Q3 2023 Cellectis SA Earnings Call
[music].
Speaker 1: Good morning everyone and welcome to the Selectix.quad.org 2023 Morning Scrolls. At this time all participants are in a listen only mode.
Good morning, everyone and welcome to the selective towards what they need when they create earnings call. At this time all participants are in a listen only mode.
Speaker 1: Later we will conduct a question and answer session and instructions will follow at that time.
Lethal V will conduct a question and answer session and instructions will follow at that time.
Speaker 1: Please be aware that today's constant call is being recorded.
Please be aware that today's conference call is being recorded.
Speaker 1: And now I'd like to introduce a first speaker, Arthur Strill, Chief Business Officer. You may begin.
I'd now like to introduce our first speak up auto stroke, Chief business Officer.
They begin.
Speaker 1: Good morning and welcome everyone to selected third quarter 2023 corporate update and financial result comfort call.
Good morning, and welcome everyone to selected third quarter 2023, corporate update and financial results Conference call.
Speaker 2: Joining me on the call today with prepared remarks are Dr. Amritsh Uli Kha, Archie's Executive Officer, Dr. Bing Wang, Archie's Financial Officer, and Dr. Mark Fattini, Archie's Medical Officer.
Joining me on the call today with prepared remarks are ductile homepage should eke out our chief Executive Officer, Dr being Wang our Chief Financial Officer, and Dr. Mark Bottini, our Chief Medical Officer.
Speaker 2: Yesterday evening, selected issue the press release reporting a corporate and business update for the third quarter 2023. And its financial results for the nine month period ended September 30th, 2020.
Yesterday evening selected issued a press release reporting of corporate and business update for the third quarter 2023, and its financial results for the nine months period ended September 30th 2020.
Speaker 2: as a reminder, we will make statements regarding selected financial outlook, including the efficiency of cash to fund operations. In addition to its manufacturing, regulatory and product development status and plan, and product development of its license partners.
As a reminder, we will make statements regarding selected financial outlook, including the sufficiency of cash to some operation in addition to manufacturing regulatory and product development status and.
And productive allotment of its licensed partners.
Speaker 2: 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 license partners, are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
These forward statements, which are based on management's current expectations and assumptions and on information currently available to management, including information provided or otherwise publicly reported by our licensed partners are subject to risks and uncertainties that may cause actual results to differ from those forecasted.
Speaker 2: A description of these risks can be found in our most recent phone 20F filed with the Security Exchange Commission, SEC, and the financial reports, including the management reports, for the year ended on December 31, 2022. And subsequent filing, select this makes with the SEC from time to time. I would now like to turn the call over to Andre.
A description of these risks can be found in our most recent form 20-F filed with the security Exchange Commission S E T and the financial reports, including the management report for the year ended on December 31st 2022, and subsequent filings. It makes with the S. E T from time to time.
I would now like to turn the call over to Andre.
Speaker 3: Thank you, Arthur, and good morning, and thank you, everyone, for joining us.
Thank you Arthur and good morning, and thank you everyone for joining us today.
Speaker 3: Last week, we announced a strategic collaboration and investment agreement with AstraZeneca.
Last week, we announced the strategic collaboration and investment agreement.
Got it.
Speaker 3: The very proud finishing this partnership was one of the top leaders in the farmer space. Faring our strong commitment and ambition.
I'm very proud to initiate this partnership with one of the top leaders in the pharma space.
During our strong commitment and ambition.
Cell and gene therapy.
Hi, Astrazeneca.
Speaker 3: Because we have been very much impressed by the long-term strategy in the space backed by strong commitment and development already made paving the way powers a top leadership in the arena.
Because we have been fairly much impressed by the long term strategy in the space.
Backed by a strong commitment and development or what did you make paving the way towards a top leadership and the screen.
Speaker 3: strongly believe that together, this AstraZeneca, that next generation of genomic medicine
We strongly believe that together.
Astrazeneca that next generation of genomic medicine will.
Speaker 3: will be developed under our collaboration to revolutionize medicine across a number of therapeutic areas in the.
They'll be developed under our collaboration.
Revolutionize medicine across a number of therapeutic areas.
In the years to come.
Okay.
Speaker 3: Part of our agreement, after IZeneca, has agreed to make an initial payment of $105 million to select this composed of $18 million equity investment in exchange of 16 million ordinary shares at $5 per share. And a $25 million of fund payment under the research collaboration agreement. And a $25 million of fund payment under the research collaboration agreement.
That's part of our agreement Astra Zeneca has agreed to make an initial payment of $105 million to selected composed of $80 million.
Investment in exchange of 16 million.
Ordinary shares at $5 per share.
$25 20.
$25 million upfront payment under the research collaboration agreements.
Okay.
Speaker 3: Select this is also a legitimate to receive an additional $114 million equity investment in exchange for $28 million convertible preferred shares at $5 per share. Subject to select a shareholder's approval and several other conditions of closing. Third ? Club Group 200.
Electric is also in digital to receive an additional $114 million equity investment.
Exchange for 28 million convertible preferred shares at $5 per share subject to select the shareholders' approval.
Several other conditions of closing.
Now some words about the research collaboration.
Speaker 3: The very ambitious proposal to develop novel felon gene therapies across ecology, immunology and rare disease.
It's very ambitious proposals to develop novel cell and gene therapies across ecology, immunology and rare diseases.
Speaker 3: has exclusively reserved 25 genetic targets for AstraZeneca, from which up to 10 level candidate products could be explored for the blood.
Have exclusively reserved 25 genetic targets for Astrazeneca from which.
10 novels candidate pulled up could be explored for at the Bluffton.
Speaker 3: The beauty of this agreement is that our clinical stage assets, UCAR T22, UCAR T123, and UCAR T20 by 22, remain under our own ownership and control. And you should expect regular updates in the advancement of these programs for us.
Q2 of this agreement is that our clinical stage assets, you're correct. You're 22, you'll catch you want your suite and you cut your 'twenty by 'twenty two.
Under our own ownership.
And control and you should expect regular updates and the advancement of these programs Baas.
Within the collaboration.
Speaker 3: Within the collaboration, we will leverage our cutting-edge innovation and best-in-class manufacturing capabilities.
We will leverage our cutting edge innovation and best in class manufacturing capability.
Speaker 3: develop new disruptive product candidates. And after Adenica, we'll have an option for worldwide exclusive license on 10 of the candidate products. We exercise before R&D file.
New disruptive product candidate.
Astrazeneca will have an option for a worldwide exclusive license on 10 of the candidate Chromebooks.
The exercise before IND filing.
Speaker 3: Our research costs under the collaboration will be funded by AstraZeneca and were eligible to receive the 9D option fee and development regulatory and sales related milestone payment ranging from $70 million and up to $220 million. For each of the 10 candidate products plus cured roles.
Our research costs under the collaboration will be funded by Astra Zeneca, and we're eligible to receive a 90 option and give bachman.
POI and field related milestone payments, ranging from $70 million and up to $220 million.
Each of the.
And do they pulled off plus tiered royalties.
Speaker 3: We're very excited to get to work with AstraZeneca to leverage our capabilities and build the next generation of genomic medicine to address area of high unmet patient needs together.
We're very excited to get to work with Astrazeneca to leverage our capabilities and build the next generation of genomic medicine to address areas of high unmet.
Patient needs together.
During the.
Speaker 3: During this past third quarter, Selective Innovation Team excelled in releasing disruptive preclinical data on gene editing of hematopoietic stem cell gene therapy for an innovation.
Third quarter.
Like this innovation.
So.
Leasing disruptive preclinical data on gene editing.
Hematopoietic stem cell gene therapy.
Mineralogical busy.
Speaker 3: Data on our proprietary TAL-based editor technology and a multi-armored allogenic CAR-T cell targeting MUC1 for triple-negative breast cancer, demonstrating one more time the span and the power of our gene-editing platform.
Peter on our perpetual a powered base technology.
And a multi arm or allogeneic car T cell targeting mark one for triple negative breast cancer, demonstrating one more time to spend and the power of our gene editing platform and to develop next generation cell and gene therapies for patients with unmet medical needs.
Speaker 3: and to develop next generation cell and gene therapies for patient with unmet medical needs. In addition, our plan...
In addition.
Our clinical team will be presenting update.
Speaker 3: of results for the phase one BALY01 trial of UCAR T22 and preliminary results of the NATALY01 trial evaluating UCAR T20 by 22 in refractory and relapsed B cell not Hodgkin lymphoma at the American Association of Immunology Annual Meet.
Our results for the phase one valleys tier one trial of Truecar to 'twenty, two and frame under where the results of the knockdown easier. One trial is evaluating your car T 20 by 22 in refractory or relapsed B cell non Hodgkin lymphoma at American Association of Hematology.
Annual meeting.
Speaker 3: But I will let Mark, in a couple of minutes, talk about these aspects.
I will let mark in a couple of minutes to talk about these abstracts.
Speaker 3: However, one thing I would like to highlight in what Mark is going to present after is the importance of the know
However.
One thing I would like to highlight and what Mark is going to present after.
Is it worth it.
The know how and manufacturing.
Speaker 3: In cell therapies, nothing is more important than the fitness of the cell that will be injected to patients.
In cell therapies, nothing is more important that the fitness of the cell that will be injected into patients.
The quality.
Speaker 3: The reproducibility of manufacturing is one of the game changer in the success of these therapies.
The reproducibility of manufacturing is one of the game changer and the success of these therapies.
Speaker 3: This is why we have fully internalized manufacturing.
Why we have.
Fully internalize manufacturing now this work is totally completed.
Speaker 3: Now this work is totally completed and this is why it's going to make a difference.
This is why it's going to make a difference.
So like this will continue.
Speaker 3: The electives will continue to control strictly cash.
Strictly cash burn.
Speaker 3: within this difficult market environment. And we will continue to focus our effort and expenses on advancing our core clinical trials, BALY01 evaluating URQ-22, NAPALY01 evaluating URQ-20 by 22.
But then he is difficult to do.
This difficult market environment.
We'll continue to focus our effort.
And expenses on advancing our core clinical trials Bally's zero, one and now reaching your car T 22, Knockdowns zero on evaluating your question 20 by 'twenty two.
Speaker 3: And Amelie01 is violating UCAR T123.
And I'm always there one is evaluating new car to you 123.
Speaker 3: With that, I would like to turn the call over to Dr. Mark Fratini, our chief medical officer, who will give an overview of these clinical trials. Mark, please go ahead.
With that I would like to turn the call over to Dr. Mark Ritchie, our Chief Medical Officer.
Bill Gates enormous U S clinical trial Mark. Please go ahead.
Speaker 4: Thank you, Andre. We will be presenting updated results of the Phase 1 VALI-01 trial of UCART-22 in relapsed refractory B-cell acute lymphoblastic leukemia and preliminary results for the NATALI-01 trial evaluating UCART-20 by 22 in relapsed refractory B-cell non-Hodgkin lymphoma at the American Association of Hematology 65th Annual Meeting in
Thank you Andre we will be presenting updated results of the phase one Bali Oh, one trial of <unk> 22 in relapsed refractory b cell acute lymphoblastic leukemia and preliminary results for the Napoli one trial evaluating new card 20 by 20.
Two in relapsed refractory b cell non Hodgkin lymphoma at the American Association of Hematology.
<unk> annual meeting in December.
Speaker 4: As Andre just mentioned, regarding our clinical trial VALI-01 evaluating UCAR-22 in relapsed or refractory B-cell ALL, we have a comparison between a product manufactured at a CDMO, this is process one, and the same product manufactured in-house here at Selective.
As Andres just mentioned regarding our clinical trial Valeo, one evaluating <unk> 22 in relapsed or refractory B cell <unk>, we have a comparison between our product manufactured at a E. D. M. O. This is process one.
And the same product manufactured in house here at select it.
This is process too.
Speaker 4: In vitro comparability studies suggested that UCARD 22 process 2, manufactured by Selectives Biologics, is more potent than UCARD 22 process 1, manufactured by an outside CDMO.
In vitro comparability study suggested that <unk> 22 process to manufactured by selected biologics is more potent than <unk> 'twenty to process one manufactured by an outside E. D M O.
In June at the 8-K Congress. We showed you data of patients enrolled at dose level, three with 5 million cells per kilogram with <unk> 22 using process what.
Speaker 4: In June , at the EHA Congress, we showed you data of patients enrolled at dose level 3 with 5 million cells per kilogram with UCAR-22 using process 1.
Since then as of July one 2023, three patients were enrolled into the first you card 20 to tier two cohort.
Speaker 4: Since then, and as of July 1st, 2023, three patients were enrolled into the first UCART22 P2 cohort at dose level 2 at 1 million cells per kilogram.
Dose level, two at 1 million cells per kilogram.
Speaker 4: UCAR-22-P2 was administered after fludarabine, cyclophosphamide, and allumtuzumab, or FCA, lymphodepletion, and was well tolerated.
You heard 22, <unk> was administered after Fludarabine cyclophosphamide and Alan He's a mab or FCA lymphoid depletion and was well tolerated.
Speaker 4: No dose limiting toxicities or immune effector cell associated neurotoxicity was observed.
No dose limiting toxicities.
Our immune effector cell associated neurotoxicity was observed.
Speaker 4: And the CRS observed was grade one or two.
And the Crs observed was grade one or two.
Speaker 4: There was a higher preliminary response rate, 67%, at dose level two with one million cells per kilogram with UCAR-22P2 compared to a 50% response rate with a dose five times higher at dose level three of UCAR-22P1 that was manufactured by an outside CDMO.
There was a higher preliminary response rate 67%.
At dose level, two with 1 million cells per kilogram with new card 22 P. Two compared to a 50% response rate with a dose five times higher at dose level three of <unk> 22 P. One that was manufactured by an outside E. D. M O.
Speaker 4: UCAR-22 expansion was observed in the responding patients and correlated with increases in serum cytokine and inflammatory markers.
<unk> 22 expansion was observed in the responding patients.
Correlated with increases in serum cytokines and inflammatory markers.
Speaker 4: The study continues to enroll patients at dose level 2i, 2.5 million cells per kilogram with UCAR-22P2.
The study continues to enroll patients at dose level, two high $2 5 million cells per kilogram with your card 20 to tier two.
Okay.
We will also be presenting preliminary results of Natalie Oh, one study evaluating <unk> 'twenty by 'twenty two.
Speaker 4: We will also be presenting preliminary results of NATALI-01 study evaluating UCAR-20 by 22, the first allogeneic dual CAR T-cell product in patients with relapsed refractory B-cell non-Hodgkin lymphoma at the ASH meeting in December .
First allogeneic <unk> car T cell product in patients with relapsed refractory b cell non hodgkin lymphoma at the <unk>.
<unk> meeting in December.
In this case <unk> 20 by 22 has been fully manufactured in house by selective.
Our Raleigh manufacturing plant.
Speaker 4: As of July 1st, 2023, three patients were enrolled and treated at dose level one.
As of July one 2023, three patients were enrolled and treated at dose level one.
Here, we are using a flat dose of 50 million cells for patients over 50 kilograms.
Speaker 4: Here we are using a flat dose of 50 million cells for patients over 50 kilograms.
Speaker 4: Cytokine release syndrome grade 1 or 2 occurred in all patients and all CRS resolved with treatment.
Cytokine release syndrome grade, one or two occurred in all patients and all Crs resolved with treatment.
Speaker 4: No immune effector cell-associated neurotoxicity or graft-versus-host disease was observed.
No immune effector cell associated neurotoxicity or graft versus host disease was observed.
There were no <unk> 2022 dose limiting toxicity and there was one.
Speaker 4: There were no UCAR 20 by 22 dose-limiting toxicities, and there was one CLLS52 or alum-tuzumab DLT.
I'll ask <unk> to our island choose the Mab DLP.
Speaker 4: All patients responded at day 28 with one partial metabolic response.
All patients responded at day 28, with one partial metabolic response.
Speaker 4: and two complete metabolic responses in patients who had failed prior autologous CD19 CAR T-cell therapy.
And to complete metabolic responses in patients who had failed prior autologous CD 19 car T out there.
Speaker 4: UCAR 20 by 22 expansion correlated with increases in serum cytokine and inflammatory marker levels as well as with cytokine release.
You acquired 20 by 'twenty, two expansion correlated with increases in serum cytokines and inflammatory marker levels as well as with cytokine release syndrome.
Yeah.
Speaker 4: These initial data, with 100% responses at the initial dose of 50 million cells per patient, supports the continued study of UCAR-20x22 in relapsed refractory B-cell NHL, and the study continues to enroll.
These initial data with 100% response is that the initial dose of 50 million cells per patient supports the continued study of your card 20 by 'twenty two in relapsed refractory B cell NHL and the study continues to enroll.
Speaker 4: Lastly, our OMILY-01 study evaluating UCART-123 in patients with relapsed or refractory acute myelogenous leukemia continues to progress and enroll patients in the FCA two-dose regimen arm.
Lastly, our Emily Oh, one study evaluating <unk> three in patients with relapsed or refractory acute myelogenous leukemia.
<unk> to progress and enroll patients in the FCA two dose regimen or.
Speaker 4: With that, I would like to hand the call over to Dr. Bing Wang, Selectus' Chief Financial Officer, for an overview of our financials for the third quarter of 2023.
With that I would like to hand, the call over to Dr. Being one selected Chief financial officer for an overview of our financials for the third quarter of 2023.
Ben Please go ahead.
Speaker 4: Thank you, Mark. I would like to highlight that in our financials, the cash cash equivalent and restricted cash position of selectives, excluding killing as of September 30th, 2023.
Thank you Mark.
I would like to highlight that in our financials, our cash cash equivalent and restricted cash position of selective excluding calix.
As of September 30th 2023.
It was $72 million compared to 95 million as of December 31, 2022.
There's $23 million difference, mainly reflects $79 million of cash out switching.
Which includes 23 million for R&D.
Speaker 4: $12 million for SG&A, $32 million for staff costs, $8 million for rent and taxes, $4 million of reimbursement of the people.
12 million for SG&A 32 million for staff costs.
8 million for rent and taxes four.
<unk> 4 million of reimbursement of the PGE loan.
Speaker 4: and $2 million unfavorable impact on foreign exchange, partially offset by a $23 million net cash inflow from the capital raise closed in February .
And 2 million unfavorable impact of foreign exchange, partially offset by a 23 million net cash inflow from the capital raise close in February.
Speaker 5: and a $21 million net cash inflow from the European Investment Bank loan. A $6 million of net cash received from the research tax credit pre-finance.
And a 21 million net cash inflow from the European investment Bank loan.
$6 million of net cash received from the research tax credit refinancing.
Speaker 5: A $1 million cash inflow related to the grant, and refundable VANS from VPI.
A 1 million cash inflow related to the grants are refundable bands from BPI three.
Speaker 5: $3 million of financial investments, capital gain in interest, and $1 million in reimbursement of social charges paid on stock options.
$3 million of financial investments capital gain in interest and 1 million reimbursement of social charges paid on stock options and.
Speaker 5: and a $2 million net cash inflow from licenses and other cash.
And a 2 million net cash inflow from licenses and other cash receipt.
Speaker 5: With cash and cash equivalent of $67.4 million as of September 30, 2023, and the $105 million from the AstraZeneca agreement.
With cash and cash equivalents.
Seven 4 million as of September 30th 2023, and a 105 million from the Astrazeneca agreement.
Speaker 5: The company believes that we have sufficient resources to continue operating for at least 12 months following the consolidated financial statements publication.
The company believes that we have sufficient resources to continue operating for at least 12 months following the consolidated financial statements publication.
Additionally, the Mou contemplates that Astrazeneca will make a potential further equity investment and stuff like that up $140 million by subscribing to newly created class of convertible preferred shares are selected.
Speaker 5: Additionally, the MOU contemplates that AstraZeneca will make a potential further equity investment in Selective of $140 million by subscribing two newly created classes of convertible preferred shares of Selective.
Speaker 5: If confirmed, the closing of the additional investment will remain subject to selected shareholder approval.
We have confirmed the closing of the additional investment will remain subject to select the shareholder approval.
With a two thirds majority of the votes cast by voting shareholders and the clearance of such investment from the French Ministry of economy. According to the foreign direct investment French regulation.
Speaker 5: two-thirds majority of the votes cast by voting shareholders and a clearance of such investment from the French Ministry of Economy according to the foreign direct investment French regulation and other
And other customary closing conditions.
Speaker 5: concurrent with these additional 140 million and are anticipated borrowing of 15 million euros under the tranche fee of the 40 million euro finance contract.
So current with these additional $140 million.
Our anticipated borrowing of 15 million euros under the tranche b of the 40 million Euro.
Finance contract with the European investment Bank account.
The company believes that we would extend its cash runway into 2026.
Speaker 5: The closing of the proposed Calix merger was finalized on May 31st of 2023.
The closing of the proposed Calix merger was finalize on May 31 2023.
Consequently, calix was de consolidated and presented as discontinued operation in our financial statement only until May 31 2023.
Speaker 5: Consequently, Calix was deconsolidated and presented as discontinued operation in the financial statement only until May 31st, 2023.
Speaker 5: The net loss attributable to shareholders of selectives was $58 million, or $1.07 per share.
The net loss attributable to shareholders of select this was $58 million or $1 seven per share.
Speaker 5: for the nine month of 2023, of which 53 million was attributed to select as continuing operation compared to 79 million, or $1.74 for sure, for the nine month ended September 30th, 2022, of which 73 million was attributed to select as continuing operation.
For the nine months of 2023.
Of which $53 million was attributed just felt like discontinuing operation compared to $79 million or $1 74 per share for the nine months ended September 32022.
$73 million was attributed to select as continuing operations.
The 21 million decrease in net loss between the first nine months of 2023, and 2022 was primarily driven by a $14 million decrease of R&D expenses.
Speaker 5: The $21 million decrease in net loss between the first nine months of 2023 and 2022 was primarily driven by a $14 million decrease of R&D expenses, a $4 million decrease of S&P.
A formula and decrease of SG&A expenses.
And also an increase of $4 million or the financial gain due to the deconsolidation of calix compensated in part by the decrease of fair value of site Tovia note receivable.
Speaker 5: and also an increase of $4 million of the financial gain due to the deconsolidation of Calix compensated in part by the decrease of fair value of Cytovia's note receivable and a decrease of $2 million of loss from the discontinued operations attributable to
A decrease of $2 million loss from the discontinued operations.
Attributable to the shareholders is selected.
Speaker 5: These downward impacts on the net loss are partially offset by a decrease of $1 million in revenue and others.
These downward impact on the net loss were partially offset by a decrease of $1 million revenue and other income.
The adjusted net loss attributable to shareholders of selectors, which excludes noncash stock based compensation expenses was $57 million or $1 <unk> per share in the first nine months period of 2023 compared to a loss of $72 million or $1 <unk>.
Speaker 5: The adjusted net loss attributable to shareholders of Selectus, which excludes non-cash stock-based compensation expenses, was $57 million.
Speaker 5: $1.05 per share in the first nine month period of 2023 compared to a loss of $72 million or $1.58 per share in the first nine month of 2022.
<unk> per share in the first nine months of 2022.
Speaker 5: We are laser-focused on spending our cash on developing our clinical candidates and operating our state-of-the-art manufacturing facilities in Paris and in Raleigh.
We are laser focused on spending our cash on developing a clinical candidate and operating our state of the art manufacturing facility in Paris and in Raleigh.
Speaker 5: In addition, our focus on maintaining an efficient corporate infrastructure should also enable more limited growth in G&A.
In addition, our focus on maintaining an efficient corporate infrastructure should also enable more limited growth in G&A spend.
Speaker 5: At this point, I'd like to hand it back to Andre for closing remarks. Thank you.
At this point I'd like to hand, it back to Andreas for closing remarks.
Thank you Bing.
Close out this call.
Speaker 3: I would like to reiterate how excited we are about the strategic collaboration with AstraZeneca and how much confident we are about the continued progress of our three ongoing clinical trials in metallurgical malignancies as well as our continued development of our preclinical program.
I would like to reiterate how excited we are about the strategic collaboration with Astrazeneca and how much confident we are about the continued progress.
Three ongoing clinical trials.
Colleague physical malignancies.
Well I thought would continue the bluffton.
The clinical program.
So like this.
We strongly believe that our product candidates or technologies.
Speaker 3: We strongly believe that our product candidates, our technologies and our in-house manufacturing capabilities will lead us.
House manufacturing capabilities will lead us.
Speaker 3: 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.
And our partners to a paradigm shift for patients with hard to treat cancers positioning.
From this promising medical and scientific field.
Speaker 6: With that, I would like to open the call for questions and answers.
With that I would like to open the call for question and answers.
Thank you.
Speaker 1: Ladies and gentlemen, we will now be conducting a question and answer session.
Ladies and gentlemen, Viva and I'll be conducting a question and answer session.
Speaker 1: If you would like to ask a question, please press star and 1 on your telephone keypad.
If you would like to ask a question. Please press star and one on your telephone keypad.
Speaker 1: A confirmation tone will indicate your line is in the question queue.
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.
Speaker 1: You may press star and 2 if you'd like to remove your question from the queue.
Speaker 1: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the stock east.
Speaker 1: Ladies and gentlemen, we will wait for a moment while we poll for questions.
Ladies and gentlemen, we will wait for a moment, while we poll for questions.
Our first question is from Kelly <unk> with Jefferies. Please go ahead.
Speaker 1: Our first question is from Kelly Shee with Jeffries. Please go ahead.
Hi, This is Dave on for Kelly. Thank you for taking our question and Oh, Congratulations on the update I have one question on you've got Kony late 'twenty two you should Uh huh.
Speaker 7: Hi, this is Dev on for Kailashi. Thank you for taking our question, and congratulations on the updates. I have one question on UCAR-20 by 22. You showed a
Speaker 7: Great result at DL1. So my question is, do you plan to increase the enrollment sites? And how many dose levels do you anticipate to study before finalizing the RP2D?
Great Okay.
One. So my question is do you plan to increase the enrollment sites and how.
How many dose levels do you anticipate to steady before finalizing the IP Judy Thank you.
Great. Thank you very much for this first question, which will go to Mark.
Speaker 2: Great. Thank you very much for this first question, which will go to Mark.
Speaker 4: Hi, thanks for the question. And yeah, we will, you know, we anticipate doing an escalation, obviously. And the data from the subsequent escalation will obviously determine, you know, where we stop and call in our P2D. So right now it's to be determined with clinical data.
Hi, Thanks for the question.
And yes, we will we anticipate doing.
And escalation, obviously and the data from the subsequent escalation will obviously determine you know where we stop and call on our Pizza U D. So right now it's right now it's to be determined with the clinical data.
Thank you.
Thank you.
Speaker 1: Our next question is from the line of Gina Wong with Barclays.
Our next question is from the line of Gena Wang with Barclays.
Please go ahead.
Yeah.
Speaker 8: So, we have two questions on your clinical programs. One is that you previously guided UCARTI 1 to 3, I believe, by end of 2023. May I ask, like, the timeline for now, would it be a sleep breaker for ASH? And another question is the next step for UCARTI 22. You mentioned about potential to advance to pivotal study without further dose escalation. Is that still the plan? Thank you. Great. Thank you.
This is <unk> on China. So we have two questions on your clinical programs. One is that you previously guided your card you went to three I believe.
Plenty plenty third.
Max like the timeline for now would it be late breaker for Ash and another question is the next step for <unk> to you.
About potential to advance two pivotal studies without further dose escalation is that still the plan. Thank you.
Great. Thank you very much for both questions.
Keep in mind.
Speaker 4: Thank you. So, for 123, as you know, we began at ASH last year. We announced how we were remodeling the treatment program to include a two-dose regimen. And we are continuing in that two-dose regimen in dose escalation. So, we anticipate that, you know, we will reveal clinical data at some point next year.
Thank you so for 123 as you know we began.
At Ash last year, we announced how we were remodeling the treatment program to include a two dose regimen.
And we are continuing in that two dose regimen and dose escalation. So we anticipate that.
We will rebuild clinical data at some point next year.
Speaker 4: And in terms of 22 study, yes, we, in fact, we even pointed out in the abstract for ash that we have those escalated to 2.5 million cells per kilo with the 22P2 product.
And in terms of 22 study.
Yes, we in fact, we even pointed out in the <unk>.
<unk> for Ash that we have dose escalated to $2 5 million cells per kilo.
With the 22 P two products so.
Speaker 4: So we will see where that data bears us out and as we move ahead.
We will see.
Where that data bears this out and.
As we move ahead.
Okay.
Do you have any questions.
Speaker 8: Oh, thank you so much for taking our questions. Maybe one last follow-up question on the AstraZeneca deal. Is there a timeline that they have to select certain lead targets? And would you only get to keep it as your own, like only hold, if they turn it down, turn some targets down?
Oh. Thank you so much for taking our questions maybe one last follow up question on the Astrazeneca deal.
Is there a timeline that they have to select certain targets and would you only get a Cuba, Cuba, that's your own like only hold.
If they turn it down.
Some targets down.
Speaker 2: Sorry, I'm not sure I understood the, this is Arthur, I'm not sure I understood the end of the question. But definitely, so as part of the agreement, AstraZeneca will have to choose up to 10 candidate products from a pool of 25. And then once the 10 products are selected, the remaining non-selected targets will come back to us.
Alright, I'm not sure I understood the Edison Arthur I'm not sure I understood. The end of the question.
Definitely so as part of the agreement.
Nick I will have to choose up to 10 candidate products from a pool of 25.
And then once the 10 products are selected.
The remaining non selected targets will come back to us.
Okay got it thank you.
Thank you.
Speaker 1: Our next question is from the line of Yeagel-Notormovitz, which city? Please go ahead.
Our next question is from the line of vehicle Nacho move it with Citi. Please go ahead.
Speaker 9: I came this is Carly on for you. Thanks for taking our questions to from us.
Hi, Jim This is Carly on for Yigal, Thanks for taking our questions.
Two from US first on 'twenty.
Speaker 9: First, on UCART 22 and 20x22, just wanted to clarify if we should expect.
'twenty, two and 'twenty by 'twenty two just wanted to clarify if we should expect data on additional patients at ash relative to the abstract or well the ash data be focused on longer term follow up from the patients just the patients included in the abstract and then the second question is on the potential.
Speaker 9: data on additional patients at ASH relative to the abstract or will the ASH data be focused on longer-term follow-up from the patients, just the patients included in the abstract? And then the second question is on the potential additional $140 million equity investment from AstraZeneca. Just wondering if you can clarify if there's a specific trigger for that from AstraZeneca's side and what the potential timing might be. Thank you.
$140 million equity investment from Astrazeneca, just wondering if you can clarify if there's a specific trigger for that from astrazeneca side and what's the potential timing might be thank you.
Speaker 2: Great, so I'll hand it over to Mark for the first clinical question and then I'll take the question on the AZD.
Great. So I'll now hand, it over to Mark for the first clinical question and then I'll take the question on the deal.
Speaker 4: So thank you, yes, for in terms of the two abstracts that we will be presenting, we will be presenting some follow-up on the patients described in the abstract.
Okay. Thank you, yes for us in terms of the two abstracts that we will be presenting we will be presenting some.
Follow up on the patients described in the abstract.
Speaker 2: Yes, on the 140 million, so this is subject to a few closing conditions, including approval of our shareholders at a two-third majority of the vote cast, clearance according to foreign direct French, foreign direct investment French regulations, and a couple of other customary closing conditions. We're working expeditiously to finalize these.
Yes.
$140 million. So this is subject to a few closing conditions.
The building approval of shareholders at the two thirds majority of the votes cast.
Kieran According to foreign Derek French.
Foreign direct investment French regulations, and a couple of other customary closing conditions.
Working expeditiously to finalize these.
Okay got it thank you.
Thank you.
Speaker 1: Our next question is from Hartaj Singh with Oppenheimer, please go ahead.
Our next question is from <unk> Singh with Oppenheimer. Please go ahead.
Great. Thank you. Thanks for the update I got two questions. One is you are starting to show some complete responses in <unk>.
Speaker 10: Great, thank you. Thanks for the update. I got two questions. One is you're starting to show some complete responses in in Bali and
In Valeant nationally.
Speaker 10: I was wondering, what would you view as sort of like a durability, from a durability perspective, how many months of follow-up would you like to see and, you know, when you could classify these as being very, you know, durable responses, especially on the CR side? And my second question is just specific to UCART 1, 2, 3. Have you switched over to the commercial product there also, and if not, what's the timing on that? Thank you. Thank you.
I was wondering what would you view as sort of like a durability.
From a durability perspective, how many months of follow up would you like to see.
When you when you could classify these as being very durable responses, especially on the CR side and my second question is just specific to <unk>.
123 have you switched over to the commercial product there also and if not what's the timing on that thank you.
Okay.
Thanks for those questions and Marc over to you.
Thanks for the question so I'll start with the 123 first and for the 123, we are still currently using that the CMO made.
Speaker 4: Thanks, Hitesh, for the question. So I'll start with the 123 first. And for the 123, we are still currently using the the CDMO made product for 123 and
Product for $1 23, and.
Speaker 4: That's where we are with that right now. In terms of your 1st question, yes, we are.
That's where we are with that right now.
In terms of your first question.
Yes, we are.
Speaker 4: Definitely seeing CRs as you pointed out in the two studies. I think importantly, the stress for the 20 by 22 studies at the initial dose level, we did see two metabolic CRs and these were in patients that failed prior CD19 CAR-T in addition to several other therapies.
Definitely seeing Crs as you pointed out in the two studies.
Importantly, the stress for the 20 by 'twenty two studies at the initial dose level we.
Did see two metabolic Crs and these were in patients that failed prior CD 19 car T.
In addition to several other therapies, so I think in the setting of 19 failures.
Speaker 4: So I think in the setting of 19 failures, having two CRs.
Moving to see ours.
Speaker 4: is great news at this dose level. I think in terms of your question for durability, I think that remains to be seen given the line of therapy that we're in and giving the extensive therapies that these patients have been relapsed and refractory from. You know, I think at some point looking in the three to six-month range is not unreasonable to look for a good duration of response in these patients.
That is great.
It's great news at this dose level.
I think in terms of your question for durability, I think that remains to be seen given the line of therapy that we're in and giving the extensive therapies that these patients have been.
Relapsed and refractory from you know I think at some point looking into three to six month range is not unreasonable.
To to look for good duration of response in these patients.
Great. Thank you Mark Thanks for all the questions.
Speaker 1: Thank you. Our next question is from Jack Allen with Baird. Please go ahead.
Thank you.
Our next question is from Jack Allen with Baird. Please go ahead.
Alright, thanks for taking the questions and congratulations to the team on the progress my.
Speaker 11: All right, thanks for taking the questions and congratulations to the team on the progress. My question is also as it relates to the ASH abstracts. Really impressive results out of the UCAR 20 by 22 program at the first dose level here. I was wondering to see if the team had any comments about the need to escalate dose or are you satisfied with the early results you're seeing here? Love to hear about that.
My question is also as it relates to the ash abstract.
Really impressive results out of the <unk> 2022 program.
At the first dose all Bahir I was I was wondering to see if the team had any comments about the need to escalate dose.
Are you satisfied with the early results were seeing here love to hear about that.
Alright.
Speaker 4: Hi, Jack, thanks for the question. And yeah, as you point out, three out of three responders at the initial dose level, and as also, you can see the safety was was.
Hi, Jack Thanks for the question yes.
As you point out three out of three responders at the initial dose level.
And as also you can see the safety was.
It was.
Speaker 4: quite good at this dose level as well. And I think given both of those facts, you know, we will be, we will in fact be dose escalating this study just, you know, to see where we can get at the next higher dose level. So stay tuned for that.
<unk> quite good at this dose level as well and I think given given both of those facts. You know we will be we will in fact be dose.
Dose escalating.
Study.
Just to see where we can get it at the next higher dose level. So.
Stay tuned for that.
Speaker 11: Yeah, and then just 1 brief follow up as it relates to longer follow up on these patients. Can you provide some context around when the data cut was taken for ash and what you expect to present the conference? And then just to clarify, we should be primarily focused on additional data from the 1st, 3 patients rather than a 2nd dose cohort as well.
Got it and then just one brief follow up.
As it relates to longer follow up on these patients could you provide some context around when the data cut was taken for ash and what you expect to present at the conference and then just to clarify we should be primarily focused on additional data from the first three patients rather than a second dose cohort as well.
Speaker 4: Yeah, so we'll be focusing on the first three patients for the poster presentation.
Yes, so we'll we'll be focusing on on the first three patients for the poster presentation.
Okay.
Speaker 11: Any thoughts on additional kind of follow-up or what kind of follow-up we could expect from those three patients at the conference?
That's an additional kind of follow up there or what kind of thought if we could expect from those three patients at the conference.
Speaker 4: You know, so we'll, you know, we'll give some further follow-up that we have on them. So please come by and visit us at the poster.
Hi.
We will give some further follow up that we have on them. So please come by and visit us at the poster.
Yes.
Great. Thanks, so much.
Thank you.
Speaker 1: Our next question is from Salveen Richter with Goldman Sachs, please go ahead.
Our next question is from <unk> Richter with Goldman Sachs. Please go ahead.
Hi, This is <unk> on for Toby and thanks, so much for taking our question.
Speaker 12: Hi, this is Lydia on for Salveen. Thanks so much for taking our question. Could you just remind us of the strategy for UCART 20 by 22 in terms of the targeted patient population given the positive data at ASH?
Could you just remind us of the strategy for your car 20 by 'twenty two in terms of the targeted patient population given the positive data at ash.
Thank you very much for the question that would be for Mark.
Speaker 4: Hi. Yeah, thank you for the question. So, you know, we are, this is in third line or greater that we're using this, and this is prior CD19 failures are also included in this study, so that's where we're continuing.
Hi, yes. Thank you for the question so.
This is in third line or greater that we're using this and this is prior CD 19 failures are also included in this study so that's where we're continuing.
Thanks, so much.
Thank you.
Speaker 1: Our next question is from the line of Sylvain Toccon with JMP Securities. Please go ahead.
Our next question is from the line of Silvana, Doug Kahn with JMP Securities. Please go ahead.
Hi, good morning, and congrats and thanks for taking my question.
Speaker 11: Hey, good morning and congrats and thanks for picking my question.
Speaker 11: My first question is, now that you have human data with UR22, with product 1 and product 2, do we know what
My first question is.
Now that you have human data.
'twenty two.
On a product to do we do we know what why products to so much more important how you measure it sounds like cytokines or et.
Speaker 11: why product two is so much more potent. Do you have any measures of cytokines or more extension peaks, et cetera? And then a second question is, are there any more near-term milestones associated with allergens, anti-CB70 or anti-clotin 18.2 programs that you could be getting?
Et cetera, and then my second question is are there any more near term milestones associated with allergy anti CD 70, or Anticlotting 18.2 programs that you could be getting thank you so much.
Speaker 2: Great, thank you very much for both questions. I'll hand it over to Andre for the.
Great. Thank you very much for both questions.
And it over to Andre for the first one.
Speaker 3: Yeah, hi, thank you very much for the nice question, because I think that the manufacturing definitely makes a huge difference. And as Mark described in his presentation, there is process one that was the process that was used at the CMO initially, and the one we've implemented after internally, there's process two. So there's like few things that have changed. We know exactly why.
Hi, Vincent and thank you very much for the nice question.
Because I think that the manufacturing that does they makes a huge difference.
And as Mark described in his presentation. There is process. One that was the process that was used at the CMO initially and the one we've implemented after internally there's process two scenarios like few things that have changed.
We know exactly why.
Speaker 3: uh one day someone asked me a question in about how we do it how we can do cells that have so much potent
One day someone asked me a question about how we do it how we can do cells that have so much potency.
Speaker 13: And let me tell you, I'm going to share the secret with you here online, so I see all the faces around me. It's awkward. Oh, Andre, don't do this. Yeah, I'm going to do it.
And let me tell I'm going to share to see quick with you here online so I see all the faces around lean.
Sure.
All the adult do this I'm going to do it.
Speaker 13: But we've done close to 10,000 batches internally in process of love.
Well, we've done close to 10000 batches internally in process development.
Speaker 13: We've done and crushed and crushed and crushed cells and tweaked every parameter and are hundreds of parameter. This is called experience.
We've done and crushed and crushed and cross sells and tweaked every pyrometer <unk> hundreds of parameter this is called experience.
Speaker 13: And we are the ones that have invented the concept of allergenic CAR T. I can tell you, the process didn't come out like this from the ground. It took a long time before we got to the point where we are. And today, I think that we're probably, you know, the best on the planet to do allergenic CAR T.
We are the ones that have invented the concept of allogeneic car T. I can tell you that.
Like the post that didn't came out like this like from from the ground. It took a long time before we got to the point, where we are in today I think that would probably.
You know the best Underplanted to do Allogeneic car T.
Speaker 13: As Mark said, come at our poster session at ASH. Watch the expansion of the cells, even at super low doses. You will see what it means to have such type of experience. And experience cannot be invented in a day. It can be transmitted, but we do not transmit these 10 years of crushing batch after batch, small, midsize, large size batch, NGMP conditions, et cetera, up to the time we have tweaked all parameters to perfection. Thank you.
As Mark said come at our poster session at Ash.
<unk> the expansion of the cells, even at Super low doses, you will see what it means to us.
As such type of experience and experience cannot be invented in a day it can be transmitted but we do not transmit the 10 years of <unk>.
Crushing batch after batch a small midsize and large size batch in GMP conditions et cetera up to the time, we have tweaked old parameter to perfection.
That's the answer.
Speaker 2: And for the allergy? Okay. Thanks, Andre. And on the allergen question, so we definitely have a significant vested interest in allergen success, just remembering up to 410 million in development and sales milestones for CD19 through our agreement with Servier and up to 2.8 billion in development and sales milestones.
And for the algae, thanks, Andrzej and on the LNG question. So we definitely have a significant vested interest analogies success, just remembering up to $410 million in development and sales milestones for 2019 through our agreement with the <unk> and up to $2 8 billion in development and sales milestones.
Speaker 11: So, we haven't disclosed the granularity of the milestones, but we'll definitely communicate that and when allogene hits those milestones and we get the amounts in our bank. Great. Thanks for revealing the sequence.
So we haven't disclosed the granularity of the milestones, but we'll definitely communicate that didn't win.
<unk> hit those milestones and.
And we get at the amounts in our bank.
Great. Thanks for revealing the secret sauce.
[laughter].
Speaker 1: Thank you. Our next question is from the line of Yannan Zoo with Wells Fargo. Please go ahead.
Thank you.
Next question is from the line of Jonathan Xu with Wells Fargo. Please go ahead.
Okay.
Speaker 14: Hi. Congrats on the progress. This is Kwan Ang for Yan'an. So my question is on UCAR T22. So can you give us more detail about the Grade 5 AE that was revealed in the abstract and how that may affect the further study contact? Thank you.
Hi, Congrats on the progress. This is kwan for Yanan. So my question is on new car T. 22, So can you give us more detail about the great buy.
And that was rebuilt in the abstract and how that may affect the further study contacts. Thank you.
Thank you for the question and this will be for Mark.
Speaker 4: Yeah, so as, you know, as it revealed in the abstract, this grade 5 event happened after long after, you know, several couple of weeks after the day 28 assessment in this patient who had a morphologic leukemia free state. So it was bacterial infection that the investigator related, you know, related to everything, which is. Yeah. Yeah.
Yeah. So as you know as we rebuild in the abstract this.
Grade five events.
Happened.
Happened after long several a couple of weeks after the day 28 assessment in this patient who had a morphologic leukemia free state so as bacterial infection that the investigator related.
Related to everything which is.
Speaker 4: uh, why it's there. So, um, it's really not affecting, you know, anything as we move, move ahead.
Why it's there so.
It's really not affecting.
Anything as we move move ahead.
Got it and.
Speaker 2: Got it. And is there a way to like quantify how much of that?
Yeah.
Is there a way to.
Thank you quantify how much of that was contributed by the <unk>.
Speaker 14: the UCAR T22 itself or the link multiplication. Thank you.
You called a 'twenty two yourself or the depletion.
Yes, so there is.
Speaker 4: You know, as we'll show on the poster, there's a level of expansion that was seen with these cells by flow cytometry. At the time point of this event happened, we don't believe there were any UCAR-22 cells remaining.
As we will show on the poster there's a level of expansion that it was seen with these cells by flow cytometry.
At the time point of this is van happen.
We don't believe there were any new card 22 cells remaining.
Speaker 4: So we think that the likelihood, it was less related to UCAR-22. This was a patient who was, again, as outlined in the abstract, was super heavily pretreated.
So we think that the likelihood that was less related to <unk> 22. This was a patient who was again as outlined in the abstract was super heavily pretreated <unk>.
Speaker 4: You know, they failed allotransplant, they failed prior autologous CAR-T times two infusions, they failed multi-agent chemo, and they also failed linitumumab, inotuzumab, and venetoclax. So, the cumulative dosing of the prior chemo that they made in going into the study, very hypocellular, explains some of the issues that developed.
Failed allo transplant. They failed prior autologous car T times, two infusions, they failed multi agent chemo and they also available in a tumor <unk> man and banana class. So.
The cumulative dosing of the prior chemo that they made in going into this study very high.
Barry Hypo cellular.
Explain some of the.
Issues that developed.
Got you that's super helpful. Thank you so much.
Thank you.
As there are no further questions I would now hand, the conference silver to Andre <unk> CEO for closing comments.
Speaker 1: As there are no further questions, I would now hand the conference over to Andre Cholika, CEO , for closing comments.
Well first of all I would like to thank the team for helping in doing the KOL here, it's been a pleasure to prepare this together and I would like very warmly. Thank all the analysts that have been following the company and supporting and watching what we're doing.
Speaker 13: Well, first of all, I would like to thank the team for helping in doing the call here. It's been a pleasure to prepare this together. And I would like very warmly thank all the analysts that have been following the company and supporting and watching what we're doing is very valuable. And I would like to make a special word also to our long term shareholders that have been continuously supporting the company over the past years.
It's very valuable and I would like to make a special word also to our long term shareholders that has been continuously supporting the company over the past years and.
I hope that the.
The company is going to have like a very strong end of 'twenty, three and 'twenty four 'twenty five 'twenty six.
Speaker 13: So we'll come up very soon for an update on the progress. Thank you very much.
So.
We will come up very soon for an update on the progress. Thank you very much.
Speaker 1: Thank you. The conference of selectors has now concluded. Thank you for your participation. You may now disconnect your lines.
Thank you.
Conference of selective has now concluded. Thank you for your participation you may now disconnect your lines.
Yeah.
Yeah.
Yeah.
Yeah.
Hum.
Hum.
Hum.
[music].