Galapagos NV

Thank you all for joining us for Galapagos' first quarter 2025 financial results and business update conference call. Last evening, we issued a press release outlining these results. This release, along with today's webcast presentation, can be found on the Galapagos website. Before we begin, I would like to remind everyone that we will be making forward-looking statements. These forward-looking statements include remarks concerning future developments of our company, and our pipeline and possible changes in the industry and competitive environments. Actual results may differ materially from those indicated by these statements and are accurate only as of the date of this recording, April 24th, 2025. Galapagos is not under any obligation to update statements regarding the future or to conform to these statements in relation to actual results unless required by law. Joining us on today's call from Galapagos' senior management team are Dr. Paul Stoffels, Chair and Chief Executive Officer, and Thad Houston, Chief Operating and Chief Financial Officer of the company. We are also joined by Drs. John Mellors, Head of Cell Therapy Discovery, Wolf Bucher, Head of Immunology, and Omataya Fasan, Clinical Program Head, Oncology, and they'll be available during the Q&A session. With that, let me now turn the call over to Paul.

Thank you, Glenn. Before starting the Q1 financial update, I want to provide some color on the recently communicated executive leadership changes. We are very pleased with the appointment of Henry Goesbroek as the founding CEO of SpinCo. This is an important milestone in the planned separation of SpinCo, as announced earlier this year. Henry has deep experience in M&A, business development and capital allocation, through his past roles as president and CEO of Nomura, Executive VP and Chief Strategy Officer at AbbVie and M&A Co-Head at G.P. Morgan. We welcome Henry into his new role and we look forward to introducing him to you in the coming weeks. I would like to provide some color on my intent to retire from my role as CEO of Galapagos in the next 12 months once a successor has been appointed. I want to underscore that I am fully committed to supporting Galapagos as its CEO and Chair of the Board. Upon a CEO successor being appointed, my intention is to serve as non-executive chair of the board of Galapagos, continue to provide strategic guidance and support. Galapagos has strong foundations in place to create value for all its stakeholders. We have built a strong company with top talent in Europe, the US and China as we continue to attract experts in cell therapy. Together, we are transforming Galapagos into a focused cell therapy company that is offering real hope to people facing cancer. I also want to thank Tad for his contribution to Galapagos. As CFO and COO, he supported the transformation of Galapagos into the dedicated cell therapy company that we are today. He will remain with the company until August 1 to ensure a smooth transition and andover of responsibilities. Let now move to our Q1 financial results and business update. We continued to make meaningful progress, advancing our clinical pipeline and expanding global access for our innovative manufacturing platform and decentralized manufacturing units, or DMUs. As we announced in a press release last night, We are particularly pleased that we have dosed our first U.S. patient in the Atalanta 1 study of GLPG5101, where in combination with our ongoing European sites, we are evaluating a novel CD19 CAR-T candidate in eight hematological malignancies with high unmet medical need. In addition, we completed enrollment of the Indolent NHL cohort, added the diffuse large B-cell racial transformation cohort, and are in the process of adding the CLL cohort to the study. All other cohorts are open and enrolling. Importantly, we have selected MCL as a lead indication to take forward in a pivotal trial and are very optimistic for our prospects with this indication, which I will discuss in greater detail in a moment. We made great progress with the earlier stage discovery programs and expect to initiate clinical development of a novel CAR-T candidate and to select at least one program for IND-enabling studies this year. In 2026, the pipeline is expected to be further expanded with at least one additional next-generation program. Throughout the first quarter, we continued to make platform and process improvements to support pivotal studies and commercial readiness by expanding our decentralized manufacturing network in the US and Europe, giving patients direct access to our therapies and limiting logistical constraints. In collaboration with our partner Adapt Immune, We also advanced preparation to develop UsaCell for solid tumors, such as head and neck cancer, and plan to initiate proof-of-concept studies in 2026. Finally, we are working towards separation and, as I mentioned at the beginning of the call, we recently announced the appointment of the founding CEO of SpinCo, Mr. Henry Goesbroek. That will talk about SpinCo in greater detail later on today's call. We have as well advanced the two phase three enabling studies in SLE and dermatomyositis with our TIK2 inhibitor, GLPG3667, and are actively seeking partners to acquire the program. Core to our strategy to build a leadership position in cell therapy in oncology is a decentralized manufacturing that was designed to overcome the limitations of current cell therapy manufacturing, which is centralized and bears high cost burdens with longer production and delivery times that require cryopreserving cells and the need for bridging therapy. A seven-day vein-to-vein time is designed to provide fresh stem-like cells, which we believe enhance the therapeutic profile by producing highly potent cells that are less exhausted, less toxic, and persist longer. In addition to logistical advantages, our DMUs are designed to enable scalable and consistent products near the clinic. We believe this approach will be more cost-effective and provide greater access to these potentially life-saving cell therapies. We are unlocking the broad-reaching potential of this decentralized cell therapy manufacturing platform as we advance our robust cell therapy pipeline. 0PG5101 is our most advanced CAR-T asset that is in clinical development in the U.S. and Europe in the Atalanta I Phase I-II clinical study in eight hematological malignancies. As I mentioned earlier, we initiated dosing of patients in the U.S. and expect enrollment to accelerate as more sites are activated. We fully enrolled the Inland NHL cohort and expect to present these top line data at the medical meeting in mid-25. Enrollment continues well in the Mantle Cell Lymphoma, or MCHL cohort, which we have selected as our lead indication to take into pivotal studies. Our plan is to start pivotal development in 2026 with an anticipated approval in 2028. We're progressing the enrollment of patients in the Phase I-II papillose study of GLPG5301, or BCMA CAR-T, as a treatment for relapsed refractory multiple myeloma. Here we expect to have top-line data in 2026. These data will direct our development plans for this product candidate. As noted earlier, we continue to build value by strengthening and advancing our early-stage pipeline of next-generation multi-targeting armed cell therapies for hematological and solid tumors. We believe that the combination of fresh, fast, and fit cells has the potential for transformative impact. And we can see that from the data recently presented at ASH, which demonstrated a promising safety and efficacy profile for GLPG5101 in patients with mantle cell lymphoma, marginal zone lymphoma, follicular lymphoma, and diffuse large B-cell lymphoma. As of April 25, 2024 data cutoff, 49 patients received CD19 CAR-T cell therapy infusion and safety and efficacy results were available for 45 patients and 42 patients respectively. As you can see, we observed high overall response and complete response rates. Here we show 100% of patients with relapsed refractory mantle cell lymphoma, 95% of patients with relapsed refractory follicle and marginal zone lymphoma, and 54% of patients with relapsed refractory DLBCL achieved a CR. Of available patients achieving CR, 80% were MRD negative and remained in CR at the time of data cutoff. Of note, strong and consistent in vivo CAR T expansion levels and products consisting of stem-like early member phenotype cells were observed in all doses tested, further supporting our innovative platform technology. And we are seeing these compelling results with very reassuring safety data with low levels of ICANs. This translates to less time in the ICU, in hospital, and more time at home with family. Importantly, the eight hematological malignancies we are evaluating have greater than 2 billion euro in peak sales potential in the US and the EU5 alone. We are excited to move forward with MCL as our lead indication for pivotal studies. We made this determination based on a number of factors, including the high medical need, strong initial data from this patient cohort, and the fact that MCL accounts for approximately 6% of all NHL cases in the U.S., all combining to make this an attractive lead indication for GLPG 5101. Patient enrollment in this cohort of Atalanta 1 is going well, and we expect to present new data from this cohort at the medical meeting in the second half of this year. Our strategic focus on MCL, supported by strong data and significant unmet medical need, positions us for pivotal development in 2026 and potential first approval in 2028, marking a major step forward to provide greater access to new medicines for patients in need. Our mission is also grounded in providing greater access to these new medicines via our DMUs, which require securing the capacity for clinical studies and commercial readiness. Our efforts here are supported by strong collaborations with Lonza for the Cocoon platform and Thermo Fisher Scientific for the development of an ultra-rapid PCR sterility test together with MyDiagnostics. We are also expanding our network of DMUs with our collaborations with Catalan for the New York, New Jersey, and Pennsylvania area, Moffitt Cancer Center in Florida region, and NextGen in the Benelux region, Collectively, these networks target nearly 250 million patients. Additional DMUs will be integrated into the company's network in the US and Europe to ensure sufficient capacity for clinical and future commercial supply in key regions. Most recently, And as announced in our press release, we have established operations in China that enable us to leverage our unique manufacturing platform and to accelerate the development and value creation of our next-generation cell therapy pipeline. With that overview of our cell therapy business, let me turn the call over to my colleague, Pat Houston, for a review of our financial and our progress on the intended separation. Pat?

Thank you, Paul. Now turning to some of the financial highlights from the quarter. which, as you would imagine, were impacted by our ongoing implementation of the restructuring and the SPINCO separation. Total net revenues for the first quarter of 2025 were €75 million, which includes €14 million of supply revenues related to Giseleca and €61 million in collaboration revenues. Increases to operating expenses were driven by our clinical expansion in Oncology CAR-T in the build-out of our DMU network, as well as €111 million of restructuring costs. These include severance costs, the early termination of collaborations, impairment on small molecule assets, as well as deal costs related to plant separation. Looking to our balance sheet, We report a cash balance of 3.3 billion euros at the end of the first quarter of 2025. Important to note here is the timing difference of the effective payouts related to the reorganization, which is not represented in our cash balance. Upon separation, SpinCo will have approximately 2.45 billion euros to execute its strategy for transformative transactions. Following this planned transaction, Galapagos expects the normalized annual cash burn to be between €175 million and €225 million, excluding restructuring costs. Upon separation, Galapagos will have approximately €500 million in cash to accelerate the cell therapy pipeline and expects to have runway to fund operations to 2028. Turning now to the value proposition for Galapagos and SpinCo. we remain very excited by the opportunities we can create by separating Galapagos into two entities. Following the separation, Galapagos will be focused on accelerating the development of our flagship CD19 CAR-T program through our innovative decentralized manufacturing platform. As noted, our aim is to start pivotal development in 2026 and first approval in 2028. We will continue to build value by developing next-gen cell therapy programs in hematological and solid tumors. Importantly, we will have the autonomy to partner our decentralized manufacturing platform and network, as well as our differentiated cell therapy pipeline. We also streamlined the organization to realign our footprint and reduce cash burn. As I just mentioned, upon separation, Galapagos will have 500 million euros in cash to execute this focus strategy. Turning to the opportunities we have by creating SpinCo. We are excited that Henry has joined as the founding CEO of SpinCo. Henry will be hiring the remainder of SpinCo's leadership team in the coming period. the board of SpinCo will comprise a majority of independent directors. SpinCo will be focusing on building a pipeline of innovative medicines through transformational transactions. The company will have sufficient resources to pursue high-quality assets, fund development, and to invest in its portfolio, which is expected to focus on oncology, immunology, and virology. If Gilead decides to opt in to SpinCo programs under the collaboration agreement, then SpinCo would be able to leverage Gilead's strong expertise and late-stage development and commercial capabilities in key therapeutic areas. Importantly, all Galapagos shareholders will receive shares of SpinCo on a pro rata basis based on the number of Galapagos shares that they owned as the record date to be established. And with that, I'll hand it over to Paul, who will walk us through our new near-term catalysts.

Thanks, Dad. As you can see on this slide, we have an exciting year ahead with the potential to achieve a number of value-driving catalysts. Our clinical programs have a number of key inflection points, including new top-line data from the Inland NHL cohort to be presented at the medical conference in the second quarter of 2025. new data from the MCL court at the medical meeting in the second half of 2025, and an end-of-phase II meeting for MCL that will align our pivotal trial design with global regulatory authorities and position us for pivotal development start in 2026. Advances with our innovative discovery engine will allow us to dose the first patients with our armed bispecific CAR-T candidate in 2025, and we will select at least one next-gen candidate to take forward to the clinic by year-end. For the planned separation of SpintCo, we expect to announce additional management and board appointments and to obtain shareholder approval for the separation by mid-year. In summary, 2025 is said to be a transformative year for Galapagos. With pivotal clinical milestones, groundbreaking advancements in our discovery engine, and the strategic separation of Spinko, we are well positioned to drive significant value for our stakeholders. We look forward to sharing our progress and achieving these ambitious goals. Thank you for your continued support and confidence in our vision. Operator, we are ready to open the call to questions.

Thank you. If you would like to ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. to withdraw your question, please press star one and one again. Please be advised that questions are limited to one question per person, and if you have further questions, then please rejoin the queue. Please stand by while we compile the Q&A roster.

Thanks, Sarah. While you compile the list, I just also want to mention that we have Valerie Knosson, Valeria Knosson, our executive and general counsel with us as well today for the Q&A period.

Thank you. We'll now take our first question. This is from Brian Abrahams from RBC Capital Markets. Please go ahead.

Hi there. Thanks for taking my questions. And best wishes to Paul and Thad on the transition out of the company and retirement. And congrats on the hiring of Henry for SpinCo. I guess now that it seems like there's a path that's even better defined for 5101, I was wondering if you could give us a better sense of your latest thinking on the registrational requirements in MCL, what a pivotal could look like and what data you might need to show there. And then if you could also talk a little bit about your expectations for the time cushion between when this pivotal data could read out and your cash runway. Thanks.

Yeah, first, the choice of MCL is based on very good results. It's a very high medical need, which we have been able to address with our CAR T in a very positive way, very high Q rates, as you have seen in the complete response rates, as you have seen in the slide, as well as very good safety data. And it's still in high medical need. with people who have a very high, a short life expectancy. And maybe our clinical lead, Tayo, may give some further comments on that, on when and how we will get to a pivotal design.

Yes, this is Omar Tayo, the clinical program head for 5101. So MCL is the right choice for the first indication for 5101, because like Paul said, there is a high medical need. The population we're targeting, the relapsed refractory population with non-CAR-T therapy have usually less than a 12-month event-free survival or progression-free survival with whatever therapy they get. So, giving this, there is a pathway for novel therapy like ICAR-T to pursue an indication using a single-arm trial design. But we also understand that with every single-arm trial design, you need to have a confirmatory study lined up. And our initial thinking is that this would be a randomized control study to confirm the findings of the clinical benefit from the SAT.

Yeah, and just to address, Brian, the question about the cash runway, we did intentionally align our capital allocation between SpinCo and Galapagos to address that pivotal readout and to align it with MCL. We say that the cash will take us into 2028, which is roughly the timing that we're anticipating for that.

Thank you.

Thank you. We'll now take our next question. This is from Phil Nadeau from TD Cowan. Please go ahead.

Good morning. Thanks for taking our question. Let us add our thanks to Paul and Thad for all your work over the years. Follow-up question to Brian's from us, and that's on manufacturing. Can you talk a bit more about your understanding or expectations for the manufacturing requirements that you'll need to file in the U.S. and Europe? how well-defined are those with the regulatory agencies, and is there more work to do to understand those requirements? And maybe a second part to the question would be, how many DMAUs do you think you'd need in the U.S. and Europe to fully satisfy the market?

Thanks. With regard to the requirements for the manufacturing process and equipment, we are in continuous discussion with the authorities and each of the steps have been very well defined from where we are now, both with EMA and the FDA, uh starting pivotal uh additional steps are taken on quality release etc and then what needs to be done by commercial and we have a whole development part in place uh for for that with all the elements in place to be able to have our pivotal studies running as as pre-commercial because we need to have the final formulation final setup and then confirming that with additional validation uh throughout uh our phase a pivotal study development. So that is very well understood. We have had multiple discussions with the authorities, and we have a clear path for that with all in place to meet the 2028 date for commercial availability.

Yeah, thanks, Phil, for the question to address the point about the number of DMUs and sites, it has been evolving. I think initially when we first acquired CellPoint, it was more about point of care. And we thought that that would be like near the hospital. I think it's been evolving more towards decentralized manufacturing hubs. Where, again, like we recently signed with Moffitt, a collaboration to cover the southeast. And so we think that we'll need fewer DMUs, but have more of a regional coverage model. And that's still under development for commercial, but we're still in the clinical phase at this point. But as it evolves, I think it will be more regional coverage. And then we're also having regional hubs as well, covering the Benelux, of course, UK and key markets throughout Europe.

Great. Thank you.

Thank you. We'll now take the next question. This is from Sebastian van der Schoot from Van Lanschot Kempen. Please go ahead.

Good morning, guys. Thank you for taking my questions. And sad to see Paul and Sted go. I think that you mentioned partnership opportunity for Galapagos after the split has been finalized. Are you also interested in partnering on the cocoon approach with other parties for the development of cell therapies? And if so, can you describe how such partnerships would look like? And then maybe can you also provide some insight on the focus of the next generation parties? Thank you.

Well, Sebastian, first I want to say I'm not yet gone. I've committed to stay for the next 12 months to make sure, first as CEO and then continue as chair. So I will stay with Galapagos for the long time. So that's my mission. Yes, the partnerships. Yes, we will be. We have a lot of interest in people who look at our manufacturing platform to be participating in that. The first collaboration we did was with Adaptimmune, where we actively studied Uza's cell in the cocoon and were able to show that we could make the TCRT also in seven days with very good quality cells. That enables us now to bring that into the clinic in 26 with a study most likely in head and neck, that is the goal. More interest is there, but at the moment we have a single focus on making sure we bring our own platform and our own products forward to commercial. Eventually, yes, there will be opportunities to partner on the platform itself. The DMU is a very, it's an exceptional, unique approach, bringing CAR-Ts close to people and also the ability to bring them global, including Asia, South America, all the rest of the world is accessible by this principle. So we'll foresee definitely collaborations as we go forward, but with a focus on making sure our own products reach the market first.

I think it's a really exciting time for us as we do the separation to have this platform, as Paul mentioned, develop our own pipeline, but also to develop next-generation assets, which John can talk more about.

John?

Yeah, hi. John Miller is head of discovery. I'm happy to talk about our next-generation assets. They will address... A high unmet medical need in both liquid and solid tumors. The approach is to take validated targets and combine them potentially with new targets through a multi-targeting strategy and also arming the cells to expand and persist and not be inhibited by the tumor microenvironment and to engage the endogenous non-CAR-T immune system to attack the tumor. And we're targeting non-Hodgkin's lymphoma that is refractory, even after first-generation CAR T therapy. But we'll move into earlier lines of therapy as data emerge, particularly in DLBCL, where there's high unmet medical need, and also refractory multiple myeloma after BCMA bispecific or CAR T therapy. The largest unmet medical need is in solid tumors, and we have identified three programs to hit various forms of lung cancer and gynecologic cancer. And as was mentioned earlier, we'll nominate our first candidate for IND this year for hematologic cancer, which will be advanced over existing therapies, and we will move into early clinical development through our recently established headquarters in Shanghai, China. Thank you. Thank you, guys.

Thank you. We'll now take our next question. This is from Manos Mastarakis from Deutsche Bank. Please go ahead.

Hi, thank you so much for taking my question. So a little bit more color on the M&A strategy, the modalities, the collaboration versus straight out acquisitions will be much appreciated, as well as whether Spinko will be completely independent in the development of its new portfolio or whether GLPG resources will be tapped into. And what are the sort of timelines for starting to see some of those deals executed by Spinko?

Thank you. Thank you, Manos, for the question. Yes, SpinCo will be an independent company. And obviously now with having, you know, Henry is the head of the CEO, we'll really focus on bringing in and acquiring new assets. And so it's not limited to, you know, a particular area that's of strategic interest to Galapagos. It's really up to Henry and the independent board and management team to do those deals and We will provide, obviously, the support to initially set up the SPINCO and the entity and provide any support, you know, like IT or finance or just those kind of general, you know, G&A support. But, yeah, they'll be an independent team. Yeah.

and for the timing of the first deal um uh as we are um approaching mid-year um most likely there will be no deal done before the the spin the spin is actually done uh um so that is uh that is but but it will be very active on uh much activity ongoing to prepare for potential opportunities

Thank you. We'll now take our next question. This is from Faisal Khurshid from Lyric Partners. Please go ahead.

Hi, everyone. Thanks for taking the question. Just can you provide some context on expectations for the MCL data update coming in the second half of this year? Curious if you can kind of say anything on, like, numbers of patients and the extent of follow-up compared to the data that we saw last year.

Tayo, can you give a short update on what to be expected?

Yes. So last ASH, ASH 2024, we had eight MCL patients in that data set. That's from April 2024, exactly a year ago. We have continued to enroll, and the numbers have increased. And we will be updating and releasing data second half of this year.

Yeah, can you say anything on how many patrons and how much follow-up?

So the median follow-up at ASH for that cohort was about three to four months, and like I said, we'll be at least one year on, so that's about the follow-up you will expect. The numbers are more than we've reported, and we're not ready to disclose at this time.

Well, let me add in general, what we are doing is in the eight indications which we are studying, we have a phase one part and a phase two part, and the phase one part in the dose finding, the phase two part in the expansion cohorts. And we typically go up to around 20 patients, might be more, but that is the range we will report on multiple of our indications in the future. So... You have seen the list on the slides on the different indications. All the indications are recruiting except for the Richter transformation and CLL, which still need to kick off. RT's Richter transformation is ready to go. CLL, the protocol, is being finalized with the authorities. And hopefully, in the next few months, we'll be able to recruit there, too. So it's a very active program. But each of the indications will be going up to a certain number in the range of 20 to confirm efficacy and safety.

Got it. That's very helpful. Thank you, Paul. And then if I can just ask a follow-up here, what is the target profile that you think you need to achieve in MCL to kind of differentiate from the two approved CAR T options?

Payal?

Yes, so the two CAR-Ts you referenced, one of them is known for its efficacy, the other for its safety. We believe our profile will match, should match the efficacy and the safety as I just explained. So we think we will merge the best of both worlds.

Well, in addition to that, the opportunity to have a cell therapy product which can be administered in a seven-day vein-to-vein. So people with live expectancy even up to one month, you still can get therapy. And that is a very important feature for what we see now in the clinics. They have relapsed patients who come back to the clinic with relapsed. refractory mental cell lymphoma with very short life expectancies. And those are specifically people where the product can be very, very differentiated to still give a solution for that patient.

And I'll just add on to what Paul said. One of the things we know from prior CAR-T data in MCL is that a percentage of patients drop out between leukapheresis and infusion. The strength of our platform is that within seven days, that number is much reduced. So we believe that this is additional value 5-101 will be able to bring to this higher medical need.

Thank you. We'll take our next question. This is from Judith Romer from Morgan Stanley. Please go ahead.

Hi, congrats on the progress, and thanks for taking the questions. Just a couple of follow-ups, I guess. First, maybe just in reference to expanding the collaboration agreements in the U.S., just curious if kind of new partners are indicating that it's supply, that's an issue for them, or that they're interested in expanding for CAR-Ts at their centers, or if it's the efficacy of the program, that's resonating more. And then just on SPINCO, we've gotten the question, is there any chance, given Henry's recent background, that neurology could be an area of focus going forward?

Yeah, so I think on the separation, I mean, clearly we see a lot of interest in our platform with cell therapy, the decentralized manufacturing. But I think where it gets really exciting is what Paul mentioned with Adaptimmune. When we test cells on the cocoon in seven days, we see better cell quality and better outcomes there. And so there has been interest, I think, post separation for us to partner with many different types of companies, both big and small, depending on whether they need a manufacturing platform or whether they want to see even better efficacy for their products that's in their pipeline. And, you know, I think related to the SPINCO, it's, you know, I think our areas of interest that we've outlined has been oncology, immunology, and virology, which again, were areas of interest for Gilead. But I think it's always possible depending on the deal.

With regard to the partnerships on the DMUs and hospitals and the interest, there is significant interest. We are building up DMU by DMU as we need to validate and cross-validate the production as biological production sites. And sometimes that takes some, that takes certain times and that's where we are building up, uh, very steadily. But, um, um, in between now and the year end, we'll have multiple, multiple of the DMUs up and running, start preparing for the pivotal. So that is ongoing. Um, Lots of interest in hospitals, and we selected the DMUs where we can manufacturing close in regions with access to multiple large hospitals and within a few-hour drive range so that we can deliver the fresh cells in the same day. Cells come from a manufacturing system in the morning. They need a few hours for quality release, and they typically are administered in the afternoon to patients. So that is the way we operate in close to large cities with multiple hospitals today. Thank you. Okay. Thank you.

Thank you. We'll now take our next question. This is from Jacob McHale from KBC Securities. Please go ahead.

Hi there, and thanks for taking my question. With the recent changes happening at the FDA, how do you think this could impact how the agency looks at point of care CAR T? And could there be a change to how open they are to new ways of manufacturing and delivering cell therapies now that they're working with less people?

Well, that's to be expected. I think, well, to be expected, to be looked for on what the change is going to be. But one thing I can say, if we work on, and we have the recent experience in the past few weeks with the FDA, working on a very high medical need, still gets priority, still gets support, still gets the help of the people at the FDA. But even more, I was at the Rome Cell and Gene Therapy Conference last week in Rome, and the senior regulators from Europe and the UK were there. And they see this also as an opportunity now for Europe and the UK to stand up and drive the innovation. And I think we'll get support there. all over the world, especially because you bring a product for a very high medical need, which can help many patients. So I expect, yes, there might be some hiccups, but so far we have not yet seen that.

Okay, thank you very much.

Thank you. We'll now take our next question. This is from Chief Fong from Bank of America. Please go ahead.

Hey, this is Chi Ong for Jason Gerberi at Bank of America. Thanks for taking our question. I have a question on 5301. So the field currently has a hypothesis that Parkinsonism is a class effect and not a molecule or contract specific effect, and that you can minimize Parkinsonism by prophylactic steroid treatment. I'm curious what's your view on that? And can you remind us what the mitigation strategy you have implemented in the AMENDA Phase 1 protocol? Are you giving patients prophylaxis dexamethasone or a similar approach? And have you seen any Parkinsonium case since you have resumed the study? Thanks so much.

So, Tai or John, can you step in here?

Yes, so I'll go and then maybe John can add as well. The mitigation strategies we put in place are strategies that have been published in literature. When the Parkinsonism associated with BCMA therapy first hit the headlines, I think this came as a surprise. And when the data was reviewed, certain risk factors were identified. such as patients with high tumor volume was a risk factor, and patients with rapidly rising lymphocyte count. So what we've done in our protocol is to try to mitigate at least two of this, or both of these issues. And we have elements in the protocol to protect patients. And since restarting the study, we have been able to manage all the patients that have been enrolled and haven't seen any further occurrences.

So as we said earlier, one comment more is that we are still in the phase one, two study phase. closing on the dose finding, and then we'll further expand, and we'll be able to report on this study in 26, because, yes, it takes time, and the spacing of the dose finding and the safety event we had, we got some delay, but now we are back on track, and we'll report on that. Based on those data, we'll decide what development path we take for our PCMA product. Thank you.

Great. Thank you.

Thank you. As a reminder, if you would like to ask a question, you'll need to press star 1 and 1 on your telephone and wait for your name to be announced. And to withdraw your question, please press star 1 and 1 again. We'll now take our next question. This is from Sean McCutcheon from Raymond James. Please go ahead.

Hi, good morning, team. Congrats on the progress in the spin-off. This is Yang, Ong, Fo, and Sean from Raymond James. We have a question regarding the US clinical trial, especially for Atlantic. Now you have your first patient, and could you provide some color on the degree of variability you have seen on per patient basis or the per site basis, especially Given your previous experience that for some patients, their products may be below the target dose, what's your thinking and strategy for the protocol action in that case? Thank you.

Tayo?

Yes. So specifically, we just began enrolling patients in the U.S. if your question was about the patient in the U.S. versus Europe. So we're still gathering data, and so I can't answer that question specifically. However, what I can say in general terms is that even in cases where the doses may not be the doses intended, when those patients have been infused, we have seen encouraging safety data and efficacy data. And an investigation and, you know, process improvements were put in place. And since then, the dosing has been more consistent at the desired dose.

Okay, thanks. Maybe I can do a follow-up for the Atlanta one. We noticed that it did not mention DLBCL. Could you give us your thoughts on this cohort and what you're thinking for defining the go-forward dose?

Yes.

Okay. So Atalanta has seven cohorts right now. And like Paul mentioned earlier, we're adding an eighth cohort, chronic lymphocytic leukemia. MCL is the first cohort that's going forth to pivotal. And the other cohorts continue to enroll, continue to gather data, analyze the data. And as the data matures, we intend to progress those cohorts to Pivotal as well. DLBCL is one of those cohorts. It's still open, and it's enrolling patients.

Okay. Thanks for the update.

Thank you. We'll take our next question. This is from David Senev from DeGroote Petercam. Please go ahead.

Hi. Good afternoon. Just wondering at the speed it's going now, when you expect the Papilio 1 patient enrollment to be completed and based around if it's going to be more likely H1 or H2 2026 when you share the top line results, or at least when you expect to be able to provide more detailed guidance on that. Thank you.

I think at the moment we are still, as I said, recruiting in the phase one part of that. Soon the phase two will start. We can't give further guidance on when we'll be able to report top line data, but it will be 26, and in one of the next calls we'll provide more detail on that, where we will land in the course of 2026.

Okay, thank you. Thank you. And there are no further questions at this time, so I will now hand the conference back to Glenn Shulman for any closing comments.

Thanks, Sarah. And thank you, everyone, for joining us today on our first quarter 2025 results conference call. On behalf of the team, I want to thank you for your attention. Also let you know that we will be attending, the team will be presenting at the Jeffries Conference coming up in June. And we'll be reporting our next webcast of first half financial results, July 23rd, followed by the webcast on July 24th. So hope everyone has a great day and be well.