the markets most relevant to BioNTech, will position the company well to deliver on its key objectives, evolve into a multi-product biopharmaceutical company, and continue its remarkable success story.

Speaker #3: With that, I would like to hand over to Ugo, and we'll be available for questions during the Q&A at the end of the call.

Speaker #4: Thank you, Helmut, and a warm welcome to everyone joining us today. I believe it is important to note that this transition reflects the natural evolution of BioNTech from a pioneering research organization into a global biopharmaceutical company with multiple commercial products.

Ugur Sahin: Thank you, Helmut, and a warm welcome to everyone joining us today. I believe it is important to note that this transition reflects the natural evolution of BioNTech from a pioneering research organization into a global biopharmaceutical company with multiple commercial products. The next phase of this evolution requires the corresponding leadership skills, and I am confident we have found it in Guido. During our exchanges, I have come to know Guido as a leader who combines a deep understanding of the pharmaceutical industry and strategic acumen with genuine respect for the culture and people of our organization. He understands what we have built, and importantly, he understands what it will take to scale it. To ensure continuity and a seamless transition, I will remain actively engaged in supporting the preparations for Guido's onboarding. As for BioNTech's next phase, our mission remains constant: to translate science into survival.

Uğur Şahin: Thank you, Helmut, and a warm welcome to everyone joining us today. I believe it is important to note that this transition reflects the natural evolution of BioNTech from a pioneering research organization into a global biopharmaceutical company with multiple commercial products. The next phase of this evolution requires the corresponding leadership skills, and I am confident we have found it in Guido. During our exchanges, I have come to know Guido as a leader who combines a deep understanding of the pharmaceutical industry and strategic acumen with genuine respect for the culture and people of our organization. He understands what we have built, and importantly, he understands what it will take to scale it. To ensure continuity and a seamless transition, I will remain actively engaged in supporting the preparations for Guido's onboarding. As for BioNTech's next phase, our mission remains constant: to translate science into survival.

Speaker #4: The next phase of this evolution requires the corresponding leadership skills, and I am confident we have found this in Gide. During our exchanges, I have come to know Gide as a leader who combines a deep understanding of the pharmaceutical industry and strategic acumen with genuine respect for the culture and people of our organization.

Speaker #4: He understands what we have built and, importantly, he understands what it will take to scale it. To ensure continuity and a seamless transition, I will remain actively engaged in supporting the corporations for Gide's onboarding.

Speaker #4: As for BioNTech's next phase, our mission remains constant: to translate science into survival. To achieve this, BioNTech has successfully built a diversified toolkit of modalities including next-generation immunomodulators, ADCs, and mRNA cancer immunotherapies.

Ugur Sahin: To achieve this, BioNTech has successfully built a diversified toolkit of modalities, including next generation immunomodulators, ADCs, and mRNA cancer immunotherapies. Our multi-product portfolio has progressed further, and a growing share of it's now in late-stage clinical development and pivotal trials. Q2 was a period of significant progress for BioNTech towards this. First, we are accelerating the late-stage development of our oncology assets. We shared encouraging global data in first-line NSCLC from the phase II portion of our phase II/III trial at ASCO from our potential next generation IO backbone, pumitamab. Second, our combination therapy strategy is gaining momentum. We have expanded our novel combination programs and presented data from ongoing combination trials with our ADCs, with more to come soon. Third, we continue our shift from platform-centric to a tumor-centric clinical development approach around cancers with greatest unmet medical need.

Uğur Şahin: To achieve this, BioNTech has successfully built a diversified toolkit of modalities, including next generation immunomodulators, ADCs, and mRNA cancer immunotherapies. Our multi-product portfolio has progressed further, and a growing share of it's now in late-stage clinical development and pivotal trials. Q2 was a period of significant progress for BioNTech towards this. First, we are accelerating the late-stage development of our oncology assets. We shared encouraging global data in first-line NSCLC from the phase II portion of our phase II/III trial at ASCO from our potential next generation IO backbone, pumitamab. Second, our combination therapy strategy is gaining momentum. We have expanded our novel combination programs and presented data from ongoing combination trials with our ADCs, with more to come soon. Third, we continue our shift from platform-centric to a tumor-centric clinical development approach around cancers with greatest unmet medical need.

Speaker #4: Our multi-product portfolio has progressed further, and a growing share of it is now in late-stage clinical development and pivotal trials. The second quarter was a period of significant progress for BioNTech towards this.

Speaker #4: First, we are accelerating the late-stage development of our oncology assets. We shared encouraging global data in first-line NSCLC from the Phase 2 portion of our Phase 2 trial at ASCO, from our potential next-generation I/O backbone, Prometheus.

Speaker #4: Second, our combination therapy strategy is gaining momentum. We have expanded our novel combination programs and presented data from ongoing combination trials with our ADCs.

Speaker #4: With more to come soon. Third, we continue our shift from platform-centric to a tumor-centric clinical development approach around cancers with greatest unmet medical need.

Ugur Sahin: Notably in our GU tumor area, we dosed the first patient in our phase III trial, evaluating our B7-H3 ADC, asfitapat dozanucan, formerly known as BNT324, in metastatic castration-resistant prostate cancer. BioNTech is well positioned for the next phase. With a growing pipeline of potentially registrational trials, strong partnerships, and financial strength, we are on track to become a diversified multi-product company by 2030. We are targeting more than 17 late-stage and pivotal trials readouts through 2030 and beyond, spanning multiple tumor types and different lines of treatment. Our progress to date sets us up for an impactful H2 2026. We enter the remainder of this year with momentum and diligent execution as we continue to progress towards our long-term mission. With this, I will hand over to Özlem for an update on our oncology execution.

Uğur Şahin: Notably in our GU tumor area, we dosed the first patient in our phase III trial, evaluating our B7-H3 ADC, asfitapat dozanucan, formerly known as BNT324, in metastatic castration-resistant prostate cancer. BioNTech is well positioned for the next phase. With a growing pipeline of potentially registrational trials, strong partnerships, and financial strength, we are on track to become a diversified multi-product company by 2030. We are targeting more than 17 late-stage and pivotal trials readouts through 2030 and beyond, spanning multiple tumor types and different lines of treatment. Our progress to date sets us up for an impactful H2 2026. We enter the remainder of this year with momentum and diligent execution as we continue to progress towards our long-term mission. With this, I will hand over to Özlem for an update on our oncology execution.

Speaker #4: Notably, in our GU tumor area, we dosed the first patient in our Phase 3 trial evaluating our B7H3 ADC, alpha-tabadosantucan, formerly known as BNT324, in metastatic castration-resistant prostate cancer.

Speaker #4: BioNTech is well positioned for the next phase. With a growing pipeline of potentially registrational trials, strong partnerships, and financial strength, we are on track to become a diversified, multi-product company by 2030.

Speaker #4: We are targeting more than 17 late-stage and pivotal trial readouts through 2030 and beyond, spanning multiple tumor types and different lines of treatment. Our progress to date sets us up for an impactful second half of 2026.

Speaker #4: We enter the remainder of this year with momentum and diligent execution as we continue to progress towards our long-term vision. With this, I will hand over to Özlem for an update on our oncology execution.

Speaker #1: Thank you, Ugo. I'm glad to be speaking with everyone today. Our ambition is to address the full continuum of cancer utilizing the approaches that Ugo outlined.

Özlem Türeci: Thank you, Ugur. I'm glad to be speaking with everyone today. Our ambition is to address the full continuum of cancer, utilizing the approaches that Ugur outlined. We have defined a tumor-focused strategy to address significant unmet medical need, where our novel combinations can extend survival outcomes for patients and maximize the potential of our pipeline. As such, we are advancing multiple assets from our multimodal oncology pipeline into late-stage development. During the H1 2026, we made progress across our pipeline, I'll cover some of these updates today. I'll begin with lung cancer, which is one of the cancers of highest unmet medical need in the tumor area where we have the broadest and most diverse coverage. We are aiming to tackle unmet medical needs at every stage of the lung cancer patient journey.

Speaker #1: We have defined a tumor-focused strategy to address significant unmet medical need where our novel combinations can extend survival outcomes for patients and maximize the potential of our pipeline.

Speaker #1: As such, we are advancing multiple assets from our multimodal oncology pipeline into late-stage development. During the first half of 2026, we made progress across our pipeline, and I'll cover some of these updates today.

Speaker #1: I'll begin with lung cancer, which is one of the cancers of highest unmet medical need and the tumor area where we have the broadest and most diverse coverage.

Speaker #1: We are aiming to tackle unmet medical needs at every stage of the lung cancer patient journey. Our lung cancer strategy covers various disease stage settings and enlists various modalities.

Özlem Türeci: Our lung cancer strategy covers various disease stages, settings, enlists various modalities, next generation immunomodulators, ADCs, and mRNA cancer immunotherapy. For certain settings, we have multiple opportunities with the aim to change the standard of care and move forward with our combination strategy. At the core of this tumor-based oncology strategy is pumitamab, our investigational bispecific immunomodulator targeting PD-L1 and VEGF-A, now in development with our partner, BMS. In lung cancer, we are now running four registrational programs for pumitamab. ROSETTA Lung-01 in first-line extensive-stage small cell lung cancer, ROSETTA Lung-02 in first-line non-small cell lung cancer, where global phase II data were presented at ASCO. ROSETTA Lung-202, our pivotal trial in first-line PD-L1 high non-small cell lung cancer, is now enrolling. ROSETTA Lung-201, our pivotal trial in unresectable stage 3 non-small cell lung cancer, is also underway.

Speaker #1: Next-generation immunomodulators, ADCs, and mRNA cancer immunotherapy. In certain settings, we have multiple opportunities, with the aim to change the standard of care and move forward with our combination strategy.

Speaker #2: It's a core of this tumor-based oncology strategy is Prometheus, our investigational bispecific immunomodulator targeting PD-L1 and VEGFA now in development with our partner BMS.

Speaker #2: In lung cancer, we are now running four registrational programs for Prometheus. Rosetta Lung 01 in first-line extensive-stage small cell lung cancer, and Rosetta Lung 02 in first-line non-small cell lung cancer, where global Phase 2 data were presented at ASCO.

Speaker #2: Rosetta Lung 202, our pivotal trial in first-line PD-L1 high non-small cell lung cancer, is now enrolling, and Rosetta Lung 201, our pivotal trial in unresectable stage 3 non-small cell lung cancer, is also underway.

Özlem Türeci: Moreover, we are generating novel combination data to inform the first wave of combination trials with registrational intent. Zooming in on pumitamab. Here we again have pioneered by delivering the first global phase II data for a PD-L1 VEGF bispecific in first-line non-small cell lung cancer. At ASCO in June, we presented phase II data from ROSETTA Lung-02, our global randomized phase II, free trial evaluating pumitamab in combination with chemotherapy in patients with previously untreated advanced non-small cell lung cancer. In 40 evaluable patients with both squamous and non-squamous histology, pumitamab plus chemotherapy demonstrated robust clinical activity with unconfirmed and confirmed overall response rates for combined doses of 72.5% and 62.5% respectively. Two features of these data deserve particular emphasis. First, the encouraging activity observed across PD-L1 expression levels is noteworthy. Second, the particularly strong response rate in PD-L1 low disease across histologies.

Speaker #2: Moreover, we are generating novel novel combination data to inform the first wave of combination trials with registrational intent.

Speaker #1: Zooming in on Prometheus, here we again have pioneered by delivering the first global Phase 2 data for a PD-L1/VEGF bispecific in first-line non-small cell lung cancer.

Speaker #1: At ASCO in June, we presented Phase 2 data from Rosetta Lung 02, our global randomized Phase 2 free trial evaluating Prometheus in combination with chemotherapy in patients with previously untreated advanced non-small cell lung cancer.

Speaker #1: In 40 evaluable patients with both squamous and non-squamous histology, Prometheus plus chemotherapy demonstrated robust clinical activity, with unconfirmed and confirmed overall response rates for combined doses of 72.5% and 62.5%, respectively.

Speaker #1: Two features of these data deserve particular emphasis. First, the encouraging activity observed across PD-L1 expression levels is noteworthy. Second, the particularly strong response rate in PD-L1 low disease across histologies.

Speaker #1: This includes patients with PD-L1 TPS less than 1% who represented approximately 58% of patients in this cohort, a subgroup typically with poor response to anti-PD-1 PD-L1 treatment.

Özlem Türeci: This includes patients with PD-L1 TPS less than 1%, who represented approximately 58% of patients in this cohort, a subgroup typically with poor response to anti-PD-1, PD-L1 treatment. In that population, the confirmed objective response rate was 47.6%. In patients with TPS between 1% and 49%, it was 77.8%, and all six patients with TPS 50% or above responded. The safety profile was manageable in both histologies with no new safety signals. These data support the ongoing global phase III program for pumitamab in lung cancer. The robust clinical responses across PD-L1 strata align with our expectations. It speaks to the potential of pumitamab to confer benefit in the all-comer patient population, including the PD-L1 low expression levels, where unmet medical need is high.

Speaker #1: In that population, the confirmed objective response rate was 47.6% in patients with TPS between 1% and 49%. It was 77.8%, and all six patients with TPS 50% or above responded.

Speaker #1: The safety profile was manageable in both histologies with no new safety signals. These data support the ongoing global Phase 3 program for Prometheus in lung cancer.

Speaker #1: The robust clinical responses across PD-L1 strata align with our expectations. It speaks to the potential of Prometheus to confer benefit in the all-coma patient population including the PD-L1 low expression levels where unmet medical need is high.

Speaker #1: The Rosetta Lung 02 trial is currently recruiting in its Phase 3 portion and we look forward to presenting additional Phase 2 data from this trial as the data mature.

Özlem Türeci: The ROSETTA Lung-02 trial is currently recruiting in its phase III portion. We look forward to presenting additional phase II data from this trial as the data mature. The central question in the PD-1, PD-L1, VEGF class has been whether the clinical activity observed in trials conducted in China would be consistent with the data in global populations. We have been able to address that question with our own asset across 3 key tumor types in phase II trials. Firstly, in first-line small cell lung cancer. The China phase I-II demonstrated a disease control rate of 94% and a confirmed overall response rate of 82%. With the global phase II trial, we showed a disease control rate of 100% and a confirmed objective response rate of 76%. There is the first-line non-small cell lung cancer indication.

Speaker #1: The central question in the PD-1 PD-L1 VEGF class has been whether the clinical activity observed in trials conducted in China would be consistent with the data in global populations.

Speaker #1: We have been able to address that question with our own asset across three key tumor types in Phase 2 trials. First, in first-line small cell lung cancer.

Speaker #1: The China Phase 1, 2 demonstrated a disease control rate of 94% and a confirmed overall response rate of 82%. With the global Phase 2 trial, we showed a disease control rate of 100% and a confirmed objective response rate of 76%.

Speaker #1: Then there is the first-line non-small cell lung cancer indication. We observed in the China monotherapy Phase 1/2 a confirmed objective response rate of approximately 47% in PD-L1 positive patients.

Özlem Türeci: We observed in the China monotherapy phase I-II, a confirmed objective response rate of approximately 47% in PD-L1 positive patients. In the global phase II of pumitamab plus chemotherapy, which includes the PD-L1 unselected population, we saw a confirmed objective response rate of approximately 63%. In TNBC, the disease control rate was 92% in both the trials conducted in China and globally. In the China phase I-II in first-line TNBC, we reported a confirmed objective response rate of approximately 74%. In the global phase II cohort, which included a heterogeneous population of first and second-line patients, we reported a confirmed objective response rate of approximately 62%, as expected given the treatment line population. Across these 3 tumor types of high unmet need, we are observing a meaningful consistency between the data generated in China and globally.

Speaker #1: In the global Phase 2 of Prometheus plus chemotherapy, which includes the PD-L1-unselected population, we saw a confirmed objective response rate of approximately 63%.

Speaker #1: In TNBC, the disease control rate was 92% in both the trials conducted in China and globally. In the China Phase 1, 2 in first-line TNBC, we reported a confirmed objective response rate of approximately 74% and in the global Phase 2 cohort, which included a heterogeneous population, a first and second-line patients, we reported a confirmed objective response rate of approximately 62%.

Speaker #1: As expected, given the treatment plan population. Across these three tumor types of high unmet need, we are observing meaningful consistency between the data generated in China and globally.

Speaker #1: While cross-trial comparisons must be interpreted with caution, we are encouraged by this cross-regional consistency. This gives us increased confidence in the global potential of Prometheus.

Özlem Türeci: While cross-trial comparisons must be interpreted with caution, we are encouraged by this cross-regional consistency. This gives us increased confidence in the global potential of pumitamig. We are advancing multiple pivotal phase III programs to confirm these signals. As covered here on our tumor map slide, we are deploying multiple modalities to tackle lung cancer. Gotistobart is a critical component of that map. As a reminder, gotistobart is our selective Treg-depleting antibody targeting CTLA-4, developed in collaboration with our partner, OncoC4. We are advancing gotistobart through the pivotal second stage of PRESERVE-003, our global phase III in patients with metastatic squamous, non-small cell lung cancer who progressed following platinum-based chemotherapy and PD-L1 inhibitor treatment. This is a setting with very few effective options and poor prognosis.

Speaker #1: We are advancing multiple pivotal Phase 3 programs to confirm these signals. As covered here on our tumor map slide, we are deploying multiple modalities to tackle lung cancer.

Speaker #1: This part is a critical component of that map. As a reminder, Gotistobart is our selective TREK-depleting antibody targeting CTLA4, developed in collaboration with our partner Oncosy4.

Speaker #1: We are advancing Gotistobart through the pivotal second stage of Preserve 003, our global Phase 3 in patients with metastatic squamous non-small cell lung cancer who progressed following platinum-based chemotherapy and PD-L1 inhibitor treatment.

Speaker #1: This is a setting with very few effective options and poor prognosis. Gotistobart’s differentiated mechanism of selectively depleting regulatory T cells in the tumor microenvironment is designed to re-engage the immune system, even after prior checkpoint inhibitor exposure.

Özlem Türeci: gotistobart's differentiated mechanism of selectively depleting regulatory T cells in the tumor microenvironment is designed to reengage the immune system even after prior checkpoint inhibitor exposure. Earlier this year at ELCC, we presented updated data from the non-pivotal stage 1 of PRESERVE-003, our global phase III trial. The data are very encouraging. The 12-month PFS rate of 25% for gotistobart, versus zero for docetaxel, is a signal of durable disease control. gotistobart reduced the risk of death in this IO pre-treated patient population by 54% compared to docetaxel, with a hazard ratio of 0.46. The median OS in the gotistobart arm has not yet been reached compared to approximately 10 months with docetaxel. At 12 months, 63% of patients treated with gotistobart were alive, versus 30% in the docetaxel arm. The safety profile was consistent with the previously established profile for gotistobart, with no new signals of concern.

Speaker #1: Earlier this year, at ELCC, we presented updated data from the non-pivotal stage one of PRESERVE-003, our global Phase 3 trial. The data are very encouraging.

Speaker #1: The 12-month PFS rate of 25% for Gotistobart versus zero for docetaxel is a signal of durable disease control. Gotistobart reduced the risk of death in this IO pre-treated patient population by 54% compared to docetaxel, with a hazard ratio of 0.46.

Speaker #1: The median OS in the Gotistobart arm has not yet been reached compared to approximately 10 months with docetaxel. At 12 months, 63% of patients treated with Gotistobart were alive versus 30% in the docetaxel arm.

Speaker #1: The safety profile was consistent with the previously established profile for Gotistobart with no new signals of concern. We expect to present longer follow-up data at the World Lung Conference next month.

Özlem Türeci: We expect to present longer follow-up data at the World Conference on Lung Cancer next month. Based on current event accrual projections, we expect to conduct the first interim analysis from the pivotal stage of the trial towards the end of this year. At ASCO this year, we presented overall survival data from the phase II study evaluating gotistobart in combination with pembrolizumab in ovarian cancer patients who had received prior platinum-based chemotherapy. The data showed a compelling and differentiated signal with a median overall survival of 18.9 months. Together, these data reinforce the potential of gotistobart to provide an extended overall survival benefit, and serve as a potential chemo-free treatment option for lung patients. I will now turn to asfitapat dozanucan or BNT324, our B7-H3-targeted ADC developed in collaboration with DualityBio. B7-H3 is overexpressed across multiple tumor types, including prostate cancer, non-small cell lung cancer, small cell lung cancer, and others.

Speaker #1: Based on current event accrual projections, we expect to conduct the first interim analysis from the pivotal stage of the trial towards the end of this year.

Speaker #1: At ESCO this year, we presented overall survival data from the Phase 2 study evaluating Gotistobart in combination with Pembrolizumab in ovarian cancer patients who had received prior platinum-based chemotherapy.

Speaker #1: The data showed a compelling and differentiated signal with a median overall survival of 18.9 months. Together, these data reinforce the potential of Gotistobart to provide an extended overall survival benefit and serve as a potential chemo-free treatment option for lung patients.

Speaker #1: I will now turn to LFD, or BNT324, our B7-H3 targeted ADC developed in collaboration with Duality Bio. B7-H3 is overexpressed across multiple tumor types, including prostate cancer, non-small cell lung cancer, small cell lung cancer, and others.

Speaker #1: The target biology, combined with the pharmacology of a TOPO1 inhibitor ADC with a drug-to-antibody ratio of six, positions LFD as a potentially versatile oncology asset across a wide range of solid tumors.

Özlem Türeci: The target biology, combined with the pharmacology of a Topo1 inhibitor, ADC with drug to antibody ratio of six, positions asfitapat dozanucan as a potentially versatile oncology asset across a wide range of solid tumors. More than 1,000 patients have now been treated with asfitapat dozanucan across more than 10 tumor types, including 400 patients treated with asfitapat dozanucan in combination with pumitamig. The growing body of clinical evidence demonstrates anti-tumor activity across multiple indications with a favorable safety profile. This quarter, we dosed our first patient in the phase III clinical trial for asfitapat dozanucan, evaluating it against docetaxel in patients with taxane-naïve metastatic castration-resistant prostate cancer. Prostate cancer is our first phase III indication for asfitapat dozanucan, and it represents one of the strongest B7-H3 expression profiles of any tumor type. The trial targets a patient population with substantial unmet need following progression on second-generation androgen receptor pathway inhibitors.

Speaker #1: More than 1,000 patients have now been treated with LFD across more than 10 tumor types, including 400 patients treated with LFD in combination with Prometheus.

Speaker #1: The growing body of clinical evidence demonstrates anti-tumor activity across multiple indications with a favorable safety profile. This quarter, we dosed our first patient in the Phase 3 clinical trial for LFD, evaluating it against docetaxel in patients with taxane-naive metastatic castration-resistant prostate cancer.

Speaker #1: Prostate cancer is our first Phase 3 indication for LFD, and it represents one of the strongest B7H3 expression profiles of any tumor type. The trial targets a patient population with substantial unmet need following progression on second generation androgen receptor pathway inhibitors.

Speaker #1: In parallel, LFD is being evaluated in combination with Prometheus across multiple Phase 1 and Phase 2 programs. These results will help inform the optimal clinical design for upcoming registrational combination trials.

Özlem Türeci: In parallel, asfitapat dozanucan is being evaluated in combination with pumitamig across multiple phase I/II programs. These results will help inform the optimal clinical design for upcoming registrational combination trials. We expect to present some of these data at a medical conference later this year. Moving now to our portfolio of innovative mRNA cancer immunotherapies, which aim to activate and educate the immune system with precision. Our individualized neoantigen-specific immunotherapy, autogene cevumeran, developed in collaboration with Genentech, is advancing into ongoing randomized phase II trials. In adjuvant ctDNA stage 2 high risk or stage 3 colorectal cancer, we have a phase II trial evaluating autogene cevumeran monotherapy against the standard of watchful waiting. Enrollment is now complete, and in June, an interim analysis based on the centrally assessed primary endpoint of disease-free survival was reviewed by the independent Data Safety Monitoring Board with the recommendation to continue the trial without modification.

Speaker #1: We expect to present some of these data at a medical conference later this year. Moving now to our portfolio of innovative mRNA cancer immunotherapies, which aim to activate and educate the immune system with precision.

Speaker #1: Our individualized neoantigen-specific immunotherapy, autogene cevumeran, developed in collaboration with Genentech, is advancing into ongoing randomized Phase 2 trials. In adjuvant ctDNA stage II high-risk or stage III colorectal cancer, we have a Phase 2 trial evaluating autogene cevumeran monotherapy against the standard of watchful waiting.

Speaker #1: Enrollment is now complete, and in June, an interim analysis based on the centrally assessed primary endpoint of disease-free survival was reviewed by the independent Data Safety Monitoring Board, with the recommendation to continue the trial without modification.

Özlem Türeci: Thus, the study will continue as planned per protocol, and we will remain masked to the data until the final analysis. The data readout from the final analysis of this trial is event-driven and expected in 2027. In adjuvant pancreatic cancer, recruitment for the phase II IMCODE003 trial is well underway. Data from a phase I investigator-initiated trial, including a 6-year update presented at AACR this year, continue to demonstrate durable immune responses against the encoded neoantigens for up to 6 years, evidence that supports our therapeutic rationale in the adjuvant and minimal residual disease setting. On our FixVac platform, BNT113, our off-the-shelf HPV16 targeting immunotherapy, is advancing in the AHEAD-MERIT phase II/III trial in combination with pembrolizumab as a first-line treatment for patients with PD-L1 positive, HPV16 positive head neck squamous cell cancer. A phase III interim analysis is expected for PFS this year.

Speaker #1: Thus, the study will continue as planned per protocol and we will remain masked to the data until the final analysis. The data readout from the final analysis of this trial is event-driven and expected in 2027.

Speaker #1: In adjuvant pancreatic cancer, recruitment for the Phase 2 IMCode 003 trial is well underway. Data from the Phase 1 investigator-initiated trial including a six-year update presented at AACR this year continued to demonstrate durable immune responses against the encoded neoantigen for up to six years.

Speaker #1: Evidence that supports our therapeutic rationale in the adjuvant and minimal residual disease setting. On our fixed spec platform, BNT113, our off-the-shelf HPV 16 targeting immunotherapy is advancing in the ahead merit Phase 2 free trial in combination with Pembrolizumab as a first-line treatment for patients with PD-L1 positive HPV 16 positive head/neck squamous cell cancer.

Speaker #1: A Phase 3 interim analysis is expected for PFS this year. For BNT116, our mRNA immunotherapy targeting multiple non-small cell lung cancer-associated antigens, we expect to present data at WCLC 2026 from cohort 6 in combination with semi-PLMAP and chemotherapy.

Özlem Türeci: For BNT116, our mRNA immunotherapy targeting multiple non-small cell lung cancer-associated antigens, we expect to present data at WCLC 2026 from cohort 6 in combination with cemiplimab and chemotherapy. These programs reflect our conviction that mRNA cancer immunotherapy, particularly in combination with checkpoint inhibition, can deliver meaningful benefit in defined patient populations. In closing, today's review underscores the significant progress across our portfolio. We have reached multiple key milestones and continue to execute on plan in 2026 and beyond. Within our late-stage programs, we anticipate three further readouts this year. Gotistobart in squamous non-small cell lung cancer, our FixVac immunotherapy BNT113 in head neck cancer, and T-Pam in breast cancer. For gotistobart, we expect a first interim analysis in late 2026 based on the projected event accrual rates. This initial review by the independent Data Monitoring Committee is intended as an early checkpoint before the next pre-planned interim analysis.

Speaker #1: These programs reflect our conviction that mRNA cancer immunotherapy, particularly in combination with checkpoint inhibition, can deliver meaningful benefit in defined patient populations. In closing, today's review underscores the significant progress across our portfolio.

Speaker #1: We have reached multiple key milestones and continue to execute on plan in 2026 and beyond. Within our late-stage programs, we anticipate free forever readouts this year.

Speaker #1: Gotistobart and squamous non-small cell lung cancer, our fixed spec immunotherapy BNT113 in head/neck cancer, and TPAM in breast cancer. For Gotistobart, we expect a first interim analysis in late 2026 based on the projected event accrual rates.

Speaker #1: This initial review by the independent data monitoring committee is intended as an early checkpoint before the next pre-planned interim analysis. For BNT113, based on current event accrual projections we expect a Phase 3 interim analysis for progression-free survival later this year.

Özlem Türeci: For BNT113, based on current event accrual projections, we expect a phase III interim analysis for progression-free survival later this year. Overall survival, which is the trial's other core primary endpoint, is not expected to be mature at this interim. T-Pam is currently being advanced in two pivotal clinical trials, one in second-line endometrial cancer and one in HER2-low hormone receptor-positive metastatic breast cancer. The candidate has generated encouraging data to date in both indications. With the primary analysis in breast cancer expected in Q4 2026, we will determine the optimal regulatory pathway based on aggregated data across both indications. With this data-driven approach, we aim to pursue a value optimization strategy for T-Pam in an evolving treatment landscape while prioritizing opportunities where we can deliver significant benefit for patients.

Speaker #1: Overall survival, which is the trial's other co-primary endpoint, is not expected to be mature at this interim. TPAM is currently being advanced into pivotal clinical trials—one in second-line endometrial cancer and one in HER2-low, hormone receptor-positive metastatic breast cancer.

Speaker #1: The candidate has generated encouraging data to date in both indications. With the primary analysis in breast cancer expected in the fourth quarter of 2026, we will determine the optimal regulatory pathway based on aggregated data across both indications.

Speaker #1: With this data-driven approach, we aim to pursue a value optimization strategy for TPAM in an evolving treatment landscape, while prioritizing opportunities where we can deliver significant benefit for patients.

Speaker #1: Following our mid-year review, of upcoming late-stage milestones, we have updated the expected timing for the Phase 3 Prometheus trial in triple-negative breast cancer in China and for the Phase 2 Gotistobart trial in second line castration-resistant prostate cancer, both of which are now expected in 2027.

Özlem Türeci: Following our mid-year review of upcoming late-stage milestones, we have updated the expected timing for the phase III pumitamig trial in triple-negative breast cancer in China and for the phase II gotistobart trial in second-line castration-resistant prostate cancer, both of which are now expected in 2027. With regards to our earlier-stage novel-novel readouts, we have already published data on some of those combinations and expect more soon. I want to highlight one data set that is strategically significant for our ambitions in lung, the upcoming readout for the phase I/II trial evaluating pumitamig in combination with BNT324, our B7H3 ADC, across advanced non-small cell lung cancer and small cell lung cancer. This will be the first clinical data for a PD-L1 VEGF-A bispecific antibody in combination with an antibody-drug conjugate in lung cancer.

Speaker #1: With regard to our earlier-stage, novel readouts, we have already published data on some of those combinations and expect more soon. I want to highlight one data set that is strategically significant for our ambitions in lung.

Speaker #1: The upcoming readout for the Phase 1-2 trial evaluating Prometheus in combination with LFD, our B7H3 ADC, across advanced non-small cell lung cancer and small cell lung cancer.

Speaker #1: This will be the first clinical data for a PD-L1 VEGFA bispecific antibody in combination with an antibody-drug conjugate in lung cancer. The combination brings together two mechanistically distinct and potentially synergistic approaches.

Özlem Türeci: The combination brings together two mechanistically distinct and potentially synergistic approaches, the immune reactivation enabled by pumitamig with the targeted cytotoxic payload of ADC. We execute these earlier combination studies to provide the signal-seeking evidence we need to inform and potentially de-risk our next steps. This data generation will guide the entry of our novel-novel combination strategy into the pivotal stage. It is the foundation of the next chapter towards BioNTech's growing leadership in oncology. With that, I will now turn the presentation over to our CFO, Ramón Zapata, for the financial update.

Speaker #1: The immune reactivation enabled by Prometheus with the targeted cytotoxic payload of LFD. We execute these earlier combination studies to provide the signal-seeking evidence we need to inform and potentially de-risk our next steps.

Speaker #1: This data generation will guide the entry of our novel combination strategy into the pivotal stage, and it is the foundation of the next chapter toward BioNTech's growing leadership in oncology.

Speaker #1: With that, I will now turn the presentation over to our CFO, Ramon Zapata, for the financial update.

Speaker #2: Thank you, Ozlem. I want to extend a warm welcome to everyone joining us. I will cover three topics today. Firstly, our second quarter and first half 2026 financials.

Ramón Zapata: Thank you, Özlem, and a warm welcome to everyone joining us. I will cover three topics today. Firstly, our Q2 and H1 2026 financials. Secondly, our full year 2026 financial guidance. Lastly, the execution of our share repurchase program announced in May 2026 as part of our capital allocation strategy. Note that all figures will be in EUR unless otherwise stated. Starting with the Q2 financial performance. Revenues for Q2 2026 were EUR 106 million, compared to EUR 261 million in the prior year's quarter. This decline mainly reflects lower demand for our COVID-19 vaccine in the US. The prior year quarter was positively impacted by a one-time revenue effect. This related to a compensation payment from Pfizer opting out from our shingles vaccine's development role. Moving to R&D.

Speaker #2: Secondly, our full year 2026 financial guidance. And lastly, the execution of our shared purchase program announced in May. This year, as part of our capital allocation strategy.

Speaker #2: Note that all figures will be in euros unless otherwise stated. Starting with the second quarter financial performance. Revenues for the second quarter of 2026 were 106 million.

Speaker #2: Compared to 261 million in the prior year quarter. This decline mainly reflects lower demand for our COVID-19 vaccine in the U.S. In addition, the prior year quarter was positively impacted by a one-time revenue effect.

Speaker #2: This related to a compensation payment from Pfizer opting out from our shingles vaccines development program. Moving to R&D, adjusted R&D expenses decreased to 477 million from 509 million in the prior year quarter.

Ramón Zapata: Adjusted R&D expenses decreased to EUR 477 million from EUR 509 million in the prior year quarter. This change mainly reflects the execution of our disciplined prioritization across the portfolio. Lower spending on unfocused programs, together with favorable cost-sharing effects from our collaboration partners, supported an efficient cost structure. We continue to invest in our prioritized immuno-oncology and ADC programs, including pumitamab and gotistobart. Moving to SG&A. SG&A expenses on an adjusted and IFRS basis were EUR 198 million, compared to EUR 137 million in the prior year's quarter. This increase was mainly driven by a global initiative on scaling our processes and ERP infrastructure to strengthen efficient operational execution and our ongoing pre-launch activities for late-stage products. Our cost base in 2026 also reflects the inclusion of CureVac operations post-merger.

Speaker #2: This change mainly reflects the execution of our discipline prioritization across the portfolio. Lower spending on non-focused programs together with favorable cost sharing effects from our collaboration partners supported an efficient cost structure.

Speaker #2: At the same time, we continue to invest in our prioritized immuno-oncology and ADC programs including Prometheus and Gotistobart. Moving to SG&A. SG&A expenses on an adjusted and IFRS basis were 198 million.

Speaker #2: Compared to 137 million in the prior year quarter. This increase was mainly driven by a global initiative on scaling our processes and ERP infrastructure to strengthen efficient operational execution and our ongoing prelaunch activities for late-stage programs.

Speaker #2: Our cost base in 2026 also reflects the inclusion of CureVac operations post-Mervin. At the same time, we continue to realize meaningful savings through pipeline prioritization measures and enhanced cost discipline across the organization.

Ramón Zapata: We continue to realize meaningful savings through pipeline prioritization measures and enhanced cost discipline across the organization. Comparing IFRS and adjusted results overall, the key adjustments are as follows. Within R&D expenses, the difference is driven by impairment charges related to intangible assets outside our focused programs. Within other operating results, the difference relates to actions we are taking following our manufacturing footprint consolidation, the decision we announced in May 2026. The costs are mainly employee-related expenses and impairment charges. These charges reflect our progression from announcing that decision to actively executing it. While these costs weigh on our near-term results, they are a deliberate investment in reshaping our future prospects. We are positioning the company for enhanced operational efficiency and expect sustainable savings going forward.

Speaker #2: When comparing IFRS and adjusted results overall, the key adjustments are as follows. Within R&D expenses, the difference is driven by impairment charges related to intangible assets outside our focus programs.

Speaker #2: Within other operating results, the difference relates to actions we are taking following our manufacturing footprint consolidation — the decision we announced in May. The costs are mainly employee-related expenses and impairment charges.

Speaker #2: These charges reflect our progression from announcing that decision to actively executing it. While these costs weigh on our near-term results, they are a deliberate investment in reshaping our future process.

Speaker #2: We are positioning the company for enhanced operational efficiency and expect sustainable savings going forward. Importantly, we are acting from a position of strength, allowing us to make this adaptations proactively since we maintain a strong financial position of 16.6 billion in cash, cash equivalents, and security investment at the end of the second quarter.

Ramón Zapata: Importantly, we are acting from a position of strength, allowing us to make these adaptations proactively, since we maintain a strong financial position of EUR 16.6 billion in cash equivalents, and security investments at the end of Q2, compared to EUR 16 billion as of 30 June 2025. This empowers sustained investments across our pipeline, our preparations for commercialization, and in our long-term goal to become a global multi-product biopharmaceutical company. Before we go into our full-year guidance, let's first turn from the quarter review to our year-to-date financials, comparing the performance of H1 2026 with the prior year period. The drivers are mostly in line with the factors I have described for the quarter. In H1 2026, revenues were EUR 224 million.

Speaker #2: Compared to 16 billion as of June 30th, 2025. This empowers sustained investments across the pipeline, our preparations for commercialization, and in our long-term goal to become a global multi-product biopharmaceutical company.

Speaker #2: Before we go into our full year guidance, let's first turn from the quarterly view to our year-to-date financials. Comparing the performance of the first half of 2026 with the prior year period.

Speaker #2: The drivers are mostly in line with the factors I have described for the quarter. In the first half of 2026, revenues were 224 million.

Speaker #2: While we expect the seasonal phasing of the COVID-19 vaccine business throughout the year, as mentioned, this decline mainly reflects lower demand in the US.

Ramón Zapata: While we expect the seasonal phasing of the COVID-19 vaccine business throughout the year, as mentioned, this decline mainly reflects lower demand in the US. Secondly, lower adjusted R&D expenses of EUR 1,004 million in comparison to the prior year period reflect our focused R&D investments approach in our prioritized programs and positive cost-sharing effects with our collaboration partners. Thirdly, higher adjusted SG&A expenses of EUR 349 million reflect the ongoing pre-launch activities and commercial buildup for our first oncology launches, as well as costs newly incorporated in 2026, like our ERP infrastructure initiative that I already mentioned. As we look to H2, we are taking a disciplined view on our full-year outlook. We anticipate changes in some of the factors driving our business and are revising our previously disclosed full-year 2026 financial guidance.

Speaker #2: Secondly, lower adjusted R&D expenses of $1,004 million in comparison to the prior-year period reflect our focused R&D investments approach in our prioritized programs and positive cost-sharing effects with our collaboration partners.

Speaker #2: Thirdly, higher adjusted SG&A expenses of 349 million reflect the ongoing prelaunch activities and commercial buildup for our first oncology launches. As well as costs newly incorporated in 2026 like our ERP infrastructure initiative that I already mentioned.

Speaker #2: As we look to the second half of the year, we are taking a discipline view on our full year outlook. We anticipate changes in some of the factors driving our business and are revising our previously disclosed full year 2026 financial guidance.

Speaker #2: We now expect revenues in the range of 1.6 to 1.9 billion. Adjusted R&D expenses in the range of 2 to 2.3 billion and adjusted SG&A expenses remaining unchanged in the range of 7 to 800 million.

Ramón Zapata: We now expect revenues in the range of EUR 1.6 to 1.9 billion, adjusted R&D expenses in the range of EUR 2 to 2.3 billion, and adjusted SG&A expenses remaining unchanged in the range of EUR 700 to 800 million. I will now detail the factors driving our revised revenue guidance. While COVID-19 has been endemic for some time, we continue to monitor the evolving vaccine market and expect softer-than-anticipated global COVID-19 vaccine demand. In addition, the European Medicines Agency recommendation issued in May allows the use of the previous year's vaccine formula as an alternative to the newly recommended XFG variant-adapted vaccines. This year, for the first time, Germany will utilize previously manufactured on-stock vaccine doses for the upcoming vaccination season. As a result, we expect significantly reduced sales in Germany this year. Also, the timing of milestone-related revenues resulting from an out-licensed R&D program, which are no longer expected in 2026.

Speaker #2: I will now detail the factors driving our revised revenue guidance. While COVID-19 has been endemic for some time, we continue to monitor the evolving vaccine market and expect softer than anticipated global COVID-19 vaccine demand.

Speaker #2: In addition, the European Medicines Agency recommendation issued in May allows the use of the previous year's vaccine formula as an alternative to the newly recommended XFG variant-adapted vaccines.

Speaker #2: This year, for the first time, Germany will utilize previously manufactured, on-stock vaccine doses for the upcoming vaccination season. As a result, we expect significantly reduced sales in Germany this year.

Speaker #2: Also, the timing of mice-related revenues resulting from an out-licensed R&D program, which are no longer expected in 2026. In terms of revenue phasing, through the rest of the year, we continue to expect the majority of our 2026 revenues to be realized in the second half of the year.

Ramón Zapata: In terms of revenue phasing through the rest of the year, we continue to expect the majority of our 2026 revenues to be realized in H2. Specifically, in Q3, when we expect to recognize the $613 million BMS collaboration payment. Moving to operating expenses, we have revised our adjusted R&D expenses to the range of EUR 2 to 2.3 billion. This reflects our focus on optimizing our R&D resources and continued cost discipline as we prioritize the development of our late-stage clinical pipeline. We expect these cost savings, based on prioritization and optimization, to continue into future years. Our assumption for adjusted SG&A expenses remain unchanged in the range of EUR 700 to 800 million, as we continue to gradually build out our commercial capabilities. Despite these changes, our strong balance sheet and disciplined cost management position us well to continue investing strategically.

Speaker #2: Specifically, in the third quarter when we expect to recognize the 613 million BMS collaboration payments. Moving to operating expenses, we have revised our adjusted R&D expenses to the range of 2 to 2.3 billion.

Speaker #2: This reflects our focus on optimizing our R&D resources and continued cost discipline, as we prioritize the development of our late-stage clinical pipeline. We expect these cost savings, based on prioritization and optimization, to continue into future years.

Speaker #2: Our assumption for adjusted SG&A expenses remain unchanged in the range of 7 to 800 million as we continue to gradually build out our commercial capabilities.

Speaker #2: Despite these changes, our strong balance sheet and disciplined cost management position us well to continue investing strategically. Turning to my final slide and giving you an update on the execution of our capital allocation framework, which we presented during our first quarter earnings call.

Ramón Zapata: Turning to my final slide, I'm giving you an update on the execution of our capital allocation framework, which we presented during our Q1 earnings call. Our approach remains clear and disciplined, centered on three priorities. First, focused R&D investments. Second, disciplined capital deployment. Third, optimized operational efficiency and sustainable value creation. We are executing against these priorities with consistency and intent. As shown on the slide, with respect to the second pillar, we have started the execution on our up to EUR 1 billion share repurchase program and repurchased an amount of EUR 152 million so far. This execution reflects our conviction in the intrinsic value of BioNTech, while importantly, we retain full optionality to advance our pipeline, execute on partnerships, and pursue corporate development opportunities.

Speaker #2: Our approach remains clear and disciplined, centered on three priorities: first, focused R&D investments; second, disciplined capital deployments; and third, optimized operational efficiency and sustainable value creation.

Speaker #2: We are executing against these priorities with consistency and intent. As shown on the slide, we respect to the second pillar we started the execution on our up to 1 billion dollar share purchase program and repurchased an amount of 162 million dollars so far.

Speaker #2: This execution reflects our conviction in the intrinsic value of BioNTech. Importantly, we retain full optionality to advance our pipeline, execute on partnerships, and pursue corporate development opportunities.

Speaker #2: Taken together, our strong financial position and these three pillars of our capital allocation strategy continue to serve as a clearly defined long-term objective. To become a global multi-product company, addressing the high unmet medical needs of cancer patients worldwide.

Ramón Zapata: Taken together, our strong financial position on these three pillars of our capital allocation strategy continue to serve as a clearly defined long-term objective to become a global multi-product company addressing the high unmet medical needs of cancer patients worldwide. On a final note, regarding the announcement of Ugur and Özlem new company and potential contributions by BioNTech, here the discussions are ongoing, and as with all potential deals, BioNTech's guiding principle in the negotiations is to maximize value for patients and our shareholders. With that, I will hand back to the operator to open the call for questions. Thank you.

Speaker #2: On a final note, regarding the announcement of Ugur and Ozlem new company and potential contributions by BioNTech, here the discussions are ongoing and, as with all potential deals, BioNTech's guiding principle in the negotiations is to maximize value for patients and our shareholders.

Speaker #2: With that, I will hand back to the operator to open the call for questions. Thank you.

Speaker #1: Thank you. To ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again.

Özlem Türeci: To ask a question, please press star 11 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 analysts to limit themselves to one question per person. We will now take our first question from the line of Cory Kasimov from Evercore ISI. Please go ahead.

Operator: To ask a question, please press star 11 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 analysts to limit themselves to one question per person. We will now take our first question from the line of Cory Kasimov from Evercore ISI. Please go ahead.

Speaker #1: We kindly ask analysts to limit themselves to one question per person. We will now take our first question. From the line of Cory Qasimov from Evercore ISI, please go ahead.

Cory Kasimov: Hey, good morning, everyone. Thank you for taking my question. I wanted to ask on BNT324, the B7H3 ADC candidate, and what data that you've seen that prompted the decision to choose metastatic CRPC as the first indication for phase III development, and kind of what gives you the confidence that you have a competitive ADC construct here? Thank you very much.

Speaker #3: Hey, good morning, everyone. Thank you for taking my question. I wanted to ask on LVD, the B7-H3 ADC candidate: what data have you seen that prompted the decision to choose metastatic CRPC as the first indication for Phase 3 development, and what gives you the confidence that you have a competitive ADC construct here?

Speaker #3: Thank you very much.

Speaker #4: Thank you, Cory. Ozlem, will you please care to answer the question from Cory?

Ramón Zapata: Thank you, Cory. Özlem, will you please care to answer the question from Cory?

Ugur Sahin: Hi, Cory. I can take the question. What is very encouraging for our B7H3 is the combination of durable disease control, plus the so far excellent safety profile that we are seeing for this B7H3. To remind you, various ADCs come either with challenges related to hematosuppression, stomatitis, or ILDs. With our B7H3 ADC, we see a very tolerable safety profile, allowing us not only to get disease control, temporary disease control, with this compound, but enable long-term application. We have a range of patients who have been dosed now for more than a year, without significant ILD events observed so far.

Özlem Türeci: Hi, Cory. I can take the question. What is very encouraging for our B7H3 is the combination of durable disease control, plus the so far excellent safety profile that we are seeing for this B7H3. To remind you, various ADCs come either with challenges related to hematosuppression, stomatitis, or ILDs. With our B7H3 ADC, we see a very tolerable safety profile, allowing us not only to get disease control, temporary disease control, with this compound, but enable long-term application. We have a range of patients who have been dosed now for more than a year, without significant ILD events observed so far.

Speaker #5: Hi, Cory. I can take the question. So, what is very encouraging for our B7-H3 is the combination of durable disease control, plus the so far excellent safety profile that we are seeing for this B7-H3.

Speaker #5: To remind you, various ADCs come either with challenges related to hematosuppression, stomatitis, or ILDs. And with our B7H3 ADC, we see a very tolerable safety profile.

Speaker #5: Allowing us not only to get disease control temporary disease control, which is compound, but enable long-term application. We have a range of patients who have been dosed now for more than a year.

Speaker #5: Without significant, significant ILD events observed so far. And if I may add to that, Cory, we have presented this data at ESCO 25 and ESCO GU 26, also follow-up data.

Özlem Türeci: If I may add to that, Cory, we have presented this data at ASCO 2025 and ASCO GU 2026, also follow-up data from our heavily pretreated population, which we have tested in a phase I-II study which is still ongoing.

Speaker #5: From our heavily pretreated population, which we have tested in a phase one/two study, which is still ongoing.

Cory Kasimov: Great. Thank you very much.

Speaker #3: Great. Thank you very much.

Speaker #1: Thank you. We will now take our next question. From the line of Taseen Ahmad from Bank of America, please go ahead.

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

Speaker #6: Hi, good morning. Thanks for taking my question. Can you just give us a sense about the data updates that are expected for the remainder of the year?

Tazeen Ahmad: Hi. Good morning. Thanks for taking my question. Can you just give us a sense about the data updates that are expected for the remainder of the year? Can you just remind us how your updated guidance for what data to expect has changed since earlier in the year? Specifically, are we still expecting Pumi China phase III data for triple-negative breast cancer this year? Should there be any expectation that this data would be presented in a press release versus just released at a medical meeting? Thanks.

Speaker #6: Can you just remind us how you're updated guidance for what data to expect has changed since earlier in the year? Specifically, are we still expecting who need China phase three data for triple negative breast cancer this year?

Speaker #6: And then, should there be any expectation that this data would be presented in a press release versus just released at a medical meeting? Thanks.

Özlem Türeci: With regard to changed milestones and specifically also the China interim analysis testing for first-line TNBC, we are continuously monitoring events, and the data readouts are event-driven. In our China TNBC study, we observe that the events take longer. The readout is pushed out to 2027, which in principle is also actually a good sign for us. Another study, which will come a bit later, with regard to its readout, is our pumitamig study in first-line CRPC in China, which is a phase II study. Here we have decided to look in more chemo combinations than originally planned. They are added on top of this. Another readout, which is now projected for 2027, is the gotistobart phase II in second-line positive prostate cancer. The reason is that we want to see more maturity.

Speaker #5: So with regard to changed milestones, and specifically also the China interim analysis testing for first-line TNBC, we are continuously monitoring events. And the data readouts are event-driven.

Speaker #5: And in our China TNBC study, we observe that the events take longer. So the readout is pushed out to 2027, which is in principle is also actually a good sign for us.

Speaker #5: Then another study, which will come a bit later, with regard to its readout, is our Pumita study in first line CRCC in China. Which is phase two study.

Speaker #5: Here, we have decided to look into more chemo combinations than originally planned, so they are added on top of this. And another readout, which is now projected for 2027, is the Gotistobart Phase II in second-line, positive prostate cancer.

Speaker #5: And the reason is that we want to see more maturity. Major milestones and readouts this year are the Gotistobard interim analysis, for the four part two, meaning the pivotal part of our non-small cell lung cancer study in squamous non-small cell lung cancer, second line in combination with docetaxel.

Özlem Türeci: Major milestones and readouts this year are the gotistobart interim analysis for Part 2, meaning the pivotal part of our non-small cell lung cancer study in squamous non-small cell lung cancer, second-line in combination with docetaxel. We are excited about that. Pardon?

Speaker #5: So we are excited about that. Pardon?

Ugur Sahin: Control.

Uğur Şahin: Control.

Speaker #7: Control.

Özlem Türeci: Yes, as a control. We are excited about that. The BNT113 trial, where we expect the phase III interim analysis for progression-free survival later this year, and the T-Pam study in HER2-low hormone receptor-positive metastatic breast cancer.

Speaker #5: Yes, as a control, we're excited about that. Then the BNT113 trial, where we expect a Phase 3 interim analysis for progression-free survival later this year.

Speaker #5: And the TPAM study in HER2 low hormone receptor positive metastatic breast cancer.

Speaker #1: Thank you. We will now take the next question. From the line of David Dye from UBS, please go ahead.

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

David Dai: Great. Thank you, sir, for taking my questions. Just on pumitamig plus chemo in front-line non-small cell lung cancer, we've seen some encouraging phase II data so far, especially showing translation from China to global. I'm just curious, what additional preclinical evidence, or let's say efficacy, safety, or biomarker features give you confidence that pumitamig can be differentiated, VEGF/PD-1 versus other VEGF/PD-1 approaches?

Speaker #3: Oh, great. Thank you for taking my questions. I just for me to make plus chemo in front line non-small cell lung cancer, we've seen some encouraging phase two data so far especially showing translation from China to global.

Speaker #3: I'm just curious, you know, what additional preclinical evidence or, let's say, efficacy, safety, or biomarker features that give you confidence that Pumita can be a differentiated veggie PD-1 versus other veggie PD-1 approaches?

Speaker #5: Maybe I’ll take the questions. With regard to the biospecific class, they have one thing in common: due to the biospecific activity, they enable either improved binding to PD-1 or to PD-L1.

Ugur Sahin: With regard to the bispecific class, they have one thing in common, that they both, due to the bispecific activity, enable either improved binding to PD-1 or to PD-L1. We have one feature which we believe is differentiating with our molecule binding to PD-L1 in the tumor microenvironment. This gives us, in principle, the opportunity to have a double tumor microenvironment-directed compound. Whether this translates at the end of the day to a differentiated efficacy, we have to see. There are, of course, no head-to-head trials here. We believe that the true differentiation will come with the overall portfolio in which we combine pumitamig not only with chemotherapy but with a differentiated set of ADCs and other compounds.

Uğur Şahin: With regard to the bispecific class, they have one thing in common, that they both, due to the bispecific activity, enable either improved binding to PD-1 or to PD-L1. We have one feature which we believe is differentiating with our molecule binding to PD-L1 in the tumor microenvironment. This gives us, in principle, the opportunity to have a double tumor microenvironment-directed compound. Whether this translates at the end of the day to a differentiated efficacy, we have to see. There are, of course, no head-to-head trials here. We believe that the true differentiation will come with the overall portfolio in which we combine pumitamig not only with chemotherapy but with a differentiated set of ADCs and other compounds.

Speaker #5: We have one feature which we believe is differentiating with our molecule binding to PD-L1 in the tumor microenvironment. This gives us, in principle, the opportunity to have a double tumor microenvironment to microenvironment directed compound.

Speaker #5: Whether this translates, at the end of the day, to a differentiated efficacy, we have to see. There are, of course, no head-to-head trials here.

Speaker #5: We believe that the two differentiation will come with the overall portfolio. In which we combine Pumita not only with chemotherapy but with a differentiated set of ADCs.

Speaker #5: And other compounds.

Speaker #1: Thank you. We will now take our next question. From the line of Dina Greybush from Learning Partners, please go ahead.

Operator: Thank you. We will now take our next question from the line of Daina Graybosch from Leerink Partners. Please go ahead.

Daina Graybosch: Hi, thank you for the question. I wonder if you could help us understand your T-Pam comments more. Give us the details. Is there a specific outcome or threshold in the HER2-low breast cancer you're looking to exceed, and how various outcomes from that study could impact your strategy forward with regulators and potentially launching T-Pam?

Speaker #6: Hi, thank you for the question. I wonder if you could help us understand your TPAM comments more. Could you give us the details? Is there a specific outcome or threshold in HER2-low breast cancer you're looking to exceed?

Speaker #6: And how various outcomes from that study could impact your strategy forward with regulators and launching potentially launching TPAM.

Speaker #5: So our TPAM program, as you know, is broader. We are developing TPAM in endometrial cancer, second line, and in breast cancer with our phase three trial in hormone receptor positive HER2 low.

Özlem Türeci: Our T-Pam program, as you know, is broader. We are developing T-Pam in endometrial cancer second-line and in breast cancer with our phase III trial in hormone receptor-positive HER2-low. We have, what is also important to note, ongoing signal-seeking studies of T-Pam with pumitamig in a different breast cancer patient segment, which is an important part of the strategy. Ultimately, our ADCs are part of our portfolio because of their potential to further elevate pumitamig and allow us to leapfrog. With regard to our breast cancer study, the benchmarks are, if you compare with published benchmarks, a medium PFS

Speaker #5: And we have what is also important to note ongoing signal seeking studies of TPAM with Pumita in different breast cancer patient segments, which is an important part of the strategy.

Speaker #5: Because ultimately, our ADCs are part of our portfolio because of their potential to permit us and allow us to leapfrog. With regard to our breast cancer study, the benchmarks are, if you compare with published benchmarks, in PFS—median PFS in the range of 9 to 13 months—and 18-month median OS of around 85%.

Ugur Sahin: In the range of nine to 13 months, 18-month median OS of around 85%, according to other studies in this indication and approved treatments.

Özlem Türeci: In the range of nine to 13 months, 18-month median OS of around 85%, according to other studies in this indication and approved treatments.

Speaker #5: According to other studies in this indication and approved treatments.

Speaker #1: Thank you. We will now take the next question from the line of Jeff Mitcham from Citi Group. Please go ahead.

Operator: Thank you. We will now take the next question from the line of Geoff Meacham from Citigroup. Please go ahead.

Speaker #7: Hey everyone, thanks for the question. Just had a bigger picture one on capital deployment. You know, you guys have a substantial cast position and what you're also streamlining the pipeline, you know, with the cost savings initiative.

Geoff Meacham: Hey, everyone. Thanks for the question. Just had a bigger picture one on capital deployment. You guys have a substantial cash position, but you are also streamlining the pipeline, with the cost savings initiative. On the latter, I guess, can you talk a little bit about what your sort of North Star is in this? Is it deprioritizing overlapping indications? Are you eliminating some earlier stuff based on competitive landscape? I just want to get a sense for the strategy there. Thank you.

Speaker #7: So, on the latter, I guess—can you talk a little bit about what your sort of North Star is in this? Is it deprioritizing overlapping indications?

Speaker #7: Are you eliminating some earlier stuff based on competitive landscape? I just want to get a sense for the strategy there. Thank you.

Ramón Zapata: Hi, thank you for the question. I think because of the cash position that we have and the strength of our balance sheet, we are able to take on the number of pivotal and phase III trials that we are running now with pumitamig. The strategy with our partners is to add on these efforts as much as possible to really widen the net of all the indications where we can use pumitamig and the novel combinations. I would say that our capital allocation priorities remain unchanged. We continue to fully fund our priority pipeline and the commercial capabilities needed to support these upcoming launches. Second, we maintain the flexibility to pursue attractive external opportunities that have the potential to strengthen our portfolio or our capabilities. Third, we continue to return capital to shareholders through the authorized share buyback program that we announced last quarter.

Speaker #3: Hi, thank you for the question. So I think because of the cash position that we have and the strength of our balance sheet, we are able to take on the number of pivotal and phase three trials that we are running now with Pumita make.

Speaker #3: And the strategy with our partners is to add on these efforts as much as possible to really widen the net of all the indications where we can use Pumita and the Nobel combinations.

Speaker #3: So I would say that our capital allocation priorities remain unchanged. We continue to fully fund our priority pipeline and the commercial capabilities needed to support these upcoming launches.

Speaker #3: Second, we maintain the flexibility to pursue attractive external opportunities that have the potential to strengthen our portfolio or our capabilities. And third, we continue to return capital to shareholders through the authorized share buyback program that we announced last quarter.

Speaker #3: So on your comment on portfolio optimization, we continuously review our pipeline to ensure that the resources are focused on the areas with the greatest strategic and value creation potential.

Ramón Zapata: On your comment on portfolio optimization, we continually review our pipeline to ensure that the resources are focused on the areas with the greatest strategic and value creation potential. That means continuing to invest behind our core programs while reducing or stopping investments in non-core assets where we feel it's appropriate.

Speaker #3: And that means continuing to invest behind our core programs while reducing or stopping investments in non-core assets where we feel it's appropriate.

Ugur Sahin: Maybe I can add here another aspect. This year is the year of combination trials where we evaluate pumitamig in combination with our larger ADC portfolio. The results of the studies, of course, will provide further prioritization of the best combinations, thereby reducing maybe the investment in some of the ADCs in certain indications. The overlap at the moment is by purpose, yeah, to identify the winners. In 2027, we expect that we will have identified the winners and engage into several phase III clinical trials, including assets from our partner, BMS.

Speaker #5: And maybe I can add here, another aspect. So this year is the year of combination trials where we evaluate Pumita make in combination with our larger ADC portfolio.

Uğur Şahin: Maybe I can add here another aspect. This year is the year of combination trials where we evaluate pumitamig in combination with our larger ADC portfolio. The results of the studies, of course, will provide further prioritization of the best combinations, thereby reducing maybe the investment in some of the ADCs in certain indications. The overlap at the moment is by purpose, yeah, to identify the winners. In 2027, we expect that we will have identified the winners and engage into several phase III clinical trials, including assets from our partner, BMS.

Speaker #5: The results of the studies, of course, will provide further prioritization of the best combinations, thereby reducing maybe the investment in some of the ADCs in certain indications.

Speaker #5: So the overlap at the moment is by purpose. To identify the winners in 2027, we expect that we will have identified the winners and engage into several phase three clinical trials including assets from our partner BMS.

Geoff Meacham: Great. Thank you.

Speaker #7: Great, thank you.

Speaker #1: Thank you. We will now take the next question from the line of Akash Tiwari from Jefferies. Please go ahead.

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

Akash Tewari: Hey, thanks so much. You have three interim phase II readouts expected in the second half of this year. You have your HER2, your CTLA-4, and then your head neck cancer vaccine. Can you talk about your confidence on a positive interim analysis for each of these programs? Is there a particular program where maybe the team's internal view is particularly bullish? Thanks so much.

Speaker #8: Hey, thanks so much. So, you have three interim phase 3 readouts expected in the second half of this year. You have your HER2, your CDLA4, and then your head and neck cancer vaccine.

Speaker #8: Can you talk about your confidence on a positive interim analysis for each of these programs? Is there a particular program where maybe the team's internal view is particularly bullish?

Speaker #8: Thanks so much.

Ugur Sahin: It's a difficult question. We have to see the data. We are positive. We have, of course, positive expectations for each of the trials. You know that if the data for gotistobart that we have seen in the first part of the phase III clinical trial is recapitulated, this would become a game-changing result in this indication. Everyone knows that docetaxel remained unbeaten for decades now. This would be the first time that if the data are recapitulated, we would have a significant benefit with a mono compound as compared to the standard of care.

Uğur Şahin: It's a difficult question. We have to see the data. We are positive. We have, of course, positive expectations for each of the trials. You know that if the data for gotistobart that we have seen in the first part of the phase III clinical trial is recapitulated, this would become a game-changing result in this indication. Everyone knows that docetaxel remained unbeaten for decades now. This would be the first time that if the data are recapitulated, we would have a significant benefit with a mono compound as compared to the standard of care.

Speaker #5: It's difficult question. So we have to see the data. And but we are positive we have, of course, positive expectations for each of the trials.

Speaker #5: You know that if the data for Gotistobart that we have seen in the first part, of the phase three clinical trials, is recapitulated, this would become a game changing result in this indication.

Speaker #5: Everyone knows that dosetaxel remains unbeaten for decades now. And this would be the first time that if the data are recapitulated, we would have a significant benefit with a mono compound.

Speaker #5: As compared to the standard of care.

Speaker #1: Thank you. We will now take the next question. From the line of Terrence Flynn from Morgan Stanley, please go ahead.

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

Terence Flynn: Hi. Thanks for taking the question. Appreciate the update on your iNeST CRC data coming next year, was wondering if you could help us think about potential read-through from the Moderna Merck iNeST adjuvant melanoma phase III data that we might get this year. What would you be looking for in that data to give you confidence in your own iNeST program? Thank you.

Speaker #7: Hi, thanks for taking the question. I appreciate the update on your INEST CRC data coming next year, but I was wondering if you could help us think about the potential read-through from the Moderna-Merck INT adjuvant melanoma phase 3 data that we might get this year.

Speaker #7: So, what would you be looking for in that data to give you confidence in your own INEST program? Thank you.

Özlem Türeci: In terms of biology and indication, we don't see any read-through opportunities. Melanoma versus colorectal cancer, these are very different biologies and indications and responsiveness to immunotherapy and, in particular, antigen-specific T-cell antigens. We remain committed to the way we are conducting, together with our partner, Genentech, our program focusing on adjuvant settings, focusing also on cancers where checkpoint inhibition immunotherapy has a lower probability of success and does not serve the medical need. You know neoantigen vaccines are not created equal, it's difficult to read from one platform to the other.

Speaker #5: So in terms of biology and indication, we don't see any read through opportunities. Melanoma versus colorectal cancer, these are very different biologies and indications and responsiveness to immunotherapy and in particular antigen specific T-cell antigens.

Speaker #5: We remain committed to the way we are conducting together with our partner Genentech our program focusing on adjuvant settings focusing also on cancers where checkpoint inhibition immunotherapy has lower probability of success and does not serve the medical need.

Speaker #5: And you know neoantigen vaccines are not created equal. So it's difficult to read from one platform to the other.

Speaker #1: Thank you. We will now take the next question from the line of Jessica Fai from JP Morgan. Please go ahead.

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

Jessica Fye [Managing Director, Equity Research Analyst: Great. Good morning, guys. Thanks for taking my question. Ramón, I was hoping you'd help us out with the EUR 400 million reduction to guide to the midpoint. Can you just quantify how much of the change was driven by the milestone pushout versus the German decision to use existing inventory? How much is just softer COVID demand? What specifically was the partner milestone that was pushed out? Thank you.

Jessica Fye: Great. Good morning, guys. Thanks for taking my question. Ramón, I was hoping you'd help us out with the EUR 400 million reduction to guide to the midpoint. Can you just quantify how much of the change was driven by the milestone pushout versus the German decision to use existing inventory? How much is just softer COVID demand? What specifically was the partner milestone that was pushed out? Thank you.

Speaker #6: Hey, good morning guys. Thanks for taking my question. Ramon, I was hoping you could hoping you could help us out with the 400 million reduction to guide the midpoint.

Speaker #6: Can you just quantify how much of the change was driven by the milestone push-out versus the German decision to use existing inventory, and how much was just softer COVID demand?

Speaker #6: And then what specifically was the partner milestone that was pushed out? Thank you.

Speaker #3: Thank you for the question. Most of the adjustment of the guidance is a reflection of the weaker COVID-19 vaccination rates. And the current regulatory and public health environment.

Ramón Zapata: Thank you for the question. Most of the adjustment of the guidance is a reflection of the weaker COVID-19 vaccination rates and the current regulatory and public health environment. It's really incorporating the latest input from our partners and the teams that are operating in our key markets. I would like to remind you that the COVID revenue is back-end weighted into the late Q3 and Q4. This will only reflect until then. Also that we're expecting approximately EUR 613 million revenues from the BMS collaboration. That is also giving us a good uplift for the H2. Based on the information currently available, we believe that this revised range is appropriate.

Speaker #3: It's really incorporating the latest input from our partners and the teams that are operating in our key markets. I would like to remind you that the COVID revenue is back ended weighted into the late Q3 and Q4.

Speaker #3: So, this will only reflect until then. Also, we are expecting approximately $613 million in revenue from the BMS collaboration. That is also giving us a good uplift for the second half of the year.

Speaker #3: So, based on the information currently available, we believe that these revised ranges are appropriate. Now, in relation to the comment of what we were expecting—yes, we were expecting that as well in the second half of the year, but it's not the key driver of the revenue adjustment.

Ramón Zapata: Now, in relation to the comment of license milestone that we were expecting, yeah, we were expecting that as well at the H2, it's not the key driver of the revenue adjustment. It's mainly lower demand across every market, specifically for Germany, it impacts us a little bit different because Germany is a direct market versus the other countries that are Pfizer-managed markets. We get the impact on our revenues a little bit more acute than versus the other markets. I would say if you would think about percentage, 80% is COVID related completely, the rest is the loss of the out licensed milestones that we would expect.

Speaker #3: So it's mainly lower demand across every market and then specifically for Germany, it impacts us a little bit different because Germany is a direct market versus the other countries that are Pfizer, managed market.

Speaker #3: So then we get the impact on our revenues a little bit more acute than versus the other markets. So I would say if you would think about percentage 80% is COVID related completely and then the rest is the loss of the out-licensed milestones that we were expecting.

Speaker #6: Thank you.

Jessica Fye [Managing Director, Equity Research Analyst: Thank you.

Jessica Fye: Thank you.

Speaker #1: Thank you. We will now take the next question from the line of Yaron Weber from TD Cowen. 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 Werber: Great. Thank you. I wanted to ask about ROSETTA-Lung02. ClinicalTrials.gov is showing data in 2029, but you changed the endpoint now to PFS and not OS. Is there any chance that we can get this data potentially earlier? Any sense when you might finish enrollment? Thank you.

Speaker #7: Great, thank you. I wanted to ask about Rosetta Lung O2. ClinicalTrials.gov is showing data in 2029, but you changed the endpoint now to PFS and not OS.

Speaker #7: Is there any chance that we can get this data potentially earlier? And any sense of when you might finish enrollment? Thank you.

Özlem Türeci: We can't at the moment, not speculate on when to expect the data. As compared to waiting for OS, it will be obviously earlier that PFS reads out, but we don't have any guidance for the final readout yet.

Speaker #5: We can't at the moment not speculate on when to expect the data. It as compared to waiting for OS, it will be obviously earlier.

Speaker #5: That PFS reads out, but we don't have any guidance for the final readout yet.

Yaron Werber: Maybe can you just remind us, when you changed the endpoint, did the interim analysis change in any way? Anything you can share would be great. Thank you.

Speaker #7: And maybe, can you just remind us, when you changed the endpoint, did the interim analysis change in any way? Anything you can share would be great.

Yaron Werber: Maybe can you just remind us, when you changed the endpoint, did the interim analysis change in any way? Anything you can share would be great. Thank you.

Speaker #7: Thank you.

Ugur Sahin: With the changed endpoint and the interim analysis for PFS, become now an opportunity to file if it's positive. We can't still, so as Özlem said, it is expected to read out earlier than the interim OS, okay? We can't at the moment say when we are going to expect, because this is again, an event-driven trial, it's the first time in this indication that we evaluate this large population.

Speaker #5: Yeah, with the changed endpoint and the interim analysis for PFS, it will now become an opportunity to file if it's positive. We can't still—so, as I said, it is expected to read out earlier than the interim OS.

Uğur Şahin: With the changed endpoint and the interim analysis for PFS, become now an opportunity to file if it's positive. We can't still, so as Özlem said, it is expected to read out earlier than the interim OS, okay? We can't at the moment say when we are going to expect, because this is again, an event-driven trial, it's the first time in this indication that we evaluate this large population.

Speaker #5: But we can't at the moment say when we are going to expect because this is again an event-driven trial and it's the first time in this indication that we evaluate this large population.

Speaker #1: Thank you. We will now take the next question. From the line of Evan Saigerman from BMO Capital Markets, please go ahead.

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

Evan Seigerman: Hi, this is Evan on for Evan. Thanks for taking our question. Just one from us. As you think about the broader opportunity for pumitamig, can you just talk to how the asset might be differentiated in MSS or CRC, given the historically limited efficacy of checkpoint inhibitors in the indication and immune cold phenotype of tumors? Also, what gives you confidence that Pumu's mechanism could overcome these past challenges? Thank you.

Speaker #8: Hi, this is Haben on for Evan. Thanks for taking our question. Just one from us. So as you think about the broader opportunity for pemetamib, can you discuss how the asset might be differentiated in MSS, CRC, given the historically limited efficacy of checkpoint inhibitors and the indication?

Speaker #8: And immune-cold phenotype of tumors. And then also, what gives you confidence that PUMI's mechanism could overcome these past challenges? Thank you.

Speaker #5: Yeah. To provide because we do not yet have data in CRC, the strongest evidence that pemetamib is or the bispecific class is differentiated comes from the observations of objective response rate, but also durable disease control in patient populations who are PDL1 negative.

Ugur Sahin: Yeah. Because we do not yet have data in CRC, the strongest evidence that pumitamig or the bispecific class is differentiated comes from the observations of objective response rate, but also durable disease control in patient populations who are PD-L1 negative. For example, in TNBC, we have documented data showing more or less the same rates of objective response in the patient, in PD-L1 positive, PD-L1 low positive, and PD-L1 high positive patient populations. CRC is an indication in which checkpoint blockade was not successful. We have now this combination, and we have to see from our interim analysis, which is coming in 2027. We are going to test, or we are testing at the moment, different chemotherapy combinations, whether this translates to better data as compared to traditional benchmarks with chemotherapy alone.

Uğur Şahin: Yeah. Because we do not yet have data in CRC, the strongest evidence that pumitamig or the bispecific class is differentiated comes from the observations of objective response rate, but also durable disease control in patient populations who are PD-L1 negative. For example, in TNBC, we have documented data showing more or less the same rates of objective response in the patient, in PD-L1 positive, PD-L1 low positive, and PD-L1 high positive patient populations. CRC is an indication in which checkpoint blockade was not successful. We have now this combination, and we have to see from our interim analysis, which is coming in 2027. We are going to test, or we are testing at the moment, different chemotherapy combinations, whether this translates to better data as compared to traditional benchmarks with chemotherapy alone.

Speaker #5: For example, in TNBC, we have documented data showing more or less the same rates of objective response in the patient in PDL1 positive, PDL1 low positive, and PDL1 high positive.

Speaker #5: So CRC is an indication in which checkpoint blockade was not successful. We now have this combination, and we have to see from our interim analysis, which is coming in 2027.

Speaker #5: We are going to test or we are testing at the moment different chemotherapy combinations whether this translates to better data as compared to traditional benchmarks with chemotherapy alone.

Speaker #5: And so but the broader pemetamib opportunity again is based on the one side improving response rate and durable disease control and OS in indications where checkpoint blockade PD1 is approved.

Ugur Sahin: The broader pumitamig opportunity again is based on the one side, improving response rate and durable disease control and OS in indications where checkpoint blockade PD-1 is approved, opening up indications in which PD-1 treatments are not approved. As a third component, combining pumitamig as a potential next standard of care with a new generation of ADCs that allow disease control even in advanced disease with a good safety profile.

Uğur Şahin: The broader pumitamig opportunity again is based on the one side, improving response rate and durable disease control and OS in indications where checkpoint blockade PD-1 is approved, opening up indications in which PD-1 treatments are not approved. As a third component, combining pumitamig as a potential next standard of care with a new generation of ADCs that allow disease control even in advanced disease with a good safety profile.

Speaker #5: Opening up indications in which PD-1 treatments are not approved. And as a third component, combining pemetamib as a potential next standard of care with a new generation of ADCs that allow disease control even in advanced disease, with a good safety profile.

Speaker #1: Thank you. We will now take the next question. From the line of Mohit Vansal from Wells Fargo, please go ahead.

Operator: Thank you. We will now take the next question from the line of Mohit Bansal from Wells Fargo. Please go ahead.

Mohit Bansal: Great. Thank you very much for taking my question. I have a question regarding squamous versus non-squamous. There will be a lot of data coming this year from competitors as well. The first trial that is reading out is for squamous lung cancer for VAXJPD1. My question is, how much read-through there could be for the non-squamous program if squamous were to be successful, and what specifically you would be looking at the competitor data to gain confidence in your own programs or think about the future trials? Thank you.

Speaker #4: Great. Thank you very much for taking my question. I have a question regarding screen versus non-screen. So there will be a lot of data coming this year from competitors as well.

Speaker #4: So, the first trial that is reading out is in squame lung cancer for VAJFPD1. My question is: how much read-through could there be for the non-screen program if squames were to be successful?

Speaker #4: And what specifically would you be looking at in the competitor data to gain confidence in your own programs or to think about future trials? Thank you.

Özlem Türeci: With regard to the read-through, in principle, these histologies are like different diseases, right? We would be very cautious to read from data in squamous to non-squamous, or vice versa. We really need to produce the clinical data for both histologies. In our ROSETTA-Lung-02 trial, for example, we have therefore also separated both histologies in sub-trials.

Speaker #5: With regard to the read-through, in principle, these histologies are like different diseases, right? So we would be very cautious to read from data in squamous to non-squamous, or vice versa.

Speaker #5: So we really need to produce the clinical data for both histologies and in our Rosetta Lung O2 trial, for example, we have therefore also a separated both histologies in subtrials.

Ugur Sahin: On the other side, our own data, also the data coming from ivonescimab indicate that in both indications, PFS is improved. We have seen now in the recent update that the improved PFS appears also to translate into OS signals in other indications. We are cautiously optimistic that we will see in both indications PFS benefit and OS benefit.

Speaker #5: But on the other side, the data—our own data, but also the data coming from IVU—indicate that in both indications, PFS is improved.

Uğur Şahin: On the other side, our own data, also the data coming from ivonescimab indicate that in both indications, PFS is improved. We have seen now in the recent update that the improved PFS appears also to translate into OS signals in other indications. We are cautiously optimistic that we will see in both indications PFS benefit and OS benefit.

Speaker #5: And we have seen now in the recent update that the improved PFS appears also to translate into OS sickness in other indications. So we are cautiously optimistic that we will see in both indications PFS benefit and OS benefit.

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

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