Q4 2021 Allogene Therapeutics Inc Earnings Call

Operator: Hello, and thank you for standing by, and welcome to Allogene Therapeutics' fourth quarter and year-end 2021 conference call. At this time, all participants are in a listen-only mode.

Hello, and thank you for standing by and welcome to Allo gene therapy.

Operator: After the speaker's presentation, there'll be a question and answer session. To ask a question, during this session, you'll need to press star 1 on your telephone. Thank you very much. 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.

<unk> fourth quarter and year end 2021 conference call at this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During the session you will need to press star one on your telephone. Please be aware that today's conference call is being recorded I would now like to turn.

On the call over to Christine Casiano, Chief Communications Officer discuss Yano. Please go ahead.

Christine Cassiano: Thank you, Operator, and welcome to all who have joined this call. After the market closed today, Allogene issued a press release that provides a business update and financial results for the fourth quarter and full year 2021. That release and today's webcast are both available on our website.

Thank you operator, and welcome to all who have joined this call. After the market closed today allergy and issued a press release that provides a business update and financial results for the fourth quarter and full year 2020 one.

At least in today's webcast are both available on our website joining.

Christine Cassiano: Joining me on the call today are Dr. David Chang, President and Chief Executive Officer, Dr. Rafael Amato, Executive Vice President of Research and Development and Chief Medical Officer, Dr. Eric Schmidt, Chief Financial Officer, and a new voice on our quarterly calls, Dr. Allison Moore, Chief Technical Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials, dated presentations, regulatory filings, future research and development efforts, manufacturing capabilities, and 2022 financial guidance, among other things. These four-looking statements are based on current information, assumptions, and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents.

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, and a new voice on our quarterly call Dr. Alison Moore, Chief Technical Officer during.

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.

Presentations regulatory filings future research and development efforts manufacturing capabilities in 2022 financial guidance among other things.

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

Christine Cassiano: [inaudible] You're a question not to place under reliance on these forward-looking statements, and Allogene explains any obligation to update these statements. I'll now turn the call over to David. Thanks, Christine, and thank you all who have joined our call. I am very excited to talk about what we believe will be an important year for allogen as we are working to advance three exciting clinical programs. From initiating our first pivotal trial in non-Hatchins, lymphoma. This is the end of the final trial in non-Hatchins, the final trial in non-Hatchins, the final trial in non-Hatchins, Thank you very much.

I'll now turn the call over to David.

Thanks, Christine and thank you all who have joined our call.

Very excited to talk about what we believe will be an important year for allergan as we are working to advance three exciting clinical programs.

Initiating our first pivotal trial in non Hodgkin's lymphoma to progressing our mid stage program in multiple myeloma, two pivotal readiness and advancing our solid tumor clinical programs to potential proof of concept.

David Chang: 2021 was both a year of significant pipeline achievement and unexpected challenge associated with the clinical whole, both of which played a meaningful role in moving allergen and the field of allogeneic cell therapy forward. With our CD19 program, we demonstrated an important first for our field as the phase one data from our alpha trials continue to support the promise of our platform and our ability to provide safe and durable alternatives to approved autologous cardiac therapy. Patients with relapsed refractory non-Hodgkin's lymphoma.

2021 was both a year of significant pipeline achievement and unexpected challenge associated with the clinical whole both of which played a meaningful role in moving allergen and the field of allogeneic cell therapy forward.

With our CD 19 program, we demonstrated an important first for our field as the phase one data from our Alpha trials continues to support the promise of our platform and our ability to provide safe and durable alternative to approved autologous car T therapies in <unk>.

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David Chang: Our next most advanced clinical program targeting BCMA is the leading allogeneic CAR-T program in multiple myeloma. Our Universe of Study opened the door for this modality as the first and still only trial to demonstrate substantive proof of concept while allogeneity in this disease setting. While we are proud to have established proof-of-concept, safety, and efficacy data in both lymphoma and myeloma, We are even more excited about the potential for allocaustic products to overcome the inherent limitations of autologous therapy.

Our next most advanced clinical program targeting <unk> is the leading allogeneic car T program in multiple myeloma.

The Universal study opened the door for this modality is the first.

Still only trials to demonstrate substantive proof of concept for allogeneic car T.

These setting.

While we are proud to have established proof of concept safety and efficacy data in both lymphoma and myeloma we are.

Even more excited about the potential for allo car T products to overcome the inherent limitation.

I guess therapies.

David Chang: Today's marketplace for autologous cell therapy is constrained by treatment delays. High Limitage, And often a requirement that patients receive breathing chemotherapy. [inaudible] No matter how compelling the data on autologous therapies might, There are of no value to the many patients. I'm not gay now.

Today's marketplace, both autologous cell therapy is constrained by treatment delays.

<unk> limitations and often a requirement that patients receive <unk> chemotherapy.

No matter, how compelling the data on autologous therapies might be there.

No value to the many patients who cannot gain access.

David Chang: Patients who are enrolled in our studies can be nearly guaranteed to receive our product. In the alpha trials, 98% of enrolled patients received our products within a median time of 2 to 5 days from enrollment to the start of the trial. By comparison, in trials deploying autologous therapies for non-Hodgkin's lymphoma, up to 30% of patients who underwent successful leukophoresis for cell manufacturing were still unable to receive treatments due to interval disease progression while waiting for CAR-T cell products or due to manufacturing failure.

With our Allo car T product, we have shown the ability to deliberate treatments to patients within days rather than weeks patients who enrolled in our studies can be nearly guaranteed to receive our products.

In the Alpha trial, 98% up in raw patients receive our products within a median time of two to five days from enrollment to that start up treatment.

By comparison in trials deploying or Carlos therapies for non Hodgkin's lymphoma up to 30% of patients who underwent successful leukapheresis for Saab manufacturing was still unable to receive treatments to enable disease progression, while waiting for car T cell product due to manufacturing.

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David Chang: Treatment delays are even more critical in the multiple myeloma setting, as many patients with rapidly progressing disease require bridging therapy as they wait for the manufacturing of their autologous CAR T cells. And those who are unable to tolerate effective breathing chemotherapy may not be considered candidates for autologous therapy.

Treatment delays that even more critical in the multiple myeloma setting as many patients with rapidly progressing disease require bridging therapy as they wait for their manufacturing.

<unk> car T cells.

And those who are unable to tolerate effective breathing chemotherapy may not be considered candidates for autologous therapies.

David Chang: Shortening time to treatment and ensuring access for nearly all suitable patients is just the beginning of how we are leveraging the attributes of Alokarthi products. Our first allogeneic candidates are only the beginning of product innovation in the field of allocarditis. Our next generation product, based on our turbo car and other technologies that are aiming to enhance the efficacy and safety of allogeneity. That'll therapy.

Shortening time to treatment and ensuring access for nearly all suitable patients is just the beginning how.

How we are leveraging the attributes of allo car T product.

Our first allogeneic candidates are only the beginning.

Innovation in the field of Allo car T.

Our next generation products based on all the turbo car and other technologies that Amy to enhance the efficacy and safety of allogeneic cell therapy.

David Chang: Aside from the data presented in 2021, Amin's unexpected challenge, our clinical home. While no company wants to be faced with a hold, the situation provided us the opportunity to retest our manufacturing process, and reconfirm the quality of our product. In responding to and quickly resolving the whole, our team under the death stewardship of Raphael, demonstrated the quality of leadership collaboration, innovation and focus required to be a pioneer in the field of a la carte. I am incredibly proud of the manner in which our employees rose to this challenge.

Aside from the data presented in 2021 came on unexpected challenge our clinical hold.

While no company wants to be faced with a whole situation provided us the opportunity to re cashed, our manufacturing processes and we confirm the quality of our products.

In responding to and quickly resolving the halt our team under the stewardship of Raphael demonstrated the quality of leadership collaboration.

Asian, and focus required to be a pioneer in the field of Allo car T.

I am incredibly proud of the manner in which our employees rose to this challenge.

David Chang: In retrospect, this experience provided us with the insight that we believe will give us a competitive edge as we look to lead the field of Allogene X out there. We look forward to sharing the results from our scientific investigation in a peer-reviewed forum. As we prepare for the next stage in our life cycle with a planned allopathic 1A SIBO-DOS trial for relapsed refractory large B-cell lymphoma in mid-2022. We are also determined to minimize hurdles that could create delays at the time of a biologic license application submission. This brings us to our technical operations, product sciences, and manufacturing organizations.

In retrospect this experience provided us with the insight that we believe will give us a competitive edge as we look to lead the field of allogeneic cell therapy.

We look forward to sharing the results from our side speak investigation.

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As we prepare for the next stage in our life cycle with a plan Allo 501 pivotal trial for relapsed refractory large b cell lymphoma in mid 2022.

Also determined to minimize hurdles that could create delays at the time of a biologic license application submission.

This brings us to our technical operations.

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David Chang: From the beginning, we have maintained that having in-house manufacturing capabilities is key to controlling the delivery of off-the-shelf cardiac therapies faster, more reliably, and at a greater scale. And we have invested heavily in this area, building a state-of-the-art manufacturing facility in Newark, California.

From the beginning we have maintained that heading in house manufacturing capability is key to controlling the deliberate of off the shelf car T therapies faster more reliably and at a greater scale and we have invested heavily in this area.

Our state of the art manufacturing facility in Newark, California coal sell for each one is now fully operational and producing GMP material with the intent of supplying allo 501 a.

Planned pivotal studies.

David Chang: Thank you. Our incredible technical operations team is led by Dr. Alex, in early 2000. As we are forming Alex, I knew Allison was the person I wanted as our chief technical officer. When you are building something that has never been built. There is no club. There is no club. There is no club. There is no club. There is no club.

Our incredible technical operations team is led by Dr. Alison Moore.

In early 2018, as we are forming allergy.

New Allison what the person I wanted as our Chief Technical Officer.

When you're building something that has never been built before there is no blueprint.

Rafael Amato: Unit Semen, Kunoz Technology Operations, Inc. Tyler. Allison came to Allogene with over 25 years of experience in chemistry, manufacturing, and controls, or CMC, at Amgen and Genentech, from process and product development to manufacturing. Supply Chain, Global Operations Planning, and CMC Regulatory Affairs. I am immensely proud to work alongside Allison and know there is no one better to navigate the evolving CMC landscape. We are excited to have her join the call today.

<unk> salmon, who knows technology operations inside out.

Allison came to Allergan with all but 25 years of experience in chemistry manufacturing and controls or CMC.

And Jim and genetics from process and product development to manufacturing supply chain global operations planning and CMC regulatory affairs.

I am immensely proud to work alongside Allison and knows there is no one better to navigate the evolving CMC landscape. We are excited to have her joining the call today.

Rafael Amato: I would now like to invite Raphael to preview our R&D priorities for the upcoming year. Thank you. As David has noted, I would like to focus my remarks today on the year ahead and our clinical programs as we prepare for a pivotal trial targeting CD19 and advance our DCMA and CD70 programs. As most are aware, we issued a press release on January 10th announcing that the FDA had removed the clinical hold on our AllocRT clinical trial.

I now would like to invite Rafael to preview our R&D priorities for the upcoming year.

Thank you as David has noted I would like to focus my remarks today on the year ahead on our clinical programs as we prepare for our pivotal trial targeting CD 19, and advance our <unk> and CD 70 programs.

As most are aware, we issued a press release on January 10th announcing that the FDA had remove the clinical hold on our <unk>.

Allo car T clinical trial.

Rafael Amato: After our extensive investigation, it was determined that the chromosomal abnormality detected in a single patient treated with Allo501A was unrelated to talent gene editing or allogene manufacturing process, and had no clinical significance. The abnormality was not detected in any manufacturer AllocRT product or in any other patient treated with the same Allo5018 log.

After our extensive investigation it was determined that the chromosomal abnormalities detected in a single patient treated with allo 501, plus unrelated to Colin gene editing or other genes manufacturing process and had no clinical significant.

<unk> was not detected in any manufacture allo car T product or in any other patients treated with the same allo 501, a small.

Rafael Amato: The abnormality developed after the cell product was administered and in both regions of the T-cell receptor and immunoglobulin genes known to undergo rearrangement as part of the T-cell or B-cell maturation process. During our hold, our engagement with study investigators was robust, and it was clear many were anxious for all of them to resume studies. We are pleased to have quickly resumed clinical trial activities and are enrolling patients focused on ALO715 and ALO605 for multiple myeloma and ALO316 for renal cell carcinoma.

Do you have a normality develop after this whole product was administered on in both regions for the T cell receptor and immunoglobulin genes known to undergo rearrangement as part of the T cell or b cell maturation process.

During our hold our engagement with study investigators what's robust and he was clear many were anxious for allergan to resume study.

We're pleased to have quickly resume clinical trial activities and are enrolling patients focused on allo 715, an allo 605 for multiple myeloma and our luxury werent stake for renal cell carcinoma with.

Rafael Amato: We have completed a cruel in the ALO 501 Alpha Study, and the study will now continue to assess longer-term patient follow. We have completed a cruel in the ALO 501 Alpha Study, and the study will continue to assess longer-term patient follow. As such, we will be directing the full CD19 focus on ALO501A and finalize with the FDA a registrational approach prior to starting the pivotal alpha dosing. Prior to the start of Phase 2, we plan to resume enrollment in the Phase 1 study in order to offer allocRT to patients.

Have completed accrual in the Allo 501 Alpha study and the study will now continue to assess longer term patient follow up.

Touch wood will be directly in the fall of 2019 focused on allo 501, eight from finalized with the FDA a registrational approach prior to starting the pivotal trial to study.

Prior to the start of phase two we plan to resume enrollment in the phase one study in order to offer olive garden to patients.

Rafael Amato: Our ultimate goal is to deliver the first approved Allogene Karti product. Our ultimate goal is to deliver the first approved Allogene Karti product. We remain on track to start our Olo 501H Pivotal Trial mid-year. We remain on track to start our Olo 501H Pivotal Trial mid-year. Our Olo 501H Pivotal Trial mid-year. One of the most commonly asked questions from investors is about pivotal trial design. Given the competitive nature of the field, we are prioritizing the finalization of our discussions with the FDA.

Our ultimate goal is to deliver the first approved allogeneic car T product.

We remain on track to start our allo $501 eight pivotal trial mid year.

One of the most commonly asked questions from investors is about pivotal trial design.

Given the competitive nature of the feel we are prioritizing the finalization of our discussions with the FDA.

Rafael Amato: We will share additional details on our single arm 501A study at the time of trawling. Separately, and as Alison will discuss, we're front-loading many of the activities that address evolving CMC requirements ahead of what would be needed for a potential VLA. We believe our lympho-depletion regimen is differentiated through the use of ALO647, our anti-CD52 monoclonal antibody intended to enable enhanced expansion and persistence of ALOCAR-T product candidates.

We will share additional details on our single arm <unk>.

At the time of trial initiations.

Separately and as <unk> will discuss where it's.

From loading many of the activities that address evolving CMC requirements ahead of what would be needed for a potential BLA submission.

We believe our LIFO depletion regimen is differentiated through the use of allo, six or seven or anti <unk> monoclonal antibody intended to enable enhanced expansion and persistence of allo car T product candidates.

Rafael Amato: Separate from our single-arm pivotal trial with ALLO501A, we also intend to launch a stand-alone registrational trial for ALLO647 at the time of the ALLO501A pivotal trial. This randomized trial, referred to as the EXPAND trial, is intended to demonstrate the safety of ALLO647 and its contribution to the overall benefit of the lymphodepletion regimen. Based on the data we have previously presented at medical conferences, we believe Allo647 enables a highly competitive product profile for patients with large visa limits.

Separate from our single arm pivotal trial with Allo 500, <unk>. We also intend to launch a standalone registration trial for Allo 647 at the time of the Allo 501 <unk> trial.

This randomized trial referred to as the <unk>.

<unk> trial is intended to demonstrate the safety of Allo 607, and its contribution to the overall benefit of the LIFO depletion regimen.

Based on the data we have previously presented at medical Congresses, We believe our six or seven enables a highly competitive product profile for patients with large b cell lymphoma.

Rafael Amato: We also remain very excited by the potential of our anti-BCMA program. But all of the scarty therapies targeted in BCMA have recently shown unprecedented response rates, which appear well in excess of what has been achieved with any other modality in relapsor factor in my law. [inaudible] Yet, there are few allergenic BCMA programs in development with the potential to bring South Therapy to the large population of patients in need.

We also remain very excited by the potential of our <unk> program.

Autologous car T therapy targeting the CMA have recently shown unprecedented response rates, which have been well in excess of what has been achieved with any other modality in relapsed refractory myeloma.

Yet there are a few allogeneic the CMA programs in development with the potential to bring cell therapy to the large population of patients in need.

Rafael Amato: This has been reinforced by discussions with investigators. Our multi-pronged strategy to address this opportunity includes the Phase I Universal Trial, which has cohorts evaluating ALO715. Hormone therapy, Consolidated Indulgences, and the combination of ALO715 with Neurogast.

These have been reinforced by discussions with investigators.

Our multi pronged strategy to address this opportunity includes the phase one universal trial, we test cohorts evaluating allo 715.

Monotherapy consolidated in dosing.

And the combination of Allo 715 year old.

Rafael Amato: The Phase 1 IGNITE trial evaluating ALOF605 is our first TurboCard candidate which allows cytokine activation signaling to be engineered selectively into Card T cells intended to improve the potency and persistence of allogeneic cells. Trial activity has resumed, and we plan to provide a BCMA program clinical update by the end of 2020. Finding from our universal drawl on Al-715 indicates that an Allogeneic heartbeat therapy can be delivered rapidly, and without any tourprudence therapy, to patients with refractory multiple myeloma, and that a single dose of therapy was capable of inducing deep response.

Yes.

Phase one ignite trial evaluating allo 605 is our first durable card candidate, which allows cytokine excavation signaling to be engineered selectively into car T cells intended to improve the potency and persistence of allogeneic cell.

While activity has resumed and we plan to provide ABC MMA program clinical updates by the end of 2022.

Findings from our Universal Drawl on Alison alone five indicate that an allogeneic car T therapy can be deliver rapidly and we felt the need for bridging therapy to patients with refractory multiple myeloma.

And that a single dose of therapy was capable of inducing deep response.

Rafael Amato: We are pleased that ALO715 as a monotherapy could achieve and maintain meaningful response rates similar to the approved autologous CAR-T therapy with a high rate of MRD negativity for patients achieving BGPR or better response. The benefits of an allogeneic option are especially valuable in aggressive disease like relapsed refractory multiple myeloma, even with new potential therapies in the horizon. Through ample discussions with investigators, the need for more therapy options is clear, and they often emphasize that an allowable margin for efficacy is offset by benefits provided by the off-the-shelf alternatives. Before I welcome Allison to discuss her technical operations, I would like to comment briefly on our clinical development of follow-through. Our anti-CD70 Allah Party candidate for solidarity.

We are pleased that Alessandro on Firestone monotherapy, good achieve or maintain meaningful response rates similar to the a proof of autologous car T therapy with a high rate of MRV negativity for patients achieving <unk> or better responses.

The benefits of an allogeneic option are especially valuable in aggressive disease like relapsed refractory multiple myeloma, even with new potential therapies in the horizon.

Through our discussions with investigators the need for more therapy options is clear and they often emphasize that reliable margin for efficacy is offset by benefits provided by the off the shelf alternatives.

Before I welcome Melissa to discuss our technical operations I would like to comment briefly on our clinical development of policy. One seats are anti CD 70 hour car T candidate for solid tumors.

Rafael Amato: Clinical trial activities have resumed for our Phase 1 Traverse Trial, which is designed to evaluate the safety, tolerability, and anti-tumor efficacy of ALO316 in patients with advanced or metastatic clear cell renal cell carcinoma. Metastatic solid tumors have historically been a challenge regardless of treatment modality. Five-year survival rates for patients with advanced kidney cancer is less than 15 percent. These are the scores, not only the unmet need, but also the necessity for scientific. Carti Therapist, in general, has faced significant challenges in poly tumors which can be summarized in 3F.

Clinical trial activities have assumed for our phase <unk> trial, which is designed to evaluate the safety tolerability and anti tumor efficacy of <unk> in patients with advanced or metastatic clear cell renal cell carcinoma.

Metastatic solid tumors have historically been a challenge regardless of treatment modality.

Five year survival rates for patients with a basket any cancer, it's less than 15%.

Some of the scores not only the unmet need but also the necessity for scientific innovation.

Car T therapies in general have faced significant telling distant solid tumors, which can be summarized in three areas.

Rafael Amato: Target recognition and selectivity, trafficking and survival with... We're working to overcome these issues with our AllocRT platform, including several next-generation approaches to overcome the inhibitory signals of the tumor microenvironment. Meanwhile, we look forward to generating data from our ongoing phase one dose escalation. I would now like to turn the call over to our. Thank you, Raphael.

That will get recognition until activity trafficking and survival between the tumor.

We're working to overcome these issues with our olive garden platform, including several next generation approaches to overcome the inhibitory signals of the tumor microenvironment.

Meanwhile, we look forward to generating data from our ongoing phase one dose escalation trial.

I would now like to turn the call over to Alison.

Thank you Rafael.

Allison Moore: I've been fortunate in my career to build high-performing. Bring multiple medicines to Mars. Filth, Theatre of the Art, Manufacturing Facilities, and redefine the scope of process devolved.

I've been fortunate in my career to build high performing teams bring multiple medicines to market.

Phil.

<unk> manufacturing facilities.

Redefine the scope of process development.

Allison Moore: However, a career highlight and something I am most proud of has been the progress we've made in making Aloe Cara Tea a reality for patients. When I joined Allogene in 2018, we were a small team, working to do something that had never been done. Create off-the-shelf CAR-T products for patients with cancer from the T-cells of healthy donors.

However, our career highlight and something I am most proud off has been the progress we've made and making allo car T. A reality for patients.

When I joined <unk> in 2018, we were a small team working to do something that had never been done before create off the shelf car T product for patients with cancer from the T cells of healthy down here.

Allison Moore: Our first clinical data presentation in 2020 provided initial proof of concept for the, showing that our allogeneic products have the potential to improve patients' lives. It represented two years of rigorous work, creativity, problem-solving, and collaborative. Understanding product quality is paramount to the development of face and effective products.

Our first clinical data presentation in 2020 provided initial proof of concept for the industry showing that our allogeneic products have the potential to improve patients' lives.

It represented two years of rigorous work creativity problem solving and collaboration.

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Understanding product quality is paramount to the development of safe and effective product.

Allison Moore: In our increasingly complex world of biopharmaceutical development. The design and control of product quality is far from simple, and we've seen time and time again in cell therapy how manufacturing delays or, Translate into patients not getting treatment. That is why excellent CMC science is so critical.

And our increasingly complex world of biopharmaceutical development.

Design and control of product quality is far from simple and we've seen time and time again and cell therapy manufacturing delays or issues translate and to patients not getting treatment.

That is why at Cowen CMC Science. It's so critical is the convergence of multiple disciplines coming together to solve some of our most difficult challenges.

Allison Moore: It is the convergence of multiple disciplines coming together to solve some of our most difficult challenges. I've been fortunate to have worked on many modalities, including monoclonal antibodies, viruses, and vice versa. But I'm particularly excited about advancing cell therapy. While we stand on the shoulders of the autologous pioneers, the field continues to evolve dramatically as the science, the industry, and regulators become increasingly sophisticated. The evolution is clear. In the emerging cell and gene therapy field, the CMC worked toward a BLA. You cannot be an afterthought.

I think fortunate to have worked on many modalities, including monoclonal antibodies viruses and bi specifics, but I'm, particularly excited about advancing cell therapies.

While we stand on the shoulders of the autologous pioneers.

<unk> continues to evolve dramatically.

The science, the industry and regulators become increasingly sophisticated.

The evolution is clear.

In the emerging cell and gene therapy field, the CMC work toward a BLA submission cannot be an after thought.

Allison Moore: It is critical for demonstrating the quality of our product, the reproducibility of the process, and the control strategy. [inaudible] Any gaps or weaknesses can compromise the entire submission. In the development of monoclonal antibodies for, Teams may have years during phase two and phase three clinical development. In which we could study performance of the process and methods and the opportunity to optimize products.

It is critical for demonstrating the quality of our product the reproducibility of the process and the control strategy.

Any gaps or weaknesses can compromise the entire submission.

And the development of monoclonal antibodies for instance.

Kim may have years during phase two and phase three clinical development, and which we could study performance of the process and method and the opportunity to optimize production.

Allison Moore: In the development of CAR-T therapy for late-stage cancer, We have the privilege of starting pivotal trials relatively quickly following the recognition that these product candidates have game-changing potential for patients. This expedited timeline is unique for CMC practitioners, and ensuring the right experience within our teams is of utmost importance. Failure to understand the evolving landscape and FDA requirements can be a common pitfall and a cause of delay for new products. The Ability to Produce Safe and Effective Biologic Products.

And the development of car T therapy for late stage cancer, we have the privilege of starting pivotal trials relatively quickly following the recognition that these product candidates have game changing potential for patients.

This expedited timeline is unique for CMC of practitioners and ensuring the right experience within our teams is of utmost important.

Failure to understand the evolving landscape and FDA requirements can be a common pitfall and it caused a delay for new product approvals.

The ability to produce safe and effective biologic product.

Complex raw materials is the difference between hope and reality for patients in need.

Allison Moore: Thank you. While the start of any pivotal trial is exciting. Approval is the ultimate goal. At Allogene, we are focused on mitigating risks as we look ahead to the BLA, by moving up the timeline for important CMC validation work prior to the start of the pivotal program. This improves our measurement of quality assets, and enables robust characterization for approval.

Well, we started any pivotal trial is exciting.

Approval is the ultimate goal at.

And I'll, let Jean we are focused on mitigating risks as we look ahead to the BLA submission by moving up the timeline for important CMC validation work prior to the start of the pivotal program.

This improves our measurement of quality attribute and enables robust characterization for approval.

Allison Moore: Strong process and product validation support our ability to deliver a well-characterized biologic with minimized variability. We believe this will work to our advantage in the long term and set us up for success. Understanding a live product requires collaboration across many disciplines, including process development, clinical, [inaudible] Translational Sciences, and Biomedes. I am so proud of the proactive work being done by our incredible, to eliminate the potential downstream delays and to, more importantly, be able to stay with contact, that we can safely and effectively deliver to patients the promise of our aloecar T product.

Strong process and product validation support our ability to deliver a well characterized biologic with minimized variability.

We believe this will work to our advantage in the long term and set us up for success.

Understanding of life product requires collaboration across many disciplines, including process development clinical research translational sciences and biometric.

I am so proud of the proactive work being done by our incredible teams to eliminate the potential downstream delays and Tim more importantly be able to say with confidence that we can safely and effectively deliver to patients the promise of our allo car T product.

Allison Moore: We look forward to advancing this important area of drug development, and Building a Robust Regulatory Document, that effectively communicates the strategic design and strong execution of our CMC activities. I will now turn the call over to Aaron. Thank you, Allison.

We look forward to advancing this important area of drug development and building a robust regulatory dossier that effectively communicates the strategic design and strong execution of our CMC activities.

I will now turn the call over to Eric.

Eric Schmidt: So we're quite privileged to have, in Allison, someone so experienced and visionary at the helm of our operations technology group. Before I provide a brief overview of our financials for the quarter and year-end, I'd like to spend a few minutes on a topic that's been at the forefront of the industry in today's very challenging market environment, cash flow. We are very fortunate to be in a strong financial position ending the year with $810 million in cash, cash equivalents, and investments and no debt.

Thank you Alison during meetings with investors, we often get a multitude of questions on manufacturing and the evolving gene and cell therapy CMC landscape sure quite privileged to have an Allison someone's so experienced and visionary at the helm of our operations technology group.

Before I provide a brief overview of our financials for the quarter and year end I'd like to spend a few minutes on the topic that's been at the forefront of the industry in today's very challenging market environment cash runway.

We were very fortunate to be in a strong financial position ending the year with $810 billion in cash cash equivalents and investments and no debt.

Eric Schmidt: As you may have been able to discern from comments by David, Rafael, and Allison, one of the most critical elements of our corporate and financial strategy is to efficiently deploy our capital resources. These support value-enhancing programs that will drive long-term growth.

May have been able to discern from comments by David Raphael and Allison what are the most critical elements of our corporate and financial strategy is to efficiently deploy our capital resources to support value enhancing programs that will drive long term growth.

Eric Schmidt: In 2022, we have taken important measures designed to keep our cash burn below $300 million. This means focusing on our most critical activities, including, number one, starting of our ALO501A pivotal trial, number two, capitalizing on the tremendous opportunity in multiple myeloma, and number three, continued exploration of the role of ALOCAR-T in solid, We strongly believe we have the operational capabilities, scientific prowess, and resources needed to succeed in all three. Taking into account the incremental investment needed to support our first pivotal trial and fully operationalized CellForge I, we expect our full year 2022 GAAP operating expenses to be between $360 million and $390 million, including estimated non-CAS stock-based compensation expense of $90 million to $100 million. This guidance excludes any impact from potential business development activities.

In 2022, we have taken important measures designed to keep our cash burn below $300 million.

This means focusing on our most critical activities, including number one starting of our allo 501, a pivotal trial number two capitalizing on the tremendous opportunity in multiple myeloma.

And number three continued exploration of the role of Allo car T. In solid tumors. We strongly believe we have the operational capabilities scientific prowess and resources needed to succeed in all three.

Taking into account the incremental investment needed to support our first pivotal trial and fully operationalized sell forged one we expect our full year 2022, GAAP operating expenses to be between $360 million and $390 million, including estimated noncash stock based compensation expense of 19.

To $100 million this guidance excludes any impact from potential business development activities.

Eric Schmidt: As we review our financials for 2021 for the full year of 2021, research and development expenses were $220.2 million, which includes $39.6 million in expenses associated with non-cash stock-based compensation. For the full year of 2021, general and administrative expenses were $74.1 million, which includes $41.2 million of non-CAS stock-based compensation expense. For the full year of 2021, our net loss was $257.0 million, or $1.89 per share, including non-cash stock-based compensation expense.

As we review our financials for 2021 for the full year of 2021 research and development expenses were $222 million, which includes $39 $6 million in expenses associated with noncash stock based compensation.

For the full year of 2021 general and administrative expenses were $74 $1 million, which includes $41 $2 million of noncash stock based compensation expense.

For the full year of 2021 our net loss was $257.0 million or $1 89 per share, including noncash stock based compensation expense of $88 million.

Operator: 80.8 million dollars. With that, we will now open the call to your questions. Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound key.

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

Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key.

Michael Yee: Our first question comes from Michael Yee with Jeffrey's. Your line is open. Hey guys, thanks for the call and thanks for the update. We had two questions. One was appreciating all the color you discussed around CMC and Manufacturing. I guess maybe you could shed some light, without giving too much away competitively, on what you're working on. What competitive advantage or what, you know, what insights you can provide us on that advantage, that you would have confidence that you will start the pivotal CD19 study by mid-year. In other words, you're commenting about all of this and those are the gaining factors, maybe give us some color on that.

First question comes from Michael Yee with Jefferies. Your line is open.

Hey, guys. Thanks for the call and thanks for the update we got two questions one was I.

I appreciate all the color you discussed around CMC and manufacturing I guess, maybe you could shed some light without giving too much away competitively on on what you're working on in and.

What competitive advantage or what what insights you can provide us on that advantage.

That you would have confidence that you will start the pivotal CD 19 study by mid year in other words, you're commenting about all of this and those are the gating factors maybe.

David Chang: And the second relates to later this year, there's a myeloma update. Can you just remind us on expectations? Presumably that's mostly data on the first generation, but not likely to have real date on triple car. Michael, this is David.

Give us some color on that.

The second relates to later this year Theres a myeloma update can you just.

And us on expectations, presumably that's mostly they don't want the first generation, but not.

Likely to have real data on turbo car. Thank you.

David Chang: Thanks for those two questions. Obviously, the CMC question, that's not something that we have spoken about in our previous earnings call, and also, this is an area that probably is very complex, and we don't want to tip too much of our head about revealing too much, but since Allison has joined in, I'll ask her to provide some high-level response to your questions about what's being done on the CMC side. Allison?

Hey, Michael This is David Thanks for those two questions. Obviously, the CMC question, that's not something that we have spoken about in our previous earnings call and also this is an area that probably is very complex.

And we don't want to tip too much.

About half about revealing too much but since Allison has joined in I'll ask Kurt to provide some high level response to your questions about what's being done on the CMC side Allison.

Allison Moore: Thanks, David. And thanks, Michael. Yeah, obviously, on the CMC side, we are really excited to advance product from CellForge1, CellForge1 was designed and built to support commercial supply, and we're so excited that that is already generating GMP material, and we are working with the agency, to ensure that we can realize our gold error of supply from self-forged ones. Also, we are, Really, interested and excited as I described in my comment. To really demonstrate that we understand our product really well, we think that it helps, All the way through development. It helps me provide the best support for.

Thanks, David.

Michael.

Obviously on the CMC side, we are really excited to advance product from sell for each one.

For each one was designed and built to support commercial supply and we're so excited that that is already generating GMP material.

And we are working with the agency.

To ensure that we can realize our goal of supply from self orange one.

Also we are.

Really.

Interested and excited as I described in my comments.

To really demonstrate that we understand our product really well, we think that does help.

All the way through development It helps me.

The best support for our clinical colleagues and it allows us to make modification optimizations and refinement.

David Chang: Our clinical colleagues. And it allows us to make modifications, optimizations, and refinements as we go towards BLA. Thank you. It sounds like it's really about so forward to one. That's a big part of it, given that that's a kind of support commercialist. And then a mile.

Does it go towards BLA filing.

Thank you it sounds like it's really about self worked one that's a big part of it given that that's the kind of support commercialization.

Myeloma.

Rafael Amato: Yeah, so, you know, just on that, I mean, you know, as Alison had said, you know, we are trying to front load as much CMC activity, you know, ahead of the BLA filing. So, you know, we are taking very careful measures to address, you know, what's known as well as our potential issues that came up down the line. And, you know, you know, being able to launch the pivotal study with the materials coming from the CF-1 is one of the big things that we are trying to do. So, with that, on the myeloma data, you know, Raphael. Yeah, thanks Michael.

Yes so.

Just on that I mean.

As Alison has said we are.

Trying to frontload as much CMC activity.

Had a BLA filing so we are taking very careful measures too.

The address what's known as well as potential issues that may come up down the line.

Doug.

Being able to launch the pivotal study with the material is coming from the CF. One is one of the big things that we are trying to do.

So with that on the myeloma data rockdale.

Rafael Amato: So, as you know, we presented a VASH data on 43 patients and in my remarks, I spoke about how excited we were about the data and how, you know, it did really compares very well to the approved product that's held there in terms of responses, VGPR, plus as well as durability. The interesting thing is that the follow-up was actually not long, so we continue to follow-up these patients and the durability made still improved.

Yes.

Thanks, Michael So as you know we presented at Ash.

Data on 43 basins on in my remarks I E.

So spoke about how excited we were about the data and how it.

It really compares very well to the approved product thats out there in terms of responses B G. P R plus as well as durability.

The interesting thing is said the follow up was actually not long. So we continue to follow up these patients on the durability of Maine still improve.

Rafael Amato: We are really excited about the fact that it's been really well received both by investigators and non-investigator community leaders in terms of the results that are obtained with the product that essentially is able to treat virtually every patient as opposed to the autologous product. So, we look forward to providing an update, as I mentioned before, that would be towards the end of the year, and it would include the patients that we have treated with neurovastastat.

We are really excited about the fact that it's been really well received both by.

The investigators on known investigators key opinion leaders in terms of.

The results that are obtained with a product that essentially is able to treat.

Virtually every patient as opposed to all of this product. So we look forward to providing an update as I mentioned before that would be towards the end of the year.

And it would include the patients that we have to do with Neovasc to start.

Rafael Amato: We are now treating now that the whole is over patients on 605, and depending on the number of patients on the follow-up, then we may be able to include some of those patients in that update towards the end of the year. So, stay tuned.

Now trading now that they're wholly silver patients. So the 605 and depending on the number of patients on the follow up then we may be able to include some of those patients in that in that update towards the end of the year. So stay tune it said really exciting program.

We are testing several approaches and it will be a big decision point for us this year.

Thank you.

Salveen Richter: It's a really exciting program that, you know, we are testing several approaches and it will be a big decision point for us this year. Thank you. Our next question comes from Salveen Richter with Goldman Sachs. Your line is open. Good afternoon.

Thank you. Our next question comes from Silviu <unk> Richter with Goldman Sachs. Your line is open.

Rafael Amato: Thanks for taking my call. Could you just speak to the ongoing discussions that you're having at the FDA that have to be finalized prior to commencing the pivotal alpha-2 trial? And then secondly, with the CD70 program, how should we think about what the bar is here for what you'd want to see to.., for that to be kind of a positive step to then move forward. Salveen, you are making my job easy. I can defer again to Rafael to answer both of those questions. Rafael?

Good afternoon. Thanks for taking my question could you just speak to the.

The ongoing discussions that youre, having with the FDA that have to be finalized prior to commencing the.

To pivotal Alpha to trial, and then secondly, with the CD 70 program, how should we think about what the bar is here for what you would want to see Q.

To for that to be kind of a positive step to move forward.

Sylvian Youre, making my job easy I can defer again to Rafael to answer both of those questions profile.

Rafael Amato: Yes, so we've been having discussions with FDA during the whole, which I think speaks to the interest and mutual interest on moving this allergenic program forward. And we, as you know, are called developing all of 647 as well. So we have had discussions as well in terms of how to develop that product. And 647 gives us a lot of precision, with regards to lymphatic lesion. But in order for it to be approved, as call development, the agency obviously requires evidence of benefit risk.

Yes, so we've been having discussions with FDA.

During the whole, which.

I think it speaks to that.

The interest in mutual interest on moving this allogeneic program forward.

And we as you know are co developing analysis for Simon as well. So we have had discussions as well in terms of how to develop that product.

607 gives us a lot of precision with two vessels for depletion.

Rafael Amato: So those discussions are being finalized. We are actually quite advanced on them. And we are very confident that the study will start the 501A study will start by mid-year, follow shortly by the all of 647 trials. Both trials are going to be in execution mode.

But in order for it to be approved let's co development.

GNC, obviously requires evidence of benefit risk. So those discussions are being finalized and we are actually quite advanced on them.

We are very confident.

This study.

We'll start the <unk> study will start by mid year.

Followed shortly by the Allo 607 trial, so both trials.

Rafael Amato: And obviously we are working very closely with Allison and her team to ensure that we work together in sync and that we finish this trial without any issues with regards to designs or any issues with regards to CMC that may jeopardize our ability to complete the trial. So stay tuned, but the discussions are proceeding according to plan. And we have full confidence on our ability to start by mid-year.

We're going to be in execution mode, and obviously we are.

Working very closely with Alison and her team to ensure that we work together in sync.

We finished.

Finish this trial.

Any issues with regards to designs or any.

Issues with regard to CMC that.

May jeopardize our ability to complete the trial so.

Stay tuned.

The discussions are proceeding according to plan and we have full confidence on our ability to start by mid year.

Yes.

Okay.

Rafael Amato: On the CD70 program, CD70 program has resumed. It's a really exciting program. We had started treating patients and we're continuing now. There's excitement in the investigator community about this program. It's in renal cell carcinoma, as you know, but it's got a lot of potential in other solid tumors and hematologic malignancies.

On the CD 70 program.

The program has resumed.

A really exciting program we had.

Started treating patients and we're continuing now.

Excitement.

The investigator community about this program.

Renal cell carcinoma, as you know, but it's got a lot of potential in other solid tumors and hematologic malignancies.

Rafael Amato: And with regards to the bar, as I said before, you know, these patients, unfortunately, once they fail checkpoint inhibitors and angiogenesis inhibitors, even if they get more than one line of therapy, their five-year survival is quite low, you know, in the order of 10, 15%. So, obviously, it's early for us to have discussions with regards to what is it that would, you know, be a meaningful regulatory threshold for approval. But, you know, this is something that we will obviously evaluate as we see it.

And with.

With regards to the bar as I said before these patients Unfortunately once they.

Failed checkpoint inhibitor sell angiogenesis inhibitors, even if they get more than one line of therapy.

There are five year survival is.

Quite low in the order of 10% to 15%.

So obviously, it's early for us to have discussions with regards to what is.

That would.

The meaningful regulatory.

Threshold for approval.

Yes.

This is something that we will obviously evaluate as we see it.

Rafael Amato: But, clearly, investigators would be happy with response rates because, really, after patients are exhausting the therapies, there really isn't very much that works. So, you know, we will have those discussions once we know a little bit more. It's a little bit early in the program for us to be able to tell.

But clearly.

The investigators would be happy with response rates because really after patients are exhausting the therapies, they're released and is very much that work.

So.

We will have those discussions once we know a little bit more it's a little bit early in the program for us to be able to tell.

Thank you.

Tyler Van Buren: Thank you. Our next question comes from Tyler Van Buren on behalf of Cowan. Your line is open.

Thank you. Our next question comes from Tyler Van Buren with Cowen Your line is open.

Rafael Amato: Hey, guys, thanks very much for taking the questions. Related to the separate ALLO 647 Registrational Trial, beyond safety, can you provide more specifics on what needs to be demonstrated for approval? And then the second question is, it should allow you guys to comprehensively detail the safety profile and demonstrate if it's adding any safety events to the ALLO CAR T regimen, which could be beneficial given the historical theoretical concerns of infections, right?

Hey, guys. Thanks, very much for taking the questions related to the separate allo six or seven Registrational trials beyond safety can you provide more specifics on what needs to be demonstrated for approval.

Then the second question is it should allow you guys to comprehensively detailed safety profile and demonstrate if it's adding any safety events to be allo car T regimen, which could be beneficial given the historical theoretical concerns of infections right. So other than end points required for approval is this a significant purpose of the trial in Europe .

Rafael Amato: So other than endpoints required for approval, is this a significant purpose of the trial in your eyes? Yes. So, as I said before, 647, we view it as a competitive advantage. As you know, lymphodepletion is critical in the allogeneic space, and 647 has provided us with incredible precision with regards to T cell depletion, which is required in the allogeneic setting for the avoidance of rejection.

Yes.

Yes so.

As I said before six or seven.

We view it as a competitive advantage as you know link for depletion is critical in the allogeneic space and six.

Our seven hubs.

It has provided us with incredible.

Incredible precision with regards to T cell depletion, which is required in the allogeneic setting for <unk>.

They have already done so if projection so but because it's called development and I've been involved in the development of many drugs, including co development drugs FDA requires the benefit risk to be shown and demonstrated for each one of the components.

Rafael Amato: But because it's co-development, and I've been involved in the development of many drugs, including co-development drugs, FDA requires the benefit risk to be shown and demonstrated for each one of the components, both 647 and 501A, hence the second study that's required. It is going to be a randomized trial. They will compare it to a C. We are pretty confident that 647 leads to better outcomes, and, you know, the need for lymphosuppression has been shown, not just in our program, but in other programs as well, and 647 is being a component that has been studied at multiple doses in our program.

With six or seven <unk>, so hence the second study that does require.

It is.

Going to be a randomized trial, they will compare to FC.

We are.

Pretty confident that six or seven.

Leads to better outcomes.

The need for Linzess depression has been shown not just in our program.

<unk> as well.

So and it's been a component there.

<unk> started at multiple doses in our program. So we're very confident that this is a study that's going to show the six or seven show superiority to FC alone and importantly.

Rafael Amato: So, we're very confident that this is a study that's going to show that 647 shows superiority to SC alone, and importantly, that the safety of it is actually, you know, very comparable with regards to what you see in the autologous setting. So, we haven't actually seen, with the use of 647, more infections or grade 3 plus infections than are seen in the autologous setting. So, you are absolutely right.

Uh huh.

The safety of it it's actually.

Very comparable with regards to what.

Well, we you see in India, It's all of those settings. So we haven't actually seen it with a use of 647.

More infections or grade three plus infections than <unk> seen in the autologous setting and so you are absolutely right. We expect to demonstrate a 670 superior to FC alone and also that the tolerability of FCA.

The FCA.

It is on par with what's seen with autologous car Ts.

Yes.

Rafael Amato: We expect to demonstrate that 647 is superior to SC alone, and also that the tolerability of FCA is on par with what's seen with autologous CAR T. Thank you. Our next question comes from Michael Schmidt with Guggenheim Securities. Your line is open. Hey, this is Kelsey on for Mike.

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

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

Michael Schmidt: I guess just to confirm one thing, will there be any update on the Phase 1 data sets from the CD19 program? And then secondly, on BCMA, I guess, will you wait to see the Allo 605 data before making a go-forward decision for the franchise, or would you consider advancing both 715 and, Hi, Kelsey. I'm going to ask Eric to respond to both of your questions. Eric?

I guess just to confirm one thing will there be any update on the phase one data sets from the 2019 program.

And then secondly on D. C N. A I guess will you wait to see the allo 605 data before making a go forward decision for the franchise or would you consider advancing both 715 and six okay. Thank you.

Hi, Kelsey going.

And I'll ask Eric to respond to both of your questions. Eric. Thanks, Kelsey in terms of the CD 19 updates. Yes, you can expect that we will present longer term follow up data set at some future medical meeting as we continue.

Eric Schmidt: Thanks, Kelsey. In terms of the CD19 updates, yes, you can expect that we'll present a longer-term follow-up data set, you know, at some future medical meeting as we continue to observe and monitor patients that have been previously dosed in that study. We don't exactly, you know, know the form for that yet, but just as a reminder, we've been really pleased with the durability in particular that we have been able to show as of the ASH data cutoff, gratifying to see 10 out of the 14 patients who achieved a complete response still in a complete response.

To observe and monitor patients that had been previously dose in that study, we don't exactly know the.

The form for that yet, but just as a reminder, we've been really pleased with the durability in particular that we have been able to show as of the ash data cutoff gratifying to see 10 out of 14 patients who achieved a complete response still in a complete response. So we're keen to see just how much longer those responses could last and then on your second.

Eric Schmidt: So we're keen to see just how much longer those responses can last. And on your second question, the evaluation of our BCMA program, it's nice to be back in control of this program, back in the clinic with the ability to execute across our multi-pronged strategy. And yes, we think 2022 is going to be a critical year for generating data sets across many of our strategies.

Question on the evaluation of RBC MMA program, it's nice to be back in control of this program back in the clinic with the ability to execute across our multi pronged strategy.

Yes, we think 2022 is going to be a critical year for generating data sets across many of our strategies and hopefully by the end of the year as Raphael has already mentioned, we will have enough data to begin to make a decision on next program steps.

Eric Schmidt: And hopefully by the end of the year, as Rafael has already mentioned, we'll have enough data to begin to make a decision on next program steps. All right, thank you. Thank you. Our next question comes from Mark Bredenbaugh with Oppenheimer. Your line is open. Hey, guys. Good afternoon.

Got it thank you.

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

Mark Bredenbaugh: Thanks for taking the question. I know you said you wouldn't tell us much about the pivotal study design, but I'll try anyway. Just given the closeness between the ORR and the CR ratio, Thank you.

Hey, guys. Good afternoon, thanks for taking the question.

I know you said you wouldn't you wouldn't tell us much about the pivotal study design.

But I'll try anyway.

Just just given the closeness between the <unk> and the CR rates you've seen in Alpha two I'm wondering if you're if you are currently viewing CRE as a potential or likely registrational endpoint in that study and if so I'm. Just wondering if you can point to any precedents.

That recent.

Recent approvals in <unk>, bcl or large b cell lymphomas that might might serve as a kind of a model.

To build this trial after thank you.

David Chang: Hey, Marc, let me take on that question. So as Rafael has said, LO501A, that's proceeding as a single pivotal study. And in any single study, two important elements of the efficacy measure is the response rate, objective response rate.

Hey, Mark let me take on that question.

So as <unk> has said allo 501 a.

Preceding as a single pivotal study and in any single arm study two important.

Elements of the efficacy measure is the response rate.

<unk> response rate and then the second one is the durability of the response.

So.

That has been part of the discussion with FDA and we expect that those two primary and co primary endpoint.

Endpoint will be the key.

Majors.

Efficacy and certainly safety is another part which will be also part I expect to be the data review.

Ren Benjamin: And then the second one is the durability of the response. So, you know, that has been part of the discussion with FDA and, you know, we expect that those two primary and co-primary, you know, endpoint will be the key way, you know, measures of efficacy and certainly, you know, safety is another part, you know, which will be also part of, you know, I expect to be the data review. Okay, super helpful. Thanks for taking the question. Our next question comes from Ren Benjamin with JMP Securities. Your line is open. Hey, good afternoon, guys. Thanks for taking the questions. It's two for me.

Okay. That's super helpful. Thanks for taking the question.

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

David Chang: Just going back to the ALO 647. Thank you. The entire application of 5-1-A and... And if it works, just, you know, kind of thinking out of the box here, could this, Could this be used as a general lump for depletion rights? Potentially even with autologous therapies, so almost, you know, so sort of.

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

Just two from me just going back to the Allo 647 study.

Can you talk a little bit about if for some reason.

It's a randomized study in that trial failed how that might impact the entire application.

5151 a M.

647, and and if it works just you know kind of thinking out of the box here could this jan could this be used as a general them for depletion regimen potentially even with autologous therapies, so almost sold sort of separately.

Eric Schmidt: And then just something for, I'm sure this is more for Eric, just the status update on the development partnerships, the ones that interest me in particular are Notch and your recent collaboration with Antioch. I'm kind of curious, you know, when you're striking these relationships, is this something that, you know, well, how do you plan on uncovering the value, or is this just something that you want to, you know, kind of keep abreast on, because it's pretty novel new technology? And any update on Oberlin, the joint venture, if there's a deliverable this year we can keep track of. So, you know, all three great questions.

And then just something for I'm sure. This is more for Eric just a status update on the development partnerships.

One that interests me in particular, our notch in your recent collaborations with pantheon.

I'm kind of curious you know when you're when you're striking these relationships is this something that yeah, well how do you plan on uncovering the value or is this or is this just something that you want to you know kind of kind of keep abreast on because it's pretty novel, New technology and any update on overland the joint venture if theres a deliverable. This year, we can keep track of.

Thanks.

Okay.

Yes.

So, but all three great questions.

David Chang: You know, the question about the 647, you know, this is a drug code development where we have to demonstrate the contribution of 647 to lymphodepletion. This is an area that we have, you know, at this point more than, you know, enough data sets coming from both CD19, 501, 501A program, as well as multiple myeloma program. Certainly, you know, there is a possibility of, you know, study failure, but all the information that we have right now, you know, we feel very comfortable and confident that the study will demonstrate the contribution of 647 in a meaningful way.

How about the $6 seven.

Is dropped co development, where we have to demonstrate the contribution of $6 seven to lymphoid depletion. This is an area that we have at this point more than.

Enough dataset coming from both 2019 at five O. One final one a program as well as our multiple myeloma program.

Certainly you know there is a possibility of study failure, but all the information that we have right now.

I feel very comfortable and confident that the study will demonstrate the contribution of $6 seven in a meaningful way.

David Chang: And the second question, this is something that we frequently discuss internally, which is really how can we best leverage the potential benefit of 647, not just in our own allogeneic setting, but can it extend to other settings, such as autologous. I would not rule that out, but for now, you know, our main focus is optimizing the use of 647.

And the second question. This is something that we frequently have a discussion internally.

Just switch is really how can we best leverage.

Potential benefit of $6 seven not just in our long.

Allogeneic setting, but can extend to other settings such as autologous.

Not rule that out but for now our main focus is optimizing the use of $6 seven and also in some of our studies. We are trying to see whether we can tease out and lowered the chemotherapy baseline for depletion moving more towards the biologic lymphoseek.

Eric Schmidt: And also in some of our studies, we are trying to see whether we can tease out and lower the chemotherapy-based lymphodepletion, you know, moving more towards the biologic lymphodepletion, which we find to have, you know, several benefits. So that will be our, you know, initial attention, but certainly your question of, you know, can this be used in an autologous setting is something that we are also looking into, but you know, that will not be immediate.

<unk>, what should we find to have several benefits so that will be our initial attention, but certainly your question.

Can this be used in the autologous setting is something that we are also looking into but that will not be immediate.

Eric Schmidt: And, you know, third question I'm going to ask, you know, Eric, to respond to. Okay. Thanks, Ren. I guess I get your third question. All three or four or five subparts, however many were in there, relating to our technology partners.

And the third question I'm going to ask Eric to respond to okay. Thanks, Ryan I guess I get your third question, all three or four or five sub parts. However, many we're in there relating to our technology partners. Yes. At this point in time, we formed a number of relationships. So we really feel give us as much access to gene engineering and cell engineering as we could.

Eric Schmidt: Yeah. At this point in time, we've formed a number of relationships that we really feel give us as much access to gene engineering and cell engineering as we could probably want, including some of the relationships you've mentioned with Notch, Antion, and the joint venture, but others that have been undisclosed that provide additional domain expertise and engineering modality relationships. In terms of Notch in particular, where we're looking at the ability to make fully functional T-cells from an IPSC source, that partnership is going really quite well. Notch has made a lot of progress in the almost two years now since we've been working with them, and much of the work is focused on continued engineering and scale-up of their product.

Probably one including some of the relationships you've mentioned with <unk> and the joint venture, but others that have been undisclosed that provide additional domain expertise and engineering modality.

Relationships in terms of notch in particular, where we're looking at the ability to make fully functional T cells from an Ips C source.

That partnership is going really quite well notches made a lot of progress in the almost two years now since we've been working with them and much of the work is focused on continued engineering and scale up of their product.

Eric Schmidt: On the Antion side, a new relationship for us where we're partnering to look at their multiplex knockdown technology to add greater functionality to some of our gene and cell engineering capabilities. Very new relationship, but we view them as leaders in this space and very pleased that we think Allogene will be a focus project for them. Lastly, on the joint venture with Allogene Overland in China, giving us access to an important commercial territory, that entity has begun building out a manufacturing facility in China, which will be required to commercialize our therapies, and they're making quite good progress as well. We'd hope to be able to launch that facility later this year.

The MTR side, a new relationship for us where we're partnering to look at their multiplex knockdown technology to add greater functionality to some of our gene and cell engineering capabilities very new relationship, but we view them as leaders in this space.

Very pleased that we think allergy and it'll be a focused project for them and then lastly on the joint venture with allergy and overland in China, giving us access to an important commercial territory.

That entity has begun building out our manufacturing facility in China, which will be required to commercialize our therapies and they're making quite good progress as well, we would hope to be able to launch that facility. Later this year. Thank you for the question.

Thank you.

Eric Schmidt: Thank you for the question. Thank you. Thank you. Our next question comes from Luca Issi with RBC. Your line is open.

Thank you. Our next question comes from Luca <unk>.

With RBC your line is open.

Luca Issi: Oh, great. Thanks so much for taking my question. Maybe on six or seven, you know, obviously, the FDA is asking you to cite a contribution of six or seven. Is this something that is just limited to nonatrial lymphoma, or should we expect the FDA may ask you for similar trials also for multiple myeloma and solid tumors? And then maybe on business development, we've seen a couple of deals recently where companies have decided to monetize some of their extra manufacturing capability to extend the runway, including Attara, Fujifilm, or Homology Oxford.

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

Maybe on six or seven obviously, the FDA is asking you decided the contribution of six or seven.

Is this something that is just limited to no not skin lymphoma or should we expect that the FDA may ask you for similar trials also for multiple myeloma in solid tumors.

Then maybe on business development, we've seen a couple of deals recently, where companies have decided to monetize some of their extra manufacturing capability to extend the runway, including a thorough Fuji film or homology, Oxford. So wondering what was your reaction to those deals and this is something that you may consider.

Luca Issi: So, wondering what was your reaction to those deals, and this is something that you may consider. And lastly, for CD70, I think I've seen on clinicaltrial.gov that the size of Traverse actually has increased from 48 patients to 120 patients a couple weeks back. So, wondering if you have any color on that. Okay. The first question?

Lastly for CD 70, I think I've seen a clinical trial Gov that the size of traverse actually has increased from 48 patients to 120 patients a couple of weeks back. So I'm wondering if you have any color on that thanks, so much.

Okay. The first question, yes. So the 647, you asking whether for different indications there is a need to do additional studies I mean, we see the Lymphoseek Lisa and is something that is.

Rafael Amato: Yeah. So, you know, the 647, you're asking whether for different indications there's a need to do additional studies. I mean, we see the lymphoid depletion as something that is generalizable and extendable to other indications. I mean, that's our current position. We have not had any specific discussion with the regulatory agencies about how to deal with the contribution of 647 in the position in the prime indication.

Generalizable and extendable to other indications I mean, that's our current position we have not had any specific discussion with the regulatory agencies about how to deal with the contribution of $6 seven and then for depletion into frame vacation. So.

Rafael Amato: So, you know, stay tuned. Thank you very much. On our manufacturing plans, Luca, no, is the short answer there. As you heard from Allison Moore, we view ownership of the CF1 facility, our Self-Forged One facility, is absolutely critical to our ability to function and commercialize across a slew of product opportunities. So given our strong cash position, $800 million plus, we don't see any need or interest in monetizing that in any way, shape, or form, just the opposite.

Stay tuned.

On our manufacturing plans Luca.

No.

The short answer there is you heard from Alison Moore, we view ownership of the CF one facility or so 41 facility is absolutely critical to our ability to function and commercialize <unk>.

Ross a slew of product opportunities so.

Given our strong cash position of $800 million, plus we don't see any need or interest in monetizing that in any way shape or form just the opposite we're going to continue to invest and then on the traverse clinical trials Dot Gov listing I wouldn't read much into that honestly the clinical team often includes.

Eric Schmidt: We're going to continue to invest. And then on the Traverse ClinicalTrials.gov listing, I wouldn't read much into that, honestly, the clinical team often includes, A number of different parameter changes to our studies, and those changes are designed to provide the utmost in flexibility going forward, but certainly we don't have plans at this stage to enroll the full cohort of patients that you referenced. Thank you. As a reminder, in the interest of time, please limit yourself to one question. Our next question comes from Asika. Goonewardene, with truest, your line is open. Goonewardene, with truest, your line is open.

A number of different parameter changes to our studies and those changes are designed to provide the utmost flexibility going forward, but certainly we don't have plans at this stage to enroll the full cohort of patients that you referenced.

Thank you as a reminder, in the interest of time, please limit yourself to one question. Our next question comes from Ashika.

Martin, which Lewis your line is open.

Asthika Goonewardene: Hi, guys. Thanks for taking the questions. I'll pick on Alson since she's on the call today if I may. Alson, you're a lot back. It's down.

Hi, guys. Thanks for taking the questions.

I'll pick on Alison since he's on the call today, if I may.

Allison a while back.

Allison Moore: We talked about the goal of the allogeneic cell therapies is to get maybe around a thousand or more batches out of a single donor draw, but you had some ways to go in reaching them. And a little while back, I think I remember you telling us… You were getting around maybe 100 batches per draw. Where are you on that today? And then also religion, more generally.

Just how should we be talking about the goal of.

It makes no therapies, maybe around 1000 or more batches out of a single donor draw, but you had some ways to go in reaching that.

And a little while back I think I remember you.

Telling us that.

You were getting around maybe 100 patches draw where are you on that today and then also relates more generally as you are are you able to get the incremental innovations to manufacturing incorporated into the production of cell therapies that are already in the clinic or does that essentially require a lot of new work and maybe even a new R&D.

Allison Moore: As you are, are you able to get these incremental innovations to manufacture? Thank you. Thank you. Yes, great questions. So, our goal at Allogene has been to, from… single leukophoresis enable approximately 100 doses. That has been our goal. That's still what we are working on. I can say that we know that we can do that, and already we have been very successful in optimizing yield. And I think that our focus right now is to ensure supply across all of these programs, but certainly as a process developer, I can see that there is extensive potential for us to continue to offer. Talk to my deal.

Thanks.

Thank you.

Yeah, Great question so.

Our goal.

It has been two from them.

Single Leukapheresis it enable approximately 100 does.

That has been our goal but still.

What we are working toward Ah I can say that I can say that we we know that we can do that.

And already we have been very successful and optimizing yield.

And I think that our focus right now is to ensure supply across all of these programs, but certainly as a process developer.

You can see that there is extensive potential for us to continue to optimize yield.

Allison Moore: So I would answer you by saying that we have more than, an adequate performance there in terms of doses. But there's definitely the opposite, for further improvement there in the future. Then.

So I would answer you by saying that we have more than and adequate.

Our performance there in terms of doses.

But there's definitely the opportunity for further improvement there in the future.

Allison Moore: Regarding your question with respect to the introduction of novel technology, Thank you. Certainly, this is a question across all biologics. And it really relates to the magnitude of the technology change, and how well you understand your, and your professor. And we certainly have been able.

Then.

Regarding your question with respect to the introduction of novel technologies.

This is certainly not just a class that is the question across all biologic product.

And it really relates to the magnitude of the technology change and how well you understand your product and your process.

And we certainly have been ample gene.

Allison Moore: Thank you very much. Thanks for the call. I appreciate it.

Introduce some novel technologies that we're very excited about them, but we will always do that in collaboration with the agency and with the very best analytical measures and that's why focusing on product quality and the measurement of product quality is always in our best interest.

Great. Thanks for the color I appreciate that.

John Newman: Thank you. Our next question comes from John Newman with Canaccord. Your line is open. Hey guys, thank you for all the information I'm going to call and thank you for taking my question. So my question is... I'm just wondering if you're confident that you can get.

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

Hey, guys. Thank you for all the information on the call and thank you for taking my question. So my question is just wondering if youre confident that you can get.

Rafael Amato: The patient population in the pivotal study that is represented, Patients that are current. Saving the Autologous Therapies, and the reason I'm asking is I feel like you're, Some of the most recent updates. You've had some patients that have already had treatment with CD-19 therapies and failed... I feel like to get a true, accurate picture of the.

The patient population in the pivotal study that is representative.

Of patients that are currently.

Saving autologous therapies and the reason I'm asking is I feel like you're.

Some of the most recent updates.

You've had some patients that have already had treatment with CD 19 therapies and sale of them.

I feel like to get a true accurate picture of the true.

Rafael Amato: True Potential, this product, the L501 product. The agency might be curious as to what it looks like. And this is a great example of a single-strand population similar to the autologous therapy. So without getting into too much detail about the design, just curious if you're confident that you'll be able to do that.

Potential of this product.

Oh, five or one product.

The agency might be curious as to what it looks like in a population similar to the autologous therapies, so without getting into too much detail about the design just curious if you're confident that you'll be able to do that.

Thanks.

Rafael Amato: Thanks, John, for the question. It's a great question. I can tell you that in a Phase I study, you know, we go through a variety of clinical situations with regards to the kinds of patients that we enroll. So, you know, one of the questions, obviously, is what happens to patients that have received C19-directed therapy as an example, which you mentioned. We, that doesn't mean that the population that we put in the Phase I study, where we're looking at doses and we're looking at populations, et cetera, is going to be the one that is actually in the PIVTalk study.

Thanks, John for the question, it's a great question.

I can tell you that.

In a phase one study.

Go through a variety of clinical situations with regards to the kinds of patients that we enroll so one of the questions. Obviously is what happens to patients who had received $2 19 directed therapy as an example, which you mentioned.

We that doesn't mean that the population that we put into phase one study, where we're looking at doses and we're looking at populations et cetera is going to be the one that is actually in the pivotal study.

Rafael Amato: So, those discussions, as I said, you know, will take place and have been taking place with FDA, but we fully expect, and our investigators are backing us up with regards to this, that they will be representative of the patients that are entering to autologous therapies with the caveat that obviously they will enter sooner and obviously they won't need apheresis and will be able to get the therapy, the majority of the patients. So, we have actually no doubt that, you know, this is achievable.

So those discussions as I said.

Will take place and have been taking place with the SBA.

But we fully expect and our investigators are backing us up with regards to this.

There will be representative of the patients that are entering to autologous therapies with the caveat that obviously that will enter sooner and.

Obviously, the 184 leases on and we'll be able to get the therapy. The majority of the patients.

So we.

We have virtually no doubt.

Achievable.

Raji Prasad: Thank you. Our next question comes from Raji Prasad with William Blair. Your line is open. Thanks for the question. Just wanted to get a sense of, Thank you. Great question.

Thank you. Our next question comes from Rajiv Prasad with William Blair. Your line is open.

Thanks for take the question.

I just wanted to get a sense of.

The bar on the BCD and EE program in terms of maybe patient numbers and durability.

To kind of go forward dose that youre looking at before taking whichever programs forward just curious to know how much.

Data do you need from the neuro guests that program as well as 605 to really make that decision and how much the.

Potential efficacy improvements of the autologous proved this August therapies. This surplus also prudently 28th.

<unk> plays a role into kind of a decision making process.

Great question, I'm going to ask Eric to respond to that.

Eric Schmidt: I'm going to ask Eric to respond to that. Yeah, thanks for that, Raj. So first, again, I think we're in a fortunate position to be evaluating multiple different strategies, starting off with a strong foundation with what we've already shown on LS715. And specifically there, as Rafael has already commented, that 715 profile essentially being right on par with the approved autologous therapy. So obviously, we're trying to build off that foundation with either the combination approach that you mentioned or consolidation therapy or the LS605 turbo car that we're also very keen on.

Yes, thanks for that Raj.

So first again I think we are unfortunate position to be evaluating multiple different strategies starting off of a strong foundation with what we've already shown on allo 715, and specifically there is Raphael has already commented that 715 profile essentially being right on par with the approved autologous therapies. So obviously, we're trying to build off.

That foundation with either the combination approach that you mentioned or consolidation therapy or the allo 605 Turbo car that we're also very keen on.

Eric Schmidt: In terms of where the bar is going forward, you referenced, I think, the silpicelle-pidufidate, which is upcoming here. We and everyone else are very persuaded by the compelling results that Johnson and Legend have been able to produce with that product. I think it really highlights what's possible with an autologous cell therapy, and the results are unprecedented. But it also is quite clear that even the most efficacious drugs are impotent if they can't be delivered to patients in need.

In terms of where the bar is going forward you referenced I think the <unk> date, which is upcoming here.

We and everyone else are.

Very persuaded by the compelling results that the Johnson and legend have been able to produce without product I think it really highlights what's possible with an autologous cell therapy and the results are unprecedented but it also.

Is quite clear that even the most efficacious drugs.

Gives me our amp attendance they can't be delivered to patients in need and as you know the current market for autologous therapies is quite capacity constrained and while we would expect supply to increase we don't know by how much with that approval.

Eric Schmidt: And as you know, the current market for autologous therapies is quite capacity-constrained. And while we would expect supply to increase, we don't know by how much with that approval. And even more importantly, the autologous cell therapies are unlikely to ever be applicable to certain patient subset populations.

And even more importantly, the autologous cell therapies are unlikely to ever be applicable to certain patient subset populations, specifically I guess I'm thinking about those patients who can't wait wait the weeks to months.

Eric Schmidt: Specifically, I guess I'm thinking about those patients who can't wait the weeks to months to be scheduled for collection and manufacturing, and also those patients who can't tolerate the bridging chemotherapy, which is being given to the majority of patients in the autologous studies. So for those reasons, we really think we have a pretty clean opportunity with our off-the-shelf product. And we're very focused on making the most of that opportunity as we collect the data and move forward.

To be scheduled for collection in manufacturing and also those patients who can't tolerate that bridging chemotherapy, which is being given to the majority of patients in the <unk> study. So for those reasons, we really think we have a pretty clean opportunity with our off the shelf product.

We're very focused on making the most of that opportunity as we collect the data and move forward.

Yes.

Eric Schmidt: Thank you. Our next question comes from Jay St. Gerberi with Bank of America. Your line is open. Hi, this is Perry on the line for Jason. Thanks for taking our question. Two parts. One is regarding manufacturing.

Thank you. Our next question comes from Jason Goldberg with Bank of America. Your line is open.

Hi, This is Kerry on the line for Jason Thanks for taking our question.

Jay St. Gerberi: The other is kind of on the broader BCMA development. So for in-house manufacturing, I guess, are you expecting, And I'm wondering if there is potential to start a pivotal trial in the third line setting given the way that the space is evolving towards earlier lines. Allison, do you want to take the manufacturing question? I'll take the manufacturing question very quickly. Our facility is designed and built to be focused on CAR-T at this time, although the build is modular and we could do other things in addition.

Two parts one is regarding manufacturing the other is kind of on the broader BC may develop.

Development.

So for in House manufacturing I guess are you expecting.

Your in.

In house capabilities to fully support both the physical pivotal as well as the commercial.

Demand for fiber one.

And then also does does your does in house manufacturing address vector supply or is that something that's.

Uh huh.

<unk> partnered with a third party manufacturer and then regarding <unk> development.

There as you.

Thinking about the broader spaces. Some of your Tor Targus market leaders are moving into the third by one setting potentially.

Essentially having data by the time that you start a pivotal and one in one of your approaches.

And I'm wondering is there potential to start a pivotal trial in third line line setting.

Given the way that the space is evolving towards earlier lines. Thanks.

Yeah.

Alison do you want to take the manufacturing question.

I'll take the manufacturing question very quickly our facility is designed and built to be focused on car T. At this time, although the build is modular and we could do other things. In addition, and the answer is yes. It will have the capacity.

Jay St. Gerberi: And the answer is yes, it will have the capacity to supply commercial product for 501A. Regarding other raw materials, including critical raw materials, we have a broad network of third-party suppliers that we work with on a daily basis.

To supply commercial product for five O. One I am regarding other raw materials, including critical raw materials, we have the broad network of third party suppliers that we work with on a daily basis.

Allison Moore: I think the point that you make about BCMA is a good one, you know, these therapies will make their way into earlier lines of therapy, as you know, they start in later lines of therapy first, but just like we plan to do in lymphoma, once we make the decision, then we will be developing a comprehensive program for BCMA. Thank you. In the interest of time, we can take one more question, and that is from Dane Leon with Raymond James. Your line is open.

Yeah.

I think the point that you make about the CMA and it's a good one.

These therapies will make their way into earlier lines of therapy.

As you know they start.

Later lines of therapy first.

Just like we plan to do in lymphoma.

If we once we make the decision then we will be developing a comprehensive program.

<unk>.

Thank you.

And the answers this time, but we can take one more question and that is from Dane Leone with Raymond James Your line is open.

Hi, Thanks for taking the questions.

<unk> kind of interrelated questions.

Do you in this.

Something we get asked almost every meeting with investors do you have an updated view.

Dane Leon: Thank you. On the impact of prior CD19 therapy, like tafecetamab, within the lymphoma program, that was an outstanding question that continues to be discussed since the presentation, the update of the ALFA program during ASH. And within that day.., of developing in multiple myeloma, does your team have a view of why or why not prior CD-BCMA-targeted therapy would have a similar potential detrimental effect in responses to an allogeneic cell therapy product, like has been discussed in lymphoma with CD19.

The impact of a prior CD 19 therapy.

<unk> type of set them up.

Within the lymphoma program that was an outstanding question that continues to be discussed since the presentation of the update of the Alpha program during ash.

And within that vein.

Of developing in multiple myeloma does your team out there view of why or why not prior a C. D. C D Bcm, hey targeted therapy.

Would have a similar potential detrimental effect in responses to an allogeneic cell therapy product.

Like has been discussed in lymphoma with CD 19.

Yeah.

Dane Leon: Thank you. With regards to C19 prior therapy, I mean, the data in autologous is actually, you know, very telling as well. Many patients do not respond, particularly if they were primary refractory or they relapse relatively quickly, and this is something that we are seeing as well in the allogeneic setting. So we are not keen on enrolling these patients, you know, going forward. With regards to BCMA, we actually don't have much experience with BCMA-experienced patients, so we can't really answer the question that, you know, whether there are parallels with C19 in BCMA. I think that's a question to be answered, but, you know, currently we plan to study BCMA-90 patients.

Yeah with regards to C 19 prior therapy, Yeah, I mean, the data I know to all of US it's actually.

Very telling as well.

Many patients do not respond, particularly if they were primary refractory or they relapse relatively quickly and this is something that we are seen as one of the in the allogeneic setting. So we are not keen on enrolling these patients going.

Going forward with regards to CMA, we actually don't have much experience with <unk> experienced patients. So we can't really answer the question whether there are parallels between 19 NBC I'm asking the question to be answered, but currently we plan to study we assume the CMA 90 patients.

Thank you.

David Chang: Thank you. That concludes the question and answer session. I would like to turn the conference back over to management for any additional comments. Thank you again for joining the call today. Based on our strong execution since inception, coupled with healthy cash position and our focused approach on drug development, I believe we remain positioned to transform and lead the field of allogeneic CAR-T. We look forward to sharing our continued progress with you throughout the year.

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

Thank you again for joining the call today.

Based on our strong execution since inception, coupled with healthy cash position and our focused approach in drug development.

I believe we remain positioned to transform and lead the field of allogeneic car T.

We look forward to sharing our continued progress with you throughout the year operator, you may now disconnect.

Operator: Operator, you may now disconnect. Thank you, ladies and gentlemen. Thank you for your participation in today's conference. This concludes the program. You may now log off and disconnect. [music] © BF-WATCH TV 2021 © BF-WATCH TV 2021

Thank you ladies and gentlemen, thank you for participating participation in today's conference. This concludes the program.

You may now log off and disconnect.

Okay.

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Yeah.

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Yes.

Okay.

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All right.

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