Q2 2025 Cellectis SA Earnigs Call
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Good day, everyone and welcome to today's selective. Second quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode.
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It is now my pleasure to turn the conference over to Arthur stril interim Chief Financial Officer. Please go ahead.
Good morning and welcome, everyone, to Cellectis. This is the second quarter 2025 business update and financial results conference call.
Joining me on the call today. Are Dr. Andre sheikah our chief executive officer and Dr. Adrian kilcoin our chief medical officer.
Yesterday evening. Select this issued a 6K and press release reporting our financial statements. For the 6-month. Period ended June 30th 2025 and a business update. The report and press release are available on our website at selective.com
As a reminder, we will make statements regarding select this financial Outlook including the presentation of our bio 1 and Natalie. 01 clinical trials the timing and ability to progress our clinical trial into a later phase.
The progress of our R&D activities under the Astro partnership, the timing and outcome of our arbitration with servier and sufficiency of cash to fund operations.
These forward statements which are based on our Management's, current expectations and assumptions. And an information currently available to management including information provided or otherwise publicly reported by our licensed Partners. Our subjects to risk and uncertainty that may cause actual results to differ from those forecasted.
A description of these risks can be found in our most recent form 20f filed with the security Exchange Commission, SEC, and the financial reports, including the management report for the year ended on December, 31st 2024 and subsequent filing select this makes for the SEC from time to time.
I would now like to turn the call over to Andre.
Thank you, Arthur.
Good morning, and thank you, everyone, for joining us today.
I'd like to begin this call with an important announcement.
On October the 16th 2025 select, this will be hosting an Investor's R&D day in New York City.
Our leadership team along with key opinion, leaders will present The Phase 1 data set and late stage development strategy. For last May sell your car t22 in relapse or refractory acute and for plastic leukemia
And we'll share insights on the company's vision and differentiated capabilities.
Select this investors R&D day is scheduled as an in-person only event. However, the recording of the event will be made available in the following days after the event.
Despite the challenges of the bitec markets.
Our teams have remained focused on advancing research and developing solutions for patient with unmet medical needs.
In July, 2025.
Select this completed end of phase. 1 discussion with both the United States Food and Drug Administration and the European medicine agency.
We're excited to prepare for the initiation of a pivotal Phase 2 trial for Lesnar cell.
Your carti 22 in relapsed or refractory acute. Lymphoblastic leukemia in the second half of this year.
Regarding the Natalie. 01 study, which is assessing ettus. Sell product your carti 20 by 22.
In relax or refractory not hot Kendall lymphoma.
Late 2025.
On the partnership front.
Research and development activities are ongoing under the 3 selling gene therapy programs. Under our joint research and collaboration agreement with Astra zenica.
1 allergenic carti for melanies 1 allergenic carti for solid tumors.
And 1 in vivo gene therapy for a genetic disorder.
Regarding our licensing agreement.
Involving survey and sublicity allergies.
And following surveys decision in September 2022 to seize the development of the licensed cd19 products.
With initiated an arbitration before the Paris mediation and arbitration Center to protect our interests.
We're asking the tribunals to terminate their agreement.
With survey and to award Fair, compensation, for the losses incurred, due to the lack of development of the licensed products, and the payment of the M, which we consider due under their agreement.
The arbitral decision is expected to be rendered on. December the 15th 2025, or before,
Earlier this quarter select, this announced that during its annual shareholders meeting.
Mr. Andre Mueller.
Has been appointed as a member of the company's board of directors.
I'm pleased to welcome Andre at select this board.
His extensive experience.
Will be an invaluable asset to the company.
We would also like to express our gratitude to Mr. Pierre bastid and Mr. Axle Sven malcolms. Who have terminated the directorship?
For their esteemed commitment to select this.
It has been a huge honor and a pleasure.
For us all to work with them during their term.
Their contribution. Over the past years has been exceptional, and their precious support has greatly contributed to the advancement of the company's strategy.
With that, I'd like to turn the call over to Dr. Adrian kilcoin our chief medical officer, who will give an overview of her clinical trials.
Adrian, please go ahead.
Thank you, Andre.
As Andre mentions, Selectis continues to focus its development efforts on the Balogh 1 and Natalie O1 studies.
Recruitment to the dose escalation component of the Phase 1 Bali or 1 Study, which is evaluating UCAR-22 in relapsed refractory B-cell acute lymphoblastic leukemia, has been completed.
This study addresses an important unmet need for patients who have relapsed following multiple prior lines of therapy, including a CD19 bispecific or a T cell engager CAR-T and a few, if any, other treatment options.
The Phase 1 data set has been shared with both FDA and dma as part of the interface 1 and scientific advice meetings.
Following productive interactions with both agencies. We now have a clear path to commence. Our pivotal Phase 2 study later this year,
We have set up additional trial sites in order to accelerate a cruel into the phase 2 study, and will continue to focus on expanding sites in United States and Europe, including the United Kingdom.
We anticipate having sites open for recruitment into our Phase 2, study by the end of the year.
We are also planning to publicly share the full Phase 1 dose escalation data set during our R&D day as highlighted by Andre earlier.
Additional data from The Phase 1 Study has also been submitted for consideration of presentation at the Ashe annual conference in the fourth quarter.
We also continue to enroll in the National 1, study of our dual tarty asset, ucart 2022 in the last refractory Non-Hodgkins Lymphoma
this study is addressing an important unmet needs who for patients who have relapsed following previous lines of therapy including when available an autologous, cd19 Clark t.
Data from this program has also been submitted for presentation at the ASH Animal Conference in the fourth quarter. We are expanding our clinical trial size to accelerate recruitment, and we hope to transition to Phase 2 preparation in 2026.
business officer for an overview of our financials for the second quarter 2025
Arthur, please go ahead.
Thank you, Adrian.
We're pleased about the progress of our wholly owned product candidates last meal and etel as well as of the 3H with Astro.
In this context, we are excited to be hosting an R&D day on October 16th on the phase 1 data set and late stage development strategy of last cell as we prepare to launch a pivotal Phase 2 in H2 2025.
We also expect to provide an update on Etsy sell by the end of the year.
Finally, the arbitral decision in our arbitration will serve. Why is expected to be rendered on or before December 15th 2025?
Importantly we are well positioned financially to execute on our pipeline as our cash cash equivalents and fixed term deposits, as of June 30th, 2025 remain, sufficient to fund our operations into H2 2027.
our cash cash, equivalents restricted cash and fixed term deposits classified as current and non-current, financial assets, as of June 30th, 2025 amount to 230 million, compared to 264 million as of December, 31st 2024,
Is 33.2 million, decrease is mainly due to 13.4 million of cash in from our revenue and 5.1 million of interest income offset by cash payments, from selected to suppliers of 23.2 million, select this is Wages. Bonuses, and social expenses paid of 23.6 million, the payments of lease debts of 5.4 million, and the repayment of the PGE loan of 2.6 million,
You are invited to refer to a press release for figures related to the consolidated net loss attributable to shareholders of Sylectus for the 6 months ended June 30, 2025.
We're very much looking forward to welcoming you at our Investor R&D Day as well as providing further updates later this year.
And now I would like to turn the call over to Andre for closing remarks.
Thank you. Arthur to close out this call. I would like to reiterate how excited we are to have 1 of our first product, moving into phase 2, pivotal trial, powered registration.
And confident about the continued progress of our ongoing clinical trials.
In hematological, malignancies, as well as how excited we are about our strategic collaboration with Astra zenica.
At sylectus.
We strongly believe that our product candidates our Technologies and our in-house. Manufacturing capabilities will lead us and our partners to paradigm shift for patients with hard to treat cancer and genetic disorders positioning us.
The Forefront of this promising medical and scientific field.
With that, I'd like to open the call for Q&A.
Thank you at this time. If you would like to ask a question, please press *1 on your telephone keypad.
You may remove yourself from the Queue at any time by pressing star 2.
Once again, that is star 1 to ask a question. We will pause for just a moment to allow questions to queue.
Thank you. Our first question will come from Jina Hwang with Barclays. Your line is open.
Thank you for taking my questions and congrats on the progress. So I have a 2 questions. 1 is regarding the survey. Your arbitration decision, uh, by December, uh, 15th, could you contextualize the different scenarios and your likely actions?
Um, the second question is regarding the, uh, last Miss sell, um, you already met with the both FDA and the EMA, uh, regarding the pivotal Phase 2 trial design. Uh, could you share a little bit high level Thoughts with us? Uh, what could be the path forward there?
Well, hi Gina. This is Andre speaking. Um I would I would like to answer the first question.
uh, it's a it's complicated to answer your question for the simple reason that
uh,
I guess that probably, there is still thinking on the
Way that things are going to go. And I don't want to draw here any kind of scenario knowing that any kind of scenario can happen.
I personally hoped that we were going to Prevail in this, uh,
In the in the arbitration it means that we're going to get back. Our cd19 uh prologues and uh that we're going to have
the uh the compensation for like the loss incurred by the nand development by survey. However it's very difficult to forecast exactly what could be the decision at the end in these type of arbitration. So I'd like to keep the door open as much as possible.
Uh, for any kind of scenarios. But we believe that we're totally right in the our position knowing that uh, there's nothing has been happening so far, but
the question mark on, if I start like putting some scenario, it means like
You know, I already thought about the fact that you can have some back position but we don't have any back position.
And for the questions regarding the interaction with the FDA and the EMA, I would like to defer this to Adrian.
Adrian: Yes, thanks Andre. Yeah, great question. Yes, we've interacted with both EMA and FDA, and just in the spirit of transparency, the EMA, um, it was a written feedback. They felt our submission was clear, and therefore they could give us very clear guidance on that, and, uh, very productive feedback that...
Was the FDA, was a face-to-face meeting. And um, while I can go into the details, but certainly at the R&D day in on October the 16th we will share a lot more detail around the study design Etc. But a few top-level take homes. Is we got clear agreement on endpoints. We had, um, there was no concerns raised around our statistical plan. Uh, there was no issues raised about the size of the database. We would have as we go to bla with the based on, um, what we had submitted. So overall, in our view there is a very clear path forward uh, for our Phase 2 program. So, again, I'd reiterate very productive meetings with both regulatory authorities who are generally aligned in their feedback, which is always uh, a bonus. I feel
Thank you.
Thank you, our next.
Our next question comes from Kelly, shei with Jeffrey's, your line is open.
Um, hi. This is Angie, you um, behalf of Kelly shei from Jeffrey's, thank you for taking our questions. Um, as I have 2 questions, um, for the R&D day, what data points should we expect? And um, um, supposing, uh, we uh, don't have, uh, the the trial design at this point. You will disclose on the R&D.
Day, then how do you consider the, um, dynamics in the FDA that could, um, potentially have any impacts on the, uh, pivotal trials? Thank you.
Good morning. This is Arthur. I will start on the R&D day and then let Adrien uh add any points uh and also on the FDA question. Uh, so the purpose of the R&D day is really twofold. Uh we won't be presenting the full uh Phase 1 data set for last Mel, that will include uh all patients that have been doing those so far. And a particular focus on the patients at the recommended Phase 2. Those uh, and that will be safety efficacy and durability, uh, data sets. Uh, and the second point is we want to present what we call the late stage development strategy, uh, which indeed will include the phase 2 design the patient population, uh, and then provide some color on the path to bla. So it will be both a look into the past at all. The phase 1, uh, set. But also look into the future as to the plans for the product, all the way to to commercialization. Uh, and then I'll hand it over to Adrian. If you want to add any color and and address the FDA question,
Yeah, I mean, I think.
Any um, significant roadblocks. So, um, again alignment between ourselves and the regulatory authorities, we, and again as Arthur said, we will be presenting the study design in detail.
And discussing through those end points. But, um, I I think again,
I would, I would restate that the registration path for this product seems relatively clear, and of course everything is dependent on ultimately safety data.
Great. Thank you.
Thank you. Our next question.
From Jack Allen with beard, your line is open.
Great. Uh, thanks so much for taking the questions. Thank you. Congratulations on the progress. Um, I guess, maybe I'll start with 1 on ukar, 22, and the upcoming R&D day. Uh, I wanted to ask, what, how the team is thinking about the bar for success in relation to factory, Alo? I know there's some data about best to knows out there and also some a cd19 cartes. But, as we move forward to pivotal study, uh, what, what are you looking at is the bar for success? And what kind of expectations do you have for durability of response? Um, from ukar 22 and how much follow-ups we expect?
Uh, on page, 1 patients. When we get that data update in the, in the back half of this year and then I guess in mid October, um, I have a quick follow-up as well.
Thanks uh Jack for the great questions. Uh, Adrian, do you want to take this?
Sure. Um, so there, there's many questions in there. Um, suffice to say, again, more detail on the endpoints, the timing of that, those endpoints, um, will be shared in detail, during the October 16th R&D day. Um, but I'm, you know, durability of response in the allergenic setting is really important and, um, on sharing the data with both regulatory authorities, they're very clear on the approach. We're taking will give you the adequate data. In order to support a registration, assuming the data is positive based on our, um, what we're showing of course this is, uh, also there will be a longer term follow-up. And all these, you know, we're committed to a 15-year follow-up for these patients, but also within the trial we have, uh, we will have a longer, um,
Uh survival. Uh, it's a long overall survival follow-up for a number of years, so uh but that is not part of the primary analysis. So the primary analysis as we will share is a much more short-term uh, surrogate endpoint which again has been agreed with the regulatory authorities.
No, it's very helpful and then maybe for injuring again, as as, as he as he sees fit, I'd love to hear any high level thoughts. You have on the the recent decision by allergy to move, away from the cd52 lipid depletion. How are you thinking about that as it relates to your programs moving forward? And you anticipate including um choosing labs in a potential pivotal study of your card, 22.
Well, I can start on that. Um, Arthur Stril. Um, yeah, we've been following the allergy story very closely. We believe that Alum is really important as part of the limited depletion regimen, and we want to be really cautious in how we interpret our approach in the context of allergies. I want to stress that these are very different positionings of the products. We're talking very late stage in AL, and we're talking very late stage in HL, compared to the allergy approaches, which are much earlier.
While we and we also don't know very much around the pharmaceutical, kinetics of the aloe product, um, but it, it appears to be in a much higher dose than we give within our clinical trials. Um, and of course, the third thing, which is really, really important. Um, is that everything we do is based on risk benefits. So the risk benefit assessments within the allergy in, um, program is very different to the risk benefit assessment. We see in our
Programs. Um, so all in all very difficult, I think it would be unfair to draw any comparisons between these programs. Uh, we, uh, are fairly confident about our risk benefit assessment across our programs with Alamos and map and we believe that our ads are critical um, Improvement in in responses uh, which we uh, we're fairly confident in our approach moving forward.
A few years back. So we know we have access to actual and do zumab, uh, alloc 647 is a different product and honestly, uh, we're not exactly aware of as to how it Compares. What are the glycol patterns? What are the, what is the structure of the, uh, the antibody? Uh, and so it's very difficult to compare apples to oranges. Uh, and we're very pleased to be moving forward with with actual anism map.
Great, thank you so much. I guess we just made one last one on the topic.
Um, any high level thoughts on on ways you can mitigate uh, potential infection risk in your study. I know the CDC is doing for the pushing can lead to a a longer depletion of uh T cells. Um, have you have you given any further thought on protocols? You can put in place to mitigate.
Infection risk.
Yeah. I mean, it's part of all our trials. We have a mandatory prophylaxis. Um, so that's already built in. We have significant risk mitigation strategies already built into our our trials. So, yeah. I I think we've already addressed much of that, but of course we remain vigilant.
Great. Thank you so much for taking the questions. Congratulations, again on the program.
Thank you. Our next question.
Our next question comes from yanan zoo with Wells. Fargo Securities your line is now open.
Oh great. Uh, thanks for taking our questions. Um, just uh, maybe a follow-up on the FDA, uh, discussion for, uh, the uh, Bal uh program wondering. Um, I know you you will provide more details, uh, at the R&D day, um, wondering if the uh, population for the pivotal trial is that, um, uh, specific population like post cd19 carti or is that a more, uh, broader population and also, in terms of the patient number, could we look to the most recent cd19, um, uh, autologous, carti programs for b, a l l, uh, for the rough range or could the trial be smaller than that. Thanks.
Yeah, good. Good questions.
Excuse me. So as as you're probably aware, we're looking at a very late stage, um, treatment. So but we're going for a fairly broad patient population in terms of age cut off. And again, we'll share the details. Um, with that. We would anticipate there will be a significant number of lines of therapy for most patients that are clinical trial. And that will include obviously cd19 cars, Etc. So you'll see uh, detailed breakdown of this at the R&D day. So it encourages you to, uh, to come along
In terms of the number of patients, I think the the number of patients in our trial is driven by 2 things 1 is the powering of our trials and the 2 is the requirement of the safety database, which often takes precedence. So, I think you're a suggestion that looking at other autologous, cd19 cars in this space will give you while not entirely accurate. It'll give you a a ballpark as to what kind of numbers we need to have in these kind of Trials. And it's driven by the size of a safety database rather than the assumed, uh, statistical power.
Great. That's super helpful. And then, uh, as a follow-up for the survey a uh, program, um, arbitration discussion. I was just wondering, could you give us a a sense of the uh size of the Milestone Milestone payments? Uh, that potentially
Actually, uh, could be awarded, um, at that point. Thank you.
Yeah, thanks. So you're not unfortunately as this is an ongoing, uh, legal matter. We're not going to be able to give more details on this, sorry.
No problem. Thanks for taking the questions, and congrats on the progress.
Thank you so much.
Thank you. Our next question will come from Sebastian Vander. Scoot with Campton, your line is open.
Hi.
Might.
Be uh another conversation with the FDA after uh, after these findings from LG. And then I follow up
Thanks Sebastian. Uh Adrian, you want to take this 1?
Sebastian, I just want to make sure I've understood the question. Could you just repeat it?
Sure. So, uh, it comes down to whether you expect that, uh, this decision from LG, which came after your, uh, conversation with the regulator, can still influence the, uh, design of the digital study, uh, with the use of the anti-CD52 antibody.
No, we honestly, we don't believe. So again, we have an established, um, safety profile, and an established risk benefit assessment as Arthur already stated. This is the allergy in product is different. Um, and even you know, if we assume they, maybe even similar are dosing levels are significantly lower than we see with the allergy in product. And and again
The regulatory authorities have reviewed our full interface 1 package including detailed look at the safety profiles so I don't see that they'll be. I I we don't foresee any changes. Um, ba based on what we've seen with allergy
Got it, thank you. Very clear. And then maybe regarding the cash funding, cash position.
Um, could you indicate whether that incorporates the entire completion of the pivotal study for lesmi cell,
Yeah, great question. So the cash Runway into H2 2027, uh, does include, um, uh, pivotal studies actually, um, we've made assumptions, both for last missile and for atis sell. So, all the costs are are fully loaded in that front. Uh, We've also been very prudent, uh, as we've always done on cash in uh, from milestones and, and, and non-diluted funding. So this 1 have been a probabil, uh, so there is potential for upside there. Uh, if they do materialize, uh, and we will provide the full detailed timelines, uh, of the phase 2 at the, at the R&D day. But to answer your question, yes, the runway does include, uh, the pivotal studies,
Great. And then maybe the last 1 is its on the data set for 80 sell by year ends. Can you just give some color on, um, the size of that say data set, will it be similar in patient size? I understand that there will not be enough follow up, but
In terms of patient size will be similar to the last missile disclosure back in October.
Yeah, I I'll take that Arthur. So um obviously um
Lakshmi is a much more it's early candidate with much more patience within the phase 1 program than Eddie cell. So you will be anticipating, uh smaller patient numbers uh and again we will um you'll see based on our submissions to uh she'll see much more of that data then.
Great, thank you so much.
Thank you. Our next question will come from Salim Richer with Goldman Sachs. Your line is open.
Hey, good morning. This is Mark on for salvian. Thank you so much for taking our question and congrats on the quarter. I have a, I guess a follow-up on Eddie cell. Um, there's a lot of news from August dual targeting cities recently. Uh, and I just, what are your thoughts? How do you view that data? Is there any read through to Eddie cell? Uh, and sort of beyond the allergenic? Atlas sort of difference, how do you think? Uh, Eddie saw his differentiated in the Dual targeting space. Thanks.
Yeah, it it's a it's a great question. Um we believe we've got a very well, differentiated product with ATL, we believe our positioning is very clear. It's a later line, diffuse large, B cell lymphoma almost likely certainly within the non Hotchkins Lymphoma space. We think our and again when
You see what's presented to dash. It'll it'll be uh assuming it's accepted. You'll see a clear strategy which I think differentiates the product significantly from the current batch of autologous products. So I can't really say much more until um, we uh, you see what we will be. Hopefully presenting at Ash
1920 or 1922 are going to be the approved autologous, 19 and potentially, some of the uh, the aloine team. Uh, I think we're at a cell is pretty unique, uh, to our knowledge at this stage, is that it is a 20 and 22. Uh, and so it will be particularly relevant uh to Physicians who have hit 19 once uh, and will then belong to or twice and will want to to alternate the targets, I think the other important thing to remember is, uh, right now, 19 is firmly entrenched in the second line. This is primarily. Yes. Carta and bonzy. Uh, if allergy and is successful, uh, with this first line consolidation approach uh to which, by the way we have a vested interest in, there is uh a potential for 19 to come already up to the first line a consolidation and then there will be a very very strong need uh to hit orthogonal targets. So coming at it with the north, the Shelf alternative that does not require an additional round of fluke, eresus harvesting of the patient's slots, Etc.
Etc. So, pure off-the-shelf alternative that does not Target 19. Uh, I think, uh, in our universe of of NHL and LDL is pretty differentiated and unique,
That is that? Thank you.
Thank you. It appears, we have no further questions at this time. I'll now like to turn the program back over to our presenters for any additional or closing remarks.
Well, we would like to thank you all and we definitely uh, there is a very, uh, Rich second half this year for select this so please stay tuned and we hope that you will be all at our R&D event R&D Day event on October the 16th and probably wait to what's going to happen for select this by the end of the year. So a lot of like, Rich event things that will come up. Thank you very much for your attention.
And have a good day.
thank you, ladies and gentlemen, this concludes
you may now disconnect