Earnings Call Transcript - AUTL Q4 2025

Operator, Operator

Good day, and thank you for standing by. Welcome to the Autolus Fourth Quarter 2025 and Full Year 2025 Financial Results Conference Call. (Operator Instructions) Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Amanda Cray, Executive Director of Investor Relations. Please go ahead.

Amanda Cray, Executive Director, Investor Relations

Thank you, Kevin. Good morning or good afternoon, everyone, and thank you for joining us on today's call. With me are Chief Executive Officer, Dr. Christian Itin; and Chief Financial Officer, Rob Dolski. On Slide 2, I'd like to remind you that during today's call, we will make statements related to our business that are forward-looking under federal securities laws and the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These may include, but are not limited to, statements regarding status of the ongoing commercial launch of AUCATZYL in the U.S. and U.K., Autolus manufacturing, sales and marketing plans for AUCATZYL, the market potential for AUCATZYL and the status of clinical trials, development and/or regulatory timelines and market opportunities for obe-cel and our other product candidates. These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views only as of today. We assume no obligation to update any such forward-looking statements. For a discussion of the material risks and uncertainties that could affect our actual results, please refer to the risks identified in today's press release and in our SEC filings, both available on the Investors section of our website. On Slide 3, you'll see the agenda for today's call. As usual, Christian will provide an overview of our operational highlights. Rob will then discuss the financial results, and Christian will conclude with upcoming milestones and closing remarks. We'll then take questions. With that, I'll turn it over to Christian.

Christian Itin, Chief Executive Officer

Thank you, Amanda, and welcome, everyone, to our Q4 and full year update. As we have communicated in January, we had a very good first year of launch with AUCATZYL in the U.S. with $74.3 million in revenue recognized in 2025. By the end of 2025, we had 67 centers activated and are building on positive physician feedback and reliable high-quality product delivery for our second year. We are reiterating our guidance for 2026 with net revenue of $120 million to $135 million, a shift to positive gross margins in 2026 and increasing our commercial footprint, targeting more than 80 activated centers by end of 2026. Regarding gross margins, larger volumes will drive down fixed costs and improvements in the operating model will reduce variable cost per batch. By the end of 2025, we had also achieved regulatory approvals in the EU and in the U.K., achieved market access in the U.K., and have initiated the launch at the very beginning of this year. On Slide 5, alongside the launch in the U.S., the ROCCA Consortium, which stands for Real-World Outcomes Collaborative of CAR T in Adult ALL, collected data from all patients treated with AUCATZYL within participating institutions. Overall, 96 patients were apheresed. Of those, 91 actually achieved the infusions. Five patients did not receive an infusion due to medical reasons, either due to progressive disease or a combination of progressive disease and infection or a lineage switch of the disease and loss of CD19. Of the 91 patients that received the dosing, both infusions were received in all of those patients. By the time of the analysis at the beginning of this year, 84 patients were evaluable for a day 28 assessment for response. The median follow-up is relatively short because this was the first year of launch. The median follow-up was 137 days from first CAR T cell infusion. Moving to Slide 6, what we're seeing in terms of the outcomes, we're looking here at both the outcome of the ROCCA Consortium in the real-world setting, and we actually juxtapose our prior clinical trial experience in the FELIX study. It is worthwhile realizing that the 96 patients that were actually collected in the database approximate about 60% of the U.S. commercial patients that were treated during the course of the first year of launch. When we look in terms of the patient population, we see a wide range of age with a median age of about 50 years comparable to what we had in FELIX and a very wide range, including patients that were on the elderly side. What was very encouraging was to also see that when moving to the real-world setting we were able to maintain the safety profile that we have seen with AUCATZYL or obe-cel in the FELIX study. The real-world observation from a CRS perspective, cytokine release syndrome, is that about 59% of the patients had a CRS of Grade 1 or Grade 2, but no patient experienced a Grade 3 or higher CRS. Similarly, on the ICANS side, 17% of the patients experienced Grade 1 or Grade 2 ICANS and only 3% experienced Grade 3 ICANS in this real-world setting. When compared to the FELIX experience, that translates very well. In FELIX on CRS, we observed a slightly higher overall level of CRS and a small proportion of 2% of patients with high-grade CRS. Similarly, on neurological toxicity, in FELIX, 23% of patients experienced ICANS and about 7% experienced high-grade ICANS. Overall, a very nice reproduction of our clinical experience now in the actual real-world setting. On the efficacy side, this is early data. What was available is tumor assessment at day 28. Further data may become available at later time points, but this is what was analyzed and presented at the ASGCT meeting in an oral presentation this year in Salt Lake City. On the left-hand side, the data from the real-world setting shows about a 92% overall complete remission rate in the real-world setting, which is quite similar to what we've seen overall with the mature FELIX data at 3 months and looks somewhat improved over the day 28 assessment in the FELIX study. This is a nice confirmation of the data and observations we had in our clinical trial now in a real-world setting and in patients treated in the normal standard-of-care environment, which can differ from clinical trial environments. The data is aligned with prior observations and corroborates past presentations. We also see a wider range of patients included from a tumor burden perspective, as expected in the real-world setting, where once you have evidence of disease coming back, you would intervene earlier rather than wait for high disease burden. It reflects actual standard of care in the disease setting. Very encouraging observation of the first year. It is a remarkable coincidence that the Consortium was ready to collect data practically from day one when we made product available, giving a real-time view of product performance from manufacturing and supply perspectives and outcomes. Moving to Slide 7, a brief word on overall activities, particularly around obe-cel's broader development. We have a strong foundation in the Adult ALL segment with our first label and product in the market performing well. We're now building to broaden utility across additional indications. One natural first indication to add is across the entire age range within acute leukemia, hence the CATULUS study. I'll briefly show data in the upcoming slides. With CATULUS, we're looking to get a dataset to support a pediatric label. We started with a Phase 1 dataset presented at ASH at the end of last year. Based on that data and discussions with the agency, we agreed to expand the study; this expanded study should provide pivotal data to support a future pediatric label. The second study we've been active in, reported at the end of last year first at ACR and then in an oral presentation at ASH, is our first autoimmune experience in systemic lupus with very advanced patients—the CARLYSLE study. This Phase 1 study evaluated activity and safety in this group. We reported initial data and, based on interaction with the agency, designed the LUMINA study focusing on lupus nephritis patients with advanced disease; enrollment is underway. We expect data in 2028 for the lupus nephritis population. We have alignment with the FDA on the design as a pivotal study to support approval if the data supports it. Additionally, we're looking at progressive MS in an exploratory Phase 1 study called BOBCAT, which is currently enrolling. We treated the first patient in October last year. We expect full Phase 1 data during 2027 and hope to have early data by the end of this year to get a first view. From a pivotal perspective, pediatric ALL (CATULUS) data is expected by the end of 2027. The LUMINA pivotal data readout is expected in 2028. In 2026, we expect a longer-term update from the CARLYSLE study, planned for year-end. There are additional opportunities: continued data collection from the ROCCA Consortium, and substantial interest in investigator-sponsored studies with focus on frontline patients to explore consolidation strategies and activity in earlier settings. There's a lot of interest to explore a broader opportunity base. For internal studies, we expect a strong news flow through '26, '27 into '28 with meaningful updates and hopefully datasets that will expand commercial opportunity. On the next slides, I briefly summarize pediatric data presented at ASH. These are all relapsed/refractory patients. On Slide 8 for safety data, the safety profile is consistent with adult population in terms of immunological toxicity, infection risk, and neutropenia. On Slide 9, a swim plot shows almost all patients achieved a complete remission, CR or CRi. Overall, CR/CRi was 95% and CR about 91%, confirming very high activity consistent with adults. We start to see a good duration of responses in the swim plot; follow-up is still relatively early with a median follow-up of 8.8 months. On Slide 10, pediatric plan: we decided to add 30 patients for the Phase 2 portion of the study. It's international with centers in the U.S., U.K., and Spain. We developed the approach with the Children's Oncology Group. Age range includes 0 to 18 years with a minimum body weight of 6 kilograms. We dose pediatric patients with a single infusion at 1 million cells per kilogram. The population is relapsed/refractory with a focus on first-line high-risk relapse populations who are often excluded from CAR T access, ensuring opportunity for those patients to benefit. We expect data by end of 2027. Slide 11 covers advanced SLE in CARLYSLE. We determined the recommended Phase 2 dose at 50 million single infusion. The Phase 1 population had significant kidney impairment and wide ranges of autoimmune manifestations represented in SLEDAI-2K scores and very challenging disease. We have 11.4 months of follow-up in the 50 million cohort. We achieved a DORIS response in 5 of 6 patients and complete renal remission in 3 of 6. The product was overall well tolerated; we saw no ICANS and no high-grade CRS. We are learning key biomarkers. Slide 12 shows ASH presentation details: summary of safety data—well tolerated with minimal immunological toxicity. SLEDAI scores show improvement over time; renal scores are highlighted and some patients had very advanced disease. The right upper panel depicts DORIS remissions—5 of 6 converted to DORIS. The DORIS response examines SLEDAI improvement and requires low corticosteroid exposure (no more than 5 mg/day) indicating patients are in a physiological steroid state. The bottom right shows persistence and B-cell recovery: median persistence is 3 months and median time to B-cell recovery is 6 months. We saw deep remission and a reset to a naive B-cell state after B-cell reappearance, consistent with mechanism of action. Slide 13 covers development in lupus nephritis. We included teenagers 12 years and older in CARLYSLE because of medical need and aggressive disease in that group. Based on this data, we moved into LUMINA, a single-arm 30-patient study in patients who have failed B-cell depleting antibodies and calcineurin inhibitors and are outside approved standard of care at that stage. The study is enrolling in the U.S., U.K., Spain, and likely adding one or two more countries. Once a foothold is established, we can broaden use to a wider set of patients. We expect LUMINA data in 2028. Slide 14 is a reminder of BOBCAT in progressive MS where we are investigating safety, clinical impact via disease scores, and biomarkers and imaging measures. Depending on outcomes, we'll decide next steps. With that, I will hand the call to Rob for financial results.

Robert Dolski, Chief Financial Officer

Thanks, Christian, and good morning or good afternoon to everyone. It's my pleasure to review our financial results for the fourth quarter of 2025, and I'll be referring to the information on Slide 16. Before diving into the specific numbers, I would like to note a refinement to the accounting treatment related to our product revenue and cost of goods sold that are reflected in the results that we'll discuss today. Importantly, this change has no material impact on our existing or anticipated AUCATZYL revenue and has a practical benefit of better aligning the timing of revenue and cost of sales. On a full year 2025 basis and moving forward, we plan to recognize both the full value of product sales and the associated cost of goods sold upon confirmation of the second dose administration for AUCATZYL. From a revenue perspective, this means we will no longer recognize a 50-50 split across the first and second dose confirmations. This also eliminates the previous deferred revenue accounting and earlier cost of goods recognition associated with those deferred revenues. The accounting for personalized cell therapy products is an emerging area. During our year-end review process, we and our auditor concluded on this refined position within the accounting standards and again, with no material impact on the financial statements. Now on to the results. Net product revenue for the fourth quarter of 2025 was $23.3 million, bringing us to a total of $74.3 million for the first full year of AUCATZYL sales. I'll also note that we recorded a $1 million license revenue component in Q4 2025 related to the achievement of a clinical milestone under our license and option agreement with Moderna. Combined, this gives you the $24.3 million in total revenue for the fourth quarter. Cost of sales in the fourth quarter totaled $25.3 million, compared to $11.4 million for the same period in 2024. This change was primarily driven by having a full quarter of sales in 2025 and having only a partial quarter of commercial manufacturing activity expense recognition upon FDA approval back in November of 2024. Additionally, cost of sales in Q4 2025 includes canceled orders in the period, patient access program product, inventory reserves or write-offs, third-party royalties for certain technology licenses. As discussed on our full year guidance, we expect to shift to positive gross margin this year based on increasing patient volume, improving overall plant utilization, and executing on operational efficiencies. Moving on, our research and development expense was $35.6 million for the fourth quarter of 2025, compared to $30.8 million during the same period in 2024. This change was primarily driven by an increase in R&D activities, including some of our new clinical trial start-up and a reduction in the period-over-period U.K. R&D tax credit. This was partially offset by commercial manufacturing-related employee and infrastructure costs that have now shifted to cost of sales and inventory. Our selling, general and administrative expenses increased to $35.8 million for the fourth quarter of 2025 compared to $33.7 million in the same period in 2024. This increase was primarily due to salaries and other employee-related costs, driven by the increased headcount supporting commercialization activities. Our loss from operations for the three months ended December 31, 2025, was $72.5 million compared to $75.9 million for the same period in 2024. Finally, net loss was $90.3 million for the three months ending December 31, 2025, compared to $27.6 million for the same period in 2024. Our cash, cash equivalents and marketable securities at December 31, 2025, totaled $300.7 million.

Operator, Operator

Hello, Rob? Rob are you still there?

Unidentified Participant, Participant

Pardon me, Amanda, can you hear me?

Christian Itin, Chief Executive Officer

This is Christian. I can hear you.

Operator, Operator

Okay. Looks like we might have just lost Rob. (Technical Difficulty).

Christian Itin, Chief Executive Officer

Okay. I think I'm going to take over.

Robert Dolski, Chief Financial Officer

Sorry about that.

Operator, Operator

Are you back? Okay.

Robert Dolski, Chief Financial Officer

Okay. I'm going to pick up on our cash and cash equivalents and marketable securities at the end of 2025 totaled $300.7 million as compared to $588 million at the end of December 2024. That decrease was primarily driven by net cash used in operating activities and impacted by a delayed receipt of approximately $18.6 million related to the 2023 R&D tax credit that we are expecting from the U.K. HMRC. As Christian noted, we are reiterating financial guidance issued in January that we expect between $120 million and $135 million in AUCATZYL net product revenue in 2026. This includes contribution from both the U.S. and U.K. markets. Finally, based on our current operating plans, including anticipated AUCATZYL net revenues, we expect that current and projected cash, cash equivalents and marketable securities will be sufficient to fund our operations into Q4 2027. I'll now hand back to Christian to wrap up with a brief outlook on expected milestones.

Christian Itin, Chief Executive Officer

Thanks, Rob. All right. Going to Slide 18, upcoming milestones. We're about two weeks away from a Virtual KOL Event focused on acute leukemia and the opportunity there. I'll talk a little more on the next slide about that. In 2026 we expect, towards the end of the year, longer-term follow-up from the CARLYSLE Phase 1 trial. We also expect first data from our AUTO8 program in collaboration with UCL on light-chain amyloidosis; the trial name is ALARIC. Early data from the BOBCAT Phase 1 trial in progressive MS is expected, with full BOBCAT data during 2027. By year-end 2027, we expect full Phase 2 data for the CATULUS study, designed as a pivotal study. The second pivotal study, LUMINA in lupus nephritis, is expected to read out in 2028. On Slide 19, the April 8 event: speakers include Dr. Jae Park from Memorial Sloan Kettering discussing the Adult ALL landscape and unmet need; Dr. Lori Muffly from Stanford discussing the ROCCA real-world experience with AUCATZYL; Dr. Elias Jabbour from MD Anderson on opportunities in earlier lines of ALL and investigator-sponsored trials; and Dr. Michael Pulsipher from the University of Utah Huntsman on pediatric needs and initial CATULUS data. The event will be webcast and recorded. We're looking forward to your participation. To finish and wrap up, our focus for 2026 is to drive market share for AUCATZYL, improve gross margins, and expand the utility of obe-cel across clinical development programs to serve a broader range of indications. That concludes prepared remarks and we're happy to take questions.

Operator, Operator

(Operator Instructions) Our first question comes from James Shin with Deutsche Bank.

James Shin, Analyst

I have a couple. For the 2026 guide of $120 million to $135 million, Christian or Rob, can you help us with how much might come from U.K. and other ex-U.S. regions? Secondly, what's the latest on more EU adoption or reimbursement for AUCATZYL? And then Christian, given we're pretty much through 1Q 2026, can you shed any light on how AUCATZYL uptake has trended?

Christian Itin, Chief Executive Officer

Thanks, James. Regarding the U.K. guidance, as Rob said, this includes both the U.S. and the U.K. We're not planning to break that out. The U.K. is a substantially smaller country than the U.S., so we will present data in the aggregate. We do not expect a major contribution yet from the U.K. given how early it is in the process. With regards to other EU countries, we do not expect any contributions from other EU countries in 2026. We have an approval in the EU and are in conversations with market access authorities in Europe to see whether there's an appropriate path. We need to be able to enter a market in a way that is economically sensible; we cannot afford to enter at a loss. We're evaluating options and will keep you updated as we learn more. For 2026, we are not guiding to any revenue outside the U.S. and U.K. Regarding Q1 trends, we're not breaking out quarters; we gave full year guidance and reiterated it. During last year we saw seasonality—summer vacations and year-end holidays impact treatment timing. There is variability quarter to quarter, so we focus on the aggregate full-year guidance.

Operator, Operator

Our next question comes from Gil Blum with Needham & Company.

Gil Blum, Analyst

Very nice ROCCA results. Do you think this is going to influence physician behavior? Is this sufficiently socialized? Feedback we've gotten is most physicians already view AUCATZYL as a preferred therapeutic?

Christian Itin, Chief Executive Officer

Thanks, Gil. We're pleased with the real-world observations. In this disease setting, adoption is incidence-driven and is about building physician confidence and experience. The ROCCA data, which is physicians' own data, is important. Physicians treating ALL include transplant physicians, CAR T therapists, and a wide range of hemato-oncologists handling frontline therapy. We are working to expand adoption across transplanters, CAR T therapists, and frontline physicians. The data is important because it reflects the centers' own experience, but there is substantial work ahead to move from current market penetration—probably around 10%—towards the levels seen with Blincyto, which we believe reflect the product's potential.

Gil Blum, Analyst

Any insights on how the LUMINA enrollment is going?

Christian Itin, Chief Executive Officer

LUMINA is taking place in several countries. We started in the U.K. building on CARLYSLE experience. It's starting to gain momentum. We're adding U.S. centers, which we expect to come online in the upcoming quarter, and we expect enrollment to pick up as U.S. centers begin enrolling. So far enrollment matches our expectations for the indication.

Gil Blum, Analyst

One last one for Rob. Now that we're recognizing revenues and costs on the second dose, how should we view patients who only receive one dose?

Robert Dolski, Chief Financial Officer

Good question. If a patient does not receive a second dose, the accounting depends on multiple factors including the payer arrangement. For patients who only ever get the first dose, recognition depends on cash receipt and reimbursement terms. We will generally wait until cash receipt to recognize that revenue for that individual patient. The reimbursement can be full or partial (for example, 50%) depending on the patient's characteristics and applicable policies. In practical terms, the number of patients who only get one dose has been relatively small.

Operator, Operator

Our next question comes from Salim Syed with Mizuho.

Salim Syed, Analyst

Congrats on the progress. On cadence of catalysts for this year: many trials like BOBCAT, LUMINA, ALARIC are open-label and you will be looking at data through the year. Is there potential for early disclosure? And can you remind us on BOBCAT the intervals you'll be measuring disability progression?

Christian Itin, Chief Executive Officer

Good question. For CATULUS and CARLYSLE, we presented baseline data late last year; next meaningful updates will be longer-term and comprehensive rather than piecemeal. For ALARIC we need a sufficient number of patients and dose-level experience before a meaningful cut. For BOBCAT, we will first evaluate pharmacodynamic and imaging markers and then see whether any clinical signal emerges. Early piecemeal data can be misleading. We plan to provide meaningful updates at appropriate times; for BOBCAT, early data may come later this year, but more interpretable clinical signals are more likely during 2027 once there is longer follow-up. Regarding measuring disability progression, BOBCAT will include standard clinical scales, imaging, CSF assessments, and pharmacodynamic markers at specified intervals; however, early individual data points can be hard to interpret. We don't plan to release piecemeal early data that would not provide clear interpretation.

Operator, Operator

Our next question comes from Matt Phipps with William Blair.

Matthew Phipps, Analyst

On the progressive MS study, Stanford recently presented data on six patients at ACTRIMS; a couple of patients saw some improvements by six months in EDSS scores and CSF oligoclonal bands. Any thoughts on that data and how it influences what you could present at BOBCAT later this year? And for AUTO8 in AL amyloidosis, cilta-cel has shown high response rates. What do you think the CD19 aspect of AUTO8 provides as differentiation versus cilta-cel?

Christian Itin, Chief Executive Officer

The Stanford data at ACTRIMS is encouraging and suggests correlations between pharmacodynamic markers and early disease score observations. Early disease scores can be subjective and difficult to interpret at early time points. Ideally, you want congruence between pharmacodynamic activity and clinical signals; that clarity is more likely with longer follow-up, probably during 2027. Early BOBCAT updates will focus on pharmacodynamics, safety, CSF presence, and B-cell depletion rather than definitive clinical outcomes. Regarding ALARIC and AUTO8 in light-chain amyloidosis, that's predominantly a plasma cell disorder where the BCMA component is expected to drive primary activity. We'll see whether the CD19 component adds benefit, but we expect BCMA to be the predominant driver of activity in that indication.

Operator, Operator

Our next question comes from Roger Song with Jefferies.

Unknown Analyst, Analyst

Congrats on the quarter. I understand you will shift to a positive gross margin this year. How should we think about near-term evolution of gross margin once it turns positive? With the partnership with Soliris/other automated platforms, how quickly can this automated platform be integrated into your commercial supply chain, and what's the magnitude of cost reduction you expect?

Christian Itin, Chief Executive Officer

Two key drivers for improving production costs and gross margins: higher volumes through our infrastructure, which dilutes fixed costs, and optimization of our operating model to reduce variable costs per batch. Between increased utilization and operational improvements, we expect meaningful cost reductions over time. The Soliris (automated platform) opportunity is under feasibility assessment to confirm comparability between manufacturing setups. For us, Solaris is primarily about the ability to scale substantially for potential larger demand from new indications, rather than immediate cost reduction. It could be an economical way to scale for much higher volumes, particularly if indications like MS drive substantial demand. It doesn't take away from improvements at our Nucleus facility, which is optimized for current ALL patients and smaller autoimmune subsets.

Operator, Operator

Our next question comes from Yanan Zhu with Wells Fargo.

Yanan Zhu, Analyst

On BOBCAT, the study has three dose cohorts at the year-end readout; how many dose cohorts should we expect overall and can a dose-response signal be discerned on metrics? Also, what would you define as a powerful success? I have a follow-up after.

Christian Itin, Chief Executive Officer

BOBCAT is an exploratory dose-escalation study. We started at a 100 million cell dose and may step up or step down based on safety and activity. Key early readouts are pharmacodynamics, presence of CAR T cells in CSF, expansion, safety, and B-cell depletion. By year-end, we expect early data from the initial cohort on product properties and pharmacodynamics, but it will be too early to definitively link those to clinical outcomes. A powerful success would be consistent pharmacodynamic activity with evidence of clinical impact over longer follow-up, supported by imaging and biomarker changes. We expect more interpretable clinical data with longer observation time in 2027.

Yanan Zhu, Analyst

On the B-ALL launch for AUCATZYL, is there any use in earlier-line settings such as MRD-positive consolidation? Sloan Kettering has an ITT that just opened for MRD-negative consolidation—thoughts on how that could be leveraged to expand opportunity?

Christian Itin, Chief Executive Officer

In current use and the ROCCA data, we see patients included with minimal residual disease or low disease burden at the time of treatment; they are still relapsed/refractory. About one-third of patients fall in that bucket, consistent with standard practice to treat when disease evidence emerges. We do not currently see frontline MRD-only use. Investigator-initiated trials, including the Memorial Sloan Kettering trial, are exploring investigator-sponsored designs to test consolidation strategies after abbreviated frontline therapy rather than lengthy full frontline regimens, aiming for definitive consolidation. These investigator studies are of interest and may provide insights on reducing overall treatment time and toxicity in frontline settings, and we'll learn from their experience.

Operator, Operator

Our next question comes from Emily Bodnar with H.C. Wainwright.

Emily Bodnar, Analyst

How much additional follow-up and durability data should we expect from the CARLYSLE trial later this year for the 50 million and 100 million cell doses? What are you looking to see to gain additional confidence for LUMINA?

Christian Itin, Chief Executive Officer

For CARLYSLE, at ASH we had a median follow-up of 8.8 months for the initial data cut on the 50 million cohort. For the upcoming update, expect roughly around 12 to 18 months of follow-up for the 50 million cohort. The 100 million cohort will likely have just under a year of follow-up and adolescent patients somewhat less. For LUMINA, the study population is more precisely defined—patients who have failed B-cell depleting antibodies and calcineurin inhibitors—so the population definition and prior lines of therapy are clearer, enabling interpretability of a pivotal endpoint. We're looking for well-defined efficacy signals in that defined population and durable responses consistent with the CARLYSLE signals.

Operator, Operator

Ladies and gentlemen, we've reached the conclusion of the Q&A portion of today's conference. I'd like to turn the call back to Christian for any further remarks.

Christian Itin, Chief Executive Officer

Thank you, everybody, for joining. We're looking forward to the April 8 event where KOLs will discuss the ALL disease setting and opportunities. We'll reconvene for the Q1 call after that. Thank you very much and have a good day.

Operator, Operator

Thank you, ladies and gentlemen. This concludes today's presentation. Thank you for your participation. You may now disconnect and have a wonderful day.