Q1 2020 Earnings Call

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Operator: Good morning, ladies and gentlemen. Thank you for standing by, and welcome to the Allogene Therapeutics first quarter 2020 conference call. After the speaker's presentation, there will be a question and answer session.

Operator: To ask a question 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.

Christine Cassiano: Thank you, operator, and good morning. We appreciate you joining us today and sincerely hope you are all doing well. Before the market opened today, Allogene issued a press release that provides a corporate update and financial results for the first quarter ended March 31, 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. Please note that we are conducting our call today from different locations, so we appreciate your patience and understanding should we 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 involve risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our Form 10-K for the year ended December 31, 2019, our Form 8-K filed on March 27, 2020, as well as our upcoming Form 10-Q for the quarter ended March 31, 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.

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Good morning, ladies and gentlemen, thank you for standing by and welcome to the allergy Therapeutics first quarter 2020 conference call. After the speakers presentation. There will be a question answer session to ask a question. During this session you.

The 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 Christine Cassiotou Chief Communications Officer. It's Cassiotou. Please go ahead.

Thank you operator and good morning, we appreciate you joining us today and that's really hope you are all doing well before market open today allergy issued a press release. It provides a corporate update and financial results for the first quarter ended March 31st 2020.

Releases available on our website at Www dot allergy and Dot 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, Dr., Eric Schmidt Chief Financial Officer.

Please note that we are conducting our call today from different locations. So we appreciate your patience and understanding should we have any technical difficulty.

During today's call, we will be making certain forward looking statements. These may include statements regarding this excess and timing of our ongoing and planned clinical trial data presentation regulatory filing your research and development effort manufacturing capability and 2020 financial guidance among other things.

David D. Chang: Thank you, Christine. Good morning, everyone, and thank you for taking the time to join us for our first quarterly conference call. It has been just over two months since our last earnings call, but the world seems a different place. We hope you and your loved ones are safe and well. Our sincere thanks to many of you who have reached out to ask about Ari Veldegren after he announced that he had tested positive for COVID-19. We all feel very fortunate that his symptoms were relatively mild, and he has fully recovered.

These forward looking statements are based on current information assumption.

Patients that are subject to change. These statements involve risks and uncertainties that may cause actual results to differ materially from that's contained in the forward looking statements.

These and other risks are described in our periodic filings made with the Securities Exchange Commission, including our form 10-K.

Year ended December 31st 2019, our form 8-K filed on March 27, 2020, as well as our upcoming form 10-Q for the quarter ended March 31st 2020.

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

Thank you Christine good morning, everyone and thanks for taking time to join US well first quarter conference call.

That's been just over two months since our last earnings call toward seems a different place. We hope you and your once that's safe and well.

David D. Chang: At the same time, we are profoundly sorry about how the current pandemic has claimed so many lives and created hardship for everyone globally. Across our industry, it is inspiring to see the way in which our scientific and regulatory communities have joined together to identify potential treatments and, hopefully, a vaccine. The pharmaceutical and biotech industry is in the business of handling some of the toughest medical challenges. One thing is clear during this time; scientific innovation is our cornerstone and true north.

Oh Watson Cirrus things too many of you who have reached out to ask the already dealt.

After.

He had pets it caused people Colby Nike we.

We all feel very fortunate that he symptoms were relatively mild and yes.

Robert.

At the same time, we're profoundly sorry about how the current endemic as claim so many lives and created Archie played we won globally.

Across all industry. It is inspiring to see the way in which I'll sign speak and they go to communities have joined together to identify potential treatment.

And hopefully a vaccine.

Pharmaceutical and biotech industry.

In the business up handling sound with a tougher medical colleges.

One thing it's clear doing just fine.

Hi, it's a big innovation is how cornerstone and true north.

At Allergan.

David D. Chang: Etiology, and our priority is having to protect the health of our employees; do our best to support our community, including the patients we serve and those fighting on the front lines, and maintain as much of our business momentum as possible. On prior calls, you've heard us speak about the caliber of talents we are fortunate to have at our school.

I didn't to protect the health about employees do our best to support.

Including the patients we serve endorsed by do you want to from mines.

Maintain as much about business momentum as possible.

On prior calls you've heard us speak about the caliber Collins, we are fortunate to have that allergan.

No more than ever.

David D. Chang: Now more than ever, the ability of our employees to demonstrate our values, innovate, focus, collaborate, and lead matters. We acted quickly to protect our workforce, implementing a work-from-home policy for the great majority of employees in advance of local and statewide shutdowns. By maintaining a small lab presence directed at critical path activities and relying on the resourcefulness of our organization, we have been able to mitigate some of the effects of COVID-19 on our business. As a result, we remain on track to achieve our five key milestones for 2020. Number one, reporting initial LL501 Phase I clinical data and number two, initiating our Allo501A phase one trial both this quarter. Number three, initiating our ALLO715 combination trial with a gamma secretase inhibitor, neurogastritis, in the second half. Number four, recording our initial ALO 715 phase one data in the fourth quarter. And number five, submitting our anti-CD70 ALO CAR-T candidate, ALO 316 IND by ERF. But this is not to say that it has been business as usual.

Oh employees to demonstrate our values to innovate full course collaborate and lead matters.

We acted quickly to protect our workforce.

Well many work from home policy for the Great majority of employees in advance of local and state like shutdowns.

By maintaining a small left presents directed at critical path activities and relying on the resourcefulness allow organization, we had been able to mitigate some of the effects of Colby 19 on our business.

As a result, we remain on track to achieve our five key milestones for 2020.

Number one reporting initial aloe fiber one phase one clinical data.

Number two initiating our outlook Bible, one a phase one trial pool this quarter.

Number three initiating our outlook seven month <unk> combination trial without gamma Secretase inhibitor never gets tested in the second half.

Number four reporting our initial I looked at 115 phase one data in the fourth quarter and number five the meeting our anti Cdseventy Albuquerque can do that although 316 I indeed.

This is not to say that it has been business as usual.

Oh partner surrogates suspended recruitment into your card Nanking studies, you do that exceptional circumstances related to Colby 19 in March.

David D. Chang: Our partners have suspended recruitment in the UCAR-19 studies due to the exceptional circumstances related to COVID-19 in March, and we're working diligently to maintain much of the momentum in our trials of Allo501 in relapsed refractory non-Hodgkin's lymphoma and Allo715 in relapsed refractory multiple myeloma. We, along with our clinical investigators, recognize that many patients are not in a position to defer treatments for risk of supply chain delays that could be further complicated by the pandemic. Our investigators were unanimous in their desire to keep these trials open for patients who had rapidly progressing disease or lacked alternative treatment options. Our technical operations and supply team maintain vigilant oversight to ensure we can deliver allocardial therapy to sites in time. In a world in which hospitals are overburdened, and scheduling and logistics have become even more challenging, the benefits of being able to provide on-demand allogeneic therapy have proven to be even more acute. We adjusted to the needs of each site as we worked through COVID-19-related challenges and facilitated best practice sharing between sites for study conduct.

And we're working diligently to maintain much of the momentum in our trials of Aloe fiber one in relapsed refractory non Hodgkin's lymphoma, and Alex <unk> five in relapsed refractory multiple myeloma.

We along with al clinical investigators Mckool nice that many patients I'm not in a position to be far treatments or supply chain delays that could be floater complicated by depend Danny.

Oh investigator well unanimous in their desire to keep these trials open for the patients who had rapidly progressing disease or lack alternative treatment options.

Our technical operations and supply can maintain vigilant oversight to ensure we can deliver aloe car T therapy to sites in time.

You know award in which hospitals, the overburden and scheduling and logistics had become even more challenging the benefits of being able to provide an on demand allogeneic therapy have proven to be even more acute.

We adjusted to the need of each site as we work through Colby 19 related challenges and facilitated best practice sharing between sites foot study conduct.

We also developed rigorous process to maintain trial integrity, while utilizing remote monitoring and data entry as well that's using the patients local point of care all fall off sample collection and too much assessments to reduce travel exposure.

David D. Chang: We have also developed rigorous processes to maintain trial integrity while utilizing remote monitoring and data entry, as well as using the patient's local point of care or follow-up sample collection and tumor assessments to reduce travel exposure. We remain on track to initiate the Alpha 2 Phase 1 trial of L0501A this quarter. As you may recall, we have eliminated the retoxicum recognition domain in LO501A, which allows LO501A to be used in a broader non-Hodgkin's lymphoma patient population. The current alpha study, including the ongoing work to optimize the dose of L0647 and L0501, has informed the design of the alpha 2 phase 1 study as we seek to confirm the safety and efficacy of L0501 As we look at the differences between autologous cardiotherapy and allocardiotherapy, some foundational questions must be addressed.

We remain on track to initiate the alpha to phase one trial of Aloe fiber one eight this quarter.

As you May recall, we have eliminated said, we've got some recognition domain in l. fiber, one eight which allows although fiber one eight to be used in a broader non hodgkin's lymphoma patient population.

The current Alpha study, including the ongoing work to optimize the doors of Alis, six or seven and Aloe fiber one has informed the design of the alpha to phase one study.

As we seek to confirmed a safety and efficacy of Aloe fiber one eight well ahead of launching the potentially pivotal phase two portion of the alpha to trial.

As we look at the differences between autologous car T therapy, and ALD car T therapy, the foundational questions must be addressed.

First.

David D. Chang: First, can we effectively manufacture genetically edited products from normal donors and safely administer allogeneic cell therapy without causing graft-versus-host disease? Second, can we safely utilize ALO647 to create a period of lymphoid depletion and prevent early CAR T-cell rejection? We are making progress on these two critical questions, which allows us as an industry to focus on optimal cell dose and optimal length and depth of lymphodepletion as we work towards the goal of demonstrating durable response. We continue to believe our lymphodepletion strategy, based on the use of ALLO647, allows us to explore and determine the optimal window for allo-carchithal expansion and persistence in a variety of clinical settings. Last week, we announced that our initial LL501 data had been selected for an oral presentation at the virtual American Society of Clinical Oncology meeting later this month.

Can we effectively manufactured genetically edited products from normal governor and safely administered allogeneic cell therapy without closing graft versus host disease second we safely utilized dollarssix lets seventh to create a peoria lymphodepletion and pretend early car T cell rejection.

We are making progress on these two critical questions, which allows us as an industry to focus on optimal sell dogs and optimal Lang and that's up lymphodepletion as we work towards the goal of demonstrating dealer responses.

We continue to believe out Lymphodepletion strategy based on the use of Alis six was seven allows us to explore and determining the optimal window for aloe car T cell expansion and persistence in a variety of clinical settings.

Last week, we announced at our initial aloe fiber one data have been selected for an oral presentation at the virtual American Society of clinical oncology meeting later this month.

Oh Alpha Phase one trial began with a three plus three both escalation designed to evaluate the safety and efficacy of a range up sell doses as well that's different than for depletion regiments, that's very good dose of Alis six plus seven.

David D. Chang: Our Alpha Phase 1 trial began with a 3 plus 3 dose escalation designed to evaluate the safety and efficacy of a range of cell doses, as well as different lymphoid depletion regimens that vary the dose of LO647. Rafael will provide additional details on what to expect from the ASCO presentation. I would like to note that the ASCO Abstract, which has data as of January, will be released on May 13. The virtual presentation, which will be released on May 29 during ASCO, will include additional patients, including those treated with a higher dose of Allo647. On that day, we will host a conference call to review the data with you. We see this initial data as an important step towards realizing the potential of allogeneic CAR-T therapy.

Wow Rafael will provide additional details on what to expect from the asphalt presentation.

I would like to military ask abstract which has data as of January will be released on May 13, the virtual presentation, which will be released on May 29 doing ESCO will include additional patients, including those treated with a higher dose of Alis six plus seven.

On that day, we will host a conference call to review the data with you.

We see this initial data as an important step towards realizing the potential of allogeneic car T therapy.

Exactly two years ago. This week Allergan launched operations from the beginning we had been consistent you know goal to have allogeneic cell therapy, followed the success of collars car T therapy, while providing major benefits in time.

David D. Chang: Exactly two years ago this week, Allogene launched operations. From the beginning, we have been consistent in our goal to have allogeneic cell therapy follow the success of autologous CAR T therapy while providing major benefits in time, convenience, Reliability, and Scale. Our development strategy and trial design have been structured to make this goal a reality. However, there are some outstanding questions that only time and experimentation will answer. We are pleased with the progress we have made to date and look forward to sharing our study progress with you at ASK. Before I turn the call over to Raphael, I would like to say how proud I am of all 200 plus employees at Allogene Therapeutics who, despite working through their own personal challenges during these times, have remained unwavering in their commitment to allogeneic cell therapy. Rafael will now further update you on the research and development activities.

Convenience.

Liability and scale.

I will develop inside again trial designs have been structure to make this goal a reality.

While there are some outstanding questions that only hi, and expand patient will answer we are pleased with the progress. We have made to date and look forward to sharing our study progress would you at asphalt.

Before I turn to coal, but to Rockpile I would like to say how proud I am all 200, plus employees at Allergan, who despite working through a day on personal challenges. During these times have remained on laboring index commitment to allogeneic cell therapy.

Apparel will now uptake Jupiter on the research and development activities.

Thank you David and good morning, as David noted our phase one trials Brownlow five alone has continued to enroll patients, but we're looking forward to sharing the initial data from the outset trial and ask only 29.

Well the focus of any phase one dose escalation trial is appropriately on safety. We continue to use this trial us an opportunity to optimize clinical and translational outcomes using all of six or seven our anti cdtwenty body that allows us to customize lymphodepletion and provides us with unique differentiation from others in the field.

As a reminder to those less familiar with the conduct of have cell therapy trial, each patient and brought a new dose level must be safely treated on follow for the 28 day dose limiting toxicity or guilty window before additional patients in the cohort can be enroll a dose cohort kind of advanced to the next when every patient in that cohort has been.

Total for the 28, they DMT windows.

Also trial, while we waited clearance to move to higher sell doses, we took the opportunity to backfill patients into lower dose cohorts as such we enrolled a total of 11 patients across the city by city dose escalation portion of the study initial data from the cell dose escalation phase of the study which utilize the initial 39.

Rafael Amado: Thank you, David, and good morning. As David noted, our Phase I trials for ILO501 have continued to enroll patients, so we're looking forward to sharing initial data from this Alpha trial at ASCO on May 29. While the focus of any Phase I dose escalation trial is appropriately on safety, we continue to use this trial as an opportunity to optimize clinical and translational outcomes using ALOS647, our anti-CD52 antibody that allows us to customize lymphodepletion and provides us with unique differentiation from others in the field. As a reminder to those less familiar with the conduct of a cell therapy trial, each patient enrolled at a new dose level must be safely treated A dose cohort can advance to the next when every patient in that cohort has been followed for the 28-day DLT window.

I'm dose will follow six or seven what's included in our ASCO abstract.

Upon completion of initial cell dose escalation phase, we began to explore a higher doses of other 647, namely 90 milligrams.

As we continue to enroll patients into this portion of the trial Gasco NHL data will also include the first set of patients from the trial, who received at higher 90 milligram dose of politics for seven.

While we expect to have one month to month assistant data on these patients. We understandably will only have very limited follow up data on those patients treated with 90 milligrams of politics for seven.

We're often asked what boots obsessing to study looked like I believed that at this stage of the feel a wing not just for a program that for the allogeneic field, a large would be the ability to demonstrate unmanageable safety profile, including control over graphics associates need an understanding of how lymphodepletion them be optimized to achieve.

Expansion count persistence and even though there's it's not the purpose of a phase one trial the ability to demonstrate antitumor activity on follow car T cells.

Longer follow up will be required to ascertain the durability of any response.

Other important markets, including the pharmacokinetics of about six or seven that's of Lymphodepletion time to recovery of to patients D.. So I'm still not kinetics of out of fiber one are critical to optimize the repository regimen prior to sell infusion our translational oncology team is collecting data to evaluate these and other parameters.

We plan for ASCO presentation.

Intensity bond market evaluation efforts will also play a role in optimizing the olive fiber one any and I love 647 doses to be explore in the alpha to phase one and potential phase two pivotal trials.

A sufficient scientists it is really gratifying to see signs planning sell pilots as we investigate defend variable unseen nimble and I'll tell one studies.

Rafael Amado: In our alpha trial, while we awaited clearance to move to higher cell doses, we took the opportunity to backfill patients into lower-dose cohorts. As such, we enrolled a total of 11 patients across the 3-by-3 dose escalation portion of the study. Initial data from the cell-dose escalation phase of the study, which utilized the initial 39-milligram dose of ALO647, were included in our ASCO abstract. Upon completion of the initial cell-dose escalation phase, we began to explore higher doses of ALO647, namely 90 milligrams. As we continue to enroll patients into this portion of the trial, the ASCO initial data will also include the first set of patients from the trial who received the higher 90-milligram dose of Allo647. While we expect to have one-month tumor assessment data on these patients, we understandably will only have very limited follow-up data on those patients treated with 90 milligrams of ALO647. We're often asked what success in this study would look like.

We will leverage the flexibility we have on hand, as we finalize the design of they also do phase two study.

Our second clinical focus is on anti VCM eight aloe car T cell therapy for the treatment of relapse refractory multiple myeloma.

We have created a robust clinical strategy to address these field centered around the use of all of seven one size Universal our phase one trial with all of sudden one five continues to actively coolant treat patients. This trial will also explore ultimate doses of all components of building for the treatment regimens, including almost six or seven.

Moving on cycle faults in mind.

We will be a second endpoints, such a safety tolerability depth and duration of Lymphodepletion cell expansion and anti tumor activity ASCII determinants of success for Adler said along fine.

Right on track to report initial data from the striving to fourth quarter. This year.

Our untied became a program will also investigator, let's say the one five in combination with investigational Gamma Secretase inhibitor and you know gas is that in collaboration with spending works, we have finalized the protocol and submitted it for regulatory discussion before initiating the combination study currently planned for the second half of this year.

Last week, we issued a press release announcing that we would present preclinical findings that support our turbo car technology at the virtual American Society of gene and cell therapy annual meeting on May 12.

As we have recently unveil discern leg of our Bcm make strategy involves started internally developed harbor car technology, which allows cytokine signaling to be engineered selectively into the car T cells.

In preclinical models sort of a car enhance the efficacy delay exhaustion and reduced aloe car T cell dose requirement. So real cost can be Taylor, we signaling domains from different set of kind receptors designed to enhance T cell expansion activation and persistent.

Rafael Amado: I believe that at this stage of the field, a win, not just for our program, but for the allogeneic field at large, would be the ability to demonstrate a manageable safety profile, including control over graft-versus-host disease, an understanding of how lymphodepletion can be optimized to achieve cell expansion and persistence, and even though this is not the purpose of a Phase I trial, the ability to demonstrate antitumor activity of Longer follow-up will be required to ascertain the durability of any response.

The results of these preclinical study demonstrates that this approach would also mini much potential safety risk associated with it. So as you know set up and administration, which unlike took what car technology will stimulate not only Dane Guinea on car T cells, but also the endogenous immune cells, which are pressing thing far greater numbers.

In many ways through a car T technology. It simplifies the innovation, we can introduce we gene engineering insulin therapy.

Well look forward to continuing to advance is technology, starting with our first durable Corticon did I love sick. So five a bcm made directed car T therapy for multiple myeloma, we anticipate submitting an eye indeed for aloe six so finding twentytwenty. One we are very excited about the potential of this technology to enhance.

Rafael Amado: All the recorded markers, including the pharmacokinetics of ALO647, depth of lymphodepletion, time to recovery of the patient's T-cells, and cellular kinetics of ALO501, are critical to optimize the preparative regimen prior to cell infusion. Our translational oncology team is collecting data to evaluate these and other parameters as we plan for our ASCO presentation. Our intensive biomarker evaluation efforts will also play a role in optimizing the ALO501A and ALO647 doses to be explored in the Alpha 2 Phase 1 and potential Phase 2 pivotal trials. As a physician scientist, it is really gratifying to see science playing itself out as we investigate different variables in the ongoing Alpha-1 study. We will leverage the flexibility we have on hand as we finalize the design of the Alpha 2 Phase 2 study.

By myeloma effect.

Lastly, we have been able to continue to progress has preclinical work on the Galaxy one six our anti Cdseventy program has our next Aloe Party clinical candidate. This work is critical as we look towards bridging use of cell therapy from hematologic malignancies into solid tumors.

As we all know despite grain advances in cancer therapeutics, most metastatic solid tumors are not curable and they represent areas of high unmet medical need.

Our outlook to one six I. Indeed that is planned by the end of this year will be for the treatment of renal cell carcinoma with other malignancies plans in the future.

I remain very excited with the strong momentum of both at least programs and we look forward to providing initial clinical results very soon.

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

Thank you referral and good morning. In addition to the brief financial overview I will provide on the call. Today you can read additional details on our first quarter in our press release issued earlier today and in our 10-K, which will be filed with the FCC.

We continue to maintain a strong financial position with cash cash equivalents and investments totaling $553 million as of March 30, Onest Twentytwenty.

In the first quarter, our research and development expenses were $42 million, which includes $6.6 million noncash stock based compensation expense.

Rafael Amado: Our second clinical focus is an anti-BCMA alocartis cell therapy for the treatment of relapsed refractory multiple myeloma. We have created a robust clinical strategy to address this field centering around the use of ALO715. Universal, our phase one trial with ALO715, continues to actively accrue and treat patients. This trial will also explore optimal doses of all components of the lymphodepletion regimen, including ALO647, fludarabine, and cyclophosisphamide. We will be assessing endpoints such as safety, tolerability, depth and duration of lymph depletion, cell expansion, and antitumor activity as key determinants of success for ALO715. We're on track to report initial data from this trial in the fourth quarter of this year. Our anti-BCMA program will also investigate ALO715 in combination with the investigational gamma secretase inhibitor neogassistab in collaboration with SpringWorks. We have finalized the protocol and submitted it for regulatory discussion before initiating the combination study currently planned for the second half of this year.

General and administrative expenses were $15.6 million for the first quarter of Twentytwenty, which includes $7.6 million should noncash stock based compensation expense.

Our net loss for the first quarter of Twentytwenty was $54.5 billion.50 per share, including noncash stock based compensation expense at $14.2 million.

In an FCC filing in late March we stated that construction of our G.M.T. cell manufacturing facility and newer California had been interrupted due to cope with 19 pandemic I'm pleased to report that we've been able to initiate construction work. While we are continuing to evaluate the situation. We currently do not expect this temporary disruption to.

Significantly affect our plans to bring the manufacturing facility online in Twentytwenty one.

As we've been able to continue with our research and development plans as well as the Buildout of our Newark manufacturing facility. We continue to expect that our full year Twentytwenty net losses will be between 260 million and $280 billion. This 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 open the call to your questions.

Ladies and gentlemen.

You asked the question you will need to press star one on your telephone to withdraw your question press the pound key please standby, we compile the Q and a roster.

Our first question comes from Salveen Richter with Goldman Sachs. Your line is now open.

Good morning, and thanks for taking my question, so with regard to the fiber one day that that's going to be presented at ASCO.

Just go over those numbers again, let me talk about preliminary data from the first nine patients and then 11 across the three by three I'm. So how should we think about the totality of data and with regard to machine data on patient per cohort I can one month or two months, how do we think about terrific.

Rafael Amado: Last week, we issued a press release announcing that we would present preclinical findings that support our TurboCard technology at the Virtual American Society of Gene and Cell Therapy annual meeting on May 12. As we have recently unveiled, the third leg of our BCMA strategy involves our internally developed TurboCard technology, which allows cytokine signaling to be engineered selectively into the CAR T-cell. In preclinical models, TurboCard enhanced the efficacy, delayed exhaustion, and reduced alocard T-cell dose requirements. Thoroughbred CARs can be tailored with signaling domains from different cytokine receptors designed to enhance T cell expansion, activation, and persistence. The results of this preclinical study demonstrate that this approach could also minimize potential safety risks associated with exogenous cytokine administration, which, unlike turbo CAR technology, will stimulate not only the engineered CAR T cells but also the endogenous immune cells, which are present in far greater numbers.

Ladies here and then comparing your your dataset versus the Tal I guess programs that we've seen to date and I have a follow up.

Alright tied up in this has stayed chains good morning, and I hope you're doing well. So let me take your first question and this is one of the questions said, we get asked a lot about what to expect did ask though as certainly me you know we're not going much into the details of the presentation, we're trying to provide us.

Much inflammation as possible. So what we have previously said it is in February is that we have completed a dose escalation and that included a minimum nine patients that had been treated.

Well you know we were conducting the dose escalation bill opportunity to put additional patients on previously treated and.

Cleared dose levels and this is really trying to address the site need as well as patients who become available while we recreating the studies. So in terms so let to be what will be included in the abstract that will come out in couple of weeks is.

The first nine patients I'm, sorry, first nine patients.

You know treated and that is from more than nine patients were enrolled to fill a couple of patients who are still waiting to be treated at the time of the data cut off so that nine patients would essentially be you know people who were treated the first two dose levels as well as beginning of the third.

And the final dose escalation up the self said, we will testing as the initial design a initial plan.

Rafael Amado: In many ways, TurboCAR-T technology exemplifies the innovation we can introduce with gene engineering in cell therapy. We look forward to continuing to advance this technology, starting with our first TurboCard candidate, ALO605, a BCMA-directed ALOcard T therapy for multiple myeloma. We anticipate submitting an IMD for ALO605 in 2021.

Hopefully that answers your question.

Yes, and then how should we think about you know in the context of getting one month to month of data per cohort how should we think about your ability here and in overall just comparing this to the existing autologous data.

Yeah. So your ability is another question that we got asked a lot. This is a phase one study that have been carried out. So obviously there are patients were treated really on we'll have a longer come fall off and I wish I should really remind that the real question around the durability.

Should be at the cell dose and the Lymphodepletion dead, we finalized Oh, you know for the phase II that will be the real comparison as we go forward as much of their earlier sell doses will essentially those exploration as well as the Lymphodepletion do we started with a 39 milligrams of.

Eric Schmidt: We are very excited about the potential of this technology to enhance anti-myeloma effects. Lastly, we have been able to continue to progress our preclinical work on ALO316, our anti-CD70 program, as our next ALO-CAR-T clinical candidate. This work is critical as we look towards bridging the use of self-therapy from hematologic malignancies into solid treatment. As we all know, despite great advances in cancer therapeutics, most metastatic solid tumors are not curable, and they represent areas of high unmet medical need. Our ALO316IND that is planned by the end of this year will be for the treatment of renal cell carcinoma, with other malignancies planned in the future. I remain very excited with the strong momentum of both elite programs, and we look forward to providing initial clinical results very soon. I'd like to now turn the call over to Eric to review our financials.

Alis six or seven I mean that is the beginning of the Lymphodepletion as you know we have gone up owned or not the six foot $7 to the 90 milligrams. So when you think about all these in the context of the data to be looked at yes. Some of the early cohort you'll have a longer follow up the really relevant dose level.

Has been treated sometime.

This year so from that patients.

The income to follow up and Rockpile has said in his prepared statement.

Got a lot will be relatively short and certainly we will include one month data, but there will be the limits of the presentation.

And David maybe just one follow up question too with regard to your other programs can you talk about the Lymphodepletion regimen, you're using in those programs versus 501, and whether there are other optimization leverage maybe playing with.

Yes, so the way that we think about optimizing as we prepare the fiber one program into the phase two.

And there will be done would apply the one eight that lacks the be tough and switch is really the three levers that we can play with stem cell dose lymphodepletion and we haven't talked much about it but potentially we dosing.

In total so [noise].

Operator: Thank you, Raphael, and good morning. In addition to the brief financial overview I will provide on the call today, you can read additional detail on our first quarter in our press release issued earlier today and in our 10-K, which will be filed with the SEC. We continue to maintain a strong financial position with cash, cash equivalents, and investments totaling $553 million as of March 31, 2020. In the first quarter, our research and development expenses were $42 million, which included $6.6 million of non-cash, stock-based compensation expense. General and administrative expenses were $15.6 million for the first quarter of 2020, which included $7.6 million of non-cash, stock-based compensation expense. Our net loss for the first quarter of 2020 was $54.5 million, or $0.50 per share, including non-cash stock-based compensation of $14.2 million.

Lymphodepletion.

This is really dealing with a patients immune system.

As we tried to keep the the union. So they can potentially lead to early rejection of our car T cells summit at Bay to allow the other car T cells to expand and persist and carry out anti tumor activity. So there is a little bit of the patient component.

Depending on a different indications how they get treated in the first second line to see that affects the patients overall union system. So there is a little bit of variability that we have to consider as we think about different indications, but overall, we are doing more than one program.

I'm at a time US right now we're starting both fiber one and 715 in non Hodgkin's lymphoma in multiple myeloma and we're trying to leverage the learnings from each study as we try to further narrowed down to Lymphodepletion. So there is a lot of between the study data comparison as we tried to Uh huh.

Tonight to Lymphodepletion.

And once we get to the final decision pulling you know we will know whether the lymphodepletion of course different indications will be all uniform, but there may be some differences in how we exactly lymphodepletion.

For different programs.

Thank you.

Thank you. Our next question comes from Biren Amin with Jefferies. Your line is no.

Yeah, Hi, guys. Thanks for taking my questions and hope you're all things see dozens of fiber one data at ASCO I think in the prepared remarks. There was some mentioned that the lower you guys back filled some more patients on the lower doses and I think David you also mentioned that you might have you know a couple more patients.

The three required in the lower doses. So just wanted to try to understand what drove this did you see any you no dose limiting talks or events in some of the patients in the lower doses, which which drove that or was it something else and then I guess what sell doses are you administering with the higher 90 milligram.

Operator: In an SEC filing in late March, we stated that construction of our GMT cell manufacturing facility in Newark, California, had been interrupted due to the COVID-19 pandemic. I am pleased to report that we have been able to reinitiate construction work. While we are continuing to evaluate the situation, we currently do not expect this temporary disruption to significantly affect our plans to bring the manufacturing facility online in 2021. As we have been able to continue with our research and development plans, as well as the buildout of our Newark manufacturing facility, we continue to expect that our full year 2020 net losses will be between $260 million and $280 million. This includes an estimated non-cash stock-based compensation expense of $70 million to $75 million and excludes any impact from potential business development activity.

I'm all for depletion six where somebody else.

Okay, appearing in let me take that question because its a.

Are you asking many different things into same questions.

Tom So the simple thing that I wanted just clear is that when we were doing dose escalation.

The process of goals escalation in the cell therapy study is huge fleet one patient.

So each dose level and then make sure that that patient completes the so called the dose limiting toxicity window or DLP window, which will take about 28 days.

And once the person clears without any safety findings, we open up the dose level for the remainder of the patients.

And when the last patient in the dose level is tested again, we wasteful at 28 days before we clearing the doors and move on to the next dose level.

And the when you start to next dose level at the same process starts the game, which means that in terms of patients who can going to study, especially when you have multiple sites open.

Can close on logistical issues, where patient may become available, but there may not be any slots.

We accommodated the site need as well as bill the patients who a war eligible to receive the treatment by putting those patients in dose level that have already been cleared and now let's say this is a theory standard practicing any phase one dose escalation study just to ensure that the patient and site.

Needs are met during the study so that's how we carried out the phase study and then your second question around the safety and others are these are somewhat the questions that we get asked.

Let me reiterate the phase one study the purpose of the phase one study was to evaluate the safety of our sell as well that's lymphodepletion regimen as well as a really testing different lymphodepletion alleged regimen to make sure that we can allow.

Operator: With that, we will now open the call to your questions. Ladies and gentlemen, to ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound key.

No window for the cells to expand and carry out anti tumor effect.

Very important question, but we are so close to the ask school presentation coming up later this month and at this point. We told you said I would be for some of your questions run the safety and any other things to the actual presentation.

Salveen Jaswal Richter: Please stand by while we compile the Q&A roster. Our first question comes from Salveen Richter with Goldman Sachs. Your line is now open.

Okay, and if I could have maybe a follow up on alpha too, which is supposed to start eminently what learnings have you been able to incorporate from the Alpha study. So you know on cell dose and Lymphodepletion I guess has that informs your design for Alpha too and then I guess are you able to.

Salveen Jaswal Richter: Good morning, and thanks for taking my question. So with regard to the 501 data that's going to be presented at ASCO, could you just go over those numbers again? You talked about preliminary data for the first nine patients and then 11 across the three-by-three, so how should we think about the totality of data? And with regard to seeing data on patients per cohort for up to one month or two months, how do we think about durability here, and then comparing your dataset versus the autologous programs that we've seen to date? And I have a follow-up.

The to translational data better identify donors for alpha to where you can optimize cell product.

[noise] so.

Fiber one may just to remind everybody.

The one difference between fiber one and fiber one a is the removal of the cuts to the switch which allows the fiber one needs to be potentially using a much wider patient population.

In the in lymphoma indication so from that perspective, the C close out the car itself hasn't really changed so essentially.

Yeah that nature of the construct as well as all the preclinical studies that we have done before we cleared I can be indicates that these two.

David D. Chang: All right, Salveen. This is Dave Chang. Good morning, and I hope you're doing well.

Products fiber, one and fiber one a should behave in almost identical way.

However, as you know what we find in the preclinical studies and well be fine in the clinical situation, maybe little bit different.

David D. Chang: So, let me take your first question. And this is one of the questions that we get asked a lot about what to expect at ASCO. And certainly, you know, without going much into the details of the presentation, we're trying to provide as much information as possible. So, what we have previously said in February is that we have completed the dose escalation. And that included at least nine patients that had been treated. While we were conducting the dose escalation, there were opportunities to put additional patients on previously treated and cleared dose levels. And this is really trying to address the site need as well as the patients who become available while we are recruiting the studies. So in terms of what will be included in the abstract that will come out in a couple of weeks, it is the first nine patients, I'm sorry, first nine patients treated, and that is from more than nine patients who have been enrolled.

And as part of the normal well control.

Study conduct we just want to confirm well be so in the fiber one in the fiber one a program. So we have previously said that we will conduct an abbreviated phase one.

And just putting adding to that we have also said that.

In the fiber one we tested the cell dose or doses from 42 360 million cells and at that time. We also said that we do not see the need to test any other cell dose is outside the book can range from 40 to 360 that we have tested so that's more or less the range and.

Certainly as fiber one hey study gets activated this quarter will provide more details on the study design, but.

Let me just stopped there I just want to sort of be cognizant, though you know sort of tiny and release of inflammation and not to stay in that nothing little bit ahead of it.

And then.

And can you just remind me the second question that you asked.

Yeah, well there on on translational data from the alpha patients that were treated whether you're able to better identify.

The donors are optimized fall product for Alcatel.

Yes that is on an ongoing effort. So the question really is said I think we and others and this is probably sometime ago.

David D. Chang: There were a couple of patients who were still waiting to be treated at the time of the data cut out. So those nine patients will essentially be people who are treated at the first two dose levels as well as the beginning of the third and the final dose escalation of the cells that we were testing as the initial design and initial plan. Hopefully, that answers your question.

Definitely have noticed at between different owners there were some variability in how cells.

You know expand during the manufacturing process and that's understandable everyone's cells are slightly different and there can be some differences.

Our fundamental approach towards that kind of variability is trying to understand some of the characteristics. So that we can adjust the manufacturing process. So the manufacturing process itself.

Salveen Jaswal Richter: Yes, and then how should we think about, you know, in the context of getting one month to two months of data per cohort, how should we think about durability here and, overall, just comparing this to the existing autologous data?

Addresses the variability that comes from the different donors and that's more or less how we approaching it and these kind of analysis as she may have guessed requires more than few samples I mean, you were looking at the trend up very complex.

You know differences in the in individuals I mean, you're talking about.

Potentially age of the go under the effects of the daughter and whether the person. They have had you know infections.

David D. Chang: Yeah, so durability is another question that we get asked a lot. This is a Phase I study that was carried out, so obviously, the patients who were treated early on will have a longer-term follow-up, but I should really remind you that the real question around durability should be at the cell dose and the lymphodepletion that we finalized for Phase II. That will be the real comparison as we go forward, as much of the earlier cell doses were essentially dose exploration, as well as the lympho-depletion that we started with the 39 mg of ALS647, and that was the beginning of the lympho-depletion. As you know, we have gone up on the ALS647 dose to 90 mg. So when you think about all this in the context of the data to be looked at, yes, some of the early cohorts will have had longer follow-up. The really relevant dose level has been treated sometime this year, so from that patient. In terms of follow-up, as Rafael has said in his prepared statement, the follow-up will be relatively short, and certainly we will include one-month data, but there will be limits to the presentation.

Good anybody would normally get you know before they donated sounds I think all these things back right. So it is an effort that will take the time, but we are well underway characterizing each of these cats.

Correct.

The manufacturing process. So it is.

Not a in a simple endeavor to really pulling out you know what leads to some differences that we see.

Okay, great. Thanks for taking my questions.

Thank you.

Our next question comes from Cory Kasimov with JP Morgan Your line is now open.

Hey, guys. Thanks for taking my questions on the says I'm asking for Corey So I guess in regard to.

The trial and I understand you can't say much about the details of that kind of read out, but how should we thinking about how different NHL sub types enrolled into the study might affect interpretation of the initial results.

So Matt Thanks for that question I think your question underlie seem to affect that within the large cell lymphoma or or so called the aggressive non hodgkin's lymphoma Dara to sort of you know differences I know one patients who have early progression.

After transplantation.

For patients who have we frac fleets are going to last line of chemotherapy. So I mean, there are some differences, but I think over a period of time you know we're learning that.

Especially when it comes to the initial responses there isn't that much difference and I should just also and then in our phase one study given the learnings that's coming from Doe accomplice car T therapy. We also included nuts as.

Relapsed refractory large cell lymphoma, but also the patients with the so called indolent lymphoma, who have relapsed after multiple lines of therapy. So there will be some patients who belong in that.

Sub types of non Hodgkin's lymphoma. So.

But keep in mind.

Salveen Jaswal Richter: David, maybe just one follow-up question, too, with regard to your other programs. Can you talk about the lymphodepletion regimen you're using in those programs versus 501 and whether there are other optimization levers you may be playing with?

The purpose of phase one is as I previously said no safety.

Lymphodepletion in early life, so that's a could see but from that perspective.

I don't think there will be much impact on a patient's tumor sub types, you talked about ability to analyze those.

Key inflammation.

Great. That's super helpful. And then I guess in terms of the nine patients that we'll get an abstract should we expect to get at a pretty dosing data.

David D. Chang: Yeah, so the way that we think about optimizing as we prepare the 501 program for phase two, and then we'll be done with a 501A that lacks the reduction switch are really the three levers that we can play with. The cell dose, lymphodepletion, and we haven't talked much about it, but potentially, we dose In terms of lymphodepletion, this is really dealing with a patient's immune system as we try to keep the immune cells that can potentially lead to early rejection of allocar T cells somewhat at bay to allow the allocar T cells to expand and persist and carry out anti-tumor activity. So there is a little bit of patient components, depending on different indications, how they get treated in the first and second line. Obviously, that affects the patient's overall immune system. So there is a little bit of variability that we have to consider as we think about different indications. But overall, we are doing more than one program at a time.

We don't saying is an amendment that we made later on the study and.

But as I said as we have said in the prepared statement the data cut off for the abstract was.

January and that is before the amendment came in effect so.

That won't be any resulting into first.

And they won't be any read dosing information in the abstract.

Okay got it that's helpful too and then I guess just maybe one last question for me I'm just thinking about this more from a high level, but how do you think cope at 19 pandemic will change Carty clinical development in the near to medium term.

Great question.

In the first of all.

We are trying to understand how the Corbett 19 pandemic will play out I mean, I think we just slipped to the early phase I mean, essentially you're talking about since.

End of February pill, what is now you know sort of early part of May So we have about a lot.

Little over two months that experience.

Within this.

Limited experience I mean, we know what we can do.

Which is controlling our own internal activities, making sure that the supply chain is not interrupted and Fortunately in our case Oh, we do have the luxury of building up inventory of car T cells. Debited, you can use to clinical studies. So from the things that we can control I think.

We are in pretty good shade.

Things said, we have to react to is what happens when an external environment.

Alluding how the hospital. So this is going beyond what the investigators may do about the hospitals due to the clinical studies as they sometimes prepare for the surge of patients. So there's a lot of different variables.

However, if the things some more or less play out the way that we have experienced over the last two month.

Salveen Jaswal Richter: Right now, we are studying both 501 and 715 in non-Hodgkin's lymphoma and in multiple myeloma, and we are trying to leverage the learnings from each study as we try to further narrow down the lymphodepletion mechanism. So there is a lot of data comparison between the studies as we try to optimize the lymphodepletion. And once we get to the final decision point, we will know whether the lymphodepletion, of course, different indications will be all uniform, or there may be some differences in how we exactly lymphodeplete for different programs.

I'm, hoping as well as you know this is hoping as well as based on the information that we have the play.

Studies that we are planning in large part a will not be affected to will not be affected by cold it.

Great. That's helpful. Thanks for taking my question.

Thanks, Cory Thanks, Matt sorry.

Thank you, ladies and gentlemen, and the interest of time and in order to accommodate as many questions as possible. We ask that you. Please limit yourself to one question.

Our next question comes from Mark from Cowen and company. Your line is now.

Yes, thanks for taking my questions.

Building on one of your prior answers David you mentioned over the.

Of course of this trial early on some of the struggles finding patients.

Who had been on offer TACNAV long enough to to enroll and you know that's kind of the driving force for Oh, five on a and now Kobe potentially can.

Highlighting the need for enough and auto can move from an auto to an album product. So should we think how should we think about kind of shifting patient populations over time, either in terms of some of the baseline you hear the disease type like you mentioned earlier or other baseline characteristics that you can do impact safety or efficacy things like your tumor burden and things like that.

Byron Ami: Thank you. Our next question comes from Byron Ami with Jefferies. Your line is now open.

Byron Ami: Yeah. Hi guys. Thanks for taking my questions and hope you're all staying safe. Just on the 501 data at ASCO, I think in the prepared remarks, there was some mention that you had backfilled some more patients on the lower doses. And I think, David, you also mentioned that you might have a couple more patients than the three required in the lower doses. So I just want to try to understand what drove this. Did you see any dose-limiting toxic events in some of the patients in the lower doses, which drove that, or was it something else? And then, I guess, what cell doses are you administering with the higher 90 milligram lymphodepletion 647 dose?

So let me.

I understand the question.

So as I.

So I use sort of asking whether the patient population will shift because of the Corbett and Danny.

Well the because of the pandemic are also just your initial population here should we think about you know those maybe being more follicular patients that might be able to be off we're talking about early on but then maybe later you're getting more very high burden very sick patients later now as you know covert just kinda impacting enrollment in the broad.

Our karkhi space.

Yes so.

Turning in Phase one you know I will experience.

You know in concert with enrolling very limited number of patients. It doesn't give you much larger view of whether there will be differences in the patient population, but that's not said.

The benefits of the pilots car T. I think it's becoming apparent lettuce and or not.

Under diffuse large b cell lymphoma, but also.

In other England sub types as well so from that perspective, the shifting up the patient population. If it occurs I don't really see that becoming an issue. But this is also a topic that could be addressed by the study design. We're doing phase one study does seem to phase.

David D. Chang: Okay, Barron, let me take that question because it's, you know, you're asking many different things in the same question. In terms of, you know, the simple thing that I want to just clear is that when we were doing those escalations, the process of dose escalation in the cell therapy study is you treat one patient at each dose level and then make sure that that patient completes the so-called dose-limiting toxicity window, or DLT window, which will take about 28 days. And once a person clears without any safety findings, we open up the dose level for the remainder of the patient. And when the last patient in the dose level is tested again, we wait for 28 days before we clear the dose and move on to the next dose level.

The study, we Wanna get as much information as possible, but as we move towards small pivotal study, especially with a current plan of conducting a people to study as a single arm study with a limited number of patients.

That's in the range of 7200, there will be some further refinements patient population. So we can interpret the data properly from a single arm study.

Okay and then you also on some of the comments about the interruption to the in house manufacturer sodium in Newark. The construction is just can you remind is kind of where you stand in terms of manufacturing doses for the duration of the phase one trials for let's see 19 and be cama and your readiness.

Advance into phase, two and what you need that manufacturing facility for.

Yes, so no we have previously sort of.

You know made it very clear dead right now we are still dependent on the contract manufacturer for the clinical supply and our plan is to shift that dependence.

Who is something that we can control by bringing in the clinical supply manufacturing in house and that is planned to be done in New York and the timeline that we are working towards is.

Completing the construction and after the physical structure of the manufacturing facility is time, there's a lot of work that needs to be done, but essentially we are working towards getting the.

I will all manufacturing facility come on line to produce clinical materials sometime in 2021.

David D. Chang: And then when you start the next dose level, the same process starts again, which means that in terms of patients who can go on to study, especially when you have multiple sites open, it can cause some logistical issues where a patient may become available, but there may not be any slots. We accommodated the site need as well as the patients who were eligible to receive the treatment by putting those patients in levels that had already been cleared. And I would say this is a very standard practice in any phase 1 dose escalation study, just to ensure that patient and site needs are met during the study. So that's how we carried out the phase study. And then your second question about safety and others; these are some of the questions that we get asked.

So you know as Eric has commented that disruption for a short period of time that occurred.

Occurred after the of course dependent and we don't expect that to significantly affect or plans to bring the site to start producing the clinical materials.

Okay, great. Thank you.

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

Hey, good morning, guys, and all law or trends like what the trend here and actually limit myself to one question.

They they quick one on maybe maybe directed at Rafael I'm wondering if you're expecting substantial variability in baseline levels of the talks about in the Alpha trial patients and will this be a parameter that will be reported as part of Gasco dataset. Thank you.

Yeah, Yeah, Hi, Mark Thanks for the question on it it's been a an important question that pertains only four to the probably the one that's you know obviously and probably about one a that won't be an issue. We have seen fortunate to good enough patients that either we're not overdone.

David D. Chang: Let me reiterate that the phase 1 study, the purpose of the phase 1 study was to evaluate the safety of our cell as well as the lymphodepletion regimen, as well as really testing different lymphodepletion regimens to make sure that we can allow enough windows for the cells to expand and carry out anti-tumor effects. Very important question, but we are so close to the ASCO presentation coming up later this month. And at this point, with all due respect, I would defer some of your questions around safety and any other things to the actual presentation.

Some of our they have I'd be nobody talks and not for greater than six to nine months.

Another patients that had we seek to sooner.

In those patients if they had a level.

So Bob City.

Oh.

We would oh allow that basin to lobby for uses for a total of three increases and that should be the level below one Mike or unparallel, which is really be allowed a level.

We actually haven't had too many problem. So getting these kinds of patient of course, the king patients a hobby talks about two months before and we knew that bluff mcaleese's wasn't going to bring the level and those patients have to wait so I'm getting to therapy and then came later some went onto other therapy, but.

Byron Ami: Okay, and if I could have maybe a follow-up on alpha-2, which is supposed to start imminently. What learnings have you been able to incorporate from the alpha study? So on cell dose and lymphodepletion, I guess, has that informed your design for alpha-2? And then, I guess, are you able to, through translational data, better identify donors for alpha-2 where you can optimize cell product?

I say, even though they are appeared to be an important hurdle.

Investigators were able to select the right patient than we've been able to.

Overcome is problem and in fact, we haven't had to a freeze too many beijing. So it's being it's been a hindrance reluctantly model one.

David D. Chang: So 501A, just to remind everybody, the one difference between 501 and 501A is the removal of the Rituximab switch, which allows the 501A to be potentially used in a much wider patient population in the lymphoma indication. So from that perspective, the sequence of the CAR itself hasn't really changed.

Okay. That's very helpful. Thanks for taking my question.

Okay.

Thank you. Our next question comes from Alexander Duncan with Piper Sandler Your line is now open.

They are glad to hear everyone is doing well and thanks for the question.

First.

A quick follow up on previous questions at ASCO will you be providing lot information on which manufacturing runs from which each alpha patient was treated.

Then on the Turbo car strategy can you explain that thought process behind advancing the first clinical candidate in myeloma as a follow on to seven one fives as opposed to Hello, everyone, six and renal or even develop a turbo card candidate as the lead program in RCC given the potential for that.

David D. Chang: So essentially, the nature of the construct, as well as all the preclinical studies that we did before we cleared the IND, indicates that these two products, 501 and 501A, should behave in almost identical ways. However, as you know, what we find in the preclinical studies and what we find in the clinical situation may be a little bit different. And as part of the normal well-controlled, you know, study conduct, we just want to confirm what we saw in the 501, in the 501A program. So we have previously said that we will conduct an abbreviated phase one. And just adding to that, we have also said that in the 501, we tested cell doses of 40 to 360 million cells. And at that time, we also said that we did not see the need to test any other cell doses outside the bookend range of 40 to 360 that we have tested. So that's more or less the range.

Technology in solid tumors. Thanks, so much.

So, let's let me take the first question and I'll ask cross sell to answer. The second question. You know income sub lot information I think as I previously said, we're getting very close to ask also.

Probably it's best to refer to the actual presentation Rafael second question.

Yeah, I mean, we are really excited about the Turbocord technology.

What we've seen the preclinical work really tells us that ER themselves can remain last exhausted or onyx shelf set for a long Peter just tying it can divide they can.

Proliferate up on encountering onto young so we think that.

He has a lot of promise and of course is gonna be that's the first thing. We became they are in may have a lot of promise in solid tumors and indeed, we are working on the optimal turbo cars. As you know the technology allows <unk> to a use different insider buying a good thing.

Gate 50, well to trigger inside of kind of signal. So we are the moment walk you know what would be the optimal one to insert into our our programs, particularly cdseventy and D. L three or they need show I in d. wouldn't be week, how it but.

Byron Ami: And certainly, as the 501A study gets activated this quarter, we'll provide more details on the study design, but let me just stop there. I just want to sort of be cognizant of, you know, sort of, timing and release of the information and not just be a little bit ahead of it. And then, Baron, can you just remind me of the second question that you asked?

I do not expect that one containing a site up they are well a lot much behind us and get all depend obviously on what we find preclinically bad, but a pretty excited but the potential of ER to vote cars in solid tumors.

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

[noise] other good morning, and thanks for taking my question. So my question is regarding Atlas six or seven I'm just curious.

David D. Chang: Yes, whether on translational data from the alpha patients that were treated, whether you're able to better identify the donors. The donors are Optimized Cell Product for Alpha-2.

Going forward here well you have the opportunity to test dosing Alis 647 on its own.

Lymphodepletion agent.

David D. Chang: Yes, that is an ongoing effort. So the question really is that we and others, and this was probably some time ago, definitely noticed that between different donors there was some variability in how cells expanded during the manufacturing process. And that's understandable. Everyone's cells are slightly different, so there can be some differences. Our fundamental approach towards that kind of variability is trying to understand some of the characteristics so that we can adjust the manufacturing process. So the manufacturing process itself, you know, addresses the variability that comes from the different donors. And that's more or less how we are approaching it.

Perhaps after.

The initial live for depletion in combination with chemotherapy just curious if that's the strategy that I'm still here considering going forward. Thanks.

[music].

Hi, John Good morning, let me take that question.

Now lets six plus seven neenah as a anti CD 52 anybody that it's a great Asian for Lymphodepletion did it selective.

Also spears, our own Aloe car T cells, because we added a CD 52.

And we effectively leveraging the strength that comes from the uniqueness. So that was six full seven based lymphodepletion.

Tom So your question, whether six plus seven can do it alone that is a great question and certainly that is something that we internally discuss.

Oh frequently.

The you know how to do that I think that is a step wise process said, we'll be taking Oh first making sure did we get to the adequate Lymphodepletion and then start test can testing what did dip nonspecific chemotherapy is really necessary for lymphodepletion. So it is in the plan, but the question.

So we'll take a little kind, but definitely something that we are very interested in [noise].

Okay. Thank you.

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

David D. Chang: And these kinds of analysis, as you may have guessed, require more than a few samples. I mean, you know, you are looking at the trend of very complex differences in individuals. I mean, you're talking about the potentially age of the donor, the sex of the donor, and whether the person may have had, you know, infections that anybody would normally get, you know, before they donate themselves. I think all these things factor in. So it is an effort that will take time, but we are well underway, characterizing each of these, you know, parameters. Thank you.

Hi, guys. Thanks for taking my question is just one more on out of 5.1 I know that the main focus here is on the optimizing lymphodepletion, but it gets David what gives you comfort that you actually opposite Max at the right Philadelphia at this point that you don't need further dosing.

Okay on that front.

Yes so.

In terms of Lymphodepletion I mean, one other things that we can look at better you really on it up.

[noise] did the reduction in the absolute lymphocyte count as well as time before the T cell also NK cells. So a b cell starts coming back I mean, that's essentially the definition of the lymphodepletion and duration of Lymphodepletion or time to that sounds recovery that we had in talking about so.

Oh from that aspect, we can get pretty early read on how different changes that we introduced into their lymphodepletion can actually translate into a you know what we're looking for in Tom So how to put that into context of cell dose. That's a great question you know the south therapy is up theory.

Corey Kasimov: Okay, great. Thanks for taking my questions. Thank you. The next question comes from Corey Kasimov with J.P. Morgan. Your line is now open. Hey, guys, thanks for taking my questions. And this is Matthew for Corey.

It's sort of dynamic therapy in many ways, we learned that too in the conduct of autonomous car T therapy, essentially how the Celtics spend is a multifactorial process to body episodes. The antigen density kind of get density or the tumor burden in patients as well as.

Corey Kasimov: So I guess in regard to the alpha trial and understand that you can't say much about the details of the upcoming readout, but how should we be thinking about how different NHL subtypes enrolled in the study might affect the interpretation of the initial results?

Lymphodepletion that allows still homeostatic changes the cytokine and promote the south expansion. So there are many different things that we're looking at that's one of the reasons that we emphasized looking at the translational parameters to make this decision and this is something that we have some experiences and optimize.

David D. Chang: So, Matt, thanks for that question. I think your question underlies the fact that within large-cell lymphoma or the so-called aggressive non-Hodgkin's lymphoma, there are two sorts of, you know, differences. And one, you know, patients who have early progression after transplantation or patients who are refractory to the last line of chemotherapy. So, I mean, there are some differences. But I think over a period of time, you know, we are learning that, especially when it comes to initial responses, there isn't that much difference.

Moving and deciding and moving forward and all that experience that comes from having worked on autonomous car T will also affect rain as we you know lock in the final two kilometers mainly the lymphodepletion regimen and the cell dose the cell dose as you said the dose range has been defined cutting fully increased 60 and certainly that's.

The range than we have playing right now.

Okay. Thanks, and just a high level question about the strategy longer term in multiple myeloma.

We now have at least three programs that that you're working on 71, five the gamma Secretase inhibitor combination that and also I was six so five I guess has now been seeing how should we think about this strategy here are you planning on moving several programs Colbert you know in parallel are you out you know for example.

David D. Chang: And I should also add that in our Phase I study, given the learnings that are coming from the autologous CAR-T therapy, we included not just the relapsed refractory large cell lymphoma but also the patients with so-called indolent lymphoma who have relapsed after multiple lines of therapy. So there will be some patients who belong to that subtype of non-oxygenous lymphoma. So, but keep in mind, you know, the purpose of Phase I is, as I previously said, safety, lymphodepletion, and early lines of efficacy. But from that perspective, I don't think there will be much impact on the patient's tumor subtypes in terms of our ability to analyze those, you know, key inflammation.

I'd like to pick one of those programs for a pivotal study after no comparing case, one data across across those programs [noise].

Yes, great question repelled is very passionate about the strategy that we are taking would a a in multiple myeloma and I'll ask rockdale to answer your question.

Yeah. Thank you David and thank you Michael a b C. N. A director therapies are blocks I mean, that's you know I had the privilege to work in underlines the mob GSK.

And you know we know that that will be in advance in this field and there will be all the other products that are approved.

Such a our job is to try to come up with the product. So it's going to derive the most benefit for patients and that's why we.

Corey Kasimov: Great, that's super helpful. And then, I guess, in terms of the nine patients that we'll get in the abstract, should we expect to get any additional data?

Initiated a three prong approach studies essentially a the cornerstone of which is is several one time the dose escalation and movement because of that trial is going very well. We said that we will is both data by the end with a year and we're on track to doing that we've accelerated if you will.

David D. Chang: Redosing is an amendment that we made later in the study, and as we have said in the prepared statement, the data cutoff for the abstract was January, and that is before the amendment came into effect, so there won't be any redosing information in the abstract.

The spring works a collaboration with you know guesses about so that's already being submitted so we should also how some patients treated as well in the combination and the preclinical data is stunning a with a combination.

And so we would be able to see even though it's not a randomized trial.

Corey Kasimov: Okay, got it. That's helpful, too. And then, I guess

The differences between 715 and 715 in combination with natural gas is that and then seek so fives will come next year. We haven't said one Oh, we're working hard to try to understand the benefits of turbo car as I said before and the recent core for these three broad.

David D. Chang: Great question. First of all, You know, we are trying to, you know, understand how the COVID-19 pandemic will play out. I mean, I think we just lived through the early phase, and essentially, you're talking about since the end of February till what is now, you know, sort of the early part of May. So we have about, what, a little over two months of experience. You know, within this, you know, limited experience, I mean, we know what we can do, which is controlling our own internal activities, making sure that the supply chain is not interrupted, and fortunately, in our case, we do have the luxury of building up an inventory of CAR T-cells that we can use in clinical studies. So, from the things that we can control, I think we are in pretty good shape.

Our approach is that even though there are lot of on babies. Your my therapies, none of them or chira tips.

And we went live waste that's all that's card, which I lived in a cars to be able to move to field and one of these strategies, we hope will do so so.

We remain a greeley passionate about or moving the needle. If you will we be CLA intelligent make setting in multiple myeloma with one of these three projects.

Great. Thank you so much.

Thank you.

Our next question comes from Tony Butler with Roth Capital Partners. Your line is now open.

Thanks very much.

Just to two brief questions. The first I want to stick with the same thing we use on the notion of the and its leasable sinochem receptor or quarterly comp store 'cause, it's obviously incredibly clever, but it strikes me that the goal here was really did see could you actually fight through the P. I mean.

And be able to have some durability in the tumor microenvironment and in theory, you wouldn't mixture, we do that with this with what the bcm, a binder or am I incorrect and that assumption part b to that question actually is.

David D. Chang: Things that we have to react to are what happens in the external environment, including, you know, how the hospital, so this is going beyond what the investigators may do, but the hospitals do to the clinical studies as they sometimes prepare for the surge of patients. So, there are a lot of different variables. However, if things more or less play out the way that we have experienced over the last two months, I'm hoping, as well as, you know, this is based on the information that we have, you know, the studies that we are planning in large part will not be affected.

Around safety and it addresses the notion of I could see why would be state for Vincent we systemically delivering saw declines, but it's if you think it's safer than for example, a one of the other 715 or constructs.

How do you think about safety there and then finally strikes me that you're happy with 90 milligrams and affords me at DCT 52.

In a body or or or 647 am I correct or do you need to move to say 120 to really be satisfied that you're getting the appropriate lymphodepletion.

With that compound app that sounds like.

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Yeah, Tony Good morning.

David D. Chang: We will not be effective.

Ill pass a rough out to asked a question. So that's public kind of great questions. I mean, certainly we see a lot of promise, but this autonomous side to kind of signaling that we introduced its harbor car, but I.

David D. Chang: will not be affected by COVID.

I mean, there there are many interesting questions did you have phones so rafael.

Corey Kasimov: Great, that's very helpful. Thanks for taking my question.

Yeah, Hi, Tony It's nice to hear your voice Ed I there a lot of clever question at the third is that's mentioned.

David D. Chang: Thanks, Corey. Thanks, Matt.

Marc Alan Frahm: Thank you. Ladies and gentlemen, in the interest of time and in order to accommodate as many questions as possible, we ask that you please limit yourselves to one question. Our next question comes from Mark Frahm with Callan & Company. Your line is now open.

D C N. A I think he's I'd really interesting targeting which stood to have sort of what cars I realized that.

It may solid tumors may also benefits from these technology, but what we're looking for is a brisk or more rapid and a robust anti tumor effect on front.

Marc Alan Frahm: Building on one of your prior answers, David, you mentioned over the course of this trial, you know, early on, kind of some of the struggles finding patients who had been on off-roteximab long enough to enroll. And, you know, that's kind of the driving force for 501A. And now, you know, COVID potentially kind of, and highlighting the need for an automaker to move from an auto to an alloted product. So should we think about kind of shifting patient populations over time, either in terms of some of the baseline characteristics, you know, the disease type, as you mentioned earlier, or other baseline characteristics that you know do impact safety or efficacy, things like tumor burden and things like that?

We know this is halogenate car T therapy. So eventually the cells will be rejected so we wanted to sales while they are expecting on site tumor activity to be fitter and younger to replicate when they see antigen on to do it in a manner that it doesn't affect or that surrounding.

Cells.

In terms of Ah safety that obviously needs to be proving a that this product has never been in humans and ER. We are doing all our preclinical toxicology work.

Dorsa 90 next year.

And that there could be a issues or having to do we see.

You know so growth autonomous so growth, but we don't believe that that's going to be an issue but.

Other than that the US you know there's no soluble cytokine Oh, we do system, which is a very unique and to my knowledge. There there aren't any other systems, where the actual cytokine is actually not a release from the selling question.

David D. Chang: So let me understand the question. So, as I.

David D. Chang: So are you sort of asking whether the patient population will shift because of the COVID pandemic?

And in terms of ER did those I'm not sure I I fully understood. Your question, but you know they said chance that you've seen sort about cars may allow us to lower than meaningful depletion or perhaps to lower the dose level. Those are hypothetic boats and I don't want to go into a hypothetical.

Marc Alan Frahm: Well, because of the pandemic, or also just your initial population, should we think about, you know, those maybe being more follicular patients that might be able to be off Rituximab early on, but then maybe later you're getting more, you know, very high-burden, very sick patients later now, as COVID is kind of impacting enrollment in the broader CAR T-scan?

Much more side in T. already that is a possibility. It. These are much more important itself. So I hope. This is gives you a flavor of hot when thinking on and answers your question.

Raphael Thanks very much.

Thank you. Thank you.

And our final question comes from a speaker good we're dealing with Suntrust. Your line is now open.

Hi, Good morning, guys and thanks for squeezing me in.

David D. Chang: Yes, so I mean, you know, in phase one, you know, our experience, you know, in terms of enrolling a very limited number of patients, it doesn't give you a much larger view of whether there will be differences in the patient population. But as I've said, the benefits of a pilot SCAR-T, I think it's in becoming a parent, not just in the not

Wanted to talk a little bit about wanting to lymphodepletion I'm here and I'm not feel your thoughts and displays but there does suggest that repricing the patients endogenous T cells in the first 14 days.

Keith expansion I, just want to get your thoughts on how important do you think it is in aggressive NHL keep b T cells. A then gardens T cell suppressed for the next 14 days.

And to have a couple of quick follow ups.

That's that's an outstanding question or on a swanda, we are exploring or in terms of our corollaries parties, we follow very closely.

TV NK cells, and all I would say at this point.

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They're longer we can keep the T cell suppressed or the better and our goal is to strike a balance between the learn to a new publishing which I was always sneak on lead to viral reactivation of another top six cities and the ability for the allogeneic car.

David D. Chang: [inaudible]

Marc Alan Frahm: Okay, and then we also have some comments about the interruption to the in-house manufacturing facility in Newark, and the construction. Can you remind us kind of where you stand in terms of manufacturing doses for the duration of the Phase 1 trials for both CD19 and BCMA and your readiness to advance into Phase 2, and what you need that manufacturing facility for?

He spoke to expand.

But certainly I think this statement that you made about longer than 14 days may actually be true in that we may need to have the self.

Suppressed a little longer so that's in part of the but the reason for doing a phase one studies really to look at all these parameters. So those lymphodepletion not just we saw the six or seven by whats chemotherapy well enroll did each one of these elements play in the suppression well what happens when they come back.

David D. Chang: Yes, so, you know, we have previously sort of made it very clear that right now we are still dependent on the contract manufacturer for the clinical supply, and our plan is to shift that dependence to something that we can control by bringing in the clinical supply manufacturing in-house, and that is planned to be done in Newark. And the timeline that we are working towards is, you know, completing the construction. After the physical structure of the manufacturing facility is done, there's a lot of work that needs to be done. But essentially, you know, we are working towards getting our own manufacturing facility online to produce clinical materials sometime in 2021. So, as Eric has commented, the disruption for a short period of time that occurred,

What happens with the pharmacokinetics of six or seven with regards to C.D. So early surgeons do we engage surgeon and so when that Mitch So bad Onyx flooding the very questions that you just on us.

Oh I hope so how about on Sir.

By the end up a phase one study.

Excellent and then I I have to ask a question about the upcoming data at ASCO don't mind.

What did you guys have time to look at a and then do denounces provide some color on the memory phenotypes up the car T cells on infusion and at peak expansion.

Yeah I'll take that question I mean, the answer is yes, it's part of the panel that we do you know both in the endogenous cells as well on its own set out a minister.

And obviously at the moment.

Phase one study with a limited number of patients David said before to make conclusions in this space. One would have to says multiple graph from multiple sources, so oh axogen ourselves to be able to make those comparisons but certainly it is a really important question and we just anymore.

David D. Chang: Thank you.

Mark Alan Breidenbach: Okay, great, thank you. Thank you. Our next question comes from Mark Breidenbach with Oppenheimer. Your line is now open. Hey, good morning, guys, and I'll try and break with the trend here and actually limit myself to one question. A very, very quick one, maybe directed at Rafael. I'm wondering if you're expecting substantial variability in baseline levels of rituximab in the alpha trial patients, and will this be a parameter that will be

Time, I'm more experimentation to be able to answer it.

Got it and finally, the back fill am I right in assuming that completely agree completely dusty that.

Might not be driven by toxicity and just more opportunistic.

Would you have back filled maybe the lowest dose I, either 40 million or was that back to more in depth 160 million dose level.

I think that the you know the proximity of the ASCO presentation is such that ER I prefer to wait and let you see for yourself the data.

Mark Alan Breidenbach: Thank you.

Rafael Amado: Yeah, hi, Mark. Thanks for the question, and it's been an important question that only applies to the 501, as you know. Obviously, on 501A, that won't be an issue. We have been fortunate to get enough patients that either were not on rituximab, or they had been on rituximab for greater than six to nine months, and other patients that had received it sooner. In those patients, if they had a level that was above three, we would allow the patient to have aphoresis for a total of three aphoresis, and that should bring the level below one microampere ml, which is really the allowed level. We actually haven't had too many problems with getting these kinds of patients. Of course, there were patients that had rituximab two months before, and we knew that plasmaphoresis wasn't going to work.

Got it okay. Thank you so much while the color today appreciate it.

Thank you ladies and gentlemen, this concludes our question and answer session.

I would not only to turn the call back over to David Chang for any closing remarks.

Thank you for joining us on the call today and your continued support of Allergan is what do we know will be an exciting year flat allogeneic cell therapy.

We look forward to speaking with you again soon and we look forward to head up I had to ask all operator, you may now disconnect.

Ladies and gentlemen. This concludes today's conference call you for participating you may now disconnect.

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Rafael Amado: [inaudible]

Alexander Duncan: Okay, that's very helpful. Thanks for taking the time to ask the question. Thank you. The next question comes from Alexander Duncan with Piper Stanley. Your line is now open. Hey all, glad to hear everyone is doing well, and thanks for the questions.

Alexander Duncan: Thank you.

David D. Chang: A quick follow-up on previous questions. At ASCO, will you be providing a lot of information on which manufacturing runs from which each alpha patient was treated? Then on the turbo car strategy, can you explain the thought process behind advancing the first clinical candidate in myeloma as a follow-on to 715s, as opposed to allo 316 in renal, or even developing a turbo car candidate as the lead program in RCC, given the potential for this technology in solid tumors? Thanks so much.

David D. Chang: So, Alex, let me take the first question and I'll ask Raphael to answer the second question. In terms of LOD information, I think, as I previously said, we're getting very close to ASCO, so probably it's best to refer to the actual presentation. Raphael, second question?

Rafael Amado: Yeah, I mean, we are really excited about the TurboCard technology. What we've seen in the preclinical work really tells us that the cells can remain less exhausted or unexhausted for a long period of time. They can divide, and they can proliferate upon encountering antigens.

Rafael Amado: So we think that it has a lot of promise. And, of course, it's going to be tested first in the BCMA. It may have a lot of promise in solid tumors, and indeed, we are working on the optimal TurboCard. As you know, the technology allows us to use different cytokines, different gaits, if you will, to trigger the cytokine signal. So we are at the moment working on what would be the optimal one to insert into our programs, particularly CD70 and DLL3. The initial IND will be without it, but I do not expect that one containing cytotale will lag much behind. And it will all depend, obviously, on what we find preclinically, but we're pretty excited about the potential of TurboCards in solid tumors.

John Lawrence Newman: Thank you. The next question comes from John Newman with Canaccord.

John Lawrence Newman: Your line is now open. Hi there. Good morning. And thanks for taking my question. So my question is regarding Atlas 647. And I'm just curious.

David D. Chang: Going forward here, will you have the opportunity to test dosing L647 on its own as a lymphoid depletion agent, perhaps after the initial lymphoid depletion in combination with chemotherapy? Just curious if that's a strategy that you're considering here going forward. Thanks.

David D. Chang: Hi John. Good morning.

David D. Chang: Let me take that question. In ALO647, you know, as an anti-CD52 antibody, that is a great patient for lymphodepletion that is selective and also spares our own allocar T cells because we edit our CD52. And we are certainly leveraging the strength that comes from the uniqueness of ALO647-based lymphodepletion. In terms of your question of whether ALO647 can do it alone, that is a great question, and certainly that is something that we internally discuss frequently. You know, how to do that? I think that is a stepwise process that we'll be taking. First, making sure that we get to adequate lymphodepletion and then start testing whether nonspecific chemotherapy is really necessary for lymphodepletion. So it is in the plan, but the question, you know, the answer will take a little time, but definitely something that we are very interested in.

Michael Schmidt: Great, thank you. Our next question comes from Michael Schmidt with Guggenheim. Your line is now open. Hey, guys, thanks for taking my questions. Just one more on IL-501. I know that the main focus here is on optimizing lymphodepletion, but I guess, David, what gives you comfort that you actually have selected the right cell dose at this point and that you don't need further dosing work on that front?

David D. Chang: Yes, so. In terms of lymphoid depletion, I mean, you know, one of the things that we can look at very early on is the reduction in the absolute lymphocyte count, as well as time before the T cells or NK cells or B cells start coming back. I mean, that's essentially the definition of the lymphodepletion and duration of lymphodepletion, or time to cell recovery that we have been talking about. So, from that aspect, you know, we can get a pretty early read on how different changes that we introduced into the lymphodepletion can actually translate into, you know, what we are looking for. In terms of how to put that into context of cell dose, that's a great question. You know, cell therapy is a very sort of dynamic therapy in many ways.

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David D. Chang: We learned that during the conduct of otolaryngoscopy therapy. Essentially, how the cells expand is, you know, a multifactorial process. The quality of the cells, the antigen density, target density, or the tumor burden in patients, as well as, you know, the lymphodepletion that allows the homeostatic changes of the cytokines to promote cell expansion. So, there are many different things that we are looking at. That's one of the reasons that we emphasize looking at, you know, translational parameters to make this decision. And this is something that, you know, we have some experience in optimizing and deciding and moving forward. And all that experience that comes from having worked on otolaryngoscopy will also factor in as we, you know, lock in the final two parameters, namely the lymphodepletion regimen and the cell dose. The cell dose, as I just said, the dose range has been defined between 40 and 360, and certainly that's the range that we are playing with right now. Okay, thanks. And then just a high-level question about the strategy.

Michael Schmidt: Thank you very much.

Michael Schmidt: I guess, how should we think?

Michael Schmidt: Think about the strategy here.

Michael Schmidt: Are you planning on moving several programs forward, you know, in parallel? Or are you, you know, for example, planning to pick one of those programs for a pivotal study after, you know, comparing, you know, case one data across all those programs?

David D. Chang: Yeah, great question. Raphael is very passionate about the strategy that we are taking with multiple myeloma, and I'll ask him to answer that question.

Rafael Amado: Thank you, David. And thank you, Michael.

Rafael Amado: BCMA-directed therapies are blossoming, as you know. I had the privilege of working on Volantamab at GSK. And, you know, we know that that will be an advance in this field, and there will be other products that are approved. As such, our job is to try to come up with a product that is going to derive the most benefit for patients, and that's why we initiated a three-prong approach that is essentially the cornerstone of which is 715. And so, we will be able to see, even though it's not a randomized trial, the differences between 715 and 715 in combination with Neurogastastat. And then, 605 will come next year. We haven't said when, but we're working hard to try to understand the benefits of Turogocara, as I said before. So, we've remained really passionate about moving the needle, if you will, with BCMA and the allogeneic setting and multiple myeloma with one of these three strategies.

Charles Anthony Butler: Great, thank you so much. Thank you. Our next question comes from Tony Butler with Roth Capital Partners. Your line is now open.

Charles Anthony Butler: Thanks very much. Just two brief questions. The first...

Charles Anthony Butler: I want to stick with the same theme, please, on the notion of an inducible cytokine receptor CAR-T construct. It's obviously incredibly clever, but it strikes me that the goal here was really to see whether you could actually fight through the TMA and be able to have some durability in the tumor microenvironment. And, in theory, you wouldn't necessarily do that with a BCMA binder, or am I incorrect in that

Charles Anthony Butler: Part B to that question actually is around safety, and it addresses the notion of why it would be safer than simply systemically delivering cytokines. But do you think it's safer than, for example, one of the other 715 constructs? How do you think about safety there? And then finally, it strikes me that you're happy with 90 milligrams for the anti-CD52 antibody or 647. Am I correct, or do you need to move to say 120 to really be satisfied that you're getting the appropriate lymphodepletion with that compound at that dose? Thanks.

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David D. Chang: Yeah, Tony, good morning. I'll ask Raphael to answer the questions on Turbocot. Great questions. I mean, certainly, we see a lot of promise in this autonomous cytokine signaling that we introduced to Turbocot, but I mean, there are many interesting questions that you have posed. So, Raphael?

Rafael Amado: Yeah. Hi Tony. Nice to hear your voice. There are a lot of clever questions, as David has mentioned.

Rafael Amado: BCMA, I think, is a really interesting target in which to test the turbo cars. I realize that solid tumors may also benefit from this technology, but what we're looking for is a brisker, more rapid, and robust anti-tumor effect up front. We know this is collagen-A CAR-T therapy, so eventually the cells will be rejected. So we want the cells, while they are expecting anti-tumor activity, to be fitter and younger, to replicate when they see antigen, and to do it in a manner that doesn't affect the surrounding cells. So I hope this gives you a flavor of how we're thinking and answers your question.

Rafael Amado: Raphael, thanks very much. Thank you. And our final question comes from Asthika Goonewardene with SunTrust. Your line is now open.

Asthika Sarith Goonewardene: Hi, good morning, guys, and thanks for squeezing me in. I want to talk a little bit about lymphodepletion here, and Raphael, what are your thoughts on this, please? The data does suggest that repressing the patient's endogenous T cells in the first 14 days is key for the expansion. I just want to get your thoughts on how important you think it is in aggressive NHL to keep these T cells, the endogenous T cells, suppressed for the next 14 days and then have a couple of quick follow-ups.

Rafael Amado: That's an outstanding question, and it's one that we are exploring in terms of our corollary studies. We will follow very closely.

Rafael Amado: TB and K-cells. And all I would say at this point is that the longer we can keep the T-cells suppressed, the better, and our goal is to strike a balance between the length of lymphodepletion, which obviously can lead to viral reactivation and other toxicities, and the ability of the allogeneic heart T-cells to expand. But certainly, I think the statement that you made about longer than 14 days may actually be true, in that we may need to have the cells suppressed a little longer. So that's in part the reason for doing a Phase I study, to really look at all these parameters, cell dose, lymphodepletion, not just with ALO647 but with chemotherapy. What role did each one of these elements play in the suppression? What happens when they come back? What happens with the pharmacokinetics of ALO647 with regard to T-cell resurgence and NK resurgence? And so we're in the midst of that and exploring the very question that you just asked, and we hope to have that answer by the end of the Phase I study.

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Asthika Sarith Goonewardene: And then I have to ask a question about the upcoming data at ASCO, I hope you don't mind. Would, did you guys have time to look at...

Rafael Amado: Yeah, I'll take that question. I mean, the answer is yes. It's part of the panel that we do, you know, both in endogenous cells as well as in cells that are administered. And obviously, at the moment, it's a phase one study with a limited number of patients. And as David said before, to make conclusions in this space, one would have to test multiple graphs from multiple sources of exogenous cells to be able to make those comparisons. But certainly, it is a really important question, and we just need more time and more experimentation to be able to answer it.

Asthika Sarith Goonewardene: Got it. And finally, the backfill, am I right in assuming that completely agree or completely does see that it might not be driven by toxicity and just more opportunistic here, but would you have backfilled maybe the lowest dose, i.e., the 40 million, or was that backfill more in that 160 million dose level?

David D. Chang: I think the, you know, the proximity of the ASCO presentation is such that I prefer to wait and, you know, let you see for yourself the data.

Asthika Sarith Goonewardene: All right, guys. Thank you so much for all the color today. Thank you. Ladies and gentlemen, this concludes our question and answer session. I would now like to turn the call back over to David Chang for any closing remarks.

David D. Chang: Thank you for joining us on the call today, and your continued support of Allogene is what we know will be an exciting year for allogeneic cell therapy. We look forward to speaking with you again soon, and we look forward to attending ASCO. Operator, you may now disconnect.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

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