Galapagos Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 3, 2023

There are 11 speakers on the call.

Operator

Good day, and thank you for standing by. Welcome to the Galapagos Q3 2023 Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sophie Van Heisel.

Operator

Please go ahead.

Speaker 1

Thank you, operator, and welcome all to the audio webcast of Galapagos' Q3 2023 results. I'm Sofie Dan Gessel, Investor Relations, representing the reporting team at Galapagos. This recorded webcast is accessible via the Galapagos website homepage and will be available for download and replay later on today. I would like to remind everyone that we will be making forward looking statements during today's webcast. These forward looking statements include remarks concerning future developments of the pipeline and our company and possible changes in the industry and competitive environment.

Speaker 1

Because these forward looking statements involve risks and uncertainties, Galapagos' actual results may differ materially from the results expressed or implied in these statements. Today's speakers will be Doctor. Paul Stoffels, CEO and Chairman Ted Houston, CFO and COO and Doctor. Jeevan Shetty, at Clinical Development Oncology. Paolo will give an introduction and provide a strategic overview.

Speaker 1

Ted will then go over the operational and financial results, and Jeevan will discuss our CAR T programs. You will see a presentation on screen. We estimate that the prepared remarks will take about 25 minutes. Then we'll open it up to Q and A with Paolo, Ted and Givan, joined by Michele Manso, Chief Commercial Officer and Doctor. Daniele D'Ambrosio, Head of Immunology.

Speaker 1

And with that, I'll now turn it over to Paul.

Speaker 2

Thank you, Sophie, and thank you all for joining today. I would like to start by taking a moment to remind you of our vision and mission to bring transformational medicines to patients around the world. This drives everything we do at Galapagos. Over the past year, we have taken key strategic steps transformation into an innovative biotech, first with the implementation of our new operating model and the new approach to research and development to accelerate innovation and strengthen our pipeline and now with the intended changes related to our Yextelica business. We reached a critical moment, and we have chosen what we believe is the best option for patients or people in DYSTELICA.

Speaker 2

Now let me walk through the key terms of the deal announced on Monday. Galapagos intends to transfer the entire iCellica business to Alpha Sigma, Including the European and UK marketing authorization, sales, marketing and all filgotinib development activities as well as approximately 400 employees across our European operations. Alpha Sigma is a profitable Privately owned pharmaceutical company in Italy ranking among the top 5 with revenues over €1,200,000,000 in 2022. In the contemplated transaction, Galapagos will receive €50,000,000 upfront and is entitled to sales based milestones of up to €120,000,000 In addition, Alpha Sigma will pay royalties in the mid single to mid double digits to Galapagos. Galapagos will pay up to $40,000,000 in development costs to Alpha Sigma before June 2025.

Speaker 2

We also announced that we plan to adjust our remaining workforce and streamline our operations to align with renewed focus on innovation. This is expected to impact approximately 100 positions. This will allow us to focus on innovation and accelerate our pipeline of best in class The completion of the intended transaction is subject to the execution of a With the signing of the letter of intent to transfer the Icelica business to Altasigma, we completed our process of exploring So let's have a look at our Pipeline focused on immunology and oncology. For our immunology franchise, the iselica is grayed out given by the planned transfer. We are progressing our TIK2 in dermatomyositis and SLE.

Speaker 2

And we aim to start a patient study with a CD19 CAR T candidate, 5.101 in severe refractory lupus early next year. Meanwhile, we are working on multiple exciting preclinical targets In oncology, we made good progress with the CD19 CAR T programs And plan to start the BCMA CAR T program in multiple myeloma in the coming weeks. Together with our research team, we are working on next gen CAR Ts as we are evaluating the opportunities in this Phase 2. Today's earnings call will focus on important progress We are very pleased that we will have the opportunity to present 3 posters at ASH in December. The data in the abstract released yesterday underline that our CAR T programs manufactured at point of care are delivering on their promise.

Speaker 2

In today's presentation, we will discuss the encouraging data in CLL and NHL observed with our product candidates 5201 and 5101 as well as the clinical study design of 5301, a third party program manufactured at point of care. Importantly, we initiated a tech transfer following the agreement with the Boston based Landmark Bio. This is a key milestone in the geographical expansion of our unique point of care production technology and the start of clinical development of ERKRP programs in the U. S. In parallel, we continue discussions with multiple centers in Europe and the U.

Speaker 2

S. To further build our point of care manufacturing network. In addition, we continue to strengthen our capabilities in oncology with key hires, amongst others, in the regulatory, clinical, PD and strategic marketing. I would like to take a moment to highlight the strong fundamentals that we put in place over the last 18 months. We renewed our discovery portfolio and are working hard on accelerating our early stage pipeline.

Speaker 2

We continue to broaden our late stage Pipeline pushing forward our internal programs and scouting for business development opportunities. We are making important progress with our CAR T programs and We are actively expanding our point of care footprint with our KOKU platform. With the transfer of KAKI SELICA, we can further To streamline our organization and to support our innovation, we aim to approximately add 100 expert roles over the course of next year. We commit to stay disciplined in our views of cash to focus our investments and to maximize value. Summarizing, we have been executing on our company transformation and now have a clear path outlined for value creation.

Speaker 2

Now I hand it over to Thad, who will provide an operational and financial update.

Speaker 3

Thank you, Paul. Let's first go over the key financial Year to date, going to our P and L, we reported a net profit of €54,000,000 in the 1st 9 months of 2023, in part driven by higher revenue recognition for filgotinib. This is driven by collaboration revenues that increased mainly due to the collaboration agreement Gilead with the filgotinib development amounting to €186,000,000 in the 1st 9 months of 2023 compared to €167,000,000

Speaker 4

for the same period last year.

Speaker 3

And by JY Celica sales coming in at €82,000,000 year to date, plus a sales milestone of €1,000,000 €7,000,000 in royalties for Giselleca. We also saw a reduction in total operating costs of €72,000,000 were down 13% versus the prior year, which can be attributed to lower R and D expenses and a reduction of €20,000,000 in SG and A expenses. Additionally, we received higher interest income as a return on our capital in the 1st 9 months of 2023. Let's now look at the GYcelica end market performance for the quarter. Sales remained flat at €28,000,000 versus the previous quarter.

Speaker 3

Year to date, we booked €82,000,000 in sales and we are confirming our reset guidance of €100,000,000 to €120,000,000 Now a few words on our cash position and guidance. Our cash and cash equivalents are €3,800,000,000 at the end of Q3 2023. Our operational cash burn for the 1st 9 months of 2023 reached EUR 344,000,000 We confirm our full year cash burn range of 380,000,000 to 420,000,000 This is explained by an increase in interest income in grants coming in the Q4. Over the full calendar year, we We expect approximately 3% return on our outstanding cash balance. With the intended transfer of GYXELICA announced earlier this We will realize significant savings well over €100,000,000 in 2024 and annualized savings of €150,000,000 to €200,000,000 as of 2025.

Speaker 3

We continue to be disciplined and remain focused on managing our resources effectively. This brings us to our business development efforts. We are actively pursuing multiple deals in oncology and immunology. Our approach is highly selective And please be assured that we are laser focused on partnering and M and A to accelerate our pipeline. And with this, I will hand it over Doctor.

Speaker 3

Jeevan Shetty, our Head of Clinical Development in Oncology, to walk us through our Part D programs and results.

Speaker 4

Thank you, Ben. Good morning to you all and many thanks for your time. My name is Jim Shetty. I'm the Head of Oncology here at Galapagos. I'm really very excited to be able to share the significant data with you all today in a number of really difficult to treat cancers.

Speaker 4

We are sharing data with respect to the ASH embargo. Please be assured that more data will be available in San Diego. I wish to just remind the audience the key differentiated features of the Galapagos Point of Galapagos uses first principles thinking, focusing on simplification and streamlining of every aspect of the current centralized production you see on the left. Weaknesses that actually lead to critically ill patients not getting the life Our innovative system consists of end to end automation, functionally closed systems, A comprehensive real time monitoring, both centrally and remotely through our Exellet platform and for our clinical and Manufacturing Support. The 7 day vein to vein time and fresh depressed cells is really at the heart of our platform.

Speaker 4

Elapagos aims to make CAR T therapies globally available to patients Not readily served for the current central manufacturing process. On the top half of the slide, one sees the seamless and continuous CAR T production with an innovative Q3, Q3, 2023 Financial Results Conference Call. In the lower half of the slide, one sees the conditioning regimen We've given a day minus 6 to day minus 4. This is given in parallel to the manufacturing of our CAR T product. This is unique to our system, a testament really to our confidence in our reliable manufacturing process and critical To deliver a 7 day vein to vein tummy.

Speaker 4

Through our unique platform, Galapagos delivers a life changing service to patients I wish to spend a moment on high risk CLL and Richter's transformation, which is the focus of our first study that I will present. Chronic lymphocytic leukemia is a disease for which there is currently no cure. It is one of the commonest hematological malignancies Richter's transformation is faithful. As you can see, the disease has a dismal prognosis with a median overall survival of only 5 to 8 months. Time is of the essence.

Speaker 4

With the Galapagos desenetralized platform being close to the patient and the 7 day vein to wait time, We can address this rapidly progressing disease with speed and with effectiveness. From an epidemiological perspective, the underserved high risk CLL population represents 2,100 new patients in the U. S. And 1800 patients in the EU 5. The Richter's transformation population represents a similar patient number With 1900 patients in the U.

Speaker 4

S. And 2,000 in the EU filing, this is a disease with no effective options, a fatal I now turn to our important study focusing on high risk CLL and rectors transmission, the Uplasia study. The design of our Uplasia study incorporates all the unique components of the Galapagos platform, I. E, concurrent conditioning, seamless CAR T production And Innovative IT and QC technology, ensuring release at the day of harvest and infusion, this is truly transformational. As you can see, the study population improves patients with relapsed refractory CLL with more than or equal to 2 prior lines of therapy.

Speaker 4

CD19 positive CLL patients. Significantly, the trial allows patients with retrotransformation and also Looking now at the baseline characteristics of the EUPLAZIA study population, we see that they are really consistent with the population risk of unfavorable outcome, shown here by age and by gender. Furthermore, the advanced nature of the disease in our study is evidenced By number 1, the prior lines of treatment, prior BTK inhibitors and etchcracks and prior allogonal stem cell transplant and also Turning now to safety. We see a good safety profile with our product. It is well tolerated.

Speaker 4

There is no grade B CRS. Only 6 patients experienced no grade CRS, grade 1 and grade 2. There were no eye cancer reported, no deaths occurred, most treatment emergent adverse events were Grade 1 and Grade 2 and most observed Grade 3 and 4 adverse events were all female I turn now to the efficacy. We observed excellent efficacy with our drug in patients with relapsedrefractory CLL with or without rigorous transformation. Objective response was assessed as per IWCLL for patients with TLL And Richard's transmission is observed as per the Lugano classification.

Speaker 4

11 out of the 12 patients, Patients responding to treatment resulting in an objective response of 92%. 75% of patients reached a complete response as their best A further key observation is the 83% complete response at dose level 2. This compelling data has transformed our decision on our recommended Phase II dose RP2D of 100,000,000 cells. At the time of analysis, 9 out of 11 patients, 82% of responders had an ongoing response. The duration was up to 9 months post infusion, which is the latest available response assessment at the time of the abstract submission.

Speaker 4

Further follow-up is clearly ongoing. Focusing on the rigorous transformation subset, 7 of 12 and low patients in the Uplasia study were diagnosed with rigorous transformation. All but one patient With richer transformation responded to treatment of 86%, and 5 out of the 6 responding patients achieved a complete response of 83%. So to conclude, though a small patient number, the efficacy together with the safety has excited experts in the field and confirms our desire to accelerate this program to bring this therapy to patients as soon as possible. The next steps for uphasia are genuinely exciting.

Speaker 4

As I alluded to earlier, with 83% CRR at a rate of dose level 2, the class leading safety and the ratification by experts both internally And externally, we will proceed with dose cycle 2. We will initiate the Phase II expansion cohort for the 2 populations we have described. Critically, we have initiated the tech transfer to the 1st U. S. Site landmark bio in Boston, as mentioned by Paul.

Speaker 4

Do remember our poster attached on the 9th December. Turning now to the NHL program. With our decentralized manufacturing and short vein to vein time, we strongly believe accessibility and efficacy of CAR T BOP is can be improved and serve the sickest NHL patients with the most aggressive disease. This has informed our thinking on the future NHL subgroups that we will pursue. Diseases currently underserved by the approved CD19 CAR T therapies.

Speaker 4

Additionally, even with approved products available, we identify Persistent unmet need in indications where most CAR T products are actually available as a result of manufacturing slot shortages This is the design of our ATLASA study Based on our unique Galapagos platform, a Phase III trial in patients with non Hodgkin's lymphoma consisting of diffuse large B cell lymphoma, Mantal cell lymphoma, mantle zone lymphoma and follicular lymphoma. The study population requires patients with relapsed or refractory disease 2 or more prior lines of therapy with the inclusion of transplant in eligible patients in addition to primary With regard to prior lines of therapy, we allow the Same patient population as would be eligible in the approved CAR T products. However, as a consequence of our 7 day base main time, Our study allows your patients with potentially more aggressive disease to be included in our trial. Here, too, we will appraise Baseline characteristics of the ADLANTA study is typical of the patient population And representative of a heavily pretreated patient in the study. We see encouraging safety data for our product in the ATLASA study.

Speaker 4

With ICANN, there were 6 patients We experienced a Grade 1 eye count and only one case of Grade B CRS, all others were Grade 1 to Grade 2. There were 2 deaths in the study. 1 was with a patient experiencing intra abdominal hemorrhage. This patient has been previously diagnosed with pulmonary thromboembolic disease and was already on low molecular weight heparin. The second was a patient who had We observed very encouraging efficacy in our therapy in patients with multiple subtypes of relapsed for refractory disease.

Speaker 4

In our data set, 13 patients were evaluable for response to the tandem analysis and 11 patients responded to treatment, resulting in an objective response of 85%. One can also observe complete response rates of 83% of dose level 2. 69% of our patients reached a complete response and their best response in the all patient population. This is the data At the time of abstract submission, the study is clearly ongoing, and we're continuing to collect more data with longer follow-up times. We now have the 1st patients in the ongoing response for over a year, and we will be presenting more of these patients at ASH.

Speaker 4

As with Eupressa, the next steps for Atlanta are similarly exciting. We will expand an indication with the benefit An indication that will benefit from the short lead time. We will implement dose level 3. And as mentioned previously by Paul, we will complete the tech transfer to the 1st U. S.

Speaker 4

Site, Landmark Bio in Boston. Given the encouraging safety and efficacy we have presented in CLL and NHL using our innovative And reliable platform, we're moving ahead with addressing the unmet need in multiple myeloma in the papillio study. Whilst, of course, there are commercially available BCME therapies, there is limited access to these products and this population remains Severely underserved. Here is the study design and the patient population we are proceeding with. We expect our first patient The data from the 26 patients that were enrolled in the Euplasia and the ELANCHA studies that we've shared with you today demonstrate that the point of care CAR T manufacturing with short day to day time is feasible.

Speaker 4

Our CAR T therapies are administered as fresh product We have shown 100% manufacturing success. All patients that underwent leukopheresis were dosed And we all received fresh CAR T product. In our trials, the clinical responses were supported by high In vivo expansion of the CAR T cells and durable persistence post infusion. This was observed across the dose levels that we tested. Furthermore, our novel point of care manufacturing models and early phenotype of the less differentiated CAR T cells is preserved This really strengthens our belief that our manufacturing process contributes to fitter CAR T product, And that leads us to believe it is not so much the number of cells that are infused, but more the quality of the cells.

Speaker 4

We believe we have a very innovative platform for the future of CAR T therapies that will serve patients around the world, patients with little time and few options. Thank you. I hand back to Paul.

Speaker 2

Thank you, Jigar. Let's look now at the remainder of 2023. As presented today, we are making excellent progress with 5,101 and 5,201 in NHL and CLL. And as Jivin just presented, we reported encouraging safety and efficacy data. At ASH, we'll be able to share more clinical data, including the expansion cohorts Phase III results of our NHL study.

Speaker 2

Also in oncology, we aim to submit an IND For VIE-1 hundred and one in NHL, our CD19 CAR T candidate in the first half of twenty twenty four. As mentioned, We aim to start the Phase Ib in multiple myeloma with a BCMA CAR T candidate 5,301 and expects to dose the first patient later in November. We also submitted a clinical trial application in Europe for our CD19 CAR T candidate Our transformation continues and we have a clear path forward, value creation for all stakeholders. We are accelerating our early stage pipeline, building on our new discovery portfolio based on best in class targets for Best in Glass Medicine. While we push forward internal programs, we are in active BD discussions with the aim to expand the clinical pipeline Very soon.

Speaker 2

And we are streamlining our organization with the aim to implement the focused with right sized organization. While we are very well capitalized, we commit to staying disciplined in our use of cash to focus our investments to maximize value. We delivered on our commitment to take action and firmly believe that we are executing on our strategy,

Speaker 1

Thank you, Paul. That concludes the presentation portion of today's audio conference call. I would now like to ask the operator to open up the line for Q and A. Thank

Operator

We will now take the first question. It comes from the line of Sharon Deng from UBS. Please go ahead.

Speaker 5

Thank you so much for taking my question. Just one on BD, please. Apologies if I missed it. So just wondering if you could Elaborate a bit more in terms of the area of interest in terms of BD, because you mentioned oncology. I'm also just wondering Like are you sort of focusing on CAR T or are you also would you also be interested in other modalities, for example, ADCs, we're seeing some major deals Secondly, etcetera.

Speaker 5

Second one, if I may. Given you are starting the CAR T trial in lupus next year, I mean, on one side, I mean, generally autoimmune, the patients would have a higher bar for safety compared to oncology patients. But at the same time, Like CRS, I can seem to be linked to a high tumor burden, which is probably missing in autoimmune patients. So just wondering in the longer term, what do you think about the safety profile for Armin, please. Thank you so much.

Speaker 2

Yes. First of all, on the details, we continue to Focus on solving high unmet medical needs, focusing on global deals, late preclinical, early clinical, But also mid stage, if there are good opportunities, we will go for either M and A or L and A for mid stage asset, which could accelerate Time to result and time to market and time to value creation. With regard to modalities, we started with small molecules only in Galapagos. And with CAR T, we brought the 2nd modality in. With that, biologics made the entrance.

Speaker 2

And our scientists today are using The CAR P but also antibodies and we are looking at bispecifics. So we don't stay on the CAR P small molecules. We look at the best Modality to solve a severe disease. And today, we think through us and through our partners, we can handle multiple modalities as needed. Your question on CD19 and autoimmune disease, lupus, you're right.

Speaker 2

It is a different it's not an as urgent, let's say, type of disease, but still Safety is important. We still are in discussion with regulators on starting our first study, and that will guide us on what they expect. But what's important for us, we think, is that we have the platform, which we'll put in place in the oncology space in now So 3 CAR Ts, and it's all the hematologists who treat the patients, including who treat the patients with autoimmune disease because it's CAR T kind of transplant. And that's where we think we have the gateway to market. We have a platform where we can introduce it on a global basis Once we have our oncology in place, and that's where we see it as leveraging our platform, but also going for Access Worldwide.

Speaker 2

And we are convinced that the platform, it shows a very good safety in oncology. And we are pretty sure or hopefully, we can confirm that the same safety will be observed in patients with lupus and autoimmune disease.

Speaker 5

Thank you very much.

Operator

Thank you. We will now take the next question from the line of Dane Leone from Raymond James. Please go ahead.

Speaker 6

Thank you for taking the questions and congratulations on all the progress. Kind of one larger question for me, if I can. So the early data that That you've shared on your CAR T programs is obviously very encouraging from the response rates and emergent durability and safety profile. But I think in the minds of many investors to give Galapagos more credit for these programs And what the value of these programs could be over the longer term. The question is really, can these results be Reproduced in larger cohorts and at more clinical sites.

Speaker 6

And not necessarily doubting The clinical outcomes, but more, can the manufacturing success rate hold up In a truly decentralized manner. So I guess, 2 parts to this. 1, can you clarify a little bit more of what we'll see, from the Patients that were not in the abstract of the 2 ongoing studies, is there kind of Size of the patient population that we'll see and or will they be more than one site contributing patients that have manufactured the Product has been treated. And then secondly, looking later into 2024, do you think we'll Start to see some of those data sets come out of true multicenter outcomes, manufacturing outcomes for the Cocoon system? Thank you.

Speaker 2

Yes. First on all additional patients at ASH, We'll present data for 15 patients for up to 15 months durability. For atalanta, 23 patients up to 15 months durability. I think the most important addition to that data set will be durability and further confirmation in a slightly larger data set of patients. So that's what we will show there.

Speaker 2

With regards to the feasibility of expanding this, Just to remind you, the system we produce, the Cocoon system, is a standardized system, Which is very independent of handling, of local handling. It is a Everything is standardized from A to Z. It's a step up system from when the cells go into when the cells come out, not come out, when the cells are pumped into the bag which goes to the patient. And it is a very standardized system with very standardized reagents and processes. And so there's little which we think will interfere with scaling it out in a larger way.

Speaker 2

What we have been thinking more recently also is can we be in the hospital or close to the hospital To make sure that GMP requirements are respected, but at the same time, we see in Europe already that one of our centers It's serving multiple hospitals. And so we think that with a decentralized network with highly controlled quality systems and a good GMP environment With a standardized cocoon in there, we will show little variability. The variability ultimately is mainly depending on the in going In areas where very advanced patients go in, that's where some variability could happen on the incoming cells. If you have really a late stage Patients with very bad cells and you still want to make the CAR T therapy, that is where the variability could be, But not in the operations we think we have that very well under control.

Speaker 6

And would Landmark Bio be that concept of a center that would service a number of hospitals in the U. S?

Speaker 2

Yes, that's correct. That is for the Boston area. We think that as long as we are with 1, 2 hours from a hospital, We will be able to do it fresh vein to vein without too much issues, transportation of more than 12 hours will make it work, That's not possible in Boston and probably in the major U. S. Cities, we would be able to operate like that.

Speaker 2

Excellent. Thank you so much.

Operator

Thank you. We will now take the next question from the line of Brian Abrahams from RBC Capital Markets. Please go ahead.

Speaker 7

Hi, this is Joe on for Brian. Thanks for taking our question and congrats on all the progress. So I guess similar Question to what was just asked. So, yes, we saw from the Ash abstracts, I guess, there might have been some Low yield issues. So just wondering what led to this issue and if it's something that you were able to resolve?

Speaker 7

Thank you.

Speaker 4

Thank you for your question. What we've observed with regards to low yields is, As Paul just mentioned, this is a very patient driven component characteristics. Even in the few patients that didn't achieve the dose level as an intensified protocol, What we actually observed were the patients actually continue to have a very good response, and we also saw good expansion And good very positive phenotype of the cells in actual fact. So therefore, the whilst the reason you said it might be the disease itself, it doesn't appear to have an impact on the outcome and it may and efficacy. So therefore, this is work we're doing very deep analysis with a very robust translational plan and program that's running in parallel to the program.

Operator

Thank you. We will now take the next question from the line of Jason Gerberry from Bank of America. Please go ahead.

Speaker 8

Hey, guys. Just 2 for me. As you advance your CAR T programs in 2024, I'm just wondering about the Scope of R and D and CMC Investments and how that sort of fits with kind of the outlay of operating spend This year, I imagine there's some cost shifting post the sale of the update. Just maybe it's a Shifting the composition of your operating spend more towards R and D. So just maybe if you can just talk about how the Cost of the CAR T program starts to scale directionally the next few years.

Speaker 8

And then can you just remind us, so Gilead will have standard opt in rights here on the CAR T program. I assume up through the readout of the pivotal Phase 2, if you get there. So, Gilead obviously has more advanced Marketed products and partnerships in these respective spaces. So how do you ensure with that Kind of dynamic best efforts if Gilead were to opt in towards your programs? Thanks.

Speaker 3

Thanks for the question. It's clear that with the transfer of JAKELICA to Alpha Sigma, it does Significantly improved our cash burn and allows us more flexibility to invest In broadening our portfolio, part of the guidance that we gave about saving roughly $150,000,000 to 200,000,000 Is assuming that we're also increasing our investments in oncology, particularly in the CAR T expansion. We're adding resources to the 100 physicians that Paul mentioned, largely in those areas to help us build out regulatory CMC Clinical capabilities to help us broaden our CAR T network in the U. S. And in Europe.

Speaker 3

So we've been actively doing that and continuing to add and roughly that 100 heads will be over the next year, year and a half roughly, Increasing our spend. But on the Gilead side, I mean, it's clear that Gilead has been a great partner. We see They have opt in rights to any of our programs after pivotal. And so, yes, they ultimately could choose To partner with us on that, we need to establish the clinical network and get to that point and then we'll ultimately see whether Bill, it opts in at that time.

Speaker 8

Yes, sir. In regards that would ensure that Your program gets prioritized versus sort of maybe minimizing a competitive

Speaker 6

threat to the existing businesses that they're in?

Speaker 2

Let me answer this one. The first one, HIFI transformation and CLL, resistant CLL, Double refractory CLL, Heliadis doesn't have the indication at this moment in their portfolio. So that's complementary. At the same time, setting up a decentralized network for CAR T provides more access, not just in the U. S, but it Could also bring us much wider than the wall.

Speaker 2

And again, there could be a significant complementarity with what Gilead is doing. And for us being able to build on the IKEA expertise in both in marketing and sales, but also especially And dealing with this type of products in the U. S. Could accelerate for us the rollout. And As long as we can make sure that we can produce all CAR Ts locally in the different network in the network locally and close to the hospital, We absolutely would welcome how we can work together with Gilead to accelerate access to patients and accelerate the reimbursement that people get access.

Operator

We will now take the next question from Sebastian Van Der Schuet from Van Leuchtenstein. Please go ahead.

Speaker 9

Hi, guys. Congrats on the progress and thank you for The first one is on the dose level. You are now moving to the dose level 3. I am assuming that you use the same production process for Each of the different dose cohorts and then insert the predefined dose, can you maybe elaborate And what percentage of patients you get to that dose level 3 in non Hodgkin lymphoma? And I was wondering also With the data that you have generated so far in CLL, whether you can expand on how many different clinical sites Have patients been treated

Speaker 2

that? On dose level 3, We are still preparing to introduce that based on the outcome of the first two dose levels, and that's a discussion with the investigators. So Commitment is there to do that. I can't give yet a percentage on how much we can how much we in how many patients we can achieve that 1st Level 3, and I don't have the production the detailed production data on the others to derive it from that. On the CLL, at the moment, it's done in one big center where a lot of Patients are flowing in from different auto centers.

Speaker 9

Okay. Thank you. And then on the non Hodgkin's lymphoma data set, is that Generated in different hospitals?

Speaker 2

Yes. There's different there's 5 different hospitals in 5 different sites in Europe.

Speaker 9

And then those three Patients that did not have a high enough dose, were those at different centers? Or was that one single center?

Speaker 2

I can't answer that on the spot.

Speaker 4

Those patients We're on different centers. We just want to point out to the patients to the point that we made earlier on. We're able to actually deliver good efficacy as well because the in vivo expansion and cell viability still being good Those that wasn't achieved. So we are interrogating that data in more detail. It will be available in coming conferences.

Speaker 2

Let me add to it. As I discussed in previous meetings, what we see in our clinical trials is that Because of the short life expectancy of the very aggressive late stage NHL patients, The patients are in very highly pretreated, but at the same time in very bad condition. And so that makes the incoming material very variable, and that's probably why it's across centers, but of course, that's why It's difficult to reach the high of those levels.

Speaker 9

Okay, got it. Thank you so much.

Operator

Thank you. We will now take the next question from the line of Phil Nadeau from Cowen. Please go ahead.

Speaker 3

Hi, this is Alex on

Speaker 7

Just wondering if you can comment on those key patients in the Abstract with same to date time greater than 7 days. Any factors as it went to the longer time here? Any Ongoing efforts to kind of optimize this process and further reduce the average vein to vein time. Thanks.

Speaker 4

So if I The question about the beyond 70 days lead time across the board and again, as you see that, That's 70 days lead times achieved quite consistently. In the patients in the abstract, there were I think you're referring to CLL. And in CLL, it was related to the yield from the patients that I reiterate the point I made previously, which is that We continue to have good efficacy in vivo expansion and Increased the cell viability of those patients as well. So it was related to the what we were able to get from the patients rather than NP specific To the actual the process itself?

Speaker 2

And to be in detail there, 2 patients had a Slight delay with from 8 to 9 days. One patient in one case, we have to do a restart Because of an issue in the manufacturing. And so that is why there is variability in delay, yes.

Speaker 4

And the important point would be that All patients were treated within 14 days, and that is incredibly competitive orders already out there, but most of the patients were 7 days.

Speaker 2

Thanks so much.

Operator

Thank you. We will now take the next question from the line of Jacob Meikle from KBC Securities. Please go ahead.

Speaker 10

Hi there and thanks for taking my question. I have 2 if I may. My first one is how do you look expansion of CD19 CAR T into other autoimmune diseases beyond lupus. Would you consider a basket trial set up, For example, to capture a number of indications in one go? And my second question is, can you perhaps share some feedback on the process of setting up new sites in the U.

Speaker 10

S? And how many do you expect to have up and running by the end of 2024, let's say?

Speaker 2

Well, on We are considering additional activities beyond SLE and looking actively We are not very much favoring a BUCKET study because all of these diseases have their own evaluation criteria, To good conclusions on moving late on into Phase twothree. So we will consider other indications, but do it In a very, yes, organized way that the indication the early data leads to conclusions on what we can do for us. So that is That's the way we approach this. And we're starting with Azaleeb, but are considering several other indications going forward.

Speaker 3

Yes, we haven't disclosed the number of U. S. Sites that we're going to set up for 24 at this time. We are Actively working with a number of different additional sites beyond Landmark Bio and will provide updates in

Speaker 10

Okay. Thank you.

Speaker 1

Thank

Operator

We will now take the next question from the line of Brian Polzin from Jefferies. Please go ahead.

Speaker 7

Hey, thanks. Can you just help us with the latest timings on when you expect to have an asset on the market? Is it still 26%, 27%, I think that's what you last said on the first half call, likely CD19 CAR

Speaker 2

T, I think

Speaker 7

it was despite the delayed time line,

Speaker 2

That's it. Great.

Speaker 3

What we have said before, yes.

Speaker 7

Got it. Yes.

Speaker 3

Review, yes.

Speaker 7

Yes, that's the first one on the BTD, right?

Speaker 9

Sorry, Olin? On breakthrough

Speaker 2

Breakthrough designation, yes. We think with the encouraging data we have, we hope to be able to recruit in an accelerated way More patients into the pivotal, and it still lands us with 26%, 27%, but that is the current time line, which we're still looking for.

Speaker 7

Got it. Thanks. And just a second one, just on T Charge Manufacturing from Novartis PHE885. I think That is 10 days door to door, showed good data. Okay, yours is 7 days, but just curious to Now how you're thinking about that as a competitor to your GLPG's 5 to 301?

Speaker 2

Yes. Feecharge is a different process When you produce fast, then freeze and do the quality control and the quality release in the next so many days. And that results in a 10 day. I don't know exactly How many days, but approximately 10 days. What we do is we keep the cells in fresh condition in the incubator.

Speaker 2

We produced fast because in fact the production is in the 1st few days, but then you have to keep them in the incubator fresh To do the quality release and the quality work and then you can release at day 7, which also fits the 7 day prep time Patient needs in order to receive the cells. So that's why the process is tailored to keeping it fresh, Making sure we can do the quality while the cells are in fresh situation and but then also fit exactly The prep time for patients, the division time, what we also do is we make sure that it's very We're organized for the physicians and the staff in the hospital because the 7 day vein to vein is always organized that there is no work in the weekend, not for the staff On the machines, not for the physicians. Anybody has to do anything in the weekend. It's all organized in a way that it's work Facilitating the work in the hospital and the labs and best possible way to bring fresh cells to patients. So Fee charge is a short process, but it's not the fresh name to make.

Speaker 7

Got it. Thanks very much.

Operator

Thank you. There are no further questions at this time. I would now like to turn the conference back to Sophie Benhuysl for closing remarks.

Speaker 1

Thank you, operator. That's all for today's call. Please feel free to reach out to the IR team if you still have questions. Our next financial results call will be our full year 2023 results on February 23, 2024.

Operator

That concludes our conference for today. Thank you for participating. You may now disconnect.

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Earnings Conference Call
Galapagos Q3 2023
00:00 / 00:00