Q2 2020 Allogene Therapeutics Inc Earnings Call

Operator: During this session, you'll need to press star 1 on your telephone. 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.

During the session you'll need to press star one on your telephone.

Please be aware that today's conference call is being recorded I would now like to turn the call over to Kristine Cassiotou Chief Communications Officer discuss capital. Please go ahead.

Christine Cassiano: Thank you, Operator, and good morning. Before the market opened today, Allogene issued a press release that provides a corporate update and financial results for the second quarter ended June 30, 2020. This press release is available on our website at www.allogene.com. We remind listeners that 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. Rafael Amado, Executive Vice President of Research and Development and Chief Medical Officer, and Dr. Eric Schmidt, Chief Financial Officer. We continue to conduct calls from different locations, so we appreciate your patience should we have any technical difficulties.

Thank you operator, and good morning before market open today Allergan issued a press release it provides a corporate update in financial results for the second quarter ended June Thirtyth 2020. It's press releases are available on our website at www Dot allergies dot com, we remind listeners that today's call is being webcast.

Just 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., Rafael Amado Executive Vice President of research and development in Chief Medical Officer, Dr., Eric Schmidt Chief Financial Officer.

Continue to conduct calls from different locations. So we appreciate your patience should be have any technical difficulties.

Christine Cassiano: 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. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. These statements may involve risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements.

During today's call, we will be making certain forward looking statements. These may include statements regarding success and tightening of our ongoing and planned clinical trial data presentation regulatory filings future research and development efforts manufacturing capabilities 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 may involve risks and uncertainties that may cause actual results to differ materially from those can change and the forward looking statements.

Christine Cassiano: These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our Form 10-2, for the quarter ended June 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.

These and other risks are described in our periodic filings made with the Securities Exchange Commission, including our form 10-Q for the quarter ended June Thirtyth 2020.

You are cautioned not to place undue reliance on these forward looking statements and allocating disclaims any obligation to update these statements I'll now turn the call over to Dr. David Chang.

Thank you Christine good morning, Thanks for joining us on our second quarter Conference call. The last few months have been very exciting Allergan as we unveiled the first clinical data from our oligarchy portfolio at our school.

David D. Chang: Good morning, and thank you for joining us on our second quarter conference call. The last few months have been very exciting for Allogene as we unveil the first clinical data from our Allocardi portfolio at AFSCME. We were very pleased with the initial data from the ongoing alpha trial with Allo501 and what it means for our Allogene platform as it paves the way for the development of Allo501A, which we expect to enter into a potential pivotal phase 2 trial in 2021. Key findings from our initial Phase 1 data presentation include that LO501 and LO647 as part of the lymphodepletion regimen were well-tolerated with no dose-limiting toxicities, graft-versus-host disease, or immune-defector cell-associated neurotoxicity syndrome in heavily pretreated patients with advanced non-Hodgkin's lymphoma.

We won't be very pleased with the initial data from the ongoing which Wildwood Aloe Bible, one and what it needs for our allergenic platform as it paves the way you put a development Hello, Michael one eight.

Which we expect campaign to a potential pivotal phase two trial in 2021.

Key findings from our initial phase one data presentation include that Alan bicycle one with Alis six plus seven as a part of the Lymphodepletion regimen was well tolerated <unk> no dose limiting toxicities.

References host disease or immune effector cell associated New York City syndrome, it's heavily pretreated patients with advanced non Hodgkin's lymphoma.

David D. Chang: We continue to believe that our anti-CD52 antibody, Allo-647, will be one of the important components in our ability to achieve the promise of allokyte therapy. Initial data from the alpha trial support our strategy, with a higher dose of Allo-647 being associated with a higher complete response rate. Of the 8 patients who received a higher dose of Allo647 of 90 mg, 5, or 63%, had a partial response, and 4, or 50%, achieved a complete remission. While we await the additional follow-up on patients to assess the durability of response, especially those who are lympho-depleted with a 90 mg dose of LO647, it is worth noting a couple of the important learnings. That came out of the initial review of the Phase 1 data beyond what might be expected from a dose escalation study.

We continue to believe that our anti CD 52, anybody alis six or seven will be one of the important components. You know I believe is to achieve the promise of Albuquerque therapies.

Additional data.

The Alpha trial supports our strategy with a high odour sub six or seven being associated with a higher complete response rate.

The eight patients who received a higher dose of Alis six or 790 milligram.

Well, 63% had a partial response and all walk 50% achieved complete remission.

While we await the additional follow up on patients to assess the deal ability of response, especially those who are lymphoma depleted with 90 milligram dose of Alis six or seven it is worth noting a couple of important learnings.

Yeah. It came out to be nice or would you have got phase one data Dion what.

I'd be expected.

From a dose escalation study.

David D. Chang: I believe I can speak for Raphael in this as well, in that as oncologist, it is critical to identify and understand the type of patients that have the potential to respond to a therapy and which do not. In the alpha data presented at AFSCME, we observed meaningful anti-tumor activity across multiple tumor histologies and patient baseline characteristics, the one exception being patients who are refractory to previous otolaryn

I believe I can't speak for Rockdale interest as well in that adds oncologist. It is critical to identify and understand the type of patients that have the potential to respond to a therapy and which do not.

In the Alpha data presented at ASCO.

We observed meaningful antitumor activity across multiple tumor histologies and patient baseline characteristics.

The one exception being patients would be frac fleet to previous because car T therapy.

David D. Chang: Initial data from ALPHA suggests such patients may have intrinsic resistance to CAR-T, and we are keen to explore the science underpinning this resistance. Across all doses of ALLO501 and ALLO647, the overall and complete response rate in CAR-T9 patients was 75% and 44%, respectively. Although follow-up was limited, these efficacy data are comparable to those reported from a tolerance CAR-T trial. Lastly, this initial readout gave us a small glimpse at what may be one of the most exciting benefits of allogeneic cell therapy, On Demand Treatment and the Ability to Reduce Patients. Overall, the time from enrollment to start of treatment averaged five days. Early experience with redosing has been very encouraging.

Initial data from Alpha suggest such patients may have intrinsic resistance to car T and we're keen to explore the science underpinning this resistance.

Across all doses of adult Bible, one and I was 6.7 overall and complete response rate in car T. Nike sense was 75% and 44% respectively.

Well don't follow up with limited these efficacy data comparable to those we quoted from autologous cocky trial.

Lastly, this initial read out gave us a small peak at what maybe one of the most exciting benefits of allogeneic cell therapy on demand treatment and the ability to read those patients overall the time from enrollment to start of treatment averaged five days.

Really experience would be dosing has been very encouraging.

David D. Chang: One case study we presented was a 62-year-old male patient with stage 3 follicular lymphoma who had been refractory to three prior lines of therapy. His first Allocar-T treatment was with 120 million cells of Allo501 and a 39 milligram dose of Allo647. He achieved a partial response at month one but progressed at month two. Shortly after progressing, he was retreated with another 120 million cells of ALO501 and this time with a 90 milligram dose of ALO647. This retreatment led to a deeper response, and the patient achieved a complete remission, which was ongoing as of the data cutoff. While there is still much to be done in terms of understanding the potential for redosing, we, along with our clinical investigators and scientific advisory board, are very excited to continue this exploration to optimize treatment outcomes.

One case study, we presented was a 62 year old male patients who stays pretty follicular lymphoma.

I had been refractory to require lines of therapy.

Yes, first aloe car T treatment was 120 million sells a lot Bible, one and a 39 milligram dose of Alis 647.

He achieved a partial response at month want and what progress and much too.

Shortly after progression U.S., we treated with another 120 million sell stuff outside the one and this time with the 90 milligram dose of Alex exposed southern.

Yes, we treatment led to a deeper response and the patient achieved a complete remission, which was ongoing adds up the data cut off.

While there's still much to be done in terms of understanding the potential quarterly dosing, we along with ongoing clinical investigators and scientific Advisory Board.

Decided to continue this exploration to optimize treatment outcome.

David D. Chang: We believe we are in an enviable position with the ability to utilize our 501A alpha trial to inform our ongoing studies as we proceed in parallel with our 501A alpha 2 trial. From an efficiency standpoint, this is a great benefit, as we plan for a potential pivotal phase 2 trial of LF501A in 2021. You will recall that ALLO501A is our anti-CD19 allocarchy construct in which the rituximab recognition domain has been removed in order to allow a broader population of patients to receive therapy.

We believe we're in an enviable position with the ability to utilize our fiber one alpha trial to inform our ongoing studies as we proceed in parallel with out by the one eight outlet to trial.

From an efficiency standpoint. This is a great benefit as we plan for a potential kubota phase two trial of L. fiber one eight in 2021.

You will recall that our fiber one he is our anti cdnineteen car construct in which the Rituximab recognition domain had been removed in order to allow a broader population of patients to receive therapy.

David D. Chang: I am pleased to report that we are successfully advancing our abbreviated dose escalation of alpha-2. We have completed the cell dose level 1 cohort with lymphoid depletion using the 90 mg dose of aryl 6.7 in combination with cyclophosisphamide and fludarabine and are now dosing patients in the higher cell dose cohort. Rafael will provide more details on the design of the AFL-2 trial.

I'm pleased to report that we have successfully advancing our abbreviated thoughts escalation of Alpha true.

We have completed the cell dose level, one cohort, we lymphodepletion using 90 moved endorsed Alis six plus seven in combination with check the box, Mike and Fludarabine and I'll dosing patients into higher cell dose cohort.

Rockpile will provide more details on the design of Africa trial.

David D. Chang: Enrollment has also continued in the universal trial of ALGO715 targeting BCMI. The strategy and trial design of Universal are in many ways similar to what we have done with LL501. We have recently completed the initial dose escalation portion of Universal, which evaluated three different cell doses of LO715. The study is continuing to involve patients to evaluate additional doses, different lymphoid depletion regimens, including those that utilize a higher dose of LR647, and treatment expansion. Our plan remains to present initial data from the universal trial in relapse refractory multiple myeloma in the fourth quarter at a medical meeting. Lastly, as we review the progress we have made across our Alokhati platform, we are increasingly enthusiastic about the potential for Allo316, our anti-CD70 candidate, and breaking down the barriers to thalaterma. CD70 expression can be found in solid tumors such as lung cancer, glioblastoma, and renal cell carcinoma, as well as in hematologic malignancies.

Enrollment has also continued into universal trial of outlook 715 are getting B.C. Ming.

The strategy and trial design of Universal is in many ways similar to what we have done with outside <unk>.

We have recently completed the initial dose escalation portion of universal, which evaluated three different sell doses of Alex I wouldn't want to buy.

The study is continuing to enroll patients to evaluate additional doses.

Different lymphodepletion regimens, including those that utilize a higher doors. So that was six booked seven and treatment expansions.

Our plan remains to present initial data from the Universal trial in relapsed refractory multiple myeloma in fourth quarter at a medical meeting.

Lastly, as we review the progress we have made across our Aloe car T platform. We are increasingly enthusiastic about the potential for outlook. We won six our anti cdseventy can do that and breaking down the barriers to solid tumors.

70, especially can be found in solid tumors, such as lung cancer, Glioblastoma and renal cell carcinoma as well, that's my logic malignancies, and with adequate preclinical safety, which makes this an exceptional target.

David D. Chang: And with adequate clinical safety, which makes this an exceptional target. RCC, in particular, is known for being responsive to immune-mediated treatment, hence we believe it could potentially be responsive to CAR-T therapy. Patients with localized renal cell cancer undergo nephrectomy.

RCC in particular is known for being responsive to immune mediated treatment. Hence we believe it could potentially be responsive to car T therapy.

Patients, we had localized renal cell cancer undergo nephrectomy, however, 30% to 40% of the patients develop metastasis with a five year median survival rate less than 15% to 20%.

David D. Chang: However, 30 to 40% of the patients develop metastasis with a five-year median survival rate less than 15 to 20%. While there has been industry progress in treating patients with metastatic renal cell carcinoma with VEGF pathway-targeting therapies and checkpoint inhibitors, many patients succumb to this treatment-resistant disease. Based on our excitement for this program, we have rapidly progressed all of 3116 and will be filing an IND for renal cell carcinoma by the end of this year with a plan to initiate a clinical trial in 2021. Operationally, we continue to manage our activities in the face of challenging external environments. Working from home has become a norm for most of our employees.

While there has been industry progress in treating patients with metastatic renal cell carcinoma with a bed yep pathway targeting therapies and checkpoint inhibitors, many patients to come to this treatment resistant disease.

Based on the excitement for this program we have rapidly congrats I look through one sex and we'll be filing an eye in d. in renal cell carcinoma by the end up this year would a plan to initiate clinical trial in 2021 operationally, we continue to manage our activities in the face a challenging external environment.

Work from home has become a norm for most of all employees. We have also group out team set out game, so those who needs to be onsite lab work have ample space to do so.

David D. Chang: We have also grouped our teams at Allogene, so those who need to be on-site for lab work have ample space to do so. This has allowed us to continue to advance all of our key clinical and preclinical programs, and I would like to thank our employees for their dedication and engagement during these difficult times. We believe we are moving closer to our goal to have allogeneic cell therapy follow the success of autologous CAR T therapy while providing major benefits in time, convenience, reliability, scale, and breadth of malignancies that can be targeted. Our efforts to validate aspects of our allopathy platform set the stage for our ability to advance multiple allocardic candidates in the near-term to mid-term. Longer term, the progress of thalamus anti-CD19 CAR-T therapies beyond relapsed and refractory patients, including a recent approval in methods for treating lymphoma, serve to forge the path for how we might quickly expand indications for our allo-CAR-T therapy, including allo-501.

So that's allowed us to continue to advance all about key clinical and preclinical programs and I would like to thank all employees for their dedication engagement during these difficult times.

We believe we're moving closer to our goal to have allogeneic cell therapy, followed the success of autologous car T therapy, while providing major benefits in time convenience reliability scale and breadth of malignancies that can be a target.

Our efforts to validate aspects of our outlook hockey platform.

At this stage for our ability to dance multiple Albuquerque candidates in the near term to mid term.

Longer term the progress autologous anti Cdnineteen car T therapy is on making beyond relapse and refractory patients, including a recent approval in mantle cell lymphoma.

Supports the path for how we might weekly expanded indications for.

I'll car T therapy, including Aloe fiber one day.

David D. Chang: As we look to transform the field of cell therapy, our research team continues its work to identify and progress next-generation tools and technologies. And we expect these efforts to keep us at the forefront of innovation as this important therapeutic breakthrough has the potential to serve many patients in need. I will now turn the call over to Rafael for further updates on our research and development activities. Thank you, David, and I hope you are all staying safe. I'm extremely pleased to report that the initial data from our Phase 1 Alpha trial of ALO501 presented in an oral session at the virtual ASCO meeting in May exceeded our expectations. Responses were observed across all cell doses and tumor histologies.

As we look to transform the field of cell therapy. Our research team continued to work to identify and progress next generation tools and technologies and we expect these efforts to keep us at the forefront of innovation as this important therapeutic mortality has the potential to serve many patients in need.

I'll now turn the call over to lot fail, but further updates on our research and development activities.

Thank you, David and I hope you're old staying safe I'm extremely pleased to report that the initial data from our phase one outlet trial from Oliver probably about 1% that in an oral session at the virtual Oscar meeting he may exceeded our expectations.

Bounces what observed across all cell dose is some tumor histologies diffuse large b cell lymphoma, follicular lymphoma within overall response rate of 63% on a complete response rate of 37%.

Rafael Amado: This study used large fissile lymphoma and follicular lymphoma with an overall response rate of 63% and a complete response rate of 37%. With a median follow-up of 3.8 months, 9 of the 12 responding patients, or 75%, remained in response until the data cut off. Included in their overall efficacy analysis are three patients who were refractory to prior autologous cardiac therapy. The best response for these patients was disease progression within three months. None of these patients responded to our CAR-T therapy.

With a median follow up with 2.8 months nine up that took responding patients or 75% remained good response, that's supposed to data cut off.

Including did all that all efficacy analysis, our t. patients who went refractory to prior autologous therapy.

The best response for these patients with disease progression within three months. None of these patients responded to all the car T therapy in car T. Naive patients there or are was 75% and the CR rate was 44%.

Rafael Amado: In CAR-T naive patients, the ORR was 75%, and the CR rate was 44%. As David noted, a higher dose of allo-647 was associated with a higher complete response rate of 50%, deeper links for depletion, and delayed host T cell recovery while sparing neutrophils and platelets. One of the ongoing responders was a patient with an initial PR who progressed by month two. This was a patient that David referred to earlier who achieved a complete response after re-treatment with the same dose of ALO501 and a 90 milligram dose of ALO647. I would like now to put this data into context. Firstly, the enrolled population was heavily pretreated. The median number of regimens was four, ninety-five percent had stage three or stage four disease, and 86 percent of the 22 patients were refractory to the last regimen as defined by progression within 12 months of therapy. We treated a mix of follicular lymphoma and diffuse large P-cell lymphoma patients.

As David noted a higher dose arlo six or seven with us and see it with a higher complete response rate of 50% deeper little depletion and delayed hosts T cell recovery well staring to feel some platelets wonder if the I'm going to respond. This was a patient with an initial PR who progressed by month too.

This was a patient that David referred to earlier, who choose to complete the sponsor after retreatment with the same dose of auto fiber one a 90 milligram dose so if I love six or seven.

I would like now to put this data into context.

Firstly general population was heavily pretreated immediate number or regiments, what's core 95% had stage three or stage for disease and 86% out the 22 patients would refractory to the Las regimen, that's defined by progression within 12 months a therapy.

We treated a mix of Follicular lymphoma in diffuse large b cell lymphoma patients.

Rafael Amado: This was done to collect as much information as possible in this Phase 1 study. We were able to gain clear signals of activity in both patients' urine. You may recall from our ASCO investor meeting that we juxtaposed our initial data from CAR-T naive patients in the alpha study with the results published from a range of autologous CAR-T studies. The point of that analysis was not to make direct comparisons, but rather to illustrate what may be possible with alocartin.

Yes, what stone to collect as much information as possible in this phase one study.

We were able to gain clear signals of activity in both patient subset.

You may recall from our Oscar Investor meeting. They we juxtapose started initial data from the car T naive patients in the also study with the results published from a range of autologous car T studies.

The point of thought analysis was not to make direct comparisons at this stage varying composition size faced with development enrollment criteria and a number of other parameters for rather to illustrate what maybe possible we follow car T.

Rafael Amado: The results of this analysis show clear similarities between autologous and allocard T in response rates at this early time point. While these promising initial findings will need to be confirmed with more patient experience and longer follow-up times, we believe we have answered yes to several important questions that the ALPHA trial aimed to address, namely whether ALOF501 can be successfully manufactured. ALLOX501 can be safely administered without causing clinically relevant graft-versus-host disease. ALO647 can be safely administered, and it leads to dose-dependent lymphodepletion that associates with ALO501 expansion. And allophile 1 can provide complete responses across multiple histologies.

The results of this analysis showed clear similarities between autologous another car T. In response rates at these early time point.

Well this promising initial findings will need to be confirm with more patient experience on longer full of times. We believe we have answer yes to several important questions that the alpha trial aim to address namely Allah five along can be successfully manufactured.

Hello, five along can be safely administered without causing clinically relevant graft versus host disease.

Although six or seven gunby safely administered I need me to dose dependent lymphodepletion that associates with olive fiber one expansion.

And final one can provide complete responses across multiple histologies.

Rafael Amado: Beyond these questions, we also gain an important understanding as to which patients may not respond to a low-carb drug therapy, how we may be able to improve patient outcomes with redosing, which continues in the current protocol, and how to optimize lymphodepletion. In addition, the promising safety profile demonstrated by ALLO501 and ALLO647 opens up the potential to explore dosing in the outpatient setting. Overall, these findings enhance our enthusiasm for what may ultimately be possible with the alocar therapy platform. We look forward to our next data readout from the ALPHA trial, which we expect to be in late 2020 or early 2021. Meanwhile, our Phase 1-2-alpha-2 study is actively enrolling patients. Alpha-2 is a single-arm, open-label, multi-center study of ALO501A in non-HLA-matched adult patients with relapsed refractory large-speed cell lymphoma. Patients with follicular lymphoma are excluded.

Beyond his questions Weve also getting important understanding as to which patients may not respond to I look I'd be therapy.

Well, we maybe able to improve patient outcomes weekly dosing, which continues from the current profitable and how to optimize sneak completion.

Vision, the promising safety profile demonstrated by all the fiber one analytics for seven open up the potential to explore dosing in the outpatient setting.

Overall this financing, hence our enthusiasm for what may ultimately be possible with yellow car T therapy platform.

We look forward to our Nics data read out from the Alpha trial, which we expect to be in late Twentytwenty or early Twentytwenty won.

Meanwhile, our phase one two outside to study effectively enrolling patients.

So to US a single arm open label multi center study of hollow fiber on a non actually much adult patients with relapsed refractory large b cell lymphoma.

Patients before they get a meaningful amount are excluded.

Rafael Amado: Patients must have received at least two prior lines of therapy, including an anticycline and an anti-CD20 monoclonal antibody. While prior autologous CAR T therapies allow if the tumor remains CD19 positive in patients who previously responded to autologous CD19 CAR T therapy, we are considering whether to enroll autologous CAR T patients as we learn more from the ALPHA trial experience about the outcome of patients who had a meaningful response to auto The primary objective of Phase I is to evaluate the safety and tolerability of escalating doses of ALO501A in combination with ALO647, trichophosamide, and fludarabine. Key secondary objectives include ALO5018 cell kinetics, ALO647 pharmacokinetics, and depth and duration of host lymphocyte depletion. The study will replicate certain aspects of the ALSA study to corroborate the findings from that trial.

Since must have received at least two prior lines of therapy, including on until cycling on an anti cdtwenty monoclonal antibody.

Both prior to tell of whats called the therapies to allow the tumor remain CD 19 positive in patients who previously responded to a total of Cdnineteen car T therapy, we are considering whether to enroll at all of those cards. The patients as we learn more from the all time travel experience about the outcome of patients who had a means.

In full response to the tallest treatment.

The primary objective of phase one is to evaluate the safety and tolerability of escalating doses of qualify the winning combination we follow suit for seven cyclophosphamide I'm Fludarabine.

Key secondary objectives include olive fiber, one ache, so kinetic out of six or seven pharmacokinetics and depth and duration of hosting infosight depletion.

The study was replicate certain aspects of the also study to corroborate the findings from that trial.

We initiated dosing with hollow fiber, one am 40 million olive cards. The positive sells a dose cohort that was attributed to a single patient.

The trial will follow a three plus three design with patients enrolling that dose level, two cohorts of 420 million cells that dose level cohort 360 million Olive garden T cells.

Rafael Amado: We initiated dosing with Halofribo 1A at 40 million Alokar-B positive cells, a dose cohort that was abbreviated to a single page. The trial will follow a 3-plus-3 design with patients enrolled in a dose-level 2 cohort of 120 million cells and a dose-level 3 cohort of 360 million Alokar T-cells. We're using a total dose of 90 milligrams of ALO647 administered concomitantly with Flucide.

Well, you've seen a toll dose of 90 milligram cervalis six or seven administered cone coming on fleet with the side.

We continue to target moving into the phase two portion of this study in 2021.

Our additional clinical focus is on diabetes may Aloe car T cell therapy for the treatment of relapse refractory multiple myeloma.

We have a three pronged clinical strategy targeting young man.

Universal our phase one trials, we follow 715 is well underway and we arent trucks will be for initial data from this trial in the fourth quarter up this year.

Rafael Amado: We continue to target moving into the Phase II portion of this study in 2021. Additionally, our additional clinical focus is our anti-BCMA alocartis cell therapy for the treatment of relapsed refractory multiple myeloma. We have a three-pronged clinical strategy targeting BCM. Universal, our Phase 1 trial with ALO715, is well underway, and we are on track to report initial data from this trial in the fourth quarter of this year. This study was initially designed to explore optimal dosing of all the components of the nipple depletion regimen, including ALO647, trudarabine, and cyclophosisphamide, with patients receiving ALO715 at one of three doses.

This study was initially designed to explore optimal dosing of all the components of the need for at least some great demand, including all of six for seven Fludarabine and cyclophosphamide with patients receiving although 715 I'd want to three doses.

40 million 160 million clean and then 20 million itself you know three plus three dose escalation design.

As David noted we have recently completed the initial dose escalation portion of the Universal trial, using 39 milligrams of all of six or seven and then broadly another lymphodepletion cohorts, which a mid to diabetes.

The endpoints Bina said safety tolerability depth and duration of clean for depletion cell expansion, an anti tumor activity, including minimal residual disease rate.

Rafael Amado: 40 million, 160 million, and 320 million cells in a 3 plus 3 dose escalation design. As David noted, we have recently completed the initial dose escalation portion of the universal trial using 39 milligrams of ALO647 and are enrolling in other lymphodepletion cohorts which omit the fluid database. The endpoints being assessed are safety, tolerability, depth and duration of lymphodepletion, cell expansion, and antitumor activity, including minimal residual disease rates. Given the complexity of this disease and propensity for disease progression in patients with multiple myeloma, we are excited to explore regimens that include both lower and higher doses of ALLO647.

Given the complexity is this the season propensity for disease progression for patients with multiple myeloma. We are excited to explore regimen, which include both lowering higher doses of politics for seven.

So look forward to applying older lessons learned across our platform such a three dosing.

We evaluate ways to optimize therapy for these patient population they need us novel treatment.

The other two prongs of RBC may strategy include exploring the use of gamma secretase inhibitor in combination with Telos 715, and investigating are twofold card technology platform to potentially enhance the efficacy of on diabetes make car T therapy in myeloma.

Since our last earnings call, we have advanced have regulatory discussion on how to best evaluate the combination of follow seven one type with the government's it could this inhibitor natural gas is that from our partner. So spring works Therapeutics, we expect to file on I N D to support the clinical evaluation of this combination this year.

Rafael Amado: We also look forward to applying other lessons learned across our platforms, such as re-dosing, as we evaluate ways to optimize therapy for this patient population in need of novel treatments. The other two prongs of our BCMA strategy include exploring the use of a gamma secretase inhibitor in combination with ALO715 and investigating our TurboCard technology platform to potentially enhance the efficacy of an anti-BCMA CAR-T therapy Since our last earnings call, we have advanced regulatory discussions on how to best evaluate the combination of ALOS-715 with the gamma secretase inhibitor neurogastrostate from our partners at SpringWorks Therapeutics. We expect to file an IND to support the clinical evaluation of this combination this year. The innovation behind turbo cars could be a breakthrough as this technology has the potential to expand allo-car T-cell viability and efficacy while reducing car T-cell dose requirement and overcoming exhaustion. These properties may enable CAR T therapies in harder-to-treat hematologic malignancies and solid tumors.

The innovation behind tumult cars could be a breakthrough at a six technology has the potential to expand olive car T cell viability on efficacy, while reducing car T cell dose requirement and nobody comment exhausting.

These properties may enable mccarthy therapies, and harder to treat hematologic malignancies on solid tumors.

Now, let's see clarifies will be our first suitable car clinical candidate.

We are excited about what this technology may mean for next generation another car T therapy in multiple myeloma and anticipate submitting a nice N D for all those six so 500 2021.

At the American Society of Gene and cell therapy annual meeting in May we presented preclinical findings on or two but part of technology.

The versatility of this technology could allow us to harness the signaling of different cytokine and we believe turbocord could eventually become a sundar for olive garden platform.

A third clinical teams focus on clinical trial progression for a long cycle, one olive Bible when they are low 715.

Rafael Amado: Allo 605 will be our first Tuvokar clinical candidate. We are excited about what this technology may mean for next-generation ALOCAR T therapy in multiple myeloma and anticipate submitting an IND for ALO605 in 2021. At the American Society of Genes and Cell Therapy Annual Meeting in May, we presented preclinical findings on our TurboCard technology. The versatility of this technology could allow us to harness the signaling of different cytokines, and we believe it could eventually become a standard for allocard TPUP.

Research teams continued to progress I preclinical activities.

Preclinical work on all of 216, our anti Cdseventy can do that continues as we look to reverse the use of cell therapy from hematologic malignancies into solid tumors.

Our olive tree wants exciting these planned by the end of this year in treating then versus something else, so carcinoma with the potential to Saudi all their malignancies in the future.

In addition to the a ball preclinical work continues in countries such as although 819, an investigation Arlo car T therapy targeting six three that's a novel treatment for acute myelogenous leukemia, as well as totally a state technologies, such as our induced pluripotent stem cell program.

Rafael Amado: As our clinical teams focus on clinical trial progression for ALO501, ALO501A, and ALO715, our research teams continue to progress our preclinical activities. Our preclinical work on ALO316, our anti-CD70 candidate, continues as we look to transition the use of cell therapy from hematologic malignancies into solid tumors. Our all of 316-IND is planned by the end of this year in treatment-resistant renal cell carcinoma, with the potential to study other malignancies in the future. In addition, preclinical work continues on candidates such as ALO819 and investigational ALOCAR T-therapy targeting FLIX3 as a novel treatment for acute myelogenous leukemia, as well as earlier stage technologies such as our induced pluripotent stem cell program We are relentless in our pursuit to bring allocarditis therapy to patients and are very excited by the strong momentum which has been achieved across both our clinical and preclinical pipelines. I look forward to continuing to provide updates at the Scientific Congress. While we continue to leverage our internal capabilities and our existing partners, we will also pursue innovation externally as we advance additional pipeline candidates and next-generation technologies.

We are relentless pursuit to bring all the car T therapy to patients and are very excited by the strong momentum with chief the across both our clinical and preclinical pipeline.

I look forward to continuing to provide updates at scientific Congress.

Well, we continue to leverage our internal capabilities on our existing partners. We will also pursuing novation externally as we advance additional pipeline candidates a next generation technology.

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

Thank you Raphael and good morning, let me start by thanking all of you on the call or those who they listen into later to the replay for your ongoing support a valid gene our efforts to bring yellow car T therapy to patients that support was particularly evident during a recent financing which benefited from the participation in many new and existing shareholders.

In June we closed the follow on offering that raised $632.5 million in gross proceeds prior to deducting underwriting discounts commissions and offering expenses payable by US included in this figure is the exercise in full by the underwriters at their option to purchase additional shares of common stock.

As a result, and as noted in our SEC filings and second quarter press release issued earlier today, our financial position stronger than ever with cash cash equivalence and investments totaling $1.1 billion as of June Thirtyth Twentytwenty.

Eric Schmidt: I'd like to now turn the call over to Eric to review the financials. Thank you, Raphael, and good morning. Let me start by thanking all of you on the call or those who may listen in later to the replay for your ongoing support of Allogene and our efforts to bring allocarditotherapy to patients. That support was particularly evident during our recent financing, which benefited from the participation of many new and existing shareholders. In June, we closed a follow-on offering that raised $632.5 million in gross proceeds prior to deducting underwriting discounts, commissions, and offering expenses payable by us. Also included in this figure is the exercise in full by the underwriters of their option to purchase additional shares of common stock. As a result, and as noted in our SEC filings and second quarter press release issued earlier today, our financial position is stronger than ever, with cash, cash equivalents, and investments totaling $1.1 billion as of June 30, 2020.

The second quarter, our research and development expenses were $47.3 million, which included $8 million noncash stock based compensation expense.

General and administrative expenses were $15.9 million for the second quarter of Twentytwenty, which includes $8.8 million noncash stock based compensation expense, our net loss for the second quarter of Twentytwenty was $61 million were 53 cents per share, including noncash stock based comp and.

<unk> expense of $16.8 million I.

I'm pleased to report that our build out for a new work manufacturing facility is continuing and full force. Thus far we've experienced only minor delays as a result of the pandemic and we remain on track to bring to manufacturing facility online and 2021.

We maintain an expectation that are full year twentytwenty net losses will be between 260 million and $280 million, which includes an estimated noncash stock based compensation expense of 70 million to $75 million and excludes any impact from potential business development activities with that we will now.

Eric Schmidt: In the second quarter, our research and development expenses were $47.3 million, which included $8 million of non-cash, stock-based compensation expense. General and administrative expenses were $15.9 million for the second quarter of 2020, which included $8.8 million of non-cash, stock-based compensation expense. Our net loss for the second quarter of 2020 was $61 million, or $0.53 per share, including non-cash stock-based compensation expense of $16.8

Open the call for your questions.

Thank you as a reminder to ask a question you will need to press Star then one on your touched on telephone to withdraw your question from the Q. Please press the pound key and the interests of time, we ask that you. Please keep yourself to one question then one follow up question before rejoining the queue I got Nice Star then one to ask your question.

Please stand by what we can Paul the culinary roster.

Eric Schmidt: I am pleased to report that our buildout for our Newark manufacturing facility is continuing in full force. Thus far, we've experienced only minor delays as a result of the pandemic, and we remain on track to bring the manufacturing facility online in 2021. We maintain an expectation that our full-year 2020 net losses will be between $260 million and $280 million, which includes an estimated non-cash stock-based compensation expense of $70 million to $75 million and excludes any impact from potential business development activities.

My first question comes I filled an adult with Cowen and company. Your line is now open.

Good morning, Thanks for taking my question a abiding by the one question rule I was wondering if you could give us the more detail on what we should expect from the Q4 data release from the Universal trial are we likely did you see results from the initial dose escalation portion with a 39 milligram of Alis six for seven or is it possible that we could get.

Data from the additional cohorts. Thanks.

Hi, Phil first about good morning, and halt for adults widened a use caused your weathering the storm well.

Here that it has passed and things like getting better.

Operator: With that, we will now open the call to your questions. Thank you. As a reminder, to ask a question, you will need to press star then 1 on your touchtone telephone.

The question that you're asking about what's expected Ah Ah settling one five data presentation at the year and I'm going to refer to.

Operator: To withdraw your question from the queue, please press the pound key. In the interest of time, we ask that you please keep yourself to one question and one follow-up question before rejoining the queue. Again, that is star, then 1 to ask a question. Please stand by while we compile the Q&A roster. Our first question comes from Phil Nadeau with Cowan & Company. Your line is now open. Good morning.

To a two part two of our path to answer the details profile.

Yeah, Hi, David Anderson.

We Oh I stayed in mentioned and I mentioned in the <unk> initial remarks finished dose escalation. So I always have three Bucks city. We would you didn't have any deal Gee. We also put some patience as I mentioned in my remarks and to see a cohorts as well.

And we will treat some patients are 90 milligrams to total number of patients. So we'll make it into the end of the your presentation is still to be determined but I think you can probably get an idea of how many patients a if you compare or what we presented at ASCO. So there would be.

Phil Nadeau: Thanks for taking my question. Abiding by the one-question rule, I was wondering if you could give us a bit more detail on what we should expect from the Q4 data release from the universal trial. Are we likely to just see results from that initial dose escalation portion with the 39 milligrams of ALIS-647, or is it possible that we could get data from the additional cohorts? So, Phil, first of all, good morning. And I hope for those who are on the East Coast, you know, you're weathering the storm well.

On bird thereabouts similarly to that.

And maybe just one follow up can you give us an idea that.

Actually the duration of follow up for the patients it'll be in that initial data released.

I went out to calculate what did median follow up will be but I I think it's difficult to know a you know obviously that base. Since I started about 40 million will have a much longer follow up when the patient access that started I did later doses, but.

David D. Chang: I hear that it has passed, and things are getting better. You know, the question that you're asking about what to expect for the 715 data presentation at the year-end, I'm going to refer to Rafael to answer the details.

But that's a number that I think we'll come up which ones. We do again on issues. We <unk>, we don't have been number right now.

Great. Thanks for taking my question and congratulations on all the purpose.

Rafael Amado: Yeah, hi David. We have, as David mentioned and I mentioned in the initial remarks, finished the dose escalation. So, that was F3 plus 3. We didn't have any DLT.

Thank you.

Thank you as a reminder, we ask you keep yourself to one question before rejoining the queue. Our next question comes from Salveen Richter with Goldman Sachs. Your line is now open.

Hi, everyone. Thanks for taking the question. This is Andrew on for Salveen.

Rafael Amado: We also put some patients, as I mentioned in my remarks, in the CA cohort as well, and we will treat some patients at 90 milligrams. The total number of patients that will make it into the end-of-the-year presentation is still to be determined, but I think you can probably get an idea of how many patients if you compare what we presented at ASCO. So, there will be a number thereabouts, similarly to that. And maybe just one follow-up. Can you give us an idea of the actual duration of follow-up for the patients that will be in that initial data release? I would have to calculate what the median follow-up will be, but I think it's difficult to know. You know, obviously, the patients that started at 40 million will have a much longer follow-up than the patients that started at lower doses. But that's a number that I think we will come up with once we do the analysis. We don't have that number right now.

David maybe just some thoughts on where do you stand with often I think the linkage accretion for the five or one trial and what still needs to be done here.

And on track the money in comps of optimizing Lymphodepletion I mean, we already saw very encouraging data as we increase that go sub alis six plus seven from 39 to 90 milligrams and obviously at the ask a presentation. The follow up was a short so we out you know waiting for the longer.

One follow up so while that's ongoing we are also doing few additional testing.

Looks at the end we had this.

Quite unique situation I'm heading to different studies ongoing and we have a great opportunity to really trying to see what the allogeneic cell therapy can ultimately do not just getting to flat autologous cell therapy can do about perhaps you can be more so we're continuing to optimize little bit more but right now the main focus is.

On the follow up of the patients were treated with a 90 milligrams of Alis six what seven where we saw higher weighted a complete remission.

Phil Nadeau: Great. Thanks for taking my question, and congratulations on all the progress. Thank you. Thank you. As a reminder, we ask that you keep yourself to one question before we join the queue. Our next question comes from Salveen Richter with Goldman Sachs. Your line is now open. Hi, everyone. Thanks for taking the question. This is Andrea on behalf of Salveen.

Thanks, so much thanks.

Thank you. Our next question comes from beer in I mean with Jefferies. Your line is now open.

Yeah, Hi, guys and thanks for taking my question. So I think you said that the next update from Alpha May come at the study at the end of the year, but there's also a window for data reporting out in early 2021. So just trying to understand what are the factors that are driving a timing for the alpha update.

Salveen Jaswal Richter: David, maybe just some thoughts on where you stand with optimizing the lymphodepletion for the 5.0.1 trial and what still needs to be done here? Andrea, good morning. In terms of optimizing lymphoid depletion, I mean, we already saw very encouraging data as we increased the dose of allo-647 from 39 to 90 milligrams. And obviously, at the ASCO presentation, the follow-up was short, so we are, you know, waiting for the longer-term follow-up. So while that's ongoing, you know, we are also doing a few additional tests because, in the end, we have this quite unique situation of having two different studies ongoing, and we have a great opportunity to really try to see what allogeneic cell therapy can ultimately do.

So actually I'm going to.

All right to respond to that question sorry, yeah, Thanks, David Beer and high it's Eric how she was the case with our initial ASKO dataset, we really want to be sure that any updated presentation that is meaningful and informative.

As you know, it's just a couple of months, it's the ASCO presentation. So we'll continue to move the also study for just a follow patients enroll additional patients.

At the same time, we'll look for a scientific form that provides an opportunity to showcase that meaningful update as you mentioned or as Rob elderly mentioned in his script that could be either late this year or early next but we we just haven't.

We haven't decided our plants are quite yet.

Salveen Jaswal Richter: And that's just, you know, getting to what a palliative cell therapy can do, but perhaps we can do more. So we are continuing to optimize a little bit more. But right now, the main focus is on the follow-up of the patients who are treated with 90 milligrams of allo-647, where we saw higher rates of complete remission. Thanks so much.

Okay, great. Thanks for taking my question.

Thank you and our next question comes on Cory Kasimov with JP Morgan. Your line is now open.

Hi, Good morning, this gathered on for Corey.

Sorry.

I acknowledge this might be a bit premature, but just interested in your thoughts nonetheless, given the scrutiny on CMC it with respect to gene and cell therapies as evidenced from some of the other car cheap auto car T. Players what steps can you take today or in early clinical development to mitigate some of the potential speed bumps down the road.

David D. Chang: Thank you. Our next question comes from Buren Amin with Jeffreys. Your line is now open.

Tyler Martin Van Buren: Yeah, hi guys. Thanks for taking my question. So, I think you said that the next update from Alpha may come at the end of the year, but there's also a window for data reporting out in early 2021. So, just trying to understand, you know, what are the factors that are driving the timing for the Alpha update? I'm going to ask Eric to respond to that question.

So let me take that question I mean, CMC is an area that we are paying a lot of attention. We certainly did that when we are involved in the development of Apollo arc is better and we are carrying that through as we enter into the allergan eight where that cell manufacturing.

Eric Schmidt: Yeah, thanks, David Buren. Hi, it's Eric. You know, as was the case with our initial ASCO dataset, we really want to be sure that any updated presentation is meaningful and informative. As you know, it's just been a couple of months since the ASCO presentation, so we'll continue to move the alpha study forward, follow patients, enroll additional patients, and at the same time, we'll look for a scientific form that provides an opportunity to showcase that meaningful update. As you mentioned, or as Rafael really mentioned in his script, that could be either late this year or early next, but we just haven't.

It is.

I would say little bit more complicated and you know we really break this down into you know how to develop the you know proper analytic assay. So today, we can continue to improve the manufacturing and certainly are taking care of all the assets that are necessary to qualify.

By the middle East material. According to the regulation and it includes both you know what we consider as a middle East test as far less additional explorer test that's necessary. So that's just one part of the equation and that you had a part is you know things that are needed.

To ensure that manufacturing facility 10 past or any kind of pre inspection, which we expect.

Eric Schmidt: We haven't decided our plans quite yet. Okay, great. Thanks for taking my question. Thank you. And our next question comes from Corey Casimov with J.P. Morgan. Your line is now open. Hi, good morning. This is Gavin on behalf of Corey.

That sounds a little bit premature I wouldn't we are still building out manufacturing facilities in New York, but already our teams are thinking ahead in preparation.

Corey Casimov: So our question, I acknowledge this might be a bit premature, but I'm just interested in your thoughts nonetheless. Given the scrutiny on CMC with respect to gene and cell therapies, as evidenced from some of the other CAR T players, what steps can you take today or in early clinical development to mitigate some of the potential speed bumps down the road? So, let me take that question. I mean, you know, CMC is an area that we are paying a lot of attention to. We certainly did that when we were involved in the development of thalascoccus therapy, and we are carrying that through as we enter into the allogene, where the cell manufacturing is, I would say, a little bit more complicated.

Oh, yeah late filing so.

You know to the extent I can answer that much I mean, but I can tell you would that experience that we have a we are looking into every possibilities to make sure that we can address any kind of regulatory questions that may come out.

Great. Thanks for the color.

Thank you. Our next question comes from Tyler Brennan around with Piper Sandler Your line is now open.

Hey, guys good morning, and congratulations progress during the quarter just wanted to get your.

Peter Dorfman durability of response with the Oprah trial and kind of what we saw at ASCO and as we think about durability response for the future clearly the overall response rate.

Corey Casimov: And, you know, we really broke this down into, you know, how to develop the proper analytic assay so that we can continue to improve the manufacturing, and certainly, you know, taking care of all the assays that are necessary to qualify the release material according to the regulation. And, you know, it includes both what we consider as a release test as well as additional exploratory tests that are necessary. So, that's just one part of the equation, and, you know, the other part is things that are needed to ensure the manufacturing facility can pass any kind of pre-inspection, which we expect.

Your next month.

Great and you had none of the 12 patients responding with the media and the 3.8 months in the K wells.

I see that in non hodgkins to get that 40% to 50% Oh relapse free rates one to two years that most of those patients aren't relapse free at three months. So if you looked at those responders I guess about eight of them made at three months in five out of it are still responding which is six.

The 3% relative to kind of though for 40 to 50 per cent that we've historically seen and that's at the 39 there.

David D. Chang: You know, that sounds a little bit premature when we are still building our manufacturing facilities in Newark, but already, our teams are, you know, thinking ahead in preparation of the VLA filing. So, you know, to an extent, you know, I can't answer that much, I mean, but I can tell you with the experience that we have, we are looking into every possibility to make sure that we can address any kind of regulatory questions that may come up. Great Thanks for the color.

Even though before you even feed more data for 90 must go through I guess.

Would you agree with her comments at the clear well made and.

Read month time point, as we think about durability of response.

Peculiarly important when we look at kind of longer term relapse free rate.

Tyler Thanks for the question and certainly we are following the durability data coming from the apologize sent continued to be encouraged by what they're seeing especially your two and three as you point out I mean, there's a good correlation between them.

Tyler Martin Van Buren: Thank you. Our next question comes from Tyler Vranuren with Piper Fandler. Your line is now open. Hey guys.

David D. Chang: Good morning, and congratulations on all the progress during the quarter. Just wanted to get your updated thoughts on durability of response with the alpha trial and kind of what we saw at ASCO and as we think about durability response for the future. Clearly, the overall response rates and the CR response rate were great, and you had 9 out of the 12 patients responding with a median of 3.8 months. The KOLs say that in non-Hodgkins, to get that 40% to 50% relapse-free rate out 1 to 2 years, most of those patients are relapse-free at 3 months.

Ability.

Yeah month, three I mean, you know I would say you know for six months and the longer term durability and.

And in our study, we haven't really gotten to that point up six month plus about certainly you know we are very encouraged with a high rate of complete remission than what we're seeing as well as people who continued to be in response at the time, a beta cuts. So durability is very important and.

You know, we will see Oh, the durability holds out, especially as we go up to the 90 milligram, where the data because at the cut off.

Tyler Martin Van Buren: So, if you look at those… Thank you. Tyler, thanks for the question, and certainly we are following the durability data coming from the autologous and continue to be encouraged by what they are seeing, especially year 2 and year 3. As you point out, there is a good correlation between the durability at month 3, I would say, in the first 6 months, and the longer term durability, and in our study, we haven't really gotten to that point of 6 months plus, but certainly we are very encouraged with a high rate of complete remission than what we are seeing, as well as people who continue to be in response at the time of data cuts. So durability is very important, and we will see how the durability holds out, especially as we go up to the 90 mg, where the data, because of the cutoff, where the follow-up was relatively short, but we are highly encouraged by what we saw at the ASCO data presentation, and we look forward to updating you in the near future. Great.

Follow what's the what could be short, but we are highly encouraged by what we so at ASCO data presentation, and we look forward to updating you in near future.

Great. Thanks for taking the question.

Thank you. Our next question comes in such a bad Suppiah with H.C. Wainwright. Your line is now open.

Hi, good morning.

Thanks for taking the call.

They are not forget it so I wanted to ask a question about re dosing patients that have been previously treated only with Albuquerque.

What kind of or do you need to see.

Relapse or you read dose or.

Other.

Biomarker clinical.

Points that you're looking for battery dosing.

And how do you.

Great question I'm going to ask Rob fell to address your question Okay.

Yeah, Hi, and it seemed as if an area. That's that's really get ready for innovation. Because in addition to you know the classical being in response of putting loans that addicting long term responses, there now and molecular assays that can be much more accurate in terms of predicting what patients.

Deja Betapayo: Thanks for taking the question. Thank you. Our next question comes from Deja Betapayo with H.C. Wainwright. Your line is now open. Thanks for taking the call. This is Aaron Offer-Debjit.

The remaining to respond to tone, which patients long.

Rafael Amado: So I wanted to ask a question about redosing patients that have been previously treated only with aloecartilage. What kind of tests do you need to see? There are other tests that you're looking for, Puerto Rico.

So at the moment, a degree dosing, if allowing all our protocols and where we don't think basing fed respond on progress and you know we have Dot example, that we've talked about in the prepared remarks.

Rafael Amado: How do you define that? Great question. I'm going to ask Rafael to address your question. Rafael?

Rafael Amado: Hi. So, I think this is an area that's really ready for innovation because, in addition to, you know, the classical being in response of three months, predicting long-term responses, there are now molecular assays that can be much more accurate in terms of predicting what patients will remain in response and which patients won't. So, at the moment, redosing is allowed in all our protocols, and we're redoing patients that respond and progress, and, you know, we have that example that we talked about in the previous remarks, and we continue to do that. And although they're fantastic, there's still a lot of room for improvement.

We continue to do that and I think what is really exciting is the fact that while we are doing the dose escalation for probably about one day, we're still being able to experiment doing probably the along with things like that goes soon and so if we go scene is now being tested entitled when a in a broader.

Number of patients to really.

See whether or not or we can improve upon the autologous resolves, which although there are fantastic there's still a lot a room for improvement. So you know you should see a reducing in all their patient populations in the future.

Rafael Amado: So, you know, you should see redosing in other patient populations in the future. Okay, we may see data on this at year-end or early. Thank you. Thank you. I'll update you with any additional data we collect, you know, whether it's year-end or early next year. And, you know, just on one other aspect, you know, right now in the ongoing studies, the redosing is a reactive redosing, meaning that patients, when they progress or when they do not achieve what we consider as a good response, we give the patient the opportunity to receive the redosing. And certainly that's an area, as Rafael has mentioned, that we are quite interested in. It's a great opportunity for allogeneic cell therapy, given the availability of cell products that can be, you know, provided to the clinical site. Next slide.

Okay, and we may see data on that.

Yearend or early 2021.

The reader.

Huh.

Oh I paid she would any additional data we collect a you know whether it's on your end or early next year I am and since one one other aspect right now in the ongoing studies.

So we don't think is a we acted read all seeing meaning that a pace and when they progress all when they do not achieved a while we consider as a good response, we use a patient opportunity to receive the we'd go skiing and certainly that's an area as Rob mentioned.

And that we are quite interested in it's a great opportunity for the allogeneic.

Cell therapy, given the availability or sell products that can be.

You know provided today to the clinic clinical site.

Okay.

Rafael Amado: Thank you, guys. Thank you. Our next question comes from Mark Breidenbach with Oppenheimer. Your line is now open.

Thank you guys.

Thank you. Our next question comes from Mark Breidenbach with Oppenheimer. Your line is now open.

Mark Alan Breidenbach: Hey, good morning, guys, and thanks for taking my question. Just wondering, with a new CD19 antibody entering the NHL treatment, if you can make any general comments on the performance of CD19 CAR-Ts, either auto or allo, in patients who have had prior tafacitumab. Are there any precedents for that? Thanks. Mark.

Hey, good morning, guys and thanks for taking my question.

Just wondering with a new CD 19 antibody entering the NHL treatment.

You can make any general comments on the performance of Cdnineteen car T is either auto or allo in patients who have had prior toughest through them or are there any precedents for that a thing. Thanks.

David D. Chang: Thank you very much for that question. I'm going to ask Rafael to provide a response. First, we are very excited about new therapy continuing to become available for patients with non-Hodgkin's lymphoma.

Hey, Mark Thank you very much for that question.

A rough out to provide the response.

We are very excited about new therapy can seem to be come available.

Ill patients would non Hodgkin's lymphoma.

Rafael Amado: Yeah, I echo those comments. I mean, I think it's fantastic that there's a new product, and I think, also, the development of that product was, I think, exemplary in the way that they obtained a label for patients with stem cells in eligible populations. But, you know, as with history in medicine, Therapies are often sequenced, and they're combined, and, you know, we expect that both types of therapies, both autologous and bispecifics and others that may be coming, will coexist. Antibodies may need to be given constantly versus, as you know, self-therapy, which may be a one-time treatment, redosing notwithstanding. So I think overall, you know, like what happened with myeloma, what happened with renal cell carcinoma, countless other tumor types, these therapies, physicians, and investigators will find a way to cycle them for the benefit of patients. So we're pretty happy that this approval took place.

Yeah, I Echo Doug's comments, I mean, I think it's a fantastic, but there's a new programs and I think a also development about product plus I think accents Larry in there in that way that they obtain a label in patients with them. So.

Ineligible population.

But you know assay said history medicine.

Piece are often seek wings and their combined and you know we expect that both types of therapies for folks all of us on bi specifics and others, maybe coming will coexist antibodies may need to be give and constantly versus us you know.

So therapy, which maybe a onetime treatment you know read dosing not withstanding. So I think overall you know like what happened in myeloma on what happened in renal cell carcinoma countless other.

Tumor types or the therapies, the physicians investigators will find a way to cycle.

For the benefit of patients so we're pretty happy, but actually induce approval took place.

Rafael Amado: But no information about patients who received the CD19 CAR-T post-CD19 antibody. That information, I think, will need to be forthcoming. I don't think there's enough information in the field to really be able to tell. I mean, we know that in the BCMA space, patients can respond to cell therapy if they haven't received BCMA antibodies, and it is possible, depending on the mechanism of resistance to the antibody, that they may respond to cell therapy. The mechanisms of resistance are being elucidated nowadays as we speak, to both antibodies as well as cell therapy.

But no information about patients who received a CD 19, Carty up post CD 19 antibody.

Did that information I think it's a as you will need to be forthcoming I don't think there's enough information in this field to really be able to.

No.

I mean, we know that into bcm, a space. They since Congress phone to cell therapy, yes. They haven't received bcm antibodies and it is possible depending on the mechanism overseas said.

To the antibody that they may respond to cell therapy or the mechanism. So resistance are being elucidated nowadays so as we speak to both antibody solar cell therapy.

Mark Alan Breidenbach: Okay, thank you. Thank you. Our next question comes from John Newman with Canaccord. Your line is now open.

Okay. Thank you.

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

John Lawrence Newman: All right, guys. Thanks for taking the question. We have a question for both of them.

Hi, guys. Thanks for taking my question, there's a question for both.

David D. Chang: This is a bit of a broader question. I wonder if thinking about autologous and allogeneic bone marrow transplants is a good corollary for ADL-501? The first allogeneic bone marrow transplant was actually done a long, long time ago, I think 1957. Obviously, allogeneic BMT has expanded greatly since then.

Yeah. This is a better for broader question I wonder thinking about autologous and allogeneic bone marrow transplant as a good corollary for al fiber one.

The first allogeneic bone marrow transplant was actually done long long time ago, I think 957, obviously allogenic BMT is expanded greatly since then one I'm wondering is [noise].

Rafael Amado: What I'm wondering is... We're back for a bone marrow transplant today. You know, do they hold out or wait for an autologous donor? Or do they normally utilize an allogeneic donor? And I'm just wondering if this might be a good way to kind of think about this autologous versus allogeneic CAR-T question.

[laughter] for bone marrow transplant today, you know do they hold out or wait for an autologous donor.

Or just they normally utilize and al generic donor I'm just wondering if it's lumpy because one way to kind of think about this autologous first as allogeneic car to question today. Thanks.

Rafael Amado: Yeah, Raphael, do you want to take that question? John, thanks for that question. Certainly, the landscape in the non-osmoclinformer, you know, continues to improve, as your question and the previous question about the new therapy come in. So, Raphael?

Yeah Rockpile do you want to think that question John Thanks for that question certainly the landscape and our non Hodgkin's lymphoma couldn't team to see as your question and a pretty good question about the new stuff is coming and so well.

Rafael Amado: Yeah, I'm assuming this is in the context of non-Hodgkin's lymphoma, but allogeneic bone marrow transplantation is relatively rare in this space. Autologous stem cell transplantation is a lot more common. So, in fact, you know, there are many patients in our studies and other studies that have received stem cell autologous therapy prior to entry into the study. You know, the bearing of that with regard to allogeneic versus autologous CAR T therapy is, I think, very disparate. Because, you know, in general, the benefits of autologous CAR T therapy are very different from the benefits of... I'm sorry, the benefits of allogeneic CAR T therapy are very different from the benefits of allogeneic bone marrow transplantation, which, again, is very toxic in They're mostly elderly patients.

Yeah I'm, assuming this is in the context, so no hosting thing from a allogeneic bone marrow transplant is relatively rare in India space.

Autologous stem cell transplant is I love more common.

So in fact, you know there are many patients.

And you know studies and other studies that have received some so.

Autologous therapy prior to entry into the study you know that bearing Oh starts with regards to.

You know allogeneic versus autologous car T therapy, I think is it.

Sorry. This bridge because you know in general the benefits of autologous <unk> car T therapy.

Very different from the benefits of Oh, I'm, sorry, the benefits of I lived in a car T therapy are very different from the benefits of allogeneic bone marrow transplant, which again is highly toxic in this space and are mostly elderly base and a unless it's a hub identical transplant is hardly ever done so I think.

John Lawrence Newman: And unless it's a haploidentical transplant, it's hardly ever done. So, I think that's...I mean, I would limit my comments to those. Okay, great. Thank you. Our next question comes from Michael Schmidt with Guggenheim. Your line is now open. Hey, guys.

Yes.

Would limit my comments too.

Yes.

Okay, great. Thanks.

Thank you. Our next question comes from Michael Schmidt with Guggenheim. Your line is now open.

Hey, guys good morning, and thanks for taking my questions.

Michael Schmidt: Good morning, and thanks for taking my questions. I just wanted to follow-up on your comments about patients in the alpha study that received prior autologous CAR-T therapies. I think you mentioned none of those responded, and there may even be sort of a maybe CAR-T resistant phenotype.

Just had a follow up on your comments around a patients in the office study that received prior autologous car T therapy is I think you mentioned none of those responded and.

There may even be sort of a maybe a car T resist and type phenotype and I was wondering how much more work you think you'll be doing two to better understand that and how this might affect ultimately that development path for adult five for one eight given that.

David D. Chang: And I was wondering how much more work you think you'll be doing to better understand that and how this might affect, ultimately, the development path for ALO501A, given that autocAR-Ts may, you know, expand in use as additional readouts for ESCAR and other products. Yeah, Michael. I'm going to ask Rafael to expand on the response, because I think, you know, what you are asking, certainly what we have seen in our study to be, you know, very interesting findings that are emerging. Now, one thing that, you know, I would emphasize, yes, there has been a lot of, well, not a lot, limited reporting of redosing, as was done at ASCO in the autologous CAR T setting, and even in the autologous CAR T setting, people were reporting that those who relapsed early on tend to respond poorly.

Autocar cheese may you know expand and.

And abuse S.S. additional trials readout for yes card and other products.

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Yeah, Michael I'm going to know asks about fail to expand on that response, because I think you know what you are asking you know certainly we have seen and I'll study to be a very interesting findings that are emerging now one thing that I would emphasize yes, there has been.

A lot of well not a lot limited reporting up at resulting in a as one side of that basketball into autologous car, you setting and even in the autologous car T setting a p. pool reporting that those who relapsed early on you know tends to respond poorly.

David D. Chang: In our study, we did something that's very unique, which was enrolling patients who failed, and we defined failure as patients who were not able to maintain response for more than one to two months. So we enrolled those exceptional patients, and we are finding something that we think is very interesting and potentially could lead to more predictive medicine at some point in the future. So with that, Rafael, do you want to expand on that a little bit more? Yeah, I would say that the mechanisms of resistance are being elucidated. There's data from Marco Davila from AdMofed about intrinsic resistance due to dissecting the death receptor pathways.

In our study we did something that's very unique which was enrolling patients who fail and we defined the failure as patients who are not able to maintain response for more than once it tomorrow. So we are enrolled don't exceptional patients and we are finding something.

We think is very interesting and potentially could that someday lead to more predictive medicine. So would that rough how do you want to expand on that little bit more.

Yeah, I would say that there then Lincoln isn't services since are being elucidated. There's there's data from our cadaver lab mofid or about a three insect resistance to do fixing to death receptor pathway on their issues, we've seen 90 molecule itself or the person.

Rafael Amado: And there are issues with the C19 molecule itself, the presence or the mutations in C19. And so there are patients that have intrinsic resistance to autocardiac cell therapy, and we wanted to try to see whether they would respond to autocardiac therapy. But we found out that the patients that we treated didn't.

Sorting mutations and see 19.

And so there are patients are having to integrate assistance auto car T cell therapy, and we wanted to try to see whether it would respond to oligarchy therapy, and we found out that the basin. So we'd be it didnt that doesn't mean that a patient the benefited from auto car T therapy for a period of time, that's long I mean, a benefit from a total of.

Rafael Amado: That doesn't mean that a patient that benefited from autocardiac therapy for a period of time that's long may not benefit from autologous. And so, therefore, we haven't yet completely given up on these patients that receive autologous cardiotherapy relapse and can benefit from allogeneic cardiotherapy. And that is something that we plan to study. So it sounds like those patients were kind of pre-selected to be very poor responders in the first place, as I understand it. Those patients we wouldn't treat further because, in my experience, those patients don't do well.

Oh, sorry, I'm. So therefore, we haven't yet completely given up on these patients.

And we will thing get an answer as to whether or not there's a sub population of patients that a b C. Bustelo car T therapy, we labs and can benefit from allogeneic car T therapy and that is something that.

We plan to study.

On the stuff so it sounds like Dallas, those patients who are kind of pre selected to be very very poor as funds and the first place as I understand that.

Right those basins. So yeah those patients would we wouldn't treats further because I think experiences that those patients don't do well.

Michael Schmidt: All right, thank you. Thank you. Our next question comes from Ren Benjamin with JMP Securities. Your line is now open. Good morning, guys. Thanks for taking the questions, and congratulations on all the progress. My first question has to do with the manufacturing facility. Can you just remind us – I know it will be online in 2021 – what kind of bridging and comparability studies need to be done? Do they need to be online prior to a pivotal study or just kind of prior to commercialization?

All right. Thank you.

Thank you. Our next question comes for rent venture men with JMP Securities. Your line is now open.

Good morning, guys. Thanks for taking the questions and congratulations on all the progress.

My first question, let's do it the manufacturing facility can you just remind us I know it will be online in 2021, and what kind of Twog bridging your comparability studies.

On the.

Needs to be online prior to a a pivotal study or just kind of prior to commercialization.

Reni John Benjamin: Can you just remind us what the capacity of that facility will be... Yeah, so great question about, you know, bringing a new facility. I mean, this is something that the industry frequently deals with, you know, doing, you know, the kind of bridging study. And in the cell therapy area, we believe that the bridging study will be limited to analytic bridging studies.

Can you just remind us what the.

Pass any of that facility will be ultimately.

Yes, so great question about bringing a new facility I mean, this is something that industry frequently deals what not doing kind, a bridging study and in the cell therapy area.

We believe that the bridging study will be limited to.

Analytic bridging studies, so I think that's already always washing plant and we are addressing that as we pull forward and as you have mentioned Newark facility, which is really a set of arc facility is going to come online in 2021 and start manufacturing or.

David D. Chang: So I think, you know, that was always in the plan, and we are addressing that as we go forward. And as you have mentioned, the new facility, which is really a state-of-the-art facility, is going to come online in 2021 and start manufacturing CGMP quality clinical materials. So everything is proceeding according to plan, and we've said we could commercialize multiple commercial products out of that facility. Absolutely. I got it. Got it. And just as a follow-up, can you just give us a sense as to how the DARTCH collaboration is going? I think in the past, you guys talked about focusing on alpha-beta T-cells, but I also wanted to get your thoughts if you guys are thinking about other types of cell types, including gamma-delta type T-cells as well.

He JMP quality clinical material. So everything is proceeding according to fine.

The Red we've said, we could commercialize multiple commercial products on about the facility.

Absolutely got.

Got it and.

And just as a follow up can you just give us our sons Husker hub notch collaboration is going I think in the in the past you guys had talked about.

Kind of a focus on alpha beta T cells, but I also wanted to get your thoughts.

You guys are thinking about other types of all types, including gamma Delta.

As well.

David D. Chang: So, I'm going to keep the responses relatively quick since we're running out of time. The NOTCH collaboration is proceeding extremely well. Certainly, the points you're making about the T cells, I mean, that's a primary focus, but we also know that cell differentiation technology that NOTCH has developed can allow cells to develop into other lymphocyte phenotypes.

Yes, so I'm going to keep their responses for all three quick since we were running out of time not collaboration is proceeding.

Can you well certainly the points, you're making about that piece, though I mean, that's the primary focus but we also know that cell differentiation technology. It got that notch has developed can allow themselves to develop into other lymphocytes phenotype. So that's an open question and you know obviously the I PFC.

David D. Chang: So, that's an open question, and, you know, obviously, the IPFC, we're really building for our future, and we'll continue to explore many different options as we expand the collaboration. And, so far, we are very pleased with how the collaboration is going.

You know, we really building for future and we'll continue to explore many different options as we expand the collaboration and so far we're very pleased with how to collaborations calling.

Great. Thanks for taking the Washington.

Reni John Benjamin: Thanks for taking the question. Thank you. Our next question comes from Roger Tresod with William Blair. Your line is now open.

Thank you. Our next question comes a Roger solved with William Blair. Your line is now open.

Roger Tresod: Thanks for taking the question. I just want to get some clarity on the universal results in the context of the broader Muscle Myeloma program. Will there be some data on maybe soluble BCMA levels in these patients and responders versus, you know, just in the context of there being a clinical trial with the GSI plus, you know, an L715 in 2021? And then any other context on data that you might get that would guide where TurboCAR might fit in for these patients, just thinking about, you know, potentially having three ongoing clinical trials in Muscle Myeloma And then just what is redosing in the protocol for universal, and could we see data on any redosed patients in Q4? Thanks. Okay, I think that's Raphael. You know, there are several questions there, so let's keep the response relatively quick, but Raphael, please take it.

Thanks for taking the question just wanted to get some clarity on the universal results in the context of deepwater myeloma program.

Will there be some data on their disciple DCN a levels in these patients and responders verse you know just in the context of there being a clinical trial with the GE ESI plus.

Selling one five in 2021 and than any other context.

On data that you might get that would guide.

Where turbo car might make fit in in these patients just thinking about potentially having three ongoing clinical trials for multiple myeloma and how you enroll patients.

And then just is reducing in the protocol for Universal and could we see data on any read those patients in Q4. Thanks.

Okay, Yeah, I think Thats rockpile.

Several questions. They are so let's keep the response wants to be quick thoughts about please thanks.

Rafael Amado: So, I think in terms of BCMA levels and circulating and also on the cell surface, that's something that we plan to study. Reducing is included in the universal protocol, so, you know, we have the ability to do that. And you know, with regard to 605, we are really excited about the innovation that that brings, and we know clinically that the results are better, and there's a lot of room for improvement in multiple myeloma. And it's something that we will cycle very closely with 715 neurogastrostat and then 605. So, I think we're, you know, sort of moving through the innovation process, you know, steadily. I hope that answers your question. Yeah, it's very helpful.

So I am I thinking in terms of Bcm <unk> levels are speculating on and also said the cell surface, that's something that we plan to study.

Reducing these included into Universal protocols. So you know we will we we have the ability to do that.

And you know with regards to six so five thought we were really excited about being ovation, but that brings a and we we no clinically that the results are better and there's a lot on room for improvement in multiple myeloma, and it's something that's going up cycle.

You know very closely we've.

I don't want five no vested and then six or five or so I think where you know sort of moving to the inhalation you know.

Secondly, I hope that that answer your question.

Yeah that's helpful. Thanks.

Roger Tresod: Thanks. Thank you. Our next question comes from Asthika Goonewardene with Truist Securities. Your line is now open. Thank you.

Thank you. Our next question comes from a stick a good in working with Trust Truest Securities. Your line is now open.

Thank you hi, good morning, guys and thanks for taking my question I'm wondering how do you got to do that just a different masco from the other parties there in multiple myeloma, we saw some.

Asthika Sarith Goonewardene: Good morning, guys, and thanks for taking the question. I was wondering, now that you've got to digest data from ASCO, from the other parties there in multiple myeloma, we saw some... Some level of MRD negative data from the Johnson & Johnson product, as well as for others. Can you maybe talk to us about what level of upfront tumor eradication do you think is necessary to have a meaningful impact on disease progression? Do you think you need to go to negative 5 or negative 6?

Maybe simple MRT negative data from a from the Johnson <unk> Johnson products as long as for others can you maybe talk this about what level upfront to me eradication do you think is necessary to have a meaningful impact on disease progression do you can go to negative five or negative six.

David D. Chang: And then are you planning on presenting this data in Q4? Yeah, so let me just take that question quickly. In terms of the question, it's really related to the new way of assessing tumor response using the, you know, the molecular basis that will take the, you know, MRD level 5 or MRD level 6. I mean, we are following the emerging data. I mean, the deeper response seems to do better.

Then are you planning and presenting this data in Q4.

Yes. So let me just take that question quickly income. So all the question is really related to the new way up assessing the tumor response using though.

You know the molecular basis, then we'll take the M. R&D level five m. I'd be level six I mean, we are following the emerging data I mean, the depot response, it seems to do better and certainly as part of the study we will be evaluating the m. R&D.

Asthika Sarith Goonewardene: And certainly, as part of the study, we will be evaluating the MRD in terms of how it relates to the duration of response. I think, you know, that's something that we are all watching as the data mature in the otolaryngoscopy setting. But I think this is really a new way that one can assess the disease response, and we are very excited that an early read on the durability can be obtained from the MRD assessment. So,

In terms of how it relates to the duration of response I think that's something that we all are watching as the data mature in gold palace cart fees setting, but I think this is really a new way that a one can assess the disease response and we're very excited that the early read to the up your ability.

Can be obtained from the MRV assessment so.

Benjamin Jay Burnett: I hope that answers your question. Yes, thank you. Thank you, and our next question comes from Ben Burnett with Stiefel. Your line is now open.

Hope that answers your question.

Yep. Thank you.

Thank you and our next question comes from Ben Bernanke with Stifel. Your line is now open.

David D. Chang: Thanks very much and good morning. Just a question back to manufacturing. As you start to bring Alpha 2 online, are there any learnings from the first Alpha study in terms of manufacturing, and I guess also in terms of donor type and donor age, anything that's led to any modifications in the manufacturing process in Alpha 2 versus the first Alpha study? Thank you. Ben, great question.

Hi, Thanks, very much and good morning.

Just a question back to manufacturing.

Did you start to bring alpha to online are there any learnings from the first Alpha study in terms of manufacturing and I guess also in terms of donor type and donor age anything that flipping modifications in the manufacturing process and altitude versus the first off the study. Thank you.

Then a quick question I mean, we try to stay relatively experiments on all the things that we're doing on the manufacturing I mean, there's a lot going on.

David D. Chang: I mean, we try to stay relatively silent on all the things that we are doing in terms of making manufacturing robust, which we have already done, but also, you know, trying to characterize the donor types. That's something that will require more data points, but it's something that we are very interested in learning.

Income stop making manufacturing robust, which we have already done if at all so im not trying to characterize that donor types that so that's something that will require more data points, but it's something that we are very interested in learning.

David D. Chang: So far, you know, we have been able to manufacture cell products consistently for not only 501 and 501A but also for 715. So, I think that gives some sense of our capability in the OPS technologies, but this is something that we will continue to invest in and continue to improve, not just in terms of the quality of the cells but also the yield, which is very important. And you may also recall that in the initial ASCO presentation, we treated all 23 patients with the same manufacturing run. So in terms of clinical findings, it's premature for us to be able to comment.

So far we have been able to manufacture and sell products out consistently for not only fiber one and fiber one eight but also included a seven one fight so I think that give some sense of our capability in apps tax.

But this is something that we will continue to invest and continuing to improve not just in terms of quality up itself, but also the yield which is very important.

And you May also recall that in the initial ASCO presentation, we treat it all 23 patients with the same manufacturing runs so in terms of clinical findings, it's premature for us to her.

David D. Chang: Thank you, and I'm showing no further questions in the queue at this time. I'd like to turn the call back to the speakers for any closing remarks. Well, first of all, thank you for joining us on the call today and for your support for Allogene as we continue to progress our pipeline for allopathy therapy. I so hope you all stay well and healthy. And with that, operator, you may now disconnect. Thank you, ladies and gentlemen. Thank you for your participation in today's conference. This does conclude your program, and you may now disconnect.

To be able to comment there.

Thank you and I'm showing no further questions in the queue at this time I'd like to turn the call back to the speakers for any closing remarks.

Well first of all thank you for joining us on the call today and your support Alogent as we continue to progress our pipeline out of car T therapy. So hope you, all say, oh, well and healthy and with that operator, you may now disconnect.

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

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