Cellectis Q3 2024 Earnings Call Transcript

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November 5, 2024

There are 12 speakers on the call.

Operator

Good morning, everyone, and welcome to the Celletics Third Quarter 2024 Earnings Call. At this time, all participants are in a listen only mode. You may begin.

Speaker 1

Good morning, and welcome, everyone, to Selecta's Q3 2024 Business Update and Financial Results Conference Call. Joining me on the call today are Doctor. Andre Schulica, our Chief Executive Officer and Doctor. Adrian Kilcoyne, our Chief Medical Officer. Yesterday evening, Selectus issued a 6 ks and press release reporting our financial statements for the 9 month period ended September 30, 2024, and a business update.

Speaker 1

The report and press release are available on our website at selectus.com. As a reminder, we will make statements regarding Selectus' 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. 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. 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 reports, including the management's report for the year ended on December 31, 2023, and subsequent filings Selectus makes with the SEC from time to time. I would now like to turn the call over to Andre.

Speaker 2

Thank you, Arthur. Good morning and thank you everyone for joining us today. This quarter we're excited to announce that research and development activities has started for 3 programs developed under our collaboration and research agreement with AstraZeneca. One allogeneic CAR T for hematological malignancies, one allogeneic CAR T for solid tumors and one in vivo gene therapy for genetic disorders. Selectus is thrilled to have this strategic collaboration with one of the most impressive pharmaceutical companies of the past decade, AstraZeneca.

Speaker 2

Together, we continue to advance our ambition in cell and gene therapy, bring potentially life saving therapies to patients with unmet medical needs. In the coming months, we will continue to focus on the enrollment of patient in our core clinical trials. We expect to present Phase 1 data set and large state development strategy in 2025. These programs are key for the company and in order to focus our resources towards success, we decided to deprioritize the development of QCAR T123 evaluated in relapsedrefractoryacute myeloid leukemia. We strongly believe that gene edited cells and gene therapies are revolutionizing medicine across a number of therapeutic areas and will become a large part of molecular medicine of the future.

Speaker 2

With that, I'd like to turn the call over to Adrian Kilcoyne, our newly appointed Chief Medical Officer. We're thrilled to welcome Adrian to Selectus. He's a strategic forward thinking drug developer who is passionate about delivering life saving therapies to patients. He joined us at the pivotal time bringing extensive experience in drug development as we're progressing in our co clinical programs. Adrian will give an overview of our clinical trials.

Speaker 2

Adrian, please go ahead.

Speaker 3

Thank you, Andre. As Andre mentioned, Selectus continues to focus its development efforts on the BALI-one and NAFLD-one studies. While we will deprioritize the AMALI-one trial assessing UCART-one hundred and twenty three in relapsedrefractoryacute myeloid leukemia, this study has provided important insights into the role of CD123 targeted allogeneic CAR T therapy in the treatment of AML and will inform the future development of our allogeneic CAR T platform. Recruitment in BOLI-one, a study evaluating UCART22 in relapsedrefractory B cell acute lymphoblastic leukemia, has progressed well. We have now completed patient identification for all remaining open slots in the BALI-one study to reach a total of 40 subjects treated.

Speaker 3

As there is no longer a requirement for subjects staggering, the remaining patients are being dosed concurrently. Therefore, we expect the Phase I data set to be available in 2025. We are currently planning our regulatory interactions in support of our potential Phase II strategy. We also continue to enroll in the NAFLD-one study of our dual CAR T acid UCART 2022 in relapsed refractory non Hodgkin's lymphoma. This study is addressing an important unmet need for patients who have relapsed following multiple lines of therapy, including, when available, an autologous CD19 CAR T.

Speaker 3

As Andre mentioned previously, we will endeavor to share the data for the Phase I program in 2025. With that, I would like to hand the call over to Arthur Stril, Selectus' Interim Chief Financial Officer, for an overview of our financials for the Q3 of 2024. Arthur, please go ahead.

Speaker 1

Thank you, Adrian and Andre. We are excited about the progress of our partnerships, which are positively impacting our financial position. In particular, dollars 47,000,000 have been triggered so far under the AstraZeneca joint research and collaboration agreement, of which $25,000,000 upfront and $22,000,000 reached development milestones, in addition to reimbursement of research costs incurred. In our financials, the cash, cash equivalents, restricted cash and fixed term deposits classified as current financial assets as of September 30, 2024, amount to $264,000,000 compared to $156,000,000 as of December 31, 2023. This $108,000,000 increase is mainly due to $140,000,000 cash received from AstraZeneca as part of the 2nd tranche of its equity investment in Selectus, dollars 16,000,000 cash received from the European Investment Bank, EIB, pursuant to the disbursement of the €15,000,000 tranche B under the finance contract with EIB, dollars 8,000,000 of cash in from our financial investments, dollars 27,000,000 of cash in from our revenue, partially offset by cash payments from Selectus to suppliers of $42,000,000 including $30,000,000 to R and D suppliers and $12,000,000 to SG and A suppliers selectus wages, bonuses and social expenses paid of $32,000,000 the payments of lease debt of $8,000,000 and the repayment of the PGE loan of $4,000,000 You're invited to refer to our press release for figures related to consolidated net loss attributable to shareholders of Selective for the 9 months ended September 30, 2024.

Speaker 1

The company believes that its cash, cash equivalents and short term deposits as of September 30, 2024 will be sufficient to fund its operations into 2027. We have been able to expand our cash runway through a combination of milestones received from the progress of our partnerships as well as prudent cash management for our wholly owned R and D pipeline and controlled SG and A expenses. We are focusing our spend on developing our clinical product candidates, UCAR22 and UCAR20x22, potential new product candidates and operating our end to end cell and gene therapy manufacturing facilities in Paris and Raleigh. Research costs under the AstraZeneca collaboration are funded by AstraZeneca. And now I would like to turn the call over to Andre for closing remarks.

Speaker 2

Thank you, Arthur. To close out this call, I would like to reiterate that we are confident about the continued progress of our ongoing clinical trials in metallurgical malignancies, as well as how excited we are about our strategic collaboration with AstraZeneca. At Selective, we strongly believe that our product candidates, our technologies and our in house manufacturing capabilities will lead us and our partners the paradigm shift for patients with hard to treat cancers and genetic disorders, positioning us at the forefront of this promising medical and scientific field. Moving forward, we have an important information to share for the future. The company has decided to hold calls only when there is a significant information to discuss or if there is a key update or business activities.

Speaker 2

We invite you to refer to our press releases for quarterly earnings and remain available to address any questions you may have. In the meantime, Selectus will participate or organize calls or in person events outside quarterly calls to update you about our progress. With that, I would like to open the call for Q and A.

Operator

We'll take our first question from Jenna Wang with Barclays. Please go ahead. Your line is open.

Speaker 4

Thank you for taking my questions, Andre and also Adrian, welcome on board. So two questions from me. First one is the UCART-twenty two, Bally-one Phase 1 data next year. Could you give a little bit more color regarding the patient numbers and the follow-up and what kind of data sets you will be sharing and in what kind of format? And the second question is regarding the deprioritized the UCAR-one hundred and twenty three in AML.

Speaker 4

In the past, you did show some encouraging or promising data. Can you give us the reason why you deprioritized? Is that because the enrollment speed or the patient population indication wise? Or you haven't seen the previous activity was able to

Speaker 2

hold? Yes.

Speaker 3

Thanks. It's a great question. So with regard, I'll take the UTAR-twenty two question first. As I said earlier, we are now on track to have 40 patients, the total patient number within the dose escalation phase of the study. So that's the number of patients we would anticipate to be able to share in 2025.

Speaker 3

Obviously, that's part of the dose escalation and we're currently, as I mentioned earlier, at a phase where we no longer require staggering. So we would anticipate these last patients to be completed at a greater pace, as you would expect it in this CAR T space. So again, 40 patients in 2025. In regards to UCART123, you're absolutely correct. We've seen some really good signals within with this targeted within AML.

Speaker 3

However, we have a responsibility to ensure that we have the best use of our cash and we prioritize the key assets. So, we are prioritizing the assets that we believe gave us the highest chance of success, And that's why we have focused on Nathalie and on Bally. That's not to say we don't believe there's a place for this therapy within the AML setting. We just have to prioritize what we can achieve with our runway. We have to optimize our runway.

Speaker 4

Okay. Thank you.

Operator

Thank you. Our next question comes from Jack Allen with Baird. Please go ahead. Your line is open.

Speaker 5

All right. Thanks so much for taking the questions and congratulations to the team on the progress and Adrian for the new role. A couple from us. I guess first on UCART22, Adrian, you mentioned that you're now enrolling patients in parallel. How should we think about the durability as it relates to the upcoming update in 2025?

Speaker 5

Is there a market which you'd like to see as it relates to follow-up before announcing that data? And then similarly for UCART 20 by 2022, how should we think about the breadth and depth of that data set as we look out on 2025?

Speaker 3

So great question. We know that with any allogeneic therapy, we do question persistence a lot, durability a lot. And that's where our ongoing conversations with the regulatory authorities are focused. What is the right indication? What is the right patient group?

Speaker 3

So absolutely, when we announce this data, we'll be announcing it in terms of durability response and our regulatory approach, which hopefully will make a lot of sense when you hear that later on in 20 25. I missed the second question. Sorry, could you repeat it?

Speaker 5

Yes. Thanks so much for that color. And then just on 20 by 2022, how should we think about the breadth and depth of that data set as we look out on 2025?

Speaker 3

Yes. We aren't as advanced in 2022 as we are with 2022. We still have fewer patients. We are, however, in a position where there's a lot of demand. And I would say across 2022 and 2022, there's a lot of demand for patients in this study.

Speaker 3

So we would anticipate relatively brisk recruitments. We know that this is far more common disease, but we do have waiting lists for slots in both of these studies. So I would anticipate we will have a pretty robust data set by 2025 to share with you.

Speaker 6

Got it. Thank you so much.

Speaker 5

And then maybe just one more if I could on the financial side. Arthur, I was hoping you could talk a little bit about the evolution of revenues from the AstraZeneca deal. Forgive me, I believe the number is about 34 $1,000,000 in revenues to date. Is that primarily from AstraZeneca? And how should we think about the Q4 with the disclosure of a number in the 40s of accrued revenues realized as it relates to milestones from AstraZeneca?

Speaker 7

Yes. Thank you so much, Jack. Great question. So just by way of reminder, so the AstraZeneca collaboration allows for up to 10, 7 gene therapy programs. We're very happy to have already initiated 3.

Speaker 7

And so I think what we wanted to report is really the number of milestones and upfront that have been triggered, which have a direct impact on our cash position, which by the way is one of the reason why we're now able to get a cash guidance to 2027 as opposed to 2026 previously. The reason why the revenue number differ is through the accounting treatment of revenue. Some of this revenue is capitalized and recognized over time as opposed to recognized as a one off item. And so you will always see some slight discrepancies between the revenue numbers and the actual milestones that are triggered. This is why in the press release, we want to focus more on the milestones that have been hit.

Speaker 7

And if you want more details, I invite you to refer to

Speaker 8

our 6 ks, which gives

Speaker 7

a bit more detail as to the accounting treatment of revenue.

Speaker 5

Thanks so much for the color and congrats on the progress.

Speaker 6

Thanks.

Operator

Thank you. Our next question comes from Yigal Nochomovitz with Citi. Please go ahead.

Speaker 5

Hi, Jim. This is Ashik Labarik on for Yigal. Thanks for taking my questions. For BALB-one, you alluded to 40 subjects being in the dose escalation phase, if that's the data set we'll see. I'm just wondering where you are in thinking about dose expansion and dose selection.

Speaker 5

Is that pending sort of Phase 2 regulatory interaction? And for that regulatory interaction, what are some of the key questions you're hoping to get some clarity on? Thanks.

Speaker 3

Yes, you're correct in your assumption. We are looking at the right approach to our Phase 2 expansion study right through to our a complete regulatory path. So we're being very careful in terms of our choice of endpoints because we believe that allogeneic therapies are unique and therefore they require a very thoughtful approach in collaboration with the regulatory authorities as to what the right endpoint is for these patients. We believe we know the position we're going in now, but again, we look forward to sharing more information with you in 2025.

Speaker 5

Got it. Thank you very much.

Operator

Thank you. Our next question comes from Yaman Xu with Wells Fargo. Please go ahead.

Speaker 6

Hi, this is Quan on for Yanan. Thanks for taking our questions. So I have a question on Nathalie O. Sorry, Nathalie O1, do you continue to see your in house products performing better than the CMO products? And any safety signal you have seen in the study?

Speaker 6

Thank you.

Speaker 3

We've seen earlier data that has suggested that our in house product is actually superior to P1 as we call it the previous product. So yes, that we're no longer dosing with P1. So we're not able to say on a patient by patient basis there are difference. What was the second part of that question, sorry?

Speaker 2

And have you seen any more

Speaker 6

yes, safety signal? Thank you.

Speaker 3

Yes. We haven't seen any dose limiting toxicities thus far. So we're very encouraged across all our programs with the safety profile we've seen across 1, 2, 3, 2022 and 2022.

Speaker 8

Like P1 and P2 are not comparable really in term of extension and we definitely see great results as P1, but like P2 in term of like translational data that we get in terms of extension is unmatched and we definitely think that it's like really a product that have a great power, but like P1 is not dosed at

Speaker 6

moment. Got it. Thank you so much for that color. And one last question from us. So for the Phase 2 studies for both 2020 and 2522, do you need active controls?

Speaker 6

And if so, what could be the controls? Thank you.

Speaker 3

We don't believe that we will need active controls. But again, we don't want to second guess what the final guidance for the regulatory authorities are. We would anticipate those single arm studies.

Speaker 6

Got it. Thank you so much for the color.

Operator

Thank you. Our next question comes from Luisa Morgasse with Kempen. Please go ahead. Your line is open.

Speaker 9

Hi, team. Thank you for taking my questions. I wanted to firstly ask in terms of the 3 programs that have been initiated under the AstraZeneca partnership, do you already have any idea when you plan to provide more updates here? Or is that totally under AstraZeneca guidance, let's say?

Speaker 7

Yes. Thank you so much. So we definitely so program is the programs are very much underway and there's daily activities and discussions between the two teams who are working very closely together. I think it's interesting and you can see also from the press release that these are 3 programs in very distinct therapeutic areas and modalities. So we are doing hematological malignancies.

Speaker 7

We're doing solid tumors and then we're doing in vivo gene therapy. So we're really leveraging the breadth and depth of the CELLECTUS platform, but also AstraZeneca's therapeutic area expertise. We plan to provide an update likely next year on the progress of the programs. We want to be at a stage where the program has progressed enough that the update is meaningful. So stay tuned for this.

Speaker 9

Okay, perfect. And in terms of costs for the remainder of the year, what can we expect in terms of R and D and also SG and A?

Speaker 7

Yes, great question. I think we'll be trending in the same vein at the beginning of the year. So I think we're not expecting any bolus at the end of the year. And we're in the process of and we will be providing more update at the next update on the future years. But the most important point is really that we were able to extend the cash runway into 2027, both through a combination of prudent cash management as well as increased revenue from our collaboration partners.

Speaker 9

Okay, perfect. Thank you for the additional color and that's all from my side.

Speaker 6

Thank you.

Operator

Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Please go ahead. Your line is open.

Speaker 10

This is Tommy on for Salveen. Thanks for taking our question. Congrats on the progress. I think that the previously disclosed expectation for BOLI-one was to have data by year end. Can you speak to what contributed to the shift to 2025?

Speaker 10

And as a follow-up, can you speak to the factors that you're thinking of towards establishing the Phase 2 dose? Thank you.

Speaker 3

The primary driver and thanks for the question. The primary driver was actually to increase patient numbers within the later cohort. So we have expanded up to the maximum number of allowed patients. We wanted to make sure we had enough data to inform a very thoughtful Phase 2 development. So we thought it prudent to actually get the extra data in order to support both us and the regulatory authorities in making the final decision.

Speaker 3

So hopefully that answers the question, but we believe it was the most strategic path forward.

Speaker 9

Thank you.

Operator

Thank you. Our next question comes from Silvan Torkin with Citizens JMP. Please go ahead.

Speaker 11

Yes, thank you. Thanks for taking my question and congrats on the progress. Maybe welcome Adrian to Selectus. Could you please tell us a little bit at a high level if you're making and what they could be any changes to the medical research organization of Selectus as you take over from Doctor. Fortuny?

Speaker 11

And then could you also remind us if there are any royalties from Iovance? Thank you so much.

Speaker 3

Thanks for the question. I'll take the

Speaker 2

first

Speaker 3

bit. So yes, of course, we believe that as we're embarking now towards Phase 2, we do need to build the capabilities in the organization. We have just recruited another hematologist oncologist into the team with extensive experience across multiple cell therapy companies, including Ocellus. So we believe that that's really helped our capabilities moving forward. We will continue to expand our clinical operations team as well.

Speaker 3

And again, we anticipate in 2025, we will have to expand further to support our Phase 2 activities. So we believe we are building the capabilities within the within the team now to support us moving forward.

Speaker 7

And I can take hi, Selwyn. This is Arthur. I can take the question on Iovance. So just a reminder, Iovance is leveraging our taileng gene editing platform to inactivate tumor infiltrating lymphocytes. And I recent BLA approval for a non edited TIL therapy is kind of testimony that we picked the right partner in the TIL space, which is now the only company that has an approved Till therapy on the market, which is very exciting.

Speaker 7

So we have one program with them already in the clinic. It's a PD-one inactivated Till therapy, IO-four thousand and one, which is currently in Phase 1 evaluated in melanoma and non small cells on cancer. And we do have economics attached to that, but they have not been disclosed.

Speaker 11

Thank you.

Operator

Thank you. And this does conclude our Q and A session as well as our conference call. Thank you all for your participation and you may disconnect at any time.

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