All right, I think we can get started now. Hi everyone, I'm Alex Kelly, one of the biotech associates on Phil Nadeau's team. Welcome back to the 45th Annual TD Cowen Healthcare Conference. For our next session, we're very pleased to be hosting Galapagos. We have with us CFO and COO Thad Huston, who will give us a presentation providing an overview of the company, its cell therapy pipeline, and its very exciting point-of-care manufacturing platform. So with that, I will hand it over to you, Thad.
Thanks, and good afternoon, everyone, and thank you all for joining us today. First of all, I would like to thank the Cowen team, and thanks, Alex, for hosting us today. Before I begin, I'd like to remind everyone we'll be making some forward-looking statements during this presentation, and I encourage you to refer to our SEC documents. Today, very excited to be here and very delighted to discuss what we have as an exciting transformation and transaction for Galapagos and its stakeholders. Just over the last two years, Galapagos has undergone a pretty significant transformation, a profound transformation, establishing a strong foundation for long-term value creation. Our journey began with a strategic pivot to transform Galapagos into a pioneering biotech company by expanding into life-changing cell therapies, and today we're deepening that commitment as we mark an important milestone in our journey.
Towards that end, you may have seen earlier this year, we decided to announce to separate into two publicly traded companies with a real focus on accelerating value creation, and I'll talk more about Galapagos and SpinCo. SpinCo is going to be a newly created Belgian company that will invest to build a pipeline of innovative medicines through transformational transactions with Gilead as a partner, and Galapagos will focus on accelerating global oncology leadership by addressing high unmet medical needs with our decentralized manufacturing platform, and now with full ownership of all of our programs. As you may know, in 2019, Galapagos entered into a 10-year global option licensing collaboration agreement, otherwise known as the OLCA, with Gilead. Since that time, both Gilead, Galapagos, and the biotech industry as a whole have all evolved.
Post-separation, SpinCo will assume the OLCA agreement with Gilead, and Galapagos will be able to focus on executing its strategy for accelerated growth and sustainable value creation as a leader in the development of innovative manufacturing of cell therapies in hematological and oncology in small and solid tumors, by further supporting our mission to bring transformational medicines to patients across the world. As such, we'll seek for partners for our small molecule programs, including our TYK2 inhibitor, as we will discontinue all future small molecule research. By separating into two companies, each company will have the flexibility to allocate resources to pursue tailored strategies and to maximize for both growth and impact. We are offering a win-win for our shareholders, and we can create even more value as independent entities with unique strategies in our respective areas of expertise.
Now, let me talk a little bit about the exciting opportunity we have with Galapagos as we forge ahead with the development of our life-changing cell therapies. This planned transaction allows Galapagos to focus its leadership in cell therapy based on the following strong fundamentals. Firstly, we will be well-capitalized to advance our portfolio and platform towards value-creating opportunities. Importantly, the termination of the OLCA for Galapagos gives us freedom to operate and allows us the autonomy to fully invest and partner our own assets and programs to realize the benefits of future achievements. We remain focused on providing broader and faster access to cell therapies with our innovative decentralized manufacturing approach, with a goal of seven days vein-to-vein time.
Not only does this bring logistical and cost benefits, but it also provides patients with fit cells, and we believe that providing efficacy and safety offers a unique solution for many more patients, especially those with a very short life expectancy. We are advancing our cell therapies currently in clinical development, and we believe that we have the potential to be best in class through the delivery of fresh and fit cells. In addition to our six European clinical sites in the Netherlands and Belgium, we're expanding the Atalanta clinical trial in the U.S., and we are engaging with leading cancer centers here in Boston. And our aim is to start pivotal studies in 2026. We believe that giving this access to our therapies really provides and addresses some of the logistical constraints with current cell therapies.
And we're also building global partnerships with hospital networks and healthcare organizations to increase this access, and we think that this can be done in a very highly cost-effective way. It takes advantage of our automated closed-sterile production system with limited manual work and is designed to provide access and reduce the cost of goods significantly. We'll also look to partner our platform with cell therapy companies, leveraging our unique manufacturing platform and network for broader access, for example, what we did with Adaptimmune in solid tumors. In order to support a sustainable value creation, we're building a pipeline also of next-generation cell therapies, and we're gonna continue to add many more things to our pipeline as we go into 2025 and 2026.
Our ambition in cell therapy, and with the planned separation, is designed to benefit the patients that we serve by expanding and bringing new medicines to market. Let's talk about our decentralized manufacturing platform. It was really to address some of the limitations that you have with current, centralized manufacturing, which has a high cost burden, longer production time, and delivery times, and delivers, cryopreserved cells. Our seven-day vein-to-vein time is designed to provide fresh, fit cells, which we believe enhance the therapeutic profile by producing highly potent cells that are less exhausted, less toxic, and persist longer. We believe that the advantages of our Cocoon process make it ideal for near point-of-care manufacturing, giving its closed system, lean design, user-friendly interface, data monitoring capabilities, and automation and scalability.
We have a long-term strategic collaboration with Lonza for the supply of cocoons and cassettes, and we currently have six operational and approved manufacturing sites in several European countries, and we're actively expanding in Europe and in the U.S. with Landmark Bio in Boston operational for Atalanta. As you can see from this schematic, our decentralized manufacturing platform is designed to enable scalable and consistent product near the clinic. This is a key feature that we believe will support our vision to provide greater access to these potentially life-saving therapies. Moreover, as I noted earlier, we believe our decentralized manufacturing platform will reduce the logistic challenges and the high cost of current centralized manufacturing processes. We're truly excited by the opportunities ahead for Galapagos to lead in cell therapy development, and this decentralized manufacturing platform is core to that strategy. Moving forward, you can see our pipeline.
We will continue to focus on unlocking the broad-reaching potential of this platform and advance our robust cell therapy platform with the goal to be a very focused and streamlined organization. We're implementing a strategic development approach to our CD19 CAR-T portfolio by prioritizing our resources on GLPG 5101, our most advanced asset cleared for clinical development by the FDA and European regulatory authority with the fastest path to market. In order to fully realize that potential, we are accelerating and expanding the Atalanta phase 1/2 clinical study of GLPG 5101 into additional aggressive lymphomas such as Richter's transformation and CLL. We also believe where we can have the biggest impact for patients. Our plan is to start pivotal studies in 2026 with our aim to have our first approval in 2028.
As part of this strategy, we are deprioritizing activities related to GLPG 5201, our second CD19 CAR-T candidate, pending the advancement of GLPG 5101 and Richter's transformation in CLL. And in tandem, we're developing and advancing the phase 1/2 study of GLPG 5301 in multiple myeloma while strengthening our early-stage pipeline of next-generation multi-targeting armored cell therapies for hematological and solid tumors to ensure long-term innovation and value creation. We expect to advance one of these preclinical assets into first-in-human clinical studies in 2025. Further, we're reinforcing our commitment to delivering transformational therapies, and we are progressing uza-cel, a collaboration with TCR-T candidate for head and neck cancer that we have with Adaptimmune through our partnership.
Here you can see some of the exciting data that we have with the Atalanta study coming from our ASH, the recent ASH publications showing promising safety and efficacy profile for GLPG 5101 with patients with mantle cell MCL, marginal zone lymphoma MZL, follicular lymphoma, and diffuse large B-cell lymphoma. At the data cutoff, 49 patients received the CD19 cell therapy infusion, and safety results were available for 45 patients, and efficacy was available for 42 patients, and as you can see, we had outstanding achieved overall high response and complete response rates, and for example, we show 100% of patients with MCL, 95% of patients with follicular lymphoma, marginal zone lymphoma, and 54% of patients with DLBCL achieved a complete response, and at dose level two, the complete response was 71%, and the overall response rate was 86% for DLBCL.
Of the evaluable patients achieving complete response, 80% were minimal residual disease negative and remained in complete response at time of data cutoff. We're very excited about the safety data and the low level of ICANS, and this translates to less patients in need of intensive care, less time in the hospital, and more time at home with family. Not only were we seeing strong data about the response rates, but we're also seeing that those responses were durable. Here, you can see across phase 1, phase 2, 32 out of 37 or 86% of responding patients had an ongoing response at the time of the last assessment or end of study. Of the 15 minimal residual disease MRD-evaluable patients with a complete response, 12 or 80% achieved minimal residual disease negativity and remained in complete response at data cutoff.
The median study was 3.3 months for follicular lymphoma and DLBCL, with a range of 0.9-21.2 months, and 4.4 for mantle cell lymphoma, with a range of 1-24.4 months. GLPG 5101 showed encouraging safety profile with a majority of higher than or equal to grade 3 events being hematological. 96% of patients received an infusion with fresh CD19 cell therapy, of which 91.5% achieved a vein-to-vein time of seven days, eliminating the need for bridging therapy. Of note, strong and consistent in vivo CAR-T expansion levels and products consisting of stem-like early memory phenotype T cells were observed in all doses tested. In summary, the data underscore our enthusiasm of going all in and are very excited about our GLPG 5101, our flagship CD19 program. Our strategy positions us to build on the clinical success that we've seen thus far.
So now let me talk a little bit about our small molecule programs in immunology, with our most advanced program being the TYK2 inhibitor, GLPG 3667. The preclinical and first-in-human data showed GLPG 3667 to be a selective and potent inhibitor of TYK2, resulting in a near-complete inhibition of type 1 interferon signaling for a 24-hour cycle, which is supportive of a once-daily administration. We intentionally selected SLE and dermatomyositis as our first indications because type 1 interferon plays a key role in both diseases. Our phase 2 program offers an attractive partnership opportunity, and I'm pleased to report that we recently completed the screening in our SLE phase 3 enabling trial study ahead of plan.
Beyond SLE and dermatomyositis, the TYK2 inhibition offers potential in several indications, and we'll have further readouts of the top line results for SLE and dermatomyositis in the first half of 2026. Our bold strategy is focused on advancing our cell therapy leadership, and we're continuing to look for partners for a small molecule portfolio that has been built on over 20 years of research, and where we've identified more than five programs in oncology and immunology. The continued unmet need in a number of these auto-immune-mediated diseases offers a significant market opportunity, and we should make our programs an attractive opportunity for companies already operating in the field of immunology. So as you can see, we have a number of near-term value-creating catalysts for 2025, obviously enrolling patients in the U.S. and Europe in the phase 2 Atalanta study and multiple indications.
We also aim to start registrational studies with 5101 in 2026. We're also actively expanding our DMU network in the U.S. and Europe. We also have to complete the TYK2 studies, as I mentioned, while seeking partnerships, and we're also looking at advancing our next-generation cell therapies in hematological and oncology in solid tumors, including uza-cel. So we have a very exciting opportunity. We announced SpinCo and the value proposition that we have ahead. We think that there is a tremendous opportunity for us to create value with SpinCo, deploying significant capital into the SpinCo value with EUR 2.45 billion in overall resources. And you can see some of the next steps here, Sure. We think that there's a unique opportunity, of course, with the market and where the market is with the capital being somewhat challenged.
We think that, you know, companies that need capital partnering with SpinCo makes a lot of sense, and we think that there's a tremendous opportunity. Some of the things that we have identified as next steps, we're preparing, we're actively working together to create the SpinCo that will be listed both on Euronext and NASDAQ by mid-2025. We're also actively recruiting for a seasoned executive leadership and independent non-executive directors with a proven track record in the biotech industry, building companies and doing strategic transactions, and we'll be providing more information in the coming months. The prospectus will be made publicly available at least a month prior to the spinoff, and the Galapagos shareholders will receive SpinCo shares on a pro rata basis proportional to their ownership of a Galapagos share. Looking at our balance sheet, we ended 2024 with EUR 3.3 billion in cash.
Our cash burn was EUR 374 million in 2024, excluding the business development deals, particularly with Adaptimmune. Our cash burn was EUR 293 million and was within our guidance range of EUR 280-320 million. And upon separation, Galapagos will be capitalized with approximately EUR 500 million in cash, which is expected to provide a runway to 2028, as our normalized, cash burn is expected to be in the range of EUR 175-225 million. SpinCo is expected upon separation to be capitalized with approximately EUR 2.45 billion.
We think that this is really a tremendous opportunity to unlock value, to unlock value for Galapagos through focus in driving our CD19 program, to develop next-generation CAR-T programs, to build out our DMU network, but also to have the autonomy to partner with other differentiated companies in cell therapy and seeing what we can do to bring next-generation cell therapies to more patients around the world. And where we're also addressing and restructuring our business to really allow us to focus and realign our resources to really unlock value in cell therapy, but also provides a tremendous opportunity for shareholders with SpinCo to deploy capital, to build an innovative pipeline of new medicines and transformational transactions.
This is very well capitalized with EUR 2.45 billion pursuing high-quality assets to fund development in the portfolio, but also to leverage Gilead's capabilities in both commercial and lead development, capabilities, and to have a SpinCo board that's focused and very experienced in dealmaking, and we're Gilead's committed to also negotiating and providing positive value for all shareholders, so with that, really excited about the opportunities to separate into two companies and to unlock value. Thank you.
Thank you so much, Thad. Thad, I agree with your presentation. Kick off the Q&A session now, so first, could you just comment on your approach to regulatory discussions with the FDA concerning your decentralized manufacturing system, so what's required to get the FDA on board and to really ensure that the expansion of your clinical program in the U.S. proceeds without any issues?
Yeah, no, we're very excited about getting the FDA clearance for 5101 with Landmark Bio here in the Boston area. And so we're gonna kick off enrolling patients very soon and in the Boston area. And then over time, we'll also add additional decentralized manufacturing sites, one in West Coast. We're also doing one also in the New Jersey, New York area, and we'll add additional sites over time. Great. Thank you. You recently announced that you'd be focusing efforts on 5101 while deprioritizing development of 5201 for the time being. Mm-hmm. Can you just walk us through the underlying rationale there? Why do you see 5101 as the higher potential opportunity? Yeah, 5101 has that IND clearance with the FDA, and we think that's the fastest path. We also think it'll simplify our manufacturing network to have one product with multiple different indications.
So we're adding the CLL and Richter's transformation to 5101 as an indication. So we've learned a lot about 5201, and we had really great data, but we think that this will be a longer-term better play to get the patients sooner. Great. And other than the selected indications, are there any notable differences between the 5101 and 5201 programs in terms of, like, the structure of the car, manufacturing, or anything else? There were slight differences, but we don't think that should have any impact on the data readout. We do think our delivery of seven-day fresh cells is really the differentiator here.
And could you maybe provide us with a bit more detail on your plans to expand the decentralized manufacturing program in the U.S.? Are you maybe seeking additional collaborations, beyond those you've already established with Landmark, Thermo and BCA?
Yeah, we're gonna continue to add additional sites. We'll probably go in a very thoughtful way to major metropolitan areas for the clinical purpose, but then also we think that model, the decentralized model, could be leveraged for other potential partners. Great. Thank you.
A nd then for the SpinCo specifically, just curious what kinds of deals might be interesting from a BD perspective in terms of modality, disease area, development stage.
Absolutely. I think it's really exciting to deploy that level of capital into really innovative clinical stage assets, phase two, potentially phase three assets, where again, you could build around a platform. We've said broadly, it could be in oncology, immunology, virology, different areas, different types of modalities. It doesn't, it could be small molecule, it could be a biologic, it could be anything. So it's really about finding innovative assets.
Could you maybe just comment on the status of the uza-cel program? So what do you see as the bar for success there, and what would you maybe like to see in the next update from that program?
Yeah, no, I think we've seen really encouraging data, at least initially on the production with the Cocoon, you know, and that's what gave Adaptimmune and us conviction to do the deal. We're gonna continue, obviously to, you know, prepare for clinical and to get more and more patients in, but that's gonna take some time. Of course, it's head and neck cancer, which again, I think is a unique opportunity. There's also potential for us to opt in for other types of indications as well. So there's a number of very exciting opportunities there.
Great.
Then for the 5301 program in multiple myeloma, what's the bar there?
Yeah, it's really continuing the enrollment. This year is really gonna be key. We had a temporary pause last year. Now we're back to enrolling patients. So we're gonna continue to do that, and then we'll provide a data update at a future conference.
Great. Thank you so much. I guess before we wrap, anything else that you would like to let investors know about Galapagos and what comes next for the company?
No, I just think it's an exciting time for the company.
I think also the fact that we're able to deploy EUR 2.45 billion in capital into SpinCo to invest in exciting new innovative assets, as well as for Galapagos to focus and to have the possibility to also partner and to find new ways to provide an innovative solution for cell therapy is really exciting. So thank you very much.
Great. Thank you so much.