Cellectis Q1 2024 Earnings Report

Cellectis EPS Results

• Actual EPS: -$0.15
• Consensus EPS: N/A
• Beat/Miss: N/A
• One Year Ago EPS: N/A

Cellectis Revenue Results

• Actual Revenue: $6.50 million
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Cellectis Announcement Details

• Quarter: Q1 2024
• Date: 5/28/2024
• Time: N/A
• Conference Call Date: Wednesday, May 29, 2024
• Conference Call Time: 8:00AM ET

Cellectis (NASDAQ:CLLS) is a clinical‐stage biopharmaceutical company specializing in the development of gene‐edited cell therapies for oncology. Founded in 1999 and headquartered in Paris, France, the company also maintains operations in New York City and Raleigh, North Carolina. Cellectis applies its proprietary TALEN genome editing platform to engineer allogeneic chimeric antigen receptor T‐cell (CAR‐T) candidates designed to target blood cancers and solid tumors.

The company’s core business activities encompass the discovery, development and manufacturing of off‐the‐shelf immunotherapies. Its pipeline includes multiple CAR‐T candidates, such as those targeting CD19 and CD22 antigens for B‐cell malignancies and other programs addressing acute myeloid leukemia. Cellectis advances these investigational therapies through preclinical research and early‐ to mid‐stage clinical trials, often in partnership with leading pharmaceutical firms to enhance development and commercialization capabilities.

Cellectis operates research and process development laboratories as well as GMP manufacturing facilities across Europe and North America. Clinical trials are conducted in premier cancer centers in the United States and Europe, reflecting the company’s global reach. Strategic collaborations and licensing agreements support the expansion of its gene‐edited therapies into new indications and geographic markets, with an emphasis on scalable production and regulatory readiness.

Under the leadership of founder and Chief Executive Officer Dr. André Choulika, Cellectis has established itself as a pioneer in TALEN‐based genome editing. The management team combines scientific and commercial expertise to drive innovation, with a focus on delivering next‐generation allogeneic CAR‐T therapies to patients worldwide.

Cellectis Q1 2024 Earnings Call Transcript

Key Takeaways

• Selectus closed a two‐part strategic collaboration with AstraZeneca, securing an initial $105 M equity investment and a subsequent $140 M round that now gives AstraZeneca ~44% ownership and extends cash runway into 2026.
• First‐quarter results showed a consolidated net income of $5.6 M (versus a $30.1 M loss a year ago) and cash, equivalents and restricted cash of $143 M, bolstered by the AstraZeneca financing.
• The company remains focused on advancing its core clinical programs—ALAE-one (UCART22p2), NATALI-one (UCART20×22) and AMALY-one (UCART123)—while collaborating with AstraZeneca on up to ten new cell and gene therapy targets.
• Early trial data are encouraging: UCART22p2 demonstrated a 67% response rate at 1 M cells/kg with no severe toxicities, and UCART20×22 showed 100% response (3/3 patients) in relapsed/refractory B-cell non-Hodgkin lymphoma.
• Arthur Strel, previously head of business development and portfolio management, was appointed Interim CFO following Bing Wang’s resignation, bringing deep familiarity with Selectus’ programs.

Presentation

[Operator]

Good morning, everyone, and welcome to the Cellectis first quarter 2024 earnings call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. Please be aware that today's conference call is being recorded. I'd now like to turn the conference over to your first speaker, Arthur Stril, Interim Chief Financial Officer. You may begin.

[Arthur Stril, Interim CFO at Cellectis]

Good morning, and welcome everyone to Cellectis's first quarter 2024 corporate update and financial results conference call. Joining me on the call today are Dr. André Choulika, our Chief Executive Officer, and Dr. Mark Frattini, our Chief Medical Officer. Yesterday evening, Cellectis issued a 6-K in a press release, reporting our financial statements for the three-month period ending March 31st, 2024, and a corporate and business update. The report and press release are available on our website at cellectis.com. As a reminder, we will 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.

[Arthur Stril, Interim CFO at Cellectis]

These forward-looking 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. 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 on December 31st, 2023, and subsequent filings Cellectis makes with the SEC from time to time. I would now like to turn the call over to André.

[André Choulika, CEO at Cellectis]

Thank you, Arthur. Good morning, and thank you everyone for joining us today. Last November, we were excited to announce our strategic collaboration and investment agreement with one of the most impressive pharmaceutical company of the past decade, AstraZeneca, to design and shape next generation of cell and gene therapies. In this agreement, AstraZeneca made an initial investment of $105 million to Cellectis, composed of an $80 million equity investment in exchange of 16 million ordinary shares at $5 per share, and a $25 million upfront payment under the Joint Research Collaboration Agreement. This month, we're proud to announce the closing of the additional equity investment of $140 million by AstraZeneca.

[André Choulika, CEO at Cellectis]

As part of the additional investment, AstraZeneca subscribed for 10 million Class A convertible preferred shares and 18 million Class B convertible preferred shares, in each case at a price of $5 per convertible preferred shares. Today, AstraZeneca owns approximately 44% of the share capital of Cellectis and 30% of the voting rights. In addition, the appointment of Mr. Marc Dunoyer and Dr. Tyrell Rivers as members of the board of directors of Cellectis is now effective. Following AstraZeneca's additional investment, we expect our cash runway to fund operations into 2026. Cellectis will continue to focus its efforts and expenses on advancing its core clinical trials, BALLI-01, NATHALI-01, and AMELI-01, our wholly owned assets, while building the next generation of genomic medicine to address areas of high unmet patient needs within our partnership with AstraZeneca and within our proprietary preclinical pipeline.

[André Choulika, CEO at Cellectis]

We strongly believe that gene-edited cell and gene therapies are revolutionizing medicine across a number of therapeutic areas and will become a large part of molecular medicine in the future. This quarter, we have also announced the appointment of Arthur Stril as Interim Chief Financial Officer, following the resignation of Bing Wang. First of all, I would like to warmly thank Bing for the great two years he has been at Cellectis. It has been a huge honor and a pleasure for us all to work alongside with him and wish him great success in his next adventures. Arthur has been managing Cellectis business development and portfolio management teams since 2020, and most recently led the execution of company's strategic collaboration investment agreements with AstraZeneca. Through his past responsibility, Arthur has a deep knowledge and detailed understanding of Cellectis.

[André Choulika, CEO at Cellectis]

He will be of tremendous value to Cellectis as Interim Chief Financial Officer, as we advance our critical pipeline of assets into expansion and pivotal trials and explore new opportunities. With that, I would like to turn the call over to Dr. Mark Frattini, our Chief Medical Officer, who will give an overview of our clinical trials. Mark, please go ahead.

[Mark Frattini, Chief Medical Officer at Cellectis]

Thank you, André. As André mentioned, Cellectis continues to focus its development efforts on the BALLI-01, AMELI-01, and NATHALI-01 studies. Last December, we shared updated clinical data in a poster from our BALLI-01 trial at the American Society of Hematology annual meeting. In vitro comparability study suggested that UCART22 P2, manufactured in-house by Cellectis, is significantly more potent than UCART22 P1, manufactured by an external CDMO. As of July 1st, 2023, three patients were enrolled in the first UCART22 P2 cohort at dose level 2, 1 million cells per kg. UCART22 P2 was administered after fludarabine, cyclophosphamide, and alemtuzumab lymphodepletion, and was well tolerated. No dose-limiting toxicities or immune effector cell-associated neurotoxicity was observed. The cytokine release syndrome observed was limited to grade 1 or 2.

[Mark Frattini, Chief Medical Officer at Cellectis]

There was a higher preliminary response rate of 67% at dose level 2, with 1 million cells per kg using the UCART22 P2, compared to a 50% response rate with a dose 5x higher at dose level 3, 5 million cells per kilogram using UCART22 P1 that was manufactured by an external CDMO. UCART22 expansion was observed in the responding patients and correlated with increases in serum cytokines and inflammatory markers. The study continues to enroll patients using UCART22 P2. I will now speak about our NATHALI-01 study, a phase I/II-A dose-finding and expansion study evaluating UCART20x22 in relapsed/refractory B-cell non-Hodgkin lymphoma. UCART20x22 has been fully manufactured in-house by Cellectis at our Raleigh manufacturing facility.

[Mark Frattini, Chief Medical Officer at Cellectis]

Cellectis presented a poster with the preliminary results from the NATHALI-01 trial at the annual ASH 2023 meeting in December. As of July 1st, 2023, three patients were enrolled and treated at dose level 1, 50 million cells flat dose. Cytokine release syndrome grade 1 or 2 occurred in all patients and resolved with standard of care treatment. No immune effector cell-associated neurotoxicity or graft versus host disease was observed. There were no UCART20x22 dose-limiting toxicities, and there was one dose-limiting toxicity related to Alemtuzumab, a CRS 2. All patients responded at day 28, with one partial metabolic response and two complete metabolic responses in patients who had failed prior autologous CD19 CAR T cell therapies. UCART20x22 expansion correlated with increases in serum cytokine and inflammatory marker levels, as well as with CRS.

[Mark Frattini, Chief Medical Officer at Cellectis]

These initial data, with all three patients responding at the starting dose of 50 million cells per patient, support the continued study of UCART20x22 in relapsed refractory B-cell non-Hodgkin lymphoma. The study continues to enroll. Lastly, I will speak about our AMELI-01 study evaluating UCART123 in patients with relapsed refractory AML. The AMELI-01 study continues to progress and is currently enrolling patients after fludarabine, cyclophosphamide, and alemtuzumab lymphodepletion in a two-dose regimen arm. With that, I would like to hand the call over to Arthur Stril, Cellectis' Interim Chief Financial Officer, for an overview of our finances for the first quarter of 2024. Arthur, please go ahead.

[Arthur Stril, Interim CFO at Cellectis]

Thank you, Mark and André. I'm very excited to step into the role of interim CFO and continue working with Cellectis' team, shareholders, and partners at such an important moment for the company. I would like to highlight that in our financials, the cash, cash equivalents, restricted cash, and fixed term deposits classified as current financial assets as of March 31st, 2024, amount to $143 million, compared to $156 million as of December 31st, 2023. This $13 million decrease is mainly due to cash payments from Cellectis to suppliers of $13 million, including $9 million to R&D suppliers and $4 million to SG&A suppliers.

[Arthur Stril, Interim CFO at Cellectis]

Cellectis' wages, bonuses, and social expenses paid of $15 million, the payments of lease debts of $3 million, and the repayment of the PGE loan of $1 million, partially offset by the $16 million cash received from EIB pursuant to the disbursement of the EUR 15 million tranche B and $2 million of cash in from our financial investments. With cash and cash equivalents of $123 million and a $15 million term deposit maturing in May 2024, classified as a current financial asset as of March 31st, 2024, and taking into account the $140 million equity investment received on May 3rd, 2024 from AstraZeneca pursuant to the subsequent investment agreement, the company believes its cash and cash equivalents will be sufficient to fund its operations into 2026.

[Arthur Stril, Interim CFO at Cellectis]

Therefore, for at least 12 months following the unaudited interim condensed consolidated financial statements publication. The consolidated net income attributable to shareholders of Cellectis was $5.6 million, or a $0.08 income per share for the three months ended March 31st, 2024, compared to a $30.1 million loss, or a $0.58 loss per share for the three months ended March 31st, 2023, of which $27.8 million was attributed to Cellectis continuing operations. This $38.2 million difference was primarily driven by an increase in revenue than other income of $2.9 million, a decrease of $0.7 million in non-cash stock-based compensation expense due to a decrease in the average unit fair value of stock options and free share awards vesting between the two periods.

[Arthur Stril, Interim CFO at Cellectis]

A $30.7 million change from a net financial loss of $4.4 million to a net financial gain of $26.3 million, and a decrease in net operating expense of $0.6 million, and a $2.5 million decrease in net loss from discontinued operations attributable to shareholders of Cellectis, partially offset by an increase of $1.3 million in purchases, external expenses, and an increase of $0.4 million in wages. The consolidated adjusted net income attributable to shareholders of Cellectis was $6.5 million, or $0.09 income per share for the three months ended March 31st, 2024, compared to a net loss of $28.1 million, or $0.55 loss per share for the three months ended March 31st, 2023.

[Arthur Stril, Interim CFO at Cellectis]

We are focusing our spend on developing our clinical candidates, UCART22, UCART20x22, and UCART123, and operating our state-of-the-art cell and gene therapy manufacturing facilities in Paris and Raleigh. Research costs under the AstraZeneca collaboration are funded by AstraZeneca. In addition, our focus on maintaining an efficient corporate infrastructure should also enable more limited growth in G&A spend. And now, I would like to turn the call over to André for closing remarks.

[André Choulika, CEO at Cellectis]

Thank you, Arthur. To close out this call, I would like to reiterate how excited we are about our strategic collaboration with AstraZeneca, and how much confident we are about the continued progress of our three ongoing clinical trials in hematological malignancies, as well as our continued development of our clinical programs. At Cellectis, we strongly believe that our product candidates, our technologies, our in-house manufacturing capabilities will lead us and our partners to a paradigm shift for patients with hard-to-treat cancers, positioning us at the forefront of this promising medical and scientific field. With that, I would like to open the call for Q&A.

[Operator]

Thank you. At this time, we'll be conducting a question-and-answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing, pressing the star keys. Our first question comes from the line of, excuse me, Gena Wang with Barclays. Please proceed with your question.

[Gena Wang, Managing Director of Biotech Equity Research at Barclays]

Thank you for taking my questions. Also want to congrats on the completion of AstraZeneca deal. So now with AstraZeneca on board, so wondering if there are any strategic, you know, change regarding the strategy from a Cellectis perspective, and also how much AstraZeneca can have access to your manufacturing capability and both in New Jersey and in Paris? And lastly, very quickly regarding, you know, the upcoming data, by the year-end 2024, I assume very likely will be at the ASH. Can you give us, you know, the status of the enrollment for both BALLI-01 and NATHALI-01, and what kind of data sets should we expect to see?

[Arthur Stril, Interim CFO at Cellectis]

Great. Thank you so much, Gena. This is, Arthur. I'm going to take the first question on the strategy and the AstraZeneca piece, and then I'll hand it over to Marc for the data updates. So I mean, we're obviously very excited to have completed the subsequent investment and now have AstraZeneca fully on board. I mean, as you have seen from their recent disclosures, they're betting very hard and very long-term on cell and gene therapy. And having them as a strong partner across a number of indications, not just oncology, but also immunology and rare diseases, is gonna be very important. So the strategy on our wholly owned asset has not changed.

[Arthur Stril, Interim CFO at Cellectis]

We're still pushing UCART22, UCART20x22, and UCART123 very hard, and Marc will give you an update on where we stand. Obviously, the big change is we are going to be doing these novel programs with them across a wide range of indications in the cell and gene therapy space. We also have a new strategic shareholder that is strongly invested in the space and that has this long-term vision which we're very excited to have. Regarding your question on manufacturing, so as you know, under the collaboration, we're gonna do up to 10 cell and gene therapy programs together. The agreement allows for the possibility for AstraZeneca to leverage our manufacturing

[Arthur Stril, Interim CFO at Cellectis]

capabilities, both the starting materials, but also the final cells, that we have in Raleigh, for Cellectis to be manufacturing these programs. So that's definitely one of the driver of the interest of AstraZeneca. And maybe I'll hand it over to Marc for the data updates.

[Mark Frattini, Chief Medical Officer at Cellectis]

Hi, Gena, it's Mark. Thanks for the, thanks for the questions. I think, as you know, our last disclosure for data was at ASH last year in December. We have continued to enroll, obviously, on both of these studies you asked about, UCART22 and UCART20x22. We expect to have data disclosure at the end of the year this year for both of these studies. Regarding UCART22, ideally, we will be completing the expansion part of the UCART22 study this year. So we'll move ahead from that. And for UCART20x22, we continue enrollment and expansion, and actually, hopefully, we'll be in the same place near completion of the escalation phase by the end of this year.

[Gena Wang, Managing Director of Biotech Equity Research at Barclays]

Thank you.

[Operator]

Thank you. Our next question comes from the line of Kelly Shi with Jefferies. Please proceed with your question.

[Dev Prasad, VP of Biotech Equity Research at Jefferies]

Hi. Congrats on the progress, and thanks for taking our question. This is Dev on for Kelly Shi. So on UCART20x22, can you add some color how many sites are active right now? And will you be able to identify RP2D by year-end? And if you are enrolling three patients per dose level, should we expect around 10-12 patient data by year-end? Thank you.

[Arthur Stril, Interim CFO at Cellectis]

Mark?

[Mark Frattini, Chief Medical Officer at Cellectis]

Hi, thanks for the question. So obviously, I can't go into a lot of details about all the sites, but I can tell you that we have sites open in the U.S. and in the EU, both in France and Spain, currently enrolling on this study. Regarding the progress with UCART20x22, we continue to enroll in the escalation phase, and we hope to be completed with the escalation by the end of this year. So to your point, in terms of you know, we would hope that at that time there would be RP2D declared as we open the expansion part of the study.

[Dev Prasad, VP of Biotech Equity Research at Jefferies]

Thank you.

[Operator]

Thank you. Our next question comes from the line of Salveen Richter with Goldman Sachs. Please proceed with your question.

[Analyst at Goldman Sachs]

Hi, this is Lydia on for Salveen. Thanks so much for taking our question. Can you provide any further granularity on the cadence of readouts across the programs this year and what your expectations are for the respective datasets? Thanks so much.

[Arthur Stril, Interim CFO at Cellectis]

Hi, Lydia. Thank you so much for the question. That's definitely one for Mark.

[Mark Frattini, Chief Medical Officer at Cellectis]

Hi, thanks. So yeah, as you just heard, from the prior two, so for UCART22 and UCART20x22. For UCART22, we will be completing escalation and we will discuss the data results later this year. For UCART20x22, again, we are also continuing enrollment in the escalation, with the aims of completing escalation and discussing that at the end of this year as well. And for the UCART123 study, I think, as you know, we, we reverted to a new treatment paradigm, where we're giving actually two doses of the cells for AML, since it's a highly aggressive, highly proliferative disease. And so we continue to enroll in this two-dose regimen part of the cohort, and when we have sufficient data, we will be disclosing that as well.

[Mark Frattini, Chief Medical Officer at Cellectis]

But it continues to actively enroll, currently.

[Analyst at Goldman Sachs]

Thanks so much.

[Operator]

Thank you. Our next question comes from the line of Jack Allen with Baird. Please proceed with your question.

[Jack Allen, Senior Research Analyst at Baird]

Great. Thanks so much for taking the questions, and congratulations on the progress. The first one was on AstraZeneca. I was hoping you could provide some color as to where things sit as it relates to the collaborative work you're doing with the large pharma here, and when we might expect to hear the first program announced. Then I was also hoping you could talk a little bit about how you're thinking about potential plans and autoimmune indications. And then finally, if I may, I wanted to ask about what the expectations are for the year-end updates from BALLI-01 and NATHALI-01, as it relates to durability. How are you thinking about the bar for success in those studies with the allogeneic platform here?

[Arthur Stril, Interim CFO at Cellectis]

Hey, Jack, this is Arthur. Thank you so much for the questions. I'll take the one on AstraZeneca. So the work has definitely kicked out in full gear. There's a ton of discussion and interactions at all levels within the AstraZeneca and Alexion teams. So as you know, there was already an initial amount of work that had been done on pre-selecting, because AstraZeneca preselected 25 targets. So we're starting from a shorter list. And there's a lot of discussion ongoing on selecting the first program and getting them into gear. So we're very excited, and obviously, there's a ton of connectivity between the research teams at all levels.

[Arthur Stril, Interim CFO at Cellectis]

And we're looking forward to be providing updates as to the first programs when that makes sense. And I think there's a question on the data for Mark.

[Jack Allen, Senior Research Analyst at Baird]

Yeah, I was just wondering if Mark had any thoughts on how we should think about durability and what the bar for durability should be as we look towards the year-end 2024 updates and these responses, hopefully?

[Mark Frattini, Chief Medical Officer at Cellectis]

Yeah, thanks, Jack. So, yeah, as you know, we're, you know, we will discuss, you know, completion of, escalation for UCART22 and, continued enrollment and complete completion of escalation for UCART20x22 as well. I think as standalone, products in the disease space, I think, you know, the bars, I think are, you know, are pretty well set. You know, particularly in terms of what the regulatory agencies would want to see, and particularly in like the relapsed refractory ALL space, you know, there would be a three-month, a CR within three months, timeframe is what, is what, the agencies would be looking for. And I think for UCART20x22 in the NHL space, we're looking at something closer to 6 months.

[Arthur Stril, Interim CFO at Cellectis]

And, Jack, this-

[Jack Allen, Senior Research Analyst at Baird]

Thanks so much.

[Arthur Stril, Interim CFO at Cellectis]

Jack, this is Arthur again. Sorry, I didn't mean to skim your question on autoimmune. So this is, I mean, definitely an interesting space that we're monitoring very carefully, and we're looking at the development in that space. It's also a space where we think the allogeneic value proposition is gonna be absolutely critical, given the size and potential scope of the market opportunity. We want to address it in a smart and thoughtful way. So we're definitely looking into this and monitoring the space. And again, we'll update when it makes sense. Thanks for the question.

[Jack Allen, Senior Research Analyst at Baird]

Thank you.

[Operator]

Thank you. Our next question comes from the line of Luísa Morgado with Van Lanschot Kempen. Please proceed with your question.

[Luísa Morgado, Equity Research Analyst at Van Lanschot Kempen]

Hi, team. First of all, indeed, congrats on the completion of the investment from AstraZeneca. I think most of my questions have been answered so far, but I do have one. In terms of the partner programs, could you just give a brief overview on what we should be on the lookout, let's say, throughout this year? What would you highlight on that side?

[Arthur Stril, Interim CFO at Cellectis]

Thank you, Luísa, for the question. I mean, we talked about AstraZeneca at length. I think I can reiterate the guidance that Allogene has provided on the anti-CD19 and anti-CD70 programs, and obviously would direct to them for future updates. I think the first one is they announced that the startup activities for the ALPHA-3 trial, which will be cema-cel, so previously ALLO-501A, in first-line consolidation, are ongoing, and they're planning a study initiation in the middle of this year. And they also have an ongoing enrollment in the relapsed refractory CLL cohort for the phase 1 ALPHA-2 trial, also of cema-cel. So that's gonna be interesting to see how cema-cel moves forward.

[Arthur Stril, Interim CFO at Cellectis]

And they also announced that they're planning by year-end a phase I data update of the Traverse trial, which is ALLO-316, the anti-CD70, in renal cell carcinoma. So we're also looking forward to this.

[Luísa Morgado, Equity Research Analyst at Van Lanschot Kempen]

Okay, that's all for me. Thank you so much.

[Operator]

Thank you. Our next question comes from the line of Yigal Nochomovitz with Citi. Please proceed with your question.

[Analyst at Citi]

Hi, this is Amin on for Yigal. Thank you for taking our questions. We had a couple. First, on dose expansion strategy, do you see a scenario that the dose expansion studies could convert to registrational studies? And if so, what would be the timeline look like? And then the second, I wanted to know, what do you think the target population would be for a registrational trial? Is that gonna be something like a relapsed refractory following the CD19 treatment?

[Arthur Stril, Interim CFO at Cellectis]

Hi, thank you so much. I think these are two great questions, definitely for Mark. Mark, we can't hear you.

[Mark Frattini, Chief Medical Officer at Cellectis]

Sorry. Pardon me, I was on mute. Thank you for the, thank you for the question. So I think in terms of the expansion, part of the study, yes, indeed, these could potentially be pivotal expansions at this level. As you know, however, this in terms of number of patients and timeline, et cetera. It will require some additional discussions with the regulatory authorities in order to nail this down. So these are things that are actively being discussed at this time. I think in terms of your other question, in terms of target populations, I think particularly in both disease spaces, I think for UCART22, we're talking about relapsed refractory ALL, as you know.

[Mark Frattini, Chief Medical Officer at Cellectis]

These will include patients who have received prior CD19-directed CAR T cell therapy, or patients, for whatever reason, could not be eligible to receive prior CD19 CAR T cell therapy. And a similar situation in terms of the relapsed refractory Non-Hodgkin lymphoma space as well.

[Analyst at Citi]

Okay, got it. Great. Thanks very much for taking our questions.

[Operator]

Thank you. Our next question comes from the line of Yanan Zhu with Wells Fargo. Please proceed with your question.

[Kuan-Hung Lin, Associate of Biotechnology Equity Research at Wells Fargo Securities]

Hi, thanks for taking our question. This is Kuan-Hung for Yana. So two questions from us. First of all, UCART22 and UCART20x22, can you remind us what dose level has been planned for the studies? And are you planning to also explore fixed dosing for UCART22? And the second question is, any colors on the safety data from the patients beyond ASH update for these two studies? Thank you.

[Arthur Stril, Interim CFO at Cellectis]

Great, thank you so much for the two questions, also for Mark.

[Mark Frattini, Chief Medical Officer at Cellectis]

Yes, thank you for the question. So, in terms of the dose level, I mean, what, you know, what we've disclosed to date is that, originally for UCART22, we were at 1 million cells per kilo at dose level 2. And for UCART20x22, we were at 50 million cells flat dose. Obviously, we have been escalating those since the last data disclosure, and we will update later this year in terms of where we're landing in terms of dose levels for both of these studies. I missed the one question you asked, something about dosing with UCART22. I missed that. Can you repeat that, please?

[Kuan-Hung Lin, Associate of Biotechnology Equity Research at Wells Fargo Securities]

Yes, sure. Just curious if you are also planning to explore fixed dosing for UCART22?

[Mark Frattini, Chief Medical Officer at Cellectis]

No. For UCART22, for UCART22, we're going to keep a weight-based dosing, obviously, because of the great age criteria in terms of this study from the very young to the very old. So we will, we will, like most all studies in the ALL space, continue with a weight-based dosing for UCART22.

[Kuan-Hung Lin, Associate of Biotechnology Equity Research at Wells Fargo Securities]

Got it. And any colors on the safety data from patients beyond the ASH update? Thank you.

[Mark Frattini, Chief Medical Officer at Cellectis]

Yeah. So, so far we have not disclosed. We will later this year. As you know, so far, both products were very safe and well-tolerated, with no DLTs related to the cells, and no graft versus host disease, and no ICANS, and the CRS limited to grade 1 and 2.

[Kuan-Hung Lin, Associate of Biotechnology Equity Research at Wells Fargo Securities]

Got it. Thank you for all the colors.

[Operator]

Thank you. Our next question comes from the line of Hartaj Singh with Oppenheimer. Please proceed with your question.

[Analyst at Oppenheimer]

Hey, everyone. Thanks for taking the question. This is Fianna, for Hartaj. We have questions for UCART20x22. So, as we talked before, it seems like half of, of this program have a great potential in EU market because, like, less competition there. So can you elaborate to talk about that? Thanks.

[Arthur Stril, Interim CFO at Cellectis]

Thank you so much for the thoughtful question. I'll leave it to Mark.

[Mark Frattini, Chief Medical Officer at Cellectis]

Yeah, thank you. So yeah, as you point out, there is, you know, just based on the slot availability for autologous, CAR T cell therapy in the EU, it is, much less than the U.S. So, there is, you know, there is a need for this, in the EU, you know, as well, obviously. And so we, have opened up, as we... As I said earlier, we have sites in France and sites in Spain that are currently open, and we are obviously, will be looking to open other, other countries as well.

[Analyst at Oppenheimer]

Got it. Thank you.

[Operator]

Thank you. Ladies and gentlemen, that concludes our question and answer session. I'll turn the floor back to Mr. Choulika for any final comments.

[André Choulika, CEO at Cellectis]

Thank you very much, everyone, for your time. It was really appreciated to have all these question and enthusiasm, and we're really excited by 2024 and what's going to happen in the coming years after 2025, 2026. I think the company is within a year where things are meaningfully changing on the shape of the company. And, I'll give you a, a rendezvous for the next time, and, I think that we'll share more of, the execution inside the company. Thank you very much, and wish you a good day.

[Operator]

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

Participants

Executives

• André Choulika, CEO
• Arthur Stril, Interim CFO
• Mark Frattini, Chief Medical Officer

Analysts

• Dev Prasad, VP of Biotech Equity Research at Jefferies
• Gena Wang, Managing Director of Biotech Equity Research at Barclays
• Jack Allen, Senior Research Analyst at Baird
• Kuan-Hung Lin, Associate of Biotechnology Equity Research at Wells Fargo Securities
• Luísa Morgado, Equity Research Analyst at Van Lanschot Kempen
• Analyst at Citi
• Analyst at Goldman Sachs
• Analyst at Oppenheimer