Q1 2024 Cellectis SA Earnings Call

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Operator: Good morning everyone and welcome to the Selectis 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.

Speaker Change: Good morning, everyone and welcome to the select US 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.

Speaker Change: Please be aware that today's conference call is being recorded.

Speaker Change: I'd now like to turn the conference over to your first Speaker Arthur stroke interim Chief Financial Officer.

Arthur Stril: You may begin.

Arthur Stril: Good morning and welcome everyone to Cellectis' first quarter 2024 corporate update and financial results conference call. Joining me on the call today are Dr. Andr Choulika, our Chief Executive Officer, and Dr. Mark Frattini, our Chief Medical Officer.

Speaker Change: Good morning, and welcome everyone to selected first quarter 'twenty 'twenty, four corporate update and financial results Conference call.

Speaker Change: Joining me on the call today are Dr actually got our Chief Executive Officer, and Dr. Marc <unk>, our Chief Medical Officer.

Arthur Stril: Yesterday evening, Cellectis issued a 6K and a press release reporting our financial statements for the three-month period ending March 31st, 2024, as well as a corporate and business update. The report and press release are available on our website at selectis.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 the product development status of its licensed partner.

Speaker Change: Yesterday evening select this issued a 6K and the press release reporting our financial statements for the three months period, ending March 31st 2024 and of corporate and business updates.

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

Speaker Change: As a reminder, we will make statements regarding selected financial outlook, including the sufficiency of cash to fund operations. In addition to its manufacturing regulatory and product development status as well as productive orphan status of its licensed partners.

Arthur Stril: 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 file with the Security Exchange Commission, SEC, and the financial report, including the management report for the year ended December 31, 2023, and subsequent filings Cellectis makes with the SEC from time to time. I would now like to turn the call over to Andre. Thank you.

Speaker Change: These forward looking statements, which are based on management's current expectations and assumptions and on information currently available to management.

Speaker Change: <unk> 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 Change: A description of these risks can be found in our most recent form 20-F filed with the Securities Exchange Commission S E T and the financial reports, including the management reports for the year ended on December 31st 2023, and subsequent filings select this makes with the SEC from time to time.

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

Andre: Thank you Arthur.

Andre Choulika: Good morning, and thank you, everyone, for joining us today. Last November, we were excited to announce a strategic collaboration and investment agreement with one of the most impressive pharmaceutical companies of the past decade, AstraZeneca, to design and shape the next generation of cell and gene therapy. In this agreement, AstraZeneca made an initial investment of $105 million to select, composed of an $80 million equity investment in exchange for 16 million ordinary shares at $5 per share and a $25 million upfront payment under the joint research collaboration agreement.

Andre: Good morning, and thank you everyone for joining us today.

Andre Choulika: This month, we're proud to announce the closing of the additional equity investment of $140 million by AstraZeneca. 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 Share.

Andre: Last November we were excited to announce a strategic collaboration and investment agreement with one of the most impressive pharmaceutical company of the past decade Astra Zeneca.

Andre: The design and shape next generation of cell and gene therapy.

Andre: Disagreement Astrazeneca made an initial investment of $205 million to select us.

Andre: Imposed off 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 agreements.

Andre: This month, we're proud to announce the closing of the additional equity investment.

Andre: $140 million by Astrazeneca.

Andre: Part of the additional investment that starts in a cast described for 10 million class a convertible preferred shares and 18 million class B convertible preferred shares in each case at a price of $5 for convertible preferred shares.

Andre Choulika: Today, AstraZeneca owns approximately 44% of the shared capital of Selectis and 30% of the voting rights. The appointment of Mr. Mark Dinwaye 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, ALI01, NATALY01, and AMLI01, our wholly owned assets, while building the next generation of genomic medicine to address areas of high unmet patient needs in our partnership with AstraZeneca and within our proprietary preclinical pipeline. We strongly believe that gene-edited cells and gene therapy are revolutionizing medicine across a number of therapeutic areas and will become a large part of molecular medicine in the future.

Andre: Okay.

Speaker Change: <unk> owns approximately 44% of the share capital afflicted and 30% of the voting rights.

Speaker Change: In addition.

Speaker Change: The appointment of Mr. Marc didn't wait and Doctor Tyrrell reverse as members of the board of director of selected is now effective.

Speaker Change: Well when Astrazeneca. This additional investment we expect our cash runway to fund operations into 'twenty 'twenty six.

Speaker Change: This will continue to focus its efforts and expenses and advancing its core clinical trials al easier one naphtha Liza one and Emily zero on our wholly owned assets while building. The next generation of genomic medicine to address areas of high unmet need.

Speaker Change: She needs within our partnership with Astrazeneca and within our appropriate to reap preclinical pipeline.

Speaker Change: We strongly believe that gene edited cell and gene therapies are revolutionizing medicine across a number of therapeutic areas.

Speaker Change: It will become a large part of molecular medicine in the future.

Andre Choulika: In 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 Selectis. It has been a huge honor and a pleasure for us all to work alongside him and wish him great success in his next adventure. Arthur has been managing Selectis' business development and portfolio management teams since 2020 and most recently led the execution of the company's strategic collaboration investment agreements with AstraZeneca.

Speaker Change: Quarter, we have also announced the appointment of auditors trail.

<unk> interim Chief Financial Officer, following the resignation of Bangladesh.

Speaker Change: First of all.

Speaker Change: I would like to warmly. Thank bang for the great. Two years. He has been it's like this 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.

Speaker Change: Arthur has been managing selected business development and portfolio management teams since 'twenty 'twenty and most recently led the execution of Companys strategic collaboration investment agreements with Astrazeneca.

Speaker Change: His past responsibility Arthur has deep knowledge and detailed understanding of selective he will be of tremendous value to select us as interim chief financial officer, as we advance our critical pipeline of asset into expansion and pivotal trials and exploring new.

Andre Choulika: Through his past responsibility, Arthur has a deep knowledge and detailed understanding of Selectis. He will be of tremendous value to Selectis 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.

Speaker Change: Opportunities with that I would like to turn the call over to Dr. Marc <unk>, Our Chief Medical Officer, who will give an overview of our clinical trials Mark. Please go ahead.

Mark Frattini: As Andre mentioned, Cellectis continues to focus its development efforts on the Bali O1, Amelie O1, and Nazli O1 studies. Last December, we shared updated clinical data from our BALI-01 trial at the American Society of Hematology annual meeting. In vitro comparability studies suggested that UCAR-22P2, manufactured in-house by Selectis, is significantly more potent than UCAR-22P1, manufactured by an external CDMO. As of July 1st, 2023, three patients were enrolled in the first UCAR-22-P2 cohort at dose level 2, 1 million cells per kilogram. UCAR-22P2 was administered after fluderabine, cyclophosisphamide, and alantuzumab lymphodepletion and was well-tolerated. No dose-limiting toxicities or immune effector cell-associated neurotoxicity were observed. The cytokine release syndrome observed was limited to grade 1 or 2.

Marc: Thank you Andre.

As Andre mentioned selective continues to focus its development efforts under Bally O one Emily Oh, one and not to the old one studies.

Speaker Change: Last December we shared updated clinical data in a poster from our Bali one trial at the American Society of Hematology annual meeting.

Speaker Change: In vitro comparability study suggested that you would call. It 22 P. Two manufactured in house by so much. This is significantly more potent than <unk> 'twenty two P. One manufactured by external C. D M O.

Mark Frattini: There was a higher preliminary response rate of 67% at dose level 2 with 1 million cells per kilogram using UCART 22P2 compared to a 50% response rate with a dose five times higher at dose level 3, 5 million cells per kilogram using UCART 22P1 that was manufactured by an external CDMO. UCAR-22 expansion was observed in the responding patients and correlated with increases in serum cytokines and inflammatory markers. The study continues to enroll patients using UCAR-22-P2.

Speaker Change: As of July 1st 2023, three patients were enrolled in the first <unk> 'twenty two P. Two cohort at dose level, two 1 million cells per kilogram.

Speaker Change: You call. It 22 P. Two was administered after fludarabine cyclophosphamide and choose the map LIFO depletion and was well tolerated.

Speaker Change: No dose limiting toxicities are immune effector cell associated neurotoxicity was observed.

Speaker Change: Hi, released syndrome observed was limited to grade one or two.

Speaker Change: There was a higher preliminary response rate of 67% at dose level, two with 1 million cells per kilogram using.

Speaker Change: You acquired 22 P to compare to a 50% response rate with a dose five times higher at dose level, three 5 million cells per kilogram using new card 22 P. One that was manufactured by external C. B M O.

Speaker Change: <unk> 22 expansion was observed in the responding patients and correlated with increases in serum cytokines and inflammatory markers.

Speaker Change: <unk> continues to enroll patients using your cards 22 P too.

Mark Frattini: I will now speak about our Natalia 1 study of phase 1, 2A dose finding, and expansion study evaluating UCART 20 by 22 in relapse refractory B cell non-Hodgkin lymphoma. UCART 20x22 has been fully manufactured in-house by Selectis at a Raleigh manufacturing facility.

Speaker Change: I will now speak about or not totally a one study a phase one two a dose finding and expansion study evaluating <unk> 2022 in relapsed refractory b cell non hodgkin lymphoma.

Speaker Change: New cards plenty by 'twenty two has been fully manufactured in house by selective at O'reilly manufacturing facility.

Mark Frattini: Cellectis presented a poster with the preliminary results from the NAFLA-01 trial at the annual ASH 2023 meeting in December. As of July 1st, 2023, three patients were enrolled and treated at dose level one, 50 million cells, a flat dose. Cytokine release syndrome grade 1 or 2 occurred in all patients and resolved with standard of care treatment. No immune effect or cell-associated neurotoxicity or graft-versus-host disease was observed. There were no UCAR-20x22 dose-limiting toxicities, and there was one dose-limiting toxicity related to alantuzumab, a CLS-52.

Speaker Change: Select this presented a poster with the preliminary results from the Napoli one trial at the annual Ash 2023 meeting in December.

Speaker Change: As of July one 2023, three patients were enrolled and treated at dose level 150 million cells flat dose.

Speaker Change: Cytokine release syndrome grade, one or two occurred in all patients and resolved with standard of care treatment.

Speaker Change: No immune effector cell associated neurotoxicity or graft versus host disease was observed.

Speaker Change: There were no <unk> 'twenty by 'twenty, two dose limiting toxicities and there was one dose limiting toxicity related to island T map of CLS 52.

Mark Frattini: 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 therapy. UCAR 20x22 expansion correlated with increases in serum cytokine and inflammatory marker levels, as well as with CRF. These initial data, with all three patients responding at the starting dose of 50 million cells per patient, support the continued study of UCAR-20x22 in relapsed refractory B-cell non-Hodgkin lymphoma.

Speaker Change: All patients responded at day 28, with one partial metabolic response and to complete metabolic responses in patients who had failed prior autologous CD 19 car T cell therapies.

Speaker Change: <unk> 20th by 'twenty, two expansion correlated with increases in serum cytokine inflammatory marker levels as well as with Crs.

These initial data with all three patients responding at the starting dose of 50 million cells per patient.

Speaker Change: Of course, the continued study of new cars 20 by 'twenty two in relapsed refractory b cell non Hodgkin lymphoma.

Mark Frattini: The study continues to evolve. Lastly, I will speak about our AMELI-01 study evaluating UCART-123 in patients with relapsed refractory AML. The Amelie-01 study continues to progress and is currently enrolling patients after fludarabine, cyclophosisphamide, and alumtuzumab 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.

Speaker Change: The study continues to enroll.

Speaker Change: Lastly, I will speak about our <unk>, one study evaluating <unk> three in patients with relapsed refractory AML.

Speaker Change: I only have one study continues to progress and is currently enrolling patients after fludarabine cyclophosphamide and al She's a mab LIFO depletion in a two dose regimen harm.

Arthur Stril: With that I would like to hand, the call over to Arthur still select us as interim Chief financial officer for an overview of our finances for the first quarter of 2024.

Speaker Change: Arthur Please go ahead.

Arthur Stril: Thank you, Mark and Andre. 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 deposit classified as current financial assets as of March 31st, 2024 amount to $143 million compared to $156 million as of December 31s

Arthur: Thank you Mark and Andre.

Arthur: I'm very excited to step into the role of interim CFO and continue working with selected this team shareholders and partners at such an important moment for the company.

Arthur: I would like to highlight that in our financials, our cash cash equivalents restricted cash and fixed term deposit classifieds that current financial assets as of.

Arthur: March 31, 2024 amount to $143 million compared to $156 million as of December 31st 2023.

Arthur Stril: This $13 million decrease is mainly due to cash payments from Selectis to suppliers of $13 million, including $9 million to R&D suppliers and $4 million to SG&A suppliers. 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 €15 million tranche B, and $2 million of cash-in from a financial investment, 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.

Arthur: This 13 million decrease is mainly due to cash payments from selected suppliers that $13 million, including 9 million to R&D suppliers, and 4 million to SG&A suppliers select us as wages bonuses and social expenses paid $16 million the payments at least that's a $3 million.

Arthur: And the repayment of the P. G E loan of $1 million, partially upset by the $16 million of cash received from EIB pursuant to the disbursement of the 15 million Euro tranche, b and $2 million of cash in from a financial investment.

Arthur: With cash and cash equivalents at $123 million and a $15 million term deposits maturing in may 2020 for classified as a current financial assets as of March 31, 2024, and taking into account the $140 million equity investment received on May three 2024.

Arthur Stril: 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 and therefore for at least 12 months following the unaudited interim condensed consolidated financial statements publication.

Arthur: 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, and therefore for at least 12 months following the unaudited interim condensed consolidated financial statements publication.

Arthur Stril: The consolidated net income attributable to shareholders of Selectis was $5.6 million, or a $0.08 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 31, 2023, of which $27.8 million was attributed to Selectis' continuing operation. This $38.2 million difference was primarily driven by an increase in revenue over other income of $2.9 million.

Arthur: The consolidated net income attributable to shareholders of select this was $5 $6 million or a 0.08 income per share.

Arthur: The three months ended March 31 2024.

Arthur Stril: 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. 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 Selectis.

Arthur: Compared to a $31 million loss or <unk> 58 dollar loss per share for the three months ended March 31, 2023 of which $27 $8 million was attributed to select discontinuing operation.

Arthur: This $38 $2 million difference was primarily driven by an increase in revenues and other income of $2 $9 million a.

Arthur: A decrease of zero point $7 million in noncash stock based compensation expense due to a decrease in the average unit fair value of stock options and three share awards vesting between the two periods.

Arthur: At $37 million changed from a net financial loss of $4 $4 million, but net financial gain of $26 $3 million.

Arthur: And the decrease in net operating expense of zero point $6 million.

Arthur: And a $2 $5 million decrease in net loss from discontinued operations attributable to shareholders of selected.

Arthur Stril: 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 Selectis was $6.5 million, or a $0.09 earnings per share for the three months ended March 31st, 2024, compared to a net loss of $28.1 million or a $0.55 loss per share for the three months ended March 31st, 2023. We are focusing our efforts on developing our clinical candidates UCAR-22, UCAR-20x22, and UCAR-123 and operating our state-of-the-art cell and gene therapy manufacturing facilities in Paris and Raleigh.

Partially offset by an increase of $1 $3 million in purchases external expenses.

Arthur: And an increase of zero point $4 million in wages.

Arthur: The consolidated adjusted net income attributable to shareholders of selected was $6 $5 million or appointed zero nine dollar income per share for the three months ended March 31 2024.

Arthur: Compared to a net loss of $28 $1 million or <unk> 55 dollar loss per share for the three months ended March 31 2023.

Arthur: We are focusing our spend on developing our clinical candidates you call 22, you got 2022, and you've got 123 and operating our state of the art cell and gene therapy manufacturing facilities in Paris and Raleigh.

Arthur Stril: 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. Now, I would like to turn the call over to Andre for closing remarks.

Arthur: Research costs under the Astrazeneca collaboration are funded by Astrazeneca.

Arthur: In addition, our focus on maintaining an efficient corporate infrastructure should also enable more limited growth in G&A spend.

Andre: And now I would like to turn the call over to Andre for closing remarks.

Andre: Thank you Arthur.

Andre Choulika: To close out this call, I would like to reiterate how excited we are about our strategic collaboration with AstraZeneca and how confident we are about the continued progress of our three ongoing clinical trials in hematological malignancies, as well as our continued development of our preclinical programs. We strongly believe that our product candidates, our technologies, and 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.

Andre: To close out this call I would like to reiterate how excited we are about our strategic collaboration with Astrazeneca and how much confidence.

Andre: About the continued progress of our three ongoing clinical trials in hematology malignancies as well as our continued development of our pretty cool clinical program.

Andre: Select is we strongly believe that our product candidates or technologies.

Andre: House manufacturing capabilities will lead us and our partners.

Andre: 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 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 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 star 2. Our first question comes from the line of... Excuse me. Dina Wang with Barclays. Please proceed with your question.

Speaker Change: 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.

Speaker Change: 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 the star keys.

Speaker Change: Our first question comes from the line of.

Speaker Change: Excuse me Gena Wang with Barclays. Please proceed with your question.

Arthur Stril: Thank you for taking my questions. Also, I want to congratulate you on the completion of the AstraZeneca deals. So now with AstraZeneca on board, I'm wondering if there are any strategic changes regarding the strategy from a selective perspective and also how much AstraZeneca can have access to your manufacturing capability both in New Jersey and in Paris. And lastly, very quickly regarding the upcoming data by the year 2024, I assume you will be at ASH. Can you give us, you know, the status of enrollment for both Bali and Natalie for one, and what kind of data sets should we expect to see?

Huidong Wang: Thank you for taking my question I also wanted to congrats on that completion of that.

Speaker Change: So now I'll Suzanne I got on board.

Speaker Change: So wondering is there any strategic.

Change regarding the strategy.

Speaker Change: This perspective and also how much oh.

Astrazeneca Kent.

Speaker Change: Have access to your manufacturing capability for proposal <unk>.

Speaker Change: Okay.

Speaker Change: And lastly, very quickly.

Speaker Change: Yeah.

Speaker Change: Having data by the year end 'twenty four I assume.

Speaker Change: It'll be at Ash.

Speaker Change: Can you give us.

Speaker Change: Woman for both Sally.

Oh one.

Speaker Change: What kind of feedback.

Speaker Change: Jesse.

Speaker Change: Yeah.

Arthur Stril: Great. Thank you so much, Gina. This is Arthur.

Arthur: 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 Mark for the for the data updates.

Arthur Stril: I'm going to take the first question on strategy and the AstraZeneca piece, and then I'll hand it over to Mark 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 going to be very important. So, the strategy on our wholly owned asset has not changed. We're still pushing 22, 20 by 22, and 123 very hard, and Mark will give you an update on where we stand.

Mark: I mean, we're obviously very excited to have completed a subsequent investment and now have the astrazeneca fully onboard I mean as you have seen from from their recent disclosures, they're betting very hard and very long term on cell and gene therapy.

Mark: And having them as a strong partner across a number of indications not just oncology, but also our immunology and rare diseases. It is going to be very important. So this strategy on our wholly owned asset has not changed we're still pushing our 'twenty to 'twenty by 'twenty, two and $1 23, a very.

Speaker Change: Harden and Mark will give you an update on that on where we stand obviously the big changes we are going to be doing these novel programs with them across a wide range of indications in the cell and gene therapy space and.

Mark Frattini: Obviously, the big change is that we are going to be doing these novel programs with them across a wide range of indications in the cell and gene therapy space, and 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, in the collaboration, we're going to do up to 10 cell and gene therapy programs together.

Speaker Change: And we also have a new strategic shareholder that is strongly invested in this space and that has this long term vision.

Speaker Change: Which we're very excited to have.

Speaker Change: Regarding your question on manufacturing so as you know under the collaboration we're going to do up to 10, a cell and gene therapy programs together.

Mark Frattini: And the agreement allows for the possibility for AstraZeneca to leverage our manufacturing capabilities, both the starting materials, but also the final cells that we have in Raleigh for Selectis to be manufacturing these programs. So that's definitely one of the drivers of the interest in AstraZeneca. And maybe I'll hand it over to Mark for the data update. Hi Gina.

Speaker Change: And the agreement allows for the possibility for Astrazeneca to leverage our manufacturing capabilities booster starting materials, but also to find those cells that we have in Raleigh.

Speaker Change: Two for selected to be manufacturing. These program. So that's definitely one of the driver of the interest of Astrazeneca.

Speaker Change: And maybe I'll hand, it over to Mark for the data.

Mark Frattini: Hi Gina, it's Mark.

Mark Frattini: Thanks for the questions. And I think, as you know, our last disclosure for data was at ASH last year in December. We have continued to enroll, obviously, in both of these studies. You asked about 22 and 20x22.

Mark: Hi, Gena, it's mark Thanks for the thanks for the questions and.

Mark: I think as you know our last disclosure for data was at Ash last year in December.

Mark: We have continued to enroll obviously on both of these studies you asked about 'twenty, two and 'twenty by 'twenty two.

Mark Frattini: We expect to have data disclosure at the end of the year this year for both of these studies. Regarding 22, ideally, we will be completing the expansion part of the 22 study this year. So we'll move ahead from that. And for 20x22, 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.

Mark: We expect to have.

Mark: Data disclosure at the end of the year. This year for both of these studies regarding.

Regarding 22.

Mark: Ideally we will be completing the expansion part of the eye of the 22 study this year.

Mark: So we will move ahead from that and for 'twenty by 'twenty, two we continue enrollment in expansion.

Mark: I actually hopefully will be in the same place near completion of the escalation phase by the end of this year.

Mark: Okay.

Speaker Change: Thank you.

Operator: Thank you. Our next question comes from the line of Kelly Hsu with Jefferies. Please proceed with your question. Hi. Congratulations.

Speaker Change: Thank you. Our next question comes from the line of Kelly <unk> with Jefferies. Please proceed with your question.

Operator: Hi, congratulations on the progress and thanks for taking our question. This is Dev on behalf of Kailishi.

Dave: Hi, Congrats on the progress and thanks for taking our question. This is Dave on par caliche, So on <unk>, Tony do by 'twenty.

Operator: So, on UCAR 22 by 20, can you add some color to how many sites are active right now, and Will you be able to identify RP2D by year end? If you are enrolling three patients per dose level, so should we expect around 10 to 12 patient data by year end? Thank you.

Speaker Change: Can you add some color of how many sites are active right now and.

Speaker Change: So you'll be able to identify a heartbeat duty by year end and.

Speaker Change: If you are controlling three patients for dose level. So should we expect at all thanks.

Speaker Change: Penetration data like okay. Thank you.

Speaker Change: [laughter].

Speaker Change: Arc.

Mark Frattini: Hi, thanks for the question. Obviously, I can't go into a lot of details about all of the sites, but I can tell you that we have sites open in the U.S. and in the E.U., both in France and Spain, currently enrolling for this study. Regarding the progress with 20x22, 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, at that time, RP2D would be declared as we open the expansion part of the study.

Speaker Change: Hi, Thanks for thanks for the question.

Speaker Change: So obviously I can't go into a lot of details about all of 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.

Speaker Change: Currently enrolling on this study.

Speaker Change: Regarding the progress with 20 by 'twenty two we continue to.

Speaker Change: <unk> ROE in the escalation phase and we hope to be completed with the escalation by our by.

Speaker Change: By the end of this year so to your point in terms of you know we would do that.

Speaker Change: At that time, there would be a <unk> declared as we hope in the expansion part of the study.

Speaker Change: Okay.

Speaker Change: Thank you.

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

Speaker Change: Thank you. Our next question comes from the line of <unk> Richter with Goldman Sachs. Please proceed with your question.

Speaker Change: Hi, This is with you on for Sylvia and thanks. So much for taking my question can you provide any further granularity on the cadence of readouts across our programs this year and what your expectations are for the respective dataset. Thanks, so much.

Arthur Stril: Hi Lydia. Thank you so much for the question. That's definitely one for Mark. All right, thank you.

Speaker Change: Yeah. Thank you so much for the question that's definitely one for Mark.

Mark Frattini: Hi, thanks. So yeah, as you just heard from the prior two, so for 22 and 20 by 22, for 22, we will be completing escalation, and we will discuss the data results later this year. For 20 by 22, 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 123 study, I think, as you know, 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. But it continues to actively enroll students currently.

Speaker Change: Hi, Thanks.

Speaker Change: As you've just heard.

Speaker Change: From the prior to so for 'twenty, two and 'twenty by 'twenty, one 'twenty two we will be completing escalation.

Mark: I'll discuss the data results later this year for 20 by 22 again, we are also.

Mark: Continuing enrollment in the escalation with the aim of completing escalation and discussing that.

Mark: At the end of this year as well and probably the $1 23 study I think as you know, we we reverted to a.

Mark: New treatment paradigm, where we're giving actually two doses of cells for AML since it's highly aggressive highly proliferative disease.

Mark: And so we continue to enroll in this two dose regimen prior to the cohort and when we have sufficient data, we will be disclosing that as well, but it continues to actively enroll.

Mark: Currently.

Speaker Change: Thanks, so much.

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

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

Arthur Stril: 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 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.

Jack Kilgannon Allen: Alright, thanks, so much for taking the questions and congratulations on the progress.

Jack Kilgannon Allen: 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 youre doing with the large pardon me 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 youre thinking about potential plans and autoimmune indications.

Arthur Stril: And then, finally, if I may, I wanted to ask about what the expectations are for the urine updates from VAL-A01 and NADAL-A01 as it relates to durability. How are you thinking about the bar for success in those studies with the Allogeneic platform?

Jack Kilgannon Allen: And then finally, if I may I wanted to ask about or what the expectations are for the yard updates from <unk>, one and not only all one as it relates to durability. How are you thinking about the bar for success in those studies with allogeneic platform here.

Arthur Stril: Hi Jack. This is Arthur.

Arthur: Hey, Jack this is Arthur Thank you so much for the questions I'll take the one on Astrazeneca. So the work has definitely ticked.

Arthur Stril: 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 pre-selected 25 targets. So we're starting from a shorter list. And there's a lot of discussion ongoing about selecting the first program and getting them into gear.

Speaker Change: Kicked kicked out in full gear are theres, a ton of discussion and interactions at all level with India, Astrazeneca and Alexia on teams. So as you know there was already an initial amount of work that had been done on pre selecting because astrazeneca pre selected our 'twenty five targets. So we're starting from a from a shorter list.

Speaker Change: And there's a lot of discussion ongoing on selecting the first program in and getting them into into gear.

Arthur Stril: So we're very excited. And obviously, there's a ton of connectivity between the research teams at all levels. And we're looking forward to being providing updates as to the first programs when that makes sense. And I think there's a question about the data for Mark.

Speaker Change: So we're very excited that now obviously theres a ton of connectivity between the research teams at at all level.

Speaker Change: And we're looking forward to be providing updates as to the first programs.

Speaker Change: When that makes sense.

Speaker Change: And I think there was a question on the on the data for Mark.

Arthur Stril: 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 24 updates and these responses.

Speaker Change: Yeah I was just wondering if mark had any thoughts on how we should think about durability and what the bar for durability, there should be as we look towards the year end 'twenty for updates.

Speaker Change: And these responses all of them.

Mark Frattini: Yeah, thanks, Jack. As you know, we're, we're, you know, we will discuss completion of escalation for 22 and continued enrollment and the completion of escalation for 20 by 22 as well. I think as standalone products in the disease space, I think, you know, the bars, I think, are, are pretty well set. You know, particularly in terms of what the regulatory agencies would want to see, and particularly in terms of what the regulatory agencies would want to see in the relapsed refractory ALL space, you know, there would be a three month, a CR within three months timeframe is what the agencies would be looking for. And I think for 20 by 22 in the NHL space, we're looking at something closer.

Jack Kilgannon Allen: Yes, Thanks, Jack So yeah, and as you know where we are.

Speaker Change: We will discuss completion.

Speaker Change: Escalation for 'twenty two and.

Speaker Change: Continued enrollment in completion of escalation for 'twenty by 'twenty, two as well.

Speaker Change: I think as stand alone.

Speaker Change: Our products in the disease space I think the borrowers I think are are you know are pretty well set.

Speaker Change: Particularly in terms of what the regulatory agencies.

Speaker Change: Wanted to see and particularly in.

Speaker Change: The relapsed refractory <unk> space, you know there there would be a three months.

Speaker Change: CR within three months timeframe is what.

Speaker Change: Is what are the agencies would be looking for and I think for 'twenty by 'twenty, two and the NHL space, we're looking at something closer to six months.

Speaker Change: Thanks Marty.

Arthur Stril: Got it. Thanks so much. Jack, this is Arthur again.

Arthur Stril: 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 developments in that space. It's also a space where we think the allergenic value proposition is going to be absolutely critical, given the size and potential scope of the market opportunity. And 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 happens. Thanks for the question.

Arthur: Jack This is Arthur again, sorry, I didn't mean to skip to your question on auto immune.

Operator: Thank you. Our next question comes from the line of Luisa Morgado with Van Lauschot Kempen. Please proceed with your question.

Speaker Change: So this is I mean definitely are an interesting space that we're monitoring very carefully and we're looking at the at the development in that space. It's also a space, where we think the allogeneic value proposition is going to be absolutely critical.

Speaker Change: Given the size and potential scope of the market opportunity we wanted to address it in a in a smart and thoughtful way. So we're we're we're definitely looking into this and that and monitoring the space and again, we'll we'll update when it makes sense. Thanks for the question.

Speaker Change: Thank you.

Speaker Change: Thank you. Our next question comes from the line of Felicia Morgado with Venmo shot Kempen. Please proceed with your question.

Operator: Hi, team. First of all, congratulations 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 of what we should be on the lookout for, let's say, throughout this year? What would you highlight on that site?

Speaker Change: Hi team first of all indeed, congrats on the completion of our debt investments from Astrazeneca.

Felicia Morgado: 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.

Felicia Morgado: On the look out let's say throughout this year, what what is what would you highlight on that site.

Arthur Stril: Thank you, Luisa, 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 you to them for future updates. I think the first one is that they announced that the startup activities for the Alpha 3 trial, which will be Semicel, so previously Allo501A, in first-line consolidation are ongoing, and they're planning initiation in the middle of this year.

Felicia Morgado: Thank you Louise for the question I mean, we we talked about that stress that Nick at lengths I think at a I can reiterate the guidance that Allergan has provided on the anti CD 19, and anti CD 70 programs.

Speaker Change: And obviously would would would direct to them for future updates I think the first one is they announced that the startup activities for the Alpha <unk> III trial, which will be set myself. So previously allo 501, a in the first line consolidation are ongoing and they are planning a study initiation in the middle of this year.

Arthur Stril: And they also have an ongoing enrollment in the relapsed refractory CLL cohort for the Phase 1 Alpha 2 trial, also with Semicel. So that's going to be interesting to see how Semicel moves forward. And they also announced that they're planning by year end a Phase 1 data update of the Traverse trial, which is Allo316, the anti-CD70 antibody in renal cell carcinoma. So we're also looking forward to this.

Speaker Change: And they also have an ongoing enrollment in the relapsed refractory CLO cohorts for the phase one alpha two trial that also.

Samad south so that's going to be interesting to see how our house MSL moves forward.

Speaker Change: And they also announced that they are planning by year end of phase one that data update of the traverse trial wishes allo three one sixth our anti CD 70 in renal cell carcinoma. So we're also looking forward to this.

Speaker Change: Okay.

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

Speaker Change: Okay. That's all for me. Thank you so much.

Yes.

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

Speaker Change: Thank you. Our next question comes from the line of Hugo <unk> with Citi. Please proceed with your question.

Operator: Hi, this is Amin An for Yigal. Thank you for taking our questions. We had a couple.

Hi, This is on the front of your call. Thank you for taking our questions. We had a couple.

Operator: First, on the dose expansion strategy, do you see a scenario that the dose expansion studies could convert to... Registration of Studies? And if so, what would the timeline look like? And then, second, I wanted to know what you think the target population would be for a registrational trial? Is that going to be something like a relapsed refractory following CD19 treatment? Hi, thank you so much. I think these are two great questions, definitely for Mark.

Speaker Change: First of all I'm doing the expansion strategy.

Speaker Change: See a scenario that the dose expansion studies could come back to us.

Speaker Change: Okay, just sorry challenge studies and if so what would be the timeline look like and then the second.

Speaker Change: I wanted to know what you think the target population would be for a registrational trial.

Speaker Change: Is that going to be something like.

Speaker Change: Subtracting our appalling of CD 19, two things.

Speaker Change: Hi, Thank you so much I think these are two great questions definitely for Mark.

Operator: Mark, we can't hear you.

Speaker Change: Mark we can't hear you.

Mark Frattini: Sorry, pardon me; I was on mute. 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. However, as you know, however, this, in terms of number of patients and timeline, et cetera, 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.

Mark: 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.

Mark: Expand expansions.

Mark: At this level as you know however this.

Mark: In terms of number of patients and timeline et cetera was it will require.

Mark: Some 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.

Mark Frattini: I think in terms of your other question, in terms of target populations, I think particularly in both disease spaces, I think for 22, we're talking about relapsed refractory ALL, as you know, and these will be 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 similar situation in terms of the relapsed refractory non-Hodgkin lymphoma space as well.

Mark: I think in terms of your other question in terms of target populations.

Mark: I think particularly in the.

Mark: In both disease spaces, I think for 'twenty, two we're talking about relapsed refractory <unk> as you know.

Mark: These will be.

Mark: They include patients who have received prior CD 19, directed car T cell therapy or patients for whatever reason could not be eligible to receive prior CD 19 car.

Mark: Car T cell therapy and.

Mark: Similar.

Mark: Similar situation in terms of the relapsed refractory non hodgkin lymphoma space as well.

Operator: Okay. Got it. Great. Thanks very much for taking our questions.

Speaker Change: 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.

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

Operator: Hi. Thanks for taking our question. This is Kwan from Yana.

kwan: Hi, Thanks for taking our question Lisa This is kwan for Yamana.

Operator: So, two questions from us. First, for 22 and 20 by 22, can you remind us what dose level has been planned for the studies, and are you planning to also explore fixed dosing for 22? And the second question is, any color on the safety data from the patients beyond ASH update for these two studies? Thank you.

Speaker Change: <unk> from us So first of all our 'twenty, two and 2022 can you remind us what dose they both have been playing for the studies.

Speaker Change: Are you, claiming to Oh, sorry explore fixed dosing for 22.

Speaker Change: And the second question is any counter some of the safety data from the patients beyond Ash update for these two studies. Thank you.

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

Speaker Change: Great. Thank you so much for the two questions are also for Mark.

Mark Frattini: Yes, thank you for the question. So, in terms of the dose level, I mean, you know, what we've disclosed to date is that originally for 22, we were at 1 million cells per kilo at dose level 2, and for 20 by 22, 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 about dosing with 22. I missed that. Can you repeat that, please?

Speaker Change: Yes. Thank you for the question so.

Speaker Change: In terms of the dose level I mean, what we've disclosed to date is that.

Speaker Change:

Speaker Change: Originally for 'twenty, two we were at 1 million cells per.

Speaker Change: Per kilo at dose level two.

Speaker Change: And for 'twenty by 'twenty, two we were at 50 million cells flat dose.

Speaker Change: Obviously, we have been escalating dose since the last data I think skeptics.

Speaker Change: Uh huh.

Speaker Change: Disclosure and.

Speaker Change: We will update later this year in terms of where we're landing in terms of dose levels for both of US both of these studies.

Speaker Change: I missed the one question you asked something about dosing was 22 I missed that.

Speaker Change: Could you repeat that please.

Operator: Oh yeah, sure; just curious if you are also planning to explore fixed doses for 22.

Speaker Change: Oh, Yeah, Yeah. Just curious if you are also planning to explore a fixed dosing for.

Speaker Change: 'twenty two.

Mark Frattini: Now, for 22, for 22, 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, like most studies in the ALL space, continue with a weight-based dosing for 22.

Speaker Change: Now for 'twenty two.

Speaker Change: For 'twenty, two we're going to keep a weight based dosing obviously because of the great.

Speaker Change: Age.

Speaker Change: Writing in terms of this study from the very young to the very old. So we will we will like most all studies in the <unk> space continue with a weight based dosing for 'twenty two.

Mark Frattini: Got it. And any color on the safety data from patients beyond the ASH update? Thank you.

Speaker Change: Got it and any.

Speaker Change: Any colors on the safety data from patients beyond the ash update thank you.

Mark Frattini: Yeah, so so far, we have not disclosed anything; 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 IK, and the CRS limited to grade one.

Speaker Change: Yes, so so far we have not disclosed we will later this year as you know so far the both products were very safe and well tolerated with no <unk> related to the cells and no graft versus host disease and no I can't.

Speaker Change: And in the Crs limited to grade one or two.

Operator: Thank you for the callers.

Speaker Change: 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.

Speaker Change: Thank you. Our next question comes from the line of Heartland with Oppenheimer. Please proceed with your question.

Operator: Hey, everyone, thanks for taking the questions. This is a fine for Hartaj.

Speaker Change: Hey, everyone. Thanks for taking my question.

Speaker Change #100: Also a hodgepodge.

Operator: We have questions for 20 by 22. So, as we talked before, it seems like half of this program has great potential on the EU market because of the last competition there. So can you elaborate to talk about that? Thanks.

Speaker Change #101: We have question from 'twenty, one 'twenty two so as we've talked before since Mike has this program has.

Speaker Change #102: That's great potential and EU markets.

Speaker Change #103: Last competition here okay.

Speaker Change #104: Elaborate can you talk about that thanks.

Mark Frattini: Thank you so much for the thoughtful question; I'll leave it to Mark. Yeah, thank you. So yeah, as you point out.

Speaker Change #105: Thank you so much for the thoughtful question I'll leave it to Mark.

Mark Frattini: Yeah, thank you. 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, as well, obviously. And so, we have opened up, as I said earlier, we have sites in France and sites in Spain that are currently open, and we are, obviously, we'll be looking to open other countries as well.

Mark: Yeah. Thank you so yeah as you point out there is.

Speaker Change #106: You know just based on the slide availability for autologous car T cell therapy in the EU. It is much less than the U S. So.

Speaker Change #106: There is.

Speaker Change #106: Even though there is a need for this in the EU.

Speaker Change #106: Now as well, obviously and so we have opened up.

Speaker Change #106: As I said earlier, we have sites in France and in Spain that are currently open and we are obviously.

Speaker Change #106: We'll be looking to open other other countries as well.

Speaker Change #107: 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.

Speaker Change #108: Thank you, ladies and gentlemen that concludes our question and answer session I'll turn the floor back to Mr. Shaw for any final comments.

Andre Choulika: Well, thank you very much, everyone, for your time. It was really appreciated to have all these questions and enthusiasm.

Mr. Shaw: Well. Thank you very much everyone for your time it was really appreciated to have all these questions and then Tuesday asthma, and we're really excited by 2024 and what's going to happen in the coming years. After 'twenty five 'twenty six I think the company is within a year, where things are meaningfully changing the shape of the company.

Andre Choulika: And we're really excited about 2024 and what's going to happen in the coming years after 2526. I think the company is within a year of meaningfully changing the shape of the company. And I'll give you 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.

Mr. Shaw: And I'll give you a rendezvous for the next time and I think that we'll share more of the.

<unk> 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.

Speaker Change #110: Thank you. This concludes today's conference call you may disconnect. Your lines at this time. Thank you for your participation.