BioNTech Q3 2026 Earnings Call Transcript

BioNTech (NASDAQ:BNTX) reported third-quarter financial results on Tuesday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

BioNTech reported third-quarter 2026 revenue of €1.3 billion, down from €1.5 billion in the prior year, mainly due to decreased demand for the COVID-19 vaccine.

The company is advancing late-stage oncology assets, including promising results for Gotistobart in lung cancer and a new collaboration with Gilead for a Phase 3 trial in breast cancer.

BioNTech is shifting focus to tumor-specific strategies and expanding its pipeline with multiple trials aimed at becoming a diversified multi-product company by 2030.

Financially, BioNTech maintains a strong cash position of €16.2 billion and has adjusted its revenue guidance to €1.7-1.9 billion for 2026, with unchanged R&D and SG&A expense forecasts.

CEO Ugur Sahin and CMO Ozlem Tureci are stepping down, with Guido Oelkers set to become the new CEO by February 2027, ensuring a smooth leadership transition.

Full Transcript

OPERATOR

Welcome to BioNTech’s third quarter 2026 earnings call. I will now hand the call over to Doug Maffei, Vice President of Investor Relations. Please go ahead.

Douglas Maffei, Ph.D. (Vice President, Strategy & Investor Relations, Head of Investor Relations)

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 a 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 3, you can find the agenda for today’s call. I’m joined by the following members of BioNTech’s management team: Ugur Sahin, 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 Hanekamp, Chief Commercial Officer. With this, I’ll hand the call over to Ugur.

Ugur Sahin (Chief Executive Officer and Co-Founder)

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 Gotistobart from the non-pivotal stage of our global Phase 3 trial. In patients with squamous non-small cell lung cancer who progressed on prior checkpoint inhibitor treatment, gotistobart nearly doubled median overall survival compared with standard-of-care chemotherapy.

This is a setting where chemotherapy has remained the standard of care for more than a decade and with kutistobat we aim to provide a chemotherapy-free monotherapy for patients who progressed after first-line 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 pumitamic in combination with their Prop 2 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 3 trial of pometanic 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 sample clinical development approach in cancers with the greatest unmet medical need. At World Lung Congress represented the first global combination data for any anti PD-L1BGF B specific immunomodulator and an ADC in lung cancer. This combination of prometamide and LCD demonstrated encouraging early efficacy and manageable safety profile in small cell lung cancer across lines of treatment, including activity in first-line patients.

This 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 3 registration and planning for Prometomic in combination with LCD. Looking ahead, BioNTech is well positioned for the next phase of growth. 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. Our late-stage development program includes multiple pivotal trial 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 the first of February, at the 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 startup 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 lives. Our employees have been instrumental in bringing this purpose to life with their expertise, dedication and commitment. It is their collective contribution that has turned 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 trials and our colleagues in the science community. Without all these 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 deep gratitude. While we hand over the operational responsibility to our successors, Ozlem and I will continue to follow BioNTech as founding shareholders. With this I will hand over to Ozlem.

Ozlem Tureci (Co-Founder and Chief Medical Officer)

Thank you, Ugur. 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, Prometermig, gotistobart and FD. The data validate the potential clinical benefit across key tumor types, most notably in lung cancer. I will review the data and discuss how it is supportive of a 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 pomitamic, a bispecific immunomodulator targeting PD-L1 and VEGF-A 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 pomitomic in combination with standard of care or monotherapy. In parallel to these registrational trials we are generating novel combination data with our ADCs and our mRNA immunotherapies to inform the first wave of chemotherapy-free combination trials with registrational intent.

Gotistobart is another key candidate of our non-small cell lung cancer strategy. As a reminder, gotistobart is a selective Treg depleting antibody targeting CTLA-4 developed with Oncocifor. We are advancing gotistobart 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 gotistobart versus 10 months with docetaxel with a hazard ratio of 0.56. Gotistobart reduced the risk of death by 44% compared with chemotherapy. The observed safety profile of gotistobart was consistent with previous findings. These results reinforce the potential of gotistobart 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 one, we anticipate an interim analysis before year end. This serves as an early data point ahead of the next pre-planned interim analysis next year. Now turning to small cell lung cancer where we are evaluating pomitomic in combination with chemotherapy, in combination with a DLL3 T-cell engager and in combination with LVD in front and later lines. LPD is our B7-H3 targeted ADC developed with Duality Bio. LFAD’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 LPhAD across over 10 tumor types, including more than 500 patients treated with LVD in combination with pumitamic.

This was a global data set from our Phase 1/2 trial of pomitamig plus ELFID in patients with advanced small cell and non-small cell lung cancer. This combination brings together three independent mechanisms of action: checkpoint inhibition, VEGF-A neutralization and the tumor cell targeted cytotoxic payload of alpha D. 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 DLL3 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 pomitomic 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 pomitamic 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 combination strategy in lung cancer into potential registration with first trials expected to begin in 2027.

From triple-negative breast cancer, our pomitamic plus ADC combination strategy is now entering the pivotal stage. At ESMO Breast in May, pomitamic 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 far 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 TROP2 ADCs. TROP2 targeted ADCs such as sacituzumab govitecan are quickly becoming the new standard of care. As a result of the evolving treatment landscape, we are adapting Rosetta Breast 01 to replace chemotherapy with sacituzumab 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/VEGF-A bispecific pomitamic in combination with an antibody drug conjugate. Adapting Rosetta Breast 01 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 autogene cevumeran in as adjuvant monotherapy 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 2 IMcode 003 trial in adjuvant pancreatic cancer where autogene cevumeran is being evaluated in combination with atezolizumab and modified FOLFIRINOX, has completed enrollment and continues as planned. BNT113, our off-the-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 AHEAD-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 antitumor 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 HPV-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 a PFS result. BioNTech is leveraging novel combinations with next generation IO targeted therapies and mRNA cancer immunotherapy to maximize pipeline potential and elevate outcomes for patients with solid tumors. The potential of mRNA cancer immunotherapies in combination regimens lies in their 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 one and two. 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 cutoff date suggest that the potential benefit to patients would be limited in the context of the HR, HER2-low metastatic breast cancer treatment landscape.

We and Duality Bio are currently discussing the totality of clinical data for trastuzumab pasumikan 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 Duality Bio are discussing plans for BLA submission and will update the markets accordingly. Looking ahead, we are on track for the first interim analysis for gotistobart 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 preplanned interim analysis. Beyond the various late stage readouts this year we also further advanced our late stage pipeline and initiated six Phase 3 trials. In 2026 we published several data sets from our 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 Ugur 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 (Chief Financial Officer)

Thank you, Ozlem, 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 VMS related to the co-development and co-commercialization of our next-generation bispecific antibody candidate Comitami.

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 IO 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 buildup, 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, multiproduct biopharmaceutical company by 2030. Let’s now turn from the third quarter to our nine months 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 SG&A expenses came in at $527 million, up from $407 million. Overall, our year-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 toward 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 alignment.

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 30, 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 a recently divested JPT Peptide Technologies business, an 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 progress.

This means the ongoing Phase 2 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 multi pro 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 Ugur and Ozlem’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 Ugur and Ozlem 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, helped 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 back to the operator to open the call for questions. Thank you.

OPERATOR

Thank you. We will now begin the question-and-answer session. If you wish to ask a question, you will need to press Star 11 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 11 again. Your first question comes from Akash Tewari from Jefferies. Please go ahead. Your line is open.

Akash Tewari (Analyst)

Hey, thanks so much and Ugur and Ozlem, 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 Gotissa? Bart, I know in the prior data there was kind of a late-onset interim curve separation on OS, so 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 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 the BioNTech vision really at this point focused on Puminimate going forward? Thank you.

Ugur Sahin (Chief Executive Officer and Co-Founder)

Akash, I can take the first question. We are very excited about Gotistobad and, as you know, in the non-pivotal first part of the trial we have seen and just recently reported near doubling of median OS. We are waiting for the first interim analysis which will happen this year. A 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.

Ozlem Tureci (Co-Founder and Chief Medical Officer)

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 Genentech 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 113 program, 116 PDAC with Genentech, and also some further efforts in early stage and innovating on our mRNA platform, be it FixVac, the off-the-shelf platform, or individualized vaccines.

OPERATOR

Thank you. We will take our next question. Your question comes from Mohit Ranso from Wells Fargo. Please go ahead. Your line is open.

Mohit Ranso (Analyst)

Great. Thank you very much for taking my question and just wanted to understand a little bit about the cancer vaccine program. So we’re looking at both PDAC and colorectal cancer, and they both are relatively IO or immuno—less immunological diseases. So 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 here?

Ozlem Tureci (Co-Founder and Chief Medical Officer)

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 in 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 adjuvant vaccine. In the PDAC setting it is integrated into chemotherapy and also combined with checkpoint inhibition.

OPERATOR

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

Dana Graybosch (Analyst)

I also want to echo my gratitude and congratulations for your next steps for Ugur and Ozlem. My question is on the TROP2 ADC. I wonder if you can tell us the status of your own TROP2 ADC which you had previously licensed from DualityBio? And how are you thinking about combinations of Pumi with TROP2 ADCs outside of TNBC? 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 TROP2 ADC?

Thank you.

Aslim

Yes, thank you, Dana, for your question. You know, we see our ADC portfolio as 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 TROP2 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 on a single AD 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 Pumita.

Annemarie Hanekamp (Chief Commercial Officer)

Yeah, thank you, Aslim. And this is Annemarie. I will just also add that in line with our strategy, what we shared before on Pumitomic, 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 BMS’s, 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, 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 Pumitomic, where we believe transformational benefit can be delivered on top of the chemo benefit that we’re hoping to see in the first wave of combinations with Pumitomic.

OPERATOR

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.

Tazeen Ahmed (Analyst)

Okay, great. Thanks for taking my question and also my best to Ugur and Ozlem 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 Gotistobart? Bart, I’d love to hear your thoughts on what to expect after you reveal this dataset 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.

Ozlem Tureci (Co-Founder and Chief Medical Officer)

I can take the first question, Tazeen. With regard to Gotistobart, 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’ll then engage with regulators.

Ramon Zapata (Chief Financial Officer)

And then, Tazeen, in terms of the Roche collaboration. So to be clear, the existing agreement remains in place. What we have done is exercise 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. We are operating from a position of strength with the balance sheet and the cash that we currently have. However, we are also advancing 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 providing that financial flexibility to other pieces of our pipeline. So that is pretty much the reason why we have exercised this contractual option.

OPERATOR

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

David Dye (Analyst)

Great, thanks for taking my questions. Also, I want to add my congratulations to Ugur and Ozlem. And so just on Pumitomig, 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 2027 onwards?

Aslim

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

David Dye (Analyst)

Yes, that’s right. Yes.

Aslim

Yeah. So I think the class is 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 we are very confident that this is something we can rely on.

OPERATOR

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

Asad Hayde (Analyst at Goldman Sachs)

Great, thanks for taking the question and congrats and best of luck to Ugur and Ozlem. 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 will be prioritizing.

And if I may on Pumitomic, just with Summit’s HARMONY-3 data approaching, would 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 Pumita. Thank you.

Aslim

I can take the Pumita question. Did not fully get which trial you were referring to. Could you repeat, Asad?

Asad Hayde (Analyst at Goldman Sachs)

Yeah, sure. Just with the Summit’s HARMONY-3 data approaching, just curious to hear your latest thinking on what this readout means as it relates to the read across to your own development strategy. 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.

Aslim

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 shares with our Rosetta Lung 02 trial that it is 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 sample size assumptions, in the statistical architecture, in stratification methods, trial sites and country mix.

So we don’t see that we have a clear read-through mechanism from HARMONY-3 to Rosetta Lung 02 and, irrespective of what we see there, we will stay committed to our study. 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.

Annemarie Hanekamp (Chief Commercial Officer)

And I can speak to the Genentech question on mRNA, and I’ll repeat in part what Ramon shared during this call already, 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.

OPERATOR

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

Jessica Fye (Analyst at J.P. Morgan)

Hey guys, good morning. Thanks for taking my questions. I had a couple. I was hoping you could characterize enrollment progress for the Pumitomig phase 3s and touch on your latest expectations for data readouts. And then coming back to Gotistobart, following 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 Gotistobart in second-line squamous non-small cell?

Aslim

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

Jessica Fye (Analyst at J.P. Morgan)

Yep. Yes, exactly.

Aslim

So we have seven global pivotal studies ongoing by end of this year and these trials are all event-driven, so we cannot predict the exact sequence and timing with confidence. But what I would like to do is to point you to ClinicalTrials.gov 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 02 and Rosetta Lung 01 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 dates may change. The company will update the market when they have enough visibility to do so responsibly.

Annemarie Hanekamp (Chief Commercial Officer)

The second question was about, I think, commercial Gotistobart positioning. Yes, yes, I can take that one. So, as Aslim already alluded to, we presented an update on the Gotistobart non-pivotal part of our phase three study with impressive benefit for patients. And as you may know, in this patient setting for a long time we haven’t seen real improvements. Many shots on goal were tried, but many also failed to demonstrate improvement in overall survival.

So if the Gotistobart pivotal part two 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 the G7. So with that context, we do view Gotistobart as a key asset in our portfolio that can meaningfully contribute to building BioNTech into a multi-product company in the longer term.

Jessica Fye (Analyst at J.P. Morgan)

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

Douglas Maffei, Ph.D. (Vice President, Strategy & Investor Relations, Head of Investor Relations)

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.

Jessica Fye (Analyst at J.P. Morgan)

Great, thank you.

OPERATOR

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

Corey Kazimuth (Analyst)

Hey guys, thanks for taking the question and congrats once again to Ugur and Ozlem and best of luck with the new endeavor. So on the heels of the encouraging results with Pumi 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 royalty would you get from Roche under or post this option you exercised?

Thank you.

Ozlem Tureci (Co-Founder and Chief Medical Officer)

So I can take the first question, and before I do that, I would like to thank everyone on the call, also on behalf of Hugo, 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 prometermic 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 FD prometer 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 indications. And this will be part of our 2027 milestones which we will disclose in a couple of months.

Ramon Zapata (Chief Financial Officer)

Thank you, Ozlem. Hi Corey. In relation to your question on INEST, we are not providing specific royalty economics under this option. However, 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.

Corey Kazimuth (Analyst)

Okay, understood. Thank you.

OPERATOR

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

Terence Flynn (Analyst)

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

Ramon Zapata (Chief Financial Officer)

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.

OPERATOR

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

Simon Bacon (Analyst)

Thank you for taking my question. Going back to INEST and FIX VAC 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.

Ozlem Tureci (Co-Founder and Chief Medical Officer)

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.

Simon Bacon (Analyst)

Thanks so much.

OPERATOR

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

Trina (Analyst at TD Cowen)

Hey, this is Trina on for Yaron. I’d like to also add my congrats to Igor and Ugur on an amazing tenure, and thanks for taking our questions. I just want to get your broader thoughts on your sense of late-stage pipeline and what you think of the most exciting asset beyond PUMI and maybe Gotistobart. And then also, I know that you’re in discussions with your partner on TPAM, but if you’ll give us any more granularity on how the recent breast cancer results might impact your filing, endometrial cancer, and your thoughts for that pivotal registrational plans.

Thank you so much.

Ugur Sahin (Chief Executive Officer and Co-Founder)

I did not get the question fully. I think one part of it was about what we find interesting in our pipeline or exciting beyond Pumitamico and Gotistobad. So actually all of our assets, Pomita and gorgistobat are particularly exciting, and we have a large body of data which supports this excitement. However, we are also very excited about our AD, in particular also LCD, because again there the excitement is supported by data which we see across tumors.

What was the second question?

Ramon Zapata (Chief Financial Officer)

I can take that, Aslim. The second question is about TPAM and potential filing. So, as Aslim already mentioned, we’re discussing with DualityBio 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 BLA submission, and we will update the markets accordingly.

Trina (Analyst at TD Cowen)

All right, thank you so much.

OPERATOR

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.

Jarway (Analyst)

Hi, good morning. This is Jarway on for Jeff. Thanks for taking our question. Maybe just a question on Fuminig. I know you guys are testing across combinations across several ADCs, but, you know, emerging data sets differ in 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 your conviction so far? Thank you.

Aslim

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 1/2 combination data sets out there together with our own ADC portfolio and mRNA portfolio. Also, BMS, our partner for Pamidomic, 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 is continuing to accelerate, which is amazing news for patients, but also requires us as sponsors of studies 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 multiproduct company by the time that we enter into 2030.

Jarway (Analyst)

Great, thank you. And also to Ugur and Asan, best of luck in your next venture. Thank you.

OPERATOR

Thank you. Thank you. This concludes today’s question and answer session and concludes today’s conference call. Thank you for participating. You may now disconnect.

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