BioNTech SE (BNTX) Q3 2026 Earnings Call Transcript

Thank you, Operator. Good morning and good afternoon, everyone. Thank you for joining Biontech's third quarter 2026 earnings call. As a reminder, the slides we will use during this call and the corresponding press release can be found in the investor section of our website. Please also note we will refer to both IFRS and adjusted non-IFRS financials. Our earnings release materials include reconciliation of the adjusted results to the most directly comparable measures based on IFRS accounting standards. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the U.S. Securities and Exchange Commission, 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 find the agenda for today's call. I'm joined by the following members of Biontech's management team. Uga Shaheen, Chief Executive Officer and Co-Founder. Oslom 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 Hanekamp, Chief Commercial Officer. With this, I'll hand the call over to Uga.

Thank you, Doug. A warm welcome to everyone joining us today. We have made good progress against our strategic milestones set out for 2026, reflecting our continued commitment to advancing our pipeline. First, we are accelerating the late-stage development of our oncology assets. At the World Conference on Lung Cancer in September, we presented updated overall survival data for Grotistobard from the non-peeratural stage of our global phase 3 trial in patients with scramus non-small cell lung cancer who progressed on prior checkpoint inhibitor treatment. Grotistobard nearly doubled median overall survival compared to the standard of care chemotherapies. This is a setting where chemotherapy has remained the standard of care for more than a decade, and with Cotistobat, we aim to provide a chemotherapy-free monotherapy for patients who progressed after first-run therapy. We are encouraged by the data, and the pivotal stage of the trial is ongoing. Second, our combination therapy strategy continues to gain momentum. We recently entered into a clinical trial collaboration and supply agreement with Gilead to evaluate prumetamib in combination with their TROP2-directed antibody drug conjugate as first-line treatment for patients with metastatic PD-L1 low or negative triple-negative breast cancer. If approved by regulators, this would be the first phase III trial of Promethamic in combination with an antibody drug conjugate and an important milestone in advancing our combination therapy strategy towards registration. Third, we continue our shift from a platform-centric to a tumor-centric clinical development approach in cancers with the greatest unmet medical need. At World Lung Congress, we presented the first global combination data for any anti-PD-L1 BGF by specific immunomodulator and an ADC in lung cancer. This combination of Prometamic and LCD demonstrated encouraging early efficacy and manageable safety profile in small cell lung cancer, the cost line of treatment, including activity in first-line patients. These data are the sickness-seeking evidence we set out to generate this year. The observed clinical responses are encouraging and speak to the potential of novel-novel combinations in lifting survival curves. These data we have seen support our Phase III registration and planning for Vomitamix in combination with LVD. Looking ahead, Biontech is well positioned for the next phase of growth. With a growing pipeline of potentially registrational trials, strong partnerships and financial strengths, we are on track to become a diversified multi-product company by 2030. Our latest development program includes multiple pivotal trials readouts to 2030 and beyond, spanning multiple tumor types and different lines of treatment. As we announced last quarter, Guido Oelkers will take office as CEO by 1st February at latest. I'm confident that he will bring in his valuable experience to continue advancing BioNTech's unique and strong pipeline. Management and Supervisory Board members have been actively engaged in supporting a seamless transition. We have built BioNTech from a start-up into a global biopharmaceutical company with a strong foundation across next-generation immunomodulators, ADCs, and messenger RNA. We have also established a distinguished combination therapy strategy in oncology. At the heart of our work is a shared purpose, advancing medical innovation to improve patient life. Our employees have been instrumental in bringing this purpose to life with their expertise, dedication, and commitment. It is their collective contribution that helps turn scientific discovery into meaningful progress for humanity and better outcomes for patients. We see significant potential in BioNTech. As this will be my last earnings call, I would like to thank the many exceptional and dedicated BioNTech team members and leaders, the management and the supervisory board, our founding partners, shareholders, and collaborators. I would also like to thank the patients, investigators, and other healthcare professionals who have been contributing to our tribe and our colleagues in the science community. Without all the contributors, none of this would have been possible. The impact we have created together to break through innovation for science, medicine, and patients is something I will look back on with gratitude. While we hand over the operational responsibility to our successors, Esdem and I will continue to follow BioNTech as founding shareholders. With this, I will hand over to Esdem.

Thank you, Ugoa. I'm glad to be speaking with everyone today. Our ambition at BioNTech is to address the full continuum of cancer care by exploring the synergies of immune modulators, ADCs, and mRNA cancer immunotherapies. We have defined a tumor-type-focused strategy to address unmet medical need in disease areas where our novel combinations can extend survival for patients. In the past two months, we presented data at key conferences for three of our leading product candidates, Pumetamik, Gotistobard, and LVD. The data validate their potential clinical benefit across key tumor types, most notably in lung cancer. I will review the data and discuss how it is supportive of the lung cancer franchise BioNTech is building. Lung cancer is an area of high medical need, and we have a broad and diverse development approach to maximize our pipeline potential. At the core of our approach is Pumitamik, a bispecific immunomodulator targeting PD-L1 and VEGFA, being developed with our partner BMS across multiple tumor types. I will focus on non-small cell lung cancer first. We are running four registrational programs for POMITAMIC in combination with standard of care on monotherapy. In parallel to these registrational trials, we are generating novel, novel combination data with our ADCs and our mRNA immunotherapies to inform the first wave of chemotherapy-free combination trials with registrational intent. Gotistobat is another key candidate of our non-small cell lung cancer strategy. As a reminder, Gotistobat is a selective T-REC depleting antibody targeting CTLA-4, developed with Oncocifor. We are advancing Gotistobard through the pivotal stage of a global phase 3 trial in patients with metastatic squamous non-small cell lung cancer who progressed following platinum-based chemotherapy and checkpoint inhibitor treatment. This is a setting with very few effective options and poor prognosis where median survival with current standard of care is less than one year. At the World Conference on Lung Cancer, we presented updated overall survival data from the non-pivotal initial part of this trial with a median follow-up of 25.4 months. Median overall survival was 18.5 months with gotistobard versus 10 months with docetaxel with a hazard ratio of 0.56. Gotistobard reduced the risk of death by 44% compared with chemotherapy. The observed safety profile of gotistobat was consistent with previous findings. These results reinforce the potential of cotistobat to provide a significant overall survival benefit as a chemotherapy-free monotherapy in this large, underserved patient population. In the pivotal part of the trial designed with identical protocol inclusion and exclusion criteria to stage 1, we anticipate an interim analysis before year end. This serves as an early data point ahead of a next pre-planned interim analysis next year. Now turning to small cell lung cancer, where we are evaluating Pumitamik in combination with chemotherapy, in combination with a DLL3 T-cell engager, and in combination with LFD in front and later lines. LFD is our B7H3-targeted ADC developed with Duality Bio. LFD's clinical profile positions it as a potentially versatile oncology asset across a wide range of solid tumors. More than 1,000 patients have now been treated with LFD across over 10 tumor types, including more than 500 patients treated with LFD in combination with Pumitamik. This was a global data set from our phase 1-2 trial of Pumitamik plus LFD in patients with advanced small cell and non-small cell lung cancer. This combination brings together three independent mechanisms of action. Checkpoint inhibition, VGFA neutralization, and the tumor cell-targeted cytotoxic payload of LFD. In 71 patients with small cell lung cancer across four dose levels, the combination showed a remarkable 92% overall response rate in first line, 76% objective response rate in second line, and 52% objective response rate in third line and later. Importantly, we saw activity in patients previously treated with immunotherapy with a 60% objective response rate and in the small group of patients previously treated with a DLL-free targeted T-cell engager with an encouraging 88% response rate. The safety profile was manageable and consistent with data from each agent individually, with limited overlap between PUMI-TAMIC and LPD-associated toxicities. No dose-limiting toxicities were observed, and the ILD rate for the combination was 2.9%. These combination data support our broader strategy of evaluating PUMI-TAMIC as a potential backbone for combination regimens of complementary mechanisms. They will help to inform the clinical development strategy to address today's unmet need and tomorrow's evolving small-cell lung cancer standard of care. These data we have seen in this trial will help guide our novel-novel combination strategy in lung cancer into potential registration with first trials expected to begin in 2027. From triple-negative breast cancer, our Pumitermic plus ADC combination strategy is now entering the pivotal stage. At ESMO Breast in May, Bumitermic, in combination with a TROP2-targeted ADC, showed a confirmed objective response rate of 76.7% and a disease control rate of 96.7% as first-line treatment in 30 patients with metastatic triple-negative breast cancer. These data confirmed that Bumitami combined with a TROP2 ADC has a manageable safety profile and warrant further investigation as first-line treatment. When we initiated Rosetta Breast 01, chemotherapy was the only option for patients with PD-L1-negative advanced TNBC. However, in 2026, the standard of care for first-line TNBC changed following updated NCCN and ESMO guidelines as well as the FDA approval of drop-2 ADCs. Dropped through targeted ADCs, such as Satchituzumab-Govitecan, are quickly becoming the new standard of care. As a result of the evolving treatment landscape, we are adapting Rosetta-Breath-01 to replace chemotherapy with Satchituzumab-Govitecan. We have entered into a clinical collaboration with Gilead. Pending the green light from regulators, this would be the first global phase 3 trial of our PD-L1 EGF bispecific, Pumitamik, in combination with an antibody drug conjugate. Adapting Rosetta Breast O1 to reflect the evolving standard of care gives the trial the best chance to inform clinical practice and ultimately treatment decisions for patients. Moving to mRNA cancer immunotherapies. As announced in August, the decision was made in alignment with Genentech to discontinue the phase 2 trial of autogen subumaran as adjuvant immunotherapy in ctDNA-positive, stage 2 high-risk, or stage 3 colorectal cancer. This decision followed a review from the Independent Data Safety Monitoring Board, in which they identified a numerical imbalance in overall survival between the treatment arms in this specific patient population and determined that continuing the trial was unlikely to change the efficacy outcome. No new safety signals were identified. The Phase II IMCODE-003 trial in atrivent pancreatic cancer, where autogen savumaran is being evaluated in combination with atezolizumab and modified falfirinox, has completed enrollment and continues as planned. BNT113, our office-shelf mRNA immunotherapy is being evaluated in a pivotal phase 2-3 trial in combination with pembrolizumab versus pembrolizumab alone as first-line treatment for patients with metastatic HPV16-positive PD-L1 expressing head and neck cancer. In October, we announced top-line results from the first pre-specified interim analysis of a head merit. While the trial did not meet its first dual primary endpoint of progression-free survival, it is continuing as planned to assess the second dual primary endpoint of overall survival. The Independent Data Monitoring Committee recommended that the trial continue in accordance with the trial protocol. As immune-mediated anti-tumor effects build and deepen over time, the analysis of the overall survival endpoint will be critical to fully assess the potential of this approach to deliver durable benefit for patients with HPD-driven head and neck cancer. Under the trial statistical design, which pre-specifies dual primary endpoints of PFS and OS, a statistically significant improvement in OS would establish a positive trial outcome, irrespective of the PFS result. BioNTech is leveraging novel combinations with next-generation I.O., targeted therapies, and mRNA cancer immune therapy to maximize pipeline potential and elevate outcomes for patients with solid tumors. The potential of mRNA cancer immunotherapies in combination regimens lies in the ability to induce immune responses that may translate into durable clinical benefit and ultimately prolonged survival of patients. Let me now move to our other late-stage milestones. Recently, we announced that our global phase 3 trial evaluating TPAM, an investigational HER2 ADC, developed in collaboration with Duality Bio in patients with HR positive HER2 low metastatic breast cancer after endocrine therapy, who are chemotherapy-naive, met its primary endpoint, demonstrating a statistically significant yet modest improvement in progression-free survival. At this interim analysis for the secondary endpoint of overall survival, data were not mature. A higher rate of interstitial lung disease was reported in this trial compared to prior trials, with most cases being grade 1 and 2. Severe and fatal events were reported in a small proportion of patients. Otherwise, the overall safety profile was consistent with prior clinical trials and no new safety signals were observed. The available efficacy and safety data as of this data cut-off date suggests that the potential benefit to patients would be limited in the context of the HR+, her too-low metastatic breast cancer treatment landscape. We and DualityBio are currently discussing the totality of clinical data for Trastuzumab pamirtecan across endometrial and breast cancer within the context of the evolving treatment landscape and areas of unmet medical need and will determine the next steps. We and DualityBio are discussing plans for BLA submission and will update the markets accordingly. Looking ahead, we are on track for the first interim analysis for gotistobard in squamous non-small cell lung cancer before year-end. This will be assessed by the IDMC to recommend whether to unblind the trial or continue to the next pre-planned interim analysis. Beyond the various late-stage readouts this year, we also further advanced our late-stage pipeline and initiated six-phase retrials. In 2026, we published several data sets from our novel novel programs with more to come. We executed these earlier combination trials to provide the signal-seeking evidence to inform and potentially de-risk the move of our combination trials into the pivotal stage. This provides the foundation for advancing BioNTech's growing late-stage oncology pipeline towards first approvals. With that, I would like to echo Ugo and thank our exceptional team at BioNTech for their conviction, for their loyalty, and dedication. Building this company together has been an unforgettable experience, from the humble foundations to receiving approval of the first mRNA-based product, To creating the diversified oncology pipeline we have today. My thanks also go to our partners, investigators, regulators, healthcare professionals, and the patients and their families who have placed their trust in us. Turning the presentation over to our CFO, Ramon Zapata.

Ramon Zapata Thank you, Oslem, and welcome to everyone joining us. I will start with our third quarter and year-to-date 2026 financial results, then provide an update on our full year 2026 financial guidance and capital allocation highlights. Note that all figures are in euros, unless otherwise stated, beginning with financial performance. Revenues for the third quarter of 2026 were 1.3 billion euros. Compared to 1.5 billion euros in the prior year third quarter. This decline mainly reflects anticipated lower market demand for our COVID-19 vaccine. As expected, revenues of 613 million were recognized in the quarter from our global strategic partnership with BMS, related to the co-development and co-commercialization of our next generation by specific antibody candidate, Pumitami. Adjusted R&D expenses for the third quarter of 2026 increased to 579 million euros. From 479 million euros in the prior year third quarter, the increase reflects greater investment in our prioritized I.O. and ADC programs, partially offset by lower spending outside of our strategic focus. On an IFRS basis, R&D expenses were $748 million. The additional expenses of $169 million include impairment losses related to intangible assets, which are outside of our strategic focus. SG&A expenses for the third quarter of 2026 on an adjusted and IFRS basis were $179 million compared to $149 million in the prior year third quarter. The increase was mainly driven by pre-launch activities for late-stage programs and the commercial build-up, as well as our ongoing global initiative to scale processes and ERP infrastructure to optimize operational execution. At the same time, we continue to realize meaningful savings from strategic pipeline prioritization execution and enhanced cost discipline across the organization. Our strong financial position of $16.2 billion in cash, cash equivalents, and security investments at the end of the third quarter provides the foundation to advance our ambition of becoming a global multi-product biopharmaceutical company by 2030. Let's now turn from the third quarter to our nine-month year-to-date 2026 financials. Comparing this year's performance with the same nine-month period of the prior year, drivers are mostly in line with the factors I have described for the quarter. Revenues were $1.5 billion for the year-to-date 2026, compared to $2 billion in the prior year period. Adjusted R&D expenses were $1.6 billion, compared to $1.5 billion. Adjusted SD&A expenses came in at $527 million, up from $407 million. Overall, our yes-to-date performance is aligned with our expectations. Our revenue performance in the third quarter allows us to raise the midpoint of our previously provided full-year 2026 revenue guidance. Our updated 2026 financial revenue guidance is now $1.7 to $1.9 billion. Our adjusted R&D and SG&A expense guidance for 2026 remains unchanged at $2 to $2.3 billion and $700 to $800 million, respectively. I will now touch on our capital allocation strategy. Our approach remains centered on prioritizing investments towards our highest value opportunities, with a focus on advancing late-stage programs towards potential approvals and launches, while investing selectively in earlier-stage innovation. This approach is designed to create diversified revenue streams and lay the foundation for a sustainable, long-term oncology business. Our strong balance sheet provides us with the flexibility to complement our portfolio, strengthen our focus areas, and access external innovation where we see strong strategic alignments. At the same time, we continue to return capital to shareholders. Since the implementation of the share buyback program in June, we have repurchased approximately 5 million shares through September 30th. Reflecting our belief in the intrinsic value of BioNTech, while maintaining full optionality to advance our pipeline, execute partnerships, and pursue corporate development opportunities. We remain focused on operational efficiency and disciplined resource allocation, optimizing our portfolio, manufacturing footprint, and cost structures to focus resources on our highest value priorities. This is reflected in our recently divested JPT Peptide Technologies business and ongoing manufacturing footprint consolidation, where we continue to assess other areas where we can elevate operational efficiency. We are also taking steps to simplify our AI operational model and strengthen its integration across BioNTech. We plan to integrate the expertise and capabilities of InstaDeep, our wholly-owned AI and machine learning subsidiary, into BioNTech's core business. As part of this initiative, we expect to focus AI development on supporting our strategic objectives, operational processes, and innovation priorities. We believe this more integrated approach will reduce complexity and enable us to deploy AI more effectively. Our conviction in mRNA is anchored by over a decade of translational and clinical research, as well as deep experience in the field. We continue to advance mRNA cancer immunotherapies and invest in them as a key pillar of our oncology strategy, including novel combination approaches intended to maximize the potential of our diversified oncology pipeline. Irrespective of our conviction in the drug class as such, we assess and optimize the financial structure of our existing collaborations. We have exercised an option in the Roche-Genentech-BioNTech collaboration agreement under which future R&D costs for this program will be reassigned to Roche-Genentech, including assessing the candidate in adjuvant pancreatic ductal adenocarcinoma, or PDAC. BioNTech will be eligible to receive royalties. The decision to exercise the option aligns with our broader capital allocation framework as we optimize operational efficiency. With this, we aim for an improved financial structure under the terms of the agreement, which does not affect our ongoing clinical program. This means the ongoing Phase II clinical trial in PDAC continues as planned, and we are excited to see more data from this mRNA cancer immunotherapy program. Taken together, our strong financial position and disciplined capital allocation approach support our long-term objective of becoming a global multiplayer company addressing the unmet medical needs of cancer patients worldwide. We remain focused on prioritizing investments that advance our pipeline and support sustainable growth while preserving the financial flexibility to respond to evolving opportunities. Finally, discussions regarding Uber and Oslem's new company and potential contributions from BioNTech remain ongoing. Any potential arrangement will be evaluated based on its strategic rationale and its ability to maximize value for patients and our shareholders. While there is an opportunity for a deal at this stage, it is optional for both parties and not a necessity. Before I close, since this is the last earnings call that we have with the co-founders of BioNTech, I would like to wish Ugor and Oslen all the best in their new venture. I also want to thank them personally for their vision, leadership, and extraordinary contributions. Together, they built BioNTech from a bold idea into a global pharmaceutical pioneer. They advanced science that has changed lives. Help patients around the world and achieved a medical breakthrough, which has entered the history books. We are deeply grateful for everything they have done for this company and the foundation they leave is one we are proud to build on. With that, I will hand it back to the operator to open the call for questions. Thank you.

Thank you. We will now begin the question and answer session. If you wish to ask a question, you will need to press star 1 1 on your telephone and wait for your name to be announced. Please limit yourself to one question only. To withdraw your question, please press star 1 1 again. Your first question comes from Akash Tawawi from Jefferies. Please go ahead. Your line is open.

Hey, thanks so much, and Ugar and Aslam, really congrats on an amazing tenure at BioNTech. Two for you. One, is your team more confident on hitting on the first or second interim for GOTISABART? I know in the prior data, there was kind of a late-onset curve separation on OS. So, um... I would love to understand which one of these interims investors should be paying more attention to. And then a bit on cancer vaccines. So it sounds like you're changing the economic agreement with Roche, but I think maybe stepping back, where does your team stand in terms of cancer vaccines, especially with the new management team coming forward? Do you think that we'll see a doubling down, potentially going into a precancerous earlier stage setting, trying different combination approaches, or is, you know, the biontech vision really at this point focused on Puminimate going forward? Thank you.

Apesh, I can take the first question. We are very excited about Gotisdobat, and as you know, in the

non-pivotal first part of the trial, we have seen and just recently reported a near doubling of median OS. Yes. We are waiting for the first interim analysis, which will happen this year. The second one will happen next year. I have to admit that the first one is early. So even though we are excited, we will not be disappointed if we cannot see a clear signal.

Thank you, Akash.

I will take on the second part of your question that is related to mRNA and our commitment to it. What I would say is that the changes in the genetic collaboration are mainly a resource allocation decision from us, as it will give us further flexibility to allocate resources to other priority programs in our pipeline. That by no means should be understood as a lack of commitment. We continue to be very excited about the PDAC program, are very much looking forward for its next milestones and readouts. And in terms of the new management, I think it's a little bit premature to talk about what the priorities would be. What I can mention is that our current strategy and one of the pillars of our current strategy is to continue to work in mRNA. We have the capabilities, we have the skills, and I believe the right to be a very strong participant in the market, and so we continue to advance our 1-1-3 program, 1-1-6, PDAC with Genentech, and also some further efforts in early stage and innovating on our mRNA platform, be it fix-back, the off-the-shelf platform, or even the individualized vaccines.

Thank you.

We will take our next question. Your question comes from Mawit Ransal from Wells Fargo. Please go ahead. Your line is open.

Great. Thank you very much for taking my question. And I just wanted to understand a little bit about the cancer vaccine program. So we're looking at both the PDAC and colorectal cancer, and they both are relatively IO or less immunological diseases. Can you help us understand if there is any read-through from colorectal cancer to PDAC, and how should we think about your confidence in the personalized cancer therapy going forward Thank you, Mohit, for your question.

I can give some background to how we see the read-through from colorectal cancer to PDAC. In principle, these are two different questions asked and two different experiments. It's correct that both are cold tumors and both are tumors with tumor mutational burden being more on the lower side. However, these are, on the one hand, entirely different tumor biologies and also different settings of positioning the vaccine. What I mean with this is that In the colorectal cancer trial, we have used our vaccine in a monotherapy setting as an actual vaccine. In the PDEC setting, it is integrated into chemotherapy and also combined with checkpoint inhibition.

Thank you. We will take our next question. The question comes from Dana Graybosch from Lear Inc. Partners. Please go ahead. Your line is open.

Hi. I also want to echo my gratitude and congratulations for your next steps for UGR and OSLIM. My question is on the Trope 2 ADC. I wonder if you can tell us the status of your own Trope 2 ADC, which you had previously licensed? from Duality Bio. And how are you thinking about combinations of PUMI with CHOP2 ADCs outside of TMBC? Are you looking at endometrial, where Gilead has an ongoing phase two trial? But what about lung and other indications where competitors are combining their VEGFI specifics or planning to with their CHOP2 ADCs? Thank you.

Yes, thank you, Dana, for your question. You know, we see our ADC portfolio as a broader design space to combine with Pumita, and we have for all of our ADCs signal-seeking trials in combination with Pumita ongoing across indications. This includes our top two ADC, but also the others. And we are now at a stage where we have a large body of data, and our approach is that we are assessing not with a single ADC lens, But, in fact, comparing these different targeted ADCs for their potential to bring clinical benefit in diverse, in different indications in combination with Pumita. We will be able to be more concrete which ADC we want to further develop in which indication as a combination with UNITA.

Yeah, thank you, Aslim, and this is Anne-Marie. I will just also add that in line with our strategy, what we shared before on Permitamik, we believe that this next-gen bispecific will be the backbone in different settings and cancer types, and that we're moving this ahead with our partner BMS in chemo combinations, but also, to your point, in combination with other assets, and ADCs are a core part of that. And we're not only moving those forward with our own portfolio or BMSs, but also, as you've seen during our announcement at ESMO, moving that forward with, in this case, Gilead's ADC. So we're closely monitoring the field. There's been some interesting data. And including in lung cancer. And if you look at our strategic priorities, we're definitely focused with multiple shots on goal in lung cancer, breast cancer, but also GI and GU cancer. So we will continue to evaluate, follow the science, and then decide which asset is best combined with pomidomik, where we believe transformational benefits can be delivered on top of the chemo benefit that we're hoping to see in the first wave of combinations with pomidomik.

Thank you. We will take our next question. Your question comes from Tazeen Ahmed from Bank of America. Please go ahead. Your line is open.

Okay, great. Thanks for taking my question, and also my back to Uber and Awesome for all their contributions as well. Can I just get some clarification about whether you've had any meetings with FDA on the exact path forward for a go-to support? I'd love to hear your thoughts on what to expect after you reveal this data set that's coming up.

And then on the...

Roche Collaboration. I was just curious to know, you guys have a really strong balance sheet, so what's the real driver of wanting that expense to really be carried by them? And does that, in exchange, also give them more influence about the pace of development and which indications will go into development? Thank you.

I can take the first question, Tessine. With regard to gotistobat, we did not have so far detailed discussions with regulatory authorities. We have an understanding how the path forward would be, and we will further refine that on the totality of data we will see in part two of the trial, and we will then engage with regulators.

And then, Haitas, in terms of the Roche collaboration, so to be clear, the existing agreement remains in place. What we have done is exercised a contractual option where, as of January 1st, we will transition from a 50-50 cost-profit sharing to royalty-based economics. So now you're totally true. So we are operating from a position of strength with the balance sheet and the cash that we currently have. However, we are also advancing the late stage, a number of late stage programs in a way that are now meaningfully. Needing investment. So this is really and truly a capital allocation decision. We continue to retain potential royalty upside and transitional supply responsibilities to the PDAC program, and we continue with the excitement about that program, but we are now, you know, providing that financial flexibility to other pieces of our pipeline. So that is pretty much the reason of why we have

exercised this contractual option.

Thank you. We will take our next question. Your question is from David Dye from UBS. Please go ahead. Your line is open.

Oh, great. Thanks for taking my questions. Also, I want to add my congratulations to Uyghur and Auslan. And so, just on permitamate, we have seen some pretty encouraging data, especially from global trials that seem to replicate the efficacy and safety profile of China trials. So, I'm just curious, what are your latest thinking on the China global translation based on totality of data generated? How should we think about the efficacy and safety translation in the phase three pivotal trials in 2007 and onwards.

David, the question was what we are thinking about translation from China or regional into global. Did I get that right?

Yes, that's right. Yes.

Yeah, so I think the class as such, not only Pumita, but also Pumita, has shown in several cases that there is translation from regional China data into global data. Our recent data packages, our data sets in TNBC and small cell lung cancer, for example, have shown that so that we are very confident that this is something we can rely on.

Thank you. We will take our next question, and the question is from Asad Haider from Goldman Sachs. Please go ahead. Your line is open.

Great. Thanks for taking the question and congrats and best of luck to Uga and Aslam. Maybe just going back to the cancer immunotherapy, asking it a little differently, there's now a validation in melanoma for mRNA cancer immunotherapy and the market's rewarding innovation there. So just are you going to shift your strategy to pursue the more validated approaches and tumor types? Just curious as to what tumor types and settings you would be prioritizing. And if I may, on Pumidamig, just with Summits, how many three data are approaching? We'd be interested in your latest thinking on how you're thinking about this readout as it relates to the read-across to your own development strategy for Pumina Make.

Thank you. I can take the question.

Did not fully get which trial you were referring to. Could you repeat as that?

Yeah, sure. Just with the Summit Harmony 3 data approaching, just curious as to hear your latest thinking on, you know, what this readout means as it relates to the read across to your own development strategy. What, you know, what are you looking for there? How should we be looking at that readout with respect to how you're thinking about your own development? Thank you.

Yes, sorry, it was just, I didn't get that you are referring to the Harmony 3 trial. So, the Harmony 3 trial is in the same class, so we will pay attention. It also is shared with our Rosetta-Lung O2 trial that it's the same patient population, and it's the same comparator. However, we have two very different studies here, right? They differ in the endpoints, in the synthesized assumptions, in the statistical architecture, in stratification methods, So we don't see that we have a clear read-through mechanism from Harmony 3 to Rosetta-Lung O2, and irrespective of what we see there, we will stay committed to our studies. And I also have to say that everything we have seen so far and reported in the phase two part of this patient population is very encouraging.

And I can speak to the Genentech question on mRNA, and I'll repeat in part what Ramon shared during this call already, is that our strategy remains focused on mRNA. We see MRNA as a key pillar of our combination strategy. And while our financial terms in the Genentech collaboration now maybe have changed slightly for the value optimization and capital allocation strategy that Ramon spoke to, the actual dynamics of the partnership have not changed. So any path we take forward with our MRNA candidates, one to two, will be in collaboration with our partner Genentech there.

Thank you. We will take our next question, and the question is from Jessica Fy from J.P. Morgan. Please go ahead. Your line is open.

Hey, guys. Good morning. Thanks for taking my questions. I had a couple. I was hoping you could characterize enrollment progress for the Pumetimig Phase 3s and touch on your latest expectations for data readouts. And then coming back to Gotistabart, flying up on one of the early questions, will you comment on whether the first interim hits one way or the other once it occurs? And how do you think about the potential commercial opportunity for Gotistabart in second-line squamous non-small-tell? Thank you.

Jessica, the first question was about Pumita readouts and timing for our pivotal studies. Did I get that right? Yep.

Yes, exactly.

So, we have seven global pivotal studies ongoing by end of this year, and these trials are all event-ridden, so we cannot predict the exact sequence and timing with confidence. But what I would like to do is to point you to clinical trial scores where we have primary completion dates as posted based on the most current or recent data. And according to those primary completion dates, we will see a first-line TNBC in China data in 2027, then Rosetta Lung O2 and Rosetta Lung O1 around 2029, and then followed by RCC, CRC, HCC, and the other studies. However, the timing, as you know, can move. As these studies mature and states may change, the company will update the market when they have enough visibility to do so responsibly. The second question was about, I think,

commercial got just about positioning.

Yes, yes, Aslim, I can take that one. So, as Aslim already alluded to, we presented an update on the Gautista BART non-pivotal part of our Phase 3 study with impressive benefit for patients. And as you may know that in this patient setting, for a long time, we haven't seen real improvements. Many, many shots on goal were tried, but many also failed to demonstrate improvement in overall survival. So if the Cotista BART Part 2 of the pivotal trial confirms the benefit that we've seen to date, we believe it could address a meaningful patient population, again, where no innovation has been happening for a while. And if you look at the current data, we would estimate around 55,000 patients in second-line squamous non-small cell lung cancer by 2030 in just a G7. So with that context, we do view Gotistabard as a key asset in our portfolio that can meaningfully contribute to building BioNTech in a multi-product company on the longer term.

Great. Thanks. And if the first interim passes, would you comment on it one way or the other once that happens?

Yes, we would comment on it one way or another as we have disclosed that we're expecting this readout. We would also expect if the IDMC would recommend the study to continue as per Aslim's earlier comments. Great. Thank you.

Thank you. Your next question comes from Corey Kazimov from Evercore ISI. Please go ahead. Your line is open.

Hey, guys. Thanks for taking the question, and congrats once again to Ugar and Oslo, and best of luck with the new endeavor. So on the heels of the encouraging results with PUMI plus LVD at ESMO, what are the next steps for this combination, and what tumor types are you most interested in advancing? And then since others are asking multiple questions, a very quick one for you, if iNest is ultimately successful, what level of loyalty would you get from Roche under or post this option you exercise? Thank you.

So, I can take the first question. Before I do that, I would like to thank everyone on the call, also on behalf of Ugo for your kind words. It was really a pleasure to work with all of you over these years. Corey, you asked for our plans for LCD plus pumicamic combinations and how we want to go ahead. Yes, we are also very excited about the data we presented for small cell lung cancer, and there is more to come because we have not fully analyzed the other tumor-type cohorts, which are still running. We have not decided on a specific indication setting or timing for LFD Pumita Pivotal Trials yet. Our prioritization and decisions will be data-driven based on the large body of data we have produced over the last couple of months in the different And this will be part of our 2027 milestones, which we will disclose in a couple of months.

Thank you, Osleman. Hi, Corey. In relation to your question on INEST, we are not providing specific royalty economics under this option. However, I mean, like, you know, all of this is dependent on successful development and then thereafter, commercialization. So these are the tiering of royalties that we currently have. But this is as much as we can disclose at the moment.

Okay. Understood. Thank you.

Thank you. Your next question comes from Terrence Flynn from Morgan Stanley. Please go ahead. Your line is open.

Great. Thanks for taking the question. It might be a little bit early, but Ramon was just wondering if you can comment broadly on how to think about 2027 numbers, both top and bottom line, just conceptually. Thank you.

Hi, Terence. Indeed, it's a little bit premature to talk about 2027. We are currently working these plans, and we will update all of you at a later stage.

Thank you. One moment, please. Your next question comes from Simon Baker from Rothschild & Co. Redburn. Please go ahead. Your line is open.

Thank you for taking my question. Going back to INEST and FIXVAC and development plans, I'm keen to get your thoughts on the recent paper in Cell that suggested the potential benefit on efficacy from adding chemotherapy, specifically carboplatin and Taxol. You do have chemo in some of these trials, but I just wonder what you thought about the utility and implications of that early work on future development plans for both INEST and FIXVAC. Thanks so much.

Thank you, Simon, for your question. So, with which compounds we combine our vaccines depends really on the standard of care and backbone, which is used in the respective indication. The data you are quoting shows that combining with chemotherapy is, first of all, feasible and, in fact, can also improve the effect because it supports antigen spreading. So we do not shy away, and you can see this in our PDAC study, for example, and also in our studies with BNT116, to combine with chemo where it makes sense from a standard of care and backbone point of view.

All right. Thanks so much.

Thank you. Your next question comes from Yaron Uweber from TD Cohen. Please go ahead. Your line is open.

Hey, this is Tina on for Yaron. I'd like to also add my congrats to Yaron Uweber on an amazing tenure, and thank you for taking our questions. I just want to get your broader thoughts on your sense of late-stage pipeline and what you think is the most exciting asset beyond who you maybe go just to Bart, and then also I know that you're in discussions with your partner on T-PAN, but do you give us any more granularity on how the recent breast cancer results might impact your filing endometrial cancer and your thoughts for that pivotal, um, registrational plans. Thank you so much.

I get the question fully. I think one part of it was about what we find interesting in our pipeline or exciting beyond Pumita and Gotistabad. Actually, all of our assets, Pumita and Gotistabad, are particularly exciting, and we have a large body of data which supports this excitement. However, we are also very excited about our ADCs, in particular also S&D, because, again, there the excitement is supported by data, which we see across tumors. What was the second question?

I can take that, Aslim. The second question is about TPAM and potential filing. So, as Aslim already mentioned, we're discussing with Duality Bio the totality of our clinical data for TPAM, both across endometrial and breast cancer. And we do that, of course, with the mind of making sure that we add both value for patients and shareholders alike. So we're looking at the context of the evolving landscape, areas of unmet medical need, and then we determine next steps. So currently, we're discussing plans for a BLA submission, and we will update the markets accordingly.

All right, thank you so much.

Thank you. We will take our final question, and the final question comes from Jeff Mecham from Citigroup. Please go ahead. Your line is open.

Hi, good morning. This is Jarway on for Jeff. Thanks for taking our question. Maybe just a question on Feminamig. I know you guys are testing across combinations, across several ADCs, but, you know, emerging data such as deferred maturity, tumor type, and partner assets, so I guess I'm just wondering what criteria will determine which PUMI combinations advance most aggressively, and where have the data increased or reduced her convictions so far? Thank you.

So, I can take this question. Thank you very much. It's, first of all, as we mentioned several times for BioNTech, really data-driven. We had a couple of phase one, two combination data sets out there together with our own ADC portfolio and mRNA portfolio. Also, BMS, our partner for Permitamik, is starting combination work, as well as we have several projects now running outside of both BMS's and BioNTech's pipeline. So we will await the first data to determine both on safety and early efficacy, which candidates and combinations we move forward. But like I mentioned in the previous question, we also continue to monitor the evolving landscape. The speed of the oncology development over the last decade has continued to accelerate, which is amazing news for patients, but also requires us as sponsors of study to make sure that by the time data reads out, we still address relevant unmet medical needs. So it's a constant monitoring of what is evolving, what is in line with our strategy. As we said, we're focused on lung, breast, GI, and GU cancers, and then making sure that the data is in line with those expectations. All in all, to become a multi-product company by the time that we enter into 2030.

Great. Thank you. And also to Ugar and Allison, you know, best of luck in your next venture. Thank you.

Thank you.