Q2 2022 Allogene Therapeutics Inc Earnings Call

August 9, 2022

Hello.

Hello, Thank you for standing by and welcome to Allergan Therapeutics second quarter of 2022 conference call.

Thank you for standing by and welcome to Allogene Therapeutics' second quarter of 2022 conference call.

All lines have been placed on mute to prevent any background noise.

After the speaker's remarks, there will be a question and answer session.

After the Speakers' remarks, there will be a question and answer session.

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

I would now like to turn the call over to Christine Cassiano, Chief Communications Officer.

Now I'd like to turn the call over to Christine Casiano, Chief Communications Officer Ms. <unk>. Please go ahead.

Ms. Cassiano, please go ahead.

Thank you, operator, and welcome to our Q2 call.

Thank you operator, and welcome to our Q2 call after market close we issued a business update and financial results press release for the second quarter of 2022.

After market closed, we issued a business update and financial result press release for the second quarter of 2022. This press release and today's webcast are available on our website.

Our release and today's webcast are available on our website.

We ask you to limit your questions to one per person, and we'll do our best to get to as many as possible during the hour.

I ask you to limit your questions to one per person and we'll do our best to get to as many as possible. During the hour. Joining me today are Dr. David Chang, President and Chief Executive Officer, Dr. Rafael Amado Executive Vice President of research and development and Dr. Eric Schmidt Chief Financial Officer.

Joining me today are Dr. David Cheng, President and Chief Executive Officer, Dr. Rafael Amato, Executive Vice President of Research and Development, 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 2022 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 the potential risks can be found in our earnings press release and latest SEC disclosure documents.

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 2022 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 the potential risks can be found in our earnings press release and latest SEC disclosure documents you are cautioned not to place undue reliance on these forward looking statements and the allergy and disclaims any obligation to update these statements.

You are cautioned not to place undue reliance on these forward-looking statements, and Allogene disclaims any obligation to update these statements.

I'll now turn the call over to David.

Thank you, Christine, and good afternoon.

Thank you Christine and good afternoon.

Since our last update, we have continued to make significant progress across our pipeline, from our lead CD19 candidate, ALO501A, and our lead BCMA candidate, ALO715, to our first thalastoma candidate, ALO316.

Since our last update we have continued to make significant progress across our pipeline.

From our lead CD 19 candidate Allo 501.

And our lead <unk> candidate Allo seven one.

Our first solid tumor candidate Allo 316.

We believe each of these programs have promising potential, and we remain focused on advancing these candidates in a way that will allow us to define, shape, and expand the future of cell therapy.

We believe each of these programs have promising potential and we remain focused on advancing these candidates.

That will allow us to define shape and expand the future of cell therapy.

This month marks the five-year anniversary of the first approval of a natalis CAR-T therapy targeting CD19. Since that time, the field has benefited from additional successes. Spectacular data sets reaffirming the treatment benefits coming from one-time infusion, label expansions to earlier lines as well as to other B-cell lymphomas, and approval of new CAR-T therapies targeting BCMA for multiple myeloma.

This month marks the five year anniversary of the first approval of <unk>.

<unk> car T therapy targeting CD 19.

Since that time the field has benefited from additional successes.

Spectacular datasets reaffirming the treatment benefit coming from onetime infusion.

Label expansions to earlier lines as well as two other b cell lymphomas.

And approval of new car T therapies targeting the CMA.

At school myeloma.

Yet one thing that has not changed is the challenges associated with delivery.

Yes, one thing that has not changed is the challenges associated with delivery.

As recently published in the Journal of Clinical Oncology, real-world access to a thalas CAR-T remains constrained due to individualized patient manufacturing, among other challenges.

<unk> recently published in the journal of clinical oncology real word access to a palace khaki remains constrained due to individualize patient manufacturing among other challenges.

This study reported that the median waiting time for an FDA-approved CAR-T treatment for, multiple myeloma patients was six months, and that only 25 percent of patients eventually received CAR-T therapy.

This study reported that the median waiting time for an FDA approved car T treatment for multiple myeloma patients was six months.

And that only 25% of patients eventually receive car T therapy.

While the focus in this study was multiple myeloma, long wait time and supply limitations, on cell therapy have also been documented in non-Hodgkin's lymphoma.

Lots of focus in this study was multiple myeloma long wait time and supply limitations on cell therapy have also been documented in non Hodgkin's lymphoma.

Clinicians have been pushed into the <unk> position of needing to choose which of their patients who will receive potential life saving therapy.

Clinicians have been forced into the unfathomable position of needing to choose which of their, patients will receive potential life-saving therapy.

As you May recall from market research, we presented in May 2021 at our C 19 Forum from over 2000 separate physician appraisal.

As you may recall from market research we presented in May 2021 at our C-19 forum from, over 2,000 separate physician appraisals, efficacy parameters are the single most important consideration in decision-making.

Efficacy parameters at the single most important consideration and decision making.

But importantly, this research foreshadowed the current market crisis by uncovering other, factors that influence physician decision-making. These included the likelihood that a patient receives the prescribed treatment, the time, to treatment, and other logistical considerations.

Importantly, this research foreshadowed the current market crisis by uncovering other factors that influence physician decision, making.

These included the likelihood that a patient receives the prescribed treatment.

Turning to treatment and other logistical considerations.

We started Allogene with a goal of correcting these limitations associated with the delivery, of our college CAR-T therapy by developing our CAR-T products and making them readily available to all eligible patients.

We started Allison with a goal of correcting this limitations associated with the deliberate <unk> car T therapy by developing our car T products and making them readily available to all eligible patients.

Four years into our journey, we believe we are on a path to transform CAR-T therapy from, a complex individualized procedure to an off-the-shelf on-demand pharmaceutical product.

Four years into our journey. We believe we are on a path to transform car T therapy from a.

Next individualized procedure to an off the shelf on demand pharmaceutical product.

Last year, we embarked on a complex set of regulatory discussions directly that enabling the first potential pivotal phase III trial of an allogeneic car T therapy.

Last year, we embarked on a complex set of regulatory discussions directed at enabling, the first potential pivotal phase two trial of an Allogene CAR-T therapy. I am very pleased by the progress we have made and am confident that in coming weeks, we could be initiating the industry's first pivotal trial for an Allogene CAR-T product, thereby paving the road not just for our 501A and our pipeline candidates, but for the field more broadly.

I am very pleased by the progress we have made and confidence then in coming weeks, we could be initiating the industry's first pivotal trial for an allogeneic car T products, thereby paving the world not just for Allo 501, and our pipeline candidates, but for the field more broadly.

The protocols we have put before FDA for the Alpha 2 Phase 2 trial was informed by clinical, and translational data we accumulated in Phase 1 trials, and we look forward to sharing study details once FDA clearance for the study has been obtained.

The protocols, we have put before FDA for the Alpha two phase III trial was informed by clinical and translational data we accumulated in phase one trials.

And we look forward to sharing study details once FDA clearance for the study has been obtained.

Throughout the development process clinical data often guests the spotlight.

Throughout the development process, clinical data often gets the spotlight, but for complex, cell and gene therapy products, chemistry, manufacturing, and controls, or CMC work is often rate limiting.

But for complex cell and gene therapy products chemistry manufacturing and controls or CMC work is often rate limiting.

We are optimistic regarding the package of CMC information we have provided to the FDA.

We are optimistic regarding the package of CMC information, we have provided to the FDA.

As we have previously noted, we believe the ability to launch L501A Phase 2 pivotal trial, with cell products that have been manufactured at our intended commercial facility would be a major competitive advantage at the time of BLA submission and launch of L501A.

As we have previously noted we believe the ability to launch allo $501 eight phase III pivotal trial with cell products that had been manufactured at our intended commercial facility would be a major competitive advantage at the time of BLA submission and launch of Allo 501 day.

We are grateful to the FDA for its ongoing cooperative engagement over the course of, many clinical, regulatory, and manufacturing discussions, especially given their staff constraints and increased workload.

We are grateful to the FDA for its ongoing cooperative engagement over the course of many clinical regulatory and manufacturing discussions, especially given their staff constraints and increased workload.

As we wait for the initiation of our Allo501A phase 2 pivotal trial, we are already thinking, about what comes next, including how to expand access of Allocar-Q to earlier lines of therapy and how to bring Allocar-Q products to other patient populations.

As we wait for the initiation of our Allo 501, eight days with pivotal trial, we are already thinking about what comes next including how to expand access of Allo car T to earlier lines of therapy, and how to bring allo car T products to other patient populations.

This includes evaluating the opportunity to advance Allo715, our lead candidate for relapsed, refractory multiple myeloma, into a potential pivotal trial and continued execution on our phase 1 trial for Allo316 in renal cell carcinoma.

This includes evaluating the opportunity to advance our 715, our lead candidate for relapsed refractory multiple myeloma into a potential pivotal trial and continued execution in our phase one trial for our <unk> six in renal cell carcinoma.

I am incredibly grateful to our One Allogene team that remains laser-focused on our vision, to deliver the first Allocar-Q product.

I am incredibly grateful to our one allergen team that remains laser focused on our vision to deliver the first our car T products.

Yeah.

I'm also grateful to have many insights coming from Allogene by way of people who are equally, energized about our mission.

I'm also grateful to have many insights coming from Allergan by way of people, who are equally energized about our mission.

To that end, we welcome Dr. Stephen Mayo, a world-renowned expert in computational protein, design, to Allogene's Board of Directors. Dr. Mayo is the Brent Professor of Biology and Chemistry and Merkin Institute Professor, at the California Institute of Technology. His decades-long success record in both academia and the biopharmaceutical industry will help, us to advance our pipeline of investigational Allocar-Q products.

To that end.

We welcome Dr. Steven Mayo Award renown expert in computation of protein design to allergens board of directors Dr.

Dr. Mayer is the brand professor of biology, and chemistry, and Merck and Institute Professor at the California Institute of Technology.

He has decades strong success record in both academia and the biopharmaceutical industry will help us to advance our pipeline of investigational Allo car T product.

Together, with each advances we make across our Allocar-Q pipeline, we are one step closer, to creating a new reality for patients.

Together with each advances we made across our allo car T pipeline, we are one step closer to creating a new reality for patients.

We are grateful for your support.

I will now turn the call over to Rafael.

Thank you David Let me first start briefly as it relates to our plan I will flip to a phase III pivotal trial of Allo, 501, interline large b cell lymphoma or <unk>.

Thank you, David.

Let me first start briefly as it relates to our Plan Alpha-2 Phase 2 Pivotal Trial of, Allo501A in third-line large piece lymphoma, or LBCL.

While the initiation of the trial remains subject to final FDA review, we are confident, in our proposed design of this trial and appreciative of the collaboration we've had with our investigators as we analyze all the data across doses and schedules from the Phase 1 portion. Prior to submitting our proposed protocol to the FDA, we undertook an in-depth analysis, of our data to determine the best dosing strategy to pursue in the pivotal trial. This included assessment of the depth and durability of clinical responses, analysis, of translational data on Allocar T cell expansion and persistence, feedback from investigators, and engagement with regulatory authorities.

Initiation of the trial remains subject to final FDA review, we are confident in Harper cluster design of this trial and appreciative of the collaboration with <unk> with our investigators as we analyze all the data across doses and schedules for the phase one portion of it.

Prior to submitting our proposed protocol to the FDA, we undertook an in depth analysis of our data to determine the best dosing strategy to pursue in the pivotal trial.

This included assessment of the depth and durability of clinical responses analysis of translational data on Allo car T cell expansion and persistence feedback from investigators and engagement with regulatory authorities.

We look forward to sharing more with you once we have initiated the trial.

We look forward to sharing more with fewer once we have initiated the trial.

As you may recall, we are planning to conduct the expand trial to establish the contribution, of Allo647 to the Lymph of the Patient Regimen. We have also conducted a full analysis of Allo647 dosing, pharmacokinetics, and pharmacodynamics.

As you May recall, we are planning to conduct the expand trial to establish the contribution of our six or seven months of the length of the patient Regiment.

We have also conducted a thorough analysis of allo 607, dosing pharmacokinetics and pharmacodynamics, we believe the use of our six or seven is critical to enable safe and effective for depletion.

We believe the use of Allo647 is critical to enabling safe and effective lymph of the, patient and uniquely able to create the needed window for Allocar T expansion.

Uniquely able to create the need of window for allo car T expansion and persistence.

A wealth of phase one dose ranging data that we have generated a gross 19 program has shown us that analysis for seven dosing is critical to achieving optimal efficacy.

Allowed us to zero in on the preferred roughly I'm glad you asked.

We have shown a strong correlation between concentrations of policies for salmon and the likelihood of clinical response.

Data as well as those of our partners on competitors.

Substantiate our belief that this trial will not only result in a positive outcome, but also differentiate our platform by demonstrating that including NALU647 in the lymphocytic lesion regimen contributes to superior outcomes, including durability of response.

<unk> belief that this trial will not only result in a positive outcome, but also differentiate our platform by demonstrating that included $6 seven in the presentation regimens continues to superior outcomes, including durability of response.

The expanded trial is expected to begin later in 2022.

Trial is expected to begin later in 2022.

We also plan to provide an update on the phase 1 portion of the alpha and alpha 2 trials at the end of 2022. This update will focus on longer-term follow-up of patients previously treated in both trials.

We also plan to provide an update on the phase one portion of the Alpha and I'll touch a trough at the end of 2022.

Update will focus on longer term follow up of previously treated in both trial I am incredibly proud of the hard work across functions.

I am incredibly proud of the hard work across functions as we prepare for this first of its kind trial. Our goal has been to supply pivotal trial material from CELF-421 to reduce complexity and risk for a regulatory strategy, including the requirement that we establish comparability between material used in our pivotal trial and material intended for commercialization.

For the first of its kind trial.

Our goal has been to supply we will trial material from Salesforce, one to reduce complexity and with our regulatory strategy, including the requirement that we established comparability between material used in our pivotal trial and material incentive for commercialization.

We chose to mitigate future risks, including at the DLA submission stage, by working to have material sourced from CELF-421 using an optimized process available prior to the start of the pivotal program.

We chose to mitigate future risk, including the BLA submission stage by working to have material sourced from Salesforce, one using an optimized process available prior to the star of the pivotal program.

We believe our strong process and prioritization capabilities support our ability to deliver a well-characterized biologic with minimal variability, and hopefully will allow us to avoid the undue delays that have been observed in the CELF field.

We believe our strong process private valuation capabilities support our ability to deliver a well capitalized biologic with minimal variability of hopefully will allow us to avoid undue delays that have been observed in the <unk> field.

I am grateful for the partnership with Dr. Allison Moore, our Chief Technical Officer, and thank the team for its leadership, collaboration, and focus, all admirable traits that are required to be a pioneer in this field.

I'm grateful for their partnership with Alison Moore, our Chief Technical Officer.

The team for its leadership collaboration and focus all admirable traits that are required to be a pioneer in this field.

Our second most advanced program and potentially next pivotal program is ALO715 targeting DCMA for myeloma.

Our second most advanced program and potentially pivotal program with Allo 71, five targeting <unk> for myeloma.

As David indicated, the current marketplace for autologous cell therapy is highly constrained with supply and delivery issues.

As David indicated the current marketplace for autologous cell therapy is highly constrained with supply on deliveries.

We know this affects not just patients with non-Hodgkin's lymphoma, but even more so patients living with multiple myeloma.

We know these effects, let's just Facebook with non Hodgkin lymphoma, or even more so based on some level with multiple myeloma.

This devastating situation has pushed us to think about how we might be able to accelerate decision-making around a lead DCMA candidate.

This devastating situation has pushed us to think about how we might be able to accelerate decision making around on <unk>.

Enrollment continues in the universal trial, exploring a single dose of ALO715 and ALO647 based on the patient. Universal also includes a cohort exploring consolidation dosing with ALO715.

Enrollment continues on the Universal trial exploring a single dose of Allo 501, five analyses for seven basically depletion.

The vessel also growth of cohort exploring consolidation dosing with our 71 five.

At the end of 2022, we intend to provide a clinical update that will focus on the longer term follow up of patients in universal, treated with a single dose of ALO715.

At the end of 'twenty, two we intend to provide a clinical update that will focus on the longer term follow up of patients from universal data with a single dose of Allo 701 five.

We have made the decision not to advance ALO715 in combination with neurogastric pads on screen works that appear.

We have made the decision not to advance all of 71 five in combination with new vessels that funds.

<unk> set up here.

The decision is based on the absence of a clear indication that the combination would, meaningfully improve the benefit-risk of ALLO715 as a monotherapy.

The decision is based on the absence of a clear indication that the combination with meaningfully improve the benefit risk of allo 715, a small effect.

The IGNITE trial with our TurboCard candidate, ALLO605, continues to enroll patients in the, dose-escalation portion of this Phase I study.

The ignite trial with our <unk> product candidate Allo 605 continues to enroll patients in the dose escalation portion of this phase one study.

As we advance clinical programs, I am pleased to announce that I have promoted Dr. Arun, Balakumaran from his current position as Head of Clinical Development to Chief Medical, Officer, reported to me. Arun is board-certified in hematology and medical oncology with a master's degree in, healthcare management. He began his industry career at Amgen after being recruited out of the NIH, where he was, the medical lead at the bone marrow stromal cell transplant center.

As we advance clinical programs I am pleased to announce that I have promoted up to our own bulk demand from his current position as head of clinical development.

Medical officer reporting to me.

<unk> Board certified in hematology and medical oncology with a master's degree in healthcare markets.

We began hosting industry career at Amgen after being recruited out of the NIH. When he was in medical lead at the bone marrow stromal cell itself.

Prior to joining Allogene in the fall of 2018, Arun was Executive Director and Product Development, Lead of Hematological Malignancies at Merck, driving the approval of Pembrolizumab in lymphomas. Arun has been and will continue to be a great thought and execution partner and highly capable, of providing day-to-day leadership and strategic oversight to our important clinical programs.

Prior to joining allergy in the fall of 2018 was executive director and product development needs of Hematological malignancy, some months driving the approval of symbolism in lymphoma.

Our role has been and will continue to be a great bolt on execution upon our highly capable of providing day to day leadership and strategic oversight to our important clinical programs.

Lastly, I would like to echo David in thanking you for your ongoing support.

Lastly, I would like to Echo David's in principle, you for your ongoing support.

Our science and clinical teams are making consistent and promising progress advancing, the Allotype P portfolio to bring this revolutionary treatment option to all patients.

Our science and clinical tools are making sense and promising progress advancing our five key portfolio to bring this revolutionary treatment option for all patients.

I'll now turn the call over to Eric.

I'll now turn the call over to Ed.

Thank you, Rafael, and good afternoon, everyone.

Thank you Raphael and good afternoon, everyone.

As David and Rafael have conveyed, Allogene is nearing a very important milestone.

As David and Raphael has conveyed allergy and is nearing a very important milestone as we progress on this journey to bring cell therapy to many more patients. We are in the fortunate position of having the financial resources required to persist in advance toward our goal.

As we progress on this journey to bring cell therapy to many more patients, we are in the, fortunate position of having the financial resources required to persist and advance toward our goal. We ended the quarter with $686 million in cash, cash equivalents, and investments. While we expect our spending to increase in the second half of 2022, we do realize the, need to be efficient and thoughtful about how we deploy our resources.

We ended the quarter with $686 million in cash cash equivalents and investments.

While we expect our spending to increase in the second half of 2022, we do realize the need to be efficient and thoughtful about how we deploy our resources.

We now expect full-year gap operating expenses to be at the low end of the previous range, of $360 million to $390 million. This includes estimated non-cash stock-based compensation expense of $90 million to $100, million and excludes any impact from potential business development activities.

We now expect full year GAAP operating expenses to be at the low end of the previous range of 360 million to $390 million.

This includes estimated noncash stock based compensation expense of 90 million to $100 million and excludes any impact from potential business development activities our.

Our cash burn for 2022 is expected to be approximately $250 million.

Our cash burn for 2022 is expected to be approximately $250 million move.

Moving to our second quarter financials, in Q2 2022, our research and development expenses, were $57.2 million, which includes $13 million of non-cash stock-based compensation expense. General and administrative expenses were $19.5 million for the second quarter of 2022, which includes $9.9 million of non-cash stock-based compensation expense. Our net loss for the second quarter of 2022 was $74.8 million, or $0.52 per share, including non-cash stock-based compensation expense of $22.9 million.

Moving to our second quarter financials in Q2, 2020 to our research and development expenses were $57 $2 million.

Which includes $13 million of noncash stock based compensation expense.

General and administrative expenses were $19 5 million for the second quarter of 2022, which includes $9 $9 million of noncash stock based compensation expense, our net loss for the second quarter of 2022 was $74 $8 million or <unk> 52 per share income.

<unk> non cash stock based compensation expense of $22 $9 million with that we will now open the call for your questions.

With that, we will now open the call for your, At this time, I would like to remind everyone, in order to ask a question, simply press star, then the number one on your telephone keypad.

At this time I would like to remind everyone in order to ask a question simply press Star then the number one on your telephone keypad.

Your first question is from the line of Tyler Van Buren with Cowan.

Our first question is from the line of Tyler Van Buren with Cowen. Please go ahead.

Please go ahead.

Hey, guys.

Good afternoon, and thank you very much for all the updates.

Hey, guys. Good afternoon, and thank you very much for all the updates.

My question is just, as you think about the ongoing durability and CR rate for LO501A, and the comparison to autologous CAR-T, can you discuss your confidence in the data at six months relative to autologous and the likelihood of those responses being durable?

My question is just as you think about the ongoing durability and CR rate for Allo 501, and the comparison to autologous car T. Can you discuss your confidence in the data at six months relative to autologous and the likelihood of those responses and durable.

All right.

Tyler, this is Day Cheng.

Alright, Tyler so stay tuned. Thank you for the call I think you asked King probably one of the most important question and as we've been saying we have the utmost confidence that.

Thank you for the call.

I think, you know, you're asking probably one of the most important questions, and as, we've been saying, you know, we have the utmost confidence that six-month benchmarking is a good prediction of what is to happen in the longer-term follow-up.

Six months benchmark King is a good prediction.

What has to be happen.

In the longer term follow up so with that let me ask Rafael to elaborate a little bit.

So with that, let me ask Rafael to elaborate a little bit.

Yeah.

Tyler, this is really a very well-established fact in the autologous setting that six-month, CR predicts for long-term durability of response and even cures.

Tyler this is Rob.

Really.

Very well established.

And yet all other setting in a six month CR predicts for long term durability of response and even QRS question was.

The question was, you know, is that going to be the same in the hologenic setting, and, what I can say is that, you know, we are really recapitulating what the autologous setting has been seeing with the lymphodepletion that we use and the strategy that we use.

Going to be the same.

Allogeneic setting and what I can say is that we are really capitulating.

Tolerable setting has been seen with.

LIFO depletion that we use and the strategy that we use so we're pretty confident.

So we're pretty confident that this six-month CR, which is in the order of 30 to 40 percent, predicts for, you know, similar percentage of long-term durability of response.

Six month, CR, which is in the order of 30% to 40% predicts for Sim.

Similar percentage of.

Long term durability of response.

Your next question is from the line of Salveen Richter with Goldman Sachs.

Your next question is from the line of solving Richter with Goldman Sachs. Please go ahead.

Please go ahead.

Good afternoon.

Thanks for taking my question.

Good afternoon. Thanks for taking my question could you just talk about how you're thinking about utilization of fiber one.

Could you just talk about how you're thinking about utilization of 501A given the move of, autologous products to earlier line settings?

And the move of autologous products earlier line setting.

Salveen, David Chang, let me defer to Rafael to elaborate what our plans are with the 501A.

Hi.

David Chang, let me defer to Rafael to elaborate what our plans are.

<unk> certainly our focus right now is starting the pivotal study in the third line, but we are definitely.

Certainly our focus right now is studying the pivotal study in the third line, but we, are definitely eyeing into the earlier lines.

Going into the earlier lines, yes.

Yeah, it's a great question because products are moving into second line, clearly, but, I think one fact that, you know, sometimes is ignored is that a lot of patients that could only receive products prior to the approvals in second line, in third line, were receiving salvage therapy to be able to, you know, get into the third line space.

Great question.

Because.

Products are moving into second line clearly.

But.

I think one fact that.

Sometimes just ignore has had a lot of patience.

Doug.

Could only receive products prior to their approval in second line.

Your line.

We're receiving salvage therapy to be able to.

Get into the third line space.

So, you know, it's unclear to what extent the second line will be, you know, a quantum, leap difference, you know, from the status that there was before.

So it's unclear to what extent the second line will be.

Quantum leap difference.

The status.

There was before I mean, clearly some patients will go straight to second line, but.

I mean, clearly some patients will go straight to second line, but what we know is that there's, a great percentage of patients that are eligible for treatment that don't get treatment, and what we hear from investigators is that there's not going to be any shortage of patients that are refractory, not just to two lines of regimens, but even more, that could come into not just our studies, but eventually when the product is approved into treatment with an allogeneic cell therapy.

But what we know as said there is.

<unk> percentage of patients that are.

Alright eligible for treatment that don't get treatment and what we hear from investigators is that theres not going to be any shortage of patients that are refractory and adjust to two lines for regimens, but even more that could come into not just our studies, but eventually when the product is approved to treatment with <unk>.

All the generic Teletherapy, having said that we have plans to move our product into second line and this is something that we are thinking about.

Having said that, we have plans to move our product into second line, and this is something, that we are thinking about and projecting to, you know, get started, you know, sometime towards the end of this year, early next year.

And projecting to get started.

Sometimes towards the end of this year early next year.

Your next question is from the line of Michael Yee with Jeffries.

Okay.

Your next question is from the line of Michael Yee with Jefferies. Please go ahead.

Please go ahead.

Hey, thanks for the question and thanks for the updates.

Hey, Thanks for the question and thanks for the update.

Looking ahead to PCMA and the development of myeloma, you made some comments about planning, for the next step.

Looking ahead to <unk>.

<unk> and the developments in myeloma, you made some comments about.

Planning for the next step so maybe you could talk a little bit about what the bar is to have made that decision given the existing therapies that are out there obviously analogous to what everyone's asking on 2019, there is already a bar here with the CMA and look at the labels and what the confidence is that you can be at least as good.

So maybe you could talk a little bit about what the bar is to have made that decision, given the existing therapies that are out there, obviously analogous to what everyone's asking on CD19.

There is already a bar here with PCMA and look at the labels and what the confidence, is that you can be at least as good and how you're thinking about the landscape there.

And how youre thinking about the landscape there. Thank you.

Thank you.

Hi, Mike.

Hi, Mike Great question.

Great question.

Our intent is to provide overall update of our PCMA program at the year end, but as we, have made comments in the prepared remarks, we are looking into how to best speed up the program, especially with the confidence that we are getting with the 715 single dose treatment where we have the most data.

<unk> is to provide overall update.

RPC MMA program at the year end, but as we have made a comment in the prepared remarks, we are looking into.

How to best speed up the program.

Basically with a confidence Ted.

We are getting with the second one five single dose treatment, where we have the most data and obviously we are following the data for a longer term durability, especially the duration of response, but as we have previously presented at Ash 2000.

And obviously we are following the data for longer term durability, especially the duration, of response.

But as we have previously presented at ASH 2021, already by then the data was looking, in a pretty comparable to what one of the approved autologous CAR T therapy, specifically of ECMA, has shown.

'twenty one already by then the data was looking in are pretty comparable to what one of the approved autologous car T therapy, specifically at Beckman has shown.

It adds a little bit of gap compared to car T, but on the other hand.

It has a little bit of gap compared to CAR VIC-T, but on the other hand, you're talking, about allergenic off-the-shelf product that can be made readily available to the patient.

Talking about allogeneic off the shelf.

<unk> product that can be made readily available to the patient.

And we've been told by the investigator for quite some time, and certainly I think that, noise has amplified quite a bit over the last few months when it comes to the availability of the autologous CAR T therapy.

And we've been told by the investigator for quite some time and certainly I think that noise has amplified quite a bit over the last few months when it comes to the availability of the autologous car T therapy ads.

And as we have made comments, we are learning that the limited availability is essentially, taking away the opportunity for the patients who could benefit from the autologous CAR, T therapy, not getting the therapy.

As we have made comments, we are learning that the limited availability is.

Essentially taking the way the opportunity for the patients who could benefit from <unk>.

<unk> car T therapy.

Getting the therapy so.

So obviously this is a window that we have, and I think window will last for some time, which is one of the reasons that we are trying to find a way to accelerate our 715 program.

Obviously this is a window that we have and I think window will last for some time and which is one of the reasons that we are trying to find a way to accelerate our 715 program.

Your next question is from the line of Michael Schmidt with Guggenheim.

Okay.

Your next question is from the line of Michael Schmidt with Guggenheim. Please go ahead.

Please go ahead.

Hey.

This is Kelsey on for Michael.

Thanks for taking our questions.

Hey, this is kelsey on for Michael Thanks for taking our question.

I guess first, for the CD19 update later this year, I guess can you just clarify what regimen, the additional patients from Alpha-2 would have been treated with?

I guess first for the <unk> update later this year I guess can you just clarify what regimen.

Additional patients from alpha to what had been treated with <unk>.

And then secondly, I guess what else needs to be done or shown to the FDA with respect, to CellForge I before it can kind of be used as the main facility for the pivotal study?

And then secondly, I guess what else needs to be done or shown to the FDA with respect to California, one before I can kind of be news.

As the main facility for the pivotal study and then can you just remind us of the capacity expectation for Salesforce one thanks, so much.

And then can you just remind us of the capacity expectations for CellForge I?

Thanks so much.

Yes, Kelsey, this is Rafael.

Yes.

So this is rafael.

I'll talk about the dose regimens that we're treating patients with.

I'll talk about.

Good dose regimens that we're treating patients with <unk>.

This study has been going on for, you know, over three years, and we're fortunate to actually, have a very large data set, both with monotherapy across multiple cell doses, as well as lymphodepletion regimens, and a lot of translational data that we can mine ourselves, as well as together with investigators and experts in the field to try to understand what the optimal lymphodepletion regimen will be.

This study has been going on for over three years, we're fortunate to actually have a.

A very large data set both with mono therapy across multiple cell doses as well as LIFO depletion regimen, so and a lot of constellation all data.

We can mine.

Ourselves as well as together with investigators and experts in the field to try to understand what the optimal LIFO depletion regimen will be.

Obviously, we have designed the trial and submitted it for review to FDA, so we already, have chosen a lymphodepletion regimen, and we will make that available once the study is approved.

Obviously, we have designed the trial.

Committed it.

For a review to FDA. So we already have chosen a link for depletion regimen, and we will make data available lungs.

The study is.

And we have a green light from regulators to get it started.

We have seen light from regulators to get it started.

Until then, we continue to treat patients in the Phase I study, and I think that's really, important, first, to keep the investigators engaged, but most importantly, to be able to make the product available to patients in need.

Until then we continue to treat patients in the phase one study and I think that's really important to keep the investigators in case, but most importantly to be able to make the product available to patients.

So, stay tuned with regards to the final lymphodepletion regimen.

So stay tuned with regards to the final.

For depletion regimen.

I think, with regards to Self-Forge I, it is incredibly extensive, the activity level, that, you know, took place, as well as the package that needed to be submitted to FDA, both with regards to comparability, as well as the methodology for validation of the release assays, and all of that package has been submitted to FDA.

I think with regards to yourself, which one it is incredibly expensive.

Activity.

Level of that.

Took place as well as the package that needed to be submitted to FDA, both with regards to comparability as well.

The methodology for validation of the release asset I'll say and all of that package has been submitted to FDA is under review.

It's under review, and it included a lot of details and a lot of runs showing comparability, between, you know, the two previous sites, as well as the optimization of the process.

Sure.

Included.

A lot of detail.

Ron This is showing comparability between the two.

Previous side as well.

Optimization of the process, so without going into further detail.

So, without going into further detail, just to remark on the fact that it was an enormous, amount of work, and we're really very proud of the organization that was able to get this done on a timely fashion and put it really in front of regulators for them to review it, and we're awaiting their response at the moment.

To remark on the fact that it was an enormous amount of work and we are really very proud of.

Monetization was able to get this done on a timely fashion and put it really in front of regulators for them to review it.

We're awaiting.

Our response at the moment and then with regards to capacity.

And then, with regards to capacity, maybe I'll pass it on to Eric to comment.

Ill pass it onto Erik to comment.

Yeah, thanks, Kelsey.

We've talked in the past about having the capacity to dose, from Self-Forge I alone, up to 20,000 patients' worth of material from that facility in a given year. So, that would be at full scale up in full capacity.

Yes, Thanks, Kelsey we've talked in the past about having the capacity to dose from <unk>, one alone up to 20000 patients worth of material from that facility in a given year, so that would be at full scale up and full capacity.

Your next question is from the line of Wren Benjamin with JMP Securities.

Your next question is from the line of Ren Benjamin with JMP Securities. Please go ahead.

Please go ahead.

Hey, good afternoon, guys.

Hey, good afternoon, guys. Thanks for taking the questions.

Thanks for taking the questions.

Can you talk a little bit about the go-no-go criteria you utilized when evaluating the, with Eric Gass, and how many patients did you evaluate before making this decision?

Can you talk a little bit about the go no go criteria utilized when evaluating the combination with Eric Yes.

Many patients.

Did you evaluate before making this decision.

Thanks.

Hi, Wren.

This is Rafael.

Hi, Ryan this is Rafael.

Thanks for the question.

We believe that we actually did the right thing.

Thanks for the question.

We believe that we actually did.

So we did a trial within the trial, if you will, of Neurogastastat, and as you know very, clearly the hypothesis was that we would get less soluble BCMA and higher BCMA in the expression in the plasma cells and lead to better outcomes. We used a cell dose as well as lymphodepletion that we knew was active and a dose of Neurogastastat, that we knew was active in decimal tumors, which is where the lead indication of this product is.

Right.

While we've seen the trial, if you will of neuro Gasser Stan.

And as you know very clearly the hypothesis was that we would get less solid will be CMA and higher <unk> expression in the plasma cell some lead to better outcomes.

We use.

Use.

Our cell dose as well as sling for depletion that we knew was active.

And a dose of neurovascular stat that we knew was active in.

Thats my tumors, which is where the lead indication of this product is.

So we treated a number of patients and a sufficient number of patients to make comparisons with, 715 by itself.

So we treated a number of patients.

And sufficient number of patients to make comparisons with 71 five by itself.

And I think the offshot of it, as I said in the prepared remarks, is that we did see activity, but in terms of increasing benefit-risk, there wasn't really a clear distinction.

And I think the.

Ill shot of it as I said in the prepared remarks, it's bad.

We did see activity, but in terms of.

Increasing benefit rates, there wasn't really a clear distinction and so just to the root of your question what I would say is that.

And so just to the root of your question, what I would say is that we treated sufficient, patients to be able to make, I think, a sound conclusion.

We treated sufficient patients to be able to make I think a solid conclusion now having said that the patients haven't been followed long enough to for us to make a final determination.

Now having said that, the patients haven't been followed long enough for us to make a, final determination, but the data that we have so far suggests that there isn't really an advantage over 715 alone to continue to test the product. So I think that's what I would say about this experiment.

But the data that we have so far suggest that there is really an advantage over 71 five alone.

To continue to test the product so I think thats, what I would say about about this experiment, we're really happy that we thought it was conducted.

We're really happy that it was conducted and that the decision was made.

And the decision was made.

Your next question is from the line of Jason Gerberry with Bank of America.

Your next question is from the line of Jason <unk> with Bank of America. Please go ahead.

Please go ahead.

Oh, hey, guys.

Thanks for taking my questions.

Oh, Hey, guys. Thanks for taking my questions.

Apologies if I missed this, but when you think ahead to the BCMA decision fourth quarter, just given the overall market size is much bigger than CD19 and the supply challenges are so notable, does this make the bar for advancement sort of worse autologous approach or like a buy-specific and not shooting for like a legend-like bar?

If I missed this but when you think ahead to the CMA decision fourth quarter, just given the overall market size is much bigger than CD 19, and the supply challenges are so notable does this make the bar for advancement sort of worst autologous approach or like a buy specific and not shoot.

For like a legend like bar.

And then, you know, just the investment being made in sell-forward, just wanted to confirm, I would assume that there's a presumed synergy to having multiple of the CAR-T programs in-house and not partnering off one or the other, but just if you could confirm that, that would be great.

Then just the investment being made in South Florida, just wanted to confirm I would assume that there is a presumed synergy to having multiple of the car T programs in house and not partnering one or the other but just if you could confirm that that would be great.

Jason Let me take your first question about the product profile that we're shooting for in myeloma and the market size. Yes. This is a tremendous we have large market by most estimates through over 50000 patients in the U S alone with refractory multiple myeloma so clear.

Jason, let me take your first question about the product profile that we're shooting for, in myeloma and the market size.

Yes, this is a tremendously large market. By most estimates, there are over 50,000 patients in the U.S. alone with refractory multiple, myeloma.

So, you know, clearly there is a need to produce cell therapy at much greater scale than is, currently available and to treat many more patients with this modality.

Clearly there is a need to produce cell therapy at much greater scale than is currently.

<unk> available to treat many more patients with this modality in terms of our profile with our 71 five I think it's pretty clear that what we're targeting here is first in class off the shelf therapy that can be dosed on demand over a defined treatment interval.

In terms of our profile with ALICE-715, I think it's pretty clear that what we're targeting, here is a first-in-class, off-the-shelf therapy that can be dosed on demand over a defined treatment interval.

This would obviously be a high-potency product with an accessible safety profile and would, enable patients to truly get away from their disease, hopefully for an extended period of time.

It would obviously be a high potency product with an acceptable safety profile and would enable patients to truly get away from their disease hopefully for extended period of time, we think this profile could be unique.

We think this profile could be unique, and thus far we haven't seen any other product, with a similar profile, and certainly highly attractive to patients.

And thus far we haven't seen any other product with a similar profile and certainly highly attractive to patients you referenced court victory and certainly that the efficacy of that product is extraordinary.

You referenced CARVICTI, and certainly the efficacy of that product is extraordinary, and for that matter, Abecmon may be the second most potent product ever developed for myeloma patients.

And for that matter a backbone baby the second most potent product ever developed for myeloma patients in the real world. Unfortunately, neither of these therapies are going to be relevant to the patients who can't get access. So that's our primary thrust to make sure that many more patients can access cell therapy and benefit from its potency.

But in the real world, you know, unfortunately, neither of these therapies are going to be, relevant to the patients who can't get access.

So, you know, that's our primary thrust to make sure that many more patients can access, Your next question is from the line of Marc Bradenbath with Oppenheimer.

Your next question is from the line of Mark Breidenbach with Oppenheimer. Please go ahead.

Please go ahead.

Hey, good afternoon, and thanks for taking the question.

Hey, good afternoon, and thanks for taking my question.

Just wondering if exploring a pivotal study for the BCMA program implies that you've got, a formal type B meeting with the FDA scheduled for later this year, and I'm also wondering how we should be interpreting that you're thinking about advancing 7.1.5 into a pivotal trial before showing us data from 6.05 or from consolidation dosing with 7.1.5.

Just wondering if if if exploring a pivotal study for the <unk> program implies that you've got a formal type b meeting with the FDA scheduled for later this year.

And I'm also wondering how we should be interpreting that youre thinking about advancing $7 5 million, who pivotal trial be.

For showing this data from 605 or from consolidation dosing with 71 five.

Thanks, Reni.

Culler, you can give on that.

Any color you can give on that.

Yeah.

Yes, Mark let me take that question as.

Marc, let me take that question.

As some of you may know, in the BCMA from the beginning, you know, we have taken a relatively, broad approach, not just the 7.1.5 as a single infusion, but also, you know, the combination with a gamma secretase inhibitor that Rafael has just covered.

Some of you may know in the CMA from the beginning we have taken a three pronged approach not just a 715 as a single infusion.

But also.

The combination with a gamma secretase inhibitor that Rafael has just covered.

We also tested a next generation, and that study is still ongoing.

We also tested.

A next generation and that study is still ongoing.

And all, you know, the last one that we added is the, you know, exploration with a consolidation, where we plan to give two doses in a very tight interval, you know, hoping that that would improve the, you know, overall outcome.

And the last one that we added is.

Exploration with a consolidation where we plan to give two doses in a very tight interval.

Hoping that that would improve.

They're at Com.

Obviously, some of the studies are ongoing, but in drug development, you know, time is, of essence.

Some of the studies are ongoing but in drug development time is our vessels and also we believe that currently there is a great opportunity as Eric has just covered.

And also, we believe that, you know, currently there is a great opportunity, as Eric has, just covered, and the target product profile that we have set out and the data that we are seeing in the 7.1.5 program is very promising.

And the target product profile that we have set out and the data that we have seen in the 71 five program is very promising so that's really the genesis of our interest in exploring moving to 715 program into the pivotal.

So that's really the genesis of our interest in, you know, exploring moving the 7.1.5 program, into the pivotal.

And what needs to be done, as we have done during the 501A experience, is pretty extensive.

And what needs to be done as we have.

During the <unk> experience is pretty extensive.

Not only we have to take care of the CMC issues, we have to take care of the protocol.

Not only we have to take care of the CMC issues.

To take care of the protocol and this is where we feel that the fact that we have the control of the manufacturing at the CF fund will be a plus and in fact, I think that's going to add in terms of quite a bit about how fast we can move and as that activity is going on certainly.

And this is where we feel that the fact that we have the control of the manufacturing at, the CF1, you know, will be a plus.

And in fact, I think that's going to add in terms of quite a bit about how fast we can, move.

And as that activity is going on, certainly the regulatory discussion will have to occur.

The regulatory discussion, we will have to occur the timing of regulatory discussion, we do not go into that but 715 currently has to Amit Thats a nation.

The timing of regulatory discussion, you know, we do not go into that, but 7.1.5 currently, has the ARMET designation, which would allow us a much, hopefully, you know, quick regulatory interaction than what we have experienced with 501A.

Would allow us a much hope fleece quick regular transaction that what we have experienced with 501 K.

Okay.

Your next question is from the line of David Dye with SM BC. Please go ahead.

Your next question is from the line of David Dai with SMBC.

Please go ahead.

Great.

Thank you for taking my questions.

Great. Thanks for taking my questions.

So I have one question on the 6.05, the decentralized part T program.

One question on the $6 five to keep the image of our car T program could you just remind us what dose level. We currently estimate the patient adds and then could you just provide some.

Could you just remind us what dose level you're currently escalating the patient at?

And then could you just provide some color in terms of when should we expect an update, from that?

A color in terms of when should we expect an update from that program.

Yes, so this is Rafael, so 605 is currently in dose escalation, as you know, we're going, to explore doses that we know that have been active in 715, and we're very close to achieving those doses.

Yes.

This is Raphael. So 605. This is currently in dose escalation is.

No.

And we're going to explore doses.

We know there have been active in seven five.

And we're very close to.

Achieving those doses.

And then after that, we will also explore various lymphodepletion regimens, just like, what we did with 605, sorry, with 715, as well as with 501 and 501A.

And then after that we will also explore various thing for depletion regimens just like we did with.

605, sorry, with total on five as well as with Tiger, one and Tiger RNA.

So there will still be a little bit of time before we complete the dose escalation, and, we get a good picture of what this next generation product can do compared to 715, so it may take us more time than, you know, the rest of the year, so it is possible that the next update or the first update that you may see with 605 may be next year rather than at the end of this year.

So there will still be a little bit of time before we complete the dose escalation and we get a good picture of.

What this next generation product can do compared to 715, so it may take us more time than the rest of the year.

So it is possible that the next update or the FERC update that you may see with 605, maybe next year rather than at the end of this year.

Your next question is from the line of John Newman with Canaccord. Please go ahead.

Your next question is from the line of John Newman with Canaccord, please go ahead. Hi, guys, thanks for taking my question, just curious, in terms of the potential design, for the pivotal study for 501A, do you expect that you would exclude patients previously treated with other CV19-targeted therapies?

Hi, guys. Thanks for taking my question.

Just curious in terms of the potential design for the pivotal study for 501, a do you expect that you would exclude patients previously treated with other.

CV 19 targeted therapies and then.

And then second question I had regarding the 715 program, just curious if we might see, some consolidation data at the end of this year, the press release mentioned single agent, but I'm not sure if the consolidation data might come this year, maybe 2023, thanks.

Second question I had regarding the 715 program just curious if we might see some consolidation data at the end of this year. The press release mentioned single agent, but just not sure if the consolidation data might come this year, maybe 2023.

Yeah, so the answer to the first question is that the pivotal trial will exclude patients, that are previously treated with CV19-directed therapy, I think that's, you know, a way for us to, you know, be able to establish the allogeneic F-benefit risk in the setting where the autologous products were developed, and so, you know, that decision has been made, you know, that we have retreated patients in the past, and we've seen some activity before, but for the purpose of the pivotal trial, these patients would be excluded.

Yes, so the answer to the first question. He said the pivotal trial will exclude patients that are previously treated with.

2019, directed therapy I think thats.

A way for us to be able to.

Establish the Apollo generic benefit risk.

In this setting where they are told all of those products were developed.

And so.

That decision has been made.

We have re treated patients in the past and we've seen some activity before but for the purpose of the pivotal trial. These patients would be excluded.

And then the 715 consolidation data is ongoing.

And then the third one five consolidation data is ongoing.

I believe that in order to present sufficient durability, we may need to wait until early, next year, but, you know, that cohort will finish, you know, relatively soon, and, you know, it depends on what we see, but most likely, you know, my projection is that it will probably cross into next year.

I believe that.

In order to present sufficient durability, we may need to wait until early next year.

But that.

That cohort.

Finish.

Relatively soon.

And it depends on what we see but most likely my projection is study will probably cross into next year.

Your next question is from the line of Luca Sisi with RBC Capital.

Your next question is from the line of Luca <unk> with RBC capital. Please go ahead.

Please go ahead.

Oh, great.

Thanks so much for taking my question.

Alright, great. Thanks, so much for taking my question.

I think it was mentioned a couple times during the call, you know, a little bit of a gap, versus CAR-VIC-T on F-158, and obviously, I appreciate all the benefit of a hollow CAR-T versus auto, but is it possible that the FDA will initially ask you to run a pivotal trial I do not want to speculate on behalf of the FDA, but if you think about what we are doing, with the Allo501A, we are going into the same third-line patient population that the Otocar-T have currently labeled in, so the discussions on the multiple myeloma, that's coming up, our current expectation is that the FDA position would not have significantly shifted over the last few months from how they've been advising us about the 501A pivotal study design.

I think it was mentioned a couple of times during the call a little bit of a gap versus car Vicki on efficacy and obviously appreciate all the benefit of Allo car T versus <unk>, but is it possible that the FDA will initially ask you to run a pivotal trial for <unk> post Autocar T. In studying outer khaki naive any color there would be great.

Yes, Luke this is David Chang I do not want to speculate on behalf of the FCA.

But if you think about what we are doing with the allo 501 a.

We are going into the same third line patient population that the auto car T have currently a label and so.

The discussions on the multiple myeloma.

Coming up.

Our current expectation is that the FDA position would not have significantly shifted.

Over the last few months from how they've been advising us about the fiber one pivotal.

Pivotal study design.

Your next question is from the line of Rajiv Prasad with William Blair.

Your next question is from the line of Rajiv Prasad with William Blair. Please go ahead.

Please go ahead.

Thanks for taking the question just regarding sell forward. One can you just give us a sense of.

Thanks for taking the question.

Where were the CMC is that now compared to where you would anticipate a potential commercial launch and just how many aspects of the manufacturing process are still <unk>.

Just regarding CellForge, one, can you just give us a sense of, where the CMC is at now compared to where you anticipated a potential commercial launch, and just how many aspects of the manufacturing process are still relying on CDMOs, is it vectors or something of that nature, versus what you'd anticipate at a commercial launch?

<unk> on <unk>.

Vectors or something of that nature.

Versus what you would anticipate kind of the commercial launch.

Hey, Raj I mean, great question.

See issues, obviously Barry.

Hot ticket item 10 days and it's also a very complex issues, but let me simplify in terms of <unk>.

Our state of art manufacturing facility that we plan to going forward not just produce the clinical materials, but also convert that facility.

The launch of the product upon the approval. So it's really designed as a multipurpose manufacturing facility and debt facilities already operational.

The clinical grade materials in terms of.

What is needed it's probably too much information to go into the details.

Our plan is use that facility for the cell manufacturing and.

And going forward, we will continue to rely on <unk> for the viral vector manufacturing.

Your next question is from the line of Austin Gordon with tourists Securities. Please go ahead.

What is the capacity currently.

Okay.

Hello.

Yes. Please go ahead.

Oh, sorry, yes, so I wanted to know what the current capacity yourself, which one is and also how long would it take to get up to 20000 per year.

Thanks, David.

Let me take that question.

That facility at full capacity, we have said we will produce.

<unk> thousand Allo 501.

Current capacity is really based on our need and certainly the capacity far exceeds what we need.

To support all our ongoing clinical programs so.

This is really one of the best manufacturing facility that I have dealt with and we're very happy that it will not only meet our current need but it will meet our future need for foreseeable years.

Yes.

Your next question is from the line of <unk> Patel with B Riley Securities. Please go ahead.

Yeah, Hey, good afternoon, and thanks for taking the question.

You noted that youre waiting on FDA clearance for the <unk> two study.

But have you received a thumbs up for the expand study already or is that guidance also expected along with the clearance of the Alpha II study and if you have received clearance are you able to disclose any additional details for the design of that trial.

Yes in terms of Capella.

<unk>.

Two pivotal study that we plan to do one is at <unk> 501, a single arm study that we plan to demonstrate.

And the benefit risk of Allo 501, and the second expand study is the one that we will.

Demonstrate the contribution.

Allo 647 in the lymphoid depletion.

Right now our focus is getting the 501, a single arm study up we believe that that is on the critical path and Thats. What we are waiting for as 4647, we already have had discussions and we expect that study to be initiated after we start.

The Allo 501 study.

Okay.

Your next question is from the line of Jack Allen with Baird. Please go ahead.

Hi, Thank you so much for taking the question and congratulations to the team on the progress.

I was hoping you might be able to speak to any color as it relates to the data you shared with the FDA to secure the <unk> designation in June for Allo 501.

Did the FDIC.

Any updated durability data and any comments you could make us as it relates to that conversation would be great. Thank you so much.

Yes, Thanks, Jack Thanks, Rafael Great question.

Okay.

Gus first Harman designation with seven five and then.

With 501 as you May know.

We submitted data.

David.

From the last presentation.

And it was across doses and schedules on LIFO depletion regimen.

It really was.

Drifted and obviously their response or durability of response.

Interested on long term durability.

But importantly interesting how many patients actually receive the product versus how many patients were enrolled.

And what was the time between enrollment and received tufted products and also whether or not they receive bridging therapy. So this question is really speak to I think the interest of the agency on the allogeneic technology.

We believe.

It's something of interest to the regulators.

I would say that we have received similar questions in the past with several of them five so.

So I think we I think you had reiterated.

The benefit does see allogeneic technology.

Sing.

Explanations investigators, but also regulators.

Thank you that concludes our question and answer session I would like to turn the conference back over to management for any additional comments.

Thank you I want to end the call by thanking you for joining us today and your ongoing support as we pave new roles in the development of Allogeneic car T products.

We very much look forward to what lies ahead for the rest of the year and updating you on our progress.

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.

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Hello, Thank you for standing by and welcome to Allergan Therapeutics second quarter of 2022 conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session.

If you would like to ask a question. During this time simply press Star then the number one on your telephone keypad to withdraw your question Press Star one again.

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

Raj, great question.

I would now like to turn the call over to Christine Casiano, Chief Communications Officer, Ms. Kathy Hello. Please go ahead.

Thank you operator, and welcome to our Q2 call after market close we issued a business update and financial results press release for the second quarter of 2020 as press.

CMC issues are obviously very hot-ticket item current days, and it's also, very complex issues, but let me simplify.

Press release and today's webcast are available on our website. We ask you to limit your questions to one per person and we'll do our best to answer as many as possible during the hour.

In terms of CF1, that's our state-of-the-art manufacturing facility that we plan to, going forward, not just produce the clinical materials, but also convert that facility for the launch of the product upon the approval. So it's really designed as a multi-purpose manufacturing facility, and that facility is already operational, and we are making the clinical-grade materials.

Joining me today are Dr. David Chang, President and Chief Executive Officer, Dr. Rafael Amado Executive Vice President of research and development and Dr. <unk> <unk> Chief Financial Officer.

On 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 2022 financial guidance among other things. Please.

Please go ahead looking statements are based on current information assumptions and expectations that are subject to change and description of the potential risks can be found in our earnings press release and latest SEC disclosure documents and you are cautioned not to place undue reliance on these forward looking statements and Allergan disclaims any obligation to update these statements.

I'll now turn the call of mix Okay.

In terms of what is needed, it's probably too much information to go into the details, but our plan is to use that facility for the cell manufacturing, and going forward, we will continue to rely on CDMOs for the viral vector manufacturing.

Thank you Christine and good afternoon.

Your next question is from the line of Astika Gunawardhan with Truist Securities.

Since our last update we have continued to make significant progress across our pipeline.

Please go ahead.

From our lead CD 19 candidate Allo, 500, <unk> and our lead <unk> candidate Allo 701 pie to our first solid tumor candidate Allo 316.

What is the capacity currently?

We believe each of these programs have promising potential and we remain focused on advancing these candidates.

That will allow us to define shape and expand the future of cell therapy.

This month marks the five year anniversary of the first approval of an autologous car T therapy targeting CD 19.

Hello?

Yes, please go ahead.

Oh, sorry.

Since that time the field has benefited from additional successes.

Spectacular datasets reaffirming the treatment benefit coming from onetime infusion.

Label expansions to earlier lines as well as two other b cell lymphomas.

And approval of new car T therapies targeting the CMA.

Michael Myeloma.

Yes, one thing that has not changed is the challenges associated with delivery.

As recently published in the journal of clinical oncology.

<unk> access to a palace khaki remains constrained due to individualized patient manufacturing among other challenges.

This study reported that the median waiting time for an FDA approved car T treatment for multiple myeloma patients was six months.

And that only 25% of patients eventually receive car T therapy.

Lots of focus in this study was multiple myeloma long wait time and supply limitations on cell therapy have also been documented and non Hodgkin's lymphoma.

Clinicians have been pushed into the unfashionable position of needing to choose which of their patients who will receive potential life saving therapy.

As you may recall from our market research we presented in May 2021 at our C 19 Forum from over 2000 separate physician appraisal effort.

Because the parameters are the single most important consideration and decision making.

But importantly, this research foreshadowed the current market crisis.

Covering other factors that influence physician decision, making.

These included the likelihood that a patient receives the prescribed treatment.

The time to treatment and other logistical considerations.

Yeah, so I want to know what the current capacity of, CellForge1 is, and also how long would it take to get up to 20,000 per year, approximately?

We started Allison with a goal of correcting this limitations associated with a deliberate commerce car T therapy.

Developing our car T products, and making them readily available to all eligible patients.

Let me take the question.

Four years into our journey. We believe we are on a path to transform car T therapy from a complex individualized procedure to an off the shelf on demand pharmaceutical product.

I mean, that facility, at full capacity, we have said will produce 20,000 out of 501A.

Current capacity is really based on our need, and certainly the capacity far exceeds what we need to support all our ongoing clinical programs.

So this is really one of the best manufacturing facilities that I have dealt with, and we're very happy that it will not only meet our current need, but it will meet our future need for foreseeable years.

Your next question is from the line of Kalpit Patel with B. Riley Securities.

Please go ahead.

Last year, we embarked on a complex set of regulatory discussions directly that enabling the first potential pivotal phase III trial of an allogeneic car T therapy.

Yeah.

Hey, good afternoon, and thanks for taking the question.

You noted that you're waiting on FDA clearance for the Alpha 2 study, but have you received, a thumbs up for the EXPAND study already, or is that guidance also expected along with the clearance of the Alpha 2 study?

And if you have received clearance, are you able to disclose any additional details for, the design of that trial?

Yeah.

In terms of, Kapil, the question about two pivotal studies that we plan to do.

One is a 501A single-arm study that we plan to demonstrate the benefit-risk of 501A, and, the second EXPAND study is the one where we will demonstrate the contribution of allo-647 in the lympho-depletion.

The protocols, we have put before the FDA for the offer to a phase III trial was informed by clinical and translational data we accumulated in phase III trials.

And we look forward to sharing study details once FDA clearance for the study has been obtained.

Throughout the development process clinical data often guests to spotlight.

But for complex cell and gene therapy products chemistry manufacturing and controls or CMC work is often rate limiting.

We are optimistic regarding the package of CMC information, we have provided to the FDA.

Right now, our focus is getting the 501A single-arm study up. We believe that that is on the critical path, and that's what we are waiting for.

As we have previously noted we believe the ability to launch Allo 501 phase III pivotal trial without product that had been manufactured at our intended commercial facility would be a major competitive advantage at the time of BLA submission and launch of Allo 501.

As for 647, we already have had discussions, and we expect that study to be initiated after, we start the allo-501A study.

Our next question is from the line of Jack Allen with Baird.

Please go ahead.

Hi.

Thank you so much for taking the question, and congratulations to the team on the progress.

As we wait for the initiation of our Allo 501, a phase II pivotal trial, we are already thinking about what comes next including how to expand access of Allo car T to earlier lines of therapy, and how to bring allo car T products to other patient populations.

I was hoping you might be able to speak to any color as it relates to the data you shared, with the FDA to secure the RMAT designation in June for allo-501A.

This includes evaluating the opportunity to advance our 715, our lead candidate for relapsed refractory multiple myeloma into a potential pivotal trial and continued execution on our phase one trial for our <unk> six in renal cell carcinoma.

I am incredibly grateful to our one allergen team that remains laser focused on our vision to deliver the first allo car T product.

Yeah.

I'm also grateful to have many insights coming from Allergan by way of people, who are equally energized about our mission.

To that end.

We welcome Dr. Steven Mayo Award renown expert in computation of protein design to allergens board of directors Dr.

Dr. Mayer is the brand professor of Biology, and chemistry, and Mercury Institute Professor at the California Institute of Technology.

He has decades strong success record in both academia and the biopharmaceutical industry will help us to advance our pipeline of investigational Allo car T product.

Together with each advances we made across our allo car T pipeline.

One step closer to creating a new reality for patients.

We are grateful for your support.

I will now turn the call over to Rafael.

Did the FDA see any updated durability data?

Thank you David.

We first start briefly as it relates to our plan all tied to the phase III pivotal trial of Allo 501, a interline large b cell lymphoma or <unk>.

Any comments you can make as it relates to that conversation would be great.

While the initiation of the trial remains subject to final FDA review, we are confident in Harper cluster design of this trial and appreciative of the collaboration with have with our investigators as we analyze all the data across doses and schedules from the phase one portion.

Prior to submitting our proposed protocol to the FDA, we undertook an in depth analysis of our data to determine the best dosing strategy to pursue in the pivotal trial.

This included assessment of the depth and durability of clinical responses analysis of translational data on Allo car T cell expansion.

System feedback from investigators and engagement with regulatory authorities.

Look forward to sharing more with fewer once we have initiated the trial.

Thank you so much.

As you May recall, we are planning to conduct the expand trial to establish the contribution of our 607 to the link of the patient Regiment.

Yes.

Thanks, Jack.

<unk> also conducted a thorough analysis of allo 607 dose.

Kinetics and pharmacodynamics, we believe the use of allo six per serving is critical to enabling safe on effectively depletion.

This is Rafael.

Great question.

Weekly able to create the need of window for allo car T expansion and persistence.

You know, we got first RMAT designation with 715 and then with 501A, as you may know.

Wealth of phase one dose ranging data that we have generated a gross 19 program has shown us that Allison for seven dosing is critical to achieving optimal efficacy.

We submitted data that was updated, obviously, from, you know, the last presentation, and, it was across doses and schedules and lympho-depletion regimens.

FDA really was interested in, obviously, the response, the durability of response, interested, on long-term durability, but importantly, interested in how many patients actually received the product versus how many patients were enrolled and what was the time between enrollment and receipt of the product and also whether or not they received bridging therapy.

So, these questions really speak to, I think, the interest of the agency on the allogeneic, technology, which we believe, you know, is something of interest to regulators.

And I can say that we have received similar questions in the past with 715.

Allowed us to zero in on the preferred roughly I'm glad you asked.

So, I think it reiterated, you know, the benefit of the allogeneic technology, both in the, eyes of clinicians, investigators, but also regulators.

Thank you.

We have shown a strong correlation between Q concentrations policies for salmon and the likelihood of clinical response.

That concludes our question and answer session.

Our data as well as those of our partners and competitors substantiated, our belief that this trial will not only result in a positive outcome, but also differentiate our platform by demonstrating that including a $6 7 million for depletion regimen contributes to superior outcomes, including durability of response.

Expand trial is expected to begin later in 2022.

We also plan to provide an update on the phase one portion of the Alpha and I'll touch a trough at the end of 2022.

This update will focus on longer term follow up of patients previously treated in both trials.

I would like to turn the conference back over to management for any additional comments.

I am incredibly proud of the hard work across functions.

For the first of its kind trial.

Thank you.

Our goal has been to supply pivotal trial material cross sell for <unk> to reduce complexity and risk for our regulatory strategy, including the requirement that we established comparability between material used in our pivotal trial and material intended for commercialization.

I want to end the call by thanking you for joining us today and your ongoing support, as we pave new roads in the development of allogeneic CAR T products.

We very much look forward to what lies ahead for the rest of the year and update you on, our progress.

We chose to mitigate future risk, including the BLA submission stage by working to have material sourced from self ports, one using an optimized process available prior to the start of the pivotal program.

We believe our strong process on profit validation capabilities support our ability to deliver a well characterized biologic with minimal variability and hopefully will allow us to avoid undue delays.

That's helpful.

I am grateful for their partnership with somehow Alison Moore, our Chief Technical Officer, and thank the team for its leadership collaboration and focus all admirable traits that are required to be a pioneer in this field.

Our second most advanced program and potentially next pivotal program with Allo 715, <unk> for myeloma.

As David indicated the current marketplace for autologous cell therapy highly constrained with supply on deliveries.

We know these effects not just patients with no hospitals pharma have you been Marseille patients living with multiple myeloma.

This devastating situation has pushed us to think about how we might be able to accelerate decision making around <unk>.

Enrollment continues on the Universal trial exploring a single dose of Allo 501, five analysis for seven based upon completion.

Universal also includes a cohort exploring consolidation dosing with allo 715.

The end of 2022, we intend to provide a clinical update that will focus on the longer term follow up of patients from universal data with a single dose of Allo 715.

We have made the decision not to advance all of 71 five in combination with new vessels that springboard therapeutics.

The decision is based on the absence of a clear indication that the combination with wound fully improve the benefit risk profile of 715 Manav that.

The ignite trial with cloud to ballpark candidate Allo six so far.

<unk> continues to enroll patients in the dose escalation portion of these phase one studies.

As we advance clinical programs I am pleased to announce that I have promoted up to our own volatile demand from his current position as head of clinical development and Chief Medical Officer reporting to me.

<unk> Board certified in hematology and medical oncology with a master's degree in health care matters.

We began hosting the superior abandon after being recruited out of the NIH when he western medical lead at the bone marrow stromal cell itself.

Sure.

Prior to joining allergy in the fall of 2018.

They beat Us director and product development need a hematological malignancy some months driving the approval of symbolism in lymphoma.

I will have seen and will continue to be a great path and execution upon our highly capable of providing day to day leadership and strategic oversight to our important clinical programs.

Lastly, I would like to Echo David's principle you Johan.

<unk> four.

Our science and clinical tools are looking.

Some promising progress advancing our five key portfolio to bnb revolutionary treatment option for all patients.

Operator, you may now disconnect.

I'll now turn the call over to Ed.

Thank you Rafael and good afternoon, everyone.

Thank you.

Ladies and gentlemen, thank you for your participation in today's conference.

As David and Raphael has conveyed allergy and is nearing a very important milestone as we progress on this journey to bring cell therapy to many more patients. We are in the fortunate position of having a financial resources required to persist and advance towards our goal.

We ended the quarter with $686 million in cash cash equivalents and investments.

While we expect our spending to increase in the second half of 2022, we do realize the need to be efficient and thoughtful about how we deploy our resources we have.

Now expect full year GAAP operating expenses to be at the low end of the previous range of 360 million to $390 million. This.

This includes estimated noncash stock based compensation expense of 90 million to $100 million and excludes any impact from potential business development activities our.

Our cash burn for 2022 is expected to be approximately $250 million move.

Moving to our second quarter financials in Q2, 2020 to our research and development expenses were $57 $2 million.

Which includes $13 million of noncash stock based compensation expense.

General and administrative expenses were $19 $5 million for the second quarter of 2022, which includes $9 $9 million of noncash stock based compensation expense, our net loss for the second quarter of 2022 was $74 $8 million or <unk> 52 per share income.

<unk> non cash stock based compensation expense of $22 $9 million with that we will now open the call for your questions.

This does conclude the program and you may now log off and disconnect.

Hello, thank you for standing by and welcome to Allogene Therapeutics' second quarter, of 2022 conference call.

At this time I would like to remind everyone in order to ask a question simply press Star then the number one on your telephone keypad.

All lines have been placed on mute to prevent any background noise.

After the speaker's remarks, there will be a question-and-answer session.

Our first question is from a line of Tyler Van Buren with Cowen. Please go ahead.

If you would like to ask a question during this time, simply press star, then the number, one on your telephone keypad.

Hey, guys. Good afternoon, and thank you very much for all the updates.

To withdraw your question, press star one again.

My question is just how do you think about the ongoing durability and CR rate for Allo 501, and the comparison to autologous car T. Can you discuss your confidence in the data at six months relative to autologous and the likelihood of those responses and durable.

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

Alright, Tyler this is Dave Chang. Thank you for the call I think you asked King probably one of the most important question and as we've been saying we have the utmost confidence that.

Six months benchmark King is a good prediction.

What has to be happen.

In the longer term follow up so with that let me ask Rafael to elaborate a little bit.

Yes.

Tyler this is <unk>.

Really.

Very well established.

And yet all other setting in a six month CR predicts for long term durability of response and even QRS question was.

Going to be the same in the allogeneic setting and what I can say that we are really capitulating.

The autologous setting has been seen with.

LIFO depletion that we use and the strategy that we use so we're pretty confident that this six month CR, which is in the order of 30% to 40% predicts for.

Similar percentage of long term durability of response.

I would now like to turn the call over to Christine Cassiano, Chief Communications Officer.

Yeah.

Your next question is from the line of solving Richter with Goldman Sachs. Please go ahead.

Ms. Cassiano, please go ahead.

Good afternoon. Thanks for taking my question could you just talk about how you're thinking about utilization of fiber one.

And then move up autologous products earlier line setting.

Thank you, operator, and welcome to our Q2 call.

Hi.

After market closed, we issued a business update and financial result press release, for the second quarter of 2022. This press release and today's webcast are available on our website.

We ask you to limit your questions to one per person, and we'll do our best to get to, as many as possible during the hour.

David Chang, let me defer to Rafael to elaborate what our plans were.

Joining me today are Dr. David Cheng, President and Chief Executive Officer, Dr. Rafael Amado, Executive Vice President of Research and Development, and Dr. Eric Schmidt, Chief Financial Officer.

<unk> certainly our focus right now is starting the pivotal study in the third line, but we are definitely.

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 2022 financial guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations, that are subject to change.

Going into the earlier lines.

Yes, it's a great question.

Because.

Products are moving into second line clearly.

But.

I think one fact that sometimes just ignore has had a lot of patience.

Hi.

Could only receive products prior to their approval in second line in <unk>.

Your line.

We're receiving salvage therapy to be able to.

Getting to the third line space.

So it's unclear to what extent the second line will be.

Quantum leap difference.

The status there.

There was before I mean, clearly some patients will go straight to second line, but.

But what we know that there is.

<unk> percentage of patients that are.

<unk> til therapy, having said that we have plans to move our product into second line and this is something that we are thinking about.

And projecting to get started.

Sometimes towards the end of this year early next year.

A description of the potential risks can be found in our earnings press release and latest, SEC disclosure documents.

Okay.

Your next question is from the line of Michael Yee with Jefferies. Please go ahead.

You are cautioned not to place undue reliance on these forward-looking statements, and the, Allogene disclaims any obligation to update these statements.

I'll now turn the call over to David.

Hey, Thanks for the question and thanks for the update.

Thank you, Christine, and good afternoon.

Looking ahead to.

PCM and the developments in myeloma, you made some comments about.

Planning for the next step so maybe you could talk a little bit about what the bar is to have made that decision given the existing therapies that are out there obviously analogous to what everyone's asking on CD 19, there is already a bar here with the CMA and look at the labels and what the confidence is that you can be at least as good.

And how youre thinking about the landscape there. Thank you.

Since our last update, we have continued to make significant progress across our pipeline. From our lead CD19 candidate, ALO501A, and our lead BCMA candidate, ALO715, to our first, thalatuma candidate, ALO316.

Hi, Mike quick question.

We believe each of these programs have promising potential, and we remain focused on advancing, these candidates in a way that will allow us to define, shape, and expand the future of cell therapy.

This month marks the five-year anniversary of the first approval of an autologous CAR-T, therapy targeting CD19.

Since that time, the field has benefited from additional successes, spectacular data sets, reaffirming the treatment benefits coming from one-time infusion, label expansions to earlier lines, as well as to other B-cell lymphomas, and approval of new CAR-T therapies, So, thank you for including me, due to individualized patient manufacturing, among other challenges.

This study reported that the median waiting time, for an FDA-approved CAR T-treatment for multiple myeloma patients was six months, and that only 25% of patients eventually received CAR T-therapy.

Intent is to provide overall update.

While the focus in this study was multiple myeloma, long wait time, and supply limitations on cell therapy have also been documented in non-Hodgkin's lymphoma.

Clinicians have been forced into the unfathomable position, of needing to choose which of their patients will receive potential lifesaving therapy.

As you may recall from market research, we presented in May 2021 at our C19 forum, from over 2,000 separate physician appraisals, efficacy parameters are the single most important consideration in decision-making.

RPC MMA program at the year end, but as we have made a comment in the prepared remarks, we are looking into.

But importantly, this research foreshadowed, the current market crisis by uncovering other factors that influence physician decision-making.

These included the likelihood that a patient receives, the prescribed treatment, the time to treatment, and other logistical considerations.

How to best speed up the program, especially with a confidant instead.

We are getting with a 715 single dose treatment, where we have the most data and obviously we are following the data for a longer term durability, especially the duration of response, but as we have previously presented at Ash 2021.

Already by then the data was looking in are pretty comparable to what one of the approved autologous car T therapy, specifically at Beckman has shown.

It adds a little bit of gap compared to car T, but on the other hand.

We started AllerGen with a goal of correcting, these limitations associated with the delivery of autologous CAR T-therapy by developing our CAR T-products and making them readily available to all eligible patients.

Talking about allogeneic off the shelf.

Four years into our journey, we believe we are on a path to transform CAR T-therapy from a complex individualized procedure to an off-the-shelf on-demand pharmaceutical product. Last year, we embarked on a complex set, of regulatory discussions directed at enabling the first potential pivotal phase two trial of an AllerGen-A CAR T-therapy.

I am very pleased by the progress we have made, and am confident that in coming weeks we could be initiating the industry's first pivotal trial for an AllerGen-A CAR T-product, thereby paving the road not just for Aller501A and our pipeline candidates, but for the field more broadly.

<unk> product that can be made readily available to the patient.

The protocols we have put before FDA, for the Alpha-2 Phase II trial was informed by clinical and translational data we accumulated in Phase I trials, and we look forward to sharing study details once FDA clearance for the study has been obtained.

Throughout the development process, clinical data often gets the spotlight.

But for complex cell and gene therapy products, chemistry, manufacturing, and controls, or CMC work is often rate-limiting.

We are optimistic regarding the package, of CMC information we have provided to that.

As we have previously noted, we believe the ability to launch LL501A Phase 2 pivotal trial, with cell products that have been manufactured at our intended commercial facility would be a major competitive advantage at the time of BLA submission and launch of LL501A.

As we have made comments, we are learning that the limited availability is.

Essentially taking the way the opportunity for the patients who could benefit from the autologous car T therapy and that getting the therapy. So.

As we wait for the initiation of our LL501A Phase 2 pivotal trial, we are already thinking about what comes next, including how to expand access of allocarditis to earlier lines of therapy and how to bring allocarditis products to other patient populations.

This is a window that we have and I think window will last for some time and which is one of the reasons that we are trying to find a way to accelerate our 715 program.

This includes evaluating the opportunity to advance LL715, our lead candidate for relapse, refractory multiple myeloma, into a potential pivotal trial and continued execution on our Phase 1 trial for LL316 in renal cell carcinoma.

I am incredibly grateful to our One Allergen team, that remains laser-focused on our vision to deliver the first allocarditis product.

I am also grateful to have many insights coming from Allergen by way of people who are equally, energized about our mission.

To that end, we welcome Dr. Stephen Mayo, a world-renowned expert in computational protein design, to Allergen's Board of Directors. Dr. Mayo is the Brandt Professor of Biology and Chemistry and Merkin Institute Professor at the California Institute of Technology.

His decades-long success record in both academia and the biopharmaceutical, industry will help us to advance our pipeline of investigational allocarditis products.

Together, with each advances we make across our allocarditis pipeline, we are one step closer, to creating a new reality for patients.

We are grateful for your support.

Okay.

Your next question is from the line of Michael Schmidt with Guggenheim. Please go ahead.

Hey, this is kelsey on for Michael Thanks for taking our question.

I guess first for the <unk> 19 update later this year I guess can you just clarify what regimen.

The additional patients from alpha to what had been treated with <unk>.

And then secondly, I guess what else needs to be done or shown to the FDA with respect to California, one before I can kind of be news.

As the main facility for the pivotal study and then can you just remind us of the capacity expectations for Salesforce one thanks, so much.

I will now turn the call over to Rafael.

Yes.

This is rafael.

Thank you, David.

Talk about.

Good dose regimen. So we're treating patients with this study has been going on for over three years and we're fortunate to actually have.

Let me first start briefly as it relates to our Plan Alpha-2 Phase 2, pivotal trial of ALO501A in third-line Large B-cell Lymphoma, or LBCL.

Very large data set with both with mono therapy across multiple cell doses as well as LIFO depletion regimens and a lot of constellation on data.

We can mine.

Ourselves as well as together with investigators and experts in the field to try to understand what the optimal link for depletion regimen will be obviously, we have designed the trial.

While the initiation of the trial remains subject to final FDA review, we are confident in our proposed design of this trial and appreciative of the collaboration we've had with our investigators as we analyze all the data across doses and schedules from the Phase 1 portion. Prior to submitting our proposed protocol to the FDA, we undertook an in-depth analysis of our data to determine the best dosing strategy to pursue in the pivotal trial. This included assessment of the depth and durability of clinical responses, analysis of translational data on allocarditis expansion and persistence, feedback from investigators, and engagement with regulatory authorities.

Our submitted it.

For a review to FDA. So we already have chosen a link for depletion regimen, and we will make data available lungs.

We look forward to sharing more with you once we have initiated the trial.

The study is.

As you may recall, we are planning to conduct the EXPAND trial to establish the contribution, of ALO647 to the lymphodepletion regimen. We have also conducted a thorough analysis of ALO647 dosing, pharmacokinetics, and pharmacodynamics. We believe the use of ALO647 is critical to enabling safe and effective lymphodepletion, and uniquely able to create the needed window for allopathy expansion and persistence. The wealth of phase 1 dose ranging data that we have generated across our CM19 program, has shown us that ALO647 dosing is critical to achieving optimal efficacy and has allowed us to zero in on the preferred dosing regimen. We have shown a strong correlation between serum concentrations of ALO647 and the likelihood, of clinical response.

Our data, as well as those of our partners and competitors, substantiate our belief that, this trial will not only result in a positive outcome, but also differentiate our platform by demonstrating that including ALO647 in the lymphodepletion regimen contributes to superior outcomes, including durability of response.

And we have a green light from regulators to get it started.

The EXPAND trial is expected to begin later in 2022.

We also plan to provide an update on the phase 1 portion of the alpha and alpha 2 trials, at the end of 2022. This update will focus on longer-term follow-up of patients previously treated in both trials.

I am incredibly proud of the hard work at CROSS-FUNCTIONS as we prepare for this first-of-its-kind, trial.

In need so stay tuned with regards to the final.

For depletion regimen.

I think with regards to yourself, which one it is incredibly expensive.

Activity.

Our goal has been to supply pivotal trial material from CELF-421 to reduce complexity, and risk to a regulatory strategy, including the requirement that we establish comparability between material used in our pivotal trial and material intended for commercialization. We chose to mitigate future risk, including at the DLA submission stage, by working to, have material sourced from CELF-421 using an optimized process available prior to the start of the pivotal program.

Level of that.

We believe our strong process and prioritization capabilities support our ability to deliver, a well-characterized trial logic with minimal variability and, hopefully, will allow us to avoid the undue delays that have been observed in the CELF-421 field.

Took place as well as the package that needed to be submitted to FDA, both with regards to comparability as well.

Our second most advanced program and potentially next pivotal program is ALO715 targeting BCMA, for myeloma.

The methodology for validation.

The release assay.

And all of that package testing.

Submitted to FDA is under review.

And.

It included.

A lot of detail.

A lot of runs showing comparability between the two previous sites as well.

The optimization of the process, so without going into further detail.

As David indicated, the current marketplace for autologous CELF therapy is highly constrained, with supply and delivery issues.

We know this affects not just patients with non-Hodgkin's lymphoma, but even more so patients, living with multiple myeloma.

To remark on the fact that it was an enormous amount of work and we're really very proud of the organization that was able to get this done on a timely fashion and put it really in front of regulators for them to review it.

This devastating situation has pushed us to think about how we might be able to accelerate, decision-making around a new BCMA candidate.

Enrollment continues in the universal trial, exploring a single dose of ALO715 and ALO647, based on the clinical trials.

At the end of 2022, we intend to provide a clinical update that will focus on the longer-term, follow-up of patients in Universal, treated with a single dose of ALO715.

We're awaiting.

The response at the moment and then with regards to capacity.

Ill pass it onto Erik to comment.

Yes, Thanks, Kelsey we've talked in the past about having the capacity to dose from self forsworn alone up to 20000 patients worth of material from from that facility in a given year, so that would be at full scale up and full capacity.

Your next question is from the line of Ren Benjamin with JMP Securities. Please go ahead.

Hey, good afternoon, guys. Thanks for taking the questions.

Can you talk a little bit about the go no go criteria utilized when evaluating the combination with guests.

Yes, and how many patients.

Did you evaluate before making this decision.

<unk>.

Hi, Ryan this is Rafael.

For the question.

We believe that we actually did.

Right.

Trial, we've seen that trial, if you will of neuro gasser span.

No very clearly the hypothesis was that we would get.

Less solid will be CMA and higher <unk> expression in the plasma cell some lead to better outcomes.

We.

Youth.

So those as well as for depletion that we knew was active.

And a dose of neurovascular stat that we knew was active in.

That's my tumors, which is leading.

Lead indication of this product this.

So we treated a number of patients.

And sufficient number of patients to make comparisons with 71 five by itself.

And I think the.

Offshore of it as I said in the prepared remarks, it's bad.

We did see activity, but in terms of.

We have made the decision not to advance ALO715 in combination with neurographic stats on, The decision is based on the absence of a clear indication that the combination would meaningfully improve the benefit-risk of ALO715 as a monotherapy.

<unk>.

Kris and benefit rates, there wasn't really a clear distinction and so just to the root of your question what I would say is that.

The IGNITE trial with our two-vote candidate, ALO605, continues to enroll patients in the, dose-escalation portion of this Phase I study.

We treated sufficient patients to be able to make I think a solid conclusion now having said that the patients haven't been followed long enough to for us to make a final determination.

The data that we have so far suggest that there is really an advantage over 75 alone to continue to test the product. So I think thats, what I would say about about this experiment, we're really happy that we thought it was conducted.

Prior to joining AllerGene in the fall of 2018, Arun was Executive Director and Product, Development Lead of Hematological Malignancies at Merck, driving the approval of Pembrolizumab in lymphomas. Arun has been and will continue to be a great thought and execution partner, and highly, capable of providing day-to-day leadership and strategic oversight to our important clinical programs.

Lastly, I would like to echo David in thanking you for your ongoing support.

Our science and clinical teams are making consistent and promising progress advancing, the Allertype P portfolio to bring this revolutionary treatment option to all patients.

And the decision was made.

I'll now turn the call over to Eric.

Your next question is from the line of Jason <unk> with Bank of America. Please go ahead.

Thank you, Rafael, and good afternoon, everyone.

Hey, guys. Thanks for taking my questions.

For like a legend like bar and then just the investment being made in sell forward just wanted to confirm I would assume that there is a presumed synergy to having multiple of the car T programs in house and not partnering up.

One or the other but.

Just if you could confirm that that would be great.

Jason Let me take your first question about the product profile that we're shooting for in myeloma and the market size. Yes. This is a tremendous large market by most estimates for over 50000 patients in the U S alone with refractory multiple myeloma. So.

Clearly there is a need to produce cell therapy at much greater scale than is currently available to treat many more patients with this modality in terms of our profile with our 71 five I think it's pretty clear that what we're targeting here is a first in class off the shelf therapy.

Can be dosed on demand over a defined treatment interval.

This will obviously be a high potency product with an acceptable safety profile and will enable patients to truly get away from their disease hopefully for extended period of time, we think this profile could be unique and thus far we haven't seen any of the product with a similar profile and certainly highly attractive to patients.

You referenced <unk> victory and certainly that the efficacy of that product is extraordinary.

And for that matter, our Beckmann baby the second most potent product ever developed for myeloma patients in the real world. Unfortunately, neither of these therapies are going to be relevant to the patients who can't get access so.

That's our primary thrust to make sure that many more patients can access cell therapy and benefit from its potency.

As David and Rafael have conveyed, AllerGene is nearing a very important milestone as we, progress on this journey to bring cell therapy to many more patients.

We are in the fortunate position of having the financial resources required to persist, and advance toward our goal. We ended the quarter with $686 million in cash, cash equivalents, and investments.

Your next question is from the line of Mark Breidenbach with Oppenheimer. Please go ahead.

While we expect our spending to increase in the second half of 2022, we do realize the, need to be efficient and thoughtful about how we deploy our resources. We now expect full-year GAAP operating expenses to be at the low end of the previous range, of $360 million to $390 million. This includes estimated non-cash stock-based compensation expense of $90 million to $100, million and excludes any impact from potential business development activities.

Hey, good afternoon, and thanks for taking my question.

Our cash burn for 2022 is expected to be approximately $250 million.

Just wondering if if if exploring a pivotal study for the <unk> program implies that you've got a formal type b meeting with the FDA scheduled for later this year.

And I'm also wondering how we should be interpreting that youre thinking about advancing $7 5 million, who pivotal trial before showing this data from 605 or from consolidation dosing with 715.

Thanks for any color you can give on that.

Yes, Mark let me take that question.

With that, we will now open the call for your questions.

At this time, I would like to remind everyone, in order to ask a question, simply press star, then the number 1 on your telephone keypad.

Your first question is from the line of Tyler Van Buren with Cowan.

Some of you may know in the CMA from the beginning we have taken a three pronged approach not just a 715 as a single infusion.

Please go ahead.

Hey guys, good afternoon and thank you very much for all the updates.

But also.

The combination with a gamma secretase inhibitor that Rafael has just covered.

We also tested.

A next generation and that study is still ongoing.

And the last one that we added is.

Exploration with a consolidation where we plan to give two doses in a very tight interval.

Hoping that that would improve.

They're at comp.

Some of the studies are ongoing but in drug development time is our vessels.

And also we believe that currently there is a great opportunity as Eric has just covered.

The target product profile that we have set out and the data that we are seeing in the 71 five program is very promising so that's really the genesis of our interest in exploring moving to 715 program into the pivotal.

And what needs to be done as we.

Entering the <unk> experience is pretty extensive.

Not only we have to take care of the CMC issues.

We have to take care of the protocol and this is where we feel that the fact that we have the control of the manufacturing at the CF Fund.

We'll be a plus and in fact, I think that's going to add in terms of quite a bit about how fast we can move and as that activity is going on certainly the regulatory discussion we will have to occur.

<unk> regulatory discussion, we do not go into that but 715 currently has to ahmet designation, which would allow us a much hopefully.

Quick regular transaction that what we have experienced with 501 K.

Yes.

My question is just, as you think about the ongoing durability and CR rate for, Allo501A and the comparison to autologous CAR T, can you discuss your confidence in the data at six months relative to autologous and the likelihood of those responses being durable?

Your next question is from the line of David Dye with SM BC. Please go ahead.

All right, Tyler, this is Dave Chang.

Thank you for the call.

Great. Thank you for taking my questions. So one question on the $6 5 billion image of a car T program could you just remind us what dose level currently ethylene in the patient.

I think you were asking probably one of the most important questions.

And as we've been saying, we have the utmost confidence that six-month benchmarking, is a good prediction of what is to happen in the longer-term follow-up.

So with that, let me ask Rafael to elaborate a little bit.

Tyler, this is really a very well-established fact in the autologous setting, that six-months CR predicts for long-term durability of response and even cures.

My question was, is that going to be the same in the allogeneic setting?

And then could you just provide some.

And what I can say is that we are really recapitulating what the autologous setting, has been seeing with the lymphodepletion that we use and the strategy that we use.

So we're pretty confident that this six-months CR, which is in the order of 30 to 40 percent, predicts for a similar percentage of long-term durability of response.

In terms of when should we expect an update from that program.

Your next question is from the line of Salveen Richter with Goldman Sachs.

Please go ahead.

Yes.

This is Raphael. So 605. This is currently in dose escalation is.

No.

And we're going to.

Explore doses that we know there have been active in seven five.

And we're very close to.

Achieving those doses.

And then after that we will also explore.

Are you seeing for depletion regimens, just like we did with <unk>.

605, I'm, sorry, with <unk>, five as well as with Tiger, one and Tiger RNA.

So there will still be a little bit of time before we complete the dose escalation and we get a good picture of what this next generation product can do compared to $7. Five so it may take us more time than the rest of the year.

It is possible that the next update or the FERC update that you may see with 605, maybe next year rather than at the end of this year.

Your next question is from the line of John Newman with Canaccord. Please go ahead.

Good afternoon.

Thanks for taking my question.

Okay.

Hi, guys. Thanks for taking my question.

Just curious in terms of the potential.

<unk> design for the pivotal study for 501, a do you expect that you would exclude patients previously treated with other.

<unk> 19 targeted therapies and then <unk>.

Second question I had regarding the 715 program.

Just curious if we might see some consolidation data at the end of this year. The press release mentioned single agent, but just not sure if the consolidation data might come this year, maybe 2023.

Could you just talk about how you're thinking about utilization of 501A, given the move of autologous products to earlier line settings?

Yes, so the answer to the first question. He said the pivotal trial will exclude patients that are previously treated with.

Hi, Salveen.

2019, directed therapy, and I think thats.

A way for us to be able to.

It's Tom Lister, our generic benefit risk.

In the setting where they are told all of those products were developed.

And so.

That decision has been made.

You know that we have re treated patients in the past and we've seen some activity before but for the purpose of the pivotal trial. These patients would be excluded.

And then the third one five consolidation data is ongoing.

I believe that.

In order to present sufficient durability, we may need to wait until early next year.

But.

That cohort.

We'll finish right.

Relatively soon.

It depends on what we see but most likely.

<unk> study will probably cross into next year.

Your next question is from the line of Luca <unk> with RBC capital. Please go ahead.

Alright, great. Thanks, so much for taking my question.

I think it was mentioned a couple of times during the call a little bit of a gap versus car Victor you on efficacy and obviously appreciate all the benefit of Allo car T versus <unk>, but is it possible that the FDA will initially ask you to run a pivotal trial for <unk> post Autocar T. In studying outer khaki naive any color there would be great.

David Chang.

Yes, Luke this is David Chang I do not want to speculate on behalf of the FCA.

Let me defer to Rafael to elaborate what our plans are with the 501A.

But if you think about what we are doing with the allo 501 a week.

We're going into the same third line patient population that the auto car T have currently a label and so.

Certainly our focus right now is studying the pivotal study in the third line, but we are definitely eyeing into the earlier lines.

The discussions on the multiple myeloma.

Coming up but our current expectation is that the FDA position would not have significantly shifted.

Over the last few months from how they've been advising us about the fiber one pivotal.

Pivotal study design.

Yeah, it's a great question because products are moving into second line, clearly.

But I think one fact that sometimes is ignored is that a lot of patients, that could only receive products prior to the approvals in second line, in third line, were receiving salvage therapy to be able to get into the third line space.

Your next question is from the line of Rajiv Prasad with William Blair. Please go ahead.

So it's unclear to what extent the second line will be a quantum leap forward, and will be a quantum leap difference from the status that there was before.

I mean, clearly some patients will go straight to second line.

Thanks for taking the question just regarding sell forward. One can you just give us a sense of.

Where were the CMC is that now compared to where you had just paid out a potential commercial launch and just how many aspects of the manufacturing process are still real.

<unk> on <unk>.

Vectors or something of that nature.

Versus what you'd anticipate kind of the commercial launch.

But what we know is that there's a great percentage of patients, that are eligible for treatment that don't get treatment.

And what we hear from investigators is that there's not going to be any shortage of patients, that are refractory, not just to two lines of regimens, but even more that could come into not just our studies, but eventually when the product is approved into treatment with allogeneic cell therapy.

Hey, Raj I mean, great question.

Having said that, we have plans to move our product into second line, and this is something that we are thinking about and projecting to get started sometime towards the end of this year, early next year.

See issues, obviously theory.

Hot ticket item 10 days and it's also very complex issues, but let me simplify in terms of CF plan.

Your next question is from the line of Michael Yee with Jeffries.

Our state of art manufacturing facility that we plan to going forward not just produce the clinical materials, but also convert that facility.

The launch of the product upon approval. So it's really designed as a multipurpose manufacturing facility and that facility is already operational and making the clinical grade materials in terms of.

What is needed, it's probably too much inflammation to go into the details.

Our plan is to use that facility for the cell manufacturing and.

And going forward, we will continue to rely on <unk> for the viral vector manufacturing.

Please go ahead.

Your next question is from the line of Austin, Good Warden with tourists Securities. Please go ahead.

Hey, thanks for the question and thanks for the updates.

What is the capacity currently.

Looking ahead to PCMA and the developments in myeloma, you made some comments about planning, for the next step.

Hmm.

So maybe you could talk a little bit about what the bar is to have made that decision, given the existing therapies that are out there, obviously analogous to what everyone's asking on CD19.

Sure.

There is already a bar here with PCMA and look at the labels and what the confidence, is that you can be at least as good and how you're thinking about the landscape there.

Yes. Please go ahead.

Thank you.

Hi, Mike.

Oh, sorry, yes, so I wanted to know what the current capacity yourself, which one is and also how long would it take to get up to 20000 per year.

Let me take that question I mean that facility at full capacity, we have said we will produce.

Great question.

And obviously we are following the data for longer term durability, especially the duration, of response.

<unk> thousand Allo 501.

But as we have previously presented at ASH 2021, already by then the data was looking, in a pretty comparable to what one of the approved autologous CAR T therapy, specifically, Avecma has shown.

Current capacity is really based on our need and certainly the capacity far exceeds what we need.

It has a little bit of gap compared to CAR VIC-T, but on the other hand, you're talking, about allergenic off-the-shelf product that can be made readily available to the patient.

And we've been told by the investigator for quite some time and certainly I think that, noise has amplified quite a bit over the last few months when it comes to the availability of the autologous CAR T therapy.

So obviously this is a window that we have and I think window will last for some time, which is one of the reasons that we are trying to find a way to accelerate our 715 program.

To support all our ongoing clinical programs. So this.

This is really one of the best manufacturing facility that I have dealt with and we're very happy that it will not only meet our current need but it will meet our future need for foreseeable years.

Your next question is from the line of Michael Schmidt with Guggenheim.

Okay.

Your next question is from the line of <unk> Patel with B Riley Securities. Please go ahead.

Please go ahead.

Yes, Hey, good afternoon, and thanks for taking the question.

You noted that youre waiting on FDA clearance for the Alpha to study.

Hey, this is Kelsey on for Michael.

But have you received a thumbs up for the expand study already or is that guidance also expected along with the clearance of the Alpha to study and if you have received clearance are you able to disclose any additional details for the design of that trial.

Yes in terms of Capella.

<unk>.

Two pivotal study that we plan to do one is <unk> 501, a single arm study that we plan to demonstrate.

In our benefit risk of Allo 501, and the second expand study is the one that we will.

Demonstrate the contribution.

Allo 647 in the lymphoid depletion.

Right now our focus is getting the 501, a single arm study up we believe that that is on the critical path and Thats. What we are waiting for as 4647, we already have had discussions.

And we expect that study to be initiated after we start the allo 501 study.

Yeah.

Yes.

Thanks for taking our questions.

Your next question is from the line of Jack Allen with Baird. Please go ahead.

I guess first for the C19 update later this year, I guess can you just clarify what regimen, the additional patients from Alpha 2 would have been treated with?

Hi, Thank you so much for taking the question and congratulations to the team on the progress I was hoping you might be able to speak to any color as it relates to the data you shared with the FDA to secure them our math designation in June for Allo 500, <unk> do.

Did that Bac.

Any updated durability data in and any comments you can make us as it relates to that conversation would be great. Thank you so much.

And then secondly, I guess what else needs to be done or shown to the FDA with respect, to cell Forge 1 before it can kind of be used as the main facility for the pivotal study?

Yes, Thanks, Jack Thanks, Rafael Great question.

Okay.

Gus first Harman designation with seven five and then.

And then can you just remind us of the capacity expectations for cell Forge 1?

With 501 as you May know.

We submitted data that was updated obviously from the last presentation.

Thanks so much.

And it was across doses and schedules on LIFO depletion regimen.

FDA really was.

And obviously the response or durability of response.

Interested on long term durability.

But importantly interesting how many patients actually receive the product versus how many patients were enrolled.

And what was the time between enrollment and receive the product and also whether or not they receive bridging therapy. So this question is really speak to I think the interest of the agency on the allogeneic technology.

Which we believe.

It's something of interest to regulators.

I can say that we have received similar questions in the past with several of them five so.

So I think we I think you had reiterated the.

The benefit does see allogeneic technology.

Sing.

Explanations investigators, but also regulators.

Thank you that concludes our question and answer session I would like to turn the conference back over to management for any additional comments.

Thank you.

I want to end the call by thanking you for joining us today and your ongoing support as we pave new roles in the development of Allogeneic car T products.

We very much look forward to what lies ahead for the rest of the year and updating you on our progress.

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.

Yes, Kelsey, this is Rafael.

I'll talk about the dose regimens that we're treating patients with.

Obviously, we have designed the trial and submitted it for review to FDA, so we already, have chosen a lymphodepletion regimen, and we will make that available once the study is approved and we have seen light from regulators to get it started.

This does conclude the program and you may now log off and disconnect.

So, stay tuned with regards to the final lymphodepletion regimen.

It's under review, and it included a lot of details and a lot of runs showing comparability, between, you know, the two previous sites, as well as the optimization of the process.

And then, with regards to capacity, maybe I'll pass it on to Eric to comment.

Yeah, thanks, Kelsey.

Your next question is from the line of Wren Benjamin with JNP Securities.

Please go ahead.

Hey, good afternoon, guys.

Thanks for taking the questions.

Can you talk a little bit about the go-no-go criteria you utilized when evaluating the, combination with SeraGas, and how many patients did you evaluate before making this decision?

Thanks.

Hi, Wren.

It's Rafael.

Thanks for the question.

We believe that we actually did the right thing.

So we treated a number of patients and a sufficient number of patients to make comparisons with, 715 by itself.

And I think the offshot of it, as I said in the previous remarks, is that we did see activity, but in terms of increasing benefit-risk, there wasn't really a clear distinction.

And so just to the root of your question, what I would say is that we treated sufficient, patients to be able to make, I think, a sound conclusion.

We're really happy that it was conducted and that the decision was made.

Your next question is from the line of Jason Gerberi with Bank of America.

Please go ahead.

Oh, hey, guys.

Thanks for taking my questions.

Apologies if I missed this.

But when you think ahead to the BCMA decision fourth quarter, just given the overall market, size is much bigger than CD19 and the supply challenges are so notable, does this make the bar for advancement sort of worse autologous approach or like a buy-specific and not shooting for like a legend-like bar?

And then just the investment being made in self-forward, just wanted to confirm.

I would assume that there's a presumed synergy to having multiple of the CAR-T programs in-house, and not partnering off one or the other, but just if you could confirm that, that would be great.

Jason, let me take your first question about the product profile that we're shooting for, in myeloma and the market size.

Yes, this is a tremendously large market. By most estimates, there are over 50,000 patients in the U.S. alone with refractory, multiple myeloma.

So, you know, clearly there is a need to produce cell therapy at much greater scale than is, currently available and to treat many more patients with this modality.

In terms of our profile with ALIS-715, I think it's pretty clear that what we're targeting, here is a first-in-class off-the-shelf therapy that can be dosed on demand over a defined treatment interval.

This would obviously be a high-potency product with an accessible safety profile and would, enable patients to truly get away from their disease, hopefully for an extended period of time.

We think this profile could be unique, and thus far we haven't seen any other product, with a similar profile, and certainly highly attractive to patients.

You referenced CAR-VIC-T, and certainly the efficacy of that product is extraordinary, and for that matter, Abacabam may be the second most potent product ever developed for myeloma patients.

But in the real world, you know, unfortunately, neither of these therapies are going to be, relevant to the patients who can't get access, so, you know, that's our primary thrust to make sure that many more patients can access cell therapy and benefit from its benefits.

Your next question is from the line of Marc Bradenbath with Oppenheimer.

Please go ahead.

Hey.

Good afternoon, and thanks for taking the question.

Just wondering if exploring a pivotal study for the BCMA program implies that you've got, a formal type B meeting with the FDA scheduled for later this year.

And I'm also wondering how we should be interpreting that you're thinking about advancing 7.1.5, into a pivotal trial before showing us data from 6.0.5 or from consolidation dosing with, 7.1.5.