Gilead Sciences, Inc. ($GLPG)

Good day, and thank you for standing by. Welcome to the Galapagos conference call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sherri Spear. Please go ahead.

Hello from Belgium. Thank you for joining Galapagos for our conference call today. Before we begin, I would like to remind everyone that we will be making forward-looking statements. These forward-looking statements include remarks concerning the collaboration agreement with Gilead and the expected benefits of such collaboration, the potential of gamgerdamic and BCMA targeted T-cell gaugers, future developments of our company and our pipeline and possible changes in the industry and competitive environment. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Actual results may differ materially from those indicated by these statements and are accurate only as of the date of this recording, March 31, 2026. Galapagos is not under any obligation to update statements regarding the future or to conform these statements in relation to actual results unless required by law. You are cautioned not to place any undue reliance on these statements. Joining us on today's call from the executive team are Henry Gosebruch, Chief Executive Officer; Eric Hedrick; Head of Clinical Evaluation and Aaron Cox, Chief Financial Officer; Sooin Kwon, Chief Business Officer; and Dan Grossman, Chief Strategy Officer, will be joining us for the Q&A session. With that, let me turn the call over to Henry.

Thank you, Sherri Hello from Belgium and our corporate headquarters in Mechelen. Galapagos has a rich history as one of the oldest and historically one of the most successful European biotech companies. And that rich history provided us with a strong balance sheet and the opportunity to create shareholder value. Last week, we announced that we were in advanced discussions to collaborate with Gilead in a transaction with Oro, a company with an exciting clinically derisked lead program, in gamgertamig, that has the potential to change the treatment paradigm in several immune-mediated diseases. Today, I'm pleased to announce that we have entered into a binding agreement with Gilead. The collaboration centers on gamgertamig, a BCMAxCD3 T-cell engager for autoimmune diseases with multibillion dollar revenue potential, currently in Phase Ib dose-ranging studies and expected to enter a registrational studies as early as 2027. Galapagos and Gilead will equally split an upfront payment of $1.675 billion in milestone payments of up to $500 million. Galapagos and Gilead will collaborate on development of gamgertamig with Galapagos responsible for development costs through initiation of registrational studies after which development costs will be shared equally. Galapagos is eligible for up to $100 million in development milestones. Galapagos also gained a preclinical portfolio of 3 additional autoimmune focused programs originally from Oro with an opt-in for Gilead for a 50-50 profit split at proof of concept for $75 million per program. Gilead will retain sole worldwide commercialization rights and pay all related costs outside of Greater China, and Galapagos will receive royalties of 20% to 23%. The proposed arrangements will amend the legacy OCA with Gilead to designate an additional $500 million of Galapagos cash available for R&D or strategic transactions outside of cilia partnerships, including up to $150 million for potential return of capital. This is an important step in our ongoing transformation, and we're really excited about it. To start, we believe the transaction is backed by a compelling strategic rationale. Gamgertamig or our sleep molecule is, in our view, a best and first-in-class T-cell engager that has demonstrated a differentiated profile in clinical studies. The collaboration brings a meaningfully clinically derisked high-potential asset into our portfolio. Registrational studies are expected to start as early as 2027. The proof-of-concept initial indications are orphan indications, where the clinical trials are manageable in size and scope with significant potential for expansion into additional indications. We are also excited about the early pipeline with 3 oral preclinical programs coming to Galapagos as part of this deal. The transaction allows us to add a talented and accomplished team of drug developers to Galapagos, building on our own capabilities and bringing top talent that has a strong track record of success. We are well positioned to continue the development of AURs programs with urgency as speed to market is critical. Additionally, we are pleased with the financial terms we've been able to negotiate. The risk-adjusted potential financial return from this collaboration is attractive. The structure of the collaboration effectively leverages our partners' capabilities in global commercialization and derisk those operational aspects for us. The transaction includes a significantly higher financial contribution from Gilead, which all in should amount to over $1 billion compared to the legacy agreement which would have allowed Gilead to opt into commercial rights outside of Europe for just $150 million. The preclinical pipeline adds additional value creation potential and the ability to share in future profits 50-50 with Gilead. Importantly, this transaction enhances our future strategic flexibility. $500 million will be available for R&D or strategic transactions independent of Gilead, including up to $150 million for renewal capital. We retained the majority of our available capital for transactions and investments beyond the Ouro transaction and the capital we have earmarked for investment in Ouro's programs. We had a very high bar to deploy cash, and this is a transaction that meets our strategic and financial criteria and advances our transformation strategy. At Galabagos, we've assembled a team with world-class business development expertise and a shared mission of leveraging our unique position to create significant shareholder value. Collectively, our team has executed hundreds of transactions in the Life Sciences sector and has been working tirelessly with the goal of creating value for our shareholders. Our objective hasn't been incremental rebuilding, but a fundamental reshaping of the company around programs we believe are capable of delivering meaningful patient impact and sustainable shareholder returns. On prior calls, we had discussed being encouraged by the level of potential transactions we had in our deal pipeline and our opportunity to become a unique player in the biotech deal ecosystem and carve out niches where we can be competitively differentiated. At the same time, we have been disciplined and selective. We declared a focus on clinically derisked opportunities in the areas where we are able to bring unique insights that represent competitive advantage. On the left side of Slide 6, you can see we've evaluated hundreds of potential opportunities since last summer, and we've conducted in-depth due diligence on a good number of them and have made nonbinding proposals to potential partners. Our discussions with JD and the team at Ouro started last fall, leveraging existing relationships our team had with both JD and some of Ouro shareholders. When we first saw some of the emerging clinical data last year, our enthusiasm strengthened, and we made pursuing a transaction with Ouro a top priority. In addition, when we highlighted gamgertamig and its clinical data to our colleagues at Gilead, they quickly saw why we were so impressed and joined us in our evaluation efforts. Discussions picked up steam earlier this year, and we have had an opportunity to conduct extensive due diligence on the opportunity along with our colleagues at Gilead, including visiting key investigators in China. We see an impressive clinical data from over 60 patients and received strong feedback from KOLs and our outside advisers regarding gamgertamig's potential. We are delighted to be able to make today's announcement following last week's announcement that Gilead signed an agreement with Ouro in our late-stage partnership discussions. Our extensive interaction with Ouro's team also strengthened our [indiscernible] That there's great chemistry among our teams. And we are looking forward to welcoming the Ouro team to our company in the near future. I hope it is clear by these remarks why we are so excited to be able to announce this transaction today and why I believe it ticks all the boxes. It's in our core focus areas of I&I. It includes a clinically meaningfully derisked asset that leverages our unique situation and relationship with Gilead. It is a long-term strategic transaction with partnership terms that significantly improve on the legacy agreement with Gilead. Beyond these features, the transaction freed up $500 million to be used outside of this transaction independent from Gilead. Additionally, given the efficient clinical development plan, we will still have the majority of our capital available for future deals after investing in Ouro's portfolio. Let me now introduce Dr. Eric Hedrick, Eric was one of my first hires at Galapagos, tasked with identifying and evaluating opportunities in oncology and I&I. Eric is a hematologist and medical oncologist by training and began his career in Biotech at Genentech, leading various aspects of Rituxan and Avastin development. He subsequently held roles of VP of Development and Interim Chief Medical Officer at Pharmacyclics, where he was responsible for IMBRUVICA development, Chief Medical Officer at Epizyme, Chief Adviser at Beijing, where he played a significant role in the development of Brukinsa and Chief Executive physician at EQRx. Eric will provide some color specifically on gamgertamig and why we are excited to bring this asset and the team that progressed rapidly to Galapagos. Eric?

Thanks, Henry. It's great to be here today to share our excitement about gamgertamig, a potentially transformative immune reset treatment for autoimmune disease and to highlight the considerable progress made by the team at Ouro in its clinical development. This slide offers a summary of our view of the opportunity. We believe that gamgertamig represents a best-in-class BCMA directed T-cell engager characterized by high potency against BCMA and a detoned CD3 binding arm, which significantly aggregates cytokine release. Note that all the studies conducted to date have used the subcutaneous formulation of the drug. So far, over 60 patients across 5 distinct autoimmune indications have been treated with gamgertamig. This clinical experience has highlighted the differentiated profile of gamgertamig, characterized by the induction of durable complete responses, minimal cytokine release syndrome with the current schedule of administration and remarkable consistency in these findings across studies and disease indications. We also believe that gamgertamig has a clear speed-to-market advantage. The initial focus on the treatment of rare autoimmune diseases has provided rapid proof of concept, enabling initiation of registrational trials as early as 2027. The program has also received fast track and orphan drug designation in the U.S. for hemolytic anemia and ITP, further supporting an accelerated development path. Lastly, the sector of diseases that may be addressable by gamgertamig encompasses over 20 separate indications, and we'll comment later in this section on the expanded opportunity. The concept of immune reset in the treatment of autoimmune disease is an exciting and rapidly evolving area of clinical investigation. Despite the diversity of clinical presentation across diseases, a central feature is the presence of autoreactive B cells and plasma cells. These populations developed during the B-cell maturation process upon exposure to antigen and with the ultimate step in the maturation process being tissue resident plasma cells with a lifespan measured in years. There are existing therapies for many of these diseases, including nonspecific immunosuppressants and B-cell modifying agents, none to date effectively reversed the central pathogenic process. The promise of the immune reset approach is the potential to eliminate pathogenic immune cell populations, allowing for the reconstitution of the immune repertoire with B cells and plasma cells that back autoreactivity. This approach potentially addresses a critical need in the treatment of these diseases. The need for a treatment given over a short course which can induce rapid, complete and durable remissions and thus eliminate the requirement for a cyclical or chronic immunosuppressive treatment. The availability of this type of therapy would fundamentally transform the treatment of these diseases. A recent and highly relevant development in the field of immune reset for autoimmune disease is a recognition of BCMA expression in the B-cell maturation sequence. The potent anti-plasma cell activity of the BCMA T-cell engagers has, of course, been demonstrated by the highly efficacious first-generation BCMA T-cell engagers such as teclistamab in multiple myeloma. More recently, it has become recognized that lower-level BCMA expression begins around the time of antigen exposure in the B-cell maturation process, the stage in the B-cell maturation process coinciding with the emergence of autoreactive T-cells. Therefore, BCMA directed T-cell engagers have the potential to eliminate all auto reactive immune cells of both B-cell and plasma cell wings. In contrast, T-cell engagers directed at B-cell restricted antigens such as CD19 or CD20, spare auto reactive classic cells. In the small clinical series of patients with various autoimmune diseases, the first-generation BCMA directed T-cell engager teclistamab validated this concept. In this series, teclistumab depleted both B cells and plasma cells and induce high-quality responses. However, most of the patients in this series experienced cytokine release syndrome about half of these patients having CRS with Grade 2 severity. Nevertheless, the framework for a BCMA directed T-cell engager in autoimmune diseases was established. Moreover, the attributes for a second-generation ECMA directed T-cell engager optimized for use in autoimmune disease were defined. Equal or greater potency against BCMA and antibody modifications directed at lowering cytokine release. Gamgertamig represented here is the second-generation BCMA CD3 bispecific antibody with superior potency against BCMA and versus first-generation BCMA directed T-cell engagers and de-tuned CD3 binding arm. These characteristics have resulted in a demonstration of profound depletion of BCMA expressing cells across various tissue compartments, both B cells and plasma cells and significantly less cytokine release compared with the first-generation BCMA directed T-cell engagers the preclinical characterization represented in the graph on the right. Represented here is the current clinical development status gamgertamig. A total of over 160 patients have been treated in clinical trials, including over 60 patients across high distinct autoimmune diseases. The initial experience of gamgertamig in autoimmune disease occurred in the context of now completed investigator-sponsored trials in autoimmune hemolytic anemia, immune thrombocytopenia purpura and pestigusvolgaris and autoimmune blistering skin disease, which is often severe in nature. The ongoing trials include Phase Ib dose-ranging studies sponsored by Ouro globally and by Kemet in China. These studies address autoimmune cytopenias and nonhematologic autoimmune diseases such as sedans disease, idiopathic inflammatory myopathies and others. We anticipate either publication or meeting presentations for many of these studies, including the company-sponsored studies over the course of 2026. The totality of the clinical trial data is notable in several ways. First, there has been remarkable consistency in the efficacy findings of gamgertamig across trials and disease indications. Rapid onset of complete responses and as the follow-up of the patients extends significant durability. We also have confidence that the safety profile of cameramen particularly the risk of cytokine release syndrome can be optimized with adjustments in the dose and schedule of treatment without sacrificing efficacy. The next 2 slides will provide an example of the clinical profile of camera that is emerging from a rapidly progressing clinical trials program. Gamgertamig, as an immune reset therapy in autoimmune disease was initially evaluated in the context of our compassionate-use program an investigator-sponsored trial in autoimmune hetomoletic anemia. The data from the first 2 patients in necessaries was published in the New England Journal of Medicine in June 2025. Note that in these patients, gamgertamig was administered a higher dose and then a longer duration than the schedules currently under evaluation. Gamgertamig [indiscernible] Profound depletion of those B-cells and plasma cells in circulation and bone marrow and produce complete remissions of rapid onset that were durable. Additionally, despite the higher dose schedule used here, the safety profile was favorable in regard to the incidence and severity of CRS and the infectious risk, which is due to hypogammaglobulinemia during the transient period of B-cell depletion was manageable. These results were particularly notable given the extent of prior treatment in these patients, which was extensive and included failure of CD19-directed CAR T therapy. This experience has now been significantly expanded in the form of investigator-sponsored trials in autoimmune hemolytic anemia and immune thrombocytopenia corporal. This slide provides an example of what is currently being observed in ITP patients in the ongoing Ouro sponsored study. There are several things to note. First, despite the attenuated dose and schedule of gamgertamig used in this study, we are seeing predictable B-cell depletion and complete responses of rapid offset and significant durability. Importantly, in this cohort of patients, no CRS was observed. And as the study continues, it's become apparent that modifications to the dose and schedule of gamgertamig meaningfully reduce the incidence and severity of CRS. I will also point out that 2 dose levels are currently being expanded and we are confident that we will identify prior to the end of 2026, a go-forward dose and schedule of gamgertamig that is characterized by durable remissions highly favorable CRS risk in the context of the robust efficacy being seen in a manageable period of hypogammaglobulinemia. I'll conclude my section by noting that the spectrum of diseases that are associated with pathogenic B cells and plasma cells, thus potentially addressable by gamgertamig to is broad and includes over 20 separate disease indications. Our intent with the future development of gamgertamig in the near term is to establish proof-of-concept where applicable. It is also important to note that the proof-of-concept signal that has emerged from the diseases evaluated thus far has not been settled. To the extent of the supplies to other disease settings, it is possible that an extensive proof-of-concept clinical trials program could be prosecuted with a high degree of efficiency, both in terms of patients treated and cost expensed. Let me now pass the call to Aaron Cox, our CFO, to talk briefly about some of the key features of the agreement with Gilead. Aaron?

Thank you, Eric. Turning now to some key highlights of this transaction and how it enhances our already strong asset base. The addition of the Ouro programs represent a significant long-term value creation opportunity for our shareholders, which is consistent with our previously communicated goals and strategic focus. More specifically, gamgertamig stands out as a highly differentiated asset that offers meaningful near-term catalysts and the potential to generate an attractive future milestone and royalty stream. Importantly, this transaction is not just about the asset, it also brings a highly experienced clinical team from Ouro which we look forward to welcoming to our company soon. This adds critical drug development capabilities and helps us take the next step in building on our foundation as we continue to evolve into a clinical stage biotech company. At the same time, we'll continue to benefit from a strong financial foundation. We will retain a majority of our cash after taking into account cash needed for the Ouro transaction and development costs and we continue to expect that cash to generate meaningful investment income. Additionally, we will continue to benefit from an expected annual income stream from existing partnerships into the 2030s, anticipated tax credit receivables over the coming years and more. The transaction will also provide partial waiver and modification of terms of our legacy option, license and collaboration agreement or OCA with Gilead, marking a meaningful step forward in our strategic and financial flexibility. Under the revised terms, $500 million is now unlocked for broader use beyond the Ouro investment, enabling Galapagos to pursue new opportunities and transactions independently of Gilead and expanding the universe of potential strategic targets. Additionally, up to $150 million of this $500 million may be used for a return of capital to shareholders, subject to certain limitations, providing us with additional optionality to drive shareholder value. This partial waiver and modification of terms to OCA further strengthens our ability to deploy capital strategically and pursue additional value-accretive opportunities. Now I'll turn it back to Henry for our closing remarks.

Thank you, Aaron. As I close, I want to thank our shareholders for their patience as we have moved through the past year. This is a seminal moment for our company, and I hope you can hear our excitement when we talk about Ouro. This transaction is transformational for many reasons. Galapagos is positioned to become a clinical stage company with a potential pipeline in a product with gamgertamig. We believe gamgertamig represents a potential first and best-in-class T-cell engager with compelling efficacy, safety, patient convenience with a short course of subcutaneous dosing and speed to market and with multibillion-dollar potential in multiple autoimmune diseases with significant unmet medical need. This transaction also signals our strong strategic relationship with Gilead and how that partnership provides a competitive advantage in business development. And as Aaron mentioned, the renegotiation of the legacy agreement with Gilead frees up $500 million to spend independent of Gilead which provides us with capital to pursue further business development opportunities independently and also allows for a potential return of capital to shareholders. Finally, we think this transaction helps fulfill our commitment to creating meaningful patient impact and sustainable shareholder returns. Thank you. And I will now turn the call over to the operator for your questions.

[Operator Instructions] The first question comes from the line of Xian Deng from UBS.

Xian Deng from UBS. Two, please. Just wondering the first one. The first question, I mean, you have a very significant cash balance. And even after the gamgertamig to make related to spending and the cost share and outside the $500 million that you can use without Gilead. Gilead info, you still have quite considerable cash that's left. So just wondering, could you give us some color in terms of your plan for the rest of the cash in terms of M&A strategy. Just wondering, would you just the current Ouro collaboration changes your focus in the future for BD? So that's the first question. And the second one is just wondering for the gamgertamig, the [ D2 C3 ], so just wondering if you could give us some extra color on this and how this mechanistically helps to lower CRS, please?

Xian, it's Henry. Thanks for the question. I'll take the first one, and I'll let Eric answer the second one. So, on the first one, yes, you're absolutely right. I mean, one of the things that we like about this transaction is that while we're obviously quite excited about gamgertamig and the potential it does leave the majority of our cash for other opportunities. And when we say majority of the cash, again, just to be clear, that means even after we invest in the portfolio and continue all the all the good work that the Ouro team has already been doing. So that gives us really excellent optionality. I mean we'll continue to have a very, very high bar for transactions, just like on this one. It needs to be something that we think is special and can create a lot of value for our shareholders. And I'm excited about continuing to have the team look for opportunities. we will, with this partnership, of course, have a really nice position in autoimmune with a really strong portfolio. So obviously, there's some natural opportunities to build on that, but we're not going to restrict ourselves just to that. Again, one of the beauties of our structure is we have just enormous opportunity. And again, we'll be very, very selective. We'll be very, very focused on not just the strategic but also the financial aspects and we're looking forward to continuing the active PD funnel. And I'll let Eric answer the second question.

Yes. Thanks, Xian. Yes, in regards to the question around the mechanism around cytokine release. I guess there's 2 points to make. One in the setting of autoimmune disease, the risk of CRS overall is less than what you would see in the setting of multiple myeloma with this class of agents. I think even beyond that, well, the D2 and CD3 arm really prevents excessive activation of T-cells, and you see that preclinically and what we're seeing clinically is consistent with that and minimizing the CRS risk.

Your next question comes from the line of Judah Frommer from Morgan Stanley.

Congratulations on the deal. Just curious, in your consideration of deals and specifically this one, I guess, kind of circling on a deal that ended up being in relatively rare indications. Just curious how the financial versus regulatory aspects factored into this deal and how it might factor into how you're thinking about BD going forward?

Yes. Judah, it's Henry. Good question. I'll start and then maybe I'll ask Sooin to comment some more. I mean one of the things we really like about this is is that the Ouro team did a great job identifying really very interesting places to take this mechanism and specifically ones that are not adequately addressed by either existing therapies or frankly, some of the other companies focused on T-cell engagers. And so that was quite important to us to have something where we can be first to market. These are -- while they're orphan, they're actually quite large markets in our view, and that's, I think, an insight we could bring to this. And last and very importantly, what we also liked about that is that the path to market is clear and the trials are not very, very expensive. Previous studies in these diseases have had pivotal studies of around 100 patients, just to sort of give you use of code. And so that's all very attractive and that, of course, feeds right into the financial model in terms of how much or how little capital really we have to continue to put to work here to ultimately get to approval. That was very attractive. And I think while we're not limiting our search for other opportunities to those types of opportunities, that was certainly quite quite attractive on this one. If there's anything you guys want to add?

Yes, I'd just like to add, I think we considered both the financial as well as regulatory considerations in evaluating this potential opportunity and in particular, having strong conviction as well as visibility on what it would take to get through the finish line and the feasibility of a company such -- with the capabilities and the size that we're at to be able to do so successfully. So I think those were all really important considerations and give us the confidence that we're able to do this successfully.

Your next question comes from the line of Brian Abrahams from RBC Capital Markets.

This is Nevin on for Brian. Congrats on the deal. Just wanted to ask if you could clarify what the decision-making conversations will look like, what Gilead especially during the funded portion of the development of gamgertamig? And then what that collaboration would also look like when you move forward to determining regulatory alignment on what a registrational program and the study design can look like?

Yes. We -- it's Henry van thanks for the question. So we'll work closely with Gilead on the development here going forward. Again, as we said in the release and in our materials, we look forward to welcoming the Ouro team. We expect that team as part of our company to continue to lead this program. And they will closely coordinate with Gilead and get the best insights from them as we work together to bring this to patients hopefully in the not-too-distant future. So it will be a really nice collaborative relationship. That's what we're envisioning. Maybe, Eric, you can comment a little bit on the sort of registrational path.

Yes. I would add that particularly in the lead indications that are on the table. I think as Henry had mentioned one of the appealing parts of this program is that there's really well-established regulatory present and the scope of pivotal stage development is pretty modest. And so that was certainly attractive to us and we're confident with bringing the team from Ouro that this is something that we can accomplish within our group. And then the collaboration with Gilead, obviously, an important part of that is will come when they're commercializing the drug. And so we want to make sure that the development programs are in sync with the ultimate commercialization. But as Henry mentioned, we imagine this to be a highly collaborative relationship and one that we can move forward within Galapagos pretty efficiently.

Your next question comes from the line of [indiscernible] from TD Cowen.

This is Salvator from TD Cowen on behalf of [indiscernible] . Congratulations on the great deal, and looking forward to more updates in the future. Just one quick question, kind of given the updated capital envelope you guys have laid out today based on the amended agreement. How realistic is it to license in another clinically derisked program going forward versus maybe focusing future deals on a more preclinical or early clinical asset where you might have some more attractive entry valuations?

Yes. [indiscernible], it's Henry. Thanks for the question. Look, we found in gamgertamig program that we believe is clinically derisked and and has a really strong body of evidence with more than 60 patients of clinical data we've reviewed and seeing all the things we were looking for rapid onset, good duration, excellent safety profile, et cetera. So given that we have the majority of our capital still with us, I'm confident we could find another one of those. And look, in addition to that, the $500 million that we have as a capital envelope now independent of Gilead also opens different deal structures that I'm also quite excited about. So it's just one example partnering deals as opposed to M&A deals, partnering deals with biotech companies, $500 million can go a pretty long way. And certainly, there are many assets that are quite at late stages of development where with a $500 million envelope, I think you can find some really interesting opportunities. So, we have had a very deep deal funnel, and I would continue to have that, and I'm excited about that.

Your question comes from the line of Sebastiaan van der Schoot from Kempen.

Congratulations on finalizing the terms for the agreement. I wanted to a little bit touch upon the 3 preclinical assets that were also disclosed in the agreement. Can you maybe give some insight on how far these programs are from the clinic?

Yes, Sebastian, thanks. I mean just stepping back, we are excited that there are these additional opportunities. I think it adds great breadth. And JD, [indiscernible] And Ouro have done a really nice job with these programs. And I think it adds a really interesting element to the story. I'll let Sooin talk a little bit more about where they are with respect to the clinic.

Yes. I mean, we're not disclosing a lot right now, but I think what we can say is that the team is working hard to identify the candidates that would be able to enter the clinic in the near term. I don't think we've said precisely when they will be entering the clinic, but it is relatively near term.

Your next question comes from the line of Sean McCutcheon from Raymond James.

Can you speak to kind of the acute near-term path towards expanding the ongoing Australian Phase Ib and autoimmune cytopenias and leverage you're able to pull to either maintain or accelerate the enrollment pace to meet that 2027 pivotal study start time line. And any other gating factors we should be thinking about for the initial indications beyond it sounds like you're aiming for a go-forward dose determination by the end of this year?

Yes. Thanks for the question, Sean. Maybe one point to clarify, Brian, the initial pivotal trials we envision coming out of the ongoing or [indiscernible] Trial in autoimmune cytopenias, right, and that's recurring quite well. And that's a study for which we are confident that there'll be a go-forward dose identified over the course of this year. In terms of additional indications, I think I mentioned in the call that there's another sort of Phase Ib dose-ranging basket study that includes a lot of autoimmune diseases, not in the hematologic realm. We listed a few of those, but that's essentially a basket study design I think the appeal of that in this molecule again is that the type of responses you see when you achieve immune reset are pretty obvious, right? Do you tend to get complete responses, complete absence of disease activity. So to the extent that, that applies to other indications, we feel that type of approach proof of concept should be pretty efficient. It doesn't take hundreds of patients to take the [indiscernible] And then figure out how to go forward with that. So we think that the approach of the team at Ouro has put in place to detect signal or detect proof of concept and additional indications is the right one and should be fairly efficient.

Your next question comes from the line of Jacob Mekhael from KBC Securities.

Congrats on this deal. I just have one follow-up on the COGS. Given that there is a broad set of indications that you can pursue with gamgertamig, can you maybe share with us which of those indications are currently baked in in your cost estimates for this program?

The -- for -- are you asking for the point that we made about majority of cash remaining?

Yes, yes.

Correct. Yes. So we've indicated in the slides, the initial primary focus of the 3 indications. And that's what's reflected in our in our forecast right now. And we'll provide further details down the road as we look at what these trial sizes may entail and what other indications could come of it will provide cost estimates later.

Your next question comes from the line of Delphine.

I know it's hard to pronounce. Delphine Le Louet, Bernstein. Regarding the proof of concept, and I was willing to know if you can give us a visibility on the dose, how many dose -- I mean, not the specific dose, but how many doses you're going to use, how many patients per trial? What about the duration time lines, just to get a frame about a potential submission date. What would be your target by the end of '27 already? Or shall we think about 2H '28?

Yes, Delphine, I appreciate the question. As we said a couple of times, we've seen more than 60 patients. I mean we've seen essentially 70 patients, and many of those were at a dose that we think actually looks quite attractive for a potential pivotal study. We're not ready today to talk about exactly what the dosing paradigm is and so forth. But as Eric talked about, the teams at Ouro's done a phenomenal job really identifying this dose already and coming up with a regimen that does a great job limiting CRS. And that gave us a lot of confidence. And so we are confident that as early as next year, we can be able to go into pivotal studies. And as you'll see some of this data published later this year, I think you see kind of what got us so excited. And I think you'll share our confidence that this could go into pivotal studies as early as next year.

Thank you. This concludes the question-and-answer session. I'll now hand back to Henry Gosebruch for closing remarks.

Okay. Well, thank you, Heidi. We really appreciate your time today. I hope you can hear an excitement in my voice that we are quite excited about this transaction and continuing the transformation of our company. As we said, we look forward to releasing additional clinical data later this year as we further advance the first and best-in-class program for patients in autoimmune disease with speed and urgency. Thank you very much.

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