Q1 2021 Allogene Therapeutics Inc Earnings Call

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Operator, you of conference call of the scale to the game showed me. Please continue at the standby.

Operator: Your conference call is scheduled to begin shortly. Please continue to stand by. Thank you.

Speaker: The Oh, and so on, and so, and so, and so, and so, and so, and so, and Thank you. Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to Al out.

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Good afternoon, ladies and gentleman. Thank you for standing by and welcome to the allergy Therapeutics first quarter of blended blunt one conference call. After the speaker's presentation, there will be a question and answer session.

Operator: and welcome to Allo Gene Therapeutics' First Quarter, 2021 conference call. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press Star 1 on your telephone keypad. If you require any further assistance, please press Star 0.

The asked the question during the session you will need the press star one on your telephone keypad. If you require end of Bridger assistance. Please press star zero.

Operator: Please be aware that today's conference call is being recorded. I would now like to turn the call over to Christine Gassiano, Chief Communications Officer. Miss Gacciano, please go ahead. Thank you, Operator, and welcome to our first quarter 2021 conference call. After the market closed today, Allerging issued a press release that provides a corporate update and financial results for Q1, 2021. This press release and today's webcast are both available on our

Be aware of that todays conference call is being recorded I would now like the turn the call over at the Christine guess, Yeah, No Chief Communications Officer discuss the I know you just go ahead.

Thank you operator, and welcome to our first quarter 2021 conference call.

After the market closed today allergy issued a press release that provides the corporate update and financial results for Q1 2021. This press release on today's webcast are both available on our website joining me on the call today are Dr. David Chang, President and Chief Executive Officer, Dr. Rafael Amado Executive Vice President of research and development.

Operator: Joining me on the call today are Dr. David Chang, President and Chief Executive Officer, Dr. Rafael O'Mada, Executive Vice President of Research and Development, and Chief Medical Officer, and Dr. Eric Schmidt, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, and 2021 financial guidance, among other things. Such forward-looking statements are based on current information, assumptions, and expectations that are subject to change.

Cash and Chief Medical Officer, and Dr. Eric Schmidt Chief Financial Officer during today's call, we will be making certain forward looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials data presentations regulatory filings future research and development efforts manufacturing capabilities.

In 2020, one financial guidance among other things. These forward looking statements are based on current information assumptions and expectations that are subject to change a description of potential risks can be found on our earnings press release and latest SEC disclosure documents you are cautioned not to place undue reliance on these forward looking statements.

Christine Cassiano: A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. Please be careful not to place undue reliance on these forward-looking statements, and Allegine disclaims any obligation to update these statements. As a reminder for these calls, we will continue to limit questions to one per person, so we can do our best to answer all questions during the hour. I'll now turn the call over to David.

On the allergy and disclaims any obligation to update these statements as a reminder for these calls we will continue to limit questions to one per person. So we can do our best to answer all questions during the hour on the.

Now I'll turn the call over to David.

David D. Chang: Thank you, Christine, and good afternoon. We are pleased to provide an update on our progress during the first quarter of 2021, which builds on our exceptional performance in 2020. Just days ago, we celebrated the third anniversary of Allegiance. As I reflected on this milestone, we have many things to be proud of.

Thank you Christine and good afternoon.

We are pleased to provide an update on our progress during the first quarter of 2021, which builds on all of exceptional performance in 2020.

Just days ago, we celebrated the third anniversary of allergy.

As I reflected on this milestone we have many things to be proud of most importantly, each and every patients we have treated so far with all of Allo car T candidate.

David D. Chang: Most importantly, each and every patient we have treated so far with our Alokarty candidate. From the first patients with Relapse Refractory Non-Hachkin Lymphoma treated with Alol5-01 in 2019, to the start of our first Allotumor trial with Allo-316 earlier this year, we are continuing to define, shape, and advance the field of Carthusor. While the initial standards in this field were set by the groundbreaking otelago cell therapy, we are increasingly able to shine a spotlight on the inherent benefits of allogenic cell therapy and our ultimate goal of improving outcomes for a broader set of patients. Aalgenic cardiophers, of course, also come with inherent challenges.

From the first patients with relapsed refractory non Hodgkin lymphoma are treated with allo 501 in 2019 two of the start of our first solid tumor trial with outlook for you on six earlier. This year, we are continuing to define and shape and advance the appeal of the car T therapy.

While the initial standard in this field was set by the groundbreaking autologous cell therapies, we are increasingly able to shine a spotlight on the inherent benefits of allogeneic cell therapy, and our ultimate goal of improving outcomes for a broader set of patients.

That was in a car T therapies of course also come with inherent challenges.

David D. Chang: We believe our platform is capable of addressing these challenges, and we are proud to continue advancing the depth and breadth of our pipeline, our next-generation technologies, and our state-of-the-art manufacturing capabilities. On the clinical front, we are expanding our Alilcarque Trials to encompass new targets, new cancers, and new technologies. As we indicated during our last quarterly call, we targeted this year's American Society of Clinical Oncology Annual Meeting for an update on our CD-19 program.

We believe our platform is capable of addressing these challenges and we are proud to continue advancing the depth and breadth of our pipeline our next generation technologies.

And our state of the art manufacturing capabilities.

On the clinical front, we are expanding our allo car T trials to encumber the target.

Cancer and new technologies.

As we indicated during our last quarterly call. We targeted this year the American society of clinical oncology annual meeting for an update on our CD 19 program.

David D. Chang: While Rafael will cover most of what to expect for ASCO during his remarks, I would like to note that we recognize the importance of this most advanced Allogenic CARC program in the field, and we look forward to discussing not just the data we will present as part of ASCO but also our broader vision for the program during our virtual CD19 forum on May 19th.

While Rob will cover most of what to expect Glasgow doing his remark I would like to note that we recognize the importance of the most advanced allogeneic car T program in the field and we look forward to discussing that rest of the data we will present as part of the basketball, but also our broader vision.

The program during our virtual CD 19 Forum on May 19th.

David D. Chang: I think it is also important to note that while we are still treating and collecting data from our alpha and alpha two trials to evaluate the full data set prior to the next phase, it remains our goal to bring allofybide 1A to a pivotal phase two trial by the end of 2021. We continue to build on the positive momentum from our presentation of the Universal Trial at last year's American Society of Hematology Annual Meeting.

I think it is also important to note debt, while we are still trading and collecting data from our alpha and alpha two trials to evaluate the full dataset prior to the next phase it remains of Volcker dense allo five of 182 of pivotal phase II trial by the end of 2021.

Yeah.

We continue to build on the positive momentum from our presentation of the universe of trial at last year's American Society of Hematology annual meeting.

David D. Chang: Interim findings from this ongoing trial demonstrated for the first time that an allogenic carthia therapy directed at PCMA can achieve deep clinical responses in heavily-treated patients with refractory multiple myeloma, while eliminating both the need for bridging therapy and treatment delays associated with otolice carcary manufacturing. Our recent Regenerative Medicine Advanced Therapy for ARMET designation for ALO715 was supported by our proof of concept data. We have continued to execute on our three-prong anti-CMA strategy in Moscow Miloma.

Interim findings from this ongoing trial demonstrated for the first time that on allogeneic car T therapy directed at P. CMA can achieve deep clinical responses in heavily pretreated patients with refractory multiple myeloma, while eliminating both the need for bridging therapy and treatment.

Delays associated with the autologous car T manufacturing.

Our recent regenerative medicine advanced therapy, or <unk> designation for all of 715 was supported by our proof of concept data.

We have continued to execute on our three pronged and tight E. P. M. A strategy in multiple myeloma.

David D. Chang: In collaboration with SpringWorks therapeutics, we have started dosing patients in the combination arm of the universal trial to evaluate ALO715 in conjunction with SpringWorks Investigation of Gamma Secretase Inhibitor, Neogastastaseaseaseaseasease. In addition, we have received IND clearance for LO-605, our eagerly awaited first turbo car candidate, and remain on track to initiate our Phase 1 Ignite We are excited about the potential of each approach to deliver meaningful results for these patients.

Through our collaboration with spring works Therapeutics, we have started dosing patients in the combination of the universe of trial to evaluate our step on the one five in conjunction with springboard investigational Gamma Secretase inhibitor never gets the stat.

In addition, we have received IND clearance for Allo 605, our eagerly awaited first turbo car candidate and remain on track to initiate a phase one ignite trial in the coming months.

We are excited about the potential of each approach to deliver a meaningful result for these patients.

Rafael tied into the details of these innovative approaches designed to further advance the potential of Allo car T therapy in myeloma.

David D. Chang: I will let Rafael dive into the details of these innovative approaches designed to further advance the potential of alilcarcarytherapine for myeloma. While our initial candidates target blood cancers and follow in the footsteps of callous carcotherapy, we have begun to blaze new trails in solid tumors. We are very excited to be dosing patients in the Traverse trial with All-O-316, which targets CD70 for the treatment of renal cell carcinoma. We believe demonstration of activity in this setting has the potential to accelerate the development of CART therapy in patients and rapidly offer the trajectory of allergen-a-car-T and look forward to executing this study.

While our initial candidates targeting blood cancers and follow in the footsteps of autologous car T therapies, we have begun to place new trails in solid tumors.

We are very excited to be dosing patients in the true burst trial with all three of one six which targets <unk> 70 for the treatment of renal cell carcinoma.

We believe demonstration of activity in the setting has the potential to accelerate the development of car T therapy in solid tumors and rapidly author of the trajectory of allogeneic car T and look forward to executing the study.

From our first day of the allergy in just three years ago controlling our on manufacturing has been core to our vision of ensuring that our therapies are available and accessible to eligible patients within a matter of days.

Under the scale for the leadership about the Alison Moore, Chief Technical Officer, we are well on our way of achieving that goal.

David D. Chang: From our first day at Allergin, just three years ago, controlling our own manufacturing has been core to our vision of ensuring that our therapies are available and accessible to eligible patients within a matter of days. Under the skillful leadership of Dr. Allison Moore, our chief technical officer, we are well on our way to achieving that goal. We believe producing our Alilcarcate therapies at CellForge One. Our state-of-the-art manufacturing facility in New York, California will allow us to scale production, control costs, and, equally importantly, continually improve and enhance the quality of the product. We have begun engineering runs at our new facility and are on track to initiate GMP production later this year.

We believe producing our allo car T therapies that sell of course, one our state of the art manufacturing facility in Newark, California will allow us to scale production.

<unk> cost and equally importantly, continually improve and enhance the quality of the output.

We have begun engineering runs at all on your facility and are on track to initiate GMP production later this year.

As we execute towards the new vision for car T therapy, one debt allows us to embrace the inherent benefits afforded to an off the shelf therapy.

The ability to treat every eligible patients.

The ease with which the consolidate therapy or even with those patients.

The potential to the extent access into community setting.

And the possibility of making therapy available to patients with solid tumor.

Raphael: As we execute towards a new vision for CARE therapy, one that allows us to embrace the inherent benefits afforded to an off-the-shelf therapy, The ability to treat every eligible patient, The ease with which to consolidate therapy or even redo patients, The potential to extend access into community settings, and the possibility of making therapy available to patients with solid tumors. We are excited about what is to come and the role we are playing in redefining the future of this therapeutic modality. I will now turn the call over to Raphael for further updates on our research and development activities. Thank you, David.

We are excited about what is to come and the role we are playing in redefining the future of just the therapeutic modality.

I will now turn the call over to Rafael for further updates on our research and development activities.

Thank you David of research and clinical teams have been pursuing numerous projects all aimed at strengthening our current allo car T pipeline on the platform both preparing to meet future challenges associated with extending the potential of allogeneic cell therapy.

Last week, we were pleased to announce that we will be presenting updated data on the phase one part of the one study together with the initial results from our Allo five of one study article.

The update on the Allo 501 will include longer term follow up from the 22 patients were initially reported on that ask for 2020.

In addition, we will provide information on additional patients treated of subsequent to ask the 2020 with a particular focus on car T naive patients.

As part of the Threet out we do intend to breakdown responses between Follicular lymphoma on large b cell lymphoma.

Raphael: Our research and clinical teams have been pursuing numerous projects, all aiming at strengthening our current Alokarty pipeline and platform while preparing to meet future challenges associated with extending the potential of allogenic cell therapy. Last week, we were pleased to announce that we will be presenting updated data on the Phase 1 Allo-Five 1 study together with initial results from our Allo-501 study at Asper. The update on ALO501 will include longer-term follow-up from the 22 patients that were initially reported on at ASCO 2020.

The initial data from 500 <unk> also two of trial will report on the phase one dose escalation portion of this trial.

Recall that the alpha two dose escalation phase with designed to quickly confirm that the finance team with all of final one translate into all of five of the one eight prior to advancing this concept forward into a potential pivotal phase II study.

For that reason this trial focuses on the homogeneous large T cell lymphoma patient population.

Escalation was completed late last year on such the duration of follow up will be limited in the all types of the trial.

More recently, we have begun treating patients in the alpha and also due under our consolidation dosing protocol.

This regimen of <unk> allows patients who have not progressed faster than the initial dose of therapy to receive the second schedule on the expiration of car T cells with the goal of improving or extending the response or ask of presentation will include results from the first few patients treated with consolidation therapy, although the duration of follow up.

Raphael: In addition, we will provide information on additional patients treated subsequent to ASCO 2020 with a particular focus on CART naive patients. As part of this readout, we do intend to break down responses between follicular lymphoma and large-becile lymphoma.

As a result the shorter.

Oscar will also feature of separate presentation on the safety on biomarker data on all of six or seven on.

As you are aware allo six for seven is a key component of our platform and we believe that it enables a differentiated approach to the use of depletion on trials with.

Raphael: Initial data from 501A, the alpha trial, will report on the phase one dose escalation portion of this trial. Recall that the alpha-2 dose escalation phase was designed to quickly confirm that the findings seen with Allo-501 translate into Allo-501A prior to advancing this contract forward into a potential pivotal phase-2 study. For that reason, this trial focuses on a homogeneous large TSA lymphoma patient population. Escalation was completed late last year, and as such, the duration of follow-up will be limited in the Altitude trial.

We look forward to reporting data across our 2019 program later this month.

That article meeting is just weeks away, we will not be discussing any further details between now and the presentation of <unk>.

Hope that you will join us on our CD 19 Forum on May 19th.

The structure of Us of course, the virtual meeting will allow us on a select group of clinical trial investigators discussed the full set of clinical results being presented at the conference and provide the allergy and the team on opportunity to share our vision for the future of Allogeneic car T therapy.

As David mentioned earlier, we're pleased with the progress we've made our gross on a multi pronged CMA strategy for relapsed refractory multiple myeloma.

Most of the <unk> program is all of a sudden one five which received the arm of designation by the FDA. Following updated proof of concept data presented from the Universal trial last year of apps.

Raphael: More recently, we have begun treating patients in Alpha and Alpha II under our consolidation dose in protocol. This regimen allows patients who have not progressed after an initial dose of therapy to receive a second scheduled administration of CARE cells with the goal of improving or extending their response. Our ASCO presentation will include results from the first few patients treated with consolidation therapy, although the duration of follow-up will, as a result, be shorter.

We continue to enroll patients in this trial and as we announced a few weeks ago, we have begun treating patients in the combination arm of the study which is evaluating allo seven of one five in combination with need Augustus that an investigational gamma secretase inhibitor being developed by screen works therapeutics.

Last month, we also announced progress on the third prong of our myeloma strategy with ion the clearance for Allo 605, our first two of our car candidate. We are very excited about all of the six five of US we prepare to launch the phase one ignite trial of learn more about how would these proprietary next generation technology performance in the plant.

Raphael: ASCO will also feature a separate presentation on the safety and biomarker data on Allo6-6-7. As you are aware, Alo 647 is a key component of our platform, and we believe that it enables a differentiated approach to lymphodepletion in our trial. We look forward to reporting data across our C-19 program later this month. Given that the ASCO meeting is just weeks away, we will not be discussing any further details between now and the presentation, but do hope that you will join us at our CD19 Forum on May 19.

Yeah.

As you May recall turbo of cars are designed to provide selective programmable cytokine signaling to car T cells in order to counter the T cell exhaustion improved T cell function on potency and potentially reduce cell dose requirements.

All six of <unk> demonstrate the benefit of this technology, we would look forward to the potential of applying it across our platform.

We feel confident in the approach, we're taking to maximize the benefit risk of allogeneic cell therapy on hopefully our ability to deliver a much needed alternative to patients with multiple myeloma, who progressively failed treatment.

Lastly, but definitely not the least we're excited to extend our allo car T platform into solid tumors.

Earlier this year, we began dosing patients in our first solid tumor trial with all of the 316 targeting CD 70 the dive.

Raphael: The structure of ASCO as a virtual meeting will allow us, and a select group of clinical trial investigators, to discuss the full set of clinical results being presented at the conference and provide the allergen team an opportunity to share our vision for the future of allogenic cardiac heart disease there. As David mentioned earlier, we're pleased with the progress we've made across our multi-pronged BCMA strategy for relapse refractory multiple mile. Our most advanced program is ALO715, which received ARMAT designation by the SDA following updated proof-of-concept data presented from the universal trial last year at A.

The first trial is enrolling patients with advanced or metastatic renal cell carcinoma and is designed to explore various all of 316 cell doses.

The endpoints being assessed the safety Tolerability, that's on duration of mean for the depletion cell expansion and anti tumor activity.

Given the high prevalence of RCC and the lack of new treatment modality for patients with advanced disease, who have failed standard of therapy. We look forward to working closely with leading kidney cancer centers on cell therapy specialists to explore allogeneic cell therapy in patients with renal cell cancer of potential meaningful treatment option.

Beyond this trial, we are leveraging internal innovation to expand the utility of our two of our core technology platform to address specific biology, namely that of tumor microenvironment in solid tumors.

Preclinical data presented of the 'twenty to 'twenty, one of American Association for cancer Research annual meeting demonstrates the ability to engineer inducible tube of cars, which confer cytokine signaling upon binding to PD, one and PDL, two and the tumor microenvironment of when stimulated with an anti PD one antibody.

Raphael: We continue to enroll patients in this trial, and as we announced a few weeks ago, we have begun treating patients in the combination arm of the study, which is evaluating Allo715 in combination with Neregastastastat, an investigational gamma secretase inhibitor being developed by SpringWorks for a period. Last month, we also announced progress on the third prong of our Maloma Strategy with IND clearance for Allo60 We are very excited about Allo Six of Five as we prepare to launch the Phase 1 Ignite trial and learn more about how this proprietary next-generation technology performs in the clinic. As you may recall, turbo cars are designed to provide selective, programmable, satokine signaling to car T cells in order to counter T cell exhaustion, improve T cell function and potency, and potentially reduce cell dose requirements.

In addition to supply and cytokine signaling the is to hold cars are designed to enhance the therapeutic index of allo car T cells, we seen an immunosuppressive solid tumor microenvironment.

So the clinical work proceeds we remain committed toward the pipeline umbrella research to make allogeneic car T therapy, the modality of the future.

Now I'd like to turn the call over to Eric to review the financials.

Thank you Raphael and good afternoon, everyone. During the first quarter, we made substantial progress in setting up our China joint venture allergies overland biopharm by establishing governance and building corporate infrastructure financially, we recognized collaboration revenue of $38 $3 million in the first quarter of 2021.

Reflecting the great majority of the upfront payment we received from the joint venture.

We ended the quarter with $964 million on cash cash equivalents and investments.

In the first quarter of 2021 of research and development expenses were $55 $2 million, which includes $7 $9 million of noncash stock based compensation expense Gen.

Raphael: Should ALO6 or 5 demonstrate the benefit of this technology, we would look forward to the potential of applying it across our platform. We feel confident in the approach we're taking to maximize the benefit risk of allogenic cell therapy and hopefully our ability to deliver a much-needed alternative to patients with multiple myeloma who have progressively failed to respond to retryons. Last but definitely not least, we're excited to extend our Al-QAR T platform into solid tumors.

General and administrative expenses were $16 $4 million for the first quarter of 2021, which includes $8 $9 million of noncash stock based compensation expense.

Our net loss for the first quarter of 2021 was $33 million or 25 per share, including noncash stock based compensation expense of $16 $8 million.

As mentioned last quarter, we expect to support five clinical trials during 2021, including the startup of a potentially pivotal trial for allo five of <unk>. We're also looking forward to initial GMP production at our Newark manufacturing facility known as self storage, one which would require a substantial incremental investment in R&D.

Raphael: Earlier this year, we began dosing patients in our first fully tumor trial with ALA316 targeting CD-17. The Traverse trial is enrolling patients with advanced or metastatic cranial cell carcinoma, and is designed to explore various All-O-316 cell doses. The endpoints being assessed are safety, tolerability, depth and duration of lymphodepletion, cell expansion, and anti-tumor activity. Given the high prevalence of RCC and the lack of new treatment modalities for patients with advanced disease who have failed standard therapy, we look forward to working closely with leading kidney cancer centers and cell therapy specialists to explore allogenic cell therapy in patients with renal cell cancer as a potential meaningful treatment option.

We continue to expect full year GAAP operating expenses to be between $300 million and $330 million, including estimated noncash stock based compensation expense of 80 million to $90 million and excluding any impact from potential new business development activities with the.

We will now open the call for your questions.

Thank you and I'm, Sorry reminder, to ask the question you Wouldnt need the press star one on your telephone.

Withdraw your question press, the pound or hash key we do ask that you. Please limit yourself to one question.

Our first question is from thousands of Mr. With Goldman Sachs. Your question. Please.

Good afternoon, Thanks for taking my question.

As we look to the CD.

Raphael: Beyond this trial, we are leveraging internal innovation to expand the utility of our TurboCar technology platform to address specific biology, namely that of the tumor microenvironment in solid tumors. The clinical data presented at the 2021 American Association for Cancer Research Annual Meeting demonstrate the ability to engineer inducible turbo cars, which concerns cytokine signaling upon binding to PDL1 and PDL2 in the tumor macroenvironment or when stimulated with an anti-PD1 antibody In addition to supplying cytokine signaling, these turbo cars are designed to enhance the therapeutic index of alokart T cells within an immunosuppressive solid tumor macroenvironment.

The 19 event around IOSCO and.

You look towards on the levers to get a whole understanding of on the go forward pivotal study Hum.

How do we think about whether there's enough information on consolidation and five O on Asia to get a picture of what the go forward is or do you think that will take more time to evolve just given the the durability of that you mentioned earlier on Monday the trial started.

Yes, good afternoon, the survey and David Chang here, let me take that question and also.

I may ask of ourselves to chime in a little bit.

Certainly you know the question that you're asking a very important.

On the other hand, we are very close to me.

19th when we are.

Planning to have the C 19 day, where we will detail all of this information.

Throughout the development of fiber on one and 501 day, we have been carefully advancing the program asking many important questions, including the cell dose.

Eric Schmidt: As our clinical work progresses, we remain committed to our deep pipeline and broad research to make allogenic cardiac heart tea therapy the modality of the future. And now I'd like to turn the call over to Eric to review your financials. Thank you, Raphael, and good afternoon, everyone. During the first quarter, we made substantial progress in setting up our China joint venture, Allogene Overland Bio Farm, by establishing governance and building corporate infrastructure. Financially, we recognized collaboration revenue of $38.3 million in the first quarter of 2021, reflecting the great majority of the upfront payment we had received from the joint venture.

And also trying to optimize the Olympic depletion, which we believe is very important to allow allogeneic car T cells to function.

And then also given the uniqueness of allogeneic income so the benefits that come with re dosing and others.

Also investigated the dosing, including the consolidation, which is sort of the later regiment of how we are investigating different levers. So from all of these things the way that we are envisioning is the 501 study, which has been going on for the longer period than the <unk>.

501 day that study most of which is based on a single dose of.

All of 501 cells will get the most informative data set on the durability of the response and then when it comes to the fiber on a as we have said in the prepared statement the.

Primary objective of up to 501 of the study is to make sure debt 501, a behaves similar to fiber on one and also we layered additional question of whether the consolidation can deepen. The response. So I think there are many different information debt. It will be included in.

Eric Schmidt: We ended the quarter with $964 million in cash, cash equivalence, and investment. For the first quarter of 2021, our research and development expenses were $55.2 million, which included $7.9 million of non-cash, stock-based compensation expense. General and administrative expenses were $16.4 million for the first quarter of 2021, which included $8.9 million of non-cash stock-based compensation expense. Our net loss for the first quarter of 2021 was $33 million, or 25 cents per share, including non-cash stock-based compensation of $16.8 million.

Our CD 19 presentation and for that reason you know, we sort of went out of our way too.

Have the CD 19 day, where we can really detail of the complexity of the data that may not be so apparent in simple.

Thanks for the presentation so.

Yes.

No that I did not directly answered the questions but.

You know I feel pretty confident that as we have done in our other presentations, we will be made.

We will provide theory informative.

The set of data in our CD 19 day.

Thank you.

Thank you. Our next question comes from Marc Frahm with Cowen and company. Your question. Please.

Hi, Thanks for taking my questions.

David as you just mentioned that one of the big kind of unknown trade into the durability of the responses, we saw last year and you know and.

Operator: As mentioned last quarter, we expect to support five clinical trials during 2021, including the start of a potentially pivotal trial for Allo 501A. We're also looking forward to initial GMP production at our Newark manufacturing facility, known as Cell Forge 1, which will require substantial incremental investment in R&D. We continue to expect full-year gap operating expenses to be between $300 million and $330 million, including estimated non-cash, stock-based compensation expense of $80 million to $90 million and excluding any impact from potential new business development activities.

I think that out of fiber one can generate.

So when you focus on the kind of higher dose of Allo 647 going forward I believe the eight patients.

A year ago with that.

That goes to the.

Thinking about that being the the bulk of you know of.

Turning the durability or is there really are a large number of patients coming forward and then.

When we think about comparing it to autologous true.

Should we really be looking at the reported on the potency of the cells with the reported kind of durable response rates on the modified intent to treat basis that they tend to be reported on or do you think we need to book more holistically of kind of the overall treatment process.

Mark. Thank you for asking you know gross important questions.

Operator: With that, we will now open the call for your question. Thank you. And as a reminder, to ask the question, you will need to press Star 1 on your telephone. To withdraw your question, press the Pound or Hashkey.

First of all in terms of.

How do the best assess the durability.

I suggest that we wait till the CD 19 day, but at the end when it comes to durability.

We'll be presenting all the available of data, including the patients that were part of the ask of 2020 presentation as well as additional patients that we have treated since in the allo 501.

Operator: We do ask that you please limit yourself to one question. Our first question is from Salvin Richter with Goldman Sachs. Your question, please. Good afternoon.

This has been a really great opportunity for us to learn so many different aspects of allogeneic cell therapy that we didn't know and with the number of patients that we have treated we have a lot of confidence about the debt.

David D. Chang: Thanks for taking my question. As we look to this CD-19 event around ASCO, and you look to all the levers to get a whole understanding of the Go-Ford Pivotal Study, you know, how do we think about whether there's enough information on consolidation and 501A to get a picture of what the Go-Fort is, or do you think that will take more time to evolve, just given the durability that you mentioned earlier? on when these trials started. Good afternoon, Sabian. David Chang here.

The data set that we have generated so on debt.

Hold up on little bit.

The second question.

You know the ITT versus T. T. This is a very important question.

Frankly, this has been a part of ongoing debate in the cell therapy field from 2016, I remembered the ACR meeting when Crystal Marco asked the question about.

No question about.

What are the M. P is the right way to assess the benefits of car T therapy and since then we have kind of a long way and as we advance the allogeneic car T therapy, we feel that there is an opportunity to correct that.

David D. Chang: And let me take that question, and also I may ask, Ralph Al to chime in a little bit. Certainly, you know, the question that you are asking are very important. On the other hand, we are very close to May 19th, when we are planning to have the CD-19 day where we will detail all these information. You know, throughout the development of 501 and 501A, you know, we have been carefully advancing the program, asking many important questions, including the cell dose, and also trying to optimize the lympho depletion, which we believe is very important to allow allergenic cartis to function, And then also, given the uniqueness of allergen egg, in terms of the benefits that it come with redosing and others, we also investigated redosing, including the consolidation, which is sort of the later regimen of how we are investigating different levers.

So the incorrect use of M. I T T to assess the clinical benefit to more robust ITT assessment. So I think this is an important aspect and we will gradually sort of try to educate.

The field the value of assessing the treatment benefit based on ITT not just the M. I T. T. So that will be on ongoing process and on the during the CD 19 day, we will talk about that topic little bit.

Okay. Thank you.

Thank you. Our next question comes from Kelly, She Wink of Jefferies. Your question. Please.

Congrats on the progress and I. Thank you for taking my question.

The answer regarding the consolidation regimen of the trial I want to confirm so far on the patient has been treated tally of the two don't get that out of one.

I don't want a bit of content Neil in house and also do you have a plan to actually increase the dose of within your information and the only going to have that day.

Data from T cell dynamics, and the biomarker of establish Chipotle dosing cohort of ask com. Thank you.

David D. Chang: So, you know, from all these things, the way that we are envisioning is the 501 study, which has been going on for a longer period than the 501A; that study, you know, most of which is based on a single dose of L501 cells, will give the most informative data set on the durability of the response. And then when it comes to the 501A, as we have said in the prepared statement, the primary objective of the 501A study is to make sure that 501A behaves similar to 501, and we have also added the additional question of whether the consolidation can deepen the response.

Kelly.

Again, you are asking all of the right questions in terms of number of patients that we have dosed in the consolidation.

Kind of deferred to the CD 19 day, but let me ask Rafael to go through the design and the objective of consolidation and what to expect during the CD 19 day, we are learning quite a bit from the consolidation regimen.

Yeah.

So the concept of consolidation is really to drive the deep and on an anti tumor response of possible using.

A second dose that is schedule of all of five O want US you know so any patient with the complete response or a PR or stable disease.

David D. Chang: So I think there are many different pieces of information that will be included in our CD19 presentation. And, you know, for that reason, we sort of went out of our way to have the CD-19 day where we can really detail the complexity of the data that may not be so apparent in simple, you know, scientific presentations.

On a day 28 is eligible to receive the second dose and you're right. We gave 120 million cells are on day zero and then again on the 30 or so after the scan is done we gave on another 120 million cells and we're providing this.

Second dose without chemotherapy.

And the will sort of of Numerate. The number of patients that we've been able to do this by Follicular and diffuse large cell lymphoma during the 19 day.

Operator: So, Savin, I know that I did not directly answer the questions, but, you know, I feel pretty confident that, as we have done in our other presentations, we will be, you know, We may, you know, we will provide a very informative set of data in our CD-19-day. Thank you. Thank you.

And give you some details as to how that is performing with the caveat that the follow on.

It's relatively short.

I just want to emphasize that the reason why we're doing this is to take advantage of diversity of allogeneic cell therapy and to see whether that.

Operator: Our next question comes from Mark Fram with Colin and Company. Your question, please. Hey, thanks for asking my questions.

The 60 plus percent of patients of dawn benefit in the autologous setting we can reduce that number you've seen allogeneic therapy and of course in terms of Biomarkers, we will have the initial responses.

David D. Chang: David, as you just mentioned, one of the big unknowns, right, is the durability of the responses we saw last year and, you know, that ALO5-1 can generate. So when you've focused on the kind of higher dose of ALL 647 going forward, I believe there were eight patients a year ago with that dose. Who would be thinking about that being the bulk of determining that durability, or is there really, you know, a large number of patients coming forward?

But we will obviously have expansion.

Traffic gain minimal residual disease on some other biomarkers.

And I will just finish by saying that we do links of the patients on the consolidation with the second dose, but all of it was six or seven provided that they meet certain hematologic parameters prior to dosing.

So you will definitely see the status of that Oh on May 19.

Thank you and thank you all.

Also as debt from our perspective, and any baseline study, especially with consolidation the same.

F T of consolidation portion is important.

David D. Chang: When we think about comparing it to autologous, should we really be looking at, you know, the reported potency of the cells with the reported, kind of durable response rates on the kind of modified intent-to-treat basis that they tend to be reported on? Or do you think we need to look more holistically at the overall treatment? Mark, thank you for asking those important questions.

And as well as the early read and early weeks here will be pretty quick.

There is anybody who only achieve the.

Parcel of stayed stable disease with a price of cell therapy can they get to the complete responses with the second cell infusion. So the yeah.

The things that we can figure out pretty quickly and we will present the <unk>.

Number of patients as well as of what we are seeing with the consolidation regimen.

Maybe some kids thank you Dennis.

Thank you. Our next question comes from Michael Schmidt with Guggenheim. Your question. Please.

David D. Chang: You know, first of all, in terms of, you know, how to best assess durability, you know, I suggest that we wait until the CD-19 day, but, you know, at the end, when it comes to durability, we'll be presenting all the available data, including, you know, the patients that were part of the ASCO 2020 presentation, as well as additional patients that we have treated since. In Allo-501, you know, this has been a really, you know, great opportunity for us to learn so many different aspects of alleligenic therapy that we didn't know. And, you know, with the number of patients that we have treated, we have a lot of confidence about the data set that we have generated. So on that, let's hold up for a little bit.

Hey, guys.

I actually had one on the piece of MA program.

Perhaps if you could comment on how you're tracking.

And the universe of study towards potentially identifying the recommended phase two dose.

And protocol and also.

Also if you could comment on how the consolidation of treatment concept has been incorporated into that study. Thanks. So much.

Michael Thanks for the question as you know the CMA is an important part of our development program and frankly, we are making a very exceptional approach towards the CMA by advancing multiple different approaches, including the combination as well as the debt.

The next generation.

In terms of 715, you know, we obviously very excited about getting the army designation based on the data that we have presented at ash last year and in terms of the.

The questions.

Now I'm going to ask about Bell, who really have spent a lot of time on the BSA program to answer the questions for Phil.

Sure So Michael will continue to.

Those patients in the 71 five.

Program we.

We have.

David D. Chang: You know, the second question of, you know, ITT versus MIT. This is a very important question, and frankly, this has been a part of ongoing debate in the cell therapy field since 2016. I remember the AACR meeting when Crystal Mako asked a question about, you know, questions about whether MITT is the right way to assess the benefits of carc therapy. And since then, we have gone a long way.

Obviously.

The way, we're using more than one lot.

On where you're seeing a.

Different doses of six or seven different cell doses.

That has continued it's a very vibrant program investigators really like it because they don't have to wait they don't have to bridge.

We are state of the just mentioned is updated data from for March two to submit to our amount of we're very excited that the agency.

The potential benefit of the therapy.

And in parallel we are executing on New York as the start and we are very excited to get started with 605.

So all of this is going to be going on.

Operator: And as we have advanced allergenic carthage therapy, we feel that there is an opportunity to correct that sort of, you know, incorrect use of MITT to assess the clinical benefit through more robust ITT assessment. So I think this is an important aspect and we will gradually sort of try to educate the field about the value of assessing the treatment benefit based on ITT, not just MITT. So that will be an ongoing process. and during the CD-19 day, we will talk about that topic a little bit. Thank you. Thank you. Our next question comes from Kelly Shee with Jeffries. Your question, please.

And in parallel and the law.

The.

<unk> that you rightfully made is the consolidation that is.

Is an amendment that we've made to the first consolidation and the type of one five.

Expect to be enrolling on that arm also very quickly.

So it's a pretty comprehensive program that goes from the car by itself to the car.

But on New York versus that the use of two doses.

Of 71, five all the way to the use of two of book car technology, and obviously the data will be sequential we have a lot of data was 71 five we will have more of by Q4 of them we are of.

<unk> given guidance that we will present.

The data by Q4, and then the address of the data with narrow on six of five accumulate we will percentage, but that may take longer and may go into 2022.

Operator: Hello, congratulations on the progress, and thank you for taking my questions. My question is also regarding the consolidation regimen in the alpha trial. I want to confirm so far all the patients.

So.

This gives you a sense that we are fully committed to this program and its done and we can sort of appreciate the breadth of it.

Operator: Patients have been treated with two doses at once.

Thank you.

Thank you. Our next question comes from John Newman with Canaccord. Your question. Please.

Operator: at 120 million sales and also

Operator: So do you have a plan to actually do it?

Hi, guys. Congrats on all the price. Thank you for taking my question.

Operator: increase the dose with new information. And are we going to have data on T-cells?

The question is also regarding.

The Universal program, where.

Operator: of T-Cell dynamics and biomarker studies for the Redosin cohort at S. Thank you. Kelly, you know, again, you're asking all the right questions.

What I'm curious about is I think you mentioned just a moment ago, where I feel that you are looking at some different dose levels for 647.

Operator: In terms of the number of patients that we have dosed in the consolidation phase, I'm going to defer to the CD-19 day. But let me ask Rafael to go through the design and the objective of consolidation and what to expect during the CD-19 day. We are learning quite a bit from the consolidation regimen.

I wondered with regard to near of gas of staff. If you're also planning on looking at different dose levels.

Well as potentially different dose schedules and I'm just curious if you might explore perhaps giving another dose of near of guests that are maybe for example in patients that undergo consolidation just curious there. Thanks.

Raphael: Yeah, so the concept of consolidation is really to drive a deep and anti-tumor response as possible using a second dose that is scheduled for all of 501, as you know. So any patient who is in a complete response or PR or stable disease at day 28 is eligible to receive this second dose. You're right; we give 120 million cells on day zero, and then again on day 30 or so after the scan is done, we give another 120 million cells.

Okay.

Oh yeah.

Yeah, I mean, we haven't disclosed the doses that we're using of neuro Augustus that.

They're seeing over hundreds of patients treated with the product in the this my.

The syndrome.

That is the development of indication.

For the New York off the start by spring work. So there's a fairly good understanding of the PK PD parameters and as well as the safety.

Of the product out various doses.

So obviously, we've been working with spring works to try to determine the dose and schedule and also the durability of treatment as well.

Raphael: And we're providing this second dose without chemotherapy, and we will, you will sort of enumerate the number of patients that we've been able to do this with follicular and diffuse Larsonophila lymphoma during the C-19 day and give you some details as to how that is performing. With the caveat that the follow-up is relatively short, I just want to emphasize that the reason why we're doing this is to take advantage of the versatility of allergenic cell therapy and to see whether, you know, that 60 plus percent of patients that don't benefit in the atollabus setting, we can reduce that number using allogenic therapy.

We are.

All of them I can say is that we're obviously using doses that we believe are active and the.

They're still suggest men based on.

Usual parameters such of safety so on.

But beyond.

Beyond that.

We think that we have covered the.

Timing, that's important to cover for the CMA expression to be as high as possible.

Great. Thank you.

Our next question comes from call it catching our breath of Jpmorgan. Your question. Please.

Hey, good afternoon, guys. Thanks for taking the question wanted to ask on your on your solid tumor program out of 316. So I know this is just getting off the ground, but as we think ahead to two future updates and data readouts here, how should we be thinking about the programming and preliminary results relative to what you've been able to show in here.

Raphael: And, of course, in terms of biomarkers, we will have the initial responses, but we will obviously have expansion, trafficking in the mal-residial disease, and some other biomarkers. And I will just finish by saying that we have lymphomalosephysiorexia. Please provide patients on consolidation with the second dose, but only with 6 or 7, provided that they meet certain hemologic parameters prior to the dose. So you will definitely see the status set on Main Area.

What's the logic indications given this is obviously a little more unchartered territory with the presumably different bar for proof of concept I guess I'm just wondering if theres any aspects of the data that will tell you that.

Of the push ahead with what you have versus tweaking the approach. Thanks a lot.

David D. Chang: Thank you very much. And Kelly, I would also add that, from our perspective, in any phase one study, especially with consolidation, the safety of the consolidation portion is important, and as well as the early weed. And early weeds here will be pretty quick, you know, if there is anybody who only achieved partial or stable disease with the first cell therapy, can they get to complete responses with the second cell infusion? So there are things that we can figure out pretty quickly, and we will present the number of patients as well as what we are seeing with consolidation. Very informative. Thank you, David.

Hey, Corey.

That's a great question and I know part of past kind of half years, we have focused so much on the hematologic cancer, but.

All of tumor I believe is where the greatest opportunity is with any innovative therapy. The unmet need there is high despite all of the dancers curious where and you know one time treatment or fewer tons of cell.

South therapy, the potential benefit could really change the.

Trajectory as I've said in the quicker statement about the of the.

The car T therapy altogether.

Alex do you want the six that's our CD 70, directed car T program we.

Prioritize this program based on the one thing which is the expression of the target, which we feel gives us sufficient safety margin because the CD 70 expression in normal tissue other than kind of hematopoietic cells is extremely rare. So we believe that this can be safely administered.

Operator: Thank you. Our next question comes from Michael Schmidt with Guggenheim. Your question, please. Hey guys, I actually had one on the BCMA program.

We have to see that in the clinical trial and then ultimately we.

We would like to see whether this works either alone or in combination with the I O regimen.

Operator: Perhaps you could comment on how you're tracking in the universal study towards potentially identifying a recommended phase two dose and protocol. And also, if you could comment on how the consolidation treatment concept has been incorporated into that study. Michael, thanks for the question. As you know, BCMA is an important part of our development program, and frankly, we are making a very exceptional approach to, in, a BCMA by advancing multiple different approaches, including the combination, as well as advancing the next generation.

In solid tumors, but before getting to the tumor reduction and others I think the many important questions that we need to address one of which is you know how the car T cells expand in patients with solid tumor.

We continually ask the question without ever having answered the question about what are the engineered cell therapy, how effectively they penetrate into the tumor.

And what are the once they get their day elicit the kind of Pharmacodynamic response that one would expect to see so are there of layers of questions that we will be asking and you know frankly.

This is where the translational research the team that we built at <unk>.

At the Allergan will really play a big pool and decide you know what happens with the car T therapy in solid tumors. So.

Operator: In terms of 715, you know, we are obviously very excited about getting the ARMET designation based on the data that we presented at Ash last year. And in terms of, you know, the questions, I'm going to ask Rafael, who really has spent a lot of time on the ESEMA program to answer the questions. Profil?

We are very excited about advancing debt and 316.

While we are initially targeting you know so you know this is the.

Target that can potentially have utility in many different.

Indications of thought would come of indications as well as heme malignancies. So stay tuned and we just started the study hopefully.

Raphael: Sure, Michael, we've continued to dose patients in the 715 program. We have, obviously, we're using more than one lot, and we're using different doses, so 6-4-7, different cell doses. And so that has continued. It's a very vibrant program. Investigators really like it because they don't have to wait; they don't have to bridge.

By early next year, we will be able to update you as well as the rest of the field about how our car T program is doing in solid tumor.

Going forward, we will be putting more emphasis on solid coverage I think there is such great opportunities.

Great. Thanks, David very helpful.

Thank you. The next question comes from Luca <unk> with RBC capital. Please go ahead.

Oh, thanks, so much.

Congrats on all of the progress here on maybe I want to circle back on Mark's question earlier, I think last time I checked zuma one the C. Our of six months was 33% on an ITT based on the 36% of the modify the temperature of population are those the right. The right benchmark that we should have at the back of the mine as we see the data.

Raphael: We, as David just mentioned, used updated data from Ash to submit to our math, and we're very excited that the agency, you know, sees the potential benefit of this therapy. And in parallel, we are executing on neurogasostat, and we are very excited to get started with 605. So all of this is going to be going on in parallel. And the last point that you rightfully made is the consolidation.

And maybe related to it should be the a bit shy of this number or do you think that some docs will still be willing to maybe compromise the bit on efficacy for all of the benefits about G&A maybe for those patients who were autologous is simply not an option.

Raphael: That is an amendment that we've made to test consolidation in the 715, and we're expected to be enrolling on that arm also very quickly. So it's a pretty comprehensive program that goes from the carbide itself to CAREFSA-Ajuva near Gassistad, the use of two doses of two doses of... 715 all the way to the use of turbo car technology. And obviously, the data will be sequential.

The call there would be great. Thanks, so much.

Look I mean I have to say we are asking the same questions and we actually not that you need to ask the physicians about these questions but.

Let me ask Eric to more to put more color to the to the to the response to your question Eric.

Alright.

Yeah. Thanks, Luca I mean, certainly appreciate the question on your interest in our views here I honestly think that our May 19th C. Forum is 219 Forum.

Raphael: We have a lot of data, with 715. We will have more by Q4, and we have given guidance that we will present updated data by Q4. And then as the rest of the data with Nero and 6 or 5 accumulates, we will present it, but that may take longer and may go into 2022, too. So, you know, hopefully this gives you a sense that we are fully committed to this program and it's going to be done, and you can sort of appreciate the breadth of it. Thank you. Thank you. The next question comes from John Newman with Kanakor. Your question, please. Hi guys.

It's probably answer that question on the context of the actual data on and how we size things up relative to the autologous products. So we'll have a lot more to say than I do think your ITT and M. I T T analyses of numbers or the right ballpark. So we see things.

Pretty pretty consistently but.

But I think in terms of laying out the strategy and where we're heading in this field and the only.

Particularly of trying to maximize all of the benefits of all of the off the shelf characteristics of an allogeneic product, we're best positioned to talk about that stuff then.

Yes.

Let's say one other thing, which is you know one of the thing that we are trying to achieve with the allogeneic cell therapy is trying to treat every eligible patient.

Operator: Congratulations on all the progress. Thank you for taking my question. My question is also regarding the Universal Program.

Which is something that autologous car T therapy has not been able to do and as heat treat every eligible patients I mean, certainly you know this is really moving the bar to the I.

Operator: What I'm curious about is, I think you mentioned just a moment ago, Raphael, that you are looking at some different dose levels for 6-4-7. I wondered with regard to Neogastat, if you're also planning on looking at different dose levels, well as potentially different dose schedules. I'm just curious if you might explore perhaps giving another dose of near a gas stat, maybe, for example, in patients that undergo consolidation therapy

The TT analysis rather than.

Simply compromising the efficacy analysis using the modified intent to treat.

Got it thanks, so much super helpful.

The next question comes on my Blade them back with Oppenheimer. Your question. Please.

Hey, Thanks for taking my question.

Certainly appreciated Ralph sales earlier comment that you'll be breaking down the response analysis.

Also studied by two months of a soldier I'm just wondering if patients who are enrolled into the Alpha study more recently were in any way enriched for large b cell lymphomas or if the proportion of patients with indolent versus more aggressive NHL will be more or less of the same as what we saw last year on ESCO.

Raphael: Yeah, I mean, we haven't disclosed the doses that we're using of Neurogastastat. You know, there have been over 100 patients treated with that product in the Dysmoy syndrome, which is the development indication for Neurogastastastat by SpringWork. So there's a fairly good understanding of the KPD parameters and as well as the safety of the product at various doses. So obviously, we've been working with SpringWorks to try to determine the dose and schedule and also the durability of treatment as well.

Okay. So you know Rafael you know.

This is something debt.

I'm going to refer to as wiped out the response.

You know one thing I would say is we're not going to go too much into the specifics about the patient population, but we can't give you a general sense of what's going on between these two studies.

Yeah, I mean I would simply.

Say that the.

We will have a on.

Sizable population of both.

Histology.

So.

Raphael: All I can say is that we're obviously using doses that we believe are active and that there are those adjustments based on, you know, usual parameters such as safety and so on. But, you know, beyond that, we think that we have covered the timing that's important to cover for BCMA expression to be as high as possible. Great, thank you.

Unlike got on school in 2020, we.

We actually have fewer patients when he was harder you know too.

Truly scientifically make any kind of conclusion on what.

We have accumulated more patients and we'll be able to separate them by histology and I get the thought of that way to you.

You would should expect to see it on it.

Elias.

Ways as you know the 501 study.

<unk> allows entry of both histology of whereas five on a its only large b cell lymphoma, because that's the program crowding the cooking to commercialize.

Operator: Our next question comes from Corey Kasemov with JPMorgan. Your question: Hey, good afternoon, guys. Thanks for taking the question. Wanted to ask about your solid tumor program, Al-1-6. I know this is just getting off the ground, but as we think ahead to future updates and data readouts here, how should we be thinking about the program and preliminary results relative to what you've been able to show in hematologic indications, given this is obviously a little more uncharted territory with a presumably different bar for proof of concept?

So.

Obviously, when we get patients we pull all of our algorithms to try to deciding which study to put them on.

But.

In terms of numbers like Inc.

You will see on May 19th.

Be able to show a good representation of both.

Okay fair enough looking forward to the 19th.

Thank you. Our next question comes from Ben Burnett with Stifel. Your question. Please.

Hey, Thank you very much for taking our question you guys are holding the allo five of one company of that on the day that ask her abstracts are released I think this is clearly something that the we're all looking forward to but this is also I guess just a bit different from how you've held these types of events in the past where I think these events were held more in line with the actual presentation.

Operator: I guess I'm just wondering if there's any aspect of the data that will tell you kind of to push ahead with what you have versus tweaking the approach. Thanks a lot. And Corey, you know, that's a great question.

At the medical meeting so I guess, just just curious why hold this event so early before the Astro meeting.

Yeah.

Ben Thanks for the question I mean, obviously, you know times are quite different with the virtual meetings being the norm and we're learning as we sort of prepare for each of the meeting. So you know this is something that we have given some thoughts before taking this correction, but let me ask of our chip communications.

David D. Chang: And I know, you know, for the past two and a half years, we have focused so much on hematologic cancer. But, you know, solid tumors, I believe, are where the greatest opportunity is with any innovative therapy. The unmet need is high. Despite all the advances, cure is rare.

The officer Christine to respond to your questions.

Hi, Ben I'm actually really happy that you asked the question because we have been putting in a lot. So everybody thinks that the meeting and linger there in person, it's very different the basket that sometime next year not of lot of people realize that the embargo lifts actually on all data when the abstracts come.

David D. Chang: And, you know, one-time treatment or, you know, a few times of cell therapy, potential benefits could really change the trajectory, as I've said in the criteria statement about CARC2 therapy all together. You know, L-O316 is our CD70 directed CARCII program. We prioritized this program based on one thing, which is the expression of the target, which we feel gives sufficient safety margin because a CD-70 expression in normal tissue other than some hematopoietic cells is extremely rare. So we believe that this can be safely administered.

So yes, the companies have the option to just focus on the abstracts or actually let me sort of data. So we decided that the post the opportunity and kind of take the advantage I bet on the opportunity the stay out of the rash of the phone conference activities and touched on that on the 19th semi synthetic Kate a substantial amount of time.

Mm Hmm okay.

Okay.

Okay. Okay I appreciate your thought process there. Thank you.

Okay. Our next question comes from Dane Leon with Raymond James Your question. Please.

Hi, Thank you for taking the questions and congratulations on the all the progress.

I want to ask a question actually on the Turbo car program, maybe hasnt been discussed as much but you are moving into clinical studies, which is exciting with six of five.

David D. Chang: We have to see that in the clinical trial. And then, ultimately, we would like to see whether this works either alone or in combination with the I.O. regimen in solid tumors.

So the question is.

Not really.

A one for one comparison, but we do have some idea about use of the utilization of auto of car T and the CD 19 space.

David D. Chang: But, you know, before getting to, you know, tumor reduction and others, I think there are many important questions that we need to address, one of which is, you know, you know, what is, you know, how do CARCC cells expand in patients with solid tumors? And we continually ask this question without ever having answered a question about whether engineered cell therapy will penetrate into the tumor and whether once they get there, they elicit the kind of pharmacodynamic response that one would, you know, expect to see. So there are layers of questions that we will be asking. And, you know, frankly, this is where I think we should start.

With our with the PD L. One.

Via the zoom of six study and some others of Ige.

Wanted to get your thoughts in terms of how your team was designing the program design. The cars how have you thought about.

Safety components.

Generally it seems like the the sequencing or actual overlap of use of the PDL on in the setting of of at least auto CD 19 car T has been acceptable, but you know there have been some events. Although you can't really figure out what you know whether it was the auto car or the the you know the tender was not there.

So just wanted to get your thoughts in terms of how you think about the safety of component of the design and what your team specifically considered in that design of the construct.

David D. Chang: The translational research team that we built at Allogen will really play a big role in deciphering what happens with the Carthusarkin solid tumors. So, you know, we are very excited about advancing this. And, you know, 316, while we are initially targeting Reno Cell, you know, this is a target that can potentially have utility in many different indications, follow-fellmer indications as well as hem malignancy. So, you know, stay tuned.

Yeah, Dan Thanks for asking all day. So important question I mean income the sub safety and income as hub.

The seeing what happens with terrible I mean every time when you are doing something that has been done I mean, there is a lot of unknowns and we are doing.

During this very carefully.

Okay, great and manner I mean the.

The first program. The Allo 605, you know it is what we would consider as a relatively straightforward simple version.

There we are just providing the cytokine stimulation.

That is programmable to the cell and so the signal of only goes to the car T of positive cells and this is really to enhance the fitness of the cell by providing signal of three as part of the activation process and you know preclinical.

David D. Chang: And we just started a study, and hopefully, you know, by early next year, we will be able to update you as well as the rest of the field about how our CARCII program is doing in Solidermin. And certainly, as we go forward, we will be, you know, putting more emphasis on solid commerce. I think there is, you know, such a great opportunity.

The results have shown debt.

T cells are much less prone to become exhausted and also in the xenograft in vivo animal studies now.

Not only we reduced the size of the tumor we eradicate the tumor which is something that's very rare to see in the car T therapy setting.

David D. Chang: Thanks, David. Very helpful. Thank you. Our next question comes from Luca EZ with our VC Capital. Please go ahead.

On a ACR. We also presented a newer version that we are sort of in the process of designing and this is where we are trying to elaborate.

The the science and the technology that is behind turbo car to potentially use the negative signals such as PDL, one or even TGF data negative signaling.

Operator: Oh, thanks so much. Congratulations on the progress here. Maybe I want to circle back on Mark's question earlier. I think last time I checked Zuma 1, the CR 6 months was 33% on an ITT base and 36% on a modifying temperature population.

And turned it into a positive signal to the sales. So in effect. It provides two ways to make the car T cells worked well in solid tumor one it provides for the cytokine signaling and two it has the potential to neutralize the negative signals in the in the tumor microenvironment.

Operator: Are those the right benchmark that we should have in the back of our minds as we see this data? And maybe related to it, should the data be a bit shy of this number? Do you think that some docs will still be willing to compromise a bit on efficacy for all the benefits of oxygenate? Maybe for those patients who arctologists are simply not an option, any call there will be great.

This is a work debt.

The team that Barbara facet of our CSO has been really leading and we are sort of beginning we will first find the initial data from 605, and there's a lot more to come with the soft platform based technologies so stay tuned.

Thank you.

Thank you. Our next question comes on rainy Benjamin with JMP Securities. Your question. Please.

Eric: Thanks so much. Luca, I mean, I have to say, we are asking the same questions, and we are actually not even beginning to ask the physicians about these questions. But, you know, let me ask Eric, you know, to give more color to the response to your question. Eric?

Hey, good afternoon, everyone. Thanks for taking the questions I guess I'd.

I'd love to get a little bit more color or an idea of the biomarkers that you were looking at for Allo 647 is this primarily you know concerning patient collection or why you know why is that of focus as part of that poster presentation at the risk of you know.

Eric: Yeah, thanks, Luca. I certainly appreciate the question and your interest in our views here. I honestly think that our May 19th CD Forum, C19 Forum, will answer that question in the context of the actual data and how we size things up relative to the analogous products. So, you know, we'll have a lot more to say, Ben. I do think your ITT and MITT analyses and numbers are in the right ballpark, so we see, if you know, pretty consistently.

The answer being or the wait till may of 19, if I could follow that with the totally separate question regarding consolidation have you have you thought about maintenance therapy.

Especially given that the second dose of constant consolidation doesn't have chemo any thoughts regarding maintenance therapy going forward.

Well you know I think I should hire you to be part of our research and development team you're asking all of the right questions. Rafael I mean, we've been talking about this constantly some of them there.

I'll, let you.

When the question.

Yeah. Ryan this is that of both really good questions.

Eric: But I think in terms of laying out the strategy and where we're heading in this field, and, you know, in particular trying to maximize all the benefits, all the off-the-shelf characteristics of an allergen-A product, we're best positioned to talk about that stuff. And look, I would say one other thing, which is, you know, one of the things that we are trying to achieve with the allergen A cell therapy is trying to treat every eligible patient, which is something that Othalus Carkey Therapy has not been able to do.

The rest of 647.

It's actually.

On really interesting I think Dara said the.

We've been able to accumulate with all of these patients.

So first of all.

We look at the ability of 6472 costs. The T cell depletion and you know this receptor of city of 52.

It's not supposed to be on on Humira.

The reported precursors of other than T cell precursors, and so we know that the deeper and the longer the.

The duration of T cell depletion.

Eric: And as you treat every eligible patient, I mean, certainly, you know, this is really moving the bar to the, you know, ITT analysis rather than, you know, simply compromising the efficacy analysis using the modified infant. Got it. Thanks so much.

The.

Lower the ability of the patient to actually be able to reject ourselves when we need the duration of it.

Expansion as well as persistence for the sales to actually be able to attack the tumor and eradicate it so knowing.

Operator: Super helpful. Your next question comes from Mark Bradenbach with Oppenheimer. What is your question? Hey, thanks for taking my question. I certainly appreciated Raphael's earlier comment that you'll be breaking down response analysis in the alpha study by tumor histology. I'm just wondering if patients who were enrolled into the alpha study more recently were in any way enriched for large B-cell lymphomas, or if the proportion of patients with indolent versus more aggressive NHL will be more or less the same as what we saw last year at S. Okay, so, you know, Raphael, I'm going to refer to, you know, ask Raphael to respond.

This correlation between PK and pharmacodynamics in this case being a T cell.

We are you know we are able to actually fine tune the stuff.

So this correlation also is made with expansion of the cells. So this is really important because of <unk> 52 of depletion is kind of the cornerstone of our ability to be able to use allogeneic cell therapy and prevent and prevent rejection.

So the next biomarker, we look at is to the cells actually expand on do they persist.

So we go from those two T cell levels two expansion.

Then ultimately we correlate that with clinical outcomes and so this is sort of the the serious of basic biomarkers that we are doing and obviously we've been doing this with single cells and the we are now doing it in the consolidation.

Arena.

That we.

The spoken about before and then the terms of.

Of chronic therapy or maintenance therapy I mean this.

Operator: You know, one thing I would say is we're not going to go too much into specifics about the population, but we can give you a general sense of what's going on between these two studies. Yeah, I mean, I would simply say that we will have a sizable population of both histologies.

This is something that.

We haven't really.

<unk> gotten into yet we are in the sort of the first forays of consolidation.

See what that shows us.

And then we will eventually make a decision in terms of what would the need of gets the best.

Dose of scanned scheduled to go to two phase two.

Okay.

I'd also add I mean, you know Brookdale had made a comment in the consolidation portion, we only limp called the clean with the allo six or seven without using chemotherapy. This is something very unique and you know that kind of decision is based on the PK PD analysis of the.

Operator: So unlike Garasco, 2020, we actually have fewer patients, and it was harder, you know, to actually scientifically make any kind of conclusions. Now, we've accumulated more patients, and we'll be able to separate them by histology and get the data that way. So you should expect to see it analyzed both ways.

What we have seen so far and the.

The question or on whether we are moving towards patient selection of I think that's a little bit too early I mean, you know I don't think.

Operator: As you know, the 501 study allows entries for both histologies, whereas 501A is only large-fifil lymphoma because that's the product that we intend to commercialize. So obviously, when we get patients, we follow algorithms to try to decide in which study to put them on. But in terms of numbers, I think, you know, as you will see on May 19th, we'll be able to show a good representation of questions. Okay, fair enough, looking forward to May 19.

That's really the goal of this kind of analysis I mean, the goal of this analysis of how the best use of $6 seven for the.

The intended purpose of lift for the cleaning safely and appropriately.

Got it thank you very much.

Thank you. Our next question is from Raju Prasad with William Blair. Your question. Please.

[laughter].

Thanks for taking the question and congrats on the progress.

Well I had a quick question on the Army's designation for 715.

Does that income past the the.

Neuro depth of step arm and how are you kind of the approach or use the.

With the.

The on that designation.

The kind of advancing that arm of the trial and then just kind of on a regulatory of the kind of part D question.

Operator: Thank you. Our next question comes from Ben Burnett with Stee So. Your question, please? Hey, thank you very much for taking our question. You guys are holding the LFO1 company event on the day that the ASCRA abstracts are released. I think this is clearly something that we're all looking forward to, but this is also, I guess, just a bit different from how you've held these types of events in the past.

How should we think about maybe applying for.

Designation for Allo 501, a on where you're waiting for maybe the consolidation therapy in and maybe moving in the pivotal before applying for that thanks.

Thanks.

Rafael do you want to take that question.

Sure. So I think the arm in arm of designation for say, one five and composed primarily of the data that was presented at ash.

Some updates.

And.

Obviously.

We're delighted to see that the agency recognized the value of.

Of the product on.

On particularly at the.

The <unk>.

Operator: I think these events were held more in line with the actual presentation at the medical meeting. So I guess I'd just curious, why hold this event so early before the ASCO meeting? Ben, thanks for that question. I mean, obviously, times are quite different, you know, with virtual meetings being the norm, and we're learning, you know, as we sort of prepare for each of the meetings. So, you know, this is something that we have given some thought before taking this direction, but let me ask our Chief Communications Officer, Christine, to respond to your question. Hi Ben.

Doses.

Higher doses, where we saw a cigna.

Significant efficacy on.

Including the G P R and complete responses and on.

It might be of negativity.

And so we had obviously some additional follow up and I'm not going to go into all of the discussions that took place between the agency and.

The answer to the sponsor in terms of so far of requests and so on but there were satisfied.

This was a product that the.

Merited.

Net or did.

This designation, we obtained we intend to take advantage of that.

Technician obviously.

As we move.

Move forward the CMA the development.

With regards to fiber when they are we.

We are we started up that.

Christine Cassiano: I'm actually really happy that you asked this question because we have been getting it a lot. So, you know, everybody thinks of the meeting, but when you're there in person, it's very different. But with Asco being virtual again, not a lot of people realize that the embargo lives on all data when the abstracts come out. So you have the, you know, companies have the option to just focus on the abstract or actually release all data.

The program. The later as you know we have.

More data with five of the warm, but if I wanted to know the product that we intend to develop so therefore, we are not seeking arm of designation or all of their designations with five of the one we would kick in with five O&M as you rightfully said.

But we started the dose escalation late last year and then we finished at the follow up is not as long and we started.

Validation relatively recently so.

We believe the better to get a little bit of a maturity of the data.

And and.

Then going but we will be seeking district.

Christine Cassiano: So we decided that we would take the opportunity and, you know, and kind of take advantage of the opportunity to stay out of the rush of the full conference activities and host our event on the 19th.

Designation of swell and.

You know what.

We do it before the phase two or not.

The decision that we need to make are based on the data that we see.

But you know of.

Always.

Thinking the sooner that we do there's obviously the better but we'll have to make sure that the.

Christine Cassiano: So we could dedicate a substantial amount of time to what will give us the full update on the first. Okay, I appreciate your thought process there. Thank you. Our next question comes from Dane Leon with Raymond James.

Thought of warranty.

That will take a little bit of time for the debt at the mature.

Great. Thank you.

Thank you. Our next question comes from Africa.

With a choice of Securities. Please go ahead.

Operator: Your question, please. I thank you for taking the questions and congratulations on all the progress. I want to ask a question actually about the turbo car program.

Hey, guys. Thanks for taking my question.

Get a quick sense check here since the data does suggest that deep upfront response may be a key driver of durability in dogs. So so just wanted to get your thoughts as to what do you think they're stayed in the public domain that also suggests that this is a holder of the case in follicular lymphoma or persistence more its more important than the.

Operator: Maybe it hasn't been discussed as much, but you are moving into clinical studies, which is exciting with 605. So the question is, we do not really have a one-for-one comparison, but we do have some idea about the utilization of Auto Car Tea in the CD-19 space. Um, with the PDL1 via the Zuma 6 study and some others. I just wanted to get your thoughts in terms of how your team was designing the program, designing your cars, and how you thought about safety components.

Setting and then just a quick follow up I just wanted to confirm I'm Rafael did you say that people see the negative data.

At the CD 19 day, thanks, so much guys.

Okay in terms of the deep response, I mean, I think that.

Based on a basic principle.

The cancer treatment more cancer cells, they do kill.

You are more close to.

Operator: You know, generally, it seems like the sequencing or actual overlap of use of PDL1 in the setting of at least auto CD19 CART has been acceptable. But, you know, there have been some events, although you can't really figure out what, you know, whether it was the car or the, you know, Tesla's map and Zoom 6th. So I just want to get your thoughts in terms of how you think about the safety component in that design and what your team specifically, you know, considered in that design of the construct.

Two potentially eradicating so the appeal of really has smoothed from the concept of tests.

The controlling progression I know of maintenance to a more upfront and you know.

Whether you know the behavior of the large b cell lymphoma, and Follicular lymphoma is when I turned out to be the same or somewhat different I think we need to wait a little more for the follicular lymphoma data set to mature.

Because the study that was done by kite.

The data kind of differences about three years. So I think time will tell but as an oncologist I do have you know this and our conviction that the more true myself that you kill of more likely that you will have a durable response.

David D. Chang: Now, Dane, thanks for asking all these important questions. I mean, you know, in terms of safety and in terms of seeing what happens with Turbo, I mean, every time when you're doing something that has been done, I mean, there's a lot of unknowns, and we are doing this in a very carefully, you know, orchestrated manner. I mean, the first program, the L605, you know; it is what we would consider relatively straightforward and simple.

M. R. D response, Rafael do you want to comment on debt.

Yeah, we've been following in my day response and on on ongoing basis on our lymphoma program. As you know, it's not a standard of cities, obviously in leukemia allergists in myeloma.

But we have.

The data.

Shares share with the rest of the biomarker.

What the MRI data to date.

Great. Thank you very much.

Thank you.

The last question is from Rob Barnes with H C. Wainwright your question. Please.

David D. Chang: version where we are just providing the cytokine stimulation, that is programmable to the cell, and so the signal only goes to the CART positive cells. And, you know, this is really to enhance the fitness of the cell by providing signal three as part of the activation process. And, you know, preclinical results have shown that these cells are much less prone to become exhausted. And also, in xenograph, in vivo animal studies, not only do we reduce the size of the tumor, we eradicate the tumor, which is something that's very rare to see in the cardiotherapy setting.

Hundreds of most speaking of.

Thanks for taking my question.

In anticipation of the.

From the Universal trial assessing the months.

I was wondering if you could provide.

That's true.

Higher gross something on five plus cyclical of southern coastal Inc.

Showing the improvement in response that's the.

The previous conference.

Yeah, Rob you of.

A little bit.

One of them coming clearly, but I think the question is whether the seventh on one five at higher dose with a higher level and then put.

David D. Chang: At AACR, you know, we also presented a newer version that we are sort of in the process of designing, and this is where, you know, we are trying to leverage the science and the technology that is behind turbocard to potentially use the negative signals, such as PDL1 or, you know, even TGF data, negative signaling, and turn that into a positive signal to the cell. So, in effect, it provides two ways to make the CARCII cells work well in cell tumors. One, it provides cytokine signaling, and two, it has the potential to neutralize the negative signals in the tumor microenvironments.

The depletion was providing better response, we covered a little bit of that aspect of doing the ash presentation last year and certainly more of investigation is ongoing and we will update the data as in the next opportunity that we have which we project will.

It will be more towards the end of the year.

Okay.

Thank you.

Thank you and this concludes our Q&A session I will pass it back to management for any final remarks.

Alright. Thanks.

We close out the call I would like to thank everybody, who joined US today as well as our teams at Allergan and our many patients investigators and collaborators.

So he talked about numerous times during the call. Please join us on May 19.

David D. Chang: So this is a work that, you know, the team that Barbara Sass, our CSO, has been really leading. And, you know, we are sort of beginning. We will first find the initial data from 605, and there's a lot more to come with these platform-based technologies. So stay tuned. Thank you. Thank you. The next question comes from Rainey Benjamin with JMP Securities. Your question, please. Hey, good afternoon, everyone.

Albert to Athene 19 Forum, we look forward to seeing you then operator you may now disconnect.

Thank you ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program and you may now log off and disconnect.

[music].

Operator: Thanks for taking the question. I guess I'd love to get a little bit more color or an idea of the biomarkers that you were looking at for Allo 647. Is this primarily concerning patient selection, or why, you know, why is that a focus as part of that poster presentation? And at the risk of, you know, the answer being, oh, it's way until May 19th.

Operator: If I could follow that with a totally separate question regarding consolidation, have you thought about maintenance therapy, especially given that the second dose of consolidation doesn't have chemo? Any thoughts regarding maintenance therapy going forward? Well, you know, I think I should hire you to be part of our research and development team. You're asking all the right questions. Rafael, I mean, we've been talking about this constantly, so I'm going to let you, you know, take Wren's questions. Yeah, right; these are both really good questions.

Raphael: I mean, with regard to 647, it's actually really interesting, I think, data that we've been able to accumulate with all these patients. So, first of all, we look at the ability of 647 to cause T-cell depletion, and, you know, these receptors, 52, are not supposed to be on hemorrhoidized precursors other than, you know, T-cell precursors. And so we know that the deeper and the longer the duration of diesel depletion, the lower the ability of the patient to actually be able to reject themselves. And we need a duration of expansion as well as constant. For the cells to actually be able to attack the tumor and eradicate it.

[music].

Raphael: So knowing this correlation between PK and pharmacodynamics, in this case being T-cell, we are able to actually fine-tune this dose. And so this correlation also is made with the expansion of the cells. So this is really important because C22 depletion is kind of the cornerstone of our ability to be able to use hologenic cell therapy and prevent rejection. So the next biomarker we look at is do the cells actually expand, and do they persist? So we go from dose to T-cell levels to expansion, and then ultimately, we correlate that with clinical outcomes. And so this is sort of a series of basic biomarkers.

Raphael: that we are doing, obviously, we've been doing this with single cells, and we are now doing it in the consolidation arena, which we've spoken about before. And then, in terms of chronic therapy or maintenance therapy, I mean, this is something that we haven't really gotten into yet. We are in the sort of the first forays into consolidation, and we will see what that shows us.

Raphael: And then, you know, we'll eventually make a decision in terms of what we believe is the best doses and schedule to go to face two. I would also add, I mean, Rafael, you know, had made a comment in the consolidation portion that we only lymphoclete with L-647, you know, without using chemotherapy. This is something very unique.

David D. Chang: And, you know, that kind of decision is based on the PKPD analysis of what we have seen so far. And, you know, the question around whether we are moving towards patient selection, I think that's just a little bit too early. I mean, you know, I don't think that's really the goal of this kind of analysis.

David D. Chang: I mean, you know, the goal of this analysis, you know, how to best use the 6-4-7 for the intended purpose of lympho-depleting safely and appropriately. Got it. Thank you very much. Thank you. Our next question is from Rahul Prasad with William Blair. Thanks, take the question and congratulations on the progress. I had a quick question on the Armat designation for 715.

Operator: Does that encompass the neurogasostecter stem arm, and how are you kind of going to approach or use the armat designation in kind of advancing that arm of the trial? And then, just kind of as a Part B question, how should we think about maybe applying for designation for Allo 501A? Are you waiting for maybe the consolidation therapy and maybe moving into Pivotal before applying for that? Thanks. Rafael, do you want to take that question?

Raphael: Sure, so I think the Armat designation for 715 covers primarily the data that was presented at Ash with some updates. And obviously, you know, we were delighted to see that the agency recognized the value of the product, and particularly at, you know, the higher doses where we see that we see. So significant efficacy and including VGPR and complete responses and MRD negativity. And so we had obviously some additional follow-up, and I'm not going to go into all the discussions that took place between the agency and us as a sponsor in terms of requests and so on, but they were satisfied that this was a product that, you know, this designated, you know, this design.

Raphael: And we intend to take advantage of this designation, obviously, as we move forward with BCMA development. With regard to 501A, we are, we started up that program later. As you know, we have more data with 501, but 501 is not the product that we intend to develop. So therefore, we're not seeking an arm of designation or other designations with 5110.

Raphael: We would seek it with 501A, as you rightfully said. But we started the dose escalation late last year, and then we finished it. The follow-up is not as long, and we started consolidation relatively recently. So we believe that it's better to get a little bit of maturity on the data and then go, but we will be seeking designation as well. And, you know, whether we do it before phase two or not, that's a decision that we need to make based on the data that we see.

[music].

Raphael: But, you know, I'm always thinking that the sooner that we do this, obviously, the better, but we'll have to make sure that the data is warranted, and that will take a little bit of time for the data to mature.

Operator: Great, thank you. Thank you. Our next question comes from Asika Gurno-Wardana with Troy Securities. Please go ahead. Hi, guys, thanks for taking my question. So just want to get a quick sense, Shakur. There's data to suggest that front response is maybe a key driver of durability in large cells.

Operator: So I just want to get your thoughts as to whether there is data in the public domain that also suggests that this is also the case in follicial lymphoma, or is persistence more important in this setting? And then just a quick follow-up. I just want to confirm, Rafael, did you say that we will see MRD negative data on the CD-19 day? Thanks so much, guys. In terms of a deep response, I mean, I think that's based on the basic principle of cancer treatment, more cancer cells that you kill, you are more close to, you know, potentially eradicating.

Operator: So, you know, the field really has moved from, you know, the concept of just, you know, controlling progression, i.e., you know, maintenance to, you know, whether, you know, the behavior of large B-cell lymphoma and follicle lymphoma is going to turn out to be the same or some are different.

David D. Chang: I think, you know, we need to wait a little more for the follicillinforma data set to mature, you know, because the study that was done by Kite, the data, you know, time difference is about three years. So I think, you know, time will tell. But, you know, as an oncologist, I do have this conviction that the more criminal cells that you kill, the more likely that you will have a durable response.

David D. Chang: You know, MRD response, Raphael, do you want to comment on that? Yeah, we've been following MRD response on an ongoing basis in our lymphoma program. As you know, it's not a standard as it is obviously in leukemia or it is in myeloma, but we have that data.

Raphael: We will share with the rest of the biomarker what the MRD data is today. Thank you very much. Thank you. Our last question is from Rob Burns with H.C. Wainwright. Your question, please. Hi, this is Miles, speaking of Harvest.

Operator: Thanks for taking my question. In anticipation of the update from the universe, 715, I was wondering if you could provide any indication as to whether the higher dose 715 plus, Seven Cull, is showing an improvement in response versus your data update at the previous Sash Conference. Yeah, Rob, you are a little bit, you know, wasn't coming clearly, but I think the question is whether the 715 at a higher dose with a higher lymph lymphal depletion was providing a better response.

David D. Chang: You know, we covered a little bit of that aspect during the ASS presentation last year, and certainly more investigation is ongoing. And we will update the data as soon as the next opportunity that we have, which we project will be more towards the end of the year. Thank you. Thank you. And this concludes our Q&A session. I will pass it back to management for any final remarks. All right, thanks. As we close out the call, I would like to thank everybody who joined us today as well as our teams at Allergin and our many patients, investigators, and collaborators.

[music].

David D. Chang: As we talked about numerous times during the call, please join us on May 19 for our virtual C19 forum. We look forward to seeing you then. Operator, you may now disconnect. Thank you, ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program, and you may now log off and

Operator: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.

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