Q3 2020 Allogene Therapeutics Inc Earnings Call

Good morning, ladies and gentlemen, thank you for standing by and welcome to Allergies Therapeutics third quarter 2020 conference call. At this time, all participants are in a listen only mode.

Operator: Good morning, ladies and gentlemen. Thank you for standing by, and welcome to Allogene Therapeutics' third quarter 2020 conference call. At this time, all participants are in the listen-only mode.

Operator: After the speaker's presentation, there will be a question-and-answer session. 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. Ms. Cassiano, please go ahead.

Speaker presentation, there will be a question and answer session.

Please be aware that Chiefs conference call is being recorded I would now like to turn the call over to Christine Casiano, Chief Communications Officer Ms. Kathy on the please go ahead.

Thank you operator, and good morning before market opened today allergy and issued a press release that provides a corporate update and financial results for the third quarter ended September 30 of 2020. This press release is available on our website at Www Dot Allergan Dot com.

Christine Cassiano: Thank you, Operator, and good morning. Before the market opened today, Allogene issued a press release that provides a corporate update and finance results for the third quarter ended September 30, 2020. This press release is available on our website at www.allogene.com. Today's call is being webcast on our website and will be available for replay.

Today's call is being webcast on our website and will be available for replay joining me on the call today are Dr., David Chang, President and Chief Executive Officer, Dr. Rafaella motto Executive Vice President of research and development and Chief Medical Officer, and Dr., Eric Schmidt Chief Financial Officer.

Christine Cassiano: Joining me on the call today are Dr. David Chang, President and Chief Executive Officer, Dr. Rafael Amato, Executive Vice President of Research and Development and Chief Medical Officer, and Dr. Eric Schmidt, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities, and 2020 financial guidance, among other things. Such forward-looking statements are based on current information, assumptions, and expectations that are subject to change. These statements involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statement.

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 trial data presentations regulatory filings future research and development efforts manufacturing capability and 2020 financial guidance among other things.

These forward looking statements are based on current information assumptions and expectations that are subject to change. These statements involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission.

Christine Cassiano: These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our Form 10-Q for the quarter ended September 30, 2020. 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 Dr. David Chang. Thank you, Christine, and my thanks to all of you for joining us on our third quarter conference call during a very busy week and new cycle. Given that this promises to be an eventful morning, we are going to keep today's prepared remarks short and focus on a few key areas.

Including our form 10-Q for the quarter ended September 30 of 2020, Youre 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 over to Dr. David Chang.

Thank you Christine and my thanks to all of you for joining us on our third quarter conference call. During a very busy weekend you cycle.

Given that this promises to be an eventful morning, we're going to keep today's prepared remarks short and focus on a few key areas.

David D. Chang: I will start with CD19, specifically our plans with ALO501 and ALO501A and our path to investigating allocardial therapy and follow-up tumors. Later in the call, Rafael will speak to the work we are doing to advance our BCMA-directed therapies, including our plans to present our initial Phase I data from our first BCMA product candidate, ALO715, at an upcoming scientific meeting later this year. Let's start with our CD19 program in relapsed and refractory non-Hodgkin lymphoma.

I will start with CD 19, specifically, our plans with aloe fiber, one and a follow up I know, one eight and I'll pass investigating Albuquerque, dark in solid tumors.

Later in the call Rafael will speak to the work we're doing to advance our DC I made directed therapies.

Putting up plans to present, our initial phase one data from our first be CNS product candidates I lost 715 in an upcoming scientific meeting later this year.

Let's start with our Cdnineteen program in relapsed and refractory non Hodgkin lymphoma.

David D. Chang: We believe the proof-of-concept data we presented at ASCO provides a strong foundation of support for our efforts to make allocardiotherapy a reality. However, one outstanding question for the allogeneic field is durability of response. Durability is critical to the value proposition of any CAR-T therapy, and we firmly believe that the answer to durability lies in how we utilize lymphodepletion, optimize cell dose, and embrace dosing flexibility that is viable and scalable with an off-the-shelf cell therapy. We have spoken at length about lymphodepletion and how we are optimizing the dose of ALO647, our anti-CD52 monoclonal antibody In our view, such controlled immune suppression is necessary to maximize tumor cell killing while minimizing the risk of cytopenia and opportunistic infection.

We believe the proof of concept data we presented at Astro provides a strong foundation of support of our efforts to make oligarchy therapy a reality.

However, one outstanding question for the Allogeneic field. These two ability of response Jordan.

Durability is critical to the value proposition of any car T therapy, and we firmly believe that the answer to do be lies in how we utilize lymphodepletion optimize cell dose and embraced dosing flexibility that is viable and scalable with an off the shelf cell therapy.

We have spoken at length about Lymphodepletion and how we're optimizing the doors that Alis 647, our anti CD 52 monoclonal antibody in concert with a standard fludarabine and cyclophosphamide, well publicized regimen to create the ideal depth and duration of lymphodepletion to allow.

Robust expansion and persistence of our car T cells.

Oh view, such a controlled immune suppression is necessary to maximise, the tumor cell, killing while minimizing the risk upside of Kenya and opportunistic infection. We.

David D. Chang: We continue to believe that this approach of utilizing Allo647 as a differentiated component will help us to achieve our goal of providing a meaningful clinical benefit with allogeneic cardiotherapy. The initial readout from the Alpha Phase I trial also gave us a glimpse at what may be one of the more exciting benefits of our potential off-the-shelf therapy, the ability to re-dose patients. In the case study presented at ASCO, one patient dosed with 120 million cells of ALO501 following lymphodepletion with a standard full site, and the 39 milligram dose of ALO607 achieved a partial response, but subsequently progressed in month two. Shortly after progression, the patient was retreated with 120 million cells of Allo501 and this time with a full size and a 90 milligram dose of Allo In the autologous setting, CAR-T dosing regimens are shaped by the inherent limitations in cell supply.

We continue to believe that this approach of utilizing our 647 as a differentiated components will help us to achieve our goal of providing a meaningful clinical benefit with allogeneic car T therapy.

The initial read out from the Alpha Phase one trial also gave us a glimpse said.

What may be one of the more exciting benefits oh potential off the shelf therapy, the ability to read those patients.

In the case study presented at ASCO, one patient dosed with 120 million cell itself Aloe fiber one following the lymphodepletion with a standard foresight and that 39 milligram dose of Alis six or seven achieved a partial response, but subsequently progressed and much too.

Certainly after progression the patient must retreated with 120 million cell itself Aloe fiber one and this time with a pool site and the 90 milligram dose of outlets 647, which led to a complete response.

Endoscopic, just setting artsy dosing regiments eye shaped by the inherent limitations in cell supply.

David D. Chang: Rather than applying autologous thinking to the design of an allogeneic trial, we want to exploit the benefit of allogeneic therapies to better understand the potential for repeat dosing. In particular, we plan to explore the risk-benefit profile of scheduled repeat dosing, which we will refer to as consolidation therapy in the alpha trial. Practically speaking, consolidation therapy entails treating patients who have no disease progression after the first Alokar T therapy with a second dose of Alokar T approximately five to six weeks later.

Rather than applying autologous thinking to the design of an allogeneic trial, we want to exploit the benefit of allogeneic therapies to better understand the potential for repeat dosing.

In particular, we plan to explore the risk benefit profile about schedule repeat dosing, which we will refer to as consolidation therapy into alpha trial right.

Practically speaking the consolidation therapy entails treating patients without disease progression. After the first aloe car T therapy with a second dose of Aloe car T. Approximately five to six weeks later.

Our hope is that this back to back dosing or consolidation might enable more patients to achieve deeper responses and maintain a durable remission.

David D. Chang: Our hope is that this back-to-back dosing or consolidation might enable more patients to achieve deeper responses and maintain a durable remission. As enrollment continues in our Alpha and Alpha 2 Phase I trials, we expect a rich data set to emerge. Pending data, our current plan is to initiate a potential pivotal Phase 2 trial of LL501A in 2021. We look forward to showcasing this holistic view of the CD19 program's progress, including additional data from the LO501-alpha trial and the dose escalation phase of the LO501A-alpha 2 study in the first half of 2021. The next update I would like to provide is on ALO 316, our anti-CD70 Alokarthi candidate. As we prepare to file our IND in renal cell carcinoma, or RCC, this quarter, our enthusiasm increases for the start of our clinical trial in 2021 and the potential to explore LO316 in solid tumors. We look forward to presenting additional preclinical data this year and believe RCC may be just the beginning of what can be addressed by ALOD316 given the expression of CD70 in lung cancer, glioblastoma, and hematologic malignancies.

As enrollment continues in our alpha and Alpha two phase one trials, we expect the rich data set to emerge.

Pending data our current plan is to initiate a potential pivotal phase two trial allo vital one eight in 2021.

We look forward to showcasing this holistic view on the CD 19 programs progress, including additional data from Aloe fiber, one alpha trial and the dose escalation phase of our fiber one eight alpha to study in the first half of 2021.

The next update I would like to provide is on our three won six our anti Cdseventy idle car T candid.

As we prepare to file our eye, India in renal cell carcinoma, or RCC. This quarter, our enthusiasm increases put a stop to allow clinical trial in 2021 and the potential to explore aloe 316 in solid tumors we.

We look forward to presenting additional preclinical data this year and believe RCC may be just the beginning of what can be addressed by Alice through you on six given the expression of cdseventy in lung cancer, Glioblastoma and hematologic malignancies.

We could not be prouder of our team said Allison tend to progress may not just across our development pipeline, but also the work being done to complete our state of the art manufacturing facility, which we expect will began producing clinical GMP lot in 2021.

David D. Chang: We could not be prouder of our teams at Allogene and the progress made not just across our development pipeline but also the work being done to complete our state-of-the-art manufacturing facility, which we expect will begin producing clinical GMP labs in 2021. Our unwavering focus on bringing allocardiotherapy to patients has allowed us to quickly advance multiple allocardiotherapy candidates. In 2021, just our third full year as a company, we expect to have five clinical trials underway, including one pivotal trial, our initial endeavor into solid tumors, and our first study using our TurboCAR T technology. I will now turn the call over to Raphael for further updates on our research and development activities with a specific focus on Arlo 715 and our BCMA program. Thank you, David.

Our unwavering focus on bringing Aloe party therapy to patients has allowed us to quickly advance multiple aloe carty candidates yes.

In 2021, just our third full year as a company we expect to have five clinical trials underway, including one pivotal trial, our initial endeavor into solid tumor and I'll first study using our turbo Parky technology.

I will now turn the call over to Rafael So further updates on our research and development activities with a specific focus on our 715 and our PCM a program.

Thank you David I know they are seeing considerable interest in our polling Alessandro one slide presentation in patients with relapsed refractory multiple myeloma I am excited to provide an update on RBC made platform more broadly.

Rafael Amato: I know there's been considerable interest in our upcoming ALO715 presentation in patients with relapsed refractory multiple myeloma, and I am excited to provide an update on our BCMA platform more broadly. Our prior Phase 1 data presentation of ALO501 at ASCO was an important step towards validating our platform as it addressed key questions, including the successful manufacture of an allogeneic CAR-T therapy, the ability to administer therapy without causing clinically relevant graft-versus-host disease, the use of ALO647 to enable deep and selective lymphodepletion required for cell expansion, and the finding that allogeneic cell therapy can generate meaningful anti We hope the initial look at our universal phase 1 dose escalation trial might reconfirm these foundational observations in a different disease setting, thereby positioning us to move on to the next steps in this study, namely optimizing cell dose, info depletion, and potential repeat administration of ALO715. Initial datasets from Universal may also allow us to apply insights across our BCMA platform.

Prior phase one data presentation of all fiber one that opco whats really important step towards validating our platform I could address key questions, including the successful manufacture of an allogeneic car T therapy, the ability to administer therapy without costing clinically relevant graft versus host disease.

So a lot of six or seven to enable deeper collectively for the gleason required for cell expansion I'm, just finding that allogeneic cell therapy can generate meaningful antitumor activity.

We hope they need to look at our Universal phase one dose escalation trial might get confirmed the foundational observation seen a different disease setting, thereby positioning us to move onto the next steps in this study, namely optimizing those needs for depletion and potential repeat administration of all of sudden one fight.

The initial data set from Universal May also allow us to apply insights across our PCM platform.

Central to our efforts, it's a recognition that I didn't I was in a car T option Lady critical for patients with multiple myeloma linear form are not in a position to wait for the availability of trying to follow the auction.

Rafael Amato: Central to our efforts is the recognition that an allogeneic RT option may be critical for patients with multiple myeloma, many of whom are not in a position to wait for the availability of an autologous option. Investigators have told us that there are significant wait times associated with the delivery of autologous cells and that the use of bridging chemotherapy during this treatment interval is quite common. As we execute on our trials, we aim to exploit the fundamental advantages of phylogenetic CAR-T therapy with regard to its on-demand availability.

Investigators have told us that there are significant wait time sensitive with a delivery or for telo itself and that the use of bridging chemotherapy. During this treatment interval is quite common.

As we execute on our trials, we aim to exploit the fundamental advantages so trying to find all generic car T therapy with regards to it on the man availability for example in a universal trial rapid treatment timeline obviate the need for bridging tariff.

Rafael Amato: For example, in our universal trial, rapid treatment timelines obviate the need for bridging therapy. While the initial Phase 1 data we will present later this quarter will be focused on the initial dose escalation portion of the trial, our ultimate goal is to be comparable to the results seen in autologous anti-DCMA CAR T therapies in later stage trials. The universal study of ALO715 was initially designed to explore optimal dosing of all components of the lymphodepletion regimen, including ALO647, fludarabine, and cyclophosisphamide, with patients receiving ALO715 at one of three doses: 40 million, 160 million, and 320 million cells in a 3 plus 3 dose escalation design.

Well the initial phase one data we will present later this quarter, we'll be focused on the initial dose escalation portion of the trial. Our ultimate goal is to be comparable to the resulting in a total of like we feel many car T therapy in later stage trials.

The Universal study of almost 715 was initially designed to explore optimal dosing of all components of the lymphodepletion regimen, including color six or seven fludarabine and cyclophosphamide with patients receiving allo 715 at one of three doses 40 million hunger and 60 million or 320.

Millions celsion or three plus three dose escalation design.

As we noted last quarter, we have completed the initial dose escalation portion of the Universal trial, using 39 milligrams of out of six or seven and began enrolling only for the initial cohorts one of which omitted fludarabine and one in which we increased the dose of politics for seven the onboard as Bina said our safety.

Rafael Amato: As we noted last quarter, we have completed the initial dose escalation portion of the universal trial using 39 milligrams of ALO647 and begun enrolling other lymphodepletion cohorts, one of which omitted fludarabine and one in which we increased the dose of ALO647. The endpoints being assessed are safety, tolerability, depth and duration of lymphodepletion, cell expansion, and signs of anti- The multiple variables in the trial design and our ability to fully optimize each component of the therapy will be critical to creating the best product profile for the myeloma setting. Much like the abstract for ALO501 at ASCO, the first look at ALO715 data will occur prior to formal presentation and will include high-level data on the first 15 evaluable patients treated with escalating doses of ALO715 and 39 milligrams of Cell activity will be based primarily on day 28 tumor assessment.

The tolerability that can do h. and looking for depletion cell expansion.

The ones that tumor activity the.

The multiple variables in the trial design and our ability to fully optimized each component of the therapy will be critical to creating the best product profile for the myeloma setting.

Looks like the abstract for I love fiber one at ASCO. The first look at olive sit on one side data will occur prior to formal presentation will include high level data on the first 15 evaluable patients treated with escalating doses will follow said and one five and 39 milligrams of other fixed for seven.

Selectivity will be based primarily on day 28 tumor assessment.

We expect to present detailed results and a virtual medical meeting later this year that presentation will include data on approximately 20 patients that goes to initial three I looked at and one five cell dose cohorts, a lower dose 39 milligrams or one of six first having a swell us a few patients treated with higher doses.

Follow suit for setting.

We may explore the consolidated cell dosing strategy as discussed in the also trial, we have not yet we dose patients can be ongoing universal trial.

As we keep an eye towards what might be possible in the future. We sell the car T therapy in a disease such as multiple myeloma, we are progressing or became a program to include the study of Allah settle one five in combination with a gun most secret ace inhibitor and R&D to support the combination of all of 715 I knew that Brad.

Rafael Amato: We expect to present detailed results at a virtual medical meeting later this year. That presentation will include data on approximately 20 patients across the initial three ALO715 cell dose cohorts and a lower dose, 39 milligrams of ALO647, as well as a few patients treated with higher doses of ALO647. While we may explore the consolidated cell dosing strategy as discussed in the alpha trial, we have not yet pre-dosed patients in the ongoing universal trial. As we keep an eye toward what might be possible in the future with ALOCAR-T therapy in a disease such as multiple myeloma, we are progressing our BCMA program to include the study of ALO715 in combination with a gamma secretase inhibitor

From our partners at Spring works Therapeutics is on track to be filed this year and we are excited to initiate the trial next year.

We also look forward to evaluating our travel card technology in the setting of myeloma. We continue to believe that the innovation behind Google cars could be a breakthrough as this technology has the potential to overcome T cell exhaustion and extend a loan car T cell viability and efficacy, while reducing car T cell dose requirements.

These properties may enable card piece accessing harder to treat hematologic malignancies, and solid tumors and proved to be an important opportunity to raise the bar in multiple myeloma treatment.

We look forward to soon sharing additional preclinical data of Oliver fix so five are first to railcar clinical candidate. Our next generation I look our T therapy in multiple myeloma and have accelerated work necessary to now submitted a 94 of those six or five in the first half of next year.

Rafael Amato: An IND to support the combination of ALO715 and neogassostat from our partners at SpringWorks Therapeutics is on track to be filed this year, and we are excited to initiate the trial next year. We also look forward to evaluating our TurboCard technology in the setting of myeloma. We continue to believe that the innovation behind TurboCards could be a breakthrough as this technology has the potential to overcome T-cell exhaustion and expand allocard T-cell viability and efficacy while reducing allocard T-cell dose requirements. These properties may enable CAR-T success in harder-to-treat hematologic malignancies and solid tumors and prove to be an important opportunity to raise the bar in multiple myel

We remain enthusiastic about our olive card P platform and what it potentially mean for patients. We look forward to continuing to provide updates scientific congresses to share our progress in the near term for outlets Center one five in the first half of next year for a little title, one and I'll have fiber one thing I'd like to now turn.

On the call over to Eric to review financial.

Thank you Ross sales and good morning, we appreciate that you were likely to be very busy. This morning. So let me briefly in my remarks as noted in our SEC filings and third quarter press release issued earlier today, our financial position remains strong with cash cash equivalents and investments totaling $1.0 billion as of September Thirtyth 20.

Rafael Amato: We look forward to soon sharing additional preclinical data for ALO605, our first TurboCard clinical candidate and next-generation ALOcard t-therapy in multiple myeloma, and we have accelerated the work necessary to now submit an IND for ALO605 in the first half of next year. We remain enthusiastic about our AlloCard Key Platform and what its potential may mean for patients. We look forward to continuing to provide updates to scientific congresses, to share our progress in the near term for ALO 715 and in the first half of next year for ALO 501 and ALO 501A. I'd like to now turn the call over to Eric to discuss the financials.

20.

In the third quarter, our research and development expenses were $51.4 million, which includes $8.8 million of non cash stock based compensation expense.

General and administrative expenses were $16.6 million for the third quarter, Twentytwenty, which includes $9 million of non cash stock based compensation expense our.

Our net loss for the third quarter, Twentytwenty was $66.2 million or 52 cents per share, including non cash stock based compensation expense of $17.8 million.

A few quick corporate updates include that we are nearing completion of construction for our self manufacturing facility in Newark, California as mentioned by David and as we prepare for a pivotal trial and beyond cgmp manufacturing from this facility expected in Twentytwenty one.

Eric Schmidt: Thank you, Rafael, and good morning. We appreciate that you are likely to be very busy this morning, so let me be brief in my remarks. As noted in our SEC filings and third-quarter press release issued earlier today, our financial position remains strong with cash, cash equivalents, and investments totaling $1.0 billion as of September 30, 2020. In the third quarter, our research and development expenses were $51.4 million, which included $8.8 million of non-cash, stock-based compensation expense. General and administrative expenses were $16.6 million for the third quarter of 2020, which included $9 million of non-cash, stock-based compensation expense.

On the business development front, we were very pleased to expand our relationship with the University of Texas, MD Anderson cancer Center, whether strategic five year collaboration aimed at accelerating the development of a broad our car T portfolio across hematologic and solid tumors under the agreement we plan to collaborate with MD Anderson on that.

Design and conduct preclinical and clinical studies Dr., Christopher flowers, and trim Division had cancer medicine and share with lymphoma and myeloma at MD Anderson and a key opinion leader in the field of cell therapy will play a key role as we advance this collaboration.

Eric Schmidt: Our net loss for the third quarter of 2020 was $66.2 million, or $0.52 per share, including non-cash, stock-based compensation expense of $17.8 million. A few quick corporate updates include that we are nearing completion of construction for our cell manufacturing facility in Newark, California, as mentioned by David, and as we prepare for a pivotal trial and beyond, CGMP manufacturing from this facility is expected in 2021. On the business development front, we were very pleased to expand our relationship with the University of Texas MD Anderson Cancer Center with a strategic five-year collaboration aimed at accelerating the development of a broad AllocRT portfolio across hematologic and solid tumors. Under the agreement, we plan to collaborate with MD Anderson on the design and conduct of preclinical and clinical studies.

Lastly to survey sponsored trials with you cart 19, and AOL has been completed or nearing completion with no additional patients and for enrollment. We Inserv da are now reviewing the development strategy for AOL, which may include the possibility of consolidating our programs around a single manufactured sell products out.

Fiber one day.

As we near the end of the year, we continue to guide to full year Twentytwenty net losses of between $260 million and $280 million, which includes estimated noncash stock based compensation expense.

70 million to $75 million and excludes any impact from potential business development activities with that we will now open the call to your questions.

As a reminder to ask question, you'll need to press star one on your telephone.

A question please press the pound key.

Thank you please limit yourself to one question. Please.

Eric Schmidt: Dr. Christopher Flowers, Interim Division Head of Cancer Medicine and Chair of Lymphoma and Myeloma at MD Anderson and a key opinion leader in the field of cell therapy, will play a key role as we advance this collaboration. Lastly, two Cervier-sponsored trials with UCART-19 and ALL have been completed or nearing completion, with no additional patients planned for enrollment. We at Cervier are now reviewing the development strategy for ALL, which may include the possibility of consolidating our programs around a single manufactured cell product, Allo501A. As we near the end of the year, we continue to guide the full year 2020 net losses of between $260 million and $280 million, which includes estimated non-cash stock-based compensation expense of $70 million to $75 million and excludes any impact from potential business development activities.

Please standby.

I'll start.

Our first question comes from Mark from Cowen Your line is open.

Hi, Thanks for taking my questions.

With the before me abstract having come out this morning, there's a patient death reported in there.

That was associated with the conditioning regimen is there any further details can provide as to you know was attribution.

Given to within the various agents of the Preconditioning.

And kind of what makes you confident that youre out whether our 647 is contributing or not.

Good morning, Mark This is Dave Ken Let me take your question I think we are little bit surprised about the asset coming out today, because the scheduled release of abstract was.

I suppose to be tomorrow.

And as you're pointing out.

Around the fact that we poured one eighth grade might be bad.

Which occurred.

In patients who will be completed.

Operator: With that, we will now open the call to your questions. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, please press star 0. We ask that you please limit yourself to one call.

Cyclophosphamide and Alex it's still setting so if anything this is a patient who received lesser lymphodepletion in other cases in studies into trial.

Patients in their head of TV rapidly progressing disease and.

Operator: And by the way we compile the Q&A... Our first question comes from Mark Frahm with Cowan, Carolina. Hi, thanks for taking my question. With the BCMA abstract having come out this morning, there's a patient death reported in there that was associated with the conditioning regimen. Are there any further details you can provide as to, you know, what attribution kind of was given to within the various agents of the preconditioning and kind of what makes you confident that, you know, whether ALIS-647 is contributing or not? Good morning, Mark. This is Dave Chang.

Yes.

The initial symptoms.

What's considered as pneumonia was.

No as you know on the day of so the fusion and.

We remain.

Some I'd refractory to treatment.

And as the pace of course deteriorated.

The family you know.

Simply want it from her care, which was to suit and the pace of expired on day eight it is and then what's that.

Incidentally, but I should remind you that both in the autologous cell therapy in a bull serious adverse events and that.

David D. Chang: Let me take your question. I think we were a little bit surprised about the abstract coming out today because the scheduled release of the abstract was, I think you're pointing out around the fact that we report one case of Grade 5 events, which occurred in patients who were lympho-depleted with. So, if anything, this is a patient who received less lymphodepletion than other patients in studies in the trial. The patient had a pretty rapidly progressing disease, and the initial symptoms of what was considered pneumonia were diagnosed on the day of cell diffusion, and it remained somewhat refractory to treatment.

What has been observed and you know we have to realize that we are dealing with very sick patient population in this particular case it like.

Like most patients with about two of my loan that had remained we frac fleets all previous lines of therapy and was progressing pretty rapidly. So.

Yeah, Ed position, having dealt with patients who had a rapidly progress you know.

This is a very difficult situation.

And in this case Unfortunately, the patient died from a great buy do that.

Thank you our next.

David D. Chang: And as the patient's course deteriorated, you know, the family, you know, simply wanted comfort care, which was pursued, and the patient expired on day eight. It is an unfortunate incident, but I should remind you that, you know, both in the autologous cell therapy, you know, both serious adverse events and death have been observed, and, you know, we have to realize that, you know, we are dealing with a very sick patient population. I mean, you know, this particular patient, unlike most patients with multiple myeloma, had remained refractory to all previous lines of therapy and was progressing pretty rapidly. So, you know, as a physician who has dealt with patients who have rapidly progressed, this is a very difficult situation, and in this case, unfortunately, the patient died from a grade five event. Our next question comes from Salveen Richter of Goldman Sachs. Good morning.

Next question comes from Salveen Richter with Goldman Sachs. Your line is open.

Good morning, Todd.

Talk about the various lymphodepletion regimens, you're looking at in the multiple myeloma study and no including revenue include Sky and how this might help with regard to the safety profile and then secondly, just given the Ash Abstracts, then how do you view that there were some integrate and just the overall profile in the context of collagen.

Eight point.

Okay sounds good thanks for the question and I'm going to be bird question too rough out.

Okay.

Yes. Thanks for the question. So we designed the trial has.

By almost six or seven and also to sequentially be able to remove.

Cyclophosphamide first fludarabine and cyclophosphamide.

And then subsequently explore higher doses, so although sales for some and we're really in the NIM. So doing this I mean, we are we're.

We still have a little bit of a week ago.

We did a drop of fludarabine such as indicates that was just described.

Rafael Amato: Could you talk about the various lymphodepletion regimens you're looking at in the multiple myeloma study and, you know, including removing flucytosis and how this might help with regard to the safety profile? And then, secondly, given the ASH abstract today, how do you view the dose response seen to date and just the overall profile in the context of the autologous data at this point? Okay, Salveen, thanks for the question. And I'm going to refer the question to Rafael Amado. Rafael?

Oh, we observed a slightly lower outcomes and we decided to go back to the CA.

We completed 50 839 milligrams.

And we continue to explore other doses. So oh looks it's for seven so you know I don't want to get ahead of the presentation, but most likely or conditioning will include old city agents at this point.

[noise]. Thank you.

Next question comes from Brian Ayman with Jefferies. Your line is open.

Rafael Amato: Yes, thanks for the question. So, we designed a trial to test FLUSAI Allo647 and also to sequentially be able to remove, so we're going to start with cyclophosisphamide, first fluidarabin, and then cyclophosisphamide, and then subsequently explore higher doses of allocyte 4-7. And we're really in the midst of doing this. I mean, we still have a little bit of a way to go.

Yeah, Hi, guys. Thanks for taking my questions just on the Ash Abstracts, I think you talked a little bit about the grade five event, but you also had three other grade three or greater infections can you just talk about that relative to the higher dose of al.

Fixed for seven whether use you for C.

No a potential increase risk of grade three or greater infections with the higher 90 milligram dose.

So Barry let me take that question.

Rafael Amato: We did drop fluidarabin, such as in the case that was just described, and we observed slightly lower outcomes, and we decided to go back to FCA. We completed FCA at 39 milligrams, and we continue to explore other doses of allocyte 4-7. So, you know, I don't want to get ahead of the presentation, but, you know, most likely, our conditioning will include all three agents at this point. Our next question comes from Brian Amon with Jeffries, Carolina. Yeah,

And in terms of.

No serious adverse events or.

Actions, let me just emphasize and these are not an infrequent events in a kind of forget it and reset the cell therapy.

So, yes, I know that there is sort of.

You know attention given to our trials about opportunistic infection, but you know at this point that degree of infection that we see in my.

My opinion, and I think many clinicians would agree especially in the refractory multiple myeloma you know, it's not really raising.

David D. Chang: Hi guys. Thanks for taking the time to answer my questions. You know, just on the ASH abstracts, I think you talked a little bit about the grade 5 event, but you also had three other grade 3 or greater infections. Can you just talk about that relative to the higher dose of allo-647, whether you foresee a potential increased risk of grade 3 or greater infections with the higher 90-milligram dose? So, Barron, let me take that question, you know.

I'd say, it's a phase one study that we are looking at the safety efficacy but.

It's not raising.

Isn't it yeah heightened concerns and.

Lastly at this point.

We are continuing on with the clinical study and the study.

Conduct has never been changed.

And as rough out had we mark during the prepared statement.

We are exploring you know.

Hi, I live in Lymphodepletion conditioning, you know using higher dose allison's plus seven and the questions about how this looks like some of those details you will have to wait for the ash presentation.

David D. Chang: In terms of serious adverse events or infections, let me just emphasize that these are not infrequent events in a primary antigen receptor cell therapy. So, yes, I know that there is a sort of heightened attention given to our trials about opportunistic infection, but at this point, the degree of infection that we are seeing, in my opinion, and I think many clinicians would agree, especially in the refractory multiple myeloma, it's not really raising, obviously it's a phase one study, we're looking at the safety very carefully, but it's not raising heightened concerns, and frankly, at this point, we are continuing on with a clinical study, and the study conduct has never been changed, and as Rafael had remarked during the prepared statement, we are exploring higher lymphodepletion conditioning using higher dose IL-647, and the questions about how that looks like, those details, you will have to wait for the ASH presentation. Our next question comes from Tyler Van Buren. Kuiper-Sandler, your line is open.

Thank you.

Our next question comes from Tyler from Baird.

Hyper Sandler your line is open.

Hey, guys. Good morning in the abstract dimensions four out of five responders were still in response at the time of data cut off so I wanted to ask a question related to that can you.

Provided you know maybe details on when that one responder progressed at what time point and then also worthy for responders or in terms of duration of response.

Okay Yeah.

Yeah, Tyler I think some of these questions are better.

You know to be weighted for the act well the data presentation at ash, but let me.

I'm going to ask a rough sales to grow by some additional comments.

Yeah, I mean does it.

Durability of response.

Of particular patient.

And you have to understand it was a relatively shorter follow up so you know what's the matter.

A few months.

And then the.

Rafael Amato: Hey guys, good morning. In the abstract, it mentions that four out of five responders were still responding at the time of data cutoff, so I want to ask a question related to that. Can you please provide us with, you know, maybe details on when that one responder progressed, at what time point, and then also where the four responders are in terms of duration of response? Okay, yeah. Yeah, Tyler, I think some of these questions are better, yeah, you know, to wait for the actual data presentation at ASH, but let me, you know, you know, ask Rafael to provide some additional comments. Yeah, I mean, it's.

The other patients I think we'll have to see when we present the totality of the data.

Thank you.

Our next question comes from John Newman with Canaccord. Your line is open.

Hi, guys. Good morning, Thanks for taking my question different question on our fiber one question.

Question is David so.

Rawlings pursuing for durability results in the first half.

Just curious.

Factoring standpoint, if if the durability for this product turns out to be better than we expect.

Do you feel confident that when the product.

His prove you'd be able to meet potentially increased demand. Thanks.

Rafael Amato: The durability of response of that particular patient, you know, you have to understand it was a relatively short follow-up. So, you know, it was a matter of, you know, a few months. And then, you know, the other patients, I think, we'll have to, you know, see when we present the totality of the data. Thank you.

Yeah, John Great question that question, you know, we used to get a lot of those questions and sort of bite out, but you know our manufacturing process I mean the.

You know the technical operations team had been a continuously improving the yield.

You know and the improvement in yield comes from many different ways because at the end, what we get to that piece and a car costs itself. So the transduction efficiency cell viability. All these things lead to what we can consider as a goal that we can use.

David D. Chang: Hi, guys. Good morning. Thanks for taking my question. Different question on ALO501. The question is, David, so. We're all anxiously waiting for durability results in the first half.

From a single manufacturing one and create you know all along we've been saying that.

David D. Chang: I'm just curious, from a manufacturing standpoint, if the durability of this product turns out to be better than we expected, do you feel confident that when the product... proves itself, you'll be able to meet potentially increased Yeah, John, great question. That question, you know, we used to get a lot of those questions and, you know, sort of died out, but, you know, our manufacturing process, I mean, the, you know, the technical operations team has been continuously improving the yield, you know, and improvement in yield comes from, you know, many different ways because, in the end, what we give to the patients are CAR-positive cells. So the transduction efficiency, cell viability, you know, all these things lead to what we can consider as goals that we can use from a single manufacturing run. And, you know, all along, we've been saying that, you know, even from the beginning, that each manufacturing unit can potentially treat up to about 100 patients. And I think, you know, we feel pretty comfortable maintaining that statement.

Even from the beginning that each manufacturing, one and potentially treat up to about 100 basis.

And I think we feel pretty comfortable you know maintaining good statements. So you know that many of you know that the yield is.

Hi, good if anything the manufacturing processes improve while we are continuing to study.

And we feel very.

In a confident that as.

As we move forward.

Manufacturing of the product will that be a major issue for us.

Thank you our next.

Question comes from Cory Kasimov with JP Morgan Your line is open.

Hey, good morning, guys. Thank you for taking my question I wanted to ask about the potential for reducing five a one or any of your our cars for that matter I'm. Just wondering is there any read through from the Alpha study on that front in terms of durability or possibly need to increase durability that's driving.

This desire this approach or is it just another way to potentially differentiate the product in your platform. Thank you.

Yes, Cory Great question, I would say that it's really to.

And so we don't see that we really want to explore you know we get asked will talk about a sales location within the first street been pacing only achieved a partial response and with the second treatment with essentially saying sell goes but you know with some.

David D. Chang: So, you know, the yield is quite good, if anything. The manufacturing process has improved, you know, while we are continuing the study. We feel very confident that as we move forward, the manufacturing of the product will not be a major issue for us. Our next question comes from Corey Caskey, in Carolina.

It has been for Depletions in a patient achieved a complete remission.

And that's a pretty unusual.

In a situation where the initial response was improved with the Retreatment.

So when we think about it I think that really creates an opportunity in the context.

What we know about the.

You know kind of keep brachytherapy non hodgkin's lymphoma.

David D. Chang: Hey, good morning guys. Thank you for taking my question. I wanted to ask about the potential for redoing 501 or any of your cars for that matter. I'm just wondering, is there any read-through from the alpha study on that front in terms of durability or possibly need to increase durability that's driving this desire, this approach, or is it just another way to potentially differentiate the product in your platform? Thank you. Corey, a great question.

Response rate is high but some.

Some of the responses that's complete responses I see responses and partial responses penta progressed relatively quickly. So that's the setting and here what we are trying to achieve is less.

Let's treat the pace and with a free cell therapy.

And my last one which is when we do the first tumor assessment.

Patients who has evidence of disease progression. Unfortunately, they will come off the study however, anybody who has a evidenced through response or stable disease a.

David D. Chang: I would say that it's really the, you know, the potential of redosing, you know, that we really want to explore. You know, we at Ascol talked about a single patient, you know, with the first treatment, the patient only achieved a partial response. And with a second treatment, you know, with essentially the same cell dose but, you know, with somewhat enhanced lymphodepletion, the patient achieved a complete remission. That's a pretty unusual situation where the initial response was improved with a retreatment.

We.

Planning to retreat or potentially consolidate the tumor response with a second cell infusion.

And you know we think we believe that we can do that you know we did face a five to six weeks that treatment, which essentially you know from our perspective with complete and dosing of fiber one yeah.

In those spaces, so what that really hoping is that with a second dose.

We'll put small pace and to complete remission.

David D. Chang: So, you know, when we think about it, I think that really creates an opportunity in the context of, you know, what we know about CAR-T therapy and non-Hodgkin's lymphoma. You know, the response rate is high, but some of the responses are not complete responses, but partial responses, and partial responses tend to progress relatively quickly. So that's the setting.

And.

If you look at all the existing data patients who achieved complete remission tend to have a more global response. So that is sort of what we are looking for and obviously the durability will take a little bit longer for us to get a sense about how the durability.

And frankly, we're still you know.

Following the durability of patients who responded after a single infusion, which some of them we presented at ASCO presentation and goals, we plan to update the data out of the first half of 2021.

David D. Chang: And here, what we're trying to achieve is, let's treat the patient with a first step therapy, and at month one, which is when we do the first tumor assessment. Patients who, you know, have evidence of disease progression, unfortunately, they will come off the study. However, anybody who has an evidenced response or a stable disease, we, you know, are planning to retreat or eventually consolidate the tumor response with a second cell infusion. And, you know, we think, we believe that we can do that within the first five to six weeks of the treatment, which essentially, from our perspective, would complete the planned dosing of the 501 in those patients. So what we're really hoping is that with a second dose, we'll push more patients into complete remission. And, you know, if you look at all the existing data, patients who achieve complete remission tend to have a more durable response. So that is, you know, sort of what we are looking for. And obviously, durability will take a little bit longer for us to get a sense about how the durability will last.

Thank you. Our next question comes from Michael Smith.

<unk> Your line is open.

Hey, guys. Thanks for taking my question I, just wanted to follow up on <unk>.

715, and the infection rate I mean, I guess, David you mentioned already but how does the a great city, Ohio infection rate compared to those that seen in the autonomous car T programs.

Programs, and and is there risk, maybe higher or different new thinking and diseases like much of my little am I supposed to non Hodgkin lymphoma.

Yeah.

That underlying medical conditions that make a lot of difference certainly me up.

Patients with multiple myeloma would oh.

Essentially refractory disease, they are much higher with a infection.

In concept the rates I don't have the details about what has to be quoting indoor probably to setting a baby.

Al do you know that answer.

No, but there so it's a fair number of infections as well, but as.

We can we can get the exact number you know incented later, but.

David D. Chang: And frankly, we're still, you know, following the durability of patients who responded after a single infusion, some of them we presented at the ASCO presentation, and those we plan to update the data on in the first half of 2021. Thank you. Our next question comes from Michael Schmidt of Guggenheim. Hey guys.

I mean in multiple myeloma patients are very prone to infections are quite book I'm, a little anemic and to develop infections spontaneously as well.

So it's fairly common.

Especially in late stage disease like like the ones we treat.

Thank you.

Our next question comes from Mark Breidenbach with Oppenheimer.

Your line is open.

David D. Chang: Thanks for taking my questions. I just wanted to follow up on Allo 715 and the infection rate. I mean, I guess, David, you mentioned it already, but how does the grade 3 or higher infection rate compare to those that are seen with autologous CAR T programs? And is the risk maybe higher or different, you think, in diseases like multiple myeloma as opposed to non-heart convalescent lymphoma?

Hey, good morning, guys and thanks for taking the question David.

David I'm wondering if you can tell us if any of the responders in universal achieved MRG negative status.

Huh March sorry.

Can you repeat the question.

Sure sure I'm, just wondering if any of the responses that you saw in the universal.

Trial dose escalating.

Study were MRG negative.

Yes, yes, great question I know that we've been building a lot of questions about that rate five events and infection, but I'm glad that you are talking about.

David D. Chang: Yeah, you know, the underlying medical conditions make a lot of difference. Certainly, you know, patients with multiple myeloma with, you know, essentially refractory disease, they are at much higher risk of infection. In terms of the rates, I don't have the details about what has been reported in the college setting.

Efficacy side at the equation.

Certainly you know we see in aisle seven amount, but as an active compounds I mean, there's a cell dose response relationship, but we are seeing very good evidence that response as we go through the highest cell doses.

Rafael Amato: Maybe, you know, Rafael, do you know that answer? No, but there's a fair number of infections as well, but we can get the exact number, you know, and send it later. But I mean, multiple myeloma patients are very prone to infections. They are hypogammaglutininemic, and they develop infections spontaneously as well.

And.

To the question you know what we are seeing at the highest dose response effect as well with the wood in first 28 days.

And.

The response tend to be pretty deep deep to begin with.

Rafael Amato: So they are fairly common, especially in late-stage diseases like the ones that we... Our next question comes from Mark. Hey, good morning, guys. And thanks for taking the question. David, I'm wondering if you can tell us if any of the responders in Universal achieved MRD negative status. Oh, Mark, sorry.

In a stringent complete remission at the very good partial responses a lovely so at.

Sales also a 320 million.

And both of those patients had a MSRP negativity by the local MRV testing.

Thank you.

Next question comes from Dane Leone.

Raymond James Your line is open.

Hi.

Thanks for taking the questions and that's just kind of classic 20 plan at this point for the Ash abstracts Duran like come out this morning.

David D. Chang: Can you repeat the question? Sure, sure. I'm just wondering if any of the responses that you saw in the universal trial dose escalating study were MRD negative. Yeah, yeah, great question. I know that we've been fielding a lot of questions about grade five events and infection, but I'm glad that you are talking about the efficacy side of the equation. Certainly, you know, we are seeing ALO795 as an active compound. I mean, there is a cell dose-response relationship, but we are seeing very good evidence of response as we go to higher cell doses. And you know, to the question, what we are seeing at the higher cell doses, the response occurs relatively quickly, within the first 28 days, and you know, the response tends to be pretty deep to begin with, you know, in a stringent complete remission, and the very good partial response is what we saw at the cell dose of 320 million. And you know, both of those patients had an MRD negativity by the local MRD test. Our next question comes from Dane.

So I O I.

This since you've had a lot of questions on the abstract itself.

From a drug development strategy.

In myeloma.

How are you thinking about patient disposition and what I mean by that is you have a blended cap, which is now being used as a late line DC may targeted age and you do have the auto car T programs either sell in the.

The JNJ program that will probably be.

Approved sometime within the near future.

And from speaking with the multiple myeloma community and the docs treating these patients in the later lines.

You know the consistent responses then up one rep does seem like a good option for these patients you might think about but probably reach for Selinexor last auto car T and the late line. This is great. If you can do it for the patients.

David D. Chang: Hi, thanks for taking the questions, and it's just kind of classic 2020 at this point for the AASHA abstracts to randomly come out this morning. So, I'll ask: Thank you. From a drug development strategy point of view, in myeloma, how are you thinking about patient disposition? And what I mean by that is you have Blenrep, which is now being used as a late-line BCMA-targeted agent. You do have the CAR-T programs, IDASL, and the J&J program that will probably be approved sometime within the near future.

And they don't have rapid progression, so where where are you thinking about what type of patients you really want to start focusing on as you get into the later stages of Dallas have more than five program.

And how you would think about this drug products fitting into you know, they're continuing to treat and as it's evolving.

Okay.

So Leon.

I'd say and I think I mean, that's.

David D. Chang: And from speaking with the multiple myeloma community in the docs, treating these patients in the later line, So, you know, the consistent response has been that blend rep does seem like a good option for these patients. You might think about it, but you probably reach for a cell next or last. Auto CAR T in the late line is great if you can do it for the patients, you know, and they don't have rapid progression. So where are you thinking about what type of patients you really want to start focusing on as you get into the later stages of the Allo 715 program and how you would think about this drug product fitting into the continuum of treatment as it's evolving? So, Leon, I'm sorry. I mean, that's a great question.

Great question, I mean, I think some of the question that you're asking for.

Most of it relates to the question that we do not respond to therapy and you've heard me. So question about comparison about data too.

You know what it has been with Coty colleagues.

I like the south therapy.

One thing that I would say is.

You know in multiple myeloma as we all know.

There's a lot to treatment options that are available and you know frankly patients remain on treatment for a long period of time, but that's how some of that produce some inhibitors as well as in its ask Jim Debello.

One thing that we know we constantly hear from the physicians that yes that it actually had been offices, but.

None of these treatments really provide what will be a cure and also all these spaces will eventually come back so.

David D. Chang: I mean, I think, you know, some of the questions that you're asking. It also relates to the question that we did not respond to, Salveen, in her initial question about comparison of our data to what has been reported for the colleague at Cell Therapy. One thing that I will say is that in multiple myeloma, as we all know, there are a lot of treatment options that are available. And frankly, patients remain on treatment for a long period of time, but that's how some of the proteasome inhibitors, as well as IMiDs, have been developed. One thing that we constantly hear from physicians is that, yes, there are treatment options, but none of these treatments really provide what would be a cure, and also, all these patients will eventually progress. So, from the existing therapy perspective, there are three major categories of drugs that are being used. Proteasome inhibitors.

You know the existing therapy perspective, I mean, they are three major categories.

Trucks that are being used to produce some inhibitor.

Emits immune modulating drugs such as in a row.

And then the third one.

Cdthirty eight monoclonal antibody therapy.

Essentially the patient population that we are targeting the ones who have already.

With those existing therapy, and this is where not bcm may target therapy, whether it be a primary antigen receptor or a DC. It's really fits in I think the good thing about all the efforts that different companies that making is that at the end sales.

David D. Chang: Essentially, the patient population that we are targeting are the ones who have already gone through those existing therapies, and this is where BCMA targeted therapy, whether it be chimeric antigen receptor or ADC, really fits in. I think, you know, the good thing about all the efforts that different companies are making is that, in the end, there will be more treatment options that physicians and patients can use, and to some extent, it will depend on the doctor's comfort level as well as preference. However, we definitely see a situation where different BCMA-targeted therapies can potentially be sequenced. You know, the data is still pretty mature in many ways, but I think we are beginning to see some sense of, you know, maybe there are some differences in the response rate. However, the so-called progression-free survival, they all seem to give a similar number. I think that's the current, you know, early read of the data, you know, which obviously we'll have to know more. So that's, you know, the setting.

We'll be more treatment options that physicians and patients can use and to some extent it will depend on the physicians' comfort level as well as our preference.

However, we definitely see a situation where different be sameer targeted therapy can potentially be sequenced.

The data, it's really still premature in many ways, but I think we're beginning to see some sense.

Maybe there are some differences in the response rate.

However, so far the progression free survival based all seem to give a similar number I think thats. The car in early read up the data, which obviously, we will have to know more so that's the that's setting and what we have coming with our BC made targeted programs et cetera, but I mean as it off.

Shelf therapy that can potentially be but the response, that's doable I think we can position our product well in this space a once we complete.

Pivotal study.

I hope this is sort of answering your question, but that's the nature of your question until you know all the dust settles is somewhat speculative at this point, but we have a clear position on how we want to put our product in this space.

David D. Chang: And, you know, what we are coming with, our BCMA-targeted programs in 701.5, I mean, as an off-the-shelf therapy that can potentially give a deep response that's durable, I think we can position our product well in this space once we complete the, you know, pivotal study. You know, I hope this is sort of, you know, answering your question, but, you know, the nature of your question, until, you know, all the dust settles, I mean, there's not much speculative at this point, but we have a clear position on how we want to put our product in this space. Our next question comes from Ren Benjamin with JNN. Hey, good morning, guys.

Thank you. Our next question comes from Ren Benjamin with JMP Securities. Your line is open.

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

Just a follow up with our fiber one <unk> can you just remind us.

The doses that are being evaluated about how many patients worth of data we might see.

Good on the in the dose escalation phase of the study I'm just wondering if we have to kind of go back to the drawing board or did we.

Hone in on on particular doses and just related to that I guess fiber one is supposed to be the test kitchen I. Just wanted to know if there is anything new being cooked up that that would be of interest. Thanks.

Yeah.

You know, we really taking advantage of that.

Having two studies fiber, one which is really the proof of concept con strat.

David D. Chang: Thanks for taking the questions. Just with ALO501A, can you just remind us of the doses that are being evaluated and about how many patients' worth of data we might see in the dose escalation phase of the study? I'm just wondering if we have to kind of go back to the drawing board, or did we hone in on particular doses? And just related to that, I guess, you know, 501 is supposed to be the test kitchen. I just wanted to know if there's anything new being, you know, cooked up that would be of interest.

Candidate that we have generated data we already short some data and then there is a fiber one eight which we are positioning for the pivotal study so to the first part of the question. We're really following what we have done.

In the fiber want with the fiber one a very accelerated way I mean in many ways with us.

Shifting to make sure that there aren't any surprises unexpected there will be of course, we have no reason to think that that these two will behave in any different ways, but I.

I think it's very important to confirm that in the clinical setting. So we are sort of you know following what was done in the fiber one in a very accelerated way.

David D. Chang: Thanks. Yeah, you know, we are really, you know, taking advantage of, you know, having two studies, you know, 501, you know, which is really, you know, the proof of concept construct, you know, candidate that we have generated data for, we've already shorted some data, and then there's a 501A, which we are positioning for the pivotal study. So, you know, to the first part of the question, I mean, in many ways, we're just testing to make sure that there aren't any surprises. We have no reason to think that these two will behave in any different ways, but I think it's very important to confirm that in the clinical setting. So, we are sort of, you know, following what was done in the 501 in a very accelerated way.

While that's going on you know.

Fiber one it really gives us an opportunity to test things in in many different ways and obviously the main thing that we're going after as we explore different things is trying to increase the depth of response at trying to improve the complete remission rate and as we've talked about.

So there is no one strategy, while we wait for the two ability of the response from.

From patients who have responded so thats more or less the underlying theme of how we are positioning these two studies and incomes in that.

Sales of the data in a number of patients and all those things.

That.

No real sort of provide additional color to it.

When we present the data in the first half of 2021.

Thank you. Our next question comes from Raj you precise with William Blair. Your line is open.

David D. Chang: While that's going on, you know, 501, you know, it really gives us an opportunity to test things in many different ways. And obviously, the main thing that we are going after as we explore different things is trying to increase the depth of response, you know, trying to improve the complete remission rate. And as we talked about, consolidation is, you know, one strategy while we wait for the, you know, durability of the response from patients who have responded. So, that's more or less the underlying theme of how we are positioning these two studies.

Thanks for taking the question just wanted a little bit of color on the southern one five and never got the trial.

Particularly in how the trial design kind of will build on our kind of learnings from universal with regards to cell dose and Lymphodepletion regimen.

Well you have to kind of restart of People's redesigning the trial or will you be able to kind of.

Based on the learnings from Universal Trawling and this added to an add on with that with the GFS. Thanks.

Okay.

Right, Phil do you want to take one more question.

Yes, sure I mean, we.

Uh huh.

We will learn.

I'm sorry.

Well you know I will just very briefly tell you what we plan to do then no. That's just started dose we will lease costs down.

David D. Chang: And in terms of the, you know, details of the data, you know, number of patients and all those things that, you know, will sort of provide additional Operator Thank you. Our next question comes from Raju Prasad with William Blair, Erlanger. Thanks for taking the question. I just wanted a little bit of color on the 715 and neurogastritis trial, particularly how the trial design kind of will build on kind of learnings from the universal trial with regard to cell dose and lymphoid depletion regimen and take some of the learnings from the universal trial and just add them to, and add an arm with the GFI.

We.

<unk> card or we're not going to start with lower doses or us we started so I'm fine.

We are planning to start with me doses and then dose escalate so most likely won't from their own 20.

And then depending on what we've seen with the higher doses, so far almost six or seven.

And we'll decide which six or seven dose we will use oh, we're going to use a F.C.A. So you will it will be there will be some dose finding but it will be pretty expedited.

Rafael Amato: Thanks. Okay, Rafael, do you want to take one of the questions? We will learn. Sorry. I'm on mute now.

Oh.

Thank you.

And our next question comes from.

HM.

I don't know why did it.

From CIMB Securities. Your line is open sorry about that.

Rafael Amato: I will just very briefly tell you what we plan to do. The neurogastrostat dose we will leave constant. And we may start, we're not going to start with lower doses as we started in 7.1.5. We are planning to start with mid-doses and then increase the doses, so most likely 120.

Hi, good morning, guys.

Thanks for taking my question and.

And interesting to petition of my name there.

David I just wanted to touch back on on a previous announcements you had on the MIT negative status on seven on five those two patients.

Rafael Amato: And then, depending on what we've seen with the higher doses of ALO647, then we'll decide which... 6 or 7 dose we will use, and we're going to use FCA. So it will be some dose finding, but it will be pretty expedited. And our next question comes from Ashita Goonewardene of Truth Securities. Your line is open.

Were you able to get some color on if they are emerging negative type or MRT negative six and then just maybe bigger picture here thinking about that the consolidation strategy.

Could you maybe tell us about how you're thinking about dosing so I flew in that consolidation.

David D. Chang: Hi. Good morning, guys. Thanks for taking my question, and that was an interesting interpretation of my name there.

Uh Huh approach and if you and one other thing to think about in terms of managing toxicities and and I'm trying to develop your protocol around that.

David D. Chang: David, I just wanted to touch back on a previous answer that you had on the MRD negative status on 7 or 5. Those two patients, were you able to get any color on whether they were MRD negative 5 or MRD negative 6? And then maybe the bigger picture here, thinking about the consolidation strategy. Could you maybe tell us about how you're thinking about dosing CyFlu in that consolidation approach? And what are the things you're thinking about in terms of managing toxicities and kind of developing your protocol around that?

Thanks, a lot.

Yes, yes, great questions, let me take on the consolidation and I'm going to ask about fellow that there might be a theater that on the coming from the settlement of five study I mean, I'd say that we're very encouraged with the kind of MRG negative is seeing in the responders, where the responses that are happening there.

Early in the B Sammy trial.

On the question about that thing solid base I.

I mean, you know we are you know we will detail in terms of how we live with the fleet.

At this time in the second fine.

David D. Chang: Ash, you know, great questions. Let me take on the consolidation, and I'm going to ask Rafael about the MRD data set coming from the 715 study. I mean, I have to say that, you know, we are very encroaching on the kind of MRD negativities seen in the responders, you know, where the responses are happening very early in the BCMA trial. Now, back on the question about consolidation, I mean, you know, we are, you know, we will detail in terms of, you know, how we limp or deplete, you know, first time and the second time. But I would say that because of the ALIS-647, we do have a lot of flexibility in terms of how we can maintain the limp or depletion, you know, through both the first and the second treatment.

I would say that because.

Yes.

Let's explore seven we do have a lot of flexibility in terms of how we can maintain the lymphodepletion through.

Doable first and the second treatment so.

Without going too much into the facebooks detail.

Let me just end by saying that.

The question is great I'm, not being able to not needing to use chemotherapy. All the time for Lymphodepletion, which is really not their advantage that comes with the Alice It's worth seven that that's fine too.

Both Brady that design out the consolidations so.

Sorry that I'm not providing the exact details, but some of these out competitive information so I must read it for Tilda trial opens.

Yeah, I would say that.

With.

David D. Chang: So, you know, without going too much into the clinical trial details, let me just end by saying that, you know, the question is great, you know, not being able to, you know, not needing to use chemotherapy all the time for limp or depletion, you know, which is really another advantage that comes with the ALIS-647 that we are trying to incorporate in the design of the consolidation. Sorry that I'm not providing the exact details, but some of these are competitive information, so I'm not sure how to defer to the trial. Yeah, with regards to MRD, this is... Yeah, very briefly, this work done by this site, we have a central lab that will do MRD at a stringent level, 10 to the minus 6, and we will supply whatever data we have on that from the central lab, but this was done at 10 to the minus 5 at a local lab. The hospital.

Yeah with regards to that idea this Friday.

Yeah very briefly do this work done by the side.

We have a central lab that will do.

Marty.

During general level of tend to amount of six and we will supply whatever data we have on down from the central lab, but dispersed on a 10 to the minus five on local club.

Okay Hospital [noise].

Thank you.

Our next question comes from Luca <unk> with RBC capital Your line is open.

Oh terrific. Thank you for taking my question two quick questions here. The first is my understanding that fate therapeutics actually will show data for their 10-K Cdnineteen car at Ash, what are your expectations around that data.

The higher level, what are some of the potential advantages and disadvantages of using he sales versus NK cell here and the second question, obviously on the abstract.

Rafael Amato: And our next question comes from Luca Issi with RBC Capital. Oh, terrific. Thank you for taking my question. Two quick questions here.

Just want to confirm it no patients received the high dose of almost six from seven to 90 milligrams should be abstract or we don't have that data at ash and really being 2021. Thank you.

David D. Chang: The first is, it is my understanding that State Therapeutics will actually show data for their NKCD19 CAR at ASH. What are your expectations around that data? And that may be a higher level. What are some of the potential advantages and disadvantages of using T-cells versus NK-cells here? And then the second question, obviously, on the abstract, I think just I want to confirm it. No patients receive the high dose of ALLO647 at 90 mg in the abstract.

So.

In terms of.

First question, which is really the case.

Papers is that.

T cells.

I mean, the biology as well as existing clinical data set.

Hi, there I mean, all the cell therapy data where.

Strong responses have been seen weather.

David D. Chang: Are we going to see that data at ASH, or will it be in 2021? Thank you.

So you're talking about sales and kind of get it in the sector and that's all coming from that T cell based therapy and you know this is a discussion that we have faith in our sales seek advisory board several times and we can consistently get the same feedback.

David D. Chang: In terms of, you know, the first question, which is really, you know, NK versus, you know, the T-cell, I mean, the biology as well as existing, you know, clinical data are very clear. I mean, all the cell therapy data where, you know, strong responses have been seen, whether, you know, so you're talking about pills and chimeric antigen receptors. And, you know, that's all coming from T cell-based therapy. And, you know, this is a discussion that we have taken to our Internal Science League Advisory Board several times, and we consistently get the same feedback, which is, you know, until, you know, you see something that, you know, is different or you learn something more, at this point, the existing evidence would point you that, you know, you need to focus on the T cell, which is what we are doing. I know that there are a number of And, you know, we are waiting for the data. Hopefully, at ASH, we'll find something out. And, you know, we'll have to see. We haven't had a chance to review the abstract that came out today.

Which is you know what.

Until you know you see something that you.

It's different annoy you learn something more at this point the existing evidence would point to that you need to focus on the T cell based therapy.

That's what we are doing I know that there are a number of.

Moving into the NK cells, and we are waiting for the data hopefully it as you know maybe we'll find something out.

We'll have to see and we haven't had a chance to review the asset that came out today, but that's more or less.

Our view.

The NK cells versus T cells and.

Second question or you know what you will see AD.

You know the ash presentation I'll Universal data.

You know, we just sent out at the press release, I mean is it a little bit like to do a catch up game. After at a price that's by releasing to aspect little bit ahead of schedule and it will detail what will be presented I mean, certainly at this point.

David D. Chang: But, you know, that's more or less our view of NK cells versus T cells. And, you know, the second question, you know, what you will see at, you know, Ash's presentation of our universal data, you know, we just sent out a press release. We're a little bit trying to do a catch-up game after Ash surprised us by, you know, releasing the abstract a little bit ahead of schedule, and it will detail what will be presented. I mean, certainly at this point, as Raphael had commented, you know, we are testing, you know, higher, you know, the higher lymphoid depletion, you know, using the higher L647. Some of that data will be included, but in terms of the exact details, you know, just give another six weeks till you find out. And our next question comes from Ben Burnett with Stiefel, Carolina.

As a rough out that commented we are testing higher.

Lymphodepletion using the higher Ellis its foot seven.

Some of those data will be fluid, but.

But.

So the exact details.

This give another six weeks till you find out.

Thank you.

Next question comes from Ben.

Stifel. Your line is open.

Hi, good morning, Thank you.

Question on 715, so the ash abstract talks about going to higher doses of Aloe 715 beyond the third dose level I think 40 480 million sales was mentioned.

I wanted to ask is that planned on being given all at once as a single bolus are you going to implement some type of like split dosing strategy and if that's the case could you just give a little color around kind of the timing and logistics of a split dose. Thank you.

David D. Chang: Hi, good morning. Thank you. Question on 7-1-5, so the ASH abstract talks about going to higher doses of aloe 7-1-5 beyond the third dose level. I think 480, 480 million cells were mentioned.

You know in a split it's also something that we are not.

So when we talk about a cell dose I mean, we are you know sort of planning to.

David D. Chang: I wanted to ask, is that planned on being given all at once as a single bolus? Or are you going to implement some type of split dosing strategy? And if that's the case, could you just give a little color around the timing and logistics of the split dose? Thank you. You know, a split dose is something that we are not entertaining, so when we talk about a cell dose, I mean, we are, you know, sort of planning to, you know, that will be given as a single infusion.

Yeah that will be given as a single infusion.

Thank you again, ladies and gentlemen to ask a question. Please press Star then one.

And that concludes our Q and a session I would like to turn the conference back over to management for any additional comments.

All right. Thank you very much.

Thanks for joining us I know that stays there you did decline and thank you for your ongoing support for Allergan as we look ahead.

That's just an exciting fourth quarter, but a busy first half of 2021.

David D. Chang: Thank you. Again, ladies and gentlemen, to ask a question, please press star. And that concludes our Q&A session. I would like to, I'm going to pass back over to the Magistrate for any additional questions.

Yes, we anticipate that you may have additional questions in the days and weeks ahead. So please don't hesitate to reach out to our team.

If you looked at any additional questions and with that operator, you may now disconnect.

Operator: All right, thank you very much. You know, thank you for joining us. I know that today is a very busy time. And, you know, thank you for your ongoing support for Allogene as we look ahead. Not just an exciting fourth quarter but a busy first half of 2021.

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

[music].

Operator: We anticipate that you may have additional questions in the days and weeks ahead, so please don't hesitate to reach out to our team if you want to have any additional questions. And with that, operator, we may now disconnect. Thank you. Ladies and gentlemen, thank you for your participation in today's... You may now log off.