Full Year 2025 Cellectis SA Earnings Call

Earnings Conference call.

At this time all participants are in a listen only mode.

Later, you will have the opportunity to ask questions. The question and answer session.

To register to ask a question at any time. Please press star one on your telephone keypad.

Please note. This call is being recorded and that we are standing by if you should need any assistance.

It is now my pleasure to turn the meeting over to Arthur Strohm.

Chief Financial Officer, and Chief Business Officer.

Please go ahead.

Good morning, and welcome everyone to selective fourth quarter and full year 2025 business updates and financial results Conference call.

Joining me on the call today are Dr. <unk>, <unk>, our Chief Executive Officer, and Dr. Adrian Kill Cohen, our Chief Medical Officer.

Yesterday evening collected issued a 20-F in the press release reporting our financial statements for the 12 months period ended December 31, 2025, and a business update.

The report and press release are available on our website at selected Dot com.

As a reminder, we will make statements regarding select this financial outlook, including the sufficiency of cash to fund operations. In addition to its manufacturing regulatory and product development status as well as product development status of its license partners.

These forward statements, which are based on management's current expectations and assumptions and on information currently available to management, including information provided or otherwise publicly reported by our license partners are subject to risks and uncertainties that may cause actual results to differ from those forecasted.

Speaker #2: Hello and welcome, everyone, to today's Cellectis full-year 2025 earnings conference call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session.

A description of these risks can be found in our most recent form 20-F filed with the security Exchange Commission SEC and the financial reports, including the management report for the year ended on December 31, 2025, and subsequent filings select this makes with the SEC from time to time.

Speaker #2: To register to ask a question at any time, please press star one on your telephone keypad. Please note this call is being recorded, and that we are standing by if you should need any assistance.

I would now like to call to turn the call over to Andre.

Speaker #2: It is now my pleasure to turn the meeting over to Arthur Stril, Chief Financial Officer and Chief Business Officer. Please go ahead.

Thank you Arthur good morning, and thank you everyone for joining us today.

This was founded with the conviction that gene editing could fit them internally transfer.

Transform how we treat patients in the 21st century.

Speaker #3: Good morning and welcome, everyone, to Cellectis' fourth quarter and full-year 2025 business update and financial results conference call. Joining me on the call today are Dr. André Choulika, our Chief Executive Officer, and Dr. Adrian Kilcoyne, our Chief Medical Officer.

That foundation.

We pioneered the allogeneic car T approach ready on day, one build for all patients regardless of their condition.

Okay.

Tough to say that this is the one of the only company running pivotal phase II Allogeneic car T trial.

Speaker #3: Yesterday evening, Cellectis issued a 20-F and press release reporting our financial statements for the 12-month period ended December 31, 2025, and a business update.

Specifically in B cell acute lymphoblastic leukemia.

Several years have been among the most challenging in recent memory of biotechnology companies.

Speaker #3: The report and press release are available on our website at cellectis.com. As a reminder, we'll make statements regarding Cellectis' financial outlook, including the sufficiency of cash to fund operations, in addition to its manufacturing, regulatory, and product development status, as well as product development status of its licensed partners.

Many programs, where shelf and many companies were forced to retreat.

While others were kept back collect this step forward.

We held the line, we manage our cash with rigor.

Where it matters and.

Speaker #3: These forward statements, which are based on our management's current expectations and assumptions, and on information currently available to management—including information provided or otherwise publicly reported by our licensed partners—are subject to risks and uncertainties that may cause actual results to differ from those forecasted.

And we kept our team focused entirely on one thing delivering clinical results for patients who are running out of time with no therapeutic solution.

In 2025 that disciplined paid off.

Tober at our R&D day, we presented the full phase one data set for last myself, our allogeneic car T candidate targeting CD 22 in relapsed or refractory b cell acute lymphoblastic leukemia.

Speaker #3: A description of these risks can be found in our most recent Form 20-F filed with the Securities and Exchange Commission (SEC), and the Financial Report, including the management report, for the year ended December 31, 2025, and subsequent filings Cellectis makes with the SEC from time to time.

<unk> achieved 100% overall response rate and the target phase III population critics.

Critically last myself converted all patients in the target population to transplant eligible candidates.

Speaker #3: I would now like to turn the call over to Andre.

Speaker #4: Thank you, Arthur. Good morning, and thank you, everyone, for joining us today. Cellectis was founded with the conviction that gene editing could fundamentally transform how we treat patients in the 21st century.

These results were achieved the patient in third line and beyond.

Most of them have already failed CD 19 car T. We've had to move out.

Speaker #4: And with that foundation and idea, we pioneered the allogeneic CAR-T approach—ready on day one, built for all patients regardless of their condition. Today, we're proud to say that Cellectis is one of the only companies running a pivotal Phase 2 allogeneic CAR-T trial, specifically in B-cell acute lymphoblastic leukemia.

There are options were exhausted.

This clinical proof.

Allogeneic car T can deliver deep.

Responses in one of the most difficult cancer to treat.

Let me take a moment to explain why our breakthrough transplant strategy is medically powerful.

For patients with refractory or relapsed or refractory B L. L.

Only known path to long term cure is a bone marrow stem cell transplant.

Speaker #4: The past several years have been among the most challenging in recent memory for biotechnology companies. Many programs were shelved, and many companies were forced to retreat.

To be eligible for transplant in a patient a patient.

<unk> achieved deep remission, ideally minimal residual disease negative or negative.

Speaker #4: While others stepped back, Cellectis stepped forward. We held the line. We managed our cash with rigor. We invested where it matters. And we kept our team focused entirely on one thing: delivering clinical results for patients who are running out of time, with no therapeutic solution.

<unk> is heavily pre treated patients.

And to burden with disease or two time constrained to wait for an installer therapy to be manufactured.

Bingo is narrow.

This is precisely where our allogeneic car T product last Michelle becomes a game changer.

Speaker #4: In 2025, that discipline paid off. In October, at our R&D Day, we presented the full Phase 1 dataset for LASTICEL, our allogeneic CAR-T candidate, targeting CD22 in relapsed or refractory B-cell acute lymphoblastic leukemia.

Off the shelf immediately available lastly itself has the potential to reach a patient in days not weeks.

Typically eliminate residual.

<unk> disease and opened the door to transplant for patients. It is the difference between a chance to.

Speaker #4: Last Missile achieved a 100% overall response rate in the target phase 2 population. Critically, Last Missile converted all patients in the target population to transplant-eligible candidates.

Cure and no chance at all.

Without our people phase II trial initiated we will continue to fight openings in North America.

And then ROE expansion.

In 2026.

Speaker #4: These results were achieved in patients in third line and beyond. Most of them have already failed CD19 CAR-T, glinetumumab, and inotuzumab. Their options were exhausted.

The first interim analysis of the pivotal phase two trial is expected Q4 2026.

Turning to our second product candidate <unk>.

For patients with relapsed.

Speaker #4: This is clinical proof that allogeneic CAR-T can deliver deep, durable responses in one of the most difficult cancers to treat. Let me take a moment to explain why our breach-of-transplant strategy is medically powerful.

Lots of refractory non Hodgkin lymphoma.

So is the best in class Allogeneic, <unk> car T targeting <unk> and CD 22 simultaneously.

We're differentiated antigens validated in oncology.

This dual targeting is it deliberate answer to one of the most stubborn clinical problem in lymphoma antigen escape.

Speaker #4: For patients with relapsed or refractory BLL, the only known path to long-term cure is a bone marrow stem cell transplant. But to be eligible for transplant, a patient must first achieve deep remission, ideally minimal residual disease negative, or MRD negative.

When cancer cells lose one surface marker terrific single targeted therapy.

They cannot hide from both editable, what's built for that challenge.

At the Ash 2025 annual meeting in December 2025.

Like this presented phase one interim results, which demonstrated an encouraging overall response rate of 80.

Speaker #4: The challenge is that heavily pre-treated patients are often too burdened with disease or too time-constrained to wait for an autologous therapy to be manufactured. The window is narrow.

8% and a complete response of 63% in heavily pre treated patient.

Speaker #4: This is precisely where our allogeneic CAR-T product, Last Missile, becomes a game changer. Off-the-shelf and immediately available, Last Missile has the potential to reach a patient in days, not weeks, rapidly eliminate residual disease, and open the door to transplant.

These preliminary data underscore the potential of this innovative approach to transform outcomes for refractory relapsed or refractory non hodgkin lymphoma patients.

File is now investigating.

Things will impact our flow dose interleukin two supported.

We significantly enhanced expansion and the persistence persistence of car T cells to post car T efficacy without exacerbating toxicity.

Speaker #4: For the patients, it is the difference between a chance to cure and no chance at all. Without our pivotal Phase 2 trial now initiated, we will continue site openings in North America and Europe and enroll expansion in 2026.

Expect to present, the full phase one data set.

That effect itself this year.

Now few words on our partners.

Speaker #4: The first interim analysis of the pivotal phase two trial is expected in Q4 2026. Turning to our second product candidate, Eticel, for patients with relapsed or refractory non-Hodgkin lymphoma, Eticel is a best-in-class allogeneic dual CAR-T targeting CD20 and CD22 simultaneously.

This is not operating in isolation.

<unk> platform has become technological backbone of our broader allogeneic car T ecosystem.

Two of our key partners are approaching pivotal moment surveys for allergies Semisolid program is currently people phase II study.

Our rating it as a consolidation therapy first line large b cell lymphoma patients.

Speaker #4: Two differentiated antigens validated in oncology. This dual targeting is a deliberate answer to one of the most stubborn clinical problems in lymphoma: antigen escape.

I would anticipate that.

An interim futility analysis is on track for Q2 2026.

Speaker #4: When cancer cells lose one surface marker to evade a single target therapy, they cannot hide from both. Eticel was built for that challenge. At the ASH 2025 annual meeting in December 2025, Cellectis presented phase one interim results which demonstrated an encouraging overall response rate of 88% and a complete response of 63% in heavily pre-treated patients.

Our partnership with <unk> is another powerful signal to reach any versatility of our platform.

<unk> is advancing I O V 4001.

PD, one in activated tumor infiltrating lymphocytes or til cell therapy.

And previously treated advanced melanoma patients leveraging down G&A think capacity clinical results of Iot for 001, and melanoma are anticipated this year.

Speaker #4: These preliminary data underscore the potential of this innovative approach to transform outcomes for relapsed or refractory non-Hodgkin lymphoma patients. The trial is now investigating any potential impact of low-dose interleukin-2 support.

R&D activities.

Under our research and collaboration agreement with Astrazeneca, which leverages.

Which leverages the collective of gene editing.

Extra cheese and manufacturing capabilities.

Up to 10 novel cell and gene therapy program for areas of high.

<unk>.

Speaker #4: Two significantly enhanced expansion and the persistence of CAR-T cells to boost CAR-T efficacy without exacerbating toxicity. Cellectis expects to present the full Phase 1 data set of Eticel this year.

Medical need, including oncology immunology and rare genetic disorders.

Partnership is further testament with industrial credibility of gene editing or gene editing platform and our manufacturing capabilities.

Speaker #4: Now, a few words on our partners. Cellectis is not operating in isolation. Our gene editing platform has become the technological backbone of a broader allogeneic CAR-T ecosystem.

<unk> 26.

We will be a year of data.

Milestones and.

That's correct.

We are grateful for continued trust and support.

We look forward to updating you through the year as we execute against each of these milestones with that I would like to turn the call over to Dr. Adrian kill point.

Speaker #4: Two of our key partners are approaching pivotal moments: Cervie through Allogene's semicell program is currently in a pivotal Phase 2 study, evaluating it as a consolidation therapy in first-line large B-cell lymphoma patients.

Our Chief Medical Officer, who will provide further details on our clinical programs.

Please go ahead.

Speaker #4: Allogene anticipates that an interim fertility analysis is on track for Q2 2026. Our partnership with Iovance is another powerful signal to reach any versatility of our platform.

Thank you Rafi.

I will provide.

Focused clinical perspective on our last myself and any selling programs.

The phase one study alone.

Studying philosophy.

Third line and beyond acute lymphoblastic leukemia enrolled 40 patients with confirmed at least 70% in CD 22 expression.

Speaker #4: Iovance is advancing IOV4001 in PD-1 inactivated tumor infiltrating lymphocytes, or TILs, cell therapy. In previously treated advanced melanoma patients, leveraging our gene editing capacity, clinical results of IOV4001 in melanoma are anticipated this year.

These patients were heavily pretreated with a median of four prior lines of therapy.

The median number of prior lines of therapy at the recommended.

Phase two dose was higher at five.

Increasingly patients have already relapsed following multiple targeted therapies most patients have been previously treated with <unk>.

Speaker #4: R&D activities continue to advance under our research and collaboration agreement with AstraZeneca, which leverages Cellectis' gene editing expertise and manufacturing capabilities to develop up to 10 novel cell and gene therapy products for areas of high unmet medical need, including oncology, immunology, and rare genetic disorders.

And cleanup.

Approximately 50% of all also.

Also relapsed following CD 19 car T and <unk>.

CD 22, directed antibody drug conjugate conjugated therefore, there remains very acute.

Computing options for these patients.

At the recommended phase two dose.

So achieved an overall response rate of 83%.

Speaker #4: The partnership is a further testament to the industrial credibility of gene editing, our gene editing platform, and our manufacturing capabilities. 2026 will be a year of data, of milestones, and of momentum for Cellectis.

CR cri rate of 42%.

And the positive phase III population with an upper age 50.

50 years old response rates are even higher with 100% overall response, CR cri rate of 56%.

Importantly, also subject to its achieved CR cri, 80% achieved.

Speaker #4: To show our gratitude for your continued trust and support, we look forward to updating you throughout the year as we execute against each of these milestones.

Status.

Additionally, all.

Speaker #4: With that, I would like to turn the call over to Dr. Adrian Kilcoyne, our Chief Medical Officer, who will provide further details on our clinical programs.

All of the nine patients.

Phase III population all of them became trusts.

With nine receiving a stem cell transplant at the time of data cut off.

Speaker #4: Adrian, please go ahead.

Speaker #3: Thank you, Audrey. I will provide a focused clinical perspective on our last missile and Eticel programs. The Phase 1 BALIO1 study of last missile in third-line and beyond acute lymphoblastic leukemia enrolled 40 patients with confirmed at least 70% CD22 expression.

This is a very positive outcome for these patients.

To achieve negative at Cri.

Overall survival was $14 eight months, a meaningful survival benefit in this heavily pretreated population.

The safety profile, perhaps Michel was favorable.

Speaker #3: These patients were heavily pretreated, with a median of four prior lines of therapy. The median number of prior lines of therapy at the recommended Phase 2 dose was higher, at five.

Sure.

Car T therapies.

Equal to credit Suisse cytokine release syndrome occurred in two 5% of patients and greater than or equal to <unk> 10.

Speaker #3: These heavily pre-treated patients have already relapsed following multiple targeted therapies. Most patients have been previously treated with lenetimumab and relapsed. Approximately 50% have also relapsed following CD19 CAR-T and inotuzumab, a CD22-directed antibody-drug conjugate.

Okay.

The percentage of patients at the recommended phase two dose.

The full phase one data has been submitted for presentation at the 2026 European Hematology Association Congress.

Stucco in June.

The phase one program also addressed.

Speaker #3: Therefore, there remain very few, if any, therapeutic options for these patients. At the recommended Phase 2 dose, Last Missile achieved an overall response rate of 83% and a CR/CRI rate of 42%.

Two important additional questions.

Further our internally manufactured product.

And similar R&D prove efficacy compared to the product manufactured by external CMO.

Yeah.

The second is weather had on Tuesday night.

Speaker #3: In the target phase two population, with an upper age cutoff of 50 years old, response rates were even higher, with 100% overall response and a CR/CRI rate of 56%.

The pre conditioning lymphoma patient regimen results in.

Purion is actually seven expansion, therefore efficacy compared to the standard.

Imagine that.

Consolidated.

I don't know what their manufacturing capabilities, so that this manufacturing product.

Speaker #3: Importantly, of those subjects who achieved a CR/CRI, 80% achieved MRD negative status. Additionally, of the nine patients in the target Phase II population, all became transplant eligible, with seven of nine receiving stem cell transplant at the time of data cutoff.

Yeah.

Higher response rate than externally.

Matter of fact.

With overall response rate of 68%, 28% respectively.

Secondly, the data demonstrates.

Let's face it increased.

Correlates with improved response. These days were outlined at the American Society of Hematology Annual conference in December 2025.

Speaker #3: This is a very positive outcome for these patients. In patients who achieved MRD-negative CR/CRI, median overall survival was 14.8 months and there was a meaningful survival benefit in this heavily pre-treated population.

There's no data have also been submitted for presentation at the 2026 European Hematology Association Congress.

We are now enrolling in the pivotal phase II program focused on the target phase III population of patients aged between 12 and 15 years of age. We are accelerating site openings are on and are on track to reach our goal of approximately 75 recruiting centers across Europe and North America.

Speaker #3: The safety profile of last missile was favorable and similar or lower than observed with other autologous CAR-T therapies. Greater than or equal to grade 3 cytokine release syndrome occurred in 2.5% of patients and greater than or equal to grade 3 ICANS occurred in 5% of patients at the recommended phase two dose.

As Andre highlighted we expect to complete the first interim analysis occupations in Q4 2026.

Speaker #3: The full Phase One data has been submitted for presentation at the 2026 European Hematology Association Congress, to be held in Stockholm in June. The Phase One program also addressed two important additional questions.

It will be shared publicly.

To be determined.

I remind you that as previously disclosed the anticipated BLA submission is planned for the second half.

G H.

Speaker #3: The first is whether our internally manufactured product could result in similar or indeed improved efficacy compared to product manufactured by an external CDMO. The second is whether allentuzumab, as part of the preconditioning lymphodepletion regimen, results in superior last missile expansion and therefore efficacy compared to the standard lymphodepletion regimen.

Our second ongoing program investigating our jewel tower assets and T cell target to see 2020 two expressing tumors in third line and beyond non Hodgkin lymphoma.

This highly differentiated product.

Operating cost that.

A much needed alternative congresses.

Jim.

I think you can save one.

The preliminary phase one data presented at Ash 2025, 88% overall response rate and a 63% complete response rate at the current dose samples indicate.

Speaker #3: Validating our decision to internalize our manufacturing capabilities, Cellectis-manufactured product demonstrated meaningfully higher response rates than externally CDMO-manufactured product, with overall response rates of 68% and 28%, respectively.

Evaluable patients.

But the Easter weekend.

These already high response rates to the addition of low dose IL two support.

Additional photos Iot offers the potential to further enhance car T expansion, Jamaica persistence without negatively impacting toxicity.

Speaker #3: Secondly, the data demonstrated that increased allentuzumab exposure correlates with improved response. These data were outlined at the American Society of Hematology Annual Conference in December 2025.

We expect to present, the phase one data sets, including the Iot part results later this year.

Speaker #3: Additional data have also been submitted for presentation at the 2026 European Hematology Association Congress. We are now enrolling in the pivotal Phase 2 program, focused on the target Phase 2 population of patients aged between 12 and 50 years.

Progressed this program to a pivotal phase two in 2027.

Anticipate a BLA submission and age to 2029.

As you can see 2026 caused us to be an exciting year for selective.

Critical milestones milestones and catalysts as we transform into a late stage development organization I look forward to sharing our progress later this year with that I would like to hand, the call over to select us as Chief Financial Officer, and Chief business Officer for Cologuard.

Speaker #3: We are accelerating site opening and are on track to reach our goal of approximately 75 recruiting centers across Europe and North America. As Audrey highlighted, we expect to complete the first interim analysis of 40 patients in Q4 2026.

Financials for the fourth quarter and full year.

Speaker #3: These data will be shared publicly in a forum to be determined. I will remind you that, as previously disclosed, the anticipated BLA submission is planned for the second half of 2028.

In 2025 Arthur opportunities.

Thank you Adrian.

Let me now walk you through our financial position.

I don't want to mention that we have managed our cash with discipline over the past year, focusing our spend on what matters most to them.

Speaker #3: Our second ongoing program, investigating our dual-care asset, Eticel, targets CD20- and CD22-expressing tumors in third-line and beyond non-Hodgkin's lymphoma. This highly differentiated product, offering important and much-needed alternative targets to CD19, continues in Phase 1.

Hello.

And the operation of our end to end manufacturing facilities in Paris and Rami.

We believe our current cash position gives us the financial runway to execute on our pivotal phase two program for Alaska.

In our phase one for Ed to sell and deliver to key readout in Q4 2026. The first interim analysis with 40 patients plasma cell and a full phase one data set for yourselves.

Speaker #3: The preliminary Phase 1 data presented at ASH 2025 showed an 88% overall response rate and a 63% complete response rate at the current dose level in the ACE evaluable patients.

We are well positioned financially to execute on these two trial as our cash cash equivalents and term deposits as of December 31, 2025 remains sufficient to fund our operations into each to 2027.

Speaker #3: Cellectis believes we can further enhance these already high response rates through the addition of low-dose IL-2 support. The addition of low-dose IL-2 offers the potential to further enhance CAR-T expansion, tumor killing, and persistence, without negatively impacting toxicities.

We're also looking forward to the upcoming data readouts for our partner programs.

Because our Serbian 77 in April 2026, and.

Speaker #3: We expect to present the Phase One dataset, including the IL-2 cohort results, later this year. We plan to progress this program to pivotal Phase Two in 2027 and anticipate a BLA submission in H2 2029.

Iot for example, and then finish.

This year as well.

Finally, we are excited that activities are progressing under our strategic collaboration with Astrazeneca, which has positively impacted our 2025 revenue.

Speaker #3: As you can see, 2026 promises to be an exciting year for Cellectis, with a number of critical milestones and catalysts, as we transform into a late-stage development organization.

Our December 31, 2025, our cash cash equivalents restricted cash and fixed term deposits classified as current financial assets amounted to $111 million compared to $264 million as of December 31, 2024.

Speaker #3: I look forward to sharing our progress later this year. With that, I would like to hand the call over to Arthur Stril, Cellectis's Chief Financial Officer and Chief Business Officer, for an overview of our financials for the fourth quarter and full year 2025.

This $53 million decrease is mainly due to $36 $9 million of cash in from revenue $8 4 million of interest received from our financial and cash equivalent investments.

Speaker #3: Arthur, over to you.

Speaker #4: Thank you, Adrian. Let me now walk you through our financial position. As Audrey mentioned, we have managed our cash with discipline over the past year, focusing our spend on what matters most: the development of last missile and Eticel, and the operation of our end-to-end manufacturing facilities in Paris and Raleigh.

Partially offset by cash payments from selected to suppliers of $55 million.

This wages bonuses until it was all expenses paid a $40 million.

Payments at least.

$11 million and the repayment of the $5 $4 million.

Speaker #4: We believe our current cash position gives us the financial runway to execute on our pivotal Phase 2 program for Last Missile and our Phase 1 for Eticel, and deliver two key readouts in Q4 2026.

Are invited to refer to our press release, our figures related to a consolidated net loss attributable to shareholders of select.

For the 12 months ended December 31 2025.

We very much look forward to reach 2026, especially with Serbian allergies readout for <unk> next month, and our two readout philosophy Salon at to sell later this year, we will now turn the call over to the operator for questions.

Speaker #4: The first interim analysis with 40 patients for LASTMILE, and the full Phase 1 dataset for Eticel. We are well-positioned financially to execute on these two trials, as our cash, cash equivalents, and fixed-term deposits as of December 31, 2025, remain sufficient to fund our operations into H2 2027.

Yeah.

Thank you.

If you would like to ask a question. Please press star one on your keypad.

Speaker #4: We are also looking forward to the upcoming data readouts for our partnered programs, in particular Servian Allogene cell missile in April 2026 and Iovance's IOV-4001 this year as well.

Until we get the Q at anytime press Star two.

Once again that is star one to ask a question.

And our first question will come from Amin.

With Jefferies. Please go ahead.

Speaker #4: Finally, we are excited that activities are progressing under our strategic collaboration with AstraZeneca, which has positively impacted our 2025 revenue. As of December 31, 2025, our cash, cash equivalents, restricted cash, and fixed-term deposits classified as current financial assets amounted to $211 million, compared to $264 million as of December 31, 2024.

Thank you for taking our question.

From us.

I think so.

Value once enrollment how is it tracking to India because at all.

When do you expect to complete enrollment for that dose selection portion.

And I have a follow up.

Yeah.

Speaker #4: This $53 million decrease is mainly due to $36.9 million cash in from revenue, $8.4 million of interest received from our financial and cash equivalent investments, partially offset by cash payments from Cellectis to suppliers of $50.5 million, Cellectis wages, bonuses, and social expenses paid of $40 million, the payments of leased debts of $11 million, and the repayment of the PGE loan of $5.4 million.

Yeah, Thanks, and then I can take that.

Currently we're doing very well.

Engaging many sites.

Opening is on track.

We're certainly on track to complete.

Data analysis by the end of the year. So that's just for the other people on the call that the first 40 patients interim analysis and Thats part of the dose optimization phase of the study is looking at two alternative doses of <unk>.

One piece of that which is required by seizure.

So, yes, it's going well.

Speaker #4: You are invited to refer to our press release for figures related to consolidated net loss attributable to shareholders of Cellectis for the 12-month period ended December 31, 2025.

We are on track for Q4 this year.

Thanks.

Hum.

Alright.

Speaker #4: We very much look forward to a rich 2026, especially with Servian Allogene's readouts for Cell Missile next month and our two readouts for Last Missile and Eticel later this year.

In addition portion.

I see.

Not at all.

What are your expectations, there and what difference it should be expect between the two arms.

Speaker #4: We'll now turn the call over to the operator for questions.

Efficacy signal.

Are you thinking.

I think the safety or do you think the two arms.

Speaker #1: Thank you. If you would like to ask a question, please press star one (*) on your keypad. To leave the queue at any time, press star two (*2).

Generally.

<unk>.

We don't.

It's very difficult to say.

Speaker #1: Once again, that is *star one* to ask a question. And our first question will come from Amin Makram with Jefferies. Please go ahead.

Almost required a crystal ball to decide will there be a big difference in terms of both we anticipate however that.

<unk> has designed to very strong analysis plan to allow us to differentiate between the two.

Speaker #5: Okay, thank you for taking our questions. Two from us. First, on the last missile and the Value One enrollment, how is recruitment tracking in the pivotal study?

That will be based on efficacy safety, but also significantly important translation markers in terms of our car T expansion seasonably Constitution et cetera. So we do believe excuse me that we will be.

Speaker #5: And when do you expect to complete enrollment for that dose selection portion? And I have a follow-up.

Able to define an optimized dose.

By the end of the year we.

We don't think that will be a significant challenge. However, we know that both of these doses is in that very important to see the work. It's all of that dose optimization now it's not a bad sign to an effective dose.

Speaker #4: Yeah, thanks, Amin. I can take that. Currently, we're doing very well. We're engaging many sites; site opening is on track. We're certainly on track to complete our data analysis by the end of the year.

That's helpful. Thanks.

Thank you.

Speaker #4: So that's just for the other people on the call. That's the first 40 patients, interim analysis. And that's part of the dose optimization phase of the study.

Our next question will come from solving with.

With Goldman Sachs. Please go ahead.

Okay.

Speaker #4: We're looking at two alternative doses of Alimtuzumab, which is required by CDER. So yes, it's going well, Amin. And we're on track for Q4 data sharing.

So my question.

Two questions from us.

Provide more details on this survey arbitration ruling that you have to engage in discussions with alto regarding the direct licensing.

Speaker #5: Thanks. And for this dose optimization portion, as you evaluate the two Alimtuzumab dose levels, what are the expectations, or what differences should we expect between the two arms in terms of efficacy signal? Or are you expecting a meaningful difference in the safety, or do you think the two arms are going to be generally in the same ballpark?

Help us understand how this impacts your eligibility for that $340 million in Miami.

Into this interim data and then secondly could you talk about your decision to include <unk> reconditioning in both the.

The studies in the context of safety on SBC, sometimes that a competitor is moving away from $2 52. Thank you.

<unk> been with Arthur Thanks for the question I'll take the question on the arbitration and then hand, it over to maintenance with a clinical question.

Speaker #4: We don't—it's very difficult to say. And I almost require a crystal ball to decide: will there be a big difference in terms of both?

So.

So the arbitrage decision in December 2025 ruled on the partial termination of the license agreements with respect to one product switches <unk> also named Allo 501 biology.

Speaker #4: We anticipate, however, that we have designed a very strong analysis plan to allow us to differentiate between the two components. That will be based on efficacy, safety, but also significantly important translational markers in terms of our CAR-T expansion, host T-cell reconstitution, etc.

So the product has been brought back to selective.

Speaker #4: So, we do believe—excuse me—that we will be able to define and optimize dose by the end of the year. We don't think that will be a significant challenge.

<unk>.

People are moving forward.

The tribunal did not.

Or.

Or some itself. So we remained free indivisible.

Speaker #4: However, we know that both of these doses of Alimtuzumab—very importantly—they work. It's all about dose optimization now; it's not about finding an effective dose.

We're up to 40 million in development and sales milestones.

That is obviously under the service agreements, which has sublicense to allergy. So this does not impact <unk>.

Speaker #5: Okay. Helpful. Thanks.

Ability to upcoming developments.

Speaker #1: Thank you. Our next question will come from Salvin Richter with Goldman Sachs. Please go ahead.

Milestone as well as growth down the line.

On some itself but.

He looks back you've got 19 or album fiber one that we're free to do.

Speaker #6: Thank you. We have two questions. First, could you provide more details on the survey arbitration, given the ruling that you have to engage in discussions with Allo regarding the direct licensing of 501?

What we'd like to do with it.

And I will hand, it over to Adrian for the chemical weapons.

One thing I would like to add.

Jonathan.

Our thinking is that flowing through.

Speaker #6: And help us understand how this impacts your eligibility for the $340 million in milestones into this interim data. And then secondly, could you talk about your decision to include CD52 preconditioning in both the studies in the context of safety, as we see some of the competitors moving away from CD52?

Trial is.

Effective and milestones should be trigger so.

Definitely we are expecting.

Okay.

Okay.

Until the MTM ask question its great question.

A few things just a few observations from our studies one is that Adam season that is really important to optimize limitation and as I said earlier.

Speaker #6: Thank you.

Speaker #4: Hi, Salvin. This is Arthur. Thanks for the question. I'll take the question on the arbitration and then hand it over to Adrian for the clinical question.

The more optimal for them for the patients the better the outcomes in terms of response, because you get a much deeper response.

Speaker #4: So just as a reminder, the arbitral decision of December 2025 ruled on a partial termination of the license agreement with respect to one product, which is UCAR-T19 V1, also named Allo 501 by Allogene.

As part of our Phase one program, we did test.

And then for depletion regimen without as Alemtuzumab, and we sales getting any <unk>.

<unk> 40 negative responses. So we know that item to something that was very effective.

The second part as you were saying some people are moving away from it now.

Speaker #4: So, this product has been brought back to Cellectis, and we are free to develop it or move forward. The tribunal did not affect ALLO-501A or Cell Missile.

We we believe as I've said already Alemtuzumab is important but we also believe that is critically important that you get the right dose.

It is.

Everything too much is always too much. So we have compared to other companies that are using alemtuzumab or alemtuzumab. Similarly, we're using a much lower dose. We've spent a lot of time already optimizing our doses. So we believe we've got the right balance between optimal let's say could see mitigate.

Speaker #4: So we remain fully eligible for up to $340 million in development and sales milestones. That is obviously under the Servier agreement, which has then been sub-licensed to Allogene.

Speaker #4: So, this does not impact any eligibility to upcoming development and sales milestones, as well as royalties down the line, on Cell Missile. But it gave us back UCART19, or ALLO-501, and we're free to do whatever we would like to do with it.

The risks that may be associated with that more enhancement of depletion regimen, but also let's not forget that <unk> has been widely used in all the time.

For context, so it's got a very well characterized safety profile that we've been able to build into all of our protocols very extensive risk mitigation.

Speaker #4: And I will hand it over to Adrian for the clinical question.

Speaker #5: One thing I would like to add, like during our thinking, is that once you—like, the pivotal trial is effective, then the milestone should be triggered.

We believe we've got the right strategy with our element to the map.

Canada answer why others may have transitioned away from it.

Speaker #5: So we're definitely expecting to have this $20 million milestone update one day.

Thank you.

Our next question will come from Jack Allen with Baird.

Speaker #7: Okay, and I'll answer the Alemtuzumab question. It's a great question. There are a few things—just a few observations from our studies. One is that Alemtuzumab is really important to optimize lymph depletion.

Great. Thanks for taking the questions and congrats to the team on all the progress.

So first of all I wanted to ask was on Etsy.

And how we should think about the update in the fourth quarter. This year.

Speaker #7: And as I said earlier, the more optimal the lymph depletion, the better the outcomes in terms of responses. You get a much deeper response.

Additional color youre willing to provide as it relates to the breadth and the number of patients and the durability of follow up there would be great and then I have a quick follow up as well.

Speaker #7: As part of our phase one program, we did test a lymph depletion regimen without Alemtuzumab. And we failed to get any MRD-negative responses.

Hi.

Top line update on top of.

The data we already have that says we've shared already at our current dose level, we are seeing a 66.

Speaker #7: So, we know that Alemtuzumab is very effective. The second part is, you were saying some people are moving away from it. Now, we believe, as I've said already, Alemtuzumab is important, but we also believe that it's critically important that you get the right dose.

63% complete remission rates, 88% overall response rates.

By the end of the year, you will see data in cohort with him was that IL two.

Now we would acknowledge that 63% complete remission rate is actually a very strong result.

Speaker #7: It's like everything—too much is always too much. So, we have, compared to other companies that are using Alemtuzumab or Alemtuzumab similars, we're using a much lower dose.

Theoretically we do not need to enhance that further we want to we believe we can with the addition of low dose IL two so by the end of the year you will see.

Speaker #7: We spent a lot of time already optimizing our doses. So we believe we've got the right balance between optimal efficacy, mitigating the risks that may be associated with that more enhanced lymph depletion regimen, but also, let's not forget that Alimtuzumab has been widely used in other clinical contexts.

We're currently expanded at a recruiting sites.

Rather significantly we've doubled them so.

Anticipate we will be able to get a reasonable and I cannot give you a.

A number because I don't know what the recruitment rates are going to be but.

We will be towards the latter part of the year also nausea, the staggering phase. So we would anticipate a significant increase and improvement you will see.

Speaker #7: So, it's got a very well-characterized safety profile. And we've been able to build into all our protocols very extensive risk mitigation. So, we believe we've got the right strategy with our Alimtuzumab.

Some.

Durability data is what you asked but of course for the patients and the later phase that will hopefully because durability signal we have in our minds. The durability levels, we want to achieve and it's around the six month Mark.

Speaker #7: I cannot answer why others may have transitioned away from it.

But hopefully by the end of the year, you'll be able to see a very clear picture I think the question's already been answered. The question is can we enhance it even further into.

Speaker #1: Thank you. Our next question will come from Jack Allen with Baird.

Speaker #5: Great. Thanks for taking the questions, and congrats to the team on all the progress. I guess the first one I wanted to ask was on Essicel.

The seventies rather than in the mid sixties.

But also it will give us a very good signal as to kind of is Io to really a potential game changer for allogeneic therapy. We obviously based on our preclinical data, which is going to be presented at ACR and again some at.

Speaker #5: And how we should think about the update in the fourth quarter of this year. Any additional color you're willing to provide as it relates to the breadth of the update and number of patients, and the durability of follow-up there, would be great.

Speaker #5: And then, I have a quick follow-up as well.

Yeah.

The debt.

Speaker #4: I can give you a top-line update.

Believe it could offer a really really a fundamental improvements for allogeneic cell therapies.

Great great. Thanks for all that color and then.

Getting ahead of ourselves a little bit here, but on last myself and the commercial opportunity I was wondering if you've been looking at our capital from <unk> and do you have any thoughts around the initial commercial launch of that CD 19 auto.

Therapy in AML.

I can give us from a medical perspective, maybe you want to talk a bit more broadly on the commercial opportunity.

Let's not forget.

<unk> are generally post CD 19 failures, so we don't know.

We're not seeing this as a as a competition.

We have a very differentiated target CD 22, we believe the market is pretty saturated with CD 19.

Not to say Oh capsule isn't very good product. It is their data is very strong but these patients are very difficult to treat many of them will relapse and they need to have an alternative targets. So we believe.

This is.

Not a competing products, but actually.

Fairly differentiated one in terms of market size.

Where we're starting to look at.

Your lines of therapy.

We will have data starts to be generated next year on that frontline consolidation is very much aligned with what <unk> has done.

He is a fantastic idea in the non Hodgkin's lymphoma in place, we will be looking at that and the <unk> space. So we believe that's a really important product for those incredibly difficult to treat patients compliant.

I can add I think from a commercial launch perspective, you absolutely cannot compare.

This launch two another generic launch and I think the two primary differences is one unique to have Luka <unk> access for the patients and this has slowed it is very competitive and it is controlled by hospitals not by the pharma company.

Adrian Kilcoyne: In our preclinical data, which is going to be presented at AACR and again some at EHA. That we believe it could offer a really a fundamental improvement for allogeneic cell therapies.

Whereas obviously with off the shelf, we will have had manufactured a huge number of doses in advance so that at the time of launch weekend addressed all our clinical centers immediately without having to set up these are cumbersome logistically.

And the second thing obviously because of our off the shelf nature, we have very significant economies of scale and we see it even.

Jack Allen: Great. Thanks for all that color. We might be getting ahead of ourselves a little bit here, but on UCART22 and the commercial opportunity, I was wondering if you've been looking at Aucatzyl from Novartis, and if you have any thoughts around the initial commercial launch of that CD19 auto therapy in ALL.

Pivotal stage, which will allow us to get extremely competitive gross margin and gross margin, which was much more the types of what pharma is now used to with small molecule.

Whereas.

Pricing.

It'd be difficult because of the significant cost of goods that make a very important impact on the margin. So I think the fact that we are off the shelf will allow us for a much smoother loans in terms of pure access due to the off the shelf nature.

Adrian Kilcoyne: I can give it from a medical perspective, and Arthur, maybe you want to talk a bit more broadly on the commercial opportunity. Let's not forget our patients are generally post CD19 failures. We are not seeing this as a competition. We have a very differentiated target, CD22. We believe the market is pretty saturated with CD19s. It's not to say Olcapixo isn't a very good product. It is. Their data is very strong, but these patients are very difficult to treat. Many of them will relapse, and they need to have an alternative target. We believe that this is not a competing product, but actually a very differentiated one. In terms of market size, you may be aware we're starting to look at earlier lines of therapy.

And also a much more economically competitive aspect.

Economic of scale at the very favorable gross margin. So I don't think that there will be a very good comparison.

Great.

To add.

One thing that was interesting I was recently visiting a clinical center, we're working with.

As a quick email was Adrian.

And.

There was one patient.

<unk>.

Kidding.

And the backlog waiting for and available after raises part since.

Adrian Kilcoyne: We will have data starting to be generated next year on that frontline consolidation, very much aligned with what Allogene has done, which we think is a fantastic idea in the non-Hodgkin's lymphoma space. We will be looking at that in the ALL space. We believe that's a really important part for those incredibly difficult to treat patients frontline.

Long time.

He'd English.

Uh huh.

And I'll hop skin lymphoma, that'll be CLO patients in multiple myeloma patients immune patient et cetera.

And this patient.

That was very aggressive disease, and still does because I'm not going to see which type of product. It was about a <unk> 10, because I don't know, but the fact is that this patient was like in real distressed waiting for this like F raise a spot and this is what you would consider.

Arthur Stril: I can add, I think from a commercial launch perspective, you absolutely cannot compare an autologous launch to an allogeneic launch. I think the two primary differences is, one, you need to have leukapheresis access for the patients, and this is slow, this is very competitive, and this is controlled by hospitals, not by the pharma company. Whereas obviously with off-the-shelf, we will have had manufactured a huge number of doses in advance so that at the time of launch, we can address all our clinical centers immediately without having to set up these cumbersome logistics aspect.

Um, not a competing product, but actually a very differentiated one, in terms of market size. Um, you may be aware, we're starting to look at, um, earlier lines of therapy. Uh, we will have data starting to be generated next year on that frontline consolidation, very much aligned with what Allogene has done, um, which we think is a fantastic idea in the non-Hodgkin's lymphoma space. We will be looking at that in the ALL space, so we believe that's a really important part for those incredibly difficult to treat patients from frontline.

The Pollo this launch of yet another CD 19 car autologous car T.

Got it. Thanks, so much that's very helpful color.

Thank you.

Our next question will come from Seldon Clarke with citizens. Please go ahead.

Hey, good morning, and thank you for taking my questions I just wanted to ask if you could just give us a brief recap of what you're expecting.

Arthur Stril: The second thing, obviously, is because of our off-the-shelf nature, we have very significant economies of scale, and we see it even at the pivotal stage, which will allow us to get extremely competitive gross margins, which was much more the types of what pharma is now used to with small molecules and antibodies. Whereas, pricing of autologous has been difficult, because of the significant cost of goods that make a very important impact on the margin. I think the fact that we're off-the-shelf will allow us for a much smoother launch in terms of patient access due to the off-the-shelf nature, and also in a much more economically competitive aspect, due to the economies of scale and the very favorable gross margins.

From these two.

Through our program through your phone growing is it mainly longer follow up. Thank you so much.

So you will be aware that we see.

We shared our days at our R&D day back in October.

I can add, I think from a commercial launch perspective. You absolutely cannot compare August launched to analog launch. And I think the 2 primary differences is 1, you need to have a look at thesis access for the patients and this is slow. This is very competitive and this is controlled by hospitals. Not by the, the, the Pharma company. Whereas obviously with other shelf, we will have had manufactured a huge number of doses in advance. So that at the time of launch, we can address all our clinical centers immediately without having to set up these cumbersome Logistics, uh, aspects. And the second thing obviously, is because of our off-the-shelf nature. Uh, we have very significant economies of scale and we see it even at the at the pivotal stage uh which will allow us to get extremely uh competitive gross. Margins and gross margin which was much more. Uh, the types of what Pharma is now used to with small molecules.

We after that actually added some more patients in because we wanted to do some level of dose optimization in advance of our phase II program, we wants to ensure that that lower dose as an acceptable dose to get to patients. So they're going to be an updated dataset the whole data set including <unk>.

Arthur Stril: I don't think Aucatzyl will be a very good comparator there.

Those additional patients. So it is I would consider it.

Jack Allen: Great.

All the nonsense because of the significant cost of goods that make a very important impact on the margin. So I think the fact that we're off the shelf will allow for a much smoother launch in terms of pure access due to the aftershock nature. Uh, and also in a much more, um, economically competitive aspect due to the economies of scale and the very favorable gross margins. So, I—I don't think, okay, though, will be a very good comparison there.

Progression so.

André Choulika: One thing I'd like to add, Jack, like one thing that was interesting, I was like recently visiting a clinical center we're working with for acute lymphoblastic leukemia with Adrian. There was one ALL patient that was sitting in the backlog waiting for an available apheresis spot for a long time, waiting with, you know, non-Hodgkin's lymphoma, DLBCL patient, multiple myeloma patient, autoimmune patient, et cetera. This patient like ALL is a very aggressive disease, and still to this day, I'm not gonna say which type of product was about to be given to him because I don't know. The fact is that this patient was like in real distress waiting for this like apheresis spot, and this is what you would consider as a autologous launch of yet another CD19 CAR-T, autologous CAR-T.

The.

The original phase one package that we presented the data are not remarkably different let me tell you, but it's an important addition to the data.

The second thing that you we hope.

Great, I’d like to add, Jack. Like, one thing. That was interesting. I, I was recently visiting a clinical center working with, for a treatment for blastic leukemia with Adrian.

Assuming that it will be accepted is really to try and understand what makes a products.

And, uh, there was one AIRL patient that was sitting.

Successful.

Again.

Build on the question from Goldman Sachs colleagues, whether we're talking about Alemtuzumab is the importance is that pre conditioning and that days zero.

In the backlog, waiting for an available spot since.

A long time.

Is that only from a level of depletion, but actually the environment in which you infuse yourselves is critically important and in many ways predicted the outcome and the fact that we have now identified a really clear picture of optimal interpretation optimal environment, which you infuse yourselves, we are now able to predict.

Eating with, you know, not have skin lymphoma, the LBL patient, multiple myeloma patient, or two immune patients, etc.

Early on are patients going to respond. So all of these data will be shared so I think we're excited by it so far.

And, uh, this patient, like, it's like all is very aggressive disease and it's still this stage. I'm not going to say which type of product it was about to be given to him because I don't know. But the fact is that this patient was, like, in real distress waiting for this, like, apheresis spot, and this is what you would consider as the top.

Team.

Thank you.

Jack Allen: Got it. Thanks so much. That's very helpful color.

Thank you. Our next question will come from Sebastian Vandergrift with CLK. Please go ahead.

Thanks so much. It's very helpful.

Operator: Thank you. Our next question will come from Sylvain Turcan with Citizens. Please go ahead.

Thank you.

Hi, guys. Good morning, and thanks for taking our question some of the offshore Youre looking at the possibility of applying an in patient procedure in the outpatient setting as well.

Sylvain Turcan: Yeah, good morning, and thank you for taking my questions. I just wanted to ask if you could just give us a brief recap of what you're expecting at EHA from these two programs that you have ongoing. Is it mainly longer follow-up? Thank you so much.

Our next question will come from Sven Turken with Citizens. Please go ahead.

Virginia car T. And then maybe can you provide some insights on how the partnership with all of the things that is growing and we would expect any updates in the next 24 months. Thank you.

Adrian Kilcoyne: You will be aware that we shared our data at our R&D day back in October. We, after that, actually added some more patients in because we wanted to do some level of dose optimization in advance of our phase 2 program. We wanted to ensure that that lower dose is an acceptable dose to give to patients. There is going to be an updated data set, the whole data set, including those additional patients. It is a level of progression from the original phase 1 package that we presented. The data are not remarkably different, let me tell you, but it's an important addition to the data.

Yeah.

I can take the first part of that Arthur in terms of outpatient setting right now that the regulatory authorities require inpatient delivery of product.

And I think that's consistent with most of autologous therapies as well as the car T space and once there becomes some clinics confidence in how to use will that transition into the outpatient setting I think thats, maybe a natural transition but for that you need a body of evidence. So hopefully that will be provided not only by the phase II program, but also by.

Clinical usage.

But again I think it's a very different offering them that's too high at this point, we do not lead that leukapheresis et cetera. So I do think it will take some time for this to be in the outpatient setting.

Adrian Kilcoyne: The second thing that we hope, we're assuming that it will be accepted, is really to try and understand what makes a product successful. Again, to build on the question from our Goldman Sachs colleagues. Whether we're talking about alemtuzumab, is the importance of that preconditioning and that day zero, not only from a level of lymph depletion, but actually the environment in which you infuse your cells is critically important and in many ways predicts the outcome. The fact that we have now identified a really clear picture of optimal lymph depletion, optimal environment in which you infuse your cells, we are now able to predict very early on are patients going to respond. All these data will be shared. I think, we're excited by it so far.

So you will be aware that we, um, we shared our data at our R&D day back in October. Um, we, after that, actually added some more patients in because we wanted to do some level of dose optimization in advance of our Phase 2 program. We want to ensure that that lower dose is an acceptable dose to, to, to get to patients. So there's going to be an updated data set—the whole data set, including those additional patients. So it is, I would consider it, a level of progression. So from the, um, the original Phase 1 package that we, uh, presented—the data are not remarkably different, let me tell you, but it's an important addition to the data.

But.

Assuming that we continue to have a fairly reassuring safety profile.

There's no real reason why that this cannot in time transition to the outpatient setting.

The second thing that we, we hope, that we're assuming that, uh, it will be accepted, is really to try and understand what makes a product, um, successful.

And I will take the question on Astrazeneca. So first of all we're extremely pleased to account astrazeneca as a strategic partner.

And again, to build on the question from our Goldman Sachs colleagues, whether we're talking about ALLO-715, is the importance of that preconditioning and that Day Zero.

You have seen that they have continued to invest very heavily in the LNG and therapy space and they're one of the few companies that are betting very hard not only on LNG in therapy, but also on the off the shelf treatments and I think we're very fortunate to have them as a key shareholder, but also strategic R&D partner.

The activities are going very well under the collaboration there is a number of activities ongoing across a range of therapeutic area.

Arthur Stril: Thank you.

Not only from a level of limited depletion, but actually, the environment in which you infuse your cells is critically important. And in many ways, it predicts the outcome, and the fact that we have now identified a really clear picture of optimal input of pollution, optimal environment in which you infuse your cells. We are now able to predict very early on, are patients going to respond. So all these data will be shared, so I think, uh, we're excited by it so far.

Thank you.

Operator: Thank you. Our next question will come from Sebastiaan van der Schoot with Kempen & Co. Please go ahead.

Do not expect updates in the short term. This is at the request of Astrazeneca.

Thank you. Our next question will come from Sebastian Vanderschoot with VLK. Please go ahead.

Sebastiaan van der Schoot: Hi, guys. Good morning, and thanks for taking our question. I wanted to ask you how you're looking at the possibility of applying your lymphodepletion procedure in the outpatient setting as well as the allogeneic CAR T. Maybe can you provide some insight on how the partnership with AstraZeneca is going? Can we expect any updates in the next 24 months? Thank you.

Essentially asking us for novel stayed reasonably quiet.

Actually given the competitive nature of certain aspects that we are working on.

But definitely as we continue the dialogue with them around disclosure as and when the time is right, we will be providing update and I think it will be of.

Interested in that.

What would be growing with them.

Hi guys, good morning. Thanks for taking our questions. So I wanted to ask you how you're looking at the possibility of applying your lymphodepletion procedure in the outpatient setting, as well as the EMO-CART-T, and then maybe can you provide some insight on how the partnership with Australia is going? Can we expect any updates in the next 24 months? Thank you.

Adrian Kilcoyne: I can take the first part of that, Arthur. In terms of outpatient setting. Right now, the regulatory authorities require inpatient delivery of product. I think that's consistent with most autologous therapies as well in the CAR T space. Once there becomes some clinical confidence in how to use, will that transition into the outpatient setting? I think that may be a natural transition, but for that you need a body of evidence. Hopefully that will be provided not only by the phase 2 program, but also by clinical usage from that. Again, I think it's a very different offering in that, to Arthur's point, we do not need that leukapheresis, et cetera.

Great. Thank you guys.

Thank you.

Once again to ask a question that is star one on your telephone keypad.

Our next question will come from Ian <unk> with Wells Fargo.

Oh, great. Thanks for taking our questions.

So first regarding the <unk>.

I'll ask me sell a pivotal study was wondering for the full Q readout.

I I can take the first part of that Arthur, um, in terms of outpatient setting right now, the regulation authorities uh require uh inpatient delivery of product. And I think that's consistent with most autologous therapies as well in the carti space. And once there becomes some clinical confidence in how to use, will that transition into the outpatient setting? I think that may be a natural transition.

Is the focus there the three months CR Cri from the two.

Arms.

In that first 40 patient cohort.

Adrian Kilcoyne: I do think it'll take some time for this to be in the outpatient setting, but, you know, assuming that we continue to have a fairly reassuring safety profile, there's no real reason why this cannot, in time, transition to the outpatient setting.

And then how do you manage the transition from completing that cohort two the start.

But for that, you need a body of evidence, so hopefully that will be provided not only by the Phase 2 program, but also by, uh, clinical usage from that. But again, I think it's a very different offering, and that to our—at this point, we do not lead that, Lucifer, etc. So I do think it'll take some time for this to be in the outpatient setting.

The enrollment of the 80 patient portion for the optimal Alan children that those.

I E.

But, you know, assuming that we continue to have a fairly reassuring safety profile, there's no real reason why this cannot, in time, transition to the outpatient setting.

The final pivotal cohort.

Arthur Stril: I will take the question on AstraZeneca. So first of all, we're extremely pleased to count AstraZeneca as a strategic partner. As you have seen, they have continued to invest very heavily in the cell and gene therapy space. They're one of the few companies that are betting very hard, not only on cell and gene therapy, but also on the off-the-shelf treatments. I think we're very fortunate to have them as a key shareholder, but also a strategic R&D partner. The activities are going very well under the collaboration. There's a number of activities ongoing across a range of therapeutic area. Do not expect updates in the short term. This is at the request of AstraZeneca.

Will you be able to start enrolling before you have the data for the comparison of the two attitudes about the cohorts.

Yes, and then I have a follow up thanks.

Great some great questions there.

First and foremost no we did see a decision for dose optimization is not based on the three months and Cri, It's actually based in an area of time cut off of the eight weeks and that's important and.

We will still be looking at efficacy safety, but all the important translation remark is predictive of not only short term, but long term outcomes.

We presented by that first eight weeks. So it's a composite of many of those that we will be presenting.

Arthur Stril: They are essentially asking us for now to stay reasonably quiet, especially given the competitive nature of certain aspects that we are working on. Definitely, as we continue to dialogue with them around disclosure, as and when the time is right, we will be providing update, and I think you will be interested in seeing what has been brewing with them.

In terms of that transition from that to the longer phase of the study we have built a lot of flexibility into the protocol to allow us to continue recruiting. So importantly, this does not mean or does he has to stop wildwood way in engaging with the regulatory authorities.

And I will take the, the question on ASA. So first of all, we're, uh, extremely pleased to count as president president as a strategic partner. Uh, as you have seen that, they have continued to invest very heavily in the cell and gene therapy space. And they're 1 of the few companies that are betting very hard, not only on Cell engine therapy, uh, but also on the off-the-shelf treatments. Um, and I think we're, uh, very fortunate to have them as a key shareholder, but also a strategic R&D partner. Uh, the activities are going very well under the collaboration. There's a number of, um, activities ongoing across a range of uh, therapeutic area. Uh, do not expect updates in the short term. This is uh, at the request of Astro to stay uh reasonably quiet uh especially given the competitive nature.

Recruitment will continue.

Further the remaining 80 patients.

Of certain aspects that we are working on, uh, but definitely as we continue the dialogue with them around disclosure, as and when the time is right, uh, we will be providing an update and I think you will be, uh, interested in, uh, seeing what has been brewing, uh, with them.

Sebastiaan van der Schoot: Great. Thank you, guys.

Great Thanks for that.

Great. Thank you guys.

Operator: Thank you. Once again, to ask a question, that is star one on your telephone keypad. Our next question will come from Yanan Zhu with Wells Fargo.

Very helpful color.

As a follow up is mainly on the competitive landscape in terms of additional modalities.

Ask a question that is star 1 on your telephone keypad.

In vivo car T.

Basically.

Yanan Zhu: Oh, great. Thanks for taking our questions. First, regarding the last AMELI-01 pivotal study. Was wondering for the Q4 readout, is the focus there the three-month CR-CRI from the two arms in that first 40-patient cohort? Then how do you manage the transition from completing that cohort to the start of the enrollment of the 80-patient portion for the optimal alemtuzumab dose, i.e., the final pivotal cohort? Will you be able to start enrolling before you have the data for the comparison of the two alemtuzumab cohorts? Yeah, then I have a follow-up. Thanks.

Our next question will come from Yin Anzo with Wells Fargo.

Can you talk about the.

Advantages or limitations for that without a T or whether you have any interest in moving in that direction.

Uh, last meal, uh, pivotal study was wondering for the Q4 readout.

That's already.

Stage effort. Thanks.

Okay.

I can have an initial.

Thoughts on this.

And I think I know what that Andre and Arthur also have views on the positioning them in vivo car.

Yeah.

No.

We're looking at incredibly sick patients with incredibly aggressive disease that need them.

A lot of therapy, we don't believe it's very difficult to treat tumors will be the destination for people because we think it will be of a car certainly has a place.

But will it be the right therapy for incredibly difficult to treat tumors and incredibly difficult to manage patients. We don't believe so.

Um, is the focus there. The 3 month Crescent. CRI from the 2, uh, uh arms. Um, in that first 40 patient cohort. Um, and then how do you manage the transition from uh completing that cohort to the start of the enrollment of the uh 80 patient portion for the optimal element to them those uh uh IE the the the final uh, pivotal cohort. Uh, will you be able to start enrolling before you have the the data for the comparison of the 2 attitudes map cohorts?

So yes, there will be in vivo car.

Adrian Kilcoyne: Great. This is some great questions there. First and foremost, no. The decision for dose optimization is not based on the three-month CR-CRI. It's actually based at an earlier time cutoff of eight weeks. That's important. We will still be looking at efficacy, safety, but all the important translational markers predictive of not only short-term but long-term outcomes. We have those answers by that first eight weeks. It's a composite of many of those that we will be presenting. In terms of that transition from that to the longer phase of the study, we have built a lot of flexibility into the protocol to allow us to continue recruiting. Importantly, this does not mean our study has to stop while we're engaging with the regulatory authorities.

Um, uh, yeah. And then I have a follow-up. Thanks.

And some may be autoimmune, maybe a bedroom a destination, but any therapy that requires extensive gene editing and extensive patient management will probably maybe it will be a bridge too far for in vivo car.

Andre you have a view on this as well.

I think their protocols that can keep a car is similar to autologous car T. The only thing it allows us to essentially try to.

And the leapfrog apparatus.

Great to have some great questions there. Uh, first and foremost, know we do—the decision for those optimizations is not based on the 3 months, CRI; it's actually based at an earlier time cut-off of 8 weeks, uh, and that's important. Um, we will still be looking at efficacy, safety, but all the important translational markers predictive of not only short-term but long-term outcomes. Uh, we have those answers by that first 8 weeks. So it's the composite of many of those that we will be presenting.

Which was a great thing its like its a huge market access.

It's given here.

Nevertheless.

It will still be totally linked.

Fitness of the cells of the patients.

Adrian Kilcoyne: The recruitment will continue for the remaining Asian patients.

Their presence.

In terms of that transition, from that to the longer phase of the study, we have built a lot of flexibility into the protocol to allow us to continue recruiting. So, importantly, this does not mean our study has to stop while we're waiting, engaging with the regulatory authorities. Uh, the recruitment will continue.

So if it doesn't respond to Blaine.

Um, for the remaining 80 patients.

Yanan Zhu: Great. Thanks for those very, very helpful color. The follow-up is mainly on the competitive landscape in terms of additional modalities, in vivo CAR T, specifically. Can you talk about the advantages or limitations for that modality or whether you have any interest in moving in that direction, at early stage efforts? Thanks.

As you can do and apologize.

Then you go for four.

For an in vivo well if the cells are not really very well functional it's going to work and more because you need the T cells to be that's one point.

Second point is it will also be very much related to the current malignancies with our treated patients essentially liquid tumors b cell malignancies or.

Aluminum.

Bug.

Great. Uh, thanks for those very, very helpful color. Um, and the follow-up is mainly on the competitive landscape in terms of additional modalities, um, in vivo CAR-T, uh, specifically. Um, can you talk about the, uh, advantages or limitations for that modality or whether you have any interest, uh, in, uh, moving in that direction, uh, at early, uh, stage efforts? Thanks.

Write offs in solid tumor is going to be different and finally do you like there is a lot of papers are coming out with like a lot of sellers are transducer.

Adrian Kilcoyne: I can have an initial thoughts on this. I think I know that André and Arthur also have views on the positioning of in vivo CAR. You know, we're looking at incredibly sick patients with incredibly aggressive disease that need a lot of therapy. We don't believe these very difficult to treat tumors will be the destination for in vivo CAR. We think in vivo CAR certainly have a place, but will it be the right therapy for incredibly difficult to treat tumors and incredibly difficult to manage patients? We don't believe so. Yes, there will be in vivo CAR in some, maybe autoimmune may be a better destination, but any therapy that requires extensive gene editing and extensive patient management will probably be a bridge too far for in vivo CAR.

<unk>.

T cell select can lead to restrict the time, but I think these technologies are going to come into the coming future.

I I can have an initial, um, thoughts on this. Um, and I think, um, I know that Andrea and Arthur also have views on the the positioning of the Google car.

You know.

Trying to restrict itself to what needs to be produced by the in vivo car T.

Want to go and deliver for example, our senior VP recently that shows more.

Sector inside for example hit back.

I think cells expressing car.

T cells so.

If you do this worldwide like really broadband.

Three questions at a time and also like the genome is only $6 4 billion base pairs.

Oh It was like 23, two times chromosomes issue.

Trillions and trillions.

Adrian Kilcoyne: I know, André, you have a view on this as well.

Factors in.

We're looking at incredibly sick, patients with incredibly aggressive disease that need. Um, a lot of therapy, we don't believe these very difficult to treat. Tumors will be the, the destination for Viva car. We think of Viva car. Certainly have a place but will it uh, be the right therapy for incredibly difficult to treat tumors and Incredibly difficult to manage patients? We don't believe so. So, yes, there will be in Vivo tar in, in some maybe autoimmune may be a better, uh, destination. But any therapy that requires extensive Gene editing and extensive patient management will probably maybe it will be a bridge too far for in Vivo car. And I know Andre you have a view on this as well.

André Choulika: I think their process like in vivo CAR is similar to autologous CAR T. The only thing it allows, it's essentially try to, you know, leapfrog apheresis, which is a great thing. It's like it's a huge, market access option that is given here. Nevertheless, it'll still be totally linked to the fitness of the cells of the patient or their presence. If it doesn't respond to Blincyto, if you can't do an autologous, then you go for an in vivo. Well, if the cells are not really very well functional, it's not gonna work anymore because you need the T-cells to be fit. That's one point. The second point is, it'll also be very much related to the current malignancies that are treated, which is essentially liquid tumors, B-cell malignancies, or multiple myeloma.

Hundreds of patients like salaries of patients.

It's like I hope that this will be safely integrated if you go where for example, with a colleague a scar tissue can matter exactly when to sell dark transduce. If you go for an allogeneic car.

I think the approach of, like, in vivo CAR is similar to a Talus Carti. The only thing it allows is, essentially, you try to

An elite frog apheresis.

Of all the QC, that's last long period of time to ensure that everything is fully square.

Which is a great thing. It's like it's a huge, uh, market access option that is given here.

Um,

If you make the product in vivo, which is the case here.

nevertheless, uh,

And you have to master how the product is made in not too.

I have a lot of byproducts all around the place, but that's like the initial concern to them.

It will still be totally linked to the fitness of the cells of the patient, or their presence.

Sure that this will be solved in coming decades.

Great. Thanks for all the insights and congrats on the quarter.

So if it doesn't respond to Blina, if you can't do an autologous—

Thank you.

Thank you.

And at this time there are no further questions in the queue. So I'll turn the meeting back over to our speakers for any additional or closing remarks.

Then you go for, uh, for an in vivo. Well, if the cells are not really very well functional, it's not going to work anymore because you need the T cells to be fit. That's one point.

Yeah.

But very much to everyone really appreciate all the questions here as you can see this will be a very exciting year 2026, with a number of updates from our partners and from ourselves.

The second point is, uh, it will also be very much related to the current malignancies that are treated, which is essentially liquid tumors, the cell malignancies, or multiple myeloma.

André Choulika: The spread of this into solid tumor is gonna be different. Finally, like, there's a lot of papers that are coming out, like a lot of cells are transduced by these vectors that are not these cells. Like you need to restrict at the time, but I think these technologies are gonna come in the coming future, to try to restrict the cells to what it needs to be transduced by the in vivo CAR T and not to go and deliver. For example, I've seen a paper recently that shows more vector inside, for example, hepatic cells expressing CAR and then in T-cells. If you do this worldwide, like really broad band, then big questions at a time. Also like the genome is only 6.4 billion base pairs, like 23, two times chromosomes.

uh,

I think we are poised for a new dawn of allogeneic car T cell therapy, so stay tuned for more updates and looking forward to further discussions a S.

Our progress in solstice, yes, thank you very much.

Thank you this brings us to the end of today's meeting we appreciate your time and participation you may now disconnect.

Uh, to try to restrict the cells to what this needs to be—transduced by the in vivo CART, and not to go and deliver, for example. I've seen a paper recently that shows more...

Vector inside, for example, hepatic cells expressing CAR, and then in T cells. So,

André Choulika: If you inject trillions and trillions of vectors in hundreds of patients or thousands of patients, it's like I hope that this will be safely integrated. If you go, for example, with a autologous CAR T, you can master exactly when the cells are transduced. If you go for an allogeneic CAR, you have all the QC that lasts a long period of time to ensure that everything is totally square. If you make the product in vivo, which is the case here, then you have to master how the product is made and not to have a lot of byproducts all around the place. That's like the initial concern, but I'm sure that this will be solved in coming decade.

If you do this worldwide, like really broadband, then the questions at the time, and also, like, the genome is only 6.4 billion base pairs—uh, like 23 (2 times) chromosomes—if you inject trillions and trillions of, uh, vectors in,

Hundreds of patients, like thousands of patients.

It's like I hope that this will be safely integrated if you go, or for example, with a mythologist, you can master exactly what the cells are transduced. If you go for an allogeneic CAR, you have all the QC that lasts a long period of time to ensure that everything is totally square.

If you make the product in vivo, which is the case here, then you have to master how the product is made and not to

Have a lot of byproducts all around the place. So that's the initial concern, but I'm sure that this will be solved in the coming decade.

Yanan Zhu: Great. Thanks for all the insights, and congrats on the quarter.

Great, thanks for all the insights and congrats on the quarter.

André Choulika: Thank you.

Operator: Thank you. At this time, there are no further questions in the queue, so I'll turn the meeting back over to our speakers for any additional or closing remarks.

Thank you.

Thank you.

And at this time, there are no further questions in the queue, so I'll turn the meeting back over to our speakers for any additional or closing remarks.

Arthur Stril: Very much everyone, really appreciate all the questions here. As you can see, this will be a very exciting year, 2026 with a number of updates from our partners and from ourselves. I think we are poised for a new dawn of allogeneic CAR T-cell therapy. Stay tuned for more updates and looking forward to further discussions as our progress unfolds this year. Thank you very much.

Thank you very much, everyone. Uh, really appreciate all the questions here. Uh, as you can see, this will be a very, uh, exciting year—2026—with a number of updates from our partners and from ourselves. Uh, and I think we are poised for, uh, a new dawn of allogeneic CAR-T cell therapy. So stay tuned for more updates, and looking forward to further discussions, uh, as our progress unfolds this year. Thank you very much.

Operator: Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

Adrian Kilcoyne: Hey, good job. We were,

Hey, good job.

we were a