BioNTech SE

Welcome to BioNTech's second quarter 2026 earnings call. I will hand the call over to Doug Maffei, Vice President Strategy and Investor Relations. Please go ahead.

Thank you, operator. Good morning and good afternoon. Thank you for joining BioNTech's second quarter 2026 earnings call. As a reminder, the slides we will be using during this call and the corresponding press release can be found in the investor section of our website. On the next slide, you will see our forward-looking statements disclaimer. Additional information about these statements and other risks are described in our filings with the US Securities and Exchange Commission, or SEC. Forward-looking statements on this call are subject to significant risks and uncertainties and speak only as of the date of this conference call. We undertake no obligation to update or revise any of these statements. On slide three, you can see the agenda for today's call. 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 Annemarie Hanekamp, Chief Commercial Officer. Related to yesterday's Chief Executive Officer announcement, we will also be joined today by Helmut Jägle, Chairman of BioNTech Supervisory Board. With this, I will hand the call over to Helmut.

Thank you, Doug, and good morning, everyone. Before we begin with a business update from the Management Board, I would like to provide further color on the appointment of BioNTech's next chief executive officer. As announced yesterday, Guido Oelkers will take office as CEO as of February 1st at the latest. From the outset, the supervisory board's CEO search was guided by three clear priorities. Proven strategic leadership, the ability to scale a global biopharmaceutical business and a strong track record, of building and growing innovation-driven science-based organizations. Guido is an excellent fit on all three dimensions. Most recently, as CEO of Zobe, he more than quadrupled the company's revenues over nine years by strengthening its global capabilities and maximizing the value of his late-stage pipeline. He brings deep expertise in launching and commercializing innovative products with a focus on the US market, as well as extensive leadership experience across Europe and Asia Pacific. The supervisory board believes that Guido is the right leader for BioNTech's next phase. His expertise in scaling innovative organizations in a focused and capital-efficient manner combined with his deep knowledge of the markets most relevant to BioNTech will position the company well to deliver on its key objectives evolve into a multi-product biopharmaceutical company and continue its remarkable success story. With that, I would like to hand over to Ugur and will be available for questions during the Q&A at the end of the call.

Thank you, Helmut, and a warm welcome to everyone joining us today. I believe it is important to note that this transition reflects the natural evolution of BioNTech from a pioneering research organization into a global biopharmaceutical company with multiple commercial products. The next phase of this evolution requires the corresponding leadership skills, and I am confident we have found this in Guido. During our exchanges, I have come to know Guido as a leader who combines a deep understanding of the pharmaceutical industry and strategic acumen with genuine respect for the culture and people of our organization. He understands what we have built and importantly he understands what it will take to scale it. To ensure continuity and a seamless transition, I will remain actively engaged in supporting the preparations for Guido's onboarding. As for BioNTech's next phase, our mission remains constant to translate science into survival. To achieve this, BioNTech has successfully built a diversified toolkit of modalities including next generation immunomodulators, ADCs, and mRNA cancer immunotherapies. Our multi-product portfolio has progressed further and growing share of its now in late stage clinical development and trials. The second quarter was a period of significant progress for BioNTech towards this. First, we are accelerating the late stage development of our oncology assets. We shared encouraging global data in first-line NSCLC from the phase 2 portion of our phase 2 free trial at ASCO from our potential next-generation IO backbone, Prometamic. Second, our combination therapy strategy is gaining momentum. We have expanded our novel, novel combination programs and presented data from ongoing combination trials with our ADCs. There's more to come soon. We continue our shift from platform-centric to a tumor-centric clinical development approach around cancers with greatest unmet medical need. Notably, in our GU tumor area, we dose the first patient in our phase 3 trial, evaluating our B7H3 ADC L3-TAPR dosantucan, formerly known as BNT324, in metastatic castration-resistant prostate cancer. BioNTech is well positioned for the next phase. With a growing pipeline of potentially registrational trials, strong partnerships, and financial strength, we are on track to become a diversified multiproduct company by 2030. We are targeting more than 17 late-stage and pivotal trial readouts through 2030 and beyond, spanning multiple tumor types and different lines of treatment. Our progress today sets us up for an impactful second half of 2026. We enter the remainder of this year with momentum and diligent execution as we continue to progress towards our long-term vision. With this, I will hand over to Özlem for an update on our oncology execution.

Thank you, Ugur. I'm glad to be speaking with everyone today. Our ambition is to address the full continuum of cancer utilizing the approaches that Ugur outlined. We have defined a tumor focus strategy to address significant unmet medical need where our novel combinations can extend survival outcomes for patients and maximize the potential of our pipeline. As such, we are advancing multiple assets from our multimodal oncology pipeline into late stage development. During the first half of 2026, we made progress across our pipeline, and I'll cover some of these updates today. I'll begin with lung cancer, which is one of the cancers of highest unmet medical need in the tumor area where we have the broadest and most diverse coverage. We are aiming to tackle unmet medical needs at every stage of the lung cancer patient journey. Our lung cancer strategy covers various disease stages, settings, and enlists various modalities, next-generation immunomodulators, ADCs, and mRNA cancer immunotherapy. For certain settings, we have multiple opportunities with the aim to change the standard of care and move forward with our combination strategy. At the core of this tumor-based oncology strategy is Pumitamic, our investigational bispecific immunomodulator targeting PD-L1 and VEGF-A, now in development with our partner BMS. In lung cancer, we are now running four registrational programs for Prometamic. Rosetta Lung 01 in first line extensive stage small cell lung cancer and Rosetta Lung 02 in first line non-small cell lung cancer where global phase two data were presented at ESCO. Rosetta Lung 202, our pivotal trial in first line PD-L1 high non-small cell lung cancer is now enrolling. and Rosetta Lung 201, our pivotal trial in unresectable stage 3 non-small cell lung cancer, is also underway. Moreover, we are generating novel-novel combination data to inform the first wave of combination trials with registrational intent. Zooming in on Pumitamik. Here we again have pioneered by delivering the first global phase 2 data for a PD-L1 VEGF biospecific in first line non-small cell lung cancer. At ESCO in June, we presented phase 2 data from Rosetta Lung O2, our global randomized phase 2 free trial evaluating Pumetamic in combination with chemotherapy in patients with previously untreated advanced non-small cell lung cancer. In 40 valuable patients with both squamous and non-squamous histology, Pumetamic Plus chemotherapy demonstrated robust clinical activity with unconfirmed and confirmed overall response rates for combined doses of 72.5% and 62.5% respectively. Two features of these data deserve particular emphasis. First, the encouraging activity observed across PD-L1 expression levels is noteworthy. Second, the particularly strong response rate in PD-L1 low disease across histologies. This includes patients with PD-L1 TPS less than 1% who represented approximately 58% of patients in this cohort, a subgroup typically with poor response to anti-PD-1 PD-L1 treatment. In that population, the confirmed objective response rate was 47.6%. In patients with TPS between 1 and 49%, it was 77.8%. And all six patients with TPS 50% or above responded. The safety profile was manageable in both histologies with no new safety signals. These data support the ongoing Global Phase III program for pumitamic in lung cancer. The robust clinical responses across PD-L1 strata align with our expectations. It speaks to the potential of Pumetamic to confer benefit in the all-coma patient population, including the PD-L1 low expression levels where unmet medical need is high. The Rosetta Lung O2 trial is currently recruiting in its phase three portion, and we look forward to presenting additional phase two data from this trial as the data mature. The central question in the PD-1, PD-L1, BEGF class has been whether the clinical activity observed in trials conducted in China would be consistent with the data in global populations. We have been able to address that question with our own effort across three key tumor types in phase two trials. Firstly, in first line small cell lung cancer. The China phase 1-2 demonstrated a disease control rate of 94% and a confirmed overall response rate of 82%. With the global phase 2 trial, we showed a disease control rate of 100% and a confirmed objective response rate of 76%. Then there is the first line non-small cell lung cancer indication. We observed in the China monotherapy phase 1-2 A confirmed objective response rate of approximately 47% in PD-L1 positive patients. In the global phase 2 of Pumitamic Plus chemotherapy, which includes the PD-L1 unselected population, we saw a confirmed objective response rate of approximately 63%. In TNBC, the disease control rate was 92% in both the trials conducted in China and globally. In the China Phase 1-2, in first-line TMBC, we reported a confirmed objective response rate of approximately 74%, and in the global Phase 2 cohort, which included a heterogeneous population of first- and second-line patients, we reported a confirmed objective response rate of approximately 62%, as expected given the treatment-line population. Across these three tumor types of high unmet need, We are observing a meaningful consistency between the data generated in China and globally. While cross-trial comparisons must be interpreted with caution, we are encouraged by this cross-regional consistency. This gives us increased confidence in the global potential of Fumitamic. We are advancing multiple pivotal Phase III programs to confirm these signals. As covered here on our tumor map slide, we are deploying multiple modalities to tackle lung cancer. Gotistobard is a critical component of that map. As a reminder, Gotistobard is our selective Treg depleting antibody targeting CTLA-4, developed in collaboration with our partner Oncocifor. We are advancing Gotistobard through the pivotal second stage of PRESERVE-003, our global phase three in patients with metastatic thrombosis non-small cell lung cancer who progressed following platinum-based chemotherapy and PD-L1 inhibitor treatment. This is a setting with very few effective options and poor prognosis. Gotistobar's differentiated mechanism of selectively depleting regulatory T-cells in the tumor microenvironment is designed to re-engage the immune system even after prior checkpoint inhibitor exposure. Earlier this year, at ELCC, we presented updated data from the non-pivotal stage 1 of PRESERVE-003, our global phase 3 trial. The data are very encouraging. The 12-month PFS rate of 25% for gotistopath versus 0 for doxetaxel is a signal of durable disease control. Gotistobat reduced the risk of death in this IO pretreated patient population by 54% compared to docetaxel with a hazard ratio of 0.46. The median OS in the Gotistobat arm has not yet been reached compared to approximately 10 months with docetaxel. At 12 months, 63% of patients treated with gotistobar were alive versus 30% in the docetaxel arm. The safety profile was consistent with the previously established profile for gotistobar with no new signals of concern. We expect to present longer follow-up data at the World Lung Conference next month. Based on current event accrual projections, We expect to conduct the first interim analysis from the pivotal stage of the trial towards the end of this year. At ESCO this year, we presented overall survival data from the Phase II study, evaluating gotistobar in combination with pembrolizumab in ovarian cancer patients who had received prior platinum-based chemotherapy. The data showed a compelling and differentiated signal with a median overall survival of 18.9 months. Together, these data reinforce the potential of gotistobat to provide an extended overall survival benefit and serve as a potential chemo-free treatment option for lung patients. I will now turn to LVD, or BNT324, our B7H3-targeted ADC developed in collaboration with Duality Bio. B7H3 is overexpressed across multiple tumor types including prostate cancer, non-small cell lung cancer, small cell lung cancer and others. The target biology combined with the pharmacology of a topo-1 inhibitor, ADC with drug to antibody ratio of 6 positions LVD as a potentially versatile oncology acid across a wide range of solid tumors. More than 1,000 patients have now been treated with LVD across more than 10 tumor types, including 400 patients treated with LVD in combination with Bumitamic. The growing body of clinical evidence demonstrates anti-tumor activity across multiple indications with a favorable safety profile. This quarter, we dosed our first patient in the Phase III clinical trial for LVD, evaluating it against docetaxel in patients with texin and Naive Metastatic Castration Resistant Prostate Cancer. Prostate cancer is our first phase 3 indication for LVD and it represents one of the strongest D7H3 expression profiles of any tumor type. The trial targets the patient population with substantial unmet need following progression on second generation androgen receptor pathway inhibitors. In parallel, LVD is being evaluated in combination with Fumitamic across multiple phase 1-2 programs. These results will help inform the optimal clinical design for upcoming registrational combination trials. We expect to present some of these data at a medical conference later this year. Moving now to our portfolio of innovative mRNA cancer immunotherapies, which aim to activate and educate the immune system with precision. Our individualized neoantigen-specific immunotherapy autogen Sevomeran developed in collaboration with Genentech is advancing into ongoing randomized phase 2 trials. In adjuvant ctDNA stage 2 high risk or stage 3 colorectal cancer, we have a phase 2 trial evaluating autogen Sevomeran monotherapy against the standard of watchful waiting. Enrollment is now complete, and in June, an interim analysis based on the centrally assessed primary endpoint of disease-free survival was reviewed by the Independent Data Safety Monitoring Board with the recommendation to continue the trial without modification. Thus, the study will continue as planned per protocol and will remain masked to the data until the final analysis. The data readout from the final analysis of this trial is event-driven. and expected in 2027. In adjuvant pancreatic cancer, recruitment for the Phase II ENCODE-003 trial is well underway. Data from a Phase I investigator-initiated trial, including a six-year update presented at AACR this year, continue to demonstrate durable immune responses against the encoded neoantigens for up to six years. Evidence that supports our therapeutic rationale in the adjuvant and Minimal Residual Disease Setting. On our fixed-track platform, BNT113, our off-the-shelf HPV16-targeting immunotherapy, is advancing in the AHEAD MERIT Phase 2 free trial in combination with pembrolizumab as a first-line treatment for patients with PD-L1-positive HPV16-positive head, neck, squamous cell cancer. A Phase 3 interim analysis is expected for PFS this year. For BNT1.1.6, our mRNA immune therapy targeting multiple non-small cell lung cancer associated antigens, we expect to present data at WCLC 2026 from cohort 6 in combination with semi-plimap and chemotherapy. These programs reflect our conviction that mRNA cancer immunotherapy, particularly in combination with checkpoint inhibition, can deliver meaningful benefit in defined patient populations. In closing, today's review underscores the significant progress across our portfolio. We have reached multiple key milestones and continue to execute on plan in 2026 and beyond. Within our late stage programs, we anticipate three further readouts this year. Gotistobard and squamous non-small cell lung cancer, or FixVac Immunotherapy BNT113 in head-neck cancer and TPAM in breast cancer. For Gotistobard, we expect a first interim analysis in late 2026 based on the projected event accrual rates. This initial review by the Independent Data Monitoring Committee is intended as an early checkpoint before the next pre-planned interim analysis. For BNT113, Based on current event accrual projections, we expect a phase III interim analysis for progression-free survival later this year. Overall survival, which is the trial's other co-primary endpoint, is not expected to be mature at this interim. TPAM is currently being advanced in two pivotal clinical trials, one in second-line endometrial cancer and one in HER2-low hormone receptor-positive metastatic breast cancer. The candidate has generated encouraging data to date in both indications. With the primary analysis in breast cancer expected in the fourth quarter of 2026, we will determine the optimal regulatory pathway based on aggregated data across both indications. With this data-driven approach, we aim to pursue a value optimization strategy for TPEM in an evolving treatment landscape while prioritizing opportunities where we can deliver significant benefit for patients. Following our mid-year review of upcoming late-stage milestones, we have updated the expected timing for the Phase III Prometeamic Trial in triple-negative breast cancer in China and for the Phase II Gotistobar Trial in second-line castration-resistant prostate cancer both of which are now expected in 2027. With regards to our earlier stage, Novel-novel readouts. We have already published data on some of those combinations and expect more soon. I want to highlight one data set that is strategically significant for our ambitions in lung. The upcoming readout for the phase 1-2 trial evaluating Pumetamic in combination with L4D, our B7H3 ADC, across advanced non-small cell lung cancer and small cell lung cancer. This will be the first clinical data for a PD-L1 VEGF-A bispecific antibody in combination with an antibody drug conjugate in lung cancer. The combination brings together two mechanistically distinct and potentially synergistic approaches. The immune reactivation enabled by pulmetamic with the targeted cytotoxic payload of LVD. We execute these earlier combination studies to provide the signal-seeking evidence we need to inform and potentially de-risk our next steps. This data generation will guide the entry of our novel-novel combination strategy into the pivotal stage and it is the foundation of the next chapter towards BioNTech's growing leadership in oncology. With that, I will now turn the presentation over to and our CFO, Ramon Zapata, for the financial update.

Thank you, Ozlem, and a warm welcome to everyone joining us. I will cover three topics today. Firstly, our second quarter and first half 2026 financials. Secondly, our full year 2026 financial guidance. And lastly, the execution of our share purchase program announced in May, this year as part of our capital allocation strategy. Note that all figures will be in euros unless otherwise stated. Starting with the second quarter financial performance. Revenues for the second quarter of 2026 were 106 million, compared to 261 million in the prior year floor. This decline mainly reflects lower demand for our COVID-19 vaccine in the U.S. In addition, the prior year quarter was positively impacted by a one-time revenue effect. These related to a compensation payment from Pfizer opting out from our shingles vaccine development program. Moving to R&D. At just R&D expenses decreased to $477 million from $509 million in the prior year course. This change mainly reflects the execution of our discipline prioritization across the portfolio. Lower spending on unfocused programs together with favorable cost-sharing effects from our collaboration partners supported an efficient cost structure. At the same time, we will continue to invest in our prioritized immunology and ADC programs, including Fumitamic and Gotix Tobalt. Moving to SD&A. SD&A expenses on an adjusted and IFRS basis were 198 million, compared to 137 million in the prior year's worth. This increase was mainly driven by a global initiative on scaling our processes and ERP infrastructure to strengthen efficient operational execution and our ongoing pre-launch activities for late-stage programs. Our cost base in 2026 also reflects the inclusion of Q-Rack operations post-mergers. At the same time, we continue to realize meaningful savings through pipeline prioritization measures and enhanced cost discipline across the organization. When comparing IFRS and adjusted results overall, the key adjustments are as follows. Within RMD expenses, the difference is driven by impairment charges related to intangible assets outside our focused roles. Within other operating results, the difference relates to actions we are taking following our manufacturing footprint consolidation, the decision we announced in May. The costs are mainly employee-related expenses and impairment charges. These charges reflect our progression from announcing that decision to actively executing it. While these costs weigh on our near-term results, they are a deliberate investment in reshaping our future prospects. We are positioning the company for enhanced operational efficiency and expect sustainable savings going forward. Importantly, we are acting from a position of strength, allowing us to make these adaptations proactively since we maintain a strong financial position of $16.6 billion in cash, cash equivalents and Security Investment at the end of the second quarter, compared to $16 billion as of June 30th, 2025. This empowers sustained investments across the pipeline, our preparations for commercialization, and in our long-term goal to become a global multi-product biopharmaceutical company. Before we go into our four-year guidance, let's first start from the portal of view to our year-to-date financials. Comparing the performance of the first half of 2026 with the prior year clearing. The drivers are mostly in line with the factors I have described for the quarter. In the first half of 2026, revenues were $224 million. While we expect the seasonal facing of the COVID-19 vaccine business throughout the year, as mentioned, this decline mainly reflects lower demand in the U.S. Lower adjusted R&D expenses of $1,004 million in comparison to the prior year period reflect our focused R&D investment approach in our prioritized programs and positive cost-sharing effects with our collaboration partners. Thirdly, higher adjusted R&D expenses of $349 million reflect the ongoing freelance activities and commercial buildup for our first oncology launches. as well as costs newly incorporated in 2026 like our ERP infrastructure initiative that I already mentioned. As we look to the second half of the year, we are taking a disciplined view on our full year outlook. We anticipate changes in some of the factors driving our business and are revising our previously disclosed full year 2026 financial guidance. We now expect revenues in the range of 1.6 to 1.9 billion. adjusted R&D expenses in the range of 2 to 2.3 billion and adjusted SD&A expenses remaining unchanged in the range of 7 to 800 million. I will now detail the factors driving our revised revenue guidance. While COVID-19 has been endemic for some time, we continue to monitor the evolving vaccine market and expect softer than anticipated global COVID-19 vaccine demand. The European Medicines Agency recommendation issued in May allows the use of the previous year's vaccine formula as an alternative to the newly recommended XFG variant-adopted vaccines. This year, for the first time, Germany will utilize previously manufactured on-stop vaccine doses for the upcoming vaccination season. As a result, we expect significantly reduced sales in Germany this year. The timing of MISON-related revenues resulting from an outlicensed R&D program, which are no longer expected in 2026. In terms of revenue facing in the rest of the year, we continue to expect the majority of our 2026 revenues to be realized in the second half of the year. Specifically, in the third quarter, when we expect to recognize the 613 million VMS collaboration payments. Moving to operating expenses, We have revised our adjusted R&D expenses to the range of $2 to $2.3 billion. This reflects our focus on optimizing our R&D resources and continued post-discipline as we prioritize the development of our late-stage clinical pipeline. We expect this cost savings based on prioritization and optimization to continue into future years. Our assumptions for adjusted SD&A expenses remain unchanged. in the range of $700 to $800 million as we continue to gradually build out our commercial capabilities. Despite these changes, our strong balance sheet and disciplined cost management position us well to continue investing strategically. Turning to my final slide, I'm giving you an update on the execution of our capital allocation framework, which we presented during our first quarter earnings poll. Our approach remains clear and disciplined, centered on three priorities. focused on the investments. Second, discipline capital deployment, as well as third, optimize operational efficiency and sustainable value creation. We are executing against these priorities with consistency and intent. As shown on the slide, with respect to the second pillar, we started the execution on our up to $1 billion share purchase program and repurchased an amount of $152 million so far. This execution reflects our conviction in the intrinsic value of BioNTech. While importantly, we retain full optionality to advance our pipeline, execute on partnerships, and pursue corporate development opportunities. Taken together, our strong financial position and these three pillars of our capital allocation strategy continue to serve as a clearly defined long-term objective to become a global multiproduct compound. addressing the high medical needs of cancer patients worldwide. On a final note, regarding the announcement of Ugur and Ozlem new company and potential contributions by BioNTech, here the discussions are ongoing and, as with all potential deals, BioNTech's guiding principle in the negotiations is to maximize value for patients and our shareholders.

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

To ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. We kindly ask analysts to limit themselves to one question per person. We will now take our first question. From the line of Corey Kasimov from Evercore ISI, please go ahead.

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

Ozlem, will you please answer the question from Corey?

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

And if I may add to that, Corey, we have presented this data at ESCO 25 and ESCO GU 26, also follow-up data, from our heavily pre-treated population, which we have tested in a Phase I-II study. which is still ongoing.

Great. Thank you very much.

Thank you. We will now take our next question from the land of Tasin Ahmad from Bank of America. Please go ahead.

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

So with regard to changed milestones and specifically also the China interim analysis testing for first-line TNBC, we are continuously monitoring events. Data readouts are event-driven, and in our China TMBC study, we observed that the events take longer, so the readout is pushed out to 2027, which in principle is also actually a good sign for us. Then another study which will come a bit later with regard to its readout is our PUMITA study in first line CRCC in China, which is a phase two study. Here we have decided to look in more chemo combinations then originally planned so they are added on top of this and another readout which will is now projected for 2027 is the gotisobar phase 2 and second line positive prostate cancer and the reason is that we want to see a more maturity. Major milestones and readouts this year are the Gotestovat interim analysis for part two, meaning the pivotal part of our non-small cell lung cancer study in squamous non-small cell lung cancer, second line in combination with docetaxel. So we are excited about that. Yes, as a control, we're excited about that. Then the BNT113 trial, where we expect the phase 3 instrument analysis for progression-free survival data this year, and the TPAM study in HER2-low hormone receptor-positive metastatic breast cancer.

Thank you.

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

David Dai Great. Thank you for taking my questions. I just want to make a plus chemo in frontline non-small cell lung cancer. We've seen some encouraging phase two data so far, especially showing transformation from China to Global. I'm just curious, you know, what additional preclinical evidence or, let's say, efficacy, safety, or biomarker features that give you confidence that Pomidama can be a differentiated VEGET PD-1 versus other, you know, VEGET PD-1 approaches?

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

Thank you.

We will now take our next question from the line of Dinah Gravosh from Learing Partners. Please go ahead. Hi. Thank you for the question.

I wonder if you could help us understand your TPAM comments more. Give us the details. Is there a specific outcome or threshold in the HER2 low breast cancer you're looking to exceed and how various outcomes from that study could impact Your strategy forward with regulators and launching, potentially launching CPAN.

So our TPAM program, as you know, is broader. We are developing TPAM in endometrial cancer second line and in breast cancer with our phase three trial in hormone receptor positive to low. And we have what is also important to note ongoing signal seeking studies of TPAM with Pumita in different breast cancer patient segments, which is an important part of the strategy because ultimately our ADCs are part of our portfolio because of their potential to further elevate Pumita and allow us to leapfrog. With regard to our breast cancer study, the benchmarks are, if you compare with published benchmarks, medium PFS, in the range of 9 to 13 months and 18 months median OS of around 85% according to other studies in this indication and approved treatment.

Thank you. We will now take the next question.

From the line of Jeff Meacham from Citigroup, please go ahead.

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

Thank you.

Hi, thank you for the question. So I think because of the cash position that we have and the strength of our balance sheet, we are able to take on the number of Pivotal and Phase 3 trials that we are running now with POMITAMEG and the strategy with our partners is to add on on these efforts as much as possible to really you know widen the net or offer the indications where we can use POMITAMEG and the novel novel combinations. So I would say that our capital allocation priorities remain unchanged. We continue to fully fund our priority pipeline and the commercial capabilities needed to support these upcoming launches. Second, we maintain the flexibility to pursue attractive external opportunities that have the potential to strengthen our portfolio or our capabilities. And third, we continue to return capital to shareholders through the authorized share buyback program that we announced last quarter. So on your comment on portfolio optimization, we continually review our pipeline to ensure that the resources are focused on the areas with the greatest strategic and value creation potential. And that means continuing to invest behind our core programs while reducing or stopping investment in non-core assets where we feel it's appropriate.

And maybe I can add here another aspect. So this year is the year of combination tiles where we evaluate PumertaMake in combination with our larger EDC portfolio. The results of the studies of course will provide further prioritization of the best combinations thereby reducing maybe the investment in some of the ADCs in certain indications. So the overlap at the moment is by purpose to identify the winners. In 2027 we expect that we will have identified the and engage into several phase three clinical trials including assets from our partner BMS.

Great, thank you.

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

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

It's a difficult question, so we have to see the data. But we have positive expectations for each of the trials. You know that if the data for gotistobar that we have seen in the first part of the phase 3 clinical trial is recapitulated, this would become a game-changing result in this indication. Everyone knows that the Cetaxel remained unbeaten for decades now and this would be the first time that if the data are recapitulated we would have a significant benefit with a monocompound as compared to the standard of care.

Thank you. We will now take the next question.

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

Hi, thanks for taking the question. Appreciate the update on your INEST CRC data coming next year, but was wondering if you could help us think about potential read-through from the Moderna Merck INT and Adjuvant Melanoma Phase 3 data that we might get this year. So what would you be looking for in that data to give you confidence in your own inest program? Thank you.

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

Thank you.

We will now take the next question from the line of Jessica Fai from J.P. Morgan. Please go ahead.

Good morning, guys. Thanks for taking my question. Ramon, I was hoping you could help us out with the 400 million reduction to guidance at the midpoint.

Can you just quantify how much of the change was driven by the milestone push out versus the German decision to use existing inventory and how much is just softer COVID demand? And then what specifically was the partner milestone that was pushed out?

Thank you.

Thank you for the question.

Most of the adjustment of the guidance is a reflection of the weaker COVID-19 vaccination rates and the current regulatory and public health environment. It's really incorporating the latest input from our partners and the teams that are operating in our key markets. I would like to remind you that the COVID revenue is back and weighted into the late Q3 and Q4. So this will only reflect until then. And also we're expecting approximately 613 million revenues from the VMS collaboration. That is also giving us a good uplift for the second half of the year. So based on the information currently available, we believe that this revised range is appropriate. Now in relation to the comment of the license milestone that we were expecting, yeah, we were expecting that Thank you very much. The impact on our revenue is a little bit more acute than versus the other markets. So I would say, if you would think about percentage, 80% is COVID-related completely, and then the rest is the loss of the outlicensed milestones that we were expecting.

Thank you. Thank you. We will now take the next question. From the line of Yaron Werber from TD Cohen, please go ahead.

Great, thank you. I wanted to ask about Rosetta Lung O2. Clinicaltrials.gov is showing data on 2029, but you changed the endpoint now to PFS and not OS. Is there any chance that we can get this data potentially earlier? And any sense when you might finish enrollment? Thank you.

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

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

Here was the change endpoint and the interim analysis for PFS. Yeah. will become now an opportunity to file if it's positive. We can't still, so as Özlem said, it is expected to read out earlier than the interim OS. But we can't at the moment say when we are going to expect because this is again an event-driven pile and it's the first time in this indication. that we evaluate the sludge population.

Thank you.

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

Hi, this is for Evan. Thanks for taking our question. Just one from us. So as you think about the broader opportunity for Primitamig, Can you discuss how the asset might be differentiated in MSS-CRC given the historically limited efficacy of checkpoint inhibitors in the indication and immune cold phenotype of tumors? And then also, what gives you confidence that PUMI's mechanism could overcome these past challenges? Thank you.

Yeah, to provide, because we do not yet have data in CLC, the strongest evidence that Pumitamic is, or the bispecific class is differentiated comes from the observations of objective response rate, but also durable disease control in patient populations who are PD-L1 negative. for example in TNBC we have documented data showing more or less the same rates of objective response in the patient in PD-L1 positive, PD-L1 low positive and PD-L1 high positive patient population. So CRC is an indication in which checkpoint blockade was not successful. We have now this combination and we have to see from our interim analysis which is coming in 2027. We are going to test or we are testing at the moment different chemotherapy combinations that this translates to better better data as compared to traditional benchmarks, the chemotherapy alone. But the broader promeutamic opportunity, again, is based on the one side, improving response rate and durable disease control and OST. in indications where checkpoint-blockade PD-1 is approved, opening up indications in which PD-1 treatments are not approved, and as a third component, combining prometamic as a potential next standard of care with a new generation of ADCs that allow disease control even in advanced disease with a good safety profile.

Thank you.

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

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

So the first trial that is reading out is for squam lung cancer for VEGFPD1. My question is how much read-through there could be for the non-squam program if claims were to be successful and what specifically you would be looking at the competitor data to gain confidence in your own programs or think about the future trials. Thank you.

With regard to the read-through, in principle, these histologies are like different diseases, right? So we would be very cautious Thank you very much.

But on the other side, the data, our own data, but also the data coming from AIVO indicate that in both indications, PFS is improved. And we have seen now in the recent update that the improved PFS appears also to translate into OS signals in other indications. We are cautiously optimistic that we will see in both indications PFS benefit and OS benefit.

Thank you. This was our final question.

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